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 : 160

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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 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.

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 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.

The importance of risk analysis techniques and quality assurance

The importance of risk analysis techniques and quality assurance PDF Author: David Onditi
Publisher: GRIN Verlag
ISBN: 3346016846
Category : Business & Economics
Languages : en
Pages : 8

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Book Description
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.

Science and Decisions

Science and Decisions PDF Author: National Research Council
Publisher: National Academies Press
ISBN: 0309120462
Category : Political Science
Languages : en
Pages : 422

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Book Description
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.

Software Quality Assurance for Safety Analysis and Risk Management at the Savannah River Site

Software Quality Assurance for Safety Analysis and Risk Management at the Savannah River Site PDF Author:
Publisher:
ISBN:
Category :
Languages : en
Pages : 10

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Book Description
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.