Risk Assessment and Risk-Driven Quality Assurance


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


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




Guidelines for Risk Based Process Safety


Book Description

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.




Risk Assessment and Risk-Driven Testing


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.


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.




Pharmaceutical Computer Systems Validation


Book Description

Thoroughly revised to include the latest industry developments, the Second Edition presents a comprehensive overview of computer validation and verification principles and how to put them into practice. To provide the current best practice and guidance on identifying and implementing improvements for computer systems, the text extensively reviews regulations of pharmaceuticals, healthcare products, blood processing, medical devices, clinical systems, and biotechnology. Ensuring that organizations transition smoothly to the new system, this guide explains how to implement the new GMP paradigm while maintaining continuity with current practices. In addition, all 24 case studies from the previous edition have been revised to reflect the new system.




Risk-based, Management-led, Audit-driven, Safety Management Systems


Book Description

Risk-based, Management-led, Audit-driven, Safety Management Systems, explains what a safety management system (SMS) is, and how it reduces risk in order to prevent accidental losses in an organization. It advocates the integration of safety and health into the day-to-day management of the enterprise as a value, rather than an add-on, and emphasizes that the safety movement must be initiated, led and maintained by management at all levels. The concepts of safety authority, responsibility and accountability are described as the key ingredients to safety system success. Safety system audits are expounded in simple terms, and leading safety performance indicators are suggested as the most important measurements, in preference to lagging indicators. McKinnon highlights the importance of the identification and control of risk as a key basis for a SMS, with examples of a simple risk matrix and daily task risk assessment, as well as a simplified method of assessing, analyzing, and controlling risks. The book refers to international Guidelines on SMS, as well as the proposed International Organization for Standardization (ISO) 45001, which could soon become the international safety benchmark for organizations worldwide. Using clear, approachable examples, the chapters give a complete overview of an SMS and its components. Confirming to most of the safety management system Guidelines published by leading world authorities, this volume will allow organizations to structure their own world-class SMS.




Testing Software and Systems


Book Description

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.




Applying HACCP-based Quality Risk Management on dairy farms


Book Description

"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"