An object-oriented approach to risk and reliability analysis : methodology and aviation safety applications.

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

Dandini, Vincent John; Duran, Felicia Angelica; Wyss, Gregory Dane

2003-09-01

This article describes how features of event tree analysis and Monte Carlo-based discrete event simulation can be combined with concepts from object-oriented analysis to develop a new risk assessment methodology, with some of the best features of each. The resultant object-based event scenario tree (OBEST) methodology enables an analyst to rapidly construct realistic models for scenarios for which an a priori discovery of event ordering is either cumbersome or impossible. Each scenario produced by OBEST is automatically associated with a likelihood estimate because probabilistic branching is integral to the object model definition. The OBEST methodology is then applied to anmore » aviation safety problem that considers mechanisms by which an aircraft might become involved in a runway incursion incident. The resulting OBEST model demonstrates how a close link between human reliability analysis and probabilistic risk assessment methods can provide important insights into aviation safety phenomenology.« less

Sounding rocket and balloon flight safety philosophy and methodologies

NASA Technical Reports Server (NTRS)

Beyma, R. J.

1986-01-01

NASA's sounding rocket and balloon goal is to successfully and safely perform scientific research. This is reflected in the design, planning, and conduct of sounding rocket and balloon operations. The purpose of this paper is to acquaint the sounding rocket and balloon scientific community with flight safety philosophy and methodologies, and how range safety affects their programs. This paper presents the flight safety philosophy for protecting the public against the risk created by the conduct of sounding rocket and balloon operations. The flight safety criteria used to implement this philosophy are defined and the methodologies used to calculate mission risk are described.

Integrated Response Time Evaluation Methodology for the Nuclear Safety Instrumentation System

NASA Astrophysics Data System (ADS)

Lee, Chang Jae; Yun, Jae Hee

2017-06-01

Safety analysis for a nuclear power plant establishes not only an analytical limit (AL) in terms of a measured or calculated variable but also an analytical response time (ART) required to complete protective action after the AL is reached. If the two constraints are met, the safety limit selected to maintain the integrity of physical barriers used for preventing uncontrolled radioactivity release will not be exceeded during anticipated operational occurrences and postulated accidents. Setpoint determination methodologies have actively been developed to ensure that the protective action is initiated before the process conditions reach the AL. However, regarding the ART for a nuclear safety instrumentation system, an integrated evaluation methodology considering the whole design process has not been systematically studied. In order to assure the safety of nuclear power plants, this paper proposes a systematic and integrated response time evaluation methodology that covers safety analyses, system designs, response time analyses, and response time tests. This methodology is applied to safety instrumentation systems for the advanced power reactor 1400 and the optimized power reactor 1000 nuclear power plants in South Korea. The quantitative evaluation results are provided herein. The evaluation results using the proposed methodology demonstrate that the nuclear safety instrumentation systems fully satisfy corresponding requirements of the ART.

Roadway safety analysis methodology for Utah : final report.

DOT National Transportation Integrated Search

2016-12-01

This research focuses on the creation of a three-part Roadway Safety Analysis methodology that applies and automates the cumulative work of recently-completed roadway safety research. The first part is to prepare the roadway and crash data for analys...

Comprehensive Safety Analysis 2010 Safety Measurement System (SMS) Methodology, Version 2.1 Revised December 2010

DOT National Transportation Integrated Search

2010-12-01

This report documents the Safety Measurement System (SMS) methodology developed to support the Comprehensive Safety Analysis 2010 (CSA 2010) Initiative for the Federal Motor Carrier Safety Administration (FMCSA). The SMS is one of the major tools for...

Tracer methodology: an appropriate tool for assessing compliance with accreditation standards?

PubMed

Bouchard, Chantal; Jean, Olivier

2017-10-01

Tracer methodology has been used by Accreditation Canada since 2008 to collect evidence on the quality and safety of care and services, and to assess compliance with accreditation standards. Given the importance of this methodology in the accreditation program, the objective of this study is to assess the quality of the methodology and identify its strengths and weaknesses. A mixed quantitative and qualitative approach was adopted to evaluate consistency, appropriateness, effectiveness and stakeholder synergy in applying the methodology. An online questionnaire was sent to 468 Accreditation Canada surveyors. According to surveyors' perceptions, tracer methodology is an effective tool for collecting useful, credible and reliable information to assess compliance with Qmentum program standards and priority processes. The results show good coherence between methodology components (appropriateness of the priority processes evaluated, activities to evaluate a tracer, etc.). The main weaknesses are the time constraints faced by surveyors and management's lack of cooperation during the evaluation of tracers. The inadequate amount of time allowed for the methodology to be applied properly raises questions about the quality of the information obtained. This study paves the way for a future, more in-depth exploration of the identified weaknesses to help the accreditation organization make more targeted improvements to the methodology. Copyright © 2016 John Wiley & Sons, Ltd. Copyright © 2016 John Wiley & Sons, Ltd.

Reliability Modeling Methodology for Independent Approaches on Parallel Runways Safety Analysis

NASA Technical Reports Server (NTRS)

Babcock, P.; Schor, A.; Rosch, G.

1998-01-01

This document is an adjunct to the final report An Integrated Safety Analysis Methodology for Emerging Air Transport Technologies. That report presents the results of our analysis of the problem of simultaneous but independent, approaches of two aircraft on parallel runways (independent approaches on parallel runways, or IAPR). This introductory chapter presents a brief overview and perspective of approaches and methodologies for performing safety analyses for complex systems. Ensuing chapter provide the technical details that underlie the approach that we have taken in performing the safety analysis for the IAPR concept.

Designing trials for pressure ulcer risk assessment research: methodological challenges.

PubMed

Balzer, K; Köpke, S; Lühmann, D; Haastert, B; Kottner, J; Meyer, G

2013-08-01

For decades various pressure ulcer risk assessment scales (PURAS) have been developed and implemented into nursing practice despite uncertainty whether use of these tools helps to prevent pressure ulcers. According to current methodological standards, randomised controlled trials (RCTs) are required to conclusively determine the clinical efficacy and safety of this risk assessment strategy. In these trials, PURAS-aided risk assessment has to be compared to nurses' clinical judgment alone in terms of its impact on pressure ulcer incidence and adverse outcomes. However, RCTs evaluating diagnostic procedures are prone to specific risks of bias and threats to the statistical power which may challenge their validity and feasibility. This discussion paper critically reflects on the rigour and feasibility of experimental research needed to substantiate the clinical efficacy of PURAS-aided risk assessment. Based on reflections of the methodological literature, a critical appraisal of available trials on this subject and an analysis of a protocol developed for a methodologically robust cluster-RCT, this paper arrives at the following conclusions: First, available trials do not provide reliable estimates of the impact of PURAS-aided risk assessment on pressure ulcer incidence compared to nurses' clinical judgement alone due to serious risks of bias and insufficient sample size. Second, it seems infeasible to assess this impact by means of rigorous experimental studies since sample size would become extremely high if likely threats to validity and power are properly taken into account. Third, means of evidence linkages seem to currently be the most promising approaches for evaluating the clinical efficacy and safety of PURAS-aided risk assessment. With this kind of secondary research, the downstream effect of use of PURAS on pressure ulcer incidence could be modelled by combining best available evidence for single parts of this pathway. However, to yield reliable modelling

Environmental probabilistic quantitative assessment methodologies

USGS Publications Warehouse

Crovelli, R.A.

1995-01-01

In this paper, four petroleum resource assessment methodologies are presented as possible pollution assessment methodologies, even though petroleum as a resource is desirable, whereas pollution is undesirable. A methodology is defined in this paper to consist of a probability model and a probabilistic method, where the method is used to solve the model. The following four basic types of probability models are considered: 1) direct assessment, 2) accumulation size, 3) volumetric yield, and 4) reservoir engineering. Three of the four petroleum resource assessment methodologies were written as microcomputer systems, viz. TRIAGG for direct assessment, APRAS for accumulation size, and FASPU for reservoir engineering. A fourth microcomputer system termed PROBDIST supports the three assessment systems. The three assessment systems have different probability models but the same type of probabilistic method. The type of advantages of the analytic method are in computational speed and flexibility, making it ideal for a microcomputer. -from Author

Reviewing methodologically disparate data: a practical guide for the patient safety research field.

PubMed

Brown, Katrina F; Long, Susannah J; Athanasiou, Thanos; Vincent, Charles A; Kroll, J Simon; Sevdalis, Nick

2012-02-01

This article addresses key questions frequently asked by researchers conducting systematic reviews in patient safety. This discipline is relatively young, and asks complex questions about complex aspects of health care delivery and experience, therefore its studies are typically methodologically heterogeneous, non-randomized and complex; but content rich and highly relevant to practice. Systematic reviews are increasingly necessary to drive forward practice and research in this area, but the data do not always lend themselves to 'standard' review methodologies. This accessible 'how-to' article demonstrates that data diversity need not preclude high-quality systematic reviews. It draws together information from published guidelines and experience within our multidisciplinary patient safety research group to provide entry-level advice for the clinician-researcher new to systematic reviewing, to non-biomedical research data or to both. It offers entry-level advice, illustrated with detailed practical examples, on defining a research question, creating a comprehensive search strategy, selecting articles for inclusion, assessing study quality, extracting data, synthesizing data and evaluating the impact of your review. The article concludes with a comment on the vital role of robust systematic reviews in the continuing advancement of the patient safety field. © 2010 Blackwell Publishing Ltd.

Safety assessment on pedestrian crossing environments using MLS data.

PubMed

Soilán, Mario; Riveiro, Belén; Sánchez-Rodríguez, Ana; Arias, Pedro

2018-02-01

In the framework of infrastructure analysis and maintenance in an urban environment, it is important to address the safety of every road user. This paper presents a methodology for the evaluation of several safety indicators on pedestrian crossing environments using geometric and radiometric information extracted from 3D point clouds collected by a Mobile Mapping System (MMS). The methodology is divided in four main modules which analyze the accessibility of the crossing area, the presence of traffic lights and traffic signs, and the visibility between a driver and a pedestrian on the proximities of a pedestrian crossing. The outputs of the analysis are exported to a Geographic Information System (GIS) where they are visualized and can be further processed in the context of city management. The methodology has been tested on approximately 30 pedestrian crossings in cluttered urban environments of two different cities. Results show that MMS are a valid mean to assess the safety of a specific urban environment, regarding its geometric conditions. Remarkable results are presented on traffic light classification, with a global F-score close to 95%. Copyright © 2017 Elsevier Ltd. All rights reserved.

Using Risk Assessment Methodologies to Meet Management Objectives

NASA Technical Reports Server (NTRS)

DeMott, D. L.

2015-01-01

Corporate and program objectives focus on desired performance and results. ?Management decisions that affect how to meet these objectives now involve a complex mix of: technology, safety issues, operations, process considerations, employee considerations, regulatory requirements, financial concerns and legal issues. ?Risk Assessments are a tool for decision makers to understand potential consequences and be in a position to reduce, mitigate or eliminate costly mistakes or catastrophic failures. Using a risk assessment methodology is only a starting point. ?A risk assessment program provides management with important input in the decision making process. ?A pro-active organization looks to the future to avoid problems, a reactive organization can be blindsided by risks that could have been avoided. ?You get out what you put in, how useful your program is will be up to the individual organization.

Work-related stress risk assessment in Italy: a methodological proposal adapted to regulatory guidelines.

PubMed

Persechino, Benedetta; Valenti, Antonio; Ronchetti, Matteo; Rondinone, Bruna Maria; Di Tecco, Cristina; Vitali, Sara; Iavicoli, Sergio

2013-06-01

Work-related stress is one of the major causes of occupational ill health. In line with the regulatory framework on occupational health and safety (OSH), adequate models for assessing and managing risk need to be identified so as to minimize the impact of this stress not only on workers' health, but also on productivity. After close analysis of the Italian and European reference regulatory framework and work-related stress assessment and management models used in some European countries, we adopted the UK Health and Safety Executive's (HSE) Management Standards (MS) approach, adapting it to the Italian context in order to provide a suitable methodological proposal for Italy. We have developed a work-related stress risk assessment strategy, meeting regulatory requirements, now available on a specific web platform that includes software, tutorials, and other tools to assist companies in their assessments. This methodological proposal is new on the Italian work-related stress risk assessment scene. Besides providing an evaluation approach using scientifically validated instruments, it ensures the active participation of occupational health professionals in each company. The assessment tools provided enable companies not only to comply with the law, but also to contribute to a database for monitoring and assessment and give access to a reserved area for data analysis and comparisons.

Application of Non-Human Biota Assessment Methodologies to the Assessment of Potential Impacts from a Nuclear Waste Repository

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

Smith, K.L.; Robinson, C.A.; Ikonen, A.T.K.

2007-07-01

The protection of the environment from the effects of ionising radiation has become increasingly more topical over the last few years as the intentions enshrined in international principles and agreements have become more binding through national and international law. For example, the Directive on impact of certain projects on the environment (EIA Directive 85/337/EEC) [CEC, 1985], amended in 1997 [CEC, 1997], places a mandatory requirement on all EU Member States to conduct environmental impact assessments for a range of project having potential impact on the environment, including radioactive waste disposal. Such assessments must consider humans, fauna and flora, the abioticmore » environment (soil, water, air), material assets and cultural heritage as well as the interactions between these factors. In Finland, Posiva Oy are responsible for the overall repository programme for spent nuclear fuel and, as such, are conducting the Safety Case Assessment for a proposed geological repository for nuclear waste. Within the European legislation framework, the Finnish regulatory body requires that the repository safety case assessment should include not only human radiological safety, but also an assessment of the potential impact upon populations of non-human biota. Specifically, the Safety Case should demonstrate that there will be: - no decline in the biodiversity of currently living populations; - no significant detriment to populations of fauna and flora; and, - no detrimental effects on individuals of domestic animals and rare plants and animals. At present, there are no internationally agreed criteria that explicitly address protection of the environment from ionising radiation. However, over recent years a number of assessment methodologies have been developed including, at a European level, the Framework for the Assessment of Environmental impact (FASSET) and Environmental Risks from Ionising Contaminants (ERICA). The International Committee on Radiation

Assessment of methodologies for analysis of the dungeness B accidental aircraft crash risk.

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

LaChance, Jeffrey L.; Hansen, Clifford W.

2010-09-01

The Health and Safety Executive (HSE) has requested Sandia National Laboratories (SNL) to review the aircraft crash methodology for nuclear facilities that are being used in the United Kingdom (UK). The scope of the work included a review of one method utilized in the UK for assessing the potential for accidental airplane crashes into nuclear facilities (Task 1) and a comparison of the UK methodology against similar International Atomic Energy Agency (IAEA), United States (US) Department of Energy (DOE), and the US Nuclear Regulatory Commission (NRC) methods (Task 2). Based on the conclusions from Tasks 1 and 2, an additionalmore » Task 3 would provide an assessment of a site-specific crash frequency for the Dungeness B facility using one of the other methodologies. This report documents the results of Task 2. The comparison of the different methods was performed for the three primary contributors to aircraft crash risk at the Dungeness B site: airfield related crashes, crashes below airways, and background crashes. The methods and data specified in each methodology were compared for each of these risk contributors, differences in the methodologies were identified, and the importance of these differences was qualitatively and quantitatively assessed. The bases for each of the methods and the data used were considered in this assessment process. A comparison of the treatment of the consequences of the aircraft crashes was not included in this assessment because the frequency of crashes into critical structures is currently low based on the existing Dungeness B assessment. Although the comparison found substantial differences between the UK and the three alternative methodologies (IAEA, NRC, and DOE) this assessment concludes that use of any of these alternative methodologies would not change the conclusions reached for the Dungeness B site. Performance of Task 3 is thus not recommended.« less

Are automatic systems the future of motorcycle safety? A novel methodology to prioritize potential safety solutions based on their projected effectiveness.

PubMed

Gil, Gustavo; Savino, Giovanni; Piantini, Simone; Baldanzini, Niccolò; Happee, Riender; Pierini, Marco

2017-11-17

Motorcycle riders are involved in significantly more crashes per kilometer driven than passenger car drivers. Nonetheless, the development and implementation of motorcycle safety systems lags far behind that of passenger cars. This research addresses the identification of the most effective motorcycle safety solutions in the context of different countries. A knowledge-based system of motorcycle safety (KBMS) was developed to assess the potential for various safety solutions to mitigate or avoid motorcycle crashes. First, a set of 26 common crash scenarios was identified from the analysis of multiple crash databases. Second, the relative effectiveness of 10 safety solutions was assessed for the 26 crash scenarios by a panel of experts. Third, relevant information about crashes was used to weigh the importance of each crash scenario in the region studied. The KBMS method was applied with an Italian database, with a total of more than 1 million motorcycle crashes in the period 2000-2012. When applied to the Italian context, the KBMS suggested that automatic systems designed to compensate for riders' or drivers' errors of commission or omission are the potentially most effective safety solution. The KBMS method showed an effective way to compare the potential of various safety solutions, through a scored list with the expected effectiveness of each safety solution for the region to which the crash data belong. A comparison of our results with a previous study that attempted a systematic prioritization of safety systems for motorcycles (PISa project) showed an encouraging agreement. Current results revealed that automatic systems have the greatest potential to improve motorcycle safety. Accumulating and encoding expertise in crash analysis from a range of disciplines into a scalable and reusable analytical tool, as proposed with the use of KBMS, has the potential to guide research and development of effective safety systems. As the expert assessment of the crash

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

Work-Related Stress Risk Assessment in Italy: A Methodological Proposal Adapted to Regulatory Guidelines

PubMed Central

Persechino, Benedetta; Valenti, Antonio; Ronchetti, Matteo; Rondinone, Bruna Maria; Di Tecco, Cristina; Vitali, Sara; Iavicoli, Sergio

2013-01-01

Background Work-related stress is one of the major causes of occupational ill health. In line with the regulatory framework on occupational health and safety (OSH), adequate models for assessing and managing risk need to be identified so as to minimize the impact of this stress not only on workers' health, but also on productivity. Methods After close analysis of the Italian and European reference regulatory framework and work-related stress assessment and management models used in some European countries, we adopted the UK Health and Safety Executive's (HSE) Management Standards (MS) approach, adapting it to the Italian context in order to provide a suitable methodological proposal for Italy. Results We have developed a work-related stress risk assessment strategy, meeting regulatory requirements, now available on a specific web platform that includes software, tutorials, and other tools to assist companies in their assessments. Conclusion This methodological proposal is new on the Italian work-related stress risk assessment scene. Besides providing an evaluation approach using scientifically validated instruments, it ensures the active participation of occupational health professionals in each company. The assessment tools provided enable companies not only to comply with the law, but also to contribute to a database for monitoring and assessment and give access to a reserved area for data analysis and comparisons. PMID:23961332

The TRIPOD e-learning Platform for the Training of Earthquake Safety Assessment

NASA Astrophysics Data System (ADS)

Coppari, S.; Di Pasquale, G.; Goretti, A.; Papa, F.; Papa, S.; Paoli, G.; Pizza, A. G.; Severino, M.

2008-07-01

The paper summarizes the results of the in progress EU Project titled TRIPOD (Training Civil Engineers on Post-Earthquake Safety Assessment of Damaged Buildings), funded under the Leonardo Da Vinci program. The main theme of the project is the development of a methodology and a learning platform for the training of technicians involved in post-earthquake building safety inspections. In the event of a catastrophic earthquake, emergency building inspections constitute a major undertaking with severe social impact. Given the inevitable chaotic conditions and the urgent need of a great number of specialized individuals to carry out inspections, past experience indicates that inspection teams are often formed in an adhoc manner, under stressful conditions, at a varying levels of technical expertise and experience, sometime impairing the reliability and consistency of the inspection results. Furthermore each Country has its own building damage and safety assessment methodology, developed according to its experience, laws, building technology and seismicity. This holds also for the partners participating to the project (Greece, Italy, Turkey, Cyprus), that all come from seismically sensitive Mediterranean countries. The project aims at alleviating the above shortcomings by designing and developing a training methodology and e-platform, forming a complete training program targeted at inspection engineers, specialized personnel and civil protection agencies. The e-learning platform will provide flexible and friendly authoring mechanisms, self-teaching and assessment capabilities, course and trainee management, etc. Courses will be also made available as stand-alone multimedia applications on CD and in the form of a complete pocket handbook. Moreover the project will offer the possibility of upgrading different experiences and practices: a first step towards the harmonization of methodologies and tools of different Countries sharing similar problems. Finally, through wide

Public acceptability of highway safety countermeasures. Volume 1, Background of study and methodology

DOT National Transportation Integrated Search

1981-06-01

This study provides information about public attitudes towards proposed highway safety countermeasures in three program areas: alcohol and drugs, unsafe driving behaviors, and pedestrian safety. This volume describes the three research methodologies ...

HSE's safety assessment principles for criticality safety.

PubMed

Simister, D N; Finnerty, M D; Warburton, S J; Thomas, E A; Macphail, M R

2008-06-01

The Health and Safety Executive (HSE) published its revised Safety Assessment Principles for Nuclear Facilities (SAPs) in December 2006. The SAPs are primarily intended for use by HSE's inspectors when judging the adequacy of safety cases for nuclear facilities. The revised SAPs relate to all aspects of safety in nuclear facilities including the technical discipline of criticality safety. The purpose of this paper is to set out for the benefit of a wider audience some of the thinking behind the final published words and to provide an insight into the development of UK regulatory guidance. The paper notes that it is HSE's intention that the Safety Assessment Principles should be viewed as a reflection of good practice in the context of interpreting primary legislation such as the requirements under site licence conditions for arrangements for producing an adequate safety case and for producing a suitable and sufficient risk assessment under the Ionising Radiations Regulations 1999 (SI1999/3232 www.opsi.gov.uk/si/si1999/uksi_19993232_en.pdf).

Portable Nanoparticle-Based Sensors for Food Safety Assessment

PubMed Central

Bülbül, Gonca; Hayat, Akhtar; Andreescu, Silvana

2015-01-01

The use of nanotechnology-derived products in the development of sensors and analytical measurement methodologies has increased significantly over the past decade. Nano-based sensing approaches include the use of nanoparticles (NPs) and nanostructures to enhance sensitivity and selectivity, design new detection schemes, improve sample preparation and increase portability. This review summarizes recent advancements in the design and development of NP-based sensors for assessing food safety. The most common types of NPs used to fabricate sensors for detection of food contaminants are discussed. Selected examples of NP-based detection schemes with colorimetric and electrochemical detection are provided with focus on sensors for the detection of chemical and biological contaminants including pesticides, heavy metals, bacterial pathogens and natural toxins. Current trends in the development of low-cost portable NP-based technology for rapid assessment of food safety as well as challenges for practical implementation and future research directions are discussed. PMID:26690169

Assessment of cognitive safety in clinical drug development

PubMed Central

Roiser, Jonathan P.; Nathan, Pradeep J.; Mander, Adrian P.; Adusei, Gabriel; Zavitz, Kenton H.; Blackwell, Andrew D.

2016-01-01

Cognitive impairment is increasingly recognised as an important potential adverse effect of medication. However, many drug development programmes do not incorporate sensitive cognitive measurements. Here, we review the rationale for cognitive safety assessment, and explain several basic methodological principles for measuring cognition during clinical drug development, including study design and statistical analysis, from Phase I through to postmarketing. The crucial issue of how cognition should be assessed is emphasized, especially the sensitivity of measurement. We also consider how best to interpret the magnitude of any identified effects, including comparison with benchmarks. We conclude by discussing strategies for the effective communication of cognitive risks. PMID:26610416

Safety evaluation methodology for advanced coal extraction systems

NASA Technical Reports Server (NTRS)

Zimmerman, W. F.

1981-01-01

Qualitative and quantitative evaluation methods for coal extraction systems were developed. The analysis examines the soundness of the design, whether or not the major hazards have been eliminated or reduced, and how the reduction would be accomplished. The quantitative methodology establishes the approximate impact of hazards on injury levels. The results are weighted by peculiar geological elements, specialized safety training, peculiar mine environmental aspects, and reductions in labor force. The outcome is compared with injury level requirements based on similar, safer industries to get a measure of the new system's success in reducing injuries. This approach provides a more detailed and comprehensive analysis of hazards and their effects than existing safety analyses.

1998 motor vehicle occupant safety survey. Volume 1, methodology report

DOT National Transportation Integrated Search

2000-03-01

This is the Methodology Report for the 1998 Motor Vehicle Occupant Safety Survey. The survey is conducted on a biennial basis (initiated in 1994), and is administered by telephone to a randomly selected national sample. Two questionnaires are used, e...

Offshore safety case approach and formal safety assessment of ships.

PubMed

Wang, J

2002-01-01

Tragic marine and offshore accidents have caused serious consequences including loss of lives, loss of property, and damage of the environment. A proactive, risk-based "goal setting" regime is introduced to the marine and offshore industries to increase the level of safety. To maximize marine and offshore safety, risks need to be modeled and safety-based decisions need to be made in a logical and confident way. Risk modeling and decision-making tools need to be developed and applied in a practical environment. This paper describes both the offshore safety case approach and formal safety assessment of ships in detail with particular reference to the design aspects. The current practices and the latest development in safety assessment in both the marine and offshore industries are described. The relationship between the offshore safety case approach and formal ship safety assessment is described and discussed. Three examples are used to demonstrate both the offshore safety case approach and formal ship safety assessment. The study of risk criteria in marine and offshore safety assessment is carried out. The recommendations on further work required are given. This paper gives safety engineers in the marine and offshore industries an overview of the offshore safety case approach and formal ship safety assessment. The significance of moving toward a risk-based "goal setting" regime is given.

Assessment of Integrated Pedestrian Protection Systems with Autonomous Emergency Braking (AEB) and Passive Safety Components.

PubMed

Edwards, Mervyn; Nathanson, Andrew; Carroll, Jolyon; Wisch, Marcus; Zander, Oliver; Lubbe, Nils

2015-01-01

Autonomous emergency braking (AEB) systems fitted to cars for pedestrians have been predicted to offer substantial benefit. On this basis, consumer rating programs-for example, the European New Car Assessment Programme (Euro NCAP)-are developing rating schemes to encourage fitment of these systems. One of the questions that needs to be answered to do this fully is how the assessment of the speed reduction offered by the AEB is integrated with the current assessment of the passive safety for mitigation of pedestrian injury. Ideally, this should be done on a benefit-related basis. The objective of this research was to develop a benefit-based methodology for assessment of integrated pedestrian protection systems with AEB and passive safety components. The method should include weighting procedures to ensure that it represents injury patterns from accident data and replicates an independently estimated benefit of AEB. A methodology has been developed to calculate the expected societal cost of pedestrian injuries, assuming that all pedestrians in the target population (i.e., pedestrians impacted by the front of a passenger car) are impacted by the car being assessed, taking into account the impact speed reduction offered by the car's AEB (if fitted) and the passive safety protection offered by the car's frontal structure. For rating purposes, the cost for the assessed car is normalized by comparing it to the cost calculated for a reference car. The speed reductions measured in AEB tests are used to determine the speed at which each pedestrian in the target population will be impacted. Injury probabilities for each impact are then calculated using the results from Euro NCAP pedestrian impactor tests and injury risk curves. These injury probabilities are converted into cost using "harm"-type costs for the body regions tested. These costs are weighted and summed. Weighting factors were determined using accident data from Germany and Great Britain and an independently

Considering new methodologies in strategies for safety assessment of foods and food ingredients.

PubMed

Blaauboer, Bas J; Boobis, Alan R; Bradford, Bobbie; Cockburn, Andrew; Constable, Anne; Daneshian, Mardas; Edwards, Gareth; Garthoff, Jossie A; Jeffery, Brett; Krul, Cyrille; Schuermans, Jeroen

2016-05-01

Toxicology and safety assessment are changing and require new strategies for evaluating risk that are less depending on apical toxicity endpoints in animal models and relying more on knowledge of the mechanism of toxicity. This manuscript describes a number of developments that could contribute to this change and implement this in a stepwise roadmap that can be applied for the evaluation of food and food ingredients. The roadmap was evaluated in four case studies by using literature and existing data. This preliminary evaluation was shown to be useful. However, this experience should be extended by including examples where experimental work needs to be included. To further implement these new insights in toxicology and safety assessment for the area of food and food ingredients, the recommendation is that stakeholders take action in addressing gaps in our knowledge, e.g. with regard to the applicability of the roadmap for mixtures and food matrices. Further development of the threshold of toxicological concern is needed, as well as cooperation with other sectors where similar schemes are under development. Moreover, a more comprehensive evaluation of the roadmap, also including the identification of the need for in vitro experimental work is recommended. Copyright © 2016 ILSI Europe. Published by Elsevier Ltd.. All rights reserved.

The TRIPOD e-learning Platform for the Training of Earthquake Safety Assessment

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

Coppari, S.; Di Pasquale, G.; Goretti, A.

2008-07-08

The paper summarizes the results of the in progress EU Project titled TRIPOD (Training Civil Engineers on Post-Earthquake Safety Assessment of Damaged Buildings), funded under the Leonardo Da Vinci program. The main theme of the project is the development of a methodology and a learning platform for the training of technicians involved in post-earthquake building safety inspections. In the event of a catastrophic earthquake, emergency building inspections constitute a major undertaking with severe social impact. Given the inevitable chaotic conditions and the urgent need of a great number of specialized individuals to carry out inspections, past experience indicates that inspectionmore » teams are often formed in an adhoc manner, under stressful conditions, at a varying levels of technical expertise and experience, sometime impairing the reliability and consistency of the inspection results. Furthermore each Country has its own building damage and safety assessment methodology, developed according to its experience, laws, building technology and seismicity. This holds also for the partners participating to the project (Greece, Italy, Turkey, Cyprus), that all come from seismically sensitive Mediterranean countries. The project aims at alleviating the above shortcomings by designing and developing a training methodology and e-platform, forming a complete training program targeted at inspection engineers, specialized personnel and civil protection agencies. The e-learning platform will provide flexible and friendly authoring mechanisms, self-teaching and assessment capabilities, course and trainee management, etc. Courses will be also made available as stand-alone multimedia applications on CD and in the form of a complete pocket handbook. Moreover the project will offer the possibility of upgrading different experiences and practices: a first step towards the harmonization of methodologies and tools of different Countries sharing similar problems. Finally, through

Safety Assessment of Multi Purpose Small Payload Rack(MSPR)

NASA Astrophysics Data System (ADS)

Mizutani, Yoshinobu; Takada, Satomi; Murata, Kosei; Ozawa, Daisaku; Kobayashi, Ryoji; Nakamura, Yasuhiro

2010-09-01

We are reporting summary of preliminary safety assessment for Multi Purpose Small Payload Rack(MSPR), which is one of the micro gravity experiment facilities that are being developed for the 2nd phase JEM utilization(JEM: Japanese Experiment Module) that will be launched on H-II Transfer Vehicle(HTV) 2nd flight in 2011. MSPR is used for multi-purpose micro-g experiment providing experimental spaces and work stations. MSPR has three experimental spaces; first, there is a space called Work Volume(WV) with capacity volume of approximately 350 litters, in which multiple resources including electricity, communication, and moving image functions can be used. Within this space, installation of devices can be done by simple, prompt attachment by Velcro and pins with high degree of flexibility. Second, there is Small Experiment Area(SEA), with capacity volume of approximately 70 litters, in which electricity, communication, and moving image functions can also be used in the same way as WV. These spaces protect experiment devices and specimens from contingent loads by the crewmembers. Third, there is Work Bench with area of 0.5 square meters, on which can be used for maintenance, inspection and data operations of installed devices, etc. This bench can be stored in the rack during contingency. Chamber for Combustion Experiment(CCE) that is planned to be installed in WV is a pressure-resistant experimental container that can be used to seal hazardous materials from combustion experiments. This CCE has double sealing design in chamber itself, which resist gas leakage under normal the temperature and pressure. Electricity, communication, moving image function can be used in the same way as WV. JAXA Phase 2 Safety Review Panel(SRP) has been held in April, 2010. For safety analysis of MSPR, hazards were identified based on Fault Tree Analysis methodology and then these hazards were classified into either eight ISS standard-type hazards or eight unique-type hazards that requires

Methodological quality of meta-analyses on treatments for chronic obstructive pulmonary disease: a cross-sectional study using the AMSTAR (Assessing the Methodological Quality of Systematic Reviews) tool.

PubMed

Ho, Robin S T; Wu, Xinyin; Yuan, Jinqiu; Liu, Siya; Lai, Xin; Wong, Samuel Y S; Chung, Vincent C H

2015-01-08

Meta-analysis (MA) of randomised trials is considered to be one of the best approaches for summarising high-quality evidence on the efficacy and safety of treatments. However, methodological flaws in MAs can reduce the validity of conclusions, subsequently impairing the quality of decision making. To assess the methodological quality of MAs on COPD treatments. A cross-sectional study on MAs of COPD trials. MAs published during 2000-2013 were sampled from the Cochrane Database of Systematic Reviews and Database of Abstracts of Reviews of Effect. Methodological quality was assessed using the validated AMSTAR (Assessing the Methodological Quality of Systematic Reviews) tool. Seventy-nine MAs were sampled. Only 18% considered the scientific quality of primary studies when formulating conclusions and 49% used appropriate meta-analytic methods to combine findings. The problems were particularly acute among MAs on pharmacological treatments. In 48% of MAs the authors did not report conflict of interest. Fifty-eight percent reported harmful effects of treatment. Publication bias was not assessed in 65% of MAs, and only 10% had searched non-English databases. The methodological quality of the included MAs was disappointing. Consideration of scientific quality when formulating conclusions should be made explicit. Future MAs should improve on reporting conflict of interest and harm, assessment of publication bias, prevention of language bias and use of appropriate meta-analytic methods.

Methodological quality of meta-analyses on treatments for chronic obstructive pulmonary disease: a cross-sectional study using the AMSTAR (Assessing the Methodological Quality of Systematic Reviews) tool

PubMed Central

Ho, Robin ST; Wu, Xinyin; Yuan, Jinqiu; Liu, Siya; Lai, Xin; Wong, Samuel YS; Chung, Vincent CH

2015-01-01

Background: Meta-analysis (MA) of randomised trials is considered to be one of the best approaches for summarising high-quality evidence on the efficacy and safety of treatments. However, methodological flaws in MAs can reduce the validity of conclusions, subsequently impairing the quality of decision making. Aims: To assess the methodological quality of MAs on COPD treatments. Methods: A cross-sectional study on MAs of COPD trials. MAs published during 2000–2013 were sampled from the Cochrane Database of Systematic Reviews and Database of Abstracts of Reviews of Effect. Methodological quality was assessed using the validated AMSTAR (Assessing the Methodological Quality of Systematic Reviews) tool. Results: Seventy-nine MAs were sampled. Only 18% considered the scientific quality of primary studies when formulating conclusions and 49% used appropriate meta-analytic methods to combine findings. The problems were particularly acute among MAs on pharmacological treatments. In 48% of MAs the authors did not report conflict of interest. Fifty-eight percent reported harmful effects of treatment. Publication bias was not assessed in 65% of MAs, and only 10% had searched non-English databases. Conclusions: The methodological quality of the included MAs was disappointing. Consideration of scientific quality when formulating conclusions should be made explicit. Future MAs should improve on reporting conflict of interest and harm, assessment of publication bias, prevention of language bias and use of appropriate meta-analytic methods. PMID:25569783

USGS Methodology for Assessing Continuous Petroleum Resources

USGS Publications Warehouse

Charpentier, Ronald R.; Cook, Troy A.

2011-01-01

The U.S. Geological Survey (USGS) has developed a new quantitative methodology for assessing resources in continuous (unconventional) petroleum deposits. Continuous petroleum resources include shale gas, coalbed gas, and other oil and gas deposits in low-permeability ("tight") reservoirs. The methodology is based on an approach combining geologic understanding with well productivities. The methodology is probabilistic, with both input and output variables as probability distributions, and uses Monte Carlo simulation to calculate the estimates. The new methodology is an improvement of previous USGS methodologies in that it better accommodates the uncertainties in undrilled or minimally drilled deposits that must be assessed using analogs. The publication is a collection of PowerPoint slides with accompanying comments.

Flightdeck Automation Problems (FLAP) Model for Safety Technology Portfolio Assessment

NASA Technical Reports Server (NTRS)

Ancel, Ersin; Shih, Ann T.

2014-01-01

NASA's Aviation Safety Program (AvSP) develops and advances methodologies and technologies to improve air transportation safety. The Safety Analysis and Integration Team (SAIT) conducts a safety technology portfolio assessment (PA) to analyze the program content, to examine the benefits and risks of products with respect to program goals, and to support programmatic decision making. The PA process includes systematic identification of current and future safety risks as well as tracking several quantitative and qualitative metrics to ensure the program goals are addressing prominent safety risks accurately and effectively. One of the metrics within the PA process involves using quantitative aviation safety models to gauge the impact of the safety products. This paper demonstrates the role of aviation safety modeling by providing model outputs and evaluating a sample of portfolio elements using the Flightdeck Automation Problems (FLAP) model. The model enables not only ranking of the quantitative relative risk reduction impact of all portfolio elements, but also highlighting the areas with high potential impact via sensitivity and gap analyses in support of the program office. Although the model outputs are preliminary and products are notional, the process shown in this paper is essential to a comprehensive PA of NASA's safety products in the current program and future programs/projects.

Ecological Momentary Assessment is a Neglected Methodology in Suicidology.

PubMed

Davidson, Collin L; Anestis, Michael D; Gutierrez, Peter M

2017-01-02

Ecological momentary assessment (EMA) is a group of research methods that collect data frequently, in many contexts, and in real-world settings. EMA has been fairly neglected in suicidology. The current article provides an overview of EMA for suicidologists including definitions, data collection considerations, and different sampling strategies. Next, the benefits of EMA in suicidology (i.e., reduced recall bias, accurate tracking of fluctuating variables, testing assumptions of theories, use in interventions), participant safety considerations, and examples of published research that investigate self-directed violence variables using EMA are discussed. The article concludes with a summary and suggested directions for EMA research in suicidology with the particular aim to spur the increased use of this methodology among suicidologists.

Review of quality assessment tools for the evaluation of pharmacoepidemiological safety studies

PubMed Central

Neyarapally, George A; Hammad, Tarek A; Pinheiro, Simone P; Iyasu, Solomon

2012-01-01

Objectives Pharmacoepidemiological studies are an important hypothesis-testing tool in the evaluation of postmarketing drug safety. Despite the potential to produce robust value-added data, interpretation of findings can be hindered due to well-recognised methodological limitations of these studies. Therefore, assessment of their quality is essential to evaluating their credibility. The objective of this review was to evaluate the suitability and relevance of available tools for the assessment of pharmacoepidemiological safety studies. Design We created an a priori assessment framework consisting of reporting elements (REs) and quality assessment attributes (QAAs). A comprehensive literature search identified distinct assessment tools and the prespecified elements and attributes were evaluated. Primary and secondary outcome measures The primary outcome measure was the percentage representation of each domain, RE and QAA for the quality assessment tools. Results A total of 61 tools were reviewed. Most tools were not designed to evaluate pharmacoepidemiological safety studies. More than 50% of the reviewed tools considered REs under the research aims, analytical approach, outcome definition and ascertainment, study population and exposure definition and ascertainment domains. REs under the discussion and interpretation, results and study team domains were considered in less than 40% of the tools. Except for the data source domain, quality attributes were considered in less than 50% of the tools. Conclusions Many tools failed to include critical assessment elements relevant to observational pharmacoepidemiological safety studies and did not distinguish between REs and QAAs. Further, there is a lack of considerations on the relative weights of different domains and elements. The development of a quality assessment tool would facilitate consistent, objective and evidence-based assessments of pharmacoepidemiological safety studies. PMID:23015600

Health economic assessment: a methodological primer.

PubMed

Simoens, Steven

2009-12-01

This review article aims to provide an introduction to the methodology of health economic assessment of a health technology. Attention is paid to defining the fundamental concepts and terms that are relevant to health economic assessments. The article describes the methodology underlying a cost study (identification, measurement and valuation of resource use, calculation of costs), an economic evaluation (type of economic evaluation, the cost-effectiveness plane, trial- and model-based economic evaluation, discounting, sensitivity analysis, incremental analysis), and a budget impact analysis. Key references are provided for those readers who wish a more advanced understanding of health economic assessments.

Health Economic Assessment: A Methodological Primer

PubMed Central

Simoens, Steven

2009-01-01

This review article aims to provide an introduction to the methodology of health economic assessment of a health technology. Attention is paid to defining the fundamental concepts and terms that are relevant to health economic assessments. The article describes the methodology underlying a cost study (identification, measurement and valuation of resource use, calculation of costs), an economic evaluation (type of economic evaluation, the cost-effectiveness plane, trial- and model-based economic evaluation, discounting, sensitivity analysis, incremental analysis), and a budget impact analysis. Key references are provided for those readers who wish a more advanced understanding of health economic assessments. PMID:20049237

Methodology, status and plans for development and assessment of Cathare code

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

Bestion, D.; Barre, F.; Faydide, B.

1997-07-01

This paper presents the methodology, status and plans for the development, assessment and uncertainty evaluation of the Cathare code. Cathare is a thermalhydraulic code developed by CEA (DRN), IPSN, EDF and FRAMATOME for PWR safety analysis. First, the status of the code development and assessment is presented. The general strategy used for the development and the assessment of the code is presented. Analytical experiments with separate effect tests, and component tests are used for the development and the validation of closure laws. Successive Revisions of constitutive laws are implemented in successive Versions of the code and assessed. System tests ormore » integral tests are used to validate the general consistency of the Revision. Each delivery of a code Version + Revision is fully assessed and documented. A methodology is being developed to determine the uncertainty on all constitutive laws of the code using calculations of many analytical tests and applying the Discrete Adjoint Sensitivity Method (DASM). At last, the plans for the future developments of the code are presented. They concern the optimization of the code performance through parallel computing - the code will be used for real time full scope plant simulators - the coupling with many other codes (neutronic codes, severe accident codes), the application of the code for containment thermalhydraulics. Also, physical improvements are required in the field of low pressure transients and in the modeling for the 3-D model.« less

Methodological Quality Assessment of Meta-Analyses of Hyperthyroidism Treatment.

PubMed

Qin, Yahong; Yao, Liang; Shao, Feifei; Yang, Kehu; Tian, Limin

2018-01-01

Hyperthyroidism is a common condition that is associated with increased morbidity and mortality. A number of meta-analyses (MAs) have assessed the therapeutic measures for hyperthyroidism, including antithyroid drugs, surgery, and radioiodine, however, the methodological quality has not been evaluated. This study evaluated the methodological quality and summarized the evidence obtained from MAs of hyperthyroidism treatments for radioiodine, antithyroid drugs, and surgery. We searched the PubMed, EMBASE, Cochrane Library, Web of Science, and Chinese Biomedical Literature Database databases. Two investigators independently assessed the meta-analyses titles and abstracts for inclusion. Methodological quality was assessed using the validated AMSTAR (Assessing the Methodological Quality of Systematic Reviews) tool. A total of 26 MAs fulfilled the inclusion criteria. Based on the AMSTAR scores, the average methodological quality was 8.31, with large variability ranging from 4 to 11. The methodological quality of English meta-analyses was better than that of Chinese meta-analyses. Cochrane reviews had better methodological quality than non-Cochrane reviews due to better study selection and data extraction, the inclusion of unpublished studies, and better reporting of study characteristics. The authors did not report conflicts of interest in 53.8% meta-analyses, and 19.2% did not report the harmful effects of treatment. Publication bias was not assessed in 38.5% of meta-analyses, and 19.2% did not report the follow-up time. Large-scale assessment of methodological quality of meta-analyses of hyperthyroidism treatment highlighted methodological strengths and weaknesses. Consideration of scientific quality when formulating conclusions should be made explicit. Future meta-analyses should improve on reporting conflict of interest. © Georg Thieme Verlag KG Stuttgart · New York.

[OCCUPATIONAL HEALTH RISK ASSESSMENT AND MANAGEMENT IN WORKERS IN IMPROVEMENT OF NATIONAL POLICY IN OCCUPATIONAL HYGIENE AND SAFETY].

PubMed

Shur, P Z; Zaĭtseva, N V; Alekseev, V B; Shliapnikov, D M

2015-01-01

In accordance with the international documents in the field of occupational safety and hygiene, the assessment and minimization of occupational risks is a key instrument for the health maintenance of workers. One of the main ways to achieve it is the minimization of occupational risks. Correspondingly, the instrument for the implementation of this method is the methodology of analysis of occupational risks. In Russian Federation there were the preconditions for the formation of the system for the assessment and management of occupational risks. As the target of the national (state) policy in the field of occupational safety in accordance with ILO Conventions it can be offered the prevention of accidents and injuries to health arising from work or related with it, minimizing the causes of hazards inherent in the working environment, as far as it is reasonably and practically feasible. Global trend ofusing the methodology of the assessment and management of occupational risks to life and health of citizens requires the improvement of national policies in the field of occupational hygiene and safety. Achieving an acceptable level of occupational risk in the formation of national policy in the field of occupational hygiene and safety can be considered as one of the main tasks.

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.

Preliminary Assessment of Operational Hazards and Safety Requirements for Airborne Trajectory Management (ABTM) Roadmap Applications

NASA Technical Reports Server (NTRS)

Cotton, William B.; Hilb, Robert; Koczo, Stefan, Jr.; Wing, David J.

2016-01-01

A set of five developmental steps building from the NASA TASAR (Traffic Aware Strategic Aircrew Requests) concept are described, each providing incrementally more efficiency and capacity benefits to airspace system users and service providers, culminating in a Full Airborne Trajectory Management capability. For each of these steps, the incremental Operational Hazards and Safety Requirements are identified for later use in future formal safety assessments intended to lead to certification and operational approval of the equipment and the associated procedures. Two established safety assessment methodologies that are compliant with the FAA's Safety Management System were used leading to Failure Effects Classifications (FEC) for each of the steps. The most likely FEC for the first three steps, Basic TASAR, Digital TASAR, and 4D TASAR, is "No effect". For step four, Strategic Airborne Trajectory Management, the likely FEC is "Minor". For Full Airborne Trajectory Management (Step 5), the most likely FEC is "Major".

Defining a reference set to support methodological research in drug safety.

PubMed

Ryan, Patrick B; Schuemie, Martijn J; Welebob, Emily; Duke, Jon; Valentine, Sarah; Hartzema, Abraham G

2013-10-01

Methodological research to evaluate the performance of methods requires a benchmark to serve as a referent comparison. In drug safety, the performance of analyses of spontaneous adverse event reporting databases and observational healthcare data, such as administrative claims and electronic health records, has been limited by the lack of such standards. To establish a reference set of test cases that contain both positive and negative controls, which can serve the basis for methodological research in evaluating methods performance in identifying drug safety issues. Systematic literature review and natural language processing of structured product labeling was performed to identify evidence to support the classification of drugs as either positive controls or negative controls for four outcomes: acute liver injury, acute kidney injury, acute myocardial infarction, and upper gastrointestinal bleeding. Three-hundred and ninety-nine test cases comprised of 165 positive controls and 234 negative controls were identified across the four outcomes. The majority of positive controls for acute kidney injury and upper gastrointestinal bleeding were supported by randomized clinical trial evidence, while the majority of positive controls for acute liver injury and acute myocardial infarction were only supported based on published case reports. Literature estimates for the positive controls shows substantial variability that limits the ability to establish a reference set with known effect sizes. A reference set of test cases can be established to facilitate methodological research in drug safety. Creating a sufficient sample of drug-outcome pairs with binary classification of having no effect (negative controls) or having an increased effect (positive controls) is possible and can enable estimation of predictive accuracy through discrimination. Since the magnitude of the positive effects cannot be reliably obtained and the quality of evidence may vary across outcomes

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.

Analysis of Alternatives for Risk Assessment Methodologies and Tools

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

Nachtigal, Noel M.; Fruetel, Julia A.; Gleason, Nathaniel J.

The purpose of this document is to provide a basic overview and understanding of risk assessment methodologies and tools from the literature and to assess the suitability of these methodologies and tools for cyber risk assessment. Sandia National Laboratories (SNL) performed this review in support of risk modeling activities performed for the Stakeholder Engagement and Cyber Infrastructure Resilience (SECIR) division of the Department of Homeland Security (DHS) Office of Cybersecurity and Communications (CS&C). The set of methodologies and tools covered in this document is not intended to be exhaustive; instead, it focuses on those that are commonly used in themore » risk assessment community. The classification of methodologies and tools was performed by a group of analysts with experience in risk analysis and cybersecurity, and the resulting analysis of alternatives has been tailored to address the needs of a cyber risk assessment.« less

A Methodology for Anatomic Ultrasound Image Diagnostic Quality Assessment.

PubMed

Hemmsen, Martin Christian; Lange, Theis; Brandt, Andreas Hjelm; Nielsen, Michael Bachmann; Jensen, Jorgen Arendt

2017-01-01

This paper discusses the methods for the assessment of ultrasound image quality based on our experiences with evaluating new methods for anatomic imaging. It presents a methodology to ensure a fair assessment between competing imaging methods using clinically relevant evaluations. The methodology is valuable in the continuing process of method optimization and guided development of new imaging methods. It includes a three phased study plan covering from initial prototype development to clinical assessment. Recommendations to the clinical assessment protocol, software, and statistical analysis are presented. Earlier uses of the methodology has shown that it ensures validity of the assessment, as it separates the influences between developer, investigator, and assessor once a research protocol has been established. This separation reduces confounding influences on the result from the developer to properly reveal the clinical value. This paper exemplifies the methodology using recent studies of synthetic aperture sequential beamforming tissue harmonic imaging.

Instruments for Assessing Risk of Bias and Other Methodological Criteria of Published Animal Studies: A Systematic Review

PubMed Central

Krauth, David; Woodruff, Tracey J.

2013-01-01

Background: Results from animal toxicology studies are critical to evaluating the potential harm from exposure to environmental chemicals or the safety of drugs prior to human testing. However, there is significant debate about how to evaluate the methodology and potential biases of the animal studies. There is no agreed-upon approach, and a systematic evaluation of current best practices is lacking. Objective: We performed a systematic review to identify and evaluate instruments for assessing the risk of bias and/or other methodological criteria of animal studies. Method: We searched Medline (January 1966–November 2011) to identify all relevant articles. We extracted data on risk of bias criteria (e.g., randomization, blinding, allocation concealment) and other study design features included in each assessment instrument. Discussion: Thirty distinct instruments were identified, with the total number of assessed risk of bias, methodological, and/or reporting criteria ranging from 2 to 25. The most common criteria assessed were randomization (25/30, 83%), investigator blinding (23/30, 77%), and sample size calculation (18/30, 60%). In general, authors failed to empirically justify why these or other criteria were included. Nearly all (28/30, 93%) of the instruments have not been rigorously tested for validity or reliability. Conclusion: Our review highlights a number of risk of bias assessment criteria that have been empirically tested for animal research, including randomization, concealment of allocation, blinding, and accounting for all animals. In addition, there is a need for empirically testing additional methodological criteria and assessing the validity and reliability of a standard risk of bias assessment instrument. Citation: Krauth D, Woodruff TJ, Bero L. 2013. Instruments for assessing risk of bias and other methodological criteria of published animal studies: a systematic review. Environ Health Perspect 121:985–992 (2013); http://dx.doi.org/10

A risk assessment methodology using intuitionistic fuzzy set in FMEA

NASA Astrophysics Data System (ADS)

Chang, Kuei-Hu; Cheng, Ching-Hsue

2010-12-01

Most current risk assessment methods use the risk priority number (RPN) value to evaluate the risk of failure. However, conventional RPN methodology has been criticised as having five main shortcomings as follows: (1) the assumption that the RPN elements are equally weighted leads to over simplification; (2) the RPN scale itself has some non-intuitive statistical properties; (3) the RPN elements have many duplicate numbers; (4) the RPN is derived from only three factors mainly in terms of safety; and (5) the conventional RPN method has not considered indirect relations between components. To address the above issues, an efficient and comprehensive algorithm to evaluate the risk of failure is needed. This article proposes an innovative approach, which integrates the intuitionistic fuzzy set (IFS) and the decision-making trial and evaluation laboratory (DEMATEL) approach on risk assessment. The proposed approach resolves some of the shortcomings of the conventional RPN method. A case study, which assesses the risk of 0.15 µm DRAM etching process, is used to demonstrate the effectiveness of the proposed approach. Finally, the result of the proposed method is compared with the listing approaches of risk assessment methods.

Safety Auditing and Assessments

NASA Technical Reports Server (NTRS)

Goodin, James Ronald (Ronnie)

2005-01-01

Safety professionals typically do not engage in audits and independent assessments with the vigor as do our quality brethren. Taking advantage of industry and government experience conducting value added Independent Assessments or Audits benefits a safety program. Most other organizations simply call this process "internal audits." Sources of audit training are presented and compared. A relation of logic between audit techniques and mishap investigation is discussed. An example of an audit process is offered. Shortcomings and pitfalls of auditing are covered.

Safety Auditing and Assessments

NASA Astrophysics Data System (ADS)

Goodin, Ronnie

2005-12-01

Safety professionals typically do not engage in audits and independent assessments with the vigor as do our quality brethren. Taking advantage of industry and government experience conducting value added Independent Assessments or Audits benefits a safety program. Most other organizations simply call this process "internal audits." Sources of audit training are presented and compared. A relation of logic between audit techniques and mishap investigation is discussed. An example of an audit process is offered. Shortcomings and pitfalls of auditing are covered.

Space Transportation Operations: Assessment of Methodologies and Models

NASA Technical Reports Server (NTRS)

Joglekar, Prafulla

2001-01-01

The systems design process for future space transportation involves understanding multiple variables and their effect on lifecycle metrics. Variables such as technology readiness or potential environmental impact are qualitative, while variables such as reliability, operations costs or flight rates are quantitative. In deciding what new design concepts to fund, NASA needs a methodology that would assess the sum total of all relevant qualitative and quantitative lifecycle metrics resulting from each proposed concept. The objective of this research was to review the state of operations assessment methodologies and models used to evaluate proposed space transportation systems and to develop recommendations for improving them. It was found that, compared to the models available from other sources, the operations assessment methodology recently developed at Kennedy Space Center has the potential to produce a decision support tool that will serve as the industry standard. Towards that goal, a number of areas of improvement in the Kennedy Space Center's methodology are identified.

Space Transportation Operations: Assessment of Methodologies and Models

NASA Technical Reports Server (NTRS)

Joglekar, Prafulla

2002-01-01

The systems design process for future space transportation involves understanding multiple variables and their effect on lifecycle metrics. Variables such as technology readiness or potential environmental impact are qualitative, while variables such as reliability, operations costs or flight rates are quantitative. In deciding what new design concepts to fund, NASA needs a methodology that would assess the sum total of all relevant qualitative and quantitative lifecycle metrics resulting from each proposed concept. The objective of this research was to review the state of operations assessment methodologies and models used to evaluate proposed space transportation systems and to develop recommendations for improving them. It was found that, compared to the models available from other sources, the operations assessment methodology recently developed at Kennedy Space Center has the potential to produce a decision support tool that will serve as the industry standard. Towards that goal, a number of areas of improvement in the Kennedy Space Center's methodology are identified.

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

Passenger rail vehicle safety assessment methodology. Volume I, Summary of safe performance limits.

DOT National Transportation Integrated Search

2000-04-01

This report presents a methodology based on computer simulation that asseses the safe dyamic performance limits of commuter passenger vehicles. The methodology consists of determining the critical design parameters and characteristic properties of bo...

Methodology for assessing laser-based equipment

NASA Astrophysics Data System (ADS)

Pelegrina-Bonilla, Gabriel; Hermsdorf, Jörg; Thombansen, Ulrich; Abels, Peter; Kaierle, Stefan; Neumann, Jörg

2017-10-01

Methodologies for the assessment of technology's maturity are widely used in industry and research. Probably the best known are technology readiness levels (TRLs), initially pioneered by the National Aeronautics and Space Administration (NASA). At the beginning, only descriptively defined TRLs existed, but over time, automated assessment techniques in the form of questionnaires emerged in order to determine TRLs. Originally TRLs targeted equipment for space applications, but the demands on industrial relevant equipment are partly different in terms of, for example, overall costs, product quantities, or the presence of competitors. Therefore, we present a commonly valid assessment methodology with the aim of assessing laser-based equipment for industrial use, in general. The assessment is carried out with the help of a questionnaire, which allows for a user-friendly and easy accessible way to monitor the progress from the lab-proven state to the application-ready product throughout the complete development period. The assessment result is presented in a multidimensional metric in order to reveal the current specific strengths and weaknesses of the equipment development process, which can be used to direct the remaining development process of the equipment in the right direction.

Biosafety Risk Assessment Methodology

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

Caskey, Susan Adele; Gaudioso, Jennifer M.; Salerno, Reynolds Mathewson

2010-10-01

Laboratories that work with biological agents need to manage their safety risks to persons working the laboratories and the human and animal community in the surrounding areas. Biosafety guidance defines a wide variety of biosafety risk mitigation measures, which include measures which fall under the following categories: engineering controls, procedural and administrative controls, and the use of personal protective equipment; the determination of which mitigation measures should be used to address the specific laboratory risks are dependent upon a risk assessment. Ideally, a risk assessment should be conducted in a manner which is standardized and systematic which allows it tomore » be repeatable and comparable. A risk assessment should clearly define the risk being assessed and avoid over complication.« less

Training effectiveness assessment: Methodological problems and issues

NASA Technical Reports Server (NTRS)

Cross, Kenneth D.

1992-01-01

The U.S. military uses a large number of simulators to train and sustain the flying skills of helicopter pilots. Despite the enormous resources required to purchase, maintain, and use those simulators, little effort has been expended in assessing their training effectiveness. One reason for this is the lack of an evaluation methodology that yields comprehensive and valid data at a practical cost. Some of these methodological problems and issues that arise in assessing simulator training effectiveness, as well as problems with the classical transfer-of-learning paradigm were discussed.

Assessment of Electrical Safety in Afghanistan

DTIC Science & Technology

2009-07-24

effectiveness of command efforts to ensure the electrical safety of Department of Defense occupied and constructed facilities in Afghanistan. We...March 31, 2009, we announced the Assessment of Electrical Safety in Afghanistan. The objective of this assessment was to review the effectiveness of...used contractors to review and identify electrical deficiencies to include life, health , and safety issues at FOBs. According to TF POWER

[A preliminary mapping methodology for occupational hazards and biomechanical risk evaluation: presentation of a simple, computerized tool kit for ergonomic hazards identification and risk assessment].

PubMed

Colombini, Daniela; Occhipinti, E; Di Leone, G

2011-01-01

During the last Congress of the International Ergonomics Association (IEA), Beijing, August 2009, an international group was founded with the task of developing a "toolkit for MSD prevention" under the IEA and in collaboration with the World Health Organization. The possible users of toolkits are: members of health and safety committees; health and safety representatives; line supervisors; foremen; workers; government representatives; health workers providing basic occupational health services; occupational health and safety specialists. According to the ISO standard 11228 series and the new Draft CD ISO 12259-2009: Application document guides for the potential user, our group developed a preliminary "mapping" methodology of occupational hazards in the craft industry, supported by software (Excel). The proposed methodology, using specific key enters and quick assessment criteria, allows a simple ergonomics hazards identification and risk estimation to be made. It is thus possible to decide for which occupational hazards a more exhaustive risk assessment will be necessary and which occupational consultant should be involved (occupational physician, safety engineer, industrial hygienist, etc.).

Risk Assessment Methodology for Hazardous Waste Management (1998)

EPA Pesticide Factsheets

A methodology is described for systematically assessing and comparing the risks to human health and the environment of hazardous waste management alternatives. The methodology selects and links appropriate models and techniques for performing the process.

Monitoring safety in a phase III real-world effectiveness trial: use of novel methodology in the Salford Lung Study.

PubMed

Collier, Sue; Harvey, Catherine; Brewster, Jill; Bakerly, Nawar Diar; Elkhenini, Hanaa F; Stanciu, Roxana; Williams, Claire; Brereton, Jacqui; New, John P; McCrae, John; McCorkindale, Sheila; Leather, David

2017-03-01

The Salford Lung Study (SLS) programme, encompassing two phase III pragmatic randomised controlled trials, was designed to generate evidence on the effectiveness of a once-daily treatment for asthma and chronic obstructive pulmonary disease in routine primary care using electronic health records. The objective of this study was to describe and discuss the safety monitoring methodology and the challenges associated with ensuring patient safety in the SLS. Refinements to safety monitoring processes and infrastructure are also discussed. The study results are outside the remit of this paper. The results of the COPD study were published recently and a more in-depth exploration of the safety results will be the subject of future publications. The SLS used a linked database system to capture relevant data from primary care practices in Salford and South Manchester, two university hospitals and other national databases. Patient data were collated and analysed to create daily summaries that were used to alert a specialist safety team to potential safety events. Clinical research teams at participating general practitioner sites and pharmacies also captured safety events during routine consultations. Confidence in the safety monitoring processes over time allowed the methodology to be refined and streamlined without compromising patient safety or the timely collection of data. The information technology infrastructure also allowed additional details of safety information to be collected. Integration of multiple data sources in the SLS may provide more comprehensive safety information than usually collected in standard randomised controlled trials. Application of the principles of safety monitoring methodology from the SLS could facilitate safety monitoring processes for future pragmatic randomised controlled trials and yield important complementary safety and effectiveness data. © 2016 The Authors Pharmacoepidemiology and Drug Safety Published by John Wiley & Sons Ltd. �

Monitoring safety in a phase III real‐world effectiveness trial: use of novel methodology in the Salford Lung Study

PubMed Central

Harvey, Catherine; Brewster, Jill; Bakerly, Nawar Diar; Elkhenini, Hanaa F.; Stanciu, Roxana; Williams, Claire; Brereton, Jacqui; New, John P.; McCrae, John; McCorkindale, Sheila; Leather, David

2016-01-01

Abstract Background The Salford Lung Study (SLS) programme, encompassing two phase III pragmatic randomised controlled trials, was designed to generate evidence on the effectiveness of a once‐daily treatment for asthma and chronic obstructive pulmonary disease in routine primary care using electronic health records. Objective The objective of this study was to describe and discuss the safety monitoring methodology and the challenges associated with ensuring patient safety in the SLS. Refinements to safety monitoring processes and infrastructure are also discussed. The study results are outside the remit of this paper. The results of the COPD study were published recently and a more in‐depth exploration of the safety results will be the subject of future publications. Achievements The SLS used a linked database system to capture relevant data from primary care practices in Salford and South Manchester, two university hospitals and other national databases. Patient data were collated and analysed to create daily summaries that were used to alert a specialist safety team to potential safety events. Clinical research teams at participating general practitioner sites and pharmacies also captured safety events during routine consultations. Confidence in the safety monitoring processes over time allowed the methodology to be refined and streamlined without compromising patient safety or the timely collection of data. The information technology infrastructure also allowed additional details of safety information to be collected. Conclusion Integration of multiple data sources in the SLS may provide more comprehensive safety information than usually collected in standard randomised controlled trials. Application of the principles of safety monitoring methodology from the SLS could facilitate safety monitoring processes for future pragmatic randomised controlled trials and yield important complementary safety and effectiveness data. © 2016 The Authors

Training and action for patient safety: embedding interprofessional education for patient safety within an improvement methodology.

PubMed

Slater, Beverley L; Lawton, Rebecca; Armitage, Gerry; Bibby, John; Wright, John

2012-01-01

Despite an explosion of interest in improving safety and reducing error in health care, one important aspect of patient safety that has received little attention is a systematic approach to education and training for the whole health care workforce. This article describes an evaluation of an innovative multiprofessional, team-based training program that embeds patient safety within quality improvement methods. Kirkpatrick's "levels of evaluation" model was adopted to evaluate the program in health organizations across one city in the north of England. Questionnaires were used to assess reaction of participants to the program (Level 1). Improvements in patient safety knowledge and patient safety culture (Level 2) were assessed using a 12-item multiple-choice questionnaire and a culture questionnaire. Interviews and project-specific quantitative measurements were used to assess changes in professional practice and patient outcomes (Levels 3 and 4). All aspects of the program were positively received by participants. Few participants completed the MCQ at both time points, but those who did showed improvement in knowledge. There were some small but significant improvements in patient safety culture. Interviews revealed a number of additional benefits beyond the specific problems addressed. Most importantly, 8 of the 11 teams showed improvements in patient safety practices and/or outcomes. This program is an example of interprofessional education in practice and demonstrates that team-based learning using quality improvement methods is feasible and can be effective in improving patient safety, but requires time and space for participants. Alignment with continuing education arrangements could support mainstream adoption of this approach within organizations. Copyright © 2012 The Alliance for Continuing Education in the Health Professions, the Society for Academic Continuing Medical Education, and the Council on CME, Association for Hospital Medical Education.

Integrated deterministic and probabilistic safety analysis for safety assessment of nuclear power plants

DOE PAGES

Di Maio, Francesco; Zio, Enrico; Smith, Curtis; ...

2015-07-06

The present special issue contains an overview of the research in the field of Integrated Deterministic and Probabilistic Safety Assessment (IDPSA) of Nuclear Power Plants (NPPs). Traditionally, safety regulation for NPPs design and operation has been based on Deterministic Safety Assessment (DSA) methods to verify criteria that assure plant safety in a number of postulated Design Basis Accident (DBA) scenarios. Referring to such criteria, it is also possible to identify those plant Structures, Systems, and Components (SSCs) and activities that are most important for safety within those postulated scenarios. Then, the design, operation, and maintenance of these “safety-related” SSCs andmore » activities are controlled through regulatory requirements and supported by Probabilistic Safety Assessment (PSA).« less

RPP-PRT-58489, Revision 1, One Systems Consistent Safety Analysis Methodologies Report. 24590-WTP-RPT-MGT-15-014

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

Gupta, Mukesh; Niemi, Belinda; Paik, Ingle

2015-09-02

In 2012, One System Nuclear Safety performed a comparison of the safety bases for the Tank Farms Operations Contractor (TOC) and Hanford Tank Waste Treatment and Immobilization Plant (WTP) (RPP-RPT-53222 / 24590-WTP-RPT-MGT-12-018, “One System Report of Comparative Evaluation of Safety Bases for Hanford Waste Treatment and Immobilization Plant Project and Tank Operations Contract”), and identified 25 recommendations that required further evaluation for consensus disposition. This report documents ten NSSC approved consistent methodologies and guides and the results of the additional evaluation process using a new set of evaluation criteria developed for the evaluation of the new methodologies.

Assessing community child passenger safety efforts in three Northwest Tribes.

PubMed

Smith, M L; Berger, L R

2002-12-01

To identify strengths and weaknesses in community based child passenger safety programs by developing a scoring instrument and conducting observations of child restraint use in three Native American communities. The three communities are autonomous Tribal reservations in the Pacific Northwest. Their per capita incomes and rates of unemployment are comparable. In each community, 100 children under 5 years old were observed for car seat use. A six item community assessment tool (100 points maximum) awarded points for such items as the type (primary or secondary) and enforcement of child restraint laws; availability of car seats from distribution programs; extent of educational programs; and access to data on vehicle injuries. For children from birth to 4 years, the car seat use rate ranged from 12%-21%. Rates for infants (71%-80%) far exceeded rates for 1-4 year old children (5%-14%). Community scores ranged from 0 to 31.5 points. There was no correlation between scores and observed car seat use. One reason was the total lack of enforcement of restraint laws. A community assessment tool can highlight weaknesses in child passenger efforts. Linking such a tool with an objective measure of impact can be applied to other injury problems, such as fire safety or domestic violence. The very process of creating and implementing a community assessment can enhance agency collaboration and publicize evidence based "best practices" for injury prevention. Further study is needed to address methodologic issues and to examine crash and medical data in relation to community child passenger safety scores.

Integrated vehicle-based safety systems heavy truck field operational test, methodology and results report.

DOT National Transportation Integrated Search

2010-12-01

"This document presents the methodology and results from the heavy-truck field operational test conducted as part of the Integrated Vehicle-Based Safety Systems program. These findings are the result of analyses performed by the University of Michiga...

Integrated vehicle-based safety systems light-vehicle field operational test, methodology and results report.

DOT National Transportation Integrated Search

2010-12-01

"This document presents the methodology and results from the light-vehicle field operational test conducted as part of the Integrated Vehicle-Based Safety Systems program. These findings are the result of analyses performed by the University of Michi...

Constantly evolving safety assessment protocols for GM foods.

PubMed

Sesikeran, B; Vasanthi, Siruguri

2008-01-01

he introduction of GM foods has led to the evolution of a food safety assessment paradigm that establishes safety of the GM food relative to its conventional counterpart. The GM foods currently approved and marketed in several countries have undergone extensive safety testing under a structured safety assessment framework evolved by international organizations like FAO, WHO, Codex and OECD. The major elements of safety assessment include molecular characterization of inserted genes and stability of the trait, toxicity and allergenicity potential of the expressed substances, compositional analysis, potential for gene transfer to gut microflora and unintentional effects of the genetic modification. As more number and type of food crops are being brought under the genetic modification regime, the adequacy of existing safety assessment protocols for establishing safety of these foods has been questioned. Such crops comprise GM crops with higher agronomic vigour, nutritional or health benefit/ by modification of plant metabolic pathways and those expressing bioactive substances and pharmaceuticals. The safety assessment challenges of these foods are the potential of the methods to detect unintentional effects with higher sensitivity and rigor. Development of databases on food compositions, toxicants and allergens is currently seen as an important aid to development of safety protocols. With the changing global trends in genetic modification technology future challenge would be to develop GM crops with minimum amount of inserted foreign DNA so as to reduce the burden of complex safety assessments while ensuring safety and utility of the technology.

Sandia National Laboratories performance assessment methodology for long-term environmental programs : the history of nuclear waste management.

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

Marietta, Melvin Gary; Anderson, D. Richard; Bonano, Evaristo J.

2011-11-01

Sandia National Laboratories (SNL) is the world leader in the development of the detailed science underpinning the application of a probabilistic risk assessment methodology, referred to in this report as performance assessment (PA), for (1) understanding and forecasting the long-term behavior of a radioactive waste disposal system, (2) estimating the ability of the disposal system and its various components to isolate the waste, (3) developing regulations, (4) implementing programs to estimate the safety that the system can afford to individuals and to the environment, and (5) demonstrating compliance with the attendant regulatory requirements. This report documents the evolution of themore » SNL PA methodology from inception in the mid-1970s, summarizing major SNL PA applications including: the Subseabed Disposal Project PAs for high-level radioactive waste; the Waste Isolation Pilot Plant PAs for disposal of defense transuranic waste; the Yucca Mountain Project total system PAs for deep geologic disposal of spent nuclear fuel and high-level radioactive waste; PAs for the Greater Confinement Borehole Disposal boreholes at the Nevada National Security Site; and PA evaluations for disposal of high-level wastes and Department of Energy spent nuclear fuels stored at Idaho National Laboratory. In addition, the report summarizes smaller PA programs for long-term cover systems implemented for the Monticello, Utah, mill-tailings repository; a PA for the SNL Mixed Waste Landfill in support of environmental restoration; PA support for radioactive waste management efforts in Egypt, Iraq, and Taiwan; and, most recently, PAs for analysis of alternative high-level radioactive waste disposal strategies including repositories deep borehole disposal and geologic repositories in shale and granite. Finally, this report summarizes the extension of the PA methodology for radioactive waste disposal toward development of an enhanced PA system for carbon sequestration and storage

Developing a Methodology for Eliciting Subjective Probability Estimates During Expert Evaluations of Safety Interventions: Application for Bayesian Belief Networks

NASA Technical Reports Server (NTRS)

Wiegmann, Douglas A.a

2005-01-01

The NASA Aviation Safety Program (AvSP) has defined several products that will potentially modify airline and/or ATC operations, enhance aircraft systems, and improve the identification of potential hazardous situations within the National Airspace System (NAS). Consequently, there is a need to develop methods for evaluating the potential safety benefit of each of these intervention products so that resources can be effectively invested to produce the judgments to develop Bayesian Belief Networks (BBN's) that model the potential impact that specific interventions may have. Specifically, the present report summarizes methodologies for improving the elicitation of probability estimates during expert evaluations of AvSP products for use in BBN's. The work involved joint efforts between Professor James Luxhoj from Rutgers University and researchers at the University of Illinois. The Rutgers' project to develop BBN's received funding by NASA entitled "Probabilistic Decision Support for Evaluating Technology Insertion and Assessing Aviation Safety System Risk." The proposed project was funded separately but supported the existing Rutgers' program.

Vending machine assessment methodology. A systematic review.

PubMed

Matthews, Melissa A; Horacek, Tanya M

2015-07-01

The nutritional quality of food and beverage products sold in vending machines has been implicated as a contributing factor to the development of an obesogenic food environment. How comprehensive, reliable, and valid are the current assessment tools for vending machines to support or refute these claims? A systematic review was conducted to summarize, compare, and evaluate the current methodologies and available tools for vending machine assessment. A total of 24 relevant research studies published between 1981 and 2013 met inclusion criteria for this review. The methodological variables reviewed in this study include assessment tool type, study location, machine accessibility, product availability, healthfulness criteria, portion size, price, product promotion, and quality of scientific practice. There were wide variations in the depth of the assessment methodologies and product healthfulness criteria utilized among the reviewed studies. Of the reviewed studies, 39% evaluated machine accessibility, 91% evaluated product availability, 96% established healthfulness criteria, 70% evaluated portion size, 48% evaluated price, 52% evaluated product promotion, and 22% evaluated the quality of scientific practice. Of all reviewed articles, 87% reached conclusions that provided insight into the healthfulness of vended products and/or vending environment. Product healthfulness criteria and complexity for snack and beverage products was also found to be variable between the reviewed studies. These findings make it difficult to compare results between studies. A universal, valid, and reliable vending machine assessment tool that is comprehensive yet user-friendly is recommended. Copyright © 2015 Elsevier Ltd. All rights reserved.

A Guide to the Application of Probability Risk Assessment Methodology and Hazard Risk Frequency Criteria as a Hazard Control for the Use of the Mobile Servicing System on the International Space Station

NASA Astrophysics Data System (ADS)

D'silva, Oneil; Kerrison, Roger

2013-09-01

A key feature for the increased utilization of space robotics is to automate Extra-Vehicular manned space activities and thus significantly reduce the potential for catastrophic hazards while simultaneously minimizing the overall costs associated with manned space. The principal scope of the paper is to evaluate the use of industry standard accepted Probability risk/safety assessment (PRA/PSA) methodologies and Hazard Risk frequency Criteria as a hazard control. This paper illustrates the applicability of combining the selected Probability risk assessment methodology and hazard risk frequency criteria, in order to apply the necessary safety controls that allow for the increased use of the Mobile Servicing system (MSS) robotic system on the International Space Station. This document will consider factors such as component failure rate reliability, software reliability, and periods of operation and dormancy, fault tree analyses and their effects on the probability risk assessments. The paper concludes with suggestions for the incorporation of existing industry Risk/Safety plans to create an applicable safety process for future activities/programs

Cumulative impact assessment: Application of a methodology

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

Witmer, G.W.; Bain, M.B.; Irving, J.S.

We expanded upon the Federal Energy Regulatory Commission's (FERC) Cluster Impact Assessment Procedure (CIAP) to provide a practical methodology for assessing potential cumulative impacts from multiple hydroelectric projects within a river basin. The objectives in designing the methodology were to allow the evaluation of a large number of combinations of proposed projects and to minimize constraints on the use of ecological knowledge for planning and regulating hydroelectric development at the river basin level. Interactive workshops and evaluative matrices were used to identify preferred development scenarios in the Snohomish (Washington) and Salmon (Idaho) River Basins. Although the methodology achieved its basicmore » objectives, some difficulties were encountered. These revolved around issues of (1) data quality and quantity, (2) alternatives analysis, (3) determination of project interactions, (4) determination of cumulative impact thresholds, and (5) the use of evaluative techniques to express degrees of impact. 8 refs., 1 fig., 2 tabs.« less

INPRO Assessment of an INS in the Area of Safety of Fuel Cycle Installations

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

Raj, B.; Busurin, Y.; Depisch, F.

2006-07-01

INPRO has defined requirements organized in a hierarchy of Basic Principles, User Requirements and Criteria (consisting of an indicator and an acceptance limit) to be met by innovative nuclear reactor systems (INS) in six areas, namely: economics, safety, waste management, environment, proliferation resistance, and infrastructure. If an INS meets all requirements in all areas it represents a sustainable system for the supply of energy, capable of making a significant contribution to meeting the energy needs of the 21. century. Draft manuals have been developed, for each INPRO area, to provide guidance for performing an assessment of whether an INS meetsmore » the INPRO requirements in a given area. The manuals set out the information that needs to be assembled to perform an assessment and provide guidance on selecting the acceptance limits and, for a given INS, for determining the value of the indicators for comparison with the associated acceptance limits. Each manual also includes an example of a specific assessment to illustrate the guidance. This paper discusses the manual for performing an INPRO assessment in the area of safety of fuel cycle installations. The example, chosen solely for the purpose of illustrating the INPRO methodology, describes an assessment of an MOX fuel fabrication plant based on sol-gel technology and illustrates an assessment performed for an INS at an early stage of development. The safety issues and the assessment steps are presented in detail in the paper. (authors)« less

Seismic performance assessment of base-isolated safety-related nuclear structures

USGS Publications Warehouse

Huang, Y.-N.; Whittaker, A.S.; Luco, N.

2010-01-01

Seismic or base isolation is a proven technology for reducing the effects of earthquake shaking on buildings, bridges and infrastructure. The benefit of base isolation has been presented in terms of reduced accelerations and drifts on superstructure components but never quantified in terms of either a percentage reduction in seismic loss (or percentage increase in safety) or the probability of an unacceptable performance. Herein, we quantify the benefits of base isolation in terms of increased safety (or smaller loss) by comparing the safety of a sample conventional and base-isolated nuclear power plant (NPP) located in the Eastern U.S. Scenario- and time-based assessments are performed using a new methodology. Three base isolation systems are considered, namely, (1) Friction Pendulum??? bearings, (2) lead-rubber bearings and (3) low-damping rubber bearings together with linear viscous dampers. Unacceptable performance is defined by the failure of key secondary systems because these systems represent much of the investment in a new build power plant and ensure the safe operation of the plant. For the scenario-based assessments, the probability of unacceptable performance is computed for an earthquake with a magnitude of 5.3 at a distance 7.5 km from the plant. For the time-based assessments, the annual frequency of unacceptable performance is computed considering all potential earthquakes that may occur. For both assessments, the implementation of base isolation reduces the probability of unacceptable performance by approximately four orders of magnitude for the same NPP superstructure and secondary systems. The increase in NPP construction cost associated with the installation of seismic isolators can be offset by substantially reducing the required seismic strength of secondary components and systems and potentially eliminating the need to seismically qualify many secondary components and systems. ?? 2010 John Wiley & Sons, Ltd.

Guidance on the Technology Performance Level (TPL) Assessment Methodology

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

Weber, Jochem; Roberts, Jesse D.; Babarit, Aurelien

This document presents the revised Technology Performance Level (TPL) assessment methodology. There are three parts to this revised methodology 1) the Stakeholder Needs and Assessment Guidance (this document), 2) the Technical Submission form, 3) the TPL scoring spreadsheet. The TPL assessment is designed to give a technology neutral or agnostic assessment of any wave energy converter technology. The focus of the TPL is on the performance of the technology in meeting the customer’s needs. The original TPL is described in [1, 2] and those references also detail the critical differences in the nature of the TPL when compared to themore » more widely used technology readiness level (TRL). (Wave energy TRL is described in [3]). The revised TPL is particularly intended to be useful to investors and also to assist technology developers to conduct comprehensive assessments in a way that is meaningful and attractive to investors. The revised TPL assessment methodology has been derived through a structured Systems Engineering approach. This was a formal process which involved analyzing customer and stakeholder needs through the discipline of Systems Engineering. The results of the process confirmed the high level of completeness of the original methodology presented in [1] (as used in the Wave Energy Prize judging) and now add a significantly increased level of detail in the assessment and an improved more investment focused structure. The revised TPL also incorporates the feedback of the Wave Energy Prize judges.« less

A methodology to quantitatively evaluate the safety of a glazing robot.

PubMed

Lee, Seungyeol; Yu, Seungnam; Choi, Junho; Han, Changsoo

2011-03-01

A new construction method using robots is spreading widely among construction sites in order to overcome labour shortages and frequent construction accidents. Along with economical efficiency, safety is a very important factor for evaluating the use of construction robots in construction sites. However, the quantitative evaluation of safety is difficult compared with that of economical efficiency. In this study, we suggested a safety evaluation methodology by defining the 'worker' and 'work conditions' as two risk factors, defining the 'worker' factor as posture load and the 'work conditions' factor as the work environment and the risk exposure time. The posture load evaluation reflects the risk of musculoskeletal disorders which can be caused by work posture and the risk of accidents which can be caused by reduced concentration. We evaluated the risk factors that may cause various accidents such as falling, colliding, capsizing, and squeezing in work environments, and evaluated the operational risk by considering worker exposure time to risky work environments. With the results of the evaluations for each factor, we calculated the general operational risk and deduced the improvement ratio in operational safety by introducing a construction robot. To verify these results, we compared the safety of the existing human manual labour and the proposed robotic labour construction methods for manipulating large glass panels. Copyright © 2010 Elsevier Ltd and The Ergonomics Society. All rights reserved.

Recommendations for benefit-risk assessment methodologies and visual representations.

PubMed

Hughes, Diana; Waddingham, Ed; Mt-Isa, Shahrul; Goginsky, Alesia; Chan, Edmond; Downey, Gerald F; Hallgreen, Christine E; Hockley, Kimberley S; Juhaeri, Juhaeri; Lieftucht, Alfons; Metcalf, Marilyn A; Noel, Rebecca A; Phillips, Lawrence D; Ashby, Deborah; Micaleff, Alain

2016-03-01

The purpose of this study is to draw on the practical experience from the PROTECT BR case studies and make recommendations regarding the application of a number of methodologies and visual representations for benefit-risk assessment. Eight case studies based on the benefit-risk balance of real medicines were used to test various methodologies that had been identified from the literature as having potential applications in benefit-risk assessment. Recommendations were drawn up based on the results of the case studies. A general pathway through the case studies was evident, with various classes of methodologies having roles to play at different stages. Descriptive and quantitative frameworks were widely used throughout to structure problems, with other methods such as metrics, estimation techniques and elicitation techniques providing ways to incorporate technical or numerical data from various sources. Similarly, tree diagrams and effects tables were universally adopted, with other visualisations available to suit specific methodologies or tasks as required. Every assessment was found to follow five broad stages: (i) Planning, (ii) Evidence gathering and data preparation, (iii) Analysis, (iv) Exploration and (v) Conclusion and dissemination. Adopting formal, structured approaches to benefit-risk assessment was feasible in real-world problems and facilitated clear, transparent decision-making. Prior to this work, no extensive practical application and appraisal of methodologies had been conducted using real-world case examples, leaving users with limited knowledge of their usefulness in the real world. The practical guidance provided here takes us one step closer to a harmonised approach to benefit-risk assessment from multiple perspectives. Copyright © 2016 John Wiley & Sons, Ltd.

A risk assessment methodology for critical transportation infrastructure.

DOT National Transportation Integrated Search

2002-01-01

Infrastructure protection typifies a problem of risk assessment and management in a large-scale system. This study offers a methodological framework to identify, prioritize, assess, and manage risks. It includes the following major considerations: (1...

SCI Hazard Report Methodology

NASA Technical Reports Server (NTRS)

Mitchell, Michael S.

2010-01-01

This slide presentation reviews the methodology in creating a Source Control Item (SCI) Hazard Report (HR). The SCI HR provides a system safety risk assessment for the following Ares I Upper Stage Production Contract (USPC) components (1) Pyro Separation Systems (2) Main Propulsion System (3) Reaction and Roll Control Systems (4) Thrust Vector Control System and (5) Ullage Settling Motor System components.

Increasing accuracy in the assessment of motion sickness: A construct methodology

NASA Technical Reports Server (NTRS)

Stout, Cynthia S.; Cowings, Patricia S.

1993-01-01

The purpose is to introduce a new methodology that should improve the accuracy of the assessment of motion sickness. This construct methodology utilizes both subjective reports of motion sickness and objective measures of physiological correlates to assess motion sickness. Current techniques and methods used in the framework of a construct methodology are inadequate. Current assessment techniques for diagnosing motion sickness and space motion sickness are reviewed, and attention is called to the problems with the current methods. Further, principles of psychophysiology that when applied will probably resolve some of these problems are described in detail.

Track train dynamics analysis and test program: Methodology development for the derailment safety analysis of six-axle locomotives

NASA Technical Reports Server (NTRS)

Marcotte, P. P.; Mathewson, K. J. R.

1982-01-01

The operational safety of six axle locomotives is analyzed. A locomotive model with corresponding data on suspension characteristics, a method of track defect characterization, and a method of characterizing operational safety are used. A user oriented software package was developed as part of the methodology and was used to study the effect (on operational safety) of various locomotive parameters and operational conditions such as speed, tractive effort, and track curvature. The operational safety of three different locomotive designs was investigated.

Biosecurity Risk Assessment Methodology (BioRAM) v. 2.0

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

CASKEY, SUSAN; GAUDIOSO, JENNIFER; SALERNO, REYNOLDS

Sandia National Laboratories International Biological Threat Reduction Dept (SNL/IBTR) has an ongoing mission to enhance biosecurity assessment methodologies, tools, and guise. These will aid labs seeking to implement biosecurity as advocated in the recently released WHO's Biorisk Management: Lab Biosecurity Guidance. BioRAM 2.0 is the software tool developed initially using the SNL LDRD process and designed to complement the "Laboratory Biosecurity Risk Handbook" written by Ren Salerno and Jennifer Gaudioso defining biosecurity risk assessment methodologies.

Application of Mls Data to the Assessment of Safety-Related Features in the Surrounding Area of Automatically Detected Pedestrian Crossings

NASA Astrophysics Data System (ADS)

Soilán, M.; Riveiro, B.; Sánchez-Rodríguez, A.; González-deSantos, L. M.

2018-05-01

During the last few years, there has been a huge methodological development regarding the automatic processing of 3D point cloud data acquired by both terrestrial and aerial mobile mapping systems, motivated by the improvement of surveying technologies and hardware performance. This paper presents a methodology that, in a first place, extracts geometric and semantic information regarding the road markings within the surveyed area from Mobile Laser Scanning (MLS) data, and then employs it to isolate street areas where pedestrian crossings are found and, therefore, pedestrians are more likely to cross the road. Then, different safety-related features can be extracted in order to offer information about the adequacy of the pedestrian crossing regarding its safety, which can be displayed in a Geographical Information System (GIS) layer. These features are defined in four different processing modules: Accessibility analysis, traffic lights classification, traffic signs classification, and visibility analysis. The validation of the proposed methodology has been carried out in two different cities in the northwest of Spain, obtaining both quantitative and qualitative results for pedestrian crossing classification and for each processing module of the safety assessment on pedestrian crossing environments.

ASSESSMENT OF TOXICANT-INDUCED ALTERATIONS IN OVARIAN STEROIDOGENESIS: A METHODOLOGICAL OVERVIEW

EPA Science Inventory

RTD-03-035

Assessment of Toxicant-induced Alterations in Ovarian Steroidogenesis:
A Methodological Overview

Jerome M. Goldman, Susan C. Laws and Ralph L. Cooper

Abstract

A variety of methodological approaches have been used for the assessment of tox...

Applicability and feasibility of systematic review for performing evidence-based risk assessment in food and feed safety.

PubMed

Aiassa, E; Higgins, J P T; Frampton, G K; Greiner, M; Afonso, A; Amzal, B; Deeks, J; Dorne, J-L; Glanville, J; Lövei, G L; Nienstedt, K; O'connor, A M; Pullin, A S; Rajić, A; Verloo, D

2015-01-01

Food and feed safety risk assessment uses multi-parameter models to evaluate the likelihood of adverse events associated with exposure to hazards in human health, plant health, animal health, animal welfare, and the environment. Systematic review and meta-analysis are established methods for answering questions in health care, and can be implemented to minimize biases in food and feed safety risk assessment. However, no methodological frameworks exist for refining risk assessment multi-parameter models into questions suitable for systematic review, and use of meta-analysis to estimate all parameters required by a risk model may not be always feasible. This paper describes novel approaches for determining question suitability and for prioritizing questions for systematic review in this area. Risk assessment questions that aim to estimate a parameter are likely to be suitable for systematic review. Such questions can be structured by their "key elements" [e.g., for intervention questions, the population(s), intervention(s), comparator(s), and outcome(s)]. Prioritization of questions to be addressed by systematic review relies on the likely impact and related uncertainty of individual parameters in the risk model. This approach to planning and prioritizing systematic review seems to have useful implications for producing evidence-based food and feed safety risk assessment.

Assessment methodology for computer-based instructional simulations.

PubMed

Koenig, Alan; Iseli, Markus; Wainess, Richard; Lee, John J

2013-10-01

Computer-based instructional simulations are becoming more and more ubiquitous, particularly in military and medical domains. As the technology that drives these simulations grows ever more sophisticated, the underlying pedagogical models for how instruction, assessment, and feedback are implemented within these systems must evolve accordingly. In this article, we review some of the existing educational approaches to medical simulations, and present pedagogical methodologies that have been used in the design and development of games and simulations at the University of California, Los Angeles, Center for Research on Evaluation, Standards, and Student Testing. In particular, we present a methodology for how automated assessments of computer-based simulations can be implemented using ontologies and Bayesian networks, and discuss their advantages and design considerations for pedagogical use. Reprint & Copyright © 2013 Association of Military Surgeons of the U.S.

Assessing species saturation: conceptual and methodological challenges.

PubMed

Olivares, Ingrid; Karger, Dirk N; Kessler, Michael

2018-05-07

Is there a maximum number of species that can coexist? Intuitively, we assume an upper limit to the number of species in a given assemblage, or that a lineage can produce, but defining and testing this limit has proven problematic. Herein, we first outline seven general challenges of studies on species saturation, most of which are independent of the actual method used to assess saturation. Among these are the challenge of defining saturation conceptually and operationally, the importance of setting an appropriate referential system, and the need to discriminate among patterns, processes and mechanisms. Second, we list and discuss the methodological approaches that have been used to study species saturation. These approaches vary in time and spatial scales, and in the variables and assumptions needed to assess saturation. We argue that assessing species saturation is possible, but that many studies conducted to date have conceptual and methodological flaws that prevent us from currently attaining a good idea of the occurrence of species saturation. © 2018 Cambridge Philosophical Society.

Safety risk assessment for vertical concrete formwork activities in civil engineering construction.

PubMed

López-Arquillos, Antonio; Rubio-Romero, Juan Carlos; Gibb, Alistair G F; Gambatese, John A

2014-01-01

The construction sector has one of the worst occupational health and safety records in Europe. Of all construction tasks, formwork activities are associated with a high frequency of accidents and injuries. This paper presents an investigation of the activities and related safety risks present in vertical formwork for in-situ concrete construction in the civil engineering sector. Using the methodology of staticized groups, twelve activities and ten safety risks were identified and validated by experts. Every safety risk identified in this manner was quantified for each activity using binary methodology according to the frequency and severity scales developed in prior research. A panel of experts was selected according to the relevant literature on staticized groups. The results obtained show that the activities with the highest risk in vertical formwork tasks are: Plumbing and leveling of forms, cutting of material, handling materials with cranes, and climbing or descending ladders. The most dangerous health and safety risks detected were falls from height, cutting and overexertion. The research findings provide construction practitioners with further evidence of the hazardous activities associated with concrete formwork construction and a starting point for targeting worker health and safety programmes.

Safety assessment of plant food supplements (PFS).

PubMed

van den Berg, Suzanne J P L; Serra-Majem, Lluis; Coppens, Patrick; Rietjens, Ivonne M C M

2011-12-01

Botanicals and botanical preparations, including plant food supplements (PFS), are widely used in Western diets. The growing use of PFS is accompanied by an increasing concern because the safety of these PFS is not generally assessed before they enter the market. Regulatory bodies have become more aware of this and are increasing their efforts to ensure the safety of PFS. The present review describes an overview of the general framework for the safety assessment of PFS, focusing on the different approaches currently in use to assess the safety of botanicals and/or botanical compounds, including their history of safe use, the tiered approach proposed by the European Food Safety Authority (EFSA), the Threshold of Toxicological Concern (TTC) and the Margin of Exposure (MOE) concept. Moreover, some examples of botanical compounds in PFS that may be of concern are discussed. Altogether, it is clear that "natural" does not equal "safe" and that PFS may contain compounds of concern at levels far above those found in the regular diet. In addition, the traditional use of a PFS compound as a herb or tea does not guarantee its safety when used as a supplement. This points at a need for stricter regulation and control of botanical containing products, especially given their expanding market volume.

Safety Assessment of Polyether Lanolins as Used in Cosmetics.

PubMed

Becker, Lillian C; Bergfeld, Wilma F; Belsito, Donald V; Hill, Ronald A; Klaassen, Curtis D; Liebler, Daniel C; Marks, James G; Shank, Ronald C; Slaga, Thomas J; Snyder, Paul W; Andersen, F Alan; Heldreth, Bart

The Cosmetic Ingredient Review (CIR) Expert Panel (Panel) assessed the safety of 39 polyether lanolin ingredients as used in cosmetics. These ingredients function mostly as hair conditioning agents, skin conditioning agent-emollients, and surfactant-emulsifying agents. The Panel reviewed available animal and clinical data, from previous CIR safety assessments of related ingredients and components. The similar structure, properties, functions, and uses of these ingredients enabled grouping them and using the available toxicological data to assess the safety of the entire group. The Panel concluded that these polyether lanolin ingredients are safe in the practices of use and concentration as given in this safety assessment.

Hydrogen Hazards Assessment Protocol (HHAP): Approach and Methodology

NASA Technical Reports Server (NTRS)

Woods, Stephen

2009-01-01

This viewgraph presentation reviews the approach and methodology to develop a assessment protocol for hydrogen hazards. Included in the presentation are the reasons to perform hazards assessment, the types of hazard assessments that exist, an analysis of hydrogen hazards, specific information about the Hydrogen Hazards Assessment Protocol (HHAP). The assessment is specifically tailored for hydrogen behavior. The end product of the assesment is a compilation of hazard, mitigations and associated factors to facilitate decision making and achieve the best practice.

Need for an "integrated safety assessment" of GMOs, linking food safety and environmental considerations.

PubMed

Haslberger, Alexander G

2006-05-03

Evidence for substantial environmental influences on health and food safety comes from work with environmental health indicators which show that agroenvironmental practices have direct and indirect effects on human health, concluding that "the quality of the environment influences the quality and safety of foods" [Fennema, O. Environ. Health Perspect. 1990, 86, 229-232). In the field of genetically modified organisms (GMOs), Codex principles have been established for the assessment of GM food safety and the Cartagena Protocol on Biosafety outlines international principles for an environmental assessment of living modified organisms. Both concepts also contain starting points for an assessment of health/food safety effects of GMOs in cases when the environment is involved in the chain of events that could lead to hazards. The environment can act as a route of unintentional entry of GMOs into the food supply, such as in the case of gene flow via pollen or seeds from GM crops, but the environment can also be involved in changes of GMO-induced agricultural practices with relevance for health/food safety. Examples for this include potential regional changes of pesticide uses and reduction in pesticide poisonings resulting from the use of Bt crops or influences on immune responses via cross-reactivity. Clearly, modern methods of biotechnology in breeding are involved in the reasons behind the rapid reduction of local varieties in agrodiversity, which constitute an identified hazard for food safety and food security. The health/food safety assessment of GM foods in cases when the environment is involved needs to be informed by data from environmental assessment. Such data might be especially important for hazard identification and exposure assessment. International organizations working in these areas will very likely be needed to initiate and enable cooperation between those institutions responsible for the different assessments, as well as for exchange and analysis of

Performance-based methodology for assessing seismic vulnerability and capacity of buildings

NASA Astrophysics Data System (ADS)

Shibin, Lin; Lili, Xie; Maosheng, Gong; Ming, Li

2010-06-01

This paper presents a performance-based methodology for the assessment of seismic vulnerability and capacity of buildings. The vulnerability assessment methodology is based on the HAZUS methodology and the improved capacitydemand-diagram method. The spectral displacement ( S d ) of performance points on a capacity curve is used to estimate the damage level of a building. The relationship between S d and peak ground acceleration (PGA) is established, and then a new vulnerability function is expressed in terms of PGA. Furthermore, the expected value of the seismic capacity index (SCev) is provided to estimate the seismic capacity of buildings based on the probability distribution of damage levels and the corresponding seismic capacity index. The results indicate that the proposed vulnerability methodology is able to assess seismic damage of a large number of building stock directly and quickly following an earthquake. The SCev provides an effective index to measure the seismic capacity of buildings and illustrate the relationship between the seismic capacity of buildings and seismic action. The estimated result is compared with damage surveys of the cities of Dujiangyan and Jiangyou in the M8.0 Wenchuan earthquake, revealing that the methodology is acceptable for seismic risk assessment and decision making. The primary reasons for discrepancies between the estimated results and the damage surveys are discussed.

Methodological Issues in Curriculum-Based Reading Assessment.

ERIC Educational Resources Information Center

Fuchs, Lynn S.; And Others

1984-01-01

Three studies involving elementary students examined methodological issues in curriculum-based reading assessment. Results indicated that (1) whereas sample duration did not affect concurrent validity, increasing duration reduced performance instability and increased performance slopes and (2) domain size was related inversely to performance slope…

A Methodology for the Development of a Reliability Database for an Advanced Reactor Probabilistic Risk Assessment

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

Grabaskas, Dave; Brunett, Acacia J.; Bucknor, Matthew

GE Hitachi Nuclear Energy (GEH) and Argonne National Laboratory are currently engaged in a joint effort to modernize and develop probabilistic risk assessment (PRA) techniques for advanced non-light water reactors. At a high level the primary outcome of this project will be the development of next-generation PRA methodologies that will enable risk-informed prioritization of safety- and reliability-focused research and development, while also identifying gaps that may be resolved through additional research. A subset of this effort is the development of a reliability database (RDB) methodology to determine applicable reliability data for inclusion in the quantification of the PRA. The RDBmore » method developed during this project seeks to satisfy the requirements of the Data Analysis element of the ASME/ANS Non-LWR PRA standard. The RDB methodology utilizes a relevancy test to examine reliability data and determine whether it is appropriate to include as part of the reliability database for the PRA. The relevancy test compares three component properties to establish the level of similarity to components examined as part of the PRA. These properties include the component function, the component failure modes, and the environment/boundary conditions of the component. The relevancy test is used to gauge the quality of data found in a variety of sources, such as advanced reactor-specific databases, non-advanced reactor nuclear databases, and non-nuclear databases. The RDB also establishes the integration of expert judgment or separate reliability analysis with past reliability data. This paper provides details on the RDB methodology, and includes an example application of the RDB methodology for determining the reliability of the intermediate heat exchanger of a sodium fast reactor. The example explores a variety of reliability data sources, and assesses their applicability for the PRA of interest through the use of the relevancy test.« less

Safety assessment and detection methods of genetically modified organisms.

PubMed

Xu, Rong; Zheng, Zhe; Jiao, Guanglian

2014-01-01

Genetically modified organisms (GMOs), are gaining importance in agriculture as well as the production of food and feed. Along with the development of GMOs, health and food safety concerns have been raised. These concerns for these new GMOs make it necessary to set up strict system on food safety assessment of GMOs. The food safety assessment of GMOs, current development status of safety and precise transgenic technologies and GMOs detection have been discussed in this review. The recent patents about GMOs and their detection methods are also reviewed. This review can provide elementary introduction on how to assess and detect GMOs.

A safety culture assessment by mixed methods at a public maternity and infant hospital in China

PubMed Central

Listyowardojo, Tita Alissa; Yan, Xiaoling; Leyshon, Stephen; Ray-Sannerud, Bobbie; Yu, Xin Yan; Zheng, Kai; Duan, Tao

2017-01-01

Objective To assess safety culture at a public maternity hospital in Shanghai, China, using a sequential mixed methods approach. The study was part of a bigger study looking at the application of the mixed methods approach to assess safety culture in health care in different organizations and countries. Methodology A mixed methods approach was utilized by first distributing the Safety Attitudes Questionnaire measuring six safety culture dimensions and five independent items to all hospital staff (n=1482) working in 18 departments at a single hospital. Afterward, semistructured interviews were conducted using convenience sampling, where 48 hospital staff from nine departments at the same hospital were individually interviewed. Results The survey received a response rate of 96%. The survey findings show significant differences between the hospital departments in almost all safety culture dimensions and independent items. Similarly, the interview findings revealed that there were different, competing priorities between departments perceived to result in a reduced quality of collaboration and bottlenecks in care delivery. Another major finding was that staff who worked more hours per week would perceive working conditions significantly more negatively. Issues related to working conditions were also the most common concerns discussed in the interviews, especially the issue on high workload. High workload was also reflected in the fact that 91.45% of survey respondents reported that they worked 40 hours or longer per week. Finally, interview findings complemented survey findings, thus providing a more complete and accurate picture of safety culture. Conclusion Hospital leaders need to prioritize interventions focused on improving the quality of cross-department collaboration and reducing workload. A mixed methods assessment of safety culture provides more meaningful, targeted results, enabling leaders to prioritize and tailor improvement efforts to increase the impact of

Safety management and risk assessment in chemical laboratories.

PubMed

Marendaz, Jean-Luc; Friedrich, Kirstin; Meyer, Thierry

2011-01-01

The present paper highlights a new safety management program, MICE (Management, Information, Control and Emergency), which has been specifically adapted for the academic environment. The process starts with an exhaustive hazard inventory supported by a platform assembling specific hazards encountered in laboratories and their subsequent classification. A proof of concept is given by a series of implementations in the domain of chemistry targeting workplace health protection. The methodology is expressed through three examples to illustrate how the MICE program can be used to address safety concerns regarding chemicals, strong magnetic fields and nanoparticles in research laboratories. A comprehensive chemical management program is also depicted.

Analysis of safety impacts of access management alternatives using the surrogate safety assessment model : final report.

DOT National Transportation Integrated Search

2017-06-01

The purpose of this study was to evaluate if the Surrogate Safety Assessment Model (SSAM) could be used to assess the safety of a highway segment or an intersection in terms of the number and type of conflicts and to compare the safety effects of mul...

Passenger rail vehicle safety assessment methodology. Volume II, Detailed analyses and simulation results.

DOT National Transportation Integrated Search

2000-04-01

This report presents detailed analytic tools and results on dynamic response which are used to develop the safe dynamic performance limits of commuter passenger vehicles. The methodology consists of determining the critical parameters and characteris...

Optimization of coupled multiphysics methodology for safety analysis of pebble bed modular reactor

NASA Astrophysics Data System (ADS)

Mkhabela, Peter Tshepo

The research conducted within the framework of this PhD thesis is devoted to the high-fidelity multi-physics (based on neutronics/thermal-hydraulics coupling) analysis of Pebble Bed Modular Reactor (PBMR), which is a High Temperature Reactor (HTR). The Next Generation Nuclear Plant (NGNP) will be a HTR design. The core design and safety analysis methods are considerably less developed and mature for HTR analysis than those currently used for Light Water Reactors (LWRs). Compared to LWRs, the HTR transient analysis is more demanding since it requires proper treatment of both slower and much longer transients (of time scale in hours and days) and fast and short transients (of time scale in minutes and seconds). There is limited operation and experimental data available for HTRs for validation of coupled multi-physics methodologies. This PhD work developed and verified reliable high fidelity coupled multi-physics models subsequently implemented in robust, efficient, and accurate computational tools to analyse the neutronics and thermal-hydraulic behaviour for design optimization and safety evaluation of PBMR concept The study provided a contribution to a greater accuracy of neutronics calculations by including the feedback from thermal hydraulics driven temperature calculation and various multi-physics effects that can influence it. Consideration of the feedback due to the influence of leakage was taken into account by development and implementation of improved buckling feedback models. Modifications were made in the calculation procedure to ensure that the xenon depletion models were accurate for proper interpolation from cross section tables. To achieve this, the NEM/THERMIX coupled code system was developed to create the system that is efficient and stable over the duration of transient calculations that last over several tens of hours. Another achievement of the PhD thesis was development and demonstration of full-physics, three-dimensional safety analysis

Lunar Surface Habitat Configuration Assessment: Methodology and Observations

NASA Technical Reports Server (NTRS)

Carpenter, Amanda

2008-01-01

The Lunar Habitat Configuration Assessment evaluated the major habitat approaches that were conceptually developed during the Lunar Architecture Team II Study. The objective of the configuration assessment was to identify desired features, operational considerations, and risks to derive habitat requirements. This assessment only considered operations pertaining to the lunar surface and did not consider all habitat conceptual designs developed. To examine multiple architectures, the Habitation Focus Element Team defined several adequate concepts which warranted the need for a method to assess the various configurations. The fundamental requirement designed into each concept included the functional and operational capability to support a crew of four on a six-month lunar surface mission; however, other conceptual aspects were diverse in comparison. The methodology utilized for this assessment consisted of defining figure of merits, providing relevant information, and establishing a scoring system. In summary, the assessment considered the geometric configuration of each concept to determine the complexity of unloading, handling, mobility, leveling, aligning, mating to other elements, and the accessibility to the lunar surface. In theory, the assessment was designed to derive habitat requirements, potential technology development needs and identify risks associated with living and working on the lunar surface. Although the results were more subjective opposed to objective, the assessment provided insightful observations for further assessments and trade studies of lunar surface habitats. This overall methodology and resulting observations will be describe in detail and illustrative examples will be discussed.

Comparative safety assessment of plant-derived foods.

PubMed

Kok, E J; Keijer, J; Kleter, G A; Kuiper, H A

2008-02-01

The second generation of genetically modified (GM) plants that are moving towards the market are characterized by modifications that may be more complex and traits that more often are to the benefit of the consumer. These developments will have implications for the safety assessment of the resulting plant products. In part of the cases the same crop plant can, however, also be obtained by 'conventional' breeding strategies. The breeder will decide on a case-by-case basis what will be the best strategy to reach the set target and whether genetic modification will form part of this strategy. This article discusses important aspects of the safety assessment of complex products derived from newly bred plant varieties obtained by different breeding strategies. On the basis of this overview, we conclude that the current process of the safety evaluation of GM versus conventionally bred plants is not well balanced. GM varieties are elaborately assessed, yet at the same time other crop plants resulting from conventional breeding strategies may warrant further food safety assessment for the benefit of the consumer. We propose to develop a general screening frame for all newly developed plant varieties to select varieties that cannot, on the basis of scientific criteria, be considered as safe as plant varieties that are already on the market.

A Probabilistic Assessment Methodology for the Evaluation of Geologic Carbon Dioxide Storage

USGS Publications Warehouse

Brennan, Sean T.; Burruss, Robert A.; Merrill, Matthew D.; Freeman, P.A.; Ruppert, Leslie F.

2010-01-01

In 2007, the Energy Independence and Security Act (Public Law 110-140) authorized the U.S. Geological Survey (USGS) to conduct a national assessment of potential geologic storage resources for carbon dioxide (CO2) in cooperation with the U.S. Environmental Protection Agency and the U.S. Department of Energy. The first year of that activity was specified for development of a methodology to estimate storage potential that could be applied uniformly to geologic formations across the United States. After its release, the methodology was to receive public comment and external expert review. An initial methodology was developed and published in March 2009 (Burruss and others, 2009), and public comments were received. The report was then sent to a panel of experts for external review. The external review report was received by the USGS in December 2009. This report is in response to those external comments and reviews and describes how the previous assessment methodology (Burruss and others, 2009) was revised. The resource that is assessed is the technically accessible storage resource, which is defined as the mass of CO2 that can be stored in the pore volume of a storage formation. The methodology that is presented in this report is intended to be used for assessments at scales ranging from regional to subbasinal in which storage assessment units are defined on the basis of common geologic and hydrologic characteristics. The methodology does not apply to site-specific evaluation of storage resources or capacity.

Health and safety impacts of nuclear, geothermal, and fossil-fuel electric generation in California. Volume 9. Methodologies for review of the health and safety aspects of proposed nuclear, geothermal, and fossil-fuel sites and facilities

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

Nero, A.V.; Quinby-Hunt, M.S.

1977-01-01

This report sets forth methodologies for review of the health and safety aspects of proposed nuclear, geothermal, and fossil-fuel sites and facilities for electric power generation. The review is divided into a Notice of Intention process and an Application for Certification process, in accordance with the structure to be used by the California Energy Resources Conservation and Development Commission, the first emphasizing site-specific considerations, the second examining the detailed facility design as well. The Notice of Intention review is divided into three possible stages: an examination of emissions and site characteristics, a basic impact analysis, and an assessment of publicmore » impacts. The Application for Certification review is divided into five possible stages: a review of the Notice of Intention treatment, review of the emission control equipment, review of the safety design, review of the general facility design, and an overall assessment of site and facility acceptability.« less

Initial development of a practical safety audit tool to assess fleet safety management practices.

PubMed

Mitchell, Rebecca; Friswell, Rena; Mooren, Lori

2012-07-01

Work-related vehicle crashes are a common cause of occupational injury. Yet, there are few studies that investigate management practices used for light vehicle fleets (i.e. vehicles less than 4.5 tonnes). One of the impediments to obtaining and sharing information on effective fleet safety management is the lack of an evidence-based, standardised measurement tool. This article describes the initial development of an audit tool to assess fleet safety management practices in light vehicle fleets. The audit tool was developed by triangulating information from a review of the literature on fleet safety management practices and from semi-structured interviews with 15 fleet managers and 21 fleet drivers. A preliminary useability assessment was conducted with 5 organisations. The audit tool assesses the management of fleet safety against five core categories: (1) management, systems and processes; (2) monitoring and assessment; (3) employee recruitment, training and education; (4) vehicle technology, selection and maintenance; and (5) vehicle journeys. Each of these core categories has between 1 and 3 sub-categories. Organisations are rated at one of 4 levels on each sub-category. The fleet safety management audit tool is designed to identify the extent to which fleet safety is managed in an organisation against best practice. It is intended that the audit tool be used to conduct audits within an organisation to provide an indicator of progress in managing fleet safety and to consistently benchmark performance against other organisations. Application of the tool by fleet safety researchers is now needed to inform its further development and refinement and to permit psychometric evaluation. Copyright © 2012 Elsevier Ltd. All rights reserved.

Animal-Free Chemical Safety Assessment

PubMed Central

Loizou, George D.

2016-01-01

The exponential growth of the Internet of Things and the global popularity and remarkable decline in cost of the mobile phone is driving the digital transformation of medical practice. The rapidly maturing digital, non-medical world of mobile (wireless) devices, cloud computing and social networking is coalescing with the emerging digital medical world of omics data, biosensors and advanced imaging which offers the increasingly realistic prospect of personalized medicine. Described as a potential “seismic” shift from the current “healthcare” model to a “wellness” paradigm that is predictive, preventative, personalized and participatory, this change is based on the development of increasingly sophisticated biosensors which can track and measure key biochemical variables in people. Additional key drivers in this shift are metabolomic and proteomic signatures, which are increasingly being reported as pre-symptomatic, diagnostic and prognostic of toxicity and disease. These advancements also have profound implications for toxicological evaluation and safety assessment of pharmaceuticals and environmental chemicals. An approach based primarily on human in vivo and high-throughput in vitro human cell-line data is a distinct possibility. This would transform current chemical safety assessment practice which operates in a human “data poor” to a human “data rich” environment. This could also lead to a seismic shift from the current animal-based to an animal-free chemical safety assessment paradigm. PMID:27493630

Applying GRADE-CERQual to qualitative evidence synthesis findings-paper 3: how to assess methodological limitations.

PubMed

Munthe-Kaas, Heather; Bohren, Meghan A; Glenton, Claire; Lewin, Simon; Noyes, Jane; Tunçalp, Özge; Booth, Andrew; Garside, Ruth; Colvin, Christopher J; Wainwright, Megan; Rashidian, Arash; Flottorp, Signe; Carlsen, Benedicte

2018-01-25

The GRADE-CERQual (Confidence in Evidence from Reviews of Qualitative research) approach has been developed by the GRADE (Grading of Recommendations Assessment, Development and Evaluation) Working Group. The approach has been developed to support the use of findings from qualitative evidence syntheses in decision-making, including guideline development and policy formulation. CERQual includes four components for assessing how much confidence to place in findings from reviews of qualitative research (also referred to as qualitative evidence syntheses): (1) methodological limitations, (2) coherence, (3) adequacy of data and (4) relevance. This paper is part of a series providing guidance on how to apply CERQual and focuses on CERQual's methodological limitations component. We developed the methodological limitations component by searching the literature for definitions, gathering feedback from relevant research communities and developing consensus through project group meetings. We tested the CERQual methodological limitations component within several qualitative evidence syntheses before agreeing on the current definition and principles for application. When applying CERQual, we define methodological limitations as the extent to which there are concerns about the design or conduct of the primary studies that contributed evidence to an individual review finding. In this paper, we describe the methodological limitations component and its rationale and offer guidance on how to assess methodological limitations of a review finding as part of the CERQual approach. This guidance outlines the information required to assess methodological limitations component, the steps that need to be taken to assess methodological limitations of data contributing to a review finding and examples of methodological limitation assessments. This paper provides guidance for review authors and others on undertaking an assessment of methodological limitations in the context of the CERQual

77 FR 70451 - Proposed Collection; Comment Request; Methodological Studies for the Population Assessment of...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-11-26

... Request; Methodological Studies for the Population Assessment of Tobacco and Health (PATH) Study SUMMARY... Collection: Title: Methodological Studies for Population Assessment of Tobacco and Health (PATH) Study. Type... methodological studies to improve the PATH study instrumentation and data collection procedures. These...

Chemical footprint: a methodological framework for bridging life cycle assessment and planetary boundaries for chemical pollution.

PubMed

Sala, Serenella; Goralczyk, Malgorzata

2013-10-01

The development and use of footprint methodologies for environmental assessment are increasingly important for both the scientific and political communities. Starting from the ecological footprint, developed at the beginning of the 1990s, several other footprints were defined, e.g., carbon and water footprint. These footprints-even though based on a different meaning of "footprint"-integrate life cycle thinking, and focus on some challenging environmental impacts including resource consumption, CO2 emission leading to climate change, and water consumption. However, they usually neglect relevant sources of impacts, as those related to the production and use of chemicals. This article presents and discusses the need and relevance of developing a methodology for assessing the chemical footprint, coupling a life cycle-based approach with methodologies developed in other contexts, such as ERA and sustainability science. Furthermore, different concepts underpin existing footprint and this could be the case also of chemical footprint. At least 2 different approaches and steps to chemical footprint could be envisaged, applicable at the micro- as well as at the meso- and macroscale. The first step (step 1) is related to the account of chemicals use and emissions along the life cycle of a product, sector, or entire economy, to assess potential impacts on ecosystems and human health. The second step (step 2) aims at assessing to which extent actual emission of chemicals harm the ecosystems above their capability to recover (carrying capacity of the system). The latter step might contribute to the wide discussion on planetary boundaries for chemical pollution: the thresholds that should not be surpassed to guarantee a sustainable use of chemicals from an environmental safety perspective. The definition of what the planetary boundaries for chemical pollution are and how the boundaries should be identified is an on-going scientific challenge for ecotoxicology and ecology. In

Architecture, Design, and System; Performance Assessment and Development Methodology for Computer-Based Systems. Volume 1. Methodology Description, Discussion, and Assessment,

DTIC Science & Technology

1983-12-30

AD-Ri46 57? ARCHITECTURE DESIGN AND SYSTEM; PERFORMANCE ASSESSMENT i/i AND DEVELOPMENT ME..(U) NAVAL SURFACE WEAPONS CENTER SILYER SPRING MD J...AD-A 146 577 NSIWC TR 83-324 ARCHITECTURE , DESIGN , AND SYSTEM; PERFORMANCE ASSESSMENT AND DEVELOPMENT METHODOLOGY...REPORT NUMBER 12. GOVT ACCESSION NO.3. RECIPIENT’S CATALOG NUMBER NSWC TR 83-324 10- 1 1 51’ 4. ?ITLE (and subtitle) ARCHITECTURE , DESIGN , AND SYSTEM; S

Safety assessment for hair-spray resins: risk assessment based on rodent inhalation studies.

PubMed

Carthew, Philip; Griffiths, Heather; Keech, Stephen; Hartop, Peter

2002-04-01

The methods involved in the safety assessment of resins used in hair-spray products have received little peer review, or debate in the published literature, despite their widespread use, in both hairdressing salons and the home. The safety assessment for these resins currently involves determining the type of lung pathology that can be caused in animal inhalation exposure studies, and establishing the no-observable-effect level (NOEL) for these pathologies. The likely human consumer exposure is determined by techniques that model the simulated exposure under "in use" conditions. From these values it is then possible to derive the likely safety factors for human exposure. An important part of this process would be to recognize the intrinsic differences between rodents and humans in terms of the respiratory doses that each species experiences during inhalation exposures, for the purpose of the safety assessment. Interspecies scaling factors become necessary when comparing the exposure doses experienced by rats, compared to humans, because of basic differences between species in lung clearance rates and the alveolar area in the lungs. The rodent inhalation data and modeled human exposure to Resin 6965, a resin polymer that is based on vinyl acetate, has been used to calculate the safety factor for human consumer exposure to this resin, under a range of "in use" exposure conditions. The use of this safety assessment process clearly demonstrates that Resin 6965 is acceptable for human consumer exposure under the conditions considered in this risk assessment.

The Impact of Novel Assessment Methodologies in Toxicology on Green Chemistry and Chemical Alternatives.

PubMed

Rusyn, Ivan; Greene, Nigel

2018-02-01

The field of experimental toxicology is rapidly advancing by incorporating novel techniques and methods that provide a much more granular view into the mechanisms of potential adverse effects of chemical exposures on human health. The data from various in vitro assays and computational models are useful not only for increasing confidence in hazard and risk decisions, but also are enabling better, faster and cheaper assessment of a greater number of compounds, mixtures, and complex products. This is of special value to the field of green chemistry where design of new materials or alternative uses of existing ones is driven, at least in part, by considerations of safety. This article reviews the state of the science and decision-making in scenarios when little to no data may be available to draw conclusions about which choice in green chemistry is "safer." It is clear that there is no "one size fits all" solution and multiple data streams need to be weighed in making a decision. Moreover, the overall level of familiarity of the decision-makers and scientists alike with new assessment methodologies, their validity, value and limitations is evolving. Thus, while the "impact" of the new developments in toxicology on the field of green chemistry is great already, it is premature to conclude that the data from new assessment methodologies have been widely accepted yet. © The Author 2017. Published by Oxford University Press on behalf of the Society of Toxicology. All rights reserved. For Permissions, please e-mail: journals.permissions@oup.com.

Methodological quality assessment of paper-based systematic reviews published in oral health.

PubMed

Wasiak, J; Shen, A Y; Tan, H B; Mahar, R; Kan, G; Khoo, W R; Faggion, C M

2016-04-01

This study aimed to conduct a methodological assessment of paper-based systematic reviews (SR) published in oral health using a validated checklist. A secondary objective was to explore temporal trends on methodological quality. Two electronic databases (OVID Medline and OVID EMBASE) were searched for paper-based SR of interventions published in oral health from inception to October 2014. Manual searches of the reference lists of paper-based SR were also conducted. Methodological quality of included paper-based SR was assessed using an 11-item questionnaire, Assessment of Multiple Systematic Reviews (AMSTAR) checklist. Methodological quality was summarized using the median and inter-quartile range (IQR) of the AMSTAR score over different categories and time periods. A total of 643 paper-based SR were included. The overall median AMSTAR score was 4 (IQR 2-6). The highest median score (5) was found in the pain dentistry and periodontology fields, while the lowest median score (3) was found in implant dentistry, restorative dentistry, oral medicine, and prosthodontics. The number of paper-based SR per year and the median AMSTAR score increased over time (median score in 1990s was 2 (IQR 2-3), 2000s was 4 (IQR 2-5), and 2010 onwards was 5 (IQR 3-6)). Although the methodological quality of paper-based SR published in oral health has improved in the last few years, there is still scope for improving quality in most evaluated dental specialties. Large-scale assessment of methodological quality of dental SR highlights areas of methodological strengths and weaknesses that can be targeted in future publications to encourage better quality review methodology.

Assessment of methodological quality of economic evaluations in belgian drug reimbursement applications.

PubMed

Simoens, Steven

2013-01-01

This paper aims to assess the methodological quality of economic evaluations included in Belgian reimbursement applications for Class 1 drugs. For 19 reimbursement applications submitted during 2011 and Spring 2012, a descriptive analysis assessed the methodological quality of the economic evaluation, evaluated the assessment of that economic evaluation by the Drug Reimbursement Committee and the response to that assessment by the company. Compliance with methodological guidelines issued by the Belgian Healthcare Knowledge Centre was assessed using a detailed checklist of 23 methodological items. The rate of compliance was calculated based on the number of economic evaluations for which the item was applicable. Economic evaluations tended to comply with guidelines regarding perspective, target population, subgroup analyses, comparator, use of comparative clinical data and final outcome measures, calculation of costs, incremental analysis, discounting and time horizon. However, more attention needs to be paid to the description of limitations of indirect comparisons, the choice of an appropriate analytic technique, the expression of unit costs in values for the current year, the estimation and valuation of outcomes, the presentation of results of sensitivity analyses, and testing the face validity of model inputs and outputs. Also, a large variation was observed in the scope and depth of the quality assessment by the Drug Reimbursement Committee. Although general guidelines exist, pharmaceutical companies and the Drug Reimbursement Committee would benefit from the existence of a more detailed checklist of methodological items that need to be reported in an economic evaluation.

Pharmacological mechanism-based drug safety assessment and prediction.

PubMed

Abernethy, D R; Woodcock, J; Lesko, L J

2011-06-01

Advances in cheminformatics, bioinformatics, and pharmacology in the context of biological systems are now at a point that these tools can be applied to mechanism-based drug safety assessment and prediction. The development of such predictive tools at the US Food and Drug Administration (FDA) will complement ongoing efforts in drug safety that are focused on spontaneous adverse event reporting and active surveillance to monitor drug safety. This effort will require the active collaboration of scientists in the pharmaceutical industry, academe, and the National Institutes of Health, as well as those at the FDA, to reach its full potential. Here, we describe the approaches and goals for the mechanism-based drug safety assessment and prediction program.

Enhancing the Assessment of Verbal Aggression through Observational Methodology

ERIC Educational Resources Information Center

van Dulmen, Manfred H. M.; Mata, Andrea D.; Klipfel, Katherine M.

2012-01-01

The assessment of verbal aggression in adolescent and young adult dating relationships has largely relied on self-report methodology. We investigated whether information on verbal aggression derived from an observational assessment would enhance the prediction of romantic relationship satisfaction and dissolution in a sample of young adult dating…

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.

Methodology for assessing the effectiveness of access management techniques : executive summary.

DOT National Transportation Integrated Search

1998-09-14

A methodology for assessing the effectiveness of access management techniques on suburban arterial highways is developed. The methodology is described as a seven-step process as follows: (1) establish the purpose of the analysis (2) establish the mea...

LANL Safety Conscious Work Environment (SCWE) Self-Assessment

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

Hargis, Barbara C.

2014-01-29

On December 21, 2012 Secretary of Energy Chu transmitted to the Defense Nuclear Facilities Safety Board (DNFSB) revised commitments on the implementation plan for Safety Culture at the Waste Treatment and Immobilization Plant. Action 2-5 was revised to require contractors and federal organizations to complete Safety Conscious Work Environment (SCWE) selfassessments and provide reports to the appropriate U.S. Department of Energy (DOE) - Headquarters Program Office by September 2013. Los Alamos National Laboratory (LANL) planned and conducted a Safety Conscious Work Environment (SCWE) Self-Assessment over the time period July through August, 2013 in accordance with the SCWE Self-Assessment Guidance providedmore » by DOE. Significant field work was conducted over the 2-week period August 5-16, 2013. The purpose of the self-assessment was to evaluate whether programs and processes associated with a SCWE are in place and whether they are effective in supporting and promoting a SCWE.« less

Assessment of Methodological Quality of Economic Evaluations in Belgian Drug Reimbursement Applications

PubMed Central

Simoens, Steven

2013-01-01

Objectives This paper aims to assess the methodological quality of economic evaluations included in Belgian reimbursement applications for Class 1 drugs. Materials and Methods For 19 reimbursement applications submitted during 2011 and Spring 2012, a descriptive analysis assessed the methodological quality of the economic evaluation, evaluated the assessment of that economic evaluation by the Drug Reimbursement Committee and the response to that assessment by the company. Compliance with methodological guidelines issued by the Belgian Healthcare Knowledge Centre was assessed using a detailed checklist of 23 methodological items. The rate of compliance was calculated based on the number of economic evaluations for which the item was applicable. Results Economic evaluations tended to comply with guidelines regarding perspective, target population, subgroup analyses, comparator, use of comparative clinical data and final outcome measures, calculation of costs, incremental analysis, discounting and time horizon. However, more attention needs to be paid to the description of limitations of indirect comparisons, the choice of an appropriate analytic technique, the expression of unit costs in values for the current year, the estimation and valuation of outcomes, the presentation of results of sensitivity analyses, and testing the face validity of model inputs and outputs. Also, a large variation was observed in the scope and depth of the quality assessment by the Drug Reimbursement Committee. Conclusions Although general guidelines exist, pharmaceutical companies and the Drug Reimbursement Committee would benefit from the existence of a more detailed checklist of methodological items that need to be reported in an economic evaluation. PMID:24386474

Advanced biosensing methodologies developed for evaluating performance quality and safety of emerging biophotonics technologies and medical devices (Conference Presentation)

NASA Astrophysics Data System (ADS)

Ilev, Ilko K.; Walker, Bennett; Calhoun, William; Hassan, Moinuddin

2016-03-01

Biophotonics is an emerging field in modern biomedical technology that has opened up new horizons for transfer of state-of-the-art techniques from the areas of lasers, fiber optics and biomedical optics to the life sciences and medicine. This field continues to vastly expand with advanced developments across the entire spectrum of biomedical applications ranging from fundamental "bench" laboratory studies to clinical patient "bedside" diagnostics and therapeutics. However, in order to translate these technologies to clinical device applications, the scientific and industrial community, and FDA are facing the requirement for a thorough evaluation and review of laser radiation safety and efficacy concerns. In many cases, however, the review process is complicated due the lack of effective means and standard test methods to precisely analyze safety and effectiveness of some of the newly developed biophotonics techniques and devices. There is, therefore, an immediate public health need for new test protocols, guidance documents and standard test methods to precisely evaluate fundamental characteristics, performance quality and safety of these technologies and devices. Here, we will overview our recent developments of novel test methodologies for safety and efficacy evaluation of some emerging biophotonics technologies and medical devices. These methodologies are based on integrating the advanced features of state-of-the-art optical sensor technologies and approaches such as high-resolution fiber-optic sensing, confocal and optical coherence tomography imaging, and infrared spectroscopy. The presentation will also illustrate some methodologies developed and implemented for testing intraocular lens implants, biochemical contaminations of medical devices, ultrahigh-resolution nanoscopy, and femtosecond laser therapeutics.

Safety management system needs assessment.

DOT National Transportation Integrated Search

2016-04-01

The safety of the traveling public is critical as each year there are approximately 200 highway fatalities in Nebraska and numerous crash injuries. The objective of this research was to conduct a needs assessment to identify the requirements of a sta...

Guiding principles of USGS methodology for assessment of undiscovered conventional oil and gas resources

USGS Publications Warehouse

Charpentier, R.R.; Klett, T.R.

2005-01-01

During the last 30 years, the methodology for assessment of undiscovered conventional oil and gas resources used by the Geological Survey has undergone considerable change. This evolution has been based on five major principles. First, the U.S. Geological Survey has responsibility for a wide range of U.S. and world assessments and requires a robust methodology suitable for immaturely explored as well as maturely explored areas. Second, the assessments should be based on as comprehensive a set of geological and exploration history data as possible. Third, the perils of methods that solely use statistical methods without geological analysis are recognized. Fourth, the methodology and course of the assessment should be documented as transparently as possible, within the limits imposed by the inevitable use of subjective judgement. Fifth, the multiple uses of the assessments require a continuing effort to provide the documentation in such ways as to increase utility to the many types of users. Undiscovered conventional oil and gas resources are those recoverable volumes in undiscovered, discrete, conventional structural or stratigraphic traps. The USGS 2000 methodology for these resources is based on a framework of assessing numbers and sizes of undiscovered oil and gas accumulations and the associated risks. The input is standardized on a form termed the Seventh Approximation Data Form for Conventional Assessment Units. Volumes of resource are then calculated using a Monte Carlo program named Emc2, but an alternative analytic (non-Monte Carlo) program named ASSESS also can be used. The resource assessment methodology continues to change. Accumulation-size distributions are being examined to determine how sensitive the results are to size-distribution assumptions. The resource assessment output is changing to provide better applicability for economic analysis. The separate methodology for assessing continuous (unconventional) resources also has been evolving. Further

A Methodology for Validating Safety Heuristics Using Clinical Simulations: Identifying and Preventing Possible Technology-Induced Errors Related to Using Health Information Systems

PubMed Central

Borycki, Elizabeth; Kushniruk, Andre; Carvalho, Christopher

2013-01-01

Internationally, health information systems (HIS) safety has emerged as a significant concern for governments. Recently, research has emerged that has documented the ability of HIS to be implicated in the harm and death of patients. Researchers have attempted to develop methods that can be used to prevent or reduce technology-induced errors. Some researchers are developing methods that can be employed prior to systems release. These methods include the development of safety heuristics and clinical simulations. In this paper, we outline our methodology for developing safety heuristics specific to identifying the features or functions of a HIS user interface design that may lead to technology-induced errors. We follow this with a description of a methodological approach to validate these heuristics using clinical simulations. PMID:23606902

A Risk Analysis Methodology to Address Human and Organizational Factors in Offshore Drilling Safety: With an Emphasis on Negative Pressure Test

NASA Astrophysics Data System (ADS)

Tabibzadeh, Maryam

According to the final Presidential National Commission report on the BP Deepwater Horizon (DWH) blowout, there is need to "integrate more sophisticated risk assessment and risk management practices" in the oil industry. Reviewing the literature of the offshore drilling industry indicates that most of the developed risk analysis methodologies do not fully and more importantly, systematically address the contribution of Human and Organizational Factors (HOFs) in accident causation. This is while results of a comprehensive study, from 1988 to 2005, of more than 600 well-documented major failures in offshore structures show that approximately 80% of those failures were due to HOFs. In addition, lack of safety culture, as an issue related to HOFs, have been identified as a common contributing cause of many accidents in this industry. This dissertation introduces an integrated risk analysis methodology to systematically assess the critical role of human and organizational factors in offshore drilling safety. The proposed methodology in this research focuses on a specific procedure called Negative Pressure Test (NPT), as the primary method to ascertain well integrity during offshore drilling, and analyzes the contributing causes of misinterpreting such a critical test. In addition, the case study of the BP Deepwater Horizon accident and their conducted NPT is discussed. The risk analysis methodology in this dissertation consists of three different approaches and their integration constitutes the big picture of my whole methodology. The first approach is the comparative analysis of a "standard" NPT, which is proposed by the author, with the test conducted by the DWH crew. This analysis contributes to identifying the involved discrepancies between the two test procedures. The second approach is a conceptual risk assessment framework to analyze the causal factors of the identified mismatches in the previous step, as the main contributors of negative pressure test

Principles of Safety Pharmacology

PubMed Central

Pugsley, M K; Authier, S; Curtis, M J

2008-01-01

Safety Pharmacology is a rapidly developing discipline that uses the basic principles of pharmacology in a regulatory-driven process to generate data to inform risk/benefit assessment. The aim of Safety Pharmacology is to characterize the pharmacodynamic/pharmacokinetic (PK/PD) relationship of a drug's adverse effects using continuously evolving methodology. Unlike toxicology, Safety Pharmacology includes within its remit a regulatory requirement to predict the risk of rare lethal events. This gives Safety Pharmacology its unique character. The key issues for Safety Pharmacology are detection of an adverse effect liability, projection of the data into safety margin calculation and finally clinical safety monitoring. This article sets out to explain the drivers for Safety Pharmacology so that the wider pharmacology community is better placed to understand the discipline. It concludes with a summary of principles that may help inform future resolution of unmet needs (especially establishing model validation for accurate risk assessment). Subsequent articles in this issue of the journal address specific aspects of Safety Pharmacology to explore the issues of model choice, the burden of proof and to highlight areas of intensive activity (such as testing for drug-induced rare event liability, and the challenge of testing the safety of so-called biologics (antibodies, gene therapy and so on.). PMID:18604233

A methodology for post-mainshock probabilistic assessment of building collapse risk

USGS Publications Warehouse

Luco, N.; Gerstenberger, M.C.; Uma, S.R.; Ryu, H.; Liel, A.B.; Raghunandan, M.

2011-01-01

This paper presents a methodology for post-earthquake probabilistic risk (of damage) assessment that we propose in order to develop a computational tool for automatic or semi-automatic assessment. The methodology utilizes the same so-called risk integral which can be used for pre-earthquake probabilistic assessment. The risk integral couples (i) ground motion hazard information for the location of a structure of interest with (ii) knowledge of the fragility of the structure with respect to potential ground motion intensities. In the proposed post-mainshock methodology, the ground motion hazard component of the risk integral is adapted to account for aftershocks which are deliberately excluded from typical pre-earthquake hazard assessments and which decrease in frequency with the time elapsed since the mainshock. Correspondingly, the structural fragility component is adapted to account for any damage caused by the mainshock, as well as any uncertainty in the extent of this damage. The result of the adapted risk integral is a fully-probabilistic quantification of post-mainshock seismic risk that can inform emergency response mobilization, inspection prioritization, and re-occupancy decisions.

The PHM-Ethics methodology: interdisciplinary technology assessment of personal health monitoring.

PubMed

Schmidt, Silke; Verweij, Marcel

2013-01-01

The contribution briefly introduces the PHM Ethics project and the PHM methodology. Within the PHM-Ethics project, a set of tools and modules had been developed that may assist in the evaluation and assessment of new technologies for personal health monitoring, referred to as "PHM methodology" or "PHM toolbox". An overview on this interdisciplinary methodology and its comprising modules is provided, areas of application and intended target groups are indicated.

Assessing safety climate in acute hospital settings: a systematic review of the adequacy of the psychometric properties of survey measurement tools.

PubMed

Alsalem, Gheed; Bowie, Paul; Morrison, Jillian

2018-05-10

The perceived importance of safety culture in improving patient safety and its impact on patient outcomes has led to a growing interest in the assessment of safety climate in healthcare organizations; however, the rigour with which safety climate tools were developed and psychometrically tested was shown to be variable. This paper aims to identify and review questionnaire studies designed to measure safety climate in acute hospital settings, in order to assess the adequacy of reported psychometric properties of identified tools. A systematic review of published empirical literature was undertaken to examine sample characteristics and instrument details including safety climate dimensions, origin and theoretical basis, and extent of psychometric evaluation (content validity, criterion validity, construct validity and internal reliability). Five questionnaire tools, designed for general evaluation of safety climate in acute hospital settings, were included. Detailed inspection revealed ambiguity around concepts of safety culture and climate, safety climate dimensions and the methodological rigour associated with the design of these measures. Standard reporting of the psychometric properties of developed questionnaires was variable, although evidence of an improving trend in the quality of the reported psychometric properties of studies was noted. Evidence of the theoretical underpinnings of climate tools was limited, while a lack of clarity in the relationship between safety culture and patient outcome measures still exists. Evidence of the adequacy of the psychometric development of safety climate questionnaire tools is still limited. Research is necessary to resolve the controversies in the definitions and dimensions of safety culture and climate in healthcare and identify related inconsistencies. More importance should be given to the appropriate validation of safety climate questionnaires before extending their usage in healthcare contexts different from those in

78 FR 12335 - Submission for OMB review; Comment Request: Methodological Studies for the Population Assessment...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-02-22

...; Comment Request: Methodological Studies for the Population Assessment of Tobacco and Health (PATH) Study... approval from OMB for methodological studies to improve the PATH study instrumentation and data collection procedures. These methodological studies will support ongoing assessment and refinement of the PATH study's...

The National Aviation Operational Monitoring Service (NAOMS): A Documentation of the Development of a Survey Methodology

NASA Technical Reports Server (NTRS)

Connors, Mary M.; Mauro, Robert; Statler, Irving C.

2012-01-01

The National Aviation Operational Monitoring Service (NAOMS) was a research project under NASA s Aviation Safety Program during the years from 2000 to 2005. The purpose of this project was to develop a methodology for gaining reliable information on changes over time in the rates-of-occurrence of safety-related events as a means of assessing the safety of the national airspace. The approach was a scientifically designed survey of the operators of the aviation system concerning their safety-related experiences. This report presents the results of the methodology developed and a demonstration of the NAOMS concept through a survey of nearly 20,000 randomly selected air-carrier pilots. Results give evidence that the NAOMS methodology can provide a statistically sound basis for evaluating trends of incidents that could compromise safety. The approach and results are summarized in the report and supporting documentation and complete analyses of results are presented in 14 appendices.

Safety Assessment of Synthetic Fluorphlogopite as Used in Cosmetics.

PubMed

Becker, Lillian C; Bergfeld, Wilma F; Belsito, Donald V; Hill, Ronald A; Klaassen, Curtis D; Liebler, Daniel C; Marks, James G; Shank, Ronald C; Slaga, Thomas J; Snyder, Paul W; Andersen, F Alan

2015-01-01

The Cosmetic Ingredient Review Expert Panel (the Panel) reviewed the safety of synthetic fluorphlogopite as used in cosmetics. Synthetic fluorphlogopite functions as a bulking agent and a viscosity-increasing agent. The Panel reviewed available animal and human data related to this ingredient along with a previous safety assessment of other magnesium silicates. The Panel concluded that synthetic fluorphlogopite was safe as cosmetic ingredients in the practices of use and concentration as given in this safety assessment. © The Author(s) 2015.

A novel safety assessment strategy applied to non-selective extracts.

PubMed

Koster, Sander; Leeman, Winfried; Verheij, Elwin; Dutman, Ellen; van Stee, Leo; Nielsen, Lene Munch; Ronsmans, Stefan; Noteborn, Hub; Krul, Lisette

2015-06-01

A main challenge in food safety research is to demonstrate that processing of foodstuffs does not lead to the formation of substances for which the safety upon consumption might be questioned. This is especially so since food is a complex matrix in which the analytical detection of substances, and consequent risk assessment thereof, is difficult to determine. Here, a pragmatic novel safety assessment strategy is applied to the production of non-selective extracts (NSEs), used for different purposes in food such as for colouring purposes, which are complex food mixtures prepared from reference juices. The Complex Mixture Safety Assessment Strategy (CoMSAS) is an exposure driven approach enabling to efficiently assess the safety of the NSE by focussing on newly formed substances or substances that may increase in exposure during the processing of the NSE. CoMSAS enables to distinguish toxicologically relevant from toxicologically less relevant substances, when related to their respective levels of exposure. This will reduce the amount of work needed for identification, characterisation and safety assessment of unknown substances detected at low concentration, without the need for toxicity testing using animal studies. In this paper, the CoMSAS approach has been applied for elderberry and pumpkin NSEs used for food colouring purposes. Copyright © 2015 Elsevier Ltd. All rights reserved.

A literature review of safety culture.

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

Cole, Kerstan Suzanne; Stevens-Adams, Susan Marie; Wenner, Caren A.

2013-03-01

Workplace safety has been historically neglected by organizations in order to enhance profitability. Over the past 30 years, safety concerns and attention to safety have increased due to a series of disastrous events occurring across many different industries (e.g., Chernobyl, Upper Big-Branch Mine, Davis-Besse etc.). Many organizations have focused on promoting a healthy safety culture as a way to understand past incidents, and to prevent future disasters. There is an extensive academic literature devoted to safety culture, and the Department of Energy has also published a significant number of documents related to safety culture. The purpose of the current endeavormore » was to conduct a review of the safety culture literature in order to understand definitions, methodologies, models, and successful interventions for improving safety culture. After reviewing the literature, we observed four emerging themes. First, it was apparent that although safety culture is a valuable construct, it has some inherent weaknesses. For example, there is no common definition of safety culture and no standard way for assessing the construct. Second, it is apparent that researchers know how to measure particular components of safety culture, with specific focus on individual and organizational factors. Such existing methodologies can be leveraged for future assessments. Third, based on the published literature, the relationship between safety culture and performance is tenuous at best. There are few empirical studies that examine the relationship between safety culture and safety performance metrics. Further, most of these studies do not include a description of the implementation of interventions to improve safety culture, or do not measure the effect of these interventions on safety culture or performance. Fourth, safety culture is best viewed as a dynamic, multi-faceted overall system composed of individual, engineered and organizational models. By addressing all three

ARAMIS project: a comprehensive methodology for the identification of reference accident scenarios in process industries.

PubMed

Delvosalle, Christian; Fievez, Cécile; Pipart, Aurore; Debray, Bruno

2006-03-31

In the frame of the Accidental Risk Assessment Methodology for Industries (ARAMIS) project, this paper aims at presenting the work carried out in the part of the project devoted to the definition of accident scenarios. This topic is a key-point in risk assessment and serves as basis for the whole risk quantification. The first result of the work is the building of a methodology for the identification of major accident hazards (MIMAH), which is carried out with the development of generic fault and event trees based on a typology of equipment and substances. The term "major accidents" must be understood as the worst accidents likely to occur on the equipment, assuming that no safety systems are installed. A second methodology, called methodology for the identification of reference accident scenarios (MIRAS) takes into account the influence of safety systems on both the frequencies and possible consequences of accidents. This methodology leads to identify more realistic accident scenarios. The reference accident scenarios are chosen with the help of a tool called "risk matrix", crossing the frequency and the consequences of accidents. This paper presents both methodologies and an application on an ethylene oxide storage.

Climate change and landscape development in post-closure safety assessment of solid radioactive waste disposal: Results of an initiative of the IAEA.

PubMed

Lindborg, T; Thorne, M; Andersson, E; Becker, J; Brandefelt, J; Cabianca, T; Gunia, M; Ikonen, A T K; Johansson, E; Kangasniemi, V; Kautsky, U; Kirchner, G; Klos, R; Kowe, R; Kontula, A; Kupiainen, P; Lahdenperä, A-M; Lord, N S; Lunt, D J; Näslund, J-O; Nordén, M; Norris, S; Pérez-Sánchez, D; Proverbio, A; Riekki, K; Rübel, A; Sweeck, L; Walke, R; Xu, S; Smith, G; Pröhl, G

2018-03-01

The International Atomic Energy Agency has coordinated an international project addressing climate change and landscape development in post-closure safety assessments of solid radioactive waste disposal. The work has been supported by results of parallel on-going research that has been published in a variety of reports and peer reviewed journal articles. The project is due to be described in detail in a forthcoming IAEA report. Noting the multi-disciplinary nature of post-closure safety assessments, here, an overview of the work is given to provide researchers in the broader fields of radioecology and radiological safety assessment with a review of the work that has been undertaken. It is hoped that such dissemination will support and promote integrated understanding and coherent treatment of climate change and landscape development within an overall assessment process. The key activities undertaken in the project were: identification of the key processes that drive environmental change (mainly those associated with climate and climate change), and description of how a relevant future may develop on a global scale; development of a methodology for characterising environmental change that is valid on a global scale, showing how modelled global changes in climate can be downscaled to provide information that may be needed for characterising environmental change in site-specific assessments, and illustrating different aspects of the methodology in a number of case studies that show the evolution of site characteristics and the implications for the dose assessment models. Overall, the study has shown that quantitative climate and landscape modelling has now developed to the stage that it can be used to define an envelope of climate and landscape change scenarios at specific sites and under specific greenhouse-gas emissions assumptions that is suitable for use in quantitative post-closure performance assessments. These scenarios are not predictions of the future, but

Mine safety assessment using gray relational analysis and bow tie model

PubMed Central

2018-01-01

Mine safety assessment is a precondition for ensuring orderly and safety in production. The main purpose of this study was to prevent mine accidents more effectively by proposing a composite risk analysis model. First, the weights of the assessment indicators were determined by the revised integrated weight method, in which the objective weights were determined by a variation coefficient method and the subjective weights determined by the Delphi method. A new formula was then adopted to calculate the integrated weights based on the subjective and objective weights. Second, after the assessment indicator weights were determined, gray relational analysis was used to evaluate the safety of mine enterprises. Mine enterprise safety was ranked according to the gray relational degree, and weak links of mine safety practices identified based on gray relational analysis. Third, to validate the revised integrated weight method adopted in the process of gray relational analysis, the fuzzy evaluation method was used to the safety assessment of mine enterprises. Fourth, for first time, bow tie model was adopted to identify the causes and consequences of weak links and allow corresponding safety measures to be taken to guarantee the mine’s safe production. A case study of mine safety assessment was presented to demonstrate the effectiveness and rationality of the proposed composite risk analysis model, which can be applied to other related industries for safety evaluation. PMID:29561875

Methodological Quality Assessment of Meta-analyses in Endodontics.

PubMed

Kattan, Sereen; Lee, Su-Min; Kohli, Meetu R; Setzer, Frank C; Karabucak, Bekir

2018-01-01

The objectives of this review were to assess the methodological quality of published meta-analyses related to endodontics using the assessment of multiple systematic reviews (AMSTAR) tool and to provide a follow-up to previously published reviews. Three electronic databases were searched for eligible studies according to the inclusion and exclusion criteria: Embase via Ovid, The Cochrane Library, and Scopus. The electronic search was amended by a hand search of 6 dental journals (International Endodontic Journal; Journal of Endodontics; Australian Endodontic Journal; Oral Surgery, Oral Medicine, Oral Pathology, Oral Radiology; Endodontics and Dental Traumatology; and Journal of Dental Research). The searches were conducted to include articles published after July 2009, and the deadline for inclusion of the meta-analyses was November 30, 2016. The AMSTAR assessment tool was used to evaluate the methodological quality of all included studies. A total of 36 reports of meta-analyses were included. The overall quality of the meta-analyses reports was found to be medium, with an estimated mean overall AMSTAR score of 7.25 (95% confidence interval, 6.59-7.90). The most poorly assessed areas were providing an a priori design, the assessment of the status of publication, and publication bias. In recent publications in the field of endodontics, the overall quality of the reported meta-analyses is medium according to AMSTAR. Copyright © 2017 American Association of Endodontists. Published by Elsevier Inc. All rights reserved.

An integrated science-based methodology to assess potential ...

EPA Pesticide Factsheets

There is an urgent need for broad and integrated studies that address the risks of engineered nanomaterials (ENMs) along the different endpoints of the society, environment, and economy (SEE) complex adaptive system. This article presents an integrated science-based methodology to assess the potential risks of engineered nanomaterials. To achieve the study objective, two major tasks are accomplished, knowledge synthesis and algorithmic computational methodology. The knowledge synthesis task is designed to capture “what is known” and to outline the gaps in knowledge from ENMs risk perspective. The algorithmic computational methodology is geared toward the provision of decisions and an understanding of the risks of ENMs along different endpoints for the constituents of the SEE complex adaptive system. The approach presented herein allows for addressing the formidable task of assessing the implications and risks of exposure to ENMs, with the long term goal to build a decision-support system to guide key stakeholders in the SEE system towards building sustainable ENMs and nano-enabled products. The following specific aims are formulated to achieve the study objective: (1) to propose a system of systems (SoS) architecture that builds a network management among the different entities in the large SEE system to track the flow of ENMs emission, fate and transport from the source to the receptor; (2) to establish a staged approach for knowledge synthesis methodo

Safety Issues at the Defense Production Reactors. A Report to the U.S. Department of Energy.

ERIC Educational Resources Information Center

National Academy of Sciences - National Research Council, Washington, DC. Commission on Physical Sciences, Mathematics, and Resources.

This report provides an assessment of safety management, safety review, and safety methodology employed by the Department of Energy (DOE) and private contractors. Chapter 1, "The DOE Safety Framework," examines safety objectives for production reactors and processes to implement the objectives. Chapter 2, "Technical Issues,"…

A methodology for the assessment of manned flight simulator fidelity

NASA Technical Reports Server (NTRS)

Hess, Ronald A.; Malsbury, Terry N.

1989-01-01

A relatively simple analytical methodology for assessing the fidelity of manned flight simulators for specific vehicles and tasks is offered. The methodology is based upon an application of a structural model of the human pilot, including motion cue effects. In particular, predicted pilot/vehicle dynamic characteristics are obtained with and without simulator limitations. A procedure for selecting model parameters can be implemented, given a probable pilot control strategy. In analyzing a pair of piloting tasks for which flight and simulation data are available, the methodology correctly predicted the existence of simulator fidelity problems. The methodology permitted the analytical evaluation of a change in simulator characteristics and indicated that a major source of the fidelity problems was a visual time delay in the simulation.

The practice of pre-marketing safety assessment in drug development.

PubMed

Chuang-Stein, Christy; Xia, H Amy

2013-01-01

The last 15 years have seen a substantial increase in efforts devoted to safety assessment by statisticians in the pharmaceutical industry. While some of these efforts were driven by regulations and public demand for safer products, much of the motivation came from the realization that there is a strong need for a systematic approach to safety planning, evaluation, and reporting at the program level throughout the drug development life cycle. An efficient process can help us identify safety signals early and afford us the opportunity to develop effective risk minimization plan early in the development cycle. This awareness has led many pharmaceutical sponsors to set up internal systems and structures to effectively conduct safety assessment at all levels (patient, study, and program). In addition to process, tools have emerged that are designed to enhance data review and pattern recognition. In this paper, we describe advancements in the practice of safety assessment during the premarketing phase of drug development. In particular, we share examples of safety assessment practice at our respective companies, some of which are based on recommendations from industry-initiated working groups on best practice in recent years.

Simulation for Prediction of Entry Article Demise (SPEAD): An Analysis Tool for Spacecraft Safety Analysis and Ascent/Reentry Risk Assessment

NASA Technical Reports Server (NTRS)

Ling, Lisa

2014-01-01

For the purpose of performing safety analysis and risk assessment for a potential off-nominal atmospheric reentry resulting in vehicle breakup, a synthesis of trajectory propagation coupled with thermal analysis and the evaluation of node failure is required to predict the sequence of events, the timeline, and the progressive demise of spacecraft components. To provide this capability, the Simulation for Prediction of Entry Article Demise (SPEAD) analysis tool was developed. The software and methodology have been validated against actual flights, telemetry data, and validated software, and safety/risk analyses were performed for various programs using SPEAD. This report discusses the capabilities, modeling, validation, and application of the SPEAD analysis tool.

Bayesian-network-based safety risk assessment for steel construction projects.

PubMed

Leu, Sou-Sen; Chang, Ching-Miao

2013-05-01

There are four primary accident types at steel building construction (SC) projects: falls (tumbles), object falls, object collapse, and electrocution. Several systematic safety risk assessment approaches, such as fault tree analysis (FTA) and failure mode and effect criticality analysis (FMECA), have been used to evaluate safety risks at SC projects. However, these traditional methods ineffectively address dependencies among safety factors at various levels that fail to provide early warnings to prevent occupational accidents. To overcome the limitations of traditional approaches, this study addresses the development of a safety risk-assessment model for SC projects by establishing the Bayesian networks (BN) based on fault tree (FT) transformation. The BN-based safety risk-assessment model was validated against the safety inspection records of six SC building projects and nine projects in which site accidents occurred. The ranks of posterior probabilities from the BN model were highly consistent with the accidents that occurred at each project site. The model accurately provides site safety-management abilities by calculating the probabilities of safety risks and further analyzing the causes of accidents based on their relationships in BNs. In practice, based on the analysis of accident risks and significant safety factors, proper preventive safety management strategies can be established to reduce the occurrence of accidents on SC sites. Copyright © 2013 Elsevier Ltd. All rights reserved.

Risk-Informed Safety Assurance and Probabilistic Assessment of Mission-Critical Software-Intensive Systems

NASA Technical Reports Server (NTRS)

Guarro, Sergio B.

2010-01-01

This report validates and documents the detailed features and practical application of the framework for software intensive digital systems risk assessment and risk-informed safety assurance presented in the NASA PRA Procedures Guide for Managers and Practitioner. This framework, called herein the "Context-based Software Risk Model" (CSRM), enables the assessment of the contribution of software and software-intensive digital systems to overall system risk, in a manner which is entirely compatible and integrated with the format of a "standard" Probabilistic Risk Assessment (PRA), as currently documented and applied for NASA missions and applications. The CSRM also provides a risk-informed path and criteria for conducting organized and systematic digital system and software testing so that, within this risk-informed paradigm, the achievement of a quantitatively defined level of safety and mission success assurance may be targeted and demonstrated. The framework is based on the concept of context-dependent software risk scenarios and on the modeling of such scenarios via the use of traditional PRA techniques - i.e., event trees and fault trees - in combination with more advanced modeling devices such as the Dynamic Flowgraph Methodology (DFM) or other dynamic logic-modeling representations. The scenarios can be synthesized and quantified in a conditional logic and probabilistic formulation. The application of the CSRM method documented in this report refers to the MiniAERCam system designed and developed by the NASA Johnson Space Center.

Extended time-to-collision measures for road traffic safety assessment.

PubMed

Minderhoud, M M; Bovy, P H

2001-01-01

This article describes two new safety indicators based on the time-to-collision notion suitable for comparative road traffic safety analyses. Such safety indicators can be applied in the comparison of a do-nothing case with an adapted situation, e.g. the introduction of intelligent driver support systems. In contrast to the classical time-to-collision value, measured at a cross section, the improved safety indicators use vehicle trajectories collected over a specific time horizon for a certain roadway segment to calculate the overall safety indicator value. Vehicle-specific indicator values as well as safety-critical probabilities can easily be determined from the developed safety measures. Application of the derived safety indicators is demonstrated for the assessment of the potential safety impacts of driver support systems from which it appears that some Autonomous Intelligent Cruise Control (AICC) designs are more safety-critical than the reference case without these systems. It is suggested that the indicator threshold value to be applied in the safety assessment has to be adapted when advanced AICC-systems with safe characteristics are introduced.

Development of a Probabilistic Assessment Methodology for Evaluation of Carbon Dioxide Storage

USGS Publications Warehouse

Burruss, Robert A.; Brennan, Sean T.; Freeman, P.A.; Merrill, Matthew D.; Ruppert, Leslie F.; Becker, Mark F.; Herkelrath, William N.; Kharaka, Yousif K.; Neuzil, Christopher E.; Swanson, Sharon M.; Cook, Troy A.; Klett, Timothy R.; Nelson, Philip H.; Schenk, Christopher J.

2009-01-01

This report describes a probabilistic assessment methodology developed by the U.S. Geological Survey (USGS) for evaluation of the resource potential for storage of carbon dioxide (CO2) in the subsurface of the United States as authorized by the Energy Independence and Security Act (Public Law 110-140, 2007). The methodology is based on USGS assessment methodologies for oil and gas resources created and refined over the last 30 years. The resource that is evaluated is the volume of pore space in the subsurface in the depth range of 3,000 to 13,000 feet that can be described within a geologically defined storage assessment unit consisting of a storage formation and an enclosing seal formation. Storage assessment units are divided into physical traps (PTs), which in most cases are oil and gas reservoirs, and the surrounding saline formation (SF), which encompasses the remainder of the storage formation. The storage resource is determined separately for these two types of storage. Monte Carlo simulation methods are used to calculate a distribution of the potential storage size for individual PTs and the SF. To estimate the aggregate storage resource of all PTs, a second Monte Carlo simulation step is used to sample the size and number of PTs. The probability of successful storage for individual PTs or the entire SF, defined in this methodology by the likelihood that the amount of CO2 stored will be greater than a prescribed minimum, is based on an estimate of the probability of containment using present-day geologic knowledge. The report concludes with a brief discussion of needed research data that could be used to refine assessment methodologies for CO2 sequestration.

How to quantitatively evaluate safety of driver behavior upon accident? A biomechanical methodology

PubMed Central

Zhang, Wen; Cao, Jieer

2017-01-01

How to evaluate driver spontaneous reactions in various collision patterns in a quantitative way is one of the most important topics in vehicle safety. Firstly, this paper constructs representative numerical crash scenarios described by impact velocity, impact angle and contact position based on finite element (FE) computation platform. Secondly, a driver cabin model is extracted and described in the well validated multi-rigid body (MB) model to compute the value of weighted injury criterion to quantitatively assess drivers’ overall injury under certain circumstances. Furthermore, based on the coupling of FE and MB, parametric studies on various crash scenarios are conducted. It is revealed that the WIC (Weighted Injury Criteria) value variation law under high impact velocities is quite distinct comparing with the one in low impact velocities. In addition, the coupling effect can be elucidated by the fact that the difference of WIC value among three impact velocities under smaller impact angles tends to be distinctly higher than that under larger impact angles. Meanwhile, high impact velocity also increases the sensitivity of WIC under different collision positions and impact angles. Results may provide a new methodology to quantitatively evaluate driving behaviors and serve as a significant guiding step towards collision avoidance for autonomous driving vehicles. PMID:29240789

How to quantitatively evaluate safety of driver behavior upon accident? A biomechanical methodology.

PubMed

Zhang, Wen; Cao, Jieer; Xu, Jun

2017-01-01

How to evaluate driver spontaneous reactions in various collision patterns in a quantitative way is one of the most important topics in vehicle safety. Firstly, this paper constructs representative numerical crash scenarios described by impact velocity, impact angle and contact position based on finite element (FE) computation platform. Secondly, a driver cabin model is extracted and described in the well validated multi-rigid body (MB) model to compute the value of weighted injury criterion to quantitatively assess drivers' overall injury under certain circumstances. Furthermore, based on the coupling of FE and MB, parametric studies on various crash scenarios are conducted. It is revealed that the WIC (Weighted Injury Criteria) value variation law under high impact velocities is quite distinct comparing with the one in low impact velocities. In addition, the coupling effect can be elucidated by the fact that the difference of WIC value among three impact velocities under smaller impact angles tends to be distinctly higher than that under larger impact angles. Meanwhile, high impact velocity also increases the sensitivity of WIC under different collision positions and impact angles. Results may provide a new methodology to quantitatively evaluate driving behaviors and serve as a significant guiding step towards collision avoidance for autonomous driving vehicles.

Safety analysis and review system (SARS) assessment report

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

Browne, E.T.

1981-03-01

Under DOE Order 5481.1, Safety Analysis and Review System for DOE Operations, safety analyses are required for DOE projects in order to ensure that: (1) potential hazards are systematically identified; (2) potential impacts are analyzed; (3) reasonable measures have been taken to eliminate, control, or mitigate the hazards; and (4) there is documented management authorization of the DOE operation based on an objective assessment of the adequacy of the safety analysis. This report is intended to provide the DOE Office of Plans and Technology Assessment (OPTA) with an independent evaluation of the adequacy of the ongoing safety analysis effort. Asmore » part of this effort, a number of site visits and interviews were conducted, and FE SARS documents were reviewed. The latter included SARS Implementation Plans for a number of FE field offices, as well as safety analysis reports completed for certain FE operations. This report summarizes SARS related efforts at the DOE field offices visited and evaluates the extent to which they fulfill the requirements of DOE 5481.1.« less

Assessment of a French scenario with the INPRO methodology

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

Vasile, A.; Fiorini, G.L.; Cazalet, J.

2006-07-01

This paper presents the French contribution to the Joint Study of the IAEA International Project on Innovative Nuclear Reactors and Fuel Cycles (INPRO). It concerns the application of the INPRO methodology to a French scenario, on the transition from present LWRs to EPRs in a first phase and to 4. generation fast reactors in a second phase during the 21. century. The scenario also considers the renewal of the present fuel cycle facilities by the third and the fourth generation ones. Present practice of plutonium recycling in PWR is replaced by the middle of the century by a global recyclingmore » of actinides, uranium, plutonium and minor actinides in fast reactors. The status and the evolution of the INPRO criteria and the corresponding indicators during the studied period are analyzed for each of the six considered areas: economics, safety, environment, waste management, proliferation resistance and infrastructure. Improvements on economic and safety are expected for both the EPR and the 4. generation systems having these improvements among their basic goals. The use of fast reactors and global recycling of actinides leads to a significant improvement on environment indicators and in particular on the natural resources utilization. The envisaged waste management policy results in significant reductions on mass, thermal loads and radiotoxicity of the final waste which only contains fission products. The use of fuels that do not relay on enriched uranium and separated plutonium increases the proliferation resistance characteristics of the future fuel cycle. The paper summarizes also some recommendations on the data, codes and methods used to support the continuous improvement of the INPRO methodology and help future assessors. (authors)« less

Use of the Home Safety Self-Assessment Tool (HSSAT) within Community Health Education to Improve Home Safety.

PubMed

Horowitz, Beverly P; Almonte, Tiffany; Vasil, Andrea

2016-10-01

This exploratory research examined the benefits of a health education program utilizing the Home Safety Self-Assessment Tool (HSSAT) to increase perceived knowledge of home safety, recognition of unsafe activities, ability to safely perform activities, and develop home safety plans of 47 older adults. Focus groups in two senior centers explored social workers' perspectives on use of the HSSAT in community practice. Results for the health education program found significant differences between reported knowledge of home safety (p = .02), ability to recognize unsafe activities (p = .01), safely perform activities (p = .04), and develop a safety plan (p = .002). Social workers identified home safety as a major concern and the HSSAT a promising assessment tool. Research has implications for reducing environmental fall risks.

Regulatory and Safety Requirements for Food Cultures

PubMed Central

Laulund, Svend; Wind, Anette; Derkx, Patrick M. F.; Zuliani, Véronique

2017-01-01

The increased use of food cultures to ferment perishable raw materials has potentiated the need for regulations to assess and assure the safety of food cultures and their uses. These regulations differ from country to country, all aimed at assuring the safe use of food cultures which has to be guaranteed by the food culture supplier. Here we highlight national differences in regulations and review a list of methods and methodologies to assess the safety of food cultures at strain level, at production, and in the final product. PMID:28545249

[Agricultural biotechnology safety assessment].

PubMed

McClain, Scott; Jones, Wendelyn; He, Xiaoyun; Ladics, Gregory; Bartholomaeus, Andrew; Raybould, Alan; Lutter, Petra; Xu, Haibin; Wang, Xue

2015-01-01

Genetically modified (GM) crops were first introduced to farmers in 1995 with the intent to provide better crop yield and meet the increasing demand for food and feed. GM crops have evolved to include a thorough safety evaluation for their use in human food and animal feed. Safety considerations begin at the level of DNA whereby the inserted GM DNA is evaluated for its content, position and stability once placed into the crop genome. The safety of the proteins coded by the inserted DNA and potential effects on the crop are considered, and the purpose is to ensure that the transgenic novel proteins are safe from a toxicity, allergy, and environmental perspective. In addition, the grain that provides the processed food or animal feed is also tested to evaluate its nutritional content and identify unintended effects to the plant composition when warranted. To provide a platform for the safety assessment, the GM crop is compared to non-GM comparators in what is typically referred to as composition equivalence testing. New technologies, such as mass spectrometry and well-designed antibody-based methods, allow better analytical measurements of crop composition, including endogenous allergens. Many of the analytical methods and their intended uses are based on regulatory guidance documents, some of which are outlined in globally recognized documents such as Codex Alimentarius. In certain cases, animal models are recommended by some regulatory agencies in specific countries, but there is typically no hypothesis or justification of their use in testing the safety of GM crops. The quality and standardization of testing methods can be supported, in some cases, by employing good laboratory practices (GLP) and is recognized in China as important to ensure quality data. Although the number of recommended, in some cases, required methods for safety testing are increasing in some regulatory agencies, it should be noted that GM crops registered to date have been shown to be

Fault displacement hazard assessment for nuclear installations based on IAEA safety standards

NASA Astrophysics Data System (ADS)

Fukushima, Y.

2016-12-01

In the IAEA Safety NS-R-3, surface fault displacement hazard assessment (FDHA) is required for the siting of nuclear installations. If any capable faults exist in the candidate site, IAEA recommends the consideration of alternative sites. However, due to the progress in palaeoseismological investigations, capable faults may be found in existing site. In such a case, IAEA recommends to evaluate the safety using probabilistic FDHA (PFDHA), which is an empirical approach based on still quite limited database. Therefore a basic and crucial improvement is to increase the database. In 2015, IAEA produced a TecDoc-1767 on Palaeoseismology as a reference for the identification of capable faults. Another IAEA Safety Report 85 on ground motion simulation based on fault rupture modelling provides an annex introducing recent PFDHAs and fault displacement simulation methodologies. The IAEA expanded the project of FDHA for the probabilistic approach and the physics based fault rupture modelling. The first approach needs a refinement of the empirical methods by building a world wide database, and the second approach needs to shift from kinematic to the dynamic scheme. Both approaches can complement each other, since simulated displacement can fill the gap of a sparse database and geological observations can be useful to calibrate the simulations. The IAEA already supported a workshop in October 2015 to discuss the existing databases with the aim of creating a common worldwide database. A consensus of a unified database was reached. The next milestone is to fill the database with as many fault rupture data sets as possible. Another IAEA work group had a WS in November 2015 to discuss the state-of-the-art PFDHA as well as simulation methodologies. Two groups jointed a consultancy meeting in February 2016, shared information, identified issues, discussed goals and outputs, and scheduled future meetings. Now we may aim at coordinating activities for the whole FDHA tasks jointly.

Comprehensive safety management and assessment at rugby football competitions.

PubMed

Tajima, T; Chosa, E; Kawahara, K; Nakamura, Y; Yoshikawa, D; Yamaguchi, N; Kashiwagi, T

2014-11-01

The present study aims to improve medical systems by designing objective safety assessment criteria for rugby competitions. We evaluated 195 competitions between 2002 and 2011 using an original safety scale comprising the following sections: 1) competence of staff such as referees, medical attendants and match day doctor; 2) environment such as weather, wet bulb globe temperature and field conditions; and 3) emergency medical care systems at the competitions. Each section was subdivided into groups A, B and C according to good, normal or fair degrees of safety determined by combinations of the results.Overall safety was assessed as A, B and C for 110, 78 and 7 competitions, respectively. The assessments of individual major factors were mostly favorable for staff, but the environment and medical care systems were assessed as C in 25 and 70, respectively, of the 195 competitions. Medical management involves not having a match day doctor, but also comprehensive management including preventive factors and responses from the staff, environment and medical-care systems. 6 cases of severe injuries and accidents occurred between 2002 and 2011, which were observed in Grade A competition. These cases revealed better prognosis without obvious impairment, thus confirming the value of the present assessment scale. © Georg Thieme Verlag KG Stuttgart · New York.

Safety Assessment of Alkyl Esters as Used in Cosmetics.

PubMed

Fiume, Monice M; Heldreth, Bart A; Bergfeld, Wilma F; Belsito, Donald V; Hill, Ronald A; Klaassen, Curtis D; Liebler, Daniel C; Marks, James G; Shank, Ronald C; Slaga, Thomas J; Snyder, Paul W; Andersen, F Alan

2015-09-01

The Cosmetic Ingredient Review Expert Panel (Panel) assessed the safety of 237 alkyl esters for use in cosmetics. The alkyl esters included in this assessment have a variety of reported functions in cosmetics, with skin-conditioning agent being the most common function. The Panel reviewed available animal and clinical data in making its determination of safety on these ingredients, and where there were data gaps, similarity in structure, properties, functions, and uses of these ingredients allowed for extrapolation of the available toxicological data to assess the safety of the entire group. The Panel concluded that these ingredients are safe in cosmetic formulations in the present practices of use and concentration when formulated to be nonirritating. © The Author(s) 2015.

Safety assessment in plant layout design using indexing approach: implementing inherent safety perspective. Part 1 - guideword applicability and method description.

PubMed

Tugnoli, Alessandro; Khan, Faisal; Amyotte, Paul; Cozzani, Valerio

2008-12-15

Layout planning plays a key role in the inherent safety performance of process plants since this design feature controls the possibility of accidental chain-events and the magnitude of possible consequences. A lack of suitable methods to promote the effective implementation of inherent safety in layout design calls for the development of new techniques and methods. In the present paper, a safety assessment approach suitable for layout design in the critical early phase is proposed. The concept of inherent safety is implemented within this safety assessment; the approach is based on an integrated assessment of inherent safety guideword applicability within the constraints typically present in layout design. Application of these guidewords is evaluated along with unit hazards and control devices to quantitatively map the safety performance of different layout options. Moreover, the economic aspects related to safety and inherent safety are evaluated by the method. Specific sub-indices are developed within the integrated safety assessment system to analyze and quantify the hazard related to domino effects. The proposed approach is quick in application, auditable and shares a common framework applicable in other phases of the design lifecycle (e.g. process design). The present work is divided in two parts: Part 1 (current paper) presents the application of inherent safety guidelines in layout design and the index method for safety assessment; Part 2 (accompanying paper) describes the domino hazard sub-index and demonstrates the proposed approach with a case study, thus evidencing the introduction of inherent safety features in layout design.

10 CFR 851.21 - Hazard identification and assessment.

Code of Federal Regulations, 2012 CFR

2012-01-01

.... Procedures must include methods to: (1) Assess worker exposure to chemical, physical, biological, or safety..., biological, and safety workplace hazards using recognized exposure assessment and testing methodologies and... hazards and the established controls within 90 days after identifying such hazards. The Head of DOE Field...

10 CFR 851.21 - Hazard identification and assessment.

Code of Federal Regulations, 2010 CFR

2010-01-01

.... Procedures must include methods to: (1) Assess worker exposure to chemical, physical, biological, or safety..., biological, and safety workplace hazards using recognized exposure assessment and testing methodologies and... hazards and the established controls within 90 days after identifying such hazards. The Head of DOE Field...

10 CFR 851.21 - Hazard identification and assessment.

Code of Federal Regulations, 2011 CFR

2011-01-01

.... Procedures must include methods to: (1) Assess worker exposure to chemical, physical, biological, or safety..., biological, and safety workplace hazards using recognized exposure assessment and testing methodologies and... hazards and the established controls within 90 days after identifying such hazards. The Head of DOE Field...

NASA's post-Challenger safety program - Themes and thrusts

NASA Technical Reports Server (NTRS)

Rodney, G. A.

1988-01-01

The range of managerial, technical, and procedural initiatives implemented by NASA's post-Challenger safety program is reviewed. The recommendations made by the Rogers Commission, the NASA post-Challenger review of Shuttle design, the Congressional investigation of the accident, the National Research Council, the Aerospace Safety Advisory Panel, and NASA internal advisory panels and studies are summarized. NASA safety initiatives regarding improved organizational accountability for safety, upgraded analytical techniques and methodologies for risk assessment and management, procedural initiatives in problem reporting and corrective-action tracking, ground processing, maintenance documentation, and improved technologies are discussed. Safety issues relevant to the planned Space Station are examined.

Assessing the relationship between patient safety culture and EHR strategy.

PubMed

Ford, Eric W; Silvera, Geoffrey A; Kazley, Abby S; Diana, Mark L; Huerta, Timothy R

2016-07-11

Purpose - The purpose of this paper is to explore the relationship between hospitals' electronic health record (EHR) adoption characteristics and their patient safety cultures. The "Meaningful Use" (MU) program is designed to increase hospitals' adoption of EHR, which will lead to better care quality, reduce medical errors, avoid unnecessary cost, and promote a patient safety culture. To reduce medical errors, hospital leaders have been encouraged to promote safety cultures common to high-reliability organizations. Expecting a positive relationship between EHR adoption and improved patient safety cultures appears sound in theory, but it has yet to be empirically demonstrated. Design/methodology/approach - Providers' perceptions of patient safety culture and counts of patient safety incidents are explored in relationship to hospital EHR adoption patterns. Multi-level modeling is employed to data drawn from the Agency for Healthcare Research and Quality's surveys on patient safety culture (level 1) and the American Hospital Association's survey and healthcare information technology supplement (level 2). Findings - The findings suggest that the early adoption of EHR capabilities hold a negative association to the number of patient safety events reported. However, this relationship was not present in providers' perceptions of overall patient safety cultures. These mixed results suggest that the understanding of the EHR-patient safety culture relationship needs further research. Originality/value - Relating EHR MU and providers' care quality attitudes is an important leading indicator for improved patient safety cultures. For healthcare facility managers and providers, the ability to effectively quantify the impact of new technologies on efforts to change organizational cultures is important for pinpointing clinical areas for process improvements.

Safety Assessment of Pentaerythrityl Tetraesters as Used in Cosmetics.

PubMed

Becker, Lillian C; Bergfeld, Wilma F; Belsito, Donald V; Hill, Ronald A; Klaassen, Curtis D; Liebler, Daniel C; Marks, James G; Shank, Ronald C; Slaga, Thomas J; Snyder, Paul W; Andersen, F Alan

2015-09-01

The Cosmetic Ingredient Review (CIR) Expert Panel (Panel) reviewed the safety of 16 pentaerythrityl tetraester compounds as used in cosmetics. These ingredients mostly function as hair-conditioning agents, skin-conditioning agents-miscellaneous and binders, skin-conditioning agents-occlusive, viscosity-increasing agents-nonaqueous, and skin-conditioning agents-emollient. The Panel reviewed the available animal and human data related to these ingredients and previous safety assessments of the fatty acid moieties. The Panel concluded that pentaerythrityl tetraisostearate and the other pentaerythrityl tetraester compounds were safe in the practices of use and concentration as given in this safety assessment. © The Author(s) 2015.

[Demonstrating patient safety requires acceptance of a broader scientific palette].

PubMed

Leistikow, I

2017-01-01

It is high time the medical community recognised that patient-safety research can be assessed using other scientific methods than the traditional medical ones. There is often a fundamental mismatch between the methodology of patient-safety research and the methodology used to assess the quality of this research. One example is research into the reliability and validity of record review as a method for detecting adverse events. This type of research is based on logical positivism, while record review itself is based on social constructivism. Record review does not lead to "one truth": adverse events are not measured on the basis of the records themselves, but by weighing the probability of certain situations being classifiable as adverse events. Healthcare should welcome behavioural and social sciences to its scientific palette. Restricting ourselves to the randomised control trial paradigm is short-sighted and dangerous; it deprives patients of much-needed improvements in safety.

A methodology for overall consequence modeling in chemical industry.

PubMed

Arunraj, N S; Maiti, J

2009-09-30

Risk assessment in chemical process industry is a very important issue for safeguarding human and the ecosystem from damages caused to them. Consequence assessment is an integral part of risk assessment. However, the commonly used consequence estimation methods involve time-consuming complex mathematical models and simple assimilation of losses without considering all the consequence factors. This lead to the deterioration of quality of estimated risk value. So, the consequence modeling has to be performed in detail considering all major losses with optimal time to improve the decisive value of risk. The losses can be broadly categorized into production loss, assets loss, human health and safety loss, and environment loss. In this paper, a conceptual framework is developed to assess the overall consequence considering all the important components of major losses. Secondly, a methodology is developed for the calculation of all the major losses, which are normalized to yield the overall consequence. Finally, as an illustration, the proposed methodology is applied to a case study plant involving benzene extraction. The case study result using the proposed consequence assessment scheme is compared with that from the existing methodologies.

DEVELOPMENT OF RISK ASSESSMENT METHODOLOGY FOR MUNICIPAL SLUDGE INCINERATION

EPA Science Inventory

This is one of a series of reports that present methodologies for assessing the potential risks to humans or other organisms from the disposal or reuse of municipal sludge. he sludge management practices addressed by this series include land application practices, distribution an...

DEVELOPMENT OF RISK ASSESSMENT METHODOLOGY FOR MUNICIPAL SLUDGE LANDFILLING

EPA Science Inventory

This is one of a series of reports that present methodologies for assessing the potential risks to humans or other organisms from the disposal or reuse of municipal sludge. he sludge management practices addressed by this series include land application practices, distribution an...

Processes of technology assessment: The National Transportation Safety Board

NASA Technical Reports Server (NTRS)

Weiss, E.

1972-01-01

The functions and operations of the Safety Board as related to technology assessment are described, and a brief history of the Safety Board is given. Recommendations made for safety in all areas of transportation and the actions taken are listed. Although accident investigation is an important aspect of NTSB's activity, it is felt that the greatest contribution is in pressing for development of better accident prevention programs. Efforts of the Safety Board in changing transportation technology to improve safety and prevent accidents are illustrated.

Multi-scale landslide hazard assessment: Advances in global and regional methodologies

NASA Astrophysics Data System (ADS)

Kirschbaum, Dalia; Peters-Lidard, Christa; Adler, Robert; Hong, Yang

2010-05-01

The increasing availability of remotely sensed surface data and precipitation provides a unique opportunity to explore how smaller-scale landslide susceptibility and hazard assessment methodologies may be applicable at larger spatial scales. This research first considers an emerging satellite-based global algorithm framework, which evaluates how the landslide susceptibility and satellite derived rainfall estimates can forecast potential landslide conditions. An analysis of this algorithm using a newly developed global landslide inventory catalog suggests that forecasting errors are geographically variable due to improper weighting of surface observables, resolution of the current susceptibility map, and limitations in the availability of landslide inventory data. These methodological and data limitation issues can be more thoroughly assessed at the regional level, where available higher resolution landslide inventories can be applied to empirically derive relationships between surface variables and landslide occurrence. The regional empirical model shows improvement over the global framework in advancing near real-time landslide forecasting efforts; however, there are many uncertainties and assumptions surrounding such a methodology that decreases the functionality and utility of this system. This research seeks to improve upon this initial concept by exploring the potential opportunities and methodological structure needed to advance larger-scale landslide hazard forecasting and make it more of an operational reality. Sensitivity analysis of the surface and rainfall parameters in the preliminary algorithm indicates that surface data resolution and the interdependency of variables must be more appropriately quantified at local and regional scales. Additionally, integrating available surface parameters must be approached in a more theoretical, physically-based manner to better represent the physical processes underlying slope instability and landslide initiation

An integrated quality function deployment and capital budgeting methodology for occupational safety and health as a systems thinking approach: the case of the construction industry.

PubMed

Bas, Esra

2014-07-01

In this paper, an integrated methodology for Quality Function Deployment (QFD) and a 0-1 knapsack model is proposed for occupational safety and health as a systems thinking approach. The House of Quality (HoQ) in QFD methodology is a systematic tool to consider the inter-relationships between two factors. In this paper, three HoQs are used to consider the interrelationships between tasks and hazards, hazards and events, and events and preventive/protective measures. The final priority weights of events are defined by considering their project-specific preliminary weights, probability of occurrence, and effects on the victim and the company. The priority weights of the preventive/protective measures obtained in the last HoQ are fed into a 0-1 knapsack model for the investment decision. Then, the selected preventive/protective measures can be adapted to the task design. The proposed step-by-step methodology can be applied to any stage of a project to design the workplace for occupational safety and health, and continuous improvement for safety is endorsed by the closed loop characteristic of the integrated methodology. Copyright © 2013 Elsevier Ltd. All rights reserved.

Safety Assessment of Talc as Used in Cosmetics.

PubMed

Fiume, Monice M; Boyer, Ivan; Bergfeld, Wilma F; Belsito, Donald V; Hill, Ronald A; Klaassen, Curtis D; Liebler, Daniel C; Marks, James G; Shank, Ronald C; Slaga, Thomas J; Snyder, Paul W; Andersen, F Alan

2015-01-01

The Cosmetic Ingredient Review Expert Panel (Panel) assessed the safety of talc for use in cosmetics. The safety of talc has been the subject of much debate through the years, partly because the relationship between talc and asbestos is commonly misunderstood. Industry specifications state that cosmetic-grade talc must contain no detectable fibrous, asbestos minerals. Therefore, the large amount of available animal and clinical data the Panel relied on in assessing the safety of talc only included those studies on talc that did not contain asbestos. The Panel concluded that talc is safe for use in cosmetics in the present practices of use and concentration (some cosmetic products are entirely composed of talc). Talc should not be applied to the skin when the epidermal barrier is missing or significantly disrupted. © The Author(s) 2015.

Adaptation of the ToxRTool to Assess the Reliability of Toxicology Studies Conducted with Genetically Modified Crops and Implications for Future Safety Testing.

PubMed

Koch, Michael S; DeSesso, John M; Williams, Amy Lavin; Michalek, Suzanne; Hammond, Bruce

2016-01-01

To determine the reliability of food safety studies carried out in rodents with genetically modified (GM) crops, a Food Safety Study Reliability Tool (FSSRTool) was adapted from the European Centre for the Validation of Alternative Methods' (ECVAM) ToxRTool. Reliability was defined as the inherent quality of the study with regard to use of standardized testing methodology, full documentation of experimental procedures and results, and the plausibility of the findings. Codex guidelines for GM crop safety evaluations indicate toxicology studies are not needed when comparability of the GM crop to its conventional counterpart has been demonstrated. This guidance notwithstanding, animal feeding studies have routinely been conducted with GM crops, but their conclusions on safety are not always consistent. To accurately evaluate potential risks from GM crops, risk assessors need clearly interpretable results from reliable studies. The development of the FSSRTool, which provides the user with a means of assessing the reliability of a toxicology study to inform risk assessment, is discussed. Its application to the body of literature on GM crop food safety studies demonstrates that reliable studies report no toxicologically relevant differences between rodents fed GM crops or their non-GM comparators.

76 FR 74723 - New Car Assessment Program (NCAP); Safety Labeling

Federal Register 2010, 2011, 2012, 2013, 2014

2011-12-01

... DEPARTMENT OF TRANSPORTATION National Highway Traffic Safety Administration 49 CFR Part 575 [Docket No. NHTSA 2010-0025] RIN 2127-AK51 New Car Assessment Program (NCAP); Safety Labeling AGENCY: National Highway Traffic Safety Administration (NHTSA), Department of Transportation (DOT). ACTION...

High-Throughput Toxicity Testing: New Strategies for Assessing Chemical Safety

EPA Science Inventory

In recent years, the food industry has made progress in improving safety testing methods focused on microbial contaminants in order to promote food safety. However, food industry toxicologists must also assess the safety of food-relevant chemicals including pesticides, direct add...

An open-label pilot study to assess the efficacy and safety of virgin coconut oil in reducing visceral adiposity.

PubMed

Liau, Kai Ming; Lee, Yeong Yeh; Chen, Chee Keong; Rasool, Aida Hanum G

2011-01-01

Introduction. This is an open-label pilot study on four weeks of virgin coconut oil (VCO) to investigate its efficacy in weight reduction and its safety of use in 20 obese but healthy Malay volunteers. Methodology. Efficacy was assessed by measuring weight and associated anthropometric parameters and lipid profile one week before and one week after VCO intake. Safety was assessed by comparing organ function tests one week before and one week after intake of VCO. Paired t-test was used to analyse any differences in all the measurable variables. Results. Only waist circumference (WC) was significantly reduced with a mean reduction of 2.86 cm or 0.97% from initial measurement (P = .02). WC reduction was only seen in males (P < .05). There was no change in the lipid profile. There was a small reduction in creatinine and alanine transferase levels. Conclusion. VCO is efficacious for WC reduction especially in males and it is safe for use in humans.

An Open-Label Pilot Study to Assess the Efficacy and Safety of Virgin Coconut Oil in Reducing Visceral Adiposity

PubMed Central

Liau, Kai Ming; Lee, Yeong Yeh; Chen, Chee Keong; Rasool, Aida Hanum G.

2011-01-01

Introduction. This is an open-label pilot study on four weeks of virgin coconut oil (VCO) to investigate its efficacy in weight reduction and its safety of use in 20 obese but healthy Malay volunteers. Methodology. Efficacy was assessed by measuring weight and associated anthropometric parameters and lipid profile one week before and one week after VCO intake. Safety was assessed by comparing organ function tests one week before and one week after intake of VCO. Paired t-test was used to analyse any differences in all the measurable variables. Results. Only waist circumference (WC) was significantly reduced with a mean reduction of 2.86 cm or 0.97% from initial measurement (P = .02). WC reduction was only seen in males (P < .05). There was no change in the lipid profile. There was a small reduction in creatinine and alanine transferase levels. Conclusion. VCO is efficacious for WC reduction especially in males and it is safe for use in humans. PMID:22164340

Assessment of Safety Standards for Automotive Electronic Control Systems

DOT National Transportation Integrated Search

2016-06-01

This report summarizes the results of a study that assessed and compared six industry and government safety standards relevant to the safety and reliability of automotive electronic control systems. These standards include ISO 26262 (Road Vehicles - ...

Why the Eurocontrol Safety Regulation Commission Policy on Safety Nets and Risk Assessment is Wrong

NASA Astrophysics Data System (ADS)

Brooker, Peter

2004-05-01

Current Eurocontrol Safety Regulation Commission (SRC) policy says that the Air Traffic Management (ATM) system (including safety minima) must be demonstrated through risk assessments to meet the Target Level of Safety (TLS) without needing to take safety nets (such as Short Term Conflict Alert) into account. This policy is wrong. The policy is invalid because it does not build rationally and consistently from ATM's firm foundations of TLS and hazard analysis. The policy is bad because it would tend to retard safety improvements. Safety net policy must rest on a clear and rational treatment of integrated ATM system safety defences. A new safety net policy, appropriate to safe ATM system improvements, is needed, which recognizes that safety nets are an integrated part of ATM system defences. The effects of safety nets in reducing deaths from mid-air collisions should be fully included in hazard analysis and safety audits in the context of the TLS for total system design.

RiskSOAP: Introducing and applying a methodology of risk self-awareness in road tunnel safety.

PubMed

Chatzimichailidou, Maria Mikela; Dokas, Ioannis M

2016-05-01

Complex socio-technical systems, such as road tunnels, can be designed and developed with more or less elements that can either positively or negatively affect the capability of their agents to recognise imminent threats or vulnerabilities that possibly lead to accidents. This capability is called risk Situation Awareness (SA) provision. Having as a motive the introduction of better tools for designing and developing systems that are self-aware of their vulnerabilities and react to prevent accidents and losses, this paper introduces the Risk Situation Awareness Provision (RiskSOAP) methodology to the field of road tunnel safety, as a means to measure this capability in this kind of systems. The main objective is to test the soundness and the applicability of RiskSOAP to infrastructure, which is advanced in terms of technology, human integration, and minimum number of safety requirements imposed by international bodies. RiskSOAP is applied to a specific road tunnel in Greece and the accompanying indicator is calculated twice, once for the tunnel design as defined by updated European safety standards and once for the 'as-is' tunnel composition, which complies with the necessary safety requirements, but calls for enhancing safety according to what EU and PIARC further suggest. The derived values indicate the extent to which each tunnel version is capable of comprehending its threats and vulnerabilities based on its elements. The former tunnel version seems to be more enhanced both in terms of it risk awareness capability and safety as well. Another interesting finding is that despite the advanced tunnel safety specifications, there is still room for enriching the safe design and maintenance of the road tunnel. Copyright © 2016 Elsevier Ltd. All rights reserved.

Safety Sufficiency for NextGen: Assessment of Selected Existing Safety Methods, Tools, Processes, and Regulations

NASA Technical Reports Server (NTRS)

Xu, Xidong; Ulrey, Mike L.; Brown, John A.; Mast, James; Lapis, Mary B.

2013-01-01

NextGen is a complex socio-technical system and, in many ways, it is expected to be more complex than the current system. It is vital to assess the safety impact of the NextGen elements (technologies, systems, and procedures) in a rigorous and systematic way and to ensure that they do not compromise safety. In this study, the NextGen elements in the form of Operational Improvements (OIs), Enablers, Research Activities, Development Activities, and Policy Issues were identified. The overall hazard situation in NextGen was outlined; a high-level hazard analysis was conducted with respect to multiple elements in a representative NextGen OI known as OI-0349 (Automation Support for Separation Management); and the hazards resulting from the highly dynamic complexity involved in an OI-0349 scenario were illustrated. A selected but representative set of the existing safety methods, tools, processes, and regulations was then reviewed and analyzed regarding whether they are sufficient to assess safety in the elements of that OI and ensure that safety will not be compromised and whether they might incur intolerably high costs.

A methodology for urban flood resilience assessment

NASA Astrophysics Data System (ADS)

Lhomme, Serge; Serre, Damien; Diab, Youssef; Laganier, Richard

2010-05-01

In Europe, river floods have been increasing in frequency and severity [Szöllösi-Nagy and Zevenbergen, 2005]. Moreover, climate change is expected to exacerbate the frequency and intensity of hydro meteorological disaster [IPCC, 2007]. Despite efforts made to maintain the flood defense assets, we often observe levee failures leading to finally increase flood risk in protected area. Furthermore, flood forecasting models, although benefiting continuous improvements, remain partly inaccurate due to uncertainties arising all along data calculation processes. In the same time, the year 2007 marks a turning point in history: half of the world population now lives in cities (UN-Habitat, 2007). Moreover, the total urban population is expected to double from two to four billion over the next 30 to 35 years (United Nations, 2006). This growing rate is equivalent to the creation of a new city of one million inhabitants every week, and this during the next four decades [Flood resilience Group]. So, this quick urban development coupled with technical failures and climate change have increased flood risk and corresponding challenges to urban flood risk management [Ashley et al., 2007], [Nie et al., 2009]. These circumstances oblige to manage flood risk by integrating new concepts like urban resilience. In recent years, resilience has become a central concept for risk management. This concept has emerged because a more resilient system is less vulnerable to risk and, therefore, more sustainable [Serre et al., 2010]. But urban flood resilience is a concept that has not yet been directly assessed. Therefore, when decision makers decide to use the resilience concept to manage urban flood, they have no tool to help them. That is why this paper proposes a methodology to assess urban flood resilience in order to make this concept operational. Networks affect the well-being of the people and the smooth functioning of services and, more generally, of economical activities. Yet

Assessing importance and satisfaction judgments of intermodal work commuters with electronic survey methodology.

DOT National Transportation Integrated Search

2013-09-01

Recent advances in multivariate methodology provide an opportunity to further the assessment of service offerings in public transportation for work commuting. We offer methodologies that are alternative to direct rating scale and have advantages in t...

Development of AMSTAR: a measurement tool to assess the methodological quality of systematic reviews.

PubMed

Shea, Beverley J; Grimshaw, Jeremy M; Wells, George A; Boers, Maarten; Andersson, Neil; Hamel, Candyce; Porter, Ashley C; Tugwell, Peter; Moher, David; Bouter, Lex M

2007-02-15

Our objective was to develop an instrument to assess the methodological quality of systematic reviews, building upon previous tools, empirical evidence and expert consensus. A 37-item assessment tool was formed by combining 1) the enhanced Overview Quality Assessment Questionnaire (OQAQ), 2) a checklist created by Sacks, and 3) three additional items recently judged to be of methodological importance. This tool was applied to 99 paper-based and 52 electronic systematic reviews. Exploratory factor analysis was used to identify underlying components. The results were considered by methodological experts using a nominal group technique aimed at item reduction and design of an assessment tool with face and content validity. The factor analysis identified 11 components. From each component, one item was selected by the nominal group. The resulting instrument was judged to have face and content validity. A measurement tool for the 'assessment of multiple systematic reviews' (AMSTAR) was developed. The tool consists of 11 items and has good face and content validity for measuring the methodological quality of systematic reviews. Additional studies are needed with a focus on the reproducibility and construct validity of AMSTAR, before strong recommendations can be made on its use.

Geoelectrical Methods and Monitoring for Dam Safety Assessment, Republic of Korea

NASA Astrophysics Data System (ADS)

Lim, S. K.; Oldenburg, D.; Kang, S.; Song, S. H.

2016-12-01

Geoelectrical methods and monitoring to detect the seepage and internal erosion are essential for the safety assessment of earth dams. This work aims to develop improved methodologies to analyze the observed data and to monitor changes in seepage flow using direct current (DC) and self-potential (SP) methods. The seasonal variation of water level at dams causes a change in seepage and water saturation and hence alters the resistivity of the dam material. DC data are sensitive to water saturation and hence changes in saturation can be obtained by repeatedly measuring DC data. However, a more diagnostic parameter for safety assessment is fluid flow, and resistivity is only weakly coupled to that. Fortunately SP signals are directly related to fluid flow, and thus an SP survey has the potential to characterize fluid flow through the earth matrix. In Korea, the safety assessment of earth fill dams has been dealt by Korea Rural Community Corporation (KRC). Most of the dams are relatively old ( >50 years), hence assessing deterioration and corresponding seepage of those dams are crucial. In order to evaluate the engineering geological properties of the soil at earth dams in Korea, two boreholes in each dam were drilled to a bedrock depth that exceeds the height of the dam. A large set of field tests, including standard penetration tests (SPT) and in-situ permeability tests, were carried out along the boreholes. However, seepage paths in the dam is complex hence those limited measurements at a few points is not sufficient to delineate the zone of preferential seepage flow. For this, KRC developed permanent DC monitoring systems at a number of agricultural dams in Korea. The data were automatically collected every 6 hours. During the monitoring, the measurements of the water level at two boreholes were gathered at the same time. In this presentation we select an agricultural dam and delineate an anomalous leakage zone by inverting and interpreting time-lapse DC resistivity

Measuring Best Practices for Workplace Safety, Health, and Well-Being: The Workplace Integrated Safety and Health Assessment.

PubMed

Sorensen, Glorian; Sparer, Emily; Williams, Jessica A R; Gundersen, Daniel; Boden, Leslie I; Dennerlein, Jack T; Hashimoto, Dean; Katz, Jeffrey N; McLellan, Deborah L; Okechukwu, Cassandra A; Pronk, Nicolaas P; Revette, Anna; Wagner, Gregory R

2018-05-01

To present a measure of effective workplace organizational policies, programs, and practices that focuses on working conditions and organizational facilitators of worker safety, health and well-being: the workplace integrated safety and health (WISH) assessment. Development of this assessment used an iterative process involving a modified Delphi method, extensive literature reviews, and systematic cognitive testing. The assessment measures six core constructs identified as central to best practices for protecting and promoting worker safety, health and well-being: leadership commitment; participation; policies, programs, and practices that foster supportive working conditions; comprehensive and collaborative strategies; adherence to federal and state regulations and ethical norms; and data-driven change. The WISH Assessment holds promise as a tool that may inform organizational priority setting and guide research around causal pathways influencing implementation and outcomes related to these approaches.

NASA Aviation Safety Program Systems Analysis/Program Assessment Metrics Review

NASA Technical Reports Server (NTRS)

Louis, Garrick E.; Anderson, Katherine; Ahmad, Tisan; Bouabid, Ali; Siriwardana, Maya; Guilbaud, Patrick

2003-01-01

The goal of this project is to evaluate the metrics and processes used by NASA's Aviation Safety Program in assessing technologies that contribute to NASA's aviation safety goals. There were three objectives for reaching this goal. First, NASA's main objectives for aviation safety were documented and their consistency was checked against the main objectives of the Aviation Safety Program. Next, the metrics used for technology investment by the Program Assessment function of AvSP were evaluated. Finally, other metrics that could be used by the Program Assessment Team (PAT) were identified and evaluated. This investigation revealed that the objectives are in fact consistent across organizational levels at NASA and with the FAA. Some of the major issues discussed in this study which should be further investigated, are the removal of the Cost and Return-on-Investment metrics, the lack of the metrics to measure the balance of investment and technology, the interdependencies between some of the metric risk driver categories, and the conflict between 'fatal accident rate' and 'accident rate' in the language of the Aviation Safety goal as stated in different sources.

Sources of Safety Data and Statistical Strategies for Design and Analysis: Transforming Data Into Evidence.

PubMed

Ma, Haijun; Russek-Cohen, Estelle; Izem, Rima; Marchenko, Olga V; Jiang, Qi

2018-03-01

Safety evaluation is a key aspect of medical product development. It is a continual and iterative process requiring thorough thinking, and dedicated time and resources. In this article, we discuss how safety data are transformed into evidence to establish and refine the safety profile of a medical product, and how the focus of safety evaluation, data sources, and statistical methods change throughout a medical product's life cycle. Some challenges and statistical strategies for medical product safety evaluation are discussed. Examples of safety issues identified in different periods, that is, premarketing and postmarketing, are discussed to illustrate how different sources are used in the safety signal identification and the iterative process of safety assessment. The examples highlighted range from commonly used pediatric vaccine given to healthy children to medical products primarily used to treat a medical condition in adults. These case studies illustrate that different products may require different approaches, and once a signal is discovered, it could impact future safety assessments. Many challenges still remain in this area despite advances in methodologies, infrastructure, public awareness, international harmonization, and regulatory enforcement. Innovations in safety assessment methodologies are pressing in order to make the medical product development process more efficient and effective, and the assessment of medical product marketing approval more streamlined and structured. Health care payers, providers, and patients may have different perspectives when weighing in on clinical, financial and personal needs when therapies are being evaluated.

[Methodological aspects of the assessment of phytotoxicic properties of ice-melter reagents].

PubMed

Sbitnev, A V; Vodianova, M A; Kriatov, I A; Donerian, L G; Evseeva, I S; Ushakova, O V; Ushakov, D I; Matveeva, I S; Rodionova, O M

One of the main criteria which determine the possibility of the use of a particular type of ice-melter reagents (IMR) is the degree of their safety for the environment and human health, which is reflected in the establishment of safe doses and concentrations. In this regard, the current area of research is to improve the ecological and epidemiological principles of risk assessment of modern types of anti-icing agents. Currently available data concerning monitoring soil studies and the snow held in various cities of Russia, show that there is a process of accumulation of the main components of IMR - sodium and chlorine ions in the areas related to the roadway. The article is designated a problem of existing methodological approaches to the assessment of the phytotoxic impact in the investigation of anti-icing agents in the laboratory. There was executed the comparative characteristics of the results of the preliminary pilot studies on the phytotoxic properties of IMR under using different substrates for germination of seeds - soil and filter paper. The data obtained are characterized by differences in the degree of phytotoxic action of the same species depending upon ice-melter reagents methodical setting circuit laboratory experiment. As a result, there was shown the imperfection of the existing method of rapid analysis in relation to ice-melter materials (IMM).

A Predictive Safety Management System Software Package Based on the Continuous Hazard Tracking and Failure Prediction Methodology

NASA Technical Reports Server (NTRS)

Quintana, Rolando

2003-01-01

The goal of this research was to integrate a previously validated and reliable safety model, called Continuous Hazard Tracking and Failure Prediction Methodology (CHTFPM), into a software application. This led to the development of a safety management information system (PSMIS). This means that the theory or principles of the CHTFPM were incorporated in a software package; hence, the PSMIS is referred to as CHTFPM management information system (CHTFPM MIS). The purpose of the PSMIS is to reduce the time and manpower required to perform predictive studies as well as to facilitate the handling of enormous quantities of information in this type of studies. The CHTFPM theory encompasses the philosophy of looking at the concept of safety engineering from a new perspective: from a proactive, than a reactive, viewpoint. That is, corrective measures are taken before a problem instead of after it happened. That is why the CHTFPM is a predictive safety because it foresees or anticipates accidents, system failures and unacceptable risks; therefore, corrective action can be taken in order to prevent all these unwanted issues. Consequently, safety and reliability of systems or processes can be further improved by taking proactive and timely corrective actions.

Development and application of the Safe Performance Index as a risk-based methodology for identifying major hazard-related safety issues in underground coal mines

NASA Astrophysics Data System (ADS)

Kinilakodi, Harisha

The underground coal mining industry has been under constant watch due to the high risk involved in its activities, and scrutiny increased because of the disasters that occurred in 2006-07. In the aftermath of the incidents, the U.S. Congress passed the Mine Improvement and New Emergency Response Act of 2006 (MINER Act), which strengthened the existing regulations and mandated new laws to address the various issues related to a safe working environment in the mines. Risk analysis in any form should be done on a regular basis to tackle the possibility of unwanted major hazard-related events such as explosions, outbursts, airbursts, inundations, spontaneous combustion, and roof fall instabilities. One of the responses by the Mine Safety and Health Administration (MSHA) in 2007 involved a new pattern of violations (POV) process to target mines with a poor safety performance, specifically to improve their safety. However, the 2010 disaster (worst in 40 years) gave an impression that the collective effort of the industry, federal/state agencies, and researchers to achieve the goal of zero fatalities and serious injuries has gone awry. The Safe Performance Index (SPI) methodology developed in this research is a straight-forward, effective, transparent, and reproducible approach that can help in identifying and addressing some of the existing issues while targeting (poor safety performance) mines which need help. It combines three injury and three citation measures that are scaled to have an equal mean (5.0) in a balanced way with proportionate weighting factors (0.05, 0.15, 0.30) and overall normalizing factor (15) into a mine safety performance evaluation tool. It can be used to assess the relative safety-related risk of mines, including by mine-size category. Using 2008 and 2009 data, comparisons were made of SPI-associated, normalized safety performance measures across mine-size categories, with emphasis on small-mine safety performance as compared to large- and

Methodological proposal for occupational health and safety actions in research laboratories with nanotechnologies activities.

PubMed

Andrade, Luís Renato Balbão; Amaral, Fernando Gonçalves

2012-01-01

Nanotechnologies is a multidisciplinary set of techniques to manipulate matter on nanoscale level, more precisely particles below 100 nm whose characteristic due to small size is essentially different from those found in macro form materials. Regarding to these new properties of the materials there are knowledge gaps about the effects of these particles on human organism and the environment. Although it still being considered emerging technology it is growing increasingly fast as well as the number of products using nanotechnologies in some production level and so the number of researchers involved with the subject. Given this scenario and based on literature related, a comprehensive methodology for health and safety at work for researching laboratories with activities in nanotechnologies was developed, based on ILO structure guidelines for safety and health at work system on which a number of nanospecific recommendations were added to. The work intends to offer food for thought on controlling risks associated to nanotechnologies.

Patient safety competencies in undergraduate nursing students: a rapid evidence assessment.

PubMed

Bianchi, Monica; Bressan, Valentina; Cadorin, Lucia; Pagnucci, Nicola; Tolotti, Angela; Valcarenghi, Dario; Watson, Roger; Bagnasco, Annamaria; Sasso, Loredana

2016-12-01

To identify patient safety competencies, and determine the clinical learning environments that facilitate the development of patient safety competencies in nursing students. Patient safety in nursing education is of key importance for health professional environments, settings and care systems. To be effective, safe nursing practice requires a good integration between increasing knowledge and the different clinical practice settings. Nurse educators have the responsibility to develop effective learning processes and ensure patient safety. Rapid Evidence Assessment. MEDLINE, CINAHL, SCOPUS and ERIC were searched, yielding 500 citations published between 1 January 2004-30 September 2014. Following the Rapid Evidence Assessment process, 17 studies were included in this review. Hawker's (2002) quality assessment tool was used to assess the quality of the selected studies. Undergraduate nursing students need to develop competencies to ensure patient safety. The quality of the pedagogical atmosphere in the clinical setting has an important impact on the students' overall level of competence. Active student engagement in clinical processes stimulates their critical reasoning, improves interpersonal communication and facilitates adequate supervision and feedback. Few studies describe the nursing students' patient safety competencies and exactly what they need to learn. In addition, studies describe only briefly which clinical learning environments facilitate the development of patient safety competencies in nursing students. Further research is needed to identify additional pedagogical strategies and the specific characteristics of the clinical learning environments that encourage the development of nursing students' patient safety competencies. © 2016 John Wiley & Sons Ltd.

Assessing Personality and Mood With Adjective Check List Methodology: A Review

ERIC Educational Resources Information Center

Craig, Robert J.

2005-01-01

This article addresses the benefits and problems in using adjective check list methodology to assess personality. Recent developments in this assessment method are reviewed, emphasizing seminal adjective-based personality tests (Gough's Adjective Check List), mood tests (Lubin's Depressive Adjective Test, Multiple Affect Adjective Check List),…

[Methodological and operational notes for the assessment and management of the risk of work-related stress].

PubMed

De Ambrogi, Francesco; Ratti, Elisabetta Ceppi

2011-01-01

Today the Italian national debate over the Work-Related Stress Risk Assessment methodology is rather heated. Several methodological proposals and guidelines have been published in recent months, not least those by the "Commissione Consultiva". But despite this wide range of proposals, it appears that there is still a lack of attention to some of the basic methodological issues that must be taken into account in order to correctly implement the above-mentioned guidelines. The aim of this paper is to outline these methodological issues. In order to achieve this, the most authoritative methodological proposals and guidelines have been reviewed. The study focuses in particular on the methodological issues that could lead to important biases if not considered properly. The study leads to some considerations about the methodological validity of a Work-Related Stress Risk Assessment based exclusively on the literal interpretation of the considered proposals. Furthermore, the study provides some hints and working hypotheses on how to overcome these methodological limits. This study should be considered as a starting point for further investigations and debate on the Work-Related Stress Risk Assessment methodology on a national level.

Renewable Energy Assessment Methodology for Japanese OCONUS Army Installations

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

Solana, Amy E.; Horner, Jacob A.; Russo, Bryan J.

2010-08-30

Since 2005, Pacific Northwest National Laboratory (PNNL) has been asked by Installation Management Command (IMCOM) to conduct strategic assessments at selected US Army installations of the potential use of renewable energy resources, including solar, wind, geothermal, biomass, waste, and ground source heat pumps (GSHPs). IMCOM has the same economic, security, and legal drivers to develop alternative, renewable energy resources overseas as it has for installations located in the US. The approach for continental US (CONUS) studies has been to use known, US-based renewable resource characterizations and information sources coupled with local, site-specific sources and interviews. However, the extent to whichmore » this sort of data might be available for outside the continental US (OCONUS) sites was unknown. An assessment at Camp Zama, Japan was completed as a trial to test the applicability of the CONUS methodology at OCONUS installations. It was found that, with some help from Camp Zama personnel in translating and locating a few Japanese sources, there was relatively little difficulty in finding sources that should provide a solid basis for conducting an assessment of comparable depth to those conducted for US installations. Project implementation will likely be more of a challenge, but the feasibility analysis will be able to use the same basic steps, with some adjusted inputs, as PNNL’s established renewable resource assessment methodology.« less

Conceptual and methodological challenges to integrating SEA and cumulative effects assessment

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

Gunn, Jill, E-mail: jill.gunn@usask.c; Noble, Bram F.

The constraints to assessing and managing cumulative environmental effects in the context of project-based environmental assessment are well documented, and the potential benefits of a more strategic approach to cumulative effects assessment (CEA) are well argued; however, such benefits have yet to be clearly demonstrated in practice. While it is widely assumed that cumulative effects are best addressed in a strategic context, there has been little investigation as to whether CEA and strategic environmental assessment (SEA) are a 'good fit' - conceptually or methodologically. This paper identifies a number of conceptual and methodological challenges to the integration of CEA andmore » SEA. Based on results of interviews with international experts and practitioners, this paper demonstrates that: definitions and conceptualizations of CEA are typically weak in practice; approaches to effects aggregation vary widely; a systems perspective lacks in both SEA and CEA; the multifarious nature of SEA complicates CEA; tiering arrangements between SEA and project-based assessment are limited to non-existing; and the relationship of SEA to regional planning remains unclear.« less

Edible safety requirements and assessment standards for agricultural genetically modified organisms.

PubMed

Deng, Pingjian; Zhou, Xiangyang; Zhou, Peng; Du, Zhong; Hou, Hongli; Yang, Dongyan; Tan, Jianjun; Wu, Xiaojin; Zhang, Jinzhou; Yang, Yongcun; Liu, Jin; Liu, Guihua; Li, Yonghong; Liu, Jianjun; Yu, Lei; Fang, Shisong; Yang, Xiaoke

2008-05-01

This paper describes the background, principles, concepts and methods of framing the technical regulation for edible safety requirement and assessment of agricultural genetically modified organisms (agri-GMOs) for Shenzhen Special Economic Zone in the People's Republic of China. It provides a set of systematic criteria for edible safety requirements and the assessment process for agri-GMOs. First, focusing on the degree of risk and impact of different agri-GMOs, we developed hazard grades for toxicity, allergenicity, anti-nutrition effects, and unintended effects and standards for the impact type of genetic manipulation. Second, for assessing edible safety, we developed indexes and standards for different hazard grades of recipient organisms, for the influence of types of genetic manipulation and hazard grades of agri-GMOs. To evaluate the applicability of these criteria and their congruency with other safety assessment systems for GMOs applied by related organizations all over the world, we selected some agri-GMOs (soybean, maize, potato, capsicum and yeast) as cases to put through our new assessment system, and compared our results with the previous assessments. It turned out that the result of each of the cases was congruent with the original assessment.

12th meeting of the Scientific Group on Methodologies for the Safety Evaluation of Chemicals: susceptibility to environmental hazards.

PubMed Central

Barrett, J C; Vainio, H; Peakall, D; Goldstein, B D

1997-01-01

The 12th meeting of the Scientific Group on Methodologies for the Safety Evaluation of Chemicals (SGOMSEC) considered the topic of methodologies for determining human and ecosystem susceptibility to environmental hazards. The report prepared at the meeting describes measurement of susceptibility through the use of biological markers of exposure, biological markers of effect, and biomarkers directly indicative of susceptibility of humans or of ecosystems. The utility and validity of these biological markers for the study of susceptibility are evaluated, as are opportunities for developing newer approaches for the study of humans or of ecosystems. For the first time a SGOMSEC workshop also formally considered the issue of ethics in relation to methodology, an issue of particular concern for studies of susceptibility. PMID:9255554

There is more to risk and safety planning than dramatic risks: Mental health nurses' risk assessment and safety-management practice.

PubMed

Higgins, Agnes; Doyle, Louise; Downes, Carmel; Morrissey, Jean; Costello, Paul; Brennan, Michael; Nash, Michael

2016-04-01

Risk assessment and safety planning are considered a cornerstone of mental health practice, yet limited research exists into how mental health nurses conceptualize 'risk' and how they engage with risk assessment and safety planning. The aim of the present study was to explore mental health nurses' practices and confidence in risk assessment and safety planning. A self-completed survey was administered to 381 mental health nurses in Ireland. The findings indicate that nurses focus on risk to self and risk to others, with the risk of suicide, self-harm, substance abuse, and violence being most frequently assessed. Risk from others and 'iatrogenic' risk were less frequently considered. Overall, there was limited evidence of recovery-oriented practice in relation to risk. The results demonstrate a lack of meaningful engagement with respect to collaborative safety planning, the identification and inclusion of protective factors, and the inclusion of positive risk-taking opportunities. In addition, respondents report a lack of confidence working with positive risk taking and involving family/carers in the risk-assessment and safety-planning process. Gaps in knowledge about risk-assessment and safety-planning practice, which could be addressed through education, are identified, as are the implications of the findings for practice and research. © 2015 Australian College of Mental Health Nurses Inc.

[Safety assessment of foods derived from genetically modified plants].

PubMed

Pöting, A; Schauzu, M

2010-06-01

The placing of genetically modified plants and derived food on the market falls under Regulation (EC) No. 1829/2003. According to this regulation, applicants need to perform a safety assessment according to the Guidance Document of the Scientific Panel on Genetically Modified Organisms of the European Food Safety Authority (EFSA), which is based on internationally agreed recommendations. This article gives an overview of the underlying legislation as well as the strategy and scientific criteria for the safety assessment, which should generally be based on the concept of substantial equivalence and carried out in relation to an unmodified conventional counterpart. Besides the intended genetic modification, potential unintended changes also have to be assessed with regard to potential adverse effects for the consumer. All genetically modified plants and derived food products, which have been evaluated by EFSA so far, were considered to be as safe as products derived from the respective conventional plants.

Methodology for assessment of undiscovered oil and gas resources for the 2008 Circum-Arctic Resource Appraisal

USGS Publications Warehouse

Charpentier, Ronald R.; Moore, Thomas E.; Gautier, D.L.

2017-11-15

The methodological procedures used in the geologic assessments of the 2008 Circum-Arctic Resource Appraisal (CARA) were based largely on the methodology developed for the 2000 U.S. Geological Survey World Petroleum Assessment. The main variables were probability distributions for numbers and sizes of undiscovered accumulations with an associated risk of occurrence. The CARA methodology expanded on the previous methodology in providing additional tools and procedures more applicable to the many Arctic basins that have little or no exploration history. Most importantly, geologic analogs from a database constructed for this study were used in many of the assessments to constrain numbers and sizes of undiscovered oil and gas accumulations.

Personality Assessment of Global Talent: Conceptual and Methodological Issues

ERIC Educational Resources Information Center

van de Vijver, Fons J. R.

2008-01-01

The recruitment of managers who will operate in a culturally heterogeneous context (as expatriate managers, managers in a global company, or managers of a multicultural workforce) is increasingly important in an age of globalization. This article describes conceptual and methodological issues in the assessment of such managers, notably in the…

Methodological Concerns about the Education Value-Added Assessment System

ERIC Educational Resources Information Center

Amrein-Beardsley, Audrey

2008-01-01

Value-added models help to evaluate the knowledge that school districts, schools, and teachers add to student learning as students progress through school. In this article, the well-known Education Value-Added Assessment System (EVAAS) is examined. The author presents a practical investigation of the methodological issues associated with the…

Safety assessment of Vitis vinifera (grape)-derived ingredients as used in cosmetics.

PubMed

Fiume, Monice M; Bergfeld, Wilma F; Belsito, Donald V; Hill, Ronald A; Klaassen, Curtis D; Liebler, Daniel C; Marks, James G; Shank, Ronald C; Slaga, Thomas J; Snyder, Paul W; Andersen, F Alan

2014-01-01

The Cosmetic Ingredient Review Expert Panel (Panel) assessed the safety of 24 Vitis vinifera (grape)-derived ingredients and found them safe in the present practices of use and concentration in cosmetics. These ingredients function in cosmetics mostly as skin-conditioning agents, but some function as antioxidants, flavoring agents, and/or colorants. The Panel reviewed the available animal and clinical data to determine the safety of these ingredients. Additionally, some constituents of grapes have been assessed previously for safety as cosmetic ingredients by the Panel, and others are compounds that have been discussed in previous Panel safety assessments. © The Author(s) 2014.

Rapid evidence assessment: increasing the transparency of an emerging methodology.

PubMed

Varker, Tracey; Forbes, David; Dell, Lisa; Weston, Adele; Merlin, Tracy; Hodson, Stephanie; O'Donnell, Meaghan

2015-12-01

Within the field of evidence-based practice, policy makers, health care professionals and consumers require timely reviews to inform decisions on efficacious health care and treatments. Rapid evidence assessment (REA), also known as rapid review, has emerged in recent years as a literature review methodology that fulfils this need. It highlights what is known in a clinical area to the target audience in a relatively short time frame. This article discusses the lack of transparency and limited critical appraisal that can occur in REA, and goes on to propose general principles for conducting a REA. The approach that we describe is consistent with the principles underlying systematic review methodology, but also makes allowances for the rapid delivery of information as required while utilizing explicit and reproducible methods at each stage. Our method for conducting REA includes: developing an explicit research question in consultation with the end-users; clear definition of the components of the research question; development of a thorough and reproducible search strategy; development of explicit evidence selection criteria; and quality assessments and transparent decisions about the level of information to be obtained from each study. In addition, the REA may also include an assessment of the quality of the total body of evidence. Transparent reporting of REA methodologies will provide greater clarity to end-users about how the information is obtained and about the trade-offs that are made between speed and rigour. © 2015 John Wiley & Sons, Ltd.

Reef Fish Survey Techniques: Assessing the Potential for Standardizing Methodologies.

PubMed

Caldwell, Zachary R; Zgliczynski, Brian J; Williams, Gareth J; Sandin, Stuart A

2016-01-01

Dramatic changes in populations of fishes living on coral reefs have been documented globally and, in response, the research community has initiated efforts to assess and monitor reef fish assemblages. A variety of visual census techniques are employed, however results are often incomparable due to differential methodological performance. Although comparability of data may promote improved assessment of fish populations, and thus management of often critically important nearshore fisheries, to date no standardized and agreed-upon survey method has emerged. This study describes the use of methods across the research community and identifies potential drivers of method selection. An online survey was distributed to researchers from academic, governmental, and non-governmental organizations internationally. Although many methods were identified, 89% of survey-based projects employed one of three methods-belt transect, stationary point count, and some variation of the timed swim method. The selection of survey method was independent of the research design (i.e., assessment goal) and region of study, but was related to the researcher's home institution. While some researchers expressed willingness to modify their current survey protocols to more standardized protocols (76%), their willingness decreased when methodologies were tied to long-term datasets spanning five or more years. Willingness to modify current methodologies was also less common among academic researchers than resource managers. By understanding both the current application of methods and the reported motivations for method selection, we hope to focus discussions towards increasing the comparability of quantitative reef fish survey data.

Validating the Octave Allegro Information Systems Risk Assessment Methodology: A Case Study

ERIC Educational Resources Information Center

Keating, Corland G.

2014-01-01

An information system (IS) risk assessment is an important part of any successful security management strategy. Risk assessments help organizations to identify mission-critical IS assets and prioritize risk mitigation efforts. Many risk assessment methodologies, however, are complex and can only be completed successfully by highly qualified and…

Quantitative safety assessment of air traffic control systems through system control capacity

NASA Astrophysics Data System (ADS)

Guo, Jingjing

Quantitative Safety Assessments (QSA) are essential to safety benefit verification and regulations of developmental changes in safety critical systems like the Air Traffic Control (ATC) systems. Effectiveness of the assessments is particularly desirable today in the safe implementations of revolutionary ATC overhauls like NextGen and SESAR. QSA of ATC systems are however challenged by system complexity and lack of accident data. Extending from the idea "safety is a control problem" in the literature, this research proposes to assess system safety from the control perspective, through quantifying a system's "control capacity". A system's safety performance correlates to this "control capacity" in the control of "safety critical processes". To examine this idea in QSA of the ATC systems, a Control-capacity Based Safety Assessment Framework (CBSAF) is developed which includes two control capacity metrics and a procedural method. The two metrics are Probabilistic System Control-capacity (PSC) and Temporal System Control-capacity (TSC); each addresses an aspect of a system's control capacity. And the procedural method consists three general stages: I) identification of safety critical processes, II) development of system control models and III) evaluation of system control capacity. The CBSAF was tested in two case studies. The first one assesses an en-route collision avoidance scenario and compares three hypothetical configurations. The CBSAF was able to capture the uncoordinated behavior between two means of control, as was observed in a historic midair collision accident. The second case study compares CBSAF with an existing risk based QSA method in assessing the safety benefits of introducing a runway incursion alert system. Similar conclusions are reached between the two methods, while the CBSAF has the advantage of simplicity and provides a new control-based perspective and interpretation to the assessments. The case studies are intended to investigate the

Published methodological quality of randomized controlled trials does not reflect the actual quality assessed in protocols

PubMed Central

Mhaskar, Rahul; Djulbegovic, Benjamin; Magazin, Anja; Soares, Heloisa P.; Kumar, Ambuj

2011-01-01

Objectives To assess whether reported methodological quality of randomized controlled trials (RCTs) reflect the actual methodological quality, and to evaluate the association of effect size (ES) and sample size with methodological quality. Study design Systematic review Setting Retrospective analysis of all consecutive phase III RCTs published by 8 National Cancer Institute Cooperative Groups until year 2006. Data were extracted from protocols (actual quality) and publications (reported quality) for each study. Results 429 RCTs met the inclusion criteria. Overall reporting of methodological quality was poor and did not reflect the actual high methodological quality of RCTs. The results showed no association between sample size and actual methodological quality of a trial. Poor reporting of allocation concealment and blinding exaggerated the ES by 6% (ratio of hazard ratio [RHR]: 0.94, 95%CI: 0.88, 0.99) and 24% (RHR: 1.24, 95%CI: 1.05, 1.43), respectively. However, actual quality assessment showed no association between ES and methodological quality. Conclusion The largest study to-date shows poor quality of reporting does not reflect the actual high methodological quality. Assessment of the impact of quality on the ES based on reported quality can produce misleading results. PMID:22424985

A Methodology for the Assessment of Experiential Learning Lean: The Lean Experience Factory Study

ERIC Educational Resources Information Center

De Zan, Giovanni; De Toni, Alberto Felice; Fornasier, Andrea; Battistella, Cinzia

2015-01-01

Purpose: The purpose of this paper is to present a methodology to assess the experiential learning processes of learning lean in an innovative learning environment: the lean model factories. Design/methodology/approach: A literature review on learning and lean management literatures was carried out to design the methodology. Then, a case study…

Biodiversity impact assessment (BIA+) - methodological framework for screening biodiversity.

PubMed

Winter, Lisa; Pflugmacher, Stephan; Berger, Markus; Finkbeiner, Matthias

2018-03-01

For the past 20 years, the life cycle assessment (LCA) community has sought to integrate impacts on biodiversity into the LCA framework. However, existing impact assessment methods still fail to do so comprehensively because they quantify only a few impacts related to specific species and regions. This paper proposes a methodological framework that will allow LCA practitioners to assess currently missing impacts on biodiversity on a global scale. Building on existing models that seek to quantify the impacts of human activities on biodiversity, the herein proposed methodological framework consists of 2 components: a habitat factor for 14 major habitat types and the impact on the biodiversity status in those major habitat types. The habitat factor is calculated by means of indicators that characterize each habitat. The biodiversity status depends on parameters from impact categories. The impact functions, relating these different parameters to a given response in the biodiversity status, rely on expert judgments. To ensure the applicability for LCA practitioners, the components of the framework can be regionalized on a country scale for which LCA inventory data is more readily available. The weighting factors for the 14 major habitat types range from 0.63 to 1.82. By means of area weighting of the major habitat types in a country, country-specific weighting factors are calculated. In order to demonstrate the main part of the framework, examples of impact functions are given for the categories "freshwater eutrophication" and "freshwater ecotoxicity" in 1 major habitat type. The results confirm suitability of the methodological framework. The major advantages are the framework's user-friendliness, given that data can be used from LCA databases directly, and the complete inclusion of all levels of biodiversity (genetic, species, and ecosystem). It is applicable for the whole world and a wide range of impact categories. Integr Environ Assess Manag 2018;14:282-297. �

'Worst case' methodology for the initial assessment of societal risk from proposed major accident installations.

PubMed

Carter, D A; Hirst, I L

2000-01-07

This paper considers the application of one of the weighted risk indicators used by the Major Hazards Assessment Unit (MHAU) of the Health and Safety Executive (HSE) in formulating advice to local planning authorities on the siting of new major accident hazard installations. In such cases the primary consideration is to ensure that the proposed installation would not be incompatible with existing developments in the vicinity, as identified by the categorisation of the existing developments and the estimation of individual risk values at those developments. In addition a simple methodology, described here, based on MHAU's "Risk Integral" and a single "worst case" even analysis, is used to enable the societal risk aspects of the hazardous installation to be considered at an early stage of the proposal, and to determine the degree of analysis that will be necessary to enable HSE to give appropriate advice.

Safety Assessment of Alumina and Aluminum Hydroxide as Used in Cosmetics.

PubMed

Becker, Lillian C; Boyer, Ivan; Bergfeld, Wilma F; Belsito, Donald V; Hill, Ronald A; Klaassen, Curtis D; Liebler, Daniel C; Marks, James G; Shank, Ronald C; Slaga, Thomas J; Snyder, Paul W; Andersen, F Alan

2016-11-01

This is a safety assessment of alumina and aluminum hydroxide as used in cosmetics. Alumina functions as an abrasive, absorbent, anticaking agent, bulking agent, and opacifying agent. Aluminum hydroxide functions as a buffering agent, corrosion inhibitor, and pH adjuster. The Food and Drug Administration (FDA) evaluated the safe use of alumina in several medical devices and aluminum hydroxide in over-the-counter drugs, which included a review of human and animal safety data. The Cosmetic Ingredient Review (CIR) Expert Panel considered the FDA evaluations as part of the basis for determining the safety of these ingredients as used in cosmetics. Alumina used in cosmetics is essentially the same as that used in medical devices. This safety assessment does not include metallic or elemental aluminum as a cosmetic ingredient. The CIR Expert Panel concluded that alumina and aluminum hydroxide are safe in the present practices of use and concentration described in this safety assessment. © The Author(s) 2016.

An Assessment Methodology to Evaluate In-Flight Engine Health Management Effectiveness

NASA Astrophysics Data System (ADS)

Maggio, Gaspare; Belyeu, Rebecca; Pelaccio, Dennis G.

2002-01-01

flight effectiveness of candidate engine health management system concepts. A next generation engine health management system will be required to be both reliable and robust in terms of anomaly detection capability. The system must be able to operate successfully in the hostile, high-stress engine system environment. This implies that its system components, such as the instrumentation, process and control, and vehicle interface and support subsystems, must be highly reliable. Additionally, the system must be able to address a vast range of possible engine operation anomalies through a host of different types of measurements supported by a fast algorithm/architecture processing capability that can identify "true" (real) engine operation anomalies. False anomaly condition reports for such a system must be essentially eliminated. The accuracy of identifying only real anomaly conditions has been an issue with the Space Shuttle Main Engine (SSME) in the past. Much improvement in many of the technologies to address these areas is required. The objectives of this study were to identify and demonstrate a consistent assessment methodology that can evaluate the capability of next generation engine health management system concepts to respond in a correct, timely manner to alleviate an operational engine anomaly condition during flight. Science Applications International Corporation (SAIC), with support from NASA Marshall Space Flight Center, identified a probabilistic modeling approach to assess engine health management system concept effectiveness using a deterministic anomaly-time event assessment modeling approach that can be applied in the engine preliminary design stage of development to assess engine health management system concept effectiveness. Much discussion in this paper focuses on the formulation and application approach in performing this assessment. This includes detailed discussion of key modeling assumptions, the overall assessment methodology approach

An Application of the Methodology for Assessment of the Sustainability of Air Transport System

NASA Technical Reports Server (NTRS)

Janic, Milan

2003-01-01

An assessment and operationalization of the concept of sustainable air transport system is recognized as an important but complex research, operational and policy task. In the scope of the academic efforts to properly address the problem, this paper aims to assess the sustainability of air transport system. It particular, the paper describes the methodology for assessment of sustainability and its potential application. The methodology consists of the indicator systems, which relate to the air transport system operational, economic, social and environmental dimension of performance. The particular indicator systems are relevant for the particular actors such users (air travellers), air transport operators, aerospace manufacturers, local communities, governmental authorities at different levels (local, national, international), international air transport associations, pressure groups and public. In the scope of application of the methodology, the specific cases are selected to estimate the particular indicators, and thus to assess the system sustainability under given conditions.

Health and Safety Checklist for Early Care and Education Programs to Assess Key National Health and Safety Standards.

PubMed

Alkon, Abbey; Rose, Roberta; Wolff, Mimi; Kotch, Jonathan B; Aronson, Susan S

2016-01-01

The project aims were to (1) develop an observational Health and Safety Checklist to assess health and safety practices and conditions in early care and education (ECE) programs using Stepping Stones To Caring For Our Children, 3rd Edition national standards, (2) pilot test the Checklist, completed by nurse child care health consultants, to assess feasibility, ease of completion, objectivity, validity, and reliability, and (3) revise the Checklist based on the qualitative and quantitative results of the pilot study. The observable national health and safety standards were identified and then rated by health, safety, and child care experts using a Delphi technique to validate the standards as essential to prevent harm and promote health. Then, child care health consultants recruited ECE centers and pilot tested the 124-item Checklist. The pilot study was conducted in Arizona, California and North Carolina. The psychometric properties of the Checklist were assessed. The 37 participating ECE centers had 2627 children from ethnically-diverse backgrounds and primarily low-income families. The child care health consultants found the Checklist easy to complete, objective, and useful for planning health and safety interventions. The Checklist had content and face validity, inter-rater reliability, internal consistency, and concurrent validity. Based on the child care health consultant feedback and psychometric properties of the Checklist, the Checklist was revised and re-written at an 8th grade literacy level. The Health and Safety Checklist provides a standardized instrument of observable, selected national standards to assess the quality of health and safety in ECE centers.

Spanish methodological approach for biosphere assessment of radioactive waste disposal.

PubMed

Agüero, A; Pinedo, P; Cancio, D; Simón, I; Moraleda, M; Pérez-Sánchez, D; Trueba, C

2007-10-01

The development of radioactive waste disposal facilities requires implementation of measures that will afford protection of human health and the environment over a specific temporal frame that depends on the characteristics of the wastes. The repository design is based on a multi-barrier system: (i) the near-field or engineered barrier, (ii) far-field or geological barrier and (iii) the biosphere system. Here, the focus is on the analysis of this last system, the biosphere. A description is provided of conceptual developments, methodological aspects and software tools used to develop the Biosphere Assessment Methodology in the context of high-level waste (HLW) disposal facilities in Spain. This methodology is based on the BIOMASS "Reference Biospheres Methodology" and provides a logical and systematic approach with supplementary documentation that helps to support the decisions necessary for model development. It follows a five-stage approach, such that a coherent biosphere system description and the corresponding conceptual, mathematical and numerical models can be built. A discussion on the improvements implemented through application of the methodology to case studies in international and national projects is included. Some facets of this methodological approach still require further consideration, principally an enhanced integration of climatology, geography and ecology into models considering evolution of the environment, some aspects of the interface between the geosphere and biosphere, and an accurate quantification of environmental change processes and rates.

Organizational Change Efforts: Methodologies for Assessing Organizational Effectiveness and Program Costs versus Benefits.

ERIC Educational Resources Information Center

Macy, Barry A.; Mirvis, Philip H.

1982-01-01

A standardized methodology for identifying, defining, and measuring work behavior and performance rather than production, and a methodology that estimates the costs and benefits of work innovation are presented for assessing organizational effectiveness and program costs versus benefits in organizational change programs. Factors in a cost-benefit…

Environment, Safety, and Health Self-Assessment Report, Fiscal Year 2008

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

Chernowski, John

2009-02-27

Lawrence Berkeley National Laboratory's Environment, Safety, and Health (ES&H) Self-Assessment Program ensures that Integrated Safety Management (ISM) is implemented institutionally and by all divisions. The Self-Assessment Program, managed by the Office of Contract Assurance (OCA), provides for an internal evaluation of all ES&H programs and systems at LBNL. The functions of the program are to ensure that work is conducted safely, and with minimal negative impact to workers, the public, and the environment. The Self-Assessment Program is also the mechanism used to institute continuous improvements to the Laboratory's ES&H programs. The program is described in LBNL/PUB 5344, Environment, Safety, andmore » Health Self-Assessment Program and is composed of four distinct assessments: the Division Self-Assessment, the Management of Environment, Safety, and Health (MESH) review, ES&H Technical Assurance, and the Appendix B Self-Assessment. The Division Self-Assessment uses the five core functions and seven guiding principles of ISM as the basis of evaluation. Metrics are created to measure performance in fulfilling ISM core functions and guiding principles, as well as promoting compliance with applicable regulations. The five core functions of ISM are as follows: (1) Define the Scope of Work; (2) Identify and Analyze Hazards; (3) Control the Hazards; (4) Perform the Work; and (5) Feedback and Improvement. The seven guiding principles of ISM are as follows: (1) Line Management Responsibility for ES&H; (2) Clear Roles and Responsibilities; (3) Competence Commensurate with Responsibilities; (4) Balanced Priorities; (5) Identification of ES&H Standards and Requirements; (6) Hazard Controls Tailored to the Work Performed; and (7) Operations Authorization. Performance indicators are developed by consensus with OCA, representatives from each division, and Environment, Health, and Safety (EH&S) Division program managers. Line management of each division performs the Division

Development of a methodology for strategic environmental assessment: application to the assessment of golf course installation policy in Taiwan.

PubMed

Chen, Ching-Ho; Wu, Ray-Shyan; Liu, Wei-Lin; Su, Wen-Ray; Chang, Yu-Min

2009-01-01

Some countries, including Taiwan, have adopted strategic environmental assessment (SEA) to assess and modify proposed policies, plans, and programs (PPPs) in the planning phase for pursuing sustainable development. However, there were only some sketchy steps focusing on policy assessment in the system of Taiwan. This study aims to develop a methodology for SEA in Taiwan to enhance the effectiveness associated with PPPs. The proposed methodology comprises an SEA procedure involving PPP management and assessment in various phases, a sustainable assessment framework, and an SEA management system. The SEA procedure is devised based on the theoretical considerations by systems thinking and the regulative requirements in Taiwan. The positive and negative impacts on ecology, society, and economy are simultaneously considered in the planning (including policy generation and evaluation), implementation, and control phases of the procedure. This study used the analytic hierarchy process, Delphi technique, and systems analysis to develop a sustainable assessment framework. An SEA management system was built based on geographic information system software to process spatial, attribute, and satellite image data during the assessment procedure. The proposed methodology was applied in the SEA of golf course installation policy in 2001 as a case study, which was the first SEA in Taiwan. Most of the 82 existing golf courses in 2001 were installed on slope lands and caused a serious ecological impact. Assessment results indicated that 15 future golf courses installed on marginal lands (including buffer zones, remedied lands, and wastelands) were acceptable because the comprehensive environmental (ecological, social, and economic) assessment value was better based on environmental characteristics and management regulations of Taiwan. The SEA procedure in the planning phase for this policy was completed but the implementation phase of this policy was not begun because the related

Safety assessment of modified terephthalate polymers as used in cosmetics.

PubMed

Becker, Lillian C; Bergfeld, Wilma F; Belsito, Donald V; Hill, Ronald A; Klaassen, Curtis D; Liebler, Daniel C; Marks, James G; Shank, Ronald C; Slaga, Thomas J; Snyder, Paul W; Andersen, F Alan

2014-01-01

The safety of 6 modified terephthalate polymers as cosmetic ingredients was assessed. These ingredients mostly function as exfoliants, bulking agents, hair fixatives, and viscosity-increasing agents-nonaqueous. Polyethylene terephthalate (PET) is used in leave-on products up to 100% and in rinse-off products up to 2%. The Cosmetic Ingredient Review Expert Panel (Panel) considered that the PET used in cosmetics is chemically equivalent to that used in medical devices. The Panel determined that the Food and Drug Administration's determination of safety of PET in several medical devices, which included human and animal safety data, can be used as the basis for the determination of safety of PET and related polymers used in cosmetics. Use studies of cosmetic eye products that contain PET demonstrated no ocular irritation or dermal sensitization. The Panel concluded that modified terephthalate polymers were safe as cosmetic ingredients in the practices of use and concentration described in this safety assessment. © The Author(s) 2014.

SURVEY OF METHODOLOGIES FOR DEVELOPING MEDIA SCREENING VALUES FOR ECOLOGICAL RISK ASSESSMENT

EPA Science Inventory

Barron, Mace G. and Steve Wharton. Submitted. Survey of Methodologies for Developing Media Screening Values for Ecological Risk Assessment. Environ. Toxicol. Chem. 44 p. (ERL,GB 1200).

Concurrent with the increase in the number of ecological risk assessments over the past...

Influence Map Methodology for Evaluating Systemic Safety Issues

NASA Technical Reports Server (NTRS)

2008-01-01

"Raising the bar" in safety performance is a critical challenge for many organizations, including Kennedy Space Center. Contributing-factor taxonomies organize information about the reasons accidents occur and therefore are essential elements of accident investigations and safety reporting systems. Organizations must balance efforts to identify causes of specific accidents with efforts to evaluate systemic safety issues in order to become more proactive about improving safety. This project successfully addressed the following two problems: (1) methods and metrics to support the design of effective taxonomies are limited and (2) influence relationships among contributing factors are not explicitly modeled within a taxonomy.

Improving timeliness and efficiency in the referral process for safety net providers: application of the Lean Six Sigma methodology.

PubMed

Deckard, Gloria J; Borkowski, Nancy; Diaz, Deisell; Sanchez, Carlos; Boisette, Serge A

2010-01-01

Designated primary care clinics largely serve low-income and uninsured patients who present a disproportionate number of chronic illnesses and face great difficulty in obtaining the medical care they need, particularly the access to specialty physicians. With limited capacity for providing specialty care, these primary care clinics generally refer patients to safety net hospitals' specialty ambulatory care clinics. A large public safety net health system successfully improved the effectiveness and efficiency of the specialty clinic referral process through application of Lean Six Sigma, an advanced process-improvement methodology and set of tools driven by statistics and engineering concepts.

Simulating geriatric home safety assessments in a three-dimensional virtual world.

PubMed

Andrade, Allen D; Cifuentes, Pedro; Mintzer, Michael J; Roos, Bernard A; Anam, Ramanakumar; Ruiz, Jorge G

2012-01-01

Virtual worlds could offer inexpensive and safe three-dimensional environments in which medical trainees can learn to identify home safety hazards. Our aim was to evaluate the feasibility, usability, and acceptability of virtual worlds for geriatric home safety assessments and to correlate performance efficiency in hazard identification with spatial ability, self-efficacy, cognitive load, and presence. In this study, 30 medical trainees found the home safety simulation easy to use, and their self-efficacy was improved. Men performed better than women in hazard identification. Presence and spatial ability were correlated significantly with performance. Educators should consider spatial ability and gender differences when implementing virtual world training for geriatric home safety assessments.

Published methodological quality of randomized controlled trials does not reflect the actual quality assessed in protocols.

PubMed

Mhaskar, Rahul; Djulbegovic, Benjamin; Magazin, Anja; Soares, Heloisa P; Kumar, Ambuj

2012-06-01

To assess whether the reported methodological quality of randomized controlled trials (RCTs) reflects the actual methodological quality and to evaluate the association of effect size (ES) and sample size with methodological quality. Systematic review. This is a retrospective analysis of all consecutive phase III RCTs published by eight National Cancer Institute Cooperative Groups up to 2006. Data were extracted from protocols (actual quality) and publications (reported quality) for each study. Four hundred twenty-nine RCTs met the inclusion criteria. Overall reporting of methodological quality was poor and did not reflect the actual high methodological quality of RCTs. The results showed no association between sample size and actual methodological quality of a trial. Poor reporting of allocation concealment and blinding exaggerated the ES by 6% (ratio of hazard ratio [RHR]: 0.94; 95% confidence interval [CI]: 0.88, 0.99) and 24% (RHR: 1.24; 95% CI: 1.05, 1.43), respectively. However, actual quality assessment showed no association between ES and methodological quality. The largest study to date shows that poor quality of reporting does not reflect the actual high methodological quality. Assessment of the impact of quality on the ES based on reported quality can produce misleading results. Copyright © 2012 Elsevier Inc. All rights reserved.

Safety assessment of genetically modified plants with deliberately altered composition

PubMed Central

Halford, Nigel G; Hudson, Elizabeth; Gimson, Amy; Weightman, Richard; Shewry, Peter R; Tompkins, Steven

2014-01-01

The development and marketing of ‘novel’ genetically modified (GM) crops in which composition has been deliberately altered poses a challenge to the European Union (EU)'s risk assessment processes, which are based on the concept of substantial equivalence with a non-GM comparator. This article gives some examples of these novel GM crops and summarizes the conclusions of a report that was commissioned by the European Food Safety Authority on how the EU's risk assessment processes could be adapted to enable their safety to be assessed. PMID:24735114

Simulation Enabled Safeguards Assessment Methodology

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

Robert Bean; Trond Bjornard; Thomas Larson

2007-09-01

It is expected that nuclear energy will be a significant component of future supplies. New facilities, operating under a strengthened international nonproliferation regime will be needed. There is good reason to believe virtual engineering applied to the facility design, as well as to the safeguards system design will reduce total project cost and improve efficiency in the design cycle. Simulation Enabled Safeguards Assessment MEthodology (SESAME) has been developed as a software package to provide this capability for nuclear reprocessing facilities. The software architecture is specifically designed for distributed computing, collaborative design efforts, and modular construction to allow step improvements inmore » functionality. Drag and drop wireframe construction allows the user to select the desired components from a component warehouse, render the system for 3D visualization, and, linked to a set of physics libraries and/or computational codes, conduct process evaluations of the system they have designed.« less

49 CFR 238.603 - Safety planning requirements.

Code of Federal Regulations, 2014 CFR

2014-10-01

... acceptable level using a formal safety methodology such as MIL-STD-882; and (4) Impose operational... using a formal safety methodology such as MIL-STD-882; (5) Monitor the progress in resolving safety...

49 CFR 238.603 - Safety planning requirements.

Code of Federal Regulations, 2013 CFR

2013-10-01

... acceptable level using a formal safety methodology such as MIL-STD-882; and (4) Impose operational... using a formal safety methodology such as MIL-STD-882; (5) Monitor the progress in resolving safety...

Safety of High Speed Guided Ground Transportation Systems: Work Breakdown Structure

DOT National Transportation Integrated Search

1994-11-30

This report provides a systems approach to the assessment, evaluation and application of high-speed guided ground transportation (HSGGT) safety criteria and : presents one potential methodology by combining a work breakdown structure (WBS) : approach...

Data collection and analysis for local roadway safety assessment.

DOT National Transportation Integrated Search

2014-11-01

The project Data Analysis for Local Roadway : Assessment conducted systematic road-safety : assessment and identified major risks that can be el : iminated or reduced by pr : actical road-improvement : measures. Specifically, the primary task o...

Ex-ante assessment of the safety effects of intelligent transport systems.

PubMed

Kulmala, Risto

2010-07-01

There is a need to develop a comprehensive framework for the safety assessment of Intelligent Transport Systems (ITS). This framework should: (1) cover all three dimensions of road safety-exposure, crash risk and consequence, (2) cover, in addition to the engineering effect, also the effects due to behavioural adaptation and (3) be compatible with the other aspects of state of the art road safety theories. A framework based on nine ITS safety mechanisms is proposed and discussed with regard to the requirements set to the framework. In order to illustrate the application of the framework in practice, the paper presents a method based on the framework and the results from applying that method for twelve intelligent vehicle systems in Europe. The framework is also compared to two recent frameworks applied in the safety assessment of intelligent vehicle safety systems. Copyright 2010 Elsevier Ltd. All rights reserved.

Safety assessment guidance in the International Atomic Energy Agency RADWASS Program

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

Vovk, I.F.; Seitz, R.R.

1995-12-31

The IAEA RADWASS programme is aimed at establishing a coherent and comprehensive set of principles and standards for the safe management of waste and formulating the guidelines necessary for their application. A large portion of this programme has been devoted to safety assessments for various waste management activities. Five Safety Guides are planned to be developed to provide general guidance to enable operators and regulators to develop necessary framework for safety assessment process in accordance with international recommendations. They cover predisposal, near surface disposal, geological disposal, uranium/thorium mining and milling waste, and decommissioning and environmental restoration. The Guide on safetymore » assessment for near surface disposal is at the most advanced stage of preparation. This draft Safety Guide contains guidance on description of the disposal system, development of a conceptual model, identification and description of relevant scenarios and pathways, consequence analysis, presentation of results and confidence building. The set of RADWASS publications is currently undergoing in-depth review to ensure a harmonized approach throughout the Safety Series.« less

Methodology for assessing the effectiveness of access management techniques : final report, September 14, 1998.

DOT National Transportation Integrated Search

1998-09-14

A methodology for assessing the effectiveness of access management techniques on suburban arterial highways is developed. The methodology is described as a seven-step process as follows: (1) establish the purpose of the analysis (2) establish the mea...

Assessment of the safety of foods derived from genetically modified (GM) crops.

PubMed

König, A; Cockburn, A; Crevel, R W R; Debruyne, E; Grafstroem, R; Hammerling, U; Kimber, I; Knudsen, I; Kuiper, H A; Peijnenburg, A A C M; Penninks, A H; Poulsen, M; Schauzu, M; Wal, J M

2004-07-01

This paper provides guidance on how to assess the safety of foods derived from genetically modified crops (GM crops); it summarises conclusions and recommendations of Working Group 1 of the ENTRANSFOOD project. The paper provides an approach for adapting the test strategy to the characteristics of the modified crop and the introduced trait, and assessing potential unintended effects from the genetic modification. The proposed approach to safety assessment starts with the comparison of the new GM crop with a traditional counterpart that is generally accepted as safe based on a history of human food use (the concept of substantial equivalence). This case-focused approach ensures that foods derived from GM crops that have passed this extensive test-regime are as safe and nutritious as currently consumed plant-derived foods. The approach is suitable for current and future GM crops with more complex modifications. First, the paper reviews test methods developed for the risk assessment of chemicals, including food additives and pesticides, discussing which of these methods are suitable for the assessment of recombinant proteins and whole foods. Second, the paper presents a systematic approach to combine test methods for the safety assessment of foods derived from a specific GM crop. Third, the paper provides an overview on developments in this area that may prove of use in the safety assessment of GM crops, and recommendations for research priorities. It is concluded that the combination of existing test methods provides a sound test-regime to assess the safety of GM crops. Advances in our understanding of molecular biology, biochemistry, and nutrition may in future allow further improvement of test methods that will over time render the safety assessment of foods even more effective and informative. Copryright 2004 Elsevier Ltd.

Assessment of elementary school safety restraint programs.

DOT National Transportation Integrated Search

1985-06-01

The purpose of this research was to identify elementary school (K-6) safety belt : education programs in use in the United States, to review their development, and : to make administrative and impact assessments of their use in selected States. : Six...

Ultraviolet safety assessments of insect light traps.

PubMed

Sliney, David H; Gilbert, David W; Lyon, Terry

2016-01-01

Near-ultraviolet (UV-A: 315-400 nm), "black-light," electric lamps were invented in 1935 and ultraviolet insect light traps (ILTs) were introduced for use in agriculture around that time. Today ILTs are used indoors in several industries and in food-service as well as in outdoor settings. With recent interest in photobiological lamp safety, safety standards are being developed to test for potentially hazardous ultraviolet emissions. A variety of UV "Black-light" ILTs were measured at a range of distances to assess potential exposures. Realistic time-weighted human exposures are shown to be well below current guidelines for human exposure to ultraviolet radiation. These UV-A exposures would be far less than the typical UV-A exposure in the outdoor environment. Proposals are made for realistic ultraviolet safety standards for ILT products.

Safety Assessment of Acyl Glucuronides-A Simplified Paradigm.

PubMed

Smith, Dennis A; Hammond, Timothy; Baillie, Thomas A

2018-06-01

While simple O - (ether-linked) and N -glucuronide drug conjugates generally are unreactive and considered benign from a safety perspective, the acyl glucuronides that derive from metabolism of carboxylic acid-containing xenobiotics can exhibit a degree of chemical reactivity that is dependent upon their molecular structure. As a result, concerns have arisen over the safety of acyl glucuronides as a class, several members of which have been implicated in the toxicity of their respective parent drugs. However, direct evidence in support of these claims remains sparse, and due to frequently encountered species differences in the systemic exposure to acyl glucuronides (both of the parent drug and oxidized derivatives thereof), coupled with their instability in aqueous media and potential to undergo chemical rearrangement (acyl migration), qualification of these conjugates by traditional safety assessment methods can be very challenging. In this Commentary, we discuss alternative (non-acyl glucuronide) mechanisms by which carboxylic acids may cause serious adverse reactions, and propose a novel, practical approach to compare systemic exposure to acyl glucuronide metabolites in humans to that in animal species used in preclinical safety assessment based on relative estimates of the total body burden of these circulating conjugates. Copyright © 2018 by The American Society for Pharmacology and Experimental Therapeutics.

A TIERED APPROACH TO LIFE STAGES TESTING FOR AGRICULTURAL CHEMICAL SAFETY ASSESSMENT

EPA Science Inventory

A proposal has been developed by the Agricultural Chemical Safety Assessment (ACSA) Technical Committee of the ILSI Health and Environmental Sciences Institute (HESI) for an improved approach to assessing the safety of crop protection chemicals. The goal is to ensure that studie...

Risk-based process safety assessment and control measures design for offshore process facilities.

PubMed

Khan, Faisal I; Sadiq, Rehan; Husain, Tahir

2002-09-02

Process operation is the most hazardous activity next to the transportation and drilling operation on an offshore oil and gas (OOG) platform. Past experiences of onshore and offshore oil and gas activities have revealed that a small mis-happening in the process operation might escalate to a catastrophe. This is of especial concern in the OOG platform due to the limited space and compact geometry of the process area, less ventilation, and difficult escape routes. On an OOG platform, each extra control measure, which is implemented, not only occupies space on the platform and increases congestion but also adds extra load to the platform. Eventualities in the OOG platform process operation can be avoided through incorporating the appropriate control measures at the early design stage. In this paper, the authors describe a methodology for risk-based process safety decision making for OOG activities. The methodology is applied to various offshore process units, that is, the compressor, separators, flash drum and driers of an OOG platform. Based on the risk potential, appropriate safety measures are designed for each unit. This paper also illustrates that implementation of the designed safety measures reduces the high Fatal accident rate (FAR) values to an acceptable level.

Safety Assessment of Dialkyl Sulfosuccinate Salts as Used in Cosmetics.

PubMed

Fiume, Monice M; Heldreth, Bart; Bergfeld, Wilma F; Belsito, Donald V; Hill, Ronald A; Klaassen, Curtis D; Liebler, Daniel C; Marks, James G; Shank, Ronald C; Slaga, Thomas J; Snyder, Paul W; Andersen, F Alan

2016-11-01

The Cosmetic Ingredient Review (CIR) Expert Panel (Panel) assessed the safety of 8 dialkyl sulfosuccinate salts for use in cosmetics, finding that these ingredients are safe in cosmetics in the present practices of use and concentration when formulated to be nonirritating. The dialkyl sulfosuccinate salts primarily function as surfactants in cosmetics. The Panel reviewed the new and existing available animal and clinical data in making its determination of safety. The Panel found it appropriate to extrapolate the data on diethylhexyl sodium sulfosuccinate to assess the safety of the entire group because all of the diesters are of a similar alkyl chain length, all are symmetrically substituted, and all have similar functions in cosmetic formulations. © The Author(s) 2016.

MULTI-MEDIA MICROBIOLOGICAL RISK ASSESSMENT METHODOLOGY FOR MUNICIPAL WASTEWATER SLUDGES

EPA Science Inventory

In order to reduce the risk of municipal sludge to acceptable levels, the U.S. EPA has undertaken a regulatory program based on risk assessment and risk management. The key to such a program is the development of a methodology which allows the regulatory agency to quantify the re...

A methodology to assess the economic impact of power storage technologies.

PubMed

El-Ghandour, Laila; Johnson, Timothy C

2017-08-13

We present a methodology for assessing the economic impact of power storage technologies. The methodology is founded on classical approaches to the optimal stopping of stochastic processes but involves an innovation that circumvents the need to, ex ante , identify the form of a driving process and works directly on observed data, avoiding model risks. Power storage is regarded as a complement to the intermittent output of renewable energy generators and is therefore important in contributing to the reduction of carbon-intensive power generation. Our aim is to present a methodology suitable for use by policy makers that is simple to maintain, adaptable to different technologies and easy to interpret. The methodology has benefits over current techniques and is able to value, by identifying a viable optimal operational strategy, a conceived storage facility based on compressed air technology operating in the UK.This article is part of the themed issue 'Energy management: flexibility, risk and optimization'. © 2017 The Author(s).

Assessment of patient safety culture in private and public hospitals in Peru.

PubMed

Arrieta, Alejandro; Suárez, Gabriela; Hakim, Galed

2018-04-01

To assess the patient safety culture in Peruvian hospitals from the perspective of healthcare professionals, and to test for differences between the private and public healthcare sectors. Patient safety is defined as the avoidance and prevention of patient injuries or adverse events resulting from the processes of healthcare delivery. A non-random cross-sectional study conducted online. An online survey was administered from July to August 2016, in Peru. This study reports results from Lima and Callao, which are the capital and the port region of Peru. A total of 1679 healthcare professionals completed the survey. Participants were physicians, medical residents and nurses working in healthcare facilities from the private sector and public sector. Assessment of the degree of patient safety and 12 dimensions of patient safety culture in hospital units as perceived by healthcare professionals. Only 18% of healthcare professionals assess the degree of patient safety in their unit of work as excellent or very good. Significant differences are observed between the patient safety grades in the private sector (37%) compared to the public sub-sectors (13-15%). Moreover, in all patient safety culture dimensions, healthcare professionals from the private sector give more favorable responses for patient safety, than those from the public sub-systems. The most significant difference in support comes from patient safety administrators through communication and information about errors. Overall, the degree of patient safety in Peru is low, with significant gaps that exist between the private and the public sectors.

Post-earthquake building safety assessments for the Canterbury Earthquakes

USGS Publications Warehouse

Marshall, J.; Barnes, J.; Gould, N.; Jaiswal, K.; Lizundia, B.; Swanson, David A.; Turner, F.

2012-01-01

This paper explores the post-earthquake building assessment program that was utilized in Christchurch, New Zealand following the Canterbury Sequence of earthquakes beginning with the Magnitude (Mw.) 7.1 Darfield event in September 2010. The aftershocks or triggered events, two of which exceeded Mw 6.0, continued with events in February and June 2011 causing the greatest amount of damage. More than 70,000 building safety assessments were completed following the February event. The timeline and assessment procedures will be discussed including the use of rapid response teams, selection of indicator buildings to monitor damage following aftershocks, risk assessments for demolition of red-tagged buildings, the use of task forces to address management of the heavily damaged downtown area and the process of demolition. Through the post-event safety assessment program that occurred throughout the Canterbury Sequence of earthquakes, many important lessons can be learned that will benefit future response to natural hazards that have potential to damage structures.

Stoffenmanager exposure model: company-specific exposure assessments using a Bayesian methodology.

PubMed

van de Ven, Peter; Fransman, Wouter; Schinkel, Jody; Rubingh, Carina; Warren, Nicholas; Tielemans, Erik

2010-04-01

The web-based tool "Stoffenmanager" was initially developed to assist small- and medium-sized enterprises in the Netherlands to make qualitative risk assessments and to provide advice on control at the workplace. The tool uses a mechanistic model to arrive at a "Stoffenmanager score" for exposure. In a recent study it was shown that variability in exposure measurements given a certain Stoffenmanager score is still substantial. This article discusses an extension to the tool that uses a Bayesian methodology for quantitative workplace/scenario-specific exposure assessment. This methodology allows for real exposure data observed in the company of interest to be combined with the prior estimate (based on the Stoffenmanager model). The output of the tool is a company-specific assessment of exposure levels for a scenario for which data is available. The Bayesian approach provides a transparent way of synthesizing different types of information and is especially preferred in situations where available data is sparse, as is often the case in small- and medium sized-enterprises. Real-world examples as well as simulation studies were used to assess how different parameters such as sample size, difference between prior and data, uncertainty in prior, and variance in the data affect the eventual posterior distribution of a Bayesian exposure assessment.

Method of operator safety assessment for underground mobile mining equipment

NASA Astrophysics Data System (ADS)

Działak, Paulina; Karliński, Jacek; Rusiński, Eugeniusz

2018-01-01

The paper presents a method of assessing the safety of operators of mobile mining equipment (MME), which is adapted to current and future geological and mining conditions. The authors focused on underground mines, with special consideration of copper mines (KGHM). As extraction reaches into deeper layers of the deposit it can activate natural hazards, which, thus far, have been considered unusual and whose range and intensity are different depending on the field of operation. One of the main hazards that affect work safety and can become the main barrier in the exploitation of deposits at greater depths is climate threat. The authors have analysed the phenomena which may impact the safety of MME operators, with consideration of accidents that have not yet been studied and are not covered by the current safety standards for this group of miners. An attempt was made to develop a method for assessing the safety of MME operators, which takes into account the mentioned natural hazards and which is adapted to current and future environmental conditions in underground mines.

Methodology Development for Passive Component Reliability Modeling in a Multi-Physics Simulation Environment

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

Aldemir, Tunc; Denning, Richard; Catalyurek, Umit

Reduction in safety margin can be expected as passive structures and components undergo degradation with time. Limitations in the traditional probabilistic risk assessment (PRA) methodology constrain its value as an effective tool to address the impact of aging effects on risk and for quantifying the impact of aging management strategies in maintaining safety margins. A methodology has been developed to address multiple aging mechanisms involving large numbers of components (with possibly statistically dependent failures) within the PRA framework in a computationally feasible manner when the sequencing of events is conditioned on the physical conditions predicted in a simulation environment, suchmore » as the New Generation System Code (NGSC) concept. Both epistemic and aleatory uncertainties can be accounted for within the same phenomenological framework and maintenance can be accounted for in a coherent fashion. The framework accommodates the prospective impacts of various intervention strategies such as testing, maintenance, and refurbishment. The methodology is illustrated with several examples.« less

Evaluation of the safety of C-spine clearance by paramedics: design and methodology

PubMed Central

2011-01-01

Background Canadian Emergency Medical Services annually transport 1.3 million patients with potential neck injuries to local emergency departments. Less than 1% of those patients have a c-spine fracture and even less (0.5%) have a spinal cord injury. Most injuries occur before the arrival of paramedics, not during transport to the hospital, yet most patients are transported in ambulances immobilized. They stay fully immobilized until a bed is available, or until physician assessment and/or X-rays are complete. The prolonged immobilization is often unnecessary and adds to the burden of already overtaxed emergency medical services systems and crowded emergency departments. Methods/Design The goal of this study is to evaluate the safety and potential impact of an active strategy that allows paramedics to assess very low-risk trauma patients using a validated clinical decision rule, the Canadian C-Spine Rule, in order to determine the need for immobilization during transport to the emergency department. This cohort study will be conducted in Ottawa, Canada with one emergency medical service. Paramedics with this service participated in an earlier validation study of the Canadian C-Spine Rule. Three thousand consecutive, alert, stable adult trauma patients with a potential c-spine injury will be enrolled in the study and evaluated using the Canadian C-Spine Rule to determine the need for immobilization. The outcomes that will be assessed include measures of safety (numbers of missed fractures and serious adverse outcomes), measures of clinical impact (proportion of patients transported without immobilization, key time intervals) and performance of the Rule. Discussion Approximately 40% of all very low-risk trauma patients could be transported safely, without c-spine immobilization, if paramedics were empowered to make clinical decisions using the Canadian C-Spine Rule. This safety study is an essential step before allowing all paramedics across Canada to selectively

Safety assessment of discharge chute isolation barrier preparation and installation. Revision 1

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

Meichle, R.H.

1994-10-10

This revision responds to RL comments and increases the discussion of the ``effective hazard categorization`` and the readiness review basis. The safety assessment is made for the activities for the preparation and installation of the discharge chute isolation barriers. The safety assessment includes a hazard assessment and comparison of potential accidents/events to those addressed by the current safety basis documentation. No significant hazards were identified. An evaluation against the USQ evaluation questions were made and the determination made that the activities do not represent a USQ. Hazard categorization techniques were used to provide a basis for readiness review classification.

Chemical plant innovative safety investments decision-support methodology.

PubMed

Reniers, G L L; Audenaert, A

2009-01-01

This article examines the extent to which investing in safety during the creation of a new chemical installation proves profitable. The authors propose a management supporting cost-benefit model that identifies and evaluates investments in safety within a chemical company. This innovative model differentiates between serious accidents and less serious accidents, thus providing an authentic image of prevention-related costs and benefits. In classic cost-benefit analyses, which do not make such differentiations, only a rudimentary image of potential profitability resulting from investments in safety is obtained. The resulting management conclusions that can be drawn from such classical analyses are of a very limited nature. The proposed model, however, is applied to a real case study and the proposed investments in safety at an appointed chemical installation are weighed against the estimated hypothetical benefits resulting from the preventive measures to be installed at the installation. In the case-study carried out in question, it would appear that the proposed prevention investments are justified. Such an economic exercise may be very important to chemical corporations trying to (further) improve their safety investments.

Ultraviolet safety assessments of insect light traps

PubMed Central

Sliney, David H.; Gilbert, David W.; Lyon, Terry

2016-01-01

ABSTRACT Near-ultraviolet (UV-A: 315–400 nm), “black-light,” electric lamps were invented in 1935 and ultraviolet insect light traps (ILTs) were introduced for use in agriculture around that time. Today ILTs are used indoors in several industries and in food-service as well as in outdoor settings. With recent interest in photobiological lamp safety, safety standards are being developed to test for potentially hazardous ultraviolet emissions. A variety of UV “Black-light” ILTs were measured at a range of distances to assess potential exposures. Realistic time-weighted human exposures are shown to be well below current guidelines for human exposure to ultraviolet radiation. These UV-A exposures would be far less than the typical UV-A exposure in the outdoor environment. Proposals are made for realistic ultraviolet safety standards for ILT products. PMID:27043058

An assessment of data and methodology of online surgeon scorecards.

PubMed

Xu, Linda W; Li, Amy; Swinney, Christian; Babu, Maya; Veeravagu, Anand; Wolfe, Stacey Quintero; Nahed, Brian V; Ratliff, John K

2017-02-01

OBJECTIVE Recently, 2 surgeon rating websites (Consumers' Checkbook and ProPublica) were published to allow the public to compare surgeons through identifying surgeon volume and complication rates. Among neurosurgeons and orthopedic surgeons, only cervical and lumbar spine, hip, and knee procedures were included in this assessment. METHODS The authors examined the methodology of each website to assess potential sources of inaccuracy. Each online tool was queried for reports on neurosurgeons specializing in spine surgery and orthopedic surgeons specializing in spine, hip, or knee surgery. Surgeons were chosen from top-ranked hospitals in the US, as recorded by a national consumer publication ranking system, within the fields of neurosurgery and orthopedic surgery. The results were compared for accuracy and surgeon representation, and the results of the 2 websites were also compared. RESULTS The methodology of each site was found to have opportunities for bias and limited risk adjustment. The end points assessed by each site were actually not complications, but proxies of complication occurrence. A search of 510 surgeons (401 orthopedic surgeons [79%] and 109 neurosurgeons [21%]) showed that only 28% and 56% of surgeons had data represented on Consumers' Checkbook and ProPublica, respectively. There was a significantly higher chance of finding surgeon data on ProPublica (p < 0.001). Of the surgeons from top-ranked programs with data available, 17% were quoted to have high complication rates, 13% with lower volume than other surgeons, and 79% had a 3-star out of 5-star rating. There was no significant correlation found between the number of stars a surgeon received on Consumers' Checkbook and his or her adjusted complication rate on ProPublica. CONCLUSIONS Both the Consumers' Checkbook and ProPublica websites have significant methodological issues. Neither site assessed complication occurrence, but rather readmissions or prolonged length of stay. Risk adjustment was

Validity of instruments to assess students' travel and pedestrian safety.

PubMed

Mendoza, Jason A; Watson, Kathy; Baranowski, Tom; Nicklas, Theresa A; Uscanga, Doris K; Hanfling, Marcus J

2010-05-18

Safe Routes to School (SRTS) programs are designed to make walking and bicycling to school safe and accessible for children. Despite their growing popularity, few validated measures exist for assessing important outcomes such as type of student transport or pedestrian safety behaviors. This research validated the SRTS school travel survey and a pedestrian safety behavior checklist. Fourth grade students completed a brief written survey on how they got to school that day with set responses. Test-retest reliability was obtained 3-4 hours apart. Convergent validity of the SRTS travel survey was assessed by comparison to parents' report. For the measure of pedestrian safety behavior, 10 research assistants observed 29 students at a school intersection for completion of 8 selected pedestrian safety behaviors. Reliability was determined in two ways: correlations between the research assistants' ratings to that of the Principal Investigator (PI) and intraclass correlations (ICC) across research assistant ratings. The SRTS travel survey had high test-retest reliability (kappa = 0.97, n = 96, p < 0.001) and convergent validity (kappa = 0.87, n = 81, p < 0.001). The pedestrian safety behavior checklist had moderate reliability across research assistants' ratings (ICC = 0.48) and moderate correlation with the PI (r = 0.55, p = < 0.01). When two raters simultaneously used the instrument, the ICC increased to 0.65. Overall percent agreement (91%), sensitivity (85%) and specificity (83%) were acceptable. These validated instruments can be used to assess SRTS programs. The pedestrian safety behavior checklist may benefit from further formative work.

Validity of instruments to assess students' travel and pedestrian safety

PubMed Central

2010-01-01

Background Safe Routes to School (SRTS) programs are designed to make walking and bicycling to school safe and accessible for children. Despite their growing popularity, few validated measures exist for assessing important outcomes such as type of student transport or pedestrian safety behaviors. This research validated the SRTS school travel survey and a pedestrian safety behavior checklist. Methods Fourth grade students completed a brief written survey on how they got to school that day with set responses. Test-retest reliability was obtained 3-4 hours apart. Convergent validity of the SRTS travel survey was assessed by comparison to parents' report. For the measure of pedestrian safety behavior, 10 research assistants observed 29 students at a school intersection for completion of 8 selected pedestrian safety behaviors. Reliability was determined in two ways: correlations between the research assistants' ratings to that of the Principal Investigator (PI) and intraclass correlations (ICC) across research assistant ratings. Results The SRTS travel survey had high test-retest reliability (κ = 0.97, n = 96, p < 0.001) and convergent validity (κ = 0.87, n = 81, p < 0.001). The pedestrian safety behavior checklist had moderate reliability across research assistants' ratings (ICC = 0.48) and moderate correlation with the PI (r = 0.55, p =< 0.01). When two raters simultaneously used the instrument, the ICC increased to 0.65. Overall percent agreement (91%), sensitivity (85%) and specificity (83%) were acceptable. Conclusions These validated instruments can be used to assess SRTS programs. The pedestrian safety behavior checklist may benefit from further formative work. PMID:20482778

Methodology to develop crash modification functions for road safety treatments with fully specified and hierarchical models.

PubMed

Chen, Yongsheng; Persaud, Bhagwant

2014-09-01

Crash modification factors (CMFs) for road safety treatments are developed as multiplicative factors that are used to reflect the expected changes in safety performance associated with changes in highway design and/or the traffic control features. However, current CMFs have methodological drawbacks. For example, variability with application circumstance is not well understood, and, as important, correlation is not addressed when several CMFs are applied multiplicatively. These issues can be addressed by developing safety performance functions (SPFs) with components of crash modification functions (CM-Functions), an approach that includes all CMF related variables, along with others, while capturing quantitative and other effects of factors and accounting for cross-factor correlations. CM-Functions can capture the safety impact of factors through a continuous and quantitative approach, avoiding the problematic categorical analysis that is often used to capture CMF variability. There are two formulations to develop such SPFs with CM-Function components - fully specified models and hierarchical models. Based on sample datasets from two Canadian cities, both approaches are investigated in this paper. While both model formulations yielded promising results and reasonable CM-Functions, the hierarchical model was found to be more suitable in retaining homogeneity of first-level SPFs, while addressing CM-Functions in sub-level modeling. In addition, hierarchical models better capture the correlations between different impact factors. Copyright © 2014 Elsevier Ltd. All rights reserved.

A Methodological Proposal for Learning Games Selection and Quality Assessment

ERIC Educational Resources Information Center

Dondi, Claudio; Moretti, Michela

2007-01-01

This paper presents a methodological proposal elaborated in the framework of two European projects dealing with game-based learning, both of which have focused on "quality" aspects in order to create suitable tools that support European educators, practitioners and lifelong learners in selecting and assessing learning games for use in…

An assessment of the safety performance of farm vehicles subject to exemptions under MAP-21.

DOT National Transportation Integrated Search

2016-05-01

This report presents the methodology and findings from an analysis conducted by the Federal Motor Carrier Safety Administrations (FMCSAs) Office of Analysis, Research, and Technology, with support from the Office of Field Operations, in respons...

Methodology to Assess No Touch Audit Software Using Field Data

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

Cai, Jie; Braun, James E.; Langner, M. Rois

The research presented in this report builds upon these previous efforts and proposes a set of tests to assess no touch audit tools using real utility bill and on-site data. The proposed assessment methodology explicitly investigates the behaviors of the monthly energy end uses with respect to outdoor temperature, i.e., the building energy signature, to help understand the Tool's disaggregation accuracy. The project team collaborated with Field Diagnosis Services, Inc. (FDSI) to identify appropriate test sites for the evaluation.

Adverse Outcome Pathways can drive non-animal approaches for safety assessment

PubMed Central

Burden, Natalie; Sewell, Fiona; Andersen, Melvin E; Boobis, Alan; Chipman, J Kevin; Cronin, Mark T D; Hutchinson, Thomas H; Kimber, Ian; Whelan, Maurice

2015-01-01

Adverse Outcome Pathways (AOPs) provide an opportunity to develop new and more accurate safety assessment processes for drugs and other chemicals, and may ultimately play an important role in regulatory decision making. Not only can the development and application of AOPs pave the way for the development of improved evidence-based approaches for hazard and risk assessment, there is also the promise of a significant impact on animal welfare, with a reduced reliance on animal-based methods. The establishment of a useable and coherent knowledge framework under which AOPs will be developed and applied has been a first critical step towards realizing this opportunity. This article explores how the development of AOPs under this framework, and their application in practice, could benefit the science and practice of safety assessment, while in parallel stimulating a move away from traditional methods towards an increased acceptance of non-animal approaches. We discuss here the key areas where current, and future initiatives should be focused to enable the translation of AOPs into routine chemical safety assessment, and lasting 3Rs benefits. © 2015 The Authors. Journal of Applied Toxicology published by John Wiley & Sons Ltd. This article explores how the development and application of Adverse Outcome Pathways (AOPs) could benefit the science and practice of chemical safety assessment, with a particular focus on how their use in practice could reduce reliance on traditional animal toxicity tests. This includes discussion of the key areas where current and future initiatives should be focused to enable the translation of AOPs into routine chemical safety assessment, and lasting 3Rs benefits. PMID:25943792

Revealing and Resolving Patient Safety Defects: The Impact of Leadership WalkRounds on Frontline Caregiver Assessments of Patient Safety

PubMed Central

Frankel, Allan; Grillo, Sarah Pratt; Pittman, Mary; Thomas, Eric J; Horowitz, Lisa; Page, Martha; Sexton, Bryan

2008-01-01

Objective To evaluate the impact of rigorous WalkRounds on frontline caregiver assessments of safety climate, and to clarify the steps and implementation of rigorous WalkRounds. Data Sources/Study Setting Primary outcome variables were baseline and post WalkRounds safety climate scores from the Safety Attitudes Questionnaire (SAQ). Secondary outcomes were safety issues elicited through WalkRounds. Study period was August 2002 to April 2005; seven hospitals in Massachusetts agreed to participate; and the project was implemented in all patient care areas. Study Design Prospective study of the impact of rigorously applied WalkRounds on frontline caregivers assessments of safety climate in their patient care area. WalkRounds were conducted weekly and according to the seven-step WalkRounds Guide. The SAQ was administered at baseline and approximately 18 months post-WalkRounds implementation to all caregivers in patient care areas. Results Two of seven hospitals complied with the rigorous WalkRounds approach; hospital A was an academic teaching center and hospital B a community teaching hospital. Of 21 patient care areas, SAQ surveys were received from 62 percent of respondents at baseline and 60 percent post WalkRounds. At baseline, 10 of 21 care areas (48 percent) had safety climate scores below 60 percent, whereas post-WalkRounds three care areas (14 percent) had safety climate scores below 60 percent without improving by 10 points or more. Safety climate scale scores in hospital A were 62 percent at baseline and 77 percent post-WalkRounds (t=2.67, p=.03), and in hospital B were 46 percent at baseline and 56 percent post WalkRounds (t=2.06, p=.06). Main safety issues by category were equipment/facility (A [26 percent] and B [33 percent]) and communication (A [24 percent] and B [18 percent]). Conclusions WalkRounds implementation requires significant organizational will; sustainability requires outstanding project management and leadership engagement. In the patient

Gaming Space: A Game-Theoretic Methodology for Assessing the Deterrent Value of Space Control Options

DTIC Science & Technology

2018-06-07

Gaming Space A Game-Theoretic Methodology for Assessing the Deterrent Value of Space Control Options C O R...in space. Adversaries have already employed non -kinetic OSC capabilities, such as Global Positioning System jammers, in recent conflicts, and they...as part of the project “Assessing the Deterrent Value of Defensive Space Control Options.” The purpose of the project was to develop a methodology

Systems Analysis of NASA Aviation Safety Program: Final Report

NASA Technical Reports Server (NTRS)

Jones, Sharon M.; Reveley, Mary S.; Withrow, Colleen A.; Evans, Joni K.; Barr, Lawrence; Leone, Karen

2013-01-01

A three-month study (February to April 2010) of the NASA Aviation Safety (AvSafe) program was conducted. This study comprised three components: (1) a statistical analysis of currently available civilian subsonic aircraft data from the National Transportation Safety Board (NTSB), the Federal Aviation Administration (FAA), and the Aviation Safety Information Analysis and Sharing (ASIAS) system to identify any significant or overlooked aviation safety issues; (2) a high-level qualitative identification of future safety risks, with an assessment of the potential impact of the NASA AvSafe research on the National Airspace System (NAS) based on these risks; and (3) a detailed, top-down analysis of the NASA AvSafe program using an established and peer-reviewed systems analysis methodology. The statistical analysis identified the top aviation "tall poles" based on NTSB accident and FAA incident data from 1997 to 2006. A separate examination of medical helicopter accidents in the United States was also conducted. Multiple external sources were used to develop a compilation of ten "tall poles" in future safety issues/risks. The top-down analysis of the AvSafe was conducted by using a modification of the Gibson methodology. Of the 17 challenging safety issues that were identified, 11 were directly addressed by the AvSafe program research portfolio.

A 2-year study of patient safety competency assessment in 29 clinical laboratories.

PubMed

Reed, Robyn C; Kim, Sara; Farquharson, Kara; Astion, Michael L

2008-06-01

Competency assessment is critical for laboratory operations and is mandated by the Clinical Laboratory Improvement Amendments of 1988. However, no previous reports describe methods for assessing competency in patient safety. We developed and implemented a Web-based tool to assess performance of 875 laboratory staff from 29 laboratories in patient safety. Question categories included workplace culture, categorizing error, prioritization of patient safety interventions, strength of specific interventions, and general patient safety concepts. The mean score was 85.0%, with individual scores ranging from 56% to 100% and scores by category from 81.3% to 88.6%. Of the most difficult questions (<72% correct), 6 were about intervention strength, 3 about categorizing error, 1 about workplace culture, and 1 about prioritization of interventions. Of the 13 questions about intervention strength, 6 (46%) were in the lowest quartile, suggesting that this may be a difficult topic for laboratory technologists. Computer-based competency assessments help laboratories identify topics for continuing education in patient safety.

Safety assessment for In-service Pressure Bending Pipe Containing Incomplete Penetration Defects

NASA Astrophysics Data System (ADS)

Wang, M.; Tang, P.; Xia, J. F.; Ling, Z. W.; Cai, G. Y.

2017-12-01

Incomplete penetration defect is a common defect in the welded joint of pressure pipes. While the safety classification of pressure pipe containing incomplete penetration defects, according to periodical inspection regulations in present, is more conservative. For reducing the repair of incomplete penetration defect, a scientific and applicable safety assessment method for pressure pipe is needed. In this paper, the stress analysis model of the pipe system was established for the in-service pressure bending pipe containing incomplete penetration defects. The local finite element model was set up to analyze the stress distribution of defect location and the stress linearization. And then, the applicability of two assessment methods, simplified assessment and U factor assessment method, to the assessment of incomplete penetration defects located at pressure bending pipe were analyzed. The results can provide some technical supports for the safety assessment of complex pipelines in the future.

An improved approach for flight readiness certification: Methodology for failure risk assessment and application examples, volume 1

NASA Technical Reports Server (NTRS)

Moore, N. R.; Ebbeler, D. H.; Newlin, L. E.; Sutharshana, S.; Creager, M.

1992-01-01

An improved methodology for quantitatively evaluating failure risk of spaceflight systems to assess flight readiness and identify risk control measures is presented. This methodology, called Probabilistic Failure Assessment (PFA), combines operating experience from tests and flights with engineering analysis to estimate failure risk. The PFA methodology is of particular value when information on which to base an assessment of failure risk, including test experience and knowledge of parameters used in engineering analyses of failure phenomena, is expensive or difficult to acquire. The PFA methodology is a prescribed statistical structure in which engineering analysis models that characterize failure phenomena are used conjointly with uncertainties about analysis parameters and/or modeling accuracy to estimate failure probability distributions for specific failure modes. These distributions can then be modified, by means of statistical procedures of the PFA methodology, to reflect any test or flight experience. Conventional engineering analysis models currently employed for design of failure prediction are used in this methodology. The PFA methodology is described and examples of its application are presented. Conventional approaches to failure risk evaluation for spaceflight systems are discussed, and the rationale for the approach taken in the PFA methodology is presented. The statistical methods, engineering models, and computer software used in fatigue failure mode applications are thoroughly documented.

Current issues and perspectives in food safety and risk assessment.

PubMed

Eisenbrand, G

2015-12-01

In this review, current issues and opportunities in food safety assessment are discussed. Food safety is considered an essential element inherent in global food security. Hazard characterization is pivotal within the continuum of risk assessment, but it may be conceived only within a very limited frame as a true alternative to risk assessment. Elucidation of the mode of action underlying a given hazard is vital to create a plausible basis for human toxicology evaluation. Risk assessment, to convey meaningful risk communication, must be based on appropriate and reliable consideration of both exposure and mode of action. New perspectives, provided by monitoring human exogenous and endogenous exposure biomarkers, are considered of great promise to support classical risk extrapolation from animal toxicology. © The Author(s) 2015.

Equine Assisted Interventions (EAIs): Methodological Considerations for Stress Assessment in Horses

PubMed Central

Cirulli, Francesca; Luzi, Fabio; Stefani, Annalisa; Toson, Marica; Odore, Rosangela; Farina, Luca

2017-01-01

Equine assisted interventions (EAIs) are recently facing an increasing popularity, and are characterized by a wide diversity of practices. However, information on the welfare of animals involved in this kind of activity is often lacking. Horses are highly susceptible to work stressors related to physical constraints and/or to the need to control emotions while interacting with humans. Considerations of the emotional state of horses involved in EAIs have multiple valences: for the safety of humans and animals involved, for the quality and efficacy of interventions, as well as for ethical reasons. The aim of this unsystematic narrative review is to summarize the different approaches used for the evaluation of horses’ stress responses, investigate their application in the context of EAIs, and discuss some methodological considerations for researchers and practitioners involved in EAI. The sources of information are mostly based on electronic databases (i.e., Medline, Scopus and Google scholar), as well as on hand searches of the references of retrieved literature, and discussions with experts in the field. At present, a few studies have investigated horses’ stress responses during EAIs, and further studies are recommended, with the final aim to derive a reliable multidimensional method for assessing a horse’s reaction during therapeutic programs, ultimately helping professionals to better develop interventions by taking into consideration the animal’s perspective. PMID:29056702

Safety analysis, risk assessment, and risk acceptance criteria

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

Jamali, K.; Stack, D.W.; Sullivan, L.H.

1997-08-01

This paper discusses a number of topics that relate safety analysis as documented in the Department of Energy (DOE) safety analysis reports (SARs), probabilistic risk assessments (PRA) as characterized primarily in the context of the techniques that have assumed some level of formality in commercial nuclear power plant applications, and risk acceptance criteria as an outgrowth of PRA applications. DOE SARs of interest are those that are prepared for DOE facilities under DOE Order 5480.23 and the implementing guidance in DOE STD-3009-94. It must be noted that the primary area of application for DOE STD-3009 is existing DOE facilities andmore » that certain modifications of the STD-3009 approach are necessary in SARs for new facilities. Moreover, it is the hazard analysis (HA) and accident analysis (AA) portions of these SARs that are relevant to the present discussions. Although PRAs can be qualitative in nature, PRA as used in this paper refers more generally to all quantitative risk assessments and their underlying methods. HA as used in this paper refers more generally to all qualitative risk assessments and their underlying methods that have been in use in hazardous facilities other than nuclear power plants. This discussion includes both quantitative and qualitative risk assessment methods. PRA has been used, improved, developed, and refined since the Reactor Safety Study (WASH-1400) was published in 1975 by the Nuclear Regulatory Commission (NRC). Much debate has ensued since WASH-1400 on exactly what the role of PRA should be in plant design, reactor licensing, `ensuring` plant and process safety, and a large number of other decisions that must be made for potentially hazardous activities. Of particular interest in this area is whether the risks quantified using PRA should be compared with numerical risk acceptance criteria (RACs) to determine whether a facility is `safe.` Use of RACs requires quantitative estimates of consequence frequency and magnitude.« less

Methodologic limitations of prescription opioid safety research and recommendations for improving the evidence base.

PubMed

Ranapurwala, Shabbar I; Naumann, Rebecca B; Austin, Anna E; Dasgupta, Nabarun; Marshall, Stephen W

2018-06-03

The ongoing opioid epidemic has claimed more than a quarter million Americans' lives over the past 15 years. The epidemic began with an escalation of prescription opioid deaths and has now evolved to include secondary waves of illicit heroin and fentanyl deaths, while the deaths due to prescription opioid overdoses are still increasing. In response, the Centers for Disease Control and Prevention (CDC) moved to limit opioid prescribing with the release of opioid prescribing guidelines for chronic noncancer pain in March 2016. The guidelines represent a logical and timely federal response to this growing crisis. However, CDC acknowledged that the evidence base linking opioid prescribing to opioid use disorders and overdose was grades 3 and 4. Motivated by the need to strengthen the evidence base, this review details limitations of the opioid safety studies cited in the CDC guidelines with a focus on methodological limitations related to internal and external validity. Internal validity concerns were related to poor confounding control, variable misclassification, selection bias, competing risks, and potential competing interventions. External validity concerns arose from the use of limited source populations, historical data (in a fast-changing epidemic), and issues with handling of cancer and acute pain patients' data. We provide a nonexhaustive list of 7 recommendations to address these limitations in future opioid safety studies. Strengthening the opioid safety evidence base will aid any future revisions of the CDC guidelines and enhance their prevention impact. Copyright © 2018 John Wiley & Sons, Ltd.

Methodology for Collision Risk Assessment of an Airspace Flow Corridor Concept

NASA Astrophysics Data System (ADS)

Zhang, Yimin

This dissertation presents a methodology to estimate the collision risk associated with a future air-transportation concept called the flow corridor. The flow corridor is a Next Generation Air Transportation System (NextGen) concept to reduce congestion and increase throughput in en-route airspace. The flow corridor has the potential to increase throughput by reducing the controller workload required to manage aircraft outside the corridor and by reducing separation of aircraft within corridor. The analysis in this dissertation is a starting point for the safety analysis required by the Federal Aviation Administration (FAA) to eventually approve and implement the corridor concept. This dissertation develops a hybrid risk analysis methodology that combines Monte Carlo simulation with dynamic event tree analysis. The analysis captures the unique characteristics of the flow corridor concept, including self-separation within the corridor, lane change maneuvers, speed adjustments, and the automated separation assurance system. Monte Carlo simulation is used to model the movement of aircraft in the flow corridor and to identify precursor events that might lead to a collision. Since these precursor events are not rare, standard Monte Carlo simulation can be used to estimate these occurrence rates. Dynamic event trees are then used to model the subsequent series of events that may lead to collision. When two aircraft are on course for a near-mid-air collision (NMAC), the on-board automated separation assurance system provides a series of safety layers to prevent the impending NNAC or collision. Dynamic event trees are used to evaluate the potential failures of these layers in order to estimate the rare-event collision probabilities. The results show that the throughput can be increased by reducing separation to 2 nautical miles while maintaining the current level of safety. A sensitivity analysis shows that the most critical parameters in the model related to the overall

Using driving simulators to assess driving safety.

PubMed

Boyle, Linda Ng; Lee, John D

2010-05-01

Changes in drivers, vehicles, and roadways pose substantial challenges to the transportation safety community. Crash records and naturalistic driving data are useful for examining the influence of past or existing technology on drivers, and the associations between risk factors and crashes. However, they are limited because causation cannot be established and technology not yet installed in production vehicles cannot be assessed. Driving simulators have become an increasingly widespread tool to understand evolving and novel technologies. The ability to manipulate independent variables in a randomized, controlled setting also provides the added benefit of identifying causal links. This paper introduces a special issue on simulator-based safety studies. The special issue comprises 25 papers that demonstrate the use of driving simulators to address pressing transportation safety problems and includes topics as diverse as neurological dysfunction, work zone design, and driver distraction. Copyright (c) 2010 Elsevier Ltd. All rights reserved.

Methodology for safety optimization of highway cross-sections for horizontal curves with restricted sight distance.

PubMed

Ibrahim, Shewkar E; Sayed, Tarek; Ismail, Karim

2012-11-01

Several earlier studies have noted the shortcomings with existing geometric design guides which provide deterministic standards. In these standards the safety margin of the design output is generally unknown and there is little knowledge of the safety implications of deviating from the standards. To mitigate these shortcomings, probabilistic geometric design has been advocated where reliability analysis can be used to account for the uncertainty in the design parameters and to provide a mechanism for risk measurement to evaluate the safety impact of deviations from design standards. This paper applies reliability analysis for optimizing the safety of highway cross-sections. The paper presents an original methodology to select a suitable combination of cross-section elements with restricted sight distance to result in reduced collisions and consistent risk levels. The purpose of this optimization method is to provide designers with a proactive approach to the design of cross-section elements in order to (i) minimize the risk associated with restricted sight distance, (ii) balance the risk across the two carriageways of the highway, and (iii) reduce the expected collision frequency. A case study involving nine cross-sections that are parts of two major highway developments in British Columbia, Canada, was presented. The results showed that an additional reduction in collisions can be realized by incorporating the reliability component, P(nc) (denoting the probability of non-compliance), in the optimization process. The proposed approach results in reduced and consistent risk levels for both travel directions in addition to further collision reductions. Copyright © 2012 Elsevier Ltd. All rights reserved.

Methodological quality of systematic reviews on influenza vaccination.

PubMed

Remschmidt, Cornelius; Wichmann, Ole; Harder, Thomas

2014-03-26

There is a growing body of evidence on the risks and benefits of influenza vaccination in various target groups. Systematic reviews are of particular importance for policy decisions. However, their methodological quality can vary considerably. To investigate the methodological quality of systematic reviews on influenza vaccination (efficacy, effectiveness, safety) and to identify influencing factors. A systematic literature search on systematic reviews on influenza vaccination was performed, using MEDLINE, EMBASE and three additional databases (1990-2013). Review characteristics were extracted and the methodological quality of the reviews was evaluated using the assessment of multiple systematic reviews (AMSTAR) tool. U-test, Kruskal-Wallis test, chi-square test, and multivariable linear regression analysis were used to assess the influence of review characteristics on AMSTAR-score. Fourty-six systematic reviews fulfilled the inclusion criteria. Average methodological quality was high (median AMSTAR-score: 8), but variability was large (AMSTAR range: 0-11). Quality did not differ significantly according to vaccination target group. Cochrane reviews had higher methodological quality than non-Cochrane reviews (p=0.001). Detailed analysis showed that this was due to better study selection and data extraction, inclusion of unpublished studies, and better reporting of study characteristics (all p<0.05). In the adjusted analysis, no other factor, including industry sponsorship or journal impact factor had an influence on AMSTAR score. Systematic reviews on influenza vaccination showed large differences regarding their methodological quality. Reviews conducted by the Cochrane collaboration were of higher quality than others. When using systematic reviews to guide the development of vaccination recommendations, the methodological quality of a review in addition to its content should be considered. Copyright © 2014 Elsevier Ltd. All rights reserved.

Safety surrogate histograms (SSH): A novel real-time safety assessment of dilemma zone related conflicts at signalized intersections.

PubMed

Ghanipoor Machiani, Sahar; Abbas, Montasir

2016-11-01

Drivers' indecisiveness in dilemma zones (DZ) could result in crash-prone situations at signalized intersections. DZ is to the area ahead of an intersection in which drivers encounter a dilemma regarding whether to stop or proceed through the intersection when the signal turns yellow. An improper decision to stop by the leading driver, combined with the following driver deciding to go, can result in a rear-end collision, unless the following driver recognizes a collision is imminent and adjusts his or her behavior at or shortly after the onset of yellow. Considering the significance of DZ-related crashes, a comprehensive safety measure is needed to characterize the level of safety at signalized intersections. In this study, a novel safety surrogate measure was developed utilizing real-time radar field data. This new measure, called safety surrogate histogram (SSH), captures the degree and frequency of DZ-related conflicts at each intersection approach. SSH includes detailed information regarding the possibility of crashes, because it is calculated based on the vehicles conflicts. An example illustrating the application of the new methodology at two study sites in Virginia is presented and discussed, and a comparison is provided between SSH and other DZ-related safety surrogate measures mentioned in the literature. The results of the study reveal the efficacy of the SSH as complementary to existing surrogate measures. Copyright © 2015 Elsevier Ltd. All rights reserved.

INTERPRETING SPONTANEOUS RENAL LESIONS IN SAFETY AND RISK ASSESSMENT

EPA Science Inventory

Interpreting Spontaneous Renal Lesions in Safety and Risk Assessment
Douglas C. Wolf, D.V.M., Ph.D.

Introduction

Risk assessment is a process whereby the potential adverse health effects from exposure to a xenobiotic are predicted after evaluation of the availab...

Methodologies For A Physically Based Rockfall Hazard Assessment

NASA Astrophysics Data System (ADS)

Agliardi, F.; Crosta, G. B.; Guzzetti, F.; Marian, M.

Rockfall hazard assessment is an important land planning tool in alpine areas, where settlements progressively expand across rockfall prone areas, rising the vulnerability of the elements at risk, the worth of potential losses and the restoration costs. Nev- ertheless, hazard definition is not simple to achieve in practice and sound, physically based assessment methodologies are still missing. In addition, the high mobility of rockfalls implies a more difficult hazard definition with respect to other slope insta- bilities for which runout is minimal. When coping with rockfalls, hazard assessment involves complex definitions for "occurrence probability" and "intensity". The local occurrence probability must derive from the combination of the triggering probability (related to the geomechanical susceptibility of rock masses to fail) and the transit or impact probability at a given location (related to the motion of falling blocks). The intensity (or magnitude) of a rockfall is a complex function of mass, velocity and fly height of involved blocks that can be defined in many different ways depending on the adopted physical description and "destructiveness" criterion. This work is an attempt to evaluate rockfall hazard using the results of numerical modelling performed by an original 3D rockfall simulation program. This is based on a kinematic algorithm and allows the spatially distributed simulation of rockfall motions on a three-dimensional topography described by a DTM. The code provides raster maps portraying the max- imum frequency of transit, velocity and height of blocks at each model cell, easily combined in a GIS in order to produce physically based rockfall hazard maps. The results of some three dimensional rockfall models, performed at both regional and lo- cal scale in areas where rockfall related problems are well known, have been used to assess rockfall hazard, by adopting an objective approach based on three-dimensional matrixes providing a positional

DEVELOPMENT OF RISK ASSESSMENT METHODOLOGY FOR SURFACE DISPOSAL OF MUNICIPAL SLUDGE

EPA Science Inventory

This is one of a series of reports that present methodologies for assessing the potential risks to humans or other organisms from the disposal or reuse of municipal sludge. he sludge management practices addressed by this series include distribution and marketing programs, landfi...

Surrogate Safety Assessment Model (SSAM)--software user manual

DOT National Transportation Integrated Search

2008-05-01

This document presents guidelines for the installation and use of the Surrogate Safety Assessment Model (SSAM) software. For more information regarding the SSAM application, including discussion of theoretical background and the results of a series o...

A Framework for Assessment of Aviation Safety Technology Portfolios

NASA Technical Reports Server (NTRS)

Jones, Sharon M.; Reveley, Mary S.

2014-01-01

The programs within NASA's Aeronautics Research Mission Directorate (ARMD) conduct research and development to improve the national air transportation system so that Americans can travel as safely as possible. NASA aviation safety systems analysis personnel support various levels of ARMD management in their fulfillment of system analysis and technology prioritization as defined in the agency's program and project requirements. This paper provides a framework for the assessment of aviation safety research and technology portfolios that includes metrics such as projected impact on current and future safety, technical development risk and implementation risk. The paper also contains methods for presenting portfolio analysis and aviation safety Bayesian Belief Network (BBN) output results to management using bubble charts and quantitative decision analysis techniques.

AGRICULTURAL CHEMICAL SAFETY ASSESSMENT: A MULTISECTOR APPROACH TO THE MODERNIZATION OF HUMAN SAFETY REQUIREMENTS.

EPA Science Inventory

Better understanding of toxicological mechanisms, enhanced testing capabilities, and demands for more sophisticated data for safety and health risk assessment have generated international interest in improving the current testing paradigm for agricultural chemicals. To address th...

Remedial Action Assessment System: A computer-based methodology for conducting feasibility studies

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

White, M.K.; Buelt, J.L.; Stottlemyre, J.A.

1991-02-01

Because of the complexity and number of potential waste sites facing the US Department of Energy (DOE) for potential cleanup, DOE is supporting the development of a computer-based methodology to streamline the remedial investigation/feasibility study process. The Remedial Action Assessment System (RAAS), can be used for screening, linking, and evaluating established technology processes in support of conducting feasibility studies. It is also intended to do the same in support of corrective measures studies. The user interface employs menus, windows, help features, and graphical information while RAAS is in operation. Object-oriented programming is used to link unit processes into sets ofmore » compatible processes that form appropriate remedial alternatives. Once the remedial alternatives are formed, the RAAS methodology can evaluate them in terms of effectiveness, implementability, and cost. RAAS will access a user-selected risk assessment code to determine the reduction of risk after remedial action by each recommended alternative. The methodology will also help determine the implementability of the remedial alternatives at a site and access cost estimating tools to provide estimates of capital, operating, and maintenance costs. This paper presents the characteristics of two RAAS prototypes currently being developed. These include the RAAS Technology Information System, which accesses graphical, tabular and textual information about technologies, and the main RAAS methodology, which screens, links, and evaluates remedial technologies. 4 refs., 3 figs., 1 tab.« less

Ecological Momentary Assessment Methodology in Chronic Pain Research: A Systematic Review.

PubMed

May, Marcella; Junghaenel, Doerte U; Ono, Masakatsu; Stone, Arthur A; Schneider, Stefan

2018-01-31

Self-reported pain intensity assessments are central to chronic pain research. Ecological momentary assessment (EMA) methodologies are uniquely positioned to collect these data, and are indeed being used in the field. However, EMA protocols are complex, and many decisions are necessary in the design of EMA research studies. A systematic literature review identified 105 articles drawing from 62 quantitative EMA research projects examining pain intensity in adult chronic pain patients. Study characteristics were tabulated to summarize and describe the use of EMA, with an emphasis placed on various dimensions of decision-making involved in executing EMA methodologies. Most identified studies considered within-person relationships between pain and other variables, and a few examined interventions on chronic pain. There was a trend toward the use of smartphones as EMA data collection devices more recently, and completion rates were not reported in nearly one third of studies. Pain intensity items varied widely with respect to number of scale points, anchor labels, and length of reporting period; most used numeric rating scales. Recommendations are provided for reporting to improve reproducibility, comparability, and interpretation of results, and for opportunities to clarify the importance of design decisions. Studies that use EMA methodologies to assess pain intensity are heterogeneous. Aspects of protocol design, including data input modality and pain item construction, have the potential to influence the data collected. Thorough reporting on design features and completion rates therefore facilitates reproducibility, comparability, and interpretation of study results. Copyright © 2018 The American Pain Society. Published by Elsevier Inc. All rights reserved.

Safety Assessment of Alkyl Ethylhexanoates as Used in Cosmetics.

PubMed

Fiume, Monice; Heldreth, Bart; Bergfeld, Wilma F; Belsito, Donald V; Hill, Ronald A; Klaassen, Curtis D; Liebler, Daniel C; Marks, James G; Shank, Ronald C; Slaga, Thomas J; Snyder, Paul W; Andersen, F Alan

2015-01-01

The Cosmetic Ingredient Review (CIR) Expert Panel (Panel) assessed the safety of 16 alkyl ethylhexanoates for use in cosmetics, concluding that these ingredients are safe in cosmetic formulations in the present practices of use and concentrations when formulated to be nonirritating. The alkyl ethylhexanoates primarily function as skin-conditioning agents in cosmetics. The highest concentration of use reported for any of the alkyl ethylhexanoates is 77.3% cetyl ethylhexanoate in rinse-off formulations used near the eye, and the highest leave-on use reported is 52% cetyl ethylhexanoate in lipstick formulations. The Panel reviewed available animal and clinical data related to these ingredients, and the similarities in structure, properties, functions, and uses of ingredients from previous CIR assessments on constituent alcohols that allowed for extrapolation of the available toxicological data to assess the safety of the entire group. © The Author(s) 2015.

National assessment of geologic carbon dioxide storage resources: methodology implementation

USGS Publications Warehouse

Blondes, Madalyn S.; Brennan, Sean T.; Merrill, Matthew D.; Buursink, Marc L.; Warwick, Peter D.; Cahan, Steven M.; Corum, Margo D.; Cook, Troy A.; Craddock, William H.; DeVera, Christina A.; Drake II, Ronald M.; Drew, Lawrence J.; Freeman, P.A.; Lohr, Celeste D.; Olea, Ricardo A.; Roberts-Ashby, Tina L.; Slucher, Ernie R.; Varela, Brian A.

2013-01-01

In response to the 2007 Energy Independence and Security Act, the U.S. Geological Survey (USGS) conducted a national assessment of potential geologic storage resources for carbon dioxide (CO2). Storage of CO2 in subsurface saline formations is one important method to reduce greenhouse gas emissions and curb global climate change. This report provides updates and implementation details of the assessment methodology of Brennan and others (2010, http://pubs.usgs.gov/of/2010/1127/) and describes the probabilistic model used to calculate potential storage resources in subsurface saline formations.

The Impact of the Feminist Critique on Tests, Assessment, and Methodology.

ERIC Educational Resources Information Center

Lewin, Miriam; Wild, Cheryl L.

1991-01-01

Discusses early feminist efforts in psychological assessment, and reviews general issues related to feminist methodology. Successful impact and lack of impact of feminist criticism are illustrated by the revisions of the Strong Campbell Interest Inventory and the Minnesota Multiphasic Personality Inventory (1990), respectively. (SLD)

U. S. Environmental Protection Agency's inhalation RFD methodology: Risk assessment for air toxics

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

Jarabek, A.M.; Menache, M.G.; Overton, J.H.

1989-01-01

The U.S. Environmental Protection Agency (U.S. EPA) has advocated the establishment of general and scientific guidelines for the evaluation of toxicological data and their use in deriving benchmark values to protect exposed populations from adverse health effects. The Agency's reference dose (RfD) methodology for deriving benchmark values for noncancer toxicity originally addressed risk assessment of oral exposures. The paper presents a brief background on the development of the inhalation reference dose (RFDi) methodology, including concepts and issues related to addressing the dynamics of the respiratory system as the portal of entry. Different dosimetric adjustments are described that were incorporated intomore » the methodology to account for the nature of the inhaled agent (particle or gas) and the site of the observed toxic effects (respiratory or extrarespiratory). Impacts of these adjustments on the extrapolation of toxicity data of inhaled agents for human health risk assessment and future research directions are also discussed.« less

Assessment of insurance incentives for safety belt usage

DOT National Transportation Integrated Search

1983-05-12

This study assesses the feasibility of insurance companies to offer incentives, in the form of premium reductions or additional benefits, which would be effective in increasing safety belt usage. The insurance types considered in this report are auto...

Methodological optimization of tinnitus assessment using prepulse inhibition of the acoustic startle reflex.

PubMed

Longenecker, R J; Galazyuk, A V

2012-11-16

Recently prepulse inhibition of the acoustic startle reflex (ASR) became a popular technique for tinnitus assessment in laboratory animals. This method confers a significant advantage over the previously used time-consuming behavioral approaches utilizing basic mechanisms of conditioning. Although this technique has been successfully used to assess tinnitus in different laboratory animals, many of the finer details of this methodology have not been described enough to be replicated, but are critical for tinnitus assessment. Here we provide detail description of key procedures and methodological issues that provide guidance for newcomers with the process of learning to correctly apply gap detection techniques for tinnitus assessment in laboratory animals. The major categories of these issues include: refinement of hardware for best performance, optimization of stimulus parameters, behavioral considerations, and identification of optimal strategies for data analysis. This article is part of a Special Issue entitled: Tinnitus Neuroscience. Copyright © 2012. Published by Elsevier B.V.

Physical Activity and Safety From Crime Among Adults: A Systematic Review.

PubMed

da Silva, Inacio C; Payne, Valerie L; Hino, Adriano Akira; Varela, Andrea Ramirez; Reis, Rodrigo S; Ekelund, Ulf; Hallal, Pedro C

2016-06-01

The aim of this study was to review the evidence to date on the association between physical activity and safety from crime. Articles with adult populations of 500+ participants investigating the association between physical activity and safety from crime were included. A methodological quality assessment was conducted using an adapted version of the Downs and Black checklist. The literature search identified 15,864 articles. After assessment of titles, abstracts and full-texts, 89 articles were included. Most articles (84.3%) were derived from high-income countries and only 3 prospective articles were identified. Articles presented high methodological quality. In 38 articles (42.7%), at least one statistically significant association in the expected direction was reported (ie, safety from crime was positively associated with physical activity). Nine articles (10.1%) found an association in the unexpected direction and 42 (47.2%) did not find statistically significant associations. The results did not change when we analyzed articles separately by sex, age, type of measurement, or domains of physical activity evaluated. The current evidence, mostly based on cross-sectional studies, suggests a lack of association between physical activity and safety from crime. Prospective studies and natural experiments are needed, particularly in areas with wide crime variability.

Hazard Identification and Risk Assessment of Health and Safety Approach JSA (Job Safety Analysis) in Plantation Company

NASA Astrophysics Data System (ADS)

Sugarindra, Muchamad; Ragil Suryoputro, Muhammad; Tiya Novitasari, Adi

2017-06-01

Plantation company needed to identify hazard and perform risk assessment as an Identification of Hazard and Risk Assessment Crime and Safety which was approached by using JSA (Job Safety Analysis). The identification was aimed to identify the potential hazards that might be the risk of workplace accidents so that preventive action could be taken to minimize the accidents. The data was collected by direct observation to the workers concerned and the results were recorded on a Job Safety Analysis form. The data were as forklift operator, macerator worker, worker’s creeper, shredder worker, workers’ workshop, mechanical line worker, trolley cleaning workers and workers’ crepe decline. The result showed that shredder worker value was 30 and had the working level with extreme risk with the risk value range was above 20. So to minimize the accidents could provide Personal Protective Equipment (PPE) which were appropriate, information about health and safety, the company should have watched the activities of workers, and rewards for the workers who obey the rules that applied in the plantation.

Risk assessment of component failure modes and human errors using a new FMECA approach: application in the safety analysis of HDR brachytherapy.

PubMed

Giardina, M; Castiglia, F; Tomarchio, E

2014-12-01

Failure mode, effects and criticality analysis (FMECA) is a safety technique extensively used in many different industrial fields to identify and prevent potential failures. In the application of traditional FMECA, the risk priority number (RPN) is determined to rank the failure modes; however, the method has been criticised for having several weaknesses. Moreover, it is unable to adequately deal with human errors or negligence. In this paper, a new versatile fuzzy rule-based assessment model is proposed to evaluate the RPN index to rank both component failure and human error. The proposed methodology is applied to potential radiological over-exposure of patients during high-dose-rate brachytherapy treatments. The critical analysis of the results can provide recommendations and suggestions regarding safety provisions for the equipment and procedures required to reduce the occurrence of accidental events.

A Microbial Assessment Scheme to measure microbial performance of Food Safety Management Systems.

PubMed

Jacxsens, L; Kussaga, J; Luning, P A; Van der Spiegel, M; Devlieghere, F; Uyttendaele, M

2009-08-31

A Food Safety Management System (FSMS) implemented in a food processing industry is based on Good Hygienic Practices (GHP), Hazard Analysis Critical Control Point (HACCP) principles and should address both food safety control and assurance activities in order to guarantee food safety. One of the most emerging challenges is to assess the performance of a present FSMS. The objective of this work is to explain the development of a Microbial Assessment Scheme (MAS) as a tool for a systematic analysis of microbial counts in order to assess the current microbial performance of an implemented FSMS. It is assumed that low numbers of microorganisms and small variations in microbial counts indicate an effective FSMS. The MAS is a procedure that defines the identification of critical sampling locations, the selection of microbiological parameters, the assessment of sampling frequency, the selection of sampling method and method of analysis, and finally data processing and interpretation. Based on the MAS assessment, microbial safety level profiles can be derived, indicating which microorganisms and to what extent they contribute to food safety for a specific food processing company. The MAS concept is illustrated with a case study in the pork processing industry, where ready-to-eat meat products are produced (cured, cooked ham and cured, dried bacon).

Aligning the 3Rs with new paradigms in the safety assessment of chemicals.

PubMed

Burden, Natalie; Mahony, Catherine; Müller, Boris P; Terry, Claire; Westmoreland, Carl; Kimber, Ian

2015-04-01

There are currently several factors driving a move away from the reliance on in vivo toxicity testing for the purposes of chemical safety assessment. Progress has started to be made in the development and validation of non-animal methods. However, recent advances in the biosciences provide exciting opportunities to accelerate this process and to ensure that the alternative paradigms for hazard identification and risk assessment deliver lasting 3Rs benefits, whilst improving the quality and relevance of safety assessment. The NC3Rs, a UK-based scientific organisation which supports the development and application of novel 3Rs techniques and approaches, held a workshop recently which brought together over 20 international experts in the field of chemical safety assessment. The aim of this workshop was to review the current scientific, technical and regulatory landscapes, and to identify key opportunities towards reaching these goals. Here, we consider areas where further strategic investment will need to be focused if significant impact on 3Rs is to be matched with improved safety science, and why the timing is right for the field to work together towards an environment where we no longer rely on whole animal data for the accurate safety assessment of chemicals.

Terrain Safety Assessment in Support of the Mars Science Laboratory Mission

NASA Technical Reports Server (NTRS)

Kipp, Devin

2012-01-01

In August 2012, the Mars Science Laboratory (MSL) mission will pioneer the next generation of robotic Entry, Descent, and Landing (EDL) systems by delivering the largest and most capable rover to date to the surface of Mars. The process to select the MSL landing site took over five years and began with over 50 initial candidate sites from which four finalist sites were chosen. The four finalist sites were examined in detail to assess overall science merit, EDL safety, and rover traversability on the surface. Ultimately, the engineering assessments demonstrated a high level of safety and robustness at all four finalist sites and differences in the assessment across those sites were small enough that neither EDL safety nor rover traversability considerations could significantly discriminate among the final four sites. Thus the MSL landing site at Gale Crater was selected from among the four finalists primarily on the basis of science considerations.

Assessing Explosives Safety Risks, Deviations, And Consequences

DTIC Science & Technology

2009-07-31

Technical Paper 23 31 July 2009 DDESB Assessing Explosives Safety Risks, Deviations, And Consequences ...Deviations, And Consequences 5a. CONTRACT NUMBER 5b. GRANT NUMBER 5c. PROGRAM ELEMENT NUMBER 6. AUTHOR(S) 5d. PROJECT NUMBER 5e. TASK NUMBER...and approaches to assist warfighters in executing their mission, conserving resources, and maximizing operational effectiveness . When mission risk

Using Delphi Methodology to Design Assessments of Teachers' Pedagogical Content Knowledge

ERIC Educational Resources Information Center

Manizade, Agida Gabil; Mason, Marguerite M.

2011-01-01

Descriptions of methodologies that can be used to create items for assessing teachers' "professionally situated" knowledge are lacking in mathematics education research literature. In this study, researchers described and used the Delphi method to design an instrument to measure teachers' pedagogical content knowledge. The instrument focused on a…

Rating methodological quality: toward improved assessment and investigation.

PubMed

Moyer, Anne; Finney, John W

2005-01-01

Assessing methodological quality is considered essential in deciding what investigations to include in research syntheses and in detecting potential sources of bias in meta-analytic results. Quality assessment is also useful in characterizing the strengths and limitations of the research in an area of study. Although numerous instruments to measure research quality have been developed, they have lacked empirically-supported components. In addition, different summary quality scales have yielded different findings when they were used to weight treatment effect estimates for the same body of research. Suggestions for developing improved quality instruments include: distinguishing distinct domains of quality, such as internal validity, external validity, the completeness of the study report, and adherence to ethical practices; focusing on individual aspects, rather than domains of quality; and focusing on empirically-verified criteria. Other ways to facilitate the constructive use of quality assessment are to improve and standardize the reporting of research investigations, so that the quality of studies can be more equitably and thoroughly compared, and to identify optimal methods for incorporating study quality ratings into meta-analyses.

Neuropsychological assessment of refugees: Methodological and cross-cultural barriers.

PubMed

Veliu, Bahrie; Leathem, Janet

2017-01-01

Cross-cultural research in neuropsychological assessment has primarily focused on Hispanic and African American populations. Less is known about the impact of language, culture, education, socioeconomic factors, and life experiences on assessment for other cultural groups. We highlight the methodological and cross-cultural barriers encountered at each stage of the neuropsychological assessment of Arabic- and Burmese-speaking refugees, who were culturally and linguistically diverse (CALD). A total of 18 refugees (13 men/five women; in their 20-50s) who were victims of torture in their countries of origin, some with post-traumatic stress disorder (PTSD) and now residents in New Zealand, were seen for neuropsychological assessment. Measures were officially translated, back translated, and administered with the assistance of professional interpreters. Multiple challenges arose in terms of administration (e.g., use of interpreters, interactions with the tester, assessment environment, assessment experience, and motivation), scoring, and interpretation (e.g., age appropriate scoring, estimation of prior function, estimation of brain injury severity, obtaining collateral information), the tests themselves, and ecological validity. There are more challenges in the neuropsychological assessment of people who are CALD than can be managed by adhering to current guidelines. The best approach is to find a balance between maintaining assessment integrity and working creatively and sensitively with this group.

Advanced Reactor PSA Methodologies for System Reliability Analysis and Source Term Assessment

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

Grabaskas, D.; Brunett, A.; Passerini, S.

Beginning in 2015, a project was initiated to update and modernize the probabilistic safety assessment (PSA) of the GE-Hitachi PRISM sodium fast reactor. This project is a collaboration between GE-Hitachi and Argonne National Laboratory (Argonne), and funded in part by the U.S. Department of Energy. Specifically, the role of Argonne is to assess the reliability of passive safety systems, complete a mechanistic source term calculation, and provide component reliability estimates. The assessment of passive system reliability focused on the performance of the Reactor Vessel Auxiliary Cooling System (RVACS) and the inherent reactivity feedback mechanisms of the metal fuel core. Themore » mechanistic source term assessment attempted to provide a sequence specific source term evaluation to quantify offsite consequences. Lastly, the reliability assessment focused on components specific to the sodium fast reactor, including electromagnetic pumps, intermediate heat exchangers, the steam generator, and sodium valves and piping.« less

Preliminary Marine Safety Risk Assessment, Brandon Road Lock and Dam Invasive Species Control Measures

DTIC Science & Technology

2016-12-01

i Classification | CG-926 RDC | author | audience | month year Preliminary Marine Safety Risk Assessment, Brandon Road Lock & Dam...No. 4. Title and Subtitle Preliminary Marine Safety Risk Assessment, Brandon Road Lock & Dam Invasive Species Control Measures 5. Report Date...safety due to proposed invasive species control measures located in the vicinity of the Brandon Road Lock and Dam (BRLD) Navigation Project on the

A Methodology for Robust Comparative Life Cycle Assessments Incorporating Uncertainty.

PubMed

Gregory, Jeremy R; Noshadravan, Arash; Olivetti, Elsa A; Kirchain, Randolph E

2016-06-21

We propose a methodology for conducting robust comparative life cycle assessments (LCA) by leveraging uncertainty. The method evaluates a broad range of the possible scenario space in a probabilistic fashion while simultaneously considering uncertainty in input data. The method is intended to ascertain which scenarios have a definitive environmentally preferable choice among the alternatives being compared and the significance of the differences given uncertainty in the parameters, which parameters have the most influence on this difference, and how we can identify the resolvable scenarios (where one alternative in the comparison has a clearly lower environmental impact). This is accomplished via an aggregated probabilistic scenario-aware analysis, followed by an assessment of which scenarios have resolvable alternatives. Decision-tree partitioning algorithms are used to isolate meaningful scenario groups. In instances where the alternatives cannot be resolved for scenarios of interest, influential parameters are identified using sensitivity analysis. If those parameters can be refined, the process can be iterated using the refined parameters. We also present definitions of uncertainty quantities that have not been applied in the field of LCA and approaches for characterizing uncertainty in those quantities. We then demonstrate the methodology through a case study of pavements.

U.S. Department of Energy worker health risk evaluation methodology for assessing risks associated with environmental restoration and waste management

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

Blaylock, B.P.; Legg, J.; Travis, C.C.

1995-06-01

This document describes a worker health risk evaluation methodology for assessing risks associated with Environmental Restoration (ER) and Waste Management (WM). The methodology is appropriate for estimating worker risks across the Department of Energy (DOE) Complex at both programmatic and site-specific levels. This document supports the worker health risk methodology used to perform the human health risk assessment portion of the DOE Programmatic Environmental Impact Statement (PEIS) although it has applications beyond the PEIS, such as installation-wide worker risk assessments, screening-level assessments, and site-specific assessments.

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.

Guidance on assessing the methodological and reporting quality of toxicologically relevant studies: A scoping review.

PubMed

Samuel, Gbeminiyi O; Hoffmann, Sebastian; Wright, Robert A; Lalu, Manoj Mathew; Patlewicz, Grace; Becker, Richard A; DeGeorge, George L; Fergusson, Dean; Hartung, Thomas; Lewis, R Jeffrey; Stephens, Martin L

2016-01-01

Assessments of methodological and reporting quality are critical to adequately judging the credibility of a study's conclusions and to gauging its potential reproducibility. To aid those seeking to assess the methodological or reporting quality of studies relevant to toxicology, we conducted a scoping review of the available guidance with respect to four types of studies: in vivo and in vitro, (quantitative) structure-activity relationships ([Q]SARs), physico-chemical, and human observational studies. Our aims were to identify the available guidance in this diverse literature, briefly summarize each document, and distill the common elements of these documents for each study type. In general, we found considerable guidance for in vivo and human studies, but only one paper addressed in vitro studies exclusively. The guidance for (Q)SAR studies and physico-chemical studies was scant but authoritative. There was substantial overlap across guidance documents in the proposed criteria for both methodological and reporting quality. Some guidance documents address toxicology research directly, whereas others address preclinical research generally or clinical research and therefore may not be fully applicable to the toxicology context without some translation. Another challenge is the degree to which assessments of methodological quality in toxicology should focus on risk of bias - as in clinical medicine and healthcare - or be broadened to include other quality measures, such as confirming the identity of test substances prior to exposure. Our review is intended primarily for those in toxicology and risk assessment seeking an entry point into the extensive and diverse literature on methodological and reporting quality applicable to their work. Copyright © 2016 The Authors. Published by Elsevier Ltd.. All rights reserved.

Prioritization Methodology for Chemical Replacement

NASA Technical Reports Server (NTRS)

Cruit, W.; Schutzenhofer, S.; Goldberg, B.; Everhart, K.

1993-01-01

This project serves to define an appropriate methodology for effective prioritization of efforts required to develop replacement technologies mandated by imposed and forecast legislation. The methodology used is a semiquantitative approach derived from quality function deployment techniques (QFD Matrix). This methodology aims to weigh the full environmental, cost, safety, reliability, and programmatic implications of replacement technology development to allow appropriate identification of viable candidates and programmatic alternatives. The results are being implemented as a guideline for consideration for current NASA propulsion systems.

A brief review of strength and ballistic assessment methodologies in sport.

PubMed

McMaster, Daniel Travis; Gill, Nicholas; Cronin, John; McGuigan, Michael

2014-05-01

An athletic profile should encompass the physiological, biomechanical, anthropometric and performance measures pertinent to the athlete's sport and discipline. The measurement systems and procedures used to create these profiles are constantly evolving and becoming more precise and practical. This is a review of strength and ballistic assessment methodologies used in sport, a critique of current maximum strength [one-repetition maximum (1RM) and isometric strength] and ballistic performance (bench throw and jump capabilities) assessments for the purpose of informing practitioners and evolving current assessment methodologies. The reliability of the various maximum strength and ballistic assessment methodologies were reported in the form of intra-class correlation coefficients (ICC) and coefficient of variation (%CV). Mean percent differences (Mdiff = [/Xmethod1 - Xmethod2/ / (Xmethod1 + Xmethod2)] x 100) and effect size (ES = [Xmethod2 - Xmethod1] ÷ SDmethod1) calculations were used to assess the magnitude and spread of methodological differences for a given performance measure of the included studies. Studies were grouped and compared according to their respective performance measure and movement pattern. The various measurement systems (e.g., force plates, position transducers, accelerometers, jump mats, optical motion sensors and jump-and-reach apparatuses) and assessment procedures (i.e., warm-up strategies, loading schemes and rest periods) currently used to assess maximum isometric squat and mid-thigh pull strength (ICC > 0.95; CV < 2.0%), 1RM bench press, back squat and clean strength (ICC > 0.91; CV < 4.3%), and ballistic (vertical jump and bench throw) capabilities (ICC > 0.82; CV < 6.5%) were deemed highly reliable. The measurement systems and assessment procedures employed to assess maximum isometric strength [M(Diff) = 2-71%; effect size (ES) = 0.13-4.37], 1RM strength (M(Diff) = 1-58%; ES = 0.01-5.43), vertical jump capabilities (M(Diff) = 2-57%; ES

Safety assessment in plant layout design using indexing approach: implementing inherent safety perspective. Part 2-Domino Hazard Index and case study.

PubMed

Tugnoli, Alessandro; Khan, Faisal; Amyotte, Paul; Cozzani, Valerio

2008-12-15

The design of layout plans requires adequate assessment tools for the quantification of safety performance. The general focus of the present work is to introduce an inherent safety perspective at different points of the layout design process. In particular, index approaches for safety assessment and decision-making in the early stages of layout design are developed and discussed in this two-part contribution. Part 1 (accompanying paper) of the current work presents an integrated index approach for safety assessment of early plant layout. In the present paper (Part 2), an index for evaluation of the hazard related to the potential of domino effects is developed. The index considers the actual consequences of possible escalation scenarios and scores or ranks the subsequent accident propagation potential. The effects of inherent and passive protection measures are also assessed. The result is a rapid quantification of domino hazard potential that can provide substantial support for choices in the early stages of layout design. Additionally, a case study concerning selection among various layout options is presented and analyzed. The case study demonstrates the use and applicability of the indices developed in both parts of the current work and highlights the value of introducing inherent safety features early in layout design.

International Harmonization of Food Safety Assessment of Pesticide Residues.

PubMed

Ambrus, Árpád

2016-01-13

This paper summarizes the development of principles and methods applied within the program of the FAO/WHO Codex Alimentarius during the past 50 years for the safety assessment of pesticide residues in food and feed and establishing maximum residue limits (MRLs) to promote free international trade and assure the safety of consumers. The role of major international organizations in this process, the FAO capacity building activities, and some problematic areas that require special attention are briefly described.

Food Safety Practices Assessment Tool: An Innovative Way to Test Food Safety Skills among Individuals with Special Needs

ERIC Educational Resources Information Center

Carbone, Elena T.; Scarpati, Stanley E.; Pivarnik, Lori F.

2013-01-01

This article describes an innovative assessment tool designed to evaluate the effectiveness of a food safety skills curriculum for learners receiving special education services. As schools respond to the increased demand for training students with special needs about food safety, the need for effective curricula and tools is also increasing. A…

Drug research methodology. Volume 4, Epidemiology in drugs and highway safety : the study of drug use among drivers and its role in traffic crashes

DOT National Transportation Integrated Search

1980-06-01

This report presents the findings of a workshop on epidemiology in drugs and highway safety. A cross-disciplinary panel of experts (1) identified methodological issues and constraints present in research to define the nature and magnitude of the drug...

Dynamic safety assessment of natural gas stations using Bayesian network.

PubMed

Zarei, Esmaeil; Azadeh, Ali; Khakzad, Nima; Aliabadi, Mostafa Mirzaei; Mohammadfam, Iraj

2017-01-05

Pipelines are one of the most popular and effective ways of transporting hazardous materials, especially natural gas. However, the rapid development of gas pipelines and stations in urban areas has introduced a serious threat to public safety and assets. Although different methods have been developed for risk analysis of gas transportation systems, a comprehensive methodology for risk analysis is still lacking, especially in natural gas stations. The present work is aimed at developing a dynamic and comprehensive quantitative risk analysis (DCQRA) approach for accident scenario and risk modeling of natural gas stations. In this approach, a FMEA is used for hazard analysis while a Bow-tie diagram and Bayesian network are employed to model the worst-case accident scenario and to assess the risks. The results have indicated that the failure of the regulator system was the worst-case accident scenario with the human error as the most contributing factor. Thus, in risk management plan of natural gas stations, priority should be given to the most probable root events and main contribution factors, which have identified in the present study, in order to reduce the occurrence probability of the accident scenarios and thus alleviate the risks. Copyright © 2016 Elsevier B.V. All rights reserved.

A Methodology for Quantifying Certain Design Requirements During the Design Phase

NASA Technical Reports Server (NTRS)

Adams, Timothy; Rhodes, Russel

2005-01-01

A methodology for developing and balancing quantitative design requirements for safety, reliability, and maintainability has been proposed. Conceived as the basis of a more rational approach to the design of spacecraft, the methodology would also be applicable to the design of automobiles, washing machines, television receivers, or almost any other commercial product. Heretofore, it has been common practice to start by determining the requirements for reliability of elements of a spacecraft or other system to ensure a given design life for the system. Next, safety requirements are determined by assessing the total reliability of the system and adding redundant components and subsystems necessary to attain safety goals. As thus described, common practice leaves the maintainability burden to fall to chance; therefore, there is no control of recurring costs or of the responsiveness of the system. The means that have been used in assessing maintainability have been oriented toward determining the logistical sparing of components so that the components are available when needed. The process established for developing and balancing quantitative requirements for safety (S), reliability (R), and maintainability (M) derives and integrates NASA s top-level safety requirements and the controls needed to obtain program key objectives for safety and recurring cost (see figure). Being quantitative, the process conveniently uses common mathematical models. Even though the process is shown as being worked from the top down, it can also be worked from the bottom up. This process uses three math models: (1) the binomial distribution (greaterthan- or-equal-to case), (2) reliability for a series system, and (3) the Poisson distribution (less-than-or-equal-to case). The zero-fail case for the binomial distribution approximates the commonly known exponential distribution or "constant failure rate" distribution. Either model can be used. The binomial distribution was selected for

A flood tide of systematic reviews on endodontic posts: methodological assessment using of R-AMSTAR.

PubMed

Schmitter, M; Sterzenbach, G; Faggion, C M; Krastl, G

2013-06-01

To help the dental practitioner solve a specific clinical problem, systematic reviews (SRs) are seen as the best guide. In addition to the unmanageable quantity of SRs, however, one should be aware of their variable quality. The present review describes the methodological quality of SRs on postendodontic restorations to work out the value of these reviews for the dental practitioner. SRs were searched in April 2012, independently and in triplicate. Post survival was used as measure of outcome. The methodological quality of included SRs was assessed with the Revised Assessment of Multiple Systematic Reviews (R-AMSTAR) checklist. Kappa statistics were used to assess reviewer agreement. Three hundred sixty-three papers were retrieved from the initial search. Ten SRs were included. One SR achieved a high R-AMSTAR score, whereas the other nine SRs achieved scores that indicate a substantial lack of methodological quality. Especially the items "grey literature," "combination of findings," "likelihood of publication bias," and conflict of interest" showed low R-AMSTAR scores. The three reviews with the highest R-AMSTAR scores tended to conclude that fewer failures occurred when using nonmetal posts. The reviewer agreement was excellent (kappa ranged from 0.79 to 0.85) in the R-AMSTAR classification. The approach presented revealed a lack of SRs with high methodological quality. Thus, no decisive conclusion can be drawn with respect to this topic. It appears that there is a trend for the superiority of fiber-reinforced posts. SRs must be of high methodological quality. This can be achieved by taking into consideration the results of this review. Improved methodological quality would make SRs more supportive for the general practitioner.

The health-nutrition dimension: a methodological approach to assess the nutritional sustainability of typical agro-food products and the Mediterranean diet.

PubMed

Azzini, Elena; Maiani, Giuseppe; Turrini, Aida; Intorre, Federica; Lo Feudo, Gabriella; Capone, Roberto; Bottalico, Francesco; El Bilali, Hamid; Polito, Angela

2018-08-01

The aim of this paper is to provide a methodological approach to evaluate the nutritional sustainability of typical agro-food products, representing Mediterranean eating habits and included in the Mediterranean food pyramid. For each group of foods, suitable and easily measurable indicators were identified. Two macro-indicators were used to assess the nutritional sustainability of each product. The first macro-indicator, called 'business distinctiveness', takes into account the application of different regulations and standards regarding quality, safety and traceability as well as the origin of raw materials. The second macro-indicator, called 'nutritional quality', assesses product nutritional quality taking into account the contents of key compounds including micronutrients and bioactive phytochemicals. For each indicator a 0-10 scoring system was set up, with scores from 0 (unsustainable) to 10 (very sustainable), with 5 as a sustainability benchmark value. The benchmark value is the value from which a product can be considered sustainable. A simple formula was developed to produce a sustainability index. The proposed sustainability index could be considered a useful tool to describe both the qualitative and quantitative value of micronutrients and bioactive phytochemical present in foodstuffs. This methodological approach can also be applied beyond the Mediterranean, to food products in other world regions. © 2018 Society of Chemical Industry. © 2018 Society of Chemical Industry.

Screening Methodologies to Support Risk and Technology ...

EPA Pesticide Factsheets

The Clean Air Act establishes a two-stage regulatory process for addressing emissions of hazardous air pollutants (HAPs) from stationary sources. In the first stage, the Act requires the EPA to develop technology-based standards for categories of industrial sources. We have largely completed the required “Maximum Achievable Control Technology” (MACT) standards. In the second stage of the regulatory process, EPA must review each MACT standard at least every eight years and revise them as necessary, “taking into account developments in practices, processes and control technologies.” We call this requirement the “technology review.” EPA is also required to complete a one-time assessment of the health and environmental risks that remain after sources come into compliance with MACT. This residual risk review also must be done within 8 years of setting the initial MACT standard. If additional risk reductions are necessary to protect public health with an ample margin of safety or to prevent adverse environmental effects, EPA must develop standards to address these remaining risks. Because the risk review is an important component of the RTR process, EPA is seeking SAB input on the scientific credibility of specific enhancements made to our risk assessment methodologies, particularly with respect to screening methodologies, since the last SAB review was completed in 2010. These enhancements to our risk methodologies are outlined in the document title

Structural health monitoring methodology for aircraft condition-based maintenance

NASA Astrophysics Data System (ADS)

Saniger, Jordi; Reithler, Livier; Guedra-Degeorges, Didier; Takeda, Nobuo; Dupuis, Jean Pierre

2001-06-01

Reducing maintenance costs while keeping a constant level of safety is a major issue for Air Forces and airlines. The long term perspective is to implement condition based maintenance to guarantee a constant safety level while decreasing maintenance costs. On this purpose, the development of a generalized Structural Health Monitoring System (SHMS) is needed. The objective of such a system is to localize the damages and to assess their severity, with enough accuracy to allow low cost corrective actions. The present paper describes a SHMS based on acoustic emission technology. This choice was driven by its reliability and wide use in the aerospace industry. The described SHMS uses a new learning methodology which relies on the generation of artificial acoustic emission events on the structure and an acoustic emission sensor network. The calibrated acoustic emission events picked up by the sensors constitute the knowledge set that the system relies on. With this methodology, the anisotropy of composite structures is taken into account, thus avoiding the major cause of errors of classical localization methods. Moreover, it is adaptive to different structures as it does not rely on any particular model but on measured data. The acquired data is processed and the event's location and corrected amplitude are computed. The methodology has been demonstrated and experimental tests on elementary samples presented a degree of accuracy of 1cm.

Opportunities to Apply the 3Rs in Safety Assessment Programs

PubMed Central

Sewell, Fiona; Edwards, Joanna; Prior, Helen; Robinson, Sally

2016-01-01

Abstract Before a potential new medicine can be administered to humans it is essential that its safety is adequately assessed. Safety assessment in animals forms an integral part of this process, from early drug discovery and initial candidate selection to the program of recommended regulatory tests in animals. The 3Rs (replacement, reduction, and refinement of animals in research) are integrated in the current regulatory requirements and expectations and, in the EU, provide a legal and ethical framework for in vivo research to ensure the scientific objectives are met whilst minimizing animal use and maintaining high animal welfare standards. Though the regulations are designed to uncover potential risks, they are intended to be flexible, so that the most appropriate approach can be taken for an individual product. This article outlines current and future opportunities to apply the 3Rs in safety assessment programs for pharmaceuticals, and the potential (scientific, financial, and ethical) benefits to the industry, across the drug discovery and development process. For example, improvements to, or the development of, novel, early screens (e.g., in vitro, in silico, or nonmammalian screens) designed to identify compounds with undesirable characteristics earlier in development have the potential to reduce late-stage attrition by improving the selection of compounds that require regulatory testing in animals. Opportunities also exist within the current regulatory framework to simultaneously reduce and/or refine animal use and improve scientific outcomes through improvements to technical procedures and/or adjustments to study designs. It is important that approaches to safety assessment are continuously reviewed and challenged to ensure they are science-driven and predictive of relevant effects in humans. PMID:28053076

Assessment of patient safety culture in Palestinian public hospitals.

PubMed

Hamdan, Motasem; Saleem, Abed Alra'oof

2013-04-01

To assess the prevalent patient safety culture in Palestinian public hospitals. A cross-sectional design, Arabic translated version of the Hospital Survey on Patient Safety Culture was used. All the 11 general public hospitals in the West Bank. A total of 1460 clinical and non-clinical hospital staff. No. Twelve patient safety culture composites and 2 outcome variables (patient safety grade and events reported in the past year) were measured. Most of the participants were nurses and physicians (69.2%) with direct contact with patients (92%), mainly employed in medical/surgical units (55.1%). The patient safety composites with the highest positive scores were teamwork within units (71%), organizational learning and continuous improvement (62%) and supervisor/manager expectations and actions promoting patient safety (56%). The composites with the lowest scores were non-punitive response to error (17%), frequency of events reported (35%), communication openness (36%), hospital management support for patient safety (37%) and staffing (38%). Although 53.2% of the respondents did not report any event in the past year, 63.5% rated patient safety level as 'excellent/very good'. Significant differences in patient safety scores and outcome variables were found between hospitals of different size and in relation to staff positions and work hours. This study highlights the existence of a punitive and blame culture, under-reporting of events, lack of communication openness and inadequate management support that are key challenges for patient safe hospital care. The baseline survey results are valuable for designing and implementing the patient safety program and for measuring future progress.

Simulating Geriatric Home Safety Assessments in a Three-Dimensional Virtual World

ERIC Educational Resources Information Center

Andrade, Allen D.; Cifuentes, Pedro; Mintzer, Michael J.; Roos, Bernard A.; Anam, Ramanakumar; Ruiz, Jorge G.

2012-01-01

Virtual worlds could offer inexpensive and safe three-dimensional environments in which medical trainees can learn to identify home safety hazards. Our aim was to evaluate the feasibility, usability, and acceptability of virtual worlds for geriatric home safety assessments and to correlate performance efficiency in hazard identification with…

A methodology for physically based rockfall hazard assessment

NASA Astrophysics Data System (ADS)

Crosta, G. B.; Agliardi, F.

Rockfall hazard assessment is not simple to achieve in practice and sound, physically based assessment methodologies are still missing. The mobility of rockfalls implies a more difficult hazard definition with respect to other slope instabilities with minimal runout. Rockfall hazard assessment involves complex definitions for "occurrence probability" and "intensity". This paper is an attempt to evaluate rockfall hazard using the results of 3-D numerical modelling on a topography described by a DEM. Maps portraying the maximum frequency of passages, velocity and height of blocks at each model cell, are easily combined in a GIS in order to produce physically based rockfall hazard maps. Different methods are suggested and discussed for rockfall hazard mapping at a regional and local scale both along linear features or within exposed areas. An objective approach based on three-dimensional matrixes providing both a positional "Rockfall Hazard Index" and a "Rockfall Hazard Vector" is presented. The opportunity of combining different parameters in the 3-D matrixes has been evaluated to better express the relative increase in hazard. Furthermore, the sensitivity of the hazard index with respect to the included variables and their combinations is preliminarily discussed in order to constrain as objective as possible assessment criteria.

The in-depth safety assessment (ISA) pilot projects in Ukraine.

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

Kot, C. A.

1998-02-10

Ukraine operates pressurized water reactors of the Soviet-designed type, VVER. All Ukrainian plants are currently operating with annually renewable permits until they update their safety analysis reports (SARs). After approval of the SARS by the Ukrainian Nuclear Regulatory Authority, the plants will be granted longer-term operating licenses. In September 1995, the Nuclear Regulatory Authority and the Government Nuclear Power Coordinating Committee of Ukraine issued a new contents requirement for the safety analysis reports of VVERs in Ukraine. It contains requirements in three major areas: design basis accident (DBA) analysis, probabilistic risk assessment (PRA), and beyond design-basis accident (BDBA) analysis. Themore » DBA requirements are an expanded version of the older SAR requirements. The last two requirements, on PRA and BDBA, are new. The US Department of Energy (USDOE), through the International Nuclear Safety Program (INSP), has initiated an assistance and technology transfer program to Ukraine to assist their nuclear power stations in developing a Western-type technical basis for the new SARS. USDOE sponsored In-Depth Safety Assessments (ISAs) have been initiated at three pilot nuclear reactor units in Ukraine, South Ukraine Unit 1, Zaporizhzhya Unit 5, and Rivne Unit 1. USDOE/INSP have structured the ISA program in such a way as to provide maximum assistance and technology transfer to Ukraine while encouraging and supporting the Ukrainian plants to take the responsibility and initiative and to perform the required assessments.« less

Prioritization methodology for chemical replacement

NASA Technical Reports Server (NTRS)

Goldberg, Ben; Cruit, Wendy; Schutzenhofer, Scott

1995-01-01

This methodology serves to define a system for effective prioritization of efforts required to develop replacement technologies mandated by imposed and forecast legislation. The methodology used is a semi quantitative approach derived from quality function deployment techniques (QFD Matrix). QFD is a conceptual map that provides a method of transforming customer wants and needs into quantitative engineering terms. This methodology aims to weight the full environmental, cost, safety, reliability, and programmatic implications of replacement technology development to allow appropriate identification of viable candidates and programmatic alternatives.

Planning the Unplanned Experiment: Assessing the Efficacy of Standards for Safety Critical Software

NASA Technical Reports Server (NTRS)

Graydon, Patrick J.; Holloway, C. Michael

2015-01-01

We need well-founded means of determining whether software is t for use in safety-critical applications. While software in industries such as aviation has an excellent safety record, the fact that software aws have contributed to deaths illustrates the need for justi ably high con dence in software. It is often argued that software is t for safety-critical use because it conforms to a standard for software in safety-critical systems. But little is known about whether such standards `work.' Reliance upon a standard without knowing whether it works is an experiment; without collecting data to assess the standard, this experiment is unplanned. This paper reports on a workshop intended to explore how standards could practicably be assessed. Planning the Unplanned Experiment: Assessing the Ecacy of Standards for Safety Critical Software (AESSCS) was held on 13 May 2014 in conjunction with the European Dependable Computing Conference (EDCC). We summarize and elaborate on the workshop's discussion of the topic, including both the presented positions and the dialogue that ensued.

Teaching and assessing procedural skills using simulation: metrics and methodology.

PubMed

Lammers, Richard L; Davenport, Moira; Korley, Frederick; Griswold-Theodorson, Sharon; Fitch, Michael T; Narang, Aneesh T; Evans, Leigh V; Gross, Amy; Rodriguez, Elliot; Dodge, Kelly L; Hamann, Cara J; Robey, Walter C

2008-11-01

Simulation allows educators to develop learner-focused training and outcomes-based assessments. However, the effectiveness and validity of simulation-based training in emergency medicine (EM) requires further investigation. Teaching and testing technical skills require methods and assessment instruments that are somewhat different than those used for cognitive or team skills. Drawing from work published by other medical disciplines as well as educational, behavioral, and human factors research, the authors developed six research themes: measurement of procedural skills; development of performance standards; assessment and validation of training methods, simulator models, and assessment tools; optimization of training methods; transfer of skills learned on simulator models to patients; and prevention of skill decay over time. The article reviews relevant and established educational research methodologies and identifies gaps in our knowledge of how physicians learn procedures. The authors present questions requiring further research that, once answered, will advance understanding of simulation-based procedural training and assessment in EM.

Making the message meaningful: a qualitative assessment of media promoting all-terrain vehicle safety.

PubMed

Brann, Maria; Mullins, Samantha Hope; Miller, Beverly K; Eoff, Shane; Graham, James; Aitken, Mary E

2012-08-01

Millions of all-terrain vehicles (ATV) are used around the world for recreation by both adults and youth. This increase in use has led to a substantial increase in the number of injuries and fatalities each year. Effective strategies for reducing this incidence are clearly needed; however, minimal research exists regarding effective educational interventions. This study was designed to assess rural ATV riders' preferences for and assessment of safety messages. 13 focus group discussions with youth and adult ATV riders were conducted. 88 formative research participants provided feedback on existing ATV safety materials, which was used to develop more useful ATV safety messages. 60 evaluative focus group participants critiqued the materials developed for this project. Existing ATV safety materials have limited effectiveness, in part because they may not address the content or design needs of the target population. ATV riders want educational and action-oriented safety messages that inform youth and adult riders about their responsibilities to learn, educate and implement safety behaviours (eg, appropriate-sized ATV, safety gear, solo riding, speed limits, riding locations). In addition, messages should be clear, realistic, visually appealing and easily accessible. Newly designed ATV safety materials using the acronym TRIPSS (training, ride off-road, impairment, plan ahead, safety gear, single rider) meet ATV riders' safety messaging needs. To reach a target population, it is crucial to include them in the development and assessment of safety messages. Germane to this particular study, ATV riders provided essential information for creating useful ATV safety materials.

LNG safety assessment evaluation methods : task 3 letter report.

DOT National Transportation Integrated Search

2016-07-01

Sandia National Laboratories evaluated published safety assessment methods across a variety of industries including Liquefied Natural Gas (LNG), hydrogen, land and marine transportation, as well as the US Department of Defense (DOD). All the methods ...

Microbial food safety in Ghana: a meta-analysis.

PubMed

Saba, Courage K S; Gonzalez-Zorn, Bruno

2012-12-16

Food safety is a crucial factor in the growth of developing countries worldwide. In this study, we present a meta-analysis of microbiological food safety publications from Ghana. The search words "Ghana food safety", "Ghana food research", and "Ghana food bacteria" were used to search for microbiological food safety publications with related abstracts or titles in PubMed, published between 1997 and 2009. We obtained 183 research articles, from which we excluded articles concerning ready-to-eat microbial fermented foods and waterborne microorganisms as well as articles without abstracts. The criteria used for analysis of these publications were based on an assessment of methodological soundness previously developed for use in the medical field, with some modifications incorporated. The most predominant bacteria in Ghanain foods are Enterobacter spp., Citrobacter spp., Klebsiella spp. and Escherichia spp., which were found to be present in 65%, 50%, 46% and 38% respectively, of the food samples considered in the studies analysed. The most contaminated food samples were macaroni, salad, and milk. Although the methodological quality of the articles was generally sound, most of them did not give directions for future research. Several did not state possible reasons for differences between studies. The microbiological food contamination in Ghana is alarming. However, we found that the downward trend in publications of microbial food safety articles is appalling. Hence a concerted effort in research on food safety is needed in Ghana to help curb the incidence of preventable food-borne disease.

Methodology for stereoscopic motion-picture quality assessment

NASA Astrophysics Data System (ADS)

Voronov, Alexander; Vatolin, Dmitriy; Sumin, Denis; Napadovsky, Vyacheslav; Borisov, Alexey

2013-03-01

Creating and processing stereoscopic video imposes additional quality requirements related to view synchronization. In this work we propose a set of algorithms for detecting typical stereoscopic-video problems, which appear owing to imprecise setup of capture equipment or incorrect postprocessing. We developed a methodology for analyzing the quality of S3D motion pictures and for revealing their most problematic scenes. We then processed 10 modern stereo films, including Avatar, Resident Evil: Afterlife and Hugo, and analyzed changes in S3D-film quality over the years. This work presents real examples of common artifacts (color and sharpness mismatch, vertical disparity and excessive horizontal disparity) in the motion pictures we processed, as well as possible solutions for each problem. Our results enable improved quality assessment during the filming and postproduction stages.

Laboratory Biosafety and Biosecurity Risk Assessment Technical Guidance Document

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

Astuto-Gribble, Lisa M; Caskey, Susan Adele

2014-07-01

The purpose of this document is threefold: 1) to describe the laboratory bio safety and biosecurity risk assessment process and its conceptual framework; 2) provide detailed guidance and suggested methodologies on how to conduct a risk assessment; and 3) present some practical risk assessment process strategies using realistic laboratory scenarios.

An improved approach for flight readiness certification: Methodology for failure risk assessment and application examples. Volume 2: Software documentation

NASA Technical Reports Server (NTRS)

Moore, N. R.; Ebbeler, D. H.; Newlin, L. E.; Sutharshana, S.; Creager, M.

1992-01-01

An improved methodology for quantitatively evaluating failure risk of spaceflight systems to assess flight readiness and identify risk control measures is presented. This methodology, called Probabilistic Failure Assessment (PFA), combines operating experience from tests and flights with engineering analysis to estimate failure risk. The PFA methodology is of particular value when information on which to base an assessment of failure risk, including test experience and knowledge of parameters used in engineering analyses of failure phenomena, is expensive or difficult to acquire. The PFA methodology is a prescribed statistical structure in which engineering analysis models that characterize failure phenomena are used conjointly with uncertainties about analysis parameters and/or modeling accuracy to estimate failure probability distributions for specific failure modes, These distributions can then be modified, by means of statistical procedures of the PFA methodology, to reflect any test or flight experience. Conventional engineering analysis models currently employed for design of failure prediction are used in this methodology. The PFA methodology is described and examples of its application are presented. Conventional approaches to failure risk evaluation for spaceflight systems are discussed, and the rationale for the approach taken in the PFA methodology is presented. The statistical methods, engineering models, and computer software used in fatigue failure mode applications are thoroughly documented.

Assessing medical students' perceptions of patient safety: the medical student safety attitudes and professionalism survey.

PubMed

Liao, Joshua M; Etchegaray, Jason M; Williams, S Tyler; Berger, David H; Bell, Sigall K; Thomas, Eric J

2014-02-01

To develop and test the psychometric properties of a survey to measure students' perceptions about patient safety as observed on clinical rotations. In 2012, the authors surveyed 367 graduating fourth-year medical students at three U.S. MD-granting medical schools. They assessed the survey's reliability and construct and concurrent validity. They examined correlations between students' perceptions of organizational cultural factors, organizational patient safety measures, and students' intended safety behaviors. They also calculated percent positive scores for cultural factors. Two hundred twenty-eight students (62%) responded. Analyses identified five cultural factors (teamwork culture, safety culture, error disclosure culture, experiences with professionalism, and comfort expressing professional concerns) that had construct validity, concurrent validity, and good reliability (Cronbach alphas > 0.70). Across schools, percent positive scores for safety culture ranged from 28% (95% confidence interval [CI], 13%-43%) to 64% (30%-98%), while those for teamwork culture ranged from 47% (32%-62%) to 74% (66%-81%). They were low for error disclosure culture (range: 10% [0%-20%] to 27% [20%-35%]), experiences with professionalism (range: 7% [0%-15%] to 23% [16%-30%]), and comfort expressing professional concerns (range: 17% [5%-29%] to 38% [8%-69%]). Each cultural factor correlated positively with perceptions of overall patient safety as observed in clinical rotations (r = 0.37-0.69, P < .05) and at least one safety behavioral intent item. This study provided initial evidence for the survey's reliability and validity and illustrated its applicability for determining whether students' clinical experiences exemplify positive patient safety environments.

Total System Design (TSD) Methodology Assessment.

DTIC Science & Technology

1983-01-01

hardware implementation. Author: Martin - Marietta Aerospace Title: Total System Design Methodology Source: Martin - Marietta Technical Report MCR -79-646...systematic, rational approach to computer systems design is needed. Martin - Marietta has produced a Total System Design Methodology to support such design...gathering and ordering. The purpose of the paper is to document the existing TSD methoeology at Martin - Marietta , describe the supporting tools, and

Positive lists of cosmetic ingredients: Analytical methodology for regulatory and safety controls - A review.

PubMed

Lores, Marta; Llompart, Maria; Alvarez-Rivera, Gerardo; Guerra, Eugenia; Vila, Marlene; Celeiro, Maria; Lamas, J Pablo; Garcia-Jares, Carmen

2016-04-07

Cosmetic products placed on the market and their ingredients, must be safe under reasonable conditions of use, in accordance to the current legislation. Therefore, regulated and allowed chemical substances must meet the regulatory criteria to be used as ingredients in cosmetics and personal care products, and adequate analytical methodology is needed to evaluate the degree of compliance. This article reviews the most recent methods (2005-2015) used for the extraction and the analytical determination of the ingredients included in the positive lists of the European Regulation of Cosmetic Products (EC 1223/2009): comprising colorants, preservatives and UV filters. It summarizes the analytical properties of the most relevant analytical methods along with the possibilities of fulfilment of the current regulatory issues. The cosmetic legislation is frequently being updated; consequently, the analytical methodology must be constantly revised and improved to meet safety requirements. The article highlights the most important advances in analytical methodology for cosmetics control, both in relation to the sample pretreatment and extraction and the different instrumental approaches developed to solve this challenge. Cosmetics are complex samples, and most of them require a sample pretreatment before analysis. In the last times, the research conducted covering this aspect, tended to the use of green extraction and microextraction techniques. Analytical methods were generally based on liquid chromatography with UV detection, and gas and liquid chromatographic techniques hyphenated with single or tandem mass spectrometry; but some interesting proposals based on electrophoresis have also been reported, together with some electroanalytical approaches. Regarding the number of ingredients considered for analytical control, single analyte methods have been proposed, although the most useful ones in the real life cosmetic analysis are the multianalyte approaches. Copyright © 2016

The KULTURisk Regional Risk Assessment methodology for water-related natural hazards - Part 1: Physical-environmental assessment

NASA Astrophysics Data System (ADS)

Ronco, P.; Gallina, V.; Torresan, S.; Zabeo, A.; Semenzin, E.; Critto, A.; Marcomini, A.

2014-07-01

In recent years, the frequency of catastrophes induced by natural hazard has increased and flood events in particular have been recognized as one of the most threatening water-related disasters. Severe floods have occurred in Europe over the last decade causing loss of life, displacement of people and heavy economic losses. Flood disasters are growing as a consequence of many factors, both climatic and non-climatic. Indeed, the current increase of water-related disasters can be mainly attributed to the increase of exposure (increase elements potentially at risk in floodplains area) and vulnerability (i.e. economic, social, geographic, cultural, and physical/environmental characteristics of the exposure). Besides these factors, the strong effect of climate change is projected to radically modify the usual pattern of the hydrological cycle by intensifying the frequency and severity of flood events both at local, regional and global scale. Within this context, it becomes urgent and dramatically relevant the need of promoting and developing effective and pro-active strategies, tools and actions which allow to assess and (possibly) to reduce the flood risks that threats different relevant receptors. Several methodologies to assess the risk posed by water-related natural hazards have been proposed so far, but very few of them can be adopted to implement the last European Flood Directive (FD). The present study is intended to introduce and present a state-of-the-art Regional Risk Assessment (RRA) methodology to evaluate the benefits of risk prevention in terms of reduced environmental risks due to floods. The methodology, developed within the recently phased out FP7-KULTURisk Project (Knowledge-based approach to develop a cULTUre of Risk prevention - KR) is flexible and can be adapted to different case studies (i.e. large rivers, alpine/mountain catchments, urban areas and coastal areas) and spatial scales (i.e. from the large river to the urban scale). The FD compliant

Safety risk assessment using analytic hierarchy process (AHP) during planning and budgeting of construction projects.

PubMed

Aminbakhsh, Saman; Gunduz, Murat; Sonmez, Rifat

2013-09-01

The inherent and unique risks on construction projects quite often present key challenges to contractors. Health and safety risks are among the most significant risks in construction projects since the construction industry is characterized by a relatively high injury and death rate compared to other industries. In construction project management, safety risk assessment is an important step toward identifying potential hazards and evaluating the risks associated with the hazards. Adequate prioritization of safety risks during risk assessment is crucial for planning, budgeting, and management of safety related risks. In this paper, a safety risk assessment framework is presented based on the theory of cost of safety (COS) model and the analytic hierarchy process (AHP). The main contribution of the proposed framework is that it presents a robust method for prioritization of safety risks in construction projects to create a rational budget and to set realistic goals without compromising safety. The framework provides a decision tool for the decision makers to determine the adequate accident/injury prevention investments while considering the funding limits. The proposed safety risk framework is illustrated using a real-life construction project and the advantages and limitations of the framework are discussed. Copyright © 2013 National Safety Council and Elsevier Ltd. All rights reserved.

Safety assessment of foods from genetically modified crops in countries with developing economies.

PubMed

Delaney, Bryan

2015-12-01

Population growth particularly in countries with developing economies will result in a need to increase food production by 70% by the year 2050. Biotechnology has been utilized to produce genetically modified (GM) crops for insect and weed control with benefits including increased crop yield and will also be used in emerging countries. A multicomponent safety assessment paradigm has been applied to individual GM crops to determine whether they as safe as foods from non-GM crops. This paper reviews methods to assess the safety of foods from GM crops for safe consumption from the first generation of GM crops. The methods can readily be applied to new products developed within country and this paper will emphasize the concept of data portability; that safety data produced in one geographic location is suitable for safety assessment regardless of where it is utilized. Copyright © 2015 The Authors. Published by Elsevier Ltd.. All rights reserved.

Preliminary safety assessment of C-8 xylitol monoester and xylitol phosphate esters.

PubMed

Silveira, J E P S; Pereda, M C V; Nogueira, C; Dieamant, G; Cesar, C K M; Assanome, K M; Silva, M S; Torello, C O; Queiroz, M L S; Eberlin, S

2016-02-01

Most of the cosmetic compounds with preservative properties available in the market pose some risks concerning safety, such as the possibility of causing sensitization. Due to the fact that there are few options, the proper development of new molecules with this purpose is needed. Xylitol is a natural sugar, and the antimicrobial properties of xylitol-derived compounds have already been described in the literature. C-8 xylitol monoester and xylitol phosphate esters may be useful for the development of skincare products. As an initial screen for safety of chemicals, the combination of in silico methods and in vitro testing can aid in prioritizing resources in toxicological investigations while reducing the ethical and monetary costs that are related to animal and human testing. This study was designed to evaluate the safety of C-8 xylitol monoester and xylitol phosphate esters regarding carcinogenicity, mutagenicity, skin and eye irritation/corrosion and sensitization through alternative methods. For the initial safety assessment, quantitative structure-activity relationship methodology was used. The prediction of the parameters carcinogenicity/mutagenicity, skin and eye irritation/corrosion and sensitization was generated from the chemical structure. The analysis also comprised physical-chemical properties, Cramer rules, threshold of toxicological concern and Michael reaction. In silico results of candidate molecules were compared to 19 compounds with preservative properties that are available in the market. Additionally, in vitro tests (Ames test for mutagenicity, cytotoxicity and phototoxicity tests and hen's egg test--chorioallantoic membrane for irritation) were performed to complement the evaluation. In silico evaluation of both molecules presented no structural alerts related to eye and skin irritation, corrosion and sensitization, but some alerts for micronucleus and carcinogenicity were detected. However, by comparison, C-8 xylitol monoester, xylitol

Safety assessment in the urban park environment in Alborz Province, Iran.

PubMed

Oostakhan, Morteza; Babaei, Aliakbar

2013-01-01

Urban parks, as one of the recreational and sports sectors, could cause serious injuries among different ages if the safety issues in their design are not considered. These injuries can result from the equipment in the park, including play and sports equipment, or even from environmental factors, too. Lack of safety benchmark in parks will impact on the development of future proposals. In this article, attempts are made to survey the important safety factors in the urban parks including playgrounds, fitness equipment, pedestrian surface and environmental factors into a risk assessment. Hence, a checklist of safety factors was used. A Yes or No descriptor was allocated to any factor for determining safety level. The study also suggests recommendations for future planning concerning existing failures for designers. It was found that the safety level of the regional and local parks differ from each other.

Acceleration-based methodology to assess the blast mitigation performance of explosive ordnance disposal helmets

NASA Astrophysics Data System (ADS)

Dionne, J. P.; Levine, J.; Makris, A.

2018-01-01

To design the next generation of blast mitigation helmets that offer increasing levels of protection against explosive devices, manufacturers must be able to rely on appropriate test methodologies and human surrogates that will differentiate the performance level of various helmet solutions and ensure user safety. Ideally, such test methodologies and associated injury thresholds should be based on widely accepted injury criteria relevant within the context of blast. Unfortunately, even though significant research has taken place over the last decade in the area of blast neurotrauma, there currently exists no agreement in terms of injury mechanisms for blast-induced traumatic brain injury. In absence of such widely accepted test methods and injury criteria, the current study presents a specific blast test methodology focusing on explosive ordnance disposal protective equipment, involving the readily available Hybrid III mannequin, initially developed for the automotive industry. The unlikely applicability of the associated brain injury criteria (based on both linear and rotational head acceleration) is discussed in the context of blast. Test results encompassing a large number of blast configurations and personal protective equipment are presented, emphasizing the possibility to develop useful correlations between blast parameters, such as the scaled distance, and mannequin engineering measurements (head acceleration). Suggestions are put forward for a practical standardized blast testing methodology taking into account limitations in the applicability of acceleration-based injury criteria as well as the inherent variability in blast testing results.

Developing Methodologies for Evaluating the Earthquake Safety of Existing Buildings.

ERIC Educational Resources Information Center

Bresler, B.; And Others

This report contains four papers written during an investigation of methods for evaluating the safety of existing school buildings under Research Applied to National Needs (RANN) grants. In "Evaluation of Earthquake Safety of Existing Buildings," by B. Bresler, preliminary ideas on the evaluation of the earthquake safety of existing…

Food and Feed Safety Assessment: The Importance of Proper Sampling.

PubMed

Kuiper, Harry A; Paoletti, Claudia

2015-03-24

The general principles for safety and nutritional evaluation of foods and feed and the potential health risks associated with hazardous compounds are described as developed by the Food and Agriculture Organization (FAO) and the World Health Organization (WHO) and further elaborated in the European Union-funded project Safe Foods. We underline the crucial role of sampling in foods/feed safety assessment. High quality sampling should always be applied to ensure the use of adequate and representative samples as test materials for hazard identification, toxicological and nutritional characterization of identified hazards, as well as for estimating quantitative and reliable exposure levels of foods/feed or related compounds of concern for humans and animals. The importance of representative sampling is emphasized through examples of risk analyses in different areas of foods/feed production. The Theory of Sampling (TOS) is recognized as the only framework within which to ensure accuracy and precision of all sampling steps involved in the field-to-fork continuum, which is crucial to monitor foods and feed safety. Therefore, TOS must be integrated in the well-established FAO/WHO risk assessment approach in order to guarantee a transparent and correct frame for the risk assessment and decision making process.

Food and feed safety assessment: the importance of proper sampling.

PubMed

Kuiper, Harry A; Paoletti, Claudia

2015-01-01

The general principles for safety and nutritional evaluation of foods and feed and the potential health risks associated with hazardous compounds are described as developed by the Food and Agriculture Organization (FAO) and the World Health Organization (WHO) and further elaborated in the European Union-funded project Safe Foods. We underline the crucial role of sampling in foods/feed safety assessment. High quality sampling should always be applied to ensure the use of adequate and representative samples as test materials for hazard identification, toxicological and nutritional characterization of identified hazards, as well as for estimating quantitative and reliable exposure levels of foods/feed or related compounds of concern for humans and animals. The importance of representative sampling is emphasized through examples of risk analyses in different areas of foods/feed production. The Theory of Sampling (TOS) is recognized as the only framework within which to ensure accuracy and precision of all sampling steps involved in the field-to-fork continuum, which is crucial to monitor foods and feed safety. Therefore, TOS must be integrated in the well-established FAO/WHO risk assessment approach in order to guarantee a transparent and correct frame for the risk assessment and decision making process.

Methodology for the Assessment of the Ecotoxicological Potential of Construction Materials

PubMed Central

Rodrigues, Patrícia; Silvestre, José D.; Flores-Colen, Inês; Viegas, Cristina A.; de Brito, Jorge; Kurad, Rawaz; Demertzi, Martha

2017-01-01

Innovation in construction materials (CM) implies changing their composition by incorporating raw materials, usually non-traditional ones, which confer the desired characteristics. However, this practice may have unknown risks. This paper discusses the ecotoxicological potential associated with raw and construction materials, and proposes and applies a methodology for the assessment of their ecotoxicological potential. This methodology is based on existing laws, such as Regulation (European Commission) No. 1907/2006 (REACH—Registration, Evaluation, Authorization and Restriction of Chemicals) and Regulation (European Commission) No. 1272/2008 (CLP—Classification, Labelling and Packaging). Its application and validation showed that raw material without clear evidence of ecotoxicological potential, but with some ability to release chemicals, can lead to the formulation of a CM with a slightly lower hazardousness in terms of chemical characterization despite a slightly higher ecotoxicological potential than the raw materials. The proposed methodology can be a useful tool for the development and manufacturing of products and the design choice of the most appropriate CM, aiming at the reduction of their environmental impact and contributing to construction sustainability. PMID:28773011

Specification of Energy Assessment Methodologies to Satisfy ISO 50001 Energy Management Standard

NASA Astrophysics Data System (ADS)

Kanneganti, Harish

Energy management has become more crucial for industrial sector as a way to lower their cost of production and in reducing their carbon footprint. Environmental regulations also force the industrial sector to increase the efficiency of their energy usage. Hence industrial sector started relying on energy management consultancies for improvements in energy efficiency. With the development of ISO 50001 standard, the entire energy management took a new dimension involving top level management and getting their commitment on energy efficiency. One of the key requirements of ISO 50001 is to demonstrate continual improvement in their (industry) energy efficiency. The major aim of this work is to develop an energy assessment methodology and reporting format to tailor the needs of ISO 50001. The developed methodology integrates the energy reduction aspect of an energy assessment with the requirements of sections 4.4.3 (Energy Review) to 4.4.6 (Objectives, Targets and Action Plans) in ISO 50001 and thus helping the facilities in easy implementation of ISO 50001.

A probabilistic seismic risk assessment procedure for nuclear power plants: (I) Methodology

USGS Publications Warehouse

Huang, Y.-N.; Whittaker, A.S.; Luco, N.

2011-01-01

A new procedure for probabilistic seismic risk assessment of nuclear power plants (NPPs) is proposed. This procedure modifies the current procedures using tools developed recently for performance-based earthquake engineering of buildings. The proposed procedure uses (a) response-based fragility curves to represent the capacity of structural and nonstructural components of NPPs, (b) nonlinear response-history analysis to characterize the demands on those components, and (c) Monte Carlo simulations to determine the damage state of the components. The use of response-rather than ground-motion-based fragility curves enables the curves to be independent of seismic hazard and closely related to component capacity. The use of Monte Carlo procedure enables the correlation in the responses of components to be directly included in the risk assessment. An example of the methodology is presented in a companion paper to demonstrate its use and provide the technical basis for aspects of the methodology. ?? 2011 Published by Elsevier B.V.

Decision-theoretic methodology for reliability and risk allocation in nuclear power plants

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

Cho, N.Z.; Papazoglou, I.A.; Bari, R.A.

1985-01-01

This paper describes a methodology for allocating reliability and risk to various reactor systems, subsystems, components, operations, and structures in a consistent manner, based on a set of global safety criteria which are not rigid. The problem is formulated as a multiattribute decision analysis paradigm; the multiobjective optimization, which is performed on a PRA model and reliability cost functions, serves as the guiding principle for reliability and risk allocation. The concept of noninferiority is used in the multiobjective optimization problem. Finding the noninferior solution set is the main theme of the current approach. The assessment of the decision maker's preferencesmore » could then be performed more easily on the noninferior solution set. Some results of the methodology applications to a nontrivial risk model are provided and several outstanding issues such as generic allocation and preference assessment are discussed.« less

Safety of railroad passenger vehicle dynamics : OMNISIM simulation and test correlations for passenger rail cars

DOT National Transportation Integrated Search

2002-07-01

The purpose of the work is to validate the safety assessment methodology previously developed for passenger rail vehicle dynamics, which requires the application of simulation tools as well as testing of vehicles under different track scenarios. This...

Development of an assessment methodology for hydrocarbon recovery potential using carbon dioxide and associated carbon sequestration-Workshop findings

USGS Publications Warehouse

Verma, Mahendra K.; Warwick, Peter D.

2011-01-01

The Energy Independence and Security Act of 2007 (Public Law 110-140) authorized the U.S. Geological Survey (USGS) to conduct a national assessment of geologic storage resources for carbon dioxide (CO2) and requested that the USGS estimate the "potential volumes of oil and gas recoverable by injection and sequestration of industrial carbon dioxide in potential sequestration formations" (121 Stat. 1711). The USGS developed a noneconomic, probability-based methodology to assess the Nation's technically assessable geologic storage resources available for sequestration of CO2 (Brennan and others, 2010) and is currently using the methodology to assess the Nation's CO2 geologic storage resources. Because the USGS has not developed a methodology to assess the potential volumes of technically recoverable hydrocarbons that could be produced by injection and sequestration of CO2, the Geologic Carbon Sequestration project initiated an effort in 2010 to develop a methodology for the assessment of the technically recoverable hydrocarbon potential in the sedimentary basins of the United States using enhanced oil recovery (EOR) techniques with CO2 (CO2-EOR). In collaboration with Stanford University, the USGS hosted a 2-day CO2-EOR workshop in May 2011, attended by 28 experts from academia, natural resource agencies and laboratories of the Federal Government, State and international geologic surveys, and representatives from the oil and gas industry. The geologic and the reservoir engineering and operations working groups formed during the workshop discussed various aspects of geology, reservoir engineering, and operations to make recommendations for the methodology.

Rational Design Methodology.

DTIC Science & Technology

1978-09-01

This report describes an effort to specify a software design methodology applicable to the Air Force software environment . Available methodologies...of techniques for proof of correctness, design specification, and performance assessment of static designs. The rational methodology selected is a

Assessment of research and development (R and D) needs in LPG safety and environmental control

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

DeSteese, J.G.

1982-05-01

The report characterizes the LPG industry covering all operations from production to end use, reviews current knowledge of LPG release phenomenology, summarizes the status of current LPG release prevention and control methodology, and identifies any remaining safety and environmental problems and recommends R and D strategies that may mitigate these problems. (ACR)

Identifying approaches for assessing methodological and reporting quality of systematic reviews: a descriptive study.

PubMed

Pussegoda, Kusala; Turner, Lucy; Garritty, Chantelle; Mayhew, Alain; Skidmore, Becky; Stevens, Adrienne; Boutron, Isabelle; Sarkis-Onofre, Rafael; Bjerre, Lise M; Hróbjartsson, Asbjørn; Altman, Douglas G; Moher, David

2017-06-19

The methodological quality and completeness of reporting of the systematic reviews (SRs) is fundamental to optimal implementation of evidence-based health care and the reduction of research waste. Methods exist to appraise SRs yet little is known about how they are used in SRs or where there are potential gaps in research best-practice guidance materials. The aims of this study are to identify reports assessing the methodological quality (MQ) and/or reporting quality (RQ) of a cohort of SRs and to assess their number, general characteristics, and approaches to 'quality' assessment over time. The Cochrane Library, MEDLINE®, and EMBASE® were searched from January 1990 to October 16, 2014, for reports assessing MQ and/or RQ of SRs. Title, abstract, and full-text screening of all reports were conducted independently by two reviewers. Reports assessing the MQ and/or RQ of a cohort of ten or more SRs of interventions were included. All results are reported as frequencies and percentages of reports. Of 20,765 unique records retrieved, 1189 of them were reviewed for full-text review, of which 76 reports were included. Eight previously published approaches to assessing MQ or reporting guidelines used as proxy to assess RQ were used in 80% (61/76) of identified reports. These included two reporting guidelines (PRISMA and QUOROM) and five quality assessment tools (AMSTAR, R-AMSTAR, OQAQ, Mulrow, Sacks) and GRADE criteria. The remaining 24% (18/76) of reports developed their own criteria. PRISMA, OQAQ, and AMSTAR were the most commonly used published tools to assess MQ or RQ. In conjunction with other approaches, published tools were used in 29% (22/76) of reports, with 36% (8/22) assessing adherence to both PRISMA and AMSTAR criteria and 26% (6/22) using QUOROM and OQAQ. The methods used to assess quality of SRs are diverse, and none has become universally accepted. The most commonly used quality assessment tools are AMSTAR, OQAQ, and PRISMA. As new tools and guidelines are

"Assessing the methodological quality of systematic reviews in radiation oncology: A systematic review".

PubMed

Hasan, Haroon; Muhammed, Taaha; Yu, Jennifer; Taguchi, Kelsi; Samargandi, Osama A; Howard, A Fuchsia; Lo, Andrea C; Olson, Robert; Goddard, Karen

2017-10-01

The objective of our study was to evaluate the methodological quality of systematic reviews and meta-analyses in Radiation Oncology. A systematic literature search was conducted for all eligible systematic reviews and meta-analyses in Radiation Oncology from 1966 to 2015. Methodological characteristics were abstracted from all works that satisfied the inclusion criteria and quality was assessed using the critical appraisal tool, AMSTAR. Regression analyses were performed to determine factors associated with a higher score of quality. Following exclusion based on a priori criteria, 410 studies (157 systematic reviews and 253 meta-analyses) satisfied the inclusion criteria. Meta-analyses were found to be of fair to good quality while systematic reviews were found to be of less than fair quality. Factors associated with higher scores of quality in the multivariable analysis were including primary studies consisting of randomized control trials, performing a meta-analysis, and applying a recommended guideline related to establishing a systematic review protocol and/or reporting. Systematic reviews and meta-analyses may introduce a high risk of bias if applied to inform decision-making based on AMSTAR. We recommend that decision-makers in Radiation Oncology scrutinize the methodological quality of systematic reviews and meta-analyses prior to assessing their utility to inform evidence-based medicine and researchers adhere to methodological standards outlined in validated guidelines when embarking on a systematic review. Copyright © 2017 Elsevier Ltd. All rights reserved.

Biomarkers: Dynamic "Tools" for Health and Safety Risk Assessment

EPA Science Inventory

Today informational flow from biomarkers contributes importantly to various types of health effects research, risk assessment and risk management decisions that impact, or have the potential to impact, public health and safety. Therefore, dependent upon the nature of the health r...

Locating Errors Through Networked Surveillance: A Multimethod Approach to Peer Assessment, Hazard Identification, and Prioritization of Patient Safety Efforts in Cardiac Surgery.

PubMed

Thompson, David A; Marsteller, Jill A; Pronovost, Peter J; Gurses, Ayse; Lubomski, Lisa H; Goeschel, Christine A; Gosbee, John W; Wahr, Joyce; Martinez, Elizabeth A

2015-09-01

The objectives were to develop a scientifically sound and feasible peer-to-peer assessment model that allows health-care organizations to evaluate patient safety in cardiovascular operating rooms and to establish safety priorities for improvement. The locating errors through networked surveillance study was conducted to identify hazards in cardiac surgical care. A multidisciplinary team, composed of organizational sociology, organizational psychology, applied social psychology, clinical medicine, human factors engineering, and health services researchers, conducted the study. We used a transdisciplinary approach, which integrated the theories, concepts, and methods from each discipline, to develop comprehensive research methods. Multiple data collection was involved: focused literature review of cardiac surgery-related adverse events, retrospective analysis of cardiovascular events from a national database in the United Kingdom, and prospective peer assessment at 5 sites, involving survey assessments, structured interviews, direct observations, and contextual inquiries. A nominal group methodology, where one single group acts to problem solve and make decisions was used to review the data and develop a list of the top priority hazards. The top 6 priority hazard themes were as follows: safety culture, teamwork and communication, infection prevention, transitions of care, failure to adhere to practices or policies, and operating room layout and equipment. We integrated the theories and methods of a diverse group of researchers to identify a broad range of hazards and good clinical practices within the cardiovascular surgical operating room. Our findings were the basis for a plan to prioritize improvements in cardiac surgical care. These study methods allowed for the comprehensive assessment of a high-risk clinical setting that may translate to other clinical settings.

Feasibility of assessing the safety and effectiveness of menstrual regulation medications purchased from pharmacies in Bangladesh: a prospective cohort study.

PubMed

Footman, Katharine; Scott, Rachel; Taleb, Fahmida; Dijkerman, Sally; Nuremowla, Sadid; Reiss, Kate; Church, Kathryn

2018-02-01

To assess the feasibility of following up women who purchase mifepristone+misoprostol or misoprostol-only from pharmacies in order to measure the safety and effectiveness of self-administration of menstrual regulation. A prospective cohort study followed women purchasing mifepristone+misoprostol or misoprostol-only from pharmacies in Bangladesh. Participants were recruited by pharmacy workers either in person or indirectly via the purchaser of the drugs. End users were contacted by phone 2 weeks after recruitment, screened and interviewed. Study recruitment rates by pharmacy workers were low (30%, 109 of 642 women informed about the study), but 2-week follow-up rates were high (87%). Of the 109 end users interviewed, 87 purchased mifepristone+misoprostol and 20 misoprostol-only, while 2 women did not know what drugs they had purchased. Mean self-reported number of weeks of pregnancy was 5.7 weeks. Information provision by pharmacy workers was inadequate (40.4% received none, 8.7% received written information or pictures). A total of 80.5% of mifepristone+misoprostol users were sold the correct regimen versus 9 out of 20 misoprostol-only users. A total of 68.8% did not report experiencing any complications (70.0% misoprostol-only; 69.0% mifepristone+misoprostol users, p=1.0). A total of 94.3% of mifepristone+misoprostol users and 75% of misoprostol-only users reported that they were not pregnant at day 15 (p=.020). However, 7.3% of all users sought additional treatment. Challenges in assessing outcomes of self-managed menstrual regulation medications purchased from pharmacies must be overcome through further development of this methodology. Interventions are urgently needed to ensure that women have access to correct dosages, accurate information and necessary referrals. This paper assesses the outcomes of women who self-manage menstrual regulation medications purchased from pharmacies. The methodology requires further development, but our study provides preliminary

A systems-based food safety evaluation: an experimental approach.

PubMed

Higgins, Charles L; Hartfield, Barry S

2004-11-01

Food establishments are complex systems with inputs, subsystems, underlying forces that affect the system, outputs, and feedback. Building on past exploration of the hazard analysis critical control point concept and Ludwig von Bertalanffy General Systems Theory, the National Park Service (NPS) is attempting to translate these ideas into a realistic field assessment of food service establishments and to use information gathered by these methods in efforts to improve food safety. Over the course of the last two years, an experimental systems-based methodology has been drafted, developed, and tested by the NPS Public Health Program. This methodology is described in this paper.

Evaluating the Safety Profile of Non-Active Implantable Medical Devices Compared with Medicines.

PubMed

Pane, Josep; Coloma, Preciosa M; Verhamme, Katia M C; Sturkenboom, Miriam C J M; Rebollo, Irene

2017-01-01

Recent safety issues involving non-active implantable medical devices (NAIMDs) have highlighted the need for better pre-market and post-market evaluation. Some stakeholders have argued that certain features of medicine safety evaluation should also be applied to medical devices. Our objectives were to compare the current processes and methodologies for the assessment of NAIMD safety profiles with those for medicines, identify potential gaps, and make recommendations for the adoption of new methodologies for the ongoing benefit-risk monitoring of these devices throughout their entire life cycle. A literature review served to examine the current tools for the safety evaluation of NAIMDs and those for medicines. We searched MEDLINE using these two categories. We supplemented this search with Google searches using the same key terms used in the MEDLINE search. Using a comparative approach, we summarized the new product design, development cycle (preclinical and clinical phases), and post-market phases for NAIMDs and drugs. We also evaluated and compared the respective processes to integrate and assess safety data during the life cycle of the products, including signal detection, signal management, and subsequent potential regulatory actions. The search identified a gap in NAIMD safety signal generation: no global program exists that collects and analyzes adverse events and product quality issues. Data sources in real-world settings, such as electronic health records, need to be effectively identified and explored as additional sources of safety information, particularly in some areas such as the EU and USA where there are plans to implement the unique device identifier (UDI). The UDI and other initiatives will enable more robust follow-up and assessment of long-term patient outcomes. The safety evaluation system for NAIMDs differs in many ways from those for drugs, but both systems face analogous challenges with respect to monitoring real-world usage. Certain features

Urban transport safety assessment in akure based on corresponding performance indicators

NASA Astrophysics Data System (ADS)

Oye, Adedamola; Aderinlewo, Olufikayo; Croope, Silvana

2013-03-01

The level of safety of the transportation system in Akure, Nigeria was assessed by identifying the associated road safety problems and developing the corresponding safety performance indicators. These indicators were analysed with respect to accidents that occurred within the city from the year 2005 to 2009 based on the corresponding attributable risk measures. The results of the analysis showed the state of existing safety programs in Akure town. Six safety performance indicators were identified namely alcohol and drug use, excessive speeds, protection system (use of seat belts and helmets), use of day time running lights, state of vehicles (passive safety) and road condition. These indicators were used to determine the percentage of injury accidents as follows: 83.33% and 86.36% for years 2005 and 2006 respectively, 81.46% for year 2007 while years 2008 and 2009 had 82.86% and 78.12% injury accidents respectively.

A methodology to assess performance of human-robotic systems in achievement of collective tasks

NASA Technical Reports Server (NTRS)

Howard, Ayanna M.

2005-01-01

In this paper, we present a methodology to assess system performance of human-robotic systems in achievement of collective tasks such as habitat construction, geological sampling, and space exploration.

A review of the current state-of-the-art methodology for handling bias and uncertainty in performing criticality safety evaluations. Final report

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

Disney, R.K.

1994-10-01

The methodology for handling bias and uncertainty when calculational methods are used in criticality safety evaluations (CSE`s) is a rapidly evolving technology. The changes in the methodology are driven by a number of factors. One factor responsible for changes in the methodology for handling bias and uncertainty in CSE`s within the overview of the US Department of Energy (DOE) is a shift in the overview function from a ``site`` perception to a more uniform or ``national`` perception. Other causes for change or improvement in the methodology for handling calculational bias and uncertainty are; (1) an increased demand for benchmark criticalsmore » data to expand the area (range) of applicability of existing data, (2) a demand for new data to supplement existing benchmark criticals data, (3) the increased reliance on (or need for) computational benchmarks which supplement (or replace) experimental measurements in critical assemblies, and (4) an increased demand for benchmark data applicable to the expanded range of conditions and configurations encountered in DOE site restoration and remediation.« less

Safety assessment in schools: beyond risk: the role of child psychiatrists and other mental health professionals.

PubMed

Rappaport, Nancy; Pollack, William S; Flaherty, Lois T; Schwartz, Sarah E O; McMickens, Courtney

2015-04-01

This article presents an overview of a comprehensive school safety assessment approach for students whose behavior raises concern about their potential for targeted violence. Case vignettes highlight the features of 2 youngsters who exemplify those seen, the comprehensive nature of the assessment, and the kind of recommendations that enhance a student's safety, connection, well-being; engage families; and share responsibility of assessing safety with the school. Copyright © 2015 Elsevier Inc. All rights reserved.

Epidemiology Characteristics, Methodological Assessment and Reporting of Statistical Analysis of Network Meta-Analyses in the Field of Cancer

PubMed Central

Ge, Long; Tian, Jin-hui; Li, Xiu-xia; Song, Fujian; Li, Lun; Zhang, Jun; Li, Ge; Pei, Gai-qin; Qiu, Xia; Yang, Ke-hu

2016-01-01

Because of the methodological complexity of network meta-analyses (NMAs), NMAs may be more vulnerable to methodological risks than conventional pair-wise meta-analysis. Our study aims to investigate epidemiology characteristics, conduction of literature search, methodological quality and reporting of statistical analysis process in the field of cancer based on PRISMA extension statement and modified AMSTAR checklist. We identified and included 102 NMAs in the field of cancer. 61 NMAs were conducted using a Bayesian framework. Of them, more than half of NMAs did not report assessment of convergence (60.66%). Inconsistency was assessed in 27.87% of NMAs. Assessment of heterogeneity in traditional meta-analyses was more common (42.62%) than in NMAs (6.56%). Most of NMAs did not report assessment of similarity (86.89%) and did not used GRADE tool to assess quality of evidence (95.08%). 43 NMAs were adjusted indirect comparisons, the methods used were described in 53.49% NMAs. Only 4.65% NMAs described the details of handling of multi group trials and 6.98% described the methods of similarity assessment. The median total AMSTAR-score was 8.00 (IQR: 6.00–8.25). Methodological quality and reporting of statistical analysis did not substantially differ by selected general characteristics. Overall, the quality of NMAs in the field of cancer was generally acceptable. PMID:27848997

An integrated science-based methodology to assess potential risks and implications of engineered nanomaterials.

PubMed

Tolaymat, Thabet; El Badawy, Amro; Sequeira, Reynold; Genaidy, Ash

2015-11-15

There is an urgent need for broad and integrated studies that address the risks of engineered nanomaterials (ENMs) along the different endpoints of the society, environment, and economy (SEE) complex adaptive system. This article presents an integrated science-based methodology to assess the potential risks of engineered nanomaterials. To achieve the study objective, two major tasks are accomplished, knowledge synthesis and algorithmic computational methodology. The knowledge synthesis task is designed to capture "what is known" and to outline the gaps in knowledge from ENMs risk perspective. The algorithmic computational methodology is geared toward the provision of decisions and an understanding of the risks of ENMs along different endpoints for the constituents of the SEE complex adaptive system. The approach presented herein allows for addressing the formidable task of assessing the implications and risks of exposure to ENMs, with the long term goal to build a decision-support system to guide key stakeholders in the SEE system towards building sustainable ENMs and nano-enabled products. Published by Elsevier B.V.

Identifying items to assess methodological quality in physical therapy trials: a factor analysis.

PubMed

Armijo-Olivo, Susan; Cummings, Greta G; Fuentes, Jorge; Saltaji, Humam; Ha, Christine; Chisholm, Annabritt; Pasichnyk, Dion; Rogers, Todd

2014-09-01

Numerous tools and individual items have been proposed to assess the methodological quality of randomized controlled trials (RCTs). The frequency of use of these items varies according to health area, which suggests a lack of agreement regarding their relevance to trial quality or risk of bias. The objectives of this study were: (1) to identify the underlying component structure of items and (2) to determine relevant items to evaluate the quality and risk of bias of trials in physical therapy by using an exploratory factor analysis (EFA). A methodological research design was used, and an EFA was performed. Randomized controlled trials used for this study were randomly selected from searches of the Cochrane Database of Systematic Reviews. Two reviewers used 45 items gathered from 7 different quality tools to assess the methodological quality of the RCTs. An exploratory factor analysis was conducted using the principal axis factoring (PAF) method followed by varimax rotation. Principal axis factoring identified 34 items loaded on 9 common factors: (1) selection bias; (2) performance and detection bias; (3) eligibility, intervention details, and description of outcome measures; (4) psychometric properties of the main outcome; (5) contamination and adherence to treatment; (6) attrition bias; (7) data analysis; (8) sample size; and (9) control and placebo adequacy. Because of the exploratory nature of the results, a confirmatory factor analysis is needed to validate this model. To the authors' knowledge, this is the first factor analysis to explore the underlying component items used to evaluate the methodological quality or risk of bias of RCTs in physical therapy. The items and factors represent a starting point for evaluating the methodological quality and risk of bias in physical therapy trials. Empirical evidence of the association among these items with treatment effects and a confirmatory factor analysis of these results are needed to validate these items. �

Assessment of contributions to patient safety knowledge by the Agency for Healthcare Research and Quality-funded patient safety projects.

PubMed

Sorbero, Melony E S; Ricci, Karen A; Lovejoy, Susan; Haviland, Amelia M; Smith, Linda; Bradley, Lily A; Hiatt, Liisa; Farley, Donna O

2009-04-01

To characterize the activities of projects funded in Agency for Healthcare Research and Quality (AHRQ)'s patient safety portfolio and assess their aggregate potential to contribute to knowledge development. Information abstracted from proposals for projects funded in AHRQ's patient safety portfolio, information on safety practices from the AHRQ Evidence Report on Patient Safety Practices, and products produced by the projects. This represented one part of the process evaluation conducted as part of a longitudinal evaluation based on the Context–Input–Process–Product model. The 234 projects funded through AHRQ's patient safety portfolio examined a wide variety of patient safety issues and extended their work beyond the hospital setting to less studied parts of the health care system. Many of the projects implemented and tested practices for which the patient safety evidence report identified a need for additional evidence. The funded projects also generated a substantial body of new patient safety knowledge through a growing number of journal articles and other products. The projects funded in AHRQ's patient safety portfolio have the potential to make substantial contributions to the knowledge base on patient safety. The full value of this new knowledge remains to be confirmed through the synthesis of results

Comparative proteomic assessment of matrisome enrichment methodologies.

PubMed

Krasny, Lukas; Paul, Angela; Wai, Patty; Howard, Beatrice A; Natrajan, Rachael C; Huang, Paul H

2016-11-01

The matrisome is a complex and heterogeneous collection of extracellular matrix (ECM) and ECM-associated proteins that play important roles in tissue development and homeostasis. While several strategies for matrisome enrichment have been developed, it is currently unknown how the performance of these different methodologies compares in the proteomic identification of matrisome components across multiple tissue types. In the present study, we perform a comparative proteomic assessment of two widely used decellularisation protocols and two extraction methods to characterise the matrisome in four murine organs (heart, mammary gland, lung and liver). We undertook a systematic evaluation of the performance of the individual methods on protein yield, matrisome enrichment capability and the ability to isolate core matrisome and matrisome-associated components. Our data find that sodium dodecyl sulphate (SDS) decellularisation leads to the highest matrisome enrichment efficiency, while the extraction protocol that comprises chemical and trypsin digestion of the ECM fraction consistently identifies the highest number of matrisomal proteins across all types of tissue examined. Matrisome enrichment had a clear benefit over non-enriched tissue for the comprehensive identification of matrisomal components in murine liver and heart. Strikingly, we find that all four matrisome enrichment methods led to significant losses in the soluble matrisome-associated proteins across all organs. Our findings highlight the multiple factors (including tissue type, matrisome class of interest and desired enrichment purity) that influence the choice of enrichment methodology, and we anticipate that these data will serve as a useful guide for the design of future proteomic studies of the matrisome. © 2016 The Author(s).

Comparative proteomic assessment of matrisome enrichment methodologies

PubMed Central

Krasny, Lukas; Paul, Angela; Wai, Patty; Howard, Beatrice A.; Natrajan, Rachael C.; Huang, Paul H.

2016-01-01

The matrisome is a complex and heterogeneous collection of extracellular matrix (ECM) and ECM-associated proteins that play important roles in tissue development and homeostasis. While several strategies for matrisome enrichment have been developed, it is currently unknown how the performance of these different methodologies compares in the proteomic identification of matrisome components across multiple tissue types. In the present study, we perform a comparative proteomic assessment of two widely used decellularisation protocols and two extraction methods to characterise the matrisome in four murine organs (heart, mammary gland, lung and liver). We undertook a systematic evaluation of the performance of the individual methods on protein yield, matrisome enrichment capability and the ability to isolate core matrisome and matrisome-associated components. Our data find that sodium dodecyl sulphate (SDS) decellularisation leads to the highest matrisome enrichment efficiency, while the extraction protocol that comprises chemical and trypsin digestion of the ECM fraction consistently identifies the highest number of matrisomal proteins across all types of tissue examined. Matrisome enrichment had a clear benefit over non-enriched tissue for the comprehensive identification of matrisomal components in murine liver and heart. Strikingly, we find that all four matrisome enrichment methods led to significant losses in the soluble matrisome-associated proteins across all organs. Our findings highlight the multiple factors (including tissue type, matrisome class of interest and desired enrichment purity) that influence the choice of enrichment methodology, and we anticipate that these data will serve as a useful guide for the design of future proteomic studies of the matrisome. PMID:27589945

Proposal and application of a regional methodology of comparative risk assessment for potentially contaminated sites.

PubMed

Marzocchini, Manrico; Tatàno, Fabio; Moretti, Michela Simona; Antinori, Caterina; Orilisi, Stefano

2018-06-05

A possible approach for determining soil and groundwater quality criteria for contaminated sites is the comparative risk assessment. Originating from but not limited to Italian interest in a decentralised (regional) implementation of comparative risk assessment, this paper first addresses the proposal of an original methodology called CORIAN REG-M , which was created with initial attention to the context of potentially contaminated sites in the Marche Region (Central Italy). To deepen the technical-scientific knowledge and applicability of the comparative risk assessment, the following characteristics of the CORIAN REG-M methodology appear to be relevant: the simplified but logical assumption of three categories of factors (source and transfer/transport of potential contamination, and impacted receptors) within each exposure pathway; the adaptation to quality and quantity of data that are available or derivable at the given scale of concern; the attention to a reliable but unsophisticated modelling; the achievement of a conceptual linkage to the absolute risk assessment approach; and the potential for easy updating and/or refining of the methodology. Further, the application of the CORIAN REG-M methodology to some case-study sites located in the Marche Region indicated the following: a positive correlation can be expected between air and direct contact pathway scores, as well as between individual pathway scores and the overall site scores based on a root-mean-square algorithm; the exposure pathway, which presents the highest variability of scores, tends to be dominant at sites with the highest computed overall site scores; and the adoption of a root-mean-square algorithm can be expected to emphasise the overall site scoring.

Error disclosure: a new domain for safety culture assessment.

PubMed

Etchegaray, Jason M; Gallagher, Thomas H; Bell, Sigall K; Dunlap, Ben; Thomas, Eric J

2012-07-01

To (1) develop and test survey items that measure error disclosure culture, (2) examine relationships among error disclosure culture, teamwork culture and safety culture and (3) establish predictive validity for survey items measuring error disclosure culture. All clinical faculty from six health institutions (four medical schools, one cancer centre and one health science centre) in The University of Texas System were invited to anonymously complete an electronic survey containing questions about safety culture and error disclosure. The authors found two factors to measure error disclosure culture: one factor is focused on the general culture of error disclosure and the second factor is focused on trust. Both error disclosure culture factors were unique from safety culture and teamwork culture (correlations were less than r=0.85). Also, error disclosure general culture and error disclosure trust culture predicted intent to disclose a hypothetical error to a patient (r=0.25, p<0.001 and r=0.16, p<0.001, respectively) while teamwork and safety culture did not predict such an intent (r=0.09, p=NS and r=0.12, p=NS). Those who received prior error disclosure training reported significantly higher levels of error disclosure general culture (t=3.7, p<0.05) and error disclosure trust culture (t=2.9, p<0.05). The authors created and validated a new measure of error disclosure culture that predicts intent to disclose an error better than other measures of healthcare culture. This measure fills an existing gap in organisational assessments by assessing transparent communication after medical error, an important aspect of culture.

A novel integrated assessment methodology of urban water reuse.

PubMed

Listowski, A; Ngo, H H; Guo, W S; Vigneswaran, S

2011-01-01

Wastewater is no longer considered a waste product and water reuse needs to play a stronger part in securing urban water supply. Although treatment technologies for water reclamation have significantly improved the question that deserves further analysis is, how selection of a particular wastewater treatment technology relates to performance and sustainability? The proposed assessment model integrates; (i) technology, characterised by selected quantity and quality performance parameters; (ii) productivity, efficiency and reliability criteria; (iii) quantitative performance indicators; (iv) development of evaluation model. The challenges related to hierarchy and selections of performance indicators have been resolved through the case study analysis. The goal of this study is to validate a new assessment methodology in relation to performance of the microfiltration (MF) technology, a key element of the treatment process. Specific performance data and measurements were obtained at specific Control and Data Acquisition Points (CP) to satisfy the input-output inventory in relation to water resources, products, material flows, energy requirements, chemicals use, etc. Performance assessment process contains analysis and necessary linking across important parametric functions leading to reliable outcomes and results.

Planning the Unplanned Experiment: Towards Assessing the Efficacy of Standards for Safety-Critical Software

NASA Technical Reports Server (NTRS)

Graydon, Patrick J.; Holloway, C. M.

2015-01-01

Safe use of software in safety-critical applications requires well-founded means of determining whether software is fit for such use. While software in industries such as aviation has a good safety record, little is known about whether standards for software in safety-critical applications 'work' (or even what that means). It is often (implicitly) argued that software is fit for safety-critical use because it conforms to an appropriate standard. Without knowing whether a standard works, such reliance is an experiment; without carefully collecting assessment data, that experiment is unplanned. To help plan the experiment, we organized a workshop to develop practical ideas for assessing software safety standards. In this paper, we relate and elaborate on the workshop discussion, which revealed subtle but important study design considerations and practical barriers to collecting appropriate historical data and recruiting appropriate experimental subjects. We discuss assessing standards as written and as applied, several candidate definitions for what it means for a standard to 'work,' and key assessment strategies and study techniques and the pros and cons of each. Finally, we conclude with thoughts about the kinds of research that will be required and how academia, industry, and regulators might collaborate to overcome the noted barriers.

Tire pressure special study : methodology

DOT National Transportation Integrated Search