There is an increasing dissatisfaction about how risk is regulated, leading to vivid debates about the use of 'risk assessment' and 'precaution'. As a result, academics, government officials and industry leaders are calling for new approaches and fresh ideas. This book provides a historical and topical perspective on the alternative concept of 'Tolerability of Risk' and its concrete regulatory applications. In the UK, Tolerability of Risk has been developed into a sophisticated framework, particularly within the health and safety sectors. It is expected to guide decision-makers when applying their legal obligation of keeping risks as low as practically reasonable. Could Tolerability of Risk become a wider source of inspiration across the full scope of risk analysis and management? Written by leading academics and risk practitioners from industry and government, The Tolerability of Risk presents a summary of theoretical perspectives on risk approaches, providing a detailed elicitation of the methods and approaches used to build the Tolerability of Risk framework and examining the prospect of universal application of that framework. From nuclear power to environmental pollution, climate change and drug testing, the Tolerability of Risk framework may offer a workable, pragmatic solution for balancing risks against the costs involved in controlling them, as well as developing the institutional capacity to make effective decisions in all jurisdictions worldwide.

This document replaces the statement and proposals made in the discussion document Tolerability of Risk form Nuclear Power Stations published in 1988. It represents a revision of the earlier document in the light of comments received and of the discussion on the document during the Hinkley Point Inquiry and in the Inquiry report.

A framework for making decisions about risks, with recommendations for research, public policy, and practice.

Introduces risk assessment with key theories, proven methods, and state-of-the-art applications Risk Assessment: Theory, Methods, and Applications remains one of the few textbooks to address current risk analysis and risk assessment with an emphasis on the possibility of sudden, major accidents across various areas of practice—from machinery and manufacturing processes to nuclear power plants and transportation systems. Updated to align with ISO 31000 and other amended standards, this all-new 2nd Edition discusses the main ideas and techniques for assessing risk today. The book begins with an introduction of risk analysis, assessment, and management, and includes a new section on the history of risk analysis. It covers hazards and threats, how to measure and evaluate risk, and risk management. It also adds new sections on risk governance and risk-informed decision making; combining accident theories and criteria for evaluating data sources; and subjective probabilities. The risk assessment process is covered, as are how to establish context; planning and preparing; and identification, analysis, and evaluation of risk. Risk Assessment also offers new coverage of safe job analysis and semi-quantitative methods, and it discusses barrier management and HRA methods for offshore application. Finally, it looks at dynamic risk analysis, security and life-cycle use of risk. Serves as a practical and modern guide to the current applications of risk analysis and assessment, supports key standards, and supplements legislation related to risk analysis Updated and revised to align with ISO 31000 Risk Management and other new standards and includes new chapters on security, dynamic risk analysis, as well as life-cycle use of risk analysis Provides in-depth coverage on hazard identification, methodologically outlining the steps for use of checklists, conducting preliminary hazard analysis, and job safety analysis Presents new coverage on the history of risk analysis, criteria for evaluating data sources, risk-informed decision making, subjective probabilities, semi-quantitative methods, and barrier management Contains more applications and examples, new and revised problems throughout, and detailed appendices that outline key terms and acronyms Supplemented with a book companion website containing Solutions to problems, presentation material and an Instructor Manual Risk Assessment: Theory, Methods, and Applications, Second Edition is ideal for courses on risk analysis/risk assessment and systems engineering at the upper-undergraduate and graduate levels. It is also an excellent reference and resource for engineers, researchers, consultants, and practitioners who carry out risk assessment techniques in their everyday work.

The establishment of the International Risk Governance Council (IRGC) was the direct result of widespread concern that the complexity and interdependence of health, environmental, and technological risks facing the world was making the development and implementation of adequate risk governance strategies ever more difficult. This volume details the IRGC developed and proposed framework for risk governance and covers how it was peer reviewed as well as tested

Randomized clinical trials are the primary tool for evaluating new medical interventions. Randomization provides for a fair comparison between treatment and control groups, balancing out, on average, distributions of known and unknown factors among the participants. Unfortunately, these studies often lack a substantial percentage of data. This missing data reduces the benefit provided by the randomization and introduces potential biases in the comparison of the treatment groups. Missing data can arise for a variety of reasons, including the inability or unwillingness of participants to meet appointments for evaluation. And in some studies, some or all of data collection ceases when participants discontinue study treatment. Existing guidelines for the design and conduct of clinical trials, and the analysis of the resulting data, provide only limited advice on how to handle missing data. Thus, approaches to the analysis of data with an appreciable amount of missing values tend to be ad hoc and variable. The Prevention and Treatment of Missing Data in Clinical Trials concludes that a more principled approach to design and analysis in the presence of missing data is both needed and possible. Such an approach needs to focus on two critical elements: (1) careful design and conduct to limit the amount and impact of missing data and (2) analysis that makes full use of information on all randomized participants and is based on careful attention to the assumptions about the nature of the missing data underlying estimates of treatment effects. In addition to the highest priority recommendations, the book offers more detailed recommendations on the conduct of clinical trials and techniques for analysis of trial data.

Reliability, Maintainability and Risk: Practical Methods for Engineers, Eighth Edition, discusses tools and techniques for reliable and safe engineering, and for optimizing maintenance strategies. It emphasizes the importance of using reliability techniques to identify and eliminate potential failures early in the design cycle. The focus is on techniques known as RAMS (reliability, availability, maintainability, and safety-integrity). The book is organized into five parts. Part 1 on reliability parameters and costs traces the history of reliability and safety technology and presents a cost-effective approach to quality, reliability, and safety. Part 2 deals with the interpretation of failure rates, while Part 3 focuses on the prediction of reliability and risk. Part 4 discusses design and assurance techniques; review and testing techniques; reliability growth modeling; field data collection and feedback; predicting and demonstrating repair times; quantified reliability maintenance; and systematic failures. Part 5 deals with legal, management and safety issues, such as project management, product liability, and safety legislation. - 8th edition of this core reference for engineers who deal with the design or operation of any safety critical systems, processes or operations - Answers the question: how can a defect that costs less than $1000 dollars to identify at the process design stage be prevented from escalating to a $100,000 field defect, or a $1m+ catastrophe - Revised throughout, with new examples, and standards, including must have material on the new edition of global functional safety standard IEC 61508, which launches in 2010

This is the first book to introduce the full spectrum of security and risks and their management. Author and field expert Bruce Newsome helps readers learn how to understand, analyze, assess, control, and generally manage security and risks from the personal to the operational. They will develop the practical knowledge and skills they need, including analytical skills, basic mathematical methods for calculating risk in different ways, and more artistic skills in making judgments and decisions about which risks to control and how to control them. Organized into 16 brief chapters, the book shows readers how to: analyze security and risk; identify the sources of risk (including hazards, threats, and contributors); analyze exposure and vulnerability; assess uncertainty and probability; develop an organization’s culture, structure, and processes congruent with better security and risk management; choose different strategies for managing risks; communicate and review; and manage security in the key domains of operations, logistics, physical sites, information, communications, cyberspace, transport, and personal levels.

Risk is a popular topic in many sciences - in natural, medical, statistical, engineering, social, economic and legal disciplines. Yet, no single discipline can grasp the full meaning of risk. Investigating risk requires a multidisciplinary approach. The authors, coming from two very different disciplinary traditions, meet this challenge by building bridges between the engineering, the statistical and the social science perspectives. The book provides a comprehensive, accessible and concise guide to risk assessment, management and governance. A basic pillar for the book is the risk governance framework proposed by the International Risk Governance Council (IRGC). This framework offers a comprehensive means of integrating risk identification, assessment, management and communication. The authors develop and explain new insights and add substance to the various elements of the framework. The theoretical analysis is illustrated by several examples from different areas of applications.

Examining the implications and practical implementation of multi-disciplinary International Conference on Harmonization (ICH) topics, this book gives an integrated view of how the guidelines inform drug development strategic planning and decision-making. • Addresses a consistent need for interpretation, training, and implementation examples of ICH guidelines via case studies • Offers a primary reference point for practitioners addressing the dual challenge of interpretation and practical implementation of ICH guidelines • Uses case studies to help readers understand and apply ICH guidelines • Provides valuable insights into guidelines development, with chapters by authors involved in generating or with experience implementing the guidelines • Includes coverage of stability testing, analytical method validation, impurities, biotechnology drugs and products, and good manufacturing practice (GMP)