Towards a systems approach to risk considerations for concurrent design

NASA Technical Reports Server (NTRS)

Meshkat, Leila; Oberto, Robert E.

2004-01-01

This paper describes the new process used by the Project Design Center at NASA's Jet Propulsion Laboratory for the identification, assessment and communication of risk elements throughout the lifecycle of a mission design. This process includes a software tool, 'RAP' that collects and communicates risk information between the various designers and a 'risk expert' who mediates this process. The establishment of this process is an attempt towards the systematic consideration of risk in the design decision making process. Using this process, we are able to better keep track of the risks associated with the design decisions. Furthermore, it helps us develop better risk profiles for the studies under consideration. We aim to refine and expand the current process to enable more thorough risk analysis capabilities in the future.

Work-related musculoskeletal disorders (WMDs) risk assessment at core assembly production of electronic components manufacturing company

NASA Astrophysics Data System (ADS)

Yahya, N. M.; Zahid, M. N. O.

2018-03-01

This study conducted to assess the work-related musculoskeletal disorders (WMDs) among the workers at core assembly production in an electronic components manufacturing company located in Pekan, Pahang, Malaysia. The study is to identify the WMDs risk factor and risk level. A set of questionnaires survey based on modified Nordic Musculoskeletal Disorder Questionnaires have been distributed to respective workers to acquire the WMDs risk factor identification. Then, postural analysis was conducted in order to measure the respective WMDs risk level. The analysis were based on two ergonomics assessment tools; Rapid Upper Limb Assessment (RULA) and Rapid Entire Body Assessment (REBA). The study found that 30 respondents out of 36 respondents suffered from WMDs especially at shoulder, wrists and lower back. The WMDs risk have been identified from unloading process, pressing process and winding process. In term of the WMDs risk level, REBA and RULA assessment tools have indicated high risk level to unloading and pressing process. Thus, this study had established the WMDs risk factor and risk level of core assembly production in an electronic components manufacturing company at Malaysia environment.

Comparative risk assessments for the production and interim storage of glass and ceramic waste forms: Defense waste processing facility

NASA Astrophysics Data System (ADS)

Huang, J. C.; Wright, W. V.

1982-04-01

The Defense Waste Processing Facility (DWPF) for immobilizing nuclear high level waste (HLW) is scheduled to be built. High level waste is produced when reactor components are subjected to chemical separation operations. Two candidates for immobilizing this HLW are borosilicate glass and crystalline ceramic, either being contained in weld sealed stainless steel canisters. A number of technical analyses are being conducted to support a selection between these two waste forms. The risks associated with the manufacture and interim storage of these two forms in the DWPF are compared. Process information used in the risk analysis was taken primarily from a DWPF processibility analysis. The DWPF environmental analysis provided much of the necessary environmental information.

Red and processed meat consumption and risk of glioma in adults: A systematic review and meta-analysis of observational studies

PubMed Central

Saneei, Parvane; Willett, Walter; Esmaillzadeh, Ahmad

2015-01-01

Background: These findings from several observational studies, investigated the association between red meat consumption and gliomas, were inconsistent. We conducted a systematic review and meta-analysis of observational studies to summarize available date on the relation between meat intake and risk of glioma. Materials and Methods: A systematic literature search of relevant reports published until May 2014 of the PubMed/Medline, ISI Web of Knowledge, Excerpta Medica database, Ovid database, Google Scholar, and Scopus databases was conducted. From 723 articles yielded in the preliminary literature search, data from eighteen publications (14 case-control, three cohort, and one nested case-control study) on unprocessed red meat, processed meat, and/or total red meat consumption in relation to glioma in adults were included in the analysis. Quality assessment of studies was performed. Random effects model was used to conduct the meta-analysis. Results: We found a positive significant association between unprocessed red meat intake and risk of glioma (relative risk [RR] = 1.30; 95% confidence interval [CI]: 1.08-1.58) after excluding three studies with uncertain type of brain cancer. This analysis included only one cohort study which revealed no relation between unprocessed red meat intake and glioma (RR = 1.75; 95% CI: 0.35-8.77). Consumption of processed meats was not related to increased risk of glioma in population-based case-control studies (RR = 1.26; 95% CI: 1.05-1.51) and reduced risk in hospital-based case-controls (RR = 0.79; 95% CI: 0.65-0.97). No significant association was seen between processed red meat intake and risk of glioma in cohort studies (RR: 1.08; 95% CI: 0.84-1.37). Total red meat consumption was not associated with risk of adult glioma in case-control or cohort studies. Conclusion: In this meta-analysis of 18 observational studies, we found a modest positive association between unprocessed red meat intake and risk of gliomas based almost entirely on case-control studies. Processed red meat was overall not associated with risk of gliomas in case-control or cohort studies. PMID:26600837

Multi-hazard risk analysis for management strategies

NASA Astrophysics Data System (ADS)

Kappes, M.; Keiler, M.; Bell, R.; Glade, T.

2009-04-01

Risk management is very often operating in a reactive way, responding to an event, instead of proactive starting with risk analysis and building up the whole process of risk evaluation, prevention, event management and regeneration. Since damage and losses from natural hazards raise continuously more and more studies, concepts (e.g. Switzerland or South Tyrol-Bolozano) and software packages (e.g. ARMAGEDOM, HAZUS or RiskScape) are developed to guide, standardize and facilitate the risk analysis. But these approaches focus on different aspects and are mostly closely adapted to the situation (legislation, organization of the administration, specific processes etc.) of the specific country or region. We propose in this study the development of a flexible methodology for multi-hazard risk analysis, identifying the stakeholders and their needs, processes and their characteristics, modeling approaches as well as incoherencies occurring by combining all these different aspects. Based on this concept a flexible software package will be established consisting of ArcGIS as central base and being complemented by various modules for hazard modeling, vulnerability assessment and risk calculation. Not all modules will be developed newly but taken from the current state-of-the-art and connected or integrated into ArcGIS. For this purpose two study sites, Valtellina in Italy and Bacelonnette in France, were chosen and the hazards types debris flows, rockfalls, landslides, avalanches and floods are planned to be included in the tool for a regional multi-hazard risk analysis. Since the central idea of this tool is its flexibility this will only be a first step, in the future further processes and scales can be included and the instrument thus adapted to any study site.

Streamlining project delivery through risk analysis.

DOT National Transportation Integrated Search

2015-08-01

Project delivery is a significant area of concern and is subject to several risks throughout Plan Development : Process (PDP). These risks are attributed to major areas of project development, such as environmental : analysis, right-of-way (ROW) acqu...

Climate change, land slide risks and sustainable development, risk analysis and decision support process tool

NASA Astrophysics Data System (ADS)

Andersson-sköld, Y. B.; Tremblay, M.

2011-12-01

Climate change is in most parts of Sweden expected to result in increased precipitation and increased sea water levels causing flooding, erosion, slope instability and related secondary consequences. Landslide risks are expected to increase with climate change in large parts of Sweden due to increased annual precipitation, more intense precipitation and increased flows combined with dryer summers. In response to the potential climate related risks, and on the commission of the Ministry of Environment, the Swedish Geotechnical Institute (SGI) is at present performing a risk analysis project for the most prominent landslide risk area in Sweden: the Göta river valley. As part of this, a methodology for land slide ex-ante consequence analysis today, and in a future climate, has been developed and applied in the Göta river valley. Human life, settlements, industry, contaminated sites, infrastructure of national importance are invented and assessed important elements at risk. The goal of the consequence analysis is to produce a map of geographically distributed expected losses, which can be combined with a corresponding map displaying landslide probability to describe the risk (the combination of probability and consequence of a (negative) event). The risk analysis is GIS-aided in presenting and visualise the risk and using existing databases for quantification of the consequences represented by ex-ante estimated monetary losses. The results will be used on national, regional and as an indication of the risk on local level, to assess the need of measures to mitigate the risk. The costs and environmental and social impacts to mitigate the risk are expected to be very high but the costs and impacts of a severe landslide are expected to be even higher. Therefore, civil servants have pronounced a need of tools to assess both the vulnerability and a more holistic picture of impacts of climate change adaptation measures. At SGI a tool for the inclusion of sustainability aspects in the decision making process on adaptation measures has been developed and is currently being tested in municipalities including central Gothenburg, and smaller municipalities in Sweden and Norway. The tool is a matrix based decision support tool (MDST) aiming for encoring discussion among experts and stakeholders. The first steps in the decision process include identification, inventory and assessment of the potential impacts of climate change such as landslides (or other events or actions). These steps are also included in general technical/physical risk and vulnerability analyses such as the risk analysis of the Göta älv valley. The MDST also includes further subsequent steps of the risk management process, and the full sequence of the MDST includes risk identification, risk specification, risk assessment, identification of measures, impact analysis of measures including an assessment of environmental, social and economical costs and benefits, a weight process and visualisation of the result. Here the MDST with some examples from the methodology for the Göta river valley analysis and the risk mitigation analysis from Sweden and Norway will be presented.

The development of a 3D risk analysis method.

PubMed

I, Yet-Pole; Cheng, Te-Lung

2008-05-01

Much attention has been paid to the quantitative risk analysis (QRA) research in recent years due to more and more severe disasters that have happened in the process industries. Owing to its calculation complexity, very few software, such as SAFETI, can really make the risk presentation meet the practice requirements. However, the traditional risk presentation method, like the individual risk contour in SAFETI, is mainly based on the consequence analysis results of dispersion modeling, which usually assumes that the vapor cloud disperses over a constant ground roughness on a flat terrain with no obstructions and concentration fluctuations, which is quite different from the real situations of a chemical process plant. All these models usually over-predict the hazardous regions in order to maintain their conservativeness, which also increases the uncertainty of the simulation results. On the other hand, a more rigorous model such as the computational fluid dynamics (CFD) model can resolve the previous limitations; however, it cannot resolve the complexity of risk calculations. In this research, a conceptual three-dimensional (3D) risk calculation method was proposed via the combination of results of a series of CFD simulations with some post-processing procedures to obtain the 3D individual risk iso-surfaces. It is believed that such technique will not only be limited to risk analysis at ground level, but also be extended into aerial, submarine, or space risk analyses in the near future.

Application of ISO22000, failure mode, and effect analysis (FMEA) cause and effect diagrams and pareto in conjunction with HACCP and risk assessment for processing of pastry products.

PubMed

Varzakas, Theodoros H

2011-09-01

The Failure Mode and Effect Analysis (FMEA) model has been applied for the risk assessment of pastry processing. A tentative approach of FMEA application to the pastry industry was attempted in conjunction with ISO22000. Preliminary Hazard Analysis was used to analyze and predict the occurring failure modes in a food chain system (pastry processing plant), based on the functions, characteristics, and/or interactions of the ingredients or the processes, upon which the system depends. Critical Control points have been identified and implemented in the cause and effect diagram (also known as Ishikawa, tree diagram, and fishbone diagram). In this work a comparison of ISO22000 analysis with HACCP is carried out over pastry processing and packaging. However, the main emphasis was put on the quantification of risk assessment by determining the Risk Priority Number (RPN) per identified processing hazard. Storage of raw materials and storage of final products at -18°C followed by freezing were the processes identified as the ones with the highest RPN (225, 225, and 144 respectively) and corrective actions were undertaken. Following the application of corrective actions, a second calculation of RPN values was carried out leading to considerably lower values (below the upper acceptable limit of 130). It is noteworthy that the application of Ishikawa (Cause and Effect or Tree diagram) led to converging results thus corroborating the validity of conclusions derived from risk assessment and FMEA. Therefore, the incorporation of FMEA analysis within the ISO22000 system of a pastry processing industry is considered imperative.

Stingray Failure Mode, Effects and Criticality Analysis: WEC Risk Registers

DOE Data Explorer

Ken Rhinefrank

2016-07-25

Analysis method to systematically identify all potential failure modes and their effects on the Stingray WEC system. This analysis is incorporated early in the development cycle such that the mitigation of the identified failure modes can be achieved cost effectively and efficiently. The FMECA can begin once there is enough detail to functions and failure modes of a given system, and its interfaces with other systems. The FMECA occurs coincidently with the design process and is an iterative process which allows for design changes to overcome deficiencies in the analysis.Risk Registers for major subsystems completed according to the methodology described in "Failure Mode Effects and Criticality Analysis Risk Reduction Program Plan.pdf" document below, in compliance with the DOE Risk Management Framework developed by NREL.

Risk analysis for biological hazards: What we need to know about invasive species

USGS Publications Warehouse

Stohlgren, T.J.; Schnase, J.L.

2006-01-01

Risk analysis for biological invasions is similar to other types of natural and human hazards. For example, risk analysis for chemical spills requires the evaluation of basic information on where a spill occurs; exposure level and toxicity of the chemical agent; knowledge of the physical processes involved in its rate and direction of spread; and potential impacts to the environment, economy, and human health relative to containment costs. Unlike typical chemical spills, biological invasions can have long lag times from introduction and establishment to successful invasion, they reproduce, and they can spread rapidly by physical and biological processes. We use a risk analysis framework to suggest a general strategy for risk analysis for invasive species and invaded habitats. It requires: (1) problem formation (scoping the problem, defining assessment endpoints); (2) analysis (information on species traits, matching species traits to suitable habitats, estimating exposure, surveys of current distribution and abundance); (3) risk characterization (understanding of data completeness, estimates of the “potential” distribution and abundance; estimates of the potential rate of spread; and probable risks, impacts, and costs); and (4) risk management (containment potential, costs, and opportunity costs; legal mandates and social considerations and information science and technology needs).

The neural bases underlying social risk perception in purchase decisions.

PubMed

Yokoyama, Ryoichi; Nozawa, Takayuki; Sugiura, Motoaki; Yomogida, Yukihito; Takeuchi, Hikaru; Akimoto, Yoritaka; Shibuya, Satoru; Kawashima, Ryuta

2014-05-01

Social considerations significantly influence daily purchase decisions, and the perception of social risk (i.e., the anticipated disapproval of others) is crucial in dissuading consumers from making purchases. However, the neural basis for consumers' perception of social risk remains undiscovered, and this novel study clarifies the relevant neural processes. A total of 26 volunteers were scanned while they evaluated purchase intention of products (purchase intention task) and their anticipation of others' disapproval for possessing a product (social risk task), using functional magnetic resonance imaging (fMRI). The fMRI data from the purchase intention task was used to identify the brain region associated with perception of social risk during purchase decision making by using subjective social risk ratings for a parametric modulation analysis. Furthermore, we aimed to explore if there was a difference between participants' purchase decisions and their explicit evaluations of social risk, with reference to the neural activity associated with social risk perception. For this, subjective social risk ratings were used for a parametric modulation analysis on fMRI data from the social risk task. Analysis of the purchase intention task revealed a significant positive correlation between ratings of social risk and activity in the anterior insula, an area of the brain that is known as part of the emotion-related network. Analysis of the social risk task revealed a significant positive correlation between ratings of social risk and activity in the temporal parietal junction and the medial prefrontal cortex, which are known as theory-of-mind regions. Our results suggest that the anterior insula processes consumers' social risk implicitly to prompt consumers not to buy socially unacceptable products, whereas ToM-related regions process such risk explicitly in considering the anticipated disapproval of others. These findings may prove helpful in understanding the mental processes involved in purchase decisions. Copyright © 2014 Elsevier Inc. All rights reserved.

Independent Pre-Transplant Recipient Cancer Risk Factors after Kidney Transplantation and the Utility of G-Chart Analysis for Clinical Process Control.

PubMed

Schrem, Harald; Schneider, Valentin; Kurok, Marlene; Goldis, Alon; Dreier, Maren; Kaltenborn, Alexander; Gwinner, Wilfried; Barthold, Marc; Liebeneiner, Jan; Winny, Markus; Klempnauer, Jürgen; Kleine, Moritz

2016-01-01

The aim of this study is to identify independent pre-transplant cancer risk factors after kidney transplantation and to assess the utility of G-chart analysis for clinical process control. This may contribute to the improvement of cancer surveillance processes in individual transplant centers. 1655 patients after kidney transplantation at our institution with a total of 9,425 person-years of follow-up were compared retrospectively to the general German population using site-specific standardized-incidence-ratios (SIRs) of observed malignancies. Risk-adjusted multivariable Cox regression was used to identify independent pre-transplant cancer risk factors. G-chart analysis was applied to determine relevant differences in the frequency of cancer occurrences. Cancer incidence rates were almost three times higher as compared to the matched general population (SIR = 2.75; 95%-CI: 2.33-3.21). Significantly increased SIRs were observed for renal cell carcinoma (SIR = 22.46), post-transplant lymphoproliferative disorder (SIR = 8.36), prostate cancer (SIR = 2.22), bladder cancer (SIR = 3.24), thyroid cancer (SIR = 10.13) and melanoma (SIR = 3.08). Independent pre-transplant risk factors for cancer-free survival were age <52.3 years (p = 0.007, Hazard ratio (HR): 0.82), age >62.6 years (p = 0.001, HR: 1.29), polycystic kidney disease other than autosomal dominant polycystic kidney disease (ADPKD) (p = 0.001, HR: 0.68), high body mass index in kg/m2 (p<0.001, HR: 1.04), ADPKD (p = 0.008, HR: 1.26) and diabetic nephropathy (p = 0.004, HR = 1.51). G-chart analysis identified relevant changes in the detection rates of cancer during aftercare with no significant relation to identified risk factors for cancer-free survival (p<0.05). Risk-adapted cancer surveillance combined with prospective G-chart analysis likely improves cancer surveillance schemes by adapting processes to identified risk factors and by using G-chart alarm signals to trigger Kaizen events and audits for root-cause analysis of relevant detection rate changes. Further, comparative G-chart analysis would enable benchmarking of cancer surveillance processes between centers.

Independent Pre-Transplant Recipient Cancer Risk Factors after Kidney Transplantation and the Utility of G-Chart Analysis for Clinical Process Control

PubMed Central

Kurok, Marlene; Goldis, Alon; Dreier, Maren; Kaltenborn, Alexander; Gwinner, Wilfried; Barthold, Marc; Liebeneiner, Jan; Winny, Markus; Klempnauer, Jürgen; Kleine, Moritz

2016-01-01

Background The aim of this study is to identify independent pre-transplant cancer risk factors after kidney transplantation and to assess the utility of G-chart analysis for clinical process control. This may contribute to the improvement of cancer surveillance processes in individual transplant centers. Patients and Methods 1655 patients after kidney transplantation at our institution with a total of 9,425 person-years of follow-up were compared retrospectively to the general German population using site-specific standardized-incidence-ratios (SIRs) of observed malignancies. Risk-adjusted multivariable Cox regression was used to identify independent pre-transplant cancer risk factors. G-chart analysis was applied to determine relevant differences in the frequency of cancer occurrences. Results Cancer incidence rates were almost three times higher as compared to the matched general population (SIR = 2.75; 95%-CI: 2.33–3.21). Significantly increased SIRs were observed for renal cell carcinoma (SIR = 22.46), post-transplant lymphoproliferative disorder (SIR = 8.36), prostate cancer (SIR = 2.22), bladder cancer (SIR = 3.24), thyroid cancer (SIR = 10.13) and melanoma (SIR = 3.08). Independent pre-transplant risk factors for cancer-free survival were age <52.3 years (p = 0.007, Hazard ratio (HR): 0.82), age >62.6 years (p = 0.001, HR: 1.29), polycystic kidney disease other than autosomal dominant polycystic kidney disease (ADPKD) (p = 0.001, HR: 0.68), high body mass index in kg/m2 (p<0.001, HR: 1.04), ADPKD (p = 0.008, HR: 1.26) and diabetic nephropathy (p = 0.004, HR = 1.51). G-chart analysis identified relevant changes in the detection rates of cancer during aftercare with no significant relation to identified risk factors for cancer-free survival (p<0.05). Conclusions Risk-adapted cancer surveillance combined with prospective G-chart analysis likely improves cancer surveillance schemes by adapting processes to identified risk factors and by using G-chart alarm signals to trigger Kaizen events and audits for root-cause analysis of relevant detection rate changes. Further, comparative G-chart analysis would enable benchmarking of cancer surveillance processes between centers. PMID:27398803

An Analysis of Department of Energy Cost Proposal Process and Effectiveness

DTIC Science & Technology

2011-10-11

processes to mitigate and manage risk , rather than derive upfront assessment and quantification of proposal risk (DoE, 2008a). The proposal...2. GM 2- Enhance the Federal Contract and Project Management Workforce Substantially Complete 3. GM 3 - Improve Project Risk Assessment ...proposal, contract proposal evaluation, risk , cost analysis = = ^Åèìáëáíáçå=oÉëÉ~êÅÜ=mêçÖê~ã= do^ar^qb=p`elli=lc=_rpfkbpp=C=mr_if`=mlif`v - ii

Red and Processed Meat Consumption Increases Risk for Non-Hodgkin Lymphoma

PubMed Central

Yang, Li; Dong, Jianming; Jiang, Shenghua; Shi, Wenyu; Xu, Xiaohong; Huang, Hongming; You, Xuefen; Liu, Hong

2015-01-01

Abstract The association between consumption of red and processed meat and non-Hodgkin lymphoma (NHL) remains unclear. We performed a meta-analysis of the published observational studies to explore this relationship. We searched databases in MEDLINE and EMBASE to identify observational studies which evaluated the association between consumption of red and processed meat and risk of NHL. Quality of included studies was evaluated using Newcastle-Ottawa Quality Assessment Scale (NOS). Random-effects models were used to calculate summary relative risk (SRR) and the corresponding 95% confidence interval (CI). We identified a total of 16 case–control and 4 prospective cohort studies, including 15,189 subjects with NHL. The SRR of NHL comparing the highest and lowest categories were 1.32 (95% CI: 1.12–1.55) for red meat and 1.17 (95% CI: 1.07–1.29) for processed meat intake. Stratified analysis indicated that a statistically significant risk association between consumption of red and processed meat and NHL risk was observed in case–control studies, but not in cohort studies. The SRR was 1.11 (95% CI: 1.04–1.18) for per 100 g/day increment in red meat intake and 1.28 (95% CI: 1.08–1.53) for per 50 g/day increment in processed meat intake. There was evidence of a nonlinear association for intake of processed meat, but not for intake of red meat. Findings from our meta-analysis indicate that consumption of red and processed meat may be related to NHL risk. More prospective epidemiological studies that control for important confounders and focus on the NHL risk related with different levels of meat consumption are required to clarify this association. PMID:26559248

Practical, transparent prospective risk analysis for the clinical laboratory.

PubMed

Janssens, Pim Mw

2014-11-01

Prospective risk analysis (PRA) is an essential element in quality assurance for clinical laboratories. Practical approaches to conducting PRA in laboratories, however, are scarce. On the basis of the classical Failure Mode and Effect Analysis method, an approach to PRA was developed for application to key laboratory processes. First, the separate, major steps of the process under investigation are identified. Scores are then given for the Probability (P) and Consequence (C) of predefined types of failures and the chances of Detecting (D) these failures. Based on the P and C scores (on a 10-point scale), an overall Risk score (R) is calculated. The scores for each process were recorded in a matrix table. Based on predetermined criteria for R and D, it was determined whether a more detailed analysis was required for potential failures and, ultimately, where risk-reducing measures were necessary, if any. As an illustration, this paper presents the results of the application of PRA to our pre-analytical and analytical activities. The highest R scores were obtained in the stat processes, the most common failure type in the collective process steps was 'delayed processing or analysis', the failure type with the highest mean R score was 'inappropriate analysis' and the failure type most frequently rated as suboptimal was 'identification error'. The PRA designed is a useful semi-objective tool to identify process steps with potential failures rated as risky. Its systematic design and convenient output in matrix tables makes it easy to perform, practical and transparent. © The Author(s) 2014 Reprints and permissions: sagepub.co.uk/journalsPermissions.nav.

The role of failure modes and effects analysis in showing the benefits of automation in the blood bank.

PubMed

Han, Tae Hee; Kim, Moon Jung; Kim, Shinyoung; Kim, Hyun Ok; Lee, Mi Ae; Choi, Ji Seon; Hur, Mina; St John, Andrew

2013-05-01

Failure modes and effects analysis (FMEA) is a risk management tool used by the manufacturing industry but now being applied in laboratories. Teams from six South Korean blood banks used this tool to map their manual and automated blood grouping processes and determine the risk priority numbers (RPNs) as a total measure of error risk. The RPNs determined by each of the teams consistently showed that the use of automation dramatically reduced the RPN compared to manual processes. In addition, FMEA showed where the major risks occur in each of the manual processes and where attention should be prioritized to improve the process. Despite no previous experience with FMEA, the teams found the technique relatively easy to use and the subjectivity associated with assigning risk numbers did not affect the validity of the data. FMEA should become a routine technique for improving processes in laboratories. © 2012 American Association of Blood Banks.

Red and processed meat intake and risk of breast cancer: a meta-analysis of prospective studies.

PubMed

Guo, Jingyu; Wei, Wei; Zhan, Lixing

2015-05-01

Epidemiological studies regarding the association between red and processed meat intake and the risk of breast cancer have yielded inconsistent results. Therefore, we conducted an updated and comprehensive meta-analysis which included 14 prospective studies to evaluate the association of red and processed meat intake with breast cancer risk. Relevant prospective cohort studies were identified by searching PubMed through October 31, 2014, and by reviewing the reference lists of retrieved articles. Study-specific relative risk (RR) estimates were pooled using a random-effects model. Fourteen prospective studies on red meat (involving 31,552 cases) and 12 prospective studies on processed meat were included in the meta-analysis. The summary RRs (95 % CI) of breast cancer for the highest versus the lowest categories were 1.10 (1.02, 1.19) for red meat, and 1.08 (1.01, 1.15) for processed meat. The estimated summary RRs (95 % CI) were 1.11 (1.05, 1.16) for an increase of 120 g/day of red meat, and 1.09 (1.03, 1.16) for an increase of 50 g/day of processed meat. Our findings indicate that increased intake of red and processed meat is associated with an increased risk of breast cancer. Further research with well-designed cohort or interventional studies is needed to confirm the association.

TU-AB-BRD-03: Fault Tree Analysis

DOE Office of Scientific and Technical Information (OSTI.GOV)

Dunscombe, P.

2015-06-15

Current quality assurance and quality management guidelines provided by various professional organizations are prescriptive in nature, focusing principally on performance characteristics of planning and delivery devices. However, published analyses of events in radiation therapy show that most events are often caused by flaws in clinical processes rather than by device failures. This suggests the need for the development of a quality management program that is based on integrated approaches to process and equipment quality assurance. Industrial engineers have developed various risk assessment tools that are used to identify and eliminate potential failures from a system or a process before amore » failure impacts a customer. These tools include, but are not limited to, process mapping, failure modes and effects analysis, fault tree analysis. Task Group 100 of the American Association of Physicists in Medicine has developed these tools and used them to formulate an example risk-based quality management program for intensity-modulated radiotherapy. This is a prospective risk assessment approach that analyzes potential error pathways inherent in a clinical process and then ranks them according to relative risk, typically before implementation, followed by the design of a new process or modification of the existing process. Appropriate controls are then put in place to ensure that failures are less likely to occur and, if they do, they will more likely be detected before they propagate through the process, compromising treatment outcome and causing harm to the patient. Such a prospective approach forms the basis of the work of Task Group 100 that has recently been approved by the AAPM. This session will be devoted to a discussion of these tools and practical examples of how these tools can be used in a given radiotherapy clinic to develop a risk based quality management program. Learning Objectives: Learn how to design a process map for a radiotherapy process Learn how to perform failure modes and effects analysis analysis for a given process Learn what fault trees are all about Learn how to design a quality management program based upon the information obtained from process mapping, failure modes and effects analysis and fault tree analysis. Dunscombe: Director, TreatSafely, LLC and Center for the Assessment of Radiological Sciences; Consultant to IAEA and Varian Thomadsen: President, Center for the Assessment of Radiological Sciences Palta: Vice President of the Center for the Assessment of Radiological Sciences.« less

TU-AB-BRD-02: Failure Modes and Effects Analysis

DOE Office of Scientific and Technical Information (OSTI.GOV)

Huq, M.

2015-06-15

Current quality assurance and quality management guidelines provided by various professional organizations are prescriptive in nature, focusing principally on performance characteristics of planning and delivery devices. However, published analyses of events in radiation therapy show that most events are often caused by flaws in clinical processes rather than by device failures. This suggests the need for the development of a quality management program that is based on integrated approaches to process and equipment quality assurance. Industrial engineers have developed various risk assessment tools that are used to identify and eliminate potential failures from a system or a process before amore » failure impacts a customer. These tools include, but are not limited to, process mapping, failure modes and effects analysis, fault tree analysis. Task Group 100 of the American Association of Physicists in Medicine has developed these tools and used them to formulate an example risk-based quality management program for intensity-modulated radiotherapy. This is a prospective risk assessment approach that analyzes potential error pathways inherent in a clinical process and then ranks them according to relative risk, typically before implementation, followed by the design of a new process or modification of the existing process. Appropriate controls are then put in place to ensure that failures are less likely to occur and, if they do, they will more likely be detected before they propagate through the process, compromising treatment outcome and causing harm to the patient. Such a prospective approach forms the basis of the work of Task Group 100 that has recently been approved by the AAPM. This session will be devoted to a discussion of these tools and practical examples of how these tools can be used in a given radiotherapy clinic to develop a risk based quality management program. Learning Objectives: Learn how to design a process map for a radiotherapy process Learn how to perform failure modes and effects analysis analysis for a given process Learn what fault trees are all about Learn how to design a quality management program based upon the information obtained from process mapping, failure modes and effects analysis and fault tree analysis. Dunscombe: Director, TreatSafely, LLC and Center for the Assessment of Radiological Sciences; Consultant to IAEA and Varian Thomadsen: President, Center for the Assessment of Radiological Sciences Palta: Vice President of the Center for the Assessment of Radiological Sciences.« less

The application of hazard analysis and critical control points and risk management in the preparation of anti-cancer drugs.

PubMed

Bonan, Brigitte; Martelli, Nicolas; Berhoune, Malik; Maestroni, Marie-Laure; Havard, Laurent; Prognon, Patrice

2009-02-01

To apply the Hazard analysis and Critical Control Points method to the preparation of anti-cancer drugs. To identify critical control points in our cancer chemotherapy process and to propose control measures and corrective actions to manage these processes. The Hazard Analysis and Critical Control Points application began in January 2004 in our centralized chemotherapy compounding unit. From October 2004 to August 2005, monitoring of the process nonconformities was performed to assess the method. According to the Hazard Analysis and Critical Control Points method, a multidisciplinary team was formed to describe and assess the cancer chemotherapy process. This team listed all of the critical points and calculated their risk indexes according to their frequency of occurrence, their severity and their detectability. The team defined monitoring, control measures and corrective actions for each identified risk. Finally, over a 10-month period, pharmacists reported each non-conformity of the process in a follow-up document. Our team described 11 steps in the cancer chemotherapy process. The team identified 39 critical control points, including 11 of higher importance with a high-risk index. Over 10 months, 16,647 preparations were performed; 1225 nonconformities were reported during this same period. The Hazard Analysis and Critical Control Points method is relevant when it is used to target a specific process such as the preparation of anti-cancer drugs. This method helped us to focus on the production steps, which can have a critical influence on product quality, and led us to improve our process.

Risk Analysis for Unintentional Slide Deployment During Airline Operations.

PubMed

Ayra, Eduardo S; Insua, David Ríos; Castellanos, María Eugenia; Larbi, Lydia

2015-09-01

We present a risk analysis undertaken to mitigate problems in relation to the unintended deployment of slides under normal operations within a commercial airline. This type of incident entails relevant costs for the airline industry. After assessing the likelihood and severity of its consequences, we conclude that such risks need to be managed. We then evaluate the effectiveness of various countermeasures, describing and justifying the chosen ones. We also discuss several issues faced when implementing and communicating the proposed measures, thus fully illustrating the risk analysis process. © 2015 Society for Risk Analysis.

Guidelines for developing NASA (National Aeronautics and Space Administration) ADP security risk management plans

NASA Technical Reports Server (NTRS)

Tompkins, F. G.

1983-01-01

This report presents guidance to NASA Computer security officials for developing ADP security risk management plans. The six components of the risk management process are identified and discussed. Guidance is presented on how to manage security risks that have been identified during a risk analysis performed at a data processing facility or during the security evaluation of an application system.

How Engineers Really Think About Risk: A Study of JPL Engineers

NASA Technical Reports Server (NTRS)

Hihn, Jairus; Chattopadhyay, Deb; Valerdi, Ricardo

2011-01-01

The objectives of this work are: To improve risk assessment practices as used during the mission design process by JPL's concurrent engineering teams. (1) Developing effective ways to identify and assess mission risks (2) Providing a process for more effective dialog between stakeholders about the existence and severity of mission risks (3) Enabling the analysis of interactions of risks across concurrent engineering roles.

The application of quality risk management to the bacterial endotoxins test: use of hazard analysis and critical control points.

PubMed

Annalaura, Carducci; Giulia, Davini; Stefano, Ceccanti

2013-01-01

Risk analysis is widely used in the pharmaceutical industry to manage production processes, validation activities, training, and other activities. Several methods of risk analysis are available (for example, failure mode and effects analysis, fault tree analysis), and one or more should be chosen and adapted to the specific field where they will be applied. Among the methods available, hazard analysis and critical control points (HACCP) is a methodology that has been applied since the 1960s, and whose areas of application have expanded over time from food to the pharmaceutical industry. It can be easily and successfully applied to several processes because its main feature is the identification, assessment, and control of hazards. It can be also integrated with other tools, such as fishbone diagram and flowcharting. The aim of this article is to show how HACCP can be used to manage an analytical process, propose how to conduct the necessary steps, and provide data templates necessary to document and useful to follow current good manufacturing practices. In the quality control process, risk analysis is a useful tool for enhancing the uniformity of technical choices and their documented rationale. Accordingly, it allows for more effective and economical laboratory management, is capable of increasing the reliability of analytical results, and enables auditors and authorities to better understand choices that have been made. The aim of this article is to show how hazard analysis and critical control points can be used to manage bacterial endotoxins testing and other analytical processes in a formal, clear, and detailed manner.

Red and Processed Meat Intake Is Associated with Higher Gastric Cancer Risk: A Meta-Analysis of Epidemiological Observational Studies

PubMed Central

Zhang, Chi; Zhu, Chen; Tao, Guangzhou; Zhao, Lianjun; Tang, Shaowen; Shu, Zheng; Cai, Jing; Dai, Shengbin; Qin, Qin; Xu, Liping; Cheng, Hongyan; Sun, Xinchen

2013-01-01

Background Red and processed meat was concluded as a limited-suggestive risk factor of gastric cancer by the World Cancer Research Fund. However, recent epidemiological studies have yielded inconclusive results. Methods We searched Medline, EMBASE, and the Cochrane Library from their inception to April 2013 for both cohort and case-control studies which assessed the association between red and/or processed meat intake and gastric cancer risk. Study-specific relative risk estimates were polled by random-effect or fixed-effect models. Results Twelve cohort and thirty case-control studies were included in the meta-analysis. Significant associations were found between both red (RR: 1.45, 95% CI: 1.22–1.73) and processed (RR: 1.45, 95% CI: 1.26–1.65) meat intake and gastric cancer risk generally. Positive findings were also existed in the items of beef (RR: 1.28, 95% CI: 1.04–1.57), bacon (RR: 1.37, 95% CI: 1.17–1.61), ham (RR: 1.44, 95% CI: 1.00–2.06), and sausage (RR: 1.33, 95% CI: 1.16–1.52). When conducted by study design, the association was significant in case-control studies (RR: 1.63, 95% CI: 1.33–1.99) but not in cohort studies (RR: 1.02, 95% CI: 0.90–1.17) for red meat. Increased relative risks were seen in high-quality, adenocarcinoma, cardia and European-population studies for red meat. And most subgroup analysis confirmed the significant association between processed meat intake and gastric cancer risk. Conclusions Our findings indicate that consumption of red and/or processed meat contributes to increased gastric cancer risk. However, further investigation is needed to confirm the association, especially for red meat. PMID:23967140

Use of FMEA analysis to reduce risk of errors in prescribing and administering drugs in paediatric wards: a quality improvement report

PubMed Central

Lago, Paola; Bizzarri, Giancarlo; Scalzotto, Francesca; Parpaiola, Antonella; Amigoni, Angela; Putoto, Giovanni; Perilongo, Giorgio

2012-01-01

Objective Administering medication to hospitalised infants and children is a complex process at high risk of error. Failure mode and effect analysis (FMEA) is a proactive tool used to analyse risks, identify failures before they happen and prioritise remedial measures. To examine the hazards associated with the process of drug delivery to children, we performed a proactive risk-assessment analysis. Design and setting Five multidisciplinary teams, representing different divisions of the paediatric department at Padua University Hospital, were trained to analyse the drug-delivery process, to identify possible causes of failures and their potential effects, to calculate a risk priority number (RPN) for each failure and plan changes in practices. Primary outcome To identify higher-priority potential failure modes as defined by RPNs and planning changes in clinical practice to reduce the risk of patients harm and improve safety in the process of medication use in children. Results In all, 37 higher-priority potential failure modes and 71 associated causes and effects were identified. The highest RPNs related (>48) mainly to errors in calculating drug doses and concentrations. Many of these failure modes were found in all the five units, suggesting the presence of common targets for improvement, particularly in enhancing the safety of prescription and preparation of endovenous drugs. The introductions of new activities in the revised process of administering drugs allowed reducing the high-risk failure modes of 60%. Conclusions FMEA is an effective proactive risk-assessment tool useful to aid multidisciplinary groups in understanding a process care and identifying errors that may occur, prioritising remedial interventions and possibly enhancing the safety of drug delivery in children. PMID:23253870

Use of FMEA analysis to reduce risk of errors in prescribing and administering drugs in paediatric wards: a quality improvement report.

PubMed

Lago, Paola; Bizzarri, Giancarlo; Scalzotto, Francesca; Parpaiola, Antonella; Amigoni, Angela; Putoto, Giovanni; Perilongo, Giorgio

2012-01-01

Administering medication to hospitalised infants and children is a complex process at high risk of error. Failure mode and effect analysis (FMEA) is a proactive tool used to analyse risks, identify failures before they happen and prioritise remedial measures. To examine the hazards associated with the process of drug delivery to children, we performed a proactive risk-assessment analysis. Five multidisciplinary teams, representing different divisions of the paediatric department at Padua University Hospital, were trained to analyse the drug-delivery process, to identify possible causes of failures and their potential effects, to calculate a risk priority number (RPN) for each failure and plan changes in practices. To identify higher-priority potential failure modes as defined by RPNs and planning changes in clinical practice to reduce the risk of patients harm and improve safety in the process of medication use in children. In all, 37 higher-priority potential failure modes and 71 associated causes and effects were identified. The highest RPNs related (>48) mainly to errors in calculating drug doses and concentrations. Many of these failure modes were found in all the five units, suggesting the presence of common targets for improvement, particularly in enhancing the safety of prescription and preparation of endovenous drugs. The introductions of new activities in the revised process of administering drugs allowed reducing the high-risk failure modes of 60%. FMEA is an effective proactive risk-assessment tool useful to aid multidisciplinary groups in understanding a process care and identifying errors that may occur, prioritising remedial interventions and possibly enhancing the safety of drug delivery in children.

Relative risk analysis of several manufactured nanomaterials: an insurance industry context.

PubMed

Robichaud, Christine Ogilvie; Tanzil, Dicksen; Weilenmann, Ulrich; Wiesner, Mark R

2005-11-15

A relative risk assessment is presented for the industrial fabrication of several nanomaterials. The production processes for five nanomaterials were selected for this analysis, based on their current or near-term potential for large-scale production and commercialization: single-walled carbon nanotubes, bucky balls (C60), one variety of quantum dots, alumoxane nanoparticles, and nano-titanium dioxide. The assessment focused on the activities surrounding the fabrication of nanomaterials, exclusive of any impacts or risks with the nanomaterials themselves. A representative synthesis method was selected for each nanomaterial based on its potential for scaleup. A list of input materials, output materials, and waste streams for each step of fabrication was developed and entered into a database that included key process characteristics such as temperature and pressure. The physical-chemical properties and quantities of the inventoried materials were used to assess relative risk based on factors such as volatility, carcinogenicity, flammability, toxicity, and persistence. These factors were first used to qualitatively rank risk, then combined using an actuarial protocol developed by the insurance industry for the purpose of calculating insurance premiums for chemical manufacturers. This protocol ranks three categories of risk relative to a 100 point scale (where 100 represents maximum risk): incident risk, normal operations risk, and latent contamination risk. Results from this analysis determined that relative environmental risk from manufacturing each of these five materials was comparatively low in relation to other common industrial manufacturing processes.

Use-related risk analysis for medical devices based on improved FMEA.

PubMed

Liu, Long; Shuai, Ma; Wang, Zhu; Li, Ping

2012-01-01

In order to effectively analyze and control use-related risk of medical devices, quantitative methodologies must be applied. Failure Mode and Effects Analysis (FMEA) is a proactive technique for error detection and risk reduction. In this article, an improved FMEA based on Fuzzy Mathematics and Grey Relational Theory is developed to better carry out user-related risk analysis for medical devices. As an example, the analysis process using this improved FMEA method for a certain medical device (C-arm X-ray machine) is described.

[The role of a specialised risk analysis group in the Veterinary Services of a developing country].

PubMed

Urbina-Amarís, M E

2003-08-01

Since the World Trade Organization (WTO) Agreement on the Application of Sanitary and Phytosanitary Measures was established, risk analysis in trade, and ultimately in Veterinary and Animal Health Services, has become strategically important. Irrespective of their concept (discipline, approach, method, process), all types of risk analysis in trade involve four periods or phases:--risk identification-- risk assessment--risk management--risk information or communication. All veterinarians involved in a risk analysis unit must have in-depth knowledge of statistics and the epidemiology of transmissible diseases, as well as a basic knowledge of veterinary science, economics, mathematics, data processing and social communication, to enable them to work with professionals in these disciplines. Many developing countries do not have enough well-qualified professionnals in these areas to support a risk analysis unit. This will need to be rectified by seeking strategic alliances with other public or private sectors that will provide the required support to run the unit properly. Due to the special nature of its risk analysis functions, its role in supporting decision-making, and the criteria of independence and transparency that are so crucial to its operations, the hierarchical position of the risk analysis unit should be close to the top management of the Veterinary Service. Due to the shortage of personnel in developing countries with the required training and scientific and technical qualifications, countries with organisations responsible for both animal and plant health protection would be advised to set up integrated plant and animal risk analysis units. In addition, these units could take charge of all activities relating to WTO agreements and regional agreements on animal and plant health management.

Train integrity detection risk analysis based on PRISM

NASA Astrophysics Data System (ADS)

Wen, Yuan

2018-04-01

GNSS based Train Integrity Monitoring System (TIMS) is an effective and low-cost detection scheme for train integrity detection. However, as an external auxiliary system of CTCS, GNSS may be influenced by external environments, such as uncertainty of wireless communication channels, which may lead to the failure of communication and positioning. In order to guarantee the reliability and safety of train operation, a risk analysis method of train integrity detection based on PRISM is proposed in this article. First, we analyze the risk factors (in GNSS communication process and the on-board communication process) and model them. Then, we evaluate the performance of the model in PRISM based on the field data. Finally, we discuss how these risk factors influence the train integrity detection process.

TU-AB-BRD-01: Process Mapping

DOE Office of Scientific and Technical Information (OSTI.GOV)

Palta, J.

2015-06-15

Current quality assurance and quality management guidelines provided by various professional organizations are prescriptive in nature, focusing principally on performance characteristics of planning and delivery devices. However, published analyses of events in radiation therapy show that most events are often caused by flaws in clinical processes rather than by device failures. This suggests the need for the development of a quality management program that is based on integrated approaches to process and equipment quality assurance. Industrial engineers have developed various risk assessment tools that are used to identify and eliminate potential failures from a system or a process before amore » failure impacts a customer. These tools include, but are not limited to, process mapping, failure modes and effects analysis, fault tree analysis. Task Group 100 of the American Association of Physicists in Medicine has developed these tools and used them to formulate an example risk-based quality management program for intensity-modulated radiotherapy. This is a prospective risk assessment approach that analyzes potential error pathways inherent in a clinical process and then ranks them according to relative risk, typically before implementation, followed by the design of a new process or modification of the existing process. Appropriate controls are then put in place to ensure that failures are less likely to occur and, if they do, they will more likely be detected before they propagate through the process, compromising treatment outcome and causing harm to the patient. Such a prospective approach forms the basis of the work of Task Group 100 that has recently been approved by the AAPM. This session will be devoted to a discussion of these tools and practical examples of how these tools can be used in a given radiotherapy clinic to develop a risk based quality management program. Learning Objectives: Learn how to design a process map for a radiotherapy process Learn how to perform failure modes and effects analysis analysis for a given process Learn what fault trees are all about Learn how to design a quality management program based upon the information obtained from process mapping, failure modes and effects analysis and fault tree analysis. Dunscombe: Director, TreatSafely, LLC and Center for the Assessment of Radiological Sciences; Consultant to IAEA and Varian Thomadsen: President, Center for the Assessment of Radiological Sciences Palta: Vice President of the Center for the Assessment of Radiological Sciences.« less

Risk Assessment of Groundwater Contamination: A Multilevel Fuzzy Comprehensive Evaluation Approach Based on DRASTIC Model

PubMed Central

Zhang, Yan; Zhong, Ming

2013-01-01

Groundwater contamination is a serious threat to water supply. Risk assessment of groundwater contamination is an effective way to protect the safety of groundwater resource. Groundwater is a complex and fuzzy system with many uncertainties, which is impacted by different geological and hydrological factors. In order to deal with the uncertainty in the risk assessment of groundwater contamination, we propose an approach with analysis hierarchy process and fuzzy comprehensive evaluation integrated together. Firstly, the risk factors of groundwater contamination are identified by the sources-pathway-receptor-consequence method, and a corresponding index system of risk assessment based on DRASTIC model is established. Due to the complexity in the process of transitions between the possible pollution risks and the uncertainties of factors, the method of analysis hierarchy process is applied to determine the weights of each factor, and the fuzzy sets theory is adopted to calculate the membership degrees of each factor. Finally, a case study is presented to illustrate and test this methodology. It is concluded that the proposed approach integrates the advantages of both analysis hierarchy process and fuzzy comprehensive evaluation, which provides a more flexible and reliable way to deal with the linguistic uncertainty and mechanism uncertainty in groundwater contamination without losing important information. PMID:24453883

Red and processed meat consumption and gastric cancer risk: a systematic review and meta-analysis

PubMed Central

Zhao, Zhanwei; Yin, Zifang; Zhao, Qingchuan

2017-01-01

The associations between red and processed meat consumption and gastric cancer risk have remained inconclusive. We performed a systematic review and meta-analysis to analyze these associations. We searched PubMed and EMBASE to identify studies published from inception through October 2016. Subtype analyses of gastric cancer (gastric cardia adenocarcinoma and gastric non-cardiac adenocarcinoma) and dose-response analyses were performed. We finally selected 42 eligible studies. The summary relative risks of highest versus lowest consumption were positive for case-control studies with 1.67 (1.36-2.05) for red meat and 1.76 (1.51-2.05) for processed meat, but negative for cohort studies with 1.14 (0.97-1.34) for red meat and 1.23 (0.98-1.55) for processed meat. Subtype analyses of cohort studies suggested null results for gastric cardia adenocarcinoma (red meat, P = 0.79; processed meat, P = 0.89) and gastric non-cardiac adenocarcinoma (red meat, P = 0.12; processed meat, P = 0.12). In conclusion, the present analysis suggested null results between red and processed meat consumption and gastric cancer risk in cohort studies, although case-control studies yielded positive associations. Further well-designed prospective studies are needed to validate these findings. PMID:28430644

Food groups and risk of type 2 diabetes mellitus: a systematic review and meta-analysis of prospective studies.

PubMed

Schwingshackl, Lukas; Hoffmann, Georg; Lampousi, Anna-Maria; Knüppel, Sven; Iqbal, Khalid; Schwedhelm, Carolina; Bechthold, Angela; Schlesinger, Sabrina; Boeing, Heiner

2017-05-01

The aim of this systematic review and meta-analysis was to synthesize the knowledge about the relation between intake of 12 major food groups and risk of type 2 diabetes (T2D). We conducted a systematic search in PubMed, Embase, Medline (Ovid), Cochrane Central, and Google Scholar for prospective studies investigating the association between whole grains, refined grains, vegetables, fruits, nuts, legumes, eggs, dairy, fish, red meat, processed meat, and sugar-sweetened beverages (SSB) on risk of T2D. Summary relative risks were estimated using a random effects model by contrasting categories, and for linear and non-linear dose-response relationships. Six out of the 12 food-groups showed a significant relation with risk of T2D, three of them a decrease of risk with increasing consumption (whole grains, fruits, and dairy), and three an increase of risk with increasing consumption (red meat, processed meat, and SSB) in the linear dose-response meta-analysis. There was evidence of a non-linear relationship between fruits, vegetables, processed meat, whole grains, and SSB and T2D risk. Optimal consumption of risk-decreasing foods resulted in a 42% reduction, and consumption of risk-increasing foods was associated with a threefold T2D risk, compared to non-consumption. The meta-evidence was graded "low" for legumes and nuts; "moderate" for refined grains, vegetables, fruit, eggs, dairy, and fish; and "high" for processed meat, red meat, whole grains, and SSB. Among the investigated food groups, selecting specific optimal intakes can lead to a considerable change in risk of T2D.

Evaluation of rail test frequencies using risk analysis

DOT National Transportation Integrated Search

2009-03-03

Several industries now use risk analysis to develop : inspection programs to ensure acceptable mechanical integrity : and reliability. These industries include nuclear and electric : power generation, oil refining, gas processing, onshore and : offsh...

TU-AB-BRD-00: Task Group 100

DOE Office of Scientific and Technical Information (OSTI.GOV)

NONE

2015-06-15

Current quality assurance and quality management guidelines provided by various professional organizations are prescriptive in nature, focusing principally on performance characteristics of planning and delivery devices. However, published analyses of events in radiation therapy show that most events are often caused by flaws in clinical processes rather than by device failures. This suggests the need for the development of a quality management program that is based on integrated approaches to process and equipment quality assurance. Industrial engineers have developed various risk assessment tools that are used to identify and eliminate potential failures from a system or a process before amore » failure impacts a customer. These tools include, but are not limited to, process mapping, failure modes and effects analysis, fault tree analysis. Task Group 100 of the American Association of Physicists in Medicine has developed these tools and used them to formulate an example risk-based quality management program for intensity-modulated radiotherapy. This is a prospective risk assessment approach that analyzes potential error pathways inherent in a clinical process and then ranks them according to relative risk, typically before implementation, followed by the design of a new process or modification of the existing process. Appropriate controls are then put in place to ensure that failures are less likely to occur and, if they do, they will more likely be detected before they propagate through the process, compromising treatment outcome and causing harm to the patient. Such a prospective approach forms the basis of the work of Task Group 100 that has recently been approved by the AAPM. This session will be devoted to a discussion of these tools and practical examples of how these tools can be used in a given radiotherapy clinic to develop a risk based quality management program. Learning Objectives: Learn how to design a process map for a radiotherapy process Learn how to perform failure modes and effects analysis analysis for a given process Learn what fault trees are all about Learn how to design a quality management program based upon the information obtained from process mapping, failure modes and effects analysis and fault tree analysis. Dunscombe: Director, TreatSafely, LLC and Center for the Assessment of Radiological Sciences; Consultant to IAEA and Varian Thomadsen: President, Center for the Assessment of Radiological Sciences Palta: Vice President of the Center for the Assessment of Radiological Sciences.« less

TU-AB-BRD-04: Development of Quality Management Program

DOE Office of Scientific and Technical Information (OSTI.GOV)

Thomadsen, B.

2015-06-15

Current quality assurance and quality management guidelines provided by various professional organizations are prescriptive in nature, focusing principally on performance characteristics of planning and delivery devices. However, published analyses of events in radiation therapy show that most events are often caused by flaws in clinical processes rather than by device failures. This suggests the need for the development of a quality management program that is based on integrated approaches to process and equipment quality assurance. Industrial engineers have developed various risk assessment tools that are used to identify and eliminate potential failures from a system or a process before amore » failure impacts a customer. These tools include, but are not limited to, process mapping, failure modes and effects analysis, fault tree analysis. Task Group 100 of the American Association of Physicists in Medicine has developed these tools and used them to formulate an example risk-based quality management program for intensity-modulated radiotherapy. This is a prospective risk assessment approach that analyzes potential error pathways inherent in a clinical process and then ranks them according to relative risk, typically before implementation, followed by the design of a new process or modification of the existing process. Appropriate controls are then put in place to ensure that failures are less likely to occur and, if they do, they will more likely be detected before they propagate through the process, compromising treatment outcome and causing harm to the patient. Such a prospective approach forms the basis of the work of Task Group 100 that has recently been approved by the AAPM. This session will be devoted to a discussion of these tools and practical examples of how these tools can be used in a given radiotherapy clinic to develop a risk based quality management program. Learning Objectives: Learn how to design a process map for a radiotherapy process Learn how to perform failure modes and effects analysis analysis for a given process Learn what fault trees are all about Learn how to design a quality management program based upon the information obtained from process mapping, failure modes and effects analysis and fault tree analysis. Dunscombe: Director, TreatSafely, LLC and Center for the Assessment of Radiological Sciences; Consultant to IAEA and Varian Thomadsen: President, Center for the Assessment of Radiological Sciences Palta: Vice President of the Center for the Assessment of Radiological Sciences.« less

Risk-Informed Decision Making: Application to Technology Development Alternative Selection

NASA Technical Reports Server (NTRS)

Dezfuli, Homayoon; Maggio, Gaspare; Everett, Christopher

2010-01-01

NASA NPR 8000.4A, Agency Risk Management Procedural Requirements, defines risk management in terms of two complementary processes: Risk-informed Decision Making (RIDM) and Continuous Risk Management (CRM). The RIDM process is used to inform decision making by emphasizing proper use of risk analysis to make decisions that impact all mission execution domains (e.g., safety, technical, cost, and schedule) for program/projects and mission support organizations. The RIDM process supports the selection of an alternative prior to program commitment. The CRM process is used to manage risk associated with the implementation of the selected alternative. The two processes work together to foster proactive risk management at NASA. The Office of Safety and Mission Assurance at NASA Headquarters has developed a technical handbook to provide guidance for implementing the RIDM process in the context of NASA risk management and systems engineering. This paper summarizes the key concepts and procedures of the RIDM process as presented in the handbook, and also illustrates how the RIDM process can be applied to the selection of technology investments as NASA's new technology development programs are initiated.

A method for scenario-based risk assessment for robust aerospace systems

NASA Astrophysics Data System (ADS)

Thomas, Victoria Katherine

In years past, aircraft conceptual design centered around creating a feasible aircraft that could be built and could fly the required missions. More recently, aircraft viability entered into conceptual design, allowing that the product's potential to be profitable should also be examined early in the design process. While examining an aerospace system's feasibility and viability early in the design process is extremely important, it is also important to examine system risk. In traditional aerospace systems risk analysis, risk is examined from the perspective of performance, schedule, and cost. Recently, safety and reliability analysis have been brought forward in the design process to also be examined during late conceptual and early preliminary design. While these analyses work as designed, existing risk analysis methods and techniques are not designed to examine an aerospace system's external operating environment and the risks present there. A new method has been developed here to examine, during the early part of concept design, the risk associated with not meeting assumptions about the system's external operating environment. The risks are examined in five categories: employment, culture, government and politics, economics, and technology. The risks are examined over a long time-period, up to the system's entire life cycle. The method consists of eight steps over three focus areas. The first focus area is Problem Setup. During problem setup, the problem is defined and understood to the best of the decision maker's ability. There are four steps in this area, in the following order: Establish the Need, Scenario Development, Identify Solution Alternatives, and Uncertainty and Risk Identification. There is significant iteration between steps two through four. Focus area two is Modeling and Simulation. In this area the solution alternatives and risks are modeled, and a numerical value for risk is calculated. A risk mitigation model is also created. The four steps involved in completing the modeling and simulation are: Alternative Solution Modeling, Uncertainty Quantification, Risk Assessment, and Risk Mitigation. Focus area three consists of Decision Support. In this area a decision support interface is created that allows for game playing between solution alternatives and risk mitigation. A multi-attribute decision making process is also implemented to aid in decision making. A demonstration problem inspired by Airbus' mid 1980s decision to break into the widebody long-range market was developed to illustrate the use of this method. The results showed that the method is able to capture additional types of risk than previous analysis methods, particularly at the early stages of aircraft design. It was also shown that the method can be used to help create a system that is robust to external environmental factors. The addition of an external environment risk analysis in the early stages of conceptual design can add another dimension to the analysis of feasibility and viability. The ability to take risk into account during the early stages of the design process can allow for the elimination of potentially feasible and viable but too-risky alternatives. The addition of a scenario-based analysis instead of a traditional probabilistic analysis enabled uncertainty to be effectively bound and examined over a variety of potential futures instead of only a single future. There is also potential for a product to be groomed for a specific future that one believes is likely to happen, or for a product to be steered during design as the future unfolds.

Risk analysis of hematopoietic stem cell transplant process: failure mode, effect, and criticality analysis and hazard analysis critical control point methods integration based on guidelines to good manufacturing practice for medicinal product ANNEX 20 (February 2008).

PubMed

Gianassi, S; Bisin, S; Bindi, B; Spitaleri, I; Bambi, F

2010-01-01

The collection and handling of hematopoietic stem cells (HSCs) must meet high quality requirements. An integrated Quality Risk Management can help to identify and contain potential risks related to HSC production. Risk analysis techniques allow one to "weigh" identified hazards, considering the seriousness of their effects, frequency, and detectability, seeking to prevent the most harmful hazards. The Hazard Analysis Critical Point, recognized as the most appropriate technique to identify risks associated with physical, chemical, and biological hazards for cellular products, consists of classifying finished product specifications and limits of acceptability, identifying all off-specifications, defining activities that can cause them, and finally establishing both a monitoring system for each Critical Control Point and corrective actions for deviations. The severity of possible effects on patients, as well as the occurrence and detectability of critical parameters, are measured on quantitative scales (Risk Priority Number [RPN]). Risk analysis was performed with this technique on manipulation process of HPC performed at our blood center. The data analysis showed that hazards with higher values of RPN with greater impact on the process are loss of dose and tracking; technical skills of operators and manual transcription of data were the most critical parameters. Problems related to operator skills are handled by defining targeted training programs, while other critical parameters can be mitigated with the use of continuous control systems. The blood center management software was completed by a labeling system with forms designed to be in compliance with standards in force and by starting implementation of a cryopreservation management module. Copyright 2010 Elsevier Inc. All rights reserved.

NASA Hazard Analysis Process

NASA Technical Reports Server (NTRS)

Deckert, George

2010-01-01

This viewgraph presentation reviews The NASA Hazard Analysis process. The contents include: 1) Significant Incidents and Close Calls in Human Spaceflight; 2) Subsystem Safety Engineering Through the Project Life Cycle; 3) The Risk Informed Design Process; 4) Types of NASA Hazard Analysis; 5) Preliminary Hazard Analysis (PHA); 6) Hazard Analysis Process; 7) Identify Hazardous Conditions; 8) Consider All Interfaces; 9) Work a Preliminary Hazard List; 10) NASA Generic Hazards List; and 11) Final Thoughts

Risk analysis by FMEA as an element of analytical validation.

PubMed

van Leeuwen, J F; Nauta, M J; de Kaste, D; Odekerken-Rombouts, Y M C F; Oldenhof, M T; Vredenbregt, M J; Barends, D M

2009-12-05

We subjected a Near-Infrared (NIR) analytical procedure used for screening drugs on authenticity to a Failure Mode and Effects Analysis (FMEA), including technical risks as well as risks related to human failure. An FMEA team broke down the NIR analytical method into process steps and identified possible failure modes for each step. Each failure mode was ranked on estimated frequency of occurrence (O), probability that the failure would remain undetected later in the process (D) and severity (S), each on a scale of 1-10. Human errors turned out to be the most common cause of failure modes. Failure risks were calculated by Risk Priority Numbers (RPNs)=O x D x S. Failure modes with the highest RPN scores were subjected to corrective actions and the FMEA was repeated, showing reductions in RPN scores and resulting in improvement indices up to 5.0. We recommend risk analysis as an addition to the usual analytical validation, as the FMEA enabled us to detect previously unidentified risks.

Risk perception and motivation to quit smoking: a partial test of the Health Action Process Approach.

PubMed

Williams, Rebecca J; Herzog, Thaddeus A; Simmons, Vani N

2011-07-01

The Health Action Process Approach (HAPA) posits a distinction between pre-intentional motivation processes and a post-intentional volition process that leads to the actual behavior change. For smoking cessation, the HAPA predicts that increased risk perceptions would foster a decision to quit smoking. From a cross-sectional perspective, the HAPA predicts that those who do not intend to quit (non-intenders) should have lower risk perceptions than those who do intend to quit (intenders). Adult smokers participated in a cross-sectional survey. Multiple measures of motivation to quit smoking and risk perceptions for smoking were assessed. ANOVA and contrast analysis were employed for data analysis. The results were generally supportive of the HAPA. Non-intenders had systematically lower risk perceptions compared to intenders. Most of these findings were statistically significant. The results demonstrated that risk perceptions distinguish non-intenders from intenders. These results suggest that smokers low in motivation to quit could benefit from information and reminders about the serious health problems caused by smoking. Copyright © 2011 Elsevier Ltd. All rights reserved.

Analysis of Contracting Processes, Internal Controls, and Procurement Fraud Schemes

DTIC Science & Technology

2013-06-01

Government Accountability Office (GAO) has kept DoD Contract Management on its High Risk Series list since 1992 (GAO, 2009). In addition, the GAO also...adopted from the Committee of Sponsoring Organizations of the Treadway Commission ( COSO ) (1992). There are five components: control environment, risk ...2001). 2. Risk Assessment Risk assessment is the identification, analysis, and management of risk faced by an organization. It entails identifying

Guidelines for Automatic Data Processing Physical Security and Risk Management. Federal Information Processing Standards Publication 31.

ERIC Educational Resources Information Center

National Bureau of Standards (DOC), Washington, DC.

These guidelines provide a handbook for use by federal organizations in structuring physical security and risk management programs for their automatic data processing facilities. This publication discusses security analysis, natural disasters, supporting utilities, system reliability, procedural measures and controls, off-site facilities,…

ITS risk analysis.

DOT National Transportation Integrated Search

1996-06-01

Risk analysis plays a key role in the implementation of an architecture. Early definition of the situations, processes, or events that have the potential for impeding the implementation of key elements of the ITS National Architecture is a critical e...

MO-E-9A-01: Risk Based Quality Management: TG100 In Action

DOE Office of Scientific and Technical Information (OSTI.GOV)

Huq, M; Palta, J; Dunscombe, P

2014-06-15

One of the goals of quality management in radiation therapy is to gain high confidence that patients will receive the prescribed treatment correctly. To accomplish these goals professional societies such as the American Association of Physicists in Medicine (AAPM) has published many quality assurance (QA), quality control (QC), and quality management (QM) guidance documents. In general, the recommendations provided in these documents have emphasized on performing device-specific QA at the expense of process flow and protection of the patient against catastrophic errors. Analyses of radiation therapy incidents find that they are most often caused by flaws in the overall therapymore » process, from initial consult through final treatment, than by isolated hardware or computer failures detectable by traditional physics QA. This challenge is shared by many intrinsically hazardous industries. Risk assessment tools and analysis techniques have been developed to define, identify, and eliminate known and/or potential failures, problems, or errors, from a system, process and/or service before they reach the customer. These include, but are not limited to, process mapping, failure modes and effects analysis (FMEA), fault tree analysis (FTA), and establishment of a quality management program that best avoids the faults and risks that have been identified in the overall process. These tools can be easily adapted to radiation therapy practices because of their simplicity and effectiveness to provide efficient ways to enhance the safety and quality of treatment processes. Task group 100 (TG100) of AAPM has developed a risk-based quality management program that uses these tools. This session will be devoted to a discussion of these tools and how these tools can be used in a given radiotherapy clinic to develop a risk based QM program. Learning Objectives: Learn how to design a process map for a radiotherapy process. Learn how to perform a FMEA analysis for a given process. Learn what Fault tree analysis is all about. Learn how to design a quality management program based upon the information obtained from process mapping, FMEA and FTA.« less

[A systemic risk analysis of hospital management processes by medical employees--an effective basis for improving patient safety].

PubMed

Sobottka, Stephan B; Eberlein-Gonska, Maria; Schackert, Gabriele; Töpfer, Armin

2009-01-01

Due to the knowledge gap that exists between patients and health care staff the quality of medical treatment usually cannot be assessed securely by patients. For an optimization of safety in treatment-related processes of medical care, the medical staff needs to be actively involved in preventive and proactive quality management. Using voluntary, confidential and non-punitive systematic employee surveys, vulnerable topics and areas in patient care revealing preventable risks can be identified at an early stage. Preventive measures to continuously optimize treatment quality can be defined by creating a risk portfolio and a priority list of vulnerable topics. Whereas critical incident reporting systems are suitable for continuous risk assessment by detecting safety-relevant single events, employee surveys permit to conduct a systematic risk analysis of all treatment-related processes of patient care at any given point in time.

Command Process Modeling & Risk Analysis

NASA Technical Reports Server (NTRS)

Meshkat, Leila

2011-01-01

Commanding Errors may be caused by a variety of root causes. It's important to understand the relative significance of each of these causes for making institutional investment decisions. One of these causes is the lack of standardized processes and procedures for command and control. We mitigate this problem by building periodic tables and models corresponding to key functions within it. These models include simulation analysis and probabilistic risk assessment models.

Analysis of the risk management decisionmaking processes and the decision support systems in the wildland fire agencies

Treesearch

Patrick Withen

2007-01-01

This paper offers an analysis of the strengths, weaknesses, opportunities, and threats in the risk management process, decision support systems (DSSs), and other types of decisionmaking, including recognition primed decisionmaking, bricolage with the goal of improving DSSs and decisionmaking. DSSs may be thought of as any technology or knowledge that is used as an aid...

Documentary analysis of risk-assessment and safety-planning policies and tools in a mental health context.

PubMed

Higgins, Agnes; Doyle, Louise; Morrissey, Jean; Downes, Carmel; Gill, Ailish; Bailey, Sive

2016-08-01

Despite the articulated need for policies and processes to guide risk assessment and safety planning, limited guidance exists on the processes or procedures to be used to develop such policies, and there is no body of research that examines the quality or content of the risk-management policies developed. The aim of the present study was to analyse the policies of risk and safety management used to guide mental health nursing practice in Ireland. A documentary analysis was performed on 123 documents received from 22 of the 23 directors of nursing contacted. Findings from the analysis revealed a wide variation in how risk, risk assessment, and risk management were defined. Emphasis within the risk documentation submitted was on risk related to self and others, with minimal attention paid to other types of risks. In addition, there was limited evidence of recovery-focused approaches to positive risk taking that involved service users and their families within the risk-related documentation. Many of the risk-assessment tools had not been validated, and lacked consistency or guidance in relation to how they were to be used or applied. The tick-box approach and absence of space for commentary within documentation have the potential to impact severely on the quality of information collected and documented, and subsequent clinical decision-making. Managers, and those tasked with ensuring safety and quality, need to ensure that policies and processes are, where possible, informed by best evidence and are in line with national mental health policy on recovery. © 2016 Australian College of Mental Health Nurses Inc.

Dynamic Positioning System (DPS) Risk Analysis Using Probabilistic Risk Assessment (PRA)

NASA Technical Reports Server (NTRS)

Thigpen, Eric B.; Boyer, Roger L.; Stewart, Michael A.; Fougere, Pete

2017-01-01

The National Aeronautics and Space Administration (NASA) Safety & Mission Assurance (S&MA) directorate at the Johnson Space Center (JSC) has applied its knowledge and experience with Probabilistic Risk Assessment (PRA) to projects in industries ranging from spacecraft to nuclear power plants. PRA is a comprehensive and structured process for analyzing risk in complex engineered systems and/or processes. The PRA process enables the user to identify potential risk contributors such as, hardware and software failure, human error, and external events. Recent developments in the oil and gas industry have presented opportunities for NASA to lend their PRA expertise to both ongoing and developmental projects within the industry. This paper provides an overview of the PRA process and demonstrates how this process was applied in estimating the probability that a Mobile Offshore Drilling Unit (MODU) operating in the Gulf of Mexico and equipped with a generically configured Dynamic Positioning System (DPS) loses location and needs to initiate an emergency disconnect. The PRA described in this paper is intended to be generic such that the vessel meets the general requirements of an International Maritime Organization (IMO) Maritime Safety Committee (MSC)/Circ. 645 Class 3 dynamically positioned vessel. The results of this analysis are not intended to be applied to any specific drilling vessel, although provisions were made to allow the analysis to be configured to a specific vessel if required.

Risk based inspection for atmospheric storage tank

NASA Astrophysics Data System (ADS)

Nugroho, Agus; Haryadi, Gunawan Dwi; Ismail, Rifky; Kim, Seon Jin

2016-04-01

Corrosion is an attack that occurs on a metallic material as a result of environment's reaction.Thus, it causes atmospheric storage tank's leakage, material loss, environmental pollution, equipment failure and affects the age of process equipment then finally financial damage. Corrosion risk measurement becomesa vital part of Asset Management at the plant for operating any aging asset.This paper provides six case studies dealing with high speed diesel atmospheric storage tank parts at a power plant. A summary of the basic principles and procedures of corrosion risk analysis and RBI applicable to the Process Industries were discussed prior to the study. Semi quantitative method based onAPI 58I Base-Resource Document was employed. The risk associated with corrosion on the equipment in terms of its likelihood and its consequences were discussed. The corrosion risk analysis outcome used to formulate Risk Based Inspection (RBI) method that should be a part of the atmospheric storage tank operation at the plant. RBI gives more concern to inspection resources which are mostly on `High Risk' and `Medium Risk' criteria and less on `Low Risk' shell. Risk categories of the evaluated equipment were illustrated through case study analysis outcome.

PDA survey of quality risk management practices in the pharmaceutical, devices, & biotechnology industries.

PubMed

Ahmed, Ruhi; Baseman, Harold; Ferreira, Jorge; Genova, Thomas; Harclerode, William; Hartman, Jeffery; Kim, Samuel; Londeree, Nanette; Long, Michael; Miele, William; Ramjit, Timothy; Raschiatore, Marlene; Tomonto, Charles

2008-01-01

In July 2006 the Parenteral Drug Association's Risk Management Task Force for Aseptic Processes, conducted an electronic survey of PDA members to determine current industry practices regarding implementation of Quality Risk Management in their organizations. This electronic survey was open and publicly available via the PDA website and targeted professionals in our industry who are involved in initiating, implementing, or reviewing risk management programs or decisions in their organizations. One hundred twenty-nine members participated and their demographics are presented in the sidebar "Correspondents Profile". Among the major findings are: *The "Aseptic Processing/Filling" operation is the functional area identified as having the greatest need for risk assessment and quality risk management. *The most widely used methodology in industry to identify risk is Failure Mode and Effects Analysis (FMEA). This tool was most widely applied in assessing change control and for adverse event, complaint, or failure investigations. *Despite the fact that personnel training was identified as the strategy most used for controlling/minimizing risk, the largest contributors to sterility failure in operations are still "Personnel". *Most companies still rely on "Manufacturing Controls" to mitigate risk and deemed the utilization of Process Analytical Technology (PAT) least important in this aspect. *A majority of correspondents verified that they did not periodically assess their risk management programs. *A majority of the correspondents desired to see case studies or examples of risk analysis implementation (as applicable to aseptic processing) in future PDA technical reports on risk management.

Risk management of key issues of FPSO

NASA Astrophysics Data System (ADS)

Sun, Liping; Sun, Hai

2012-12-01

Risk analysis of key systems have become a growing topic late of because of the development of offshore structures. Equipment failures of offloading system and fire accidents were analyzed based on the floating production, storage and offloading (FPSO) features. Fault tree analysis (FTA), and failure modes and effects analysis (FMEA) methods were examined based on information already researched on modules of relex reliability studio (RRS). Equipment failures were also analyzed qualitatively by establishing a fault tree and Boolean structure function based on the shortage of failure cases, statistical data, and risk control measures examined. Failure modes of fire accident were classified according to the different areas of fire occurrences during the FMEA process, using risk priority number (RPN) methods to evaluate their severity rank. The qualitative analysis of FTA gave the basic insight of forming the failure modes of FPSO offloading, and the fire FMEA gave the priorities and suggested processes. The research has practical importance for the security analysis problems of FPSO.

The use of failure mode and effect analysis in a radiation oncology setting: the Cancer Treatment Centers of America experience.

PubMed

Denny, Diane S; Allen, Debra K; Worthington, Nicole; Gupta, Digant

2014-01-01

Delivering radiation therapy in an oncology setting is a high-risk process where system failures are more likely to occur because of increasing utilization, complexity, and sophistication of the equipment and related processes. Healthcare failure mode and effect analysis (FMEA) is a method used to proactively detect risks to the patient in a particular healthcare process and correct potential errors before adverse events occur. FMEA is a systematic, multidisciplinary team-based approach to error prevention and enhancing patient safety. We describe our experience of using FMEA as a prospective risk-management technique in radiation oncology at a national network of oncology hospitals in the United States, capitalizing not only on the use of a team-based tool but also creating momentum across a network of collaborative facilities seeking to learn from and share best practices with each other. The major steps of our analysis across 4 sites and collectively were: choosing the process and subprocesses to be studied, assembling a multidisciplinary team at each site responsible for conducting the hazard analysis, and developing and implementing actions related to our findings. We identified 5 areas of performance improvement for which risk-reducing actions were successfully implemented across our enterprise. © 2012 National Association for Healthcare Quality.

Use of a systematic risk analysis method (FMECA) to improve quality in a clinical laboratory procedure.

PubMed

Serafini, A; Troiano, G; Franceschini, E; Calzoni, P; Nante, N; Scapellato, C

2016-01-01

Risk management is a set of actions to recognize or identify risks, errors and their consequences and to take the steps to counter it. The aim of our study was to apply FMECA (Failure Mode, Effects and Criticality Analysis) to the Activated Protein C resistance (APCR) test in order to detect and avoid mistakes in this process. We created a team and the process was divided in phases and sub phases. For each phase we calculated the probability of occurrence (O) of an error, the detectability score (D) and the severity (S). The product of these three indexes yields the RPN (Risk Priority Number). Phases with a higher RPN need corrective actions with a higher priority. The calculation of RPN showed that more than 20 activities have a score higher than 150 and need important preventive actions; 8 have a score between 100 and 150. Only 23 actions obtained an acceptable score lower than 100. This was one of the first experience of application of FMECA analysis to a laboratory process, and the first one which applies this technique to the identification of the factor V Leiden, and our results confirm that FMECA could be a simple, powerful and useful tool in risk management and helps to identify quickly the criticality in a laboratory process.

Failure mode and effects analysis of witnessing protocols for ensuring traceability during IVF.

PubMed

Rienzi, Laura; Bariani, Fiorenza; Dalla Zorza, Michela; Romano, Stefania; Scarica, Catello; Maggiulli, Roberta; Nanni Costa, Alessandro; Ubaldi, Filippo Maria

2015-10-01

Traceability of cells during IVF is a fundamental aspect of treatment, and involves witnessing protocols. Failure mode and effects analysis (FMEA) is a method of identifying real or potential breakdowns in processes, and allows strategies to mitigate risks to be developed. To examine the risks associated with witnessing protocols, an FMEA was carried out in a busy IVF centre, before and after implementation of an electronic witnessing system (EWS). A multidisciplinary team was formed and moderated by human factors specialists. Possible causes of failures, and their potential effects, were identified and risk priority number (RPN) for each failure calculated. A second FMEA analysis was carried out after implementation of an EWS. The IVF team identified seven main process phases, 19 associated process steps and 32 possible failure modes. The highest RPN was 30, confirming the relatively low risk that mismatches may occur in IVF when a manual witnessing system is used. The introduction of the EWS allowed a reduction in the moderate-risk failure mode by two-thirds (highest RPN = 10). In our experience, FMEA is effective in supporting multidisciplinary IVF groups to understand the witnessing process, identifying critical steps and planning changes in practice to enable safety to be enhanced. Copyright © 2015 Reproductive Healthcare Ltd. Published by Elsevier Ltd. All rights reserved.

INDOOR AIR ASSESSMENT - A REVIEW OF INDOOR AIR QUALITY RISK CHARACTERIZATION

EPA Science Inventory

Risk assessment methodologies provide a mechanism for incorporating scientific evidence and Judgments Into the risk management decision process. isk characterization framework has been developed to provide a systematic approach for analysis and presentation of risk characterizati...

The function of credibility in information processing for risk perception.

PubMed

Trumbo, Craig W; McComas, Katherine A

2003-04-01

This study examines how credibility affects the way people process information and how they subsequently perceive risk. Three conceptual areas are brought together in this analysis: the psychometric model of risk perception, Eagly and Chaiken's heuristic-systematic information processing model, and Meyer's credibility index. Data come from a study of risk communication in the circumstance of state health department investigations of suspected cancer clusters (five cases, N = 696). Credibility is assessed for three information sources: state health departments, citizen groups, and industries involved in each case. Higher credibility for industry and the state directly predicts lower risk perception, whereas high credibility for citizen groups predicts greater risk perception. A path model shows that perceiving high credibility for industry and state-and perceiving low credibility for citizen groups-promotes heuristic processing, which in turn is a strong predictor of lower risk perception. Alternately, perceiving industry and the state to have low credibility also promotes greater systematic processing, which consistently leads to perception of greater risk. Between a one-fifth and one-third of the effect of credibility on risk perception is shown to be indirectly transmitted through information processing.

An Accident Precursor Analysis Process Tailored for NASA Space Systems

NASA Technical Reports Server (NTRS)

Groen, Frank; Stamatelatos, Michael; Dezfuli, Homayoon; Maggio, Gaspare

2010-01-01

Accident Precursor Analysis (APA) serves as the bridge between existing risk modeling activities, which are often based on historical or generic failure statistics, and system anomalies, which provide crucial information about the failure mechanisms that are actually operative in the system and which may differ in frequency or type from those in the various models. These discrepancies between the models (perceived risk) and the system (actual risk) provide the leading indication of an underappreciated risk. This paper presents an APA process developed specifically for NASA Earth-to-Orbit space systems. The purpose of the process is to identify and characterize potential sources of system risk as evidenced by anomalous events which, although not necessarily presenting an immediate safety impact, may indicate that an unknown or insufficiently understood risk-significant condition exists in the system. Such anomalous events are considered accident precursors because they signal the potential for severe consequences that may occur in the future, due to causes that are discernible from their occurrence today. Their early identification allows them to be integrated into the overall system risk model used to intbrm decisions relating to safety.

[Analysis and countermeasure for quality risk in process of traditional Chinese medicine preparations].

PubMed

Yang, Ming; Yang, Yuan-Zhen; Wang, Ya-Qi; Wu, Zhen-Feng; Wang, Xue-Cheng; Luo, Jing

2017-03-01

Product quality relies on not only testing methods,but also the design and development, production control and product manufacturing all aspects of logistics management. Quality comes from the process control level.Therefore, it is very important to accurately identify the factors that may induce quality risk in the production process and quality control measures correspondingly.This article systematically analyzes the source of the quality risk of all aspects of the production process in traditional Chinese medicine preparation. Discussing ways and methods of quality risk identification of traditional Chinese medicine preparation and providing references for perfecting the whole process quality management of traditional Chinese medicine preparation. Copyright© by the Chinese Pharmaceutical Association.

Disentangling the influence of value predispositions and risk/benefit perceptions on support for nanotechnology among the American public.

PubMed

Kim, Jiyoun; Yeo, Sara K; Brossard, Dominique; Scheufele, Dietram A; Xenos, Michael A

2014-05-01

Using nanotechnology as a case study, this article explores (1) how people's perceptions of benefits and risks are related to their approval of nanotechnology, (2) which information-processing factors contribute to public risk/benefit perceptions, and (3) whether individuals' predispositions (i.e., deference to scientific authority and ideology) may moderate the relationship between cognitive processing and risk perceptions of the technology. Results indicate that benefit perceptions positively affect public support for nanotechnology; perceptions of risk tend to be more influenced by systematic processing than by heuristic cues, whereas both heuristic and systematic processing influence benefit perceptions. People who are more liberal-minded tend to be more affected by systematic processing when thinking about the benefits of nanotechnology than those who are more conservative. Compared to less deferent individuals, those who are more deferent to scientific authority tend to be less influenced by systematic processing when making judgments about the benefits and risks of nanotechnology. Implications are discussed. © 2013 Society for Risk Analysis.

DOE Office of Scientific and Technical Information (OSTI.GOV)

Mossahebi, S; Feigenberg, S; Nichols, E

Purpose: GammaPod™, the first stereotactic radiotherapy device for early stage breast cancer treatment, has been recently installed and commissioned at our institution. A multidisciplinary working group applied the failure mode and effects analysis (FMEA) approach to perform a risk analysis. Methods: FMEA was applied to the GammaPod™ treatment process by: 1) generating process maps for each stage of treatment; 2) identifying potential failure modes and outlining their causes and effects; 3) scoring the potential failure modes using the risk priority number (RPN) system based on the product of severity, frequency of occurrence, and detectability (ranging 1–10). An RPN of highermore » than 150 was set as the threshold for minimal concern of risk. For these high-risk failure modes, potential quality assurance procedures and risk control techniques have been proposed. A new set of severity, occurrence, and detectability values were re-assessed in presence of the suggested mitigation strategies. Results: In the single-day image-and-treat workflow, 19, 22, and 27 sub-processes were identified for the stages of simulation, treatment planning, and delivery processes, respectively. During the simulation stage, 38 potential failure modes were found and scored, in terms of RPN, in the range of 9-392. 34 potential failure modes were analyzed in treatment planning with a score range of 16-200. For the treatment delivery stage, 47 potential failure modes were found with an RPN score range of 16-392. The most critical failure modes consisted of breast-cup pressure loss and incorrect target localization due to patient upper-body alignment inaccuracies. The final RPN score of these failure modes based on recommended actions were assessed to be below 150. Conclusion: FMEA risk analysis technique was applied to the treatment process of GammaPod™, a new stereotactic radiotherapy technology. Application of systematic risk analysis methods is projected to lead to improved quality of GammaPod™ treatments. Ying Niu and Cedric Yu are affiliated with Xcision Medical Systems.« less

Salmonella contamination risk points in broiler carcasses during slaughter line processing.

PubMed

Rivera-Pérez, Walter; Barquero-Calvo, Elías; Zamora-Sanabria, Rebeca

2014-12-01

Salmonella is one of the foodborne pathogens most commonly associated with poultry products. The aim of this work was to identify and analyze key sampling points creating risk of Salmonella contamination in a chicken processing plant in Costa Rica and perform a salmonellosis risk analysis. Accordingly, the following examinations were performed: (i) qualitative testing (presence or absence of Salmonella), (ii) quantitative testing (Salmonella CFU counts), and (iii) salmonellosis risk analysis, assuming consumption of contaminated meat from the processing plant selected. Salmonella was isolated in 26% of the carcasses selected, indicating 60% positive in the flocks sampled. The highest Salmonella counts were observed after bleeding (6.1 log CFU per carcass), followed by a gradual decrease during the subsequent control steps. An increase in the percentage of contamination (10 to 40%) was observed during evisceration and spray washing (after evisceration), with Salmonella counts increasing from 3.9 to 5.1 log CFU per carcass. According to the prevalence of Salmonella -contaminated carcasses released to trade (20%), we estimated a risk of 272 cases of salmonellosis per year as a result of the consumption of contaminated chicken. Our study suggests that the processes of evisceration and spray washing represent a risk of Salmonella cross-contamination and/ or recontamination in broilers during slaughter line processing.

[Process management in the hospital pharmacy for the improvement of the patient safety].

PubMed

Govindarajan, R; Perelló-Juncá, A; Parès-Marimòn, R M; Serrais-Benavente, J; Ferrandez-Martí, D; Sala-Robinat, R; Camacho-Calvente, A; Campabanal-Prats, C; Solà-Anderiu, I; Sanchez-Caparrós, S; Gonzalez-Estrada, J; Martinez-Olalla, P; Colomer-Palomo, J; Perez-Mañosas, R; Rodríguez-Gallego, D

2013-01-01

To define a process management model for a hospital pharmacy in order to measure, analyse and make continuous improvements in patient safety and healthcare quality. In order to implement process management, Igualada Hospital was divided into different processes, one of which was the Hospital Pharmacy. A multidisciplinary management team was given responsibility for each process. For each sub-process one person was identified to be responsible, and a working group was formed under his/her leadership. With the help of each working group, a risk analysis using failure modes and effects analysis (FMEA) was performed, and the corresponding improvement actions were implemented. Sub-process indicators were also identified, and different process management mechanisms were introduced. The first risk analysis with FMEA produced more than thirty preventive actions to improve patient safety. Later, the weekly analysis of errors, as well as the monthly analysis of key process indicators, permitted us to monitor process results and, as each sub-process manager participated in these meetings, also to assume accountability and responsibility, thus consolidating the culture of excellence. The introduction of different process management mechanisms, with the participation of people responsible for each sub-process, introduces a participative management tool for the continuous improvement of patient safety and healthcare quality. Copyright © 2012 SECA. Published by Elsevier Espana. All rights reserved.

Development of a pest risk analysis for Phytophthora ramorum for the European Union; the key deliverable from the EU-Funded project RAPRA

Treesearch

Claire Sansford; Alan Inman; Joan Webber

2010-01-01

Pest Risk Analysis (PRA) is an internationally recognized, structured process of determining whether plant pests and pathogens that are absent from a country or area could enter, establish, and cause an economic or environmental risk that is deemed unacceptable. PRA is also used to help identify phytosanitary measures to reduce risks to an acceptable level. United...

Proactive risk assessment of blood transfusion process, in pediatric emergency, using the Health Care Failure Mode and Effects Analysis (HFMEA).

PubMed

Dehnavieh, Reza; Ebrahimipour, Hossein; Molavi-Taleghani, Yasamin; Vafaee-Najar, Ali; Noori Hekmat, Somayeh; Esmailzdeh, Hamid

2014-12-25

Pediatric emergency has been considered as a high risk area, and blood transfusion is known as a unique clinical measure, therefore this study was conducted with the purpose of assessing the proactive risk assessment of blood transfusion process in Pediatric Emergency of Qaem education- treatment center in Mashhad, by the Healthcare Failure Mode and Effects Analysis (HFMEA) methodology. This cross-sectional study analyzed the failure mode and effects of blood transfusion process by a mixture of quantitative-qualitative method. The proactive HFMEA was used to identify and analyze the potential failures of the process. The information of the items in HFMEA forms was collected after obtaining a consensus of experts' panel views via the interview and focus group discussion sessions. The Number of 77 failure modes were identified for 24 sub-processes enlisted in 8 processes of blood transfusion. Totally 13 failure modes were identified as non-acceptable risk (a hazard score above 8) in the blood transfusion process and were transferred to the decision tree. Root causes of high risk modes were discussed in cause-effect meetings and were classified based on the UK national health system (NHS) approved classifications model. Action types were classified in the form of acceptance (11.6%), control (74.2%) and elimination (14.2%). Recommendations were placed in 7 categories using TRIZ ("Theory of Inventive Problem Solving.") The re-engineering process for the required changes, standardizing and updating the blood transfusion procedure, root cause analysis of blood transfusion catastrophic events, patient identification bracelet, training classes and educational pamphlets for raising awareness of personnel, and monthly gathering of transfusion medicine committee have all been considered as executive strategies in work agenda in pediatric emergency.

Proactive Risk Assessment of Blood Transfusion Process, in Pediatric Emergency, Using the Health Care Failure Mode and Effects Analysis (HFMEA)

PubMed Central

Dehnavieh, Reza; Ebrahimipour, Hossein; Molavi-Taleghani, Yasamin; Vafaee-Najar, Ali; Hekmat, Somayeh Noori; Esmailzdeh, Hamid

2015-01-01

Introduction: Pediatric emergency has been considered as a high risk area, and blood transfusion is known as a unique clinical measure, therefore this study was conducted with the purpose of assessing the proactive risk assessment of blood transfusion process in Pediatric Emergency of Qaem education- treatment center in Mashhad, by the Healthcare Failure Mode and Effects Analysis (HFMEA) methodology. Methodology: This cross-sectional study analyzed the failure mode and effects of blood transfusion process by a mixture of quantitative-qualitative method. The proactive HFMEA was used to identify and analyze the potential failures of the process. The information of the items in HFMEA forms was collected after obtaining a consensus of experts’ panel views via the interview and focus group discussion sessions. Results: The Number of 77 failure modes were identified for 24 sub-processes enlisted in 8 processes of blood transfusion. Totally 13 failure modes were identified as non-acceptable risk (a hazard score above 8) in the blood transfusion process and were transferred to the decision tree. Root causes of high risk modes were discussed in cause-effect meetings and were classified based on the UK national health system (NHS) approved classifications model. Action types were classified in the form of acceptance (11.6%), control (74.2%) and elimination (14.2%). Recommendations were placed in 7 categories using TRIZ (“Theory of Inventive Problem Solving.”) Conclusion: The re-engineering process for the required changes, standardizing and updating the blood transfusion procedure, root cause analysis of blood transfusion catastrophic events, patient identification bracelet, training classes and educational pamphlets for raising awareness of personnel, and monthly gathering of transfusion medicine committee have all been considered as executive strategies in work agenda in pediatric emergency. PMID:25560332

Risk Assessment for Stonecutting Enterprises

NASA Astrophysics Data System (ADS)

Aleksandrova, A. J.; Timofeeva, S. S.

2017-04-01

Working conditions at enterprises and artisanal workshops for the processing of jewelry and ornamental stones were considered. The main stages of the technological process for processing of stone raw materials were shown; dangerous processes in the extraction of stone and its processing were identified. The characteristic of harmful and dangerous production factors affecting stonecutters is given. It was revealed that the most dangerous are the increased level of noise and vibration, as well as chemical reagents. The results of a special assessment of the working conditions of stone-cutting plant workers are studied. Professions with high professional risk were identified; an analysis of occupational risks and occupational injuries was carried out. Risk assessment was produced by several methods; professions with high and medium risk indicators were identified by results of the evaluation. The application of risk assessment methods was given the possibility to justify rational measures reducing risks to the lowest possible level. The received quantitative indicators of risk of workers of the stone-cutting enterprises are the result of this work.

Managing Risk to Ensure a Successful Cassini/Huygens Saturn Orbit Insertion (SOI)

NASA Technical Reports Server (NTRS)

Witkowski, Mona M.; Huh, Shin M.; Burt, John B.; Webster, Julie L.

2004-01-01

I. Design: a) S/C designed to be largely single fault tolerant; b) Operate in flight demonstrated envelope, with margin; and c) Strict compliance with requirements & flight rules. II. Test: a) Baseline, fault & stress testing using flight system testbeds (H/W & S/W); b) In-flight checkout & demos to remove first time events. III. Failure Analysis: a) Critical event driven fault tree analysis; b) Risk mitigation & development of contingencies. IV) Residual Risks: a) Accepted pre-launch waivers to Single Point Failures; b) Unavoidable risks (e.g. natural disaster). V) Mission Assurance: a) Strict process for characterization of variances (ISAs, PFRs & Waivers; b) Full time Mission Assurance Manager reports to Program Manager: 1) Independent assessment of compliance with institutional standards; 2) Oversight & risk assessment of ISAs, PFRs & Waivers etc.; and 3) Risk Management Process facilitator.

Failure mode effect analysis and fault tree analysis as a combined methodology in risk management

NASA Astrophysics Data System (ADS)

Wessiani, N. A.; Yoshio, F.

2018-04-01

There have been many studies reported the implementation of Failure Mode Effect Analysis (FMEA) and Fault Tree Analysis (FTA) as a method in risk management. However, most of the studies usually only choose one of these two methods in their risk management methodology. On the other side, combining these two methods will reduce the drawbacks of each methods when implemented separately. This paper aims to combine the methodology of FMEA and FTA in assessing risk. A case study in the metal company will illustrate how this methodology can be implemented. In the case study, this combined methodology will assess the internal risks that occur in the production process. Further, those internal risks should be mitigated based on their level of risks.

Red and processed meat intake and risk of colorectal adenomas: a meta-analysis of observational studies.

PubMed

Xu, Xiaodong; Yu, Enda; Gao, Xianhua; Song, Ning; Liu, Lianjie; Wei, Xubiao; Zhang, Wei; Fu, Chuangang

2013-01-15

Inconsistent results regarding the association between red and processed meat intake and the risk of colorectal adenoma (CRA), the precursor of colorectal cancer (CRC), have been reported. To provide a quantitative assessment of this association, we summarized the evidence from observational studies. Relevant studies were identified in MEDLINE and EMBASE until December 31, 2011. Summary relative risks (SRRs) with 95% confidence intervals (CIs) were pooled with a random-effects model. Between-study heterogeneity was assessed using the Cochran's Q and I(2) statistics. A total of 21 studies (16 case-control studies and five cohort/nested case-control studies) were included in this meta-analysis. The SRRs of CRA were 1.36 (95% CI = 1.17-1.58) for every 100 g/day increase in red meat intake, and 1.24 (95% CI = 1.12-1.36) for the highest versus the lowest level of red meat intake. Nonlinear dose-response meta-analysis indicated that CRA risk increased approximately linearly with increasing intake of red meat up to ~ 90 g/day, where the curve reached its plateau. Subgrouped analyses revealed that the increased risk of CRA with intake of red meat was independent of geographic locations, design and confounders. The SRRs of CRA was 1.28 (95% CI = 1.03-1.60) for per 50 g/day increase in processed meat intake, and 1.17 (95% CI = 1.08-1.26) for the highest versus the lowest level of processed meat intake. Increased intake of red and processed meat is associated with significantly increased risk of CRA. Copyright © 2012 UICC.

Cognitive mapping tools: review and risk management needs.

PubMed

Wood, Matthew D; Bostrom, Ann; Bridges, Todd; Linkov, Igor

2012-08-01

Risk managers are increasingly interested in incorporating stakeholder beliefs and other human factors into the planning process. Effective risk assessment and management requires understanding perceptions and beliefs of involved stakeholders, and how these beliefs give rise to actions that influence risk management decisions. Formal analyses of risk manager and stakeholder cognitions represent an important first step. Techniques for diagramming stakeholder mental models provide one tool for risk managers to better understand stakeholder beliefs and perceptions concerning risk, and to leverage this new understanding in developing risk management strategies. This article reviews three methodologies for assessing and diagramming stakeholder mental models--decision-analysis-based mental modeling, concept mapping, and semantic web analysis--and assesses them with regard to their ability to address risk manager needs. © 2012 Society for Risk Analysis.

Ecological Risk Assessment with MCDM of Some Invasive Alien Plants in China

NASA Astrophysics Data System (ADS)

Xie, Guowen; Chen, Weiguang; Lin, Meizhen; Zheng, Yanling; Guo, Peiguo; Zheng, Yisheng

Alien plant invasion is an urgent global issue that threatens the sustainable development of the ecosystem health. The study of its ecological risk assessment (ERA) could help us to prevent and reduce the invasion risk more effectively. Based on the theory of ERA and methods of the analytic hierarchy process (AHP) of multi-criteria decision-making (MCDM), and through the analyses of the characteristics and processes of alien plant invasion, this paper discusses the methodologies of ERA of alien plant invasion. The assessment procedure consisted of risk source analysis, receptor analysis, exposure and hazard assessment, integral assessment, and countermeasure of risk management. The indicator system of risk source assessment as well as the indices and formulas applied to measure the ecological loss and risk were established, and the method for comprehensively assessing the ecological risk of alien plant invasion was worked out. The result of ecological risk analysis to 9 representative invasive alien plants in China shows that the ecological risk of Erigeron annuus, Ageratum conyzoides, Alternanthera philoxeroides and Mikania midrantha is high (grade1-2), that of Oxalis corymbosa and Wedelia chinensis comes next (grade3), while Mirabilis jalapa, Pilea microphylla and Calendula officinalis of the last (grade 4). Risk strategies are put forward on this basis.

Intake of red and processed meat and risk of renal cell carcinoma: a meta-analysis of observational studies

PubMed Central

Zhang, Shaojing; Wang, Qingwei; He, Juanjuan

2017-01-01

Background Findings on the association between intake of red and processed meat with renal cell carcinoma (RCC) risk are mixed. We conducted a meta-analysis to investigate this association. Materials and Methods Eligible studies up to August 31, 2016, were identified and retrieved by searching the MEDLINE and Embase databases along with manual review of the reference lists from the retrieved studies. The quality of the included studies was evaluated using the Newcastle-Ottawa Quality Assessment Scale. The summary relative risk (SRR) and corresponding 95% confidence interval (CI) were calculated using a random-effects model. Results Twenty-three publications were included in this meta-analysis: four cohort studies, one pooled study, and 18 case-control studies. The SRR (95% CI) for the highest vs. lowest intake of red meat was 1.36 (1.16–1.58, Pheterogeneity < 0.001); that for processed meat was 1.13 (95% CI, 1.03–1.24, Pheterogeneity = 0.014). Linear dose-response analysis yielded similar results, i.e., the SRR for per 100 g/day increment of red meat and per 50 g/day increment of processed meat was 1.21 (95% CI, 1.08–1.36) and 1.16 (95% CI, 0.99–1.36), respectively. A non-linear association was observed only for red meat (Pnonlinearity = 0.002), and not for processed meat (Pnonlinearity = 0.231). Statistically significant positive associations were observed for intake of beef, salami/ham/bacon/sausage, and hamburger. Conclusions This meta-analysis indicates a significant positive association between red and processed meat intake and RCC risk. PMID:29100437

Application of Failure Mode and Effect Analysis (FMEA) and cause and effect analysis in conjunction with ISO 22000 to a snails (Helix aspersa) processing plant; A case study.

PubMed

Arvanitoyannis, Ioannis S; Varzakas, Theodoros H

2009-08-01

Failure Mode and Effect Analysis (FMEA) has been applied for the risk assessment of snails manufacturing. A tentative approach of FMEA application to the snails industry was attempted in conjunction with ISO 22000. Preliminary Hazard Analysis was used to analyze and predict the occurring failure modes in a food chain system (snails processing plant), based on the functions, characteristics, and/or interactions of the ingredients or the processes, upon which the system depends. Critical Control points have been identified and implemented in the cause and effect diagram (also known as Ishikawa, tree diagram, and fishbone diagram). In this work a comparison of ISO22000 analysis with HACCP is carried out over snails processing and packaging. However, the main emphasis was put on the quantification of risk assessment by determining the RPN per identified processing hazard. Sterilization of tins, bioaccumulation of heavy metals, packaging of shells and poisonous mushrooms, were the processes identified as the ones with the highest RPN (280, 240, 147, 144, respectively) and corrective actions were undertaken. Following the application of corrective actions, a second calculation of RPN values was carried out leading to considerably lower values (below the upper acceptable limit of 130). It is noteworthy that the application of Ishikawa (Cause and Effect or Tree diagram) led to converging results thus corroborating the validity of conclusions derived from risk assessment and FMEA. Therefore, the incorporation of FMEA analysis within the ISO22000 system of a snails processing industry is considered imperative.

Process-based Cost Estimation for Ramjet/Scramjet Engines

NASA Technical Reports Server (NTRS)

Singh, Brijendra; Torres, Felix; Nesman, Miles; Reynolds, John

2003-01-01

Process-based cost estimation plays a key role in effecting cultural change that integrates distributed science, technology and engineering teams to rapidly create innovative and affordable products. Working together, NASA Glenn Research Center and Boeing Canoga Park have developed a methodology of process-based cost estimation bridging the methodologies of high-level parametric models and detailed bottoms-up estimation. The NASA GRC/Boeing CP process-based cost model provides a probabilistic structure of layered cost drivers. High-level inputs characterize mission requirements, system performance, and relevant economic factors. Design alternatives are extracted from a standard, product-specific work breakdown structure to pre-load lower-level cost driver inputs and generate the cost-risk analysis. As product design progresses and matures the lower level more detailed cost drivers can be re-accessed and the projected variation of input values narrowed, thereby generating a progressively more accurate estimate of cost-risk. Incorporated into the process-based cost model are techniques for decision analysis, specifically, the analytic hierarchy process (AHP) and functional utility analysis. Design alternatives may then be evaluated not just on cost-risk, but also user defined performance and schedule criteria. This implementation of full-trade study support contributes significantly to the realization of the integrated development environment. The process-based cost estimation model generates development and manufacturing cost estimates. The development team plans to expand the manufacturing process base from approximately 80 manufacturing processes to over 250 processes. Operation and support cost modeling is also envisioned. Process-based estimation considers the materials, resources, and processes in establishing cost-risk and rather depending on weight as an input, actually estimates weight along with cost and schedule.

[FMEA applied to the radiotherapy patient care process].

PubMed

Meyrieux, C; Garcia, R; Pourel, N; Mège, A; Bodez, V

2012-10-01

Failure modes and effects analysis (FMEA), is a risk analysis method used at the Radiotherapy Department of Institute Sainte-Catherine as part of a strategy seeking to continuously improve the quality and security of treatments. The method comprises several steps: definition of main processes; for each of them, description for every step of prescription, treatment preparation, treatment application; identification of the possible risks, their consequences, their origins; research of existing safety elements which may avoid these risks; grading of risks to assign a criticality score resulting in a numerical organisation of the risks. Finally, the impact of proposed corrective actions was then estimated by a new grading round. For each process studied, a detailed map of the risks was obtained, facilitating the identification of priority actions to be undertaken. For example, we obtain five steps in patient treatment planning with an unacceptable level of risk, 62 a level of moderate risk and 31 an acceptable level of risk. The FMEA method, used in the industrial domain and applied here to health care, is an effective tool for the management of risks in patient care. However, the time and training requirements necessary to implement this method should not be underestimated. Copyright © 2012 Société française de radiothérapie oncologique (SFRO). Published by Elsevier SAS. All rights reserved.

Human factors process failure modes and effects analysis (HF PFMEA) software tool

NASA Technical Reports Server (NTRS)

Chandler, Faith T. (Inventor); Relvini, Kristine M. (Inventor); Shedd, Nathaneal P. (Inventor); Valentino, William D. (Inventor); Philippart, Monica F. (Inventor); Bessette, Colette I. (Inventor)

2011-01-01

Methods, computer-readable media, and systems for automatically performing Human Factors Process Failure Modes and Effects Analysis for a process are provided. At least one task involved in a process is identified, where the task includes at least one human activity. The human activity is described using at least one verb. A human error potentially resulting from the human activity is automatically identified, the human error is related to the verb used in describing the task. A likelihood of occurrence, detection, and correction of the human error is identified. The severity of the effect of the human error is identified. The likelihood of occurrence, and the severity of the risk of potential harm is identified. The risk of potential harm is compared with a risk threshold to identify the appropriateness of corrective measures.

Guidelines for contingency planning NASA (National Aeronautics and Space Administration) ADP security risk reduction decision studies

NASA Technical Reports Server (NTRS)

Tompkins, F. G.

1984-01-01

Guidance is presented to NASA Computer Security Officials for determining the acceptability or unacceptability of ADP security risks based on the technical, operational and economic feasibility of potential safeguards. The risk management process is reviewed as a specialized application of the systems approach to problem solving and information systems analysis and design. Reporting the results of the risk reduction analysis to management is considered. Report formats for the risk reduction study are provided.

Hydrotreater/Distillation Column Hazard Analysis Report Rev. 2

DOE Office of Scientific and Technical Information (OSTI.GOV)

Lowry, Peter P.; Wagner, Katie A.

This project Hazard and Risk Analysis Report contains the results of several hazard analyses and risk assessments. An initial assessment was conducted in 2012, which included a multi-step approach ranging from design reviews to a formal What-If hazard analysis. A second What-If hazard analysis was completed during February 2013 to evaluate the operation of the hydrotreater/distillation column processes to be installed in a process enclosure within the Process Development Laboratory West (PDL-West) facility located on the PNNL campus. The qualitative analysis included participation of project and operations personnel and applicable subject matter experts. The analysis identified potential hazardous scenarios, eachmore » based on an initiating event coupled with a postulated upset condition. The unmitigated consequences of each hazardous scenario were generally characterized as a process upset; the exposure of personnel to steam, vapors or hazardous material; a spray or spill of hazardous material; the creation of a flammable atmosphere; or an energetic release from a pressure boundary.« less

Applicability of the Common Safety Method for Risk Evaluation and Assessment (CSM-RA) to the Space Domain

NASA Astrophysics Data System (ADS)

Moreira, Francisco; Silva, Nuno

2016-08-01

Safety systems require accident avoidance. This is covered by application standards, processes, techniques and tools that support the identification, analysis, elimination or reduction to an acceptable level of system risks and hazards. Ideally, a safety system should be free of hazards. However, both industry and academia have been struggling to ensure appropriate risk and hazard analysis, especially in what concerns completeness of the hazards, formalization, and timely analysis in order to influence the specifications and the implementation. Such analysis is also important when considering a change to an existing system. The Common Safety Method for Risk Evaluation and Assessment (CSM- RA) is a mandatory procedure whenever any significant change is proposed to the railway system in a European Member State. This paper provides insights on the fundamentals of CSM-RA based and complemented with Hazard Analysis. When and how to apply them, and the relation and similarities of these processes with industry standards and the system life cycles is highlighted. Finally, the paper shows how CSM-RA can be the basis of a change management process, guiding the identification and management of the hazards helping ensuring the similar safety level as the initial system. This paper will show how the CSM-RA principles can be used in other domains particularly for space system evolution.

Application of a risk analysis method to different technologies for producing a monoclonal antibody employed in hepatitis B vaccine manufacturing.

PubMed

Milá, Lorely; Valdés, Rodolfo; Tamayo, Andrés; Padilla, Sigifredo; Ferro, Williams

2012-03-01

CB.Hep-1 monoclonal antibody (mAb) is used for a recombinant Hepatitis B vaccine manufacturing, which is included in a worldwide vaccination program against Hepatitis B disease. The use of this mAb as immunoligand has been addressed into one of the most efficient steps of active pharmaceutical ingredient purification process. Regarding this, Quality Risk Management (QRM) provides an excellent framework for the risk management use in pharmaceutical manufacturing and quality decision-making applications. Consequently, this study sought applying a prospective risk analysis methodology Failure Mode Effects Analysis (FMEA) as QRM tool for analyzing different CB.Hep-1 mAb manufacturing technologies. As main conclusions FMEA was successfully used to assess risks associated with potential problems in CB.Hep-1 mAb manufacturing processes. The severity and occurrence of risks analysis evidenced that the percentage of very high severe risks ranged 31.0-38.7% of all risks and the huge majority of risks have a very low occurrence level (61.9-83.3%) in all assessed technologies. Finally, additive Risk Priority Number, was descending ordered as follow: transgenic plants (2636), ascites (2577), transgenic animals (2046) and hollow fiber bioreactors (1654), which also corroborated that in vitro technology, should be the technology of choice for CB.Hep-1 mAb manufacturing in terms of risks and mAb molecule quality. Copyright © 2011 The International Alliance for Biological Standardization. Published by Elsevier Ltd. All rights reserved.

Is risk analysis scientific?

PubMed

Hansson, Sven Ove; Aven, Terje

2014-07-01

This article discusses to what extent risk analysis is scientific in view of a set of commonly used definitions and criteria. We consider scientific knowledge to be characterized by its subject matter, its success in developing the best available knowledge in its fields of study, and the epistemic norms and values that guide scientific investigations. We proceed to assess the field of risk analysis according to these criteria. For this purpose, we use a model for risk analysis in which science is used as a base for decision making on risks, which covers the five elements evidence, knowledge base, broad risk evaluation, managerial review and judgment, and the decision; and that relates these elements to the domains experts and decisionmakers, and to the domains fact-based or value-based. We conclude that risk analysis is a scientific field of study, when understood as consisting primarily of (i) knowledge about risk-related phenomena, processes, events, etc., and (ii) concepts, theories, frameworks, approaches, principles, methods and models to understand, assess, characterize, communicate, and manage risk, in general and for specific applications (the instrumental part). © 2014 Society for Risk Analysis.

Risk Modeling of Interdependent Complex Systems of Systems: Theory and Practice.

PubMed

Haimes, Yacov Y

2018-01-01

The emergence of the complexity characterizing our systems of systems (SoS) requires a reevaluation of the way we model, assess, manage, communicate, and analyze the risk thereto. Current models for risk analysis of emergent complex SoS are insufficient because too often they rely on the same risk functions and models used for single systems. These models commonly fail to incorporate the complexity derived from the networks of interdependencies and interconnectedness (I-I) characterizing SoS. There is a need to reevaluate currently practiced risk analysis to respond to this reality by examining, and thus comprehending, what makes emergent SoS complex. The key to evaluating the risk to SoS lies in understanding the genesis of characterizing I-I of systems manifested through shared states and other essential entities within and among the systems that constitute SoS. The term "essential entities" includes shared decisions, resources, functions, policies, decisionmakers, stakeholders, organizational setups, and others. This undertaking can be accomplished by building on state-space theory, which is fundamental to systems engineering and process control. This article presents a theoretical and analytical framework for modeling the risk to SoS with two case studies performed with the MITRE Corporation and demonstrates the pivotal contributions made by shared states and other essential entities to modeling and analysis of the risk to complex SoS. A third case study highlights the multifarious representations of SoS, which require harmonizing the risk analysis process currently applied to single systems when applied to complex SoS. © 2017 Society for Risk Analysis.

From Physical Process to Economic Cost - Integrated Approaches of Landslide Risk Assessment

NASA Astrophysics Data System (ADS)

Klose, M.; Damm, B.

2014-12-01

The nature of landslides is complex in many respects, with landslide hazard and impact being dependent on a variety of factors. This obviously requires an integrated assessment for fundamental understanding of landslide risk. Integrated risk assessment, according to the approach presented in this contribution, implies combining prediction of future landslide occurrence with analysis of landslide impact in the past. A critical step for assessing landslide risk in integrated perspective is to analyze what types of landslide damage affected people and property in which way and how people contributed and responded to these damage types. In integrated risk assessment, the focus is on systematic identification and monetization of landslide damage, and analytical tools that allow deriving economic costs from physical landslide processes are at the heart of this approach. The broad spectrum of landslide types and process mechanisms as well as nonlinearity between landslide magnitude, damage intensity, and direct costs are some main factors explaining recent challenges in risk assessment. The two prevailing approaches for assessing the impact of landslides in economic terms are cost survey (ex-post) and risk analysis (ex-ante). Both approaches are able to complement each other, but yet a combination of them has not been realized so far. It is common practice today to derive landslide risk without considering landslide process-based cause-effect relationships, since integrated concepts or new modeling tools expanding conventional methods are still widely missing. The approach introduced in this contribution is based on a systematic framework that combines cost survey and GIS-based tools for hazard or cost modeling with methods to assess interactions between land use practices and landslides in historical perspective. Fundamental understanding of landslide risk also requires knowledge about the economic and fiscal relevance of landslide losses, wherefore analysis of their impact on public budgets is a further component of this approach. In integrated risk assessment, combination of methods plays an important role, with the objective of collecting and integrating complex data sets on landslide risk.

Using incident response trees as a tool for risk management of online financial services.

PubMed

Gorton, Dan

2014-09-01

The article introduces the use of probabilistic risk assessment for modeling the incident response process of online financial services. The main contribution is the creation of incident response trees, using event tree analysis, which provides us with a visual tool and a systematic way to estimate the probability of a successful incident response process against the currently known risk landscape, making it possible to measure the balance between front-end and back-end security measures. The model is presented using an illustrative example, and is then applied to the incident response process of a Swedish bank. Access to relevant data is verified and the applicability and usability of the proposed model is verified using one year of historical data. Potential advantages and possible shortcomings are discussed, referring to both the design phase and the operational phase, and future work is presented. © 2014 Society for Risk Analysis.

[Development of whole process quality control and management system of traditional Chinese medicine decoction pieces based on traditional Chinese medicine quality tree].

PubMed

Yu, Wen-Kang; Dong, Ling; Pei, Wen-Xuan; Sun, Zhi-Rong; Dai, Jun-Dong; Wang, Yun

2017-12-01

The whole process quality control and management of traditional Chinese medicine (TCM) decoction pieces is a system engineering, involving the base environment, seeds and seedlings, harvesting, processing and other multiple steps, so the accurate identification of factors in TCM production process that may induce the quality risk, as well as reasonable quality control measures are very important. At present, the concept of quality risk is mainly concentrated in the aspects of management and regulations, etc. There is no comprehensive analysis on possible risks in the quality control process of TCM decoction pieces, or analysis summary of effective quality control schemes. A whole process quality control and management system for TCM decoction pieces based on TCM quality tree was proposed in this study. This system effectively combined the process analysis method of TCM quality tree with the quality risk management, and can help managers to make real-time decisions while realizing the whole process quality control of TCM. By providing personalized web interface, this system can realize user-oriented information feedback, and was convenient for users to predict, evaluate and control the quality of TCM. In the application process, the whole process quality control and management system of the TCM decoction pieces can identify the related quality factors such as base environment, cultivation and pieces processing, extend and modify the existing scientific workflow according to their own production conditions, and provide different enterprises with their own quality systems, to achieve the personalized service. As a new quality management model, this paper can provide reference for improving the quality of Chinese medicine production and quality standardization. Copyright© by the Chinese Pharmaceutical Association.

[Use of bivariate survival curves for analyzing mortality of heart failure and sudden death in dilated cardiomiopathy].

PubMed

Gregori, Dario; Rosato, Rosalba; Zecchin, Massimo; Di Lenarda, Andrea

2005-01-01

This paper discusses the use of bivariate survival curves estimators within the competing risk framework. Competing risks models are used for the analysis of medical data with more than one cause of death. The case of dilated cardiomiopathy is explored. Bivariate survival curves plot the conjoint mortality processes. The different graphic representation of bivariate survival analysis is the major contribute of this methodology to the competing risks analysis.

Uncertainty analysis in vulnerability estimations for elements at risk- a review of concepts and some examples on landslides

NASA Astrophysics Data System (ADS)

Ciurean, R. L.; Glade, T.

2012-04-01

Decision under uncertainty is a constant of everyday life and an important component of risk management and governance. Recently, experts have emphasized the importance of quantifying uncertainty in all phases of landslide risk analysis. Due to its multi-dimensional and dynamic nature, (physical) vulnerability is inherently complex and the "degree of loss" estimates imprecise and to some extent even subjective. Uncertainty analysis introduces quantitative modeling approaches that allow for a more explicitly objective output, improving the risk management process as well as enhancing communication between various stakeholders for better risk governance. This study presents a review of concepts for uncertainty analysis in vulnerability of elements at risk to landslides. Different semi-quantitative and quantitative methods are compared based on their feasibility in real-world situations, hazard dependency, process stage in vulnerability assessment (i.e. input data, model, output), and applicability within an integrated landslide hazard and risk framework. The resulted observations will help to identify current gaps and future needs in vulnerability assessment, including estimation of uncertainty propagation, transferability of the methods, development of visualization tools, but also address basic questions like what is uncertainty and how uncertainty can be quantified or treated in a reliable and reproducible way.

Sustainability Analysis for Products and Processes

EPA Science Inventory

Sustainability Analysis for Products and Processes Subhas K. Sikdar National Risk Management Research Laboratory United States Environmental protection Agency 26 W. M.L. King Dr. Cincinnati, OH 45237 Sikdar.subhas@epa.gov ABSTRACT Claims of both sustainable and unsu...

Grand Junction projects office mixed-waste treatment program, VAC*TRAX mobile treatment unit process hazards analysis

DOE Office of Scientific and Technical Information (OSTI.GOV)

Bloom, R.R.

1996-04-01

The objective of this report is to demonstrate that a thorough assessment of the risks associated with the operation of the Rust Geotech patented VAC*TRAX mobile treatment unit (MTU) has been performed and documented. The MTU was developed to treat mixed wastes at the US Department of Energy (DOE) Albuquerque Operations Office sites. The MTU uses an indirectly heated, batch vacuum dryer to thermally desorb organic compounds from mixed wastes. This process hazards analysis evaluated 102 potential hazards. The three significant hazards identified involved the inclusion of oxygen in a process that also included an ignition source and fuel. Changesmore » to the design of the MTU were made concurrent with the hazard identification and analysis; all hazards with initial risk rankings of 1 or 2 were reduced to acceptable risk rankings of 3 or 4. The overall risk to any population group from operation of the MTU was determined to be very low; the MTU is classified as a Radiological Facility with low hazards.« less

Risk management in medical product development process using traditional FMEA and fuzzy linguistic approach: a case study

NASA Astrophysics Data System (ADS)

Kirkire, Milind Shrikant; Rane, Santosh B.; Jadhav, Jagdish Rajaram

2015-12-01

Medical product development (MPD) process is highly multidisciplinary in nature, which increases the complexity and the associated risks. Managing the risks during MPD process is very crucial. The objective of this research is to explore risks during MPD in a dental product manufacturing company and propose a model for risk mitigation during MPD process to minimize failure events. A case study approach is employed. The existing MPD process is mapped with five phases of the customized phase gate process. The activities during each phase of development and risks associated with each activity are identified and categorized based on the source of occurrence. The risks are analyzed using traditional Failure mode and effect analysis (FMEA) and fuzzy FMEA. The results of two methods when compared show that fuzzy approach avoids the duplication of RPNs and helps more to convert cognition of experts into information to get values of risk factors. The critical, moderate, low level and negligible risks are identified based on criticality; risk treatments and mitigation model are proposed. During initial phases of MPD, the risks are less severe, but as the process progresses the severity of risks goes on increasing. The MPD process should be critically designed and simulated to minimize the number of risk events and their severity. To successfully develop the products/devices within the manufacturing companies, the process risk management is very essential. A systematic approach to manage risks during MPD process will lead to the development of medical products with expected quality and reliability. This is the first research of its kind having focus on MPD process risks and its management. The methodology adopted in this paper will help the developers, managers and researchers to have a competitive edge over the other companies by managing the risks during the development process.

SU-F-T-246: Evaluation of Healthcare Failure Mode And Effect Analysis For Risk Assessment

DOE Office of Scientific and Technical Information (OSTI.GOV)

Harry, T; University of California, San Diego, La Jolla, CA; Manger, R

Purpose: To evaluate the differences between the Veteran Affairs Healthcare Failure Modes and Effect Analysis (HFMEA) and the AAPM Task Group 100 Failure and Effect Analysis (FMEA) risk assessment techniques in the setting of a stereotactic radiosurgery (SRS) procedure were compared respectively. Understanding the differences in the techniques methodologies and outcomes will provide further insight into the applicability and utility of risk assessments exercises in radiation therapy. Methods: HFMEA risk assessment analysis was performed on a stereotactic radiosurgery procedure. A previous study from our institution completed a FMEA of our SRS procedure and the process map generated from this workmore » was used for the HFMEA. The process of performing the HFMEA scoring was analyzed, and the results from both analyses were compared. Results: The key differences between the two risk assessments are the scoring criteria for failure modes and identifying critical failure modes for potential hazards. The general consensus among the team performing the analyses was that scoring for the HFMEA was simpler and more intuitive then the FMEA. The FMEA identified 25 critical failure modes while the HFMEA identified 39. Seven of the FMEA critical failure modes were not identified by the HFMEA and 21 of the HFMEA critical failure modes were not identified by the FMEA. HFMEA as described by the Veteran Affairs provides guidelines on which failure modes to address first. Conclusion: HFMEA is a more efficient model for identifying gross risks in a process than FMEA. Clinics with minimal staff, time and resources can benefit from this type of risk assessment to eliminate or mitigate high risk hazards with nominal effort. FMEA can provide more in depth details but at the cost of elevated effort.« less

Assessment, Planning, and Execution Considerations for Conjunction Risk Assessment and Mitigation Operations

NASA Technical Reports Server (NTRS)

Frigm, Ryan C.; Levi, Joshua A.; Mantziaras, Dimitrios C.

2010-01-01

An operational Conjunction Assessment Risk Analysis (CARA) concept is the real-time process of assessing risk posed by close approaches and reacting to those risks if necessary. The most effective way to completely mitigate conjunction risk is to perform an avoidance maneuver. The NASA Goddard Space Flight Center has implemented a routine CARA process since 2005. Over this period, considerable experience has been gained and many lessons have been learned. This paper identifies and presents these experiences as general concepts in the description of the Conjunction Assessment, Flight Dynamics, and Flight Operations methodologies and processes. These general concepts will be tied together and will be exemplified through a case study of an actual high risk conjunction event for the Aura mission.

Low-thrust mission risk analysis, with application to a 1980 rendezvous with the comet Encke

NASA Technical Reports Server (NTRS)

Yen, C. L.; Smith, D. B.

1973-01-01

A computerized failure process simulation procedure is used to evaluate the risk in a solar electric space mission. The procedure uses currently available thrust-subsystem reliability data and performs approximate simulations of the thrust sybsystem burn operation, the system failure processes, and the retargeting operations. The method is applied to assess the risks in carrying out a 1980 rendezvous mission to the comet Encke. Analysis of the results and evaluation of the effects of various risk factors on the mission show that system component failure rates are the limiting factors in attaining a high mission relability. It is also shown that a well-designed trajectory and system operation mode can be used effectively to partially compensate for unreliable thruster performance.

Program risk analysis handbook

NASA Technical Reports Server (NTRS)

Batson, R. G.

1987-01-01

NASA regulations specify that formal risk analysis be performed on a program at each of several milestones. Program risk analysis is discussed as a systems analysis approach, an iterative process (identification, assessment, management), and a collection of techniques. These techniques, which range from extremely simple to complex network-based simulation, are described in this handbook in order to provide both analyst and manager with a guide for selection of the most appropriate technique. All program risk assessment techniques are shown to be based on elicitation and encoding of subjective probability estimates from the various area experts on a program. Techniques to encode the five most common distribution types are given. Then, a total of twelve distinct approaches to risk assessment are given. Steps involved, good and bad points, time involved, and degree of computer support needed are listed. Why risk analysis should be used by all NASA program managers is discussed. Tools available at NASA-MSFC are identified, along with commercially available software. Bibliography (150 entries) and a program risk analysis check-list are provided.

Analysis of dengue fever risk using geostatistics model in bone regency

NASA Astrophysics Data System (ADS)

Amran, Stang, Mallongi, Anwar

2017-03-01

This research aim is to analysis of dengue fever risk based on Geostatistics model in Bone Regency. Risk levels of dengue fever are denoted by parameter of Binomial distribution. Effect of temperature, rainfalls, elevation, and larvae abundance are investigated through Geostatistics model. Bayesian hierarchical method is used in estimation process. Using dengue fever data in eleven locations this research shows that temperature and rainfall have significant effect of dengue fever risk in Bone regency.

The role of models in estimating consequences as part of the risk assessment process.

PubMed

Forde-Folle, K; Mitchell, D; Zepeda, C

2011-08-01

The degree of disease risk represented by the introduction, spread, or establishment of one or several diseases through the importation of animals and animal products is assessed by importing countries through an analysis of risk. The components of a risk analysis include hazard identification, risk assessment, risk management, and risk communication. A risk assessment starts with identification of the hazard(s) and then continues with four interrelated steps: release assessment, exposure assessment, consequence assessment, and risk estimation. Risk assessments may be either qualitative or quantitative. This paper describes how, through the integration of epidemiological and economic models, the potential adverse biological and economic consequences of exposure can be quantified.

Assessment and Control of Spacecraft Charging Risks on the International Space Station

NASA Technical Reports Server (NTRS)

Koontz, Steve; Valentine, Mark; Keeping, Thomas; Edeen, Marybeth; Spetch, William; Dalton, Penni

2004-01-01

The International Space Station (ISS) operates in the F2 region of Earth's ionosphere, orbiting at altitudes ranging from 350 to 450 km at an inclination of 51.6 degrees. The relatively dense, cool F2 ionospheric plasma suppresses surface charging processes much of the time, and the flux of relativistic electrons is low enough to preclude deep dielectric charging processes. The most important spacecraft charging processes in the ISS orbital environment are: 1) ISS electrical power system interactions with the F2 plasma, 2) magnetic induction processes resulting from flight through the geomagnetic field and, 3) charging processes that result from interaction with auroral electrons at high latitude. Recently, the continuing review and evaluation of putative ISS charging hazards required by the ISS Program Office revealed that ISS charging could produce an electrical shock hazard to the ISS crew during extravehicular activity (EVA). ISS charging risks are being evaluated in an ongoing measurement and analysis campaign. The results of ISS charging measurements are combined with a recently developed model of ISS charging (the Plasma Interaction Model) and an exhaustive analysis of historical ionospheric variability data (ISS Ionospheric Specification) to evaluate ISS charging risks using Probabilistic Risk Assessment (PRA) methods. The PRA combines estimates of the frequency of occurrence and severity of the charging hazards with estimates of the reliability of various hazard controls systems, as required by NASA s safety and risk management programs, to enable design and selection of a hazard control approach that minimizes overall programmatic and personnel risk. The PRA provides a quantitative methodology for incorporating the results of the ISS charging measurement and analysis campaigns into the necessary hazard reports, EVA procedures, and ISS flight rules required for operating ISS in a safe and productive manner.

Application of ISO 22000 and Failure Mode and Effect Analysis (FMEA) for industrial processing of salmon: a case study.

PubMed

Arvanitoyannis, Ioannis S; Varzakas, Theodoros H

2008-05-01

The Failure Mode and Effect Analysis (FMEA) model was applied for risk assessment of salmon manufacturing. A tentative approach of FMEA application to the salmon industry was attempted in conjunction with ISO 22000. Preliminary Hazard Analysis was used to analyze and predict the occurring failure modes in a food chain system (salmon processing plant), based on the functions, characteristics, and/or interactions of the ingredients or the processes, upon which the system depends. Critical Control points were identified and implemented in the cause and effect diagram (also known as Ishikawa, tree diagram and fishbone diagram). In this work, a comparison of ISO 22000 analysis with HACCP is carried out over salmon processing and packaging. However, the main emphasis was put on the quantification of risk assessment by determining the RPN per identified processing hazard. Fish receiving, casing/marking, blood removal, evisceration, filet-making cooling/freezing, and distribution were the processes identified as the ones with the highest RPN (252, 240, 210, 210, 210, 210, 200 respectively) and corrective actions were undertaken. After the application of corrective actions, a second calculation of RPN values was carried out resulting in substantially lower values (below the upper acceptable limit of 130). It is noteworthy that the application of Ishikawa (Cause and Effect or Tree diagram) led to converging results thus corroborating the validity of conclusions derived from risk assessment and FMEA. Therefore, the incorporation of FMEA analysis within the ISO 22000 system of a salmon processing industry is anticipated to prove advantageous to industrialists, state food inspectors, and consumers.

Proposal for a new categorization of aseptic processing facilities based on risk assessment scores.

PubMed

Katayama, Hirohito; Toda, Atsushi; Tokunaga, Yuji; Katoh, Shigeo

2008-01-01

Risk assessment of aseptic processing facilities was performed using two published risk assessment tools. Calculated risk scores were compared with experimental test results, including environmental monitoring and media fill run results, in three different types of facilities. The two risk assessment tools used gave a generally similar outcome. However, depending on the tool used, variations were observed in the relative scores between the facilities. For the facility yielding the lowest risk scores, the corresponding experimental test results showed no contamination, indicating that these ordinal testing methods are insufficient to evaluate this kind of facility. A conventional facility having acceptable aseptic processing lines gave relatively high risk scores. The facility showing a rather high risk score demonstrated the usefulness of conventional microbiological test methods. Considering the significant gaps observed in calculated risk scores and in the ordinal microbiological test results between advanced and conventional facilities, we propose a facility categorization based on risk assessment. The most important risk factor in aseptic processing is human intervention. When human intervention is eliminated from the process by advanced hardware design, the aseptic processing facility can be classified into a new risk category that is better suited for assuring sterility based on a new set of criteria rather than on currently used microbiological analysis. To fully benefit from advanced technologies, we propose three risk categories for these aseptic facilities.

Effects of changes along the risk chain on flood risk

NASA Astrophysics Data System (ADS)

Duha Metin, Ayse; Apel, Heiko; Viet Dung, Nguyen; Guse, Björn; Kreibich, Heidi; Schröter, Kai; Vorogushyn, Sergiy; Merz, Bruno

2017-04-01

Interactions of hydrological and socio-economic factors shape flood disaster risk. For this reason, assessment of flood risk ideally takes into account the whole flood risk chain from atmospheric processes, through the catchment and river system processes to the damage mechanisms in the affected areas. Since very different processes at various scales are interacting along the flood risk, the impact of the single components is rather unclear. However for flood risk management, it is required to know the controlling factor of flood damages. The present study, using the flood-prone Mulde catchment in Germany, discusses the sensitivity of flood risk to disturbances along the risk chain: How do disturbances propagate through the risk chain? How do different disturbances combine or conflict and affect flood risk? In this sensitivity analysis, the five components of the flood risk change are included. These are climate, catchment, river system, exposure and vulnerability. A model framework representing the complete risk chain is combined with observational data to understand how the sensitivities evolve along the risk chain by considering three plausible change scenarios for each of five components. The flood risk is calculated by using the Regional Flood Model (RFM) which is based on a continuous simulation approach, including rainfall-runoff, 1D river network, 2D hinterland inundation and damage estimation models. The sensitivity analysis covers more than 240 scenarios with different combinations of the five components. It is investigated how changes in different components affect risk indicators, such as the risk curve and expected annual damage (EAD). In conclusion, it seems that changes in exposure and vulnerability seem to outweigh changes in hazard.

Costing the satellite power system

NASA Technical Reports Server (NTRS)

Hazelrigg, G. A., Jr.

1978-01-01

The paper presents a methodology for satellite power system costing, places approximate limits on the accuracy possible in cost estimates made at this time, and outlines the use of probabilistic cost information in support of the decision-making process. Reasons for using probabilistic costing or risk analysis procedures instead of standard deterministic costing procedures are considered. Components of cost, costing estimating relationships, grass roots costing, and risk analysis are discussed. Risk analysis using a Monte Carlo simulation model is used to estimate future costs.

Spatial and temporal variation in evacuee risk perception throughout the evacuation and return-entry process.

PubMed

Siebeneck, Laura K; Cova, Thomas J

2012-09-01

Developing effective evacuation and return-entry plans requires understanding the spatial and temporal dimensions of risk perception experienced by evacuees throughout a disaster event. Using data gathered from the 2008 Cedar Rapids, Iowa Flood, this article explores how risk perception and location influence evacuee behavior during the evacuation and return-entry process. Three themes are discussed: (1) the spatial and temporal characteristics of risk perception throughout the evacuation and return-entry process, (2) the relationship between risk perception and household compliance with return-entry orders, and (3) the role social influences have on the timing of the return by households. The results indicate that geographic location and spatial variation of risk influenced household risk perception and compliance with return-entry plans. In addition, sociodemographic characteristics influenced the timing and characteristics of the return groups. The findings of this study advance knowledge of evacuee behavior throughout a disaster and can inform strategies used by emergency managers throughout the evacuation and return-entry process. © 2012 Society for Risk Analysis.

MO-D-213-02: Quality Improvement Through a Failure Mode and Effects Analysis of Pediatric External Beam Radiotherapy

DOE Office of Scientific and Technical Information (OSTI.GOV)

Gray, J; Lukose, R; Bronson, J

2015-06-15

Purpose: To conduct a failure mode and effects analysis (FMEA) as per AAPM Task Group 100 on clinical processes associated with teletherapy, and the development of mitigations for processes with identified high risk. Methods: A FMEA was conducted on clinical processes relating to teletherapy treatment plan development and delivery. Nine major processes were identified for analysis. These steps included CT simulation, data transfer, image registration and segmentation, treatment planning, plan approval and preparation, and initial and subsequent treatments. Process tree mapping was utilized to identify the steps contained within each process. Failure modes (FM) were identified and evaluated with amore » scale of 1–10 based upon three metrics: the severity of the effect, the probability of occurrence, and the detectability of the cause. The analyzed metrics were scored as follows: severity – no harm = 1, lethal = 10; probability – not likely = 1, certainty = 10; detectability – always detected = 1, undetectable = 10. The three metrics were combined multiplicatively to determine the risk priority number (RPN) which defined the overall score for each FM and the order in which process modifications should be deployed. Results: Eighty-nine procedural steps were identified with 186 FM accompanied by 193 failure effects with 213 potential causes. Eighty-one of the FM were scored with a RPN > 10, and mitigations were developed for FM with RPN values exceeding ten. The initial treatment had the most FM (16) requiring mitigation development followed closely by treatment planning, segmentation, and plan preparation with fourteen each. The maximum RPN was 400 and involved target delineation. Conclusion: The FMEA process proved extremely useful in identifying previously unforeseen risks. New methods were developed and implemented for risk mitigation and error prevention. Similar to findings reported for adult patients, the process leading to the initial treatment has an associated high risk.« less

Development of a Premium Quality Plasma-derived IVIg (IQYMUNE®) Utilizing the Principles of Quality by Design-A Worked-through Case Study.

PubMed

Paolantonacci, Philippe; Appourchaux, Philippe; Claudel, Béatrice; Ollivier, Monique; Dennett, Richard; Siret, Laurent

2018-01-01

Polyvalent human normal immunoglobulins for intravenous use (IVIg), indicated for rare and often severe diseases, are complex plasma-derived protein preparations. A quality by design approach has been used to develop the Laboratoire Français du Fractionnement et des Biotechnologies new-generation IVIg, targeting a high level of purity to generate an enhanced safety profile while maintaining a high level of efficacy. A modular approach of quality by design was implemented consisting of five consecutive steps to cover all the stages from the product design to the final product control strategy.A well-defined target product profile was translated into 27 product quality attributes that formed the basis of the process design. In parallel, a product risk analysis was conducted and identified 19 critical quality attributes among the product quality attributes. Process risk analysis was carried out to establish the links between process parameters and critical quality attributes. Twelve critical steps were identified, and for each of these steps a risk mitigation plan was established.Among the different process risk mitigation exercises, five process robustness studies were conducted at qualified small scale with a design of experiment approach. For each process step, critical process parameters were identified and, for each critical process parameter, proven acceptable ranges were established. The quality risk management and risk mitigation outputs, including verification of proven acceptable ranges, were used to design the process verification exercise at industrial scale.Finally, the control strategy was established using a mix, or hybrid, of the traditional approach plus elements of the quality by design enhanced approach, as illustrated, to more robustly assign material and process controls and in order to securely meet product specifications.The advantages of this quality by design approach were improved process knowledge for industrial design and process validation and a clear justification of the process and product specifications as a basis for control strategy and future comparability exercises. © PDA, Inc. 2018.

Quantitative evaluation of the risk induced by dominant geomorphological processes on different land uses, based on GIS spatial analysis models

NASA Astrophysics Data System (ADS)

Ştefan, Bilaşco; Sanda, Roşca; Ioan, Fodorean; Iuliu, Vescan; Sorin, Filip; Dănuţ, Petrea

2017-12-01

Maramureş Land is mostly characterized by agricultural and forestry land use due to its specific configuration of topography and its specific pedoclimatic conditions. Taking into consideration the trend of the last century from the perspective of land management, a decrease in the surface of agricultural lands to the advantage of built-up and grass lands, as well as an accelerated decrease in the forest cover due to uncontrolled and irrational forest exploitation, has become obvious. The field analysis performed on the territory of Maramureş Land has highlighted a high frequency of two geomorphologic processes — landslides and soil erosion — which have a major negative impact on land use due to their rate of occurrence. The main aim of the present study is the GIS modeling of the two geomorphologic processes, determining a state of vulnerability (the USLE model for soil erosion and a quantitative model based on the morphometric characteristics of the territory, derived from the HG. 447/2003) and their integration in a complex model of cumulated vulnerability identification. The modeling of the risk exposure was performed using a quantitative approach based on models and equations of spatial analysis, which were developed with modeled raster data structures and primary vector data, through a matrix highlighting the correspondence between vulnerability and land use classes. The quantitative analysis of the risk was performed by taking into consideration the exposure classes as modeled databases and the land price as a primary alphanumeric database using spatial analysis techniques for each class by means of the attribute table. The spatial results highlight the territories with a high risk to present geomorphologic processes that have a high degree of occurrence and represent a useful tool in the process of spatial planning.

Quantitative evaluation of the risk induced by dominant geomorphological processes on different land uses, based on GIS spatial analysis models

NASA Astrophysics Data System (ADS)

Ştefan, Bilaşco; Sanda, Roşca; Ioan, Fodorean; Iuliu, Vescan; Sorin, Filip; Dănuţ, Petrea

2018-06-01

Maramureş Land is mostly characterized by agricultural and forestry land use due to its specific configuration of topography and its specific pedoclimatic conditions. Taking into consideration the trend of the last century from the perspective of land management, a decrease in the surface of agricultural lands to the advantage of built-up and grass lands, as well as an accelerated decrease in the forest cover due to uncontrolled and irrational forest exploitation, has become obvious. The field analysis performed on the territory of Maramureş Land has highlighted a high frequency of two geomorphologic processes — landslides and soil erosion — which have a major negative impact on land use due to their rate of occurrence. The main aim of the present study is the GIS modeling of the two geomorphologic processes, determining a state of vulnerability (the USLE model for soil erosion and a quantitative model based on the morphometric characteristics of the territory, derived from the HG. 447/2003) and their integration in a complex model of cumulated vulnerability identification. The modeling of the risk exposure was performed using a quantitative approach based on models and equations of spatial analysis, which were developed with modeled raster data structures and primary vector data, through a matrix highlighting the correspondence between vulnerability and land use classes. The quantitative analysis of the risk was performed by taking into consideration the exposure classes as modeled databases and the land price as a primary alphanumeric database using spatial analysis techniques for each class by means of the attribute table. The spatial results highlight the territories with a high risk to present geomorphologic processes that have a high degree of occurrence and represent a useful tool in the process of spatial planning.

A Systematic Approach of Employing Quality by Design Principles: Risk Assessment and Design of Experiments to Demonstrate Process Understanding and Identify the Critical Process Parameters for Coating of the Ethylcellulose Pseudolatex Dispersion Using Non-Conventional Fluid Bed Process.

PubMed

Kothari, Bhaveshkumar H; Fahmy, Raafat; Claycamp, H Gregg; Moore, Christine M V; Chatterjee, Sharmista; Hoag, Stephen W

2017-05-01

The goal of this study was to utilize risk assessment techniques and statistical design of experiments (DoE) to gain process understanding and to identify critical process parameters for the manufacture of controlled release multiparticulate beads using a novel disk-jet fluid bed technology. The material attributes and process parameters were systematically assessed using the Ishikawa fish bone diagram and failure mode and effect analysis (FMEA) risk assessment methods. The high risk attributes identified by the FMEA analysis were further explored using resolution V fractional factorial design. To gain an understanding of the processing parameters, a resolution V fractional factorial study was conducted. Using knowledge gained from the resolution V study, a resolution IV fractional factorial study was conducted; the purpose of this IV study was to identify the critical process parameters (CPP) that impact the critical quality attributes and understand the influence of these parameters on film formation. For both studies, the microclimate, atomization pressure, inlet air volume, product temperature (during spraying and curing), curing time, and percent solids in the coating solutions were studied. The responses evaluated were percent agglomeration, percent fines, percent yield, bead aspect ratio, median particle size diameter (d50), assay, and drug release rate. Pyrobuttons® were used to record real-time temperature and humidity changes in the fluid bed. The risk assessment methods and process analytical tools helped to understand the novel disk-jet technology and to systematically develop models of the coating process parameters like process efficiency and the extent of curing during the coating process.

Risk analysis for renewable energy projects due to constraints arising

NASA Astrophysics Data System (ADS)

Prostean, G.; Vasar, C.; Prostean, O.; Vartosu, A.

2016-02-01

Starting from the target of the European Union (EU) to use renewable energy in the area that aims a binding target of 20% renewable energy in final energy consumption by 2020, this article illustrates the identification of risks for implementation of wind energy projects in Romania, which could lead to complex technical implications, social and administrative. In specific projects analyzed in this paper were identified critical bottlenecks in the future wind power supply chain and reasonable time periods that may arise. Renewable energy technologies have to face a number of constraints that delayed scaling-up their production process, their transport process, the equipment reliability, etc. so implementing these types of projects requiring complex specialized team, the coordination of which also involve specific risks. The research team applied an analytical risk approach to identify major risks encountered within a wind farm project developed in Romania in isolated regions with different particularities, configured for different geographical areas (hill and mountain locations in Romania). Identification of major risks was based on the conceptual model set up for the entire project implementation process. Throughout this conceptual model there were identified specific constraints of such process. Integration risks were examined by an empirical study based on the method HAZOP (Hazard and Operability). The discussion describes the analysis of our results implementation context of renewable energy projects in Romania and creates a framework for assessing energy supply to any entity from renewable sources.

Use of evidential reasoning and AHP to assess regional industrial safety

PubMed Central

Chen, Zhichao; Chen, Tao; Qu, Zhuohua; Ji, Xuewei; Zhou, Yi; Zhang, Hui

2018-01-01

China’s fast economic growth contributes to the rapid development of its urbanization process, and also renders a series of industrial accidents, which often cause loss of life, damage to property and environment, thus requiring the associated risk analysis and safety control measures to be implemented in advance. However, incompleteness of historical failure data before the occurrence of accidents makes it difficult to use traditional risk analysis approaches such as probabilistic risk analysis in many cases. This paper aims to develop a new methodology capable of assessing regional industrial safety (RIS) in an uncertain environment. A hierarchical structure for modelling the risks influencing RIS is first constructed. The hybrid of evidential reasoning (ER) and Analytical Hierarchy Process (AHP) is then used to assess the risks in a complementary way, in which AHP is hired to evaluate the weight of each risk factor and ER is employed to synthesise the safety evaluations of the investigated region(s) against the risk factors from the bottom to the top level in the hierarchy. The successful application of the hybrid approach in a real case analysis of RIS in several major districts of Beijing (capital of China) demonstrates its feasibility as well as provides risk analysts and safety engineers with useful insights on effective solutions to comprehensive risk assessment of RIS in metropolitan cities. The contribution of this paper is made by the findings on the comparison of risk levels of RIS at different regions against various risk factors so that best practices from the good performer(s) can be used to improve the safety of the others. PMID:29795593

Use of evidential reasoning and AHP to assess regional industrial safety.

PubMed

Chen, Zhichao; Chen, Tao; Qu, Zhuohua; Yang, Zaili; Ji, Xuewei; Zhou, Yi; Zhang, Hui

2018-01-01

China's fast economic growth contributes to the rapid development of its urbanization process, and also renders a series of industrial accidents, which often cause loss of life, damage to property and environment, thus requiring the associated risk analysis and safety control measures to be implemented in advance. However, incompleteness of historical failure data before the occurrence of accidents makes it difficult to use traditional risk analysis approaches such as probabilistic risk analysis in many cases. This paper aims to develop a new methodology capable of assessing regional industrial safety (RIS) in an uncertain environment. A hierarchical structure for modelling the risks influencing RIS is first constructed. The hybrid of evidential reasoning (ER) and Analytical Hierarchy Process (AHP) is then used to assess the risks in a complementary way, in which AHP is hired to evaluate the weight of each risk factor and ER is employed to synthesise the safety evaluations of the investigated region(s) against the risk factors from the bottom to the top level in the hierarchy. The successful application of the hybrid approach in a real case analysis of RIS in several major districts of Beijing (capital of China) demonstrates its feasibility as well as provides risk analysts and safety engineers with useful insights on effective solutions to comprehensive risk assessment of RIS in metropolitan cities. The contribution of this paper is made by the findings on the comparison of risk levels of RIS at different regions against various risk factors so that best practices from the good performer(s) can be used to improve the safety of the others.

Foresight begins with FMEA. Delivering accurate risk assessments.

PubMed

Passey, R D

1999-03-01

If sufficient factors are taken into account and two- or three-stage analysis is employed, failure mode and effect analysis represents an excellent technique for delivering accurate risk assessments for products and processes, and for relating them to legal liability. This article describes a format that facilitates easy interpretation.

Results of research on development of an intellectual information system of bankruptcy risk assessment of the enterprise

NASA Astrophysics Data System (ADS)

Telipenko, E.; Chernysheva, T.; Zakharova, A.; Dumchev, A.

2015-10-01

The article represents research results about the knowledge base development for the intellectual information system for the bankruptcy risk assessment of the enterprise. It is described the process analysis of the knowledge base development; the main process stages, some problems and their solutions are given. The article introduces the connectionist model for the bankruptcy risk assessment based on the analysis of industrial enterprise financial accounting. The basis for this connectionist model is a three-layer perceptron with the back propagation of error algorithm. The knowledge base for the intellectual information system consists of processed information and the processing operation method represented as the connectionist model. The article represents the structure of the intellectual information system, the knowledge base, and the information processing algorithm for neural network training. The paper shows mean values of 10 indexes for industrial enterprises; with the help of them it is possible to carry out a financial analysis of industrial enterprises and identify correctly the current situation for well-timed managerial decisions. Results are given about neural network testing on the data of both bankrupt and financially strong enterprises, which were not included into training and test sets.

Red and processed meat intake and risk of bladder cancer: a meta-analysis

PubMed Central

Li, Fei; An, Shengli; Hou, Lina; Chen, Pengliang; Lei, Chengyong; Tan, Wanlong

2014-01-01

Findings from epidemiologic studies concerning red and processed meat intake and bladder cancer risk remain conflicting. Thus, we conducted this meta-analysis to examine the associations of red and processed meat intake with bladder cancer. Eligible studies published up to May 2014 were retrieved via both computer searches and review of references. Finally, we identified 14 studies on red meat (involving 9,084 cases) and 11 studies on processed meat (7,562 cases) involving up to 1,558,848 individuals. Random-effects models were used to estimate summary relative risk estimates (SRRE) based on high vs. low intake, and heterogeneity between study results was explored through stratified analyses on the basis of red/processed meat category, gender, study design and geographical region. Overall, the SRRE for all studies regarding red meat intake was 1.15 (95% CI: 0.97-1.36). Significant positive association was observed between processed meat consumption and bladder cancer (SRRE = 1.22; 95% CI: 1.04-1.43). Interestingly, increased by 25% and 33% risk of bladder cancer were observed for red meat and processed meat intake respectively in populations from the American continent. In conclusion, our fi ndings showed that there was an absence of an association between red meat intake and bladder cancer, but suggested that high consumption of processed meat probably correlated with rising risk of bladder cancer. In addition, positive relationships were observed regarding people intake of red and processed meat in the American continent. These findings need to be confirmed in future research. PMID:25232394

Risk analysis of sterile production plants: a new and simple, workable approach.

PubMed

Gapp, Guenther; Holzknecht, Peter

2011-01-01

A sterile active ingredient plant and a sterile finished dosage filling plant both comprise very complex production processes and systems. The sterility of the final product cannot be assured solely by sterility testing, in-process controls, environmental monitoring of cleanrooms, and media fill validations. Based on more than 15 years experience, 4 years ago the authors created a new but very simple approach to the risk analysis of sterile plants. This approach is not a failure mode and effects analysis and therefore differs from the PDA Technical Report 44 Quality Risk Management for Aseptic Processes of 2008. The principle involves specific questions, which have been defined in the risk analysis questionnaire in advance, to be answered by an expert team. If the questionnaire item is dealt with appropriately, the answer is assigned a low-risk number (1) and if very weak or deficient it gets a high-risk number (5). In addition to the numbers, colors from green (not problematic) through orange to red (very problematic) are attributed to make the results more striking. Because the individual units of each production plant have a defined and different impact on the overall sterility of the final product, different risk emphasis factors have to be taken into account (impact factor 1, 3, or 5). In a well run cleanroom, the cleanroom operators have a lower impact than other units with regard to the contamination risk. The resulting number of the analyzed production plant and the diagram of the assessment subsequently offers very important and valuable information about a) the risk for microbiological contamination (sterility/endotoxins) of the product, and b) the compliance status of the production plant and the risk of failing lots, as well as probable observations of upcoming regulatory agency audits. Both items above are highly important for the safety of the patient. It is also an ideal tool to identify deficient or weak systems requiring improvement and upgrade, and delivers sound arguments for investments. Practical experience with this risk analysis, which has already been executed in several production sites in various countries, has demonstrated that it is simple, workable, and delivers valuable information. Many important pharmaceutical products need to be sterile because they are to be injected into the patient's bloodstream or muscle. Sterile means that the product must be free of microorganisms (i.e., bacteria, yeast, and moulds). A non-sterile injection or infusion could lead to very serious or even lethal effects on the patient. Therefore one of the biggest challenges in the pharmaceutical industry nowadays is still the sterile production process itself. Microorganisms are everywhere in the environment, and humans are known to be a significant source of microbial contamination of a sterile product. It is necessary to set up a very effective quality assurance system as well as many quality control analysis tools to assure the sterility of the produced vials/syringes or of the bulk material intended for later filling into vials (bulk material, e.g., 10 kg in bags or cans). Above all, to get an accurate indication of the risk of non-compliance of product quality, regulatory agencies such as the U.S. Food and Drug Administration and the updated E.U. Good Manufacturing Practice (GMP) Guide have made it mandatory to perform a risk analysis of the production process. This provides in advance valuable information about the potential risk of a product's non-compliance with product specifications and GMP requirements, in our case regarding sterility. The authors set up a new approach for a risk analysis 4 years ago; this approach stems from fundamental experience gained over the past 15 years. Several specific questions are asked regarding various topics that correlate to the sterile production line and associated quality assurance/control systems. If the answer for an item is satisfactory and the best system is in place with regard to sterility, it is assessed with the prime rating of 1. If the topic is not satisfactory and very weak, the response is 5. Risk numbers from 2 to 4 are for intermediate situations. Because each unit of the production process could have a different type of impact of varying severity on the total product sterility, the average of the answers regarding the unit (e.g., 1, 2) is multiplied by the risk emphasis factor, which could be 1, 3, or 5. To make the rating even more distinct, colors are assigned from green (very good) through orange to red (very weak). There are currently three different risk analyses available for three different production processes. The results provide the users, that is, production personnel and quality assurance personnel, valuable feedback about the risk for possible non-sterility in their process as well as sound arguments to present to management defending upgrades of their production line and control systems in the case of high numbers and red colors. Three years of implementation have demonstrated that this new risk analysis approach works and is very useful in identifying potentially risky components of a production process, thus preventing in advance the production of non-sterile product batches for the market, and finally protecting the patient from hazardous products.

Adverse Drug Event Causality Analysis (ADECA): A Process for Evaluating Evidence and Assigning Drugs to Risk Categories for Sudden Death.

PubMed

Woosley, Raymond L; Romero, Klaus; Heise, Craig W; Gallo, Tyler; Tate, Jared; Woosley, Raymond David; Ward, Sophie

2017-06-01

Growing evidence indicates that many drugs have the ability to cause a potentially lethal cardiac arrhythmia, torsades de pointes (TdP). This necessitates the development of a compilation of drugs that have this potential toxicity. Such a list is helpful in identifying the etiology of TdP in patients taking multiple drugs and assists decision making by those caring for patients at high risk of TdP. The Arizona Center for Education and Research on Therapeutics (AZCERT) has developed a process to standardize the identification of drugs and place them in risk categories for their clinical ability to cause TdP and QT prolongation. AZCERT's Adverse Drug Event Causality Analysis (ADECA) utilizes 16 types of data drawn from four sources to compile an open-source knowledge base, QTdrugs, which is maintained on the CredibleMeds.org website. Because the evidence for most drugs is incomplete, the ADECA process is used to place drugs into one of three categories that represent different levels of certainty: known TdP risk, possible TdP risk, and conditional TdP risk. Each category has strict evidentiary requirements for clinical evidence of TdP and/or QT prolongation. These are described in this paper. Because evidence can evolve over time, the ADECA process includes the continuous gathering and analysis of newly emerging evidence to revise the lists. The QTdrugs lists have proven to be a valued, readily available, commercial influence-free resource for healthcare providers, patients, researchers, and authors of consensus guidelines for the safe use of medicines.

Risk-Based Approach for Microbiological Food Safety Management in the Dairy Industry: The Case of Listeria monocytogenes in Soft Cheese Made from Pasteurized Milk.

PubMed

Tenenhaus-Aziza, Fanny; Daudin, Jean-Jacques; Maffre, Alexandre; Sanaa, Moez

2014-01-01

According to Codex Alimentarius Commission recommendations, management options applied at the process production level should be based on good hygiene practices, HACCP system, and new risk management metrics such as the food safety objective. To follow this last recommendation, the use of quantitative microbiological risk assessment is an appealing approach to link new risk-based metrics to management options that may be applied by food operators. Through a specific case study, Listeria monocytogenes in soft cheese made from pasteurized milk, the objective of the present article is to practically show how quantitative risk assessment could be used to direct potential intervention strategies at different food processing steps. Based on many assumptions, the model developed estimates the risk of listeriosis at the moment of consumption taking into account the entire manufacturing process and potential sources of contamination. From pasteurization to consumption, the amplification of a primo-contamination event of the milk, the fresh cheese or the process environment is simulated, over time, space, and between products, accounting for the impact of management options, such as hygienic operations and sampling plans. A sensitivity analysis of the model will help orientating data to be collected prioritarily for the improvement and the validation of the model. What-if scenarios were simulated and allowed for the identification of major parameters contributing to the risk of listeriosis and the optimization of preventive and corrective measures. © 2013 Society for Risk Analysis.

Framework for managing mycotoxin risks in the food industry.

PubMed

Baker, Robert C; Ford, Randall M; Helander, Mary E; Marecki, Janusz; Natarajan, Ramesh; Ray, Bonnie

2014-12-01

We propose a methodological framework for managing mycotoxin risks in the food processing industry. Mycotoxin contamination is a well-known threat to public health that has economic significance for the food processing industry; it is imperative to address mycotoxin risks holistically, at all points in the procurement, processing, and distribution pipeline, by tracking the relevant data, adopting best practices, and providing suitable adaptive controls. The proposed framework includes (i) an information and data repository, (ii) a collaborative infrastructure with analysis and simulation tools, (iii) standardized testing and acceptance sampling procedures, and (iv) processes that link the risk assessments and testing results to the sourcing, production, and product release steps. The implementation of suitable acceptance sampling protocols for mycotoxin testing is considered in some detail.

Information Processing and Risk Perception: An Adaptation of the Heuristic-Systematic Model.

ERIC Educational Resources Information Center

Trumbo, Craig W.

2002-01-01

Describes heuristic-systematic information-processing model and risk perception--the two major conceptual areas of the analysis. Discusses the proposed model, describing the context of the data collections (public health communication involving cancer epidemiology) and providing the results of a set of three replications using the proposed model.…

Using Fuzzy Analytic Hierarchy Process multicriteria and Geographical information system for coastal vulnerability analysis in Morocco: The case of Mohammedia

NASA Astrophysics Data System (ADS)

Tahri, Meryem; Maanan, Mohamed; Hakdaoui, Mustapha

2016-04-01

This paper shows a method to assess the vulnerability of coastal risks such as coastal erosion or submarine applying Fuzzy Analytic Hierarchy Process (FAHP) and spatial analysis techniques with Geographic Information System (GIS). The coast of the Mohammedia located in Morocco was chosen as the study site to implement and validate the proposed framework by applying a GIS-FAHP based methodology. The coastal risk vulnerability mapping follows multi-parametric causative factors as sea level rise, significant wave height, tidal range, coastal erosion, elevation, geomorphology and distance to an urban area. The Fuzzy Analytic Hierarchy Process methodology enables the calculation of corresponding criteria weights. The result shows that the coastline of the Mohammedia is characterized by a moderate, high and very high level of vulnerability to coastal risk. The high vulnerability areas are situated in the east at Monika and Sablette beaches. This technical approach is based on the efficiency of the Geographic Information System tool based on Fuzzy Analytical Hierarchy Process to help decision maker to find optimal strategies to minimize coastal risks.

Gambler Risk Perception: A Mental Model and Grounded Theory Analysis.

PubMed

Spurrier, Michael; Blaszczynski, Alexander; Rhodes, Paul

2015-09-01

Few studies have investigated how gamblers perceive risk or the role of risk perception in disordered gambling. The purpose of the current study therefore was to obtain data on lay gamblers' beliefs on these variables and their effects on decision-making, behaviour, and disordered gambling aetiology. Fifteen regular lay gamblers (non-problem/low risk, moderate risk and problem gamblers) completed a semi-structured interview following mental models and grounded theory methodologies. Gambler interview data was compared to an expert 'map' of risk-perception, to identify comparative gaps or differences associated with harmful or safe gambling. Systematic overlapping processes of data gathering and analysis were used to iteratively extend, saturate, test for exception, and verify concepts and themes emerging from the data. The preliminary findings suggested that gambler accounts supported the presence of expert conceptual constructs, and to some degree the role of risk perception in protecting against or increasing vulnerability to harm and disordered gambling. Gambler accounts of causality, meaning, motivation, and strategy were highly idiosyncratic, and often contained content inconsistent with measures of disordered gambling. Disordered gambling appears heavily influenced by relative underestimation of risk and overvaluation of gambling, based on explicit and implicit analysis, and deliberate, innate, contextual, and learned processing evaluations and biases.

Strategic and Market Analysis | Bioenergy | NREL

Science.gov Websites

recent efforts in comparative techno-economic analysis. Our analysis considers a wide range of conversion Intermediates NREL has developed first-of-its-kind process models and economic assessments of the co-processing work strives to understand the economic incentives, technical risks, and key data gaps that need to be

Usage of information safety requirements in improving tube bending process

NASA Astrophysics Data System (ADS)

Livshitz, I. I.; Kunakov, E.; Lontsikh, P. A.

2018-05-01

This article is devoted to an improvement of the technological process's analysis with the information security requirements implementation. The aim of this research is the competition increase analysis in aircraft industry enterprises due to the information technology implementation by the example of the tube bending technological process. The article analyzes tube bending kinds and current technique. In addition, a potential risks analysis in a tube bending technological process is carried out in terms of information security.

[Risk management--a new aspect of quality assessment in intensive care medicine: first results of an analysis of the DIVI's interdisciplinary quality assessment research group].

PubMed

Stiletto, R; Röthke, M; Schäfer, E; Lefering, R; Waydhas, Ch

2006-10-01

Patient security has become one of the major aspects of clinical management in recent years. The crucial point in research was focused on malpractice. In contradiction to the economic process in non medical fields, the analysis of errors during the in-patient treatment time was neglected. Patient risk management can be defined as a structured procedure in a clinical unit with the aim to reduce harmful events. A risk point model was created based on a Delphi process and founded on the DIVI data register. The risk point model was evaluated in clinically working ICU departments participating in the register data base. The results of the risk point evaluation will be integrated in the next data base update. This might be a step to improve the reliability of the register to measure quality assessment in the ICU.

Atlas-guided volumetric diffuse optical tomography enhanced by generalized linear model analysis to image risk decision-making responses in young adults.

PubMed

Lin, Zi-Jing; Li, Lin; Cazzell, Mary; Liu, Hanli

2014-08-01

Diffuse optical tomography (DOT) is a variant of functional near infrared spectroscopy and has the capability of mapping or reconstructing three dimensional (3D) hemodynamic changes due to brain activity. Common methods used in DOT image analysis to define brain activation have limitations because the selection of activation period is relatively subjective. General linear model (GLM)-based analysis can overcome this limitation. In this study, we combine the atlas-guided 3D DOT image reconstruction with GLM-based analysis (i.e., voxel-wise GLM analysis) to investigate the brain activity that is associated with risk decision-making processes. Risk decision-making is an important cognitive process and thus is an essential topic in the field of neuroscience. The Balloon Analog Risk Task (BART) is a valid experimental model and has been commonly used to assess human risk-taking actions and tendencies while facing risks. We have used the BART paradigm with a blocked design to investigate brain activations in the prefrontal and frontal cortical areas during decision-making from 37 human participants (22 males and 15 females). Voxel-wise GLM analysis was performed after a human brain atlas template and a depth compensation algorithm were combined to form atlas-guided DOT images. In this work, we wish to demonstrate the excellence of using voxel-wise GLM analysis with DOT to image and study cognitive functions in response to risk decision-making. Results have shown significant hemodynamic changes in the dorsal lateral prefrontal cortex (DLPFC) during the active-choice mode and a different activation pattern between genders; these findings correlate well with published literature in functional magnetic resonance imaging (fMRI) and fNIRS studies. Copyright © 2014 The Authors. Human Brain Mapping Published by Wiley Periodicals, Inc.

FMEA of manual and automated methods for commissioning a radiotherapy treatment planning system.

PubMed

Wexler, Amy; Gu, Bruce; Goddu, Sreekrishna; Mutic, Maya; Yaddanapudi, Sridhar; Olsen, Lindsey; Harry, Taylor; Noel, Camille; Pawlicki, Todd; Mutic, Sasa; Cai, Bin

2017-09-01

To evaluate the level of risk involved in treatment planning system (TPS) commissioning using a manual test procedure, and to compare the associated process-based risk to that of an automated commissioning process (ACP) by performing an in-depth failure modes and effects analysis (FMEA). The authors collaborated to determine the potential failure modes of the TPS commissioning process using (a) approaches involving manual data measurement, modeling, and validation tests and (b) an automated process utilizing application programming interface (API) scripting, preloaded, and premodeled standard radiation beam data, digital heterogeneous phantom, and an automated commissioning test suite (ACTS). The severity (S), occurrence (O), and detectability (D) were scored for each failure mode and the risk priority numbers (RPN) were derived based on TG-100 scale. Failure modes were then analyzed and ranked based on RPN. The total number of failure modes, RPN scores and the top 10 failure modes with highest risk were described and cross-compared between the two approaches. RPN reduction analysis is also presented and used as another quantifiable metric to evaluate the proposed approach. The FMEA of a MTP resulted in 47 failure modes with an RPN ave of 161 and S ave of 6.7. The highest risk process of "Measurement Equipment Selection" resulted in an RPN max of 640. The FMEA of an ACP resulted in 36 failure modes with an RPN ave of 73 and S ave of 6.7. The highest risk process of "EPID Calibration" resulted in an RPN max of 576. An FMEA of treatment planning commissioning tests using automation and standardization via API scripting, preloaded, and pre-modeled standard beam data, and digital phantoms suggests that errors and risks may be reduced through the use of an ACP. © 2017 American Association of Physicists in Medicine.

Assessment and management of the performance risk of a pilot reclaimed water disinfection process.

PubMed

Zhou, Guangyu; Zhao, Xinhua; Zhang, Lei; Wu, Qing

2013-10-01

Chlorination disinfection has been widely used in reclaimed water treatment plants to ensure water quality. In order to assess the downstream quality risk of a running reclaimed water disinfection process, a set of dynamic equations was developed to simulate reactions in the disinfection process concerning variables of bacteria, chemical oxygen demand (COD), ammonia and monochloramine. The model was calibrated by the observations obtained from a pilot disinfection process which was designed to simulate the actual process in a reclaimed water treatment plant. A Monte Carlo algorithm was applied to calculate the predictive effluent quality distributions that were used in the established hierarchical assessment system for the downstream quality risk, and the key factors affecting the downstream quality risk were defined using the Regional Sensitivity Analysis method. The results showed that the seasonal upstream quality variation caused considerable downstream quality risk; the effluent ammonia was significantly influenced by its upstream concentration; the upstream COD was a key factor determining the process effluent risk of bacterial, COD and residual disinfectant indexes; and lower COD and ammonia concentrations in the influent would mean better downstream quality.

Failure mode and effects analysis and fault tree analysis of surface image guided cranial radiosurgery.

PubMed

Manger, Ryan P; Paxton, Adam B; Pawlicki, Todd; Kim, Gwe-Ya

2015-05-01

Surface image guided, Linac-based radiosurgery (SIG-RS) is a modern approach for delivering radiosurgery that utilizes optical stereoscopic imaging to monitor the surface of the patient during treatment in lieu of using a head frame for patient immobilization. Considering the novelty of the SIG-RS approach and the severity of errors associated with delivery of large doses per fraction, a risk assessment should be conducted to identify potential hazards, determine their causes, and formulate mitigation strategies. The purpose of this work is to investigate SIG-RS using the combined application of failure modes and effects analysis (FMEA) and fault tree analysis (FTA), report on the effort required to complete the analysis, and evaluate the use of FTA in conjunction with FMEA. A multidisciplinary team was assembled to conduct the FMEA on the SIG-RS process. A process map detailing the steps of the SIG-RS was created to guide the FMEA. Failure modes were determined for each step in the SIG-RS process, and risk priority numbers (RPNs) were estimated for each failure mode to facilitate risk stratification. The failure modes were ranked by RPN, and FTA was used to determine the root factors contributing to the riskiest failure modes. Using the FTA, mitigation strategies were formulated to address the root factors and reduce the risk of the process. The RPNs were re-estimated based on the mitigation strategies to determine the margin of risk reduction. The FMEA and FTAs for the top two failure modes required an effort of 36 person-hours (30 person-hours for the FMEA and 6 person-hours for two FTAs). The SIG-RS process consisted of 13 major subprocesses and 91 steps, which amounted to 167 failure modes. Of the 91 steps, 16 were directly related to surface imaging. Twenty-five failure modes resulted in a RPN of 100 or greater. Only one of these top 25 failure modes was specific to surface imaging. The riskiest surface imaging failure mode had an overall RPN-rank of eighth. Mitigation strategies for the top failure mode decreased the RPN from 288 to 72. Based on the FMEA performed in this work, the use of surface imaging for monitoring intrafraction position in Linac-based stereotactic radiosurgery (SRS) did not greatly increase the risk of the Linac-based SRS process. In some cases, SIG helped to reduce the risk of Linac-based RS. The FMEA was augmented by the use of FTA since it divided the failure modes into their fundamental components, which simplified the task of developing mitigation strategies.

Risk Management in Biologics Technology Transfer.

PubMed

Toso, Robert; Tsang, Jonathan; Xie, Jasmina; Hohwald, Stephen; Bain, David; Willison-Parry, Derek

Technology transfer of biological products is a complex process that is important for product commercialization. To achieve a successful technology transfer, the risks that arise from changes throughout the project must be managed. Iterative risk analysis and mitigation tools can be used to both evaluate and reduce risk. The technology transfer stage gate model is used as an example tool to help manage risks derived from both designed process change and unplanned changes that arise due to unforeseen circumstances. The strategy of risk assessment for a change can be tailored to the type of change. In addition, a cross-functional team and centralized documentation helps maximize risk management efficiency to achieve a successful technology transfer. © PDA, Inc. 2016.

Impact of model-based risk analysis for liver surgery planning.

PubMed

Hansen, C; Zidowitz, S; Preim, B; Stavrou, G; Oldhafer, K J; Hahn, H K

2014-05-01

A model-based risk analysis for oncologic liver surgery was described in previous work (Preim et al. in Proceedings of international symposium on computer assisted radiology and surgery (CARS), Elsevier, Amsterdam, pp. 353–358, 2002; Hansen et al. Int I Comput Assist Radiol Surg 4(5):469–474, 2009). In this paper, we present an evaluation of this method. To prove whether and how the risk analysis facilitates the process of liver surgery planning, an explorative user study with 10 liver experts was conducted. The purpose was to compare and analyze their decision-making. The results of the study show that model-based risk analysis enhances the awareness of surgical risk in the planning stage. Participants preferred smaller resection volumes and agreed more on the safety margins’ width in case the risk analysis was available. In addition, time to complete the planning task and confidence of participants were not increased when using the risk analysis. This work shows that the applied model-based risk analysis may influence important planning decisions in liver surgery. It lays a basis for further clinical evaluations and points out important fields for future research.

Enhancing the ecological risk assessment process.

PubMed

Dale, Virginia H; Biddinger, Gregory R; Newman, Michael C; Oris, James T; Suter, Glenn W; Thompson, Timothy; Armitage, Thomas M; Meyer, Judith L; Allen-King, Richelle M; Burton, G Allen; Chapman, Peter M; Conquest, Loveday L; Fernandez, Ivan J; Landis, Wayne G; Master, Lawrence L; Mitsch, William J; Mueller, Thomas C; Rabeni, Charles F; Rodewald, Amanda D; Sanders, James G; van Heerden, Ivor L

2008-07-01

The Ecological Processes and Effects Committee of the US Environmental Protection Agency Science Advisory Board conducted a self-initiated study and convened a public workshop to characterize the state of the ecological risk assessment (ERA), with a view toward advancing the science and application of the process. That survey and analysis of ERA in decision making shows that such assessments have been most effective when clear management goals were included in the problem formulation; translated into information needs; and developed in collaboration with decision makers, assessors, scientists, and stakeholders. This process is best facilitated when risk managers, risk assessors, and stakeholders are engaged in an ongoing dialogue about problem formulation. Identification and acknowledgment of uncertainties that have the potential to profoundly affect the results and outcome of risk assessments also improves assessment effectiveness. Thus we suggest 1) through peer review of ERAs be conducted at the problem formulation stage and 2) the predictive power of risk-based decision making be expanded to reduce uncertainties through analytical and methodological approaches like life cycle analysis. Risk assessment and monitoring programs need better integration to reduce uncertainty and to evaluate risk management decision outcomes. Postdecision audit programs should be initiated to evaluate the environmental outcomes of risk-based decisions. In addition, a process should be developed to demonstrate how monitoring data can be used to reduce uncertainties. Ecological risk assessments should include the effects of chemical and nonchemical stressors at multiple levels of biological organization and spatial scale, and the extent and resolution of the pertinent scales and levels of organization should be explicitly considered during problem formulation. An approach to interpreting lines of evidence and weight of evidence is critically needed for complex assessments, and it would be useful to develop case studies and/or standards of practice for interpreting lines of evidence. In addition, tools for cumulative risk assessment should be developed because contaminants are often released into stressed environments.

Red and processed meat consumption and breast cancer: UK Biobank cohort study and meta-analysis.

PubMed

Anderson, Jana J; Darwis, Narisa D M; Mackay, Daniel F; Celis-Morales, Carlos A; Lyall, Donald M; Sattar, Naveed; Gill, Jason M R; Pell, Jill P

2018-02-01

Red and processed meat may be risk factors for breast cancer due to their iron content, administration of oestrogens to cattle or mutagens created during cooking. We studied the associations in UK Biobank and then included the results in a meta-analysis of published cohort studies. UK Biobank, a general population cohort study, recruited participants aged 40-69 years. Incident breast cancer was ascertained via linkage to routine hospital admission, cancer registry and death certificate data. Univariate and multivariable Cox proportional hazard models were used to explore the associations between red and processed meat consumption and breast cancer. Previously published cohort studies were identified from a systematic review using PubMed and Ovid and a meta-analysis conducted using a random effects model. Over a median of 7 years follow-up, 4819 of the 262,195 women developed breast cancer. The risk was increased in the highest tertile (>9 g/day) of processed meat consumption (adjusted hazard ratio [HR] 1.21, 95% confidence interval [CI] 1.08-1.35, p = 0.001). Collation with 10 previous cohort studies provided data on 40,257 incident breast cancers in 1.65 million women. On meta-analysis, processed meat consumption was associated with overall (relative risk [RR] 1.06, 95% CI 1.01-1.11) and post-menopausal (RR 1.09, 95% CI 1.03-1.15), but not pre-menopausal (RR 0.99, 95% CI 0.88-1.10), breast cancer. In UK Biobank and the meta-analysis, red meat consumption was not associated with breast cancer (adjusted HR 0.99 95% CI 0.88-1.12 and RR 1.03, 95% CI 0.99-1.08, respectively). Consumption of processed meat, but not red meat, may increase the risk of breast cancer. Crown Copyright © 2017. Published by Elsevier Ltd. All rights reserved.

Application of ICH Q9 Quality Risk Management Tools for Advanced Development of Hot Melt Coated Multiparticulate Systems.

PubMed

Stocker, Elena; Becker, Karin; Hate, Siddhi; Hohl, Roland; Schiemenz, Wolfgang; Sacher, Stephan; Zimmer, Andreas; Salar-Behzadi, Sharareh

2017-01-01

This study aimed to apply quality risk management based on the The International Conference on Harmonisation guideline Q9 for the early development stage of hot melt coated multiparticulate systems for oral administration. N-acetylcysteine crystals were coated with a formulation composing tripalmitin and polysorbate 65. The critical quality attributes (CQAs) were initially prioritized using failure mode and effects analysis. The CQAs of the coated material were defined as particle size, taste-masking efficiency, and immediate release profile. The hot melt coated process was characterized via a flowchart, based on the identified potential critical process parameters (CPPs) and their impact on the CQAs. These CPPs were prioritized using a process failure mode, effects, and criticality analysis and their critical impact on the CQAs was experimentally confirmed using a statistical design of experiments. Spray rate, atomization air pressure, and air flow rate were identified as CPPs. Coating amount and content of polysorbate 65 in the coating formulation were identified as critical material attributes. A hazard and critical control points analysis was applied to define control strategies at the critical process points. A fault tree analysis evaluated causes for potential process failures. We successfully demonstrated that a standardized quality risk management approach optimizes the product development sustainability and supports the regulatory aspects. Copyright © 2016 American Pharmacists Association®. Published by Elsevier Inc. All rights reserved.

78 FR 17142 - Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-03-20

... Manufacturing Practice and Hazard Analysis and Risk- Based Preventive Controls for Human Food; Correction AGENCY... manufacturing, packing, or holding human food (CGMPs) to modernize it and to add requirements for domestic and... ``food-production purposes (i.e., manufacturing, processing, packing, and holding) to consistently use...

Reliability and Probabilistic Risk Assessment - How They Play Together

NASA Technical Reports Server (NTRS)

Safie, Fayssal M.; Stutts, Richard G.; Zhaofeng, Huang

2015-01-01

PRA methodology is one of the probabilistic analysis methods that NASA brought from the nuclear industry to assess the risk of LOM, LOV and LOC for launch vehicles. PRA is a system scenario based risk assessment that uses a combination of fault trees, event trees, event sequence diagrams, and probability and statistical data to analyze the risk of a system, a process, or an activity. It is a process designed to answer three basic questions: What can go wrong? How likely is it? What is the severity of the degradation? Since 1986, NASA, along with industry partners, has conducted a number of PRA studies to predict the overall launch vehicles risks. Planning Research Corporation conducted the first of these studies in 1988. In 1995, Science Applications International Corporation (SAIC) conducted a comprehensive PRA study. In July 1996, NASA conducted a two-year study (October 1996 - September 1998) to develop a model that provided the overall Space Shuttle risk and estimates of risk changes due to proposed Space Shuttle upgrades. After the Columbia accident, NASA conducted a PRA on the Shuttle External Tank (ET) foam. This study was the most focused and extensive risk assessment that NASA has conducted in recent years. It used a dynamic, physics-based, integrated system analysis approach to understand the integrated system risk due to ET foam loss in flight. Most recently, a PRA for Ares I launch vehicle has been performed in support of the Constellation program. Reliability, on the other hand, addresses the loss of functions. In a broader sense, reliability engineering is a discipline that involves the application of engineering principles to the design and processing of products, both hardware and software, for meeting product reliability requirements or goals. It is a very broad design-support discipline. It has important interfaces with many other engineering disciplines. Reliability as a figure of merit (i.e. the metric) is the probability that an item will perform its intended function(s) for a specified mission profile. In general, the reliability metric can be calculated through the analyses using reliability demonstration and reliability prediction methodologies. Reliability analysis is very critical for understanding component failure mechanisms and in identifying reliability critical design and process drivers. The following sections discuss the PRA process and reliability engineering in detail and provide an application where reliability analysis and PRA were jointly used in a complementary manner to support a Space Shuttle flight risk assessment.

[How the information system can contribute to the implementation of a risk management program in a hospital?].

PubMed

Staccini, P; Quaranta, J F; Staccini-Myx, A; Veyres, P; Jambou, P

2003-09-01

Nowadays, information system is recognised as one of the key points of the management strategy. An information system is regarded conceptualised as a mean to link 3 aspects of a firm (structure, organisation rules and staff). Its design and implementation have to meet the objectives of medical and economical evaluation, especially risk management objectives. In order to identify, analyse, reduce and prevent the occurrence of adverse events, and also to measure the efficacy and efficiency of the production of care services, the design of information systems should be based on a process analysis in order to describe and classify all the working practices within the hospital. According to various methodologies (usually top-down analysis), each process can be divided into activities. Each activity (especially each care activity) can be described according to its potential risks and expected results. For care professionals performing a task, the access to official or internal guidelines and the adverse events reporting forms has also to be defined. Putting together all the elements of such a process analysis will contribute to integrate, into daily practice, the management of risks, supported by the information system.

Failure mode and effects analysis using intuitionistic fuzzy hybrid weighted Euclidean distance operator

NASA Astrophysics Data System (ADS)

Liu, Hu-Chen; Liu, Long; Li, Ping

2014-10-01

Failure mode and effects analysis (FMEA) has shown its effectiveness in examining potential failures in products, process, designs or services and has been extensively used for safety and reliability analysis in a wide range of industries. However, its approach to prioritise failure modes through a crisp risk priority number (RPN) has been criticised as having several shortcomings. The aim of this paper is to develop an efficient and comprehensive risk assessment methodology using intuitionistic fuzzy hybrid weighted Euclidean distance (IFHWED) operator to overcome the limitations and improve the effectiveness of the traditional FMEA. The diversified and uncertain assessments given by FMEA team members are treated as linguistic terms expressed in intuitionistic fuzzy numbers (IFNs). Intuitionistic fuzzy weighted averaging (IFWA) operator is used to aggregate the FMEA team members' individual assessments into a group assessment. IFHWED operator is applied thereafter to the prioritisation and selection of failure modes. Particularly, both subjective and objective weights of risk factors are considered during the risk evaluation process. A numerical example for risk assessment is given to illustrate the proposed method finally.

Reliability and Probabilistic Risk Assessment - How They Play Together

NASA Technical Reports Server (NTRS)

Safie, Fayssal; Stutts, Richard; Huang, Zhaofeng

2015-01-01

Since the Space Shuttle Challenger accident in 1986, NASA has extensively used probabilistic analysis methods to assess, understand, and communicate the risk of space launch vehicles. Probabilistic Risk Assessment (PRA), used in the nuclear industry, is one of the probabilistic analysis methods NASA utilizes to assess Loss of Mission (LOM) and Loss of Crew (LOC) risk for launch vehicles. PRA is a system scenario based risk assessment that uses a combination of fault trees, event trees, event sequence diagrams, and probability distributions to analyze the risk of a system, a process, or an activity. It is a process designed to answer three basic questions: 1) what can go wrong that would lead to loss or degraded performance (i.e., scenarios involving undesired consequences of interest), 2) how likely is it (probabilities), and 3) what is the severity of the degradation (consequences). Since the Challenger accident, PRA has been used in supporting decisions regarding safety upgrades for launch vehicles. Another area that was given a lot of emphasis at NASA after the Challenger accident is reliability engineering. Reliability engineering has been a critical design function at NASA since the early Apollo days. However, after the Challenger accident, quantitative reliability analysis and reliability predictions were given more scrutiny because of their importance in understanding failure mechanism and quantifying the probability of failure, which are key elements in resolving technical issues, performing design trades, and implementing design improvements. Although PRA and reliability are both probabilistic in nature and, in some cases, use the same tools, they are two different activities. Specifically, reliability engineering is a broad design discipline that deals with loss of function and helps understand failure mechanism and improve component and system design. PRA is a system scenario based risk assessment process intended to assess the risk scenarios that could lead to a major/top undesirable system event, and to identify those scenarios that are high-risk drivers. PRA output is critical to support risk informed decisions concerning system design. This paper describes the PRA process and the reliability engineering discipline in detail. It discusses their differences and similarities and how they work together as complementary analyses to support the design and risk assessment processes. Lessons learned, applications, and case studies in both areas are also discussed in the paper to demonstrate and explain these differences and similarities.

Incident Learning and Failure-Mode-and-Effects-Analysis Guided Safety Initiatives in Radiation Medicine

PubMed Central

Kapur, Ajay; Goode, Gina; Riehl, Catherine; Zuvic, Petrina; Joseph, Sherin; Adair, Nilda; Interrante, Michael; Bloom, Beatrice; Lee, Lucille; Sharma, Rajiv; Sharma, Anurag; Antone, Jeffrey; Riegel, Adam; Vijeh, Lili; Zhang, Honglai; Cao, Yijian; Morgenstern, Carol; Montchal, Elaine; Cox, Brett; Potters, Louis

2013-01-01

By combining incident learning and process failure-mode-and-effects-analysis (FMEA) in a structure-process-outcome framework we have created a risk profile for our radiation medicine practice and implemented evidence-based risk-mitigation initiatives focused on patient safety. Based on reactive reviews of incidents reported in our departmental incident-reporting system and proactive FMEA, high safety-risk procedures in our paperless radiation medicine process and latent risk factors were identified. Six initiatives aimed at the mitigation of associated severity, likelihood-of-occurrence, and detectability risks were implemented. These were the standardization of care pathways and toxicity grading, pre-treatment-planning peer review, a policy to thwart delay-rushed processes, an electronic whiteboard to enhance coordination, and the use of six sigma metrics to monitor operational efficiencies. The effectiveness of these initiatives over a 3-years period was assessed using process and outcome specific metrics within the framework of the department structure. There has been a 47% increase in incident-reporting, with no increase in adverse events. Care pathways have been used with greater than 97% clinical compliance rate. The implementation of peer review prior to treatment-planning and use of the whiteboard have provided opportunities for proactive detection and correction of errors. There has been a twofold drop in the occurrence of high-risk procedural delays. Patient treatment start delays are routinely enforced on cases that would have historically been rushed. Z-scores for high-risk procedures have steadily improved from 1.78 to 2.35. The initiatives resulted in sustained reductions of failure-mode risks as measured by a set of evidence-based metrics over a 3-years period. These augment or incorporate many of the published recommendations for patient safety in radiation medicine by translating them to clinical practice. PMID:24380074

TU-FG-201-12: Designing a Risk-Based Quality Assurance Program for a Newly Implemented Y-90 Microspheres Procedure

DOE Office of Scientific and Technical Information (OSTI.GOV)

Vile, D; Zhang, L; Cuttino, L

2016-06-15

Purpose: To create a quality assurance program based upon a risk-based assessment of a newly implemented SirSpheres Y-90 procedure. Methods: A process map was created for a newly implemented SirSpheres procedure at a community hospital. The process map documented each step of this collaborative procedure, as well as the roles and responsibilities of each member. From the process map, different potential failure modes were determined as well as any current controls in place. From this list, a full failure mode and effects analysis (FMEA) was performed by grading each failure mode’s likelihood of occurrence, likelihood of detection, and potential severity.more » These numbers were then multiplied to compute the risk priority number (RPN) for each potential failure mode. Failure modes were then ranked based on their RPN. Additional controls were then added, with failure modes corresponding to the highest RPNs taking priority. Results: A process map was created that succinctly outlined each step in the SirSpheres procedure in its current implementation. From this, 72 potential failure modes were identified and ranked according to their associated RPN. Quality assurance controls and safety barriers were then added for failure modes associated with the highest risk being addressed first. Conclusion: A quality assurance program was created from a risk-based assessment of the SirSpheres process. Process mapping and FMEA were effective in identifying potential high-risk failure modes for this new procedure, which were prioritized for new quality assurance controls. TG 100 recommends the fault tree analysis methodology to design a comprehensive and effective QC/QM program, yet we found that by simply introducing additional safety barriers to address high RPN failure modes makes the whole process simpler and safer.« less

Risk analysis for autonomous underwater vehicle operations in extreme environments.

PubMed

Brito, Mario Paulo; Griffiths, Gwyn; Challenor, Peter

2010-12-01

Autonomous underwater vehicles (AUVs) are used increasingly to explore hazardous marine environments. Risk assessment for such complex systems is based on subjective judgment and expert knowledge as much as on hard statistics. Here, we describe the use of a risk management process tailored to AUV operations, the implementation of which requires the elicitation of expert judgment. We conducted a formal judgment elicitation process where eight world experts in AUV design and operation were asked to assign a probability of AUV loss given the emergence of each fault or incident from the vehicle's life history of 63 faults and incidents. After discussing methods of aggregation and analysis, we show how the aggregated risk estimates obtained from the expert judgments were used to create a risk model. To estimate AUV survival with mission distance, we adopted a statistical survival function based on the nonparametric Kaplan-Meier estimator. We present theoretical formulations for the estimator, its variance, and confidence limits. We also present a numerical example where the approach is applied to estimate the probability that the Autosub3 AUV would survive a set of missions under Pine Island Glacier, Antarctica in January-March 2009. © 2010 Society for Risk Analysis.

Periodic benefit-risk assessment using Bayesian stochastic multi-criteria acceptability analysis

PubMed Central

Li, Kan; Yuan, Shuai Sammy; Wang, William; Wan, Shuyan Sabrina; Ceesay, Paulette; Heyse, Joseph F.; Mt-Isa, Shahrul; Luo, Sheng

2018-01-01

Benefit-risk (BR) assessment is essential to ensure the best decisions are made for a medical product in the clinical development process, regulatory marketing authorization, post-market surveillance, and coverage and reimbursement decisions. One challenge of BR assessment in practice is that the benefit and risk profile may keep evolving while new evidence is accumulating. Regulators and the International Conference on Harmonization (ICH) recommend performing periodic benefit-risk evaluation report (PBRER) through the product's lifecycle. In this paper, we propose a general statistical framework for periodic benefit-risk assessment, in which Bayesian meta-analysis and stochastic multi-criteria acceptability analysis (SMAA) will be combined to synthesize the accumulating evidence. The proposed approach allows us to compare the acceptability of different drugs dynamically and effectively and accounts for the uncertainty of clinical measurements and imprecise or incomplete preference information of decision makers. We apply our approaches to two real examples in a post-hoc way for illustration purpose. The proposed method may easily be modified for other pre and post market settings, and thus be an important complement to the current structured benefit-risk assessment (sBRA) framework to improve the transparent and consistency of the decision-making process. PMID:29505866

Considering Risk and Resilience in Decision-Making

NASA Technical Reports Server (NTRS)

Torres-Pomales, Wilfredo

2015-01-01

This paper examines the concepts of decision-making, risk analysis, uncertainty and resilience analysis. The relation between risk, vulnerability, and resilience is analyzed. The paper describes how complexity, uncertainty, and ambiguity are the most critical factors in the definition of the approach and criteria for decision-making. Uncertainty in its various forms is what limits our ability to offer definitive answers to questions about the outcomes of alternatives in a decision-making process. It is shown that, although resilience-informed decision-making would seem fundamentally different from risk-informed decision-making, this is not the case as resilience-analysis can be easily incorporated within existing analytic-deliberative decision-making frameworks.

Essays in financial economics and econometrics

NASA Astrophysics Data System (ADS)

La Spada, Gabriele

Chapter 1 (my job market paper) asks the following question: Do asset managers reach for yield because of competitive pressures in a low rate environment? I propose a tournament model of money market funds (MMFs) to study this issue. I show that funds with different costs of default respond differently to changes in interest rates, and that it is important to distinguish the role of risk-free rates from that of risk premia. An increase in the risk premium leads funds with lower default costs to increase risk-taking, while funds with higher default costs reduce risk-taking. Without changes in the premium, low risk-free rates reduce risk-taking. My empirical analysis shows that these predictions are consistent with the risk-taking of MMFs during the 2006--2008 period. Chapter 2, co-authored with Fabrizio Lillo and published in Studies in Nonlinear Dynamics and Econometrics (2014), studies the effect of round-off error (or discretization) on stationary Gaussian long-memory process. For large lags, the autocovariance is rescaled by a factor smaller than one, and we compute this factor exactly. Hence, the discretized process has the same Hurst exponent as the underlying one. We show that in presence of round-off error, two common estimators of the Hurst exponent, the local Whittle (LW) estimator and the detrended fluctuation analysis (DFA), are severely negatively biased in finite samples. We derive conditions for consistency and asymptotic normality of the LW estimator applied to discretized processes and compute the asymptotic properties of the DFA for generic long-memory processes that encompass discretized processes. Chapter 3, co-authored with Fabrizio Lillo, studies the effect of round-off error on integrated Gaussian processes with possibly correlated increments. We derive the variance and kurtosis of the realized increment process in the limit of both "small" and "large" round-off errors, and its autocovariance for large lags. We propose novel estimators for the variance and lag-one autocorrelation of the underlying, unobserved increment process. We also show that for fractionally integrated processes, the realized increments have the same Hurst exponent as the underlying ones, but the LW estimator applied to the realized series is severely negatively biased in medium-sized samples.

Knowledge and expectations of women undergoing cancer genetic risk assessment: a qualitative analysis of free-text questionnaire comments.

PubMed

Phelps, C; Wood, F; Bennett, P; Brain, K; Gray, J

2007-08-01

Individuals undergoing cancer genetic risk assessment have been found to have a poor understanding of the process, which may affect how well they cope with learning their risk. This paper reports free-text data from questionnaires completed by women undergoing a randomised controlled trial of a psychological intervention. Of the 268 women undergoing genetic assessment for familial breast/ovarian cancer risk who were invited to take part in the trial, 157 women returned research questionnaires. Of these, 97 women provided free-text comments upon referral to a cancer genetics clinic, 62 provided comments whilst waiting for risk information (average, moderate or high), and 36 women provided comments following notification of risk. This paper reports a thematic analysis of the free-text data. Themes reflected individuals' poor knowledge and uncertainty about genetic risk assessment. How well individuals responded to learning their risk depended upon whether expectations had been met. Regardless of risk, individuals undergoing cancer genetic risk assessment are likely to benefit from increased information about its process and timescales, and access to increased psychological support. Free-text comments can provide valuable data about individuals' expectations and knowledge of genetics services.

An overview of safety assessment, regulation, and control of hazardous material use at NREL

NASA Astrophysics Data System (ADS)

Nelson, B. P.; Crandall, R. S.; Moskowitz, P. D.; Fthenakis, V. M.

1992-12-01

This paper summarizes the methodology we use to ensure the safe use of hazardous materials at the National Renewable Energy Laboratory (NREL). First, we analyze the processes and the materials used in those processes to identify the hazards presented. Then we study federal, state, and local regulations and apply the relevant requirements to our operations. When necessary, we generate internal safety documents to consolidate this information. We design research operations and support systems to conform to these requirements. Before we construct the systems, we perform a semiquantitative risk analysis on likely accident scenarios. All scenarios presenting an unacceptable risk require system or procedural modifications to reduce the risk. Following these modifications, we repeat the risk analysis to ensure that the respective accident scenarios present an acceptable risk. Once all risks are acceptable, we conduct an operational readiness review (ORR). A management-appointed panel performs the ORR ensuring compliance with all relevant requirements. After successful completion of the ORR, operations can begin.

Using a familiar risk comparison within a risk ladder to improve risk understanding by low numerates: a study of visual attention.

PubMed

Keller, Carmen

2011-07-01

Previous experimental research provides evidence that a familiar risk comparison within a risk ladder is understood by low- and high-numerate individuals. It especially helps low numerates to better evaluate risk. In the present study, an eye tracker was used to capture individuals' visual attention to a familiar risk comparison, such as the risk associated with smoking. Two parameters of information processing-efficiency and level-were derived from visual attention. A random sample of participants from the general population (N= 68) interpreted a given risk level with the help of the risk ladder. Numeracy was negatively correlated with overall visual attention on the risk ladder (r(s) =-0.28, p= 0.01), indicating that the lower the numeracy, the more the time spent looking at the whole risk ladder. Numeracy was positively correlated with the efficiency of processing relevant frequency (r(s) = 0.34, p < 0.001) and relevant textual information (r(s) = 0.34, p < 0.001), but not with the efficiency of processing relevant comparative information and numerical information. There was a significant negative correlation between numeracy and the level of processing of relevant comparative risk information (r(s) =-0.21, p < 0.01), indicating that low numerates processed the comparative risk information more deeply than the high numerates. There was no correlation between numeracy and perceived risk. These results add to previous experimental research, indicating that the smoking risk comparison was crucial for low numerates to evaluate and understand risk. Furthermore, the eye-tracker method is promising for studying information processing and improving risk communication formats. © 2011 Society for Risk Analysis.

Ontology-based specification, identification and analysis of perioperative risks.

PubMed

Uciteli, Alexandr; Neumann, Juliane; Tahar, Kais; Saleh, Kutaiba; Stucke, Stephan; Faulbrück-Röhr, Sebastian; Kaeding, André; Specht, Martin; Schmidt, Tobias; Neumuth, Thomas; Besting, Andreas; Stegemann, Dominik; Portheine, Frank; Herre, Heinrich

2017-09-06

Medical personnel in hospitals often works under great physical and mental strain. In medical decision-making, errors can never be completely ruled out. Several studies have shown that between 50 and 60% of adverse events could have been avoided through better organization, more attention or more effective security procedures. Critical situations especially arise during interdisciplinary collaboration and the use of complex medical technology, for example during surgical interventions and in perioperative settings (the period of time before, during and after surgical intervention). In this paper, we present an ontology and an ontology-based software system, which can identify risks across medical processes and supports the avoidance of errors in particular in the perioperative setting. We developed a practicable definition of the risk notion, which is easily understandable by the medical staff and is usable for the software tools. Based on this definition, we developed a Risk Identification Ontology (RIO) and used it for the specification and the identification of perioperative risks. An agent system was developed, which gathers risk-relevant data during the whole perioperative treatment process from various sources and provides it for risk identification and analysis in a centralized fashion. The results of such an analysis are provided to the medical personnel in form of context-sensitive hints and alerts. For the identification of the ontologically specified risks, we developed an ontology-based software module, called Ontology-based Risk Detector (OntoRiDe). About 20 risks relating to cochlear implantation (CI) have already been implemented. Comprehensive testing has indicated the correctness of the data acquisition, risk identification and analysis components, as well as the web-based visualization of results.

Multiple health risk perception and information processing among African Americans and whites living in poverty.

PubMed

Hovick, Shelly R; Freimuth, Vicki S; Johnson-Turbes, Ashani; Chervin, Doryn D

2011-11-01

We investigated the risk-information-processing behaviors of people living at or near the poverty line. Because significant gaps in health and communication exist among high- and low-income groups, increasing the information seeking and knowledge of poor individuals may help them better understand risks to their health and increase their engagement in health-protective behaviors. Most earlier studies assessed only a single health risk selected by the researcher, whereas we listed 10 health risks and allowed the respondents to identify the one that they worried about most but took little action to prevent. Using this risk, we tested one pathway inspired by the risk information seeking and processing model to examine predictors of information insufficiency and of systematic processing and extended this pathway to include health-protective action. A phone survey was conducted of African Americans and whites living in the southern United States with an annual income of ≤$35,000 (N= 431). The results supported the model pathway: worry partially mediated the relationship between perceived risk and information insufficiency, which, in turn, increased systematic processing. In addition, systematic processing increased health-protective action. Compared with whites and better educated respondents, African Americans and respondents with little education had significantly higher levels of information insufficiency but higher levels of systematic processing and health-protective action. That systematic processing and knowledge influenced health behavior suggests a potential strategy for reducing health disparities. © 2011 Society for Risk Analysis.

Generating Options for Active Risk Control (GO-ARC): introducing a novel technique.

PubMed

Card, Alan J; Ward, James R; Clarkson, P John

2014-01-01

After investing significant amounts of time and money in conducting formal risk assessments, such as root cause analysis (RCA) or failure mode and effects analysis (FMEA), healthcare workers are left to their own devices in generating high-quality risk control options. They often experience difficulty in doing so, and tend toward an overreliance on administrative controls (the weakest category in the hierarchy of risk controls). This has important implications for patient safety and the cost effectiveness of risk management operations. This paper describes a before and after pilot study of the Generating Options for Active Risk Control (GO-ARC) technique, a novel tool to improve the quality of the risk control options generation process. The quantity, quality (using the three-tiered hierarchy of risk controls), variety, and novelty of risk controls generated. Use of the GO-ARC technique was associated with improvement on all measures. While this pilot study has some notable limitations, it appears that the GO-ARC technique improved the risk control options generation process. Further research is needed to confirm this finding. It is also important to note that improved risk control options are a necessary, but not sufficient, step toward the implementation of more robust risk controls. © 2013 National Association for Healthcare Quality.

Developing an Integrated, Brief Biobehavioral HIV Prevention Intervention for High-Risk Drug Users in Treatment: The Process and Outcome of Formative Research

PubMed Central

Shrestha, Roman; Altice, Frederick; Karki, Pramila; Copenhaver, Michael

2017-01-01

To date, HIV prevention efforts have largely relied on singular strategies (e.g., behavioral or biomedical approaches alone) with modest HIV risk-reduction outcomes for people who use drugs (PWUD), many of whom experience a wide range of neurocognitive impairments (NCI). We report on the process and outcome of our formative research aimed at developing an integrated biobehavioral approach that incorporates innovative strategies to address the HIV prevention and cognitive needs of high-risk PWUD in drug treatment. Our formative work involved first adapting an evidence-based behavioral intervention—guided by the Assessment–Decision–Administration–Production–Topical experts–Integration–Training–Testing model—and then combining the behavioral intervention with an evidence-based biomedical intervention for implementation among the target population. This process involved eliciting data through structured focus groups (FGs) with key stakeholders—members of the target population (n = 20) and treatment providers (n = 10). Analysis of FG data followed a thematic analysis approach utilizing several qualitative data analysis techniques, including inductive analysis and cross-case analysis. Based on all information, we integrated the adapted community-friendly health recovery program—a brief evidence-based HIV prevention behavioral intervention—with the evidence-based biomedical component [i.e., preexposure prophylaxis (PrEP)], an approach that incorporates innovative strategies to accommodate individuals with NCI. This combination approach—now called the biobehavioral community-friendly health recovery program—is designed to address HIV-related risk behaviors and PrEP uptake and adherence as experienced by many PWUD in treatment. This study provides a complete example of the process of selecting, adapting, and integrating the evidence-based interventions—taking into account both empirical evidence and input from target population members and target organization stakeholders. The resultant brief evidence-based biobehavioral approach could significantly advance primary prevention science by cost-effectively optimizing PrEP adherence and HIV risk reduction within common drug treatment settings. PMID:28553295

Comparative hazard analysis of processes leading to remarkable flash floods (France, 1930-1999)

NASA Astrophysics Data System (ADS)

Boudou, M.; Lang, M.; Vinet, F.; Cœur, D.

2016-10-01

Flash flood events are responsible for large economic losses and lead to fatalities every year in France. This is especially the case in the Mediterranean and oversea territories/departments of France, characterized by extreme hydro-climatological features and with a large part of the population exposed to flood risks. The recurrence of remarkable flash flood events, associated with high hazard intensity, significant damage and socio-political consequences, therefore raises several issues for authorities and risk management policies. This study aims to improve our understanding of the hazard analysis process in the case of four remarkable flood events: March 1930, October 1940, January 1980 and November 1999. Firstly, we present the methodology used to define the remarkability score of a flood event. Then, to identify the factors leading to a remarkable flood event, we explore the main parameters of the hazard analysis process, such as the meteorological triggering conditions, the return period of the rainfall and peak discharge, as well as some additional factors (initial catchment state, flood chronology, cascade effects, etc.). The results contribute to understanding the complexity of the processes leading to flood hazard and highlight the importance for risk managers of taking additional factors into account.

Analysis and Risk Evaluation on the Case of Alteration, Revitalization and Conversion of a Historic Building in Gdańsk

NASA Astrophysics Data System (ADS)

Grzyl, Beata; Kristowski, Adam; Miszewska-Urbańska, Emilia

2017-10-01

Each investment plan, including the one concerning a building, is exposed to the consequences of various types of threats taking place. Therefore, in the case of some large-scale, atypical and complicated building ventures, some actions included in the procedure of risk management should be taken (identifications, analysis, measurements, control and supervision of the risk). This will allow for the risk to be eliminated or limited. While preparing a building venture, an investor does not possess full information about the course of events on each stage of investment completion. The identification of the above-mentioned unknowns, subjecting them to quantification and specifying the method of dealing with them, allows an investor to increase the effectiveness of the intended plan. The enterprise discussed in this article and analyzed in the context of risk, concerns alteration, revitalization and conversion for office purposes of two buildings located in Gdańsk at 1 and 2 Lastadia Street. These buildings are situated on the area of historical urban layout of Gdańsk, in the northern-eastern part of Stare Przedmieście District (Old Suburb), about 800 meters south from Dlugi Targ Street and 200 meters west from The Old Motława River. The investor is “Gdańskie Melioracje Ltd.”, a limited liability company, which belongs to the Council of Gdańsk. In order to increase the effectiveness of the intended investment venture, while organizing the investment process, the investor commissioned preparation of an analysis and risk evaluation connected with the above-mentioned intention. Based on an on-site visit, the opinions of experts, who have been involved in the process of the preparation of the investment, studies of the available monographies about the technical condition of the buildings at 1 and 2 Lastadia Street and their own experiences, the authors identified 54 types of relevant risks, which have been systematized into 10 subject groups (among others- investor’s risk due to the designing process, location of the investment, third party or investor business activity, force majeure, political, legal, financial, technical). The scope of the study includes the identification, analysis and risk evaluation connected with planning and completion of alteration, revitalization and conversion of a historic building located at 2 Lastadia Street for the office purposes. The risk has been analyzed from the investor’s perspective. The authors used a method of preliminary analysis and risk evaluation PHA (Preliminary Hazard Analysis) and the expert method.

SU-E-T-420: Failure Effects Mode Analysis for Trigeminal Neuralgia Frameless Radiosurgery

DOE Office of Scientific and Technical Information (OSTI.GOV)

Howe, J

2015-06-15

Purpose: Functional radiosurgery has been used successfully in the treatment of trigeminal neuralgia but presents significant challenges to ensuring the high prescription dose is delivered accurately. A review of existing practice should help direct the focus of quality improvement for this treatment regime. Method: Failure modes and effects analysis was used to identify the processes in preparing radiosurgery treatment for TN. The map was developed by a multidisciplinary team including: neurosurgeon, radiation oncology, physicist and therapist. Potential failure modes were identified for each step in the process map as well as potential causes and end effect. A risk priority numbermore » was assigned to each cause. Results: The process map identified 66 individual steps (see attached supporting document). Corrective actions were developed for areas of high risk priority number. Wrong site treatment is at higher risk for trigeminal neuralgia treatment due to the lack of site specific pathologic imaging on MR and CT – additional site specific checks were implemented to minimize the risk of wrong site treatment. Failed collision checks resulted from an insufficient collision model in the treatment planning system and a plan template was developed to address this problem. Conclusion: Failure modes and effects analysis is an effective tool for developing quality improvement in high risk radiotherapy procedures such as functional radiosurgery.« less

Taking Risk Assessment and Management to the Next Level: Program-Level Risk Analysis to Enable Solid Decision-Making on Priorities and Funding

DOE Office of Scientific and Technical Information (OSTI.GOV)

Nelson, J. G.; Morton, R. L.; Castillo, C.

2011-02-01

A multi-level (facility and programmatic) risk assessment was conducted for the facilities in the Nevada National Security Site (NNSS) Readiness in Technical Base and Facilities (RTBF) Program and results were included in a new Risk Management Plan (RMP), which was incorporated into the fiscal year (FY) 2010 Integrated Plans. Risks, risk events, probability, consequence(s), and mitigation strategies were identified and captured, for most scope areas (i.e., risk categories) during the facilitated risk workshops. Risk mitigations (i.e., efforts in addition to existing controls) were identified during the facilitated risk workshops when the risk event was identified. Risk mitigation strategies fell intomore » two broad categories: threats or opportunities. Improvement projects were identified and linked to specific risks they mitigate, making the connection of risk reduction through investments for the annual Site Execution Plan. Due to the amount of that was collected, analysis to be performed, and reports to be generated, a Risk Assessment/ Management Tool (RAMtool) database was developed to analyze the risks in real-time, at multiple levels, which reinforced the site-level risk management process and procedures. The RAMtool database was developed and designed to assist in the capturing and analysis of the key elements of risk: probability, consequence, and impact. The RAMtool calculates the facility-level and programmatic-level risk factors to enable a side-by-side comparison to see where the facility manager and program manager should focus their risk reduction efforts and funding. This enables them to make solid decisions on priorities and funding to maximize the risk reduction. A more active risk management process was developed where risks and opportunities are actively managed, monitored, and controlled by each facility more aggressively and frequently. risk owners have the responsibility and accountability to manage their assigned risk in real-time, using the RAMtool database.« less

PSP, TSP, XP, CMMI...Eating the Alphabet Soup!

DTIC Science & Technology

2011-05-19

Operations and Reports, 1215 Jefferson Davis Highway, Suite 1204, Arlington VA 22202-4302. Respondents should be aware that notwithstanding any other...4 Q tit t Continuous process improvement Organizational Performance Management Causal Analysis and Resolution Level Focus Process Areas Requirements...Project Management process standardization Risk management Decision Analysis and Resolution Product Integration 2 M d R i t t anage Basic Project

Risk Management for the International Space Station

NASA Technical Reports Server (NTRS)

Sebastian, J.; Brezovic, Philip

2002-01-01

The International Space Station (ISS) is an extremely complex system, both technically and programmatically. The Space Station must support a wide range of payloads and missions. It must be launched in numerous launch packages and be safely assembled and operated in the harsh environment of space. It is being designed and manufactured by many organizations, including the prime contractor, Boeing, the NASA institutions, and international partners and their contractors. Finally, the ISS has multiple customers, (e.g., the Administration, Congress, users, public, international partners, etc.) with contrasting needs and constraints. It is the ISS Risk Management Office strategy to proactively and systematically manages risks to help ensure ISS Program success. ISS program follows integrated risk management process (both quantitative and qualitative) and is integrated into ISS project management. The process and tools are simple and seamless and permeate to the lowest levels (at a level where effective management can be realized) and follows the continuous risk management methodology. The risk process assesses continually what could go wrong (risks), determine which risks need to be managed, implement strategies to deal with those risks, and measure effectiveness of the implemented strategies. The process integrates all facets of risk including cost, schedule and technical aspects. Support analysis risk tools like PRA are used to support programatic decisions and assist in analyzing risks.

Initial Risk Analysis and Decision Making Framework

DOE Office of Scientific and Technical Information (OSTI.GOV)

Engel, David W.

2012-02-01

Commercialization of new carbon capture simulation initiative (CCSI) technology will include two key elements of risk management, namely, technical risk (will process and plant performance be effective, safe, and reliable) and enterprise risk (can project losses and costs be controlled within the constraints of market demand to maintain profitability and investor confidence). Both of these elements of risk are incorporated into the risk analysis subtask of Task 7. Thus far, this subtask has developed a prototype demonstration tool that quantifies risk based on the expected profitability of expenditures when retrofitting carbon capture technology on a stylized 650 MW pulverized coalmore » electric power generator. The prototype is based on the selection of specific technical and financial factors believed to be important determinants of the expected profitability of carbon capture, subject to uncertainty. The uncertainty surrounding the technical performance and financial variables selected thus far is propagated in a model that calculates the expected profitability of investments in carbon capture and measures risk in terms of variability in expected net returns from these investments. Given the preliminary nature of the results of this prototype, additional work is required to expand the scope of the model to include additional risk factors, additional information on extant and proposed risk factors, the results of a qualitative risk factor elicitation process, and feedback from utilities and other interested parties involved in the carbon capture project. Additional information on proposed distributions of these risk factors will be integrated into a commercial implementation framework for the purpose of a comparative technology investment analysis.« less

Multiattribute risk analysis in nuclear emergency management.

PubMed

Hämäläinen, R P; Lindstedt, M R; Sinkko, K

2000-08-01

Radiation protection authorities have seen a potential for applying multiattribute risk analysis in nuclear emergency management and planning to deal with conflicting objectives, different parties involved, and uncertainties. This type of approach is expected to help in the following areas: to ensure that all relevant attributes are considered in decision making; to enhance communication between the concerned parties, including the public; and to provide a method for explicitly including risk analysis in the process. A multiattribute utility theory analysis was used to select a strategy for protecting the population after a simulated nuclear accident. The value-focused approach and the use of a neutral facilitator were identified as being useful.

Development of NASA's Accident Precursor Analysis Process Through Application on the Space Shuttle Orbiter

NASA Technical Reports Server (NTRS)

Maggio, Gaspare; Groen, Frank; Hamlin, Teri; Youngblood, Robert

2010-01-01

Accident Precursor Analysis (APA) serves as the bridge between existing risk modeling activities, which are often based on historical or generic failure statistics, and system anomalies, which provide crucial information about the failure mechanisms that are actually operative in the system. APA docs more than simply track experience: it systematically evaluates experience, looking for under-appreciated risks that may warrant changes to design or operational practice. This paper presents the pilot application of the NASA APA process to Space Shuttle Orbiter systems. In this effort, the working sessions conducted at Johnson Space Center (JSC) piloted the APA process developed by Information Systems Laboratories (ISL) over the last two years under the auspices of NASA's Office of Safety & Mission Assurance, with the assistance of the Safety & Mission Assurance (S&MA) Shuttle & Exploration Analysis Branch. This process is built around facilitated working sessions involving diverse system experts. One important aspect of this particular APA process is its focus on understanding the physical mechanism responsible for an operational anomaly, followed by evaluation of the risk significance of the observed anomaly as well as consideration of generalizations of the underlying mechanism to other contexts. Model completeness will probably always be an issue, but this process tries to leverage operating experience to the extent possible in order to address completeness issues before a catastrophe occurs.

Risk Analysis for Nonthermal process interventions

USDA-ARS?s Scientific Manuscript database

Over the last few years a number of nonthermal process interventions including ionizing radiation and ultraviolet light, high pressure processing, pulsed-electric and radiofrequency electric fields, microwave and infrared technologies, bacteriophages, etc. have been approved by regulatory agencies, ...

General RMP Guidance - Chapter 7: Prevention Program (Program 3)

EPA Pesticide Factsheets

Many Program 3 processes are already addressed by the OSHA Process Safety Management Program, which covers on-site consequences. So for compliance with the risk management program, process hazard analysis teams must consider potential offsite consequences.

Environmental Risk Assessment of dredging processes - application to Marin harbour (NW Spain)

NASA Astrophysics Data System (ADS)

Gómez, A. G.; García Alba, J.; Puente, A.; Juanes, J. A.

2014-04-01

A methodological procedure to estimate the environmental risk of dredging operations in aquatic systems has been developed. Environmental risk estimations are based on numerical models results, which provide an appropriated spatio-temporal framework analysis to guarantee an effective decision-making process. The methodological procedure has been applied on a real dredging operation in the port of Marin (NW Spain). Results from Marin harbour confirmed the suitability of the developed methodology and the conceptual approaches as a comprehensive and practical management tool.

Managing Risk for Cassini During Mission Operations and Data Analysis (MOandDA)

NASA Technical Reports Server (NTRS)

Witkowski, Mona M.

2002-01-01

A Risk Management Process has been tailored for Cassini that not only satisfies the requirements of NASA and JPL, but also allows the Program to proactively identify and assess risks that threaten mission objectives. Cassini Risk Management is a team effort that involves both management and engineering staff. The process is managed and facilitated by the Mission Assurance Manager (MAM), but requires regular interactions with Program Staff and team members to instill the risk management philosophy into the day to day mission operations. While Risk Management is well defined for projects in the development phase, it is a relatively new concept for Mission Operations. The Cassini team has embraced this process and has begun using it in an effective, proactive manner, to ensure mission success. It is hoped that the Cassini Risk Management Process will form the basis by which risk management is conducted during MO&DA on future projects. proactive in identifying, assessing and mitigating risks before they become problems. Cost ehtiveness is achieved by: Comprehensively identifying risks Rapidly assessing which risks require the expenditure of pruject cewums Taking early actions to mitigate these risks Iterating the process frequently, to be responsive to the dynamic internal and external environments The Cassini Program has successfully implemented a Risk Management Process for mission operations, The initial SRL has been developed and input into he online tool. The Risk Management webbased system has been rolled out for use by the flight team and risk owners we working proactive in identifying, assessing and mitigating risks before they become problems. Cost ehtiveness is achieved by: Comprehensively identifying risks Rapidly assessing which risks require the expenditure of pruject cewums Taking early actions to mitigate these risks Iterating the process frequently, to be responsive to the dynamic internal and external environments The Cassini Program has successfully implemented a Risk Management Process for mission operations, The initial SRL has been developed and input into he online tool. The Risk Management webbased system has been rolled out for use by the flight team and risk owners we working put into place will become visible and will be illusmted in future papers.

Uncertainty analysis as essential step in the establishment of the dynamic Design Space of primary drying during freeze-drying.

PubMed

Mortier, Séverine Thérèse F C; Van Bockstal, Pieter-Jan; Corver, Jos; Nopens, Ingmar; Gernaey, Krist V; De Beer, Thomas

2016-06-01

Large molecules, such as biopharmaceuticals, are considered the key driver of growth for the pharmaceutical industry. Freeze-drying is the preferred way to stabilise these products when needed. However, it is an expensive, inefficient, time- and energy-consuming process. During freeze-drying, there are only two main process variables to be set, i.e. the shelf temperature and the chamber pressure, however preferably in a dynamic way. This manuscript focuses on the essential use of uncertainty analysis for the determination and experimental verification of the dynamic primary drying Design Space for pharmaceutical freeze-drying. Traditionally, the chamber pressure and shelf temperature are kept constant during primary drying, leading to less optimal process conditions. In this paper it is demonstrated how a mechanistic model of the primary drying step gives the opportunity to determine the optimal dynamic values for both process variables during processing, resulting in a dynamic Design Space with a well-known risk of failure. This allows running the primary drying process step as time efficient as possible, hereby guaranteeing that the temperature at the sublimation front does not exceed the collapse temperature. The Design Space is the multidimensional combination and interaction of input variables and process parameters leading to the expected product specifications with a controlled (i.e., high) probability. Therefore, inclusion of parameter uncertainty is an essential part in the definition of the Design Space, although it is often neglected. To quantitatively assess the inherent uncertainty on the parameters of the mechanistic model, an uncertainty analysis was performed to establish the borders of the dynamic Design Space, i.e. a time-varying shelf temperature and chamber pressure, associated with a specific risk of failure. A risk of failure acceptance level of 0.01%, i.e. a 'zero-failure' situation, results in an increased primary drying process time compared to the deterministic dynamic Design Space; however, the risk of failure is under control. Experimental verification revealed that only a risk of failure acceptance level of 0.01% yielded a guaranteed zero-defect quality end-product. The computed process settings with a risk of failure acceptance level of 0.01% resulted in a decrease of more than half of the primary drying time in comparison with a regular, conservative cycle with fixed settings. Copyright © 2016. Published by Elsevier B.V.

A Theoretical Model and Analysis of the Effect of Self-Regulation on Attrition from Voluntary Online Training

ERIC Educational Resources Information Center

Sitzmann, Traci

2012-01-01

A theoretical model is presented that examines self-regulatory processes and trainee characteristics as predictors of attrition from voluntary online training in order to determine who is at risk of dropping out and the processes that occur during training that determine when they are at risk of dropping out. Attrition increased following declines…

The integration of the risk management process with the lifecycle of medical device software.

PubMed

Pecoraro, F; Luzi, D

2014-01-01

The application of software in the Medical Device (MD) domain has become central to the improvement of diagnoses and treatments. The new European regulations that specifically address software as an important component of MD, require complex procedures to make software compliant with safety requirements, introducing thereby new challenges in the qualification and classification of MD software as well as in the performance of risk management activities. Under this perspective, the aim of this paper is to propose an integrated framework that combines the activities to be carried out by the manufacturer to develop safe software within the development lifecycle based on the regulatory requirements reported in US and European regulations as well as in the relevant standards and guidelines. A comparative analysis was carried out to identify the main issues related to the application of the current new regulations. In addition, standards and guidelines recently released to harmonise procedures for the validation of MD software have been used to define the risk management activities to be carried out by the manufacturer during the software development process. This paper highlights the main issues related to the qualification and classification of MD software, providing an analysis of the different regulations applied in Europe and the US. A model that integrates the risk management process within the software development lifecycle has been proposed too. It is based on regulatory requirements and considers software risk analysis as a central input to be managed by the manufacturer already at the initial stages of the software design, in order to prevent MD failures. Relevant changes in the process of MD development have been introduced with the recognition of software being an important component of MDs as stated in regulations and standards. This implies the performance of highly iterative processes that have to integrate the risk management in the framework of software development. It also makes it necessary to involve both medical and software engineering competences to safeguard patient and user safety.

A simulation framework for mapping risks in clinical processes: the case of in-patient transfers.

PubMed

Dunn, Adam G; Ong, Mei-Sing; Westbrook, Johanna I; Magrabi, Farah; Coiera, Enrico; Wobcke, Wayne

2011-05-01

To model how individual violations in routine clinical processes cumulatively contribute to the risk of adverse events in hospital using an agent-based simulation framework. An agent-based simulation was designed to model the cascade of common violations that contribute to the risk of adverse events in routine clinical processes. Clinicians and the information systems that support them were represented as a group of interacting agents using data from direct observations. The model was calibrated using data from 101 patient transfers observed in a hospital and results were validated for one of two scenarios (a misidentification scenario and an infection control scenario). Repeated simulations using the calibrated model were undertaken to create a distribution of possible process outcomes. The likelihood of end-of-chain risk is the main outcome measure, reported for each of the two scenarios. The simulations demonstrate end-of-chain risks of 8% and 24% for the misidentification and infection control scenarios, respectively. Over 95% of the simulations in both scenarios are unique, indicating that the in-patient transfer process diverges from prescribed work practices in a variety of ways. The simulation allowed us to model the risk of adverse events in a clinical process, by generating the variety of possible work subject to violations, a novel prospective risk analysis method. The in-patient transfer process has a high proportion of unique trajectories, implying that risk mitigation may benefit from focusing on reducing complexity rather than augmenting the process with further rule-based protocols.

Use of mechanistic simulations as a quantitative risk-ranking tool within the quality by design framework.

PubMed

Stocker, Elena; Toschkoff, Gregor; Sacher, Stephan; Khinast, Johannes G

2014-11-20

The purpose of this study is to evaluate the use of computer simulations for generating quantitative knowledge as a basis for risk ranking and mechanistic process understanding, as required by ICH Q9 on quality risk management systems. In this specific publication, the main focus is the demonstration of a risk assessment workflow, including a computer simulation for the generation of mechanistic understanding of active tablet coating in a pan coater. Process parameter screening studies are statistically planned under consideration of impacts on a potentially critical quality attribute, i.e., coating mass uniformity. Based on computer simulation data the process failure mode and effects analysis of the risk factors is performed. This results in a quantitative criticality assessment of process parameters and the risk priority evaluation of failure modes. The factor for a quantitative reassessment of the criticality and risk priority is the coefficient of variation, which represents the coating mass uniformity. The major conclusion drawn from this work is a successful demonstration of the integration of computer simulation in the risk management workflow leading to an objective and quantitative risk assessment. Copyright © 2014. Published by Elsevier B.V.

The effectiveness of risk management: an analysis of project risk planning across industries and countries.

PubMed

Zwikael, Ofer; Ahn, Mark

2011-01-01

This article examines the effectiveness of current risk management practices to reduce project risk using a multinational, multi-industry study across different scenarios and cultures. A survey was administered to 701 project managers, and their supervisors, in seven industries and three diverse countries (New Zealand, Israel, and Japan), in multiple languages during the 2002-2007 period. Results of this study show that project context--industry and country where a project is executed--significantly impacts perceived levels of project risk, and the intensity of risk management processes. Our findings also suggest that risk management moderates the relationship between risk level and project success. Specifically, we found that even moderate levels of risk management planning are sufficient to reduce the negative effect risk levels have on project success. © 2010 Society for Risk Analysis.

Expanding the Political Philosophy Dimension of the RISP Model: Examining the Conditional Indirect Effects of Cultural Cognition.

PubMed

Hmielowski, Jay D; Wang, Meredith Y; Donaway, Rebecca R

2018-04-25

This article attempts to connect literatures from the Risk Information Seeking and Processing (RISP) model and cultural cognition theory. We do this by assessing the relationship between the two prominent cultural cognition variables (i.e., group and grid) and risk perceptions. We then examine whether these risk perceptions are associated with three outcomes important to the RISP model: information seeking, systematic processing, and heuristic processing, through a serial mediation model. We used 2015 data collected from 10 communities across the United States to test our hypotheses. Our results show that people high on group and low on grid (egalitarian communitarians) show greater risk perceptions regarding water quality issues. Moreover, these higher levels of perceived risk translate into increased information seeking, systematic processing of information, and lower heuristic processing through intervening variables from the RISP model (e.g., negative emotions and information insufficiency). These results extend the extant literature by expanding on the treatment of political ideology within the RISP model literature and taking a more nuanced approach to political beliefs in accordance with the cultural cognitions literature. Our article also expands on the RISP literature by looking at information-processing variables. © 2018 Society for Risk Analysis.

Middle Man Concept for In-Orbit Collision Risks Mitigation, CAESAR and CARA Examples

NASA Technical Reports Server (NTRS)

Moury, Monique; Newman, Lauri K.; Laporte, Francois

2014-01-01

This paper describes the conjunction analysis which has to be performed using data provided by JSpOC. This description not only demonstrates that Collision Avoidance is a 2- step process (close approach detection followed by risk evaluation for collision avoidance decision) but also leads to the conclusion that there is a need for a Middle Man role. After describing the Middle Man concept, this paper introduces two examples with their similarities and particularities: the American civil space effort delivered by the NASA CARA team (Conjunction Assessment Risk Analysis) and the French response CAESAR (Conjunction Assessment and Evaluation Service: Alerts and Recommendations). For both, statistics are presented and feedbacks discussed. All together, around 80 satellites are served by CARA and/or CAESAR. Both processes regularly evolve in order either to follow JSpOC upgrades or to improve analysis according to experience acquired during the past years.

Risk Assessment and Risk Governance of Liquefied Natural Gas Development in Gladstone, Australia.

PubMed

van der Vegt, R G

2018-02-26

This article is a retrospective analysis of liquefied natural gas development (LNG) in Gladstone, Australia by using the structure of the risk governance framework developed by the International Risk Governance Council (IRGC). Since 2010 the port of Gladstone has undergone extensive expansion to facilitate the increasing coal export as well as the new development of three recently completed LNG facilities. Significant environmental and socio-economic impacts and concerns have occurred as a result of these developments. The overall aim of the article, therefore, is to identify the risk governance deficits that arose and to formulate processes capable of improving similar decision-making problems in the future. The structure of the IRGC framework is followed because it represents a broad analytical approach for considering risk assessment and risk governance in Gladstone in ways that include, but also go beyond, the risk approach of the ISO 31000:2009 standard that was employed at the time. The IRGC risk framework is argued to be a consistent and comprehensive risk governance framework that integrates scientific, economic, social, and cultural aspects and advocates the notion of inclusive risk governance through stakeholder communication and involvement. Key aspects related to risk preassessment, risk appraisal, risk tolerability and acceptability, risk management, and stakeholder communication and involvement are considered. The results indicate that the risk governance deficits include aspects related to (i) the risk matrix methodology, (ii) reflecting uncertainties, (iii) cumulative risks, (iv) the regulatory process, and (v) stakeholder communication and involvement. © 2018 Society for Risk Analysis.

Climate Risk Informed Decision Analysis: A Hypothetical Application to the Waas Region

NASA Astrophysics Data System (ADS)

Gilroy, Kristin; Mens, Marjolein; Haasnoot, Marjolijn; Jeuken, Ad

2016-04-01

More frequent and intense hydrologic events under climate change are expected to enhance water security and flood risk management challenges worldwide. Traditional planning approaches must be adapted to address climate change and develop solutions with an appropriate level of robustness and flexibility. The Climate Risk Informed Decision Analysis (CRIDA) method is a novel planning approach embodying a suite of complementary methods, including decision scaling and adaptation pathways. Decision scaling offers a bottom-up approach to assess risk and tailors the complexity of the analysis to the problem at hand and the available capacity. Through adaptation pathway,s an array of future strategies towards climate robustness are developed, ranging in flexibility and immediacy of investments. Flexible pathways include transfer points to other strategies to ensure that the system can be adapted if future conditions vary from those expected. CRIDA combines these two approaches in a stakeholder driven process which guides decision makers through the planning and decision process, taking into account how the confidence in the available science, the consequences in the system, and the capacity of institutions should influence strategy selection. In this presentation, we will explain the CRIDA method and compare it to existing planning processes, such as the US Army Corps of Engineers Principles and Guidelines as well as Integrated Water Resources Management Planning. Then, we will apply the approach to a hypothetical case study for the Waas Region, a large downstream river basin facing rapid development threatened by increased flood risks. Through the case study, we will demonstrate how a stakeholder driven process can be used to evaluate system robustness to climate change; develop adaptation pathways for multiple objectives and criteria; and illustrate how varying levels of confidence, consequences, and capacity would play a role in the decision making process, specifically in regards to the level of robustness and flexibility in the selected strategy. This work will equip practitioners and decision makers with an example of a structured process for decision making under climate uncertainty that can be scaled as needed to the problem at hand. This presentation builds further on another submitted abstract "Climate Risk Informed Decision Analysis (CRIDA): A novel practical guidance for Climate Resilient Investments and Planning" by Jeuken et al.

Multi-Criteria Decision Making for a Spatial Decision Support System on the Analysis of Changing Risk

NASA Astrophysics Data System (ADS)

Olyazadeh, Roya; van Westen, Cees; Bakker, Wim H.; Aye, Zar Chi; Jaboyedoff, Michel; Derron, Marc-Henri

2014-05-01

Natural hazard risk management requires decision making in several stages. Decision making on alternatives for risk reduction planning starts with an intelligence phase for recognition of the decision problems and identifying the objectives. Development of the alternatives and assigning the variable by decision makers to each alternative are employed to the design phase. Final phase evaluates the optimal choice by comparing the alternatives, defining indicators, assigning a weight to each and ranking them. This process is referred to as Multi-Criteria Decision Making analysis (MCDM), Multi-Criteria Evaluation (MCE) or Multi-Criteria Analysis (MCA). In the framework of the ongoing 7th Framework Program "CHANGES" (2011-2014, Grant Agreement No. 263953) of the European Commission, a Spatial Decision Support System is under development, that has the aim to analyse changes in hydro-meteorological risk and provide support to selecting the best risk reduction alternative. This paper describes the module for Multi-Criteria Decision Making analysis (MCDM) that incorporates monetary and non-monetary criteria in the analysis of the optimal alternative. The MCDM module consists of several components. The first step is to define criteria (or Indicators) which are subdivided into disadvantages (criteria that indicate the difficulty for implementing the risk reduction strategy, also referred to as Costs) and advantages (criteria that indicate the favorability, also referred to as benefits). In the next step the stakeholders can use the developed web-based tool for prioritizing criteria and decision matrix. Public participation plays a role in decision making and this is also planned through the use of a mobile web-version where the general local public can indicate their agreement on the proposed alternatives. The application is being tested through a case study related to risk reduction of a mountainous valley in the Alps affected by flooding. Four alternatives are evaluated in this case study namely: construction of defense structures, relocation, implementation of an early warning system and spatial planning regulations. Some of the criteria are determined partly in other modules of the CHANGES SDSS, such as the costs for implementation, the risk reduction in monetary values, and societal risk. Other criteria, which could be environmental, economic, cultural, perception in nature, are defined by different stakeholders such as local authorities, expert organizations, private sector, and local public. In the next step, the stakeholders weight the importance of the criteria by pairwise comparison and visualize the decision matrix, which is a matrix based on criteria versus alternatives values. Finally alternatives are ranked by Analytic Hierarchy Process (AHP) method. We expect that this approach will help the decision makers to ease their works and reduce their costs, because the process is more transparent, more accurate and involves a group decision. In that way there will be more confidence in the overall decision making process. Keywords: MCDM, Analytic Hierarchy Process (AHP), SDSS, Natural Hazard Risk Management

System Theoretic Frameworks for Mitigating Risk Complexity in the Nuclear Fuel Cycle

DOE Office of Scientific and Technical Information (OSTI.GOV)

Williams, Adam David; Mohagheghi, Amir H.; Cohn, Brian

In response to the expansion of nuclear fuel cycle (NFC) activities -- and the associated suite of risks -- around the world, this project evaluated systems-based solutions for managing such risk complexity in multimodal and multi-jurisdictional international spent nuclear fuel (SNF) transportation. By better understanding systemic risks in SNF transportation, developing SNF transportation risk assessment frameworks, and evaluating these systems-based risk assessment frameworks, this research illustrated interdependency between safety, security, and safeguards risks is inherent in NFC activities and can go unidentified when each "S" is independently evaluated. Two novel system-theoretic analysis techniques -- dynamic probabilistic risk assessment (DPRA) andmore » system-theoretic process analysis (STPA) -- provide integrated "3S" analysis to address these interdependencies and the research results suggest a need -- and provide a way -- to reprioritize United States engagement efforts to reduce global nuclear risks. Lastly, this research identifies areas where Sandia National Laboratories can spearhead technical advances to reduce global nuclear dangers.« less

TH-EF-BRC-03: Fault Tree Analysis

DOE Office of Scientific and Technical Information (OSTI.GOV)

Thomadsen, B.

2016-06-15

This Hands-on Workshop will be focused on providing participants with experience with the principal tools of TG 100 and hence start to build both competence and confidence in the use of risk-based quality management techniques. The three principal tools forming the basis of TG 100’s risk analysis: Process mapping, Failure-Modes and Effects Analysis and fault-tree analysis will be introduced with a 5 minute refresher presentation and each presentation will be followed by a 30 minute small group exercise. An exercise on developing QM from the risk analysis follows. During the exercise periods, participants will apply the principles in 2 differentmore » clinical scenarios. At the conclusion of each exercise there will be ample time for participants to discuss with each other and the faculty their experience and any challenges encountered. Learning Objectives: To review the principles of Process Mapping, Failure Modes and Effects Analysis and Fault Tree Analysis. To gain familiarity with these three techniques in a small group setting. To share and discuss experiences with the three techniques with faculty and participants. Director, TreatSafely, LLC. Director, Center for the Assessment of Radiological Sciences. Occasional Consultant to the IAEA and Varian.« less

The Study Elements and Indicators of Risk Management System for Secondary Schools in Thailand

ERIC Educational Resources Information Center

Wandee, Methenan; Sirisuthi, Chaiyuth; Leamvijarn, Subunn

2017-01-01

The purposes of this research aimed 1) to study the elements and indicators of risk management system for secondary schools in Thailand. 2) to study suitable the elements and indicators of the risk management system for secondary schools in Thailand. 3) to study the results of CFA (Confirmatory Factors Analysis) risk management process of risk…

Do Service Users with Intellectual Disabilities Want to Be Involved in the Risk Management Process? A Thematic Analysis

ERIC Educational Resources Information Center

Kilcommons, Aoiffe M.; Withers, Paul; Moreno-Lopez, Agueda

2012-01-01

Background: Involving ID service users in risk decision making necessitates consideration of an individual's ability to assess the implications and associated risks and thus make an informed choice. This calls for research on service users' awareness and understanding of risk management (RM). Method: Thirteen people in a residential ID service who…

Risk-based design of process plants with regard to domino effects and land use planning.

PubMed

Khakzad, Nima; Reniers, Genserik

2015-12-15

Land use planning (LUP) as an effective and crucial safety measure has widely been employed by safety experts and decision makers to mitigate off-site risks posed by major accidents. Accordingly, the concept of LUP in chemical plants has traditionally been considered from two perspectives: (i) land developments around existing chemical plants considering potential off-site risks posed by major accidents and (ii) development of existing chemical plants considering nearby land developments and the level of additional off-site risks the land developments would be exposed to. However, the attempts made to design chemical plants with regard to LUP requirements have been few, most of which have neglected the role of domino effects in risk analysis of major accidents. To overcome the limitations of previous work, first, we developed a Bayesian network methodology to calculate both on-site and off-site risks of major accidents while taking domino effects into account. Second, we combined the results of risk analysis with Analytic Hierarchical Process to design an optimal layout for which the levels of on-site and off-site risks would be minimum. Copyright © 2015 Elsevier B.V. All rights reserved.

Dietary protein intakes and risk of ulcerative colitis.

PubMed

Rashvand, Samaneh; Somi, Mohammad Hossein; Rashidkhani, Bahram; Hekmatdoost, Azita

2015-01-01

The incidence of ulcerative colitis (UC) is rising in populations with western-style diet, rich in fat and protein, and low in fruits and vegetables. In the present study, we aimed to evaluate the association between dietary protein intakes and the risk of developing incident UC. Sixty two cases of UC and 124 controls were studied using country-specific food frequency questionnaire (FFQ). Group comparisons by each factor were done using χ2 test, and significance level was set at α= 0.05. Logistic regression adjusted for potential confounding variables was carried out. Univariate analysis suggested positive associations between processed meat, red meat and organ meat with risk of ulcerative colitis. Comparing highest versus lowest categories of consumption, multivariate conditional logistic regression analysis accounting for potential confounding variables indicated that patients who consumed a higher amount of processed meat were at a higher risk for developing UC (P value for trend= 0.02). Similarly, patients who consumed higher amounts of red meat were at a higher risk for UC (P value for trend= 0.01). The highest tertile of intake of organ meat was associated with an increased risk of ulcerative colitis with a statistically significant trend across tertiles (P value for trend= 0.01) when adjusted. In this case-control study we observed that higher consumptions of processed meat, red meat and organ meat were associated with increased risk for UC.

Software analysis handbook: Software complexity analysis and software reliability estimation and prediction

NASA Technical Reports Server (NTRS)

Lee, Alice T.; Gunn, Todd; Pham, Tuan; Ricaldi, Ron

1994-01-01

This handbook documents the three software analysis processes the Space Station Software Analysis team uses to assess space station software, including their backgrounds, theories, tools, and analysis procedures. Potential applications of these analysis results are also presented. The first section describes how software complexity analysis provides quantitative information on code, such as code structure and risk areas, throughout the software life cycle. Software complexity analysis allows an analyst to understand the software structure, identify critical software components, assess risk areas within a software system, identify testing deficiencies, and recommend program improvements. Performing this type of analysis during the early design phases of software development can positively affect the process, and may prevent later, much larger, difficulties. The second section describes how software reliability estimation and prediction analysis, or software reliability, provides a quantitative means to measure the probability of failure-free operation of a computer program, and describes the two tools used by JSC to determine failure rates and design tradeoffs between reliability, costs, performance, and schedule.

Possibilities of Utilizing the Method of Analytical Hierarchy Process Within the Strategy of Corporate Social Business

NASA Astrophysics Data System (ADS)

Drieniková, Katarína; Hrdinová, Gabriela; Naňo, Tomáš; Sakál, Peter

2010-01-01

The paper deals with the analysis of the theory of corporate social responsibility, risk management and the exact method of analytic hierarchic process that is used in the decision-making processes. The Chapters 2 and 3 focus on presentation of the experience with the application of the method in formulating the stakeholders' strategic goals within the Corporate Social Responsibility (CSR) and simultaneously its utilization in minimizing the environmental risks. The major benefit of this paper is the application of Analytical Hierarchy Process (AHP).

Study of the outlook for the development of the gas industry in Russia and analysis of risk associated with this process

NASA Astrophysics Data System (ADS)

Eliseeva, O. A.; Luk'yanova, A. S.; Tarasov, A. E.

2010-12-01

The gas industry in Russia will develop under conditions of the persistence of existing risks and emergence of the new ones caused by the world financial crisis, increased uncertainty in estimating world prices for natural gas, together with disturbed balance between interests of gas producers and consumers, and threat of loss of the competitiveness of Russian natural gas on foreign markets. In this context, in choosing a strategy of the development of the gas industry and its production-and-financial program, it is necessary to carry out a risk analysis of optimum decisions. Specific features of carrying out a risk analysis and results of the risk analysis of strategic decisions that would provide enhanced steadiness and the effectiveness of the development of the gas industry under conditions of the uncertainty of both external and internal factors are presented.

Food Groups and Risk of Hypertension: A Systematic Review and Dose-Response Meta-Analysis of Prospective Studies.

PubMed

Schwingshackl, Lukas; Schwedhelm, Carolina; Hoffmann, Georg; Knüppel, Sven; Iqbal, Khalid; Andriolo, Violetta; Bechthold, Angela; Schlesinger, Sabrina; Boeing, Heiner

2017-11-01

The aim of this systematic review and meta-analysis was to summarize the evidence on the relation of the intakes of 12 major food groups, including whole grains, refined grains, vegetables, fruits, nuts, legumes, eggs, dairy, fish, red meat, processed meat, and sugar-sweetened beverages (SSBs) with the risk of hypertension. PubMed, Scopus, and Web of Science were searched systematically until June 2017 for prospective studies having quantitatively investigated the above-mentioned foods. We conducted meta-analysis on the highest compared with the lowest intake categories and linear and nonlinear dose-response meta-analyses to analyze the association. Summary RRs and 95% CIs were estimated by using a random-effects model. Overall, 28 reports were included in the meta-analysis. An inverse association for the risk of hypertension was observed for 30 g whole grains/d (RR: 0.92; 95% CI: 0.87, 0.98), 100 g fruits/d (RR: 0.97; 95% CI: 0.96, 0.99), 28 g nuts/d (RR: 0.70; 95% CI: 0.45, 1.08), and 200 g dairy/d (RR: 0.95; 95% CI: 0.94, 0.97), whereas a positive association for 100 g red meat/d (RR: 1.14; 95% CI: 1.02, 1.28), 50 g processed meat/d (RR: 1.12; 95% CI: 1.00, 1.26), and 250 mL SSB/d (RR: 1.07; 95% CI: 1.04, 1.10) was seen in the linear dose-response meta-analysis. Indication for nonlinear relations of the intakes of whole grains, fruits, fish, and processed meats with the risk of hypertension was detected. In summary, this comprehensive dose-response meta-analysis of 28 reports identified optimal intakes of whole grains, fruits, nuts, legumes, dairy, red and processed meats, and SSBs related to the risk of hypertension. These findings need to be seen under the light of very-low to low quality of meta-evidence. However, the findings support the current dietary guidelines in the prevention of hypertension. © 2017 American Society for Nutrition.

Quality risk management of top spray fluidized bed process for antihypertensive drug formulation with control strategy engendered by Box-behnken experimental design space.

PubMed

Mukharya, Amit; Patel, Paresh U; Shenoy, Dinesh; Chaudhary, Shivang

2013-01-01

Lacidipine (LCDP) is a very low soluble and highly biovariable calcium channel blocker used in the treatment of hypertension. To increase its apparent solubility and to reduce its biovariability, solid dispersion fluid bed processing technology was explored, as it produces highly dispersible granules with a characteristic porous structure that enhances dispersibility, wettability, blend uniformity (by dissolving and spraying a solution of actives), flow ability and compressibility of granules for tableting and reducing variability by uniform drug-binder solution distribution on carrier molecules. Main object of this quality risk management (QRM) study is to provide a sophisticated "robust and rugged" Fluidized Bed Process (FBP) for the preparation of LCDP tablets with desired quality (stability) and performance (dissolution) by quality by design (QbD) concept. THIS STUDY IS PRINCIPALLY FOCUSING ON THOROUGH MECHANISTIC UNDERSTANDING OF THE FBP BY WHICH IT IS DEVELOPED AND SCALED UP WITH A KNOWLEDGE OF THE CRITICAL RISKS INVOLVED IN MANUFACTURING PROCESS ANALYZED BY RISK ASSESSMENT TOOLS LIKE: Qualitative Initial Risk-based Matrix Analysis (IRMA) and Quantitative Failure Mode Effective Analysis (FMEA) to identify and rank parameters with potential to have an impact on In Process/Finished Product Critical Quality Attributes (IP/FP CQAs). These Critical Process Parameters (CPPs) were further refined by DoE and MVDA to develop design space with Real Time Release Testing (RTRT) that leads to implementation of a control strategy to achieve consistent finished product quality at lab scale itself to prevent possible product failure at larger manufacturing scale.

Quality risk management of top spray fluidized bed process for antihypertensive drug formulation with control strategy engendered by Box-behnken experimental design space

PubMed Central

Mukharya, Amit; Patel, Paresh U; Shenoy, Dinesh; Chaudhary, Shivang

2013-01-01

Introduction: Lacidipine (LCDP) is a very low soluble and highly biovariable calcium channel blocker used in the treatment of hypertension. To increase its apparent solubility and to reduce its biovariability, solid dispersion fluid bed processing technology was explored, as it produces highly dispersible granules with a characteristic porous structure that enhances dispersibility, wettability, blend uniformity (by dissolving and spraying a solution of actives), flow ability and compressibility of granules for tableting and reducing variability by uniform drug-binder solution distribution on carrier molecules. Materials and Methods: Main object of this quality risk management (QRM) study is to provide a sophisticated “robust and rugged” Fluidized Bed Process (FBP) for the preparation of LCDP tablets with desired quality (stability) and performance (dissolution) by quality by design (QbD) concept. Results and Conclusion: This study is principally focusing on thorough mechanistic understanding of the FBP by which it is developed and scaled up with a knowledge of the critical risks involved in manufacturing process analyzed by risk assessment tools like: Qualitative Initial Risk-based Matrix Analysis (IRMA) and Quantitative Failure Mode Effective Analysis (FMEA) to identify and rank parameters with potential to have an impact on In Process/Finished Product Critical Quality Attributes (IP/FP CQAs). These Critical Process Parameters (CPPs) were further refined by DoE and MVDA to develop design space with Real Time Release Testing (RTRT) that leads to implementation of a control strategy to achieve consistent finished product quality at lab scale itself to prevent possible product failure at larger manufacturing scale. PMID:23799202

Periodic benefit-risk assessment using Bayesian stochastic multi-criteria acceptability analysis.

PubMed

Li, Kan; Yuan, Shuai Sammy; Wang, William; Wan, Shuyan Sabrina; Ceesay, Paulette; Heyse, Joseph F; Mt-Isa, Shahrul; Luo, Sheng

2018-04-01

Benefit-risk (BR) assessment is essential to ensure the best decisions are made for a medical product in the clinical development process, regulatory marketing authorization, post-market surveillance, and coverage and reimbursement decisions. One challenge of BR assessment in practice is that the benefit and risk profile may keep evolving while new evidence is accumulating. Regulators and the International Conference on Harmonization (ICH) recommend performing periodic benefit-risk evaluation report (PBRER) through the product's lifecycle. In this paper, we propose a general statistical framework for periodic benefit-risk assessment, in which Bayesian meta-analysis and stochastic multi-criteria acceptability analysis (SMAA) will be combined to synthesize the accumulating evidence. The proposed approach allows us to compare the acceptability of different drugs dynamically and effectively and accounts for the uncertainty of clinical measurements and imprecise or incomplete preference information of decision makers. We apply our approaches to two real examples in a post-hoc way for illustration purpose. The proposed method may easily be modified for other pre and post market settings, and thus be an important complement to the current structured benefit-risk assessment (sBRA) framework to improve the transparent and consistency of the decision-making process. Copyright © 2018 Elsevier Inc. All rights reserved.

Patient Safety in Complementary Medicine through the Application of Clinical Risk Management in the Public Health System

PubMed Central

Rossi, Elio G.; Picchi, Marco; Baccetti, Sonia; Monechi, Maria Valeria; Vuono, Catia; Sabatini, Federica; Traversi, Antonella; Di Stefano, Mariella; Firenzuoli, Fabio; Albolino, Sara; Tartaglia, Riccardo

2017-01-01

Aim: To develop a systematic approach to detect and prevent clinical risks in complementary medicine (CM) and increase patient safety through the analysis of activities in homeopathy and acupuncture centres in the Tuscan region using a significant event audit (SEA) and failure modes and effects analysis (FMEA). Methods: SEA is the selected tool for studying adverse events (AE) and detecting the best solutions to prevent future incidents in our Regional Healthcare Service (RHS). This requires the active participation of all the actors and external experts to validate the analysis. FMEA is a proactive risk assessment tool involving the selection of the clinical process, the input of a multidisciplinary group of experts, description of the process, identification of the failure modes (FMs) for each step, estimates of the frequency, severity, and detectability of FMs, calculation of the risk priority number (RPN), and prioritized improvement actions to prevent FMs. Results: In homeopathy, the greatest risk depends on the decision to switch from allopathic to homeopathic therapy. In acupuncture, major problems can arise, mainly from delayed treatment and from the modalities of needle insertion. Conclusions: The combination of SEA and FMEA can reveal potential risks for patients and suggest actions for safer and more reliable services in CM. PMID:29258191

Patient Safety in Complementary Medicine through the Application of Clinical Risk Management in the Public Health System.

PubMed

Rossi, Elio G; Bellandi, Tommaso; Picchi, Marco; Baccetti, Sonia; Monechi, Maria Valeria; Vuono, Catia; Sabatini, Federica; Traversi, Antonella; Di Stefano, Mariella; Firenzuoli, Fabio; Albolino, Sara; Tartaglia, Riccardo

2017-12-16

Aim: To develop a systematic approach to detect and prevent clinical risks in complementary medicine (CM) and increase patient safety through the analysis of activities in homeopathy and acupuncture centres in the Tuscan region using a significant event audit (SEA) and failure modes and effects analysis (FMEA). Methods: SEA is the selected tool for studying adverse events (AE) and detecting the best solutions to prevent future incidents in our Regional Healthcare Service (RHS). This requires the active participation of all the actors and external experts to validate the analysis. FMEA is a proactive risk assessment tool involving the selection of the clinical process, the input of a multidisciplinary group of experts, description of the process, identification of the failure modes (FMs) for each step, estimates of the frequency, severity, and detectability of FMs, calculation of the risk priority number (RPN), and prioritized improvement actions to prevent FMs. Results: In homeopathy, the greatest risk depends on the decision to switch from allopathic to homeopathic therapy. In acupuncture, major problems can arise, mainly from delayed treatment and from the modalities of needle insertion. Conclusions: The combination of SEA and FMEA can reveal potential risks for patients and suggest actions for safer and more reliable services in CM.

NASA Langley Systems Analysis & Concepts Directorate Technology Assessment/Portfolio Analysis

NASA Technical Reports Server (NTRS)

Cavanaugh, Stephen; Chytka, Trina; Arcara, Phil; Jones, Sharon; Stanley, Doug; Wilhite, Alan W.

2006-01-01

Systems analysis develops and documents candidate mission and architectures, associated system concepts, enabling capabilities and investment strategies to achieve NASA s strategic objectives. The technology assessment process connects the mission and architectures to the investment strategies. In order to successfully implement a technology assessment, there is a need to collect, manipulate, analyze, document, and disseminate technology-related information. Information must be collected and organized on the wide variety of potentially applicable technologies, including: previous research results, key technical parameters and characteristics, technology readiness levels, relationships to other technologies, costs, and potential barriers and risks. This information must be manipulated to facilitate planning and documentation. An assessment is included of the programmatic and technical risks associated with each technology task as well as potential risk mitigation plans. Risks are assessed and tracked in terms of likelihood of the risk occurring and consequences of the risk if it does occur. The risk assessments take into account cost, schedule, and technical risk dimensions. Assessment data must be simplified for presentation to decision makers. The Systems Analysis and Concepts Directorate (SACD) at NASA Langley Research Center has a wealth of experience in performing Technology Assessment and Portfolio Analysis as this has been a business line since 1978.

Probabilistic Risk Assessment Procedures Guide for NASA Managers and Practitioners (Second Edition)

NASA Technical Reports Server (NTRS)

Stamatelatos,Michael; Dezfuli, Homayoon; Apostolakis, George; Everline, Chester; Guarro, Sergio; Mathias, Donovan; Mosleh, Ali; Paulos, Todd; Riha, David; Smith, Curtis;

Hyperspectral remote sensing and GIS techniques application for the evaluation and monitoring of interactions between natural risks and industrial hazards

NASA Astrophysics Data System (ADS)

Marino, Alessandra; Ludovisi, Giancarlo; Moccaldi, Antonio; Damiani, Fiorenzo

2001-02-01

The aim of this paper is to outline the potential of imaging spectroscopy and GIS techniques as tool for the management of data rich environments, as complex fluvial areas, exposed to geological, geomorphological, and hydrogeological risks. The area of study, the Pescara River Basin is characterized by the presence of important industrial sites and by the occurrence of floods, landslides and seismic events. Data were collected, during a specific flight, using an hyperspectral MIVIS sensor. Images have been processed in order to obtain updated and accurate land-cover and land-use maps that have been inserted in a specific GIS database and integrated with further information like lithology, geological structure, geomorphology, hydrogeological features, productive plants location and characters. The processing of data layers was performed, using a dedicated software, through typical GIS operators like indexing, recording, matrix analysis, proximity analysis. The interactions between natural risks, industrial installations, agricultural areas, water resources and urban settlements have been analyzed. This allowed the creation and processing of thematic layers like vulnerability, risk and impact maps.

Earth Sciences Data and Information System (ESDIS) program planning and evaluation methodology development

NASA Technical Reports Server (NTRS)

Dickinson, William B.

1995-01-01

An Earth Sciences Data and Information System (ESDIS) Project Management Plan (PMP) is prepared. An ESDIS Project Systems Engineering Management Plan (SEMP) consistent with the developed PMP is also prepared. ESDIS and related EOS program requirements developments, management and analysis processes are evaluated. Opportunities to improve the effectiveness of these processes and program/project responsiveness to requirements are identified. Overall ESDIS cost estimation processes are evaluated, and recommendations to improve cost estimating and modeling techniques are developed. ESDIS schedules and scheduling tools are evaluated. Risk assessment, risk mitigation strategies and approaches, and use of risk information in management decision-making are addressed.

Analysis of Risk Compensation Behavior on Night Vision Enhancement System

NASA Astrophysics Data System (ADS)

Hiraoka, Toshihiro; Masui, Junya; Nishikawa, Seimei

Advanced driver assistance systems (ADAS) such as a forward obstacle collision warning system (FOCWS) and a night vision enhancement system (NVES) aim to decrease driver's mental workload and enhance vehicle safety by provision of useful information to support driver's perception process and judgment process. On the other hand, the risk homeostasis theory (RHT) cautions that an enhanced safety and a reduced risk would cause a risk compensation behavior such as increasing the vehicle velocity. Therefore, the present paper performed the driving simulator experiments to discuss dependence on the NVES and emergence of the risk compensation behavior. Moreover, we verified the side-effects of spontaneous behavioral adaptation derived from the presentation of the fuel-consumption meter on the risk compensation behavior.

IT Operational Risk Measurement Model Based on Internal Loss Data of Banks

NASA Astrophysics Data System (ADS)

Hao, Xiaoling

Business operation of banks relies increasingly on information technology (IT) and the most important role of IT is to guarantee the operational continuity of business process. Therefore, IT Risk management efforts need to be seen from the perspective of operational continuity. Traditional IT risk studies focused on IT asset-based risk analysis and risk-matrix based qualitative risk evaluation. In practice, IT risk management practices of banking industry are still limited to the IT department and aren't integrated into business risk management, which causes the two departments to work in isolation. This paper presents an improved methodology for dealing with IT operational risk. It adopts quantitative measurement method, based on the internal business loss data about IT events, and uses Monte Carlo simulation to predict the potential losses. We establish the correlation between the IT resources and business processes to make sure risk management of IT and business can work synergistically.

The Effect of Sleep Problems on Suicidal Risk among Young Adults in the Presence of Depressive Symptoms and Cognitive Processes.

PubMed

Weis, Dafna; Rothenberg, Lee; Moshe, Lital; Brent, David A; Hamdan, Sami

2015-01-01

We aimed to investigate the effect of sleep problems, depression, and cognitive processes on suicidal risk among 460 young adults. They completed self-report questionnaires assessing suicidal behavior, sleep quality, depressive symptoms, emotion regulation, rumination, and impulsivity. Suicidal participants exhibited higher rates of depressive symptoms, sleep problems, expressive suppression, rumination, and impulsivity. A confirmatory factor analysis model revealed pathways to suicidal risk that showed no direct pathways between sleep problems and suicidal risk. Instead, sleep was related to suicidal risk via depression and rumination, which in turn increased suicidal risk. These results suggest that addressing sleep problems will be useful in either the treatment or prevention of depressive and rumination symptoms and reduction in suicidal risk.

Development and validation of a scoring index to predict the presence of lesions in capsule endoscopy in patients with suspected Crohn's disease of the small bowel: a Spanish multicenter study.

PubMed

Egea-Valenzuela, Juan; González Suárez, Begoña; Sierra Bernal, Cristian; Juanmartiñena Fernández, José Francisco; Luján-Sanchís, Marisol; San Juan Acosta, Mileidis; Martínez Andrés, Blanca; Pons Beltrán, Vicente; Sastre Lozano, Violeta; Carretero Ribón, Cristina; de Vera Almenar, Félix; Sánchez Cuenca, Joaquín; Alberca de Las Parras, Fernando; Rodríguez de Miguel, Cristina; Valle Muñoz, Julio; Férnandez-Urién Sainz, Ignacio; Torres González, Carolina; Borque Barrera, Pilar; Pérez-Cuadrado Robles, Enrique; Alonso Lázaro, Noelia; Martínez García, Pilar; Prieto de Frías, César; Carballo Álvarez, Fernando

2018-05-01

Capsule endoscopy (CE) is the first-line investigation in cases of suspected Crohn's disease (CD) of the small bowel, but the factors associated with a higher diagnostic yield remain unclear. Our aim is to develop and validate a scoring index to assess the risk of the patients in this setting on the basis of biomarkers. Data on fecal calprotectin, C-reactive protein, and other biomarkers from a population of 124 patients with suspected CD of the small bowel studied by CE and included in a PhD study were used to build a scoring index. This was first used on this population (internal validation process) and after that on a different set of patients from a multicenter study (external validation process). An index was designed in which every biomarker is assigned a score. Three risk groups have been established (low, intermediate, and high). In the internal validation analysis (124 individuals), patients had a 10, 46.5, and 81% probability of showing inflammatory lesions in CE in the low-risk, intermediate-risk, and high-risk groups, respectively. In the external validation analysis, including 410 patients from 12 Spanish hospitals, this probability was 15.8, 49.7, and 80.6% for the low-risk, intermediate-risk, and high-risk groups, respectively. Results from the internal validation process show that the scoring index is coherent, and results from the external validation process confirm its reliability. This index can be a useful tool for selecting patients before CE studies in cases of suspected CD of the small bowel.

Collaborative risk governance in informal urban areas: The case of Wallacedene temporary relocation area

PubMed Central

2017-01-01

Community-based disaster risk management (CBDRM) is an emancipatory approach that aims to empower local communities in reducing their own risks. A community risk assessment (CRA) is an essential element of CBDRM, incorporating highly participatory processes of hazard identification and vulnerability analysis. By incorporating local knowledge and insights, together with those contributed by other external role players, the nature of local risks can be more accurately identified, giving consideration to their causal factors, the nature of their realised impacts or potential effects on a local community and the challenges posed in addressing them. Reflecting on the process and outcomes of a CRA conducted in an informal settlement in the Cape Town metropolitan area, this article describes how one such risk assessment contributed to building local agency through a process of collaborative engagement. Offered as an example of possible best practice, it illustrates both the immediate and potentially longer term benefits to be derived from such a collaborative process, suggesting that a community-based risk assessment may contribute significantly to building more resilient communities. It concludes with a consideration of the challenges of sustaining longer term risk reduction efforts.

White paper on the promotion of an integrated risk assessment concept in European regulatory frameworks for chemicals.

PubMed

Wilks, M F; Roth, N; Aicher, L; Faust, M; Papadaki, P; Marchis, A; Calliera, M; Ginebreda, A; Andres, S; Kühne, R; Schüürmann, G

2015-07-15

The vision of a sustainable and safe use of chemicals to protect human health, preserve the environment and maintain the ecosystem requires innovative and more holistic approaches to risk assessment (RA) in order to better inform decision making. Integrated risk assessment (IRA) has been proposed as a solution to current scientific, societal and policy needs. It is defined as the mutual exploitation of environmental risk assessment (ERA) for human health risk assessment (HHRA) and vice versa in order to coherently and more efficiently characterize an overall risk to humans and the environment for better informing the risk analysis process. Extrapolating between species which are relevant for HHRA and ERA requires a detailed understanding of pathways of toxicity/modes of action (MoA) for the various toxicological endpoints. Significant scientific advances, changes in chemical legislation, and increasing environmental consciousness have created a favourable scientific and regulatory environment to develop and promote the concept and vision of IRA. An initial proof of concept is needed to foster the incorporation of IRA approaches into different chemical sectorial regulations and demonstrate their reliability for regulatory purposes. More familiarity and confidence with IRA will ultimately contribute to an overall reduction in in vivo toxicity testing requirements. However, significant progress will only be made if long-term support for MoA-related research is secured. In the short term, further exchange and harmonization of RA terminology, models and methodologies across chemical categories and regulatory agencies will support these efforts. Since societal values, public perceptions and cultural factors are of increasing importance for the acceptance of risk analysis and successful implementation of risk mitigation measures, the integration of socio-economic analysis and socio-behavioural considerations into the risk analysis process may help to produce a more effective risk evaluation and consideration of the risks and benefits associated with the use of chemicals. Copyright © 2015 Elsevier B.V. All rights reserved.

Failure Mode and Effect Analysis for Delivery of Lung Stereotactic Body Radiation Therapy

DOE Office of Scientific and Technical Information (OSTI.GOV)

Perks, Julian R., E-mail: julian.perks@ucdmc.ucdavis.edu; Stanic, Sinisa; Stern, Robin L.

2012-07-15

Purpose: To improve the quality and safety of our practice of stereotactic body radiation therapy (SBRT), we analyzed the process following the failure mode and effects analysis (FMEA) method. Methods: The FMEA was performed by a multidisciplinary team. For each step in the SBRT delivery process, a potential failure occurrence was derived and three factors were assessed: the probability of each occurrence, the severity if the event occurs, and the probability of detection by the treatment team. A rank of 1 to 10 was assigned to each factor, and then the multiplied ranks yielded the relative risks (risk priority numbers).more » The failure modes with the highest risk priority numbers were then considered to implement process improvement measures. Results: A total of 28 occurrences were derived, of which nine events scored with significantly high risk priority numbers. The risk priority numbers of the highest ranked events ranged from 20 to 80. These included transcription errors of the stereotactic coordinates and machine failures. Conclusion: Several areas of our SBRT delivery were reconsidered in terms of process improvement, and safety measures, including treatment checklists and a surgical time-out, were added for our practice of gantry-based image-guided SBRT. This study serves as a guide for other users of SBRT to perform FMEA of their own practice.« less

Applicability of risk-based management and the need for risk-based economic decision analysis at hazardous waste contaminated sites.

PubMed

Khadam, Ibrahim; Kaluarachchi, Jagath J

2003-07-01

Decision analysis in subsurface contamination management is generally carried out through a traditional engineering economic viewpoint. However, new advances in human health risk assessment, namely, the probabilistic risk assessment, and the growing awareness of the importance of soft data in the decision-making process, require decision analysis methodologies that are capable of accommodating non-technical and politically biased qualitative information. In this work, we discuss the major limitations of the currently practiced decision analysis framework, which evolves around the definition of risk and cost of risk, and its poor ability to communicate risk-related information. A demonstration using a numerical example was conducted to provide insight on these limitations of the current decision analysis framework. The results from this simple ground water contamination and remediation scenario were identical to those obtained from studies carried out on existing Superfund sites, which suggests serious flaws in the current risk management framework. In order to provide a perspective on how these limitations may be avoided in future formulation of the management framework, more matured and well-accepted approaches to decision analysis in dam safety and the utility industry, where public health and public investment are of great concern, are presented and their applicability in subsurface remediation management is discussed. Finally, in light of the success of the application of risk-based decision analysis in dam safety and the utility industry, potential options for decision analysis in subsurface contamination management are discussed.

Continuous Risk Management: A NASA Program Initiative

NASA Technical Reports Server (NTRS)

Hammer, Theodore F.; Rosenberg, Linda

1999-01-01

NPG 7120.5A, "NASA Program and Project Management Processes and Requirements" enacted in April, 1998, requires that "The program or project manager shall apply risk management principles..." The Software Assurance Technology Center (SATC) at NASA GSFC has been tasked with the responsibility for developing and teaching a systems level course for risk management that provides information on how to comply with this edict. The course was developed in conjunction with the Software Engineering Institute at Carnegie Mellon University, then tailored to the NASA systems community. This presentation will briefly discuss the six functions for risk management: (1) Identify the risks in a specific format; (2) Analyze the risk probability, impact/severity, and timeframe; (3) Plan the approach; (4) Track the risk through data compilation and analysis; (5) Control and monitor the risk; (6) Communicate and document the process and decisions.

Risk-Based Contaminated Land Investigation and Assessment

NASA Astrophysics Data System (ADS)

Davis, Donald R.

With increasing frequency, problems of environmental contamination are being analyzed from a risk perspective. Risk-Based Contaminated Land Investigation and Assessment is written for those who wish to present the results of their examination of contaminated land in terms of risk.The opening chapters introduce the concepts of risk analysis for contaminated land. Risk management and the risk assessment process are based on a source-pathway-target framework. Readers are warned against an “over-reliance on the identification of contaminants rather than the potential pathways by which targets may be exposed to these hazards.” In the risk management framework presented in this book, risk evaluation and resultant decision making are seen as part of both the risk assessment and risk reduction process. The sharp separation of risk assessment from risk management as seen in the National Academy of Sciences' (NAS) risk assessment paradigm is not advocatedsemi; perhaps this is because the NAS' concern was regulatory decision while the book's concern is the assessment of a specific site.

Project risk management in the construction of high-rise buildings

NASA Astrophysics Data System (ADS)

Titarenko, Boris; Hasnaoui, Amir; Titarenko, Roman; Buzuk, Liliya

2018-03-01

This paper shows the project risk management methods, which allow to better identify risks in the construction of high-rise buildings and to manage them throughout the life cycle of the project. One of the project risk management processes is a quantitative analysis of risks. The quantitative analysis usually includes the assessment of the potential impact of project risks and their probabilities. This paper shows the most popular methods of risk probability assessment and tries to indicate the advantages of the robust approach over the traditional methods. Within the framework of the project risk management model a robust approach of P. Huber is applied and expanded for the tasks of regression analysis of project data. The suggested algorithms used to assess the parameters in statistical models allow to obtain reliable estimates. A review of the theoretical problems of the development of robust models built on the methodology of the minimax estimates was done and the algorithm for the situation of asymmetric "contamination" was developed.

Estimating and controlling workplace risk: an approach for occupational hygiene and safety professionals.

PubMed

Toffel, Michael W; Birkner, Lawrence R

2002-07-01

The protection of people and physical assets is the objective of health and safety professionals and is accomplished through the paradigm of anticipation, recognition, evaluation, and control of risks in the occupational environment. Risk assessment concepts are not only used by health and safety professionals, but also by business and financial planners. Since meeting health and safety objectives requires financial resources provided by business and governmental managers, the hypothesis addressed here is that health and safety risk decisions should be made with probabilistic processes used in financial decision-making and which are familiar and recognizable to business and government planners and managers. This article develops the processes and demonstrates the use of incident probabilities, historic outcome information, and incremental impact analysis to estimate risk of multiple alternatives in the chemical process industry. It also analyzes how the ethical aspects of decision-making can be addressed in formulating health and safety risk management plans. It is concluded that certain, easily understood, and applied probabilistic risk assessment methods used by business and government to assess financial and outcome risk have applicability to improving workplace health and safety in three ways: 1) by linking the business and health and safety risk assessment processes to securing resources, 2) by providing an additional set of tools for health and safety risk assessment, and 3) by requiring the risk assessor to consider multiple risk management alternatives.

A Methodology to Support Decision Making in Flood Plan Mitigation

NASA Astrophysics Data System (ADS)

Biscarini, C.; di Francesco, S.; Manciola, P.

2009-04-01

The focus of the present document is on specific decision-making aspects of flood risk analysis. A flood is the result of runoff from rainfall in quantities too great to be confined in the low-water channels of streams. Little can be done to prevent a major flood, but we may be able to minimize damage within the flood plain of the river. This broad definition encompasses many possible mitigation measures. Floodplain management considers the integrated view of all engineering, nonstructural, and administrative measures for managing (minimizing) losses due to flooding on a comprehensive scale. The structural measures are the flood-control facilities designed according to flood characteristics and they include reservoirs, diversions, levees or dikes, and channel modifications. Flood-control measures that modify the damage susceptibility of floodplains are usually referred to as nonstructural measures and may require minor engineering works. On the other hand, those measures designed to modify the damage potential of permanent facilities are called non-structural and allow reducing potential damage during a flood event. Technical information is required to support the tasks of problem definition, plan formulation, and plan evaluation. The specific information needed and the related level of detail are dependent on the nature of the problem, the potential solutions, and the sensitivity of the findings to the basic information. Actions performed to set up and lay out the study are preliminary to the detailed analysis. They include: defining the study scope and detail, the field data collection, a review of previous studies and reports, and the assembly of needed maps and surveys. Risk analysis can be viewed as having many components: risk assessment, risk communication and risk management. Risk assessment comprises an analysis of the technical aspects of the problem, risk communication deals with conveying the information and risk management involves the decision process. In the present paper we propose a novel methodology for supporting the priority setting in the assessment of such issues, beyond the typical "expected value" approach. Scientific contribution and management aspects are merged to create a simplified method for plan basin implementation, based on risk and economic analyses. However, the economic evaluation is not the sole criterion for flood-damage reduction plan selection. Among the different criteria that are relevant to the decision process, safety and quality of human life, economic damage, expenses related with the chosen measures and environmental issues should play a fundamental role on the decisions made by the authorities. Some numerical indices, taking in account administrative, technical, economical and risk aspects, are defined and are combined together in a mathematical formula that defines a Priority Index (PI). In particular, the priority index defines a ranking of priority interventions, thus allowing the formulation of the investment plan. The research is mainly focused on the technical factors of risk assessment, providing quantitative and qualitative estimates of possible alternatives, containing measures of the risk associated with those alternatives. Moreover, the issues of risk management are analyzed, in particular with respect to the role of decision making in the presence of risk information. However, a great effort is devoted to make this index easy to be formulated and effective to allow a clear and transparent comparison between the alternatives. Summarizing this document describes a major- steps for incorporation of risk analysis into the decision making process: framing of the problem in terms of risk analysis, application of appropriate tools and techniques to obtain quantified results, use of the quantified results in the choice of structural and non-structural measures. In order to prove the reliability of the proposed methodology and to show how risk-based information can be incorporated into a flood analysis process, its application to some middle italy river basins is presented. The methodology assessment is performed by comparing different scenarios and showing that the optimal decision stems from a feasibility evaluation.

Potential application of quantitative microbiological risk assessment techniques to an aseptic-UHT process in the food industry.

PubMed

Pujol, Laure; Albert, Isabelle; Johnson, Nicholas Brian; Membré, Jeanne-Marie

2013-04-01

Aseptic ultra-high-temperature (UHT)-type processed food products (e.g., milk or soup) are ready to eat products which are consumed extensively globally due to a combination of their comparative high quality and long shelf life, with no cold chain or other preservation requirements. Due to the inherent microbial vulnerability of aseptic-UHT product formulations, the safety and stability-related performance objectives (POs) required at the end of the manufacturing process are the most demanding found in the food industry. The key determinants to achieving sterility, and which also differentiates aseptic-UHT from in-pack sterilised products, are the challenges associated with the processes of aseptic filling and sealing. This is a complex process that has traditionally been run using deterministic or empirical process settings. Quantifying the risk of microbial contamination and recontamination along the aseptic-UHT process, using the scientifically based process quantitative microbial risk assessment (QMRA), offers the possibility to improve on the currently tolerable sterility failure rate (i.e., 1 defect per 10,000 units). In addition, benefits of applying QMRA are (i) to implement process settings in a transparent and scientific manner; (ii) to develop a uniform common structure whatever the production line, leading to a harmonisation of these process settings, and; (iii) to bring elements of a cost-benefit analysis of the management measures. The objective of this article is to explore how QMRA techniques and risk management metrics may be applied to aseptic-UHT-type processed food products. In particular, the aseptic-UHT process should benefit from a number of novel mathematical and statistical concepts that have been developed in the field of QMRA. Probabilistic techniques such as Monte Carlo simulation, Bayesian inference and sensitivity analysis, should help in assessing the compliance with safety and stability-related POs set at the end of the manufacturing process. The understanding of aseptic-UHT process contamination will be extended beyond the current "as-low-as-reasonably-achievable" targets to a risk-based framework, through which current sterility performance and future process designs can be optimised. Copyright © 2013 Elsevier B.V. All rights reserved.

Neyman, Markov processes and survival analysis.

PubMed

Yang, Grace

2013-07-01

J. Neyman used stochastic processes extensively in his applied work. One example is the Fix and Neyman (F-N) competing risks model (1951) that uses finite homogeneous Markov processes to analyse clinical trials with breast cancer patients. We revisit the F-N model, and compare it with the Kaplan-Meier (K-M) formulation for right censored data. The comparison offers a way to generalize the K-M formulation to include risks of recovery and relapses in the calculation of a patient's survival probability. The generalization is to extend the F-N model to a nonhomogeneous Markov process. Closed-form solutions of the survival probability are available in special cases of the nonhomogeneous processes, like the popular multiple decrement model (including the K-M model) and Chiang's staging model, but these models do not consider recovery and relapses while the F-N model does. An analysis of sero-epidemiology current status data with recurrent events is illustrated. Fix and Neyman used Neyman's RBAN (regular best asymptotic normal) estimates for the risks, and provided a numerical example showing the importance of considering both the survival probability and the length of time of a patient living a normal life in the evaluation of clinical trials. The said extension would result in a complicated model and it is unlikely to find analytical closed-form solutions for survival analysis. With ever increasing computing power, numerical methods offer a viable way of investigating the problem.

Bridging the gap between individual-level risk for HIV and structural determinants: using root cause analysis in strategic planning.

PubMed

Willard, Nancy; Chutuape, Kate; Stines, Stephanie; Ellen, Jonathan M

2012-01-01

HIV prevention efforts have expanded beyond individual-level interventions to address structural determinants of risk. Coalitions have been an important vehicle for addressing similar intractable and deeply rooted health-related issues. A root cause analysis process may aid coalitions in identifying fundamental, structural-level contributors to risk and in identifying appropriate solutions. For this article, strategic plans for 13 coalitions were analyzed both before and after a root cause analysis approach was applied to determine the coalitions' strategic plans potential impact and comprehensiveness. After root cause analysis, strategic plans trended toward targeting policies and practices rather than on single agency programmatic changes. Plans expanded to target multiple sectors and several changes within sectors to penetrate deeply into a sector or system. Findings suggest that root cause analysis may be a viable tool to assist coalitions in identifying structural determinants and possible solutions for HIV risk.

SU-F-T-245: The Investigation of Failure Mode and Effects Analysis and PDCA for the Radiotherapy Risk Reduction

DOE Office of Scientific and Technical Information (OSTI.GOV)

Xie, J; Wang, J; P, J

2016-06-15

Purpose: To optimize the clinical processes of radiotherapy and to reduce the radiotherapy risks by implementing the powerful risk management tools of failure mode and effects analysis(FMEA) and PDCA(plan-do-check-act). Methods: A multidiciplinary QA(Quality Assurance) team from our department consisting of oncologists, physicists, dosimetrists, therapists and administrator was established and an entire workflow QA process management using FMEA and PDCA tools was implemented for the whole treatment process. After the primary process tree was created, the failure modes and Risk priority numbers(RPNs) were determined by each member, and then the RPNs were averaged after team discussion. Results: 3 of 9 failuremore » modes with RPN above 100 in the practice were identified in the first PDCA cycle, which were further analyzed to investigate the RPNs: including of patient registration error, prescription error and treating wrong patient. New process controls reduced the occurrence, or detectability scores from the top 3 failure modes. Two important corrective actions reduced the highest RPNs from 300 to 50, and the error rate of radiotherapy decreased remarkably. Conclusion: FMEA and PDCA are helpful in identifying potential problems in the radiotherapy process, which was proven to improve the safety, quality and efficiency of radiation therapy in our department. The implementation of the FMEA approach may improve the understanding of the overall process of radiotherapy while may identify potential flaws in the whole process. Further more, repeating the PDCA cycle can bring us closer to the goal: higher safety and accuracy radiotherapy.« less

TH-EF-BRC-04: Quality Management Program

DOE Office of Scientific and Technical Information (OSTI.GOV)

Yorke, E.

2016-06-15

This Hands-on Workshop will be focused on providing participants with experience with the principal tools of TG 100 and hence start to build both competence and confidence in the use of risk-based quality management techniques. The three principal tools forming the basis of TG 100’s risk analysis: Process mapping, Failure-Modes and Effects Analysis and fault-tree analysis will be introduced with a 5 minute refresher presentation and each presentation will be followed by a 30 minute small group exercise. An exercise on developing QM from the risk analysis follows. During the exercise periods, participants will apply the principles in 2 differentmore » clinical scenarios. At the conclusion of each exercise there will be ample time for participants to discuss with each other and the faculty their experience and any challenges encountered. Learning Objectives: To review the principles of Process Mapping, Failure Modes and Effects Analysis and Fault Tree Analysis. To gain familiarity with these three techniques in a small group setting. To share and discuss experiences with the three techniques with faculty and participants. Director, TreatSafely, LLC. Director, Center for the Assessment of Radiological Sciences. Occasional Consultant to the IAEA and Varian.« less

TH-EF-BRC-00: TG-100 Workshop

DOE Office of Scientific and Technical Information (OSTI.GOV)

NONE

2016-06-15

This Hands-on Workshop will be focused on providing participants with experience with the principal tools of TG 100 and hence start to build both competence and confidence in the use of risk-based quality management techniques. The three principal tools forming the basis of TG 100’s risk analysis: Process mapping, Failure-Modes and Effects Analysis and fault-tree analysis will be introduced with a 5 minute refresher presentation and each presentation will be followed by a 30 minute small group exercise. An exercise on developing QM from the risk analysis follows. During the exercise periods, participants will apply the principles in 2 differentmore » clinical scenarios. At the conclusion of each exercise there will be ample time for participants to discuss with each other and the faculty their experience and any challenges encountered. Learning Objectives: To review the principles of Process Mapping, Failure Modes and Effects Analysis and Fault Tree Analysis. To gain familiarity with these three techniques in a small group setting. To share and discuss experiences with the three techniques with faculty and participants. Director, TreatSafely, LLC. Director, Center for the Assessment of Radiological Sciences. Occasional Consultant to the IAEA and Varian.« less

TH-EF-BRC-02: FMEA

DOE Office of Scientific and Technical Information (OSTI.GOV)

Huq, M.

2016-06-15

This Hands-on Workshop will be focused on providing participants with experience with the principal tools of TG 100 and hence start to build both competence and confidence in the use of risk-based quality management techniques. The three principal tools forming the basis of TG 100’s risk analysis: Process mapping, Failure-Modes and Effects Analysis and fault-tree analysis will be introduced with a 5 minute refresher presentation and each presentation will be followed by a 30 minute small group exercise. An exercise on developing QM from the risk analysis follows. During the exercise periods, participants will apply the principles in 2 differentmore » clinical scenarios. At the conclusion of each exercise there will be ample time for participants to discuss with each other and the faculty their experience and any challenges encountered. Learning Objectives: To review the principles of Process Mapping, Failure Modes and Effects Analysis and Fault Tree Analysis. To gain familiarity with these three techniques in a small group setting. To share and discuss experiences with the three techniques with faculty and participants. Director, TreatSafely, LLC. Director, Center for the Assessment of Radiological Sciences. Occasional Consultant to the IAEA and Varian.« less

DOE Office of Scientific and Technical Information (OSTI.GOV)

Dunscombe, P.

This Hands-on Workshop will be focused on providing participants with experience with the principal tools of TG 100 and hence start to build both competence and confidence in the use of risk-based quality management techniques. The three principal tools forming the basis of TG 100’s risk analysis: Process mapping, Failure-Modes and Effects Analysis and fault-tree analysis will be introduced with a 5 minute refresher presentation and each presentation will be followed by a 30 minute small group exercise. An exercise on developing QM from the risk analysis follows. During the exercise periods, participants will apply the principles in 2 differentmore » clinical scenarios. At the conclusion of each exercise there will be ample time for participants to discuss with each other and the faculty their experience and any challenges encountered. Learning Objectives: To review the principles of Process Mapping, Failure Modes and Effects Analysis and Fault Tree Analysis. To gain familiarity with these three techniques in a small group setting. To share and discuss experiences with the three techniques with faculty and participants. Director, TreatSafely, LLC. Director, Center for the Assessment of Radiological Sciences. Occasional Consultant to the IAEA and Varian.« less

Use of Failure Mode and Effects Analysis to Improve Emergency Department Handoff Processes.

PubMed

Sorrentino, Patricia

2016-01-01

The purpose of this article is to describe a quality improvement process using failure mode and effects analysis (FMEA) to evaluate systems handoff communication processes, improve emergency department (ED) throughput and reduce crowding through development of a standardized handoff, and, ultimately, improve patient safety. Risk of patient harm through ineffective communication during handoff transitions is a major reason for breakdown of systems. Complexities of ED processes put patient safety at risk. An increased incidence of submitted patient safety event reports for handoff communication failures between the ED and inpatient units solidified a decision to implement the use of FMEA to identify handoff failures to mitigate patient harm through redesign. The clinical nurse specialist implemented an FMEA. Handoff failure themes were created from deidentified retrospective reviews. Weekly meetings were held over a 3-month period to identify failure modes and determine cause and effect on the process. A functional block diagram process map tool was used to illustrate handoff processes. An FMEA grid was used to list failure modes and assign a risk priority number to quantify results. Multiple areas with actionable failures were identified. A majority of causes for high-priority failure modes were specific to communications. Findings demonstrate the complexity of transition and handoff processes. The FMEA served to identify and evaluate risk of handoff failures and provide a framework for process improvement. A focus on mentoring nurses to quality handoff processes so that it becomes habitual practice is crucial to safe patient transitions. Standardizing content and hardwiring within the system are best practice. The clinical nurse specialist is prepared to provide strong leadership to drive and implement system-wide quality projects.

Failure mode and effect analysis in blood transfusion: a proactive tool to reduce risks.

PubMed

Lu, Yao; Teng, Fang; Zhou, Jie; Wen, Aiqing; Bi, Yutian

2013-12-01

The aim of blood transfusion risk management is to improve the quality of blood products and to assure patient safety. We utilize failure mode and effect analysis (FMEA), a tool employed for evaluating risks and identifying preventive measures to reduce the risks in blood transfusion. The failure modes and effects occurring throughout the whole process of blood transfusion were studied. Each failure mode was evaluated using three scores: severity of effect (S), likelihood of occurrence (O), and probability of detection (D). Risk priority numbers (RPNs) were calculated by multiplying the S, O, and D scores. The plan-do-check-act cycle was also used for continuous improvement. Analysis has showed that failure modes with the highest RPNs, and therefore the greatest risk, were insufficient preoperative assessment of the blood product requirement (RPN, 245), preparation time before infusion of more than 30 minutes (RPN, 240), blood transfusion reaction occurring during the transfusion process (RPN, 224), blood plasma abuse (RPN, 180), and insufficient and/or incorrect clinical information on request form (RPN, 126). After implementation of preventative measures and reassessment, a reduction in RPN was detected with each risk. The failure mode with the second highest RPN, namely, preparation time before infusion of more than 30 minutes, was shown in detail to prove the efficiency of this tool. FMEA evaluation model is a useful tool in proactively analyzing and reducing the risks associated with the blood transfusion procedure. © 2013 American Association of Blood Banks.

Extractive waste management: A risk analysis approach.

PubMed

Mehta, Neha; Dino, Giovanna Antonella; Ajmone-Marsan, Franco; Lasagna, Manuela; Romè, Chiara; De Luca, Domenico Antonio

2018-05-01

Abandoned mine sites continue to present serious environmental hazards because the heavy metals associated with extractive waste are continuously released into the environment, where they threaten human life and the environment. Remediating and securing extractive waste are complex, lengthy and costly processes. Thus, in most European countries, a site is considered for intervention when it poses a risk to human health and the surrounding environment. As a consequence, risk analysis presents a viable decisional approach towards the management of extractive waste. To evaluate the effects posed by extractive waste to human health and groundwater, a risk analysis approach was used for an abandoned nickel extraction site in Campello Monti in North Italy. This site is located in the Southern Italian Alps. The area consists of large and voluminous mafic rocks intruded by mantle peridotite. The mining activities in this area have generated extractive waste. A risk analysis of the site was performed using Risk Based Corrective Action (RBCA) guidelines, considering the properties of extractive waste and water for the properties of environmental matrices. The results showed the presence of carcinogenic risk due to arsenic and risks to groundwater due to nickel. The results of the risk analysis form a basic understanding of the current situation at the site, which is affected by extractive waste. Copyright © 2017 Elsevier B.V. All rights reserved.

[Does clinical risk management require a structured conflict management?].

PubMed

Neumann, Stefan

2015-01-01

A key element of clinical risk management is the analysis of errors causing near misses or patient damage. After analyzing the causes and circumstances, measures for process improvement have to be taken. Process management, human resource development and other established methods are used. If an interpersonal conflict is a contributory factor to the error, there is usually no structured conflict management available which includes selection criteria for various methods of conflict processing. The European University Viadrina in Frankfurt (Oder) has created a process model for introducing a structured conflict management system which is suitable for hospitals and could fill the gap in the methodological spectrum of clinical risk management. There is initial evidence that a structured conflict management reduces staff fluctuation and hidden conflict costs. This article should be understood as an impulse for discussion on to what extent the range of methods of clinical risk management should be complemented by conflict management.

DOE Office of Scientific and Technical Information (OSTI.GOV)

Stayner, L.T.; Meinhardt, T.; Hardin, B.

Under the Occupational Safety and Health, and Mine Safety and Health Acts, the National Institute for Occupational Safety and Health (NIOSH) is charged with development of recommended occupational safety and health standards, and with conducting research to support the development of these standards. Thus, NIOSH has been actively involved in the analysis of risk associated with occupational exposures, and in the development of research information that is critical for the risk assessment process. NIOSH research programs and other information resources relevant to the risk assessment process are described in this paper. Future needs for information resources are also discussed.

SU-E-T-421: Failure Mode and Effects Analysis (FMEA) of Xoft Electronic Brachytherapy for the Treatment of Superficial Skin Cancers

DOE Office of Scientific and Technical Information (OSTI.GOV)

Hoisak, J; Manger, R; Dragojevic, I

Purpose: To perform a failure mode and effects analysis (FMEA) of the process for treating superficial skin cancers with the Xoft Axxent electronic brachytherapy (eBx) system, given the recent introduction of expanded quality control (QC) initiatives at our institution. Methods: A process map was developed listing all steps in superficial treatments with Xoft eBx, from the initial patient consult to the completion of the treatment course. The process map guided the FMEA to identify the failure modes for each step in the treatment workflow and assign Risk Priority Numbers (RPN), calculated as the product of the failure mode’s probability ofmore » occurrence (O), severity (S) and lack of detectability (D). FMEA was done with and without the inclusion of recent QC initiatives such as increased staffing, physics oversight, standardized source calibration, treatment planning and documentation. The failure modes with the highest RPNs were identified and contrasted before and after introduction of the QC initiatives. Results: Based on the FMEA, the failure modes with the highest RPN were related to source calibration, treatment planning, and patient setup/treatment delivery (Fig. 1). The introduction of additional physics oversight, standardized planning and safety initiatives such as checklists and time-outs reduced the RPNs of these failure modes. High-risk failure modes that could be mitigated with improved hardware and software interlocks were identified. Conclusion: The FMEA analysis identified the steps in the treatment process presenting the highest risk. The introduction of enhanced QC initiatives mitigated the risk of some of these failure modes by decreasing their probability of occurrence and increasing their detectability. This analysis demonstrates the importance of well-designed QC policies, procedures and oversight in a Xoft eBx programme for treatment of superficial skin cancers. Unresolved high risk failure modes highlight the need for non-procedural quality initiatives such as improved planning software and more robust hardware interlock systems.« less

Risk assessment as standard work in design.

PubMed

Morrill, Patricia W

2013-01-01

This case study article examines a formal risk assessment as part of the decision making process for design solutions in high risk areas. The overview of the Failure Modes and Effects Analysis (FMEA) tool with examples of its application in hospital building projects will demonstrate the benefit of those structured conversations. This article illustrates how two hospitals used FMEA when integrating operational processes with building projects: (1) adjacency decision for Intensive Care Unit (ICU); and (2) distance concern for handling of specimens from Surgery to Lab. Both case studies involved interviews that exposed facility solution concerns. Just-in-time studies using the FMEA followed the same risk assessment process with the same workshop facilitator involving structured conversations in analyzing risks. In both cases, participants uncovered key areas of risk enabling them to take the necessary next steps. While the focus of this article is not the actual design solution, it is apparent that the risk assessment brought clarity to the situations resulting in prompt decision making about facility solutions. Hospitals are inherently risky environments; therefore, use of the formal risk assessment process, FMEA, is an opportunity for design professionals to apply more rigor to design decision making when facility solutions impact operations in high risk areas. Case study, decision making, hospital, infection control, strategy, work environment.

Looking beyond borders: integrating best practices in benefit-risk analysis into the field of food and nutrition.

PubMed

Tijhuis, M J; Pohjola, M V; Gunnlaugsdóttir, H; Kalogeras, N; Leino, O; Luteijn, J M; Magnússon, S H; Odekerken-Schröder, G; Poto, M; Tuomisto, J T; Ueland, O; White, B C; Holm, F; Verhagen, H

2012-01-01

An integrated benefit-risk analysis aims to give guidance in decision situations where benefits do not clearly prevail over risks, and explicit weighing of benefits and risks is thus indicated. The BEPRARIBEAN project aims to advance benefit-risk analysis in the area of food and nutrition by learning from other fields. This paper constitutes the final stage of the project, in which commonalities and differences in benefit-risk analysis are identified between the Food and Nutrition field and other fields, namely Medicines, Food Microbiology, Environmental Health, Economics and Marketing-Finance, and Consumer Perception. From this, ways forward are characterized for benefit-risk analysis in Food and Nutrition. Integrated benefit-risk analysis in Food and Nutrition may advance in the following ways: Increased engagement and communication between assessors, managers, and stakeholders; more pragmatic problem-oriented framing of assessment; accepting some risk; pre- and post-market analysis; explicit communication of the assessment purpose, input and output; more human (dose-response) data and more efficient use of human data; segmenting populations based on physiology; explicit consideration of value judgments in assessment; integration of multiple benefits and risks from multiple domains; explicit recognition of the impact of consumer beliefs, opinions, views, perceptions, and attitudes on behaviour; and segmenting populations based on behaviour; the opportunities proposed here do not provide ultimate solutions; rather, they define a collection of issues to be taken account of in developing methods, tools, practices and policies, as well as refining the regulatory context, for benefit-risk analysis in Food and Nutrition and other fields. Thus, these opportunities will now need to be explored further and incorporated into benefit-risk practice and policy. If accepted, incorporation of these opportunities will also involve a paradigm shift in Food and Nutrition benefit-risk analysis towards conceiving the analysis as a process of creating shared knowledge among all stakeholders. Copyright © 2011 Elsevier Ltd. All rights reserved.

A practical discussion of risk management for manufacturing of pharmaceutical products.

PubMed

Mollah, A Hamid; Baseman, Harold S; Long, Mike; Rathore, Anurag S

2014-01-01

Quality risk management (QRM) is now a regulatory expectation, and it makes good business sense. The goal of the risk assessment is to increase process understanding and deliver safe and effective product to the patients. Risk analysis and management is an acceptable and effective way to minimize patient risk and determine the appropriate level of controls in manufacturing. While understanding the elements of QRM is important, knowing how to apply them in the manufacturing environment is essential for effective process performance and control. This article will preview application of QRM in pharmaceutical and biopharmaceutical manufacturing to illustrate how QRM can help the reader achieve that objective. There are several areas of risk that a drug company may encounter in pharmaceutical manufacturing, specifically addressing oral solid and liquid formulations. QRM tools can be used effectively to identify the risks and develop strategy to minimize or control them. Risks are associated throughout the biopharmaceutical manufacturing process-from raw material supply through manufacturing and filling operations to final distribution via a controlled cold chain process. Assessing relevant attributes and risks for biotechnology-derived products is more complicated and challenging for complex pharmaceuticals. This paper discusses key risk factors in biopharmaceutical manufacturing. Successful development and commercialization of pharmaceutical products is all about managing risks. If a company was to take zero risk, most likely the path to commercialization would not be commercially viable. On the other hand, if the risk taken was too much, the product is likely to have a suboptimal safety and efficacy profile and thus is unlikely to be a successful product. This article addresses the topic of quality risk management with the key objective of minimizing patient risk while creating an optimal process and product. Various tools are presented to aid implementation of these concepts. © PDA, Inc. 2014.

Process monitoring in intensive care with the use of cumulative expected minus observed mortality and risk-adjusted P charts.

PubMed

Cockings, Jerome G L; Cook, David A; Iqbal, Rehana K

2006-02-01

A health care system is a complex adaptive system. The effect of a single intervention, incorporated into a complex clinical environment, may be different from that expected. A national database such as the Intensive Care National Audit & Research Centre (ICNARC) Case Mix Programme in the UK represents a centralised monitoring, surveillance and reporting system for retrospective quality and comparative audit. This can be supplemented with real-time process monitoring at a local level for continuous process improvement, allowing early detection of the impact of both unplanned and deliberately imposed changes in the clinical environment. Demographic and UK Acute Physiology and Chronic Health Evaluation II (APACHE II) data were prospectively collected on all patients admitted to a UK regional hospital between 1 January 2003 and 30 June 2004 in accordance with the ICNARC Case Mix Programme. We present a cumulative expected minus observed (E-O) plot and the risk-adjusted p chart as methods of continuous process monitoring. We describe the construction and interpretation of these charts and show how they can be used to detect planned or unplanned organisational process changes affecting mortality outcomes. Five hundred and eighty-nine adult patients were included. The overall death rate was 0.78 of predicted. Calibration showed excess survival in ranges above 30% risk of death. The E-O plot confirmed a survival above that predicted. Small transient variations were seen in the slope that could represent random effects, or real but transient changes in the quality of care. The risk-adjusted p chart showed several observations below the 2 SD control limits of the expected mortality rate. These plots provide rapid analysis of risk-adjusted performance suitable for local application and interpretation. The E-O chart provided rapid easily visible feedback of changes in risk-adjusted mortality, while the risk-adjusted p chart allowed statistical evaluation. Local analysis of risk-adjusted mortality data with an E-O plot and a risk-adjusted p chart is feasible and allows the rapid detection of changes in risk-adjusted outcome of intensive care patients. This complements the centralised national database, which is more archival and comparative in nature.

Integrating Household Risk Mitigation Behavior in Flood Risk Analysis: An Agent-Based Model Approach.

PubMed

Haer, Toon; Botzen, W J Wouter; de Moel, Hans; Aerts, Jeroen C J H

2017-10-01

Recent studies showed that climate change and socioeconomic trends are expected to increase flood risks in many regions. However, in these studies, human behavior is commonly assumed to be constant, which neglects interaction and feedback loops between human and environmental systems. This neglect of human adaptation leads to a misrepresentation of flood risk. This article presents an agent-based model that incorporates human decision making in flood risk analysis. In particular, household investments in loss-reducing measures are examined under three economic decision models: (1) expected utility theory, which is the traditional economic model of rational agents; (2) prospect theory, which takes account of bounded rationality; and (3) a prospect theory model, which accounts for changing risk perceptions and social interactions through a process of Bayesian updating. We show that neglecting human behavior in flood risk assessment studies can result in a considerable misestimation of future flood risk, which is in our case study an overestimation of a factor two. Furthermore, we show how behavior models can support flood risk analysis under different behavioral assumptions, illustrating the need to include the dynamic adaptive human behavior of, for instance, households, insurers, and governments. The method presented here provides a solid basis for exploring human behavior and the resulting flood risk with respect to low-probability/high-impact risks. © 2016 The Authors Risk Analysis published by Wiley Periodicals, Inc. on behalf of Society for Risk Analysis.

[Failure mode and effects analysis to improve quality in clinical trials].

PubMed

Mañes-Sevilla, M; Marzal-Alfaro, M B; Romero Jiménez, R; Herranz-Alonso, A; Sanchez Fresneda, M N; Benedi Gonzalez, J; Sanjurjo-Sáez, M

The failure mode and effects analysis (FMEA) has been used as a tool in risk management and quality improvement. The objective of this study is to identify the weaknesses in processes in the clinical trials area, of a Pharmacy Department (PD) with great research activity, in order to improve the safety of the usual procedures. A multidisciplinary team was created to analyse each of the critical points, identified as possible failure modes, in the development of clinical trial in the PD. For each failure mode, the possible cause and effect were identified, criticality was calculated using the risk priority number and the possible corrective actions were discussed. Six sub-processes were defined in the development of the clinical trials in PD. The FMEA identified 67 failure modes, being the dispensing and prescription/validation sub-processes the most likely to generate errors. All the improvement actions established in the AMFE were implemented in the Clinical Trials area. The FMEA is a useful tool in proactive risk management because it allows us to identify where we are making mistakes and analyze the causes that originate them, to prioritize and to adopt solutions to risk reduction. The FMEA improves process safety and quality in PD. Copyright © 2018 SECA. Publicado por Elsevier España, S.L.U. All rights reserved.

Computational methods using genome-wide association studies to predict radiotherapy complications and to identify correlative molecular processes

NASA Astrophysics Data System (ADS)

Oh, Jung Hun; Kerns, Sarah; Ostrer, Harry; Powell, Simon N.; Rosenstein, Barry; Deasy, Joseph O.

2017-02-01

The biological cause of clinically observed variability of normal tissue damage following radiotherapy is poorly understood. We hypothesized that machine/statistical learning methods using single nucleotide polymorphism (SNP)-based genome-wide association studies (GWAS) would identify groups of patients of differing complication risk, and furthermore could be used to identify key biological sources of variability. We developed a novel learning algorithm, called pre-conditioned random forest regression (PRFR), to construct polygenic risk models using hundreds of SNPs, thereby capturing genomic features that confer small differential risk. Predictive models were trained and validated on a cohort of 368 prostate cancer patients for two post-radiotherapy clinical endpoints: late rectal bleeding and erectile dysfunction. The proposed method results in better predictive performance compared with existing computational methods. Gene ontology enrichment analysis and protein-protein interaction network analysis are used to identify key biological processes and proteins that were plausible based on other published studies. In conclusion, we confirm that novel machine learning methods can produce large predictive models (hundreds of SNPs), yielding clinically useful risk stratification models, as well as identifying important underlying biological processes in the radiation damage and tissue repair process. The methods are generally applicable to GWAS data and are not specific to radiotherapy endpoints.

Risk assessment for enterprise resource planning (ERP) system implementations: a fault tree analysis approach

NASA Astrophysics Data System (ADS)

Zeng, Yajun; Skibniewski, Miroslaw J.

2013-08-01

Enterprise resource planning (ERP) system implementations are often characterised with large capital outlay, long implementation duration, and high risk of failure. In order to avoid ERP implementation failure and realise the benefits of the system, sound risk management is the key. This paper proposes a probabilistic risk assessment approach for ERP system implementation projects based on fault tree analysis, which models the relationship between ERP system components and specific risk factors. Unlike traditional risk management approaches that have been mostly focused on meeting project budget and schedule objectives, the proposed approach intends to address the risks that may cause ERP system usage failure. The approach can be used to identify the root causes of ERP system implementation usage failure and quantify the impact of critical component failures or critical risk events in the implementation process.

Risk-based consequences of extreme natural hazard processes in mountain regions - Multi-hazard analysis in Tyrol (Austria)

NASA Astrophysics Data System (ADS)

Huttenlau, Matthias; Stötter, Johann

2010-05-01

Reinsurance companies are stating a high increase in natural hazard related losses, both insured and economic losses, within the last decades on a global scale. This ongoing trend can be described as a product of the dynamic in the natural and in the anthroposphere. To analyze the potential impact of natural hazard process to a certain insurance portfolio or to the society in general, reinsurance companies or risk management consultants have developed loss models. However, those models are generally not fitting the scale dependent demand on regional scales like it is appropriate (i) for analyses on the scale of a specific province or (ii) for portfolio analyses of regional insurance companies. Moreover, the scientific basis of most of the models is not transparent documented and therefore scientific evaluations concerning the methodology concepts are not possible (black box). This is contrary to the scientific principles of transparency and traceability. Especially in mountain regions like the European Alps with their inherent (i) specific characteristic on small scales, (ii) the relative high process dynamics in general, (iii) the occurrence of gravitative mass movements which are related to high relief energy and thus only exists in mountain regions, (iv) the small proportion of the area of permanent settlement on the overall area, (v) the high value concentration in the valley floors, (vi) the exposition of important infrastructures and lifelines, and others, analyses must consider these circumstances adequately. Therefore, risk-based analyses are methodically estimating the potential consequences of hazard process on the built environment standardized with the risk components (i) hazard, (ii) elements at risk, and (iii) vulnerability. However, most research and progress have been made in the field of hazard analyses, whereas the other both components are not developed accordingly. Since these three general components are influencing factors without any weighting within the risk concept, this has sufficient implications on the results of risk analyses. Thus, an equal and scale appropriated balance of those risk components is a fundamental key factor for effective natural hazard risk analyses. The results of such analyses inform especially decision makers in the insurance industry, the administration, and politicians on potential consequences and are the basis for appropriate risk management strategies. Thereby, results (i) on an annual or probabilistic risk comprehension have to be distinguished from (ii) scenario-based analyses. The first analyses are based on statistics of periodically or episodically occurring events whereas the latter approach is especially applied for extreme, non-linear, stochastic events. Focusing on the needs especially of insurance companies, the first approaches are appropriate for premium pricing and reinsurance strategies with an annual perspective, whereas the latter is focusing on events with extreme loss burdens under worst-case criteria to guarantee accordant reinsurance coverage. Moreover, the demand of adequate loss model approaches and methods is strengthened by the risk-based requirements of the upcoming capital requirement directive Solvency II. The present study estimates the potential elements at risk, their corresponding damage potentials and the Probable Maximum Losses (PMLs) of extreme natural hazards events in Tyrol (Austria) and considers adequatly the scale dependency and balanced application of the introduced risk components. Beside the introduced analysis an additionally portfolio analysis of a regional insurance company was executed. The geocoded insurance contracts of this portfolio analysis were the basis to estimate spatial, socio-economical and functional differentiated mean insurance values for the different risk categories of (i) buildings, (ii) contents or inventory, (iii) vehicles, and (iv) persons in the study area. The estimated mean insurance values were incorporated with additional GIS and statistic data to a comprehensive property-by-property geodatabase of the existing elements and values. This stock of elements and values geodatabase is furthermore the consistent basis for all natural hazard analyses and enables the comparison of the results. The study follows the general accepted moduls (i) hazard analysis, (ii) exposition analysis, and (iii) consequence analysis, whereas the exposition analysis estimates the elements at risk with their corresponding damage potentials and the consequence analysis estimates the PMLs. This multi-hazard analysis focuses on process types with a high to extreme potential of negative consequences on a regional scale. In this context, (i) floodings, (ii) rockslides with the potential of corresponding consequence effects (backwater ponding and outburst flood), (iii) earthquakes, (iv) hail events, and (v) winter storms were considered as hazard processes. Based on general hazard analyses (hazard maps) concrete scenarios and their spatial affectedness were determined. For the different hazard processes, different vulnerability approaches were considered to demonstrate their sensitivity and implication on the results. Thus, no absolute values of losses but probable loss ranges were estimated. It can be shown, that the most serious amount of losses would arise from extreme earthquake events with loss burdens up to more than € 7 bn. solely on buildings and inventory. Possible extreme flood events could lead to losses between € 2 and 2.5 bn., whereas a severe hail swath which affects the central Inn valley could result in losses of ca. € 455 mill. (thereof € 285 mill. on vehicles). The potential most serious rockslide with additional consequence effects would result in losses up to ca. € 185 mill. and extreme winter storms can induce losses between € 100 mill. and 150 mill..

Risk Assessment on Constructors during Over-water Riprap Based on Entropy Weight and FAHP

NASA Astrophysics Data System (ADS)

Wu, Tongqing; Li, Liang; Liang, Zelong; Mao, Tian; Shao, Weifeng

2017-07-01

Being aimed at waterway regulation engineering, there exist risks of over-water riprap for constructors which keeps uncertainty and complexity. For the purpose of evaluating the possibility and consequence, this paper utilizes fuzzy analytic hierarchy process with abbreviation of FAHP to do empowerment on the related risk indicators, constructs FAHP under entropy weight and establishes relevant evaluation factor set and evaluation language for constructors during over-water riprap construction process. Through doing risk probability estimation and risk consequence size evaluation on the factor of constructors, this paper introduces this model into risk analysis on constructors during over-water riprap of Ching River waterway regulation project. Results show that evaluation of this method is so credible that it could be utilized in practical engineering.

Space Shuttle Systems Engineering Processes for Liftoff Debris Risk Mitigation

NASA Technical Reports Server (NTRS)

Mitchell, Michael; Riley, Christopher

2011-01-01

This slide presentation reviews the systems engineering process designed to reduce the risk from debris during Space Shuttle Launching. This process begins the day of launch from the tanking to the vehicle tower clearance. Other debris risks (i.e., Ascent, and micrometeoroid orbital debit) are mentioned) but are not the subject of this presentation. The Liftoff debris systems engineering process and an example of how it works are reviewed (i.e.,STS-119 revealed a bolt liberation trend on the Fixed Service Structure (FSS) 275 level elevator room). The process includes preparation of a Certification of Flight Readiness (CoFR) that includes (1) Lift-off debris from previous mission dispositioned, (2) Flight acceptance rationale has been provided for Lift-off debris sources/causes (3) Lift-off debris mission support documentation, processes and tools are in place for the up-coming mission. The process includes a liftoff debris data collection that occurs after each launch. This includes a post launch walkdown, that records each liftoff debris, and the entry of the debris into a database, it also includes a review of the imagery from the launch, and a review of the instrumentation data. There is also a review of the debris transport analysis process, that includes temporal and spatial framework and a computational fluid dynamics (CFD) analysis. which incorporates a debris transport analyses (DTA), debris materials and impact tests, and impact analyses.

C-Band Airport Surface Communications System Engineering-Initial High-Level Safety Risk Assessment and Mitigation

NASA Technical Reports Server (NTRS)

Zelkin, Natalie; Henriksen, Stephen

2011-01-01

This document is being provided as part of ITT's NASA Glenn Research Center Aerospace Communication Systems Technical Support (ACSTS) contract: "New ATM Requirements--Future Communications, C-Band and L-Band Communications Standard Development." ITT has completed a safety hazard analysis providing a preliminary safety assessment for the proposed C-band (5091- to 5150-MHz) airport surface communication system. The assessment was performed following the guidelines outlined in the Federal Aviation Administration Safety Risk Management Guidance for System Acquisitions document. The safety analysis did not identify any hazards with an unacceptable risk, though a number of hazards with a medium risk were documented. This effort represents an initial high-level safety hazard analysis and notes the triggers for risk reassessment. A detailed safety hazards analysis is recommended as a follow-on activity to assess particular components of the C-band communication system after the profile is finalized and system rollout timing is determined. A security risk assessment has been performed by NASA as a parallel activity. While safety analysis is concerned with a prevention of accidental errors and failures, the security threat analysis focuses on deliberate attacks. Both processes identify the events that affect operation of the system; and from a safety perspective the security threats may present safety risks.

Risk assessment techniques with applicability in marine engineering

NASA Astrophysics Data System (ADS)

Rudenko, E.; Panaitescu, F. V.; Panaitescu, M.

2015-11-01

Nowadays risk management is a carefully planned process. The task of risk management is organically woven into the general problem of increasing the efficiency of business. Passive attitude to risk and awareness of its existence are replaced by active management techniques. Risk assessment is one of the most important stages of risk management, since for risk management it is necessary first to analyze and evaluate risk. There are many definitions of this notion but in general case risk assessment refers to the systematic process of identifying the factors and types of risk and their quantitative assessment, i.e. risk analysis methodology combines mutually complementary quantitative and qualitative approaches. Purpose of the work: In this paper we will consider as risk assessment technique Fault Tree analysis (FTA). The objectives are: understand purpose of FTA, understand and apply rules of Boolean algebra, analyse a simple system using FTA, FTA advantages and disadvantages. Research and methodology: The main purpose is to help identify potential causes of system failures before the failures actually occur. We can evaluate the probability of the Top event.The steps of this analize are: the system's examination from Top to Down, the use of symbols to represent events, the use of mathematical tools for critical areas, the use of Fault tree logic diagrams to identify the cause of the Top event. Results: In the finally of study it will be obtained: critical areas, Fault tree logical diagrams and the probability of the Top event. These results can be used for the risk assessment analyses.

Monitoring of human brain functions in risk decision-making task by diffuse optical tomography using voxel-wise general linear model

NASA Astrophysics Data System (ADS)

Lin, Zi-Jing; Li, Lin; Cazzell, Marry; Liu, Hanli

2013-03-01

Functional near-infrared spectroscopy (fNIRS) is a non-invasive imaging technique which measures the hemodynamic changes that reflect the brain activity. Diffuse optical tomography (DOT), a variant of fNIRS with multi-channel NIRS measurements, has demonstrated capability of three dimensional (3D) reconstructions of hemodynamic changes due to the brain activity. Conventional method of DOT image analysis to define the brain activation is based upon the paired t-test between two different states, such as resting-state versus task-state. However, it has limitation because the selection of activation and post-activation period is relatively subjective. General linear model (GLM) based analysis can overcome this limitation. In this study, we combine the 3D DOT image reconstruction with GLM-based analysis (i.e., voxel-wise GLM analysis) to investigate the brain activity that is associated with the risk-decision making process. Risk decision-making is an important cognitive process and thus is an essential topic in the field of neuroscience. The balloon analogue risk task (BART) is a valid experimental model and has been commonly used in behavioral measures to assess human risk taking action and tendency while facing risks. We have utilized the BART paradigm with a blocked design to investigate brain activations in the prefrontal and frontal cortical areas during decision-making. Voxel-wise GLM analysis was performed on 18human participants (10 males and 8females).In this work, we wish to demonstrate the feasibility of using voxel-wise GLM analysis to image and study cognitive functions in response to risk decision making by DOT. Results have shown significant changes in the dorsal lateral prefrontal cortex (DLPFC) during the active choice mode and a different hemodynamic pattern between genders, which are in good agreements with published literatures in functional magnetic resonance imaging (fMRI) and fNIRS studies.

WE-B-BRC-02: Risk Analysis and Incident Learning

DOE Office of Scientific and Technical Information (OSTI.GOV)

Fraass, B.

Prospective quality management techniques, long used by engineering and industry, have become a growing aspect of efforts to improve quality management and safety in healthcare. These techniques are of particular interest to medical physics as scope and complexity of clinical practice continue to grow, thus making the prescriptive methods we have used harder to apply and potentially less effective for our interconnected and highly complex healthcare enterprise, especially in imaging and radiation oncology. An essential part of most prospective methods is the need to assess the various risks associated with problems, failures, errors, and design flaws in our systems. Wemore » therefore begin with an overview of risk assessment methodologies used in healthcare and industry and discuss their strengths and weaknesses. The rationale for use of process mapping, failure modes and effects analysis (FMEA) and fault tree analysis (FTA) by TG-100 will be described, as well as suggestions for the way forward. This is followed by discussion of radiation oncology specific risk assessment strategies and issues, including the TG-100 effort to evaluate IMRT and other ways to think about risk in the context of radiotherapy. Incident learning systems, local as well as the ASTRO/AAPM ROILS system, can also be useful in the risk assessment process. Finally, risk in the context of medical imaging will be discussed. Radiation (and other) safety considerations, as well as lack of quality and certainty all contribute to the potential risks associated with suboptimal imaging. The goal of this session is to summarize a wide variety of risk analysis methods and issues to give the medical physicist access to tools which can better define risks (and their importance) which we work to mitigate with both prescriptive and prospective risk-based quality management methods. Learning Objectives: Description of risk assessment methodologies used in healthcare and industry Discussion of radiation oncology-specific risk assessment strategies and issues Evaluation of risk in the context of medical imaging and image quality E. Samei: Research grants from Siemens and GE.« less

Critical laboratory value notification: a failure mode effects and criticality analysis.

PubMed

Saxena, Sunita; Kempf, Raymond; Wilcox, Susan; Shulman, Ira A; Wong, Louise; Cunningham, Glenn; Vega, Elaine; Hall, Stephanie

2005-09-01

The Failure Mode Effects and Criticality Analysis (FMECA) was applied to improve the timeliness of reporting and the timeliness of receipt by the responsible licensed caregiver of critical laboratory values (CLVs) for outpatients and non-critical care inpatients. Through a risk prioritization process, the most important areas for improvement, including contacting the provider, assisting the provider in contacting the patient, and educating the provider in follow-up options available during off hours, were identified. A variety of systemic improvements were made; for example, the CLV notification process was centralized in the customer service center, with databases to help providers select options and make arrangements for follow-up care and an electronic abstract form to document the CLV notification process. Review of documentation and appropriateness of CLV follow-up care was integrated into the quality monitoring process to detect any variations or problems. The average CLV notification time for the month steadily declined during an eight-month period. Compliance was 100% for the "read-back" requirement and documentation in patient's health record. This proactive risk assessment project successfully modified the CLV notification program from a high- to a low-risk process, identified activities to further improve the process, and helped ensure compliance with a variety of requirements.

Evaluating the operational risks of biomedical waste using failure mode and effects analysis.

PubMed

Chen, Ying-Chu; Tsai, Pei-Yi

2017-06-01

The potential problems and risks of biomedical waste generation have become increasingly apparent in recent years. This study applied a failure mode and effects analysis to evaluate the operational problems and risks of biomedical waste. The microbiological contamination of biomedical waste seldom receives the attention of researchers. In this study, the biomedical waste lifecycle was divided into seven processes: Production, classification, packaging, sterilisation, weighing, storage, and transportation. Twenty main failure modes were identified in these phases and risks were assessed based on their risk priority numbers. The failure modes in the production phase accounted for the highest proportion of the risk priority number score (27.7%). In the packaging phase, the failure mode 'sharp articles not placed in solid containers' had the highest risk priority number score, mainly owing to its high severity rating. The sterilisation process is the main difference in the treatment of infectious and non-infectious biomedical waste. The failure modes in the sterilisation phase were mainly owing to human factors (mostly related to operators). This study increases the understanding of the potential problems and risks associated with biomedical waste, thereby increasing awareness of how to improve the management of biomedical waste to better protect workers, the public, and the environment.

Red and processed meat consumption and risk of incident coronary heart disease, stroke, and diabetes mellitus: a systematic review and meta-analysis.

PubMed

Micha, Renata; Wallace, Sarah K; Mozaffarian, Dariush

2010-06-01

Meat consumption is inconsistently associated with development of coronary heart disease (CHD), stroke, and diabetes mellitus, limiting quantitative recommendations for consumption levels. Effects of meat intake on these different outcomes, as well as of red versus processed meat, may also vary. We performed a systematic review and meta-analysis of evidence for relationships of red (unprocessed), processed, and total meat consumption with incident CHD, stroke, and diabetes mellitus. We searched for any cohort study, case-control study, or randomized trial that assessed these exposures and outcomes in generally healthy adults. Of 1598 identified abstracts, 20 studies met inclusion criteria, including 17 prospective cohorts and 3 case-control studies. All data were abstracted independently in duplicate. Random-effects generalized least squares models for trend estimation were used to derive pooled dose-response estimates. The 20 studies included 1 218 380 individuals and 23 889 CHD, 2280 stroke, and 10 797 diabetes mellitus cases. Red meat intake was not associated with CHD (n=4 studies; relative risk per 100-g serving per day=1.00; 95% confidence interval, 0.81 to 1.23; P for heterogeneity=0.36) or diabetes mellitus (n=5; relative risk=1.16; 95% confidence interval, 0.92 to 1.46; P=0.25). Conversely, processed meat intake was associated with 42% higher risk of CHD (n=5; relative risk per 50-g serving per day=1.42; 95% confidence interval, 1.07 to 1.89; P=0.04) and 19% higher risk of diabetes mellitus (n=7; relative risk=1.19; 95% confidence interval, 1.11 to 1.27; P<0.001). Associations were intermediate for total meat intake. Consumption of red and processed meat were not associated with stroke, but only 3 studies evaluated these relationships. Consumption of processed meats, but not red meats, is associated with higher incidence of CHD and diabetes mellitus. These results highlight the need for better understanding of potential mechanisms of effects and for particular focus on processed meats for dietary and policy recommendations.

Does Iconicity in Pictographs Matter? The Influence of Iconicity and Numeracy on Information Processing, Decision Making, and Liking in an Eye-Tracking Study.

PubMed

Kreuzmair, Christina; Siegrist, Michael; Keller, Carmen

2017-03-01

Researchers recommend the use of pictographs in medical risk communication to improve people's risk comprehension and decision making. However, it is not yet clear whether the iconicity used in pictographs to convey risk information influences individuals' information processing and comprehension. In an eye-tracking experiment with participants from the general population (N = 188), we examined whether specific types of pictograph icons influence the processing strategy viewers use to extract numerical information. In addition, we examined the effect of iconicity and numeracy on probability estimation, recall, and icon liking. This experiment used a 2 (iconicity: blocks vs. restroom icons) × 2 (scenario: medical vs. nonmedical) between-subject design. Numeracy had a significant effect on information processing strategy, but we found no effect of iconicity or scenario. Results indicated that both icon types enabled high and low numerates to use their default way of processing and extracting the gist of the message from the pictorial risk communication format: high numerates counted icons, whereas low numerates used large-area processing. There was no effect of iconicity in the probability estimation. However, people who saw restroom icons had a higher probability of correctly recalling the exact risk level. Iconicity had no effect on icon liking. Although the effects are small, our findings suggest that person-like restroom icons in pictographs seem to have some advantages for risk communication. Specifically, in nonpersonalized prevention brochures, person-like restroom icons may maintain reader motivation for processing the risk information. © 2016 Society for Risk Analysis.

Risk, rationality, and community: Psychology, ethnography, and transactions in the risk management process

DOE Office of Scientific and Technical Information (OSTI.GOV)

Cantor, R.; Schoepfle, M.

Communities at risk are confronted by an increasingly complex array of opportunities and need for involvement in decisions affecting them. Policy analysis often demands from researchers insights into the complicated process of how best to account for community involvement in decision making. Often, this requires additional understanding of how decisions are made by community members. Researchers trying to capture the important features of decision making will necessarily make assumptions regarding the rationality underlying the decision process. Two implicit and often incompatible sets of research assumptions about decision processes have emerged: outcome rationality and process rationality. Using outcome rationality, the principalmore » goal of risk research often is to predict how people will react to risk regardless of what they say they would do. Using process rationality, the research goal is to determine how people perceive the risks to which they are exposed and how perceptions actually influence responses. The former approach is associated with research in risk communication, conducted by economists and cognitive psychologists; the latter approach is associated with the field of risk negotiation and acceptance, conducted by anthropologists, some sociologists, and planners. This article describes (1) the difference between the assumptions behind outcome and process rationality regarding decision making and the problems resulting from these differences; (2) the promise and limitations of both sets of assumptions; (3) the potential contributions from cognitive psychology, cognitive ethnography, and the theory of transaction costs in reconciling the differences in assumptions and making them more complementary; and (4) the implications of such complementarity.« less

Screening Analysis for the Environmental Risk Evaluation System Task 2.1.1.2: Evaluating Effects of Stressors Fiscal Year 2011 Progress Report - Environmental Effects of Marine and Hydrokinetic Energy

DOE Office of Scientific and Technical Information (OSTI.GOV)

Copping, Andrea E.; Blake, Kara M.; Anderson, Richard M.

2011-09-01

Potential environmental effects of marine and hydrokinetic (MHK) energy development are not well understood, and yet regulatory agencies are required to make decisions in spite of substantial uncertainty about environmental impacts and their long-term consequences. An understanding of risks associated with interactions between MHK installations and aquatic receptors, including animals, habitats, and ecosystems, can help define key uncertainties and focus regulatory actions and scientific studies on interactions of most concern. As a first step in developing the Pacific Northwest National Laboratory (PNNL) Environmental Risk Evaluation System (ERES), PNNL scientists conducted a preliminary risk screening analysis on three initial MHK cases.more » During FY 2011, two additional cases were added: a tidal project in the Gulf of Maine using Ocean Renewable Power Company TidGenTM turbines and a wave project planned for the coast of Oregon using Aquamarine Oyster surge devices. Through an iterative process, the screening analysis revealed that top-tier stressors in the two FY 2011 cases were the dynamic effects of the device (e.g., strike), accidents/disasters, and effects of the static physical presence of the device (e.g., habitat alteration). Receptor interactions with these stressors at the highest tiers of risk were dominated by threatened and endangered animals. Risk to the physical environment from changes in flow regime also ranked high. Peer review of this process and results will be conducted in early FY 2012. The ERES screening analysis provides an analysis of vulnerability of environmental receptors to stressors associated with MHK installations, probability analysis is needed to determine specific risk levels to receptors. “Risk” has two components: (1) The likelihood, or “probability”, of the occurrence of a given interaction or event, and (2) the potential “consequence” if that interaction or event were to occur. During FY 2011, the ERES screening analysis focused primarily on the second component of risk, “consequence”, with focused probability analysis for interactions where data was sufficient for probability modeling. Consequence analysis provides an assessment of vulnerability of environmental receptors to stressors associated with MHK installations. Probability analysis is needed to determine specific risk levels to receptors and requires significant data inputs to drive risk models. During FY 2011, two stressor-receptor interactions were examined for the probability of occurrence. The two interactions (spill probability due to an encounter between a surface vessel and an MHK device; and toxicity from anti-biofouling paints on MHK devices) were seen to present relatively low risks to marine and freshwater receptors of greatest concern in siting and permitting MHK devices. A third probability analysis was scoped and initial steps taken to understand the risk of encounter between marine animals and rotating turbine blades. This analysis will be completed in FY 2012.« less

Space Shuttle critical function audit

NASA Technical Reports Server (NTRS)

Sacks, Ivan J.; Dipol, John; Su, Paul

1990-01-01

A large fault-tolerance model of the main propulsion system of the US space shuttle has been developed. This model is being used to identify single components and pairs of components that will cause loss of shuttle critical functions. In addition, this model is the basis for risk quantification of the shuttle. The process used to develop and analyze the model is digraph matrix analysis (DMA). The DMA modeling and analysis process is accessed via a graphics-based computer user interface. This interface provides coupled display of the integrated system schematics, the digraph models, the component database, and the results of the fault tolerance and risk analyses.

Cascading processes and interactions in torrent catchments and their influence on the damage pattern

NASA Astrophysics Data System (ADS)

Keiler, Margreth; Gebbers, David

2014-05-01

Research on single geomorphological processes during damaging events has a long history; however, comprehensive documentations and analyses of the events have been conducted not until the late 1980s. Thus, for highly damaging events insights about triggering, the evolution and the impacts of processes during an event and the resulting damage were produced. Though, in the majority of cases the processes were studied in a well-defined procedure of one disciplinary focus. These focused studies neglect mutable influences which may alter the sequence of the process or the event. During damaging events multiple geomorphological processes are active which leads to the assumption that they have a certain impact on each other and the course of damaging effect. Consequently, for a comprehensive hazard and risk analysis all processes of a catchment have to be analysed and evaluated quantitatively and qualitatively (MARZOCCHI, 2007). Although the demand for a sophisticated risk management is increasing, the research on interactions as well as on physical vulnerability to multiple hazards, including the different processes impact effects, is still very limited (KAPPES et al., 2010, 2011). The challenges in this field are the quantity of data needed, and furthermore to conduct this kind of analysis is very complex and complicated (KAPPES et al. 2012). Yet, knowledge about possible interactions and resulting impact effects could significantly contribute to the reduction of risk in a region. The objective of this study is to analyse, i) how geomorphological processes interact with each other and with other factors of the surrounding during a damaging event, ii) what influences those interactions have on the resulting damage of the event and iii) whether or not different events are comparable in terms of those interactions and their impacts. To meet these objectives, 15 damaging torrent events, which occurred between 2000 and 2011 in the Bernese Oberland and the Pennine Alps, Switzerland, were analysed on the basis of event reports and general catchment parameters. The interactions were classified into different categories regarding a process and the interacting counterpart (another process, with structures or disposition) and the temporal and spatial extent in which these interactions occurred. Additionally, positive and negative feedbacks of the processes were considered. First results highlight that some types of interaction can be extracted in several events and that their temporal and spatial extent is comparable. However, the analysis indicates that single interaction exhibits multi-path consequences which are a challenge for general propositions of interactions influencing damage patterns. In the further step of this study, clusters of interactions which could occur in different events in similar ways are analysed in more detail. REFERENCES Kappes, M.S., Papathoma-Köhle, M. & Keiler, M. 2011: Assessing physical vulnerability for multi-hazards using an indicator-based methodology, Applied Geography, 32, 577-590. Kappes, M.S., Keiler, M. & Glade, T. 2010: From single- to multi-hazard risk analyses: a concept addressing emerging challenges. In: Malet, J.-P.; Glade, T. & N. Casagli (eds.) Mountain Risks: bringing science to society. Proceedings of the 'Mountain Risks' International Conference, Firenze, Italy. Strasbourg. CERG Editions: 351-356 Kappes, M. S., Keiler, M., von Eleverfeldt, K., Glade, T. 2012: Challenges of analyzing multi-hazard risk: a review. NAT HAZARDS 64: 1925-1958. Marzocchi, W., Mastellone, M.L., Ruocco, A. 2009: Principles of multi-risk assessment: Interaction amongst natural and man-induced risks. European Commission. Brussels.

Preventing blood transfusion failures: FMEA, an effective assessment method.

PubMed

Najafpour, Zhila; Hasoumi, Mojtaba; Behzadi, Faranak; Mohamadi, Efat; Jafary, Mohamadreza; Saeedi, Morteza

2017-06-30

Failure Mode and Effect Analysis (FMEA) is a method used to assess the risk of failures and harms to patients during the medical process and to identify the associated clinical issues. The aim of this study was to conduct an assessment of blood transfusion process in a teaching general hospital, using FMEA as the method. A structured FMEA was recruited in our study performed in 2014, and corrective actions were implemented and re-evaluated after 6 months. Sixteen 2-h sessions were held to perform FMEA in the blood transfusion process, including five steps: establishing the context, selecting team members, analysis of the processes, hazard analysis, and developing a risk reduction protocol for blood transfusion. Failure modes with the highest risk priority numbers (RPNs) were identified. The overall RPN scores ranged from 5 to 100 among which, four failure modes were associated with RPNs over 75. The data analysis indicated that failures with the highest RPNs were: labelling (RPN: 100), transfusion of blood or the component (RPN: 100), patient identification (RPN: 80) and sampling (RPN: 75). The results demonstrated that mis-transfusion of blood or blood component is the most important error, which can lead to serious morbidity or mortality. Provision of training to the personnel on blood transfusion, knowledge raising on hazards and appropriate preventative measures, as well as developing standard safety guidelines are essential, and must be implemented during all steps of blood and blood component transfusion.

Egg, red meat, and poultry intake and risk of lethal prostate cancer in the prostate specific antigen-era: incidence and survival

PubMed Central

Richman, Erin L.; Kenfield, Stacey A.; Stampfer, Meir J.; Giovannucci, Edward L.; Chan, June M.

2011-01-01

Red and processed meat may increase risk of advanced prostate cancer. Data on post-diagnostic diet and prostate cancer are sparse, but post-diagnostic intake of poultry with skin and eggs may increase risk of disease progression. Therefore, we prospectively examined total, unprocessed, and processed red meat, poultry, and eggs in relation to risk of lethal prostate cancer (e.g. men without cancer at baseline who developed distant organ metastases or died from prostate cancer during follow-up) among 27, 607 men followed from 1994–2008. We also performed a case-only survival analysis to examine post-diagnostic consumption of these foods and risk of lethal prostate cancer among the 3,127 men initially diagnosed with non-metastatic prostate cancer during follow-up. In the incidence analysis, we observed 199 events during 306,715 person-years. Men who consumed 2.5 or more eggs per week had an 81% increased risk of lethal prostate cancer compared to men who consumed less than 0.5 eggs per week (HR: 1.81; 95% confidence interval (CI): 1.13, 2.89; p-trend: 0.01). In the case-only survival analysis, we observed 123 events during 19,354 person-years. There were suggestive, but not statistically significant, positive associations between post-diagnostic poultry (HR ≥3.5 vs. <1.5 servings per week: 1.69; 95%CI: 0.96, 2.99; p-trend: 0.07) and post-diagnostic processed red meat (HR ≥3 vs. <0.5 servings per week: 1.45; 95%CI: 0.73, 2.87; p-trend: 0.08) and risk of progression of localized prostate cancer to lethal disease. In conclusion, consumption of eggs may increase risk of developing a lethal-form of prostate cancer among healthy men. PMID:21930800

Risk analysis of information security in a mobile instant messaging and presence system for healthcare.

PubMed

Bønes, Erlend; Hasvold, Per; Henriksen, Eva; Strandenaes, Thomas

2007-09-01

Instant messaging (IM) is suited for immediate communication because messages are delivered almost in real time. Results from studies of IM use in enterprise work settings make us believe that IM based services may prove useful also within the healthcare sector. However, today's public instant messaging services do not have the level of information security required for adoption of IM in healthcare. We proposed MedIMob, our own architecture for a secure enterprise IM service for use in healthcare. MedIMob supports IM clients on mobile devices in addition to desktop based clients. Security threats were identified in a risk analysis of the MedIMob architecture. The risk analysis process consists of context identification, threat identification, analysis of consequences and likelihood, risk evaluation, and proposals for risk treatment. The risk analysis revealed a number of potential threats to the information security of a service like this. Many of the identified threats are general when dealing with mobile devices and sensitive data; others are threats which are more specific to our service and architecture. Individual threats identified in the risks analysis are discussed and possible counter measures presented. The risk analysis showed that most of the proposed risk treatment measures must be implemented to obtain an acceptable risk level; among others blocking much of the additional functionality of the smartphone. To conclude on the usefulness of this IM service, it will be evaluated in a trial study of the human-computer interaction. Further work also includes an improved design of the proposed MedIMob architecture. 2006 Elsevier Ireland Ltd

Efficient and Flexible Climate Analysis with Python in a Cloud-Based Distributed Computing Framework

NASA Astrophysics Data System (ADS)

Gannon, C.

2017-12-01

As climate models become progressively more advanced, and spatial resolution further improved through various downscaling projects, climate projections at a local level are increasingly insightful and valuable. However, the raw size of climate datasets presents numerous hurdles for analysts wishing to develop customized climate risk metrics or perform site-specific statistical analysis. Four Twenty Seven, a climate risk consultancy, has implemented a Python-based distributed framework to analyze large climate datasets in the cloud. With the freedom afforded by efficiently processing these datasets, we are able to customize and continually develop new climate risk metrics using the most up-to-date data. Here we outline our process for using Python packages such as XArray and Dask to evaluate netCDF files in a distributed framework, StarCluster to operate in a cluster-computing environment, cloud computing services to access publicly hosted datasets, and how this setup is particularly valuable for generating climate change indicators and performing localized statistical analysis.

Is there a relationship between red or processed meat intake and obesity? A systematic review and meta-analysis of observational studies.

PubMed

Rouhani, M H; Salehi-Abargouei, A; Surkan, P J; Azadbakht, L

2014-09-01

A body of literature exists regarding the association of red and processed meats with obesity; however, the nature and extent of this relation has not been clearly established. The aim of this study is to conduct a systematic review and meta-analysis of the relationship between red and processed meat intake and obesity. We searched multiple electronic databases for observational studies on the relationship between red and processed meat intake and obesity published until July 2013. Odds ratios (ORs) and means for obesity-related indices and for variables that may contribute to heterogeneity were calculated. A systematic review and a meta-analysis were conducted with 21 and 18 studies, respectively (n = 1,135,661). The meta-analysis (n = 113,477) showed that consumption of higher quantities of red and processed meats was a risk factor for obesity (OR: 1.37; 95% CI: 1.14-1.64). Pooled mean body mass index (BMI) and waist circumference (WC) trends showed that in comparison to those in the lowest ntile, subjects in the highest ntile of red and processed meat consumption had higher BMI (mean difference: 1.37; 95% CI: 0.90-1.84 for red meat; mean difference: 1.32; 95% CI: 0.64-2.00 for processed meat) and WC (mean difference: 2.79; 95% CI: 1.86-3.70 for red meat; mean difference: 2.77; 95% CI: 1.87-2.66 for processed meat). The current analysis revealed that red and processed meat intake is directly associated with risk of obesity, and higher BMI and WC. However, the heterogeneity among studies is significant. These findings suggest a decrease in red and processed meat intake. © 2014 The Authors. obesity reviews © 2014 World Obesity.

Geo-hazard harmonised data a driven process to environmental analysis system

NASA Astrophysics Data System (ADS)

Cipolloni, Carlo; Iadanza, Carla; Pantaloni, Marco; Trigila, Alessandro

2015-04-01

In the last decade an increase of damage caused by natural disasters has been recorded in Italy. To support environmental safety and human protection, by reducing vulnerability of exposed elements as well as improving the resilience of the involved communities, it need to give access to harmonized and customized data that is one of several steps towards delivering adequate support to risk assessment, reduction and management. In this contest has been developed SEIS and Copernicus-GEMES as infrastructure based on web services for environmental analysis, to integrates in its own system specifications and results from INSPIRE. The two landslide risk scenarios developed in different European projects driven the harmonization process of data that represents the basic element to have interoperable web services in environmental analysis system. From two different perspective we have built a common methodology to analyse dataset and transform them into INSPIRE compliant format following the Data Specification on Geology and on Natural Risk Zone given by INSPIRE. To ensure the maximum results and re-usability of data we have also applied to the landslide and geological datasets a wider Data model standard like GeoSciML, that represents the natural extension of INSPIRE data model to provide more information. The aim of this work is to present the first results of two projects concerning the data harmonisation process, where an important role is played by the semantic harmonisation using the ontology service and/or the hierarchy vocabularies available as Link Data or Link Open Data by means of URI directly in the data spatial services. It will be presented how the harmonised web services can provide an add value in a risk scenario analysis system, showing the first results of the landslide environmental analysis developed by the eENVplus and LIFE+IMAGINE projects.

Application of failure mode and effects analysis to intracranial stereotactic radiation surgery by linear accelerator.

PubMed

Masini, Laura; Donis, Laura; Loi, Gianfranco; Mones, Eleonora; Molina, Elisa; Bolchini, Cesare; Krengli, Marco

2014-01-01

The aim of this study was to analyze the application of the failure modes and effects analysis (FMEA) to intracranial stereotactic radiation surgery (SRS) by linear accelerator in order to identify the potential failure modes in the process tree and adopt appropriate safety measures to prevent adverse events (AEs) and near-misses, thus improving the process quality. A working group was set up to perform FMEA for intracranial SRS in the framework of a quality assurance program. FMEA was performed in 4 consecutive tasks: (1) creation of a visual map of the process; (2) identification of possible failure modes; (3) assignment of a risk probability number (RPN) to each failure mode based on tabulated scores of severity, frequency of occurrence and detectability; and (4) identification of preventive measures to minimize the risk of occurrence. The whole SRS procedure was subdivided into 73 single steps; 116 total possible failure modes were identified and a score of severity, occurrence, and detectability was assigned to each. Based on these scores, RPN was calculated for each failure mode thus obtaining values from 1 to 180. In our analysis, 112/116 (96.6%) RPN values were <60, 2 (1.7%) between 60 and 125 (63, 70), and 2 (1.7%) >125 (135, 180). The 2 highest RPN scores were assigned to the risk of using the wrong collimator's size and incorrect coordinates on the laser target localizer frame. Failure modes and effects analysis is a simple and practical proactive tool for systematic analysis of risks in radiation therapy. In our experience of SRS, FMEA led to the adoption of major changes in various steps of the SRS procedure.

Point process methods in epidemiology: application to the analysis of human immunodeficiency virus/acquired immunodeficiency syndrome mortality in urban areas.

PubMed

Quesada, Jose Antonio; Melchor, Inmaculada; Nolasco, Andreu

2017-05-26

The analysis of spatio-temporal patterns of disease or death in urban areas has been developed mainly from the ecological studies approach. These designs may have some limitations like the ecological fallacy and instability with few cases. The objective of this study was to apply the point process methodology, as a complement to that of aggregated data, to study HIV/AIDS mortality in men in the city of Alicante (Spain). A case-control study in residents in the city during the period 2004-2011 was designed. Cases were men who died from HIV/AIDS and controls represented the general population, matched by age to cases. The risk surfaces of death over the city were estimated using the log-risk function of intensities, and we contrasted their temporal variations over the two periods. High risk significant areas of death by HIV/AIDS, which coincide with the most deprived areas in the city, were detected. Significant spatial change of the areas at risk between the periods studied was not detected. The point process methodology is a useful tool to analyse the patterns of death by HIV/AIDS in urban areas.

Air Force Project Risk Management - The Impact of Inconsistent Processes

DTIC Science & Technology

2016-09-15

grave development of a project. The Challenger disaster drove rigor in process based risk analysis which began to emerge formally in the early 1990’s...is a natural tendency to be aggressive with assumptions early in a program to make the program appear attractive” (p. 30). The literature dovetails...and having an unwanted pregnancy (Burger & Burns, 1988). Investigations revealed that the siting of the Fukushima Daiichi reactors and a 5.7

Application of ISO22000 and Failure Mode and Effect Analysis (fmea) for Industrial Processing of Poultry Products

NASA Astrophysics Data System (ADS)

Varzakas, Theodoros H.; Arvanitoyannis, Ioannis S.

Failure Mode and Effect Analysis (FMEA) model has been applied for the risk assessment of poultry slaughtering and manufacturing. In this work comparison of ISO22000 analysis with HACCP is carried out over poultry slaughtering, processing and packaging. Critical Control points and Prerequisite programs (PrPs) have been identified and implemented in the cause and effect diagram (also known as Ishikawa, tree diagram and fishbone diagram).

Documentation Protocols to Generate Risk Indicators Regarding Degradation Processes for Cultural Heritage Risk Evaluation

NASA Astrophysics Data System (ADS)

Kioussi, A.; Karoglou, M.; Bakolas, A.; Labropoulos, K.; Moropoulou, A.

2013-07-01

Sustainable maintenance and preservation of cultural heritage assets depends highly on its resilience to external or internal alterations and to various hazards. Risk assessment of a heritage asset's can be defined as the identification of all potential hazards affecting it and the evaluation of the asset's vulnerability (building materials and building structure conservation state).Potential hazards for cultural heritage are complex and varying. The risk of decay and damage associated with monuments is not limited to certain long term natural processes, sudden events and human impact (macroscale of the heritage asset) but is also a function of the degradation processes within materials and structural elements due to physical and chemical procedures. Obviously, these factors cover different scales of the problem. The deteriorating processes in materials may be triggered by external influences or caused because of internal chemical and/or physical variations of materials properties and characteristics. Therefore risk evaluation should be dealt in the direction of revealing the specific active decay and damage mechanism both in mesoscale [type of decay and damage] and microscale [decay phenomenon mechanism] level. A prerequisite for risk indicators identification and development is the existence of an organised source of comparable and interoperable data about heritage assets under observation. This unified source of information offers a knowledge based background of the asset's vulnerability through the diagnosis of building materials' and building structure's conservation state, through the identification of all potential hazards affecting these and through mapping of its possible alterations during its entire life-time. In this framework the identification and analysis of risks regarding degradation processes for the development of qualitative and quantitative indicators can be supported by documentation protocols. The data investigated by such protocols help identify the parameters needed for the assessment of the preservation state of a monument and its monitoring through its entire lifetime. The main tool for detecting these indicators is a diagnostic methodology based on appropriate standards that reveals the actual degradation processes responsible of the asset's vulnerability. It is very important that the integration between the material's diagnosis and the overall documentation is taken into consideration in order to identify the required levels of protection and preventive conservation for heritage assets depending on the most frequent local risks. The ranging of risks is therefore necessary according to their importance in each area. Documentation protocols provide with a specific diagnostic tool for materials characterization, decay diagnosis, evaluation process of former conservation materials and interventions, standard procedures for monitoring and control as well as data documentation based on specific guidelines and standards. Implementation and analysis of a "standardised" diagnostic study will reveal the main risks due to degradation processes affecting the heritage asset to be subsequently recorded in order to result into risk indicators. The development of risk indicators regarding degradation processes is the basic step towards uptaking efficient management, preventive conservation and strategic planning for heritage assets against various threats. These risk indicators could be further elaborated according to the activities of inspection, diagnosis and intervention works, offering scientific support to the decision making process for cultural heritage preventive conservation and overall protection.

Comparison of a Traditional Probabilistic Risk Assessment Approach with Advanced Safety Analysis

DOE Office of Scientific and Technical Information (OSTI.GOV)

Smith, Curtis L; Mandelli, Diego; Zhegang Ma

2014-11-01

As part of the Light Water Sustainability Program (LWRS) [1], the purpose of the Risk Informed Safety Margin Characterization (RISMC) [2] Pathway research and development (R&D) is to support plant decisions for risk-informed margin management with the aim to improve economics, reliability, and sustain safety of current NPPs. In this paper, we describe the RISMC analysis process illustrating how mechanistic and probabilistic approaches are combined in order to estimate a safety margin. We use the scenario of a “station blackout” (SBO) wherein offsite power and onsite power is lost, thereby causing a challenge to plant safety systems. We describe themore » RISMC approach, illustrate the station blackout modeling, and contrast this with traditional risk analysis modeling for this type of accident scenario. We also describe our approach we are using to represent advanced flooding analysis.« less

Integrating Human Factors into Space Vehicle Processing for Risk Management

NASA Technical Reports Server (NTRS)

Woodbury, Sarah; Richards, Kimberly J.

2008-01-01

This presentation will discuss the multiple projects performed in United Space Alliance's Human Engineering Modeling and Performance (HEMAP) Lab, improvements that resulted from analysis, and the future applications of the HEMAP Lab for risk assessment by evaluating human/machine interaction and ergonomic designs.

A comprehensive Network Security Risk Model for process control networks.

PubMed

Henry, Matthew H; Haimes, Yacov Y

2009-02-01

The risk of cyber attacks on process control networks (PCN) is receiving significant attention due to the potentially catastrophic extent to which PCN failures can damage the infrastructures and commodity flows that they support. Risk management addresses the coupled problems of (1) reducing the likelihood that cyber attacks would succeed in disrupting PCN operation and (2) reducing the severity of consequences in the event of PCN failure or manipulation. The Network Security Risk Model (NSRM) developed in this article provides a means of evaluating the efficacy of candidate risk management policies by modeling the baseline risk and assessing expectations of risk after the implementation of candidate measures. Where existing risk models fall short of providing adequate insight into the efficacy of candidate risk management policies due to shortcomings in their structure or formulation, the NSRM provides model structure and an associated modeling methodology that captures the relevant dynamics of cyber attacks on PCN for risk analysis. This article develops the NSRM in detail in the context of an illustrative example.

Probabilistic cost-benefit analysis of disaster risk management in a development context.

PubMed

Kull, Daniel; Mechler, Reinhard; Hochrainer-Stigler, Stefan

2013-07-01

Limited studies have shown that disaster risk management (DRM) can be cost-efficient in a development context. Cost-benefit analysis (CBA) is an evaluation tool to analyse economic efficiency. This research introduces quantitative, stochastic CBA frameworks and applies them in case studies of flood and drought risk reduction in India and Pakistan, while also incorporating projected climate change impacts. DRM interventions are shown to be economically efficient, with integrated approaches more cost-effective and robust than singular interventions. The paper highlights that CBA can be a useful tool if certain issues are considered properly, including: complexities in estimating risk; data dependency of results; negative effects of interventions; and distributional aspects. The design and process of CBA must take into account specific objectives, available information, resources, and the perceptions and needs of stakeholders as transparently as possible. Intervention design and uncertainties should be qualified through dialogue, indicating that process is as important as numerical results. © 2013 The Author(s). Journal compilation © Overseas Development Institute, 2013.

FMEA: a model for reducing medical errors.

PubMed

Chiozza, Maria Laura; Ponzetti, Clemente

2009-06-01

Patient safety is a management issue, in view of the fact that clinical risk management has become an important part of hospital management. Failure Mode and Effect Analysis (FMEA) is a proactive technique for error detection and reduction, firstly introduced within the aerospace industry in the 1960s. Early applications in the health care industry dating back to the 1990s included critical systems in the development and manufacture of drugs and in the prevention of medication errors in hospitals. In 2008, the Technical Committee of the International Organization for Standardization (ISO), licensed a technical specification for medical laboratories suggesting FMEA as a method for prospective risk analysis of high-risk processes. Here we describe the main steps of the FMEA process and review data available on the application of this technique to laboratory medicine. A significant reduction of the risk priority number (RPN) was obtained when applying FMEA to blood cross-matching, to clinical chemistry analytes, as well as to point-of-care testing (POCT).

SCAP: a new methodology for safety management based on feedback from credible accident-probabilistic fault tree analysis system.

PubMed

Khan, F I; Iqbal, A; Ramesh, N; Abbasi, S A

2001-10-12

As it is conventionally done, strategies for incorporating accident--prevention measures in any hazardous chemical process industry are developed on the basis of input from risk assessment. However, the two steps-- risk assessment and hazard reduction (or safety) measures--are not linked interactively in the existing methodologies. This prevents a quantitative assessment of the impacts of safety measures on risk control. We have made an attempt to develop a methodology in which risk assessment steps are interactively linked with implementation of safety measures. The resultant system tells us the extent of reduction of risk by each successive safety measure. It also tells based on sophisticated maximum credible accident analysis (MCAA) and probabilistic fault tree analysis (PFTA) whether a given unit can ever be made 'safe'. The application of the methodology has been illustrated with a case study.

Consumption of different types of meat and the risk of renal cancer: meta-analysis of case-control studies.

PubMed

Faramawi, Mohammed F; Johnson, Eric; Fry, M Whitney; Sall, Macodu; Zhou, Yi; Yi, Zhou

2007-03-01

Kidney cancers account for almost 2% of all cancers worldwide, with 150,000 new cases and 78,000 deaths from the disease occurring annually. An increase in the incidence of kidney neoplasm in western countries was noticed in the past few years. Between 1988 and 1992, the incidence of renal cancer per 100,000 person-year among males in USA, Norway, and France was 34.1, 9.00, and 16.10, respectively. Among females in the same countries, it was 5.70, 5.00, and 7.30, respectively. Although several individual case-control studies examined the association of meat intake and renal cancer risk, the results were inconsistent because of the insufficient statistical power of the individual studies. Therefore, the following meta-analysis was designed to help in clarifying the association. Electronic search of MEDLINE, OVID, and PUBMED databases which have articles published between (1966 and 2006) was conducted to select studies for this meta-analysis. Fixed and random-effects meta-analytical techniques were used to estimate the overall association between meat consumption and kidney cancer. Thirteen case-control studies were found. This meta-analysis supported a positive relationship between meat consumption and risk of renal cancer. Summary results indicated that there was from 20% to 22% higher risk of renal cancer among those in the highest relative to the lowest category of poultry and processed meat consumption. Consumption of all meat and red meat was associated with 27% and 30% higher risk, respectively. The increased risks were statistically significant. Increased consumption of all meat, red meat, poultry, and processed meat is associated with an increase risk of kidney cancer. Reduction of meat consumption is an important approach to decreasing the incidence of kidney cancer in the general population.

Averse to Initiative: Risk Management’s Effect on Mission Command

DTIC Science & Technology

2017-05-25

military decision making process (MDMP). Other changes to structure reveal administrative and safety risk information (i.e. personal operated vehicle... decision making , it requires commanders to have the capacity to make an informed , intuitive decision . Uncertainty...analysis. His situation required him to embrace uncertainty, and exercise an informed intuition to make a risk decision to create opportunity

Risk analysis and management

NASA Technical Reports Server (NTRS)

Smith, H. E.

1990-01-01

Present software development accomplishments are indicative of the emerging interest in and increasing efforts to provide risk assessment backbone tools in the manned spacecraft engineering community. There are indications that similar efforts are underway in the chemical processes industry and are probably being planned for other high risk ground base environments. It appears that complex flight systems intended for extended manned planetary exploration will drive this technology.

Risk Management using Dependency Stucture Matrix

NASA Astrophysics Data System (ADS)

Petković, Ivan

2011-09-01

An efficient method based on dependency structure matrix (DSM) analysis is given for ranking risks in a complex system or process whose entities are mutually dependent. This rank is determined according to the element's values of the unique positive eigenvector which corresponds to the matrix spectral radius modeling the considered engineering system. For demonstration, the risk problem of NASA's robotic spacecraft is analyzed.

An integrated tool to support engineers for WMSDs risk assessment during the assembly line balancing.

PubMed

Di Benedetto, Raffaele; Fanti, Michele

2012-01-01

This paper wants to present an integrated approach to Line Balancing and Risk Assessment and a Software Tool named ErgoAnalysis that makes it easy to control the whole production process and produces a Risk Index for the actual work tasks in an Assembly Line. Assembly Line Balancing, or simply Line Balancing, is the problem of assigning operations to workstations along an assembly line, in such a way that the assignment be optimal in some sense. Assembly lines are characterized by production constraints and restrictions due to several aspects such as the nature of the product and the flow of orders. To be able to respond effectively to the needs of production, companies need to frequently change the workload and production models. Each manufacturing process might be quite different from another. To optimize very specific operations, assembly line balancing might utilize a number of methods and the Engineer must consider ergonomic constraints, in order to reduce the risk of WMDSs. Risk Assessment may result very expensive because the Engineer must evaluate it at every change. ErgoAnalysis can reduce cost and improve effectiveness in Risk Assessment during the Line Balancing.

Sensemaking of patient safety risks and hazards.

PubMed

Battles, James B; Dixon, Nancy M; Borotkanics, Robert J; Rabin-Fastmen, Barbara; Kaplan, Harold S

2006-08-01

In order for organizations to become learning organizations, they must make sense of their environment and learn from safety events. Sensemaking, as described by Weick (1995), literally means making sense of events. The ultimate goal of sensemaking is to build the understanding that can inform and direct actions to eliminate risk and hazards that are a threat to patient safety. True sensemaking in patient safety must use both retrospective and prospective approach to learning. Sensemaking is as an essential part of the design process leading to risk informed design. Sensemaking serves as a conceptual framework to bring together well established approaches to assessment of risk and hazards: (1) at the single event level using root cause analysis (RCA), (2) at the processes level using failure modes effects analysis (FMEA) and (3) at the system level using probabilistic risk assessment (PRA). The results of these separate or combined approaches are most effective when end users in conversation-based meetings add their expertise and knowledge to the data produced by the RCA, FMEA, and/or PRA in order to make sense of the risks and hazards. Without ownership engendered by such conversations, the possibility of effective action to eliminate or minimize them is greatly reduced.

Sensemaking of Patient Safety Risks and Hazards

PubMed Central

Battles, James B; Dixon, Nancy M; Borotkanics, Robert J; Rabin-Fastmen, Barbara; Kaplan, Harold S

2006-01-01

In order for organizations to become learning organizations, they must make sense of their environment and learn from safety events. Sensemaking, as described by Weick (1995), literally means making sense of events. The ultimate goal of sensemaking is to build the understanding that can inform and direct actions to eliminate risk and hazards that are a threat to patient safety. True sensemaking in patient safety must use both retrospective and prospective approach to learning. Sensemaking is as an essential part of the design process leading to risk informed design. Sensemaking serves as a conceptual framework to bring together well established approaches to assessment of risk and hazards: (1) at the single event level using root cause analysis (RCA), (2) at the processes level using failure modes effects analysis (FMEA) and (3) at the system level using probabilistic risk assessment (PRA). The results of these separate or combined approaches are most effective when end users in conversation-based meetings add their expertise and knowledge to the data produced by the RCA, FMEA, and/or PRA in order to make sense of the risks and hazards. Without ownership engendered by such conversations, the possibility of effective action to eliminate or minimize them is greatly reduced. PMID:16898979

Cyber crime: can a standard risk analysis help in the challenges facing business continuity managers?

PubMed

Vande Putte, Danny; Verhelst, Marc

Risk management has never been easy. Finding efficient mitigating measures is not always straightforward. Finding measures for cyber crime, however, is a really huge challenge because cyber threats are changing all the time. As the sophistication of these threats is growing, their impact increases. Moreover, society and its economy have become increasingly dependent on information and communication technologies. Standard risk analysis methodologies will help to score the cyber risk and to place it in the risk tolerance matrix. This will allow business continuity managers to figure out if there is still a gap with the maximum tolerable outage for time-critical business processes and if extra business continuity measures are necessary to fill the gap.

Interprofessional communication supporting clinical handover in emergency departments: An observation study.

PubMed

Redley, Bernice; Botti, Mari; Wood, Beverley; Bucknall, Tracey

2017-08-01

Poor interprofessional communication poses a risk to patient safety at change-of-shift in emergency departments (EDs). The purpose of this study was to identify and describe patterns and processes of interprofessional communication impacting quality of ED change-of-shift handovers. Observation of 66 change-of-shift handovers at two acute hospital EDs in Victoria, Australia. Focus groups with 34 nurse participants complemented the observations. Qualitative data analysis involved content and thematic methods. Four structural components of ED handover processes emerged represented by (ABCD): (1) Antecedents; (2) Behaviours and interactions; (3) Content; and (4) Delegation of ongoing care. Infrequent and ad hoc interprofessional communication and discipline-specific handover content and processes emerged as specific risks to patient safety at change-of-shift handovers. Three themes related to risky and effective practices to support interprofessional communications across the four stages of ED handovers emerged: 1) standard processes and practices, 2) teamwork and interactions and 3) communication activities and practices. Unreliable interprofessional communication can impact the quality of change-of-shift handovers in EDs and poses risk to patient safety. Structured reflective analysis of existing practices can identify opportunities for standardisation, enhanced team practices and effective communication across four stages of the handover process to support clinicians to enhance local handover practices. Future research should test and refine models to support analysis of practice, and identify and test strategies to enhance ED interprofessional communication to support clinical handovers. Copyright © 2017 College of Emergency Nursing Australasia. Published by Elsevier Ltd. All rights reserved.

Lifestyle risk management--a qualitative analysis of women's descriptions of taking hormone therapy following surgically induced menopause.

PubMed

Crowe, Marie; Burrell, Beverly; Whitehead, Lisa

2012-08-01

This article is a report of a study that examined how women describe their decisions in relation to the use of menopausal hormone therapy following surgical menopause. Women who have had a surgically induced menopause generally experience more intense menopausal symptoms than natural menopause and are regularly prescribed menopausal hormone therapy. Since 2002 the risks associated with this therapy have been widely reported. This study is a qualitative analysis of semi-structured interviews between March and May 2009 with 30 participants who had experienced surgical menopause and were, or had in the past, taken menopausal hormone therapy. This was a community sample recruited in Christchurch, New Zealand. A risk management theoretical approach underpinned the analysis. The womens' descriptions of managing the risks associated with menopausal therapy fell into two main themes: Life has to go on and Waiting for someone to tell me. All these women had either made an active decision to continue on treatment because of the impact of menopausal symptoms or took their doctor's advice to continue. A less dominant theme but one that was also evident was Relying on my body to get me through in which the women had decided to discontinue treatment because they regarded it as unnatural. The study provided insights into how women utilize an experiential reasoning process to manage the health and lifestyle risks associated with taking menopausal hormone therapy. Nurses need to be aware of how this process influences women's reasoning processes when working with women following surgical menopause. © 2011 Blackwell Publishing Ltd.

[The workplace injury trends in the petrochemical industry: from data analysis to risk management].

PubMed

Campo, Giuseppe; Martini, Benedetta

2013-01-01

The most recent INAIL data show that, in 2009-2011, the accident frequency rate and the severity rate of workplace injuries in the chemical industry are lower than for the total non-agricultural workforce. The chemical industry, primarily because of the complex and hazardous work processes, requires an appropriate system for assessing and monitoring specific risks.The implementation of Responsible Care, a risk management system specific for the chemical industry, in 1984, has represented a historical step in the process of critical awareness of risk management by the chemical companies. Responsible Care is a risk management system specifically designed on the risk profiles of this type of enterprise, which integrates safety, health and environment. A risk management system, suitable for the needs of a chemical company, should extend its coverage area, beyond the responsible management of products throughout the entire production cycle, to the issues of corporate responsibility.

Fault and event tree analyses for process systems risk analysis: uncertainty handling formulations.

PubMed

Ferdous, Refaul; Khan, Faisal; Sadiq, Rehan; Amyotte, Paul; Veitch, Brian

2011-01-01

Quantitative risk analysis (QRA) is a systematic approach for evaluating likelihood, consequences, and risk of adverse events. QRA based on event (ETA) and fault tree analyses (FTA) employs two basic assumptions. The first assumption is related to likelihood values of input events, and the second assumption is regarding interdependence among the events (for ETA) or basic events (for FTA). Traditionally, FTA and ETA both use crisp probabilities; however, to deal with uncertainties, the probability distributions of input event likelihoods are assumed. These probability distributions are often hard to come by and even if available, they are subject to incompleteness (partial ignorance) and imprecision. Furthermore, both FTA and ETA assume that events (or basic events) are independent. In practice, these two assumptions are often unrealistic. This article focuses on handling uncertainty in a QRA framework of a process system. Fuzzy set theory and evidence theory are used to describe the uncertainties in the input event likelihoods. A method based on a dependency coefficient is used to express interdependencies of events (or basic events) in ETA and FTA. To demonstrate the approach, two case studies are discussed. © 2010 Society for Risk Analysis.

A Model of Risk Analysis in Analytical Methodology for Biopharmaceutical Quality Control.

PubMed

Andrade, Cleyton Lage; Herrera, Miguel Angel De La O; Lemes, Elezer Monte Blanco

2018-01-01

One key quality control parameter for biopharmaceutical products is the analysis of residual cellular DNA. To determine small amounts of DNA (around 100 pg) that may be in a biologically derived drug substance, an analytical method should be sensitive, robust, reliable, and accurate. In principle, three techniques have the ability to measure residual cellular DNA: radioactive dot-blot, a type of hybridization; threshold analysis; and quantitative polymerase chain reaction. Quality risk management is a systematic process for evaluating, controlling, and reporting of risks that may affects method capabilities and supports a scientific and practical approach to decision making. This paper evaluates, by quality risk management, an alternative approach to assessing the performance risks associated with quality control methods used with biopharmaceuticals, using the tool hazard analysis and critical control points. This tool provides the possibility to find the steps in an analytical procedure with higher impact on method performance. By applying these principles to DNA analysis methods, we conclude that the radioactive dot-blot assay has the largest number of critical control points, followed by quantitative polymerase chain reaction, and threshold analysis. From the analysis of hazards (i.e., points of method failure) and the associated method procedure critical control points, we conclude that the analytical methodology with the lowest risk for performance failure for residual cellular DNA testing is quantitative polymerase chain reaction. LAY ABSTRACT: In order to mitigate the risk of adverse events by residual cellular DNA that is not completely cleared from downstream production processes, regulatory agencies have required the industry to guarantee a very low level of DNA in biologically derived pharmaceutical products. The technique historically used was radioactive blot hybridization. However, the technique is a challenging method to implement in a quality control laboratory: It is laborious, time consuming, semi-quantitative, and requires a radioisotope. Along with dot-blot hybridization, two alternatives techniques were evaluated: threshold analysis and quantitative polymerase chain reaction. Quality risk management tools were applied to compare the techniques, taking into account the uncertainties, the possibility of circumstances or future events, and their effects upon method performance. By illustrating the application of these tools with DNA methods, we provide an example of how they can be used to support a scientific and practical approach to decision making and can assess and manage method performance risk using such tools. This paper discusses, considering the principles of quality risk management, an additional approach to the development and selection of analytical quality control methods using the risk analysis tool hazard analysis and critical control points. This tool provides the possibility to find the method procedural steps with higher impact on method reliability (called critical control points). Our model concluded that the radioactive dot-blot assay has the larger number of critical control points, followed by quantitative polymerase chain reaction and threshold analysis. Quantitative polymerase chain reaction is shown to be the better alternative analytical methodology in residual cellular DNA analysis. © PDA, Inc. 2018.

SU-E-T-635: Process Mapping of Eye Plaque Brachytherapy

DOE Office of Scientific and Technical Information (OSTI.GOV)

Huynh, J; Kim, Y

Purpose: To apply a risk-based assessment and analysis technique (AAPM TG 100) to eye plaque brachytherapy treatment of ocular melanoma. Methods: The role and responsibility of personnel involved in the eye plaque brachytherapy is defined for retinal specialist, radiation oncologist, nurse and medical physicist. The entire procedure was examined carefully. First, major processes were identified and then details for each major process were followed. Results: Seventy-one total potential modes were identified. Eight major processes (corresponding detailed number of modes) are patient consultation (2 modes), pretreatment tumor localization (11), treatment planning (13), seed ordering and calibration (10), eye plaque assembly (10),more » implantation (11), removal (11), and deconstruction (3), respectively. Half of the total modes (36 modes) are related to physicist while physicist is not involved in processes such as during the actual procedure of suturing and removing the plaque. Conclusion: Not only can failure modes arise from physicist-related procedures such as treatment planning and source activity calibration, but it can also exist in more clinical procedures by other medical staff. The improvement of the accurate communication for non-physicist-related clinical procedures could potentially be an approach to prevent human errors. More rigorous physics double check would reduce the error for physicist-related procedures. Eventually, based on this detailed process map, failure mode and effect analysis (FMEA) will identify top tiers of modes by ranking all possible modes with risk priority number (RPN). For those high risk modes, fault tree analysis (FTA) will provide possible preventive action plans.« less

Cost Estimation and Control for Flight Systems

NASA Technical Reports Server (NTRS)

Hammond, Walter E.; Vanhook, Michael E. (Technical Monitor)

2002-01-01

Good program management practices, cost analysis, cost estimation, and cost control for aerospace flight systems are interrelated and depend upon each other. The best cost control process cannot overcome poor design or poor systems trades that lead to the wrong approach. The project needs robust Technical, Schedule, Cost, Risk, and Cost Risk practices before it can incorporate adequate Cost Control. Cost analysis both precedes and follows cost estimation -- the two are closely coupled with each other and with Risk analysis. Parametric cost estimating relationships and computerized models are most often used. NASA has learned some valuable lessons in controlling cost problems, and recommends use of a summary Project Manager's checklist as shown here.

Public Risk Assessment Program

NASA Technical Reports Server (NTRS)

Mendeck, Gavin

2010-01-01

The Public Entry Risk Assessment (PERA) program addresses risk to the public from shuttle or other spacecraft re-entry trajectories. Managing public risk to acceptable levels is a major component of safe spacecraft operation. PERA is given scenario inputs of vehicle trajectory, probability of failure along that trajectory, the resulting debris characteristics, and field size and distribution, and returns risk metrics that quantify the individual and collective risk posed by that scenario. Due to the large volume of data required to perform such a risk analysis, PERA was designed to streamline the analysis process by using innovative mathematical analysis of the risk assessment equations. Real-time analysis in the event of a shuttle contingency operation, such as damage to the Orbiter, is possible because PERA allows for a change to the probability of failure models, therefore providing a much quicker estimation of public risk. PERA also provides the ability to generate movie files showing how the entry risk changes as the entry develops. PERA was designed to streamline the computation of the enormous amounts of data needed for this type of risk assessment by using an average distribution of debris on the ground, rather than pinpointing the impact point of every piece of debris. This has reduced the amount of computational time significantly without reducing the accuracy of the results. PERA was written in MATLAB; a compiled version can run from a DOS or UNIX prompt.

DOE Office of Scientific and Technical Information (OSTI.GOV)

Zitney, S.E.; McCorkle, D.; Yang, C.

Process modeling and simulation tools are widely used for the design and operation of advanced power generation systems. These tools enable engineers to solve the critical process systems engineering problems that arise throughout the lifecycle of a power plant, such as designing a new process, troubleshooting a process unit or optimizing operations of the full process. To analyze the impact of complex thermal and fluid flow phenomena on overall power plant performance, the Department of Energy’s (DOE) National Energy Technology Laboratory (NETL) has developed the Advanced Process Engineering Co-Simulator (APECS). The APECS system is an integrated software suite that combinesmore » process simulation (e.g., Aspen Plus) and high-fidelity equipment simulations such as those based on computational fluid dynamics (CFD), together with advanced analysis capabilities including case studies, sensitivity analysis, stochastic simulation for risk/uncertainty analysis, and multi-objective optimization. In this paper we discuss the initial phases of the integration of the APECS system with the immersive and interactive virtual engineering software, VE-Suite, developed at Iowa State University and Ames Laboratory. VE-Suite uses the ActiveX (OLE Automation) controls in the Aspen Plus process simulator wrapped by the CASI library developed by Reaction Engineering International to run process/CFD co-simulations and query for results. This integration represents a necessary step in the development of virtual power plant co-simulations that will ultimately reduce the time, cost, and technical risk of developing advanced power generation systems.« less

ExMC Work Prioritization Process

NASA Technical Reports Server (NTRS)

Simon, Matthew

2015-01-01

Last year, NASA's Human Research Program (HRP) introduced the concept of a "Path to Risk Reduction" (PRR), which will provide a roadmap that shows how the work being done within each HRP element can be mapped to reducing or closing exploration risks. Efforts are currently underway within the Exploration Medical Capability (ExMC) Element to develop a structured, repeatable process for prioritizing work utilizing decision analysis techniques and risk estimation tools. The goal of this effort is to ensure that the work done within the element maximizes risk reduction for future exploration missions in a quantifiable way and better aligns with the intent and content of the Path to Risk Reduction. The Integrated Medical Model (IMM) will be used to identify those conditions that are major contributors of medical risk for a given design reference mission. For each of these conditions, potential prevention, screening, diagnosis, and treatment methods will be identified. ExMC will then aim to prioritize its potential investments in these mitigation methods based upon their potential for risk reduction and other factors such as vehicle performance impacts, near term schedule needs, duplication with external efforts, and cost. This presentation will describe the process developed to perform this prioritization and inform investment discussions in future element planning efforts. It will also provide an overview of the required input information, types of process participants, figures of merit, and the expected outputs of the process.

Structural Health Monitoring Analysis for the Orbiter Wing Leading Edge

NASA Technical Reports Server (NTRS)

Yap, Keng C.

2010-01-01

This viewgraph presentation reviews Structural Health Monitoring Analysis for the Orbiter Wing Leading Edge. The Wing Leading Edge Impact Detection System (WLE IDS) and the Impact Analysis Process are also described to monitor WLE debris threats. The contents include: 1) Risk Management via SHM; 2) Hardware Overview; 3) Instrumentation; 4) Sensor Configuration; 5) Debris Hazard Monitoring; 6) Ascent Response Summary; 7) Response Signal; 8) Distribution of Flight Indications; 9) Probabilistic Risk Analysis (PRA); 10) Model Correlation; 11) Impact Tests; 12) Wing Leading Edge Modeling; 13) Ascent Debris PRA Results; and 14) MM/OD PRA Results.

Do service users with intellectual disabilities want to be involved in the risk management process? A thematic analysis.

PubMed

Kilcommons, Aoiffe M; Withers, Paul; Moreno-Lopez, Águeda

2012-09-01

Involving ID service users in risk decision making necessitates consideration of an individual's ability to assess the implications and associated risks and thus make an informed choice. This calls for research on service users' awareness and understanding of risk management (RM). Thirteen people in a residential ID service who were reviewed under the risk management process (RMP) participated in the research. Thematic analysis explored participants' knowledge and understanding of risk management to establish ability to make informed choice. Two main meta-themes (lack of awareness about RM and awareness about RM) and four meta-themes (extent of RM awareness, locus of control, compliance and empowerment) emerged. Nine of 13 participants demonstrated some knowledge and awareness of RM and wanted to contribute to the RMP, despite not being consulted about or given the opportunity to be involved in RM. The majority of service users in this sample had some awareness of the purpose of RM and could make partially informed decisions about whether they would like to be involved in the RMP. The findings highlight the need for professionals to actively attempt to involve ID service users in the management of their own risk. © 2012 Blackwell Publishing Ltd.

Relative risk analysis in regulating the use of radiation-emitting medical devices. A preliminary application

DOE Office of Scientific and Technical Information (OSTI.GOV)

Jones, E.D.; Banks, W.W.; Altenbach, T.J.

1995-09-01

This report describes a preliminary application of an analysis approach for assessing relative risks in the use of radiation- emitting medical devices. Results are presented on human-initiated actions and failure modes that are most likely to occur in the use of the Gamma Knife, a gamma irradiation therapy device. This effort represents an initial step in a US Nuclear Regulatory Commission (NRC) plan to evaluate the potential role of risk analysis in regulating the use of nuclear medical devices. For this preliminary application of risk assessment, the focus was to develop a basic process using existing techniques for identifying themore » most likely risk contributors and their relative importance. The approach taken developed relative risk rankings and profiles that incorporated the type and quality of data available and could present results in an easily understood form. This work was performed by the Lawrence Livermore National Laboratory for the NRC.« less

Risk analysis of analytical validations by probabilistic modification of FMEA.

PubMed

Barends, D M; Oldenhof, M T; Vredenbregt, M J; Nauta, M J

2012-05-01

Risk analysis is a valuable addition to validation of an analytical chemistry process, enabling not only detecting technical risks, but also risks related to human failures. Failure Mode and Effect Analysis (FMEA) can be applied, using a categorical risk scoring of the occurrence, detection and severity of failure modes, and calculating the Risk Priority Number (RPN) to select failure modes for correction. We propose a probabilistic modification of FMEA, replacing the categorical scoring of occurrence and detection by their estimated relative frequency and maintaining the categorical scoring of severity. In an example, the results of traditional FMEA of a Near Infrared (NIR) analytical procedure used for the screening of suspected counterfeited tablets are re-interpretated by this probabilistic modification of FMEA. Using this probabilistic modification of FMEA, the frequency of occurrence of undetected failure mode(s) can be estimated quantitatively, for each individual failure mode, for a set of failure modes, and the full analytical procedure. Copyright © 2012 Elsevier B.V. All rights reserved.

HUMAN AND ECOLOIGCAL RISK: CORRELATIONS AMONG HUMAN HEALTH, ECOLOGICAL AND ENVIORNMENTAL MONITORING DATA

EPA Science Inventory

While all life is affected by the quality of the environment, environmental risk factors for human and wildlife health are typically assessed using independent processes that are dissimilar in scale and scope. However, the integrated analysis of human, ecological, and environmen...

HUMAN AND ECOLOGICAL RISK ASSESSMENT: ASSOCIATIONS AMONG HUMAN HEALTH, ECOLOGICAL, AND ENVIRONMENTAL MONITORING

EPA Science Inventory

While all life is affected by the quality of the environment, environmental risk factors for human and wildlife health are typically assessed using independent processes that are dissimilar in scale and scope. However, the integrated analysis of human, ecological, and environmen...

HUMAN AND ECOLOGICAL RISK: CORRELATIONS AMONG HUMAN HEALTH, ECOLOGICAL AND ENVIRONMENTAL MONITORING DATA

EPA Science Inventory

While all life is affected by the quality of the environment, environmental risk factors for human and wildlife health are typically assessed using independent processes that are dissimilar in scale and scope. However, the integrated analysis of human, ecological, and environmen...

HUMAN AND ECOLOGICAL RISK ASSESSMENT: ASSOCIATIONS AMONG HUMAN HEALTH, ECOLOGICAL AND ENVIRONMENTAL MONITORING DATA

EPA Science Inventory

While all life is affected by the quality of the environment, environmental risk factors for human and wildlife health are typically assessed using independent processes that are dissimilar in scale and scope. However, the integrated analysis of human, ecological, and environmen...

HUMAN AND ECOLOGICAL RISK ASSESSMENT: ASSOCIATIONS AMONH HUMAN HEALTH, ECOLOGICAL AND ENVIRONMENTAL MONITORING DATA

EPA Science Inventory

While all life is affected by the quality of the environment, environmental risk factors for human and wildlife health are typically assessed using independent processes that are dissimilar in scale and scope. However, the integrated analysis of human, ecological, and environmen...

Dietary patterns and depression risk: A meta-analysis.

PubMed

Li, Ye; Lv, Mei-Rong; Wei, Yan-Jin; Sun, Ling; Zhang, Ji-Xiang; Zhang, Huai-Guo; Li, Bin

2017-07-01

Although some studies have reported potential associations of dietary patterns with depression risk, a consistent perspective hasn't been estimated to date. Therefore, we conducted this meta-analysis to evaluate the relation between dietary patterns and the risk of depression. A literature research was conducted searching MEDLINE and EMBASE databases up to September 2016. In total, 21 studies from ten countries met the inclusion criteria and were included in the present meta-analysis. A dietary pattern characterized by a high intakes of fruit, vegetables, whole grain, fish, olive oil, low-fat dairy and antioxidants and low intakes of animal foods was apparently associated with a decreased risk of depression. A dietary pattern characterized by a high consumption of red and/or processed meat, refined grains, sweets, high-fat dairy products, butter, potatoes and high-fat gravy, and low intakes of fruits and vegetables is associated with an increased risk of depression. The results of this meta-analysis suggest that healthy pattern may decrease the risk of depression, whereas western-style may increase the risk of depression. However, more randomized controlled trails and cohort studies are urgently required to confirm this findings. Copyright © 2017 Elsevier Ireland Ltd. All rights reserved.

Risk factors for incidental durotomy during lumbar surgery: a retrospective study by multivariate analysis.

PubMed

Chen, Zhixiang; Shao, Peng; Sun, Qizhao; Zhao, Dong

2015-03-01

The purpose of the present study was to use a prospectively collected data to evaluate the rate of incidental durotomy (ID) during lumbar surgery and determine the associated risk factors by using univariate and multivariate analysis. We retrospectively reviewed 2184 patients who underwent lumbar surgery from January 1, 2009 to December 31, 2011 at a single hospital. Patients with ID (n=97) were compared with the patients without ID (n=2019). The influences of several potential risk factors that might affect the occurrence of ID were assessed using univariate and multivariate analyses. The overall incidence of ID was 4.62%. Univariate analysis demonstrated that older age, diabetes, lumbar central stenosis, posterior approach, revision surgery, prior lumber surgery and minimal invasive surgery are risk factors for ID during lumbar surgery. However, multivariate analysis identified older age, prior lumber surgery, revision surgery, and minimally invasive surgery as independent risk factors. Older age, prior lumber surgery, revision surgery, and minimal invasive surgery were independent risk factors for ID during lumbar surgery. These findings may guide clinicians making future surgical decisions regarding ID and aid in the patient counseling process to alleviate risks and complications. Copyright © 2015 Elsevier B.V. All rights reserved.

Comprehensive protocol of traceability during IVF: the result of a multicentre failure mode and effect analysis.

PubMed

Rienzi, L; Bariani, F; Dalla Zorza, M; Albani, E; Benini, F; Chamayou, S; Minasi, M G; Parmegiani, L; Restelli, L; Vizziello, G; Costa, A Nanni

2017-08-01

Can traceability of gametes and embryos be ensured during IVF? The use of a simple and comprehensive traceability system that includes the most susceptible phases during the IVF process minimizes the risk of mismatches. Mismatches in IVF are very rare but unfortunately possible with dramatic consequences for both patients and health care professionals. Traceability is thus a fundamental aspect of the treatment. A clear process of patient and cell identification involving witnessing protocols has to be in place in every unit. To identify potential failures in the traceability process and to develop strategies to mitigate the risk of mismatches, previously failure mode and effects analysis (FMEA) has been used effectively. The FMEA approach is however a subjective analysis, strictly related to specific protocols and thus the results are not always widely applicable. To reduce subjectivity and to obtain a widespread comprehensive protocol of traceability, a multicentre centrally coordinated FMEA was performed. Seven representative Italian centres (three public and four private) were selected. The study had a duration of 21 months (from April 2015 to December 2016) and was centrally coordinated by a team of experts: a risk analysis specialist, an expert embryologist and a specialist in human factor. Principal investigators of each centre were first instructed about proactive risk assessment and FMEA methodology. A multidisciplinary team to perform the FMEA analysis was then formed in each centre. After mapping the traceability process, each team identified the possible causes of mistakes in their protocol. A risk priority number (RPN) for each identified potential failure mode was calculated. The results of the FMEA analyses were centrally investigated and consistent corrective measures suggested. The teams performed new FMEA analyses after the recommended implementations. In each centre, this study involved: the laboratory director, the Quality Control & Quality Assurance responsible, Embryologist(s), Gynaecologist(s), Nurse(s) and Administration. The FMEA analyses were performed according to the Joint Commission International. The FMEA teams identified seven main process phases: oocyte collection, sperm collection, gamete processing, insemination, embryo culture, embryo transfer and gamete/embryo cryopreservation. A mean of 19.3 (SD ± 5.8) associated process steps and 41.9 (SD ± 12.4) possible failure modes were recognized per centre. A RPN ≥15 was calculated in a mean of 6.4 steps (range 2-12, SD ± 3.60). A total of 293 failure modes were centrally analysed 45 of which were considered at medium/high risk. After consistent corrective measures implementation and re-evaluation, a significant reduction in the RPNs in all centres (RPN <15 for all steps) was observed. A simple and comprehensive traceability system was designed as the result of the seven FMEA analyses. The validity of FMEA is in general questionable due to the subjectivity of the judgments. The design of this study has however minimized this risk by introducing external experts for the analysis of the FMEA results. Specific situations such as sperm/oocyte donation, import/export and pre-implantation genetic testing were not taken into consideration. Finally, this study is only limited to the analysis of failure modes that may lead to mismatches, other possible procedural mistakes are not accounted for. Every single IVF centre should have a clear and reliable protocol for identification of patients and traceability of cells during manipulation. The results of this study can support IVF groups in better recognizing critical steps in their protocols, understanding identification and witnessing process, and in turn enhancing safety by introducing validated corrective measures. This study was designed by the Italian Society of Embryology Reproduction and Research (SIERR) and funded by the Italian National Transplant Centre (CNT) of the Italian National Institute of Health (ISS). The authors have no conflicts of interest. N/A. © The Author 2017. Published by Oxford University Press on behalf of the European Society of Human Reproduction and Embryology. All rights reserved. For Permissions, please e-mail: journals.permissions@oup.com

Failure modes and effects analysis for ocular brachytherapy.

PubMed

Lee, Yongsook C; Kim, Yongbok; Huynh, Jason Wei-Yeong; Hamilton, Russell J

The aim of the study was to identify potential failure modes (FMs) having a high risk and to improve our current quality management (QM) program in Collaborative Ocular Melanoma Study (COMS) ocular brachytherapy by undertaking a failure modes and effects analysis (FMEA) and a fault tree analysis (FTA). Process mapping and FMEA were performed for COMS ocular brachytherapy. For all FMs identified in FMEA, risk priority numbers (RPNs) were determined by assigning and multiplying occurrence, severity, and lack of detectability values, each ranging from 1 to 10. FTA was performed for the major process that had the highest ranked FM. Twelve major processes, 121 sub-process steps, 188 potential FMs, and 209 possible causes were identified. For 188 FMs, RPN scores ranged from 1.0 to 236.1. The plaque assembly process had the highest ranked FM. The majority of FMs were attributable to human failure (85.6%), and medical physicist-related failures were the most numerous (58.9% of all causes). After FMEA, additional QM methods were included for the top 10 FMs and 6 FMs with severity values > 9.0. As a result, for these 16 FMs and the 5 major processes involved, quality control steps were increased from 8 (50%) to 15 (93.8%), and major processes having quality assurance steps were increased from 2 to 4. To reduce high risk in current clinical practice, we proposed QM methods. They mainly include a check or verification of procedures/steps and the use of checklists for both ophthalmology and radiation oncology staff, and intraoperative ultrasound-guided plaque positioning for ophthalmology staff. Copyright © 2017 American Brachytherapy Society. Published by Elsevier Inc. All rights reserved.

A process for assessing the feasibility of a network meta-analysis: a case study of everolimus in combination with hormonal therapy versus chemotherapy for advanced breast cancer.

PubMed

Cope, Shannon; Zhang, Jie; Saletan, Stephen; Smiechowski, Brielan; Jansen, Jeroen P; Schmid, Peter

2014-06-05

The aim of this study is to outline a general process for assessing the feasibility of performing a valid network meta-analysis (NMA) of randomized controlled trials (RCTs) to synthesize direct and indirect evidence for alternative treatments for a specific disease population. Several steps to assess the feasibility of an NMA are proposed based on existing recommendations. Next, a case study is used to illustrate this NMA feasibility assessment process in order to compare everolimus in combination with hormonal therapy to alternative chemotherapies in terms of progression-free survival for women with advanced breast cancer. A general process for assessing the feasibility of an NMA is outlined that incorporates explicit steps to visualize the heterogeneity in terms of treatment and outcome characteristics (Part A) as well as the study and patient characteristics (Part B). Additionally, steps are performed to illustrate differences within and across different types of direct comparisons in terms of baseline risk (Part C) and observed treatment effects (Part D) since there is a risk that the treatment effect modifiers identified may not explain the observed heterogeneity or inconsistency in the results due to unexpected, unreported or unmeasured differences. Depending on the data available, alternative approaches are suggested: list assumptions, perform a meta-regression analysis, subgroup analysis, sensitivity analyses, or summarize why an NMA is not feasible. The process outlined to assess the feasibility of an NMA provides a stepwise framework that will help to ensure that the underlying assumptions are systematically explored and that the risks (and benefits) of pooling and indirectly comparing treatment effects from RCTs for a particular research question are transparent.

Risk analysis of heat recovery steam generator with semi quantitative risk based inspection API 581

NASA Astrophysics Data System (ADS)

Prayogo, Galang Sandy; Haryadi, Gunawan Dwi; Ismail, Rifky; Kim, Seon Jin

2016-04-01

Corrosion is a major problem that most often occurs in the power plant. Heat recovery steam generator (HRSG) is an equipment that has a high risk to the power plant. The impact of corrosion damage causing HRSG power plant stops operating. Furthermore, it could be threaten the safety of employees. The Risk Based Inspection (RBI) guidelines by the American Petroleum Institute (API) 58 has been used to risk analysis in the HRSG 1. By using this methodology, the risk that caused by unexpected failure as a function of the probability and consequence of failure can be estimated. This paper presented a case study relating to the risk analysis in the HRSG, starting with a summary of the basic principles and procedures of risk assessment and applying corrosion RBI for process industries. The risk level of each HRSG equipment were analyzed: HP superheater has a medium high risk (4C), HP evaporator has a medium-high risk (4C), and the HP economizer has a medium risk (3C). The results of the risk assessment using semi-quantitative method of standard API 581 based on the existing equipment at medium risk. In the fact, there is no critical problem in the equipment components. Damage mechanisms were prominent throughout the equipment is thinning mechanism. The evaluation of the risk approach was done with the aim of reducing risk by optimizing the risk assessment activities.

L-Band Digital Aeronautical Communications System Engineering - Initial Safety and Security Risk Assessment and Mitigation

NASA Technical Reports Server (NTRS)

Zelkin, Natalie; Henriksen, Stephen

2011-01-01

This document is being provided as part of ITT's NASA Glenn Research Center Aerospace Communication Systems Technical Support (ACSTS) contract NNC05CA85C, Task 7: "New ATM Requirements--Future Communications, C-Band and L-Band Communications Standard Development." ITT has completed a safety hazard analysis providing a preliminary safety assessment for the proposed L-band (960 to 1164 MHz) terrestrial en route communications system. The assessment was performed following the guidelines outlined in the Federal Aviation Administration Safety Risk Management Guidance for System Acquisitions document. The safety analysis did not identify any hazards with an unacceptable risk, though a number of hazards with a medium risk were documented. This effort represents a preliminary safety hazard analysis and notes the triggers for risk reassessment. A detailed safety hazards analysis is recommended as a follow-on activity to assess particular components of the L-band communication system after the technology is chosen and system rollout timing is determined. The security risk analysis resulted in identifying main security threats to the proposed system as well as noting additional threats recommended for a future security analysis conducted at a later stage in the system development process. The document discusses various security controls, including those suggested in the COCR Version 2.0.

Developing smartphone apps for behavioural studies: The AlcoRisk app case study.

PubMed

Smith, Anthony; de Salas, Kristy; Lewis, Ian; Schüz, Benjamin

2017-08-01

Smartphone apps have emerged as valuable research tools to sample human behaviours at their time of occurrence within natural environments. Human behaviour sampling methods, such as Ecological Momentary Assessment (EMA), aim to facilitate research that is situated in ecologically valid real world environments rather than laboratory environments. Researchers have trialled a range of EMA smartphone apps to sample human behaviours such as dieting, physical activity and smoking. Software development processes for EMA smartphones apps, however, are not widely documented with little guidance provided for the integration of complex multidisciplinary behavioural and technical fields. In this paper, the AlcoRisk app for studying alcohol consumption and risk taking tendencies is presented alongside a software development process that integrates these multidisciplinary fields. The software development process consists of three stages including requirements analysis, feature and interface design followed by app implementation. Results from a preliminary feasibility study support the efficacy of the AlcoRisk app's software development process. Copyright © 2017 Elsevier Inc. All rights reserved.

Enhancing Safety of Artificially Ventilated Patients Using Ambient Process Analysis.

PubMed

Lins, Christian; Gerka, Alexander; Lüpkes, Christian; Röhrig, Rainer; Hein, Andreas

2018-01-01

In this paper, we present an approach for enhancing the safety of artificially ventilated patients using ambient process analysis. We propose to use an analysis system consisting of low-cost ambient sensors such as power sensor, RGB-D sensor, passage detector, and matrix infrared temperature sensor to reduce risks for artificially ventilated patients in both home and clinical environments. We describe the system concept and our implementation and show how the system can contribute to patient safety.

Risk seeking for losses modulates the functional connectivity of the default mode and left frontoparietal networks in young males.

PubMed

Deza Araujo, Yacila I; Nebe, Stephan; Neukam, Philipp T; Pooseh, Shakoor; Sebold, Miriam; Garbusow, Maria; Heinz, Andreas; Smolka, Michael N

2018-06-01

Value-based decision making (VBDM) is a principle that states that humans and other species adapt their behavior according to the dynamic subjective values of the chosen or unchosen options. The neural bases of this process have been extensively investigated using task-based fMRI and lesion studies. However, the growing field of resting-state functional connectivity (RSFC) may shed light on the organization and function of brain connections across different decision-making domains. With this aim, we used independent component analysis to study the brain network dynamics in a large cohort of young males (N = 145) and the relationship of these dynamics with VBDM. Participants completed a battery of behavioral tests that evaluated delay aversion, risk seeking for losses, risk aversion for gains, and loss aversion, followed by an RSFC scan session. We identified a set of large-scale brain networks and conducted our analysis only on the default mode network (DMN) and networks comprising cognitive control, appetitive-driven, and reward-processing regions. Higher risk seeking for losses was associated with increased connectivity between medial temporal regions, frontal regions, and the DMN. Higher risk seeking for losses was also associated with increased coupling between the left frontoparietal network and occipital cortices. These associations illustrate the participation of brain regions involved in prospective thinking, affective decision making, and visual processing in participants who are greater risk-seekers, and they demonstrate the sensitivity of RSFC to detect brain connectivity differences associated with distinct VBDM parameters.

Risk analysis of a biomass combustion process using MOSAR and FMEA methods.

PubMed

Thivel, P-X; Bultel, Y; Delpech, F

2008-02-28

Thermal and chemical conversion processes that convert in energy the sewage sludge, pasty waste and other pre-processed waste are increasingly common, for economic and ecological reasons. Fluidized bed combustion is currently one of the most promising methods of energy conversion, since it burns biomass very efficiently, and produces only very small quantities of sulphur and nitrogen oxides. The hazards associated with biomass combustion processes are fire, explosion and poisoning from the combustion gases (CO, etc.). The risk analysis presented in this paper uses the MADS-MOSAR methodology, applied to a semi-industrial pilot scheme comprising a fluidization column, a conventional cyclone, two natural gas burners and a continuous supply of biomass. The methodology uses a generic approach, with an initial macroscopic stage where hazard sources are identified, scenarios for undesired events are recognized and ranked using a grid of SeverityxProbability and safety barriers suggested. A microscopic stage then analyzes in detail the major risks identified during the first stage. This analysis may use various different tools, such as HAZOP, FMEA, etc.: our analysis is based on FMEA. Using MOSAR, we were able to identify five subsystems: the reactor (fluidized bed and centrifuge), the fuel and biomass supply lines, the operator and the environment. When we drew up scenarios based on these subsystems, we found that malfunction of the gas supply burners was a common trigger in many scenarios. Our subsequent microscopic analysis, therefore, focused on the burners, looking at the ways they failed, and at the effects and criticality of those failures (FMEA). We were, thus, able to identify a number of critical factors such as the incoming gas lines and the ignition electrode.

Mission safety evaluation report for STS-35: Postflight edition

NASA Technical Reports Server (NTRS)

Hill, William C.; Finkel, Seymour I.

1991-01-01

Space Transportation System 35 (STS-35) safety risk factors that represent a change from previous flights that had an impact on this flight, and factors that were unique to this flight are discussed. While some changes to the safety risk baseline since the previous flight are included to highlight their significance in risk level change, the primary purpose is to insure that changes which were too late too include in formal changes through the Failure Modes and Effects Analysis/Critical Items List (FMEA/CIL) and Hazard Analysis process are documented along with the safety position, which includes the acceptance rationale.

Risk/Requirements Trade-off Guidelines for Low Cost Satellite Systems

NASA Technical Reports Server (NTRS)

Cornford, Steven L.; Man, Kin F.

1996-01-01

The accelerating trend toward faster, better, cheaper missions places increasing emphasis on the trade-offs between requirements and risk to reduce cost and development times, while still improving quality and reliability. The Risk/Requirement Trade-off Guidelines discussed in this paper are part of an integrated approach to address the main issues by focusing on the sum of prevention, analysis, control, or test (PACT) processes.

Failure mode and effects analysis based risk profile assessment for stereotactic radiosurgery programs at three cancer centers in Brazil.

PubMed

Teixeira, Flavia C; de Almeida, Carlos E; Saiful Huq, M

2016-01-01

The goal of this study was to evaluate the safety and quality management program for stereotactic radiosurgery (SRS) treatment processes at three radiotherapy centers in Brazil by using three industrial engineering tools (1) process mapping, (2) failure modes and effects analysis (FMEA), and (3) fault tree analysis. The recommendations of Task Group 100 of American Association of Physicists in Medicine were followed to apply the three tools described above to create a process tree for SRS procedure for each radiotherapy center and then FMEA was performed. Failure modes were identified for all process steps and values of risk priority number (RPN) were calculated from O, S, and D (RPN = O × S × D) values assigned by a professional team responsible for patient care. The subprocess treatment planning was presented with the highest number of failure modes for all centers. The total number of failure modes were 135, 104, and 131 for centers I, II, and III, respectively. The highest RPN value for each center is as follows: center I (204), center II (372), and center III (370). Failure modes with RPN ≥ 100: center I (22), center II (115), and center III (110). Failure modes characterized by S ≥ 7, represented 68% of the failure modes for center III, 62% for center II, and 45% for center I. Failure modes with RPNs values ≥100 and S ≥ 7, D ≥ 5, and O ≥ 5 were considered as high priority in this study. The results of the present study show that the safety risk profiles for the same stereotactic radiotherapy process are different at three radiotherapy centers in Brazil. Although this is the same treatment process, this present study showed that the risk priority is different and it will lead to implementation of different safety interventions among the centers. Therefore, the current practice of applying universal device-centric QA is not adequate to address all possible failures in clinical processes at different radiotherapy centers. Integrated approaches to device-centric and process specific quality management program specific to each radiotherapy center are the key to a safe quality management program.

Quality Interaction Between Mission Assurance and Project Team Members

NASA Technical Reports Server (NTRS)

Kwong-Fu, Helenann H.; Wilson, Robert K.

2006-01-01

Mission Assurance independent assessments started during the development cycle and continued through post launch operations. In operations, Health and Safety of the Observatory is of utmost importance. Therefore, Mission Assurance must ensure requirements compliance and focus on process improvements required across the operational systems including new/modified products, tools, and procedures. The deployment of the interactive model involves three objectives: Team member Interaction, Good Root Cause Analysis Practices, and Risk Assessment to avoid reoccurrences. In applying this model, we use a metric based measurement process and was found to have the most significant effect, which points to the importance of focuses on a combination of root cause analysis and risk approaches allowing the engineers the ability to prioritize and quantify their corrective actions based on a well-defined set of root cause definitions (i.e. closure criteria for problem reports), success criteria and risk rating definitions.

Consumption of ultra-processed foods and cancer risk: results from NutriNet-Santé prospective cohort

PubMed Central

Fiolet, Thibault; Sellem, Laury; Kesse-Guyot, Emmanuelle; Allès, Benjamin; Méjean, Caroline; Deschasaux, Mélanie; Fassier, Philippine; Latino-Martel, Paule; Beslay, Marie; Hercberg, Serge; Lavalette, Céline; Monteiro, Carlos A; Julia, Chantal; Touvier, Mathilde

2018-01-01

Abstract Objective To assess the prospective associations between consumption of ultra-processed food and risk of cancer. Design Population based cohort study. Setting and participants 104 980 participants aged at least 18 years (median age 42.8 years) from the French NutriNet-Santé cohort (2009-17). Dietary intakes were collected using repeated 24 hour dietary records, designed to register participants’ usual consumption for 3300 different food items. These were categorised according to their degree of processing by the NOVA classification. Main outcome measures Associations between ultra-processed food intake and risk of overall, breast, prostate, and colorectal cancer assessed by multivariable Cox proportional hazard models adjusted for known risk factors. Results Ultra-processed food intake was associated with higher overall cancer risk (n=2228 cases; hazard ratio for a 10% increment in the proportion of ultra-processed food in the diet 1.12 (95% confidence interval 1.06 to 1.18); P for trend<0.001) and breast cancer risk (n=739 cases; hazard ratio 1.11 (1.02 to 1.22); P for trend=0.02). These results remained statistically significant after adjustment for several markers of the nutritional quality of the diet (lipid, sodium, and carbohydrate intakes and/or a Western pattern derived by principal component analysis). Conclusions In this large prospective study, a 10% increase in the proportion of ultra-processed foods in the diet was associated with a significant increase of greater than 10% in risks of overall and breast cancer. Further studies are needed to better understand the relative effect of the various dimensions of processing (nutritional composition, food additives, contact materials, and neoformed contaminants) in these associations. Study registration Clinicaltrials.gov NCT03335644. PMID:29444771

Application of a generic bow-tie based risk analysis framework on risk management of sea ports and offshore terminals.

PubMed

Mokhtari, Kambiz; Ren, Jun; Roberts, Charles; Wang, Jin

2011-08-30

Ports and offshore terminals are critical infrastructure resources and play key roles in the transportation of goods and people. With more than 80 percent of international trade by volume being carried out by sea, ports and offshore terminals are vital for seaborne trade and international commerce. Furthermore in today's uncertain and complex environment there is a need to analyse the participated risk factors in order to prioritise protective measures in these critically logistics infrastructures. As a result of this study is carried out to support the risk assessment phase of the proposed Risk Management (RM) framework used for the purpose of sea ports and offshore terminals operations and management (PTOM). This has been fulfilled by integration of a generic bow-tie based risk analysis framework into the risk assessment phase as a backbone of the phase. For this reason Fault Tree Analysis (FTA) and Event Tree Analysis (ETA) are used to analyse the risk factors associated within the PTOM. This process will eventually help the port professionals and port risk managers to investigate the identified risk factors more in detail. In order to deal with vagueness of the data Fuzzy Set Theory (FST) and possibility approach are used to overcome the disadvantages of the conventional probability based approaches. Copyright © 2011 Elsevier B.V. All rights reserved.

Comparing decision making between cancer patients and the general population: thoughts, emotions, or social influence?

PubMed

Yang, Z Janet; McComas, Katherine A; Gay, Geri K; Leonard, John P; Dannenberg, Andrew J; Dillon, Hildy

2012-01-01

This study extends a risk information seeking and processing model to explore the relative effect of cognitive processing strategies, positive and negative emotions, and normative beliefs on individuals' decision making about potential health risks. Most previous research based on this theoretical framework has examined environmental risks. Applying this risk communication model to study health decision making presents an opportunity to explore theoretical boundaries of the model, while also bringing this research to bear on a pressing medical issue: low enrollment in clinical trials. Comparative analysis of data gathered from 2 telephone surveys of a representative national sample (n = 500) and a random sample of cancer patients (n = 411) indicated that emotions played a more substantive role in cancer patients' decisions to enroll in a potential trial, whereas cognitive processing strategies and normative beliefs had greater influences on the decisions of respondents from the national sample.

Disappearance of six pesticides in fresh and processed zucchini, bioavailability and health risk assessment.

PubMed

Oliva, J; Cermeño, S; Cámara, M A; Martínez, G; Barba, A

2017-08-15

A field study was carried out on the dissipation of three insecticides and three fungicides during the freezing of zucchini. A simultaneous residue analysis method is validated using QuEChERS extraction with acetonitrile and CG-MS and LC-MS analysis. The residues detected after field application never exceeded the established maximum residue limits. The processing factors calculated (fresh product/frozen product) are lower than 1, indicating a clear influence of the stages of the freezing process, especially the washing and blanching. The in vitro study of bioavailability establishes a low percentage of stomach absorption capacity. The level of residues detected in fresh zucchini and the Estimated Daily Intake calculated for Spain suggest that there is no risk of acute toxicity due to dietary exposure. Copyright © 2017 Elsevier Ltd. All rights reserved.

Risk-based audit selection of dairy farms.

PubMed

van Asseldonk, M A P M; Velthuis, A G J

2014-02-01

Dairy farms are audited in the Netherlands on numerous process standards. Each farm is audited once every 2 years. Increasing demands for cost-effectiveness in farm audits can be met by introducing risk-based principles. This implies targeting subpopulations with a higher risk of poor process standards. To select farms for an audit that present higher risks, a statistical analysis was conducted to test the relationship between the outcome of farm audits and bulk milk laboratory results before the audit. The analysis comprised 28,358 farm audits and all conducted laboratory tests of bulk milk samples 12 mo before the audit. The overall outcome of each farm audit was classified as approved or rejected. Laboratory results included somatic cell count (SCC), total bacterial count (TBC), antimicrobial drug residues (ADR), level of butyric acid spores (BAB), freezing point depression (FPD), level of free fatty acids (FFA), and cleanliness of the milk (CLN). The bulk milk laboratory results were significantly related to audit outcomes. Rejected audits are likely to occur on dairy farms with higher mean levels of SCC, TBC, ADR, and BAB. Moreover, in a multivariable model, maxima for TBC, SCC, and FPD as well as standard deviations for TBC and FPD are risk factors for negative audit outcomes. The efficiency curve of a risk-based selection approach, on the basis of the derived regression results, dominated the current random selection approach. To capture 25, 50, or 75% of the population with poor process standards (i.e., audit outcome of rejected), respectively, only 8, 20, or 47% of the population had to be sampled based on a risk-based selection approach. Milk quality information can thus be used to preselect high-risk farms to be audited more frequently. Copyright © 2014 American Dairy Science Association. Published by Elsevier Inc. All rights reserved.

The role of Indigenous knowledge in environmental health risk management in Yukon, Canada

PubMed Central

Friendship, Katelyn A.; Furgal, Chris M.

2012-01-01

Objectives This project aimed to gain better understandings of northern Indigenous risk perception related to food safety and to identify the role that Indigenous knowledge (IK) plays in risk management processes to support more effective and culturally relevant benefit-risk (B-R) management strategies. Study design The project used an exploratory qualitative case study design to investigate the role and place of IK in the management of environmental contaminants exposure via consumption of traditional foods in Yukon First Nations (YFNs). Methods Forty-one semi-directive interviews with Traditional Food Knowledge Holders and Health and Environment Decision-makers were conducted. A review and analysis of organizational documents related to past risk management events for the issue was conducted. Thematic content analysis was used to analyze transcripts and documents for key themes related to the research question. Results There was a recognized need by all participants for better collaboration between scientists and YFN communities. YFNs have been involved in identifying and defining community concerns about past risk issues, setting a local context, and participating in communications strategies. Interviewees stressed the need to commit adequate time for building relationships, physically being in the community, and facilitating open communication. Conducting community-based projects was identified as critical for collaboration and for cooperative learning and management of these issues. Conclusions The perception of “effective” benefit-risk management is significantly influenced by the efforts made to include local communities in the process. A set of common guiding principles within a process that brings together people and knowledge systems may provide a more effective way forward in cross-cultural, multiple knowledge system contexts for complex benefit-risk issues than a prescriptive rigid framework. PMID:22868192

Risks with older adults in acute care settings: UK occupational therapists' and physiotherapists' perceptions of risks associated with discharge and professional practice.

PubMed

Atwal, Anita; McIntyre, Anne; Wiggett, Claire

2012-06-01

Internationally, there is evidence that hospital discharge to home for older adults is a complex and challenging process that is dependent upon multidisciplinary team working. At the centre of the discharge process is the management of risk, which involves occupational therapists and other healthcare professionals managing perceived dangers and determining why some dangers are seen as presenting risks while others are not. This study did not aim to explore interprofessional differences but to ascertain a greater understanding of professionals' perceptions of risk in acute care settings. This qualitative study utilised 12 semi-structured interviews with seven occupational therapists and five physiotherapists in the United Kingdom (UK). During the interview, therapists were asked to read and answer questions on a validated vignette. The interview data were subjected to thematic content analysis and the vignettes to template analysis. Our research is one of the first studies to explore therapists' perceptions of risk with older adults in acute care settings. Our study has highlighted that perception of risk does have an impact on discharge decision-making and location. Therapists used negative terminology to refer to patients who wanted to take risks, which could be a reflection of the therapists' anxiety. Mental capacity, and patients' functioning and safety were key factors in risk decision-making with older adults. Our research has highlighted the potential value of multidisciplinary working to manage risk situations and the need for reflection and discussion regarding how persons who do not have capacity wishes are managed within acute care settings. There is a need to develop an interprofessional care pathway to guide clinicians through the risk decision-making process which needs to ensure that the client's opinions and wishes are taken into account throughout. © 2011 The Authors. Scandinavian Journal of Caring Sciences © 2011 Nordic College of Caring Science.

Managing IT service management implementation complexity: from the perspective of the Warfield Version of systems science

NASA Astrophysics Data System (ADS)

Wan, Jiangping; Jones, James D.

2013-11-01

The Warfield version of systems science supports a wide variety of application areas, and is useful to practitioners who use the work program of complexity (WPOC) tool. In this article, WPOC is applied to information technology service management (ITSM) for managing the complexity of projects. In discussing the application of WPOC to ITSM, we discuss several steps of WPOC. The discovery step of WPOC consists of a description process and a diagnosis process. During the description process, 52 risk factors are identified, which are then narrowed to 20 key risk factors. All of this is done by interviews and surveys. Root risk factors (the most basic risk factors) consist of 11 kinds of common 'mindbugs' which are selected from an interpretive structural model. This is achieved by empirical analysis of 25 kinds of mindbugs. (A lesser aim of this research is to affirm that these mindbugs developed from a Western mindset have corresponding relevance in a completely different culture: the Peoples Republic of China.) During the diagnosis process, the relationships among the root risk factors in the implementation of the ITSM project are identified. The resolution step of WPOC consists of a design process and an implementation process. During the design process, issues related to the ITSM application are compared to both e-Government operation and maintenance, and software process improvement. The ITSM knowledge support structure is also designed at this time. During the implementation process, 10 keys to the successful implementation of ITSM projects are identified.

Assessing secondary soil salinization risk based on the PSR sustainability framework.

PubMed

Zhou, De; Lin, Zhulu; Liu, Liming; Zimmermann, David

2013-10-15

Risk assessment of secondary soil salinization, which is caused in part by the way people manage the land, is an essential challenge to agricultural sustainability. The objective of our study was to develop a soil salinity risk assessment methodology by selecting a consistent set of risk factors based on the conceptual Pressure-State-Response (PSR) sustainability framework and incorporating the grey relational analysis and the Analytic Hierarchy Process methods. The proposed salinity risk assessment methodology was demonstrated through a case study of developing composite risk index maps for the Yinchuan Plain, a major irrigation agriculture district in northwest China. Fourteen risk factors were selected in terms of the three PSR criteria: pressure, state, and response. The results showed that the salinity risk in the Yinchuan Plain was strongly influenced by the subsoil and groundwater salinity, land use, distance to irrigation canals, and depth to groundwater. To maintain agricultural sustainability in the Yinchuan Plain, a suite of remedial and preventative actions were proposed to manage soil salinity risk in the regions that are affected by salinity at different levels and by different salinization processes. The weight sensitivity analysis results also showed that the overall salinity risk of the Yinchuan Plain would increase or decrease as the weights for pressure or response risk factors increased, signifying the importance of human activities on secondary soil salinization. Ideally, the proposed methodology will help us develop more consistent management tools for risk assessment and management and for control of secondary soil salinization. Copyright © 2013 Elsevier Ltd. All rights reserved.

Perceived risks around choice and decision making at end-of-life: a literature review.

PubMed

Wilson, F; Gott, M; Ingleton, C

2013-01-01

the World Health Organization identifies meeting patient choice for care as central to effective palliative care delivery. Little is known about how choice, which implies an objective balancing of options and risks, is understood and enacted through decision making at end-of-life. to explore how perceptions of 'risk' may inform decision-making processes at end-of-life. an integrative literature review was conducted between January and February 2010. Papers were reviewed using Hawker et al.'s criteria and evaluated according to clarity of methods, analysis and evidence of ethical consideration. All literature was retained as background data, but given the significant international heterogeneity the final analysis specifically focused on the UK context. the databases Medline, PsycINFO, Assia, British Nursing Index, High Wire Press and CINAHL were explored using the search terms decision*, risk, anxiety, hospice and palliative care, end-of-life care and publication date of 1998-2010. thematic analysis of 25 papers suggests that decision making at end-of-life is multifactorial, involving a balancing of risks related to caregiver support; service provider resources; health inequalities and access; challenges to information giving; and perceptions of self-identity. Overall there is a dissonance in understandings of choice and decision making between service providers and service users. the concept of risk acknowledges the factors that shape and constrain end-of-life choices. Recognition of perceived risks as a central factor in decision making would be of value in acknowledging and supporting meaningful decision making processes for patients with palliative care needs and their families.

New risk metrics and mathematical tools for risk analysis: Current and future challenges

DOE Office of Scientific and Technical Information (OSTI.GOV)

Skandamis, Panagiotis N., E-mail: pskan@aua.gr; Andritsos, Nikolaos, E-mail: pskan@aua.gr; Psomas, Antonios, E-mail: pskan@aua.gr

The current status of the food safety supply world wide, has led Food and Agriculture Organization (FAO) and World Health Organization (WHO) to establishing Risk Analysis as the single framework for building food safety control programs. A series of guidelines and reports that detail out the various steps in Risk Analysis, namely Risk Management, Risk Assessment and Risk Communication is available. The Risk Analysis approach enables integration between operational food management systems, such as Hazard Analysis Critical Control Points, public health and governmental decisions. To do that, a series of new Risk Metrics has been established as follows: i) themore » Appropriate Level of Protection (ALOP), which indicates the maximum numbers of illnesses in a population per annum, defined by quantitative risk assessments, and used to establish; ii) Food Safety Objective (FSO), which sets the maximum frequency and/or concentration of a hazard in a food at the time of consumption that provides or contributes to the ALOP. Given that ALOP is rather a metric of the public health tolerable burden (it addresses the total ‘failure’ that may be handled at a national level), it is difficult to be interpreted into control measures applied at the manufacturing level. Thus, a series of specific objectives and criteria for performance of individual processes and products have been established, all of them assisting in the achievement of FSO and hence, ALOP. In order to achieve FSO, tools quantifying the effect of processes and intrinsic properties of foods on survival and growth of pathogens are essential. In this context, predictive microbiology and risk assessment have offered an important assistance to Food Safety Management. Predictive modelling is the basis of exposure assessment and the development of stochastic and kinetic models, which are also available in the form of Web-based applications, e.g., COMBASE and Microbial Responses Viewer), or introduced into user-friendly softwares, (e.g., Seafood Spoilage Predictor) have evolved the use of information systems in the food safety management. Such tools are updateable with new food-pathogen specific models containing cardinal parameters and multiple dependent variables, including plate counts, concentration of metabolic products, or even expression levels of certain genes. Then, these tools may further serve as decision-support tools which may assist in product logistics, based on their scientifically-based and “momentary” expressed spoilage and safety level.« less

New risk metrics and mathematical tools for risk analysis: Current and future challenges

NASA Astrophysics Data System (ADS)

Skandamis, Panagiotis N.; Andritsos, Nikolaos; Psomas, Antonios; Paramythiotis, Spyridon

2015-01-01

The current status of the food safety supply world wide, has led Food and Agriculture Organization (FAO) and World Health Organization (WHO) to establishing Risk Analysis as the single framework for building food safety control programs. A series of guidelines and reports that detail out the various steps in Risk Analysis, namely Risk Management, Risk Assessment and Risk Communication is available. The Risk Analysis approach enables integration between operational food management systems, such as Hazard Analysis Critical Control Points, public health and governmental decisions. To do that, a series of new Risk Metrics has been established as follows: i) the Appropriate Level of Protection (ALOP), which indicates the maximum numbers of illnesses in a population per annum, defined by quantitative risk assessments, and used to establish; ii) Food Safety Objective (FSO), which sets the maximum frequency and/or concentration of a hazard in a food at the time of consumption that provides or contributes to the ALOP. Given that ALOP is rather a metric of the public health tolerable burden (it addresses the total `failure' that may be handled at a national level), it is difficult to be interpreted into control measures applied at the manufacturing level. Thus, a series of specific objectives and criteria for performance of individual processes and products have been established, all of them assisting in the achievement of FSO and hence, ALOP. In order to achieve FSO, tools quantifying the effect of processes and intrinsic properties of foods on survival and growth of pathogens are essential. In this context, predictive microbiology and risk assessment have offered an important assistance to Food Safety Management. Predictive modelling is the basis of exposure assessment and the development of stochastic and kinetic models, which are also available in the form of Web-based applications, e.g., COMBASE and Microbial Responses Viewer), or introduced into user-friendly softwares, (e.g., Seafood Spoilage Predictor) have evolved the use of information systems in the food safety management. Such tools are updateable with new food-pathogen specific models containing cardinal parameters and multiple dependent variables, including plate counts, concentration of metabolic products, or even expression levels of certain genes. Then, these tools may further serve as decision-support tools which may assist in product logistics, based on their scientifically-based and "momentary" expressed spoilage and safety level.

Evaluation of risk and benefit in thermal effusivity sensor for monitoring lubrication process in pharmaceutical product manufacturing.

PubMed

Uchiyama, Jumpei; Kato, Yoshiteru; Uemoto, Yoshifumi

2014-08-01

In the process design of tablet manufacturing, understanding and control of the lubrication process is important from various viewpoints. A detailed analysis of thermal effusivity data in the lubrication process was conducted in this study. In addition, we evaluated the risk and benefit in the lubrication process by a detailed investigation. It was found that monitoring of thermal effusivity detected mainly the physical change of bulk density, which was changed by dispersal of the lubricant and the coating powder particle by the lubricant. The monitoring of thermal effusivity was almost the monitoring of bulk density, thermal effusivity could have a high correlation with tablet hardness. Moreover, as thermal effusivity sensor could detect not only the change of the conventional bulk density but also the fractional change of thermal conductivity and thermal capacity, two-phase progress of lubrication process could be revealed. However, each contribution of density, thermal conductivity, or heat capacity to thermal effusivity has the risk of fluctuation by formulation. After carefully considering the change factor with the risk to be changed by formulation, thermal effusivity sensor can be a useful tool for monitoring as process analytical technology, estimating tablet hardness and investigating the detailed mechanism of the lubrication process.

Analysing the external supply chain risk driver competitiveness: a risk mitigation framework and business continuity plan.

PubMed

Blos, Mauricio F; Wee, Hui-Ming; Yang, Joshua

2010-11-01

Innovation challenges for handling supply chain risks have become one of the most important drivers in business competitiveness and differentiation. This study analyses competitiveness at the external supply chain level as a driver of risks and provides a framework for mitigating these risks. The mitigation framework, also called the supply chain continuity framework, provides insight into six stages of the business continuity planning (BCP) process life cycle (risk mitigation management, business impact analysis, supply continuity strategy development, supply continuity plan development, supply continuity plan testing and supply continuity plan maintenance), together with the operational constructs: customer service, inventory management, flexibility, time to market, ordering cycle time and quality. The purpose of the BCP process life cycle and operational constructs working together is to emphasise the way in which a supply chain can deal with disruption risks and, consequently, bring competitive advantage. Future research will consider the new risk scenarios and analyse the consequences to promote the improvement of supply chain resilience.

Role of scientific data in health decisions.

PubMed Central

Samuels, S W

1979-01-01

The distinction between reality and models or methodological assumptions is necessary for an understanding of the use of data--economic, technical or biological--in decision-making. The traditional modes of analysis used in decisions are discussed historically and analytically. Utilitarian-based concepts such as cost-benefit analysis and cannibalistic concepts such as "acceptable risk" are rejected on logical and moral grounds. Historical reality suggests the concept of socially necessary risk determined through the dialectic process in democracy. PMID:120251

The role of risk-based prioritization in total quality management

DOE Office of Scientific and Technical Information (OSTI.GOV)

Bennett, C.T.

1994-10-01

The climate in which government managers must make decisions grows more complex and uncertain. All stakeholders - the public, industry, and Congress - are demanding greater consciousness, responsibility, and accountability of programs and their budgets. Yet, managerial decisions have become multifaceted, involve greater risk, and operate over much longer time periods. Over the last four or five decades, as policy analysis and decisions became more complex, scientists from psychology, operations research, systems science, and economics have developed a more or less coherent process called decision analysis to aid program management. The process of decision analysis - a systems theoretic approachmore » - provides the backdrop for this paper. The Laboratory Integrated Prioritization System (LIPS) has been developed as a systems analytic and risk-based prioritization tool to aid the management of the Tri-Labs` (Lawrence Livermore, Los Alamos, and Sandia) operating resources. Preliminary analyses of the effects of LIPS has confirmed the practical benefits of decision and systems sciences - the systematic, quantitative reduction in uncertainty. To date, the use of LIPS - and, hence, its value - has been restricted to resource allocation within the Tri-Labs` operations budgets. This report extends the role of risk-based prioritization to the support of DOE Total Quality Management (TQM) programs. Furthermore, this paper will argue for the requirement to institutionalize an evolutionary, decision theoretic approach to the policy analysis of the Department of Energy`s Program Budget.« less

Groundwater chemistry and human health risk assessment in the mining region of East Singhbhum, Jharkhand, India.

PubMed

Singh, Umesh Kumar; Ramanathan, A L; Subramanian, V

2018-08-01

Groundwater chemistry of mining region of East Singhbhum district having complex contaminant sources were investigated based on heavy metals loads and other hydrochemical constituents. This study aimed to identify the degree of heavy metals exposure and their potential health risk to local population. The results of hydrochemical analysis showed that Na + , K + , and Ca 2+ ions are the dominant cations in the groundwater, while HCO 3 - , F - and Cl - ions dominate the anionic part of the groundwater. The weathering process was considered the dominant factor to determine the major ionic composition in the study area. Compositional analysis for heavy metal has identified that groundwater of the study area is contaminated by Cd, Pb and Cr elements. Source of these metals have been identified as an anthropogenic inputs from mining activities and mineral processing units. Health risk analysis of individual heavy metal for chronic daily intake (CDI) and hazard quotient (HQ) was found in the order of Cr > As > Cd > Pb which is indicating high health risk for the population. In addition, Hazard Index (HI) analysis for heavy metals was found significantly high (>1) which is considered as a threat for human population because they have the tendency to accumulate in the body and cause variety of diseases like kidney problem, dysfunction of liver and renal cortex as well as cancer. Copyright © 2018 Elsevier Ltd. All rights reserved.

Imagining flood futures: risk assessment and management in practice.

PubMed

Lane, Stuart N; Landström, Catharina; Whatmore, Sarah J

2011-05-13

The mantra that policy and management should be 'evidence-based' is well established. Less so are the implications that follow from 'evidence' being predictions of the future (forecasts, scenarios, horizons) even though such futures define the actions taken today to make the future sustainable. Here, we consider the tension between 'evidence', reliable because it is observed, and predictions of the future, unobservable in conventional terms. For flood risk management in England and Wales, we show that futures are actively constituted, and so imagined, through 'suites of practices' entwining policy, management and scientific analysis. Management has to constrain analysis because of the many ways in which flood futures can be constructed, but also because of commitment to an accounting calculus, which requires risk to be expressed in monetary terms. It is grounded in numerical simulation, undertaken by scientific consultants who follow policy/management guidelines that define the futures to be considered. Historical evidence is needed to deal with process and parameter uncertainties and the futures imagined are tied to pasts experienced. Reliance on past events is a challenge for prediction, given changing probability (e.g. climate change) and consequence (e.g. development on floodplains). So, risk management allows some elements of risk analysis to become unstable (notably in relation to climate change) but forces others to remain stable (e.g. invoking regulation to prevent inappropriate floodplain development). We conclude that the assumed separation of risk assessment and management is false because the risk calculation has to be defined by management. Making this process accountable requires openness about the procedures that make flood risk analysis more (or less) reliable to those we entrust to produce and act upon them such that, unlike the 'pseudosciences', they can be put to the test of public interrogation by those who have to live with their consequences. © 2011 Royal Society

Applying machine learning to pattern analysis for automated in-design layout optimization

NASA Astrophysics Data System (ADS)

Cain, Jason P.; Fakhry, Moutaz; Pathak, Piyush; Sweis, Jason; Gennari, Frank; Lai, Ya-Chieh

2018-04-01

Building on previous work for cataloging unique topological patterns in an integrated circuit physical design, a new process is defined in which a risk scoring methodology is used to rank patterns based on manufacturing risk. Patterns with high risk are then mapped to functionally equivalent patterns with lower risk. The higher risk patterns are then replaced in the design with their lower risk equivalents. The pattern selection and replacement is fully automated and suitable for use for full-chip designs. Results from 14nm product designs show that the approach can identify and replace risk patterns with quantifiable positive impact on the risk score distribution after replacement.

Red meat consumption and risk of type 2 diabetes: 3 cohorts of US adults and an updated meta-analysis123

PubMed Central

Pan, An; Sun, Qi; Bernstein, Adam M; Schulze, Matthias B; Manson, JoAnn E; Willett, Walter C

2011-01-01

Background: The relation between consumption of different types of red meats and risk of type 2 diabetes (T2D) remains uncertain. Objective: We evaluated the association between unprocessed and processed red meat consumption and incident T2D in US adults. Design: We followed 37,083 men in the Health Professionals Follow-Up Study (1986–2006), 79,570 women in the Nurses’ Health Study I (1980–2008), and 87,504 women in the Nurses’ Health Study II (1991–2005). Diet was assessed by validated food-frequency questionnaires, and data were updated every 4 y. Incident T2D was confirmed by a validated supplementary questionnaire. Results: During 4,033,322 person-years of follow-up, we documented 13,759 incident T2D cases. After adjustment for age, BMI, and other lifestyle and dietary risk factors, both unprocessed and processed red meat intakes were positively associated with T2D risk in each cohort (all P-trend <0.001). The pooled HRs (95% CIs) for a one serving/d increase in unprocessed, processed, and total red meat consumption were 1.12 (1.08, 1.16), 1.32 (1.25, 1.40), and 1.14 (1.10, 1.18), respectively. The results were confirmed by a meta-analysis (442,101 participants and 28,228 diabetes cases): the RRs (95% CIs) were 1.19 (1.04, 1.37) and 1.51 (1.25, 1.83) for 100 g unprocessed red meat/d and for 50 g processed red meat/d, respectively. We estimated that substitutions of one serving of nuts, low-fat dairy, and whole grains per day for one serving of red meat per day were associated with a 16–35% lower risk of T2D. Conclusion: Our results suggest that red meat consumption, particularly processed red meat, is associated with an increased risk of T2D. PMID:21831992

Red meat consumption and risk of type 2 diabetes: 3 cohorts of US adults and an updated meta-analysis.

PubMed

Pan, An; Sun, Qi; Bernstein, Adam M; Schulze, Matthias B; Manson, JoAnn E; Willett, Walter C; Hu, Frank B

2011-10-01

The relation between consumption of different types of red meats and risk of type 2 diabetes (T2D) remains uncertain. We evaluated the association between unprocessed and processed red meat consumption and incident T2D in US adults. We followed 37,083 men in the Health Professionals Follow-Up Study (1986-2006), 79,570 women in the Nurses' Health Study I (1980-2008), and 87,504 women in the Nurses' Health Study II (1991-2005). Diet was assessed by validated food-frequency questionnaires, and data were updated every 4 y. Incident T2D was confirmed by a validated supplementary questionnaire. During 4,033,322 person-years of follow-up, we documented 13,759 incident T2D cases. After adjustment for age, BMI, and other lifestyle and dietary risk factors, both unprocessed and processed red meat intakes were positively associated with T2D risk in each cohort (all P-trend <0.001). The pooled HRs (95% CIs) for a one serving/d increase in unprocessed, processed, and total red meat consumption were 1.12 (1.08, 1.16), 1.32 (1.25, 1.40), and 1.14 (1.10, 1.18), respectively. The results were confirmed by a meta-analysis (442,101 participants and 28,228 diabetes cases): the RRs (95% CIs) were 1.19 (1.04, 1.37) and 1.51 (1.25, 1.83) for 100 g unprocessed red meat/d and for 50 g processed red meat/d, respectively. We estimated that substitutions of one serving of nuts, low-fat dairy, and whole grains per day for one serving of red meat per day were associated with a 16-35% lower risk of T2D. Our results suggest that red meat consumption, particularly processed red meat, is associated with an increased risk of T2D.

Interventionist and participatory approaches to flood risk mitigation decisions: two case studies in the Italian Alps

NASA Astrophysics Data System (ADS)

Bianchizza, C.; Del Bianco, D.; Pellizzoni, L.; Scolobig, A.

2012-04-01

Flood risk mitigation decisions pose key challenges not only from a technical but also from a social, economic and political viewpoint. There is an increasing demand for improving the quality of these processes by including different stakeholders - and especially by involving the local residents in the decision making process - and by guaranteeing the actual improvement of local social capacities during and after the decision making. In this paper we analyse two case studies of flood risk mitigation decisions, Malborghetto-Valbruna and Vipiteno-Sterzing, in the Italian Alps. In both of them, mitigation works have been completed or planned, yet following completely different approaches especially in terms of responses of residents and involvement of local authorities. In Malborghetto-Valbruna an 'interventionist' approach (i.e. leaning towards a top down/technocratic decision process) was used to make decisions after the flood event that affected the municipality in the year 2003. In Vipiteno-Sterzing, a 'participatory' approach (i.e. leaning towards a bottom-up/inclusive decision process) was applied: decisions about risk mitigation measures were made by submitting different projects to the local citizens and by involving them in the decision making process. The analysis of the two case studies presented in the paper is grounded on the results of two research projects. Structured and in-depth interviews, as well as questionnaire surveys were used to explore residents' and local authorities' orientations toward flood risk mitigation. Also a SWOT analysis (Strengths, Weaknesses, Opportunities and Threats) involving key stakeholders was used to better understand the characteristics of the communities and their perception of flood risk mitigation issues. The results highlight some key differences between interventionist and participatory approaches, together with some implications of their adoption in the local context. Strengths and weaknesses of the two approaches, as well as key challenges for the future are also discussed.

Uncertainty assessment of urban pluvial flood risk in a context of climate change adaptation decision making

NASA Astrophysics Data System (ADS)

Arnbjerg-Nielsen, Karsten; Zhou, Qianqian

2014-05-01

There has been a significant increase in climatic extremes in many regions. In Central and Northern Europe, this has led to more frequent and more severe floods. Along with improved flood modelling technologies this has enabled development of economic assessment of climate change adaptation to increasing urban flood risk. Assessment of adaptation strategies often requires a comprehensive risk-based economic analysis of current risk, drivers of change of risk over time, and measures to reduce the risk. However, such studies are often associated with large uncertainties. The uncertainties arise from basic assumptions in the economic analysis and the hydrological model, but also from the projection of future societies to local climate change impacts and suitable adaptation options. This presents a challenge to decision makers when trying to identify robust measures. We present an integrated uncertainty analysis, which can assess and quantify the overall uncertainty in relation to climate change adaptation to urban flash floods. The analysis is based on an uncertainty cascade that by means of Monte Carlo simulations of flood risk assessments incorporates climate change impacts as a key driver of risk changes over time. The overall uncertainty is then attributed to six bulk processes: climate change impact, urban rainfall-runoff processes, stage-depth functions, unit cost of repair, cost of adaptation measures, and discount rate. We apply the approach on an urban hydrological catchment in Odense, Denmark, and find that the uncertainty on the climate change impact appears to have the least influence on the net present value of the studied adaptation measures-. This does not imply that the climate change impact is not important, but that the uncertainties are not dominating when deciding on action or in-action. We then consider the uncertainty related to choosing between adaptation options given that a decision of action has been taken. In this case the major part of the uncertainty on the estimated net present values is identical for all adaptation options and will therefore not affect a comparison between adaptation measures. This makes the chose among the options easier. Furthermore, the explicit attribution of uncertainty also enables a reduction of the overall uncertainty by identifying the processes which contributes the most. This knowledge can then be used to further reduce the uncertainty related to decision making, as a substantial part of the remaining uncertainty is epistemic.

Human Factors Process Task Analysis: Liquid Oxygen Pump Acceptance Test Procedure at the Advanced Technology Development Center

NASA Technical Reports Server (NTRS)

Diorio, Kimberly A.; Voska, Ned (Technical Monitor)

2002-01-01

This viewgraph presentation provides information on Human Factors Process Failure Modes and Effects Analysis (HF PFMEA). HF PFMEA includes the following 10 steps: Describe mission; Define System; Identify human-machine; List human actions; Identify potential errors; Identify factors that effect error; Determine likelihood of error; Determine potential effects of errors; Evaluate risk; Generate solutions (manage error). The presentation also describes how this analysis was applied to a liquid oxygen pump acceptance test.

Towards Rapid Re-Certification Using Formal Analysis

DTIC Science & Technology

2015-07-22

profiles will help ensure that information assurance requirements are commensurate with risk and scalable based on an application’s changing external...20 Scalability Evaluation .......................................................................................................... 22...agility in certification processes. Software re-certification processes require significant expenditure in order to provide evidence of information

A novel method of fuzzy fault tree analysis combined with VB program to identify and assess the risk of coal dust explosions

PubMed Central

Li, Jia; Wang, Deming; Huang, Zonghou

2017-01-01

Coal dust explosions (CDE) are one of the main threats to the occupational safety of coal miners. Aiming to identify and assess the risk of CDE, this paper proposes a novel method of fuzzy fault tree analysis combined with the Visual Basic (VB) program. In this methodology, various potential causes of the CDE are identified and a CDE fault tree is constructed. To overcome drawbacks from the lack of exact probability data for the basic events, fuzzy set theory is employed and the probability data of each basic event is treated as intuitionistic trapezoidal fuzzy numbers. In addition, a new approach for calculating the weighting of each expert is also introduced in this paper to reduce the error during the expert elicitation process. Specifically, an in-depth quantitative analysis of the fuzzy fault tree, such as the importance measure of the basic events and the cut sets, and the CDE occurrence probability is given to assess the explosion risk and acquire more details of the CDE. The VB program is applied to simplify the analysis process. A case study and analysis is provided to illustrate the effectiveness of this proposed method, and some suggestions are given to take preventive measures in advance and avoid CDE accidents. PMID:28793348

A novel method of fuzzy fault tree analysis combined with VB program to identify and assess the risk of coal dust explosions.

PubMed

Wang, Hetang; Li, Jia; Wang, Deming; Huang, Zonghou

2017-01-01

Coal dust explosions (CDE) are one of the main threats to the occupational safety of coal miners. Aiming to identify and assess the risk of CDE, this paper proposes a novel method of fuzzy fault tree analysis combined with the Visual Basic (VB) program. In this methodology, various potential causes of the CDE are identified and a CDE fault tree is constructed. To overcome drawbacks from the lack of exact probability data for the basic events, fuzzy set theory is employed and the probability data of each basic event is treated as intuitionistic trapezoidal fuzzy numbers. In addition, a new approach for calculating the weighting of each expert is also introduced in this paper to reduce the error during the expert elicitation process. Specifically, an in-depth quantitative analysis of the fuzzy fault tree, such as the importance measure of the basic events and the cut sets, and the CDE occurrence probability is given to assess the explosion risk and acquire more details of the CDE. The VB program is applied to simplify the analysis process. A case study and analysis is provided to illustrate the effectiveness of this proposed method, and some suggestions are given to take preventive measures in advance and avoid CDE accidents.

Gis-Based Multi-Criteria Decision Analysis for Forest Fire Risk Mapping

NASA Astrophysics Data System (ADS)

Akay, A. E.; Erdoğan, A.

2017-11-01

The forested areas along the coastal zone of the Mediterranean region in Turkey are classified as first-degree fire sensitive areas. Forest fires are major environmental disaster that affects the sustainability of forest ecosystems. Besides, forest fires result in important economic losses and even threaten human lives. Thus, it is critical to determine the forested areas with fire risks and thereby minimize the damages on forest resources by taking necessary precaution measures in these areas. The risk of forest fire can be assessed based on various factors such as forest vegetation structures (tree species, crown closure, tree stage), topographic features (slope and aspect), and climatic parameters (temperature, wind). In this study, GIS-based Multi-Criteria Decision Analysis (MCDA) method was used to generate forest fire risk map. The study was implemented in the forested areas within Yayla Forest Enterprise Chiefs at Dursunbey Forest Enterprise Directorate which is classified as first degree fire sensitive area. In the solution process, "extAhp 2.0" plug-in running Analytic Hierarchy Process (AHP) method in ArcGIS 10.4.1 was used to categorize study area under five fire risk classes: extreme risk, high risk, moderate risk, and low risk. The results indicated that 23.81 % of the area was of extreme risk, while 25.81 % was of high risk. The result indicated that the most effective criterion was tree species, followed by tree stages. The aspect had the least effective criterion on forest fire risk. It was revealed that GIS techniques integrated with MCDA methods are effective tools to quickly estimate forest fire risk at low cost. The integration of these factors into GIS can be very useful to determine forested areas with high fire risk and also to plan forestry management after fire.

Risk Management in Complex Construction Projects that Apply Renewable Energy Sources: A Case Study of the Realization Phase of the Energis Educational and Research Intelligent Building

NASA Astrophysics Data System (ADS)

Krechowicz, Maria

2017-10-01

Nowadays, one of the characteristic features of construction industry is an increased complexity of a growing number of projects. Almost each construction project is unique, has its project-specific purpose, its own project structural complexity, owner’s expectations, ground conditions unique to a certain location, and its own dynamics. Failure costs and costs resulting from unforeseen problems in complex construction projects are very high. Project complexity drivers pose many vulnerabilities to a successful completion of a number of projects. This paper discusses the process of effective risk management in complex construction projects in which renewable energy sources were used, on the example of the realization phase of the ENERGIS teaching-laboratory building, from the point of view of DORBUD S.A., its general contractor. This paper suggests a new approach to risk management for complex construction projects in which renewable energy sources were applied. The risk management process was divided into six stages: gathering information, identification of the top, critical project risks resulting from the project complexity, construction of the fault tree for each top, critical risks, logical analysis of the fault tree, quantitative risk assessment applying fuzzy logic and development of risk response strategy. A new methodology for the qualitative and quantitative risk assessment for top, critical risks in complex construction projects was developed. Risk assessment was carried out applying Fuzzy Fault Tree analysis on the example of one top critical risk. Application of the Fuzzy sets theory to the proposed model allowed to decrease uncertainty and eliminate problems with gaining the crisp values of the basic events probability, common during expert risk assessment with the objective to give the exact risk score of each unwanted event probability.

Quality transitivity and traceability system of herbal medicine products based on quality markers.

PubMed

Liu, Changxiao; Guo, De-An; Liu, Liang

2018-05-15

Due to a variety of factors to affect the herb quality, the existing quality management model is unable to evaluate the process control. The development of the concept of "quality marker" (Q-marker) lays basis for establishing an independent process quality control system for herbal products. To ensure the highest degree of safety, effectiveness and quality process control of herbal products, it is aimed to establish a quality transitivity and traceability system of quality and process control from raw materials to finished herbal products. Based on the key issues and challenges of quality assessment, the current status of quality and process controls from raw materials to herbal medicinal products listed in Pharmacopoeia were analyzed and the research models including discovery and identification of Q-markers, analysis and quality management of risk evaluation were designed. Authors introduced a few new technologies and methodologies, such as DNA barcoding, chromatographic technologies, fingerprint analysis, chemical markers, bio-responses, risk management and solution for quality process control. The quality and process control models for herbal medicinal products were proposed and the transitivity and traceability system from raw materials to the finished products was constructed to improve the herbal quality from the entire supply and production chain. The transitivity and traceability system has been established based on quality markers, especially on how to control the production process under Good Engineering Practices, as well as to implement the risk management for quality and process control in herbal medicine production. Copyright © 2018 Elsevier GmbH. All rights reserved.

Safety Risk Knowledge Elicitation in Support of Aeronautical R and D Portfolio Management: A Case Study

NASA Technical Reports Server (NTRS)

Shih, Ann T.; Ancel, Ersin; Jones, Sharon Monica; Reveley, Mary S.; Luxhoj, James T.

2012-01-01

Aviation is a problem domain characterized by a high level of system complexity and uncertainty. Safety risk analysis in such a domain is especially challenging given the multitude of operations and diverse stakeholders. The Federal Aviation Administration (FAA) projects that by 2025 air traffic will increase by more than 50 percent with 1.1 billion passengers a year and more than 85,000 flights every 24 hours contributing to further delays and congestion in the sky (Circelli, 2011). This increased system complexity necessitates the application of structured safety risk analysis methods to understand and eliminate where possible, reduce, and/or mitigate risk factors. The use of expert judgments for probabilistic safety analysis in such a complex domain is necessary especially when evaluating the projected impact of future technologies, capabilities, and procedures for which current operational data may be scarce. Management of an R&D product portfolio in such a dynamic domain needs a systematic process to elicit these expert judgments, process modeling results, perform sensitivity analyses, and efficiently communicate the modeling results to decision makers. In this paper a case study focusing on the application of an R&D portfolio of aeronautical products intended to mitigate aircraft Loss of Control (LOC) accidents is presented. In particular, the knowledge elicitation process with three subject matter experts who contributed to the safety risk model is emphasized. The application and refinement of a verbal-numerical scale for conditional probability elicitation in a Bayesian Belief Network (BBN) is discussed. The preliminary findings from this initial step of a three-part elicitation are important to project management practitioners as they illustrate the vital contribution of systematic knowledge elicitation in complex domains.

An Independent Evaluation of the FMEA/CIL Hazard Analysis Alternative Study

NASA Technical Reports Server (NTRS)

Ray, Paul S.

1996-01-01

The present instruments of safety and reliability risk control for a majority of the National Aeronautics and Space Administration (NASA) programs/projects consist of Failure Mode and Effects Analysis (FMEA), Hazard Analysis (HA), Critical Items List (CIL), and Hazard Report (HR). This extensive analytical approach was introduced in the early 1970's and was implemented for the Space Shuttle Program by NHB 5300.4 (1D-2. Since the Challenger accident in 1986, the process has been expanded considerably and resulted in introduction of similar and/or duplicated activities in the safety/reliability risk analysis. A study initiated in 1995, to search for an alternative to the current FMEA/CIL Hazard Analysis methodology generated a proposed method on April 30, 1996. The objective of this Summer Faculty Study was to participate in and conduct an independent evaluation of the proposed alternative to simplify the present safety and reliability risk control procedure.

Safety analysis of occupational exposure of healthcare workers to residual contaminations of cytotoxic drugs using FMECA security approach.

PubMed

Le, Laetitia Minh Mai; Reitter, Delphine; He, Sophie; Bonle, Franck Té; Launois, Amélie; Martinez, Diane; Prognon, Patrice; Caudron, Eric

2017-12-01

Handling cytotoxic drugs is associated with chemical contamination of workplace surfaces. The potential mutagenic, teratogenic and oncogenic properties of those drugs create a risk of occupational exposure for healthcare workers, from reception of starting materials to the preparation and administration of cytotoxic therapies. The Security Failure Mode Effects and Criticality Analysis (FMECA) was used as a proactive method to assess the risks involved in the chemotherapy compounding process. FMECA was carried out by a multidisciplinary team from 2011 to 2016. Potential failure modes of the process were identified based on the Risk Priority Number (RPN) that prioritizes corrective actions. Twenty-five potential failure modes were identified. Based on RPN results, the corrective actions plan was revised annually to reduce the risk of exposure and improve practices. Since 2011, 16 specific measures were implemented successively. In six years, a cumulative RPN reduction of 626 was observed, with a decrease from 912 to 286 (-69%) despite an increase of cytotoxic compounding activity of around 23.2%. In order to anticipate and prevent occupational exposure, FMECA is a valuable tool to identify, prioritize and eliminate potential failure modes for operators involved in the cytotoxic drug preparation process before the failures occur. Copyright © 2017 Elsevier B.V. All rights reserved.

Characterization of heavy-metal-contaminated sediment by using unsupervised multivariate techniques and health risk assessment.

PubMed

Wang, Yeuh-Bin; Liu, Chen-Wuing; Wang, Sheng-Wei

2015-03-01

This study characterized the sediment quality of the severely contaminated Erjen River in Taiwan by using multivariate analysis methods-including factor analysis (FA), self-organizing maps (SOMs), and positive matrix factorization (PMF)-and health risk assessment. The SOMs classified the dataset with similar heavy-metal-contaminated sediment into five groups. FA extracted three major factors-traditional electroplating and metal-surface processing factor, nontraditional heavy-metal-industry factor, and natural geological factor-which accounted for 80.8% of the variance. The SOMs and FA revealed the heavy-metal-contaminated-sediment hotspots in the middle and upper reaches of the major tributary in the dry season. The hazardous index value for health risk via ingestion was 0.302. PMF further qualified the source apportionment, indicating that traditional electroplating and metal-surface-processing industries comprised 47% of the health risk posed by heavy-metal-contaminated sediment. Contaminants discharged from traditional electroplating and metal-surface-processing industries in the middle and upper reaches of the major tributary must be eliminated first to improve the sediment quality in Erjen River. The proposed assessment framework for heavy-metal-contaminated sediment can be applied to contaminated-sediment river sites in other regions. Copyright © 2014 Elsevier Inc. All rights reserved.

Pharmaceutical supply chain risk assessment in Iran using analytic hierarchy process (AHP) and simple additive weighting (SAW) methods.

PubMed

Jaberidoost, Mona; Olfat, Laya; Hosseini, Alireza; Kebriaeezadeh, Abbas; Abdollahi, Mohammad; Alaeddini, Mahdi; Dinarvand, Rassoul

2015-01-01

Pharmaceutical supply chain is a significant component of the health system in supplying medicines, particularly in countries where main drugs are provided by local pharmaceutical companies. No previous studies exist assessing risks and disruptions in pharmaceutical companies while assessing the pharmaceutical supply chain. Any risks affecting the pharmaceutical companies could disrupt supply medicines and health system efficiency. The goal of this study was the risk assessment in pharmaceutical industry in Iran considering process's priority, hazard and probability of risks. The study was carried out in 4 phases; risk identification through literature review, risk identification in Iranian pharmaceutical companies through interview with experts, risk analysis through a questionnaire and consultation with experts using group analytic hierarchy process (AHP) method and rating scale (RS) and risk evaluation of simple additive weighting (SAW) method. In total, 86 main risks were identified in the pharmaceutical supply chain with perspective of pharmaceutical companies classified in 11 classes. The majority of risks described in this study were related to the financial and economic category. Also financial management was found to be the most important factor for consideration. Although pharmaceutical industry and supply chain were affected by current political conditions in Iran during the study time, but half of total risks in the pharmaceutical supply chain were found to be internal risks which could be fixed by companies, internally. Likewise, political status and related risks forced companies to focus more on financial and supply management resulting in less attention to quality management.

Failure mode and effects analysis drastically reduced potential risks in clinical trial conduct.

PubMed

Lee, Howard; Lee, Heechan; Baik, Jungmi; Kim, Hyunjung; Kim, Rachel

2017-01-01

Failure mode and effects analysis (FMEA) is a risk management tool to proactively identify and assess the causes and effects of potential failures in a system, thereby preventing them from happening. The objective of this study was to evaluate effectiveness of FMEA applied to an academic clinical trial center in a tertiary care setting. A multidisciplinary FMEA focus group at the Seoul National University Hospital Clinical Trials Center selected 6 core clinical trial processes, for which potential failure modes were identified and their risk priority number (RPN) was assessed. Remedial action plans for high-risk failure modes (RPN >160) were devised and a follow-up RPN scoring was conducted a year later. A total of 114 failure modes were identified with an RPN score ranging 3-378, which was mainly driven by the severity score. Fourteen failure modes were of high risk, 11 of which were addressed by remedial actions. Rescoring showed a dramatic improvement attributed to reduction in the occurrence and detection scores by >3 and >2 points, respectively. FMEA is a powerful tool to improve quality in clinical trials. The Seoul National University Hospital Clinical Trials Center is expanding its FMEA capability to other core clinical trial processes.

The risk variant in ODZ4 for bipolar disorder impacts on amygdala activation during reward processing.

PubMed

Heinrich, Angela; Lourdusamy, Anbarasu; Tzschoppe, Jelka; Vollstädt-Klein, Sabine; Bühler, Mira; Steiner, Sabina; Bach, Christiane; Poustka, Luise; Banaschewski, Tobias; Barker, Gareth; Büchel, Christian; Conrod, Patricia; Garavan, Hugh; Gallinat, Jürgen; Heinz, Andreas; Ittermann, Bernd; Loth, Eva; Mann, Karl; Martinot, Jean-Luc; Paus, Tomáš; Pausova, Zdenka; Smolka, Michael; Ströhle, Andreas; Struve, Maren; Witt, Stephanie; Flor, Herta; Schumann, Gunter; Rietschel, Marcella; Nees, Frauke

2013-06-01

Bipolar disorder is a severe mood disorder, which normally begins during adolescence or early adulthood and has a heritability of up to 80%. The largest genome-wide association analysis of bipolar disorder recently identified a new genome-wide associated variant in OZD4 (rs12576775). The aim of the present study was to further elucidate the role of this risk variant in the disease process using an imaging genetics approach. As increased amygdala and striatal responses during the processing of reward and emotion are characteristic for bipolar disorder patients, it was tested whether the risk variant has an influence on this endophenotype in healthy adolescents. We examined the impact of the risk variant rs12576775 on functional magnetic resonance imaging data in an adolescent sample (N = 485). Differential activation between carriers of the risk allele (G-allele) and homozygous A-allele carriers in the amygdala and the striatum during a modification of the monetary incentive delay task (examining reward) and a face task (examining emotion) was analyzed. Carriers of the risk allele showed an increased blood oxygen level-dependent response in the amygdala during reward sensitivity (p = 0.05) and reward expectation (p < 0.05) but not during the face task. No significant group differences were found in the striatum during both reward and emotion processing. Our results indicate that the ODZ4 risk variant influences reward processing in the amygdala. Alterations in the processing of emotion may have different underlying mechanisms and need to be further examined. © 2013 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

DOE Office of Scientific and Technical Information (OSTI.GOV)

Glantz, C.S.; DiMassa, F.V.; Pelto, P.J.

The Western Area Power Administration (Western) views environmental protection and compliance as a top priority as it manages the construction, operation, and maintenance of its vast network of transmission lines, substations, and other facilities. A recent Department of Energy audit of Western`s environmental management activities recommends that Western adopt a formal environmental risk program. To accomplish this goal, Western, in conjunction with Pacific Northwest Laboratory, is in the process of developing a centrally coordinated environmental risk program. This report presents the results of this design effort, and indicates the direction in which Western`s environmental risk program is heading. Western`s environmentalmore » risk program will consist of three main components: risk communication, risk assessment, and risk management/decision making. Risk communication is defined as an exchange of information on the potential for threats to human health, public safety, or the environment. This information exchange provides a mechanism for public involvement, and also for the participation in the risk assessment and management process by diverse groups or offices within Western. The objective of risk assessment is to evaluate and rank the relative magnitude of risks associated with specific environmental issues that are facing Western. The evaluation and ranking is based on the best available scientific information and judgment and serves as input to the risk management process. Risk management takes risk information and combines it with relevant non-risk factors (e.g., legal mandates, public opinion, costs) to generate risk management options. A risk management tool, such as decision analysis, can be used to help make risk management choices.« less

Continuous Risk Management at NASA

NASA Technical Reports Server (NTRS)

Hammer, Theodore F.; Rosenberg, Linda

1999-01-01

NPG 7120.5A, "NASA Program and Project Management Processes and Requirements" enacted in April, 1998, requires that "The program or project manager shall apply risk management principles..." The Software Assurance Technology Center (SATC) at NASA GSFC has been tasked with the responsibility for developing and teaching a systems level course for risk management that provides information on how to comply with this edict. The course was developed in conjunction with the Software Engineering Institute at Carnegie Mellon University, then tailored to the NASA systems community. This presentation will briefly discuss the six functions for risk management: (1) Identify the risks in a specific format; (2) Analyze the risk probability, impact/severity, and timeframe; (3) Plan the approach; (4) Track the risk through data compilation and analysis; (5) Control and monitor the risk; (6) Communicate and document the process and decisions. This risk management structure of functions has been taught to projects at all NASA Centers and is being successfully implemented on many projects. This presentation will give project managers the information they need to understand if risk management is to be effectively implemented on their projects at a cost they can afford.

The effects of alcohol intoxication on young adult women's identification of risk for sexual assault: A systematic review.

PubMed

Melkonian, Alexander J; Ham, Lindsay S

2018-03-01

Alcohol-related sexual assault among young adult women continues to present a public health concern. Social information-processing theory provides an organizing framework for understanding how alcohol intoxication can impair the processing of sexual assault risk cues and behavioral responding in sexual assault scenarios. The aim of the present article was to systematically review the extant research on the effects of alcohol intoxication on sexual assault risk information processing among young adult women. We selected relevant research through a systematic search of scientific databases, using key words related to young adult women, alcohol intoxication, and risk recognition, resulting in 14 independent research samples meeting all criteria. Studies used a variety of methods and dependent measures, precluding quantitative analysis of results. Thirteen of the 14 studies identified report at least partial support for intoxication impairing the attention to cues, interpretation of social information, or intended behavioral response in a hypothetical sexual assault scenario. Given some mixed findings, further research is warranted to identify contextual and individual differences related to risk detection and intended responding and to fully test other aspects of social information processing. Results have implications for improving alcohol-related sexual assault prevention programs by addressing the impact of alcohol intoxication on processing sexual assault risk information. (PsycINFO Database Record (c) 2018 APA, all rights reserved).

DOE Office of Scientific and Technical Information (OSTI.GOV)

R. L. VanHorn; N. L. Hampton; R. C. Morris

This document presents reference material for conducting screening level ecological risk assessments (SLERAs)for the waste area groups (WAGs) at the Idaho National Engineering Laboratory. Included in this document are discussions of the objectives of and processes for conducting SLERAs. The Environmental Protection Agency ecological risk assessment framework is closely followed. Guidance for site characterization, stressor characterization, ecological effects, pathways of contaminant migration, the conceptual site model, assessment endpoints, measurement endpoints, analysis guidance, and risk characterization are included.

Benefit-Risk Assessment, Communication, and Evaluation (BRACE) throughout the life cycle of therapeutic products: overall perspective and role of the pharmacoepidemiologist.

PubMed

Radawski, Christine; Morrato, Elaine; Hornbuckle, Kenneth; Bahri, Priya; Smith, Meredith; Juhaeri, Juhaeri; Mol, Peter; Levitan, Bennett; Huang, Han-Yao; Coplan, Paul; Li, Hu

2015-12-01

Optimizing a therapeutic product's benefit-risk profile is an on-going process throughout the product's life cycle. Different, yet related, benefit-risk assessment strategies and frameworks are being developed by various regulatory agencies, industry groups, and stakeholders. This paper summarizes current best practices and discusses the role of the pharmacoepidemiologist in these activities, taking a life-cycle approach to integrated Benefit-Risk Assessment, Communication, and Evaluation (BRACE). A review of the medical and regulatory literature was performed for the following steps involved in therapeutic benefit-risk optimization: benefit-risk evidence generation; data integration and analysis; decision making; regulatory and policy decision making; benefit-risk communication and risk minimization; and evaluation. Feedback from International Society for Pharmacoepidemiology members was solicited on the role of the pharmacoepidemiologist. The case example of natalizumab is provided to illustrate the cyclic nature of the benefit-risk optimization process. No single, globally adopted benefit-risk assessment process exists. The BRACE heuristic offers a way to clarify research needs and to promote best practices in a cyclic and integrated manner and highlight the critical importance of cross-disciplinary input. Its approach focuses on the integration of BRACE activities for risk minimization and optimization of the benefit-risk profile. The activities defined in the BRACE heuristic contribute to the optimization of the benefit-risk profile of therapeutic products in the clinical world at both the patient and population health level. With interdisciplinary collaboration, pharmacoepidemiologists are well suited for bringing in methodology expertise, relevant research, and public health perspectives into the BRACE process. Copyright © 2015 John Wiley & Sons, Ltd.

Criteria for the Research Institute for Fragrance Materials, Inc. (RIFM) safety evaluation process for fragrance ingredients.

PubMed

Api, A M; Belsito, D; Bruze, M; Cadby, P; Calow, P; Dagli, M L; Dekant, W; Ellis, G; Fryer, A D; Fukayama, M; Griem, P; Hickey, C; Kromidas, L; Lalko, J F; Liebler, D C; Miyachi, Y; Politano, V T; Renskers, K; Ritacco, G; Salvito, D; Schultz, T W; Sipes, I G; Smith, B; Vitale, D; Wilcox, D K

2015-08-01

The Research Institute for Fragrance Materials, Inc. (RIFM) has been engaged in the generation and evaluation of safety data for fragrance materials since its inception over 45 years ago. Over time, RIFM's approach to gathering data, estimating exposure and assessing safety has evolved as the tools for risk assessment evolved. This publication is designed to update the RIFM safety assessment process, which follows a series of decision trees, reflecting advances in approaches in risk assessment and new and classical toxicological methodologies employed by RIFM over the past ten years. These changes include incorporating 1) new scientific information including a framework for choosing structural analogs, 2) consideration of the Threshold of Toxicological Concern (TTC), 3) the Quantitative Risk Assessment (QRA) for dermal sensitization, 4) the respiratory route of exposure, 5) aggregate exposure assessment methodology, 6) the latest methodology and approaches to risk assessments, 7) the latest alternatives to animal testing methodology and 8) environmental risk assessment. The assessment begins with a thorough analysis of existing data followed by in silico analysis, identification of 'read across' analogs, generation of additional data through in vitro testing as well as consideration of the TTC approach. If necessary, risk management may be considered. Copyright © 2014 Elsevier Ltd. All rights reserved.

Safety assessment, detection and traceability, and societal aspects of genetically modified foods. European Network on Safety Assessment of Genetically Modified Food Crops (ENTRANSFOOD). Concluding remarks.

PubMed

Kuiper, H A; König, A; Kleter, G A; Hammes, W P; Knudsen, I

2004-07-01

The most important results from the EU-sponsored ENTRANSFOOD Thematic Network project are reviewed, including the design of a detailed step-wise procedure for the risk assessment of foods derived from genetically modified crops based on the latest scientific developments, evaluation of topical risk assessment issues, and the formulation of proposals for improved risk management and public involvement in the risk analysis process. Copyright 2004 Elsevier Ltd.

A semi-quantitative approach to GMO risk-benefit analysis.

PubMed

Morris, E Jane

2011-10-01

In many countries there are increasing calls for the benefits of genetically modified organisms (GMOs) to be considered as well as the risks, and for a risk-benefit analysis to form an integral part of GMO regulatory frameworks. This trend represents a shift away from the strict emphasis on risks, which is encapsulated in the Precautionary Principle that forms the basis for the Cartagena Protocol on Biosafety, and which is reflected in the national legislation of many countries. The introduction of risk-benefit analysis of GMOs would be facilitated if clear methodologies were available to support the analysis. Up to now, methodologies for risk-benefit analysis that would be applicable to the introduction of GMOs have not been well defined. This paper describes a relatively simple semi-quantitative methodology that could be easily applied as a decision support tool, giving particular consideration to the needs of regulators in developing countries where there are limited resources and experience. The application of the methodology is demonstrated using the release of an insect resistant maize variety in South Africa as a case study. The applicability of the method in the South African regulatory system is also discussed, as an example of what might be involved in introducing changes into an existing regulatory process.

Modeling adverse environmental impacts on the reproductive system.

PubMed

Sussman, N B; Mazumdar, S; Mattison, D R

1999-03-01

When priority topics are being established for the study of women's health, it is generally agreed that one important area on which to focus research is reproduction. For example, increasing attention has been directed to environmental exposures that disrupt the endocrine system and alter reproduction. These concerns also suggest the need to give greater attention to the use of animal toxicologic testing to draw inferences about human reproductive risks. Successful reproduction requires multiple simultaneous and sequential processes in both the male and female, and the effect of toxicity on reproduction-related processes is time dependent. Currently, however, the risk assessment approach does not allow for the use of multiple processes or for considering the reproductive process response as a function of time. We discuss several issues in modeling exposure effects on reproductive function for risk assessment and present an overview of approaches for reproductive risk assessment. Recommendations are provided for an effective animal study design for determining reproductive risk that addresses optimization of the duration of dosing, observation of the effects of exposure on validated biomarkers, analysis of several biomarkers for complete characterization of the exposure on the underlying biologic processes, the need for longitudinally observed exposure effects, and a procedure for estimating human reproductive risk from the animal findings. An approach to characterizing reproductive toxicity to estimate the increased fertility risks in a dibromochloropropane (DBCP)-exposed human population is illustrated, using several reproductive biomarkers simultaneously from a longitudinal rabbit inhalation study of DBCP and an interspecies extrapolation method.

U.K. Foot and Mouth Disease: A Systemic Risk Assessment of Existing Controls.

PubMed

Delgado, João; Pollard, Simon; Pearn, Kerry; Snary, Emma L; Black, Edgar; Prpich, George; Longhurst, Phil

2017-09-01

This article details a systemic analysis of the controls in place and possible interventions available to further reduce the risk of a foot and mouth disease (FMD) outbreak in the United Kingdom. Using a research-based network analysis tool, we identify vulnerabilities within the multibarrier control system and their corresponding critical control points (CCPs). CCPs represent opportunities for active intervention that produce the greatest improvement to United Kingdom's resilience to future FMD outbreaks. Using an adapted 'features, events, and processes' (FEPs) methodology and network analysis, our results suggest that movements of animals and goods associated with legal activities significantly influence the system's behavior due to their higher frequency and ability to combine and create scenarios of exposure similar in origin to the U.K. FMD outbreaks of 1967/8 and 2001. The systemic risk assessment highlights areas outside of disease control that are relevant to disease spread. Further, it proves to be a powerful tool for demonstrating the need for implementing disease controls that have not previously been part of the system. © 2016 The Authors Risk Analysis published by Wiley Periodicals, Inc. on behalf of Society for Risk Analysis.

Risk analysis of heat recovery steam generator with semi quantitative risk based inspection API 581

DOE Office of Scientific and Technical Information (OSTI.GOV)

Prayogo, Galang Sandy, E-mail: gasandylang@live.com; Haryadi, Gunawan Dwi; Ismail, Rifky

Corrosion is a major problem that most often occurs in the power plant. Heat recovery steam generator (HRSG) is an equipment that has a high risk to the power plant. The impact of corrosion damage causing HRSG power plant stops operating. Furthermore, it could be threaten the safety of employees. The Risk Based Inspection (RBI) guidelines by the American Petroleum Institute (API) 58 has been used to risk analysis in the HRSG 1. By using this methodology, the risk that caused by unexpected failure as a function of the probability and consequence of failure can be estimated. This paper presentedmore » a case study relating to the risk analysis in the HRSG, starting with a summary of the basic principles and procedures of risk assessment and applying corrosion RBI for process industries. The risk level of each HRSG equipment were analyzed: HP superheater has a medium high risk (4C), HP evaporator has a medium-high risk (4C), and the HP economizer has a medium risk (3C). The results of the risk assessment using semi-quantitative method of standard API 581 based on the existing equipment at medium risk. In the fact, there is no critical problem in the equipment components. Damage mechanisms were prominent throughout the equipment is thinning mechanism. The evaluation of the risk approach was done with the aim of reducing risk by optimizing the risk assessment activities.« less

Regulatory Science in Professional Education.

PubMed

Akiyama, Hiroshi

2017-01-01

In the field of pharmaceutical sciences, the subject of regulatory science (RS) includes pharmaceuticals, food, and living environments. For pharmaceuticals, considering the balance between efficacy and safety is a point required for public acceptance, and in that balance, more importance is given to efficacy in curing disease. For food, however, safety is the most important consideration for public acceptance because food should be essentially free of risk. To ensure food safety, first, any hazard that is an agent in food or condition of food with the potential to cause adverse health effects should be identified and characterized. Then the risk that it will affect public health is scientifically analyzed. This process is called risk assessment. Second, risk management should be conducted to reduce a risk that has the potential to affect public health found in a risk assessment. Furthermore, risk communication, which is the interactive exchange of information and opinions concerning risk and risk management among risk assessors, risk managers, consumers, and other interested parties, should be conducted. Food safety is ensured based on risk analysis consisting of the three components of risk assessment, risk management, and risk communication. RS in the field of food safety supports risk analysis, such as scientific research and development of test methods to evaluate food quality, efficacy, and safety. RS is also applied in the field of living environments because the safety of environmental chemical substances is ensured based on risk analysis, similar to that conducted for food.

Analysis of the medication-use process in North American hospital systems: underlining key points for adoption to improve patient safety in French hospitals.

PubMed

Brouard, Agnes; Fagon, Jean Yves; Daniels, Charles E

2011-01-01

This project was designed to underline any actions relative to medication error prevention and patient safety improvement setting up in North American hospitals which could be implemented in French Parisian hospitals. A literature research and analysis of medication-use process in the North American hospitals and a validation survey of hospital pharmacist managers in the San Diego area was performed to assess main points of hospital medication-use process. Literature analysis, survey analysis of respondents highlighted main differences between the two countries at three levels: nationwide, hospital level and pharmaceutical service level. According to this, proposal development to optimize medication-use process in the French system includes the following topics: implementation of an expanded use of information technology and robotics; increase pharmaceutical human resources allowing expansion of clinical pharmacy activities; focus on high-risk medications and high-risk patient populations; develop a collective sense of responsibility for medication error prevention in hospital settings, involving medical, pharmaceutical and administrative teams. Along with a strong emphasis that should be put on the identified topics to improve the quality and safety of hospital care in France, consideration of patient safety as a priority at a nationwide level needs to be reinforced.

Applying Qualitative Hazard Analysis to Support Quantitative Safety Analysis for Proposed Reduced Wake Separation Conops

NASA Technical Reports Server (NTRS)

Shortle, John F.; Allocco, Michael

2005-01-01

This paper describes a scenario-driven hazard analysis process to identify, eliminate, and control safety-related risks. Within this process, we develop selective criteria to determine the applicability of applying engineering modeling to hypothesized hazard scenarios. This provides a basis for evaluating and prioritizing the scenarios as candidates for further quantitative analysis. We have applied this methodology to proposed concepts of operations for reduced wake separation for closely spaced parallel runways. For arrivals, the process identified 43 core hazard scenarios. Of these, we classified 12 as appropriate for further quantitative modeling, 24 that should be mitigated through controls, recommendations, and / or procedures (that is, scenarios not appropriate for quantitative modeling), and 7 that have the lowest priority for further analysis.

Increased prolactin levels are associated with impaired processing speed in subjects with early psychosis.

PubMed

Montalvo, Itziar; Gutiérrez-Zotes, Alfonso; Creus, Marta; Monseny, Rosa; Ortega, Laura; Franch, Joan; Lawrie, Stephen M; Reynolds, Rebecca M; Vilella, Elisabet; Labad, Javier

2014-01-01

Hyperprolactinaemia, a common side effect of some antipsychotic drugs, is also present in drug-naïve psychotic patients and subjects at risk for psychosis. Recent studies in non-psychiatric populations suggest that increased prolactin may have negative effects on cognition. The aim of our study was to explore whether high plasma prolactin levels are associated with poorer cognitive functioning in subjects with early psychoses. We studied 107 participants: 29 healthy subjects and 78 subjects with an early psychosis (55 psychotic disorders with <3 years of illness, 23 high-risk subjects). Cognitive assessment was performed with the MATRICS Cognitive Consensus Cognitive Battery, and prolactin levels were determined as well as total cortisol levels in plasma. Psychopathological status was assessed and the use of psychopharmacological treatments (antipsychotics, antidepressants, benzodiazepines) recorded. Prolactin levels were negatively associated with cognitive performance in processing speed, in patients with a psychotic disorder and high-risk subjects. In the latter group, increased prolactin levels were also associated with impaired reasoning and problem solving and poorer general cognition. In a multiple linear regression analysis conducted in both high-risk and psychotic patients, controlling for potential confounders, prolactin and benzodiazepines were independently related to poorer cognitive performance in the speed of processing domain. A mediation analysis showed that both prolactin and benzodiazepine treatment act as mediators of the relationship between risperidone/paliperidone treatment and speed of processing. These results suggest that increased prolactin levels are associated with impaired processing speed in early psychosis. If these results are confirmed in future studies, strategies targeting reduction of prolactin levels may improve cognition in this population.

A Mathematical Model for Pathogen Cross-Contamination Dynamics during the Postharvest Processing of Leafy Greens.

PubMed

Mokhtari, Amir; Oryang, David; Chen, Yuhuan; Pouillot, Regis; Van Doren, Jane

2018-01-08

We developed a probabilistic mathematical model for the postharvest processing of leafy greens focusing on Escherichia coli O157:H7 contamination of fresh-cut romaine lettuce as the case study. Our model can (i) support the investigation of cross-contamination scenarios, and (ii) evaluate and compare different risk mitigation options. We used an agent-based modeling framework to predict the pathogen prevalence and levels in bags of fresh-cut lettuce and quantify spread of E. coli O157:H7 from contaminated lettuce to surface areas of processing equipment. Using an unbalanced factorial design, we were able to propagate combinations of random values assigned to model inputs through different processing steps and ranked statistically significant inputs with respect to their impacts on selected model outputs. Results indicated that whether contamination originated on incoming lettuce heads or on the surface areas of processing equipment, pathogen prevalence among bags of fresh-cut lettuce and batches was most significantly impacted by the level of free chlorine in the flume tank and frequency of replacing the wash water inside the tank. Pathogen levels in bags of fresh-cut lettuce were most significantly influenced by the initial levels of contamination on incoming lettuce heads or surface areas of processing equipment. The influence of surface contamination on pathogen prevalence or levels in fresh-cut bags depended on the location of that surface relative to the flume tank. This study demonstrates that developing a flexible yet mathematically rigorous modeling tool, a "virtual laboratory," can provide valuable insights into the effectiveness of individual and combined risk mitigation options. © 2018 The Authors Risk Analysis published by Wiley Periodicals, Inc. on behalf of Society for Risk Analysis.

Network Analysis: A Novel Approach to Understand Suicidal Behaviour

PubMed Central

de Beurs, Derek

2017-01-01

Although suicide is a major public health issue worldwide, we understand little of the onset and development of suicidal behaviour. Suicidal behaviour is argued to be the end result of the complex interaction between psychological, social and biological factors. Epidemiological studies resulted in a range of risk factors for suicidal behaviour, but we do not yet understand how their interaction increases the risk for suicidal behaviour. A new approach called network analysis can help us better understand this process as it allows us to visualize and quantify the complex association between many different symptoms or risk factors. A network analysis of data containing information on suicidal patients can help us understand how risk factors interact and how their interaction is related to suicidal thoughts and behaviour. A network perspective has been successfully applied to the field of depression and psychosis, but not yet to the field of suicidology. In this theoretical article, I will introduce the concept of network analysis to the field of suicide prevention, and offer directions for future applications and studies.

Multi-institutional application of Failure Mode and Effects Analysis (FMEA) to CyberKnife Stereotactic Body Radiation Therapy (SBRT).

PubMed

Veronese, Ivan; De Martin, Elena; Martinotti, Anna Stefania; Fumagalli, Maria Luisa; Vite, Cristina; Redaelli, Irene; Malatesta, Tiziana; Mancosu, Pietro; Beltramo, Giancarlo; Fariselli, Laura; Cantone, Marie Claire

2015-06-13

A multidisciplinary and multi-institutional working group applied the Failure Mode and Effects Analysis (FMEA) approach to assess the risks for patients undergoing Stereotactic Body Radiation Therapy (SBRT) treatments for lesions located in spine and liver in two CyberKnife® Centres. The various sub-processes characterizing the SBRT treatment were identified to generate the process trees of both the treatment planning and delivery phases. This analysis drove to the identification and subsequent scoring of the potential failure modes, together with their causes and effects, using the risk probability number (RPN) scoring system. Novel solutions aimed to increase patient safety were accordingly considered. The process-tree characterising the SBRT treatment planning stage was composed with a total of 48 sub-processes. Similarly, 42 sub-processes were identified in the stage of delivery to liver tumours and 30 in the stage of delivery to spine lesions. All the sub-processes were judged to be potentially prone to one or more failure modes. Nineteen failures (i.e. 5 in treatment planning stage, 5 in the delivery to liver lesions and 9 in the delivery to spine lesions) were considered of high concern in view of the high RPN and/or severity index value. The analysis of the potential failures, their causes and effects allowed to improve the safety strategies already adopted in the clinical practice with additional measures for optimizing quality management workflow and increasing patient safety.

Decision strategies to reduce teenage and young adult deaths in the United States.

PubMed

Keeney, Ralph L; Palley, Asa B

2013-09-01

This article uses decision analysis concepts and techniques to address an extremely important problem to any family with children, namely, how to avoid the tragic death of a child during the high-risk ages of 15-24. Descriptively, our analysis indicates that of the 35,000 annual deaths among this age group in the United States, approximately 20,000 could be avoided if individuals chose readily available alternatives for decisions relating to these deaths. Prescriptively, we develop a decision framework for parents and a child to both identify and proactively pursue decisions that can lower that child's exposure to life-threatening risks and positively alter decisions when facing such risks. Applying this framework for parents and the youth themselves, we illustrate the logic and process of generating proactive alternatives with numerous examples that each could pursue to lower these life-threatening risks and possibly avoid a tragic premature death, and discuss some public policy implications of our findings. © 2013 Society for Risk Analysis.

Optimal linear and nonlinear feature extraction based on the minimization of the increased risk of misclassification. [Bayes theorem - statistical analysis/data processing

NASA Technical Reports Server (NTRS)

Defigueiredo, R. J. P.

1974-01-01

General classes of nonlinear and linear transformations were investigated for the reduction of the dimensionality of the classification (feature) space so that, for a prescribed dimension m of this space, the increase of the misclassification risk is minimized.

Conversion economics of forest biomaterials: risk and financial analysis of CNC manufacturing

Treesearch

Camilla Abbati de Assis; Carl Houtman; Richard Phillips; E.M. Ted Bilek; Orlando J. Rojas; Lokendra Pal; Maria Soledad Peresin; Hasan Jameel; Ronalds Gonzalez

2017-01-01

Commercialization of cellulose nanocrystals (CNC) presents opportunities for a wide range of new products. Techno-economic assessments can provide insightful information for the effi cient design of conversion processes, drive cost-saving efforts, and reduce fi nancial risks. In this study, we conducted techno-economic assessments for CNC production using information...

A Human Factor Analysis to Mitigate Fall Risk Factors in an Aerospace Environment

NASA Technical Reports Server (NTRS)

Ware, Joylene H.

2010-01-01

This slide presentation reviews the study done to quanitfy the risks from falls from three locations (i.e., Shuttle Landing Facility Launch Complex Payloads and Vehicle Assembly Building) at the Kennedy Space Center. The Analytical Hierarchy Process (AHP) is reviewed and the mathematical model developed is detailed.

75 FR 55619 - Self-Regulatory Organizations; The Options Clearing Corporation; Notice of Filing of Proposed...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-09-13

... Numerical Simulations Risk Management Methodology September 7, 2010. Pursuant to Section 19(b)(1) of the... for incorporation in the System for Theoretical Analysis and Numerical Simulations (``STANS'') risk... ETFs \\3\\ in the STANS margin calculation process.\\4\\ When OCC began including common stock and ETFs in...

Ergonomic assessment for the task of repairing computers in a manufacturing company: A case study.

PubMed

Maldonado-Macías, Aidé; Realyvásquez, Arturo; Hernández, Juan Luis; García-Alcaraz, Jorge

2015-01-01

Manufacturing industry workers who repair computers may be exposed to ergonomic risk factors. This project analyzes the tasks involved in the computer repair process to (1) find the risk level for musculoskeletal disorders (MSDs) and (2) propose ergonomic interventions to address any ergonomic issues. Work procedures and main body postures were video recorded and analyzed using task analysis, the Rapid Entire Body Assessment (REBA) postural method, and biomechanical analysis. High risk for MSDs was found on every subtask using REBA. Although biomechanical analysis found an acceptable mass center displacement during tasks, a hazardous level of compression on the lower back during computer's transportation was detected. This assessment found ergonomic risks mainly in the trunk, arm/forearm, and legs; the neck and hand/wrist were also compromised. Opportunities for ergonomic analyses and interventions in the design and execution of computer repair tasks are discussed.

Disaster risk management in prospect mining area Blitar district, East Java, using microtremor analysis and ANP (analytical network processing) approach

DOE Office of Scientific and Technical Information (OSTI.GOV)

Parwatiningtyas, Diyan, E-mail: diane.tyas@gmail.com, E-mail: erlinunindra@gmail.com; Ambarsari, Erlin Windia, E-mail: diane.tyas@gmail.com, E-mail: erlinunindra@gmail.com; Marlina, Dwi, E-mail: diane.tyas@gmail.com, E-mail: erlinunindra@gmail.com

Indonesia has a wealth of natural assets is so large to be managed and utilized, either from its own local government and local communities, especially in the mining sector. However, mining activities can change the state of the surface layer of the earth that have a high impact disaster risk. This could threaten the safety and disrupt human life, environmental damage, loss of property, and the psychological impact, sulking to the rule of law no 24 of 2007. That's why we strive to manage and minimize the risk of mine disasters in the region, how to use the method ofmore » calculation of Amplification Factor (AF) from the analysis based microtremor sulking Kanai and Nakamura, and decision systems were tested by analysis of ANP. Based on the amplification factor and Analytical Network Processing (ANP) obtained, some points showed instability in the surface layer of a mining area include the site of the TP-7, TP-8, TP-9, TP-10, (Birowo2). If in terms of structure, location indicated unstable due to have a sloping surface layer, resulting in the occurrence of landslides and earthquake risk is high. In the meantime, other areas of the mine site can be said to be a stable area.« less

Systems Toxicology: From Basic Research to Risk Assessment

PubMed Central

2014-01-01

Systems Toxicology is the integration of classical toxicology with quantitative analysis of large networks of molecular and functional changes occurring across multiple levels of biological organization. Society demands increasingly close scrutiny of the potential health risks associated with exposure to chemicals present in our everyday life, leading to an increasing need for more predictive and accurate risk-assessment approaches. Developing such approaches requires a detailed mechanistic understanding of the ways in which xenobiotic substances perturb biological systems and lead to adverse outcomes. Thus, Systems Toxicology approaches offer modern strategies for gaining such mechanistic knowledge by combining advanced analytical and computational tools. Furthermore, Systems Toxicology is a means for the identification and application of biomarkers for improved safety assessments. In Systems Toxicology, quantitative systems-wide molecular changes in the context of an exposure are measured, and a causal chain of molecular events linking exposures with adverse outcomes (i.e., functional and apical end points) is deciphered. Mathematical models are then built to describe these processes in a quantitative manner. The integrated data analysis leads to the identification of how biological networks are perturbed by the exposure and enables the development of predictive mathematical models of toxicological processes. This perspective integrates current knowledge regarding bioanalytical approaches, computational analysis, and the potential for improved risk assessment. PMID:24446777

Disaster risk management in prospect mining area Blitar district, East Java, using microtremor analysis and ANP (analytical network processing) approach

NASA Astrophysics Data System (ADS)

Parwatiningtyas, Diyan; Ambarsari, Erlin Windia; Marlina, Dwi; Wiratomo, Yogi

2014-03-01

Indonesia has a wealth of natural assets is so large to be managed and utilized, either from its own local government and local communities, especially in the mining sector. However, mining activities can change the state of the surface layer of the earth that have a high impact disaster risk. This could threaten the safety and disrupt human life, environmental damage, loss of property, and the psychological impact, sulking to the rule of law no 24 of 2007. That's why we strive to manage and minimize the risk of mine disasters in the region, how to use the method of calculation of Amplification Factor (AF) from the analysis based microtremor sulking Kanai and Nakamura, and decision systems were tested by analysis of ANP. Based on the amplification factor and Analytical Network Processing (ANP) obtained, some points showed instability in the surface layer of a mining area include the site of the TP-7, TP-8, TP-9, TP-10, (Birowo2). If in terms of structure, location indicated unstable due to have a sloping surface layer, resulting in the occurrence of landslides and earthquake risk is high. In the meantime, other areas of the mine site can be said to be a stable area.

Systems toxicology: from basic research to risk assessment.

PubMed

Sturla, Shana J; Boobis, Alan R; FitzGerald, Rex E; Hoeng, Julia; Kavlock, Robert J; Schirmer, Kristin; Whelan, Maurice; Wilks, Martin F; Peitsch, Manuel C

2014-03-17

Systems Toxicology is the integration of classical toxicology with quantitative analysis of large networks of molecular and functional changes occurring across multiple levels of biological organization. Society demands increasingly close scrutiny of the potential health risks associated with exposure to chemicals present in our everyday life, leading to an increasing need for more predictive and accurate risk-assessment approaches. Developing such approaches requires a detailed mechanistic understanding of the ways in which xenobiotic substances perturb biological systems and lead to adverse outcomes. Thus, Systems Toxicology approaches offer modern strategies for gaining such mechanistic knowledge by combining advanced analytical and computational tools. Furthermore, Systems Toxicology is a means for the identification and application of biomarkers for improved safety assessments. In Systems Toxicology, quantitative systems-wide molecular changes in the context of an exposure are measured, and a causal chain of molecular events linking exposures with adverse outcomes (i.e., functional and apical end points) is deciphered. Mathematical models are then built to describe these processes in a quantitative manner. The integrated data analysis leads to the identification of how biological networks are perturbed by the exposure and enables the development of predictive mathematical models of toxicological processes. This perspective integrates current knowledge regarding bioanalytical approaches, computational analysis, and the potential for improved risk assessment.

A multicriteria decision analysis model and risk assessment framework for carbon capture and storage.

PubMed

Humphries Choptiany, John Michael; Pelot, Ronald

2014-09-01

Multicriteria decision analysis (MCDA) has been applied to various energy problems to incorporate a variety of qualitative and quantitative criteria, usually spanning environmental, social, engineering, and economic fields. MCDA and associated methods such as life-cycle assessments and cost-benefit analysis can also include risk analysis to address uncertainties in criteria estimates. One technology now being assessed to help mitigate climate change is carbon capture and storage (CCS). CCS is a new process that captures CO2 emissions from fossil-fueled power plants and injects them into geological reservoirs for storage. It presents a unique challenge to decisionmakers (DMs) due to its technical complexity, range of environmental, social, and economic impacts, variety of stakeholders, and long time spans. The authors have developed a risk assessment model using a MCDA approach for CCS decisions such as selecting between CO2 storage locations and choosing among different mitigation actions for reducing risks. The model includes uncertainty measures for several factors, utility curve representations of all variables, Monte Carlo simulation, and sensitivity analysis. This article uses a CCS scenario example to demonstrate the development and application of the model based on data derived from published articles and publicly available sources. The model allows high-level DMs to better understand project risks and the tradeoffs inherent in modern, complex energy decisions. © 2014 Society for Risk Analysis.

Dynamic Data Management Based on Archival Process Integration at the Centre for Environmental Data Archival

NASA Astrophysics Data System (ADS)

Conway, Esther; Waterfall, Alison; Pepler, Sam; Newey, Charles

2015-04-01

In this paper we decribe a business process modelling approach to the integration of exisiting archival activities. We provide a high level overview of existing practice and discuss how procedures can be extended and supported through the description of preservation state. The aim of which is to faciliate the dynamic controlled management of scientific data through its lifecycle. The main types of archival processes considered are: • Management processes that govern the operation of an archive. These management processes include archival governance (preservation state management, selection of archival candidates and strategic management) . • Operational processes that constitute the core activities of the archive which maintain the value of research assets. These operational processes are the acquisition, ingestion, deletion, generation of metadata and preservation actvities, • Supporting processes, which include planning, risk analysis and monitoring of the community/preservation environment. We then proceed by describing the feasability testing of extended risk management and planning procedures which integrate current practices. This was done through the CEDA Archival Format Audit which inspected British Atmospherics Data Centre and National Earth Observation Data Centre Archival holdings. These holdings are extensive, comprising of around 2PB of data and 137 million individual files which were analysed and characterised in terms of format based risk. We are then able to present an overview of the risk burden faced by a large scale archive attempting to maintain the usability of heterogeneous environmental data sets. We conclude by presenting a dynamic data management information model that is capable of describing the preservation state of archival holdings throughout the data lifecycle. We provide discussion of the following core model entities and their relationships: • Aspirational entities, which include Data Entity definitions and their associated Preservation Objectives. • Risk entities, which act as drivers for change within the data lifecycle. These include Acquisitional Risks, Technical Risks, Strategic Risks and External Risks • Plan entities, which detail the actions to bring about change within an archive. These include Acquisition Plans, Preservation Plans and Monitoring plans • The Result entities describe the successful outcomes of the executed plans. These include Acquisitions, Mitigations and Accepted Risks.

WE-B-BRC-01: Current Methodologies in Risk Assessment

DOE Office of Scientific and Technical Information (OSTI.GOV)

Rath, F.

Prospective quality management techniques, long used by engineering and industry, have become a growing aspect of efforts to improve quality management and safety in healthcare. These techniques are of particular interest to medical physics as scope and complexity of clinical practice continue to grow, thus making the prescriptive methods we have used harder to apply and potentially less effective for our interconnected and highly complex healthcare enterprise, especially in imaging and radiation oncology. An essential part of most prospective methods is the need to assess the various risks associated with problems, failures, errors, and design flaws in our systems. Wemore » therefore begin with an overview of risk assessment methodologies used in healthcare and industry and discuss their strengths and weaknesses. The rationale for use of process mapping, failure modes and effects analysis (FMEA) and fault tree analysis (FTA) by TG-100 will be described, as well as suggestions for the way forward. This is followed by discussion of radiation oncology specific risk assessment strategies and issues, including the TG-100 effort to evaluate IMRT and other ways to think about risk in the context of radiotherapy. Incident learning systems, local as well as the ASTRO/AAPM ROILS system, can also be useful in the risk assessment process. Finally, risk in the context of medical imaging will be discussed. Radiation (and other) safety considerations, as well as lack of quality and certainty all contribute to the potential risks associated with suboptimal imaging. The goal of this session is to summarize a wide variety of risk analysis methods and issues to give the medical physicist access to tools which can better define risks (and their importance) which we work to mitigate with both prescriptive and prospective risk-based quality management methods. Learning Objectives: Description of risk assessment methodologies used in healthcare and industry Discussion of radiation oncology-specific risk assessment strategies and issues Evaluation of risk in the context of medical imaging and image quality E. Samei: Research grants from Siemens and GE.« less

WE-B-BRC-03: Risk in the Context of Medical Imaging

DOE Office of Scientific and Technical Information (OSTI.GOV)

Samei, E.

Prospective quality management techniques, long used by engineering and industry, have become a growing aspect of efforts to improve quality management and safety in healthcare. These techniques are of particular interest to medical physics as scope and complexity of clinical practice continue to grow, thus making the prescriptive methods we have used harder to apply and potentially less effective for our interconnected and highly complex healthcare enterprise, especially in imaging and radiation oncology. An essential part of most prospective methods is the need to assess the various risks associated with problems, failures, errors, and design flaws in our systems. Wemore » therefore begin with an overview of risk assessment methodologies used in healthcare and industry and discuss their strengths and weaknesses. The rationale for use of process mapping, failure modes and effects analysis (FMEA) and fault tree analysis (FTA) by TG-100 will be described, as well as suggestions for the way forward. This is followed by discussion of radiation oncology specific risk assessment strategies and issues, including the TG-100 effort to evaluate IMRT and other ways to think about risk in the context of radiotherapy. Incident learning systems, local as well as the ASTRO/AAPM ROILS system, can also be useful in the risk assessment process. Finally, risk in the context of medical imaging will be discussed. Radiation (and other) safety considerations, as well as lack of quality and certainty all contribute to the potential risks associated with suboptimal imaging. The goal of this session is to summarize a wide variety of risk analysis methods and issues to give the medical physicist access to tools which can better define risks (and their importance) which we work to mitigate with both prescriptive and prospective risk-based quality management methods. Learning Objectives: Description of risk assessment methodologies used in healthcare and industry Discussion of radiation oncology-specific risk assessment strategies and issues Evaluation of risk in the context of medical imaging and image quality E. Samei: Research grants from Siemens and GE.« less

WE-B-BRC-00: Concepts in Risk-Based Assessment

DOE Office of Scientific and Technical Information (OSTI.GOV)

NONE

Prospective quality management techniques, long used by engineering and industry, have become a growing aspect of efforts to improve quality management and safety in healthcare. These techniques are of particular interest to medical physics as scope and complexity of clinical practice continue to grow, thus making the prescriptive methods we have used harder to apply and potentially less effective for our interconnected and highly complex healthcare enterprise, especially in imaging and radiation oncology. An essential part of most prospective methods is the need to assess the various risks associated with problems, failures, errors, and design flaws in our systems. Wemore » therefore begin with an overview of risk assessment methodologies used in healthcare and industry and discuss their strengths and weaknesses. The rationale for use of process mapping, failure modes and effects analysis (FMEA) and fault tree analysis (FTA) by TG-100 will be described, as well as suggestions for the way forward. This is followed by discussion of radiation oncology specific risk assessment strategies and issues, including the TG-100 effort to evaluate IMRT and other ways to think about risk in the context of radiotherapy. Incident learning systems, local as well as the ASTRO/AAPM ROILS system, can also be useful in the risk assessment process. Finally, risk in the context of medical imaging will be discussed. Radiation (and other) safety considerations, as well as lack of quality and certainty all contribute to the potential risks associated with suboptimal imaging. The goal of this session is to summarize a wide variety of risk analysis methods and issues to give the medical physicist access to tools which can better define risks (and their importance) which we work to mitigate with both prescriptive and prospective risk-based quality management methods. Learning Objectives: Description of risk assessment methodologies used in healthcare and industry Discussion of radiation oncology-specific risk assessment strategies and issues Evaluation of risk in the context of medical imaging and image quality E. Samei: Research grants from Siemens and GE.« less

NASA System Safety Handbook. Volume 1; System Safety Framework and Concepts for Implementation

NASA Technical Reports Server (NTRS)

Dezfuli, Homayoon; Benjamin, Allan; Everett, Christopher; Smith, Curtis; Stamatelatos, Michael; Youngblood, Robert

2011-01-01

System safety assessment is defined in NPR 8715.3C, NASA General Safety Program Requirements as a disciplined, systematic approach to the analysis of risks resulting from hazards that can affect humans, the environment, and mission assets. Achievement of the highest practicable degree of system safety is one of NASA's highest priorities. Traditionally, system safety assessment at NASA and elsewhere has focused on the application of a set of safety analysis tools to identify safety risks and formulate effective controls.1 Familiar tools used for this purpose include various forms of hazard analyses, failure modes and effects analyses, and probabilistic safety assessment (commonly also referred to as probabilistic risk assessment (PRA)). In the past, it has been assumed that to show that a system is safe, it is sufficient to provide assurance that the process for identifying the hazards has been as comprehensive as possible and that each identified hazard has one or more associated controls. The NASA Aerospace Safety Advisory Panel (ASAP) has made several statements in its annual reports supporting a more holistic approach. In 2006, it recommended that "... a comprehensive risk assessment, communication and acceptance process be implemented to ensure that overall launch risk is considered in an integrated and consistent manner." In 2009, it advocated for "... a process for using a risk-informed design approach to produce a design that is optimally and sufficiently safe." As a rationale for the latter advocacy, it stated that "... the ASAP applauds switching to a performance-based approach because it emphasizes early risk identification to guide designs, thus enabling creative design approaches that might be more efficient, safer, or both." For purposes of this preface, it is worth mentioning three areas where the handbook emphasizes a more holistic type of thinking. First, the handbook takes the position that it is important to not just focus on risk on an individual basis but to consider measures of aggregate safety risk and to ensure wherever possible that there be quantitative measures for evaluating how effective the controls are in reducing these aggregate risks. The term aggregate risk, when used in this handbook, refers to the accumulation of risks from individual scenarios that lead to a shortfall in safety performance at a high level: e.g., an excessively high probability of loss of crew, loss of mission, planetary contamination, etc. Without aggregated quantitative measures such as these, it is not reasonable to expect that safety has been optimized with respect to other technical and programmatic objectives. At the same time, it is fully recognized that not all sources of risk are amenable to precise quantitative analysis and that the use of qualitative approaches and bounding estimates may be appropriate for those risk sources. Second, the handbook stresses the necessity of developing confidence that the controls derived for the purpose of achieving system safety not only handle risks that have been identified and properly characterized but also provide a general, more holistic means for protecting against unidentified or uncharacterized risks. For example, while it is not possible to be assured that all credible causes of risk have been identified, there are defenses that can provide protection against broad categories of risks and thereby increase the chances that individual causes are contained. Third, the handbook strives at all times to treat uncertainties as an integral aspect of risk and as a part of making decisions. The term "uncertainty" here does not refer to an actuarial type of data analysis, but rather to a characterization of our state of knowledge regarding results from logical and physical models that approximate reality. Uncertainty analysis finds how the output parameters of the models are related to plausible variations in the input parameters and in the modeling assumptions. The evaluation of unrtainties represents a method of probabilistic thinking wherein the analyst and decision makers recognize possible outcomes other than the outcome perceived to be "most likely." Without this type of analysis, it is not possible to determine the worth of an analysis product as a basis for making decisions related to safety and mission success. In line with these considerations the handbook does not take a hazard-analysis-centric approach to system safety. Hazard analysis remains a useful tool to facilitate brainstorming but does not substitute for a more holistic approach geared to a comprehensive identification and understanding of individual risk issues and their contributions to aggregate safety risks. The handbook strives to emphasize the importance of identifying the most critical scenarios that contribute to the risk of not meeting the agreed-upon safety objectives and requirements using all appropriate tools (including but not limited to hazard analysis). Thereafter, emphasis shifts to identifying the risk drivers that cause these scenarios to be critical and ensuring that there are controls directed toward preventing or mitigating the risk drivers. To address these and other areas, the handbook advocates a proactive, analytic-deliberative, risk-informed approach to system safety, enabling the integration of system safety activities with systems engineering and risk management processes. It emphasizes how one can systematically provide the necessary evidence to substantiate the claim that a system is safe to within an acceptable risk tolerance, and that safety has been achieved in a cost-effective manner. The methodology discussed in this handbook is part of a systems engineering process and is intended to be integral to the system safety practices being conducted by the NASA safety and mission assurance and systems engineering organizations. The handbook posits that to conclude that a system is adequately safe, it is necessary to consider a set of safety claims that derive from the safety objectives of the organization. The safety claims are developed from a hierarchy of safety objectives and are therefore hierarchical themselves. Assurance that all the claims are true within acceptable risk tolerance limits implies that all of the safety objectives have been satisfied, and therefore that the system is safe. The acceptable risk tolerance limits are provided by the authority who must make the decision whether or not to proceed to the next step in the life cycle. These tolerances are therefore referred to as the decision maker's risk tolerances. In general, the safety claims address two fundamental facets of safety: 1) whether required safety thresholds or goals have been achieved, and 2) whether the safety risk is as low as possible within reasonable impacts on cost, schedule, and performance. The latter facet includes consideration of controls that are collective in nature (i.e., apply generically to broad categories of risks) and thereby provide protection against unidentified or uncharacterized risks.

Root Source Analysis/ValuStream[Trade Mark] - A Methodology for Identifying and Managing Risks

NASA Technical Reports Server (NTRS)

Brown, Richard Lee

2008-01-01

Root Source Analysis (RoSA) is a systems engineering methodology that has been developed at NASA over the past five years. It is designed to reduce costs, schedule, and technical risks by systematically examining critical assumptions and the state of the knowledge needed to bring to fruition the products that satisfy mission-driven requirements, as defined for each element of the Work (or Product) Breakdown Structure (WBS or PBS). This methodology is sometimes referred to as the ValuStream method, as inherent in the process is the linking and prioritizing of uncertainties arising from knowledge shortfalls directly to the customer's mission driven requirements. RoSA and ValuStream are synonymous terms. RoSA is not simply an alternate or improved method for identifying risks. It represents a paradigm shift. The emphasis is placed on identifying very specific knowledge shortfalls and assumptions that are the root sources of the risk (the why), rather than on assessing the WBS product(s) themselves (the what). In so doing RoSA looks forward to anticipate, identify, and prioritize knowledge shortfalls and assumptions that are likely to create significant uncertainties/ risks (as compared to Root Cause Analysis, which is most often used to look back to discover what was not known, or was assumed, that caused the failure). Experience indicates that RoSA, with its primary focus on assumptions and the state of the underlying knowledge needed to define, design, build, verify, and operate the products, can identify critical risks that historically have been missed by the usual approaches (i.e., design review process and classical risk identification methods). Further, the methodology answers four critical questions for decision makers and risk managers: 1. What s been included? 2. What's been left out? 3. How has it been validated? 4. Has the real source of the uncertainty/ risk been identified, i.e., is the perceived problem the real problem? Users of the RoSA methodology have characterized it as a true bottoms up risk assessment.

Conversion of Questionnaire Data

DOE Office of Scientific and Technical Information (OSTI.GOV)

Powell, Danny H; Elwood Jr, Robert H

During the survey, respondents are asked to provide qualitative answers (well, adequate, needs improvement) on how well material control and accountability (MC&A) functions are being performed. These responses can be used to develop failure probabilities for basic events performed during routine operation of the MC&A systems. The failure frequencies for individual events may be used to estimate total system effectiveness using a fault tree in a probabilistic risk analysis (PRA). Numeric risk values are required for the PRA fault tree calculations that are performed to evaluate system effectiveness. So, the performance ratings in the questionnaire must be converted to relativemore » risk values for all of the basic MC&A tasks performed in the facility. If a specific material protection, control, and accountability (MPC&A) task is being performed at the 'perfect' level, the task is considered to have a near zero risk of failure. If the task is performed at a less than perfect level, the deficiency in performance represents some risk of failure for the event. As the degree of deficiency in performance increases, the risk of failure increases. If a task that should be performed is not being performed, that task is in a state of failure. The failure probabilities of all basic events contribute to the total system risk. Conversion of questionnaire MPC&A system performance data to numeric values is a separate function from the process of completing the questionnaire. When specific questions in the questionnaire are answered, the focus is on correctly assessing and reporting, in an adjectival manner, the actual performance of the related MC&A function. Prior to conversion, consideration should not be given to the numeric value that will be assigned during the conversion process. In the conversion process, adjectival responses to questions on system performance are quantified based on a log normal scale typically used in human error analysis (see A.D. Swain and H.E. Guttmann, 'Handbook of Human Reliability Analysis with Emphasis on Nuclear Power Plant Applications,' NUREG/CR-1278). This conversion produces the basic event risk of failure values required for the fault tree calculations. The fault tree is a deductive logic structure that corresponds to the operational nuclear MC&A system at a nuclear facility. The conventional Delphi process is a time-honored approach commonly used in the risk assessment field to extract numerical values for the failure rates of actions or activities when statistically significant data is absent.« less

Safety Analysis of Soybean Processing for Advanced Life Support

NASA Technical Reports Server (NTRS)

Hentges, Dawn L.

1999-01-01

Soybeans (cv. Hoyt) is one of the crops planned for food production within the Advanced Life Support System Integration Testbed (ALSSIT), a proposed habitat simulation for long duration lunar/Mars missions. Soybeans may be processed into a variety of food products, including soymilk, tofu, and tempeh. Due to the closed environmental system and importance of crew health maintenance, food safety is a primary concern on long duration space missions. Identification of the food safety hazards and critical control points associated with the closed ALSSIT system is essential for the development of safe food processing techniques and equipment. A Hazard Analysis Critical Control Point (HACCP) model was developed to reflect proposed production and processing protocols for ALSSIT soybeans. Soybean processing was placed in the type III risk category. During the processing of ALSSIT-grown soybeans, critical control points were identified to control microbiological hazards, particularly mycotoxins, and chemical hazards from antinutrients. Critical limits were suggested at each CCP. Food safety recommendations regarding the hazards and risks associated with growing, harvesting, and processing soybeans; biomass management; and use of multifunctional equipment were made in consideration of the limitations and restraints of the closed ALSSIT.

Job safety analysis and hazard identification for work accident prevention in para rubber wood sawmills in southern Thailand.

PubMed

Thepaksorn, Phayong; Thongjerm, Supawan; Incharoen, Salee; Siriwong, Wattasit; Harada, Kouji; Koizumi, Akio

2017-11-25

We utilized job safety analysis (JSA) and hazard identification for work accident prevention in Para rubber wood sawmills, which aimed to investigate occupational health risk exposures and assess the health hazards at sawmills in the Trang Province, located in southern Thailand. We conducted a cross-sectional study which included a walk-through survey, JSA, occupational risk assessment, and environmental samplings from March through September 2015 at four Para rubber wood sawmills. We identified potential occupational safety and health hazards associated with six main processes, including: 1) logging and cutting, 2) sawing the lumber into sheets, 3) planing and re-arranging, 4) vacuuming and wood preservation, 5) drying and planks re-arranging, and 6) grading, packing, and storing. Working in sawmills was associated with high risk of wood dust and noise exposure, occupational accidents injuring hands and feet, chemicals and fungicide exposure, and injury due to poor ergonomics or repetitive work. Several high-risk areas were identified from JSA and hazard identification of the working processes, especially high wood dust and noise exposure when sawing lumber into sheets and risk of occupational accidents of the hands and feet when struck by lumber. All workers were strongly recommended to use personal protective equipment in any working processes. Exposures should be controlled using local ventilation systems and reducing noise transmission. We recommend that the results from the risk assessment performed in this study be used to create an action plan for reducing occupational health hazards in Para rubber sawmills.

Job safety analysis and hazard identification for work accident prevention in para rubber wood sawmills in southern Thailand

PubMed Central

Thepaksorn, Phayong; Thongjerm, Supawan; Incharoen, Salee; Siriwong, Wattasit; Harada, Kouji; Koizumi, Akio

2017-01-01

Objective: We utilized job safety analysis (JSA) and hazard identification for work accident prevention in Para rubber wood sawmills, which aimed to investigate occupational health risk exposures and assess the health hazards at sawmills in the Trang Province, located in southern Thailand. Methods: We conducted a cross-sectional study which included a walk-through survey, JSA, occupational risk assessment, and environmental samplings from March through September 2015 at four Para rubber wood sawmills. Results: We identified potential occupational safety and health hazards associated with six main processes, including: 1) logging and cutting, 2) sawing the lumber into sheets, 3) planing and re-arranging, 4) vacuuming and wood preservation, 5) drying and planks re-arranging, and 6) grading, packing, and storing. Working in sawmills was associated with high risk of wood dust and noise exposure, occupational accidents injuring hands and feet, chemicals and fungicide exposure, and injury due to poor ergonomics or repetitive work. Discussion: Several high-risk areas were identified from JSA and hazard identification of the working processes, especially high wood dust and noise exposure when sawing lumber into sheets and risk of occupational accidents of the hands and feet when struck by lumber. All workers were strongly recommended to use personal protective equipment in any working processes. Exposures should be controlled using local ventilation systems and reducing noise transmission. We recommend that the results from the risk assessment performed in this study be used to create an action plan for reducing occupational health hazards in Para rubber sawmills. PMID:28993571

Integrated risk assessment and screening analysis of drinking water safety of a conventional water supply system.

PubMed

Sun, F; Chen, J; Tong, Q; Zeng, S

2007-01-01

Management of drinking water safety is changing towards an integrated risk assessment and risk management approach that includes all processes in a water supply system from catchment to consumers. However, given the large number of water supply systems in China and the cost of implementing such a risk assessment procedure, there is a necessity to first conduct a strategic screening analysis at a national level. An integrated methodology of risk assessment and screening analysis is thus proposed to evaluate drinking water safety of a conventional water supply system. The violation probability, indicating drinking water safety, is estimated at different locations of a water supply system in terms of permanganate index, ammonia nitrogen, turbidity, residual chlorine and trihalomethanes. Critical parameters with respect to drinking water safety are then identified, based on which an index system is developed to prioritize conventional water supply systems in implementing a detailed risk assessment procedure. The evaluation results are represented as graphic check matrices for the concerned hazards in drinking water, from which the vulnerability of a conventional water supply system is characterized.

Social amplification of risk in the Internet environment.

PubMed

Chung, Ik Jae

2011-12-01

This article analyzes the dynamic process of risk amplification in the Internet environment with special emphasis on public concern for environmental risks from a high-speed railway tunnel construction project in South Korea. Environmental organizations and activists serving as social stations collected information about the project and its ecological impact, and communicated this with the general public, social groups, and institutions. The Internet provides social stations and the public with an efficient means for interactive communication and an open space for active information sharing and public participation. For example, while the website of an organization such as an environmental activist group can initially trigger local interest, the Internet allows this information to be disseminated to a much wider audience in a manner unavailable to the traditional media. Interaction among social stations demonstrates an amplifying process of public attention to the risk. Analyses of the volume of readers' comments to online newspaper articles and public opinions posted on message board of public and nonprofit organizations show the ripple effects of the amplification process as measured along temporal, geographical, and sectoral dimensions. Public attention is also influenced by the symbolic connotations of risk information. Interpretations of risk in religious, political, or legal terms intensify public concern for the environmental risk. © 2011 Society for Risk Analysis.

Using software security analysis to verify the secure socket layer (SSL) protocol

NASA Technical Reports Server (NTRS)

Powell, John D.

2004-01-01

nal Aeronautics and Space Administration (NASA) have tens of thousands of networked computer systems and applications. Software Security vulnerabilities present risks such as lost or corrupted data, information the3, and unavailability of critical systems. These risks represent potentially enormous costs to NASA. The NASA Code Q research initiative 'Reducing Software Security Risk (RSSR) Trough an Integrated Approach '' offers, among its capabilities, formal verification of software security properties, through the use of model based verification (MBV) to address software security risks. [1,2,3,4,5,6] MBV is a formal approach to software assurance that combines analysis of software, via abstract models, with technology, such as model checkers, that provide automation of the mechanical portions of the analysis process. This paper will discuss: The need for formal analysis to assure software systems with respect to software and why testing alone cannot provide it. The means by which MBV with a Flexible Modeling Framework (FMF) accomplishes the necessary analysis task. An example of FMF style MBV in the verification of properties over the Secure Socket Layer (SSL) communication protocol as a demonstration.

Through ARIPAR-GIS the quantified area risk analysis supports land-use planning activities.

PubMed

Spadoni, G; Egidi, D; Contini, S

2000-01-07

The paper first summarises the main aspects of the ARIPAR methodology whose steps can be applied to quantify the impact on a territory of major accident risks due to processing, storing and transporting dangerous substances. Then the capabilities of the new decision support tool ARIPAR-GIS, implementing the mentioned procedure, are described, together with its main features and types of results. These are clearly shown through a short description of the updated ARIPAR study (reference year 1994), in which the impact of changes due to industrial and transportation dynamics on the Ravenna territory in Italy were evaluated. The brief explanation of how results have been used by local administrations offers the opportunity to discuss about advantages of the quantitative area risk analysis tool in supporting activities of risk management, risk control and land-use planning.

Improving the treatment planning and delivery process of Xoft electronic skin brachytherapy.

PubMed

Manger, Ryan; Rahn, Douglas; Hoisak, Jeremy; Dragojević, Irena

2018-05-14

To develop an improved Xoft electronic skin brachytherapy process and identify areas of further improvement. A multidisciplinary team conducted a failure modes and effects analysis (FMEA) by developing a process map and a corresponding list of failure modes. The failure modes were scored for their occurrence, severity, and detectability, and a risk priority number (RPN) was calculated for each failure mode as the product of occurrence, severity, and detectability. Corrective actions were implemented to address the higher risk failure modes, and a revised process was generated. The RPNs of the failure modes were compared between the initial process and final process to assess the perceived benefits of the corrective actions. The final treatment process consists of 100 steps and 114 failure modes. The FMEA took approximately 20 person-hours (one physician, three physicists, and two therapists) to complete. The 10 most dangerous failure modes had RPNs ranging from 336 to 630. Corrective actions were effective at addressing most failure modes (10 riskiest RPNs ranging from 189 to 310), yet the RPNs were higher than those published for alternative systems. Many of these high-risk failure modes remained due to hardware design limitations. FMEA helps guide process improvement efforts by emphasizing the riskiest steps. Significant risks are apparent when using a Xoft treatment unit for skin brachytherapy due to hardware limitations such as the lack of several interlocks, a short source lifespan, and variability in source output. The process presented in this article is expected to reduce but not eliminate these risks. Copyright © 2018 American Brachytherapy Society. Published by Elsevier Inc. All rights reserved.

Are Suicide Attempters Wired Differently?: A Comparison With Nonsuicidal Depressed Individuals Using Plan Analysis.

PubMed

Brüdern, Juliane; Berger, Thomas; Michel, Konrad; Maillart, Anja Gysin; Held, Isabelle Schmutz; Caspar, Franz

2015-07-01

Limited research exists on internal risk processes in suicide attempters and factors that distinguish them from nonsuicidal depressive individuals. In this qualitative study, we investigated Plans, motives, and underlying self-regulatory processes of the two groups and conducted a comparative analysis. We analyzed narrative interviews of 17 suicide attempters and intake interviews of 17 nonsuicidal depressive patients using Plan Analysis. Then, we developed a prototypical Plan structure for both groups. Suicidal behavior serves various Plans found only in suicide attempters. Plans of this group are especially related to social perfectionism and withdrawal to protect their self-esteem. Depressive patients use several interpersonal control and coping strategies, which might help prevent suicidal behavior. The prototypical Plan structure of suicide attempters may be a valuable tool for clinicians to detect critical Plans and motives in their interaction with patients, which are related to suicide risk.

Chemical facility vulnerability assessment project.

PubMed

Jaeger, Calvin D

2003-11-14

Sandia National Laboratories, under the direction of the Office of Science and Technology, National Institute of Justice, conducted the chemical facility vulnerability assessment (CFVA) project. The primary objective of this project was to develop, test and validate a vulnerability assessment methodology (VAM) for determining the security of chemical facilities against terrorist or criminal attacks (VAM-CF). The project also included a report to the Department of Justice for Congress that in addition to describing the VAM-CF also addressed general observations related to security practices, threats and risks at chemical facilities and chemical transport. In the development of the VAM-CF Sandia leveraged the experience gained from the use and development of VAs in other areas and the input from the chemical industry and Federal agencies. The VAM-CF is a systematic, risk-based approach where risk is a function of the severity of consequences of an undesired event, the attack potential, and the likelihood of adversary success in causing the undesired event. For the purpose of the VAM-CF analyses Risk is a function of S, L(A), and L(AS), where S is the severity of consequence of an event, L(A) is the attack potential and L(AS) likelihood of adversary success in causing a catastrophic event. The VAM-CF consists of 13 basic steps. It involves an initial screening step, which helps to identify and prioritize facilities for further analysis. This step is similar to the prioritization approach developed by the American Chemistry Council (ACC). Other steps help to determine the components of the risk equation and ultimately the risk. The VAM-CF process involves identifying the hazardous chemicals and processes at a chemical facility. It helps chemical facilities to focus their attention on the most critical areas. The VAM-CF is not a quantitative analysis but, rather, compares relative security risks. If the risks are deemed too high, recommendations are developed for measures to reduce the risk. This paper will briefly discuss the CFVA project and VAM-CF process.

Application of risk-based multiple criteria decision analysis for selection of the best agricultural scenario for effective watershed management.

PubMed

Javidi Sabbaghian, Reza; Zarghami, Mahdi; Nejadhashemi, A Pouyan; Sharifi, Mohammad Bagher; Herman, Matthew R; Daneshvar, Fariborz

2016-03-01

Effective watershed management requires the evaluation of agricultural best management practice (BMP) scenarios which carefully consider the relevant environmental, economic, and social criteria involved. In the Multiple Criteria Decision-Making (MCDM) process, scenarios are first evaluated and then ranked to determine the most desirable outcome for the particular watershed. The main challenge of this process is the accurate identification of the best solution for the watershed in question, despite the various risk attitudes presented by the associated decision-makers (DMs). This paper introduces a novel approach for implementation of the MCDM process based on a comparative neutral risk/risk-based decision analysis, which results in the selection of the most desirable scenario for use in the entire watershed. At the sub-basin level, each scenario includes multiple BMPs with scores that have been calculated using the criteria derived from two cases of neutral risk and risk-based decision-making. The simple additive weighting (SAW) operator is applied for use in neutral risk decision-making, while the ordered weighted averaging (OWA) and induced OWA (IOWA) operators are effective for risk-based decision-making. At the watershed level, the BMP scores of the sub-basins are aggregated to calculate each scenarios' combined goodness measurements; the most desirable scenario for the entire watershed is then selected based on the combined goodness measurements. Our final results illustrate the type of operator and risk attitudes needed to satisfy the relevant criteria within the number of sub-basins, and how they ultimately affect the final ranking of the given scenarios. The methodology proposed here has been successfully applied to the Honeyoey Creek-Pine Creek watershed in Michigan, USA to evaluate various BMP scenarios and determine the best solution for both the stakeholders and the overall stream health. Copyright © 2015 Elsevier Ltd. All rights reserved.

Inhalation Anthrax: Dose Response and Risk Analysis

PubMed Central

Thran, Brandolyn; Morse, Stephen S.; Hugh-Jones, Martin; Massulik, Stacey

2008-01-01

The notion that inhalation of a single Bacillus anthracis spore is fatal has become entrenched nearly to the point of urban legend, in part because of incomplete articulation of the scientific basis for microbial risk assessment, particularly dose-response assessment. Risk analysis (ie, risk assessment, risk communication, risk management) necessitates transparency: distinguishing scientific facts, hypotheses, judgments, biases in interpretations, and potential misinformation. The difficulty in achieving transparency for biothreat risk is magnified by misinformation and poor characterization of both dose-response relationships and the driving mechanisms that cause susceptibility or resistance to disease progression. Regrettably, this entrenchment unnecessarily restricts preparedness planning to a single response scenario: decontaminate until no spores are detectable in air, water, or on surfaces—essentially forcing a zero-tolerance policy inconsistent with the biology of anthrax. We present evidence about inhalation anthrax dose-response relationships, including reports from multiple studies documenting exposures insufficient to cause inhalation anthrax in laboratory animals and humans. The emphasis of the article is clarification about what is known from objective scientific evidence for doses of anthrax spores associated with survival and mortality. From this knowledge base, we discuss the need for future applications of more formal risk analysis processes to guide development of alternative non-zero criteria or standards based on science to inform preparedness planning and other risk management activities. PMID:18582166

[Risk Management: concepts and chances for public health].

PubMed

Palm, Stefan; Cardeneo, Margareta; Halber, Marco; Schrappe, Matthias

2002-01-15

Errors are a common problem in medicine and occur as a result of a complex process involving many contributing factors. Medical errors significantly reduce the safety margin for the patient and contribute additional costs in health care delivery. In most cases adverse events cannot be attributed to a single underlying cause. Therefore an effective risk management strategy must follow a system approach, which is based on counting and analysis of near misses. The development of defenses against the undesired effects of errors should be the main focus rather than asking the question "Who blundered?". Analysis of near misses (which in this context can be compared to indicators) offers several methodological advantages as compared to the analysis of errors and adverse events. Risk management is an integral element of quality management.

The Mutable Nature of Risk and Acceptability: A Hybrid Risk Governance Framework.

PubMed

Wong, Catherine Mei Ling

2015-11-01

This article focuses on the fluid nature of risk problems and the challenges it presents to establishing acceptability in risk governance. It introduces an actor-network theory (ANT) perspective as a way to deal with the mutable nature of risk controversies and the configuration of stakeholders. To translate this into a practicable framework, the article proposes a hybrid risk governance framework that combines ANT with integrative risk governance, deliberative democracy, and responsive regulation. This addresses a number of the limitations in existing risk governance models, including: (1) the lack of more substantive public participation throughout the lifecycle of a project; (2) hijacking of deliberative forums by particular groups; and (3) the treatment of risk problems and their associated stakeholders as immutable entities. The framework constitutes a five-stage process of co-selection, co-design, co-planning, and co-regulation to facilitate the co-production of collective interests and knowledge, build capacities, and strengthen accountability in the process. The aims of this article are twofold: conceptually, it introduces a framework of risk governance that accounts for the mutable nature of risk problems and configuration of stakeholders. In practice, this article offers risk managers and practitioners of risk governance a set of procedures with which to operationalize this conceptual approach to risk and stakeholder engagement. © 2015 Society for Risk Analysis.

Maximizing User Satisfaction With Office Practice Data Processing Systems

PubMed Central

O'Flaherty, Thomas; Jussim, Judith

1980-01-01

Significant numbers of physicians are using data processing services and a large number of firms are offering an increasing variety of services. This paper quantifies user dissatisfaction with office practice data processing systems and analyzes factors affecting dissatisfaction in large group practices. Based on this analysis, a proposal is made for a more structured approach to obtaining data processing services in order to lower the risks and increase satisfaction with data processing.

Public Health Risk Conditioned by Chemical Composition of Ground Water

NASA Astrophysics Data System (ADS)

Yankovich, E.; Osipova, N.; Yankovich, K.; Matveenko, I.

2016-03-01

The article studies the public health potential risk originated from water consumption and estimated on the basis of the groundwater chemical composition. We have processed the results of chemical groundwater analysis in different aquifers of Tomsk district (Tomsk Oblast, Russia). More than 8400 samples of chemical groundwater analyses were taken during long-term observation period. Human health risk assessment of exposure to contaminants in drinking water was performed in accordance with the risk assessment guidance for public health concerning chemical pollution of the environment (Russian reference number: 2.1.10.1920-04-M, 2004). Identified potential risks were estimated for consuming water of each aquifer. The comparative analysis of water quality of different aquifers was performed on the basis of the risk coefficient of the total non-carcinogenic effects. The non-carcinogenic risk for the health of the Tomsk district population due to groundwater consumption without prior sanitary treatment was admitted acceptable. A rather similar picture is observed for all aquifers, although deeper aquifers show lower hazard coefficients.

Reliability Analysis and Standardization of Spacecraft Command Generation Processes

NASA Technical Reports Server (NTRS)

Meshkat, Leila; Grenander, Sven; Evensen, Ken

2011-01-01

center dot In order to reduce commanding errors that are caused by humans, we create an approach and corresponding artifacts for standardizing the command generation process and conducting risk management during the design and assurance of such processes. center dot The literature review conducted during the standardization process revealed that very few atomic level human activities are associated with even a broad set of missions. center dot Applicable human reliability metrics for performing these atomic level tasks are available. center dot The process for building a "Periodic Table" of Command and Control Functions as well as Probabilistic Risk Assessment (PRA) models is demonstrated. center dot The PRA models are executed using data from human reliability data banks. center dot The Periodic Table is related to the PRA models via Fault Links.

A Geometric Analysis to Protect Manned Assets from Newly Launched Objects - Cola Gap Analysis

NASA Technical Reports Server (NTRS)

Hametz, Mark E.; Beaver, Brian A.

2013-01-01

A safety risk was identified for the International Space Station (ISS) by The Aerospace Corporation, where the ISS would be unable to react to a conjunction with a newly launched object following the end of the launch Collision Avoidance (COLA) process. Once an object is launched, there is a finite period of time required to track, catalog, and evaluate that new object as part of standard onorbit COLA screening processes. Additionally, should a conjunction be identified, there is an additional period of time required to plan and execute a collision avoidance maneuver. While the computed prelaunch probability of collision with any object is extremely low, NASA/JSC has requested that all US launches take additional steps to protect the ISS during this "COLA gap" period. This paper details a geometric-based COLA gap analysis method developed by the NASA Launch Services Program to determine if launch window cutouts are required to mitigate this risk. Additionally, this paper presents the results of several missions where this process has been used operationally.

Large-scale experiments for the vulnerability analysis of buildings impacted and intruded by fluviatile torrential hazard processes

NASA Astrophysics Data System (ADS)

Sturm, Michael; Gems, Bernhard; Fuchs, Sven; Mazzorana, Bruno; Papathoma-Köhle, Maria; Aufleger, Markus

2016-04-01

In European mountain regions, losses due to torrential hazards are still considerable high despite the ongoing debate on an overall increasing or decreasing trend. Recent events in Austria severely revealed that due to technical and economic reasons, an overall protection of settlements in the alpine environment against torrential hazards is not feasible. On the side of the hazard process, events with unpredictable intensities may represent overload scenarios for existent protection structures in the torrent catchments. They bear a particular risk of significant losses in the living space. Although the importance of vulnerability is widely recognised, there is still a research gap concerning its assessment. Currently, potential losses at buildings due to torrential hazards and their comparison with reinstatement costs are determined by the use of empirical functions. Hence, relations of process intensities and the extent of losses, gathered by the analysis of historic hazard events and the information of object-specific restoration values, are used. This approach does not represent a physics-based and integral concept since relevant and often crucial processes, as the intrusion of the fluid-sediment-mixture into elements at risk, are not considered. Based on these findings, our work is targeted at extending these findings and models of present risk research in the context of an integral, more physics-based vulnerability analysis concept. Fluviatile torrential hazard processes and their impacts on the building envelope are experimentally modelled. Material intrusion processes are thereby explicitly considered. Dynamic impacts are gathered quantitatively and spatially distributed by the use of a large set of force transducers. The experimental tests are accomplished with artificial, vertical and skewed plates, including also openings for material intrusion. Further, the impacts on specific buildings within the test site of the work, the fan apex of the Schnannerbach torrent in Tyrol (Austria), are analysed in detail. A couple of buildings are entirely reconstructed within the physical scale model at the scale 1:30. They include basement and first floor and thereby all relevant openings on the building envelopes. The results from experimental modelling represent the data basis for further physics-based vulnerability analysis. Hence, the applied vulnerability analysis concept significantly extends the methods presently used in flood risk assessment. The results of the study are of basic importance for practical application, as they provide extensive information to support hazard zone mapping and management, as well as the planning of local technical protection measures.

Military Ecological Risk Assessment Framework (MERAF) for Assessment of Risks of Military Training and Testing to Natural Resources

DOE Office of Scientific and Technical Information (OSTI.GOV)

Suter II, G.W.

2003-06-18

The objective of this research is to provide the DoD with a framework based on a systematic, risk-based approach to assess impacts for management of natural resources in an ecosystem context. This risk assessment framework is consistent with, but extends beyond, the EPA's ecological risk assessment framework, and specifically addresses DoD activities and management needs. MERAF is intended to be consistent with existing procedures for environmental assessment and planning with DoD testing and training. The intention is to supplement these procedures rather than creating new procedural requirements. MERAF is suitable for use for training and testing area assessment and management.more » It does not include human health risks nor does it address specific permitting or compliance requirements, although it may be useful in some of these cases. Use of MERAF fits into the National Environmental Policy Act (NEPA) process by providing a consistent and rigorous way of organizing and conducting the technical analysis for Environmental Impact Statements (EISs) (Sigal 1993; Carpenter 1995; Canter and Sadler 1997). It neither conflicts with, nor replaces, procedural requirements within the NEPA process or document management processes already in place within DoD.« less

Cognitive and affective influences on perceived risk of ovarian cancer†

PubMed Central

Peipins, Lucy A.; McCarty, Frances; Hawkins, Nikki A.; Rodriguez, Juan L.; Scholl, Lawrence E.; Leadbetter, Steven

2015-01-01

Introduction Studies suggest that both affective and cognitive processes are involved in the perception of vulnerability to cancer and that affect has an early influence in this assessment of risk. We constructed a path model based on a conceptual framework of heuristic reasoning (affect, resemblance, and availability) coupled with cognitive processes involved in developing personal models of cancer causation. Methods From an eligible cohort of 16 700 women in a managed care organization, we randomly selected 2524 women at high, elevated, and average risk of ovarian cancer and administered a questionnaire to test our model (response rate 76.3%). Path analysis delineated the relationships between personal and cognitive characteristics (number of relatives with cancer, age, ideas about cancer causation, perceived resemblance to an affected friend or relative, and ovarian cancer knowledge) and emotional constructs (closeness to an affected relative or friend, time spent processing the cancer experience, and cancer worry) on perceived risk of ovarian cancer. Results Our final model fit the data well (root mean square error of approximation (RMSEA) = 0.028, comparative fit index (CFI) = 0.99, normed fit index (NFI) = 0.98). This final model (1) demonstrated the nature and direction of relationships between cognitive characteristics and perceived risk; (2) showed that time spent processing the cancer experience was associated with cancer worry; and (3) showed that cancer worry moderately influenced perceived risk. Discussion Our results highlight the important role that family cancer experience has on cancer worry and shows how cancer experience translates into personal risk perceptions. This understanding informs the discordance between medical or objective risk assessment and personal risk assessment. PMID:24916837

Brief Intervention for Truant Youth Sexual Risk Behavior and Alcohol Use: A Parallel Process Growth Model Analysis

ERIC Educational Resources Information Center

Dembo, Richard; Briones-Robinson, Rhissa; Ungaro, Rocio; Barrett, Kimberly; Gulledge, Laura; Winters, Ken C.; Belenko, Steven; Karas, Lora M.; Wareham, Jennifer

2014-01-01

Truant youths frequently experience family problems, emotional/psychological issues, substance misuse, and delinquency. They are likely engaging in alcohol use and sexual risk behavior at a higher rate than the general youth population. Early intervention services would benefit them, their families, and society. We present interim findings from an…

Literacy Profiles of At-Risk Young Adults Enrolled in Career and Technical Education

ERIC Educational Resources Information Center

Mellard, Daryl F.; Woods, Kari L.; Lee, Jae Hoon

2016-01-01

A latent profile analysis of 323 economically and academically at-risk adolescent and young adult learners yielded two classes: an average literacy class (92%) and a low literacy class (8%). The class profiles significantly differed in their word reading and math skills, and in their processing speeds and self-reported learning disabilities. The…

Risk management of emergency service vehicle crashes in the United States fire service: process, outputs, and recommendations.

PubMed

Bui, David P; Pollack Porter, Keshia; Griffin, Stephanie; French, Dustin D; Jung, Alesia M; Crothers, Stephen; Burgess, Jefferey L

2017-11-17

Emergency service vehicle crashes (ESVCs) are a leading cause of death in the United States fire service. Risk management (RM) is a proactive process for identifying occupational risks and reducing hazards and unwanted events through an iterative process of scoping hazards, risk assessment, and implementing controls. We describe the process, outputs, and lessons learned from the application of a proactive RM process to reduce ESVCs in US fire departments. Three fire departments representative of urban, suburban, and rural geographies, participated in a facilitated RM process delivered through focus groups and stakeholder discussion. Crash reports from department databases were reviewed to characterize the context, circumstances, hazards and risks of ESVCs. Identified risks were ranked using a risk matrix that considered risk likelihood and severity. Department-specific control measures were selected based on group consensus. Interviews, and focus groups were used to assess acceptability and utility of the RM process and perceived facilitators and barriers of implementation. Three to six RM meetings were conducted at each fire department. There were 7.4 crashes per 100 personnel in the urban department and 10.5 per 100 personnel in the suburban department; the rural department experienced zero crashes. All departments identified emergency response, backing, on scene struck by, driver distraction, vehicle/road visibility, and driver training as high or medium concerns. Additional high priority risks varied by department; the urban department prioritized turning and rear ending crashes; the suburban firefighters prioritized inclement weather/road environment and low visibility related crashes; and the rural volunteer fire department prioritized exiting station, vehicle failure, and inclement weather/road environment related incidents. Selected controls included new policies and standard operating procedures to reduce emergency response, cameras to enhance driver visibility while backing, and increased training frequency and enhanced training. The RM process was generally acceptable to department participants and considered useful. All departments reported that the focused and systematic analysis of crashes was particularly helpful. Implementation of controls was a commonly cited challenge. Proactive RM of ESVCs in three US fire departments was positively received and supported the establishment of interventions tailored to each department's needs and priorities.

Failure Modes and Effects Analysis (FMEA): A Bibliography

NASA Technical Reports Server (NTRS)

2000-01-01

Failure modes and effects analysis (FMEA) is a bottom-up analytical process that identifies process hazards, which helps managers understand vulnerabilities of systems, as well as assess and mitigate risk. It is one of several engineering tools and techniques available to program and project managers aimed at increasing the likelihood of safe and successful NASA programs and missions. This bibliography references 465 documents in the NASA STI Database that contain the major concepts, failure modes or failure analysis, in either the basic index of the major subject terms.

Managing the care needs of low-income board-and-care home residents: a process of negotiating risks.

PubMed

Perkins, Molly M; Ball, Mary M; Whittington, Frank J; Combs, Bess L

2004-04-01

Small, low-income board-and-care homes play a critical role in the long-term care system, serving a variety of at-risk groups, including chronically mentally ill individuals, frail elders, and developmentally disabled adults. Unfortunately, the supply of homes available to serve these populations is decreasing. The purpose of this study, based on an in-depth ethnographic case study of one small (13-bed) African American-owned and -operated home in metropolitan Atlanta, was to understand how and why some homes continue to operate despite significant challenges. Grounded theory analysis showed that the survival of this home and residents' ability to remain in it involved a basic social process conceptualized as Negotiating Risks. This survival process often put participants at risk of losing their means of subsistence. Community support emerged as an important protective factor. Findings have implications for community interventions to increase these homes' survival and improve resident care.

Meat Consumption and Risk of Metabolic Syndrome: Results from the Korean Population and a Meta-Analysis of Observational Studies

PubMed Central

Kim, Youngyo; Je, Youjin

2018-01-01

Many studies have reported harmful effects of red meat or processed meat on chronic diseases including cancer and diabetes, but epidemiological evidence for metabolic syndrome is limited and remains controversial. Therefore, we performed a meta-analysis of observational studies to assess the association between various meat consumption and risk of metabolic syndrome. The PubMed and ISI Web of Science databases were searched through June 2017, and further included unpublished results from Korea National Health and Nutrition Examination Survey 2012–2015, including 8387 Korean adults. Sixteen studies were suitable for meta-analysis, which included 19,579 cases among 76,111 participants. We used a random-effects model to calculate the pooled relative risks (RR) and 95% confidence intervals (CI). The pooled RR for metabolic syndrome of the highest versus lowest category of meat intake was 1.14 (95% CI: 1.05, 1.23) for total meat, 1.33 (95% CI: 1.01, 1.74) for red meat, 1.35 (95% CI: 1.18, 1.54) for processed meat, and 0.86 (95% CI: 0.76, 0.97) for white meat. All of these associations did not differ significantly by study design and adjustment factors. Our findings indicated that total, red, and processed meat intake is positively associated with metabolic syndrome, and white meat intake is inversely associated with metabolic syndrome. PMID:29565803

The efficacy of mobile application use on recall of surgical risks in nasal bone fracture reduction surgery

PubMed Central

Kim, Choong Hyeon; Cheon, Ji Seon; Choi, Woo Young; Son, Kyung Min

2018-01-01

Background The number of surgical risks recalled by a patient after surgery can be used as a parameter for assessing how well the patient has understood the informed consent process. No study has investigated the usefulness of a self-developed mobile application in the traditional informed consent process in patients with a nasal bone fracture. This study aimed to investigate whether delivery of information, such as surgical risks, through a mobile application is more effective than delivery of information through only verbal means and a paper. Methods This prospective, randomized study included 60 patients with a nasal bone fracture. The experimental group (n=30) received preoperative explanation with the traditional informed consent process in addition to a mobile application, while the control group (n=30) received preoperative explanation with only the traditional informed consent process. Four weeks after surgery, the number of recalled surgical risks was compared for analysis. The following six surgical risks were explained: pain, bleeding, nasal deformity, numbness, nasal obstruction, and nasal cartilage necrosis. Results The mean number of recalled surgical risks among all patients was 1.58±0.56. The most frequently recalled surgical risk was nasal deformity in both groups. The mean number of recalled surgical risks was 1.72±0.52 in the experimental group and 1.49±0.57 in the control group. There was a significant association between mobile application use and the mean number of recalled surgical risks (p=0.047). Age, sex, and the level of education were not significantly associated with the mean number of recalled surgical risks. Conclusion This study found that a mobile application could contribute to the efficient delivery of information during the informed consent process. With further improvement, it could be used in other plastic surgeries and other surgeries, and such an application can potentially be used for explaining risks as well as delivering other types of information. PMID:29609431

The efficacy of mobile application use on recall of surgical risks in nasal bone fracture reduction surgery.

PubMed

Kim, Choong Hyeon; Cheon, Ji Seon; Choi, Woo Young; Son, Kyung Min

2018-03-01

The number of surgical risks recalled by a patient after surgery can be used as a parameter for assessing how well the patient has understood the informed consent process. No study has investigated the usefulness of a self-developed mobile application in the traditional informed consent process in patients with a nasal bone fracture. This study aimed to investigate whether delivery of information, such as surgical risks, through a mobile application is more effective than delivery of information through only verbal means and a paper. This prospective, randomized study included 60 patients with a nasal bone fracture. The experimental group (n=30) received preoperative explanation with the traditional informed consent process in addition to a mobile application, while the control group (n=30) received preoperative explanation with only the traditional informed consent process. Four weeks after surgery, the number of recalled surgical risks was compared for analysis. The following six surgical risks were explained: pain, bleeding, nasal deformity, numbness, nasal obstruction, and nasal cartilage necrosis. The mean number of recalled surgical risks among all patients was 1.58±0.56. The most frequently recalled surgical risk was nasal deformity in both groups. The mean number of recalled surgical risks was 1.72±0.52 in the experimental group and 1.49±0.57 in the control group. There was a significant association between mobile application use and the mean number of recalled surgical risks ( p =0.047). Age, sex, and the level of education were not significantly associated with the mean number of recalled surgical risks. This study found that a mobile application could contribute to the efficient delivery of information during the informed consent process. With further improvement, it could be used in other plastic surgeries and other surgeries, and such an application can potentially be used for explaining risks as well as delivering other types of information.

A new process for organizing assessments of social, economic and environmental outcomes: case study of wildland fire management in the U.S.A.

EPA Science Inventory

Ecological risk assessments typically are organized using the processes of planning (a discussion among managers, stakeholders and analysis to clarify ecosystem management goals and assessment scope) and problem formulation (evaluation of existing information to generate hypothes...

An Expert Map of Gambling Risk Perception.

PubMed

Spurrier, Michael; Blaszczynski, Alexander; Rhodes, Paul

2015-12-01

The purpose of the current study was to investigate the moderating or mediating role played by risk perception in decision-making, gambling behaviour, and disordered gambling aetiology. Eleven gambling expert clinicians and researchers completed a semi-structured interview derived from mental models and grounded theory methodologies. Expert interview data was used to construct a comprehensive expert mental model 'map' detailing risk-perception related factors contributing to harmful or safe gambling. Systematic overlapping processes of data gathering and analysis were used to iteratively extend, saturate, test for exception, and verify concepts and emergent themes. Findings indicated that experts considered idiosyncratic beliefs among gamblers result in overall underestimates of risk and loss, insufficient prioritization of needs, and planning and implementation of risk management strategies. Additional contextual factors influencing use of risk information (reinforcement and learning; mental states, environmental cues, ambivalence; and socio-cultural and biological variables) acted to shape risk perceptions and increase vulnerabilities to harm or disordered gambling. It was concluded that understanding the nature, extent and processes by which risk perception predisposes an individual to maintain gambling despite adverse consequences can guide the content of preventative educational responsible gambling campaigns.

Closing Intelligence Gaps: Synchronizing the Collection Management Process

DTIC Science & Technology

information flow. The US military divides the world into six distinct geographic areas with corresponding commanders managing risk and weighing...analyzed information , creating a mismatch between supply and demand. The result is a burden on all facets of the intelligence process. However, if the target...system, or problem requiring analysis is not collected, intelligence fails. Executing collection management under the traditional tasking process

A dynamical systems model for nuclear power plant risk

NASA Astrophysics Data System (ADS)

Hess, Stephen Michael

The recent transition to an open access generation marketplace has forced nuclear plant operators to become much more cost conscious and focused on plant performance. Coincidentally, the regulatory perspective also is in a state of transition from a command and control framework to one that is risk-informed and performance-based. Due to these structural changes in the economics and regulatory system associated with commercial nuclear power plant operation, there is an increased need for plant management to explicitly manage nuclear safety risk. Application of probabilistic risk assessment techniques to model plant hardware has provided a significant contribution to understanding the potential initiating events and equipment failures that can lead to core damage accidents. Application of the lessons learned from these analyses has supported improved plant operation and safety over the previous decade. However, this analytical approach has not been nearly as successful in addressing the impact of plant processes and management effectiveness on the risks of plant operation. Thus, the research described in this dissertation presents a different approach to address this issue. Here we propose a dynamical model that describes the interaction of important plant processes among themselves and their overall impact on nuclear safety risk. We first provide a review of the techniques that are applied in a conventional probabilistic risk assessment of commercially operating nuclear power plants and summarize the typical results obtained. The limitations of the conventional approach and the status of research previously performed to address these limitations also are presented. Next, we present the case for the application of an alternative approach using dynamical systems theory. This includes a discussion of previous applications of dynamical models to study other important socio-economic issues. Next, we review the analytical techniques that are applicable to analysis of these models. Details of the development of the mathematical risk model are presented. This includes discussion of the processes included in the model and the identification of significant interprocess interactions. This is followed by analysis of the model that demonstrates that its dynamical evolution displays characteristics that have been observed at commercially operating plants. The model is analyzed using the previously described techniques from dynamical systems theory. From this analysis, several significant insights are obtained with respect to the effective control of nuclear safety risk. Finally, we present conclusions and recommendations for further research.

PO*WW*ER mobile treatment unit process hazards analysis

DOE Office of Scientific and Technical Information (OSTI.GOV)

Richardson, R.B.

1996-06-01

The objective of this report is to demonstrate that a thorough assessment of the risks associated with the operation of the Rust Geotech patented PO*WW*ER mobile treatment unit (MTU) has been performed and documented. The MTU was developed to treat aqueous mixed wastes at the US Department of Energy (DOE) Albuquerque Operations Office sites. The MTU uses evaporation to separate organics and water from radionuclides and solids, and catalytic oxidation to convert the hazardous into byproducts. This process hazards analysis evaluated a number of accident scenarios not directly related to the operation of the MTU, such as natural phenomena damagemore » and mishandling of chemical containers. Worst case accident scenarios were further evaluated to determine the risk potential to the MTU and to workers, the public, and the environment. The overall risk to any group from operation of the MTU was determined to be very low; the MTU is classified as a Radiological Facility with low hazards.« less

Evolution and Implementation of the NASA Robotic Conjunction Assessment Risk Analysis Concept of Operations

NASA Astrophysics Data System (ADS)

Newman, L.; Hejduk, M.; Frigm, R.; Duncan, M.

2014-09-01

On-orbit collisions pose a significant mission risk to satellites operating in the space environment. Recognizing the likelihood and consequence of on-orbit collisions, NASA has taken several proactive measures to mitigate the risk of both a catastrophic loss of mission and the increase in the space debris population. In fall 2004, NASA GSFC established an Agency-wide, institutionalized process and service for identifying and reacting to predicted close approaches. The team responsible for executing this mission is the NASA Robotic Conjunction Assessment Risk Analysis (CARA) team. By fall 2005, this process had resulted in the execution of the first collision avoidance maneuver by a NASA unmanned satellite. In February 2008, NASA adopted a policy, documented in NASA Procedural Requirement 8715.6a Process for Limiting Orbital Debris that directed maneuverable satellites to have such an on-orbit collision mitigation process. In 2009, NASA decided to require support for all operational satellites. By January 2014, the CARA team has processed nearly 500,000 close approach messages from the Joint Space Operations Center (JSpOC) and has assisted our mission customers with planning and executing over 75 collision avoidance maneuvers for unmanned satellites in LEO, GEO, and HEO orbital regimes. With the increase in number of operational missions supported; growth in the orbital debris environment due to events such as the intentional destruction of the Fengyun 1-C satellite in 2007 and collision between Iridium-33 and Cosmos-2251; and improvements to the United States Space Surveillance Network (SSN) and its ability to track, catalog, and screen against small debris objects, the demands on the CARA process have consequently required the CARA Concept of Operations (CONOPS) to evolve to manage those demands. This evolution is centered on the ability to effectively and efficiently manage JSpOC, CARA, and Mission Operations resources, applying operational and analytical efforts for conjunction events that pose significant collision risk and rapidly discarding conjunction events that do not. While the overall CARA methodology is largely unaffected, this CONOPS evolution manifests itself in several aspects of the CARA process: required data and information, communication of those data and information, and courses of actions based on those data and information. The changes affect all relevant stakeholders, including the CARA team at NASA GSFC, GSFC-dedicated Orbital Safety Analysts at the JSpOC, and Mission Operations flight teams and management. In each step of the CARA process, the CONOPS ensures that necessary (whether situational or actionable) information be sent to stakeholders to facilitate an effective and efficient management of resources and appropriate protection of data. The most significant paradigm shift is the movement to risk-based reporting. Since the consequence of the on-orbit collision scenario can be catastrophic, the CARA risk-based framework hinges on the collision probability, Pc, as the encapsulation of collision risk. This CONOPS characterizes collision risk as Red (high collision risk), Yellow (potential for becoming a high collision risk), or Green (low collision risk) based on the operationally-computed Pc. Using this risk characterization schema, the amount and content of conjunction information and analyses is determined and communicated to mission stakeholders. Major technical analyses that have been conducted in support of this CONOPS include defining risk-based thresholds for red, yellow, and green criteria; determining when conjunction-related information may not be mature enough to be actionable; and accounting for uncertainties in all the inputs to the process so that a nuanced assessment of risk can be made. This paper summarizes the analyses executed and decisions rendered during the implementation of this evolved CONOPS. Historical conjunction events of note are used as example scenarios of each risk characterization.

Risk analysis of the thermal sterilization process. Analysis of factors affecting the thermal resistance of microorganisms.

PubMed

Akterian, S G; Fernandez, P S; Hendrickx, M E; Tobback, P P; Periago, P M; Martinez, A

1999-03-01

A risk analysis was applied to experimental heat resistance data. This analysis is an approach for processing experimental thermobacteriological data in order to study the variability of D and z values of target microorganisms depending on the deviations range of environmental factors, to determine the critical factors and to specify their critical tolerance. This analysis is based on sets of sensitivity functions applied to a specific case of experimental data related to the thermoresistance of Clostridium sporogenes and Bacillus stearothermophilus spores. The effect of the following factors was analyzed: the type of target microorganism; nature of the heating substrate; pH, temperature; type of acid employed and NaCl concentration. The type of target microorganism to be inactivated, the nature of the substrate (reference or real food) and the heating temperature were identified as critical factors, determining about 90% of the alteration of the microbiological risk. The effect of the type of acid used for the acidification of products and the concentration of NaCl can be assumed to be negligible factors for the purposes of engineering calculations. The critical non-uniformity in temperature during thermobacteriological studies was set as 0.5% and the critical tolerances of pH value and NaCl concentration were 5%. These results are related to a specific case study, for that reason their direct generalization is not correct.

Ares-I-X Vehicle Preliminary Range Safety Malfunction Turn Analysis

NASA Technical Reports Server (NTRS)

Beaty, James R.; Starr, Brett R.; Gowan, John W., Jr.

2008-01-01

Ares-I-X is the designation given to the flight test version of the Ares-I rocket (also known as the Crew Launch Vehicle - CLV) being developed by NASA. As part of the preliminary flight plan approval process for the test vehicle, a range safety malfunction turn analysis was performed to support the launch area risk assessment and vehicle destruct criteria development processes. Several vehicle failure scenarios were identified which could cause the vehicle trajectory to deviate from its normal flight path, and the effects of these failures were evaluated with an Ares-I-X 6 degrees-of-freedom (6-DOF) digital simulation, using the Program to Optimize Simulated Trajectories Version 2 (POST2) simulation framework. The Ares-I-X simulation analysis provides output files containing vehicle state information, which are used by other risk assessment and vehicle debris trajectory simulation tools to determine the risk to personnel and facilities in the vicinity of the launch area at Kennedy Space Center (KSC), and to develop the vehicle destruct criteria used by the flight test range safety officer. The simulation analysis approach used for this study is described, including descriptions of the failure modes which were considered and the underlying assumptions and ground rules of the study, and preliminary results are presented, determined by analysis of the trajectory deviation of the failure cases, compared with the expected vehicle trajectory.

Paediatric x-ray radiation dose reduction and image quality analysis.

PubMed

Martin, L; Ruddlesden, R; Makepeace, C; Robinson, L; Mistry, T; Starritt, H

2013-09-01

Collaboration of multiple staff groups has resulted in significant reduction in the risk of radiation-induced cancer from radiographic x-ray exposure during childhood. In this study at an acute NHS hospital trust, a preliminary audit identified initial exposure factors. These were compared with European and UK guidance, leading to the introduction of new factors that were in compliance with European guidance on x-ray tube potentials. Image quality was assessed using standard anatomical criteria scoring, and visual grading characteristics analysis assessed the impact on image quality of changes in exposure factors. This analysis determined the acceptability of gradual radiation dose reduction below the European and UK guidance levels. Chest and pelvis exposures were optimised, achieving dose reduction for each age group, with 7%-55% decrease in critical organ dose. Clinicians confirmed diagnostic image quality throughout the iterative process. Analysis of images acquired with preliminary and final exposure factors indicated an average visual grading analysis result of 0.5, demonstrating equivalent image quality. The optimisation process and final radiation doses are reported for Carestream computed radiography to aid other hospitals in minimising radiation risks to children.

Designing a risk-based surveillance program for Mycobacterium avium ssp. paratuberculosis in Norwegian dairy herds using multivariate statistical process control analysis.

PubMed

Whist, A C; Liland, K H; Jonsson, M E; Sæbø, S; Sviland, S; Østerås, O; Norström, M; Hopp, P

2014-11-01

Surveillance programs for animal diseases are critical to early disease detection and risk estimation and to documenting a population's disease status at a given time. The aim of this study was to describe a risk-based surveillance program for detecting Mycobacterium avium ssp. paratuberculosis (MAP) infection in Norwegian dairy cattle. The included risk factors for detecting MAP were purchase of cattle, combined cattle and goat farming, and location of the cattle farm in counties containing goats with MAP. The risk indicators included production data [culling of animals >3 yr of age, carcass conformation of animals >3 yr of age, milk production decrease in older lactating cows (lactations 3, 4, and 5)], and clinical data (diarrhea, enteritis, or both, in animals >3 yr of age). Except for combined cattle and goat farming and cattle farm location, all data were collected at the cow level and summarized at the herd level. Predefined risk factors and risk indicators were extracted from different national databases and combined in a multivariate statistical process control to obtain a risk assessment for each herd. The ordinary Hotelling's T(2) statistic was applied as a multivariate, standardized measure of difference between the current observed state and the average state of the risk factors for a given herd. To make the analysis more robust and adapt it to the slowly developing nature of MAP, monthly risk calculations were based on data accumulated during a 24-mo period. Monitoring of these variables was performed to identify outliers that may indicate deviance in one or more of the underlying processes. The highest-ranked herds were scattered all over Norway and clustered in high-density dairy cattle farm areas. The resulting rankings of herds are being used in the national surveillance program for MAP in 2014 to increase the sensitivity of the ongoing surveillance program in which 5 fecal samples for bacteriological examination are collected from 25 dairy herds. The use of multivariate statistical process control for selection of herds will be beneficial when a diagnostic test suitable for mass screening is available and validated on the Norwegian cattle population, thus making it possible to increase the number of sampled herds. Copyright © 2014 American Dairy Science Association. Published by Elsevier Inc. All rights reserved.

Managing fear in public health campaigns: a theory-based formative evaluation process.

PubMed

Cho, Hyunyi; Witte, Kim

2005-10-01

The HIV/AIDS infection rate of Ethiopia is one of the world's highest. Prevention campaigns should systematically incorporate and respond to at-risk population's existing beliefs, emotions, and perceived barriers in the message design process to effectively promote behavior change. However, guidelines for conducting formative evaluation that are grounded in proven risk communication theory and empirical data analysis techniques are hard to find. This article provides a five-step formative evaluation process that translates theory and research for developing effective messages for behavior change. Guided by the extended parallel process model, the five-step process helps message designers manage public's fear surrounding issues such as HIV/AIDS. An entertainment education project that used the process to design HIV/AIDS prevention messages for Ethiopian urban youth is reported. Data were collected in five urban regions of Ethiopia and analyzed according to the process to develop key messages for a 26-week radio soap opera.

An Interoperable System toward Cardiac Risk Stratification from ECG Monitoring

PubMed Central

Mora-Jiménez, Inmaculada; Ramos-López, Javier; Quintanilla Fernández, Teresa; García-García, Antonio; Díez-Mazuela, Daniel; García-Alberola, Arcadi

2018-01-01

Many indices have been proposed for cardiovascular risk stratification from electrocardiogram signal processing, still with limited use in clinical practice. We created a system integrating the clinical definition of cardiac risk subdomains from ECGs and the use of diverse signal processing techniques. Three subdomains were defined from the joint analysis of the technical and clinical viewpoints. One subdomain was devoted to demographic and clinical data. The other two subdomains were intended to obtain widely defined risk indices from ECG monitoring: a simple-domain (heart rate turbulence (HRT)), and a complex-domain (heart rate variability (HRV)). Data provided by the three subdomains allowed for the generation of alerts with different intensity and nature, as well as for the grouping and scrutinization of patients according to the established processing and risk-thresholding criteria. The implemented system was tested by connecting data from real-world in-hospital electronic health records and ECG monitoring by considering standards for syntactic (HL7 messages) and semantic interoperability (archetypes based on CEN/ISO EN13606 and SNOMED-CT). The system was able to provide risk indices and to generate alerts in the health records to support decision-making. Overall, the system allows for the agile interaction of research and clinical practice in the Holter-ECG-based cardiac risk domain. PMID:29494497

Failure mode and effects analysis: too little for too much?

PubMed

Dean Franklin, Bryony; Shebl, Nada Atef; Barber, Nick

2012-07-01

Failure mode and effects analysis (FMEA) is a structured prospective risk assessment method that is widely used within healthcare. FMEA involves a multidisciplinary team mapping out a high-risk process of care, identifying the failures that can occur, and then characterising each of these in terms of probability of occurrence, severity of effects and detectability, to give a risk priority number used to identify failures most in need of attention. One might assume that such a widely used tool would have an established evidence base. This paper considers whether or not this is the case, examining the evidence for the reliability and validity of its outputs, the mathematical principles behind the calculation of a risk prioirty number, and variation in how it is used in practice. We also consider the likely advantages of this approach, together with the disadvantages in terms of the healthcare professionals' time involved. We conclude that although FMEA is popular and many published studies have reported its use within healthcare, there is little evidence to support its use for the quantitative prioritisation of process failures. It lacks both reliability and validity, and is very time consuming. We would not recommend its use as a quantitative technique to prioritise, promote or study patient safety interventions. However, the stage of FMEA involving multidisciplinary mapping process seems valuable and work is now needed to identify the best way of converting this into plans for action.

Probabilistic modeling of percutaneous absorption for risk-based exposure assessments and transdermal drug delivery.

DOE Office of Scientific and Technical Information (OSTI.GOV)

Ho, Clifford Kuofei

Chemical transport through human skin can play a significant role in human exposure to toxic chemicals in the workplace, as well as to chemical/biological warfare agents in the battlefield. The viability of transdermal drug delivery also relies on chemical transport processes through the skin. Models of percutaneous absorption are needed for risk-based exposure assessments and drug-delivery analyses, but previous mechanistic models have been largely deterministic. A probabilistic, transient, three-phase model of percutaneous absorption of chemicals has been developed to assess the relative importance of uncertain parameters and processes that may be important to risk-based assessments. Penetration routes through the skinmore » that were modeled include the following: (1) intercellular diffusion through the multiphase stratum corneum; (2) aqueous-phase diffusion through sweat ducts; and (3) oil-phase diffusion through hair follicles. Uncertainty distributions were developed for the model parameters, and a Monte Carlo analysis was performed to simulate probability distributions of mass fluxes through each of the routes. Sensitivity analyses using stepwise linear regression were also performed to identify model parameters that were most important to the simulated mass fluxes at different times. This probabilistic analysis of percutaneous absorption (PAPA) method has been developed to improve risk-based exposure assessments and transdermal drug-delivery analyses, where parameters and processes can be highly uncertain.« less

Increased Prolactin Levels Are Associated with Impaired Processing Speed in Subjects with Early Psychosis

PubMed Central

Montalvo, Itziar; Gutiérrez-Zotes, Alfonso; Creus, Marta; Monseny, Rosa; Ortega, Laura; Franch, Joan; Lawrie, Stephen M.; Reynolds, Rebecca M.; Vilella, Elisabet; Labad, Javier

2014-01-01

Hyperprolactinaemia, a common side effect of some antipsychotic drugs, is also present in drug-naïve psychotic patients and subjects at risk for psychosis. Recent studies in non-psychiatric populations suggest that increased prolactin may have negative effects on cognition. The aim of our study was to explore whether high plasma prolactin levels are associated with poorer cognitive functioning in subjects with early psychoses. We studied 107 participants: 29 healthy subjects and 78 subjects with an early psychosis (55 psychotic disorders with <3 years of illness, 23 high-risk subjects). Cognitive assessment was performed with the MATRICS Cognitive Consensus Cognitive Battery, and prolactin levels were determined as well as total cortisol levels in plasma. Psychopathological status was assessed and the use of psychopharmacological treatments (antipsychotics, antidepressants, benzodiazepines) recorded. Prolactin levels were negatively associated with cognitive performance in processing speed, in patients with a psychotic disorder and high-risk subjects. In the latter group, increased prolactin levels were also associated with impaired reasoning and problem solving and poorer general cognition. In a multiple linear regression analysis conducted in both high-risk and psychotic patients, controlling for potential confounders, prolactin and benzodiazepines were independently related to poorer cognitive performance in the speed of processing domain. A mediation analysis showed that both prolactin and benzodiazepine treatment act as mediators of the relationship between risperidone/paliperidone treatment and speed of processing. These results suggest that increased prolactin levels are associated with impaired processing speed in early psychosis. If these results are confirmed in future studies, strategies targeting reduction of prolactin levels may improve cognition in this population. PMID:24586772

Meat Consumption and Its Association With C-Reactive Protein and Incident Type 2 Diabetes

PubMed Central

van Woudenbergh, Geertruida J.; Kuijsten, Anneleen; Tigcheler, Basia; Sijbrands, Eric J.G.; van Rooij, Frank J.A.; Hofman, Albert; Witteman, Jacqueline C.M.; Feskens, Edith J.M.

2012-01-01

OBJECTIVE To investigate whether intake of different types of meat is associated with circulating C-reactive protein (CRP) and risk of type 2 diabetes in a prospective cohort study. RESEARCH DESIGN AND METHODS Our analysis included 4,366 Dutch participants who did not have diabetes at baseline. During a median follow-up period of 12.4 years, 456 diabetes cases were confirmed. Intake of red meat, processed meat, and poultry was derived from a food frequency questionnaire, and their association with serum high-sensitivity CRP was examined cross-sectionally using linear regression models. Their association with risk of type 2 diabetes was examined using multivariate Cox proportional hazards model, including age, sex, family history of diabetes, and lifestyle and dietary factors. RESULTS An increment of 50 g of processed meat was associated with increased CRP concentration (βprocessed meat = 0.12; P = 0.01), whereas intake of red meat and poultry was not. When comparing the highest to the lowest category of meat intake with respect to diabetes incidence, the adjusted relative risks were as follows: for red meat (1.42 [95% CI 1.06–1.91]), for processed meat (1.87 [1.26–2.78]), and for poultry (0.95 [0.74–1.22]). Additional analysis showed that the associations were not affected appreciably after inclusion of CRP into the model. After adjustment for BMI, however, the association for red meat attenuated to 1.18 (0.88–1.59). CONCLUSIONS Intake of processed meat is associated with higher risk of type 2 diabetes. It appears unlikely that CRP mediates this association. PMID:22596177

The use of failure mode and effects analysis to construct an effective disposal and prevention mechanism for infectious hospital waste

DOE Office of Scientific and Technical Information (OSTI.GOV)

Ho, Chao Chung, E-mail: ho919@pchome.com.tw; Liao, Ching-Jong

Highlights: > This study is based on a real case in a regional teaching hospital in Taiwan. > We use Failure mode and effects analysis (FMEA) as the evaluation method. > We successfully identify the risk factors of infectious waste disposal. > We propose plans for the detection of exceptional cases of infectious waste. - Abstract: In recent times, the quality of medical care has been continuously improving in medical institutions wherein patient-centred care has been emphasized. Failure mode and effects analysis (FMEA) has also been promoted as a method of basic risk management and as part of total qualitymore » management (TQM) for improving the quality of medical care and preventing mistakes. Therefore, a study was conducted using FMEA to evaluate the potential risk causes in the process of infectious medical waste disposal, devise standard procedures concerning the waste, and propose feasible plans for facilitating the detection of exceptional cases of infectious waste. The analysis revealed the following results regarding medical institutions: (a) FMEA can be used to identify the risk factors of infectious waste disposal. (b) During the infectious waste disposal process, six items were scored over 100 in the assessment of uncontrolled risks: erroneous discarding of infectious waste by patients and their families, erroneous discarding by nursing staff, erroneous discarding by medical staff, cleaning drivers pierced by sharp articles, cleaning staff pierced by sharp articles, and unmarked output units. Therefore, the study concluded that it was necessary to (1) provide education and training about waste classification to the medical staff, patients and their families, nursing staff, and cleaning staff; (2) clarify the signs of caution; and (3) evaluate the failure mode and strengthen the effects.« less

Landslide risk models for decision making.

PubMed

Bonachea, Jaime; Remondo, Juan; de Terán, José Ramón Díaz; González-Díez, Alberto; Cendrero, Antonio

2009-11-01

This contribution presents a quantitative procedure for landslide risk analysis and zoning considering hazard, exposure (or value of elements at risk), and vulnerability. The method provides the means to obtain landslide risk models (expressing expected damage due to landslides on material elements and economic activities in monetary terms, according to different scenarios and periods) useful to identify areas where mitigation efforts will be most cost effective. It allows identifying priority areas for the implementation of actions to reduce vulnerability (elements) or hazard (processes). The procedure proposed can also be used as a preventive tool, through its application to strategic environmental impact analysis (SEIA) of land-use plans. The underlying hypothesis is that reliable predictions about hazard and risk can be made using models based on a detailed analysis of past landslide occurrences in connection with conditioning factors and data on past damage. The results show that the approach proposed and the hypothesis formulated are essentially correct, providing estimates of the order of magnitude of expected losses for a given time period. Uncertainties, strengths, and shortcomings of the procedure and results obtained are discussed and potential lines of research to improve the models are indicated. Finally, comments and suggestions are provided to generalize this type of analysis.

Risk management and lessons learned solutions for satellite product assurance

NASA Astrophysics Data System (ADS)

Larrère, Jean-Luc

2004-08-01

The historic trend of the space industry towards lower cost programmes and more generally a better economic efficiency raises a difficult question to the quality assurance community: how to achieve the same—or better—mission success rate while drastically reducing the cost of programmes, hence the cost and level of quality assurance activities. EADS Astrium Earth Observation and Science (France) Business Unit have experimented Risk Management and Lessons Learned on their satellite programmes to achieve this goal. Risk analysis and management are deployed from the programme proposal phase through the development and operations phases. Results of the analysis and the corresponding risk mitigation actions are used to tailor the product assurance programme and activities. Lessons learned have been deployed as a systematic process to collect positive and negative experience from past and on-going programmes and feed them into new programmes. Monitoring and justification of their implementation in programmes is done under supervision from the BU quality assurance function. Control of the system is ensured by the company internal review system. Deployment of these methods has shown that the quality assurance function becomes more integrated in the programme team and development process and that its tasks gain focus and efficiency while minimising the risks associated with new space programmes.

Predicting risky choices from brain activity patterns

PubMed Central

Helfinstein, Sarah M.; Schonberg, Tom; Congdon, Eliza; Karlsgodt, Katherine H.; Mumford, Jeanette A.; Sabb, Fred W.; Cannon, Tyrone D.; London, Edythe D.; Bilder, Robert M.; Poldrack, Russell A.

2014-01-01

Previous research has implicated a large network of brain regions in the processing of risk during decision making. However, it has not yet been determined if activity in these regions is predictive of choices on future risky decisions. Here, we examined functional MRI data from a large sample of healthy subjects performing a naturalistic risk-taking task and used a classification analysis approach to predict whether individuals would choose risky or safe options on upcoming trials. We were able to predict choice category successfully in 71.8% of cases. Searchlight analysis revealed a network of brain regions where activity patterns were reliably predictive of subsequent risk-taking behavior, including a number of regions known to play a role in control processes. Searchlights with significant predictive accuracy were primarily located in regions more active when preparing to avoid a risk than when preparing to engage in one, suggesting that risk taking may be due, in part, to a failure of the control systems necessary to initiate a safe choice. Additional analyses revealed that subject choice can be successfully predicted with minimal decrements in accuracy using highly condensed data, suggesting that information relevant for risky choice behavior is encoded in coarse global patterns of activation as well as within highly local activation within searchlights. PMID:24550270

Failure mode and effects analysis drastically reduced potential risks in clinical trial conduct

PubMed Central

Baik, Jungmi; Kim, Hyunjung; Kim, Rachel

2017-01-01

Background Failure mode and effects analysis (FMEA) is a risk management tool to proactively identify and assess the causes and effects of potential failures in a system, thereby preventing them from happening. The objective of this study was to evaluate effectiveness of FMEA applied to an academic clinical trial center in a tertiary care setting. Methods A multidisciplinary FMEA focus group at the Seoul National University Hospital Clinical Trials Center selected 6 core clinical trial processes, for which potential failure modes were identified and their risk priority number (RPN) was assessed. Remedial action plans for high-risk failure modes (RPN >160) were devised and a follow-up RPN scoring was conducted a year later. Results A total of 114 failure modes were identified with an RPN score ranging 3–378, which was mainly driven by the severity score. Fourteen failure modes were of high risk, 11 of which were addressed by remedial actions. Rescoring showed a dramatic improvement attributed to reduction in the occurrence and detection scores by >3 and >2 points, respectively. Conclusions FMEA is a powerful tool to improve quality in clinical trials. The Seoul National University Hospital Clinical Trials Center is expanding its FMEA capability to other core clinical trial processes. PMID:29089745

The relationship between spontaneous abortion and female workers in the semiconductor industry.

PubMed

Kim, Heechan; Kwon, Ho-Jang; Rhie, Jeongbae; Lim, Sinye; Kang, Yun-Dan; Eom, Sang-Yong; Lim, Hyungryul; Myong, Jun-Pyo; Roh, Sangchul

2017-01-01

This study investigated the relationship between job type and the risk for spontaneous abortion to assess the reproductive toxicity of female workers in the semiconductor industry. A questionnaire survey was administered to current female workers of two semiconductor manufacturing plants in Korea. We included female workers who became pregnant at least 6 months after the start of their employment with the company. The pregnancy outcomes of 2,242 female workers who experienced 4,037 pregnancies were investigated. Personnel records were used to assign the subjects to one of three groups: fabrication process workers, packaging process workers, and clerical workers. To adjust for within-person correlations between pregnancies, a generalized estimating equation was used. The logistic regression analysis was limited to the first pregnancy after joining the company to satisfy the assumption of independence among pregnancies. Moreover, we stratified the analysis by time period (pregnancy in the years prior to 2008 vs. after 2009) to reflect differences in occupational exposure based on semiconductor production periods. The risk for spontaneous abortion in female semiconductor workers was not significantly higher for fabrication and packaging process workers than for clerical workers. However, when we stratified by time period, the odds ratio for spontaneous abortion was significantly higher for packaging process workers who became pregnant prior to 2008 when compared with clerical workers (odds ratio: 2.21; 95% confidence interval: 1.01-4.81). When examining the pregnancies of female semiconductor workers that occurred prior to 2008, packaging process workers showed a significantly higher risk for spontaneous abortions than did clerical workers. The two semiconductor production periods in our study (prior to 2008 vs. after 2009) had different automated processes, chemical exposure levels, and working environments. Thus, the conditions prior to 2008 may have increased the risk for spontaneous abortions in packaging process workers in the semiconductor industry.

Morphometric Analysis to Prioritize Sub-Watershed for Flood Risk Assessment in Central Karakoram National Park Using Gis/rs Approach

NASA Astrophysics Data System (ADS)

Syed, N. H.; Rehman, A. A.; Hussain, D.; Ishaq, S.; Khan, A. A.

2017-11-01

Morphometric analysis is vital for any watershed investigation and it is inevitable for flood risk assessment in sub-watershed basins. Present study undertaken to carry out critical evaluation and assessment of sub watershed morphological parameters for flood risk assessment of Central Karakorum National Park (CKNP), where Geographical information system and remote sensing (GIS & RS) approach used for quantifying the parameter and mapping of sub watershed units. ASTER DEM used as a geo-spatial data for watershed delineation and stream network. Morphometric analysis carried out using spatial analyst tool of ArcGIS 10.2. The parameters included were bifurcation ratio (Rb), Drainage Texture (Rt), Circulatory ratio (Rc), Elongated ratio (Re), Drainage density (Dd), Stream Length (Lu), Stream order (Su), Slope and Basin length (Lb) have calculated separately. The analysis revealed that the stream order varies from order 1 to 6 and the total numbers of stream segments of all orders were 52. Multi criteria analysis process used to calculate the risk factor. As an accomplished result, map of sub watershed prioritization developed using weighted standardized risk factor. These results helped to understand sensitivity of flush floods in different sub watersheds of the study area and leaded to better management of the mountainous regions in prospect of flush floods.

Quantitative risk analysis of oil storage facilities in seismic areas.

PubMed

Fabbrocino, Giovanni; Iervolino, Iunio; Orlando, Francesca; Salzano, Ernesto

2005-08-31

Quantitative risk analysis (QRA) of industrial facilities has to take into account multiple hazards threatening critical equipment. Nevertheless, engineering procedures able to evaluate quantitatively the effect of seismic action are not well established. Indeed, relevant industrial accidents may be triggered by loss of containment following ground shaking or other relevant natural hazards, either directly or through cascade effects ('domino effects'). The issue of integrating structural seismic risk into quantitative probabilistic seismic risk analysis (QpsRA) is addressed in this paper by a representative study case regarding an oil storage plant with a number of atmospheric steel tanks containing flammable substances. Empirical seismic fragility curves and probit functions, properly defined both for building-like and non building-like industrial components, have been crossed with outcomes of probabilistic seismic hazard analysis (PSHA) for a test site located in south Italy. Once the seismic failure probabilities have been quantified, consequence analysis has been performed for those events which may be triggered by the loss of containment following seismic action. Results are combined by means of a specific developed code in terms of local risk contour plots, i.e. the contour line for the probability of fatal injures at any point (x, y) in the analysed area. Finally, a comparison with QRA obtained by considering only process-related top events is reported for reference.

Rethinking vulnerability analysis and governance with emphasis on a participatory approach.

PubMed

Rossignol, Nicolas; Delvenne, Pierre; Turcanu, Catrinel

2015-01-01

This article draws on vulnerability analysis as it emerged as a complement to classical risk analysis, and it aims at exploring its ability for nurturing risk and vulnerability governance actions. An analysis of the literature on vulnerability analysis allows us to formulate a three-fold critique: first, vulnerability analysis has been treated separately in the natural and the technological hazards fields. This separation prevents vulnerability from unleashing the full range of its potential, as it constrains appraisals into artificial categories and thus already closes down the outcomes of the analysis. Second, vulnerability analysis focused on assessment tools that are mainly quantitative, whereas qualitative appraisal is a key to assessing vulnerability in a comprehensive way and to informing policy making. Third, a systematic literature review of case studies reporting on participatory approaches to vulnerability analysis allows us to argue that participation has been important to address the above, but it remains too closed down in its approach and would benefit from embracing a more open, encompassing perspective. Therefore, we suggest rethinking vulnerability analysis as one part of a dynamic process between opening-up and closing-down strategies, in order to support a vulnerability governance framework. © 2014 Society for Risk Analysis.

Executive Overview of SEI MOSAIC: Managing for Success Using a Risk-Based Approach

DTIC Science & Technology

2007-03-01

and pro - vides the lens through which all potential outcomes are viewed and interpreted. Defining the con - text is thus an essential first step when...Success Analysis and Improvement Crite- ria (SEI MOSAIC)—a suite of advanced analysis methods for assessing complex, distributed pro - grams, processes...achieve that set of objectives, four ac- tivities must be executed in the order shown, while also adhering to any cost and schedule con - straints. Process

Human Factors Process Task Analysis Liquid Oxygen Pump Acceptance Test Procedure for the Advanced Technology Development Center

NASA Technical Reports Server (NTRS)

Diorio, Kimberly A.

2002-01-01

A process task analysis effort was undertaken by Dynacs Inc. commencing in June 2002 under contract from NASA YA-D6. Funding was provided through NASA's Ames Research Center (ARC), Code M/HQ, and Industrial Engineering and Safety (IES). The John F. Kennedy Space Center (KSC) Engineering Development Contract (EDC) Task Order was 5SMA768. The scope of the effort was to conduct a Human Factors Process Failure Modes and Effects Analysis (HF PFMEA) of a hazardous activity and provide recommendations to eliminate or reduce the effects of errors caused by human factors. The Liquid Oxygen (LOX) Pump Acceptance Test Procedure (ATP) was selected for this analysis. The HF PFMEA table (see appendix A) provides an analysis of six major categories evaluated for this study. These categories include Personnel Certification, Test Procedure Format, Test Procedure Safety Controls, Test Article Data, Instrumentation, and Voice Communication. For each specific requirement listed in appendix A, the following topics were addressed: Requirement, Potential Human Error, Performance-Shaping Factors, Potential Effects of the Error, Barriers and Controls, Risk Priority Numbers, and Recommended Actions. This report summarizes findings and gives recommendations as determined by the data contained in appendix A. It also includes a discussion of technology barriers and challenges to performing task analyses, as well as lessons learned. The HF PFMEA table in appendix A recommends the use of accepted and required safety criteria in order to reduce the risk of human error. The items with the highest risk priority numbers should receive the greatest amount of consideration. Implementation of the recommendations will result in a safer operation for all personnel.

Station Blackout: A case study in the interaction of mechanistic and probabilistic safety analysis

DOE Office of Scientific and Technical Information (OSTI.GOV)

Curtis Smith; Diego Mandelli; Cristian Rabiti

2013-11-01

The ability to better characterize and quantify safety margins is important to improved decision making about nuclear power plant design, operation, and plant life extension. As research and development (R&D) in the light-water reactor (LWR) Sustainability (LWRS) Program and other collaborative efforts yield new data, sensors, and improved scientific understanding of physical processes that govern the aging and degradation of plant SSCs needs and opportunities to better optimize plant safety and performance will become known. The purpose of the Risk Informed Safety Margin Characterization (RISMC) Pathway R&D is to support plant decisions for risk-informed margin management with the aim tomore » improve economics, reliability, and sustain safety of current NPPs. In this paper, we describe the RISMC analysis process illustrating how mechanistic and probabilistic approaches are combined in order to estimate a safety margin. We use the scenario of a “station blackout” wherein offsite power and onsite power is lost, thereby causing a challenge to plant safety systems. We describe the RISMC approach, illustrate the station blackout modeling, and contrast this with traditional risk analysis modeling for this type of accident scenario.« less

An assessment of temporal effect on extreme rainfall estimates

NASA Astrophysics Data System (ADS)

Das, Samiran; Zhu, Dehua; Chi-Han, Cheng

2018-06-01

This study assesses the temporal behaviour in terms of inter-decadal variability of extreme daily rainfall of stated return period relevant for hydrologic risk analysis using a novel regional parametric approach. The assessment is carried out based on annual maximum daily rainfall series of 180 meteorological stations of Yangtze River Basin over a 50-year period (1961-2010). The outcomes of the analysis reveal that while there were effects present indicating higher quantile values when estimated from data of the 1990s, it is found not to be noteworthy to exclude the data of any decade from the extreme rainfall estimation process for hydrologic risk analysis.

The safer clinical systems project in renal care.

PubMed

Weale, Andy R

2013-09-01

Current systems in place in healthcare are designed to detect harm after it has happened (e.g critical incident reports) and make recommendations based on an assessment of that event. Safer Clinical Systems, a Health Foundation funded project, is designed to proactively search for risk within systems, rather than being reactive to harm. The aim of the Safer Clinical Systems project in Renal Care was to reduce the risks associated with shared care for patients who are undergoing surgery but are looked after peri-operatively by nephrology teams on nephrology wards. This report details our findings of the diagnostic phase of Safer Clinical Systems: the proactive search for risk. We have evaluated the current system of care using a set of risk evaluation and process mapping tools (Failure Modes and Effects Analysis (FMEA) and Hierarchical Task Analysis HTA). We have engaged staff with the process mapping and risk assessment tools. We now understand our system and understand where the highest risk tasks are undertaken during a renal in-patient stay during which a patient has an operation. These key tasks occur across the perioperaive period and are not confined to one aspect of care. A measurement strategy and intervention plan have been designed around these tasks. Safer Clinical Systems has identified high risk, low reliability tasks in our system. We look forward to fully reporting these data in 2014. © 2013 European Dialysis and Transplant Nurses Association/European Renal Care Association.

LinkIT: a ludic elicitation game for eliciting risk perceptions.

PubMed

Cao, Yan; McGill, William L

2013-06-01

The mental models approach, a leading strategy to develop risk communications, involves a time- and labor-intensive interview process and a lengthy questionnaire to elicit group-level risk perceptions. We propose that a similarity ratings approach for structural knowledge elicitation can be adopted to assist the risk mental models approach. The LinkIT game, inspired by games with a purpose (GWAP) technology, is a ludic elicitation tool designed to elicit group understanding of the relations between risk factors in a more enjoyable and productive manner when compared to traditional approaches. That is, consistent with the idea of ludic elicitation, LinkIT was designed to make the elicitation process fun and enjoyable in the hopes of increasing participation and data quality in risk studies. Like the mental models approach, the group mental model obtained via the LinkIT game can hence be generated and represented in a form of influence diagrams. In order to examine the external validity of LinkIT, we conducted a study to compare its performance with respect to a more conventional questionnaire-driven approach. Data analysis results conclude that the two group mental models elicited from the two approaches are similar to an extent. Yet, LinkIT was more productive and enjoyable than the questionnaire. However, participants commented that the current game has some usability concerns. This presentation summarizes the design and evaluation of the LinkIT game and suggests areas for future work. © 2012 Society for Risk Analysis.

Dietary Protein Sources and Incidence of Breast Cancer: A Dose-Response Meta-Analysis of Prospective Studies

PubMed Central

Wu, Jing; Zeng, Rong; Huang, Junpeng; Li, Xufeng; Zhang, Jiren; Ho, James Chung-Man; Zheng, Yanfang

2016-01-01

Protein is important to the human body, and different sources of protein may have different effects on the risk of breast cancer. Thus, we conducted a meta-analysis to investigate the association between different dietary protein sources and breast cancer risk. PubMed and several databases were searched until December 2015. Relevant articles were retrieved according to specific searching criteria. Forty-six prospective studies were included. The summary relative risk (RR) for highest versus lowest intake was 1.07 (95% confidence interval (CI) 1.01–1.14, I2 = 34.6%) for processed meat, 0.92 (95% CI 0.84–1.00, I2 = 0%) for soy food, 0.93 (95% CI 0.85–1.00, I2 = 40.1%) for skim milk, and 0.90 (95% CI 0.82–1.00, I2 = 0%) for yogurt. Similar conclusions were obtained in dose-response association for each serving increase: total red meat (RR: 1.07; 95% CI 1.01–1.14, I2 = 7.1%), fresh red meat (RR: 1.13; 95% CI 1.01–1.26, I2 = 56.4%), processed meat (RR: 1.09; 95% CI 1.02–1.17, I2 = 11.8%), soy food (RR: 0.91; 95% CI 0.84–1.00, I2 = 0%), and skim milk (RR: 0.96; 95% CI 0.92–1.00, I2 = 11.9%). There was a null association between poultry, fish, egg, nuts, total milk, and whole milk intake and breast cancer risk. Higher total red meat, fresh red meat, and processed meat intake may be risk factors for breast cancer, whereas higher soy food and skim milk intake may reduce the risk of breast cancer. PMID:27869663

RELEASE OF DRIED RADIOACTIVE WASTE MATERIALS TECHNICAL BASIS DOCUMENT

DOE Office of Scientific and Technical Information (OSTI.GOV)

KOZLOWSKI, S.D.

2007-05-30

This technical basis document was developed to support RPP-23429, Preliminary Documented Safety Analysis for the Demonstration Bulk Vitrification System (PDSA) and RPP-23479, Preliminary Documented Safety Analysis for the Contact-Handled Transuranic Mixed (CH-TRUM) Waste Facility. The main document describes the risk binning process and the technical basis for assigning risk bins to the representative accidents involving the release of dried radioactive waste materials from the Demonstration Bulk Vitrification System (DBVS) and to the associated represented hazardous conditions. Appendices D through F provide the technical basis for assigning risk bins to the representative dried waste release accident and associated represented hazardous conditionsmore » for the Contact-Handled Transuranic Mixed (CH-TRUM) Waste Packaging Unit (WPU). The risk binning process uses an evaluation of the frequency and consequence of a given representative accident or represented hazardous condition to determine the need for safety structures, systems, and components (SSC) and technical safety requirement (TSR)-level controls. A representative accident or a represented hazardous condition is assigned to a risk bin based on the potential radiological and toxicological consequences to the public and the collocated worker. Note that the risk binning process is not applied to facility workers because credible hazardous conditions with the potential for significant facility worker consequences are considered for safety-significant SSCs and/or TSR-level controls regardless of their estimated frequency. The controls for protection of the facility workers are described in RPP-23429 and RPP-23479. Determination of the need for safety-class SSCs was performed in accordance with DOE-STD-3009-94, Preparation Guide for US. Department of Energy Nonreactor Nuclear Facility Documented Safety Analyses, as described below.« less

Dietary Protein Sources and Incidence of Breast Cancer: A Dose-Response Meta-Analysis of Prospective Studies.

PubMed

Wu, Jing; Zeng, Rong; Huang, Junpeng; Li, Xufeng; Zhang, Jiren; Ho, James Chung-Man; Zheng, Yanfang

2016-11-17

Protein is important to the human body, and different sources of protein may have different effects on the risk of breast cancer. Thus, we conducted a meta-analysis to investigate the association between different dietary protein sources and breast cancer risk. PubMed and several databases were searched until December 2015. Relevant articles were retrieved according to specific searching criteria. Forty-six prospective studies were included. The summary relative risk (RR) for highest versus lowest intake was 1.07 (95% confidence interval (CI) 1.01-1.14, I ² = 34.6%) for processed meat, 0.92 (95% CI 0.84-1.00, I ² = 0%) for soy food, 0.93 (95% CI 0.85-1.00, I ² = 40.1%) for skim milk, and 0.90 (95% CI 0.82-1.00, I ² = 0%) for yogurt. Similar conclusions were obtained in dose-response association for each serving increase: total red meat (RR: 1.07; 95% CI 1.01-1.14, I ² = 7.1%), fresh red meat (RR: 1.13; 95% CI 1.01-1.26, I ² = 56.4%), processed meat (RR: 1.09; 95% CI 1.02-1.17, I ² = 11.8%), soy food (RR: 0.91; 95% CI 0.84-1.00, I ² = 0%), and skim milk (RR: 0.96; 95% CI 0.92-1.00, I ² = 11.9%). There was a null association between poultry, fish, egg, nuts, total milk, and whole milk intake and breast cancer risk. Higher total red meat, fresh red meat, and processed meat intake may be risk factors for breast cancer, whereas higher soy food and skim milk intake may reduce the risk of breast cancer.

Early somatosensory processing in individuals at risk for developing psychoses.

PubMed

Hagenmuller, Florence; Heekeren, Karsten; Theodoridou, Anastasia; Walitza, Susanne; Haker, Helene; Rössler, Wulf; Kawohl, Wolfram

2014-01-01

Human cortical somatosensory evoked potentials (SEPs) allow an accurate investigation of thalamocortical and early cortical processing. SEPs reveal a burst of superimposed early (N20) high-frequency oscillations around 600 Hz. Previous studies reported alterations of SEPs in patients with schizophrenia. This study addresses the question whether those alterations are also observable in populations at risk for developing schizophrenia or bipolar disorders. To our knowledge to date, this is the first study investigating SEPs in a population at risk for developing psychoses. Median nerve SEPs were investigated using multichannel EEG in individuals at risk for developing bipolar disorders (n = 25), individuals with high-risk status (n = 59) and ultra-high-risk status for schizophrenia (n = 73) and a gender and age-matched control group (n = 45). Strengths and latencies of low- and high-frequency components as estimated by dipole source analysis were compared between groups. Low- and high-frequency source activity was reduced in both groups at risk for schizophrenia, in comparison to the group at risk for bipolar disorders. HFO amplitudes were also significant reduced in subjects with high-risk status for schizophrenia compared to healthy controls. These differences were accentuated among cannabis non-users. Reduced N20 source strengths were related to higher positive symptom load. These results suggest that the risk for schizophrenia, in contrast to bipolar disorders, may involve an impairment of early cerebral somatosensory processing. Neurophysiologic alterations in schizophrenia precede the onset of initial psychotic episode and may serve as indicator of vulnerability for developing schizophrenia.

Early somatosensory processing in individuals at risk for developing psychoses

PubMed Central

Hagenmuller, Florence; Heekeren, Karsten; Theodoridou, Anastasia; Walitza, Susanne; Haker, Helene; Rössler, Wulf; Kawohl, Wolfram

2014-01-01

Human cortical somatosensory evoked potentials (SEPs) allow an accurate investigation of thalamocortical and early cortical processing. SEPs reveal a burst of superimposed early (N20) high-frequency oscillations around 600 Hz. Previous studies reported alterations of SEPs in patients with schizophrenia. This study addresses the question whether those alterations are also observable in populations at risk for developing schizophrenia or bipolar disorders. To our knowledge to date, this is the first study investigating SEPs in a population at risk for developing psychoses. Median nerve SEPs were investigated using multichannel EEG in individuals at risk for developing bipolar disorders (n = 25), individuals with high-risk status (n = 59) and ultra-high-risk status for schizophrenia (n = 73) and a gender and age-matched control group (n = 45). Strengths and latencies of low- and high-frequency components as estimated by dipole source analysis were compared between groups. Low- and high-frequency source activity was reduced in both groups at risk for schizophrenia, in comparison to the group at risk for bipolar disorders. HFO amplitudes were also significant reduced in subjects with high-risk status for schizophrenia compared to healthy controls. These differences were accentuated among cannabis non-users. Reduced N20 source strengths were related to higher positive symptom load. These results suggest that the risk for schizophrenia, in contrast to bipolar disorders, may involve an impairment of early cerebral somatosensory processing. Neurophysiologic alterations in schizophrenia precede the onset of initial psychotic episode and may serve as indicator of vulnerability for developing schizophrenia. PMID:25309363

Comprehensive risk assessment method of catastrophic accident based on complex network properties

NASA Astrophysics Data System (ADS)

Cui, Zhen; Pang, Jun; Shen, Xiaohong

2017-09-01

On the macro level, the structural properties of the network and the electrical characteristics of the micro components determine the risk of cascading failures. And the cascading failures, as a process with dynamic development, not only the direct risk but also potential risk should be considered. In this paper, comprehensively considered the direct risk and potential risk of failures based on uncertain risk analysis theory and connection number theory, quantified uncertain correlation by the node degree and node clustering coefficient, then established a comprehensive risk indicator of failure. The proposed method has been proved by simulation on the actual power grid. Modeling a network according to the actual power grid, and verified the rationality of the proposed method.

Bacillus Calmette-Guérin (BCG) vaccine: A global assessment of demand and supply balance.

PubMed

Cernuschi, Tania; Malvolti, Stefano; Nickels, Emily; Friede, Martin

2018-01-25

Over the past decade, several countries across all regions, income groups and procurement methods have been unable to secure sufficient BCG vaccine supply. While the frequency of stock-outs has remained rather stable, duration increased in 2014-2015 due to manufacturing issues and attracted the attention of national, regional and global immunization stakeholders. This prompted an in-depth analysis of supply and demand dynamics aiming to characterize supply risks. This analysis is unique as it provides a global picture, where previous analyses have focused on a portion of the market procuring through UN entities. Through literature review, supplier interviews, appraisal of shortages, stock-outs and historical procurement data, and through demand forecasting, this analysis shows an important increase in global capacity in 2017: supply is sufficient to meet forecasted BCG vaccine demand and possibly buffer market shocks. Nevertheless, risks remain mainly due to supply concentration and limited investment in production process improvements, as well as inflexibility in demand. Identification of these market risks will allow implementation of risk-mitigating interventions in three areas: (1) enhancing information sharing between major global health actors, countries and suppliers, (2) identifying interests and incentives to expand product registration and investment in the BCG manufacturing process, and (3) working with countries for tighter vaccine management. Copyright © 2017. Published by Elsevier Ltd.

Post-Challenger evaluation of space shuttle risk assessment and management

NASA Technical Reports Server (NTRS)

1988-01-01

As the shock of the Space Shuttle Challenger accident began to subside, NASA initiated a wide range of actions designed to ensure greater safety in various aspects of the Shuttle system and an improved focus on safety throughout the National Space Transportation System (NSTS) Program. Certain specific features of the NASA safety process are examined: the Critical Items List (CIL) and the NASA review of the Shuttle primary and backup units whose failure might result in the loss of life, the Shuttle vehicle, or the mission; the failure modes and effects analyses (FMEA); and the hazard analysis and their review. The conception of modern risk management, including the essential element of objective risk assessment is described and it is contrasted with NASA's safety process in general terms. The discussion, findings, and recommendations regarding particular aspects of the NASA STS safety assurance process are reported. The 11 subsections each deal with a different aspect of the process. The main lessons learned by SCRHAAC in the course of the audit are summarized.

DNA repair gene polymorphisms and risk of cutaneous melanoma: a systematic review and meta-analysis.

PubMed

Mocellin, Simone; Verdi, Daunia; Nitti, Donato

2009-10-01

Polymorphisms of DNA repair-related genes might modulate cancer predisposition. We performed a systematic review and meta-analysis of the available evidence regarding the relationship between these polymorphisms and the risk of developing cutaneous melanoma. Relevant studies were searched using PubMed, Medline, Embase, Cancerlit, Cochrane and ISI Web of Knowledge databases. Data were gathered according to the Meta-analysis Of Observational Studies in Epidemiology (MOOSE) guidelines. The model-free approach was adopted to perform the meta-analysis of the retrieved data. We identified 20 original reports that describe the relationship between melanoma risk and the single-nucleotide polymorphisms (SNPs) of 16 genes (cases = 4195). For seven SNPs considered in at least two studies, the findings were heterogeneous. Data were suitable for meta-analysis only in the case of the XPD/ERCC2 SNP rs13181 (cases = 2308, controls = 3698) and demonstrated that the variant C allele is associated with increased melanoma risk (odds ratio = 1.12, 95% confidence interval = 1.03-1.21, P = 0.01; population attributable risk = 9.6%). This is the first meta-analysis suggesting that XPD/ERCC2 might represent a low-penetrance melanoma susceptibility gene. Much work is still to be done before definitive conclusions can be drawn on the role of DNA repair alterations in melanomagenesis since for the other genes involved in this highly complex process, the available information is scarce or null.

Improving Nutritional Status of Older Persons with Dementia Using a National Preventive Care Program.

PubMed

Johansson, L; Wijk, H; Christensson, L

2017-01-01

The aim of the study was to investigate the outcome of change in body weight associated with use of a structured preventive care process among persons with dementia assessed as at risk of malnutrition or malnourished. The preventive care process is a pedagogical model used in the Senior Alert (SA) quality register, where nutrition is one of the prioritized areas and includes four steps: assessment, analysis of underlying causes, actions performed and outcome. An analysis of data from SA with a pre-post design was performed. The participants were living in ordinary housing or special housing in Sweden. 1912 persons, 65 years and older, registered in both SA and the dementia quality register Svedem were included. A national preventive care program including individualized actions. The Mini Nutritional Assessment-Short Form was used to assess nutritional status at baseline. Body weight was measured during baseline and follow-up (7-106 days after baseline). 74.3% persons were malnourished or at risk of malnutrition. Those at risk of malnutrition or malnourished who were registered in all four steps of the preventive care process, increased in body weight from baseline (Md 60.0 kg) to follow-up (Md 62.0 kg) (p=0.013). In those with incomplete registration no increase in body weight was found. Using all steps in the structured preventive care process seems to improve nutritional status of persons with dementia assessed as at risk of malnutrition or malnourished. This study contributes to the development of evidence-based practice regarding malnutrition and persons with dementia.

Potential of Breastmilk Analysis to Inform Early Events in Breast Carcinogenesis: Rationale and Considerations

PubMed Central

Murphy, Jeanne; Sherman, Mark E.; Browne, Eva P.; Caballero, Ana I.; Punska, Elizabeth C.; Pfeiffer, Ruth M.; Yang, Hannah P.; Lee, Maxwell; Yang, Howard; Gierach, Gretchen L.; Arcaro, Kathleen F.

2016-01-01

This review summarizes methods related to the study of human breastmilk in etiologic and biomarkers research. Despite the importance of reproductive factors in breast carcinogenesis, factors that act early in life are difficult to study because young women rarely require breast imaging or biopsy, and analysis of critical circulating factors (e.g. hormones) is often complicated by the requirement to accurately account for menstrual cycle date. Accordingly, novel approaches are needed to understand how events such as pregnancy, breastfeeding, weaning, and post-weaning breast remodeling influence breast cancer risk. Analysis of breastmilk offers opportunities to understand mechanisms related to carcinogenesis in the breast, and to identify risk markers that may inform efforts to identify high-risk women early in the carcinogenic process. In addition, analysis of breastmilk could have value in early detection or diagnosis of breast cancer. In this article we describe the potential for using breastmilk to characterize the microenvironment of the lactating breast with the goal of advancing research on risk assessment, prevention, and detection of breast cancer. PMID:27107568

Project delay analysis of HRSG

NASA Astrophysics Data System (ADS)

Silvianita; Novega, A. S.; Rosyid, D. M.; Suntoyo

2017-08-01

Completion of HRSG (Heat Recovery Steam Generator) fabrication project sometimes is not sufficient with the targeted time written on the contract. The delay on fabrication process can cause some disadvantages for fabricator, including forfeit payment, delay on HRSG construction process up until HRSG trials delay. In this paper, the author is using semi quantitative on HRSG pressure part fabrication delay with configuration plant 1 GT (Gas Turbine) + 1 HRSG + 1 STG (Steam Turbine Generator) using bow-tie analysis method. Bow-tie analysis method is a combination from FTA (Fault tree analysis) and ETA (Event tree analysis) to develop the risk matrix of HRSG. The result from FTA analysis is use as a threat for preventive measure. The result from ETA analysis is use as impact from fabrication delay.

Risk Acceptance Personality Paradigm: How We View What We Don't Know We Don't Know

NASA Technical Reports Server (NTRS)

Massie, Michael J.; Morris, A. Terry

2011-01-01

The purpose of integrated hazard analyses, probabilistic risk assessments, failure modes and effects analyses, fault trees and many other similar tools is to give managers of a program some idea of the risks associated with their program. All risk tools establish a set of undesired events and then try to evaluate the risk to the program by assessing the severity of the undesired event and the likelihood of that event occurring. Some tools provide qualitative results, some provide quantitative results and some do both. However, in the end the program manager and his/her team must decide which risks are acceptable and which are not. Even with a wide array of analysis tools available, risk acceptance is often a controversial and difficult decision making process. And yet, today's space exploration programs are moving toward more risk based design approaches. Thus, risk identification and good risk assessment is becoming even more vital to the engineering development process. This paper explores how known and unknown information influences risk-based decisions by looking at how the various parts of our personalities are affected by what they know and what they don't know. This paper then offers some criteria for consideration when making risk-based decisions.

Assessment of Uncertainty-Based Screening Volumes for NASA Robotic LEO and GEO Conjunction Risk Assessment

NASA Technical Reports Server (NTRS)

Narvet, Steven W.; Frigm, Ryan C.; Hejduk, Matthew D.

2011-01-01

Conjunction Assessment operations require screening assets against the space object catalog by placing a pre-determined spatial volume around each asset and predicting when another object will violate that volume. The selection of the screening volume used for each spacecraft is a trade-off between observing all conjunction events that may pose a potential risk to the primary spacecraft and the ability to analyze those predicted events. If the screening volumes are larger, then more conjunctions can be observed and therefore the probability of a missed detection of a high risk conjunction event is small; however, the amount of data which needs to be analyzed increases. This paper characterizes the sensitivity of screening volume size to capturing typical orbit uncertainties and the expected number of conjunction events observed. These sensitivities are quantified in the form of a trade space that allows for selection of appropriate screen-ing volumes to fit the desired concept of operations, system limitations, and tolerable analyst workloads. This analysis will specifically highlight the screening volume determination and selection process for use in the NASA Conjunction Assessment Risk Analysis process but will also provide a general framework for other Owner / Operators faced with similar decisions.

Neural Processing of Facial Identity and Emotion in Infants at High-Risk for Autism Spectrum Disorders

PubMed Central

Fox, Sharon E.; Wagner, Jennifer B.; Shrock, Christine L.; Tager-Flusberg, Helen; Nelson, Charles A.

2013-01-01

Deficits in face processing and social impairment are core characteristics of autism spectrum disorder. The present work examined 7-month-old infants at high-risk for developing autism and typically developing controls at low-risk, using a face perception task designed to differentiate between the effects of face identity and facial emotions on neural response using functional Near-Infrared Spectroscopy. In addition, we employed independent component analysis, as well as a novel method of condition-related component selection and classification to identify group differences in hemodynamic waveforms and response distributions associated with face and emotion processing. The results indicate similarities of waveforms, but differences in the magnitude, spatial distribution, and timing of responses between groups. These early differences in local cortical regions and the hemodynamic response may, in turn, contribute to differences in patterns of functional connectivity. PMID:23576966

Evolutionary Capability Delivery of Coast Guard Manpower System

DTIC Science & Technology

2014-06-01

Office IID iterative incremental development model IT information technology MA major accomplishment MRA manpower requirements analysis MRD manpower...CG will need to ensure that development is low risk. The CG uses Manpower Requirements Analysis ( MRAs ) to collect the necessary manpower data to...of users. The CG uses two business processes to manage human capital: Manpower Requirements Analysis ( MRA ) and Manpower Requirements

FINDING A METHOD FOR THE MADNESS: A COMPARATIVE ANALYSIS OF STRATEGIC DESIGN METHODOLOGIES

DTIC Science & Technology

2017-06-01

FINDING A METHOD FOR THE MADNESS: A COMPARATIVE ANALYSIS OF STRATEGIC DESIGN METHODOLOGIES BY AMANDA DONNELLY A THESIS...work develops a comparative model for strategic design methodologies, focusing on the primary elements of vision, time, process, communication and...collaboration, and risk assessment. My analysis dissects and compares three potential design methodologies including, net assessment, scenarios and

2009 Space Shuttle Probabilistic Risk Assessment Overview

NASA Technical Reports Server (NTRS)

Hamlin, Teri L.; Canga, Michael A.; Boyer, Roger L.; Thigpen, Eric B.

2010-01-01

Loss of a Space Shuttle during flight has severe consequences, including loss of a significant national asset; loss of national confidence and pride; and, most importantly, loss of human life. The Shuttle Probabilistic Risk Assessment (SPRA) is used to identify risk contributors and their significance; thus, assisting management in determining how to reduce risk. In 2006, an overview of the SPRA Iteration 2.1 was presented at PSAM 8 [1]. Like all successful PRAs, the SPRA is a living PRA and has undergone revisions since PSAM 8. The latest revision to the SPRA is Iteration 3. 1, and it will not be the last as the Shuttle program progresses and more is learned. This paper discusses the SPRA scope, overall methodology, and results, as well as provides risk insights. The scope, assumptions, uncertainties, and limitations of this assessment provide risk-informed perspective to aid management s decision-making process. In addition, this paper compares the Iteration 3.1 analysis and results to the Iteration 2.1 analysis and results presented at PSAM 8.

Patient safety in external beam radiotherapy, results of the ACCIRAD project: Recommendations for radiotherapy institutions and national authorities on assessing risks and analysing adverse error-events and near misses.

PubMed

Malicki, Julian; Bly, Ritva; Bulot, Mireille; Godet, Jean-Luc; Jahnen, Andreas; Krengli, Marco; Maingon, Philippe; Prieto Martin, Carlos; Skrobala, Agnieszka; Valero, Marc; Jarvinen, Hannu

2018-05-02

The ACCIRAD project, commissioned by the European Commission (EC) to develop guidelines for risk analysis of accidental and unintended exposures in external beam radiotherapy (EBRT), was completed in the year 2014. In 2015, the "General guidelines on risk management in external beam radiotherapy" were published as EC report Radiation Protection (RP)-181. The present document is the third and final report of the findings from the ACCIRAD project. The main aim of this paper is to describe the key features of the risk management process and to provide general guidelines for radiotherapy departments and national authorities on risk assessment and analysis of adverse error-events and near misses. The recommendations provided here and in EC report RP-181 are aimed at promoting the harmonisation of risk management systems across Europe, improving patient safety, and enabling more reliable inter-country comparisons. Copyright © 2018 Elsevier B.V. All rights reserved.

Trialability, observability and risk reduction accelerating individual innovation adoption decisions.

PubMed

Hayes, Kathryn J; Eljiz, Kathy; Dadich, Ann; Fitzgerald, Janna-Anneke; Sloan, Terry

2015-01-01

The purpose of this paper is to provide a retrospective analysis of computer simulation's role in accelerating individual innovation adoption decisions. The process innovation examined is Lean Systems Thinking, and the organizational context is the imaging department of an Australian public hospital. Intrinsic case study methods including observation, interviews with radiology and emergency personnel about scheduling procedures, mapping patient appointment processes and document analysis were used over three years and then complemented with retrospective interviews with key hospital staff. The multiple data sources and methods were combined in a pragmatic and reflexive manner to explore an extreme case that provides potential to act as an instructive template for effective change. Computer simulation of process change ideas offered by staff to improve patient-flow accelerated the adoption of the process changes, largely because animated computer simulation permitted experimentation (trialability), provided observable predictions of change results (observability) and minimized perceived risk. The difficulty of making accurate comparisons between time periods in a health care setting is acknowledged. This work has implications for policy, practice and theory, particularly for inducing the rapid diffusion of process innovations to address challenges facing health service organizations and national health systems. Originality/value - The research demonstrates the value of animated computer simulation in presenting the need for change, identifying options, and predicting change outcomes and is the first work to indicate the importance of trialability, observability and risk reduction in individual adoption decisions in health services.

Red and Processed Meat and Colorectal Cancer Incidence: Meta-Analysis of Prospective Studies

PubMed Central

Chan, Doris S. M.; Lau, Rosa; Aune, Dagfinn; Vieira, Rui; Greenwood, Darren C.; Kampman, Ellen; Norat, Teresa

2011-01-01

Background The evidence that red and processed meat influences colorectal carcinogenesis was judged convincing in the 2007 World Cancer Research Fund/American Institute of Cancer Research report. Since then, ten prospective studies have published new results. Here we update the evidence from prospective studies and explore whether there is a non-linear association of red and processed meats with colorectal cancer risk. Methods and Findings Relevant prospective studies were identified in PubMed until March 2011. For each study, relative risks and 95% confidence intervals (CI) were extracted and pooled with a random-effects model, weighting for the inverse of the variance, in highest versus lowest intake comparison, and dose-response meta-analyses. Red and processed meats intake was associated with increased colorectal cancer risk. The summary relative risk (RR) of colorectal cancer for the highest versus the lowest intake was 1.22 (95% CI  = 1.11−1.34) and the RR for every 100 g/day increase was 1.14 (95% CI  = 1.04−1.24). Non-linear dose-response meta-analyses revealed that colorectal cancer risk increases approximately linearly with increasing intake of red and processed meats up to approximately 140 g/day, where the curve approaches its plateau. The associations were similar for colon and rectal cancer risk. When analyzed separately, colorectal cancer risk was related to intake of fresh red meat (RR for 100 g/day increase  = 1.17, 95% CI  = 1.05−1.31) and processed meat (RR for 50 g/day increase  = 1.18, 95% CI  = 1.10−1.28). Similar results were observed for colon cancer, but for rectal cancer, no significant associations were observed. Conclusions High intake of red and processed meat is associated with significant increased risk of colorectal, colon and rectal cancers. The overall evidence of prospective studies supports limiting red and processed meat consumption as one of the dietary recommendations for the prevention of colorectal cancer. PMID:21674008

[Intention of purchasing generic prescription drugs on the part of consumers in Asturias, Spain].

PubMed

González Hernando, Santiago; González Mieres, Celina; Díaz Martín, Ana M

2003-01-01

Ascertaining how consumers perceive the risk related to the use of generic prescription drugs and those factors which have the greatest impact on the intention to request a generic drug from the prescribing physician and/or the pharmacist for the purpose of determining any possible barriers or hindrances to the acceptance of generics and to gather information to aid healthcare managers in their decision-making processes. Study on prescription drug use revolving around the degree to which patients are willing to request an EFG. In this quantitative transversal study, a total of 542 individuals were individually surveyed upon exiting a healthcare center or pharmacy in Asturias. A scale for measuring the perceived risk involved in the purchase of a prescription drug including 15 attributes grouped into five aspects was included in the questionnaire. Information was also gathered regarding the intention of using generic prescription drugs and on the demographic and socioeconomic characteristics of those surveyed. For the analysis of the results, a factorial confirmational analysis, multiple regression and univariate analysis were used. The data was processed using the EQS and SPSS statistics programs. Mean perception of the risk (scales 1-7): functional: 2.75; physical: 2.68: financial: 2.19; psychological: 1.99; social: 1.42. Factors having a bearing on the intention of requesting generic prescription drugs from their physician: psychological risk (p = 0.000). On requesting the same from their pharmacist: psychological risk (p = 0.000) and social risk (p = 0.020). The agents interested in the development on the EFG market should target their communication efforts on putting the functional and financial aspects of the manufacturer's specialties and generic specialties on the same level, but should not leave out psychological and social aspects of the consumers' purchasing behavior.

Integrating diverse scientific and practitioner knowledge in ecological risk analysis: a case study of biodiversity risk assessment in South Africa.

PubMed

Dana, G V; Kapuscinski, A R; Donaldson, J S

2012-05-15

Ecological risk analysis (ERA) is a structured evaluation of threats to species, natural communities, and ecosystem processes from pollutants and toxicants and more complicated living stressors such as invasive species, genetically modified organisms, and biological control agents. Such analyses are typically conducted by a narrowly-focused group of scientific experts using technical information. We evaluate whether the inclusion of more diverse experts and practitioners in ERA improved the ecological knowledge base about South African biodiversity and the potential impacts of genetically modified (GM) crops. We conducted two participatory ERA workshops in South Africa, analyzing potential impacts of GM maize on biodiversity. The first workshop involved only four biological scientists, who were joined by 18 diverse scientists and practitioners in the second, and we compared the ERA process and results between the two using descriptive statistics and semi-structured interview responses. The addition of diverse experts and practitioners led to a more comprehensive understanding of biological composition of the agro-ecosystem and a more ecologically relevant set of hazards, but impeded hazard prioritization and the generation of precise risk assessment values. Results suggest that diverse participation can improve the scoping or problem formulation of the ERA, by generating an ecologically robust set of information on which to base the subsequent, more technical risk assessment. The participatory ERA process also increased the transparency of the ERA by exposing the logic and rationale for decisions made at each step. Copyright © 2011 Elsevier Ltd. All rights reserved.

Analysis of Alternatives (AoA) Process Improvement Study

DTIC Science & Technology

2016-12-01

stakeholders, and mapped the process activities and durations. We tasked the SAG members with providing the information required on case studies and...are the expected time saves/cost/risk of any changes? (3) Utilization of case studies for both “good” and “challenged” AoAs to identify lessons...16 4 CASE STUDIES

Time-varying nonstationary multivariate risk analysis using a dynamic Bayesian copula

NASA Astrophysics Data System (ADS)

Sarhadi, Ali; Burn, Donald H.; Concepción Ausín, María.; Wiper, Michael P.

2016-03-01

A time-varying risk analysis is proposed for an adaptive design framework in nonstationary conditions arising from climate change. A Bayesian, dynamic conditional copula is developed for modeling the time-varying dependence structure between mixed continuous and discrete multiattributes of multidimensional hydrometeorological phenomena. Joint Bayesian inference is carried out to fit the marginals and copula in an illustrative example using an adaptive, Gibbs Markov Chain Monte Carlo (MCMC) sampler. Posterior mean estimates and credible intervals are provided for the model parameters and the Deviance Information Criterion (DIC) is used to select the model that best captures different forms of nonstationarity over time. This study also introduces a fully Bayesian, time-varying joint return period for multivariate time-dependent risk analysis in nonstationary environments. The results demonstrate that the nature and the risk of extreme-climate multidimensional processes are changed over time under the impact of climate change, and accordingly the long-term decision making strategies should be updated based on the anomalies of the nonstationary environment.

Pitfalls and Precautions When Using Predicted Failure Data for Quantitative Analysis of Safety Risk for Human Rated Launch Vehicles

NASA Technical Reports Server (NTRS)

Hatfield, Glen S.; Hark, Frank; Stott, James

2016-01-01

Launch vehicle reliability analysis is largely dependent upon using predicted failure rates from data sources such as MIL-HDBK-217F. Reliability prediction methodologies based on component data do not take into account risks attributable to manufacturing, assembly, and process controls. These sources often dominate component level reliability or risk of failure probability. While consequences of failure is often understood in assessing risk, using predicted values in a risk model to estimate the probability of occurrence will likely underestimate the risk. Managers and decision makers often use the probability of occurrence in determining whether to accept the risk or require a design modification. Due to the absence of system level test and operational data inherent in aerospace applications, the actual risk threshold for acceptance may not be appropriately characterized for decision making purposes. This paper will establish a method and approach to identify the pitfalls and precautions of accepting risk based solely upon predicted failure data. This approach will provide a set of guidelines that may be useful to arrive at a more realistic quantification of risk prior to acceptance by a program.

Nanotechnology risk perceptions and communication: emerging technologies, emerging challenges.

PubMed

Pidgeon, Nick; Harthorn, Barbara; Satterfield, Terre

2011-11-01

Nanotechnology involves the fabrication, manipulation, and control of materials at the atomic level and may also bring novel uncertainties and risks. Potential parallels with other controversial technologies mean there is a need to develop a comprehensive understanding of processes of public perception of nanotechnology uncertainties, risks, and benefits, alongside related communication issues. Study of perceptions, at so early a stage in the development trajectory of a technology, is probably unique in the risk perception and communication field. As such it also brings new methodological and conceptual challenges. These include: dealing with the inherent diversity of the nanotechnology field itself; the unfamiliar and intangible nature of the concept, with few analogies to anchor mental models or risk perceptions; and the ethical and value questions underlying many nanotechnology debates. Utilizing the lens of social amplification of risk, and drawing upon the various contributions to this special issue of Risk Analysis on Nanotechnology Risk Perceptions and Communication, nanotechnology may at present be an attenuated hazard. The generic idea of "upstream public engagement" for emerging technologies such as nanotechnology is also discussed, alongside its importance for future work with emerging technologies in the risk communication field. © 2011 Society for Risk Analysis.

Bullying and HIV Risk Among High School Teenagers: The Mediating Role of Teen Dating Violence.

PubMed

Okumu, Moses; Mengo, Cecilia; Ombayo, Bernadette; Small, Eusebius

2017-10-01

Teen dating violence (TDV), bullying, and HIV risk behaviors are public health concerns that impact adolescents in the United States. National estimates reveal high rates of these risk behaviors among high school students. Based on theoretical and empirical evidence, we hypothesized that experiencing teen dating violence (sexual and physical) would mediate the impact of bullying on HIV risk. Data were from the 2013 National Youth Behavior Risk Surveillance Survey (YRBSS) among students who answered questions on bullying, TDV, and HIV risk (N = 13,571). The YRBSS is conducted biennially among 9th- to 12th-grade students nationally. We used multiple regression analysis and Hayes' SPSS process macro to examine the 2 study hypotheses. Findings from bivariate analysis suggest an association between bullying and HIV risk. The study also found associations between physical, sexual teen dating violence and HIV risk. Results also indicate that both physical and sexual teen dating violence mediate the association between bullying and HIV risk. Our findings suggest that multidimensional interventions should be developed to reduce the rate of teen dating violence and combat bullying as a preventative method for HIV risk among high school students. © 2017, American School Health Association.

Risk management in waste water treatment.

PubMed

Wagner, M; Strube, I

2005-01-01

With the continuous restructuring of the water market due to liberalisation, privatisation and internationalisation processes, the requirements on waste water disposal companies have grown. Increasing competition requires a target-oriented and clearly structured procedure. At the same time it is necessary to meet the environment-relevant legal requirements and to design the processes to be environment-oriented. The implementation of risk management and the integration of such a management instrument in an existing system in addition to the use of modern technologies and procedures can help to make the operation of the waste water treatment safer and consequently strengthen market position. The risk management process consists of three phases, risk identification, risk analysis/risk assessment and risk handling, which are based on each other, as well as of the risk managing. To achieve an identification of the risks as complete as possible, a subdivision of the kind of risks (e.g. legal, financial, market, operational) is suggested. One possibility to assess risks is the portfolio method which offers clear representation. It allows a division of the risks into classes showing which areas need handling. The determination of the appropriate measures to handle a risk (e.g. avoidance, reduction, shift) is included in the concluding third phase. Different strategies can be applied here. On the one hand, the cause-oriented strategy, aiming at preventive measures which aim to reduce the probability of occurrence of a risk (e.g. creation of redundancy, systems with low susceptibility to malfunction). On the other hand, the effect-oriented strategy, aiming to minimise the level of damage in case of an undesired occurrence (e.g. use of alarm systems, insurance cover).

Using a Systematic Conceptual Model for a Process Evaluation of a Middle School Obesity Risk-Reduction Nutrition Curriculum Intervention: Choice, Control & Change

PubMed Central

Lee, Heewon; Contento, Isobel R.; Koch, Pamela

2012-01-01

Objective To use and review a conceptual model of process evaluation and to examine the implementation of a nutrition education curriculum, Choice, Control & Change, designed to promote dietary and physical activity behaviors that reduce obesity risk. Design A process evaluation study based on a systematic conceptual model. Setting Five middle schools in New York City. Participants 562 students in 20 classes and their science teachers (n=8). Main Outcome Measures Based on the model, teacher professional development, teacher implementation, and student reception were evaluated. Also measured were teacher characteristics, teachers’ curriculum evaluation, and satisfaction with teaching the curriculum. Analysis Descriptive statistics and Spearman’s Rho Correlation for quantitative analysis and content analysis for qualitative data were used. Results Mean score of the teacher professional development evaluation was 4.75 on a 5-point scale. Average teacher implementation rate was 73%, and student reception rate was 69%. Ongoing teacher support was highly valued by teachers. Teachers’ satisfaction with teaching the curriculum was highly correlated with students’ satisfaction (p <.05). Teachers’ perception of amount of student work was negatively correlated with implementation and with student satisfaction (p<.05). Conclusions and implications Use of a systematic conceptual model and comprehensive process measures improves understanding of the implementation process and helps educators to better implement interventions as designed. PMID:23321021

Adverse outcomes in maternity care for women with a low risk profile in The Netherlands: a case series analysis

PubMed Central

2013-01-01

Background This study aimed to perform a structural analysis of determinants of risk of critical incidents in care for women with a low risk profile at the start of pregnancy with a view on improving patient safety. Methods We included 71 critical incidents in primary midwifery care and subsequent hospital care in case of referral after 36 weeks of pregnancy that were related to substandard care and for that reason were reported to the Health Care Inspectorate in The Netherlands in 36 months (n = 357). We performed a case-by-case analysis, using a previously validated instrument which covered five broad domains: healthcare organization, communication between healthcare providers, patient risk factors, clinical management, and clinical outcomes. Results Determinants that were associated with risk concerned healthcare organization (n = 20 incidents), communication about treatment procedures (n = 39), referral processes (n = 19), risk assessment by telephone triage (n = 10), and clinical management in an out of hours setting (n = 19). The 71 critical incidents included three cases of maternal death, eight cases of severe maternal morbidity, 42 perinatal deaths and 12 critical incidents with severe morbidity for the child. Suboptimal prenatal risk assessment, a delay in availability of health care providers in urgent situations, miscommunication about treatment between care providers, and miscommunication with patients in situations with a language barrier were associated with safety risks. Conclusions Systematic analysis of critical incidents improves insight in determinants of safety risk. The wide variety of determinants of risk of critical incidents implies that there is no single intervention to improve patient safety in the care for pregnant women with initially a low risk profile. PMID:24286376

An Evidential Reasoning-Based CREAM to Human Reliability Analysis in Maritime Accident Process.

PubMed

Wu, Bing; Yan, Xinping; Wang, Yang; Soares, C Guedes

2017-10-01

This article proposes a modified cognitive reliability and error analysis method (CREAM) for estimating the human error probability in the maritime accident process on the basis of an evidential reasoning approach. This modified CREAM is developed to precisely quantify the linguistic variables of the common performance conditions and to overcome the problem of ignoring the uncertainty caused by incomplete information in the existing CREAM models. Moreover, this article views maritime accident development from the sequential perspective, where a scenario- and barrier-based framework is proposed to describe the maritime accident process. This evidential reasoning-based CREAM approach together with the proposed accident development framework are applied to human reliability analysis of a ship capsizing accident. It will facilitate subjective human reliability analysis in different engineering systems where uncertainty exists in practice. © 2017 Society for Risk Analysis.

Using the failure mode and effects analysis model to improve parathyroid hormone and adrenocorticotropic hormone testing

PubMed Central

Magnezi, Racheli; Hemi, Asaf; Hemi, Rina

2016-01-01

Background Risk management in health care systems applies to all hospital employees and directors as they deal with human life and emergency routines. There is a constant need to decrease risk and increase patient safety in the hospital environment. The purpose of this article is to review the laboratory testing procedures for parathyroid hormone and adrenocorticotropic hormone (which are characterized by short half-lives) and to track failure modes and risks, and offer solutions to prevent them. During a routine quality improvement review at the Endocrine Laboratory in Tel Hashomer Hospital, we discovered these tests are frequently repeated unnecessarily due to multiple failures. The repetition of the tests inconveniences patients and leads to extra work for the laboratory and logistics personnel as well as the nurses and doctors who have to perform many tasks with limited resources. Methods A team of eight staff members accompanied by the Head of the Endocrine Laboratory formed the team for analysis. The failure mode and effects analysis model (FMEA) was used to analyze the laboratory testing procedure and was designed to simplify the process steps and indicate and rank possible failures. Results A total of 23 failure modes were found within the process, 19 of which were ranked by level of severity. The FMEA model prioritizes failures by their risk priority number (RPN). For example, the most serious failure was the delay after the samples were collected from the department (RPN =226.1). Conclusion This model helped us to visualize the process in a simple way. After analyzing the information, solutions were proposed to prevent failures, and a method to completely avoid the top four problems was also developed. PMID:27980440

No association of SORL1 SNPs with Alzheimer's disease.

PubMed

Minster, Ryan L; DeKosky, Steven T; Kamboh, M Ilyas

2008-08-01

SORL1 is an element of the amyloid precursor protein processing pathway and is therefore a good candidate for affecting Alzheimer's disease (AD) risk. Indeed, there have been reports of associations between variation in SORL1 and AD risk. We examined six statistically significant single-nucleotide polymorphisms from the initial observation in a large Caucasian American case-controls cohort (1000 late-onset AD [LOAD] cases and 1000 older controls). Analysis of allele, genotype and haplotype frequencies revealed no association with LOAD risk in our cohort.

Minimum risk wavelet shrinkage operator for Poisson image denoising.

PubMed

Cheng, Wu; Hirakawa, Keigo

2015-05-01

The pixel values of images taken by an image sensor are said to be corrupted by Poisson noise. To date, multiscale Poisson image denoising techniques have processed Haar frame and wavelet coefficients--the modeling of coefficients is enabled by the Skellam distribution analysis. We extend these results by solving for shrinkage operators for Skellam that minimizes the risk functional in the multiscale Poisson image denoising setting. The minimum risk shrinkage operator of this kind effectively produces denoised wavelet coefficients with minimum attainable L2 error.

Naval Ship Maintenance: An Analysis of the Dutch Shipbuilding Industry using the Knowledge Value Added, Systems Dynamics, and Integrated Risk Management Methodologies

DTIC Science & Technology

2013-04-01

and Integrated Risk Management Methodologies 5a. CONTRACT NUMBER 5b. GRANT NUMBER 5c. PROGRAM ELEMENT NUMBER 6. AUTHOR(S) 5d. PROJECT NUMBER 5e...supply chains, risk management with real options, and sustainability . [dnford@nps.edu] Thomas J. Housel—Housel specializes in valuing intellectual...maintenance services for the RDN. Damen Schelde has used an ILS since 2002 to manage the shipbuilding process from project initiation through the

A risk-based approach to management of leachables utilizing statistical analysis of extractables.

PubMed

Stults, Cheryl L M; Mikl, Jaromir; Whelehan, Oliver; Morrical, Bradley; Duffield, William; Nagao, Lee M

2015-04-01

To incorporate quality by design concepts into the management of leachables, an emphasis is often put on understanding the extractable profile for the materials of construction for manufacturing disposables, container-closure, or delivery systems. Component manufacturing processes may also impact the extractable profile. An approach was developed to (1) identify critical components that may be sources of leachables, (2) enable an understanding of manufacturing process factors that affect extractable profiles, (3) determine if quantitative models can be developed that predict the effect of those key factors, and (4) evaluate the practical impact of the key factors on the product. A risk evaluation for an inhalation product identified injection molding as a key process. Designed experiments were performed to evaluate the impact of molding process parameters on the extractable profile from an ABS inhaler component. Statistical analysis of the resulting GC chromatographic profiles identified processing factors that were correlated with peak levels in the extractable profiles. The combination of statistically significant molding process parameters was different for different types of extractable compounds. ANOVA models were used to obtain optimal process settings and predict extractable levels for a selected number of compounds. The proposed paradigm may be applied to evaluate the impact of material composition and processing parameters on extractable profiles and utilized to manage product leachables early in the development process and throughout the product lifecycle.

Medication safety--reliability of preference cards.

PubMed

Dawson, Anthony; Orsini, Michael J; Cooper, Mary R; Wollenburg, Karol

2005-09-01

A CLINICAL ANALYSIS of surgeons' preference cards was initiated in one hospital as part of a comprehensive analysis to reduce medication-error risks by standardizing and simplifying the intraoperative medication-use process specific to the sterile field. THE PREFERENCE CARD ANALYSIS involved two subanalyses: a review of the information as it appeared on the cards and a failure mode and effects analysis of the process involved in using and maintaining the cards. THE ANALYSIS FOUND that the preference card system in use at this hospital is outdated. Variations and inconsistencies within the preference card system indicate that the use of preference cards as guides for medication selection for surgical procedures presents an opportunity for medication errors to occur.