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 Risk management in software quality assurance written by Jan Sickinger and published by GRIN Verlag. This book was released on 2011 with total page 53 pages. Available in PDF, EPUB and Kindle. Book excerpt: Studienarbeit aus dem Jahr 2010 im Fachbereich BWL - Unternehmensführung, Management, Organisation, Note: 2,0, FOM Essen, Hochschule für Oekonomie & Management gemeinnützige GmbH, Hochschulleitung Essen früher Fachhochschule, Veranstaltung: Risk & Contract Management, Sprache: Deutsch, Abstract: In general, risk can be expressed as product of amount of damage and probability of damage. Due to the fact that software controls more and more aspects of life in modern industrialised societies, software failures inherit risks for businesses, human health or even human life. Software testing is a structured approach to minimise product risks of software systems. When the problem arises that, due to a given budget and timeframe, it is not possible to cover all parts of the software through testing, Risk-Based Testing is a possibility to test the most critical parts of the software first or more intensive. When using this method, both amount of damage and probability of damage must be quantified. Quantifying the amount of damage must happen by considering the different viewpoints of the software system's stakeholders, while quantifying the probability of damage can only happen indirectly, for example through quality indicators like the complexity of the software itself, the quality of the documentation etc. When having derived quantitative values both for the amount of damage and the probability of damage, the priority of the test cases can be determined by using a risk matrix. Furthermore, these values can also be used for metrics. An extension of Risk-Based Testing is Risk and Requirement-Based Testing, where product risks are linked to the requirements against which the software is tested in order to gain an overview if the lists of requirements and risks defined for the software are complete.
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 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 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 Risk Based Thinking written by Greg Hutchins PE CERM and published by Greg Hutchins. This book was released on 2018-11-28 with total page 400 pages. Available in PDF, EPUB and Kindle. Book excerpt: What is Risk Based Thinking (RBT)? International Organization for Standardization (ISO) incorporated Risk Based Thinking (RBT) into ISO 9001:2015 and its management system standards. ISO: Risk Based Thinking is the first book to address risk in the new ISO families of standards. Learn what RBT means and most importantly understand what you need to do to adopt RBT. Everyone who is certified to ISO 9001:2015 should read this book to understand and implement RBT. What This Book Can Do for You? · Explains the integration of risk into ISO management systems. · Answers the most critical questions you need to know about RBT and risk management. · Explains key risk concepts such as RBT, risk management assessment, risk management, VUCA, risk context, Risk Maturity, and etc. · Explains in detail ISO 31000, ISO 31010, and other key risk standards. · Explains the steps in the RBT journey. · Presents insider tips and tools known to standards developers and high-priced risk consultants. · Lists critical risk, process, effectiveness, and RBT questions that your QMS consultant and Certification Body should be able to answer. Bonus Materials/Resources · Access almost 2,000 risk and quality articles through CERM Academy. · Get Lessons Learned at the end of each key question. · Get free course materials such as using FMEA’s in ISO 9001:2015.
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.
Download or read book The importance of risk analysis techniques and quality assurance written by David Onditi and published by GRIN Verlag. This book was released on 2019-09-16 with total page 8 pages. Available in PDF, EPUB and Kindle. Book excerpt: Academic Paper from the year 2018 in the subject Business economics - Business Management, Corporate Governance, grade: 1.0, University of South Australia (McGill), course: Business Managament, language: English, abstract: The author gives an example of a quality assurance and control plan and a risk matrix, which includes the risks, probability and importance of the risks and the action plan as well as the person responsible for the risks. There are a number of risk analysis techniques. Brainstorming is primarily used in the project planning stage to identify as well as postulate the various risk scenarios. It helps project teams to creatively think as a group by building on various ideas. SWOT analysis is another framework of risk analysis that can be applied in a project as a means of assessing the external and internal influence that can have an impact on the project. The influences can either be positive or negative. Root cause analysis (RCA) is a method applied in analysing the adverse and serious events through the identification of problems that increase the likelihood of errors without focusing on individuals’ mistakes.
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 Software Quality Assurance for Safety Analysis and Risk Management at the Savannah River Site written by and published by . This book was released on 1991 with total page 10 pages. Available in PDF, EPUB and Kindle. Book excerpt: As part of its Reactor Operations Improvement Program at the Savannah River Site (SRS), Westinghouse Savannah River Company (WSRC), in cooperation with the Westinghouse Hanford Company, has developed and implemented quality assurance for safety-related software for technical programs essential to the safety and reliability of reactor operations. More specifically, the quality assurance process involved the development and implementation of quality standards and attendant procedures based on industry software quality standards. These procedures were then applied to computer codes in reactor safety and probabilistic risk assessment analyses. This paper provides a review of the major aspects of the WSRC safety-related software quality assurance. In particular, quality assurance procedures are described for the different life cycle phases of the software that include the Requirements, Software Design and Implementation, Testing and Installation, Operation and Maintenance, and Retirement Phases. For each phase, specific provisions are made to categorize the range of activities, the level of responsibilities, and the documentation needed to assure the control of the software. The software quality assurance procedures developed and implemented are evolutionary in nature, and thus, prone to further refinements. These procedures, nevertheless, represent an effective controlling tool for the development, production, and operation of safety-related software applicable to reactor safety and probabilistic risk assessment analyses.
Download or read book Risk Based Thinking written by Greg Hutchins and published by Q+e. This book was released on 2018-07-10 with total page 406 pages. Available in PDF, EPUB and Kindle. Book excerpt: Twenty years ago, we wrote 4 best selling, ISO 9001 books. They were fun times. Quality was Job #1. W. Edwards Deming, Joseph Juran, Phil Crosby, and other quality gurus were considered quality management and general management authorities. We would give a quality or ISO talk and then walk away with 1 or more clients. So why are we writing another book on quality and replowing a topic that has been written about extensively? The challenge is there is little information on Risk Based Thinking (RBT) addressing ISO 9001:2015 and ISO other management system standards. ISO: Risk Based Thinking is the first book on RBT and operational risk. This book in its second edition is the first update.
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.
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 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 ICH Quality Guidelines written by Andrew Teasdale and published by John Wiley & Sons. This book was released on 2017-10-09 with total page 740 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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)
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 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"