Risk Assessment and Risk-Driven Quality Assurance

Risk Assessment and Risk-Driven Quality Assurance PDF Author: Jürgen Großmann
Publisher: Springer
ISBN: 3319578588
Category : Computers
Languages : en
Pages : 157

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Book Description
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.

Risk Assessment and Risk-Driven Quality Assurance

Risk Assessment and Risk-Driven Quality Assurance PDF Author: Jürgen Großmann
Publisher: Springer
ISBN: 3319578588
Category : Computers
Languages : en
Pages : 157

Get Book

Book Description
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.

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

Risk management in software quality assurance

Risk management in software quality assurance PDF Author: Jan Sickinger
Publisher: GRIN Verlag
ISBN: 3640999940
Category : Business & Economics
Languages : de
Pages : 53

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Book Description
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.

Risk Assessment and Risk-Driven Testing

Risk Assessment and Risk-Driven Testing PDF Author: Fredrik Seehusen
Publisher: Springer
ISBN: 3319264168
Category : Computers
Languages : en
Pages : 125

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Book Description
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.

Object-oriented Quality and Risk Management (OQRM). A practical and generic method to manage quality and risk.

Object-oriented Quality and Risk Management (OQRM). A practical and generic method to manage quality and risk. PDF Author: P.W.M. van Nederpelt
Publisher: Lulu.com
ISBN: 1291037357
Category : Business & Economics
Languages : en
Pages : 101

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Book Description
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.

Risk Based Thinking

Risk Based Thinking PDF Author: Greg Hutchins PE CERM
Publisher: Greg Hutchins
ISBN: 1732554587
Category : Business & Economics
Languages : en
Pages : 400

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Book Description
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.

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: 1953079326
Category : Business & Economics
Languages : en
Pages : 252

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Book Description
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.

Risk Assessment and Risk-Driven Testing

Risk Assessment and Risk-Driven Testing PDF Author: Thomas Bauer
Publisher: Springer
ISBN: 3319070762
Category : Computers
Languages : en
Pages : 141

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Book Description
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.

ICH Quality Guidelines

ICH Quality Guidelines PDF Author: Andrew Teasdale
Publisher: John Wiley & Sons
ISBN: 1118971116
Category : Medical
Languages : en
Pages : 740

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Book Description
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)

Risk-Led Safety: Evidence-Driven Management, Second Edition

Risk-Led Safety: Evidence-Driven Management, Second Edition PDF Author: Duncan Spencer
Publisher: CRC Press
ISBN: 1000732940
Category : Technology & Engineering
Languages : en
Pages : 122

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Book Description
Pressure from consultants, insurers, trainers or those supporting National & International Standards seem to create the feeling that somehow you haven’t done enough to ensure people are safe yet. Of course, they have vested interest in trying to sell you solutions that you may not necessarily need. Then there is the challenge many enlightened boards are wrestling with; how do you move beyond mere legal compliance without making things too complicated and costly or by inadvertently going too far? In many disciplines, getting the basics right can be very powerful in achieving great performance and health & safety is no different. This book is packed with ideas that will help any organisation to "get the basics right". It is the direct experience of the authors that these ideas are applicable to all industries, all operational circumstances and in many different countries. It contains simple and powerful messages that can transform performance and help to create a positive organisational health & safety culture. It is a "how to" handbook that has evolved from real-world experience. Being risk-led and evidence-driven delivers business benefit and keeps people safe.