Download or read book Risk Assessment and Risk Driven Quality Assurance written by Jürgen Großmann and published by Springer. This book was released on 2017-04-21 with total page 160 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book constitutes the thoroughly refereed conference proceedings of the Fourth International Workshop on Risk Assessment and Risk-Driven Quality Assurance, RISK 2016, held in conjunction with ICTSS 2016, in Graz, Austria, in October 2016. The revised 9 full papers were carefully reviewed and selected from 11 submissions. They focus on research studying, developing and evaluating innovative techniques, tools, languages and methods risk assessment and risk-driven quality engineering. The papers are organized topical sections: security risk management; security risk analysis; risk-based testing.

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

Download or read book Guidelines for Risk Based Process Safety written by CCPS (Center for Chemical Process Safety) and published by John Wiley & Sons. This book was released on 2011-11-30 with total page 759 pages. Available in PDF, EPUB and Kindle. Book excerpt: Guidelines for Risk Based Process Safety provides guidelines for industries that manufacture, consume, or handle chemicals, by focusing on new ways to design, correct, or improve process safety management practices. This new framework for thinking about process safety builds upon the original process safety management ideas published in the early 1990s, integrates industry lessons learned over the intervening years, utilizes applicable "total quality" principles (i.e., plan, do, check, act), and organizes it in a way that will be useful to all organizations - even those with relatively lower hazard activities - throughout the life-cycle of a company.

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.

Download or read book Applying HACCP based Quality Risk Management on dairy farms written by J.P.T.M. Noordhuizen and published by BRILL. This book was released on 2023-08-28 with total page 311 pages. Available in PDF, EPUB and Kindle. Book excerpt: "Quality is a keyword in animal production. Next to product quality, process quality has also become relevant for dairy farmers. Issues like food safety, public health, animal health and welfare are determined by the conditions of the production process. To address these, he EU has issued the General Food Law (178-2002) and the Hygiene directives (EC 852/853/854-2004) dealing with the forenamed domains with the aim to protect consumers. The suggestion was also made by the EU that farmers apply a HACCP-like plan to meet these new quality demands. Key issues are structure, organisation, planning, formalisation and demonstrability, which can also be found in the HACCP concept. This book addresses Quality Risk Management through applying the HACCP-like concept. First, the assessment of strong and weak points on a dairy farm are dealt with, which is useful for farm inspection and herd health programmes. Then, the 12-steps for developing a HACCP plan are followed through the various chapters. Many examples and elaborations are given. An example farm, FX, is introduced to show how the different elements may look in reality. At the end of the book characteristics of entrepreneur-like dairy farmers are given and compared to strong and weak points of cattle practitioners. Practitioners may conclude how to better serve this type of farmer. Communication plays a paramount role. Finally, several general issues are addressed: economics, integrating classical herd health with quality risk management programmes. The aim of this book is to give practical guidelines and examples for dairy farmers, cattle practitioners and extension people, who desire to jointly develop and implement a HACCP-based quality risk management programme. 'This book is well written with many practical flow charts and ""Good Practice"" advice. I would recommend it to any veterinarian involved in producing risk management programs or ""Standard Operating Procedure"" type documents for dairy farms. The chapters on good communication and marketing would be useful for most veterinarians.' David S. Beggs, book review editor 'The Australian Cattle Veterinarian' Volume 50, p. 34-35, March '09"

Download or read book Risk Management for Project Driven Organizations written by Andy Jordan and published by J. Ross Publishing. This book was released on 2013-05-13 with total page 361 pages. Available in PDF, EPUB and Kindle. Book excerpt: Organizations invest a lot of time, money, and energy into developing and utilizing risk management practices as part of their project management disciplines. Yet, when you move beyond the project to the program, portfolio, PMO and even organizational level, that same level of risk command and control rarely exists. With this in mind, well-known subject matter expert and author Andy Jordan starts where most leave off. He explores risk management in detail at the portfolio, program, and PMO levels. Using an engaging and easy-to-read writing style, Mr. Jordan takes readers from concepts to a process model, and then to the application of that customizable model in the user’s unique environment, helping dramatically improve their risk command and control at the organizational level. He also provides a detailed discussion of some of the challenges involved in this process. Risk Management for Project Driven Organizations is designed to aid strategic C-level decision makers and those involved in the project, program, portfolio, and PMO levels of an organization. J. Ross Publishing offers an add-on for a nominal fee -- Downloadable tools and templates for easy customization and implementation.

Download or read book Quality Control in the age of Risk Management An Issue of Clinics in Laboratory Medicine written by James O. Westgard and published by Elsevier Health Sciences. This book was released on 2013-03-28 with total page 220 pages. Available in PDF, EPUB and Kindle. Book excerpt: In October of 2011, CLSI published a new guideline EP23A on “Laboratory Quality Control Based on Risk Management. In March, 2012, CMS announced its intention to incorporate key concepts from EP23A into its Interpretative Guidelines and QC policy for “Individualized Quality Control Plans. Thus begins a new era of Quality Control in the Age of Risk Management. This issue is intended to help laboratories with the transition between traditional QC practices and the new risk management approach. Laboratories face a steep learning curve to apply risk analysis for identifying and prioritizing failure-modes, developing and implementing control mechanisms to detect those failure-modes, and assessing the acceptability of the residual risks that exist after implementation of a QC Plan. One of the main benefits of the new risk analysis based QC Plans should be an integration of all the control mechanisms that are needed to monitor the total testing process, including pre-analytic, analytic, and post-analytic controls. One of the main risks of the new approach is an expectation that Statistical QC is no longer important, even though SQC still remains the most useful and flexible approach for monitoring the quality of the analytic process. The key to the future is the successful integration of all these control mechanisms to provide a cost-effective quality system that monitors all phases of the total testing process. This issue should help laboratories understand the evolution of QC practices to include risk management, but also to recognize the need to maintain traditional techniques such as Statistical QC, especially during the transition to well-designed and carefully-validated QC Plans. Risk analysis may be risky business unless laboratories proceed carefully and cautiously.

Download or read book Risk Assessment and Risk Driven Testing written by Fredrik Seehusen and published by Springer. This book was released on 2015-11-12 with total page 125 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book constitutes the thoroughly refereed conference proceedings of the Third International Workshop on Risk Assessment and Risk-driven Testing, RISK 2015, held in conjunction with the OMG Technical Meeting in Berlin, Germany, in June 2015. The revised 8 full papers were carefully reviewed and selected from 12 submissions. This workshop addresses systematic approaches that combine risk assessment and testing. Also, the workshop was structured into the three sessions namely Risk Assessment, Risk and Development and Security Testing.

Download or read book Testing Software and Systems written by Franz Wotawa and published by Springer. This book was released on 2016-10-10 with total page 266 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book constitutes the refereed proceedings of the 278th IFIP WG 6.1 International Conference on Testing Software and Systems, ICTSS 2016, held in Graz, Austria, in October 2016. The 12 revised full papers and 6 short papers presented were carefully reviewed and selected from 41 submissions. The papers are organized in topical sections on testing methodologies, heuristics and non-determinism in testing, practical applications, and short contributions.

Download or read book Science and Decisions written by National Research Council and published by National Academies Press. This book was released on 2009-03-24 with total page 422 pages. Available in PDF, EPUB and Kindle. Book excerpt: Risk assessment has become a dominant public policy tool for making choices, based on limited resources, to protect public health and the environment. It has been instrumental to the mission of the U.S. Environmental Protection Agency (EPA) as well as other federal agencies in evaluating public health concerns, informing regulatory and technological decisions, prioritizing research needs and funding, and in developing approaches for cost-benefit analysis. However, risk assessment is at a crossroads. Despite advances in the field, risk assessment faces a number of significant challenges including lengthy delays in making complex decisions; lack of data leading to significant uncertainty in risk assessments; and many chemicals in the marketplace that have not been evaluated and emerging agents requiring assessment. Science and Decisions makes practical scientific and technical recommendations to address these challenges. This book is a complement to the widely used 1983 National Academies book, Risk Assessment in the Federal Government (also known as the Red Book). The earlier book established a framework for the concepts and conduct of risk assessment that has been adopted by numerous expert committees, regulatory agencies, and public health institutions. The new book embeds these concepts within a broader framework for risk-based decision-making. Together, these are essential references for those working in the regulatory and public health fields.

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.

Download or read book The Risk Management Memory Jogger written by Karen Tate and published by . This book was released on 2013-12-31 with total page 200 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book RISK MANAGEMENT FOR THE MEDICAL DEVICE INDUSTRY written by Dr. Akash Sharma, Ms. Vriti Gamta , Mr. Gaurav Luthra and published by Notion Press. This book was released on 2023-07-25 with total page 139 pages. Available in PDF, EPUB and Kindle. Book excerpt: "Risk Management for the Medical Device Industry: A Guide based on ISO 14971" is an essential resource for professionals in the fast-paced medical device industry. Authored by Dr. Akash Sharma, Ms. Vriti Gamta, and Mr. Gaurav Luthra, experts in regulatory affairs and quality management systems, this practical guide offers comprehensive insights into risk management and compliance. Covering the entire risk management lifecycle, it includes case studies, best practices, and practical examples, along with discussions on integrating risk management with quality management systems and emerging technologies. Equip yourself with the knowledge and tools to ensure safety and effectiveness in the global market.

Download or read book Risk Thinking for Cloud Based Application Services written by Eric Bauer and published by CRC Press. This book was released on 2017-04-07 with total page 487 pages. Available in PDF, EPUB and Kindle. Book excerpt: Many enterprises are moving their applications and IT services to the cloud. Better risk management results in fewer operational surprises and failures, greater stakeholder confidence and reduced regulatory concerns; proactive risk management maximizes the likelihood that an enterprise’s objectives will be achieved, thereby enabling organizational success. This work methodically considers the risks and opportunities that an enterprise taking their applications or services onto the cloud must consider to obtain the cost reductions and service velocity improvements they desire without suffering the consequences of unacceptable user service quality.

Download or read book Security Science written by Clifton Smith and published by Butterworth-Heinemann. This book was released on 2012-12-31 with total page 275 pages. Available in PDF, EPUB and Kindle. Book excerpt: Security Science integrates the multi-disciplined practice areas of security into a single structured body of knowledge, where each chapter takes an evidence-based approach to one of the core knowledge categories. The authors give practitioners and students the underlying scientific perspective based on robust underlying theories, principles, models or frameworks. Demonstrating the relationships and underlying concepts, they present an approach to each core security function within the context of both organizational security and homeland security. The book is unique in its application of the scientific method to the increasingly challenging tasks of preventing crime and foiling terrorist attacks. Incorporating the latest security theories and principles, it considers security from both a national and corporate perspective, applied at a strategic and tactical level. It provides a rational basis for complex decisions and begins the process of defining the emerging discipline of security science. - A fresh and provocative approach to the key facets of security - Presentation of theories and models for a reasoned approach to decision making - Strategic and tactical support for corporate leaders handling security challenges - Methodologies for protecting national assets in government and private sectors - Exploration of security's emerging body of knowledge across domains

Download or read book Project Risk Management Guidelines written by Dale Cooper and published by Wiley Global Education. This book was released on 2014-09-23 with total page 434 pages. Available in PDF, EPUB and Kindle. Book excerpt: This new edition of Project Risk Management Guidelines has been fully updated to include the new international standards, ISO 31000 Risk management and IEC 62198 Managing risk in projects. The book explains the standards and how they can be applied. It provides a clear introduction to basic project risk management, introduces the reader to specialized areas of projects and procurement, and shows how quantitative risk analysis methods can be used in large projects. Chapter by chapter, the authors present simple, practical steps and illustrate them with examples drawn from their extensive experience from around the world, in many different industry sectors and cultures and at all stages of projects from conception through development and into execution. Qualitative and quantitative approaches are covered. Traditional structures and processes are discussed as well as developments in the way projects are conducted, such as outsourcing arrangements and risk-sharing structures like public–private partnerships. Improved outcomes can be achieved when sound risk management is used to capture opportunities and reduce threats. Its unique focus and wealth of checklists, tables and other resources make this book an essential and enduring tool for anyone involved with project work.

Download or read book Risk Assessment and Risk Driven Testing written by Thomas Bauer and published by Springer. This book was released on 2014-07-09 with total page 141 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book constitutes the thoroughly refereed conference proceedings of the First International Workshop on Risk Assessment and Risk-driven Testing, RISK 2013, held in conjunction with 25th IFIP International Conference on Testing Software and Systems, ICTSS 2013, in Istanbul, Turkey, in November 2013. The revised full papers were carefully reviewed and selected from 13 submissions. The papers are organized in topical sections on risk analysis, risk modeling and risk-based testing.