Foundations of Quality Risk Management

Foundations of Quality Risk Management PDF Author: Jayet Moon
Publisher: Quality Press
ISBN: 195105833X
Category : Business & Economics
Languages : en
Pages : 340

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Book Description
In today's uncertain times, risk has become the biggest part of management. Risk management is central to the science of prediction and decision-making; holistic and scientific risk management creates resilient organizations, which survive and thrive by being adaptable. This book is the perfect guide for anyone interested in understanding and excelling at risk management. It begins with a focus on the foundational elements of risk management, with a thorough explanation of the basic concepts, many illustrated by real-life examples. Next, the book focuses on equipping the reader with a working knowledge of the subject from an organizational process and systems perspective. Every concept in almost every chapter is calibrated to not only ISO 9001 and ISO 31000, but several other international standards. In addition, this book presents several tools and methods for discussion. Ranging from industry standard to cutting edge, each receives a thorough analysis and description of its role in the risk management process. Finally, you'll find a detailed and practical discussion of contemporary topics in risk management, such as supply chain risk management, risk-based auditing, risk in 4.0 (digital transformation), benefit-risk analyses, risk-based design thinking, and pandemic/epidemic risk management. Jayet Moon is a Senior ASQ member and holds ASQ CQE, CSQP, and CQIA certifications. He is also a chartered quality professional in the U.K. (CQP-MCQI). He earned a master's degree in biomedical engineering from Drexel University in Philadelphia and is a Project Management Institute (PMI) Certified Risk Management Professional (PMI-RMP). He is a doctoral candidate in Systems and Engineering Management at Texas Tech University

Foundations of Quality Risk Management

Foundations of Quality Risk Management PDF Author: Jayet Moon
Publisher: Quality Press
ISBN: 195105833X
Category : Business & Economics
Languages : en
Pages : 340

Get Book Here

Book Description
In today's uncertain times, risk has become the biggest part of management. Risk management is central to the science of prediction and decision-making; holistic and scientific risk management creates resilient organizations, which survive and thrive by being adaptable. This book is the perfect guide for anyone interested in understanding and excelling at risk management. It begins with a focus on the foundational elements of risk management, with a thorough explanation of the basic concepts, many illustrated by real-life examples. Next, the book focuses on equipping the reader with a working knowledge of the subject from an organizational process and systems perspective. Every concept in almost every chapter is calibrated to not only ISO 9001 and ISO 31000, but several other international standards. In addition, this book presents several tools and methods for discussion. Ranging from industry standard to cutting edge, each receives a thorough analysis and description of its role in the risk management process. Finally, you'll find a detailed and practical discussion of contemporary topics in risk management, such as supply chain risk management, risk-based auditing, risk in 4.0 (digital transformation), benefit-risk analyses, risk-based design thinking, and pandemic/epidemic risk management. Jayet Moon is a Senior ASQ member and holds ASQ CQE, CSQP, and CQIA certifications. He is also a chartered quality professional in the U.K. (CQP-MCQI). He earned a master's degree in biomedical engineering from Drexel University in Philadelphia and is a Project Management Institute (PMI) Certified Risk Management Professional (PMI-RMP). He is a doctoral candidate in Systems and Engineering Management at Texas Tech University

Quality Risk Management in the FDA-Regulated Industry

Quality Risk Management in the FDA-Regulated Industry PDF Author: José Rodríguez Pérez
Publisher: Quality Press
ISBN: 0873898346
Category : Business & Economics
Languages : en
Pages : 289

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Book Description
Risk management principles are effectively utilized in many areas of business and government, including finance, insurance, occupational safety, and public health, and by agencies regulating these industries. The U.S. Food and Drug Administration (FDA) and its worldwide counterparts are responsible for protecting public health by ensuring the safety and effectiveness of the drugs and medical devices. Regulators must decide whether the benefits of a specific product for patients and users outweigh its risk, while recognizing that “absolute safety” (or zero risk) is not achievable. Every product and every process has an associated risk. Although there are some examples of the use of quality risk management in the FDA-regulated industry today, they are limited and do not represent the full contribution that risk management has to offer. The present FDA focus on risk-based determination is requiring that the regulated industries improve dramatically their understanding and capability of hazard control concepts. In addition, the importance of quality systems has been recognized in the life sciences industry, and it is becoming evident that quality risk management is a valuable component of an effective quality system. The purpose of this book is to offer a systematic and very comprehensive approach to quality risk management. It will assist medical and food product manufacturers with the integration of a risk management system or risk management principles and activities into their existing quality management system by providing practical explanations and examples. The appropriate use of quality risk management can facilitate compliance with regulatory requirements such as good manufacturing practices or good laboratory practices. The content of this book will provide FDA-regulated manufacturers with a framework within which experience, insight, and judgment are applied systematically to manage the risks associated with their products. Manufacturers in other industries may use it as an informative guidance in developing and maintaining a risk management system and process. The two appendices add even more insight: Appendix A contains general examples of risk management, while Appendix B includes 10 case studies illustrating real examples of the quality risk management process across the medical product arena.

Foundations of Risk Analysis

Foundations of Risk Analysis PDF Author: Terje Aven
Publisher: John Wiley & Sons
ISBN: 0470871237
Category : Mathematics
Languages : en
Pages : 208

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Book Description
Everyday we face decisions that carry an element of risk and uncertainty. The ability to analyse, communicate and control the level of risk entailed by these decisions remains one of the most pressing challenges to the analyst, scientist and manager. This book presents the foundational issues in risk analysis ? expressing risk, understanding what risk means, building risk models, addressing uncertainty, and applying probability models to real problems. The principal aim of the book is to give the reader the knowledge and basic thinking they require to approach risk and uncertainty to support decision making. Presents a statistical framework for dealing with risk and uncertainty. Includes detailed coverage of building and applying risk models and methods. Offers new perspectives on risk, risk assessment and the use of parametric probability models. Highlights a number of applications from business and industry. Adopts a conceptual approach based on elementary probability calculus and statistical theory. Foundations of Risk Analysis provides a framework for understanding, conducting and using risk analysis suitable for advanced undergraduates, graduates, analysts and researchers from statistics, engineering, finance, medicine and the physical sciences, as well as for managers facing decision making problems involving risk and uncertainty.

Probabilistic Risk Analysis

Probabilistic Risk Analysis PDF Author: Tim Bedford
Publisher: Cambridge University Press
ISBN: 9780521773201
Category : Mathematics
Languages : en
Pages : 228

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Book Description
Probabilistic risk analysis aims to quantify the risk caused by high technology installations. Increasingly, such analyses are being applied to a wider class of systems in which problems such as lack of data, complexity of the systems, uncertainty about consequences, make a classical statistical analysis difficult or impossible. The authors discuss the fundamental notion of uncertainty, its relationship with probability, and the limits to the quantification of uncertainty. Drawing on extensive experience in the theory and applications of risk analysis, the authors focus on the conceptual and mathematical foundations underlying the quantification, interpretation and management of risk. They cover standard topics as well as important new subjects such as the use of expert judgement and uncertainty propagation. The relationship of risk analysis with decision making is highlighted in chapters on influence diagrams and decision theory. Finally, the difficulties of choosing metrics to quantify risk, and current regulatory frameworks are discussed.

Foundations of Banking Risk

Foundations of Banking Risk PDF Author: GARP (Global Association of Risk Professionals)
Publisher: John Wiley & Sons
ISBN: 0470555696
Category : Business & Economics
Languages : en
Pages : 267

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Book Description
GARP's Foundations of Banking Risk and Regulation introduces risk professionals to the advanced components and terminology in banking risk and regulation globally. It helps them develop an understanding of the methods for the measurement and management of credit risk and operational risk, and the regulation of minimum capital requirements. It educates them about banking regulation and disclosure of market information. The book is GARP's required text used by risk professionals looking to obtain their International Certification in Banking Risk and Regulation.

The Science of Risk Analysis

The Science of Risk Analysis PDF Author: Terje Aven
Publisher: Routledge
ISBN: 0429642725
Category : Business & Economics
Languages : en
Pages : 331

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Book Description
This book provides a comprehensive demonstration of risk analysis as a distinct science covering risk understanding, assessment, perception, communication, management, governance and policy. It presents and discusses the key pillars of this science, and provides guidance on how to conduct high-quality risk analysis. The Science of Risk Analysis seeks to strengthen risk analysis as a field and science by summarizing and extending current work on the topic. It presents the foundation for a distinct risk field and science based on recent research, and explains the difference between applied risk analysis (to provide risk knowledge and tackle risk problems in relation to for example medicine, engineering, business or climate change) and generic risk analysis (on concepts, theories, frameworks, approaches, principles, methods and models to understand, assess, characterise, communicate, manage and govern risk). The book clarifies and describes key risk science concepts, and builds on recent foundational work conducted by the Society for Risk Analysis in order to provide new perspectives on science and risk analysis. The topics covered are accompanied by cases and examples relating to current issues throughout. This book is essential reading for risk analysis professionals, scientists, students and practitioners, and will also be of interest to scientists and practitioners from other fields who apply risk analysis in their work.

Risk Management in Student Affairs

Risk Management in Student Affairs PDF Author: Thomas E. Miller
Publisher: John Wiley & Sons
ISBN: 1118100913
Category : Education
Languages : en
Pages : 260

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Book Description
A comprehensive, accessible guide to the policies and practices of risk management in higher education Student affairs staff at all types of colleges and universities need to be equipped to help manage risk and protect their institutions, the people they serve, and their resources from unintended consequences. Risk Management in Student Affairs: Foundations for Safety and Success helps practitioners understand the sources of risk in their work, and the practices and strategies they can employ to help mitigate that risk. Written for those without legal training, the book is accessible to new and mid-level professionals as well as students preparing to enter the profession. It teaches how to limit, control, and respond to risk in order to protect oneself and one's institution. The book covers all aspects of risk management in higher education, including: Tort liability (such as damage due to negligence, accidents on campus, injuries resulting from alcohol use, and incidents during study-abroad trips) Contracts (such as off-campus incidents, contracts for events and activities, and employment and disciplinary issues) State and federal violations (including the freedoms of speech, religion, and the press, search and seizure, due process, OSHA, Title IX, FERPA, and ADA) Resource protection (including information and data security, facilities, financial resources, and physical environments) Managing risk is an integral part of the work of student affairs, and the ability to manage risk well can save time, money, and personnel at a time when resources can be scarce. Whether you work in a public or private institution, and whether you manage personal or institutional risk, no other book addresses risk management within higher education in such a focused, comprehensive manner.

Fundamentals of Risk Management

Fundamentals of Risk Management PDF Author: Paul Hopkin
Publisher: Kogan Page Publishers
ISBN: 0749479620
Category : Business & Economics
Languages : en
Pages : 488

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Book Description
Fundamentals of Risk Management, now in its fourth edition, is a comprehensive introduction to commercial and business risk for students and a broad range of risk professionals. Providing extensive coverage of the core frameworks of business continuity planning, enterprise risk management and project risk management, this is the definitive guide to dealing with the different types of risk an organization faces. With relevant international case examples from both the private and public sectors, this revised edition of Fundamentals of Risk Management is completely aligned to ISO 31000 and provides a full analysis of changes in contemporary risk areas including supply chain, cyber risk, risk culture and improvements in risk management documentation and statutory risk reporting. This new edition of Fundamentals of Risk Management has been fully updated to reflect the development of risk management standards and practice, in particular business continuity standards, regulatory developments, risks to reputation and the business model, changes in enterprise risk management (ERM), loss control and the value of insurance as a risk management method. Also including a thorough overview of the international risk management standards and frameworks, strategy and policy, this book is the definitive professional text for risk managers.

Improving Risk Analysis

Improving Risk Analysis PDF Author: Louis Anthony Cox Jr.
Publisher: Springer Science & Business Media
ISBN: 1461460581
Category : Business & Economics
Languages : en
Pages : 403

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Book Description
Improving Risk Analysis shows how to better assess and manage uncertain risks when the consequences of alternative actions are in doubt. The constructive methods of causal analysis and risk modeling presented in this monograph will enable to better understand uncertain risks and decide how to manage them. The book is divided into three parts. Parts 1 shows how high-quality risk analysis can improve the clarity and effectiveness of individual, community, and enterprise decisions when the consequences of different choices are uncertain. Part 2 discusses social decisions. Part 3 illustrates these methods and models, showing how to apply them to health effects of particulate air pollution. "Tony Cox’s new book addresses what risk analysts and policy makers most need to know: How to find out what causes what, and how to quantify the practical differences that changes in risk management practices would make. The constructive methods in Improving Risk Analysis will be invaluable in helping practitioners to deliver more useful insights to inform high-stakes decisions and policy,in areas ranging from disaster planning to counter-terrorism investments to enterprise risk management to air pollution abatement policies. Better risk management is possible and practicable; Improving Risk Analysis explains how." Elisabeth Pate-Cornell, Stanford University "Improving Risk Analysis offers crucial advice for moving policy-relevant risk analyses towards more defensible, causally-based methods. Tony Cox draws on his extensive experience to offer sound advice and insights that will be invaluable to both policy makers and analysts in strengthening the foundations for important risk analyses. This much-needed book should be required reading for policy makers and policy analysts confronting uncertain risks and seeking more trustworthy risk analyses." Seth Guikema, Johns Hopkins University "Tony Cox has been a trail blazer in quantitative risk analysis, and his new book gives readers the knowledge and tools needed to cut through the complexity and advocacy inherent in risk analysis. Cox’s careful exposition is detailed and thorough, yet accessible to non-technical readers interested in understanding uncertain risks and the outcomes associated with different mitigation actions. Improving Risk Analysis should be required reading for public officials responsible for making policy decisions about how best to protect public health and safety in an uncertain world." Susan E. Dudley, George Washington University

Risk Management and Regulation

Risk Management and Regulation PDF Author: Tobias Adrian
Publisher: International Monetary Fund
ISBN: 1484343913
Category : Business & Economics
Languages : en
Pages : 53

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Book Description
The evolution of risk management has resulted from the interplay of financial crises, risk management practices, and regulatory actions. In the 1970s, research lay the intellectual foundations for the risk management practices that were systematically implemented in the 1980s as bond trading revolutionized Wall Street. Quants developed dynamic hedging, Value-at-Risk, and credit risk models based on the insights of financial economics. In parallel, the Basel I framework created a level playing field among banks across countries. Following the 1987 stock market crash, the near failure of Salomon Brothers, and the failure of Drexel Burnham Lambert, in 1996 the Basel Committee on Banking Supervision published the Market Risk Amendment to the Basel I Capital Accord; the amendment went into effect in 1998. It led to a migration of bank risk management practices toward market risk regulations. The framework was further developed in the Basel II Accord, which, however, from the very beginning, was labeled as being procyclical due to the reliance of capital requirements on contemporaneous volatility estimates. Indeed, the failure to measure and manage risk adequately can be viewed as a key contributor to the 2008 global financial crisis. Subsequent innovations in risk management practices have been dominated by regulatory innovations, including capital and liquidity stress testing, macroprudential surcharges, resolution regimes, and countercyclical capital requirements.