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.

Risk Analysis Foundations, Models, and Methods

Risk Analysis Foundations, Models, and Methods PDF Author: Louis Anthony Cox Jr.
Publisher: Springer Science & Business Media
ISBN: 1461508479
Category : Business & Economics
Languages : en
Pages : 564

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Book Description
Risk Analysis: Foundations, Models, and Methods fully addresses the questions of "What is health risk analysis?" and "How can its potentialities be developed to be most valuable to public health decision-makers and other health risk managers?" Risk analysis provides methods and principles for answering these questions. It is divided into methods for assessing, communicating, and managing health risks. Risk assessment quantitatively estimates the health risks to individuals and to groups from hazardous exposures and from the decisions or activities that create them. It applies specialized models and methods to quantify likely exposures and their resulting health risks. Its goal is to produce information to improve decisions. It does this by relating alternative decisions to their probable consequences and by identifying those decisions that make preferred outcomes more likely. Health risk assessment draws on explicit engineering, biomathematical, and statistical consequence models to describe or simulate the causal relations between actions and their probable effects on health. Risk communication characterizes and presents information about health risks and uncertainties to decision-makers and stakeholders. Risk management applies principles for choosing among alternative decision alternatives or actions that affect exposure, health risks, or their consequences.

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.

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
A graduate level textbook on probabilistic risk analysis, aimed at statisticians, operations researchers and engineers.

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 : 316

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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.

Quality and Risk Management in the IVF Laboratory

Quality and Risk Management in the IVF Laboratory PDF Author: Sharon T. Mortimer
Publisher: Cambridge University Press
ISBN: 1107421284
Category : Medical
Languages : en
Pages : 241

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Book Description
Updated edition of this bestselling book, now extended to include quality and risk management in the ART clinic.

Fundamentals of Quality Control and Improvement 2e

Fundamentals of Quality Control and Improvement 2e PDF Author: Amitava Mitra
Publisher: Custom Pub
ISBN: 9780759351721
Category : Business & Economics
Languages : en
Pages : 682

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Book Description
This book covers the foundations of modern methods of quality control and improvement that are used in the manufacturing and service industries. Quality is key to surviving tough competition. Consequently, business needs technically competent people who are well-versed in statistical quality control and improvement. This book should serve the needs of students in business and management and students in engineering, technology, and other related disciplines. Professionals will find this book to be a valuable reference in the field.