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

NASA Technical Reports Server (NTRS)

Zelkin, Natalie; Henriksen, Stephen

2011-01-01

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

Development of Risk Assessment Matrix for NASA Engineering and Safety Center

NASA Technical Reports Server (NTRS)

Malone, Roy W., Jr.; Moses, Kelly

2004-01-01

This paper describes a study, which had as its principal goal the development of a sufficiently detailed 5 x 5 Risk Matrix Scorecard. The purpose of this scorecard is to outline the criteria by which technical issues can be qualitatively and initially prioritized. The tool using this score card has been proposed to be one of the information resources the NASA Engineering and Safety Center (NESC) takes into consideration when making decisions with respect to incoming information on safety concerns across the entire NASA agency. The contents of this paper discuss in detail each element of the risk matrix scorecard, definitions for those elements and the rationale behind the development of those definitions. This scorecard development was performed in parallel with the tailoring of the existing Futron Corporation Integrated Risk Management Application (IRMA) software tool. IRMA was tailored to fit NESC needs for evaluating incoming safety concerns and was renamed NESC Assessment Risk Management Application (NAFMA) which is still in developmental phase.

Software Safety Risk in Legacy Safety-Critical Computer Systems

NASA Technical Reports Server (NTRS)

Hill, Janice; Baggs, Rhoda

2007-01-01

Safety-critical computer systems must be engineered to meet system and software safety requirements. For legacy safety-critical computer systems, software safety requirements may not have been formally specified during development. When process-oriented software safety requirements are levied on a legacy system after the fact, where software development artifacts don't exist or are incomplete, the question becomes 'how can this be done?' The risks associated with only meeting certain software safety requirements in a legacy safety-critical computer system must be addressed should such systems be selected as candidates for reuse. This paper proposes a method for ascertaining formally, a software safety risk assessment, that provides measurements for software safety for legacy systems which may or may not have a suite of software engineering documentation that is now normally required. It relies upon the NASA Software Safety Standard, risk assessment methods based upon the Taxonomy-Based Questionnaire, and the application of reverse engineering CASE tools to produce original design documents for legacy systems.

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.

A 3S Risk ?3SR? Assessment Approach for Nuclear Power: Safety Security and Safeguards.

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

Forrest, Robert; Reinhardt, Jason Christian; Wheeler, Timothy A.

Safety-focused risk analysis and assessment approaches struggle to adequately include malicious, deliberate acts against the nuclear power industry's fissile and waste material, infrastructure, and facilities. Further, existing methods do not adequately address non- proliferation issues. Treating safety, security, and safeguards concerns independently is inefficient because, at best, it may not take explicit advantage of measures that provide benefits against multiple risk domains, and, at worst, it may lead to implementations that increase overall risk due to incompatibilities. What is needed is an integrated safety, security and safeguards risk (or "3SR") framework for describing and assessing nuclear power risks that canmore » enable direct trade-offs and interactions in order to inform risk management processes -- a potential paradigm shift in risk analysis and management. These proceedings of the Sandia ePRA Workshop (held August 22-23, 2017) are an attempt to begin the discussions and deliberations to extend and augment safety focused risk assessment approaches to include security concerns and begin moving towards a 3S Risk approach. Safeguards concerns were not included in this initial workshop and are left to future efforts. This workshop focused on four themes in order to begin building out a the safety and security portions of the 3S Risk toolkit: 1. Historical Approaches and Tools 2. Current Challenges 3. Modern Approaches 4. Paths Forward and Next Steps This report is organized along the four areas described above, and concludes with a summary of key points. 2 Contact: rforres@sandia.gov; +1 (925) 294-2728« less

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.

Hazard Identification and Risk Assessment in Water Treatment Plant considering Environmental Health and Safety Practice

NASA Astrophysics Data System (ADS)

Falakh, Fajrul; Setiani, Onny

2018-02-01

Water Treatment Plant (WTP) is an important infrastructure to ensure human health and the environment. In its development, aspects of environmental safety and health are of concern. This paper case study was conducted at the Water Treatment Plant Company in Semarang, Central Java, Indonesia. Hazard identification and risk assessment is one part of the occupational safety and health program at the risk management stage. The purpose of this study was to identify potential hazards using hazard identification methods and risk assessment methods. Risk assessment is done using criteria of severity and probability of accident. The results obtained from this risk assessment are 22 potential hazards present in the water purification process. Extreme categories that exist in the risk assessment are leakage of chlorine and industrial fires. Chlorine and fire leakage gets the highest value because its impact threatens many things, such as industrial disasters that could endanger human life and the environment. Control measures undertaken to avoid potential hazards are to apply the use of personal protective equipment, but management will also be better managed in accordance with hazard control hazards, occupational safety and health programs such as issuing work permits, emergency response training is required, Very useful in overcoming potential hazards that have been determined.

Use of System Safety Risk Assessments for the Space Shuttle Reusable Solid Rocket Motor (RSRM)

NASA Technical Reports Server (NTRS)

Greenhalgh, Phillip O.; McCool, Alex (Technical Monitor)

2001-01-01

This paper discusses the System Safety approach used to assess risk for the Space Shuttle Reusable Solid Rocket Motor (RSRM). Previous to the first RSRM flight in the fall of 1988, all systems were analyzed extensively to assure that hazards were identified, assessed and that the baseline risk was understood and appropriately communicated. Since the original RSRM baseline was established, Thiokol and NASA have implemented a number of initiatives that have further improved the RSRM. The robust design, completion of rigorous testing and flight success of the RSRM has resulted in a wise reluctance to make changes. One of the primary assessments required to accompany the documentation of each proposed change and aid in the decision making process is a risk assessment. Documentation supporting proposed changes, including the risk assessments from System Safety, are reviewed and assessed by Thiokol and NASA technical management. After thorough consideration, approved changes are implemented adding improvements to and reducing risk of the Space Shuttle RSRM.

Determining an appropriate integrated assessment model of tourism safety risk within the Changbai Mountain Scenic Area

NASA Astrophysics Data System (ADS)

Zhou, Lijun; Liu, Jisheng

2017-03-01

Tourism safety is gradually gaining more attention due to the rapid development of the tourism industry in China. Changbai Mountain is one of the most famous mountainous scenic areas in Northeast Asia. Assessment on Changbai Mountain scenic area’s tourism safety risk could do a favor in detecting influence factor of tourism safety risk and classifying tourism safety risk rank, thereby reducing and preventing associated tourism safety risks. This paper uses the Changbai Mountain scenic area as the study subject. By the means of experts scoring and analytic hierarchy process on quantified relevant evaluation indicator, the grid GIS method is used to vectorize the relevant data within a 1000m grid. It respectively analyzes main indicators associated tourism safety risk in Changbai Mountain scenic area, including hazard, exposure, vulnerability and ability to prevent and mitigate disasters. The integrated tourism safety risk model is used to comprehensively evaluate tourism safety risk in Changbai Mountain scenic area.

Probabilistic Causal Analysis for System Safety Risk Assessments in Commercial Air Transport

NASA Technical Reports Server (NTRS)

Luxhoj, James T.

2003-01-01

Aviation is one of the critical modes of our national transportation system. As such, it is essential that new technologies be continually developed to ensure that a safe mode of transportation becomes even safer in the future. The NASA Aviation Safety Program (AvSP) is managing the development of new technologies and interventions aimed at reducing the fatal aviation accident rate by a factor of 5 by year 2007 and by a factor of 10 by year 2022. A portfolio assessment is currently being conducted to determine the projected impact that the new technologies and/or interventions may have on reducing aviation safety system risk. This paper reports on advanced risk analytics that combine the use of a human error taxonomy, probabilistic Bayesian Belief Networks, and case-based scenarios to assess a relative risk intensity metric. A sample case is used for illustrative purposes.

Neuropsychological Assessment of Driving Safety Risk in Older Adults With and Without Neurologic Disease

PubMed Central

Anderson, Steven W.; Aksan, Nazan; Dawson, Jeffrey D.; Uc, Ergun Y.; Johnson, Amy M.; Rizzo, Matthew

2013-01-01

Decline in cognitive abilities can be an important contributor to the driving problems encountered by older adults, and neuropsychological assessment may provide a practical approach to evaluating this aspect of driving safety risk. The purpose of the present study was to evaluate several commonly used neuropsychological tests in the assessment of driving safety risk in older adults with and without neurological disease. A further goal of this study was to identify brief combinations of neuropsychological tests that sample performances in key functional domains and thus could be used to efficiently assess driving safety risk. 345 legally licensed and active drivers over the age of 50, with either no neurologic disease (N=185), probable Alzheimer's disease (N=40), Parkinson's disease (N=91), or stroke (N=29), completed vision testing, a battery of 10 neuropsychological tests, and an 18 mile drive on urban and rural roads in an instrumented vehicle. Performances on all neuropsychological tests were significantly correlated with driving safety errors. Confirmatory factor analysis was used to identify 3 key cognitive domains assessed by the tests (speed of processing, visuospatial abilities, and memory), and several brief batteries consisting of one test from each domain showed moderate corrected correlations with driving performance. These findings are consistent with the notion that driving places demands on multiple cognitive abilities that can be affected by aging and age-related neurological disease, and that neuropsychological assessment may provide a practical off-road window into the functional status of these cognitive systems. PMID:22943767

Neuropsychological assessment of driving safety risk in older adults with and without neurologic disease.

PubMed

Anderson, Steven W; Aksan, Nazan; Dawson, Jeffrey D; Uc, Ergun Y; Johnson, Amy M; Rizzo, Matthew

2012-01-01

Decline in cognitive abilities can be an important contributor to the driving problems encountered by older adults, and neuropsychological assessment may provide a practical approach to evaluating this aspect of driving safety risk. The purpose of the present study was to evaluate several commonly used neuropsychological tests in the assessment of driving safety risk in older adults with and without neurological disease. A further goal of this study was to identify brief combinations of neuropsychological tests that sample performances in key functional domains and thus could be used to efficiently assess driving safety risk. A total of 345 legally licensed and active drivers over the age of 50, with no neurologic disease (N = 185), probable Alzheimer's disease (N = 40), Parkinson's disease (N = 91), or stroke (N = 29), completed vision testing, a battery of 10 neuropsychological tests, and an 18-mile drive on urban and rural roads in an instrumented vehicle. Performances on all neuropsychological tests were significantly correlated with driving safety errors. Confirmatory factor analysis was used to identify 3 key cognitive domains assessed by the tests (speed of processing, visuospatial abilities, and memory), and several brief batteries consisting of one test from each domain showed moderate corrected correlations with driving performance. These findings are consistent with the notion that driving places demands on multiple cognitive abilities that can be affected by aging and age-related neurological disease, and that neuropsychological assessment may provide a practical off-road window into the functional status of these cognitive systems.

Risk perception, risk management and safety assessment: what can governments do to increase public confidence in their vaccine system?

PubMed

MacDonald, Noni E; Smith, Jennifer; Appleton, Mary

2012-09-01

For decades vaccine program managers and governments have devoted many resources to addressing public vaccine concerns, vaccine risk perception, risk management and safety assessment. Despite ever growing evidence that vaccines are safe and effective, public concerns continue. Education and evidence based scientific messages have not ended concerns. How can governments and programs more effectively address the public's vaccine concerns and increase confidence in the vaccine safety system? Vaccination hesitation has been attributed to concerns about vaccine safety, perceptions of high vaccine risks and low disease risk and consequences. Even when the public believes vaccines are important for protection many still have concerns about vaccine safety. This overview explores how heuristics affect public perception of vaccines and vaccine safety, how the public finds and uses vaccine information, and then proposes strategies for changes in the approach to vaccine safety communications. Facts and evidence confirming the safety of vaccines are not enough. Vaccine beliefs and behaviours must be shaped. This will require a shift in the what, when, how and why of vaccine risk and benefit communication content and practice. A change to a behavioural change strategy such as the WHO COMBI program that has been applied to disease eradication efforts is suggested. Copyright © 2011. Published by Elsevier Ltd.. All rights reserved.

Fundamentals of health risk assessment. Use, derivation, validity and limitations of safety indices.

PubMed

Putzrath, R M; Wilson, J D

1999-04-01

We investigated the way results of human health risk assessments are used, and the theory used to describe those methods, sometimes called the "NAS paradigm." Contrary to a key tenet of that theory, current methods have strictly limited utility. The characterizations now considered standard, Safety Indices such as "Acceptable Daily Intake," "Reference Dose," and so on, usefully inform only decisions that require a choice between two policy alternatives (e.g., approve a food additive or not), decided solely on the basis of a finding of safety. Risk is characterized as the quotient of one of these Safety Indices divided by an estimate of exposure: a quotient greater than one implies that the situation may be considered safe. Such decisions are very widespread, both in the U.S. federal government and elsewhere. No current method is universal; different policies lead to different practices, for example, in California's "Proposition 65," where statutory provisions specify some practices. Further, an important kind of human health risk assessment is not recognized by this theory: this kind characterizes risk as likelihood of harm, given estimates of exposure consequent to various decision choices. Likelihood estimates are necessary whenever decision makers have many possible decision choices and must weigh more than two societal values, such as in EPA's implementation of "conventional air pollutants." These estimates can not be derived using current methods; different methods are needed. Our analysis suggests changes needed in both the theory and practice of human health risk assessment, and how what is done is depicted.

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 of occupational safety risks in Floridian solid waste systems using Bayesian analysis.

PubMed

Bastani, Mehrad; Celik, Nurcin

2015-10-01

Safety risks embedded within solid waste management systems continue to be a significant issue and are prevalent at every step in the solid waste management process. To recognise and address these occupational hazards, it is necessary to discover the potential safety concerns that cause them, as well as their direct and/or indirect impacts on the different types of solid waste workers. In this research, our goal is to statistically assess occupational safety risks to solid waste workers in the state of Florida. Here, we first review the related standard industrial codes to major solid waste management methods including recycling, incineration, landfilling, and composting. Then, a quantitative assessment of major risks is conducted based on the data collected using a Bayesian data analysis and predictive methods. The risks estimated in this study for the period of 2005-2012 are then compared with historical statistics (1993-1997) from previous assessment studies. The results have shown that the injury rates among refuse collectors in both musculoskeletal and dermal injuries have decreased from 88 and 15 to 16 and three injuries per 1000 workers, respectively. However, a contrasting trend is observed for the injury rates among recycling workers, for whom musculoskeletal and dermal injuries have increased from 13 and four injuries to 14 and six injuries per 1000 workers, respectively. Lastly, a linear regression model has been proposed to identify major elements of the high number of musculoskeletal and dermal injuries. © The Author(s) 2015.

Risk assessment for safety laboratories in Politeknik Negeri Medan

NASA Astrophysics Data System (ADS)

Viyata Sundawa, Bakti; Hutajulu, Elferida; Sirait, Regina; Banurea, Waldemar; Indrayadi; Mulyadi, Sangap

2017-09-01

International Labour Organization (ILO) estimated 2.34 million people die each year because accidents and diseases in workplace. It also impact to economic losses in some countries. It need to do safety and healthy in working environment especially in laboratory. Identification of potential hazards and risks must be done in Telecommunication Laboratory Politeknik Negeri Medan. Therefore, this study was assessed 5 of potential hazards and risks in our laboratory by Likert Scale. This object was divided into 2 assessment namely likelihood of hazards and severity of consequences. Collecting data is taken from questionnaire who involved 100 students at random academic level. The result showed The highest score is chemical hazards 73.2% in likelihood of hazards and electrical hazards 85% in severity of consequences. This condition is classified as “high” state. Big attention must be given to “high” state because it can help us to determine mitigate action.

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.

Vaccine safety evaluation: Practical aspects in assessing benefits and risks.

PubMed

Di Pasquale, Alberta; Bonanni, Paolo; Garçon, Nathalie; Stanberry, Lawrence R; El-Hodhod, Mostafa; Tavares Da Silva, Fernanda

2016-12-20

Vaccines are different from most medicines in that they are administered to large and mostly healthy populations including infants and children, so there is a low tolerance for potential risks or side-effects. In addition, the long-term benefits of immunisation in reducing or eliminating infectious diseases may induce complacency due to the absence of cases. However, as demonstrated in recent measles outbreaks in Europe and United States, reappearance of the disease occurs as soon as vaccine coverage falls. Unfounded vaccine scares such as those associating the combined measles-mumps-rubella vaccine with autism, and whole-cell pertussis vaccines with encephalopathy, can also have massive impacts, resulting in reduced vaccine uptake and disease resurgence. The safety assessment of vaccines is exhaustive and continuous; beginning with non-clinical evaluation of their individual components in terms of purity, stability and sterility, continuing throughout the clinical development phase and entire duration of use of the vaccine; including post-approval. The breadth and depth of safety assessments conducted at multiple levels by a range of independent organizations increases confidence in the rigour with which any potential risks or side-effects are investigated and managed. Industry, regulatory agencies, academia, the medical community and the general public all play a role in monitoring vaccine safety. Within these stakeholder groups, the healthcare professional and vaccine provider have key roles in the prevention, identification, investigation and management of adverse events following immunisation (AEFI). Guidelines and algorithms aid in determining whether AEFI may have been caused by the vaccine, or whether it is coincidental to it. Healthcare providers are encouraged to rigorously investigate AEFIs and to report them via local reporting processes. The ultimate objective for all parties is to ensure vaccines have a favourable benefit-risk profile. Copyright �

Relationship between Risk Assessment and Compliance to Health and Safety in Ugandan Secondary Schools

ERIC Educational Resources Information Center

Sekiwu, Denis; Kabanda, Milly; Naluwemba, Esther Frances; Kaggwa, Victoria Tamale

2015-01-01

Health hazards are part and parcel of human life necessitating the provision of safety in every organizational environment (WHO regional Office for Africa, 2004). Likewise, the area of safety and accident prevention is of great concern to school improvement. The study sought to investigate the relationship between Risk Assessment and Compliancy to…

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

PubMed

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

2016-08-01

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

Risk-based Spacecraft Fire Safety Experiments

NASA Technical Reports Server (NTRS)

Apostolakis, G.; Catton, I.; Issacci, F.; Paulos, T.; Jones, S.; Paxton, K.; Paul, M.

1992-01-01

Viewgraphs on risk-based spacecraft fire safety experiments are presented. Spacecraft fire risk can never be reduced to a zero probability. Probabilistic risk assessment is a tool to reduce risk to an acceptable level.

[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.

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).

Field application of farm-food safety risk assessment (FRAMp) tool for small and medium fresh produce farms.

PubMed

Soon, J M; Davies, W P; Chadd, S A; Baines, R N

2013-02-15

The objective of this study was to develop a farm food safety-risk assessment tool (FRAMp) which serves as a self-assessment and educational tool for fresh produce farms. FRAMp was developed in Microsoft® Excel spreadsheet software using standard mathematical and logical functions and utilised a qualitative risk assessment approach for farmers to evaluate their food safety practices. The FRAMp tool has since been tested on 12 fresh produce farms throughout UK. All the farms determined that FRAMp was interesting but 17% found it too long while 25% of the farms felt the tool was too complicated. The instructions on FRAMp usage were revised and farmers were given the options to skip and select specific steps in the farm risk assessment. The end users (farmers/farm managers) determined that developing their own action plans and using it as proof of assessment for future third-party audits were most useful to them. FRAMp tool can be described as an illustrative risk ranking tool to facilitate farms to identify potential risk factors during their crop production. Copyright © 2012 Elsevier Ltd. All rights reserved.

Survey of mental health nurses' attitudes towards risk assessment, risk assessment tools and positive risk.

PubMed

Downes, C; Gill, A; Doyle, L; Morrissey, J; Higgins, A

2016-04-01

WHAT IS KNOWN ON THE SUBJECT?: Risk assessment and safety planning are a core aspect of the role of the mental health nurse. Conflicting views exist on the value of risk assessment tools. Few studies have examined mental health nurses' attitudes towards risk, including use of tools and the role of positive risk in recovery. WHAT THE PAPER ADDS TO EXISTING KNOWLEDGE?: Mental health nurses view risk assessment as a core dimension of their role and not merely an exercise to fulfil organizational clinical safety and governance obligations. The majority of nurses hold positive attitudes towards therapeutic or positive risk, and consider creative risk taking as vital to people's recovery. The majority of nurses believe that risk assessment tools facilitate professional decision making, however, some are concerned that tools may negatively impact upon therapeutic relationships. WHAT ARE THE IMPLICATIONS FOR PRACTICE?: Ongoing education on the use of risk assessment tools is required to minimize views that their use is incompatible with therapeutic engagement, and to enable nurses to develop confidence to engage with positive risk and to allow service users make decisions and take responsibility. Introduction Risk assessment and safety planning are considered core components of the role of the mental health nurse; however, little is known about nurses' attitudes towards risk assessment, use of tools to assess risk or therapeutic risk taking. Aim This study aimed to explore mental health nurses' attitudes towards completing risk assessments, use of tools as an aid, and therapeutic or positive risk. Method An anonymous survey which included 13 attitudinal statements, rated on a five-point Likert scale, was completed by 381 mental health nurses working in adult services in Ireland. Findings Findings indicate strong support for the practice of risk assessment in mental health practice. The vast majority of nurses believe that risk assessment tools facilitate professional

Qualitative Future Safety Risk Identification an Update

NASA Technical Reports Server (NTRS)

Barr, Lawrence C.

2017-01-01

The purpose of this report is to document the results of a high-level qualitative study that was conducted to identify future aviation safety risks and to assess the potential impacts to the National Airspace System (NAS) of NASA Aviation Safety research on these risks. Multiple external sources (for example, the National Transportation Safety Board, the Flight Safety Foundation, the National Research Council, and the Joint Planning and Development Office) were used to develop a compilation of future safety issues risks, also referred to as future tall poles. The primary criterion used to identify the most critical future safety risk issues was that the issue must be cited in several of these sources as a safety area of concern. The tall poles in future safety risk, in no particular order of importance, are as follows: Runway Safety, Loss of Control In Flight, Icing Ice Detection, Loss of Separation, Near Midair Collision Human Fatigue, Increasing Complexity and Reliance on Automation, Vulnerability Discovery, Data Sharing and Dissemination, and Enhanced Survivability in the Event of an Accident.

Medication Safety of Five Oral Chemotherapies: A Proactive Risk Assessment

PubMed Central

Weingart, Saul N.; Spencer, Justin; Buia, Stephanie; Duncombe, Deborah; Singh, Prabhjyot; Gadkari, Mrinalini; Connor, Maureen

2011-01-01

Purpose: Oral chemotherapies represent an emerging risk area in ambulatory oncology practice. To examine the hazards associated with five oral chemotherapies, we performed a proactive risk assessment. Methods: We convened interdisciplinary teams and conducted failure mode and effects analyses (FMEAs) for five oral chemotherapy agents: capecitabine, imatinib, temozolomide, 6-mercaptopurine, and an investigational agent. This involved the creation of process maps for each medication, identification of failure modes, selection of high-risk failure modes, and development of recommendations to mitigate these risks. We analyzed the number of steps and types of failure modes and compared this information across the study drugs. Results: Key vulnerabilities include patient education about drug handling and adverse effects, prescription writing, patient self-administration and medication adherence, and failure to monitor and manage toxicities. Many of these failure modes were common across the five oral chemotherapies, suggesting the presence of common targets for improvement. Streamlining the FMEA itself may promote the dissemination of this method. Conclusion: Each stage of the medication process poses risks to the safe use of oral chemotherapies. FMEAs may identify opportunities to improve medication safety and reduce the risk of patient harm. PMID:21532801

University building safety index measurement using risk and implementation matrix

NASA Astrophysics Data System (ADS)

Rahman, A.; Arumsari, F.; Maryani, A.

2018-04-01

Many high rise building constructed in several universities in Indonesia. The high-rise building management must provide the safety planning and proper safety equipment in each part of the building. Unfortunately, most of the university in Indonesia have not been applying safety policy yet and less awareness on treating safety facilities. Several fire accidents in university showed that some significant risk should be managed by the building management. This research developed a framework for measuring the high rise building safety index in university The framework is not only assessed the risk magnitude but also designed modular building safety checklist for measuring the safety implementation level. The safety checklist has been developed for 8 types of the university rooms, i.e.: office, classroom, 4 type of laboratories, canteen, and library. University building safety index determined using risk-implementation matrix by measuring the risk magnitude and assessing the safety implementation level. Building Safety Index measurement has been applied in 4 high rise buildings in ITS Campus. The building assessment showed that the rectorate building in secure condition and chemical department building in beware condition. While the library and administration center building was in less secure condition.

A fuzzy model for assessing risk of occupational safety in the processing industry.

PubMed

Tadic, Danijela; Djapan, Marko; Misita, Mirjana; Stefanovic, Miladin; Milanovic, Dragan D

2012-01-01

Managing occupational safety in any kind of industry, especially in processing, is very important and complex. This paper develops a new method for occupational risk assessment in the presence of uncertainties. Uncertain values of hazardous factors and consequence frequencies are described with linguistic expressions defined by a safety management team. They are modeled with fuzzy sets. Consequence severities depend on current hazardous factors, and their values are calculated with the proposed procedure. The proposed model is tested with real-life data from fruit processing firms in Central Serbia.

Managing risk in healthcare: understanding your safety culture using the Manchester Patient Safety Framework (MaPSaF).

PubMed

Parker, Dianne

2009-03-01

To provide sufficient information about the Manchester Patient Safety Framework (MaPSaF) to allow healthcare professionals to assess its potential usefulness. The assessment of safety culture is an important aspect of risk management, and one in which there is increasing interest among healthcare organizations. Manchester Patient Safety Framework offers a theory-based framework for assessing safety culture, designed specifically for use in the NHS. The framework covers multiple dimensions of safety culture, and five levels of safety culture development. This allows the generation of a profile of an organization's safety culture in terms of areas of relative strength and challenge, which can be used to identify focus issues for change and improvement. Manchester Patient Safety Framework provides a useful method for engaging healthcare professionals in assessing and improving the safety culture in their organization, as part of a programme of risk management.

Safety and risk assessment of ceramide 3 in cosmetic products.

PubMed

Choi, Seul Min; Lee, Byung-Mu

2015-10-01

Ceramide 3 is used mainly as a moisturizer in various cosmetic products. Although several safety studies on formulations containing pseudo-ceramide or ceramide have been conducted at the preclinical and clinical levels for regulatory approval, no studies have evaluated the systemic toxicity of ceramide 3. To address this issue, we conducted a risk assessment and comprehensive toxicological review of ceramide and pseudo-ceramide. We assumed that ceramide 3 is present in various personal and cosmetic products at concentrations of 0.5-10%. Based on previously reported exposure data, the margin of safety (MOS) was calculated for product type, use pattern, and ceramide 3 concentration. Lipsticks with up to 10% ceramide 3 (MOS = 4111) are considered safe, while shampoos containing 0.5% ceramide 3 (MOS = 148) are known to be safe. Reported MOS values for body lotion applied to the hands (1% ceramide 3) and back (5% ceramide 3) were 103 and 168, respectively. We anticipate that face cream would be safe up to a ceramide 3 concentration of 3% (MOS = 149). Collectively, the MOS approach indicated no safety concerns for cosmetic products containing less than 1% ceramide 3. Copyright © 2015 Elsevier Ltd. All rights reserved.

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

PubMed

Toffel, Michael W; Birkner, Lawrence R

2002-07-01

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

Proactive assessment of accident risk to improve safety on a system of freeways : [research brief].

DOT National Transportation Integrated Search

2012-05-01

As traffic safety on freeways continues to be a growing concern, much progress has been made in shifting from reactive (incident detection) to proactive (real-time crash risk assessment) traffic strategies. Reliable models that can take in real-time ...

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.

A Risk Assessment Model for Reduced Aircraft Separation: A Quantitative Method to Evaluate the Safety of Free Flight

NASA Technical Reports Server (NTRS)

Cassell, Rick; Smith, Alex; Connors, Mary; Wojciech, Jack; Rosekind, Mark R. (Technical Monitor)

1996-01-01

As new technologies and procedures are introduced into the National Airspace System, whether they are intended to improve efficiency, capacity, or safety level, the quantification of potential changes in safety levels is of vital concern. Applications of technology can improve safety levels and allow the reduction of separation standards. An excellent example is the Precision Runway Monitor (PRM). By taking advantage of the surveillance and display advances of PRM, airports can run instrument parallel approaches to runways separated by 3400 feet with the same level of safety as parallel approaches to runways separated by 4300 feet using the standard technology. Despite a wealth of information from flight operations and testing programs, there is no readily quantifiable relationship between numerical safety levels and the separation standards that apply to aircraft on final approach. This paper presents a modeling approach to quantify the risk associated with reducing separation on final approach. Reducing aircraft separation, both laterally and longitudinally, has been the goal of several aviation R&D programs over the past several years. Many of these programs have focused on technological solutions to improve navigation accuracy, surveillance accuracy, aircraft situational awareness, controller situational awareness, and other technical and operational factors that are vital to maintaining flight safety. The risk assessment model relates different types of potential aircraft accidents and incidents and their contribution to overall accident risk. The framework links accident risks to a hierarchy of failsafe mechanisms characterized by procedures and interventions. The model will be used to assess the overall level of safety associated with reducing separation standards and the introduction of new technology and procedures, as envisaged under the Free Flight concept. The model framework can be applied to various aircraft scenarios, including parallel and in

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

The risk/safety assessment of transgenic crops: the transportability of data.

PubMed

Kearns, Peter; Dagallier, Bertrand; Suwabe, Kazuyuki

2014-12-01

This paper presents the activities and publications of Organisation for Economic Co-operation and Developments (OECD's) Working Group on Harmonisation of Regulatory Oversight in Biotechnology and the Task Force for the Safety of Novel Foods and Feeds. The main outputs of the work are the Series of "consensus documents" of the respective groups. These documents compile information which is intended to be used by those involved in the business of risk/safety assessment. These documents are one means of ensuring the transportability of data amongst authorities. An increasing trend in both the Working Group and Task Force is to consider crop species which are relevant to tropical regions and therefore to countries that are not necessarily members of the OECD. For example, the Working Group has recently published a consensus document on bananas and plantains while the Task Force has published a document on cassava. This trend towards crops of greater interest in the tropics is likely to continue into the future.

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

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

Smith, Curtis L; Mandelli, Diego; Zhegang Ma

2014-11-01

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

Sensemaking of patient safety risks and hazards.

PubMed

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

2006-08-01

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

Sensemaking of Patient Safety Risks and Hazards

PubMed Central

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

2006-01-01

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

Understanding Risk Tolerance and Building an Effective Safety Culture

NASA Technical Reports Server (NTRS)

Loyd, David

2018-01-01

Estimates range from 65-90 percent of catastrophic mishaps are due to human error. NASA's human factors-related mishaps causes are estimated at approximately 75 percent. As much as we'd like to error-proof our work environment, even the most automated and complex technical endeavors require human interaction... and are vulnerable to human frailty. Industry and government are focusing not only on human factors integration into hazardous work environments, but also looking for practical approaches to cultivating a strong Safety Culture that diminishes risk. Industry and government organizations have recognized the value of monitoring leading indicators to identify potential risk vulnerabilities. NASA has adapted this approach to assess risk controls associated with hazardous, critical, and complex facilities. NASA's facility risk assessments integrate commercial loss control, OSHA (Occupational Safety and Health Administration) Process Safety, API (American Petroleum Institute) Performance Indicator Standard, and NASA Operational Readiness Inspection concepts to identify risk control vulnerabilities.

Hazards, risks and safety of diagnostic ultrasound.

PubMed

Duck, Francis A

2008-12-01

The safety of exposure to diagnostic ultrasound is evaluated using a structured approach to risk assessment, based on the acoustic output of present ultrasound scanners. Thermal hazard is described, the magnitude and probability of temperature rise is reviewed, and the severity of harm from any outcome is reviewed. Similar assessments are made separately for acoustic cavitation and gas-body effects, which have previously been considered together. Finally, radiation pressure is considered in a similar manner. In each case, means to minimize the risk are suggested where appropriate. The highest risks are associated with the use of gas-bubble contrast agents. It is concluded that there is a medium risk associated with trans-cranial Doppler use, and that this use of ultrasound deserves more detailed safety review. The risks associated with the current practice of obstetric ultrasound are low. Whilst the severity of radiation pressure as a hazard is low, it is always present. Little is known about any associated cell responses and so the associated risk cannot be evaluated.

Executive Order 13045: Protection of Children from Environmental Health Risks and Safety Risks

EPA Pesticide Factsheets

President William Jefferson Clinton's Executive Order that each Federal agency assess safety risks to children; and ensure that policies, programs, activities, and standards address disproportionate risks. Also established the Task Force.

Benchmarking Global Food Safety Performances: The Era of Risk Intelligence.

PubMed

Valleé, Jean-Charles Le; Charlebois, Sylvain

2015-10-01

Food safety data segmentation and limitations hamper the world's ability to select, build up, monitor, and evaluate food safety performance. Currently, there is no metric that captures the entire food safety system, and performance data are not collected strategically on a global scale. Therefore, food safety benchmarking is essential not only to help monitor ongoing performance but also to inform continued food safety system design, adoption, and implementation toward more efficient and effective food safety preparedness, responsiveness, and accountability. This comparative study identifies and evaluates common elements among global food safety systems. It provides an overall world ranking of food safety performance for 17 Organisation for Economic Co-Operation and Development (OECD) countries, illustrated by 10 indicators organized across three food safety risk governance domains: risk assessment (chemical risks, microbial risks, and national reporting on food consumption), risk management (national food safety capacities, food recalls, food traceability, and radionuclides standards), and risk communication (allergenic risks, labeling, and public trust). Results show all countries have very high food safety standards, but Canada and Ireland, followed by France, earned excellent grades relative to their peers. However, any subsequent global ranking study should consider the development of survey instruments to gather adequate and comparable national evidence on food safety.

Using Risk Assessment Methodologies to Meet Management Objectives

NASA Technical Reports Server (NTRS)

DeMott, D. L.

2015-01-01

Current decision making involves numerous possible combinations of technology elements, safety and health issues, operational aspects and process considerations to satisfy program goals. Identifying potential risk considerations as part of the management decision making process provides additional tools to make more informed management decision. Adapting and using risk assessment methodologies can generate new perspectives on various risk and safety concerns that are not immediately apparent. Safety and operational risks can be identified and final decisions can balance these considerations with cost and schedule risks. Additional assessments can also show likelihood of event occurrence and event consequence to provide a more informed basis for decision making, as well as cost effective mitigation strategies. Methodologies available to perform Risk Assessments range from qualitative identification of risk potential, to detailed assessments where quantitative probabilities are calculated. Methodology used should be based on factors that include: 1) type of industry and industry standards, 2) tasks, tools, and environment 3) type and availability of data and 4) industry views and requirements regarding risk & reliability. 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.

The application of quantitative risk assessment to microbial food safety risks.

PubMed

Jaykus, L A

1996-01-01

Regulatory programs and guidelines for the control of foodborne microbial agents have existed in the U.S. for nearly 100 years. However, increased awareness of the scope and magnitude of foodborne disease, as well as the emergence of previously unrecognized human pathogens transmitted via the foodborne route, have prompted regulatory officials to consider new and improved strategies to reduce the health risks associated with pathogenic microorganisms in foods. Implementation of these proposed strategies will involve definitive costs for a finite level of risk reduction. While regulatory decisions regarding the management of foodborne disease risk have traditionally been done with the aid of the scientific community, a formal conceptual framework for the evaluation of health risks from pathogenic microorganisms in foods is warranted. Quantitative risk assessment (QRA), which is formally defined as the technical assessment of the nature and magnitude of a risk caused by a hazard, provides such a framework. Reproducing microorganisms in foods present a particular challenge to QRA because both their introduction and numbers may be affected by numerous factors within the food chain, with all of these factors representing significant stages in food production, handling, and consumption, in a farm-to-table type of approach. The process of QRA entails four designated phases: (1) hazard identification, (2) exposure assessment, (3) dose-response assessment, and (4) risk characterization. Specific analytical tools are available to accomplish the analyses required for each phase of the QRA. The purpose of this paper is to provide a description of the conceptual framework for quantitative microbial risk assessment within the standard description provided by the National Academy of Sciences (NAS) paradigm. Each of the sequential steps in QRA are discussed in detail, providing information on current applications, tools for conducting the analyses, and methodological and/or data

Understanding safety and production risks in rail engineering planning and protection.

PubMed

Wilson, John R; Ryan, Brendan; Schock, Alex; Ferreira, Pedro; Smith, Stuart; Pitsopoulos, Julia

2009-07-01

Much of the published human factors work on risk is to do with safety and within this is concerned with prediction and analysis of human error and with human reliability assessment. Less has been published on human factors contributions to understanding and managing project, business, engineering and other forms of risk and still less jointly assessing risk to do with broad issues of 'safety' and broad issues of 'production' or 'performance'. This paper contains a general commentary on human factors and assessment of risk of various kinds, in the context of the aims of ergonomics and concerns about being too risk averse. The paper then describes a specific project, in rail engineering, where the notion of a human factors case has been employed to analyse engineering functions and related human factors issues. A human factors issues register for potential system disturbances has been developed, prior to a human factors risk assessment, which jointly covers safety and production (engineering delivery) concerns. The paper concludes with a commentary on the potential relevance of a resilience engineering perspective to understanding rail engineering systems risk. Design, planning and management of complex systems will increasingly have to address the issue of making trade-offs between safety and production, and ergonomics should be central to this. The paper addresses the relevant issues and does so in an under-published domain - rail systems engineering work.

Risk Assessment Overview

NASA Technical Reports Server (NTRS)

Prassinos, Peter G.; Lyver, John W., IV; Bui, Chinh T.

2011-01-01

Risk assessment is used in many industries to identify and manage risks. Initially developed for use on aeronautical and nuclear systems, risk assessment has been applied to transportation, chemical, computer, financial, and security systems among others. It is used to gain an understanding of the weaknesses or vulnerabilities in a system so modification can be made to increase operability, efficiency, and safety and to reduce failure and down-time. Risk assessment results are primary inputs to risk-informed decision making; where risk information including uncertainty is used along with other pertinent information to assist management in the decision-making process. Therefore, to be useful, a risk assessment must be directed at specific objectives. As the world embraces the globalization of trade and manufacturing, understanding the associated risk become important to decision making. Applying risk assessment techniques to a global system of development, manufacturing, and transportation can provide insight into how the system can fail, the likelihood of system failure and the consequences of system failure. The risk assessment can identify those elements that contribute most to risk and identify measures to prevent and mitigate failures, disruptions, and damaging outcomes. In addition, risk associated with public and environment impact can be identified. The risk insights gained can be applied to making decisions concerning suitable development and manufacturing locations, supply chains, and transportation strategies. While risk assessment has been mostly applied to mechanical and electrical systems, the concepts and techniques can be applied across other systems and activities. This paper provides a basic overview of the development of a risk assessment.

What is safety?: Miracles, benefit-risk assessments, and the "right to try".

PubMed

DeTora, Lisa M

2017-07-01

Public discourse is full of quick solutions to health care problems like cancer and rare diseases. Among these is Right to Try legislation for experimental therapies. Right to Try legislation is based on the premise that all experimental agents in clinical trials are safe and guaranteed to produce miracles. Unfortunately, this notion is at odds with expert understanding, which indicates that the benefits and risks of drug products can only be understood together and evaluated incrementally and over time. The current manuscript examines why benefit to risk considerations, a lynchpin of the ethical conduct of clinical research since the Nuremberg Code, might be easily elided from public discourse. This paper considers guidelines for regulatory writing, which routinely separate discussions of effectiveness and safety, as a possible source for some confusion. The internationally-accepted ICH M4E (Common Technical Document) guideline published in 2016 now provides additional guidance for composing Benefits and Risks Conclusions, which weigh and consider effectiveness and safety together. Yet fundamental differences in understanding the "safety" of medicinal products continue to exist between experts in biomedicine, politicians, and healthcare activists. Examining differences in the understanding of "safety" between experts and non-experts also may help explain the source for flawed logic about the safety of investigational products in Right To Try narratives. No drug product is 100% safe. Continuing to weigh benefits and risks together is an important intellectual practice necessary to safeguard human health worldwide, and testing clinical safety is the only way to provide meaningful protections to patients. Science, not miracles, can ensure the protection of patients in clinical research as well as clinical practice. Weighing benefits and risks is an essential intellectual act that informs public health. Science, not miracles, can guide this work. © 2017 John Wiley

Upholding science in health, safety and environmental risk assessments and regulations.

PubMed

Aschner, Michael; Autrup, Herman N; Berry, Sir Colin L; Boobis, Alan R; Cohen, Samuel M; Creppy, Edmond E; Dekant, Wolfgang; Doull, John; Galli, Corrado L; Goodman, Jay I; Gori, Gio B; Greim, Helmut A; Joudrier, Philippe; Kaminski, Norbert E; Klaassen, Curtis D; Klaunig, James E; Lotti, Marcello; Marquardt, Hans W J; Pelkonen, Olavi; Sipes, I Glenn; Wallace, Kendall B; Yamazaki, Hiroshi

2016-09-14

A public appeal has been advanced by a large group of scientists, concerned that science has been misused in attempting to quantify and regulate unmeasurable hazards and risks. 1 The appeal recalls that science is unable to evaluate hazards that cannot be measured, and that science in such cases should not be invoked to justify risk assessments in health, safety and environmental regulations. The appeal also notes that most national and international statutes delineating the discretion of regulators are ambiguous about what rules of evidence ought to apply. Those statutes should be revised to ensure that the evidence for regulatory action is grounded on the standards of the scientific method, whenever feasible. When independent scientific evidence is not possible, policies and regulations should be informed by publicly debated trade-offs between socially desirable uses and social perceptions of affordable precaution. This article explores the premises, implications and actions supporting the appeal and its objectives. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

Risk management modeling and its application in maritime safety

NASA Astrophysics Data System (ADS)

Qin, Ting-Rong; Chen, Wei-Jiong; Zeng, Xiang-Kun

2008-12-01

Quantified risk assessment (QRA) needs mathematicization of risk theory. However, attention has been paid almost exclusively to applications of assessment methods, which has led to neglect of research into fundamental theories, such as the relationships among risk, safety, danger, and so on. In order to solve this problem, as a first step, fundamental theoretical relationships about risk and risk management were analyzed for this paper in the light of mathematics, and then illustrated with some charts. Second, man-machine-environment-management (MMEM) theory was introduced into risk theory to analyze some properties of risk. On the basis of this, a three-dimensional model of risk management was established that includes: a goal dimension; a management dimension; an operation dimension. This goal management operation (GMO) model was explained and then emphasis was laid on the discussion of the risk flowchart (operation dimension), which lays the groundwork for further study of risk management and qualitative and quantitative assessment. Next, the relationship between Formal Safety Assessment (FSA) and Risk Management was researched. This revealed that the FSA method, which the international maritime organization (IMO) is actively spreading, comes from Risk Management theory. Finally, conclusion were made about how to apply this risk management method to concrete fields efficiently and conveniently, as well as areas where further research is required.

Dams and Levees: Safety Risks

NASA Astrophysics Data System (ADS)

Carter, N. T.

2017-12-01

The nation's flood risk is increasing. The condition of U.S. dams and levees contributes to that risk. Dams and levee owners are responsible for the safety, maintenance, and rehabilitation of their facilities. Dams-Of the more than 90,000 dams in the United States, about 4% are federally owned and operated; 96% are owned by state and local governments, public utilities, or private companies. States regulate dams that are not federally owned. The number of high-hazard dams (i.e., dams whose failure would likely result in the loss of human life) has increased in the past decade. Roughly 1,780 state-regulated, high-hazard facilities with structural ratings of poor or unsatisfactory need rehabilitation. Levees-There are approximately 100,000 miles of levees in the nation; most levees are owned and maintained by municipalities and agricultural districts. Few states have levee safety programs. The U.S. Army Corps of Engineers (Corps) inspects 15,000 miles of levees, including levees that it owns and local levees participating in a federal program to assist with certain post-flood repairs. Information is limited on how regularly other levees are inspected. The consequence of a breach or failure is another aspect of risk. State and local governments have significant authority over land use and development, which can shape the social and economic impacts of a breach or failure; they also lead on emergency planning and related outreach. To date, federal dam and levee safety efforts have consisted primarily of (1) support for state dam safety standards and programs, (2) investments at federally owned dams and levees, and (3) since 2007, creation of a national levee database and enhanced efforts and procedures for Corps levee inspections and assessments. In Public Law 113-121, enacted in 2014, Congress (1) directed the Corps to develop voluntary guidelines for levee safety and an associated hazard potential classification system for levees, and (2) authorized support for the

Preparing Safety Cases for Operating Outside Prescriptive Fatigue Risk Management Regulations.

PubMed

Gander, Philippa; Mangie, Jim; Wu, Lora; van den Berg, Margo; Signal, Leigh; Phillips, Adrienne

2017-07-01

Transport operators seeking to operate outside prescriptive fatigue management regulations are typically required to present a safety case justifying how they will manage the associated risk. This paper details a method for constructing a successful safety case. The method includes four elements: 1) scope (prescriptive rules and operations affected); 2) risk assessment; 3) risk mitigation strategies; and 4) monitoring ongoing risk. A successful safety case illustrates this method. It enables landing pilots in 3-pilot crews to choose the second or third in-flight rest break, rather than the regulatory requirement to take the third break. Scope was defined using a month of scheduled flights that would be covered (N = 4151). These were analyzed in the risk assessment using existing literature on factors affecting fatigue to estimate the maximum time awake at top of descent and sleep opportunities in each break. Additionally, limited data collected before the new regulations showed that pilots flying at landing chose the third break on only 6% of flights. A prospective survey comparing subjective reports (N = 280) of sleep in the second vs. third break and fatigue and sleepiness ratings at top of descent confirmed that the third break is not consistently superior. The safety case also summarized established systems for fatigue monitoring, risk assessment and hazard identification, and multiple fatigue mitigation strategies that are in place. Other successful safety cases have used this method. The evidence required depends on the expected level of risk and should evolve as experience with fatigue risk management systems builds.Gander P, Mangie J, Wu L, van den Berg M, Signal L, Phillips A. Preparing safety cases for operating outside prescriptive fatigue risk management regulations. Aerosp Med Hum Perform. 2017; 88(7):688-696.

Risk Management Plans: are they a tool for improving drug safety?

PubMed

Frau, Serena; Font Pous, Maria; Luppino, Maria Rosa; Conforti, Anita

2010-08-01

In 2005, new European legislation authorised Regulatory Agencies to require drug companies to submit a risk management plan (RMP) comprising detailed commitments for post-marketing pharmacovigilance. The aim of the study is to describe the characteristics of RMP for 15 drugs approved by the European Medicines Agency (EMA) and their impact on post-marketing safety issues. Of the 90 new Chemical Entities approved through a centralised procedure by the EMA during 2006 and 2007, 15 of them were selected and their safety aspects and relative RMPs analysed. All post-marketing communications released for safety reasons related to these drugs were also considered. A total of 157 safety specifications were established for the drugs assessed. Risk minimisation activities were foreseen for 5 drugs as training activities. Post-marketing safety issues emerged for 12 of them, leading to 39 type II variations in Summary of Product Characteristics (SPC). Nearly half of such variations, 19 (49%), concerned safety aspects not envisaged by the RMPs. Besides this, 9 Safety Communications were published for 6 out of 15 drugs assessed. The present study reveals several critical points on the way RMPs have been implemented. Several activities proposed by the RMPs do not appear to be adequate in dealing with the potential risks of drugs. Poor communication of risk to practitioners and to the public, and above all limited transparency for the total assessment of risk, seem to transform RMPs into a tool to reassure the public when inadequately evaluated drugs are granted premature marketing authorisation.

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

NASA Astrophysics Data System (ADS)

Moreira, Francisco; Silva, Nuno

2016-08-01

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

Geriatric Cyclists: Assessing Risks, Safety, and Benefits

PubMed Central

Ikpeze, Tochukwu C.; Glaun, Gabriel; McCalla, Daren

2018-01-01

Nearly 1 in every 3 Americans ride bicycles each year, but only 20% of the reported 100 million cyclists ride on a weekly basis. Bicycling is a common form of transportation and recreation and has gained popularity among the elderly patients. In recent years, the number of elderly cyclists has increased steadily and studies have cited ease of use, need for exercise, and enjoyment as important contributing factors. The benefits of physical activity on health is well-documented, and elderly individuals are encouraged to remain active to reduce the progression of age-related weakness and loss of muscle mass. Safety concerns, however, have been a prevalent public health issue. According to the Center for Disease Control and Prevention, elderly and teenage cyclists account for the highest number of head injuries and fatalities among all cyclists. Safety measures that include wearing protective gear such as helmets and choosing the appropriate bicycle have been recommended to minimize the risk of sustaining injuries while riding. Despite these concerns, bicycling has remained a popular and exciting activity for the elderly patients. PMID:29383267

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.

78 FR 78063 - Appendix 4 to Draft Qualitative Risk Assessment of Risk of Activity/Food Combinations for...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-12-24

...ScienceResearch/UCM334110.pdf . 2. FDA, ``Appendix 4 to Draft Qualitative Risk Assessment of Risk of....regulations.gov and at http://www.fda.gov/downloads/Food/FoodScienceResearch/RiskSafetyAssessment/UCM377408... on a Farm,'' 2013. Available at: http://www.fda.gov/downloads/Food/FoodScienceResearch/RiskSafety...

Understanding children's injury-risk behavior: wearing safety gear can lead to increased risk taking.

PubMed

Morrongiello, Barbara A; Walpole, Beverly; Lasenby, Jennifer

2007-05-01

The present study examined whether school-age children show risk compensation and engage in greater risk taking when wearing safety gear compared to when not doing so when running an obstacle course containing hazards that could lead to physical injury. Because sensation seeking has been shown to influence risk taking, this child attribute was also assessed and related to risk compensation. Children 7-12 years of age were videotaped navigating the obstacle course twice, once wearing safety gear and once without safety gear, with reverse directions used to minimize possible practice effects. The time it took the child to run through the course and the number of reckless behaviors (e.g., falls, trips, bumping into things) that the child made while running the course were compared for the gear and no-gear conditions. Results indicated that children went more quickly and behaved more recklessly when wearing safety gear than when not wearing gear, providing evidence of risk compensation. Moreover, those high in sensation seeking showed greater risk compensation compared with other children. Implications for childhood injury prevention are discussed.

Implications of applying cumulative risk assessment to the workplace.

PubMed

Fox, Mary A; Spicer, Kristen; Chosewood, L Casey; Susi, Pam; Johns, Douglas O; Dotson, G Scott

2018-06-01

Multiple changes are influencing work, workplaces and workers in the US including shifts in the main types of work and the rise of the 'gig' economy. Work and workplace changes have coincided with a decline in unions and associated advocacy for improved safety and health conditions. Risk assessment has been the primary method to inform occupational and environmental health policy and management for many types of hazards. Although often focused on one hazard at a time, risk assessment frameworks and methods have advanced toward cumulative risk assessment recognizing that exposure to a single chemical or non-chemical stressor rarely occurs in isolation. We explore how applying cumulative risk approaches may change the roles of workers and employers as they pursue improved health and safety and elucidate some of the challenges and opportunities that might arise. Application of cumulative risk assessment should result in better understanding of complex exposures and health risks with the potential to inform more effective controls and improved safety and health risk management overall. Roles and responsibilities of both employers and workers are anticipated to change with potential for a greater burden of responsibility on workers to address risk factors both inside and outside the workplace that affect health at work. A range of policies, guidance and training have helped develop cumulative risk assessment for the environmental health field and similar approaches are available to foster the practice in occupational safety and health. Copyright © 2018 Elsevier Ltd. 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

An assessment of food safety information provision for UK chemotherapy patients to reduce the risk of foodborne infection.

PubMed

Evans, E W; Redmond, E C

2017-12-01

Given the increased risk of foodborne infection to cancer patients receiving chemotherapy treatment, and the risk of listeriosis reportedly five-times greater to this immunocompromised patient group, there is a need to ensure the implementation of domestic food safety practices among chemotherapy patients and their family caregivers. However, information regarding the adequacy of resources to inform and enable patients to implement domestic food safety practices to reduce the risk of foodborne infection is limited. Consequently, this study aimed to evaluate the provision of food safety information available to UK chemotherapy patients. In-depth semi-structured interviews and content analysis of online patient information resources. Interviews with patients and family caregivers (n = 15) were conducted to explore food-related experiences during chemotherapy treatment. Online food-related information resources for chemotherapy patients (n = 45) were obtained from 35 of 154 National Health Service chemotherapy providers in England, Scotland, and Wales, the Department of Health (DoH) and three of 184 identified UK cancer charities. Identified food-related information resources were reviewed using a content-analysis approach to assess the inclusion of food safety information for chemotherapy patients. In-depth interviews established that many patients indicated awareness of immunosuppression during treatment. Although patients reported practicing caution to reduce the risk of communicable diseases by avoiding crowded spaces/public transport, food safety was reported to be of minimal concern during treatment and the risk of foodborne infection was often underestimated. The review of online food-related patient information resources established that many resources failed to highlight the increased risk of foodborne infection and emphasize the importance of food safety for patients during chemotherapy treatment. Considerable information gaps exist, particularly in

Integrating Safety Assessment Methods using the Risk Informed Safety Margins Characterization (RISMC) Approach

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

Curtis Smith; Diego Mandelli

Safety is central to the design, licensing, operation, and economics of nuclear power plants (NPPs). As the current light water reactor (LWR) NPPs age beyond 60 years, there are possibilities for increased frequency of systems, structures, and components (SSC) degradations or failures that initiate safety significant events, reduce existing accident mitigation capabilities, or create new failure modes. Plant designers commonly “over-design” portions of NPPs and provide robustness in the form of redundant and diverse engineered safety features to ensure that, even in the case of well-beyond design basis scenarios, public health and safety will be protected with a very highmore » degree of assurance. This form of defense-in-depth is a reasoned response to uncertainties and is often referred to generically as “safety margin.” Historically, specific safety margin provisions have been formulated primarily based on engineering judgment backed by a set of conservative engineering calculations. The ability to better characterize and quantify safety margin is important to improved decision making about LWR design, operation, and plant life extension. A systematic approach to characterization of safety margins and the subsequent margin management options represents a vital input to the licensee and regulatory analysis and decision making that will be involved. In addition, as research and development (R&D) in the LWR Sustainability (LWRS) Program and other collaborative efforts yield new data, sensors, and improved scientific understanding of physical processes that govern the aging and degradation of plant SSCs needs and opportunities to better optimize plant safety and performance will become known. To support decision making related to economics, readability, and safety, the RISMC Pathway provides methods and tools that enable mitigation options known as margins management strategies. The purpose of the RISMC Pathway R&D is to support plant decisions for risk

RESIDUAL RISK ASSESSMENT: ETHYLENE OXIDE ...

EPA Pesticide Factsheets

This document describes the residual risk assessment for the Ethylene Oxide Commercial Sterilization source category. For stationary sources, section 112 (f) of the Clean Air Act requires EPA to assess risks to human health and the environment following implementation of technology-based control standards. If these technology-based control standards do not provide an ample margin of safety, then EPA is required to promulgate addtional standards. This document describes the methodology and results of the residual risk assessment performed for the Ethylene Oxide Commercial Sterilization source category. The results of this analyiss will assist EPA in determining whether a residual risk rule for this source category is appropriate.

RESIDUAL RISK ASSESSMENT: MAGNETIC TAPE ...

EPA Pesticide Factsheets

This document describes the residual risk assessment for the Magnetic Tape Manufacturing source category. For stationary sources, section 112 (f) of the Clean Air Act requires EPA to assess risks to human health and the environment following implementation of technology-based control standards. If these technology-based control standards do not provide an ample margin of safety, then EPA is required to promulgate addtional standards. This document describes the methodology and results of the residual risk assessment performed for the Magnetic Tape Manufacturing source category. The results of this analyiss will assist EPA in determining whether a residual risk rule for this source category is appropriate.

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

Risk assessment and risk management of mycotoxins.

PubMed

2012-01-01

Risk assessment is the process of quantifying the magnitude and exposure, or probability, of a harmful effect to individuals or populations from certain agents or activities. Here, we summarize the four steps of risk assessment: hazard identification, dose-response assessment, exposure assessment, and risk characterization. Risk assessments using these principles have been conducted on the major mycotoxins (aflatoxins, fumonisins, ochratoxin A, deoxynivalenol, and zearalenone) by various regulatory agencies for the purpose of setting food safety guidelines. We critically evaluate the impact of these risk assessment parameters on the estimated global burden of the associated diseases as well as the impact of regulatory measures on food supply and international trade. Apart from the well-established risk posed by aflatoxins, many uncertainties still exist about risk assessments for the other major mycotoxins, often reflecting a lack of epidemiological data. Differences exist in the risk management strategies and in the ways different governments impose regulations and technologies to reduce levels of mycotoxins in the food-chain. Regulatory measures have very little impact on remote rural and subsistence farming communities in developing countries, in contrast to developed countries, where regulations are strictly enforced to reduce and/or remove mycotoxin contamination. However, in the absence of the relevant technologies or the necessary infrastructure, we highlight simple intervention practices to reduce mycotoxin contamination in the field and/or prevent mycotoxin formation during storage.

Pesticide Exposure, Safety Issues, and Risk Assessment Indicators

PubMed Central

Damalas, Christos A.; Eleftherohorinos, Ilias G.

2011-01-01

Pesticides are widely used in agricultural production to prevent or control pests, diseases, weeds, and other plant pathogens in an effort to reduce or eliminate yield losses and maintain high product quality. Although pesticides are developed through very strict regulation processes to function with reasonable certainty and minimal impact on human health and the environment, serious concerns have been raised about health risks resulting from occupational exposure and from residues in food and drinking water. Occupational exposure to pesticides often occurs in the case of agricultural workers in open fields and greenhouses, workers in the pesticide industry, and exterminators of house pests. Exposure of the general population to pesticides occurs primarily through eating food and drinking water contaminated with pesticide residues, whereas substantial exposure can also occur in or around the home. Regarding the adverse effects on the environment (water, soil and air contamination from leaching, runoff, and spray drift, as well as the detrimental effects on wildlife, fish, plants, and other non-target organisms), many of these effects depend on the toxicity of the pesticide, the measures taken during its application, the dosage applied, the adsorption on soil colloids, the weather conditions prevailing after application, and how long the pesticide persists in the environment. Therefore, the risk assessment of the impact of pesticides either on human health or on the environment is not an easy and particularly accurate process because of differences in the periods and levels of exposure, the types of pesticides used (regarding toxicity and persistence), and the environmental characteristics of the areas where pesticides are usually applied. Also, the number of the criteria used and the method of their implementation to assess the adverse effects of pesticides on human health could affect risk assessment and would possibly affect the characterization of the already

Assessing cardiac risks in police officers.

PubMed

Brown, J; Trottier, A

1995-12-01

It is necessary to assess the cardiovascular risks of police officers in order to address the issue of police officer safety, as well as the issue of public safety. In the past there has been a tendency to determine these risks according to the presence or absence of demonstrable ischaemia. Increased understanding of pathophysiology of coronary vascular disease leads to a different approach to this problem. This modified approach is discussed.

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

Microbiological risk assessment for personal care products.

PubMed

Stewart, S E; Parker, M D; Amézquita, A; Pitt, T L

2016-12-01

Regulatory decisions regarding microbiological safety of cosmetics and personal care products are primarily hazard-based, where the presence of a potential pathogen determines decision-making. This contrasts with the Food industry where it is a commonplace to use a risk-based approach for ensuring microbiological safety. A risk-based approach allows consideration of the degree of exposure to assess unacceptable health risks. As there can be a number of advantages in using a risk-based approach to safety, this study explores the Codex Alimentarius (Codex) four-step Microbiological Risk Assessment (MRA) framework frequently used in the Food industry and examines how it can be applied to the safety assessment of personal care products. The hazard identification and hazard characterization steps (one and two) of the Codex MRA framework consider the main microorganisms of concern. These are addressed by reviewing the current industry guidelines for objectionable organisms and analysing reports of contaminated products notified by government agencies over a recent 5-year period, together with examples of reported outbreaks. Data related to estimation of exposure (step three) are discussed, and examples of possible calculations and references are included. The fourth step, performed by the risk assessor (risk characterization), is specific to each assessment and brings together the information from the first three steps to assess the risk. Although there are very few documented uses of the MRA approach for personal care products, this study illustrates that it is a practicable and sound approach for producing products that are safe by design. It can be helpful in the context of designing products and processes going to market and with setting of microbiological specifications. Additionally, it can be applied reactively to facilitate decision-making when contaminated products are released on to the marketplace. Currently, the knowledge available may only allow a

Discussing Firearm Ownership and Access as Part of Suicide Risk Assessment and Prevention: "Means Safety" versus "Means Restriction".

PubMed

Stanley, Ian H; Hom, Melanie A; Rogers, Megan L; Anestis, Michael D; Joiner, Thomas E

2017-01-01

The goal of this study was to describe the relative utility of the terms "means safety" versus "means restriction" in counseling individuals to limit their access to firearms in the context of a mock suicide risk assessment. Overall, 370 participants were randomized to read a vignette depicting a clinical scenario in which managing firearm ownership and access was discussed either using the term "means safety" or "means restriction." Participants rated the term "means safety" as significantly more acceptable and preferable than "means restriction." Participants randomized to the "means safety" condition reported greater intentions to adhere to clinicians' recommendations to limit access to a firearm for safety purposes (F[1,367] = 7.393, p = .007, [Formula: see text]). The term "means safety" may be more advantageous than "means restriction" when discussing firearm ownership and access in clinical settings and public health-oriented suicide prevention efforts.

The implementation of nice guidance on venous thromboembolism risk assessment and prophylaxis: a before-after observational study to assess the impact on patient safety across four hospitals in England

PubMed Central

2013-01-01

Background Venous thromboembolism (VTE) is a major cause of morbidity and mortality in hospitalised patients. VTE prevention has been identified as a major health need internationally to improve patient safety. A National Institute for Health and Clinical Excellence (NICE) guideline was issued in February 2010. Its key priorities were to assess patients for risk of VTE on admission to hospital, assess patients for bleeding risk and evaluate the risks and benefits of prescribing VTE prophylaxis. The aim of this study was to evaluate the implementation of NICE guidance and its impact on patient safety. Methods A before-after observational design was used to investigate changes in VTE risk assessment documentation and inappropriate prescribing of prophylaxis between the year prior to (2009) and the year following (2010) the implementation of NICE guidance, using data from a 3-week period during each year. A total of 408 patients were sampled in each year across four hospitals in the NHS South region. Results Implementation strategies such as audit, education and training were used. The percentage of patients for whom a VTE risk assessment was documented increased from 51.5% (210/408) in 2009 to 79.2% (323/408) in 2010; difference 27.7% (95% CI: 21.4% to 33.9%; p < 0.001). There was little evidence of change in the percentage who were prescribed prophylaxis amongst patients without a risk assessment (71.7% (142/198) in 2009 and 68.2% (58/85) in 2010; difference −3.5% (95% CI: -15.2% to 8.2%; p =0.56) nor the percentage who were prescribed low molecular weight heparin amongst patients with a contraindication (14% (4/28) in 2009 and 15% (6/41) in 2010; RD = 0.3% (95% CI: -16.5% to 17.2%; p =0.97). Conclusions The documentation of risk assessment improved following the implementation of NICE guidance; it is questionable, however, whether this led to improved patient safety with respect to prescribing appropriate prophylaxis. PMID:23734903

Payload Safety: Risk and Characteristic-Based Control of Engineered Nanomaterials

NASA Astrophysics Data System (ADS)

Abou, Seraphin Chally; Saad, Maarouf

2013-09-01

In the last decade progress has been made to assist organizations that are developing payloads intended for flight on the International Space Station (ISS) and/or Space Shuttle. Collaboration programs for comprehensive risk assessment have been initiated between the U.S. and the European Union to generate requirements and data needed to comply with payloads safety and to perform risk assessment and controls guidance. Yet, substantial research gaps remain, as do challenges in the translation of these research findings to control for exposure to nanoscale material payloads, and the health effects. Since nanomaterial structures are different from traditional molecules, some standard material properties can change at size of 50nm or less. Changes in material properties at this scale challenge our understanding of hazards posed by nanomaterial payloads in the ISS realistic exposure conditions, and our ability to anticipate, evaluate, and control potential health issues, and safety. The research question addressed in this framework is: what kind of descriptors can be developed for nanomaterial payloads risks assessment? Methods proposed incorporate elements of characteristic- based risk an alysis: (1) to enable characterization of anthropogenic nanomaterials which can result in incidental from natural nanoparticles; and (2) to better understand safety attributes in terms of human health impacts from exposure to varying types of engineered nanomaterials.

Making Patient Risk Visible: Implementation of a Nursing Document Information System to Improve Patient Safety.

PubMed

Wang, Panfeng; Zhang, Hongjun; Li, Baohua; Lin, Keke

2016-01-01

The aims of this study were to develop a nursing information system (NIS), enhance the visibility of patient risk, and identify challenges and facilitators to adoption of the NIS risk assessment system for nurse leaders. This article describes the function of a nursing risk assessment information system, and the results of a survey on the risk assessment system. The results suggested that quality of information processing in nursing significantly improved patient safety. Nurses surveyed demonstrated a high degree of satisfaction, with saving time and improving safety. The nursing document information system described was introduced to improve patient safety and decrease risk. The application of the system has greatly enhanced the efficiency of nursing work, and guides the nurses to make an accurate, comprehensive and objective assessment of patient information, contributing significantly to further improvement in care standards and care decisions.

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...

INTEGRATED RISK ASSESSMENT - RESULTS FROM AN INTERNATIONAL WORKSHOP

EPA Science Inventory

The WHO International Programme on Chemical Safety and international partners have developed a framework for integrated assessment of human health and ecological risks and four case studies. An international workshop was convened to consider how ecological and health risk assess...

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.

Assessing the Biological Safety Profession's Evaluation and Control of Risks Associated with the Field Collection of Potentially Infectious Specimens.

PubMed

Patlovich, Scott J; Emery, Robert J; Whitehead, Lawrence W; Brown, Eric L; Flores, Rene

2015-03-01

Because the origins of the biological safety profession are rooted in the control and prevention of laboratory-associated infections, the vocation focuses primarily on the safe handling of specimens within the laboratory. But in many cases, the specimens and samples handled in the lab are originally collected in the field where a broader set of possible exposure considerations may be present, each with varying degrees of controllability. The failure to adequately control the risks associated with collecting biological specimens in the field may result in illness or injury, and could have a direct impact on laboratory safety, if infectious specimens were packaged or transported inappropriately, for example. This study developed a web-based survey distributed to practicing biological safety professionals to determine the prevalence of and extent to which biological safety programs consider and evaluate field collection activities. In cases where such issues were considered, the data collected characterize the types of controls and methods of oversight at the institutional level that are employed. Sixty-one percent (61%) of the survey respondents indicated that research involving the field collection of biological specimens is conducted at their institutions. A majority (79%) of these field collection activities occur at academic institutions. Twenty-seven percent (27%) of respondents indicated that their safety committees do not consider issues related to biological specimens collected in the field, and only 25% with an oversight committee charged to review field collection protocols have generated a field research-specific risk assessment form to facilitate the assembly of pertinent information for a project risk assessment review. The results also indicated that most biosafety professionals (73% overall; 71% from institutions conducting field collection activities) have not been formally trained on the topic, but many (64% overall; 87% from institutions conducting

Risk Assessment in Underground Coalmines Using Fuzzy Logic in the Presence of Uncertainty

NASA Astrophysics Data System (ADS)

Tripathy, Debi Prasad; Ala, Charan Kumar

2018-04-01

Fatal accidents are occurring every year as regular events in Indian coal mining industry. To increase the safety conditions, it has become a prerequisite to performing a risk assessment of various operations in mines. However, due to uncertain accident data, it is hard to conduct a risk assessment in mines. The object of this study is to present a method to assess safety risks in underground coalmines. The assessment of safety risks is based on the fuzzy reasoning approach. Mamdani fuzzy logic model is developed in the fuzzy logic toolbox of MATLAB. A case study is used to demonstrate the applicability of the developed model. The summary of risk evaluation in case study mine indicated that mine fire has the highest risk level among all the hazard factors. This study could help the mine management to prepare safety measures based on the risk rankings obtained.

Status and future of Quantitative Microbiological Risk Assessment in China

PubMed Central

Dong, Q.L.; Barker, G.C.; Gorris, L.G.M.; Tian, M.S.; Song, X.Y.; Malakar, P.K.

2015-01-01

Since the implementation of the Food Safety Law of the People's Republic of China in 2009 use of Quantitative Microbiological Risk Assessment (QMRA) has increased. QMRA is used to assess the risk posed to consumers by pathogenic bacteria which cause the majority of foodborne outbreaks in China. This review analyses the progress of QMRA research in China from 2000 to 2013 and discusses 3 possible improvements for the future. These improvements include planning and scoping to initiate QMRA, effectiveness of microbial risk assessment utility for risk management decision making, and application of QMRA to establish appropriate Food Safety Objectives. PMID:26089594

Safety testing of monoclonal antibodies in non-human primates: Case studies highlighting their impact on human risk assessment.

PubMed

Brennan, Frank R; Cavagnaro, Joy; McKeever, Kathleen; Ryan, Patricia C; Schutten, Melissa M; Vahle, John; Weinbauer, Gerhard F; Marrer-Berger, Estelle; Black, Lauren E

2018-01-01

Monoclonal antibodies (mAbs) are improving the quality of life for patients suffering from serious diseases due to their high specificity for their target and low potential for off-target toxicity. The toxicity of mAbs is primarily driven by their pharmacological activity, and therefore safety testing of these drugs prior to clinical testing is performed in species in which the mAb binds and engages the target to a similar extent to that anticipated in humans. For highly human-specific mAbs, this testing often requires the use of non-human primates (NHPs) as relevant species. It has been argued that the value of these NHP studies is limited because most of the adverse events can be predicted from the knowledge of the target, data from transgenic rodents or target-deficient humans, and other sources. However, many of the mAbs currently in development target novel pathways and may comprise novel scaffolds with multi-functional domains; hence, the pharmacological effects and potential safety risks are less predictable. Here, we present a total of 18 case studies, including some of these novel mAbs, with the aim of interrogating the value of NHP safety studies in human risk assessment. These studies have identified mAb candidate molecules and pharmacological pathways with severe safety risks, leading to candidate or target program termination, as well as highlighting that some pathways with theoretical safety concerns are amenable to safe modulation by mAbs. NHP studies have also informed the rational design of safer drug candidates suitable for human testing and informed human clinical trial design (route, dose and regimen, patient inclusion and exclusion criteria and safety monitoring), further protecting the safety of clinical trial participants.

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

NASA Technical Reports Server (NTRS)

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

Influence of safety measures on the risks of transporting dangerous goods through road tunnels.

PubMed

Saccomanno, Frank; Haastrup, Palle

2002-12-01

Quantitative risk assessment (QRA) models are used to estimate the risks of transporting dangerous goods and to assess the merits of introducing alternative risk reduction measures for different transportation scenarios and assumptions. A comprehensive QRA model recently was developed in Europe for application to road tunnels. This model can assess the merits of a limited number of "native safety measures." In this article, we introduce a procedure for extending its scope to include the treatment of a number of important "nonnative safety measures" of interest to tunnel operators and decisionmakers. Nonnative safety measures were not included in the original model specification. The suggested procedure makes use of expert judgment and Monte Carlo simulation methods to model uncertainty in the revised risk estimates. The results of a case study application are presented that involve the risks of transporting a given volume of flammable liquid through a 10-km road tunnel.

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.

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.

Quality of life, Risk Assessment, and Safety Research in Liver Transplantation: New Frontiers in Health Services and Outcomes Research

PubMed Central

Butt, Zeeshan; Parikh, Neehar D.; Skaro, Anton; Ladner, Daniela; Cella, David

2013-01-01

Purpose of review In this review, we briefly summarize three fruitful, emerging areas in liver transplantation research: quality of life; risk assessment; and patient safety. Our goal is to highlight recent findings in these areas, with a call for increased integration of social scientists and transplant clinicians to address how best to shape policy and improve outcomes. Recent findings After liver transplantation, recipients generally experience clinically significant, sustained improvement in their physical, social and emotional well-being. However, a sizeable minority of patients do experience excess morbidity that may benefit from ongoing surveillance and/or intervention. There is growing body of research that describes risks associated with liver transplantation, which can be useful aids to better inform decision making by patients, clinicians, payers, and policy makers. In contrast, there has been a relative lack of empirical data on transplant patient safety vulnerabilities, placing the field of surgery in stark contrast to other high risk industries, where such assessments inform continuous process improvement. Summary Health services and outcomes research has grown in importance in the liver transplantation literature, but several important questions remain unanswered that merit programmatic, interdisciplinary research. PMID:22476225

Taking the Risk Out of Risk Assessment

NASA Technical Reports Server (NTRS)

2005-01-01

The ability to understand risks and have the right strategies in place when risky events occur is essential in the workplace. More and more organizations are being confronted with concerns over how to measure their risks or what kind of risks they can take when certain events transpire that could have a negative impact. NASA is one organization that faces these challenges on a daily basis, as effective risk management is critical to the success of its missions especially the Space Shuttle missions. On July 29, 1996, former NASA Administrator Daniel Goldin charged NASA s Office of Safety and Mission Assurance with developing a probabilistic risk assessment (PRA) tool to support decisions on the funding of Space Shuttle upgrades. When issuing the directive, Goldin said, "Since I came to NASA [in 1992], we've spent billions of dollars on Shuttle upgrades without knowing how much they improve safety. I want a tool to help base upgrade decisions on risk." Work on the PRA tool began immediately. The resulting prototype, the Quantitative Risk Assessment System (QRAS) Version 1.0, was jointly developed by NASA s Marshall Space Flight Center, its Office of Safety and Mission Assurance, and researchers at the University of Maryland. QRAS software automatically expands the reliability logic models of systems to evaluate the probability of highly detrimental outcomes occurring in complex systems that are subject to potential accident scenarios. Even in its earliest forms, QRAS was used to begin PRA modeling of the Space Shuttle. In parallel, the development of QRAS continued, with the goal of making it a world-class tool, one that was especially suited to NASA s unique needs. From the beginning, an important conceptual goal in the development of QRAS was for it to help bridge the gap between the professional risk analyst and the design engineer. In the past, only the professional risk analyst could perform, modify, use, and perhaps even adequately understand PRA. NASA wanted

Product Engineering Class in the Software Safety Risk Taxonomy for Building Safety-Critical Systems

NASA Technical Reports Server (NTRS)

Hill, Janice; Victor, Daniel

2008-01-01

When software safety requirements are imposed on legacy safety-critical systems, retrospective safety cases need to be formulated as part of recertifying the systems for further use and risks must be documented and managed to give confidence for reusing the systems. The SEJ Software Development Risk Taxonomy [4] focuses on general software development issues. It does not, however, cover all the safety risks. The Software Safety Risk Taxonomy [8] was developed which provides a construct for eliciting and categorizing software safety risks in a straightforward manner. In this paper, we present extended work on the taxonomy for safety that incorporates the additional issues inherent in the development and maintenance of safety-critical systems with software. An instrument called a Software Safety Risk Taxonomy Based Questionnaire (TBQ) is generated containing questions addressing each safety attribute in the Software Safety Risk Taxonomy. Software safety risks are surfaced using the new TBQ and then analyzed. In this paper we give the definitions for the specialized Product Engineering Class within the Software Safety Risk Taxonomy. At the end of the paper, we present the tool known as the 'Legacy Systems Risk Database Tool' that is used to collect and analyze the data required to show traceability to a particular safety standard

Therapeutic risk management of the suicidal patient: augmenting clinical suicide risk assessment with structured instruments.

PubMed

Homaifar, Beeta; Matarazzo, Bridget; Wortzel, Hal S

2013-09-01

This column is the second in a series presenting a model for therapeutic risk management of the suicidal patient. As discussed in the first part of the series, the model involves several elements including augmenting clinical risk assessment with structured instruments, stratifying risk in terms of both severity and temporality, and developing and documenting a safety plan. This column explores in more detail how to augment clinical risk assessment with structured instruments. Unstructured clinical interviews have the potential to miss important aspects of suicide risk assessment. By augmenting the free-form clinical interview with structured instruments that demonstrate reliability and validity, a more nuanced and multifaceted approach to suicide risk assessment is achieved. Incorporating structured instruments into practice also serves a medicolegal function, since these instruments may become a living part of the medical record, establishing baseline levels of suicidal thoughts and behaviors and facilitating future clinical determinations regarding safety needs. We describe several instruments used in a multidisciplinary suicide consultation service, each of which has demonstrated relevance to suicide risk assessment and screening, ease of administration, and strong psychometric properties. In addition, we emphasize the importance of viewing suicide risk assessment as an ongoing process rather than as a singular event. Finally, we discuss special considerations in the evolving practice of risk assessment.

Statistical, epidemiological, and risk-assessment approaches to evaluating safety of vaccines throughout the life cycle at the Food and Drug Administration.

PubMed

Ball, Robert; Horne, Dale; Izurieta, Hector; Sutherland, Andrea; Walderhaug, Mark; Hsu, Henry

2011-05-01

The public health community faces increasing demands for improving vaccine safety while simultaneously increasing the number of vaccines available to prevent infectious diseases. The passage of the US Food and Drug Administration (FDA) Amendment Act of 2007 formalized the concept of life-cycle management of the risks and benefits of vaccines, from early clinical development through many years of use in large numbers of people. Harnessing scientific and technologic advances is necessary to improve vaccine-safety evaluation. The Office of Biostatistics and Epidemiology in the Center for Biologics Evaluation and Research is working to improve the FDA's ability to monitor vaccine safety by improving statistical, epidemiologic, and risk-assessment methods, gaining access to new sources of data, and exploring the use of genomics data. In this article we describe the current approaches, new resources, and future directions that the FDA is taking to improve the evaluation of vaccine safety.

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.

Risk assessment principle for engineered nanotechnology in food and drug.

PubMed

Hwang, Myungsil; Lee, Eun Ji; Kweon, Se Young; Park, Mi Sun; Jeong, Ji Yoon; Um, Jun Ho; Kim, Sun Ah; Han, Bum Suk; Lee, Kwang Ho; Yoon, Hae Jung

2012-06-01

While the ability to develop nanomaterials and incorporate them into products is advancing rapidly worldwide, understanding of the potential health safety effects of nanomaterials has proceeded at a much slower pace. Since 2008, Korea Food and Drug Administration (KFDA) started an investigation to prepare "Strategic Action Plan" to evaluate safety and nano risk management associated with foods, drugs, medical devices and cosmetics using nano-scale materials. Although there are some studies related to potential risk of nanomaterials, physical-chemical characterization of nanomaterials is not clear yet and these do not offer enough information due to their limitations. Their uncertainties make it impossible to determine whether nanomaterials are actually hazardous to human. According to the above mention, we have some problems to conduct the human exposure risk assessment currently. On the other hand, uncertainty about safety may lead to polarized public debate and to businesses unwillingness for further nanotechnology investigation. Therefore, the criteria and methods to assess possible adverse effects of nanomaterials have been vigorously taken into consideration by many international organizations: the World Health Organization, the Organization for Economic and Commercial Development and the European Commission. The object of this study was to develop risk assessment principles for safety management of future nanoproducts and also to identify areas of research to strengthen risk assessment for nanomaterials. The research roadmaps which were proposed in this study will be helpful to fill up the current gaps in knowledge relevant nano risk assessment.

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.

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...

Workplace bullying in risk and safety professionals.

PubMed

Brewer, Gayle; Holt, Barry; Malik, Shahzeb

2018-02-01

Previous research demonstrates that workplace bullying impacts the welfare of victimized employees, with further consequences for the organization and profession. There is, however, a paucity of information relating to the bullying directed at risk and safety professionals. The present study was conducted to address this issue. Risk and safety professionals (N=420) completed the Negative Acts Questionnaire - Revised and Brief Cope, and reported the extent to which they had been pressured to make or amend a risk or safety based decision. Those experiencing workplace bullying were more likely to engage in a range of coping behaviors, with exposure to work-related and personal bullying particularly influential. Workplace bullying also predicted pressure to make or change a risk or safety based decision. Work related and physically intimidating bullying were particularly important for this aspect of professional practice. Findings are discussed with regard to current practice and the support available to risk and safety professionals. Risk and safety professionals require additional support in relation to workplace bullying and specifically guidance to resist pressure to make or change a risk or safety based decision. Copyright © 2017 National Safety Council and Elsevier Ltd. All rights reserved.

Consideration of the FQPA Safety Factor and Other Uncertainty Factors in Cumulative Risk Assessment of Chemicals Sharing a Common Mechanism of Toxicity

EPA Pesticide Factsheets

This guidance document provides OPP's current thinking on application of the provision in FFDCA about an additional safety factor for the protection of infants and children in the context of cumulative risk assessments.

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.

The Research on Safety Management Information System of Railway Passenger Based on Risk Management Theory

NASA Astrophysics Data System (ADS)

Zhu, Wenmin; Jia, Yuanhua

2018-01-01

Based on the risk management theory and the PDCA cycle model, requirements of the railway passenger transport safety production is analyzed, and the establishment of the security risk assessment team is proposed to manage risk by FTA with Delphi from both qualitative and quantitative aspects. The safety production committee is also established to accomplish performance appraisal, which is for further ensuring the correctness of risk management results, optimizing the safety management business processes and improving risk management capabilities. The basic framework and risk information database of risk management information system of railway passenger transport safety are designed by Ajax, Web Services and SQL technologies. The system realizes functions about risk management, performance appraisal and data management, and provides an efficient and convenient information management platform for railway passenger safety manager.

Research on Occupational Safety, Health Management and Risk Control Technology in Coal Mines.

PubMed

Zhou, Lu-Jie; Cao, Qing-Gui; Yu, Kai; Wang, Lin-Lin; Wang, Hai-Bin

2018-04-26

This paper studies the occupational safety and health management methods as well as risk control technology associated with the coal mining industry, including daily management of occupational safety and health, identification and assessment of risks, early warning and dynamic monitoring of risks, etc.; also, a B/S mode software (Geting Coal Mine, Jining, Shandong, China), i.e., Coal Mine Occupational Safety and Health Management and Risk Control System, is developed to attain the aforementioned objectives, namely promoting the coal mine occupational safety and health management based on early warning and dynamic monitoring of risks. Furthermore, the practical effectiveness and the associated pattern for applying this software package to coal mining is analyzed. The study indicates that the presently developed coal mine occupational safety and health management and risk control technology and the associated software can support the occupational safety and health management efforts in coal mines in a standardized and effective manner. It can also control the accident risks scientifically and effectively; its effective implementation can further improve the coal mine occupational safety and health management mechanism, and further enhance the risk management approaches. Besides, its implementation indicates that the occupational safety and health management and risk control technology has been established based on a benign cycle involving dynamic feedback and scientific development, which can provide a reliable assurance to the safe operation of coal mines.

Research on Occupational Safety, Health Management and Risk Control Technology in Coal Mines

PubMed Central

Zhou, Lu-jie; Cao, Qing-gui; Yu, Kai; Wang, Lin-lin; Wang, Hai-bin

2018-01-01

This paper studies the occupational safety and health management methods as well as risk control technology associated with the coal mining industry, including daily management of occupational safety and health, identification and assessment of risks, early warning and dynamic monitoring of risks, etc.; also, a B/S mode software (Geting Coal Mine, Jining, Shandong, China), i.e., Coal Mine Occupational Safety and Health Management and Risk Control System, is developed to attain the aforementioned objectives, namely promoting the coal mine occupational safety and health management based on early warning and dynamic monitoring of risks. Furthermore, the practical effectiveness and the associated pattern for applying this software package to coal mining is analyzed. The study indicates that the presently developed coal mine occupational safety and health management and risk control technology and the associated software can support the occupational safety and health management efforts in coal mines in a standardized and effective manner. It can also control the accident risks scientifically and effectively; its effective implementation can further improve the coal mine occupational safety and health management mechanism, and further enhance the risk management approaches. Besides, its implementation indicates that the occupational safety and health management and risk control technology has been established based on a benign cycle involving dynamic feedback and scientific development, which can provide a reliable assurance to the safe operation of coal mines. PMID:29701715

A quantitative risk assessment for the safety of carcase storage systems for scrapie infected farms.

PubMed

Adkin, A; Jones, D L; Eckford, R L; Edwards-Jones, G; Williams, A P

2014-10-01

To determine the risk associated with the use of carcase storage vessels on a scrapie infected farm. A stochastic quantitative risk assessment was developed to determine the rate of accumulation and fate of scrapie in a novel low-input storage system. For an example farm infected with classical scrapie, a mean of 10(3·6) Ovine Oral ID50 s was estimated to accumulate annually. Research indicates that the degradation of any prions present may range from insignificant to a magnitude of one or two logs over several months of storage. For infected farms, the likely partitioning of remaining prion into the sludge phase would necessitate the safe operation and removal of resulting materials from these systems. If complete mixing could be assumed, on average, the concentrations of infectivity are estimated to be slightly lower than that measured in placenta from infected sheep at lambing. This is the first quantitative assessment of the scrapie risk associated with fallen stock on farm and provides guidance to policy makers on the safety of one type of storage system and the relative risk when compared to other materials present on an infected farm. © 2014 Crown Copyright. Journal of Applied Microbiology © 2014 Society for Applied Microbiology This article is published with the permission of the Controller of HMSO and the Queen's Printer for Scotland.

Confounders in interpreting pathology for safety and risk assessment

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

Wolf, Douglas C.; Mann, Peter C.

2005-02-01

The contribution of pathology to toxicity assessment is invaluable but often not clearly understood. Pathology endpoints are the central response around which human health risk assessment is frequently determined; therefore, it is important that the general toxicology community understand current concepts and nomenclature of toxicologic pathology. Toxicologic pathology encompasses the study of changes in tissue morphology that help define the risk of exposure to xenobiotics. Toxicologic pathology is a discipline that has changed and adapted over time including methods of analysis and nomenclature of lesions. As risk assessments are updated for chemicals in commerce, frequently the older literature must bemore » reviewed and reevaluated. When interpreting pathology data from animal studies, it is important to consider the biological significance of a lesion as well as its relationship to the ultimate adverse health effect. Assessing the potential for a chemical to cause harm to humans must include the examination of the entire pathology database in context of the study design, the mode of action of the chemical of concern, and using the most current interpretation of a lesion to determine the significance for human health effects of a particular tissue response.« less

Do we see how they perceive risk? An integrated analysis of risk perception and its effect on workplace safety behavior.

PubMed

Xia, Nini; Wang, Xueqing; Griffin, Mark A; Wu, Chunlin; Liu, Bingsheng

2017-09-01

While risk perception is a key factor influencing safety behavior, the academia lacks specific attention to the ways that workers perceive risk, and thus little is known about the mechanisms through which different risk perceptions influence safety behavior. Most previous research in the workplace safety domain argues that people tend to perceive risk based on rational formulations of risk criticality. However, individuals' emotions can be also useful in understanding their perceptions. Therefore, this research employs an integrated analysis concerning the rational and emotional perspectives. Specifically, it was expected that the identified three rational ways of perceiving risk, i.e., perceived probability, severity, and negative utility, would influence the direct emotional risk perception. Furthermore, these four risk perceptions were all expected to positively but differently influence safety behavior. The hypotheses were tested using a sample of 120 construction workers. It was found that all the three rational risk perceptions significantly influenced workers' direct perception of risk that is mainly based on emotions. Furthermore, safety behavior among workers relied mainly on emotional perception but not rational calculations of risk. This research contributes to workplace safety research by highlighting the importance of integrating the emotional assessment of risk, especially when workers' risk perception and behavior are concerned. Suggested avenues for improving safety behavior through improvement in risk perception include being aware of the possibility of different ways of perceiving risk, promoting experience sharing and accident simulation, and uncovering risk information. Copyright © 2017 Elsevier Ltd. All rights reserved.

A 21st Century Roadmap for Human Health Risk Assessment ...

EPA Pesticide Factsheets

For decades human health risk assessment has depended primarily on animal testing to predict adverse effects in humans, but that paradigm has come under question because of calls for more accurate information, less use of animals, and more efficient use of resources. Moreover, the disproportionate use of hazard information has overshadowed the important role of exposure science in determinations of human safety. In addition, major risk assessments lack the clarity and transparency that hinder an understanding of the analysis and communication of key safety messages. To help answer these challenges, the HESI-managed RISK21 project was initiated to develop a scientific, transparent, and efficient approach to the evolving world of human health risk assessment. RISK21 involved over 120 participants from 12 countries, 15 government institutions, 20 universities, 2 non-governmental organizations, and 12 corporations. RISK21 developed a tiered approach that is problem formulation-based, makes maximum use of prior knowledge, and is led by exposure science to produce a highly transparent and flexible visualization of and approach to assessing human safety and risk. The general principles underlying the RISK21 approach as well as an overview of the RISK21 Roadmap are presented here. This paper will be followed by a series of publications that will articulate the details that comprise this systematic approach. The purpose of this manuscript is to provide an overview

Assessments of direct human exposure: the approach of EU risk assessments compared to scenario-based risk assessment.

PubMed

Wormuth, Matthias; Demou, Evangelia; Scheringer, Martin; Hungerbühler, Konrad

2007-08-01

The awareness of potential risks emerging from the use of chemicals in all parts of daily life has increased the need for risk assessments that are able to cover a high number of exposure situations and thereby ensure the safety of workers and consumers. In the European Union (EU), the practice of risk assessments for chemicals is laid down in a Technical Guidance Document; it is designed to consider environmental and human occupational and residential exposure. Almost 70 EU risk assessment reports (RARs) have been finalized for high-production-volume chemicals during the last decade. In the present study, we analyze the assessment of occupational and consumer exposure to trichloroethylene and phthalates presented in six EU RARs. Exposure scenarios in these six RARs were compared to scenarios used in applications of the scenario-based risk assessment approach to the same set of chemicals. We find that scenarios used in the selected EU RARs to represent typical exposure situations in occupational or private use of chemicals and products do not necessarily represent worst-case conditions. This can be due to the use of outdated information on technical equipment and conditions in workplaces or omission of pathways that can cause consumer exposure. Considering the need for exposure and risk assessments under the new chemicals legislation of the EU, we suggest that a transparent process of collecting data on exposure situations and of generating representative exposure scenarios is implemented to improve the accuracy of risk assessments. Also, the data sets used to assess human exposure should be harmonized, summarized in a transparent fashion, and made accessible for all risk assessors and the public.

A quantitative risk-assessment system (QR-AS) evaluating operation safety of Organic Rankine Cycle using flammable mixture working fluid.

PubMed

Tian, Hua; Wang, Xueying; Shu, Gequn; Wu, Mingqiang; Yan, Nanhua; Ma, Xiaonan

2017-09-15

Mixture of hydrocarbon and carbon dioxide shows excellent cycle performance in Organic Rankine Cycle (ORC) used for engine waste heat recovery, but the unavoidable leakage in practical application is a threat for safety due to its flammability. In this work, a quantitative risk assessment system (QR-AS) is established aiming at providing a general method of risk assessment for flammable working fluid leakage. The QR-AS covers three main aspects: analysis of concentration distribution based on CFD simulations, explosive risk assessment based on the TNT equivalent method and risk mitigation based on evaluation results. A typical case of propane/carbon dioxide mixture leaking from ORC is investigated to illustrate the application of QR-AS. According to the assessment results, proper ventilation speed, safe mixture ratio and location of gas-detecting devices have been proposed to guarantee the security in case of leakage. The results revealed that this presented QR-AS was reliable for the practical application and the evaluation results could provide valuable guidance for the design of mitigation measures to improve the safe performance of ORC system. Copyright © 2017 Elsevier B.V. All rights reserved.

Towards a better reliability of risk assessment: development of a qualitative & quantitative risk evaluation model (Q2REM) for different trades of construction works in Hong Kong.

PubMed

Fung, Ivan W H; Lo, Tommy Y; Tung, Karen C F

2012-09-01

Since the safety professionals are the key decision makers dealing with project safety and risk assessment in the construction industry, their perceptions of safety risk would directly affect the reliability of risk assessment. The safety professionals generally tend to heavily rely on their own past experiences to make subjective decisions on risk assessment without systematic decision making. Indeed, understanding of the underlying principles of risk assessment is significant. In this study, the qualitative analysis on the safety professionals' beliefs of risk assessment and their perceptions towards risk assessment, including their recognitions of possible accident causes, the degree of differentiations on their perceptions of risk levels of different trades of works, recognitions of the occurrence of different types of accidents, and their inter-relationships with safety performance in terms of accident rates will be explored in the Stage 1. At the second stage, the deficiencies of the current general practice for risk assessment can be sorted out firstly. Based on the findings from Stage 1 and the historical accident data from 15 large-scaled construction projects in 3-year average, a risk evaluation model prioritizing the risk levels of different trades of works and which cause different types of site accident due to various accident causes will be developed quantitatively. With the suggested systematic accident recording techniques, this model can be implemented in the construction industry at both project level and organizational level. The model (Q(2)REM) not only act as a useful supplementary guideline of risk assessment for the construction safety professionals, but also assists them to pinpoint the potential risks on site for the construction workers under respective trades of works through safety trainings and education. It, in turn, arouses their awareness on safety risk. As the Q(2)REM can clearly show the potential accident causes leading to

Relationship among food-safety knowledge, beliefs, and risk-reduction behavior in university students in Japan.

PubMed

Takeda, Sayaka; Akamatsu, Rie; Horiguchi, Itsuko; Marui, Eiji

2011-01-01

To identify whether university students who have both food-safety knowledge and beliefs perform risk-reduction behaviors. Cross-sectional research using a questionnaire that included food-safety knowledge, perceptions, risk-reduction behavior, stages for the selection of safer food based on the Transtheoretical Model, and demographic characteristics. Four universities in eastern Japan and 2 universities in western Japan. University students (n = 799). Food-safety knowledge, beliefs, and risk-reduction behaviors. Answers on measures assessing risk perception and food-safety knowledge were combined to form 4 groups of participants. Relationships among demographic characteristics, the 4 groups, risk-reduction behaviors, stage of change, and severity and susceptibility were assessed. The proportion of students who had more knowledge of food safety and a belief that "there are no 100% safe food items" was high in the group that frequently performed risk-reduction behaviors, as it was in the group who had taken a basic class about food or health care and who had, or were working toward, a food or nutrition qualification. University students who thought that there were no 100% safe food items and who had more knowledge about food safety were more likely to confirm food-safety information when selecting food. Copyright © 2011 Society for Nutrition Education and Behavior. Published by Elsevier Inc. All rights reserved.

Occupational health policies on risk assessment in Japan.

PubMed

Horie, Seichi

2010-09-01

Industrial Safety and Health Law (ISH Law) of Japan requires abnormalities identified in evaluations of worker health and working environments are reported to occupational physicians, and employers are advised of measures to ensure appropriate accommodations in working environments and work procedures. Since the 1980s, notions of a risk assessment and occupational safety and health management system were expected to further prevent industrial accidents. In 2005, ISH Law stipulated workplace risk assessment using the wording "employers shall endeavor." Following the amendment, multiple documents and guidelines for risk assessment for different work procedures were developed. They require ISH Laws to be implemented fully and workplaces to plan and execute measures to reduce risks, ranking them from those addressing potential hazards to those requiring workers to wear protective articles. A governmental survey in 2005 found the performance of risk assessment was 20.4% and common reasons for not implementing risk assessments were lack of adequate personnel or knowledge. ISH Law specifies criminal penalties for both individuals and organizations. Moreover, under the Labor Contract Law promulgated in 2007, employers are obliged to make reasonable efforts to ensure employee health for foreseeable and avoidable risks. Therefore, enterprises neglecting even the non-binding provisions of guidelines are likely to suffer significant business impact if judged to be responsible for industrial accidents or occupational disease. To promote risk assessment, we must strengthen technical, financial, and physical support from public-service organizations, encourage the dissemination of good practices to reduce risks, and consider additional employer incentives, including relaxed mandatory regulations.

Principle considerations for the risk assessment of sprayed consumer products.

PubMed

Steiling, W; Bascompta, M; Carthew, P; Catalano, G; Corea, N; D'Haese, A; Jackson, P; Kromidas, L; Meurice, P; Rothe, H; Singal, M

2014-05-16

In recent years, the official regulation of chemicals and chemical products has been intensified. Explicitly for spray products enhanced requirements to assess the consumers'/professionals' exposure to such product type have been introduced. In this regard the Aerosol-Dispensers-Directive (75/324/EEC) with obligation for marketing aerosol dispensers, and the Cosmetic-Products-Regulation (1223/2009/EC) which obliges the insurance of a safety assessment, have to be mentioned. Both enactments, similar to the REACH regulation (1907/2006/EC), require a robust chemical safety assessment. From such assessment, appropriate risk management measures may be identified to adequately control the risk of these chemicals/products to human health and the environment when used. Currently, the above-mentioned regulations lack the guidance on which data are needed for preparing a proper hazard analysis and safety assessment of spray products. Mandatory in the process of inhalation risk and safety assessment is the determination and quantification of the actual exposure to the spray product and more specifically, its ingredients. In this respect the current article, prepared by the European Aerosol Federation (FEA, Brussels) task force "Inhalation Toxicology", intends to introduce toxicological principles and the state of the art in currently available exposure models adapted for typical application scenarios. This review on current methodologies is intended to guide safety assessors to better estimate inhalation exposure by using the most relevant data. Copyright © 2014 The Authors. Published by Elsevier Ireland Ltd.. All rights reserved.

Implementing Toxicity Testing in the 21st Century (TT21C): Making safety decisions using toxicity pathways, and progress in a prototype risk assessment.

PubMed

Adeleye, Yeyejide; Andersen, Melvin; Clewell, Rebecca; Davies, Michael; Dent, Matthew; Edwards, Sue; Fowler, Paul; Malcomber, Sophie; Nicol, Beate; Scott, Andrew; Scott, Sharon; Sun, Bin; Westmoreland, Carl; White, Andrew; Zhang, Qiang; Carmichael, Paul L

2015-06-05

Risk assessment methodologies in toxicology have remained largely unchanged for decades. The default approach uses high dose animal studies, together with human exposure estimates, and conservative assessment (uncertainty) factors or linear extrapolations to determine whether a specific chemical exposure is 'safe' or 'unsafe'. Although some incremental changes have appeared over the years, results from all new approaches are still judged against this process of extrapolating high-dose effects in animals to low-dose exposures in humans. The US National Research Council blueprint for change, entitled Toxicity Testing in the 21st Century: A Vision and Strategy called for a transformation of toxicity testing from a system based on high-dose studies in laboratory animals to one founded primarily on in vitro methods that evaluate changes in normal cellular signalling pathways using human-relevant cells or tissues. More recently, this concept of pathways-based approaches to risk assessment has been expanded by the description of 'Adverse Outcome Pathways' (AOPs). The question, however, has been how to translate this AOP/TT21C vision into the practical tools that will be useful to those expected to make safety decisions. We have sought to provide a practical example of how the TT21C vision can be implemented to facilitate a safety assessment for a commercial chemical without the use of animal testing. To this end, the key elements of the TT21C vision have been broken down to a set of actions that can be brought together to achieve such a safety assessment. Such components of a pathways-based risk assessment have been widely discussed, however to-date, no worked examples of the entire risk assessment process exist. In order to begin to test the process, we have taken the approach of examining a prototype toxicity pathway (DNA damage responses mediated by the p53 network) and constructing a strategy for the development of a pathway based risk assessment for a specific

Exploration Health Risks: Probabilistic Risk Assessment

NASA Technical Reports Server (NTRS)

Rhatigan, Jennifer; Charles, John; Hayes, Judith; Wren, Kiley

2006-01-01

Maintenance of human health on long-duration exploration missions is a primary challenge to mission designers. Indeed, human health risks are currently the largest risk contributors to the risks of evacuation or loss of the crew on long-duration International Space Station missions. We describe a quantitative assessment of the relative probabilities of occurrence of the individual risks to human safety and efficiency during space flight to augment qualitative assessments used in this field to date. Quantitative probabilistic risk assessments will allow program managers to focus resources on those human health risks most likely to occur with undesirable consequences. Truly quantitative assessments are common, even expected, in the engineering and actuarial spheres, but that capability is just emerging in some arenas of life sciences research, such as identifying and minimize the hazards to astronauts during future space exploration missions. Our expectation is that these results can be used to inform NASA mission design trade studies in the near future with the objective of preventing the higher among the human health risks. We identify and discuss statistical techniques to provide this risk quantification based on relevant sets of astronaut biomedical data from short and long duration space flights as well as relevant analog populations. We outline critical assumptions made in the calculations and discuss the rationale for these. Our efforts to date have focussed on quantifying the probabilities of medical risks that are qualitatively perceived as relatively high risks of radiation sickness, cardiac dysrhythmias, medically significant renal stone formation due to increased calcium mobilization, decompression sickness as a result of EVA (extravehicular activity), and bone fracture due to loss of bone mineral density. We present these quantitative probabilities in order-of-magnitude comparison format so that relative risk can be gauged. We address the effects of

Nuclear power and probabilistic safety assessment (PSA): past through future applications

NASA Astrophysics Data System (ADS)

Stamatelatos, M. G.; Moieni, P.; Everline, C. J.

1995-03-01

Nuclear power reactor safety in the United States is about to enter a new era -- an era of risk- based management and risk-based regulation. First, there was the age of `prescribed safety assessment,' during which a series of design-basis accidents in eight categories of severity, or classes, were postulated and analyzed. Toward the end of that era, it was recognized that `Class 9,' or `beyond design basis,' accidents would need special attention because of the potentially severe health and financial consequences of these accidents. The accident at Three Mile Island showed that sequences of low-consequence, high-frequency events and human errors can be much more risk dominant than the Class 9 accidents. A different form of safety assessment, PSA, emerged and began to gain ground against the deterministic safety establishment. Eventually, this led to the current regulatory requirements for individual plant examinations (IPEs). The IPEs can serve as a basis for risk-based regulation and management, a concept that may ultimately transform the U.S. regulatory process from its traditional deterministic foundations to a process predicated upon PSA. Beyond the possibility of a regulatory environment predicated upon PSA lies the possibility of using PSA as the foundation for managing daily nuclear power plant operations.

[International trend of guidance for nanomaterial risk assessment].

PubMed

Hirose, Akihiko

2013-01-01

In the past few years, several kinds of opinions or recommendations on the nanomaterial safety assessment have been published from international or national bodies. Among the reports, the first practical guidance of risk assessment from the regulatory body was published from the European Food Safety Authorities in May 2011, which included the determination of exposure scenario and toxicity testing strategy. In October 2011, European Commission (EC) adopted the definition of "nanomaterial" for regulation. And more recently, Scientific Committee on Consumer Safety of EC released guidance for assessment of nanomaterials in cosmetics in June 2012. A series of activities in EU marks an important step towards realistic safety assessment of nanomaterials. On the other hand, the US FDA announced a draft guidance for industry in June 2011, and then published draft guidance documents for both "Cosmetic Products" and "Food Ingredients and Food Contact Substances" in April 2012. These draft documents do not restrictedly define the physical properties of nanomaterials, but when manufacturing changes alter the dimensions, properties, or effects of an FDA-regulated product, the products are treated as new products. Such international movements indicate that most of nanomaterials with any new properties would be assessed or regulated as new products by most of national authorities in near future, although the approaches are still case by case basis. We will introduce such current international activities and consideration points for regulatory risk assessment.

Discounting the value of safety: effects of perceived risk and effort.

PubMed

Sigurdsson, Sigurdur O; Taylor, Matthew A; Wirth, Oliver

2013-09-01

Although falls from heights remain the most prevalent cause of fatalities in the construction industry, factors impacting safety-related choices associated with work at heights are not completely understood. Better tools are needed to identify and study the factors influencing safety-related choices and decision making. Using a computer-based task within a behavioral economics paradigm, college students were presented a choice between two hypothetical scenarios that differed in working height and effort associated with retrieving and donning a safety harness. Participants were instructed to choose the scenario in which they were more likely to wear the safety harness. Based on choice patterns, switch points were identified, indicating when the perceived risk in both scenarios was equivalent. Switch points were a systematic function of working height and effort, and the quantified relation between perceived risk and effort was described well by a hyperbolic equation. Choice patterns revealed that the perceived risk of working at heights decreased as the effort to retrieve and don a safety harness increased. Results contribute to the development of computer-based procedure for assessing risk discounting within a behavioral economics framework. Such a procedure can be used as a research tool to study factors that influence safety-related decision making with a goal of informing more effective prevention and intervention strategies. Copyright © 2013 National Safety Council and Elsevier Ltd. All rights reserved.

Operationalization Of The Professional Risks Assessment Activity

NASA Astrophysics Data System (ADS)

Ivascu, Victoria Larisa; Cirjaliu, Bianca; Draghici, Anca

2015-07-01

Professional risks assessment approach (integration of analysis and evaluation processes) is linked with the general concerns of nowadays companies for their employees' health and safety assurances, in the context of organizations sustainable development. The paper presents an approach for the operationalization of the professional risk assessment activity in companies through the implementation and use of the OnRisk platform (this have been tested in some industrial companies). The short presentation of the relevant technical reports and statistics on OSH management at the European Union level underlines the need for the development of a professional risks assessment. Finally, there have been described the designed and developed OnRisk platform as a web platform together with some case studies that have validate the created tool.

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.

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.

[Endorsement of risk management and patient safety by certification of conformity in health care quality assessment].

PubMed

Waßmuth, Ralf

2015-01-01

Certification of conformity in health care should provide assurance of compliance with quality standards. This also includes risk management and patient safety. Based on a comprehensive definition of quality, beneficial effects on the management of risks and the enhancement of patient safety can be expected from certification of conformity. While these effects have strong face validity, they are currently not sufficiently supported by evidence from health care research. Whether this relates to a lack of evidence or a lack of investigation remains open. Advancing safety culture and "climate", as well as learning from adverse events rely in part on quality management and are at least in part reflected in the certification of healthcare quality. However, again, evidence of the effectiveness of such measures is limited. Moreover, additional factors related to personality, attitude and proactive action of healthcare professionals are crucial factors in advancing risk management and patient safety which are currently not adequately reflected in certification of conformity programs.

Microbiological Quantitative Risk Assessment

NASA Astrophysics Data System (ADS)

Dominguez, Silvia; Schaffner, Donald W.

The meat and poultry industry faces ongoing challenges due to the natural association of pathogens of concern (e.g., Salmonella, Campylobacter jejuni, Escherichia coli O157:H7) with a variety of domesticated food animals. In addition, pathogens such as Listeria monocytogenes pose a significant cross-contamination risk during further meat and poultry processing, distribution, and storage. Furthermore, the meat and poultry industries are constantly changing with the addition of new products, use of new raw materials, and targeting of new consumer populations, each of which may give rise to potential new risks. National and international regulations are increasingly using a “risk-based” approach to food safety (where the regulatory focus is driven by the magnitude of the risk), so risk assessment is becoming a valuable tool to systematically organize and evaluate the potential public health risk posed by food processing operations.

Emerging Infectious Diseases and Blood Safety: Modeling the Transfusion-Transmission Risk.

PubMed

Kiely, Philip; Gambhir, Manoj; Cheng, Allen C; McQuilten, Zoe K; Seed, Clive R; Wood, Erica M

2017-07-01

While the transfusion-transmission (TT) risk associated with the major transfusion-relevant viruses such as HIV is now very low, during the last 20 years there has been a growing awareness of the threat to blood safety from emerging infectious diseases, a number of which are known to be, or are potentially, transfusion transmissible. Two published models for estimating the transfusion-transmission risk from EIDs, referred to as the Biggerstaff-Petersen model and the European Upfront Risk Assessment Tool (EUFRAT), respectively, have been applied to several EIDs in outbreak situations. We describe and compare the methodological principles of both models, highlighting their similarities and differences. We also discuss the appropriateness of comparing results from the two models. Quantitating the TT risk of EIDs can inform decisions about risk mitigation strategies and their cost-effectiveness. Finally, we present a qualitative risk assessment for Zika virus (ZIKV), an EID agent that has caused several outbreaks since 2007. In the latest and largest ever outbreak, several probable cases of transfusion-transmission ZIKV have been reported, indicating that it is transfusion-transmissible and therefore a risk to blood safety. We discuss why quantitative modeling the TT risk of ZIKV is currently problematic. Crown Copyright © 2017. Published by Elsevier Inc. All rights reserved.

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.

The MARINA Risk Assessment Strategy: A Flexible Strategy for Efficient Information Collection and Risk Assessment of Nanomaterials

PubMed Central

Bos, Peter M. J.; Gottardo, Stefania; Scott-Fordsmand, Janeck J.; van Tongeren, Martie; Semenzin, Elena; Fernandes, Teresa F.; Hristozov, Danail; Hund-Rinke, Kerstin; Hunt, Neil; Irfan, Muhammad-Adeel; Landsiedel, Robert; Peijnenburg, Willie J. G. M.; Sánchez Jiménez, Araceli; van Kesteren, Petra C. E.; Oomen, Agnes G.

2015-01-01

An engineered nanomaterial (ENM) may actually consist of a population of primary particles, aggregates and agglomerates of various sizes. Furthermore, their physico-chemical characteristics may change during the various life-cycle stages. It will probably not be feasible to test all varieties of all ENMs for possible health and environmental risks. There is therefore a need to further develop the approaches for risk assessment of ENMs. Within the EU FP7 project Managing Risks of Nanoparticles (MARINA) a two-phase risk assessment strategy has been developed. In Phase 1 (Problem framing) a base set of information is considered, relevant exposure scenarios (RESs) are identified and the scope for Phase 2 (Risk assessment) is established. The relevance of an RES is indicated by information on exposure, fate/kinetics and/or hazard; these three domains are included as separate pillars that contain specific tools. Phase 2 consists of an iterative process of risk characterization, identification of data needs and integrated collection and evaluation of data on the three domains, until sufficient information is obtained to conclude on possible risks in a RES. Only data are generated that are considered to be needed for the purpose of risk assessment. A fourth pillar, risk characterization, is defined and it contains risk assessment tools. This strategy describes a flexible and efficient approach for data collection and risk assessment which is essential to ensure safety of ENMs. Further developments are needed to provide guidance and make the MARINA Risk Assessment Strategy operational. Case studies will be needed to refine the strategy. PMID:26633430

The MARINA Risk Assessment Strategy: A Flexible Strategy for Efficient Information Collection and Risk Assessment of Nanomaterials.

PubMed

Bos, Peter M J; Gottardo, Stefania; Scott-Fordsmand, Janeck J; van Tongeren, Martie; Semenzin, Elena; Fernandes, Teresa F; Hristozov, Danail; Hund-Rinke, Kerstin; Hunt, Neil; Irfan, Muhammad-Adeel; Landsiedel, Robert; Peijnenburg, Willie J G M; Sánchez Jiménez, Araceli; van Kesteren, Petra C E; Oomen, Agnes G

2015-11-27

An engineered nanomaterial (ENM) may actually consist of a population of primary particles, aggregates and agglomerates of various sizes. Furthermore, their physico-chemical characteristics may change during the various life-cycle stages. It will probably not be feasible to test all varieties of all ENMs for possible health and environmental risks. There is therefore a need to further develop the approaches for risk assessment of ENMs. Within the EU FP7 project Managing Risks of Nanoparticles (MARINA) a two-phase risk assessment strategy has been developed. In Phase 1 (Problem framing) a base set of information is considered, relevant exposure scenarios (RESs) are identified and the scope for Phase 2 (Risk assessment) is established. The relevance of an RES is indicated by information on exposure, fate/kinetics and/or hazard; these three domains are included as separate pillars that contain specific tools. Phase 2 consists of an iterative process of risk characterization, identification of data needs and integrated collection and evaluation of data on the three domains, until sufficient information is obtained to conclude on possible risks in a RES. Only data are generated that are considered to be needed for the purpose of risk assessment. A fourth pillar, risk characterization, is defined and it contains risk assessment tools. This strategy describes a flexible and efficient approach for data collection and risk assessment which is essential to ensure safety of ENMs. Further developments are needed to provide guidance and make the MARINA Risk Assessment Strategy operational. Case studies will be needed to refine the strategy.

Practice-specific risk perceptions and self-reported food safety practices.

PubMed

Levy, Alan S; Choinière, Conrad J; Fein, Sara B

2008-06-01

The relationship between risk perception and risk avoidance is typically analyzed using self-reported measures. However, in domains such as driving or food handling, the validity of responses about usual behavior is threatened because people think about the situations in which they are self-aware, such as when they encounter a hazard. Indeed, researchers have often noted a divergence between what people say about their behavior and how they actually behave. Thus, in order to draw conclusions about risk perceptions and risk avoidance from survey data, it is important to identify particular cognitive elements, such as those measured by questions about risk and safety knowledge, risk perceptions, or information search behavior, which may be effective antecedents of self-reported safety behavior. It is also important to identify and correct for potential sources of bias that may exist in the data. The authors analyze the Food and Drug Administration's 1998 Food Safety Survey to determine whether there are consistent cognitive antecedents for three types of safe food practices: preparation, eating, and cooling of foods. An assessment of measurement biases shows that endogeneity of food choices affects reports of food preparation. In addition, response bias affects reports of cooling practices as evidenced by its relation to knowledge and information search, a pattern of cognitive effects unique to cooling practices. After correcting for these biases, results show that practice-specific risk perceptions are the primary cognitive antecedents of safe food behavior, which has implications for the design of effective education messages about food safety.

Scientific Opinion on Risk Assessment of Synthetic Biology.

PubMed

Epstein, Michelle M; Vermeire, Theo

2016-08-01

In 2013, three Scientific Committees of the European Commission (EC) drafted Scientific Opinions on synthetic biology that provide an operational definition and address risk assessment methodology, safety aspects, environmental risks, knowledge gaps, and research priorities. These Opinions contribute to the international discussions on the risk governance for synthetic biology developments. Copyright © 2016 Elsevier Ltd. All rights reserved.

Pushing and pulling: an assessment tool for occupational health and safety practitioners.

PubMed

Lind, Carl Mikael

2018-03-01

A tool has been developed for supporting practitioners when assessing manual pushing and pulling operations based on an initiative by two global companies in the manufacturing industry. The aim of the tool is to support occupational health and safety practitioners in risk assessment and risk management of pushing and pulling operations in the manufacturing and logistics industries. The tool is based on a nine-multiplier equation that includes a wide range of factors affecting an operator's health risk and capacity in pushing and pulling. These multipliers are based on psychophysical, physiological and biomechanical studies in combination with judgments from an expert group consisting of senior researchers and ergonomists. In order to consider usability, more than 50 occupational health and safety practitioners (e.g., ergonomists, managers, safety representatives and production personnel) participated in the development of the tool. An evaluation by 22 ergonomists supports that the push/pull tool is user friendly in general.

Assessment of food safety practices of food service food handlers (risk assessment data): testing a communication intervention (evaluation of tools).

PubMed

Chapman, Benjamin; Eversley, Tiffany; Fillion, Katie; Maclaurin, Tanya; Powell, Douglas

2010-06-01

Globally, foodborne illness affects an estimated 30% of individuals annually. Meals prepared outside of the home are a risk factor for acquiring foodborne illness and have been implicated in up to 70% of traced outbreaks. The Centers for Disease Control and Prevention has called on food safety communicators to design new methods and messages aimed at increasing food safety risk-reduction practices from farm to fork. Food safety infosheets, a novel communication tool designed to appeal to food handlers and compel behavior change, were evaluated. Food safety infosheets were provided weekly to food handlers in working food service operations for 7 weeks. It was hypothesized that through the posting of food safety infosheets in highly visible locations, such as kitchen work areas and hand washing stations, that safe food handling behaviors of food service staff could be positively influenced. Using video observation, food handlers (n = 47) in eight food service operations were observed for a total of 348 h (pre- and postintervention combined). After the food safety infosheets were introduced, food handlers demonstrated a significant increase (6.7%, P < 0.05, 95% confidence interval) in mean hand washing attempts, and a significant reduction in indirect cross-contamination events (19.6%, P < 0.05, 95% confidence interval). Results of the research demonstrate that posting food safety infosheets is an effective intervention tool that positively influences the food safety behaviors of food handlers.

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.

Hydrogen quantitative risk assessment workshop proceedings.

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

Groth, Katrina M.; Harris, Aaron P.

2013-09-01

The Quantitative Risk Assessment (QRA) Toolkit Introduction Workshop was held at Energetics on June 11-12. The workshop was co-hosted by Sandia National Laboratories (Sandia) and HySafe, the International Association for Hydrogen Safety. The objective of the workshop was twofold: (1) Present a hydrogen-specific methodology and toolkit (currently under development) for conducting QRA to support the development of codes and standards and safety assessments of hydrogen-fueled vehicles and fueling stations, and (2) Obtain feedback on the needs of early-stage users (hydrogen as well as potential leveraging for Compressed Natural Gas [CNG], and Liquefied Natural Gas [LNG]) and set priorities for %E2%80%9CVersionmore » 1%E2%80%9D of the toolkit in the context of the commercial evolution of hydrogen fuel cell electric vehicles (FCEV). The workshop consisted of an introduction and three technical sessions: Risk Informed Development and Approach; CNG/LNG Applications; and Introduction of a Hydrogen Specific QRA Toolkit.« less

Occupational health and safety: Designing and building with MACBETH a value risk-matrix for evaluating health and safety risks

NASA Astrophysics Data System (ADS)

Lopes, D. F.; Oliveira, M. D.; Costa, C. A. Bana e.

2015-05-01

Risk matrices (RMs) are commonly used to evaluate health and safety risks. Nonetheless, they violate some theoretical principles that compromise their feasibility and use. This study describes how multiple criteria decision analysis methods have been used to improve the design and the deployment of RMs to evaluate health and safety risks at the Occupational Health and Safety Unit (OHSU) of the Regional Health Administration of Lisbon and Tagus Valley. ‘Value risk-matrices’ (VRMs) are built with the MACBETH approach in four modelling steps: a) structuring risk impacts, involving the construction of descriptors of impact that link risk events with health impacts and are informed by scientific evidence; b) generating a value measurement scale of risk impacts, by applying the MACBETH-Choquet procedure; c) building a system for eliciting subjective probabilities that makes use of a numerical probability scale that was constructed with MACBETH qualitative judgments on likelihood; d) and defining a classification colouring scheme for the VRM. A VRM built with OHSU members was implemented in a decision support system which will be used by OHSU members to evaluate health and safety risks and to identify risk mitigation actions.

La Conchita Landslide Risk Assessment

NASA Astrophysics Data System (ADS)

Kropp, A.; Johnson, L.; Magnusen, W.; Hitchcock, C. S.

2009-12-01

Following the disastrous landslide in La Conchita in 2005 that resulted in ten deaths, the State of California selected our team to prepare a risk assessment for a committee of key stakeholders. The stakeholders represented the State of California, Ventura County, members of the La Conchita community, the railroad, and the upslope ranch owner (where the slide originated); a group with widely varying views and interests. Our team was charged with characterizing the major hazards, developing a series of mitigation concepts, evaluating the benefits and costs of mitigation, and gathering stakeholder input throughout the process. Two unique elements of the study were the methodologies utilized for the consequence assessment and for the decision-making framework. La Conchita is exposed to multiple slope hazards, each with differing geographical distributions, as well as depth and velocity characteristics. Three consequence matrices were developed so that the potential financial losses, structural vulnerabilities, and human safety exposure could be evaluated. The matrices utilized semi-quantitative loss evaluations (both financial and life safety) based on a generalized understanding of likely vulnerability and hazard characteristics. The model provided a quantitative estimate of cumulative losses over a 50-year period, including losses of life based on FEMA evaluation criteria. Conceptual mitigation options and loss estimates were developed to provide a range of risk management solutions that were feasible from a cost-benefit standpoint. A decision tree approach was adopted to focus on fundamental risk management questions rather than on specific outcomes since the committee did not have a consensus view on the preferred solution. These questions included: 1. Over what time period can risks be tolerated before implementation of decisions? 2. Whose responsibility is it to identify a workable risk management solution? 3. Who will own the project? The decision tree

Risk assessment of pesticides and other stressors in bees: Principles, data gaps and perspectives from the European Food Safety Authority.

PubMed

Rortais, Agnès; Arnold, Gérard; Dorne, Jean-Lou; More, Simon J; Sperandio, Giorgio; Streissl, Franz; Szentes, Csaba; Verdonck, Frank

2017-06-01

Current approaches to risk assessment in bees do not take into account co-exposures from multiple stressors. The European Food Safety Authority (EFSA) is deploying resources and efforts to move towards a holistic risk assessment approach of multiple stressors in bees. This paper describes the general principles of pesticide risk assessment in bees, including recent developments at EFSA dealing with risk assessment of single and multiple pesticide residues and biological hazards. The EFSA Guidance Document on the risk assessment of plant protection products in bees highlights the need for the inclusion of an uncertainty analysis, other routes of exposures and multiple stressors such as chemical mixtures and biological agents. The EFSA risk assessment on the survival, spread and establishment of the small hive beetle, Aethina tumida, an invasive alien species, is provided with potential insights for other bee pests such as the Asian hornet, Vespa velutina. Furthermore, data gaps are identified at each step of the risk assessment, and recommendations are made for future research that could be supported under the framework of Horizon 2020. Finally, the recent work conducted at EFSA is presented, under the overarching MUST-B project ("EU efforts towards the development of a holistic approach for the risk assessment on MUltiple STressors in Bees") comprising a toolbox for harmonised data collection under field conditions and a mechanistic model to assess effects from pesticides and other stressors such as biological agents and beekeeping management practices, at the colony level and in a spatially complex landscape. Future perspectives at EFSA include the development of a data model to collate high quality data to calibrate and validate the model to be used as a regulatory tool. Finally, the evidence collected within the framework of MUST-B will support EFSA's activities on the development of a holistic approach to the risk assessment of multiple stressors in bees. In

Advancing environmental risk assessment for transgenic biofeedstock crops

PubMed Central

Wolt, Jeffrey D

2009-01-01

Transgenic modification of plants is a key enabling technology for developing sustainable biofeedstocks for biofuels production. Regulatory decisions and the wider acceptance and development of transgenic biofeedstock crops are considered from the context of science-based risk assessment. The risk assessment paradigm for transgenic biofeedstock crops is fundamentally no different from that of current generation transgenic crops, except that the focus of the assessment must consider the unique attributes of a given biofeedstock crop and its environmental release. For currently envisioned biofeedstock crops, particular emphasis in risk assessment will be given to characterization of altered metabolic profiles and their implications relative to non-target environmental effects and food safety; weediness and invasiveness when plants are modified for abiotic stress tolerance or are domesticated; and aggregate risk when plants are platforms for multi-product production. Robust risk assessments for transgenic biofeedstock crops are case-specific, initiated through problem formulation, and use tiered approaches for risk characterization. PMID:19883509

Plenary lecture: innovative modeling approaches applicable to risk assessments

USDA-ARS?s Scientific Manuscript database

Proper identification of safe and unsafe food at the processing plant is important for maximizing the public health benefit of food by ensuring both its consumption and safety. Risk assessment is a holistic approach to food safety that consists of four steps: 1) hazard identification; 2) exposure a...

Managing health and safety risks: Implications for tailoring health and safety management system practices.

PubMed

Willmer, D R; Haas, E J

2016-01-01

As national and international health and safety management system (HSMS) standards are voluntarily accepted or regulated into practice, organizations are making an effort to modify and integrate strategic elements of a connected management system into their daily risk management practices. In high-risk industries such as mining, that effort takes on added importance. The mining industry has long recognized the importance of a more integrated approach to recognizing and responding to site-specific risks, encouraging the adoption of a risk-based management framework. Recently, the U.S. National Mining Association led the development of an industry-specific HSMS built on the strategic frameworks of ANSI: Z10, OHSAS 18001, The American Chemistry Council's Responsible Care, and ILO-OSH 2001. All of these standards provide strategic guidance and focus on how to incorporate a plan-do-check-act cycle into the identification, management and evaluation of worksite risks. This paper details an exploratory study into whether practices associated with executing a risk-based management framework are visible through the actions of an organization's site-level management of health and safety risks. The results of this study show ways that site-level leaders manage day-to-day risk at their operations that can be characterized according to practices associated with a risk-based management framework. Having tangible operational examples of day-to-day risk management can serve as a starting point for evaluating field-level risk assessment efforts and their alignment to overall company efforts at effective risk mitigation through a HSMS or other processes.

Post-disaster Risk Assessment for Hilly Terrain exposed to Seismic Loading

NASA Astrophysics Data System (ADS)

Yates, Katherine; Villeneuve, Marlene; Wilson, Thomas

2013-04-01

The 2010-present Canterbury earthquake sequence in the central South Island of New Zealand has identified and highlighted the value of practical, standardised and coordinated geotechnical risk assessment guidelines for inhabited structures in the aftermath of a geotechnical disaster. The lack of such guidelines and provisions to enforce risk assessments was a major gap which hindered coordinated, timely and transparent management of geotechnical risk. The earthquake sequence initiated a series of rockfall, cliff collapse and landslide events around the Port Hills southeast of Christchurch. This was particularly the case with the 22 February 2011 earthquakes, which put thousands of people inhabiting the area at risk. Lives were lost and thousands of houses and critical infrastructure were damaged. Given the highly seismic environment in New Zealand and a significant number of active faults near population centres, it is prudent to develop such guidelines to ensure response mechanisms and geotechnical risk assessment is effective following an earthquake rupture in a largely populated urban environment. For response and associated risk assessments to be effective, the mechanisms of the geotechnical failure should be taken into consideration as part of the life safety assessment. This is to ensure that the hazard's potential risk is fully assessed and encompassed in decisions regarding life safety. This paper examines the event sequence, slope failure mechanisms and the geotechnical risk management approach that developed immediately post-earthquake. It highlights experiences from key municipal, management and operational stakeholders who were involved in geotechnical risk assessment during the Canterbury earthquake sequence, and sheds light on the evolution of information needed through time during the emergency response and identify the hard won lessons. It then discusses what is needed for life safety assessment post-earthquake and create awareness of potential

Reliability and safety, and the risk of construction damage in mining areas

NASA Astrophysics Data System (ADS)

Skrzypczak, Izabela; Kogut, Janusz P.; Kokoszka, Wanda; Oleniacz, Grzegorz

2018-04-01

This article concerns the reliability and safety of building structures in mining areas, with a particular emphasis on the quantitative risk analysis of buildings. The issues of threat assessment and risk estimation, in the design of facilities in mining exploitation areas, are presented here, indicating the difficulties and ambiguities associated with their quantification and quantitative analysis. This article presents the concept of quantitative risk assessment of the impact of mining exploitation, in accordance with ISO 13824 [1]. The risk analysis is illustrated through an example of a construction located within an area affected by mining exploitation.

Subjective Risk Assessment and Perception in the Greek and English Bakery Industries

PubMed Central

Alexopoulos, Evangelos C.; Kavadi, Zafira; Bakoyannis, Giorgos; Papantonopoulos, Sotiris

2009-01-01

Several factors influencing risk perception in the area of occupational health and safety are known, but there is still lack of a full understanding of the ways in which people characterize risk. This study aimed to provide an insight of employee risk assessment and perception in the bakery industry. 87 British and 64 Greek employees in two comparable bakery companies were asked to estimate and evaluate hazards at their workplace. The participants' judgments of 12 hazards—according to 7 risk aspects—were collected and analyzed. Subjective assessment on important occupational hazards included handling heavy loads, repetitiveness, high temperatures, high rate of work, stressful deadlines, and noise. Although limited in the population involved, our findings revealed strong cross-national differences in employee risk perception of specific groups of hazards in the bakery industry. Additional interviews revealed evidence that Greek employees' risk perception depends mostly on work experience while British employees were aware of risks due to company health and safety policy, recognizing that safety is the responsibility of both the management and the worker. Cross-national (cultural) factors that influence workforce risk perception and attitudes towards safety have to be taken into account by technical experts and policy makers in the designing of prevention strategies and risk communication. PMID:20041018

Risk and safety perception on urban and rural roads: Effects of environmental features, driver age and risk sensitivity.

PubMed

Cox, Jolene A; Beanland, Vanessa; Filtness, Ashleigh J

2017-10-03

impact changes; however, the effect was larger for urban environments. There were also effects of object type, with certain objects rated as consistently more safety relevant. In urban scenes, changes involving pedestrians were rated significantly more hazardous than all other objects, and in rural scenes, changes involving animals were rated as significantly more hazardous. Notably, hazard ratings were found to be higher in urban compared with rural driving environments, even when changes were matched between environments. This study demonstrates that drivers perceive rural roads as less risky than urban roads, even when similar scenarios occur in both environments. Age did not affect hazard ratings. Instead, the findings suggest that the assessment of risk posed by hazards is influenced more by individual differences in risk sensitivity. This highlights the need for driver education to account for appraisal of hazards' risk and relevance, in addition to hazard detection, when considering factors that promote road safety.

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.

The importance of data collection for timely and accurate risk assessment

NASA Astrophysics Data System (ADS)

Gilsenan, MB

2017-09-01

The European Food Safety Authority (EFSA) is responsible for food safety risk assessments at EU level. It provides independent scientific advice on risks associated with the food chain to support EU risk management decisions. Since its establishment, EFSA has amassed a wealth of data to underpin its risk assessments, such as food consumption data, monitoring data and experimental data. Increasing transparency of its risk assessments is a core objective of EFSA. EFSA aims to enhance the quality and transparency of its outputs by giving insofar as possible access to data and methods underpinning its scientific outputs. This paper provides an overview of the role of EFSA, its core data collections and their regulatory framework, as well as data quality and standardisation aspects. Finally, the paper elaborates on EFSA’s 2020 strategy in relation to data, and describes EFSA scientific data warehouse and Knowledge Junction in this regard.

Risk assessment of supply chain for pharmaceutical excipients with AHP-fuzzy comprehensive evaluation.

PubMed

Li, Maozhong; Du, Yunai; Wang, Qiyue; Sun, Chunmeng; Ling, Xiang; Yu, Boyang; Tu, Jiasheng; Xiong, Yerong

2016-01-01

As the essential components in formulations, pharmaceutical excipients directly affect the safety, efficacy, and stability of drugs. Recently, safety incidents of pharmaceutical excipients posing seriously threats to the patients highlight the necessity of controlling the potential risks. Hence, it is indispensable for the industry to establish an effective risk assessment system of supply chain. In this study, an AHP-fuzzy comprehensive evaluation model was developed based on the analytic hierarchy process and fuzzy mathematical theory, which quantitatively assessed the risks of supply chain. Taking polysorbate 80 as the example for model analysis, it was concluded that polysorbate 80 for injection use is a high-risk ingredient in the supply chain compared to that for oral use to achieve safety application in clinic, thus measures should be taken to control and minimize those risks.

Risk assessment of supply chain for pharmaceutical excipients with AHP-fuzzy comprehensive evaluation.

PubMed

Li, Maozhong; Du, Yunai; Wang, Qiyue; Sun, Chunmeng; Ling, Xiang; Yu, Boyang; Tu, Jiasheng; Xiong, Yerong

2016-04-01

As the essential components in formulations, pharmaceutical excipients directly affect the safety, efficacy, and stability of drugs. Recently, safety incidents of pharmaceutical excipients posing seriously threats to the patients highlight the necessity of controlling the potential risks. Hence, it is indispensable for the industry to establish an effective risk assessment system of supply chain. In this study, an AHP-fuzzy comprehensive evaluation model was developed based on the analytic hierarchy process and fuzzy mathematical theory, which quantitatively assessed the risks of supply chain. Taking polysorbate 80 as the example for model analysis, it was concluded that polysorbate 80 for injection use is a high-risk ingredient in the supply chain compared to that for oral use to achieve safety application in clinic, thus measures should be taken to control and minimize those risks.

Methods of quantitative risk assessment: The case of the propellant supply system

NASA Astrophysics Data System (ADS)

Merz, H. A.; Bienz, A.

1984-08-01

As a consequence of the disastrous accident in Lapua (Finland) in 1976, where an explosion in a cartridge loading facility killed 40 and injured more than 70 persons, efforts were undertaken to examine and improve the safety of such installations. An ammunition factory in Switzerland considered the replacement of the manual supply of propellant hoppers by a new pneumatic supply system. This would reduce the maximum quantity of propellant in the hoppers to a level, where an accidental ignition would no longer lead to a detonation, and this would drastically limit the effects on persons. A quantitative risk assessment of the present and the planned supply system demonstrated that, in this particular case, the pneumatic supply system would not reduce the risk enough to justify the related costs. In addition, it could be shown that the safety of the existing system can be improved more effectively by other safety measures at considerably lower costs. Based on this practical example, the advantages of a strictly quantitative risk assessment for the safety planning in explosives factories are demonstrated. The methodological background of a risk assessment and the steps involved in the analysis are summarized. In addition, problems of quantification are discussed.

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.

Reducing safety risk among underserved caregivers with an Alzheimer's home safety program.

PubMed

Levy-Storms, Lené; Cherry, Debra L; Lee, Linda J; Wolf, Sheldon M

2017-09-01

Older adults living with Alzheimer's disease (AD) experience more of the types of accidents and injuries prevalent among older adults. Relatively few studies specifically on safety risks have included older adults of color and tested interventions. This pilot study tested the feasibility and evaluability of educating Hispanic and African American caregivers of patients living with AD about reducing safety risks in their homes. This outpatient memory clinic-based intervention study included a pre-/post-test survey design with two nonequivalent groups and predominately serves Hispanic and African Americans. Of 60 eligible caregivers, 67% participated in a tailored, safety training class with an optional follow-up call. The results indicate a reduction in some safety risks compared to baseline and/or a no intervention group, respectively, including leaving patients at home alone part-time (p < .01 and p < .01), getting lost (p < .05 and p < .05), going outdoors alone less often (p < .05 and p < .01), and giving themselves medicine (p < .05 and p < .01). At post-test, 47 clinically significant instances occurred, in which caregivers who participated in the intervention self-reported patients living with AD to be 'completely safe' in one or more of the safety risk items compared to 8 instances among those who did not. This pilot pre/post design with non-equivalent groups study needs refinement in a future randomized control trial. Despite limitations, this pilot study demonstrates the first feasible and evaluable intervention with both statistically and clinically significant results that suggest potential for reducing safety risks among at-risk minority patients living with AD in future research.

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.

Correlation between safety climate and contractor safety assessment programs in construction

PubMed Central

Sparer, EH1; Murphy, LA; Taylor, KM; Dennerlein, Jt

2015-01-01

Background Contractor safety assessment programs (CSAPs) measure safety performance by integrating multiple data sources together; however, the relationship between these measures of safety performance and safety climate within the construction industry is unknown. Methods 401 construction workers employed by 68 companies on 26 sites and 11 safety managers employed by 11 companies completed brief surveys containing a nine-item safety climate scale developed for the construction industry. CSAP scores from ConstructSecure, Inc., an online CSAP database, classified these 68 companies as high or low scorers, with the median score of the sample population as the threshold. Spearman rank correlations evaluated the association between the CSAP score and the safety climate score at the individual level, as well as with various grouping methodologies. In addition, Spearman correlations evaluated the comparison between manager-assessed safety climate and worker-assessed safety climate. Results There were no statistically significant differences between safety climate scores reported by workers in the high and low CSAP groups. There were, at best, weak correlations between workers’ safety climate scores and the company CSAP scores, with marginal statistical significance with two groupings of the data. There were also no significant differences between the manager-assessed safety climate and the worker-assessed safety climate scores. Conclusions A CSAP safety performance score does not appear to capture safety climate, as measured in this study. The nature of safety climate in construction is complex, which may be reflective of the challenges in measuring safety climate within this industry. PMID:24038403

An outline of a risk assessment-based system of meat safety assurance and its future prospects.

PubMed

Berends, B R; van Knapen, F

1999-10-01

Discussed are the outlines of a risk assessment-based system of meat safety assurance to replace the current meat inspection. An example of a system that uses the Hazard Analysis of Critical Control Points (HACCP)-principles in the entire production chain from stable to table is also given. Continuous evaluation of risks is the main driving force of the new system. Only then the system has the means to remain flexible and provide for the data necessary to convince trade partners that the products they buy are safe. A monitoring system that keeps track of the important health hazards in the entire chain from stable to table is therefore necessary. This includes monitoring of cases of disease in the human population caused by the hazardous agents of concern. Coordination of the monitoring and control and processing of the information is done by an independent body. Furthermore, the system demands a production from stable to table that is based on the ideas of Integrated Quality Control (IQC), HACCP, and certification of production processes and quality control procedures. Clear legislation provides for criteria about acceptable or unacceptable health risks for the consumer and determines at what moments which risks should be controlled by the producers. Simultaneously, the legislation has to be flexible enough to be able to adapt quickly to any changes in risks, or in the way risks should be controlled. In the new system current meat inspection can easily be carried out by employees of the slaughter houses and is no longer a direct responsibility of the authorities. The authorities only demand certain safety levels and verify whether producers stick to these. Producers remain fully responsible for the safety and quality of their products, and fully liable in case of any damage to the consumers' health. However, it is to be expected that some EU Member-States miss the organizational and agricultural basis for a successful application of the new system. Consequences

Food safety in the domestic environment: the effect of consumer risk information on human disease risks.

PubMed

Nauta, Maarten J; Fischer, Arnout R H; van Asselt, Esther D; de Jong, Aarieke E I; Frewer, Lynn J; de Jonge, Rob

2008-02-01

The improvement of food safety in the domestic environment requires a transdisciplinary approach, involving interaction between both the social and natural sciences. This approach is applied in a study on risks associated with Campylobacter on broiler meat. First, some web-based information interventions were designed and tested on participant motivation and intentions to cook more safely. Based on these self-reported measures, the intervention supported by the emotion "disgust" was selected as the most promising information intervention. Its effect on microbial cross-contamination was tested by recruiting a set of participants who prepared a salad with chicken breast fillet carrying a known amount of tracer bacteria. The amount of tracer that could be recovered from the salad revealed the transfer and survival of Campylobacter and was used as a measure of hygiene. This was introduced into an existing risk model on Campylobacter in the Netherlands to assess the effect of the information intervention both at the level of exposure and the level of human disease risk. We showed that the information intervention supported by the emotion "disgust" alone had no measurable effect on the health risk. However, when a behavioral cue was embedded within the instruction for the salad preparation, the risk decreased sharply. It is shown that a transdisciplinary approach, involving research on risk perception, microbiology, and risk assessment, is successful in evaluating the efficacy of an information intervention in terms of human health risks. The approach offers a novel tool for science-based risk management in the area of food safety.

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.

Correlation between safety climate and contractor safety assessment programs in construction.

PubMed

Sparer, Emily H; Murphy, Lauren A; Taylor, Kathryn M; Dennerlein, Jack T

2013-12-01

Contractor safety assessment programs (CSAPs) measure safety performance by integrating multiple data sources together; however, the relationship between these measures of safety performance and safety climate within the construction industry is unknown. Four hundred and one construction workers employed by 68 companies on 26 sites and 11 safety managers employed by 11 companies completed brief surveys containing a nine-item safety climate scale developed for the construction industry. CSAP scores from ConstructSecure, Inc., an online CSAP database, classified these 68 companies as high or low scorers, with the median score of the sample population as the threshold. Spearman rank correlations evaluated the association between the CSAP score and the safety climate score at the individual level, as well as with various grouping methodologies. In addition, Spearman correlations evaluated the comparison between manager-assessed safety climate and worker-assessed safety climate. There were no statistically significant differences between safety climate scores reported by workers in the high and low CSAP groups. There were, at best, weak correlations between workers' safety climate scores and the company CSAP scores, with marginal statistical significance with two groupings of the data. There were also no significant differences between the manager-assessed safety climate and the worker-assessed safety climate scores. A CSAP safety performance score does not appear to capture safety climate, as measured in this study. The nature of safety climate in construction is complex, which may be reflective of the challenges in measuring safety climate within this industry. Am. J. Ind. Med. 56:1463-1472, 2013. © 2013 Wiley Periodicals, Inc. © 2013 Wiley Periodicals, Inc.

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

WE-B-BRC-00: Concepts in Risk-Based Assessment

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

NONE

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

Risk assessment of carcinogens in food.

PubMed

Barlow, Susan; Schlatter, Josef

2010-03-01

Approaches for the risk assessment of carcinogens in food have evolved as scientific knowledge has advanced. Early methods allowed little more than hazard identification and an indication of carcinogenic potency. Evaluation of the modes of action of carcinogens and their broad division into genotoxic and epigenetic (non-genotoxic, non-DNA reactive) carcinogens have played an increasing role in determining the approach followed and provide possibilities for more detailed risk characterisation, including provision of quantitative estimates of risk. Reliance on experimental animal data for the majority of risk assessments and the fact that human exposures to dietary carcinogens are often orders of magnitude below doses used in experimental studies has provided a fertile ground for discussion and diverging views on the most appropriate way to offer risk assessment advice. Approaches used by national and international bodies differ, with some offering numerical estimates of potential risks to human health, while others express considerable reservations about the validity of quantitative approaches requiring extrapolation of dose-response data below the observed range and instead offer qualitative advice. Recognising that qualitative advice alone does not provide risk managers with information on which to prioritise the need for risk management actions, a "margin of exposure" approach for substances that are both genotoxic and carcinogenic has been developed, which is now being used by the World Health Organization and the European Food Safety Authority. This review describes the evolution of risk assessment advice on carcinogens and discusses examples of ways in which carcinogens in food have been assessed in Europe.

Risk assessment of carcinogens in food

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

Barlow, Susan, E-mail: suebarlow@mistral.co.u; Schlatter, Josef; Federal Office of Public Health, Consumer Protection Directorate, Stauffacherstrasse 101, CH-8004 Zuerich

2010-03-01

Approaches for the risk assessment of carcinogens in food have evolved as scientific knowledge has advanced. Early methods allowed little more than hazard identification and an indication of carcinogenic potency. Evaluation of the modes of action of carcinogens and their broad division into genotoxic and epigenetic (non-genotoxic, non-DNA reactive) carcinogens have played an increasing role in determining the approach followed and provide possibilities for more detailed risk characterisation, including provision of quantitative estimates of risk. Reliance on experimental animal data for the majority of risk assessments and the fact that human exposures to dietary carcinogens are often orders of magnitudemore » below doses used in experimental studies has provided a fertile ground for discussion and diverging views on the most appropriate way to offer risk assessment advice. Approaches used by national and international bodies differ, with some offering numerical estimates of potential risks to human health, while others express considerable reservations about the validity of quantitative approaches requiring extrapolation of dose-response data below the observed range and instead offer qualitative advice. Recognising that qualitative advice alone does not provide risk managers with information on which to prioritise the need for risk management actions, a 'margin of exposure' approach for substances that are both genotoxic and carcinogenic has been developed, which is now being used by the World Health Organization and the European Food Safety Authority. This review describes the evolution of risk assessment advice on carcinogens and discusses examples of ways in which carcinogens in food have been assessed in Europe.« less

Promoting patient safety through prospective risk identification: example from peri-operative care.

PubMed

Smith, A; Boult, M; Woods, I; Johnson, S

2010-02-01

Investigation of patient safety incidents has focused on retrospective analyses once incidents have occurred. Prospective risk analysis techniques complement this but have not been widely used in healthcare. Prospective risk identification of non-operative risks associated with adult elective surgery under general anaesthesia using a customised structured "what if" checklist and development of risk matrix. Prioritisation of recommendations arising by cost, ease and likely speed of implementation. Groups totalling 20 clinical and administrative healthcare staff involved in peri-operative care and risk experts convened by the UK National Patient Safety Agency. 102 risks were identified and 95 recommendations made. The top 20 recommendations together were judged to encompass about 75% of the total estimated risk attributable to the processes considered. Staffing and organisational issues (21% of total estimated risk) included recommendations for removing distractions from the operating theatre, ensuring the availability of senior anaesthetists and promoting standards and flexible working among theatre staff. Devices and equipment (19% of total estimated risk) could be improved by training and standardisation; airway control and temperature monitoring were identified as two specific areas. Pre-assessment of patients before admission to hospital (12% of estimated risk) could be improved by defining a data set for adequate pre-assessment and making this available throughout the NHS. This technique can be successfully applied by healthcare staff but expert facilitation of groups is advisable. Such wider-ranging processes can potentially lead to more comprehensive risk reduction than "single-issue" risk alerts.

A Software Safety Risk Taxonomy for Use in Retrospective Safety Cases

NASA Technical Reports Server (NTRS)

Hill, Janice L.

2007-01-01

Safety standards contain technical and process-oriented safely requirements. The best time to include these requirements is early in the development lifecycle of the system. When software safety requirements are levied on a legacy system after the fact, a retrospective safety case will need to be constructed for the software in the system. This can be a difficult task because there may be few to no art facts available to show compliance to the software safely requirements. The risks associated with not meeting safely requirements in a legacy safely-critical computer system must be addressed to give confidence for reuse. This paper introduces a proposal for a software safely risk taxonomy for legacy safely-critical computer systems, by specializing the Software Engineering Institute's 'Software Development Risk Taxonomy' with safely elements and attributes.

Integrated Safety Risk Reduction Approach to Enhancing Human-Rated Spaceflight Safety

NASA Astrophysics Data System (ADS)

Mikula, J. F. Kip

2005-12-01

This paper explores and defines the current accepted concept and philosophy of safety improvement based on a Reliability enhancement (called here Reliability Enhancement Based Safety Theory [REBST]). In this theory a Reliability calculation is used as a measure of the safety achieved on the program. This calculation may be based on a math model or a Fault Tree Analysis (FTA) of the system, or on an Event Tree Analysis (ETA) of the system's operational mission sequence. In each case, the numbers used in this calculation are hardware failure rates gleaned from past similar programs. As part of this paper, a fictional but representative case study is provided that helps to illustrate the problems and inaccuracies of this approach to safety determination. Then a safety determination and enhancement approach based on hazard, worst case analysis, and safety risk determination (called here Worst Case Based Safety Theory [WCBST]) is included. This approach is defined and detailed using the same example case study as shown in the REBST case study. In the end it is concluded that an approach combining the two theories works best to reduce Safety Risk.

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.

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.

Behavior-Based Safety and Occupational Risk Management

ERIC Educational Resources Information Center

Geller, E. Scott

2005-01-01

The behavior-based approach to managing occupational risk and preventing workplace injuries is reviewed. Unlike the typical top-down control approach to industrial safety, behavior-based safety (BBS) provides tools and procedures workers can use to take personal control of occupational risks. Strategies the author and his colleagues have been…

An assessment of food hygiene and safety at farmers' markets.

PubMed

Worsfold, D; Worsfold, P M; Griffith, C J

2004-04-01

Farmers' markets are becoming a more significant part of the food-retailing sector. A survey of farmers' markets was conducted to assess aspects of food hygiene and safety. The views of the public using the markets were also examined. The range of farm products was wide and the methods utilised varied. The markets were usually temporary outdoor events with few facilities. Traders had received elementary food hygiene training and rated their hygiene standards highly. Less than half had risk management procedures in place, most did not perceive their produce as high-risk. They believed consumers to be mainly interested in food quality and to regard food safety issues highly. Consumers shopped at the markets because of the quality of the products sold. Their overall satisfaction with the markets was high and they raised no concerns about food safety. Given the restricted facilities at farmers' markets and the early phase of implementation of hygiene management systems by market traders, it may be precautionary to restrict the sale of farm products at farmers markets to those that are regarded as low-risk.

Assessment of Occupational Health and Safety for a Gas Meter Manufacturing Plant

NASA Astrophysics Data System (ADS)

Korkmaz, Ece; Iskender, Gulen; Germirli Babuna, Fatos

2016-10-01

This study investigates the occupational health and safety for a gas meter manufacturing plant. The risk assessment and management study is applied to plastic injection and mounting departments of the factory through quantitative Fine Kinney method and the effect of adopting 5S workplace organization procedure on risk assessment is examined. The risk assessment reveals that there are 17 risks involved; 14 grouped in high risk class (immediate improvement as required action); 2 in significant (measures to be taken as required action) and one in possible risk class (monitoring as required action). Among 14 high risks, 4 can be reduced by 83 % to be grouped under possible class when 5S is applied. One significant risk is observed to be lowered by 78 % and considered as possible risk due to the application of 5S. As a result of either 67 or 50 % reductions in 7 high risks, these risks are converted to be members of significant risk group after 5S implications.

Microbial Risk Assessment

NASA Technical Reports Server (NTRS)

Ott, C. M.; Mena, K. D.; Nickerson, C.A.; Pierson, D. L.

2009-01-01

-response characteristics may be affected by a potentially dysfunctional crew immune system during a mission. In addition, microbial virulence has been shown to change under certain conditions during spaceflight, further complicating dose-response characterization. An initial study of the applicability of microbial risk assessment techniques was performed using Crew Health Care System (CHeCS) operational data from the International Space Station potable water systems. The risk of infection from potable water was selected as the flight systems and microbial ecology are well defined. This initial study confirmed the feasibility of using microbial risk assessment modeling for spaceflight systems. While no immediate threat was detected, the study identified several medically significant microorganisms that could pose a health risk if uncontrolled. The study also identified several specific knowledge gaps in making a risk assessment and noted that filling these knowledge gaps is essential as the risk estimates may change by orders of magnitude depending on the answers. The current phase of the microbial risk assessment studies focuses on the dose-response relationship of specific infectious agents, focusing on Salmonella enterica Typhimurium, Pseudomonas spp., and Escherichia coli, as their evaluation will provide a better baseline for determining the overall hazard characterization. The organisms were chosen as they either have been isolated on spacecraft or have an identified route of infection during a mission. The characterization will utilize dose-response models selected either from the peer-reviewed literature and/or by using statistical approaches. Development of these modeling and risk assessment techniques will help to optimize flight requirements and to protect the safety, health, and performance of the crew.

76 FR 48119 - Oral Rabies Vaccine Trial; Availability of a Risk Assessment and an Environmental Assessment

Federal Register 2010, 2011, 2012, 2013, 2014

2011-08-08

...] Oral Rabies Vaccine Trial; Availability of a Risk Assessment and an Environmental Assessment AGENCY... environmental assessment relative to an oral rabies vaccination field trial in West Virginia. The environmental... rabies vaccine, analyzes the use of that vaccine in field safety and efficacy trials in West Virginia...

49 CFR Appendix B to Part 236 - Risk Assessment Criteria

Code of Federal Regulations, 2012 CFR

2012-10-01

... availability calculations for subsystems and components, Fault Tree Analysis (FTA) of the subsystems, and... upper bound, as estimated with a sensitivity analysis, and the risk value selected must be demonstrated... interconnected subsystems/components? The risk assessment of each safety-critical system (product) must account...

49 CFR Appendix B to Part 236 - Risk Assessment Criteria

Code of Federal Regulations, 2014 CFR

2014-10-01

... availability calculations for subsystems and components, Fault Tree Analysis (FTA) of the subsystems, and... upper bound, as estimated with a sensitivity analysis, and the risk value selected must be demonstrated... interconnected subsystems/components? The risk assessment of each safety-critical system (product) must account...

Patient safety risks associated with telecare: a systematic review and narrative synthesis of the literature.

PubMed

Guise, Veslemøy; Anderson, Janet; Wiig, Siri

2014-11-25

Patient safety risk in the homecare context and patient safety risk related to telecare are both emerging research areas. Patient safety issues associated with the use of telecare in homecare services are therefore not clearly understood. It is unclear what the patient safety risks are, how patient safety issues have been investigated, and what research is still needed to provide a comprehensive picture of risks, challenges and potential harm to patients due to the implementation and use of telecare services in the home. Furthermore, it is unclear how training for telecare users has addressed patient safety issues. A systematic review of the literature was conducted to identify patient safety risks associated with telecare use in homecare services and to investigate whether and how these patient safety risks have been addressed in telecare training. Six electronic databases were searched in addition to hand searches of key items, reference tracking and citation tracking. Strict inclusion and exclusion criteria were set. All included items were assessed according to set quality criteria and subjected to a narrative synthesis to organise and synthesize the findings. A human factors systems framework of patient safety was used to frame and analyse the results. 22 items were included in the review. 11 types of patient safety risks associated with telecare use in homecare services emerged. These are in the main related to the nature of homecare tasks and practices, and person-centred characteristics and capabilities, and to a lesser extent, problems with the technology and devices, organisational issues, and environmental factors. Training initiatives related to safe telecare use are not described in the literature. There is a need to better identify and describe patient safety risks related to telecare services to improve understandings of how to avoid and minimize potential harm to patients. This process can be aided by reframing known telecare implementation

Workplace road safety risk management: An investigation into Australian practices.

PubMed

Warmerdam, Amanda; Newnam, Sharon; Sheppard, Dianne; Griffin, Mark; Stevenson, Mark

2017-01-01

In Australia, more than 30% of the traffic volume can be attributed to work-related vehicles. Although work-related driver safety has been given increasing attention in the scientific literature, it is uncertain how well this knowledge has been translated into practice in industry. It is also unclear how current practice in industry can inform scientific knowledge. The aim of the research was to use a benchmarking tool developed by the National Road Safety Partnership Program to assess industry maturity in relation to risk management practices. A total of 83 managers from a range of small, medium and large organisations were recruited through the Victorian Work Authority. Semi-structured interviews aimed at eliciting information on current organisational practices, as well as policy and procedures around work-related driving were conducted and the data mapped onto the benchmarking tool. Overall, the results demonstrated varying levels of maturity of risk management practices across organisations, highlighting the need to build accountability within organisations, improve communication practices, improve journey management, reduce vehicle-related risk, improve driver competency through an effective workplace road safety management program and review organisational incident and infringement management. The findings of the study have important implications for industry and highlight the need to review current risk management practices. Copyright © 2016 Elsevier Ltd. All rights reserved.

Avalanche risk assessment in Russia

NASA Astrophysics Data System (ADS)

Komarov, Anton; Seliverstov, Yury; Sokratov, Sergey; Glazovskaya, Tatiana; Turchaniniva, Alla

2017-04-01

The avalanche prone area covers about 3 million square kilometers or 18% of total area of Russia and pose a significant problem in most mountain regions of the country. The constant growth of economic activity, especially in the North Caucasus region and therefore the increased avalanche hazard lead to the demand of the large-scale avalanche risk assessment methods development. Such methods are needed for the determination of appropriate avalanche protection measures as well as for economic assessments during all stages of spatial planning of the territory. The requirement of natural hazard risk assessments is determined by the Federal Law of Russian Federation. However, Russian Guidelines (SP 11-103-97; SP 47.13330.2012) are not clearly presented concerning avalanche risk assessment calculations. A great size of Russia territory, vast diversity of natural conditions and large variations in type and level of economic development of different regions cause significant variations in avalanche risk values. At the first stage of research the small scale avalanche risk assessment was performed in order to identify the most common patterns of risk situations and to calculate full social risk and individual risk. The full social avalanche risk for the territory of country was estimated at 91 victims. The area of territory with individual risk values lesser then 1×10(-6) covers more than 92 % of mountain areas of the country. Within these territories the safety of population can be achieved mainly by organizational activities. Approximately 7% of mountain areas have 1×10(-6) - 1×10(-4) individual risk values and require specific mitigation measures to protect people and infrastructure. Territories with individual risk values 1×10(-4) and above covers about 0,1 % of the territory and include the most severe and hazardous mountain areas. The whole specter of mitigation measures is required in order to minimize risk. The future development of such areas is not recommended

[Occupational risks among public safety and security forces].

PubMed

Candura, S M; Verni, P; Minelli, C M; Rosso, G L; Cappelli, M I; Strambi, S; Martellosio, V

2006-01-01

The present paper tries to identify the occupational risk factors (physical, chemical, biological, psychological), variable depending on jobs and tasks, to which the heterogeneous public safety/security workers are exposed. The fight against criminality and public order maintenance imply (sometimes fatal) traumatic risks, and expose to psychophysical and sensorial tiring, unfavourable macro- and microclimatic conditions, the risk of baropathy (air navigation, underwater activities), noise (generated by firearms and several other sources), vibrations and shakings (automatic weapons, transport vehicles), the risk of electric injury, ionizing (X and gamma rays) and non-inonizing (ultraviolet rays, microwaves and radiofrequencies, electromagnetic fields) radiations. Chemical hazards include carbon monoxide and other combustion products (fires, urban traffic), substances released in chemical accidents, tear gases, lead (firing grounds, metal works, environmental pollution), solvents, lubrificants and cutting oils (mechanic repair and maintenance), laboratory materials and reagents, irritant and/or sensitizing agents contained in gloves. The main biological risks are tetanus, blood-borne diseases (viral hepatitis, AIDS), aerogenous diseases (e.g., tuberculosis, Legionnaire's disease, epidemic cerebrospinal meningitis), dog- or horse-transmitted zoonosis. Finally, emotional, psychosomatic and behavioural stress-related disorders (e.g., burn-out syndrome, post-traumatic stress disorder) are typically frequent. The presence of numerous and diversified hazards among public safety/security forces imposes the adoption of occupational medicine measures, including risk assessment, health education, technical and environmental prevention, personal protective devices, sanitary surveillance and biological monitoring, clinical interventions (diagnosis, therapy and rehabilitation of occupational accidents and illnesses), prompt medico-legal evaluation of occupational

Factors Influencing Young Children's Risk of Unintentional Injury: Parenting Style and Strategies for Teaching about Home Safety

ERIC Educational Resources Information Center

Morrongiello, Barbara A.; Corbett, Michael; Lasenby, Jennifer; Johnston, Natalie; McCourt, Meghan

2006-01-01

This study examined mothers' teaching about home-safety issues to 24-30 month and 36-42 month old children, explored the relationship of teaching strategies to parenting styles, and assessed how these factors are related to children's risk of unintentional injury. A structured interview assessed home-safety issues relevant to falls, burns, cuts,…

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

Safety Assessment of Probiotics

NASA Astrophysics Data System (ADS)

Lahtinen, Sampo J.; Boyle, Robert J.; Margolles, Abelardo; Frias, Rafael; Gueimonde, Miguel

Viable microbes have been a natural part of human diet throughout the history of mankind. Today, different fermented foods and other foods containing live microbes are consumed around the world, including industrialized countries, where the diet has become increasingly sterile during the last decades. By definition, probiotics are viable microbes with documented beneficial effects on host health. Probiotics have an excellent safety record, both in humans and in animals. Despite the wide and continuously increasing consumption of probiotics, adverse events related to probiotic use are extremely rare. Many popular probiotic strains such as lactobacilli and bifidobacteria can be considered as components of normal healthy intestinal microbiota, and thus are not thought to pose a risk for the host health - in contrast, beneficial effects on health are commonly reported. Nevertheless, the safety of probiotics is an important issue, in particular in the case of new potential probiotics which do not have a long history of safe use, and of probiotics belonging to species for which general assumption of safety cannot be made. Furthermore, safety of probiotics in high-risk populations such as critically ill patients and immunocompromized subjects deserves particular attention, as virtually all reported cases of bacteremia and fungemia associated with probiotic use, involve subjects with underlying diseases, compromised immune system or compromised intestinal integrity.

Using toxicokinetic-toxicodynamic modeling as an acute risk assessment refinement approach in vertebrate ecological risk assessment.

PubMed

Ducrot, Virginie; Ashauer, Roman; Bednarska, Agnieszka J; Hinarejos, Silvia; Thorbek, Pernille; Weyman, Gabriel

2016-01-01

Recent guidance identified toxicokinetic-toxicodynamic (TK-TD) modeling as a relevant approach for risk assessment refinement. Yet, its added value compared to other refinement options is not detailed, and how to conduct the modeling appropriately is not explained. This case study addresses these issues through 2 examples of individual-level risk assessment for 2 hypothetical plant protection products: 1) evaluating the risk for small granivorous birds and small omnivorous mammals of a single application, as a seed treatment in winter cereals, and 2) evaluating the risk for fish after a pulsed treatment in the edge-of-field zone. Using acute test data, we conducted the first tier risk assessment as defined in the European Food Safety Authority (EFSA) guidance. When first tier risk assessment highlighted a concern, refinement options were discussed. Cases where the use of models should be preferred over other existing refinement approaches were highlighted. We then practically conducted the risk assessment refinement by using 2 different models as examples. In example 1, a TK model accounting for toxicokinetics and relevant feeding patterns in the skylark and in the wood mouse was used to predict internal doses of the hypothetical active ingredient in individuals, based on relevant feeding patterns in an in-crop situation, and identify the residue levels leading to mortality. In example 2, a TK-TD model accounting for toxicokinetics, toxicodynamics, and relevant exposure patterns in the fathead minnow was used to predict the time-course of fish survival for relevant FOCUS SW exposure scenarios and identify which scenarios might lead to mortality. Models were calibrated using available standard data and implemented to simulate the time-course of internal dose of active ingredient or survival for different exposure scenarios. Simulation results were discussed and used to derive the risk assessment refinement endpoints used for decision. Finally, we compared the

Bus operator perceptions of safety risks.

DOT National Transportation Integrated Search

2013-07-01

This paper presents the results of a survey of TriMet bus operators addressing safety risks in their assigned work. Surveyed risk factors : were organized into five categories: vehicle design and condition; route layout; operating conditions; fatigue...

A counterfactual p-value approach for benefit-risk assessment in clinical trials.

PubMed

Zeng, Donglin; Chen, Ming-Hui; Ibrahim, Joseph G; Wei, Rachel; Ding, Beiying; Ke, Chunlei; Jiang, Qi

2015-01-01

Clinical trials generally allow various efficacy and safety outcomes to be collected for health interventions. Benefit-risk assessment is an important issue when evaluating a new drug. Currently, there is a lack of standardized and validated benefit-risk assessment approaches in drug development due to various challenges. To quantify benefits and risks, we propose a counterfactual p-value (CP) approach. Our approach considers a spectrum of weights for weighting benefit-risk values and computes the extreme probabilities of observing the weighted benefit-risk value in one treatment group as if patients were treated in the other treatment group. The proposed approach is applicable to single benefit and single risk outcome as well as multiple benefit and risk outcomes assessment. In addition, the prior information in the weight schemes relevant to the importance of outcomes can be incorporated in the approach. The proposed CPs plot is intuitive with a visualized weight pattern. The average area under CP and preferred probability over time are used for overall treatment comparison and a bootstrap approach is applied for statistical inference. We assess the proposed approach using simulated data with multiple efficacy and safety endpoints and compare its performance with a stochastic multi-criteria acceptability analysis approach.

Applying Lessons Learned from Space Safety to Unmanned Aerial Vehicle Risk Assessments

NASA Astrophysics Data System (ADS)

Devoid, Wayne E.

2013-09-01

This paper will examine the application of current orbital launch risk methodology to assessing risk for unmanned aerial vehicle flights over populated areas. Major differences, such as the added complexity of lifting bodies, accounting for pilots-in-the-loop, and the complexity of using current population data to estimate risk for unmanned aerial vehicles, will be highlighted.

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.

The role of PRA in the safety assessment of VVER Nuclear Power Plants in Ukraine.

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

Kot, C.

1999-05-10

Ukraine operates thirteen (13) Soviet-designed pressurized water reactors, VVERS. All Ukrainian plants are currently operating with annually renewable permits until they update their safety analysis reports (SARs), in accordance with new SAR content requirements issued in September 1995, by the Nuclear Regulatory Authority and the Government Nuclear Power Coordinating Committee of Ukraine. The requirements are in three major areas: design basis accident (DBA) analysis, probabilistic risk assessment (PRA), and beyond design-basis accident (BDBA) analysis. The last two requirements, on PRA and BDBA, are new, and the DBA requirements are an expanded version of the older SAR requirements. The US Departmentmore » of Energy (USDOE), as part of its Soviet-Designed Reactor Safety activities, is providing assistance and technology transfer to Ukraine to support their nuclear power plants (NPPs) in developing a Western-type technical basis for the new SARs. USDOE sponsored In-Depth Safety Assessments (ISAs) are in progress at three pilot nuclear reactor units in Ukraine, South Ukraine Unit 1, Zaporizhzhya Unit 5, and Rivne Unit 1, and a follow-on study has been initiated at Khmenytskyy Unit 1. The ISA projects encompass most areas of plant safety evaluation, but the initial emphasis is on performing a detailed, plant-specific Level 1 Internal Events PRA. This allows the early definition of the plant risk profile, the identification of risk significant accident sequences and plant vulnerabilities and provides guidance for the remainder of the safety assessments.« less

FRAMEWORK FOR EVALUATION OF PHYSIOLOGICALLY-BASED PHARMACOKINETIC MODELS FOR USE IN SAFETY OR RISK ASSESSMENT

EPA Science Inventory

ABSTRACT

Proposed applications of increasingly sophisticated biologically-based computational models, such as physiologically-based pharmacokinetic (PBPK) models, raise the issue of how to evaluate whether the models are adequate for proposed uses including safety or risk ...

Systematic assessment of laser safety in otolaryngology

NASA Astrophysics Data System (ADS)

Oswal, V. H.

2001-01-01

Risk management of lasers can be broadly define das a process of identification of the risk, assessment of the risk and steps taken to avert the risk. The risk management may be divided into: Risk inherent to the technology and risk in clinical use. Within the National Health Service in the UK, a useful document, which provides hospital laser users with advice on safety, is the 'Guidance on the Safe Use of Lasers in Medical and Dental Practice' issued by the Medical Devices Agency for the Department of Health in the UK. It recommends the appointment of a Laser Protection Adviser (LPA) who is knowledgeable in the evaluation of laser hazards. One of the duties LPA is to ensure that Local Rules are drawn up for each specific application of a laser. A Laser Protection Supervisor (LPS) should also be appointed with responsibility to ensure that the Local Rules are observed. It is a sensible precaution that laser users should be those approved by the Laser Protection Supervisor in consultation with the Laser Protection Advisor. All laser users should sign a statement that they have read and understood the Local Rules.

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.

Safety assessment of personal care products/cosmetics and their ingredients.

PubMed

Nohynek, Gerhard J; Antignac, Eric; Re, Thomas; Toutain, Herve

2010-03-01

We attempt to review the safety assessment of personal care products (PCP) and ingredients that are representative and pose complex safety issues. PCP are generally applied to human skin and mainly produce local exposure, although skin penetration or use in the oral cavity, on the face, lips, eyes and mucosa may also produce human systemic exposure. In the EU, US and Japan, the safety of PCP is regulated under cosmetic and/or drug regulations. Oxidative hair dyes contain arylamines, the most chemically reactive ingredients of PCP. Although arylamines have an allergic potential, taking into account the high number of consumers exposed, the incidence and prevalence of hair dye allergy appears to be low and stable. A recent (2001) epidemiology study suggested an association of oxidative hair dye use and increased bladder cancer risk in consumers, although this was not confirmed by subsequent or previous epidemiologic investigations. The results of genetic toxicity, carcinogenicity and reproductive toxicity studies suggest that modern hair dyes and their ingredients pose no genotoxic, carcinogenic or reproductive risk. Recent reports suggest that arylamines contained in oxidative hair dyes are N-acetylated in human or mammalian skin resulting in systemic exposure to traces of detoxified, i.e. non-genotoxic, metabolites, whereas human hepatocytes were unable to transform hair dye arylamines to potentially carcinogenic metabolites. An expert panel of the International Agency on Research of Cancer (IARC) concluded that there is no evidence for a causal association of hair dye exposure with an elevated cancer risk in consumers. Ultraviolet filters have important benefits by protecting the consumer against adverse effects of UV radiation; these substances undergo a stringent safety evaluation under current international regulations prior to their marketing. Concerns were also raised about the safety of solid nanoparticles in PCP, mainly TiO(2) and ZnO in sunscreens. However

Safety assessment of personal care products/cosmetics and their ingredients

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

Nohynek, Gerhard J., E-mail: gnohynec@rd.loreal.co; Antignac, Eric; Re, Thomas

2010-03-01

We attempt to review the safety assessment of personal care products (PCP) and ingredients that are representative and pose complex safety issues. PCP are generally applied to human skin and mainly produce local exposure, although skin penetration or use in the oral cavity, on the face, lips, eyes and mucosa may also produce human systemic exposure. In the EU, US and Japan, the safety of PCP is regulated under cosmetic and/or drug regulations. Oxidative hair dyes contain arylamines, the most chemically reactive ingredients of PCP. Although arylamines have an allergic potential, taking into account the high number of consumers exposed,more » the incidence and prevalence of hair dye allergy appears to be low and stable. A recent (2001) epidemiology study suggested an association of oxidative hair dye use and increased bladder cancer risk in consumers, although this was not confirmed by subsequent or previous epidemiologic investigations. The results of genetic toxicity, carcinogenicity and reproductive toxicity studies suggest that modern hair dyes and their ingredients pose no genotoxic, carcinogenic or reproductive risk. Recent reports suggest that arylamines contained in oxidative hair dyes are N-acetylated in human or mammalian skin resulting in systemic exposure to traces of detoxified, i.e. non-genotoxic, metabolites, whereas human hepatocytes were unable to transform hair dye arylamines to potentially carcinogenic metabolites. An expert panel of the International Agency on Research of Cancer (IARC) concluded that there is no evidence for a causal association of hair dye exposure with an elevated cancer risk in consumers. Ultraviolet filters have important benefits by protecting the consumer against adverse effects of UV radiation; these substances undergo a stringent safety evaluation under current international regulations prior to their marketing. Concerns were also raised about the safety of solid nanoparticles in PCP, mainly TiO{sub 2} and ZnO in

Improving antenatal risk assessment in women exposed to high risks.

PubMed

Perry, Natasha; Newman, Louise K; Hunter, Mick; Dunlop, Adrian

2015-01-01

Antenatal substance use and related psychosocial risk factors are known to increase the likelihood of child protection involvement; less is known about the predictive nature of maternal reflective functioning (RF) in this population. This preliminary study assessed psychosocial and psychological risk factors for a group of substance dependent women exposed to high risks in pregnancy, and their impact on child protection involvement. Pregnant women on opiate substitution treatment (n = 11) and a comparison group (n = 15) were recruited during their third trimester to complete measures of RF (Pregnancy Interview), childhood trauma, mental health and psychosocial assessments. At postnatal follow-up, RF was reassessed (Parent Development Interview - Revised Short Version) and mother-infant dyads were videotaped to assess emotional availability (EA). Child protection services were contacted to determine if any concerns had been raised for infant safety. Significant between-group differences were observed for demographics, psychosocial factors, trauma and mental health symptoms. Unexpectedly, no significant differences were found for RF or EA between groups. Eight women in the 'exposed to high risks' group became involved with child protection services. Reflective functioning was not significantly associated with psychosocial risk factors, and therefore did not mediate the outcome of child protection involvement. Women 'exposed to high risks' were equally able to generate a model of their own and their infants' mental states and should not be seen within a deficit perspective. Further research is required to better understand the range of risk factors that predict child protection involvement in high risk groups. © The Author(s) 2013.

78 FR 3824 - Draft Qualitative Risk Assessment of Risk of Activity/Food Combinations for Activities (Outside...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-01-16

... available electronically at http://www.regulations.gov and at http://www.fda.gov/Food/ScienceResearch.... Available at: http://www.fda.gov/Food/ScienceResearch/ResearchAreas/RiskAssessmentSafetyAssessment/default...) Conducted in a Facility Co-Located on a Farm,'' 2012. Available at: http://www.fda.gov/ScienceResearch...

Risk Assessment at the Cosmetic Product Manufacturer by Expert Judgment Method

NASA Astrophysics Data System (ADS)

Vtorushina, A. N.; Larionova, E. V.; Mezenceva, I. L.; Nikonova, E. D.

2017-05-01

A case study was performed in a cosmetic product manufacturer. We have identified the main risk factors of occupational accidents and their causes. Risk of accidents is assessed by the expert judgment method. Event tree for the most probable accident is built and recommendations on improvement of occupational health and safety protection system at the cosmetic product manufacturer are developed. The results of this paper can be used to develop actions to improve the occupational safety and health system in the chemical industry.

All Hazards Risk Assessment Transition Project: Report on Capability Assessment Management System (CAMS) Automation

DTIC Science & Technology

2014-04-01

All Hazards Risk Assessment Transition Project : Report on Capability Assessment Management System (CAMS) Automation...Prepared by: George Giroux Computer Applications Specialist Modis155 Queen Street, Suite 1206 Ottawa, ON K1P 6L1 Contract # THS 2335474-2 Project ...Under a Canadian Safety and Security Program (CSSP) targeted investigation (TI) project (CSSP-2012-TI- 1108), Defence Research and Development

The Certification Framework: Risk Assessment for Safety and Effectiveness of Geologic Carbon Sequestration

NASA Astrophysics Data System (ADS)

Oldenburg, C. M.; Nicot, J.; Bryant, S. L.

2008-12-01

Motivated by the dual objectives of (1) encouraging geologic carbon sequestration (GCS) as one of several strategies urgently needed to reduce CO2 emissions, and (2) protecting the environment from unintended CO2 injection-related impacts, we have developed a simple and transparent framework for certifying GCS safety and effectiveness at individual sites. The approach we developed, called the Certification Framework (CF), is proposed as a standard way for project proponents, regulators, and the public to analyze and understand risks and uncertainties of GCS. In the CF, we relate effective trapping to CO2 leakage risk, where we use the standard definition of risk involving the two factors (1) probability of a particular leakage scenario, and (2) impact of that leakage scenario. In short, if the CO2 leakage risk as calculated by the CF is below threshold values for the life of the project, then effective trapping is predicted and the site can be certified. The concept of effective trapping is more general than traditional "no migration" approaches to underground injection regulation. We achieve simplicity in the CF by using (1) wells and faults as the potential leakage pathways, (2) five compartments to represent where impacts can occur (underground sources of drinking water, hydrocarbon and mineral resources, near-surface environment, health and safety, and emission credits and atmosphere), (3) modeled CO2 fluxes and concentrations as proxies for impact to compartments, (4) broad ranges of storage formation properties to generate a catalog of simulated CO2 plumes, and (5) probabilities of intersection of the CO2 plume with the conduits and compartments. In a case study application of the CF for a saline formation GCS site in the Texas Gulf Coast, analysis with the CF suggested the overall leakage risk to be very small, with the largest contribution coming from risk to the near-surface environment due to potential leakage up abandoned wells, depending on the

An Online Risk Monitor System (ORMS) to Increase Safety and Security Levels in Industry

NASA Astrophysics Data System (ADS)

Zubair, M.; Rahman, Khalil Ur; Hassan, Mehmood Ul

2013-12-01

The main idea of this research is to develop an Online Risk Monitor System (ORMS) based on Living Probabilistic Safety Assessment (LPSA). The article highlights the essential features and functions of ORMS. The basic models and modules such as, Reliability Data Update Model (RDUM), running time update, redundant system unavailability update, Engineered Safety Features (ESF) unavailability update and general system update have been described in this study. ORMS not only provides quantitative analysis but also highlights qualitative aspects of risk measures. ORMS is capable of automatically updating the online risk models and reliability parameters of equipment. ORMS can support in the decision making process of operators and managers in Nuclear Power Plants.

Risk assessment strategies as a tool in the application of the Appropriate Level of Protection (ALOP) and Food Safety Objective (FSO) by risk managers.

PubMed

Gkogka, E; Reij, M W; Gorris, L G M; Zwietering, M H

2013-10-01

In the course of the last decade, the Appropriate Level of Protection (ALOP), the Food Safety Objective (FSO) and their associated metrics have been proposed by the World Trade Organization and Codex Alimentarius as a means for competent authorities to ultimately translate governmental public health policy regarding food safety into risk-based targets for the food industry. The industry needs to meet these targets through the effective choice of control measures that are part of its operational food safety management system. The aim of this study was to put the practical application of ALOP and FSO to the test in the case of Salmonella in chicken meat in the Netherlands. Two different risk assessment approaches were applied to derive potential ALOP and FSO values, a 'top-down' approach based on epidemiological data and a 'bottom-up' approach based on food supply chain data. To this end, two stochastic models specific to the Dutch situation were built. Comparisons between 23 countries in Europe were also made using the top-down model. The mean estimated current Level Of Protection values were similar for the two approaches applied, with the bottom-up model yielding 87 cases per 100,000 inhabitants per year (95% CI: 0.03, 904) and the top-down model 71 (95% CI: 9.9, 155). The estimated FSO values on the other hand were considerably different with the mean 'top down' FSO being -4.6 log CFU/g (95% CI: -5.4, -4.1) and the mean 'bottom-up' FSO -6.0 log CFU/g (95% CI: -8.1, -2.9) reflecting major differences in the output distributions of this parameter obtained with the two approaches. Significant differences were observed between current LOP values for different EU countries, although it was not clear whether this was due to actual differences in the factors influencing the risk of salmonellosis or due to the quality of the available data. Copyright © 2013 Elsevier B.V. All rights reserved.

Do expert assessments converge? An exploratory case study of evaluating and managing a blood supply risk.

PubMed

Eyles, John; Heddle, Nancy; Webert, Kathryn; Arnold, Emmy; McCurdy, Bronwen

2011-08-24

Examining professional assessments of a blood product recall/withdrawal and its implications for risk and public health, the paper introduces ideas about perceptions of minimal risk and its management. It also describes the context of publicly funded blood transfusion in Canada and the withdrawal event that is the basis of this study. Interviews with 45 experts from administration, medicine, blood supply, laboratory services and risk assessment took place using a multi-level sampling framework in the aftermath of the recall. These experts either directly dealt with the withdrawal or were involved in the management of the blood supply at the national level. Data from these interviews were coded in NVivo for analysis and interpretation. Analytically, data were interpreted to derive typifications to relate interview responses to risk management heuristics. While all those interviewed agreed on the importance of patient safety, differences in the ways in which the risk was contextualized and explicated were discerned. Risk was seen in terms of patient safety, liability or precaution. These different risk logics are illustrated by selected quotations. Expert assessments did not fully converge and it is possible that these different risk logics and discourses may affect the risk management process more generally, although not necessarily in a negative way. Patient safety is not to be compromised but management of blood risk in publicly funded systems may vary. We suggest ways of managing blood risk using formal and safety case approaches.

Do expert assessments converge? An exploratory case study of evaluating and managing a blood supply risk

PubMed Central

2011-01-01

Background Examining professional assessments of a blood product recall/withdrawal and its implications for risk and public health, the paper introduces ideas about perceptions of minimal risk and its management. It also describes the context of publicly funded blood transfusion in Canada and the withdrawal event that is the basis of this study. Methods Interviews with 45 experts from administration, medicine, blood supply, laboratory services and risk assessment took place using a multi-level sampling framework in the aftermath of the recall. These experts either directly dealt with the withdrawal or were involved in the management of the blood supply at the national level. Data from these interviews were coded in NVivo for analysis and interpretation. Analytically, data were interpreted to derive typifications to relate interview responses to risk management heuristics. Results While all those interviewed agreed on the importance of patient safety, differences in the ways in which the risk was contextualized and explicated were discerned. Risk was seen in terms of patient safety, liability or precaution. These different risk logics are illustrated by selected quotations. Conclusions Expert assessments did not fully converge and it is possible that these different risk logics and discourses may affect the risk management process more generally, although not necessarily in a negative way. Patient safety is not to be compromised but management of blood risk in publicly funded systems may vary. We suggest ways of managing blood risk using formal and safety case approaches. PMID:21864330

Safety Training--A Special Case?

ERIC Educational Resources Information Center

Cooper, Mark; Cotton, David

2000-01-01

Review of research on industrial training and occupational safety and health did not find materials on training safely or risk assessment for training. A study of 34 safety inspectors indicated that risk decision making and assessment are serious concerns that should be addressed in safety training. (Contains 56 references.) (SK)

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.

Approaches in the risk assessment of genetically modified foods by the Hellenic Food Safety Authority.

PubMed

Varzakas, Theodoros H; Chryssochoidis, G; Argyropoulos, D

2007-04-01

Risk analysis has become important to assess conditions and take decisions on control procedures. In this context it is considered a prerequisite in the evaluation of GM food. Many consumers worldwide worry that food derived from genetically modified organisms (GMOs) may be unhealthy and hence regulations on GMO authorisations and labelling have become more stringent. Nowadays there is a higher demand for non-GM products and these products could be differentiated from GM products using the identity preservation system (IP) that could apply throughout the grain processing system. IP is the creation of a transparent communication system that encompasses HACCP, traceability and related systems in the supply chain. This process guarantees that certain characteristics of the lots of food (non-GM origin) are maintained "from farm to fork". This article examines the steps taken by the Hellenic Food Safety Authority to examine the presence of GMOs in foods. The whole integrated European legislation framework currently in place still needs to be implemented in Greece. Penalties should be enforced to those who import, process GMOs without special licence and do not label those products. Similar penalties should be enforced to those companies that issue false certificates beyond the liabilities taken by the food enterprises for farmers' compensation. We argue that Greece has no serious reasons to choose the use of GMOs due to the fact that the structural and pedologic characteristics of the Greek agriculture favour the biological and integrated cultivation more. Greece is not in favour of the politics behind coexistence of conventional and GM plants and objects to the use of GMOs in the food and the environment because the processor has a big burden in terms of money, time and will suffer a great deal in order to prove that their products are GMO free or that any contamination is adventitious or technically unavoidable. Moreover, Greece owns a large variety of genetic

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

[Post-marketing drug safety-risk management plan(RMP)].

PubMed

Ezaki, Asami; Hori, Akiko

2013-03-01

The Guidance for Risk Management Plan(RMP)was released by the Ministry of Health, Labour and Welfare in April 2012. The RMP consists of safety specifications, pharmacovigilance plans and risk minimization action plans. In this paper, we outline post-marketing drug safety operations in PMDA and the RMP, with examples of some anticancer drugs.

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.

Science and Safety: 'Acceptable' Risk

ERIC Educational Resources Information Center

Science News, 1976

1976-01-01

Stresses ways to answer questions related to widespread publicity - are nuclear reactors safe, will dangerous research in genetic manipulation be banned? - with emphasis on true meaning of safety as related to risks. (EB)

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

Overview of Risk Mitigation for Safety-Critical Computer-Based Systems

NASA Technical Reports Server (NTRS)

Torres-Pomales, Wilfredo

2015-01-01

This report presents a high-level overview of a general strategy to mitigate the risks from threats to safety-critical computer-based systems. In this context, a safety threat is a process or phenomenon that can cause operational safety hazards in the form of computational system failures. This report is intended to provide insight into the safety-risk mitigation problem and the characteristics of potential solutions. The limitations of the general risk mitigation strategy are discussed and some options to overcome these limitations are provided. This work is part of an ongoing effort to enable well-founded assurance of safety-related properties of complex safety-critical computer-based aircraft systems by developing an effective capability to model and reason about the safety implications of system requirements and design.

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

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.

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

Application of Risk Assessment Tools in the Continuous Risk Management (CRM) Process

NASA Technical Reports Server (NTRS)

Ray, Paul S.

2002-01-01

Marshall Space Flight Center (MSFC) of the National Aeronautics and Space Administration (NASA) is currently implementing the Continuous Risk Management (CRM) Program developed by the Carnegie Mellon University and recommended by NASA as the Risk Management (RM) implementation approach. The four most frequently used risk assessment tools in the center are: (a) Failure Modes and Effects Analysis (FMEA), Hazard Analysis (HA), Fault Tree Analysis (FTA), and Probabilistic Risk Analysis (PRA). There are some guidelines for selecting the type of risk assessment tools during the project formulation phase of a project, but there is not enough guidance as to how to apply these tools in the Continuous Risk Management process (CRM). But the ways the safety and risk assessment tools are used make a significant difference in the effectiveness in the risk management function. Decisions regarding, what events are to be included in the analysis, to what level of details should the analysis be continued, make significant difference in the effectiveness of risk management program. Tools of risk analysis also depends on the phase of a project e.g. at the initial phase of a project, when not much data are available on hardware, standard FMEA cannot be applied; instead a functional FMEA may be appropriate. This study attempted to provide some directives to alleviate the difficulty in applying FTA, PRA, and FMEA in the CRM process. Hazard Analysis was not included in the scope of the study due to the short duration of the summer research project.

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

Patient safety in external beam radiotherapy, results of the ACCIRAD project: Current status of proactive risk assessment, reactive analysis of events, and reporting and learning systems in Europe.

PubMed

Malicki, Julian; Bly, Ritva; Bulot, Mireille; Godet, Jean-Luc; Jahnen, Andreas; Krengli, Marco; Maingon, Philippe; Prieto Martin, Carlos; Przybylska, Kamila; Skrobała, Agnieszka; Valero, Marc; Jarvinen, Hannu

2017-04-01

To describe the current status of implementation of European directives for risk management in radiotherapy and to assess variability in risk management in the following areas: 1) in-country regulatory framework; 2) proactive risk assessment; (3) reactive analysis of events; and (4) reporting and learning systems. The original data were collected as part of the ACCIRAD project through two online surveys. Risk assessment criteria are closely associated with quality assurance programs. Only 9/32 responding countries (28%) with national regulations reported clear "requirements" for proactive risk assessment and/or reactive risk analysis, with wide variability in assessment methods. Reporting of adverse error events is mandatory in most (70%) but not all surveyed countries. Most European countries have taken steps to implement European directives designed to reduce the probability and magnitude of accidents in radiotherapy. Variability between countries is substantial in terms of legal frameworks, tools used to conduct proactive risk assessment and reactive analysis of events, and in the reporting and learning systems utilized. These findings underscore the need for greater harmonisation in common terminology, classification and reporting practices across Europe to improve patient safety and to enable more reliable inter-country comparisons. Copyright © 2017 Elsevier B.V. All rights reserved.

Food safety management and risk assessment in the fresh produce supply chain

NASA Astrophysics Data System (ADS)

Jacxsens, L.; Uyttendaele, M.; Luning, P.; Allende, A.

2017-04-01

This paper is the output of several years of scientific research coordinated by Laboratory of Food Preservation and Food Microbiology at UGent, within the EU FP7 Research project Veg-i-trade (www.vegitrade.org), in collaboration with among other partners, Wageningen University and Cebas-CSIC. Fresh produce and derived products are globally traded and subjected to an inherent sensitive towards enteric pathogens as Salmonella and pathogenic E. coli due to their cultivation practices. As fruits and vegetables are increasingly being consumed raw, a potential health risk towards consumers is present. In the Veg-i-Trade project the extend of presence of pathogens in leafy greens and strawberry fruit and their cultivation environment (as water, soil, manured soil, etc.) was analysed. Insight in the food safety management system enlighted the need for further fostering and guidance towards farmers in good practices in order to reduce the potential pressure of the presence of the pathogens both in EU and non EU countries. Exposure assessment calculations demonstrated the usefulness of mathematic modelling to gain more insight in fragmented microbiological analysis and information of cultivation practices, as such the impact of contamination of irrigation water and the impact of a flooding event. Veg-i-Trade was a challenging project both in scientific and management perspective as 23 partners collaborated.

Risk Informed Margins Management as part of Risk Informed Safety Margin Characterization

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

Curtis Smith

2014-06-01

The ability to better characterize and quantify safety margin is important to improved decision making about Light Water Reactor (LWR) design, operation, and plant life extension. A systematic approach to characterization of safety margins and the subsequent margin management options represents a vital input to the licensee and regulatory analysis and decision making that will be involved. In addition, as research and development in the LWR Sustainability (LWRS) Program and other collaborative efforts yield new data, sensors, and improved scientific understanding of physical processes that govern the aging and degradation of plant SSCs needs and opportunities to better optimize plantmore » safety and performance will become known. To support decision making related to economics, readability, and safety, the Risk Informed Safety Margin Characterization (RISMC) Pathway provides methods and tools that enable mitigation options known as risk informed margins management (RIMM) strategies.« less

A Big Data Analysis Approach for Rail Failure Risk Assessment.

PubMed

Jamshidi, Ali; Faghih-Roohi, Shahrzad; Hajizadeh, Siamak; Núñez, Alfredo; Babuska, Robert; Dollevoet, Rolf; Li, Zili; De Schutter, Bart

2017-08-01

Railway infrastructure monitoring is a vital task to ensure rail transportation safety. A rail failure could result in not only a considerable impact on train delays and maintenance costs, but also on safety of passengers. In this article, the aim is to assess the risk of a rail failure by analyzing a type of rail surface defect called squats that are detected automatically among the huge number of records from video cameras. We propose an image processing approach for automatic detection of squats, especially severe types that are prone to rail breaks. We measure the visual length of the squats and use them to model the failure risk. For the assessment of the rail failure risk, we estimate the probability of rail failure based on the growth of squats. Moreover, we perform severity and crack growth analyses to consider the impact of rail traffic loads on defects in three different growth scenarios. The failure risk estimations are provided for several samples of squats with different crack growth lengths on a busy rail track of the Dutch railway network. The results illustrate the practicality and efficiency of the proposed approach. © 2017 The Authors Risk Analysis published by Wiley Periodicals, Inc. on behalf of Society for Risk Analysis.

Eating nanomaterials: cruelty-free and safe? the EFSA guidance on risk assessment of nanomaterials in food and feed.

PubMed

Sauer, Ursula G

2011-12-01

Nanomaterials are increasingly being added to food handling and packaging materials, or directly, to human food and animal feed. To ensure the safety of such engineered nanomaterials (ENMs), in May 2011, the European Food Safety Authority (EFSA) published a guidance document on Risk assessment of the application of nanoscience and nanotechnologies in the food and feed chain. It states that risk assessment should be performed by following a step-wise procedure. Whenever human or animal exposure to nanomaterials is expected, the general hazard characterisation scheme requests information from in vitro genotoxicity, toxicokinetic and repeated dose 90-day oral toxicity studies in rodents. Numerous prevailing uncertainties with regard to nanomaterial characterisation and their hazard and risk assessment are addressed in the guidance document. This article discusses the impact of these knowledge gaps on meeting the goal of ensuring human safety. The EFSA's guidance on the risk assessment of ENMs in food and animal feed is taken as an example for discussion, from the point of view of animal welfare, on what level of uncertainty should be considered acceptable for human safety assessment of products with non-medical applications, and whether animal testing should be considered ethically acceptable for such products.

Risk-Based Explosive Safety Analysis

DTIC Science & Technology

2016-11-30

safety siting of energetic liquids and propellants can be greatly aided by the use of risk-based methodologies. The low probability of exposed...liquids or propellants . 15. SUBJECT TERMS N/A 16. SECURITY CLASSIFICATION OF: 17. LIMITATION OF ABSTRACT 18. NUMBER OF PAGES 19a. NAME OF...of energetic liquids and propellants can be greatly aided by the use of risk-based methodologies. The low probability of exposed personnel and the

Identification of Potential Hazard using Hazard Identification and Risk Assessment

NASA Astrophysics Data System (ADS)

Sari, R. M.; Syahputri, K.; Rizkya, I.; Siregar, I.

2017-03-01

This research was conducted in the paper production’s company. These Paper products will be used as a cigarette paper. Along in the production’s process, Company provides the machines and equipment that operated by workers. During the operations, all workers may potentially injured. It known as a potential hazard. Hazard identification and risk assessment is one part of a safety and health program in the stage of risk management. This is very important as part of efforts to prevent occupational injuries and diseases resulting from work. This research is experiencing a problem that is not the identification of potential hazards and risks that would be faced by workers during the running production process. The purpose of this study was to identify the potential hazards by using hazard identification and risk assessment methods. Risk assessment is done using severity criteria and the probability of an accident. According to the research there are 23 potential hazard that occurs with varying severity and probability. Then made the determination Risk Assessment Code (RAC) for each potential hazard, and gained 3 extreme risks, 10 high risks, 6 medium risks and 3 low risks. We have successfully identified potential hazard using RAC.

ARAMIS project: a more explicit demonstration of risk control through the use of bow-tie diagrams and the evaluation of safety barrier performance.

PubMed

de Dianous, Valérie; Fiévez, Cécile

2006-03-31

Over the last two decades a growing interest for risk analysis has been noted in the industries. The ARAMIS project has defined a methodology for risk assessment. This methodology has been built to help the industrialist to demonstrate that they have a sufficient risk control on their site. Risk analysis consists first in the identification of all the major accidents, assuming that safety functions in place are inefficient. This step of identification of the major accidents uses bow-tie diagrams. Secondly, the safety barriers really implemented on the site are taken into account. The barriers are identified on the bow-ties. An evaluation of their performance (response time, efficiency, and level of confidence) is performed to validate that they are relevant for the expected safety function. At last, the evaluation of their probability of failure enables to assess the frequency of occurrence of the accident. The demonstration of the risk control based on a couple gravity/frequency of occurrence is also possible for all the accident scenarios. During the risk analysis, a practical tool called risk graph is used to assess if the number and the reliability of the safety functions for a given cause are sufficient to reach a good risk control.

Industrial machine systems risk assessment: a critical review of concepts and methods.

PubMed

Etherton, John R

2007-02-01

Reducing the risk of work-related death and injury to machine operators and maintenance personnel poses a continuing occupational safety challenge. The risk of injury from machinery in U.S. workplaces is high. Between 1992 and 2001, there were, on average, 520 fatalities per year involving machines and, on average, 3.8 cases per 10,000 workers of nonfatal caught-in-running-machine injuries involving lost workdays. A U.S. task group recently developed a technical reference guideline, ANSI B11 TR3, "A Guide to Estimate, Evaluate, & Reduce Risks Associated with Machine Tools," that is intended to bring machine tool risk assessment practice in the United States up to or above the level now required by the international standard, ISO 14121. The ANSI guideline emphasizes identifying tasks and hazards not previously considered, particularly those associated with maintenance; and it further emphasizes teamwork among line workers, engineers, and safety professionals. The value of this critical review of concepts and methods resides in (1) its linking current risk theory to machine system risk assessment and (2) its exploration of how various risk estimation tools translate into risk-informed decisions on industrial machine system design and use. The review was undertaken to set the stage for a field evaluation study on machine risk assessment among users of the ANSI B11 TR3 method.

Safety Priorities and Underestimations in Recreational Scuba Diving Operations: A European Study Supporting the Implementation of New Risk Management Programmes

PubMed Central

Lucrezi, Serena; Egi, Salih Murat; Pieri, Massimo; Burman, Francois; Ozyigit, Tamer; Cialoni, Danilo; Thomas, Guy; Marroni, Alessandro; Saayman, Melville

2018-01-01

Introduction: Scuba diving is an important marine tourism sector, but requires proper safety standards to reduce the risks and increase accessibility to its market. To achieve safety goals, safety awareness and positive safety attitudes in recreational scuba diving operations are essential. However, there is no published research exclusively focusing on scuba divers’ and dive centres’ perceptions toward safety. This study assessed safety perceptions in recreational scuba diving operations, with the aim to inform and enhance safety and risk management programmes within the scuba diving tourism industry. Materials and Methods: Two structured questionnaire surveys were prepared by the organisation Divers Alert Network and administered online to scuba diving operators in Italy and scuba divers in Europe, using a mixture of convenience and snowball sampling. Questions in the survey included experience and safety offered at the dive centre; the buddy system; equipment and accessories for safe diving activities; safety issues in the certification of new scuba divers; incidents/accidents; and attitudes toward safety. Results: 91 scuba diving centres and 3,766 scuba divers participated in the study. Scuba divers gave importance to safety and the responsiveness of service providers, here represented by the dive centres. However, they underestimated the importance of a personal emergency action/assistance plan and, partly, of the buddy system alongside other safety procedures. Scuba divers agreed that some risks, such as those associated with running out of gas, deserve attention. Dive centres gave importance to aspects such as training and emergency action/assistance plans. However, they were limitedly involved in safety campaigning. Dive centres’ perceptions of safety in part aligned with those of scuba divers, with some exceptions. Conclusion: Greater responsibility is required in raising awareness and educating scuba divers, through participation in prevention

Safety Priorities and Underestimations in Recreational Scuba Diving Operations: A European Study Supporting the Implementation of New Risk Management Programmes.

PubMed

Lucrezi, Serena; Egi, Salih Murat; Pieri, Massimo; Burman, Francois; Ozyigit, Tamer; Cialoni, Danilo; Thomas, Guy; Marroni, Alessandro; Saayman, Melville

2018-01-01

Introduction: Scuba diving is an important marine tourism sector, but requires proper safety standards to reduce the risks and increase accessibility to its market. To achieve safety goals, safety awareness and positive safety attitudes in recreational scuba diving operations are essential. However, there is no published research exclusively focusing on scuba divers' and dive centres' perceptions toward safety. This study assessed safety perceptions in recreational scuba diving operations, with the aim to inform and enhance safety and risk management programmes within the scuba diving tourism industry. Materials and Methods: Two structured questionnaire surveys were prepared by the organisation Divers Alert Network and administered online to scuba diving operators in Italy and scuba divers in Europe, using a mixture of convenience and snowball sampling. Questions in the survey included experience and safety offered at the dive centre; the buddy system; equipment and accessories for safe diving activities; safety issues in the certification of new scuba divers; incidents/accidents; and attitudes toward safety. Results: 91 scuba diving centres and 3,766 scuba divers participated in the study. Scuba divers gave importance to safety and the responsiveness of service providers, here represented by the dive centres. However, they underestimated the importance of a personal emergency action/assistance plan and, partly, of the buddy system alongside other safety procedures. Scuba divers agreed that some risks, such as those associated with running out of gas, deserve attention. Dive centres gave importance to aspects such as training and emergency action/assistance plans. However, they were limitedly involved in safety campaigning. Dive centres' perceptions of safety in part aligned with those of scuba divers, with some exceptions. Conclusion: Greater responsibility is required in raising awareness and educating scuba divers, through participation in prevention campaigns

Implementation of Alternative Test Strategies for the Safety Assessment of Engineered Nanomaterials

PubMed Central

Nel, Andre

2014-01-01

Nanotechnology introduces a new field that requires novel approaches and methods for hazard and risk assessment. For an appropriate scientific platform for safety assessment, nanoscale properties and functions of engineered nanomaterials (ENMs), including how the physicochemical properties of the materials related to mechanisms of injury at the nano-bio interface, must be considered. Moreover, this rapidly advancing new field requires novel test strategies that allow multiple toxicants to be screened in robust, mechanism-based assays in which the bulk of the investigation can be carried out at the cellular and biomolecular level whilst maintaining limited animal use and is based on the contribution of toxicological pathways to the pathophysiology of disease. First, a predictive toxicological approach for the safety assessment of ENMs will be discussed against the background of a ‘21st-century vision’ for using alternative test strategies (ATSs) to perform toxicological assessment of large numbers of untested chemicals, thereby reducing a backlog that could otherwise become a problem for nanotechnology. An ATS is defined here as an alternative/reduction alternative to traditional animal testing. Secondly, the approach of selecting pathways of toxicity to screen for the pulmonary hazard potential of carbon nanotubes and metal oxides will be discussed, as well as how to use these pathways to perform high-content or high-throughput testing and how the data can be used for hazard ranking, risk assessment, regulatory decision-making and ‘safer-by-design’ strategies. Finally, the utility and disadvantages of this predictive toxicological approach to ENM safety assessment, and how it can assist the 21st- century vision, will be addressed PMID:23879741

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.

A risk-based, product-level approach for assuring aquatic environmental safety of cleaning products in the context of sustainability: The Environmental Safety Check (ESC) scheme of the A.I.S.E. Charter for Sustainable Cleaning.

PubMed

Pickup, John Alexander; Dewaele, Joost; Furmanski, Nicola L; Kowalczyk, Agnieszka; Luijkx, Gerard Ca; Mathieu, Sophie; Stelter, Norbert

2017-01-01

Cleaning products have long been a focus of efforts to improve sustainability and assure safety for the aquatic environment when disposed of after use. The latter is addressed at ingredient level through environmental risk assessment, including in formal frameworks such as REACH. Nevertheless, in the context of programs to improve overall sustainability, stakeholders demand both environmental safety assurance and progress at product level. Current product-level approaches for aquatic toxicity (e.g., USEtox™, Critical Dilution Volume) can be seen as predominantly hazard-based. The more logical approach would be risk-based, because ecotoxicity is generally threshold-dependent and hazard-based assessment produces conflicts with risk-based learnings. The development of a risk-based approach to assess formulated products is described: the International Association for Soaps, Detergents and Maintenance Products (A.I.S.E.) Charter Environmental Safety Check (ESC), which is consistent with the scientific principles underlying REACH. This is implemented through a simple spreadsheet tool and internal database of ingredient parameters including predicted no-effect concentration (PNEC) and removal rate. A novel feature is applying market volume information for both product types and ingredients to permit a risk-based calculation. To pass the ESC check, the projected environmental safety ratio (PESR) for each ingredient as formulated and dosed (unless cleared by a published risk assessment or exempted as inherently low risk) must be less than 1. The advantages of a risk-based approach are discussed. The strengths and limitations of various possible approaches to standard-setting, product-ranking and driving continuous improvement in respect of potential ecotoxic impacts on the aquatic environment are considered. It is proposed that as ecotoxicity is generally accepted to be threshold-dependent, with no effect below the threshold, the most constructive approach to continuous

Weight of contribution of in vitro chromosomal aberration assay for evaluation of pesticides: Experience of risk assessment at the Food Safety Commission of Japan.

PubMed

Horibe, Atsuko; Odashima, Shigenori; Hamasuna, Nobuyuki; Morita, Takeshi; Hayashi, Makoto

2018-06-01

Due to the course of registration of pesticides in Japan, the Food Safety Commission (FSC) has the responsibility to make a risk assessment of residual pesticides and related chemicals through foods. Among the set of safety evaluations for pesticides, genotoxicity assay data are mandatory. The standard test battery for this evaluation consists of a bacterial gene mutation assay, in vitro mammalian chromosomal aberrations and/or other chromosome damage assay, and in vivo rodent micronucleus assay. These assay outcomes are used for mechanistic consideration of carcinogenicity, if any. As a rule, if a certain substance is carcinogenic and the mechanism of it includes genotoxicity, the FSC might decide it is not possible to establish the acceptable daily intake of that pesticide. Therefore, the information about genotoxicity is critical for potentially carcinogenic chemicals, whether the applied substance will be adopted and permitted for use or not as pesticides. It is important to assess fairly, carefully, and transparently, but feasible, rapid, and efficient assessment also should be taken into account. Therefore, needless to say, the assay(s) should have the sensitivity to detect potent mutagens. It is also important to be aware that the required data set should be consisted of reliable assays without certain assay(s) that give(s) false positive information or offer less of a contribution for the safety assessment. Copyright © 2018. Published by Elsevier Inc.

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

Assessing safety of herbal products for menopausal complaints: an international perspective.

PubMed

Dog, Tieraona Low; Marles, Robin; Mahady, Gail; Gardiner, Paula; Ko, Richard; Barnes, Jo; Chavez, Mary L; Griffiths, James; Giancaspro, Gabriel; Sarma, Nandakumara D

2010-08-01

Future research of herbal products for menopausal women should include long-term safety assessments because women may use these products for prolonged periods of time. Growing numbers of women take prescription medications and concurrently use herbal products for alleviation of menopausal symptoms. Because of possible herb-drug interactions, both drug and supplement manufacturers should provide basic pharmacokinetic data to reduce the risk of adverse interactions. In addition, herbal products produced to high quality standards are essential for ensuring consumer safety. Regulatory frameworks must be in place to ensure that herbal ingredients' identities have been verified, that they have been properly quantified per unit dose, that the product is within tolerance limits for contaminants, that the product's safety and effectiveness under the recommended conditions of use have been assessed before sale to the public, and that a system is in place to detect and deal with adverse reactions when they arise. This article explores these and related concerns. Copyright 2010. Published by Elsevier Ireland Ltd.

Reference dose (RfD): description and use in health risk assessments

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

Barnes, D.G.; Dourson, M.

1988-12-01

For many years the concept of the acceptable daily intake has served the toxicological and regulatory fields quite well. However, as approaches to assessing the health significance of exposures to noncarcinogenic substances receive greater scrutiny, some difficulties with this traditional approach have become more apparent. Consequently, the concept of the reference dose is introduced in order to avoid use of prejudicial terms (e.g., safety and acceptable), to promote greater consistency in the assessment of noncarcinogenic chemicals, and to maintain the functional separation between risk assessment and risk management.

[Sleepiness, safety on the road and management of risk].

PubMed

Garbarino, S; Traversa, F; Spigno, F

2012-01-01

Public health studies have shown that sleepiness at the wheel and other risks associated with sleep are responsible for 5% to 30% of road accidents, depending on the type of driver and/or road. In industrialized countries one-fifth of all traffic accidents can be ascribed to sleepiness behind the wheel. Sleep disorders and various common acute and chronic medical conditions together with lifestyles, extended work hours and prolonged wakefulness directly or indirectly affect the quality and quantity of one's sleep increasing the number of workers with sleep debt and staggered hours. These conditions may increase the risk of road accidents. Strategies to reduce this risk of both commercial and non-commercial drivers related to sleepiness include reliable diagnosis and treatment of sleep disorders, management of chronobiological conflicts, adequate catch-up sleep, and countermeasures against sleepiness at the wheel. Road transport safety requires the adoption of occupational health measures, including risk assessment, health education, technical-environmental prevention and health surveillance.

A Simplified Approach to Risk Assessment Based on System Dynamics: An Industrial Case Study.

PubMed

Garbolino, Emmanuel; Chery, Jean-Pierre; Guarnieri, Franck

2016-01-01

Seveso plants are complex sociotechnical systems, which makes it appropriate to support any risk assessment with a model of the system. However, more often than not, this step is only partially addressed, simplified, or avoided in safety reports. At the same time, investigations have shown that the complexity of industrial systems is frequently a factor in accidents, due to interactions between their technical, human, and organizational dimensions. In order to handle both this complexity and changes in the system over time, this article proposes an original and simplified qualitative risk evaluation method based on the system dynamics theory developed by Forrester in the early 1960s. The methodology supports the development of a dynamic risk assessment framework dedicated to industrial activities. It consists of 10 complementary steps grouped into two main activities: system dynamics modeling of the sociotechnical system and risk analysis. This system dynamics risk analysis is applied to a case study of a chemical plant and provides a way to assess the technological and organizational components of safety. © 2016 Society for Risk Analysis.

Evaluating Micrometeoroid and Orbital Debris Risk Assessments Using Anomaly Data

NASA Technical Reports Server (NTRS)

Squire, Michael

2017-01-01

The accuracy of micrometeoroid and orbital debris (MMOD) risk assessments can be difficult to evaluate. A team from the National Aeronautics and Space Administration (NASA) Engineering and Safety Center (NESC) has completed a study that compared MMOD-related failures on operational satellites to predictions of how many of those failures should occur using NASA's TM"s MMOD risk assessment methodology and tools. The study team used the Poisson probability to quantify the degree of inconsistency between the predicted and reported numbers of failures. Many elements go into a risk assessment, and each of those elements represent a possible source of uncertainty or bias that will influence the end result. There are also challenges in obtaining accurate and useful data on MMOD-related failures.

Eye Protection: Safety Glasses. Safety Spotlight

ERIC Educational Resources Information Center

Deck, Anita; Roy, Ken

2017-01-01

When it comes to eye safety, there are some situations in which regular safety glasses will work adequately for the needs of the STEM education classroom or laboratory. However, there are certain instances in which safety goggles must be used for safer protection. Taking the time to analyze hazards and assess the risks prior to any activity in the…

Post-Challenger evaluation of space shuttle risk assessment and management

NASA Technical Reports Server (NTRS)

1988-01-01

As the shock of the Space Shuttle Challenger accident began to subside, NASA initiated a wide range of actions designed to ensure greater safety in various aspects of the Shuttle system and an improved focus on safety throughout the National Space Transportation System (NSTS) Program. Certain specific features of the NASA safety process are examined: the Critical Items List (CIL) and the NASA review of the Shuttle primary and backup units whose failure might result in the loss of life, the Shuttle vehicle, or the mission; the failure modes and effects analyses (FMEA); and the hazard analysis and their review. The conception of modern risk management, including the essential element of objective risk assessment is described and it is contrasted with NASA's safety process in general terms. The discussion, findings, and recommendations regarding particular aspects of the NASA STS safety assurance process are reported. The 11 subsections each deal with a different aspect of the process. The main lessons learned by SCRHAAC in the course of the audit are summarized.

[Study on building index system of risk assessment of post-marketing Chinese patent medicine based on AHP-fuzzy neural network].

PubMed

Li, Yuanyuan; Xie, Yanming; Fu, Yingkun

2011-10-01

Currently massive researches have been launched about the safety, efficiency and economy of post-marketing Chinese patent medicine (CPM) proprietary Chinese medicine, but it was lack of a comprehensive interpretation. Establishing the risk evaluation index system and risk assessment model of CPM is the key to solve drug safety problems and protect people's health. The clinical risk factors of CPM exist similarities with the Western medicine, can draw lessons from foreign experience, but also have itself multi-factor multivariate multi-level complex features. Drug safety risk assessment for the uncertainty and complexity, using analytic hierarchy process (AHP) to empower the index weights, AHP-based fuzzy neural network to build post-marketing CPM risk evaluation index system and risk assessment model and constantly improving the application of traditional Chinese medicine characteristic is accord with the road and feasible beneficial exploration.

Human health and safety risks management in underground coal mines using fuzzy TOPSIS.

PubMed

Mahdevari, Satar; Shahriar, Kourosh; Esfahanipour, Akbar

2014-08-01

The scrutiny of health and safety of personnel working in underground coal mines is heightened because of fatalities and disasters that occur every year worldwide. A methodology based on fuzzy TOPSIS was proposed to assess the risks associated with human health in order to manage control measures and support decision-making, which could provide the right balance between different concerns, such as safety and costs. For this purpose, information collected from three hazardous coal mines namely Hashouni, Hojedk and Babnizu located at the Kerman coal deposit, Iran, were used to manage the risks affecting the health and safety of their miners. Altogether 86 hazards were identified and classified under eight categories: geomechanical, geochemical, electrical, mechanical, chemical, environmental, personal, and social, cultural and managerial risks. Overcoming the uncertainty of qualitative data, the ranking process is accomplished by fuzzy TOPSIS. After running the model, twelve groups with different risks were obtained. Located in the first group, the most important risks with the highest negative effects are: materials falling, catastrophic failure, instability of coalface and immediate roof, firedamp explosion, gas emission, misfire, stopping of ventilation system, wagon separation at inclines, asphyxiation, inadequate training and poor site management system. According to the results, the proposed methodology can be a reliable technique for management of the minatory hazards and coping with uncertainties affecting the health and safety of miners when performance ratings are imprecise. The proposed model can be primarily designed to identify potential hazards and help in taking appropriate measures to minimize or remove the risks before accidents can occur. Copyright © 2014 Elsevier B.V. All rights reserved.

Rapid Response Risk Assessment in New Project Development

NASA Technical Reports Server (NTRS)

Graber, Robert R.

2010-01-01

A capability for rapidly performing quantitative risk assessments has been developed by JSC Safety and Mission Assurance for use on project design trade studies early in the project life cycle, i.e., concept development through preliminary design phases. A risk assessment tool set has been developed consisting of interactive and integrated software modules that allow a user/project designer to assess the impact of alternative design or programmatic options on the probability of mission success or other risk metrics. The risk and design trade space includes interactive options for selecting parameters and/or metrics for numerous design characteristics including component reliability characteristics, functional redundancy levels, item or system technology readiness levels, and mission event characteristics. This capability is intended for use on any project or system development with a defined mission, and an example project will used for demonstration and descriptive purposes, e.g., landing a robot on the moon. The effects of various alternative design considerations and their impact of these decisions on mission success (or failure) can be measured in real time on a personal computer. This capability provides a high degree of efficiency for quickly providing information in NASA s evolving risk-based decision environment

Quantitative risk assessment for skin sensitization: Success or failure?

PubMed

Kimber, Ian; Gerberick, G Frank; Basketter, David A

2017-02-01

Skin sensitization is unique in the world of toxicology. There is a combination of reliable, validated predictive test methods for identification of skin sensitizing chemicals, a clearly documented and transparent approach to risk assessment, and effective feedback from dermatology clinics around the world delivering evidence of the success or failure of the hazard identification/risk assessment/management process. Recent epidemics of contact allergy, particularly to preservatives, have raised questions of whether the safety/risk assessment process is working in an optimal manner (or indeed is working at all!). This review has as its focus skin sensitization quantitative risk assessment (QRA). The core toxicological principles of QRA are reviewed, and evidence of use and misuse examined. What becomes clear is that skin sensitization QRA will only function adequately if two essential criteria are met. The first is that QRA is applied rigourously, and the second is that potential exposure to the sensitizing substance is assessed adequately. This conclusion will come as no surprise to any toxicologist who appreciates the basic premise that "risk = hazard x exposure". Accordingly, use of skin sensitization QRA is encouraged, not least because the essential feedback from dermatology clinics can be used as a tool to refine QRA in situations where this risk assessment tool has not been properly used. Copyright © 2016 Elsevier Inc. All rights reserved.

Critical factors and paths influencing construction workers' safety risk tolerances.

PubMed

Wang, Jiayuan; Zou, Patrick X W; Li, Penny P

2016-08-01

While workers' safety risk tolerances have been regarded as a main reason for their unsafe behaviors, little is known about why different people have different risk tolerances even when confronting the same situation. The aim of this research is to identify the critical factors and paths that influence workers' safety risk tolerance and to explore how they contribute to accident causal model from a system thinking perceptive. A number of methods were carried out to analyze the data collected through interviews and questionnaire surveys. In the first and second steps of the research, factor identification, factor ranking and factor analysis were carried out, and the results show that workers' safety risk tolerance can be influenced by four groups of factors, namely: (1) personal subjective perception; (2) work knowledge and experiences; (3) work characteristics; and (4) safety management. In the third step of the research, hypothetical influencing path model was developed and tested by using structural equation modeling (SEM). It is found that the effects of external factors (safety management and work characteristics) on risk tolerance are larger than that of internal factors (personal subjective perception and work knowledge & experiences). Specifically, safety management contributes the most to workers' safety risk tolerance through its direct effect and indirect effect; while personal subjective perception comes the second and can act as an intermedia for work characteristics. This research provides an in-depth insight of workers' unsafe behaviors by depicting the contributing factors as shown in the accident causal model developed in this research. Copyright © 2015 Elsevier Ltd. All rights reserved.

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

PubMed

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

2009-01-01

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

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.

Risk Assessment Terminology: Risk Communication Part 2

PubMed Central

Bentley, Stefano; Giacometti, Federica; Piva, Silvia; Serraino, Andrea

2016-01-01

The paper describes the terminology of risk communication in the view of food safety: different aspects of risk perception (perceived risk, media triggers, the psychometric paradigm, fright factors and cultural determinants of risk perception) are described. The risk profile elements are illustrated in the manuscript: hazard-food commodity combination(s) of concern; description of the public health problem; food production, processing, distribution and consumption; needs and questions for the risk assessors; available information and major knowledge gaps and other risk profile elements. PMID:27800443

Knowledge and perceived implementation of food safety risk analysis framework in Latin America and the Caribbean region.

PubMed

Cherry, C; Mohr, A Hofelich; Lindsay, T; Diez-Gonzalez, F; Hueston, W; Sampedro, F

2014-12-01

Risk analysis is increasingly promoted as a tool to support science-based decisions regarding food safety. An online survey comprising 45 questions was used to gather information on the implementation of food safety risk analysis within the Latin American and Caribbean regions. Professionals working in food safety in academia, government, and private sectors in Latin American and Caribbean countries were contacted by email and surveyed to assess their individual knowledge of risk analysis and perceptions of its implementation in the region. From a total of 279 participants, 97% reported a familiarity with risk analysis concepts; however, fewer than 25% were able to correctly identify its key principles. The reported implementation of risk analysis among the different professional sectors was relatively low (46%). Participants from industries in countries with a long history of trade with the United States and the European Union, such as Mexico, Brazil, and Chile, reported perceptions of a higher degree of risk analysis implementation (56, 50, and 20%, respectively) than those from the rest of the countries, suggesting that commerce may be a driver for achieving higher food safety standards. Disagreement among respondents on the extent of the use of risk analysis in national food safety regulations was common, illustrating a systematic lack of understanding of the current regulatory status of the country. The results of this survey can be used to target further risk analysis training on selected sectors and countries.

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

Principles for the risk assessment of genetically modified microorganisms and their food products in the European Union.

PubMed

Aguilera, Jaime; Gomes, Ana R; Olaru, Irina

2013-10-01

Genetically modified microorganisms (GMMs) are involved in the production of a variety of food and feed. The release and consumption of these products can raise questions about health and environmental safety. Therefore, the European Union has different legislative instruments in place in order to ensure the safety of such products. A key requirement is to conduct a scientific risk assessment as a prerequisite for the product to be placed on the market. This risk assessment is performed by the European Food Safety Authority (EFSA), through its Scientific Panels. The EFSA Panel on Genetically Modified Organisms has published complete and comprehensive guidance for the risk assessment of GMMs and their products for food and/or feed use, in which the strategy and the criteria to conduct the assessment are explained, as well as the scientific data to be provided in applications for regulated products. This Guidance follows the main risk assessment principles developed by various international organisations (Codex Alimentarius, 2003; OECD, 2010). The assessment considers two aspects: the characterisation of the GMM and the possible effects of its modification with respect to safety, and the safety of the product itself. Due to the existing diversity of GMMs and their products, a categorisation is recommended to optimise the assessment and to determine the extent of the required data. The assessment starts with a comprehensive characterisation of the GMM, covering the recipient/parental organism, the donor(s) of the genetic material, the genetic modification, and the final GMM and its phenotype. Evaluation of the composition, potential toxicity and/or allergenicity, nutritional value and environmental impact of the product constitute further cornerstones of the process. The outcome of the assessment is reflected in a scientific opinion which indicates whether the product raises any safety issues. This opinion is taken into account by the different European regulatory

Modeling logistic performance in quantitative microbial risk assessment.

PubMed

Rijgersberg, Hajo; Tromp, Seth; Jacxsens, Liesbeth; Uyttendaele, Mieke

2010-01-01

In quantitative microbial risk assessment (QMRA), food safety in the food chain is modeled and simulated. In general, prevalences, concentrations, and numbers of microorganisms in media are investigated in the different steps from farm to fork. The underlying rates and conditions (such as storage times, temperatures, gas conditions, and their distributions) are determined. However, the logistic chain with its queues (storages, shelves) and mechanisms for ordering products is usually not taken into account. As a consequence, storage times-mutually dependent in successive steps in the chain-cannot be described adequately. This may have a great impact on the tails of risk distributions. Because food safety risks are generally very small, it is crucial to model the tails of (underlying) distributions as accurately as possible. Logistic performance can be modeled by describing the underlying planning and scheduling mechanisms in discrete-event modeling. This is common practice in operations research, specifically in supply chain management. In this article, we present the application of discrete-event modeling in the context of a QMRA for Listeria monocytogenes in fresh-cut iceberg lettuce. We show the potential value of discrete-event modeling in QMRA by calculating logistic interventions (modifications in the logistic chain) and determining their significance with respect to food safety.

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.

Are safety data sheets for cleaning products used in Norway a factor contributing to the risk of workers exposure to chemicals?

PubMed

Suleiman, Abdulqadir M; Svendsen, Kristin V H

2014-10-01

Cleaning products are considered less hazardous than those used in other sectors. Suppliers and distributors are less conscientious when it comes to informing users on health risks. The aim of the study was to elaborate on the usefulness and clarity of information in the safety data sheets (SDS) for cleaning products, and considering if the use of these SDSs can be seen as a risk factor towards occupational exposure to hazardous chemicals in the sector. Safety data sheets were selected based on the risk level of the product assigned in an industrial sector scheme. 320 SDSs for cleaning products were reviewed. Constituent components found in the products over a given threshold were listed and available information thereof used to assess the perceived non-hazard consideration of the chemicals. The contents of the SDSs was generic and mostly incomplete. Safety measures and health information lacked sufficient specificity despite varying compositions and concentrations of components. There is generally incompatibility between mentioned sections on the suggested non-hazardous nature of the products and health effects. Not all substances used in these products have harmonized classifications, which makes them open to various classification of the products and the suggested safety measures. This results in different companies classifying similar products differently. Risk management measures and suggested personal protective equipment (PPEs) are given haphazardly. Physical properties relevant to risk assessment are not included. The safety data sheets are ambiguous, and they lack relevant and important information. Inadequate information and risk assessment concerning the products can lead to workers being exposed to hazardous chemicals. Underestimation of the hazard contribution of the components of the products and the insufficient, non-objective mention of appropriate control and protective measures are the major contributing elements. There is a need to test the

Road Infrastructure Safety Management in Poland

NASA Astrophysics Data System (ADS)

Budzynski, Marcin; Jamroz, Kazimierz; Kustra, Wojciech; Michalski, Lech; Gaca, Stanislaw

2017-10-01

The objective of road safety infrastructure management is to ensure that when roads are planned, designed, built and used road risks can be identified, assessed and mitigated. Road transport safety is significantly less developed than that of rail, water and air transport. The average individual risk of being a fatality in relation to the distance covered is thirty times higher in road transport that in the other modes. This is mainly because the different modes have a different approach to safety management and to the use of risk management methods and tools. In recent years Poland has had one of the European Union’s highest road death numbers. In 2016 there were 3026 fatalities on Polish roads with 40,766 injuries. Protecting road users from the risk of injury and death should be given top priority. While Poland’s national and regional road safety programmes address this problem and are instrumental in systematically reducing the number of casualties, the effects are far from the expectations. Modern approaches to safety focus on three integrated elements: infrastructure measures, safety management and safety culture. Due to its complexity, the process of road safety management requires modern tools to help with identifying road user risks, assess and evaluate the safety of road infrastructure and select effective measures to improve road safety. One possible tool for tackling this problem is the risk-based method for road infrastructure safety management. European Union Directive 2008/96/EC regulates and proposes a list of tools for managing road infrastructure safety. Road safety tools look at two criteria: the life cycle of a road structure and the process of risk management. Risk can be minimized through the application of the proposed interventions during design process as reasonable. The proposed methods of risk management bring together two stages: risk assessment and risk response occurring within the analyzed road structure (road network, road

NASA Human System Risk Assessment Process

NASA Technical Reports Server (NTRS)

Francisco, D.; Romero, E.

2016-01-01

two-page assessment representing the state of knowledge/evidence of that risk, available risk mitigations, traceability to the Space Flight Human System Standards (SFHSS) and program requirements, and future work required. These data then can drive coordinated budgets across the Human Research Program, the International Space Station, Crew Health and Safety and Advanced Exploration System budgets to provide the most economical and timely mitigations. The risk assessments were completed for the 6 DRMs and serve as the baseline for which subsequent research and technology development and crew health care portfolios can be assessed. The HSRB reviews each risk at least annually or when new evidence/information is available that adds to the body of evidence. The current status of each risk can be reported to program management for operations, budget reviews and general oversight of the human system risk management program.

How to Assess the Biomechanical Risk Levels in Beekeeping.

PubMed

Maina, G; Rossi, F; Baracco, A

2016-01-01

Beekeepers are at particular risk of developing work-related musculoskeletal disorders, but many of the studies lack detailed exposure assessment. To evaluate the biomechanical overload exposure in a specific farming activity, a multitasking model has been developed through the characterization of 37 basic operational tasks typical of the beekeeping activity. The Occupational Repetitive Actions (OCRA) Checklist and the National Institute for Occupational Safety and Health (NIOSH) Lifting Index methodologies have been applied to these elementary tasks to evaluate the exposure, and the resulting risk indices have been time-weighted averaged. Finally, an easy access, computer-assisted toolkit has been developed to help the beekeepers in the biomechanical risk assessment process. The risk of biomechanical overload for the upper limbs ranges from acceptable (maintenance and recovery of woody material and honey packaging with dosing machine tasks) to high (distribution of the top supers) risk level. The risk for back injury is always borderline in women and increases with exposure time, whereas it ranges from acceptable to borderline in men. The definition of the biomechanical risk levels allows for planning of corrective actions aimed at preventing and reducing the risk of musculoskeletal disorders through engineering, administrative, and behavioral interventions. The methodology can be used for risk assessment in other mainly manual agricultural activities.

Scenario Analysis for the Safety Assessment of Nuclear Waste Repositories: A Critical Review.

PubMed

Tosoni, Edoardo; Salo, Ahti; Zio, Enrico

2018-04-01

A major challenge in scenario analysis for the safety assessment of nuclear waste repositories pertains to the comprehensiveness of the set of scenarios selected for assessing the safety of the repository. Motivated by this challenge, we discuss the aspects of scenario analysis relevant to comprehensiveness. Specifically, we note that (1) it is necessary to make it clear why scenarios usually focus on a restricted set of features, events, and processes; (2) there is not yet consensus on the interpretation of comprehensiveness for guiding the generation of scenarios; and (3) there is a need for sound approaches to the treatment of epistemic uncertainties. © 2017 Society for Risk Analysis.

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.

Risk and Safety of Probiotics

PubMed Central

Doron, Shira; Snydman, David R.

2015-01-01

Probiotics have been used safely for years. Safety outcomes are inconsistently reported in published clinical trials. In 2011, a report released by the Agency for Healthcare Research and Quality concluded that, although the existing probiotic clinical trials reveal no evidence of increased risk, “the current literature is not well equipped to answer questions on the safety of probiotics in intervention studies with confidence.” Critics point out that the preponderance of evidence, including the long history of safe probiotic use as well as data from clinical trials, and animal and in vitro studies all support the assumption that probiotics are generally safe for most populations. Theoretical risks have been described in case reports, clinical trial results and experimental models, include systemic infections, deleterious metabolic activities, excessive immune stimulation in susceptible individuals, gene transfer and gastrointestinal side effects. More research is needed to properly describe the incidence and severity of adverse events related to probiotics. PMID:25922398

Data-driven risk models could help target pipeline safety inspections

DOT National Transportation Integrated Search

2008-07-01

Federal safety agencies share a common problemthe : need to target resources effectively to reduce risk. One : way this targeting is commonly done is with a risk model : that uses safety data along with expert judgment to identify : and weight ris...

Assessment of herbal medicinal products: Challenges, and opportunities to increase the knowledge base for safety assessment

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

Jordan, Scott A., E-mail: scott.jordan@hc-sc.gc.c; Cunningham, David G.; Marles, Robin J.

Although herbal medicinal products (HMP) have been perceived by the public as relatively low risk, there has been more recognition of the potential risks associated with this type of product as the use of HMPs increases. Potential harm can occur via inherent toxicity of herbs, as well as from contamination, adulteration, plant misidentification, and interactions with other herbal products or pharmaceutical drugs. Regulatory safety assessment for HMPs relies on both the assessment of cases of adverse reactions and the review of published toxicity information. However, the conduct of such an integrated investigation has many challenges in terms of the quantitymore » and quality of information. Adverse reactions are under-reported, product quality may be less than ideal, herbs have a complex composition and there is lack of information on the toxicity of medicinal herbs or their constituents. Nevertheless, opportunities exist to capitalise on newer information to increase the current body of scientific evidence. Novel sources of information are reviewed, such as the use of poison control data to augment adverse reaction information from national pharmacovigilance databases, and the use of more recent toxicological assessment techniques such as predictive toxicology and omics. The integration of all available information can reduce the uncertainty in decision making with respect to herbal medicinal products. The example of Aristolochia and aristolochic acids is used to highlight the challenges related to safety assessment, and the opportunities that exist to more accurately elucidate the toxicity of herbal medicines.« less

Using the Job Demands-Resources model to investigate risk perception, safety climate and job satisfaction in safety critical organizations.

PubMed

Nielsen, Morten Birkeland; Mearns, Kathryn; Matthiesen, Stig Berge; Eid, Jarle

2011-10-01

Using the Job Demands-Resources model (JD-R) as a theoretical framework, this study investigated the relationship between risk perception as a job demand and psychological safety climate as a job resource with regard to job satisfaction in safety critical organizations. In line with the JD-R model, it was hypothesized that high levels of risk perception is related to low job satisfaction and that a positive perception of safety climate is related to high job satisfaction. In addition, it was hypothesized that safety climate moderates the relationship between risk perception and job satisfaction. Using a sample of Norwegian offshore workers (N = 986), all three hypotheses were supported. In summary, workers who perceived high levels of risk reported lower levels of job satisfaction, whereas this effect diminished when workers perceived their safety climate as positive. Follow-up analyses revealed that this interaction was dependent on the type of risks in question. The results of this study supports the JD-R model, and provides further evidence for relationships between safety-related concepts and work-related outcomes indicating that organizations should not only develop and implement sound safety procedures to reduce the effects of risks and hazards on workers, but can also enhance other areas of organizational life through a focus on safety. © 2011 The Authors. Scandinavian Journal of Psychology © 2011 The Scandinavian Psychological Associations.

Health, safety and environmental risk of a gas pipeline in an oil exploring area of Gachsaran.

PubMed

Kalatpoor, Omid; Goshtasp, Kambiz; Khavaji, Solieman

2011-01-01

The purpose of this study was assessing health, safety and environmental risk of a gas transfer pipeline in an oily area of Gachsaran. In this method, we used the Kent's pipeline risk assessment method except that to facilitate using the method more practically some changes were exerted into Kent's method. A pipeline with 16 kilometers length was selected considering surrounding nature of the pipeline. It was divided into two sections. Analogous to Kent's method, in this method, parameters included: interested party's injuries, corrosion, design factor, incorrect operation index and consequence scoring. The difference here was that for consequence scoring we used ALOHA 5.6 software instead of Kent's pattern. Results showed that health, safety and environmental risks of section 2 (the next 13 kilometers of outgoing pipeline from gas station after the first 3 kilometers) were greater. It seems the main cause of gaining a bigger risk number was related to more activities of interested parties around section 2. Because all figures gathered from indexes are almost close to gather except third parties activity.

Physicians' and nurses' perceptions of patient safety risks in the emergency department.

PubMed

Källberg, Ann-Sofie; Ehrenberg, Anna; Florin, Jan; Östergren, Jan; Göransson, Katarina E

2017-07-01

The emergency department has been described as a high-risk area for errors. It is also known that working conditions such as a high workload and shortage off staff in the healthcare field are common factors that negatively affect patient safety. A limited amount of research has been conducted with regard to patient safety in Swedish emergency departments. Additionally, there is a lack of knowledge about clinicians' perceptions of patient safety risks. Therefore, the purpose of this study was to describe emergency department clinicians' experiences with regard to patient safety risks. Semi-structured interviews were conducted with 10 physicians and 10 registered nurses from two emergency departments. Interviews were analysed by inductive content analysis. The experiences reflect the complexities involved in the daily operation of a professional practice, and the perception of risks due to a high workload, lack of control, communication and organizational failures. The results reflect a complex system in which high workload was perceived as a risk for patient safety and that, in a combination with other risks, was thought to further jeopardize patient safety. Emergency department staff should be involved in the development of patient safety procedures in order to increase knowledge regarding risk factors as well as identify strategies which can facilitate the maintenance of patient safety during periods in which the workload is high. Copyright © 2017 Elsevier Ltd. All rights reserved.

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

Projected Impact of Compositional Verification on Current and Future Aviation Safety Risk

NASA Technical Reports Server (NTRS)

Reveley, Mary S.; Withrow, Colleen A.; Leone, Karen M.; Jones, Sharon M.

2014-01-01

The projected impact of compositional verification research conducted by the National Aeronautic and Space Administration System-Wide Safety and Assurance Technologies on aviation safety risk was assessed. Software and compositional verification was described. Traditional verification techniques have two major problems: testing at the prototype stage where error discovery can be quite costly and the inability to test for all potential interactions leaving some errors undetected until used by the end user. Increasingly complex and nondeterministic aviation systems are becoming too large for these tools to check and verify. Compositional verification is a "divide and conquer" solution to addressing increasingly larger and more complex systems. A review of compositional verification research being conducted by academia, industry, and Government agencies is provided. Forty-four aviation safety risks in the Biennial NextGen Safety Issues Survey were identified that could be impacted by compositional verification and grouped into five categories: automation design; system complexity; software, flight control, or equipment failure or malfunction; new technology or operations; and verification and validation. One capability, 1 research action, 5 operational improvements, and 13 enablers within the Federal Aviation Administration Joint Planning and Development Office Integrated Work Plan that could be addressed by compositional verification were identified.

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

Study on the Application of the Kent Index Method on the Risk Assessment of Disastrous Accidents in Subway Engineering

PubMed Central

Lu, Hao; Wang, Mingyang; Yang, Baohuai; Rong, Xiaoli

2013-01-01

With the development of subway engineering, according to uncertain factors and serious accidents involved in the construction of subways, implementing risk assessment is necessary and may bring a number of benefits for construction safety. The Kent index method extensively used in pipeline construction is improved to make risk assessment much more practical for the risk assessment of disastrous accidents in subway engineering. In the improved method, the indexes are divided into four categories, namely, basic, design, construction, and consequence indexes. In this study, a risk assessment model containing four kinds of indexes is provided. Three kinds of risk occurrence modes are listed. The probability index model which considers the relativity of the indexes is established according to the risk occurrence modes. The model provides the risk assessment process through the fault tree method and has been applied in the risk assessment of Nanjing subway's river-crossing tunnel construction. Based on the assessment results, the builders were informed of what risks should be noticed and what they should do to avoid the risks. The need for further research is discussed. Overall, this method may provide a tool for the builders, and improve the safety of the construction. PMID:23710136

Natural-technological risk assessment and management

NASA Astrophysics Data System (ADS)

Burova, Valentina; Frolova, Nina

2016-04-01

EM-DAT statistical data on human impact and economic damages in the 1st semester 2015 are the highest since 2011: 41% of disasters were floods, responsible for 39% of economic damage and 7% of events were earthquakes responsible for 59% of total death toll. This suggests that disaster risk assessment and management still need to be improved and stay the principle issue in national and international related programs. The paper investigates the risk assessment and management practice in the Russian Federation at different levels. The method is proposed to identify the territories characterized by integrated natural-technological hazard. The maps of the Russian Federation zoning according to the integrated natural-technological hazard level are presented, as well as the procedure of updating the integrated hazard level taking into account the activity of separate processes. Special attention is paid to data bases on past natural and technological processes consequences, which are used for verification of current hazard estimation. The examples of natural-technological risk zoning for the country and some regions territory are presented. Different output risk indexes: both social and economic, are estimated taking into account requirements of end-users. In order to increase the safety of population of the Russian Federation the trans-boundaries hazards are also taken into account.

Assessment of the Impact of Scheduled Postmarketing Safety Summary Analyses on Regulatory Actions

PubMed Central

Sekine, S; Pinnow, EE; Wu, E; Kurtzig, R; Hall, M; Dal Pan, GJ

2016-01-01

In addition to standard postmarketing drug safety monitoring, Section 915 of the Food and Drug Administration Amendments Act of 2007 (FDAAA) requires the US Food and Drug Administration (FDA) to conduct a summary analysis of adverse event reports to identify risks of a drug or biologic product 18 months after product approval, or after 10,000 patients have used the product, whichever is later. We assessed the extent to which these analyses identified new safety signals and resultant safety-related label changes. Among 458 newly approved products, 300 were the subjects of a scheduled analysis; a new safety signal that resulted in a safety-related label change was found for 11 of these products. Less than 2% of 713 safety-related label changes were based on the scheduled analyses. Our study suggests that the safety summary analyses provide only marginal value over other pharmacovigilance activities. PMID:26853718

Safety Assessment and Biological Effects of a New Cold Processed SilEmulsion for Dermatological Purpose

PubMed Central

Salgado, Ana; Gonçalves, Lídia; Pinto, Pedro C.; Urbano, Manuela; Ribeiro, Helena M.

2013-01-01

It is of crucial importance to evaluate the safety profile of the ingredients used in dermatological emulsions. A suitable equilibrium between safety and efficacy is a pivotal concern before the marketing of a dermatological product. The aim was to assess the safety and biological effects of a new cold processed silicone-based emulsion (SilEmulsion). The hazard, exposure, and dose-response assessment were used to characterize the risk for each ingredient. EpiSkin assay and human repeat insult patch tests were performed to compare the theoretical safety assessment to in vitro and in vivo data. The efficacy of the SilEmulsion was studied using biophysical measurements in human volunteers during 21 days. According to the safety assessment of the ingredients, 1,5-pentanediol was an ingredient of special concern since its margin of safety was below the threshold of 100 (36.53). EpiSkin assay showed that the tissue viability after the application of the SilEmulsion was 92 ± 6% and, thus considered nonirritant to the skin. The human studies confirmed that the SilEmulsion was not a skin irritant and did not induce any sensitization on the volunteers, being safe for human use. Moreover, biological effects demonstrated that the SilEmulsion increased both the skin hydration and skin surface lipids. PMID:24294598

Safety assessment and biological effects of a new cold processed SilEmulsion for dermatological purpose.

PubMed

Raposo, Sara; Salgado, Ana; Gonçalves, Lídia; Pinto, Pedro C; Urbano, Manuela; Ribeiro, Helena M

2013-01-01

It is of crucial importance to evaluate the safety profile of the ingredients used in dermatological emulsions. A suitable equilibrium between safety and efficacy is a pivotal concern before the marketing of a dermatological product. The aim was to assess the safety and biological effects of a new cold processed silicone-based emulsion (SilEmulsion). The hazard, exposure, and dose-response assessment were used to characterize the risk for each ingredient. EpiSkin assay and human repeat insult patch tests were performed to compare the theoretical safety assessment to in vitro and in vivo data. The efficacy of the SilEmulsion was studied using biophysical measurements in human volunteers during 21 days. According to the safety assessment of the ingredients, 1,5-pentanediol was an ingredient of special concern since its margin of safety was below the threshold of 100 (36.53). EpiSkin assay showed that the tissue viability after the application of the SilEmulsion was 92 ± 6% and, thus considered nonirritant to the skin. The human studies confirmed that the SilEmulsion was not a skin irritant and did not induce any sensitization on the volunteers, being safe for human use. Moreover, biological effects demonstrated that the SilEmulsion increased both the skin hydration and skin surface lipids.

Validation of Risk Assessment Models of Venous Thromboembolism in Hospitalized Medical Patients.

PubMed

Greene, M Todd; Spyropoulos, Alex C; Chopra, Vineet; Grant, Paul J; Kaatz, Scott; Bernstein, Steven J; Flanders, Scott A

2016-09-01

Patients hospitalized for acute medical illness are at increased risk for venous thromboembolism. Although risk assessment is recommended and several at-admission risk assessment models have been developed, these have not been adequately derived or externally validated. Therefore, an optimal approach to evaluate venous thromboembolism risk in medical patients is not known. We conducted an external validation study of existing venous thromboembolism risk assessment models using data collected on 63,548 hospitalized medical patients as part of the Michigan Hospital Medicine Safety (HMS) Consortium. For each patient, cumulative venous thromboembolism risk scores and risk categories were calculated. Cox regression models were used to quantify the association between venous thromboembolism events and assigned risk categories. Model discrimination was assessed using Harrell's C-index. Venous thromboembolism incidence in hospitalized medical patients is low (1%). Although existing risk assessment models demonstrate good calibration (hazard ratios for "at-risk" range 2.97-3.59), model discrimination is generally poor for all risk assessment models (C-index range 0.58-0.64). The performance of several existing risk assessment models for predicting venous thromboembolism among acutely ill, hospitalized medical patients at admission is limited. Given the low venous thromboembolism incidence in this nonsurgical patient population, careful consideration of how best to utilize existing venous thromboembolism risk assessment models is necessary, and further development and validation of novel venous thromboembolism risk assessment models for this patient population may be warranted. Published by Elsevier Inc.

Risk assessment of low-level chemical exposures from consumer products under the U.S. Consumer Product Safety Commission chronic hazard guidelines.

PubMed Central

Babich, M A

1998-01-01

The U.S. Consumer Product Safety Commission (CPSC) is an independent regulatory agency that was created in 1973. The CPSC has jurisdiction over more the 15,000 types of consumer products used in and around the home or by children, except items such as food, drugs, cosmetics, medical devices, pesticides, certain radioactive materials, products that emit radiation (e.g., microwave ovens), and automobiles. The CPSC has investigated many low-level exposures from consumer products, including formaldehyde emissions from urea-formaldehyde foam insulation and pressed wood products, CO and NO2 emmissions from combustion appliances, and dioxin in paper products. Many chemical hazards are addressed under the Federal Hazardous Substances Act (FHSA), which applies to acute and chronic health effects resulting from high- or low-level exposures. In 1992 the Commission issued guidelines for assessing chronic hazards under the FHSA, including carcinogenicity, neurotoxicity, reproductive/developmental toxicity, exposure, bioavailability, risk assessment, and acceptable risk. The chronic hazard guidelines describe a series of default assumptions, which are used in the absence of evidence to the contrary. However, the guidelines are intended to be sufficiently flexible to incorporate the latest scientific information. The use of alternative procedures is permissible, on a case-by-case basis, provided that the procedures used are scientifically defensible and supported by appropriate data. The application of the chronic hazard guidelines in assessing the risks from low-level exposures is discussed. PMID:9539035

Theories of risk and safety: what is their relevance to nursing?

PubMed

Cooke, Hannah

2009-03-01

The aim of this paper is to review key theories of risk and safety and their implications for nursing. The concept of of patient safety has only recently risen to prominence as an organising principle in healthcare. The paper considers the wider social context in which contemporary concepts of risk and safety have developed. In particular it looks at sociological debates about the rise of risk culture and the risk society and their influence on the patient safety movement. The paper discusses three bodies of theory which have attempted to explain the management of risk and safety in organisations: normal accident theory, high reliability theory, and grid-group cultural theory. It examine debates between these theories and their implications for healthcare. It discusses reasons for the dominance of high reliability theory in healthcare and its strengths and limitations. The paper suggest that high reliability theory has particular difficulties in explaining some aspects of organisational culture. It also suggest that the implementation of high reliability theory in healthcare has involved over reliance on numerical indicators. It suggests that patient safety could be improved by openness to a wider range of theoretical perspectives.

Risk Assessment Terminology: Risk Communication Part 1

PubMed Central

Bentley, Stefano; Giacometti, Federica; Piva, Silvia; Serraino, Andrea

2016-01-01

The paper describes the terminology of risk communication in the view of food safety: the theory of stakeholders, the citizens’ involvement and the community interest and consultation are reported. Different aspects of risk communication (public communication, scientific uncertainty, trust, care, consensus and crisis communication) are discussed. PMID:27800435

Cumulative Risk Assessment (CRA): Transforming the Way We Assess Health Risks

PubMed Central

Williams, Pamela R. D.; Dotson, G. Scott; Maier, Andrew

2016-01-01

Human health risk assessments continue to evolve and now focus on the need for cumulative risk assessment (CRA). CRA involves assessing the combined risk from coexposure to multiple chemical and nonchemical stressors for varying health effects. CRAs are broader in scope than traditional chemical risk assessments because they allow for a more comprehensive evaluation of the interaction between different stressors and their combined impact on human health. Future directions of CRA include greater emphasis on local-level community-based assessments; integrating environmental, occupational, community, and individual risk factors; and identifying and implementing common frameworks and risk metrics for incorporating multiple stressors. PMID:22938698

CONTEXTUALIZED ASSESSMENT WITH BATTERED WOMEN: STRATEGIC SAFETY PLANNING TO COPE WITH MULTIPLE HARMS

PubMed Central

Lindhorst, Taryn; Nurius, Paula; Macy, Rebecca J.

2007-01-01

Given the prevalence of domestic violence and the likelihood that many victims will not receive services from specialized domestic violence providers, this article provides a framework for contextualized assessment that can be used by generalist practitioners. Drawing from stress and coping theory, the authors discuss the relevance of assessing appraisals and emotional responses within the context of environmental and individual risk and protective factors. Through an illustrative case assessment, the authors describe the contextualized assessment process and its ramifications for strategic safety planning. PMID:18167523

Accident frequency and unrealistic optimism: Children's assessment of risk.

PubMed

Joshi, Mary Sissons; Maclean, Morag; Stevens, Claire

2018-02-01

Accidental injury is a major cause of mortality and morbidity among children, warranting research on their risk perceptions. Three hundred and seven children aged 10-11 years assessed the frequency, danger and personal risk likelihood of 8 accidents. Two social-cognitive biases were manifested. The frequency of rare accidents (e.g. drowning) was overestimated, and the frequency of common accidents (e.g. bike accidents) underestimated; and the majority of children showed unrealistic optimism tending to see themselves as less likely to suffer these accidents in comparison to their peers, offering superior skills or parental control of the environment as an explanation. In the case of pedestrian accidents, children recognised their seriousness, underestimated the frequency of this risk and regarded their own road crossing skill as protection. These findings highlight the challenging task facing safety educators who, when teaching conventional safety knowledge and routines, also need to alert children to the danger of over-confidence without disabling them though fear. Copyright © 2017 Elsevier Ltd. All rights reserved.

Schools and Disasters: Safety and Mental Health Assessment and Interventions for Children.

PubMed

Lai, Betty S; Esnard, Ann-Margaret; Lowe, Sarah R; Peek, Lori

2016-12-01

This article draws on experiences and lessons from global disasters and utilizes the United Nations Comprehensive School Safety Framework to highlight the necessary role of safe schools in protecting children, as well as adult staff, from the immediate threats and long-term implications of disasters. Specifically, we focus on three well-established pillars of school safety: Pillar I: Safe Learning Facilities; Pillar II: Disaster Management; and Pillar III: Risk Reduction and Resilience Education. In addition, we propose a potential fourth pillar, which underscores the function of schools in postdisaster mental health assessment and intervention for children. We argue that schools offer a central location and trusted institutional space for mental health assessment and intervention after disasters. We also examine the important linkages between schools, child mental health, and household and family recovery. We conclude with recommendations for filling gaps in research and practice related to ensuring the safety of schools and the associated health and well-being of children in the face of future disasters.

The spread model of food safety risk under the supply-demand disturbance.

PubMed

Wang, Jining; Chen, Tingqiang

2016-01-01

In this paper, based on the imbalance of the supply-demand relationship of food, we design a spreading model of food safety risk, which is about from food producers to consumers in the food supply chain. We use theoretical analysis and numerical simulation to describe the supply-demand relationship and government supervision behaviors' influence on the risk spread of food safety and the behaviors of the food producers and the food retailers. We also analyze the influence of the awareness of consumer rights protection and the level of legal protection of consumer rights on the risk spread of food safety. This model contributes to the explicit investigation of the influence relationship among supply-demand factors, the regulation behavioral choice of government, the behavioral choice of food supply chain members and food safety risk spread. And this paper provides a new viewpoint for considering food safety risk spread in the food supply chain, which has a great reference for food safety management.

Participation of low-income women in genetic cancer risk assessment and BRCA 1/2 testing: the experience of a safety-net institution.

PubMed

Komenaka, Ian K; Nodora, Jesse N; Madlensky, Lisa; Winton, Lisa M; Heberer, Meredith A; Schwab, Richard B; Weitzel, Jeffrey N; Martinez, Maria Elena

2016-07-01

Some communities and populations lack access to genetic cancer risk assessment (GCRA) and testing. This is particularly evident in safety-net institutions, which serve a large segment of low-income, uninsured individuals. We describe the experience of a safety-net clinic with limited resources in providing GCRA and BRCA1/2 testing. We compared the proportion and characteristics of high-risk women who were offered and underwent GCRA and genetic testing. We also provide a description of the mutation profile for affected women. All 125 patients who were offered GCRA accepted to undergo GCRA. Of these, 72 % had a breast cancer diagnosis, 70 % were Hispanic, 52.8 % were non-English speakers, and 66 % did not have health insurance. Eighty four (67 %) were offered genetic testing and 81 (96 %) agreed. Hispanic women, those with no medical insurance, and those with a family history of breast cancer were significantly more likely to undergo testing (p > 0.01). Twelve of 81 (15 %) patients were found to have deleterious mutations, seven BRCA1, and five BRCA2. Our experience shows that it is possible to offer GCRA and genetic testing even in the setting of limited resources for these services. This is important given that a large majority of the low-income women in our study agreed to undergo counseling and testing. Our experience could serve as a model for similar low-resource safety-net health settings.

Environmental risk assessment in GMO analysis.

PubMed

Pirondini, Andrea; Marmiroli, Nelson

2010-01-01

Genetically modified or engineered organisms (GMOs, GEOs) are utilised in agriculture, expressing traits of interest, such as insect or herbicide resistance. Soybean, maize, cotton and oilseed rape are the GM crops with the largest acreage in the world. The distribution of GM acreage in the different countries is related with the different positions concerning labelling of GMO products: based on the principle of substantial equivalence, or rather based on the precautionary principle. The paper provides an overview on how the risks associated with release of GMO in the environments can be analysed and predicted, in view of a possible coexistence of GM and non-GM organisms in agriculture.Risk assessment procedures, both qualitative and quantitative, are compared in the context of application to GMOs considering also legislation requirements (Directive 2001/18/EC). Criteria and measurable properties to assess harm for human health and environmental safety are listed, and the possible consequences are evaluated in terms of significance.Finally, a mapping of the possible risks deriving from GMO release is reported, focusing on gene transfer to related species, horizontal gene transfer, direct and indirect effects on non target organisms, development of resistance in target organisms, and effects on biodiversity.

Environmental risk assessment in GMO analysis.

PubMed

Pirondini, Andrea; Marmiroli, Nelson

2008-01-01

Genetically modified or engineered organisms (GMOs, GEOs) are utilised in agriculture, expressing traits of interest, such as insect or herbicide resistance. Soybean, maize, cotton and oilseed rape are the GM crops with the largest acreage in the world. The distribution of GM acreage in the different countries is related with the different positions concerning labelling of GMO products: based on the principle of substantial equivalence, or rather based on the precautionary principle. The paper provides an overview on how the risks associated with release of GMO in the environments can be analysed and predicted, in view of a possible coexistence of GM and non-GM organisms in agriculture.Risk assessment procedures, both qualitative and quantitative, are compared in the context of application to GMOs considering also legislation requirements (Directive 2001/18/EC). Criteria and measurable properties to assess harm for human health and environmental safety are listed, and the possible consequences are evaluated in terms of significance.Finally, a mapping of the possible risks deriving from GMO release is reported, focusing on gene transfer to related species, horizontal gene transfer, direct and indirect effects on non target organisms, development of resistance in target organisms, and effects on biodiversity.

Risk Scan: A Review of Risk Assessment Capability and Maturity within the Canadian Safety and Security Program

DTIC Science & Technology

2014-06-01

SCADA / ICS Cyber Test Lab initiated in 2013 Psychosocial – academic research exists,; opportunity for sharing and developing impact assessment...ecosystems and species at risk), accidents / system failure (rail; pipelines ; ferries CSSP strategy for the North Focus on regional l(and local) problem...Guidance; business planning; environmental scan; proposal evaluation; and performance measurement Program Risk Management – Guidelines for project

For Our Own Safety: Examining the Safety of High-Risk Interventions for Children and Young People

ERIC Educational Resources Information Center

Nunno, Michael A., Ed.; Day, David M., Ed.; Bullard, Lloyd B., Ed.

2008-01-01

"For Our Own Safety" is devoted entirely to the subject of, and risks associated with, restraint and seclusion of children. This book is a collection of the diverse viewpoints presented at the international symposium, "Examining the Safety of High-Risk Interventions for Children and Young People" (Ithaca, New York, June 1-4, 2005). It presents…

Development of an algorithm for assessing the risk to food safety posed by a new animal disease.

PubMed

Parker, E M; Jenson, I; Jordan, D; Ward, M P

2012-05-01

An algorithm was developed as a tool to rapidly assess the potential for a new or emerging disease of livestock to adversely affect humans via consumption or handling of meat product, so that the risks and uncertainties can be understood and appropriate risk management and communication implemented. An algorithm describing the sequence of events from occurrence of the disease in livestock, release of the causative agent from an infected animal, contamination of fresh meat and then possible adverse effects in humans following meat handling and consumption was created. A list of questions complements the algorithm to help the assessors address the issues of concern at each step of the decision pathway. The algorithm was refined and validated through consultation with a panel of experts and a review group of animal health and food safety policy advisors via five case studies of potential emerging diseases of cattle. Tasks for model validation included describing the path taken in the algorithm and stating an outcome. Twenty-nine per cent of the 62 experts commented on the model, and one-third of those responding also completed the tasks required for model validation. The feedback from the panel of experts and the review group was used to further develop the tool and remove redundancies and ambiguities. There was agreement in the pathways and assessments for diseases in which the causative agent was well understood (for example, bovine pneumonia due to Mycoplasma bovis). The stated pathways and assessments of other diseases (for example, bovine Johne's disease) were not as consistent. The framework helps to promote objectivity by requiring questions to be answered sequentially and providing the opportunity to record consensus or differences of opinion. Areas for discussion and future investigation are highlighted by the points of diversion on the pathway taken by different assessors. © 2011 Blackwell Verlag GmbH.

NASA Post-Columbia Safety & Mission Assurance, Review and Assessment Initiatives

NASA Astrophysics Data System (ADS)

Newman, J. Steven; Wander, Stephen M.; Vecellio, Don; Miller, Andrew J.

2005-12-01

On February 1, 2003, NASA again experienced a tragic accident as the Space Shuttle Columbia broke apart upon reentry, resulting in the loss of seven astronauts. Several of the findings and observations of the Columbia Accident Investigation Board addressed the need to strengthen the safety and mission assurance function at NASA. This paper highlights key steps undertaken by the NASA Office of Safety and Mission Assurance (OSMA) to establish a stronger and more- robust safety and mission assurance function for NASA programs, projects, facilities and operations. This paper provides an overview of the interlocking OSMA Review and Assessment Division (RAD) institutional and programmatic processes designed to 1) educate, inform, and prepare for audits, 2) verify requirements flow-down, 3) verify process capability, 4) verify compliance with requirements, 5) support risk management decision making, 6) facilitate secure web- based collaboration, and 7) foster continual improvement and the use of lessons learned.

Integrating bioassays and analytical chemistry as an improved approach to support safety assessment of food contact materials.

PubMed

Veyrand, Julien; Marin-Kuan, Maricel; Bezencon, Claudine; Frank, Nancy; Guérin, Violaine; Koster, Sander; Latado, Hélia; Mollergues, Julie; Patin, Amaury; Piguet, Dominique; Serrant, Patrick; Varela, Jesus; Schilter, Benoît

2017-10-01

Food contact materials (FCM) contain chemicals which can migrate into food and result in human exposure. Although it is mandatory to ensure that migration does not endanger human health, there is still no consensus on how to pragmatically assess the safety of FCM since traditional approaches would require extensive toxicological and analytical testing which are expensive and time consuming. Recently, the combination of bioassays, analytical chemistry and risk assessment has been promoted as a new paradigm to identify toxicologically relevant molecules and address safety issues. However, there has been debate on the actual value of bioassays in that framework. In the present work, a FCM anticipated to release the endocrine active chemical 4-nonyphenol (4NP) was used as a model. In a migration study, the leaching of 4NP was confirmed by LC-MS/MS and GC-MS. This was correlated with an increase in both estrogenic and anti-androgenic activities as measured with bioassays. A standard risk assessment indicated that according to the food intake scenario applied, the level of 4NP measured was lower, close or slightly above the acceptable daily intake. Altogether these results show that bioassays could reveal the presence of an endocrine active chemical in a real-case FCM migration study. The levels reported were relevant for safety assessment. In addition, this work also highlighted that bioactivity measured in migrate does not necessarily represent a safety issue. In conclusion, together with analytics, bioassays contribute to identify toxicologically relevant molecules leaching from FCM and enable improved safety assessment.

[Application of three risk assessment models in occupational health risk assessment of dimethylformamide].

PubMed

Wu, Z J; Xu, B; Jiang, H; Zheng, M; Zhang, M; Zhao, W J; Cheng, J

2016-08-20

Objective: To investigate the application of United States Environmental Protection Agency (EPA) inhalation risk assessment model, Singapore semi-quantitative risk assessment model, and occupational hazards risk assessment index method in occupational health risk in enterprises using dimethylformamide (DMF) in a certain area in Jiangsu, China, and to put forward related risk control measures. Methods: The industries involving DMF exposure in Jiangsu province were chosen as the evaluation objects in 2013 and three risk assessment models were used in the evaluation. EPA inhalation risk assessment model: HQ=EC/RfC; Singapore semi-quantitative risk assessment model: Risk= (HR×ER) 1/2 ; Occupational hazards risk assessment index=2 Health effect level ×2 exposure ratio ×Operation condition level. Results: The results of hazard quotient (HQ>1) from EPA inhalation risk assessment model suggested that all the workshops (dry method, wet method and printing) and work positions (pasting, burdening, unreeling, rolling, assisting) were high risk. The results of Singapore semi-quantitative risk assessment model indicated that the workshop risk level of dry method, wet method and printing were 3.5 (high) , 3.5 (high) and 2.8 (general) , and position risk level of pasting, burdening, unreeling, rolling, assisting were 4 (high) , 4 (high) , 2.8 (general) , 2.8 (general) and 2.8 (general) . The results of occupational hazards risk assessment index method demonstrated that the position risk index of pasting, burdening, unreeling, rolling, assisting were 42 (high) , 33 (high) , 23 (middle) , 21 (middle) and 22 (middle) . The results of Singapore semi-quantitative risk assessment model and occupational hazards risk assessment index method were similar, while EPA inhalation risk assessment model indicated all the workshops and positions were high risk. Conclusion: The occupational hazards risk assessment index method fully considers health effects, exposure, and operating conditions

75 FR 45591 - Pipeline Safety: Notice of Technical Pipeline Safety Advisory Committee Meetings

Federal Register 2010, 2011, 2012, 2013, 2014

2010-08-03

... DEPARTMENT OF TRANSPORTATION Pipeline and Hazardous Materials Safety Administration 49 CFR Part... Committee Meetings AGENCY: Pipeline and Hazardous Materials Safety Administration (PHMSA); DOT. ACTION... safety standards, risk assessments, and safety policies for natural gas pipelines and for hazardous...

The School Assessment for Environmental Typology (SAfETy): An Observational Measure of the School Environment.

PubMed

Bradshaw, Catherine P; Milam, Adam J; Furr-Holden, C Debra M; Johnson, Sarah Lindstrom

2015-12-01

School safety is of great concern for prevention researchers, school officials, parents, and students, yet there are a dearth of assessments that have operationalized school safety from an organizational framework using objective tools and measures. Such a tool would be important for deriving unbiased assessments of the school environment, which in turn could be used as an evaluative tool for school violence prevention efforts. The current paper presents a framework for conceptualizing school safety consistent with Crime Prevention through Environmental Design (CPTED) model and social disorganization theory, both of which highlight the importance of context as a driver for adolescents' risk for involvement in substance use and violence. This paper describes the development of a novel observational measure, called the School Assessment for Environmental Typology (SAfETy), which applies CPTED and social disorganizational frameworks to schools to measure eight indicators of school physical and social environment (i.e., disorder, trash, graffiti/vandalism, appearance, illumination, surveillance, ownership, and positive behavioral expectations). Drawing upon data from 58 high schools, we provide preliminary data regarding the validity and reliability of the SAfETy and describe patterns of the school safety indicators. Findings demonstrate the reliability and validity of the SAfETy and are discussed with regard to the prevention of violence in schools.

Safety assessment in primary Mycobacterium tuberculosis smear microscopy centres in Blantyre Malawi: a facility based cross sectional survey.

PubMed

Majamanda, J; Ndhlovu, P; Shawa, I T

2013-12-01

Tuberculosis (TB) is caused by Mycobacterium tuberculosis and is transmitted mainly through aerosolization of infected sputum which puts laboratory workers at risk in spite of the laboratory workers' risk of infection being at 3 to 9 times higher than the general public. Laboratory safety should therefore be prioritized and optimized to provide sufficient safety to laboratory workers. To assess the safety for the laboratory workers in TB primary microscopy centres in Blantyre urban. TB primary microscopy centers in Blantyre urban were assessed in aspects of equipment availability, facility layout, and work practice, using a standardized WHO/AFRO ISO 15189 checklist for the developing countries which sets the minimum safety score at ≥80%. Each center was graded according to the score it earned upon assessment. Only one (1) microscopy center out nine (9) reached the minimum safety requirement. Four (4) centers were awarded 1 star level, four (4) centers were awarded 2 star level and only one (1) center was awarded 3 star level. In Blantyre urban, 89% of the Tuberculosis microscopy centers are failing to provide the minimum safety to the laboratory workers. Government and other stake holders should be committed in addressing the safety challenges of TB microscopy centres in the country to ensure safety for the laboratory workers. It is recommended that the study be conducted at the regional or national level for both public and private laboratories in order to have a general picture of safety in Tb microscopy centres possibly across the country.

[Hazard assessment and occupational safety measures in surgery : Relevant knowledge on occupational medicine].

PubMed

Darius, S; Meyer, F; Böckelmann, I

2016-11-01

Surgeons routinely work in an environment with occupational risks and hazards about which they are often uninformed. Based on the currently available scientific literature this review article describes the various hazards in the operating theater and their effects on personnel, particularly from the surgical perspective. A further aim of this article is to describe the occupational safety measures to reduce the burdens and to maintain the long-term health of personnel. Ultimately, surgeons should be equipped with the necessary knowledge for implementing hazard assessments according to the German Occupational Health and Safety Act. Surgeons are exposed to increased risks and hazards by working in awkward positions with a high risk for musculoskeletal pain and injuries. They are also commonly exposed to inhalational anesthetics, surgical smoke, radiation, noise and infectious agents. Furthermore, the mental and emotional stress associated with these activities is also high. Meaningful occupational safety measures for reduction of burdens are from a technical aspect the installation of effective air extraction systems, measures to reduce exposure to radiation and noise and the use of safer instruments to prevent needle stick injuries. Furthermore, individual occupational safety measures, such as the use of personal protective equipment (e.g. radiation protective clothing and double gloves) must be observed. The consistent implementation and also adherence to these described occupational safety measures and regulations can reduce the burden on operating theater personnel and contribute to maintaining health. Furthermore, periodic preventive healthcare controls and health checks by the company medical officer and individually initiated additional prevention measures can be a sensible augmentation to these safety measures.

Neighborhood disadvantage, neighborhood safety and cardiometabolic risk factors in African Americans: biosocial associations in the Jackson Heart study.

PubMed

Clark, Cheryl R; Ommerborn, Mark J; Hickson, DeMarc A; Grooms, Kya N; Sims, Mario; Taylor, Herman A; Albert, Michelle A

2013-01-01

We examined associations between neighborhood socioeconomic disadvantage, perceived neighborhood safety and cardiometabolic risk factors, adjusting for health behaviors and socioeconomic status (SES) among African Americans. Study participants were non-diabetic African Americans (n = 3,909) in the baseline examination (2000-2004) of the Jackson Heart Study. We measured eight risk factors: the metabolic syndrome, its five components, insulin resistance and cardiovascular inflammation. We assessed neighborhood socioeconomic disadvantage with US Census 2000 data. We assessed perceived neighborhood safety, health behaviors and SES via survey. We used generalized estimating equations to estimate associations with a random intercept model for neighborhood effects. After adjustment for health behaviors and SES, neighborhood socioeconomic disadvantage was associated with the metabolic syndrome in women (PR 1.13, 95% CI 1.01, 1.27). Lack of perceived safety was associated with elevated glucose (OR 1.36, 95% CI 1.03, 1.80) and waist circumference (PR 1.06, 95% CI 1.02, 1.11) among women, and with elevated glucose (PR 1.30, 95% CI 1.02, 1.66) and insulin resistance (PR 1.25, 95% CI 1.08, 1.46) among men. Neighborhood socioeconomic disadvantage and perceived safety should be considered as targets for intervention to reduce cardiometabolic risks among African Americans.

Neighborhood Disadvantage, Neighborhood Safety and Cardiometabolic Risk Factors in African Americans: Biosocial Associations in the Jackson Heart Study

PubMed Central

Clark, Cheryl R.; Ommerborn, Mark J.; Hickson, DeMarc A.; Grooms, Kya N.; Sims, Mario; Taylor, Herman A.; Albert, Michelle A.

2013-01-01

Objective We examined associations between neighborhood socioeconomic disadvantage, perceived neighborhood safety and cardiometabolic risk factors, adjusting for health behaviors and socioeconomic status (SES) among African Americans. Methods Study participants were non-diabetic African Americans (n = 3,909) in the baseline examination (2000–2004) of the Jackson Heart Study. We measured eight risk factors: the metabolic syndrome, its five components, insulin resistance and cardiovascular inflammation. We assessed neighborhood socioeconomic disadvantage with US Census 2000 data. We assessed perceived neighborhood safety, health behaviors and SES via survey. We used generalized estimating equations to estimate associations with a random intercept model for neighborhood effects. Results After adjustment for health behaviors and SES, neighborhood socioeconomic disadvantage was associated with the metabolic syndrome in women (PR 1.13, 95% CI 1.01, 1.27). Lack of perceived safety was associated with elevated glucose (OR 1.36, 95% CI 1.03, 1.80) and waist circumference (PR 1.06, 95% CI 1.02, 1.11) among women, and with elevated glucose (PR 1.30, 95% CI 1.02, 1.66) and insulin resistance (PR 1.25, 95% CI 1.08, 1.46) among men. Conclusions Neighborhood socioeconomic disadvantage and perceived safety should be considered as targets for intervention to reduce cardiometabolic risks among African Americans. PMID:23691005

[Adolescents, risk situations and road safety].

PubMed

Meneses Falcón, Carmen; Gil García, Eugenia; Romo Avilés, Nuria

2010-09-01

Describe the risk behaviour relationships with road safety in adolescents. Cross-sectional descriptive study. Madrid and Andalusia Regions, representative samples. The sample included 3,612 in secondary school pupils from Madrid (n=1708) and Andalusia (n=1904). The survey was carried out during May and June 2007. The data collected included sociodemographic areas (age, sex, grade, father's profession, birth place, etc.) and risk situation and behaviour (risk behaviour as driver or passenger). 16.2% of the adolescents have been involved in a dangerous situation with motorcycles during the last year. 16.7% never use a helmet when riding a motorcycle and 62% do not wear one when riding a bicycle on the road; 17.4% frequently ride a motorcycle over the speed limit and 24.5% when driving a car. There are significant differences regarding sex, grade and region (Madrid or Andalusia). There are four factors which explain 62% of the variance: drug factor, speed factor, security factor and passenger factor. Two of these have twice the probability of having a dangerous situation when riding a motorcycle: drug factor (OR=1.96; 95% CI, 1.77-2.18) and the speed factor ((OR=2.13; 95% CI, 1.92-2.36). Adolescents in higher grades and living in Andalusia were less road safety conscious. This pattern should be taken into account when designing preventive actions in Road Safety Education. 2009 Elsevier España, S.L. All rights reserved.

Clinical Risk Assessment in Intensive Care Unit

PubMed Central

Asefzadeh, Saeed; Yarmohammadian, Mohammad H.; Nikpey, Ahmad; Atighechian, Golrokh

2013-01-01

Background: Clinical risk management focuses on improving the quality and safety of health care services by identifying the circumstances and opportunities that put patients at risk of harm and acting to prevent or control those risks. The goal of this study is to identify and assess the failure modes in the ICU of Qazvin's Social Security Hospital (Razi Hospital) through Failure Mode and Effect Analysis (FMEA). Methods: This was a qualitative-quantitative research by Focus Discussion Group (FDG) performed in Qazvin Province, Iran during 2011. The study population included all individuals and owners who are familiar with the process in ICU. Sampling method was purposeful and the FDG group members were selected by the researcher. The research instrument was standard worksheet that has been used by several researchers. Data was analyzed by FMEA technique. Results: Forty eight clinical errors and failure modes identified, results showed that the highest risk probability number (RPN) was in respiratory care “Ventilator's alarm malfunction (no alarm)” with the score 288, and the lowest was in gastrointestinal “not washing the NG-Tube” with the score 8. Conclusions: Many of the identified errors can be prevented by group members. Clinical risk assessment and management is the key to delivery of effective health care. PMID:23930171

77 FR 65000 - Drug Safety and Risk Management Advisory Committee; Notice of Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2012-10-24

...] Drug Safety and Risk Management Advisory Committee; Notice of Meeting AGENCY: Food and Drug...: Drug Safety and Risk Management Advisory Committee. General Function of the Committee: To provide... Use (ETASU) before CDER's Drug Safety and Risk Management Advisory Committee (DSaRM). The Agency plans...

78 FR 30929 - Drug Safety and Risk Management Advisory Committee; Notice of Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2013-05-23

...] Drug Safety and Risk Management Advisory Committee; Notice of Meeting AGENCY: Food and Drug...: Drug Safety and Risk Management Advisory Committee. General Function of the Committee: To provide... (REMS) with elements to assure safe use (ETASU) before its Drug Safety and Risk Management Advisory...

Bridging the Divide between Safety and Risk Management for your Project or Program

NASA Technical Reports Server (NTRS)

Lutomski, Mike

2005-01-01

This presentation will bridge the divide between these separate but overlapping disciplines and help explain how to use Risk Management as an effective management decision support tool that includes safety. Risk Management is an over arching communication tool used by management to prioritize and effectively mitigate potential problems before they concur. Risk Management encompasses every kind of potential problem that can occur on a program or project. Some of these are safety issues such as hazards that have a specific likelihood and consequence that need to be controlled and included to show an integrated picture of accepted) mitigated, and residual risk. Integrating safety and other assurance disciplines is paramount to accurately representing a program s or projects risk posture. Risk is made up of several components such as technical) cost, schedule, or supportability. Safety should also be a consideration for every risk. The safety component can also have an impact on the technical, cost, and schedule aspect of a given risk. The current formats used for communication of safety and risk issues are not consistent or integrated. The presentation will explore the history of these disciplines, current work to integrate them, and suggestions for integration for the future.

77 FR 45329 - Availability of Microbial Risk Assessment Guideline: Pathogenic Microorganisms With Focus on Food...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-07-31

... DEPARTMENT OF AGRICULTURE Food Safety and Inspection Service [Docket No. FSIS-2012-0023... Dearfield, U.S. Department of Agriculture, Food Safety and Inspection Service, 1400 Independence Ave. SW... Academics of Science, helped unify the risk assessment process for chemicals in foods and the environment...

Operational risk assessment.

PubMed

McKim, Vicky L

2017-06-01

In the world of risk management, which encompasses the business continuity disciplines, many types of risk require evaluation. Financial risk is most often the primary focus, followed by product and market risks. Another critical area, which typically lacks a thorough review or may be overlooked, is operational risk. This category encompasses many risk exposure types including those around building structures and systems, environmental issues, nature, neighbours, clients, regulatory compliance, network, data security and so on. At times, insurance carriers will assess internal hazards, but seldom do these assessments include more than a cursory look at other types of operational risk. In heavily regulated environments, risk assessments are required but may not always include thorough assessments of operational exposures. Vulnerabilities may linger or go unnoticed, only to become the catalyst for a business disruption at a later time, some of which are so severe that business recovery becomes nearly impossible. Businesses may suffer loss of clients as the result of a prolonged disruption of services. Comprehensive operational risk assessments can assist in identifying such vulnerabilities, exposures and threats so that the risk can be minimised or removed. This paper lays out how an assessment of this type can be successfully conducted.

Overview of DOE-NE Proliferation and Terrorism Risk Assessment

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

Sadasivan, Pratap

2012-08-24

Research objectives are: (1) Develop technologies and other solutions that can improve the reliability, sustain the safety, and extend the life of current reactors; (2) Develop improvements in the affordability of new reactors to enable nuclear energy; (3) Develop Sustainable Nuclear Fuel Cycles; and (4) Understand and minimize the risks of nuclear proliferation and terrorism. The goal is to enable the use of risk information to inform NE R&D program planning. The PTRA program supports DOE-NE's goal of using risk information to inform R&D program planning. The FY12 PTRA program is focused on terrorism risk. The program includes a mixmore » of innovative methods that support the general practice of risk assessments, and selected applications.« less

77 FR 75176 - Drug Safety and Risk Management Advisory Committee; Notice of Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2012-12-19

...] Drug Safety and Risk Management Advisory Committee; Notice of Meeting AGENCY: Food and Drug... being rescheduled due to the postponement of the October 29-30, 2012, Drug Safety and Risk Management... Committee: Drug Safety and Risk Management Advisory Committee. General Function of the Committee: To provide...

[Contaminants from food packaging : New developments in risk assessment].

PubMed

Pfaff, Karla; Wölfle, Detlef; Luch, Andreas

2017-07-01

Diverse materials intended for contact with food are important sources of food contamination. Harmonised European regulations including whitelists (so-called "positive lists") of substances along with migration limits and restrictions exist for plastics and regenerated cellulose films only. The European Food Safety Authority (EFSA) is responsible for the risk assessment of substances prior to their authorization and inclusion into the positive lists. In 2016 the EFSA issued an opinion on recent developments in the risk assessment of substances migrating into food for public consideration. Also migration related to non-intentionally added substances (NIASs), e. g. impurities, degradations products or oligomers, may be relevant for risk assessment. For substances migrating in quantities up to 50 ppb the requested data are restricted to genotoxicity testing based on a tiered approach for toxicological data requirements. In the case of higher migration levels (>50 ppb) experimental animal studies are also requested. Along with an evaluation of the available information, toxicological data on structurally similar substances may be used for the assessment if sufficiently justified with the aim to reduce animal studies as far as possible. For the risk assessment of NIASs it is possible to apply in silico methods in the absence of experimental toxicological data. Additionally, new technologies such as the use of nanomaterials, active and intelligent packaging and recycled plastics are challenging tasks in EFSA's risk assessment in accordance with the regulations by the European Commission.

Aviation Safety Risk Modeling: Lessons Learned From Multiple Knowledge Elicitation Sessions

NASA Technical Reports Server (NTRS)

Luxhoj, J. T.; Ancel, E.; Green, L. L.; Shih, A. T.; Jones, S. M.; Reveley, M. S.

2014-01-01

Aviation safety risk modeling has elements of both art and science. In a complex domain, such as the National Airspace System (NAS), it is essential that knowledge elicitation (KE) sessions with domain experts be performed to facilitate the making of plausible inferences about the possible impacts of future technologies and procedures. This study discusses lessons learned throughout the multiple KE sessions held with domain experts to construct probabilistic safety risk models for a Loss of Control Accident Framework (LOCAF), FLightdeck Automation Problems (FLAP), and Runway Incursion (RI) mishap scenarios. The intent of these safety risk models is to support a portfolio analysis of NASA's Aviation Safety Program (AvSP). These models use the flexible, probabilistic approach of Bayesian Belief Networks (BBNs) and influence diagrams to model the complex interactions of aviation system risk factors. Each KE session had a different set of experts with diverse expertise, such as pilot, air traffic controller, certification, and/or human factors knowledge that was elicited to construct a composite, systems-level risk model. There were numerous "lessons learned" from these KE sessions that deal with behavioral aggregation, conditional probability modeling, object-oriented construction, interpretation of the safety risk results, and model verification/validation that are presented in this paper.

Assessment of methods used to determine the safety of the topical insect repellent N,N-diethyl-m-toluamide (DEET).