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Risk And Quality Management System
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Book Synopsis Quality Risk Management in the FDA-Regulated Industry by : José Rodríguez Pérez
Download or read book Quality Risk Management in the FDA-Regulated Industry written by José Rodríguez Pérez and published by Quality Press. This book was released on 2012-06-12 with total page 289 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Book Synopsis Object-oriented Quality and Risk Management (OQRM). A practical and generic method to manage quality and risk. by : P.W.M. van Nederpelt
Download or read book Object-oriented Quality and Risk Management (OQRM). A practical and generic method to manage quality and risk. written by P.W.M. van Nederpelt and published by Lulu.com. This book was released on 2012-10-01 with total page 101 pages. Available in PDF, EPUB and Kindle. Book excerpt: Management aims to control quality and risks, but it often does not know where to start. Preferably, it should not be too complex, nor should it take up too much time, but it must make sense. Moreover, management would like to start small and possibly build on it further, at a later time. The Object-oriented Quality and Risk Management (OQRM) model described in this book seeks to address this need. The purpose of the book is to enable managers to apply this model in their organizations. The OQRM model is generic in the way it is set up and it may be applied in any organization, at any level and on any scale. The model will help to systematically adopt the right measures. It integrates quality and risk management and furthermore, it meets the need for customization.
Book Synopsis Quality Risk Management in the FDA-Regulated Industry by : José Rodríguez-Pérez
Download or read book Quality Risk Management in the FDA-Regulated Industry written by José Rodríguez-Pérez and published by Quality Press. This book was released on 2017-02-21 with total page 252 pages. Available in PDF, EPUB and Kindle. Book excerpt: The purpose of this new edition is to offer an updated view of the risk management field as it applies to medical products. Since the publication of the first edition (2012), the emphasis on risk-based processes has growth exponentially across all sectors, and risk management is now considered as significant as quality management. ISO 9001 was revised and now requires that top management promote the use of risk-based thinking. ISO 13485:2016, which specifies the requirements for a quality management system specific to the medical devices industry, also now shows a greater emphasis on risk management and risk-based decision making. In addition, the FDA Food Safety Modernization Act (FSMA) is the most important reform of U.S. food safety laws in more than 70 years. This indispensable book presents a systematic and 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 practice or good laboratory practice. All chapters have been updated and revised, and a new chapter has been added to discuss some of the most common pitfalls and misunderstandings regarding risk management, specifically those related to the use of FMEA as the only element of risk management programs. One of the appendices includes 12 case studies, and the companion CD-ROM contains dozens of U.S. FDA and European guidance documents as well as international harmonization documents (ICH and GHTF-IMDRF) related to risk management activities, as well as a 30-question exam (with answers) on the material discussed in the book.
Book Synopsis Foundations of Quality Risk Management by : Jayet Moon
Download or read book Foundations of Quality Risk Management written by Jayet Moon and published by Quality Press. This book was released on 2022-10-22 with total page 340 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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
Book Synopsis Quality and Risk Management in the IVF Laboratory by : Sharon T. Mortimer
Download or read book Quality and Risk Management in the IVF Laboratory written by Sharon T. Mortimer and published by Cambridge University Press. This book was released on 2015-03-02 with total page 241 pages. Available in PDF, EPUB and Kindle. Book excerpt: Updated edition of this bestselling book, now extended to include quality and risk management in the ART clinic.
Book Synopsis Practical Engineering, Process, and Reliability Statistics by : Mark Allen Durivage
Download or read book Practical Engineering, Process, and Reliability Statistics written by Mark Allen Durivage and published by Quality Press. This book was released on 2022-03-31 with total page 313 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book is a convenient and comprehensive guide to statistics. A resource for quality technicians and engineers in any industry, this second edition provides even more equations and examples for the reader—with a continued focus on algebra-based math. Those preparing for ASQ certification examinations, such as the Certified Quality Technician (CQT), Certified Six Sigma Green Belt (CSSGB), Certified Quality Engineer (CQE), Certified Six Sigma Black Belt (CSSBB), Certified Reliability Engineer (CRE), and Certified Supplier Quality Professional (CSQP), will find this book helpful as well. Inside you’ll find: • Complete calculations for determining confidence intervals, tolerances, sample size, outliers, process capability, and system reliability • Newly added equations for hypothesis tests (such as the Kruskal-Wallis test and Levene’s test for equality of variances), the Taguchi method, and Weibull and log-normal distributions • Hundreds of completed examples to demonstrate practical use of each equation • 20+ appendices, including distribution tables, critical values tables, control charts, sampling plans, and a beta table
Book Synopsis Achieving Customer Experience Excellence through a Quality Management System by : Alka Jarvis
Download or read book Achieving Customer Experience Excellence through a Quality Management System written by Alka Jarvis and published by Quality Press. This book was released on 2016-07-08 with total page 245 pages. Available in PDF, EPUB and Kindle. Book excerpt: We are in what many call The Age of the Customer. Customers are empowered more than ever before and demand a high level of customer attention and service. Their increasing expectations and demands worldwide have forced organizations to transform themselves and prepare for the customer experience (CX) battlefield. This landmark book addresses: What customer experience really means Why it matters Whether it has any substantial business impact What your organization can do to deliver and sustain your CX efforts, and How we got to this particular point in CX history This book is the result of exhaustive research conducted to incorporate various components that affect customer experience. Based on the research results, the authors make a case for seeing CX and associated transformations as the next natural evolution of the quality management system (QMS) already in place in most companies. Using an existing QMS as the foundation for CX not only creates a more sustainable platform, but it allows for a faster and more cost effective way to enable an organization to attain world-class CX.
Book Synopsis Variation Risk Management by : Anna C. Thornton
Download or read book Variation Risk Management written by Anna C. Thornton and published by John Wiley & Sons. This book was released on 2003-11-05 with total page 324 pages. Available in PDF, EPUB and Kindle. Book excerpt: "A thoughtful, complete, and very readable approach to robust engineering. It presents insights that correlate with those learned at Ford while developing and executing Design for Six Sigma. Having this book three years ago could’ve helped with that effort."–David Amos, DFSS Deployment Director, Ford Motor Company Written by Anna C. Thornton, the well-known author who coined the phrase "variation risk management," this comprehensive book presents new methods and implementation strategies based on her research of industry practices and her personal experience with such companies as The Boeing Company, Eastman Kodak Company, Ford Motor Company, Johnson & Johnson, and many others. Step-by-step guidelines show how you can implement and apply variation risk management to real-world problems within the existing systems of an organization.
Book Synopsis Fundamentals of Risk Management by : Paul Hopkin
Download or read book Fundamentals of Risk Management written by Paul Hopkin and published by Kogan Page Publishers. This book was released on 2017-01-03 with total page 488 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Book Synopsis Risk-Based Quality Management in Healthcare Organization by : Dr. Akash Sharma, Ms. Vriti Gamta, Mr.Gaurav Luthra
Download or read book Risk-Based Quality Management in Healthcare Organization written by Dr. Akash Sharma, Ms. Vriti Gamta, Mr.Gaurav Luthra and published by Notion Press. This book was released on 2023-08-09 with total page 105 pages. Available in PDF, EPUB and Kindle. Book excerpt: "Risk-Based Quality Management in Healthcare Organization: A Guide based on ISO 13485 and EU MDR" is a comprehensive handbook that offers practical guidance for healthcare professionals to excel in risk-based quality management. It explores the regulatory landscape of the healthcare industry, emphasizing ISO 13485 and EU MDR as the foundation. The book provides a step-by-step approach to implementing effective risk assessment and mitigation strategies, ensuring compliance with international standards. It includes best practices to navigate risk management throughout the medical device lifecycle. The guide also addresses integrating risk management into existing quality management systems, conducting audits, and meeting EU MDR requirements. By mastering the principles in this guide, professionals can enhance patient safety, improve product quality, and achieve regulatory compliance. It is a valuable resource for healthcare professionals involved in device design, manufacturing, testing, and regulatory affairs.
Book Synopsis Service Quality Management by : Peter D. Mauch
Download or read book Service Quality Management written by Peter D. Mauch and published by Dr Peter D Mauch. This book was released on 2008 with total page 103 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis Managing Risk by : Elaine M. Hall Ph.D.
Download or read book Managing Risk written by Elaine M. Hall Ph.D. and published by Pearson Education. This book was released on 1998-02-05 with total page 451 pages. Available in PDF, EPUB and Kindle. Book excerpt: "The increasing rate of technological change we are experiencing in our lifetime yields competitive advantage to organizations and individuals who are willing to embrace risk and the opportunities it presents. Those who choose to minimize or avoid risk, as opposed to managing it, set a course for obsolescence. Hall has captured the essence of risk management and given us a practical guide for the application of useful principles in software-intensive product development. This is must reading for public and private sector managers who want to succeed as we begin the next century." - Daniel P. Czelusniak, Director, Acquisition Program Integration Office of the Under Secretary of Defense (Acquisition and Technology) The Pentagon "Since it is more than just common sense, the newcomer to risk management needs an intelligent guide. It is in this role that Elaine Hall's book excels. This book provides a set of practical and well-delineated processes for implementation of the discipline." - Tom DeMarco, from the Foreword Risk is inherent in the development of any large software system. A common approach to risk in software development is to ignore it and hope that no serious problems occur. Leading software companies use quantitative risk management methods as a more useful approach to achieve success. Written for busy professionals charged with delivering high-quality products on time and within budget, Managing Risk is a comprehensive guide that describes a success formula for managing software risk. The book is divided into five parts that describe a risk management road map designed to take you from crisis to control of your software project. Highlights include: Six disciplines for managing product development. Steps to predictable risk-management process results. How to establish the infrastructure for a risk-aware culture. Methods for the implementation of a risk management plan. Case studies of people in crisis and in control.
Book Synopsis Intelligent Internal Control and Risk Management by : Matthew Leitch
Download or read book Intelligent Internal Control and Risk Management written by Matthew Leitch and published by CRC Press. This book was released on 2016-05-23 with total page 271 pages. Available in PDF, EPUB and Kindle. Book excerpt: Many people in organizations resent internal control and risk management; these two processes representing unwelcome tasks to be completed for the benefit of auditors and regulators. Over the last few years this perception has been heightened by the disastrous implementation of section 404 of the Sarbanes-Oxley Act of 2002, which is generally regarded as having been too expensive for the benefits it has brought. This important book offers a way of improving this prevailing perception and increasing the value of control and risk management by bringing creativity and design skills to the fore. The value of risk and control activities is often limited by the value of the control ideas available and so Matthew Leitch provides an arsenal of 60 high performance control mechanisms. These include several alternative ways to design controls and control systems, as well as providing controls for monitoring and audit, controls for accelerated learning, and techniques for finding and recovering cash. This design material is combined with insights into the psychology of risk control, strategies for encouraging helpful behaviour and enabling change, and a surprisingly simple integration of internal control with risk management. The book is realistic, practical, original, and easier reading than most in the field. The material is not specific to any one country and has international appeal for internal auditors and all those concerned with risk management, corporate governance and security.
Book Synopsis The Global Quality Management System by : Suresh Patel
Download or read book The Global Quality Management System written by Suresh Patel and published by CRC Press. This book was released on 2016-02-24 with total page 234 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Global Quality Management System: Improvement Through Systems Thinking shows you how to understand and implement a global quality management system (GQMS) to achieve world-class business excellence. It illustrates the business excellence pyramid with the foundation of management systems at the system level, Lean System at the operational level,
Book Synopsis Understanding ISO 9001 : 2015 Quality Management System, 2nd Edition, Revised and Expanded by : Virendra Kumar Gupta
Download or read book Understanding ISO 9001 : 2015 Quality Management System, 2nd Edition, Revised and Expanded written by Virendra Kumar Gupta and published by Kojo Press. This book was released on 2017-06-15 with total page 243 pages. Available in PDF, EPUB and Kindle. Book excerpt: The 2015 version of ISO 9001 brings many enriching changes to promote quality excellence by organizations. The most significant change is the reinforcement of the fact that ISO 9001 is not just a quality issue. It is relevant as an overarching management topic. The book explains the requirements of the revised (2015) version of ISO 9001 in simple and practical manner. The objective has been to enhance understanding of the subject matter by managers and quality professionals. A conceptual understanding shall enable managers and professionals to design better systems and processes uniquely suited to their respective organizations. In view of this the first five chapters of the book explain concepts on QUALITY, PROCESS, PROCESS APPROACH / MANAGEMENT and PDCA. These are relevant for all management system standards being developed by International Organization for Standardization with the High Level Structure. Part II of the book goes into details of each clause focusing on processes and process interactions. We expect that the readers will appreciate that ISO 9001, now focuses more on expected outcomes through processes than mandating too many requirements.
Book Synopsis Quality Risk Management in the FDA-Regulated Industry by : Jose (Pepe) Rodriguez-Perez
Download or read book Quality Risk Management in the FDA-Regulated Industry written by Jose (Pepe) Rodriguez-Perez and published by Quality Press. This book was released on 2024-04-18 with total page 313 pages. Available in PDF, EPUB and Kindle. Book excerpt: For quality professionals and manufacturers in the food safety and medical device industries, risk management is essential to ensuring organizations meet FDA regulations and requirements. Without these recognized standards, the lives of patients and consumers are placed in jeopardy. In this third edition of Quality Risk Management in the FDA-Regulated Industry, Jose Rodriguez-Perez provides an updated view of the risk management field as it applies to FDA-regulated products using risk-based thinking.
Book Synopsis Public Health and Economic Resiliency in the Post-COVID-19 Era by : Kahime, Kholoud
Download or read book Public Health and Economic Resiliency in the Post-COVID-19 Era written by Kahime, Kholoud and published by IGI Global. This book was released on 2021-10-15 with total page 276 pages. Available in PDF, EPUB and Kindle. Book excerpt: The COVID-19 pandemic has affected individuals and caused destabilization of households and business activities. In emerging economies, many sectors and companies, especially small and medium enterprises (SMEs), are severely influenced by the reduction or cessation of economic activity. Overcoming the COVID-19 virus and allowing the world to heal will allow the economy to grow more resilient. First, however, we must understand that old managerial practices can no longer generate competitive advantage in the post-pandemic world. Public Health and Economic Resiliency in the Post-COVID-19 Era presents epidemiological studies of the COVID-19 pandemic, identifies the impacts it has on human health, and analyzes the impacts on public health and economy. This management tool also discusses the socio-economic human vulnerability related to the COVID-19 pandemic. Covering topics such as risk analysis, quality management systems, and therapeutic systems, this book is a dynamic resource for academic researchers and investigators, university professors, students, epidemiologists, health professionals, economists, managers, sociologists, physicians, policymakers, government officials, and academicians.
