Draws together twenty-two WHO guidelines relevant to the quality assurance and control of pharmaceutical products. Most of these guidelines have appeared as annexes in various reports of the WHO Expert Committee on Specifications for Pharmaceutical Preparations. Others are published here for the first time. By making these available in a single reference work, the book facilitates access to the complete body of WHO guidelines and recommendations issued to assist national drug regulatory and control authorities, particularly in developing countries. When viewed together, the collected guidelines also underscore the need for a comprehensive system of quality assurance and illustrate its various technical and administrative components in a logical way. The book has nine chapters organized to reflect the sequence of administrative and technical procedures needed to ensure that drugs meet acceptable standards of quality, safety, and efficacy. Chapter one sets out guiding principles for small national drug regulatory authorities. The second and most extensive chapter, on product assessment and registration, gives guidelines for the assessment of herbal medicines, the stability of drug dosage forms, the stability testing of products containing well established drug substances, and registration requirements to establish the interchangeability of multisource (generic) pharmaceutical products. Other chapters present recommendations for quality assurance in pharmaceutical supply systems, use of the International Pharmacopoeia to control the identity, purity and quality of products, and the development of simplified tests for verifying the identity of pharmaceutical products. A chapter onlaboratory services contains proposed models for a first-stage laboratory for drug surveillance, and a medium-size drug control laboratory. The remaining chapters provide guidelines for international trade in pharmaceuticals, recommendations for dealing with the new threat posed by counterfeit products, and advice on training programmes for personnel conducting drug analysis for regulatory purposes.

An introduction and companion to United Mind Workers, one of the most provocative educational reform books of the 90s. This booklet is the ultimate study-group discussion starter on teacher's union reform. Taking Charge of Quality outlines proposals for improving the quality of teaching, touching on issues such as standards, peer review, career ladders, hiring halls, school-based compacts, and teacher accountability. Includes a resource section.

This book contains the most recent information about the standard, including all its final modifications. The book outlines the scope and purpose of the standard and makes it accessible to everyone. The book leads the reader through the theory and implementation of an ISO14000-compliant environmental management system, including the consultant's and auditor's perspective, and give case studies from industries that have actually undergone the process. Finally there is input from training organisations and certification and accreditation bodies to help with trouble-shooting and assessment.

The book rounds off with an examination of the likely future, including the potential role of the European sub-set' of ISO14000 - EMAS - and what chances it has of international adoption.
Author has years of practical experience with a world-renowned organisation
Real-life case-studies provide meat for readers wondering about relevance to their companies

"Web of inclusion" is used to describe integrated and organic organizations that become effective because management puts itself at the center rather than at the top.

Die vorliegende Arbeit wendet sich an Fuhrungskrafte technisch-wirtschaftlicher Pragung, Entwicklungsingenieure, Oualitats- und Zuverlassigkeitsfachleute, sowie Studierende technischer Universitaten und Hochschulen, die sich uber die Schlus- selstellung wirtschaftlicher Oualitats-und Zuverlassigkeitsarbeit informieren wollen. Mit diesem Buch, welches von der Fakultat fur Maschinenbau der Technischen Universitat Wien als Habilitationsschrift angenommen wurde, wird eine Wcke zwi- schen Zuverlassigkeitsarbeit und Betriebswirtschaft im Unternehmen geschlossen. Unternehmensleitungen wissen in der Regel, daB der Markt zuverlassige, langle- bige Produkte fordert, kennen aber zu wenig die wirtschaftlichen Zusammen- hange und Auswirkungen, bzw. vereinfacht ausgedruckt: das Kosten/Nutzen-Ver- haltnis der Oualitats-und Zuverlassigkeitsarbeit. Die vielen praktischen Ansatze und Beispiele in den einzelnen Kapitein basieren auf Erfahrungen aus einem guten Jahrzehnt einschlagiger, verantwortlicher Tatig- keit bei IVECO-Fiat S. p.A. und Fiat-Auto S. p.A. Turin, sowie in international en Fachgremien. Ermoeglicht und gefoerdert wurde diese Tatigkeit vom stellvertreten- den Prasidenten der IVECO-Fiat, Dr.-Ing. Heinz W Hahn, sowie dem Vizeprasiden- ten und Chefingenieur von Fiat-Auto Dr.-Ing. Paolo Scolari, denen mein besonde- rer Dank gilt. Wertvolle Hinweise erhielt ich auch von dem international bekannten Oualitatswissenschaftler-Ehepaar Dr.-Ing. F. H. Zalud und Dr. A. H. Zaludova in Prag, mit denen mich ein langjahriger, fachlicher Gedankenaustausch verbindet. Fur die Beurteilung und Foerderung der Arbeit als Habilitationsschrift moechte ich den Professoren Dipl.-Ing. Dr. techno D. Biberschick und Dipl.-Ing. Dr. techno G. Pat- zack von der Technischen Universitat Wien, sowie Dr.-Ing. Dr.-Ing. e. h. T. Pfeiffer von der Technischen Hochschule Aachen besonders danken.

Quality is a form of management that is composed of the double approach of driving an organization towards excellence, while conforming to established standards and laws. The objective of quality confers advantages to companies: it makes them more resilient to change that can be unexpected or even chaotic; it makes them more competitive by identifying those steps in processes that do not offer added value. No longer the concern of a small community of experts, even scientists and engineers working in the private sector will find that they will have to con- front questions related to quality management in their day-to-day professional lives. This volume offers such people an unique entry into the universe of quality management, providing not only a cartography of quality standards and their modes of application - with particular attention to the ISO standards - but also a broader cultural context, with chapters on the history, prizes, deontology and moral implications of systems of quality management. This book thus opens the door to all those eager to take the first steps to learning how the principles of quality are organized today, and how they can be applied to his or her own activity.

The most important reference to Lean Six Sigma fully updated for the latest advances This thoroughly revised, industry standard guide delivers all the information you need to apply Lean Six Sigma techniques and dramatically improve processes, profitability, sustainability, and long-term growth. Written by two of the foremost authorities in the field, the book contains full explanations of the latest lean, problem solving and change management principles and methods. You will discover how to build the best teams and foster effective leadership while maximizing customer satisfaction and boosting profits. The book includes coverage of the recently released Minitab 18. The Six Sigma Handbook, Fifth Edition covers:*Building the responsive Six Sigma organization*Recognizing and capitalizing on opportunity*Data-driven management*Maximizing resources*Project management using DMAIC and DMADV*The define phase*The measure phase*Process behavior charts*Measurement systems evaluation*The analyze phase*The improve/design phase*The control/verify phase

The best time to stop projects or programs that will not be successful is before they are ever started. Research has shown that the focused use of realistic business case analysis on proposed initiatives could enable your organization to reduce the amount of project waste and churn (rework) by up to 40 percent, potentially avoiding millions of dollars lost on projects, programs, and initiatives that would fail to produce the desired results. This book illustrates how to develop a strong business case which links investments to program results and, ultimately, with the strategic outcomes of the organization. In addition, the book provides a template and example case studies for those seeking to fast-track the development of a business case within their organization. Making the Case for Change: Using Effective Business Cases to Minimize Project and Innovation Failures provides executive teams and change agents with the information required to make better business case decisions. This book can be used throughout the life cycle of the project to assist with gaining a better understanding of the following key knowledge areas for developing a business case: Understanding the present problem/improvement opportunity Documenting how the project, program, or initiative will add value to the organization Validating the data and the assumptions that the projected improvements are based upon Calculating the level of confidence that can be placed upon the conclusions that are reached Assessing the alternative solutions that were considered Weighing the costs vs. the benefits of the proposed initiative Analyzing and mitigating the risks to completing 100 percent of the project's goals Eliciting and prioritizing the requirements of key stakeholders and subject matter experts Identifying the key people that are involved in the proposed project and the skills needed to implement the proposed change Obtaining consensus on the decision to move forward, as well as on the methods used and the conclusions specified in the analysis Ideal for executives and project/initiative managers seeking approval of an activity, initiative, program, or project, the book presents proven tips, advice, suggestions, and recommended courses of action for developing effective business cases. In addition, suggestions for recruiting a responsible senior officer or sponsor for the project and for engaging an audience are provided. The authors combine their own experience in business case development with approaches used by world-class organizations. They provide a general range of assessment criteria that can be applied to almost any type of project business cases. The text discusses each of the 8 activities and the 35 tasks that make up the business case development process. This process supplies you with a proven approach for creating comprehensive and well-constructed business case evaluations that will either ensure the success of your project, or eliminate unsuccessful projects, programs, and initiatives before they start.

Whether you are establishing a quality management system for the first time or improving your existing system, this best-selling guide to effective quality management using the ISO 9000 family of standards as a framework for business process management (BPM) and improvement is an essential addition to your quality bookshelf. For newcomers to the field and those needing a refresh on the fundamental principles, quality expert David Hoyle covers the crucial background including the importance and implications of quality system management, enabling those seeking ISO 9001 certification to take a holistic approach that will bring about true business improvement and sustained success. Packed with insights into how the standard has been used, misused and misunderstood, ISO 9000 Quality Systems Handbook will help you to build an effective management system, help you decide if ISO 9001 certification is right for your company and gently guide you through the terminology, requirements and implementation of practices to enhance performance. With chapter headings matched to the structure of the standard and clause numbers included for ease of reference, each chapter now also begins with a preview to help you decide which to study and which to skip. The book also includes essential concepts and principles, important issues to be understood before embarking upon implementation, different approaches that can be taken to achieving, sustaining and improving quality, and guidance on system assessment, certification and continuing development. Clear tables, summary checklists and diagrams make light work of challenging concepts and downloadable template report forms, available from the book's companion website, take the pain out of compiling the necessary documentation. Don't waste time trying to achieve certification without this tried and trusted guide to improving your business-let David Hoyle lead you towards a better quality management system and see the difference it can make to your processes and profits!

Today, the concept of using quality as a competitive advantage has been diminished or even lost completely. It is not that there is a lack of quality improvement models, as there are many available. While each has had success, no one model that taken hold as the model. Why do improvement efforts seem to fizzle out? Why are they not sustainable? Something has been missing from the strategy, planning, and implementation of these quality efforts. That missing ingredient has been culture. This book provides the strategy, tools, and methods needed for sustainable quality. The book is based on a new quality model and explains why a positive culture is a prerequisite to sustainable quality improvement. Excellence is achieved through people, and it is this people-centric approach that should be the basis for success. By building a foundation based on inclusion, positive culture, and strong leadership, great achievements are possible. This inside-out approach creates a strong internal community which can be the catalyst for embracing change and sustainable improvement.

Quality function deployment (QFD) is an effective tool to help organizations to become more competitive by designing their products and services to satisfy customers' requirements. This book is precise and direct and focuses on the key issues in building the House of Quality otherwise known as Quality Function Deployment (QFD). By reading this book, the manager understands how to solicit customer requirement information, how design requirements are matched to customer requirements, how priorities of customer needs are established, and how activities are benchmarked. Furthermore, this new edition expands the topic to include process change initiatives on the premise that QFD cannot be achieved if the organization itself is not transformed to achieve customer satisfaction. The manager is guided on how to solve critical problems to achieve customer satisfaction. The book guides the reader to understand how companywide quality activities are related to QFD. This association is often lacking in other presentations that treat QFD as if it is independent of other quality efforts, such as process change initiative. The book will therefore include information on related quality initiatives such as: Identification of customer needs Benchmarking & re-engineering Strategic planning Quality assurance Stakeholder teams Cost control & productivity improvement Six sigma Process change initiative