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Setting up a GXP environment where none existed previously is a very daunting task. Getting staff to write down what they do for every task is a correspondingly difficult and time-consuming exercise. Examining how to maintain quality control in clinical trial research, A Practical Guide to Quality Management in Clinical Trial Research provides a co
The ISO 9000 family of quality standards has been adopted world-wide as a framework for building better relationships between suppliers and customers. Originally a manufacturing-industry concern, quality is now acknowledged to be a key issue for the construction sector whose clients increasingly demand quality certification. This book explains the concepts and practice of quality assurance and management in construction. Clearly written and well illustrated, with plenty of sample quality system documents and other pro-forma, this book will make the daunting task of developing, implementing and managing a quality system a great deal easier for contractors. This is practical guide for building and construction contractors and sub-contractors, project managers and other construction professionals. Also for undergraduate and postgraduate students of building, construction management and project management.
While there are many quality assurance books on the market, very few address the application of the concept to the seafood industry. In addition, many of the books that are available take a theoretical approach and there fore do not provide actual examples of the "fins and bones" of quality programs. The author, in teaching quality assurance over nine years, has not been able to find a textbook that is suitable as a reference text in quality assurance courses for the seafood industry. It is this situation that has prompted the preparation of this book, which takes a practical approach to the subject of quality assurance in seafood processing operations. This book can serve as either a textbook or as a reference text. As a textbook it is written for students of quality assurance at the technician, technologist, and university levels. In this role it is intended that the student will start at the beginning of the book and proceed through in sequence, so as to gain a complete understanding of the design, implementation, and operation of a quality program in seafood processing operations. It is the hope of the author that the book also functions quite well as a desk reference for the managers of seafood processing operations who need to refer occa sionally to particular items or chapters. In this sense, each chapter is designed to stand alone as a discussion of a particular concept within the quality assurance discipline.
Do you remember the first time you drove a car? To prepare for this you probably read the drivers manual, watched movies, practiced in your driveway, and endlessly discussed the impending event with your friends. The result - you knew a lot about the theory of driving, you just didn't know how to translate that theory into practice. Quality Management poses a similar problem to many organizations. The time has come to put Quality Management theory to use. Since the early 1980s, you may have read books and journals, attended seminars and training sessions, or watched films and videos about Quality Management. Once again you must make the jump from theory to application. Quality Management Systems: A Practical Guide for Improvement makes it possible. This book presents a model of Quality Management that combines the theoretical base of Dr. W. Edwards Deming and the practical techniques of the Japanese into a useful application. The fork shaped model includes: oThe Handle - Management's Commitment to Transformation oThe Neck - Management's Education oProng One - Daily Management oProng Two - Cross-Functional Management oProng Three - Policy Management Quality Management Systems: A Practical Guide for Improvement supplies an integrated approach that explains the theory and how to put it into practice using a step-by-step method.
This book is an easy-to-read, practical guide for any medical school preparing for accreditation or institutional review. It contains practical guidance on the use of internationally accepted standards with a particular focus on what it is that external accrediting teams will be looking for both before and during their site visit. This book will appeal to medical school faculty as well as faculty from other health professions schools who are preparing for either high stakes accreditation or internal review. It may also appeal to agencies responsible for accrediting medical schools who wish to become more familiar with the international standards.
Relying on practical examples from the authors’ experience, this book provides a thorough and modern approach to controlling and monitoring microbial contaminations during the manufacturing of non-sterile pharmaceuticals. Offers a comprehensive guidance for non-sterile pharmaceuticals microbiological QA/QC Presents the latest developments in both regulatory expectations and technical advancements Provides guidance on statistical tools for risk assessment and trending of microbiological data Describes strategy and practical examples from the authors’ experience in globalized pharmaceutical companies and expert networks Offers a comprehensive guidance for non-sterile pharmaceuticals microbiological QA/QC Presents the latest developments in both regulatory expectations and technical advancements Provides guidance on statistical tools for risk assessment and trending of microbiological data Describes strategy and practical examples from the authors’ experience in globalized pharmaceutical companies and expert networks
This book provides a clear, easy to digest overview of Quality Management Systems (QMS). Critically, it offers the reader an explanation of the International Standards Organization’s (ISO) requirement that in future all new and existing Management Systems Standards will need to have the same high-level structure, commonly referred to as Annex SL, with identical core text, as well as common terms and definitions. In addition to explaining what Annex SL entails, this book provides the reader with a guide to the principles, requirements and interoperability of Quality Management System standards, how to complete internal and external management reviews, third-party audits and evaluations, as well as how to become an ISO Certified Organisation once your QMS is fully established. As a simple and straightforward explanation of QMS Standards and their current requirements, this is a perfect guide for practitioners who need a comprehensive overview to put theory into practice, as well as for undergraduate and postgraduate students studying quality management as part of broader Operations and Management courses.
By adopting Total Quality Management (TQM) strategies, business organizations are working smarter and gaining the competitive edge. The authors cite examples of successes of TQM in specific government agencies, including the Treasury Department, to reveal how the principles of TQM can be applied at all levels of government. The book provides numerous charts and diagrams that show concretely how to apply the concepts and techniques of TQM within any governmental organization. The authors offer case examples that detail what organizational changes are to be implemented when TQM is introduced.
This book is one of the first to comprehensively summarise the latest thinking and research in the rapidly evolving field of quality management in intensive care. Quality indicators and outcome measures are discussed with a practical focus on patient-centred, evidence-based implementation for safer and more effective clinical practice. Chapters on topics such as teambuilding, patient satisfaction, mortality and morbidity, and electronic management systems are organised into three sections, covering quality management at the scale of the individual patient, the intensive care unit, and the national and international level. Written by a team of over forty international experts in the specialty, with editors who have been heavily involved for many years with the European Society of Intensive Care Medicine, the book reflects commonly accepted goals and guidelines for best practice, and will be valuable for practitioners worldwide. The ideal one-stop resource for intensive care physicians as well as ICU and hospital managers.