This book concentrates on the quality of electronic products. Electronics in general, including semiconductor technology and software, has become the key technology for wide areas of industrial production. In nearly all expanding branches of industry electronics, especially digital electronics, is involved. And the spread of electronic technology has not yet come to an end. This rapid development, coupled with growing competition and the shorter innovation cycle, have caused economic problems which tend to have adverse effects on quality. Therefore, good quality at low cost is a very attractive goal in industry today. The demand for better quality continues along with a demand for more studies in quality assurance. At the same time, many companies are experiencing a drop in profits just when better quality of their products is essential in order to survive against the competition. There have been many proposals in the past to improve quality without increase in cost, or to reduce cost for quality assurance without loss of quality. This book tries to summarize the practical content of many of these proposals and to give some advice, above all to the designer and manufacturer of electronic devices. It mainly addresses practically minded engineers and managers. It is probably of less interest to pure scientists. The book covers all aspects of quality assurance of components used in electronic devices. Integrated circuits (lCs) are considered to be the most important components because the degree of integration is still rising.

A practical guide to Quality by Design for pharmaceutical product development Pharmaceutical Quality by Design: A Practical Approach outlines a new and proven approach to pharmaceutical product development which is now being rolled out across the pharmaceutical industry internationally. Written by experts in the field, the text explores the QbD approach to product development. This innovative approach is based on the application of product and process understanding underpinned by a systematic methodology which can enable pharmaceutical companies to ensure that quality is built into the product. Familiarity with Quality by Design is essential for scientists working in the pharmaceutical industry. The authors take a practical approach and put the focus on the industrial aspects of the new QbD approach to pharmaceutical product development and manufacturing. The text covers quality risk management tools and analysis, applications of QbD to analytical methods, regulatory aspects, quality systems and knowledge management. In addition, the book explores the development and manufacture of drug substance and product, design of experiments, the role of excipients, multivariate analysis, and include several examples of applications of QbD in actual practice. This important resource: Covers the essential information about Quality by Design (QbD) that is at the heart of modern pharmaceutical development Puts the focus on the industrial aspects of the new QbD approach Includes several illustrative examples of applications of QbD in practice Offers advanced specialist topics that can be systematically applied to industry Pharmaceutical Quality by Design offers a guide to the principles and application of Quality by Design (QbD), the holistic approach to manufacturing that offers a complete understanding of the manufacturing processes involved, in order to yield consistent and high quality products.

Covers a widespread view of Quality by Design (QbD) encompassing the many stages involved in the development of a new drug product. The book provides a broad view of Quality by Design (QbD) and shows how QbD concepts and analysis facilitate the development and manufacture of high quality products. QbD is seen as a framework for building process understanding, for implementing robust and effective manufacturing processes and provides the underpinnings for a science-based regulation of the pharmaceutical industry. Edited by the three renowned researchers in the field, Comprehensive Quality by Design for Pharmaceutical Product Development and Manufacture guides pharmaceutical engineers and scientists involved in product and process development, as well as teachers, on how to utilize QbD practices and applications effectively while complying with government regulations. The material is divided into three main sections: the first six chapters address the role of key technologies, including process modeling, process analytical technology, automated process control and statistical methodology in supporting QbD and establishing the associated design space. The second section consisting of seven chapters present a range of thoroughly developed case studies in which the tools and methodologies discussed in the first section are used to support specific drug substance and drug-product QbD related developments. The last section discussed the needs for integrated tools and reviews the status of information technology tools available for systematic data and knowledge management to support QbD and related activities. Highlights Demonstrates Quality by Design (QbD) concepts through concrete detailed industrial case studies involving of the use of best practices and assessment of regulatory implications Chapters are devoted to applications of QbD methodology in three main processing sectors—drug substance process development, oral drug product manufacture, parenteral product processing, and solid-liquid processing Reviews the spectrum of process model types and their relevance, the range of state-of-the-art real-time monitoring tools and chemometrics, and alternative automatic process control strategies and methods for both batch and continuous processes The role of the design space is demonstrated through specific examples and the importance of understanding the risk management aspects of design space definition is highlighted Comprehensive Quality by Design for Pharmaceutical Product Development and Manufacture is an ideal book for practitioners, researchers, and graduate students involved in the development, research, or studying of a new drug and its associated manufacturing process.

Handbook of Analytical Quality by Design addresses the steps involved in analytical method development and validation in an effort to avoid quality crises in later stages. The AQbD approach significantly enhances method performance and robustness which are crucial during inter-laboratory studies and also affect the analytical lifecycle of the developed method. Sections cover sample preparation problems and the usefulness of the QbD concept involving Quality Risk Management (QRM), Design of Experiments (DoE) and Multivariate (MVT) Statistical Approaches to solve by optimizing the developed method, along with validation for different techniques like HPLC, UPLC, UFLC, LC-MS and electrophoresis. This will be an ideal resource for graduate students and professionals working in the pharmaceutical industry, analytical chemistry, regulatory agencies, and those in related academic fields. - Concise language for easy understanding of the novel and holistic concept - Covers key aspects of analytical development and validation - Provides a robust, flexible, operable range for an analytical method with greater excellence and regulatory compliance

In a radical departure from the dozens of other quality books, this one makes the case that the traditional TQM procedures used in the electronics assembly field are not only ineffective-they contribute to many failures. The only book to focus exclusively on quality in electronics manufacturing-& to propose a measurable cost/benefit methodology-this provocative volume shows what's lacking in current quality programs, & how fresh approaches can yet avoid a quality "catastrophe" in the electronics industry. Along the way, numerous quality myths are exploded, hidden issues are confronted, & an array of electronics specific solutions are offered.

An authoritative guide to optimizing design for manufacturability and reliability from a team of experts Design for Excellence in Electronics Manufacturing is a comprehensive, state-of-the-art book that covers design and reliability of electronics. The authors—noted experts on the topic—explain how using the DfX concepts of design for reliability, design for manufacturability, design for environment, design for testability, and more, reduce research and development costs and decrease time to market and allow companies to confidently issue warranty coverage. By employing the concepts outlined in Design for Excellence in Electronics Manufacturing, engineers and managers can increase customer satisfaction, market share, and long-term profits. In addition, the authors describe the best practices regarding product design and show how the practices can be adapted for different manufacturing processes, suppliers, use environments, and reliability expectations. This important book: Contains a comprehensive review of the design and reliability of electronics Covers a range of topics: establishing a reliability program, design for the use environment, design for manufacturability, and more Includes technical information on electronic packaging, discrete components, and assembly processes Shows how aspects of electronics can fail under different environmental stresses Written for reliability engineers, electronics engineers, design engineers, component engineers, and others, Design for Excellence in Electronics Manufacturing is a comprehensive book that reveals how to get product design right the first time.

J.M. Juran, whom Business Week calls, "the man who taught Japan how to manage for quality", presents a new, exhaustively comprehensive approach to planning, setting, and reaching goals in Juran's Quality Road Map. New emphasis is placed on setting goals, planning in "multifunctional" processes, establishing data bases, motivating managers and introducing quality planning into organizations. 30 line drawings.

The quality your customers really need inevitably differs from the quality as prescribed in specifications, rules and regulations. The author's message is, in short, to be aware of this fact in all quality related issues. Quality as required by fitness for purpose can be in conflict with quality according to prevailing specifications, rules and regulations. It is then in the interest of the buyer to agree with the supplier on desirable exemptions. But often we can see that the supplier chooses the easy way out of just complying with the contract specifications without caring too much about the particular interests of the customer. In the Damen Shipyards Group, we try to induce a corporate culture of always paying attention to the interests of our customers and making serious efforts to serve those interests, also when there is no contractual obligation to do so. This book constitutes a welcome means to spread this word throughout the entire organisation. I wholeheartedly recommend it to whoever wishes to be a genuine quality supplier -- From publisher's provided.

This volume explores the application of Quality by Design (QbD) to biopharmaceutical drug product development. Twenty-eight comprehensive chapters cover dosage forms, liquid and lyophilized drug products. The introductory chapters of this book define key elements of QbD and examine how these elements are integrated into drug product development. These chapters also discuss lessons learned from the FDA Office of Biotechnology Products pilot program. Following chapters demonstrate how QbD is used for formulation development ranging from screening of formulations to developability assessment to development of lyophilized and liquid formats. The next few chapters study the use of small-scale and surrogate models as well as QbD application to drug product processes such as drug substance freezing and thawing, mixing, sterile filtration, filling, lyophilization, inspection and shipping and handling. Later chapters describe more specialized applications of QbD in the drug product realm. This includes the use of QbD in primary containers, devices and combination product development. The volume also explores QbD applied to vaccine development, automation, mathematical modeling and monitoring, and controlling processes and defining control strategies. It concludes with a discussion on the application of QbD to drug product technology transfer as well as overall regulatory considerations and lifecycle management. Quality by Design for Biopharmaceutical Drug Product Development is an authoritative resource for scientists and researchers interested in expanding their knowledge on QbD principles and uses in creating better drugs.

The author compiles valuable lessons learned from his work with hundreds of suppliers and customers world-wide. The design of electronics is fundamental to quality and reliability; manufacturing must follow rules regarding what to and what not to do to make defect-free products; transportation, storage and warehousing operations must adhere to certain disciplines; installation should be done correctly to avoid premature degradation; and failed products must be repaired carefully to avoid damage. Large volume and complex logistics will amplify errors so mistakes in these steps will cost the business huge amounts of money. Also covered are criteria for relevant metrics. The book concisely summarizes few very specific and high impact precautions necessary to build the quality in design. It highlights pitfalls that must be avoided in subsequent manufacturing and delivery operations that can degrade product reliability. The author emphasizes the leadership team must inspire team dynamics and collaboration with central focus on customers. The book will be useful to management and technical ranks involved in design, manufacturing and deployment and customer service. Service provider companies will also benefit from this book. As technology evolves, new products are reaching the market faster, and customers are demanding higher quality and lower cost. For your business to thrive in this environment, it will need to master the processes discussed in these pages that will serve as a valuable reference for a roadmap to success.