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Cela fait maintenant des décennies que des chercheurs et des praticiens travaillent sur le thème du management de la qualité et de la norme ISO 9001. Pour autant, des questions et des difficultés demeurent, notamment en ce qui concerne l'appropriation de la normalisation du management de la qualité et de la norme ISO 9001. C'est dans l'objectif d'y apporter des éléments de réponse que l'auteur a rédigé cet ouvrage issu partiellement de sa thèse de doctorat en sciences de gestion et du management sur l'appropriation de la norme de management ISO 9001 et son influence sur les attitudes au travail. Après avoir présenté dans une première partie le corpus théorique de la normalisation du management de la qualité, en partant du concept général de norme jusqu'à la norme ISO 9001, l'approche pragmatique de l'appropriation de la norme ISO 9001 est discutée dans la seconde partie du livre.

Kompaktes Lehrbuch für Studium und PraxisDieses Lehrbuch für Studium und Praxis ist speziell abgestimmt auf das Wirtschaftsingenieurwesen. Es wird ein breites Wissen über die wesentlichen Elemente des Qualitätsmanagements dargestellt: vom Qualitätsmanagement in der Beschaffung, der Statistik, der ISO 9001, den Qualitätsmethoden, bis hin zum Projekt- und Risikomanagement und der Servicequalität. Zudem wird ein Schwerpunkt auf das internationale Qualitätsmanagement gelegt. Zentral für das Wirtschaftsingenieurwesen sind kommunikative Kompetenzen – sei es beim Umgang mit Fehlern, bei der Lösungssuche oder beim Aufbau eines Qualitätsmanagementsystems.- Alles Wichtige zum Thema QM- Kompakte und anschauliche Darstellung- Praxisorientiert und wissenschaftlich fundiert

QUALITY PLANNING AND ASSURANCE Discover the most crucial aspects of quality systems planning critical to manufacturing and service success In Quality Planning and Assurance: Principles, Approaches, and Methods for Product and Service Development, accomplished engineer Dr. Herman Tang delivers an incisive presentation of the principles of quality systems planning. The book begins with an introduction to the meaning of the word “quality” before moving on to review the principles of quality strategy and policy management. The author then offers a detailed discussion of customer needs and the corresponding quality planning tasks in design phases, as well as a treatment of the design processes necessary to ensure product or service quality. Readers will enjoy explorations of advanced topics related to proactive approaches to quality management, like failure modes and effects analysis (FMEA). They???ll discover discussions of issues like supplier quality management and the key processes associated with quality planning and execution. The book also includes: A thorough introduction to quality planning, including definitions, discussions of quality system, and an overview of the planning process A comprehensive exploration of strategic planning development, including strategic management, risk management and analysis, and pull and push strategies Practical discussions of customer-centric planning, including customer-oriented design, quality function deployment, and affective engineering In-depth examinations of quality assurance by design, including the design review process, design verification and validation, and concurrent engineering Perfect for senior undergraduate and graduate students in technology and management programs, Quality Planning and Assurance will also earn a place in the libraries of managers and technical specialists in a wide range of fields, including quality management.

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

Lean is about building and improving stable and predictable systems and processes to deliver to customers high-quality products/services on time by engaging everyone in the organization. Combined with this, organizations need to create an environment of respect for people and continuous learning. It's all about people. People create the product or service, drive innovation, and create systems and processes, and with leadership buy-in and accountability to ensure sustainment with this philosophy, employees will be committed to the organization as they learn and grow personally and professionally. Lean is a term that describes a way of thinking about and managing companies as an enterprise. Becoming Lean requires the following: the continual pursuit to identify and eliminate waste; the establishment of efficient flow of both information and process; and an unwavering top-level commitment. The concept of continuous improvement applies to any process in any industry. Based on the contents of The Lean Practitioners Field Book, the purpose of this series is to show, in detail, how any process can be improved utilizing a combination of tasks and people tools and introduces the BASICS Lean® concept. The books are designed for all levels of Lean practitioners and introduces proven tools for analysis and implementation that go beyond the traditional point kaizen event. Each book can be used as a stand-alone volume or used in combination with other titles based on specific needs. Each book is chock-full of case studies and stories from the authors'own experiences in training organizations that have started or are continuing their Lean journey of continuous improvement. Contents include valuable lessons learned and each chapter concludes with questions pertaining to the focus of the chapter. Numerous photographs enrich and illustrate specific tools used in Lean methodologyCheck: Identifying Gaps on the Path to Success Transactional Processes contains chapters on implementing Lean, Kanban systems, line balancing, Heijunka-leveling, and the +QDIP process plus case studies of machine shop and transactional implementations. The implementation model describes the different approaches to Lean, compares them to Toyota, and explains each implementation model.

El libro contempla el proceso de auditoría en todas sus fases y las distintas actividades que dentro de cada una de ellas deben realizarse pero haciendo especial mención a aquellos aspectos que resultan críticos en cada una de ellas, sobre todo para que las pequeñas y medianas empresas puedan centrarse en ellos y dejar un poco de lado otros aspectos más accesorios que, no dejando de tener su importancia, tal vez sean más necesarios en grandes empresas.

A combination of source inspection and mistake-proofing devices is the only method to get you to zero defects. Shigeo Shingo shows you how this proven system for reducing errors turns out the highest quality products in the shortest period of time. Shingo provides 112 specific examples of poka-yoke development devices on the shop floor, most of them costing less than $100 to implement. He also discusses inspection systems, quality control circles, and the function of management with regard to inspection.

Fehlerfrei in der Produktion!Fehlerfreie Produkte sind entscheidend für die langfristige Wettbewerbsfähigkeit eines Unternehmens! Voraussetzung hierfür sind robuste und fähige Produktionsprozesse. Highlights- Ein wahre Fundgrube für Praktiker- Viele Beispiele und konkrete Tipps- Arbeitshilfen zum DownloadDieses Werk zeigt, wie sich die Qualität in der Produktion sichern und die Produktion in Richtung „null Fehler“ weiterentwickeln lässt. Die Planung und Durchführung von Prüfungen der Produktionsprozesse wird dabei ebenso behandelt wie die dabei eingesetzten Werkzeuge. Weitere Kapitel widmen sich den Themen Verbesserungsmanagement im Produktionsprozess, Audits und kontinuierliche Verbesserung durch Mitarbeiter.

These two volumes are about understanding—why—and application—how—with the aim of providing guidance and introduction to both.Quality is the consistent achievement of the user's expectations of a product or service. The achievement needs to be “The right thing, right first time, every time, in time.” Beginning with manufacturing and services, it also includes professional, personal, and spiritual dimensions.Variation does not sit happily with consistency and skill in handling risk and opportunity requires competence in the use of statistics, probability, and uncertainty; and needs to complement the critically essential soft dimensions of quality and the overarching and underpinning primacy of personal relationships.There are no clear boundaries to the applicability of quality and the related processes and procedures expressed in management systems, and this is why it matters so much to show “how it applies in diverse business and social environments.” Increasingly, the acceptability of boundaries that are drawn depends on their effect on the user and the achievement of quality, and the latest standards on quality management are explicit on this key point.Quality is everyone's business, and there is no single professional discipline that can properly express this. Insights, knowledge, experience, best practice, tools, and techniques need to be shared across all kinds of organizational and professional boundaries, and there is no departmental boundary that can stand apart from the organization-wide commitment to quality achievement.

These two volumes are about understanding—why—and application—how—with the aim of providing guidance and introduction to both.Quality is the consistent achievement of the user's expectations of a product or service. The achievement needs to be “The right thing, right first time, every time, in time.” Beginning with manufacturing and services, it also includes professional, personal, and spiritual dimensions.Variation does not sit happily with consistency and skill in handling risk and opportunity requires competence in the use of statistics, probability, and uncertainty; and needs to complement the critically essential soft dimensions of quality and the overarching and underpinning primacy of personal relationships.There are no clear boundaries to the applicability of quality and the related processes and procedures expressed in management systems, and this is why it matters so much to show “how it applies in diverse business and social environments.” Increasingly, the acceptability of boundaries that are drawn depends on their effect on the user and the achievement of quality, and the latest standards on quality management are explicit on this key point.Quality is everyone's business, and there is no single professional discipline that can properly express this. Insights, knowledge, experience, best practice, tools, and techniques need to be shared across all kinds of organizational and professional boundaries, and there is no departmental boundary that can stand apart from the organization-wide commitment to quality achievement.

The BASICS Handbook is designed to show personnel at all levels within a manufacturing operations environment that, with easy to understand continuous improvement tools, they can make a difference to operational performance where safety, quality, cost, delivery, and people are paramount to business success. The tools and techniques throughout, based upon examples from the author's experience, demonstrate that no matter what industry, they can bring the desired added value.This book will help any manufacturing shop floor add value in terms of quality/cost and delivery performance. It will also show how using tools and techniques from the “coal face” out will improve process performance by using simple data collection and measurement – not only on outputs, but just as importantly on “critical to quality inputs” such as process parameters and their processing windows – to deliver the desired output KPIs. The power and confidence that this gives to local experts and processing teams enable them to make informed decisions, preventing drifts and non-conforming product: prevention being better than cure.The result of these changes is a tangible cultural impact on the shop floor, raising the level at which operating teams work and improving morale. BASICS will enable staff at all levels to understand their performance measures and produce sustainable results. The book contains practical tools, methods, and techniques that have been tried and tested by the author over a successful 30-year career as a contractor transforming variable processing and inconsistent KPI results.

Von A wie Audit bis Z wie Zuverlässigkeit: Dieser Band enthält die wichtigsten Begriffe und Abkürzungen des Qualitätsmanagements. In knapper, aber trotzdem verständlicher Form und direkt auf die Praxis zugeschnitten erhalten Sie einen Überblick über die aktuelle Bandbreite des Qualitätsmanagements, können Zusammenhänge erkennen und Handlungsanleitungen ableiten.Highlights- Sowohl für den erfahrenen Fachmann als auch für den Einsteiger geeignet- Zum Nachschlagen oder zum Schmökern- Kompakt, klar und auf den Punkt gebracht

The facilitator's guide is a companion to Organization Teams: Building a Continuous Quality Improvement. This guide provides lesson plans, including suggested time allocation, masters that can be used to create your own transparencies, quality bucks photocopy masters, a method for randomly assigning participants to teams, a'little instructor'who will offer suggstions and share ideas.

The implementation of quality management can be seen as a sequence of projects and evolves as a result of how projects are planned, executed and closed. This book explores quality management from a project management perspective, based on the author's long experience of teaching and practicing, including the implementation and operation of quality management systems within various types of organisations.The author explores the origins of quality management as a discipline, it's appearance in the present form and how quality management can be implemented and applied in all kinds of organisations to achieve stability and better results. The basic principles of quality management and the ISO9001 quality management standard are discussed and explained from a broad perspective, with illustrative examples from different types of organisations.Quality Management offers a global, accessible guide for undergraduate and postgraduate university students. Written clearly and with illustrative examples, it will also appeal to all those interested in project management and quality management and wishing to expand their knowledge base.

Freedom Within a Framework: Hearing the Voice of the Customer on the Factory Floor (978-0-367-08577-3, K406714)Shelving Guide: Business and Management/Customer Satisfaction/QualityThis book shows you how to harmonize three business functions to address customer needs by using a novel approach that combines Design for Six Sigma (DFSS) and Continuous Improvement tools. The DFSS tool used is the Quality Function Deployment (QFD) process, which is also known as the House of Quality (HOQ). Although these are techniques reserved for the design of new products, the book illustrates how the HOQ helps translate exactly what customers specifically find important about your products. In addition, if customers are experiencing issues with that product, it helps map those issues and prioritizes the Critical to Quality (CTQ) parameters. Because the HOQs tie the Voice of the Customer to CTQs, it continues to connect to the product design and ends with manufacturing process variables. This linkage makes this idea and approach unique.Stopping there may show that there is linkage between the customer and manufacturing process variables, but moving ahead, we must also connect the functions within the business that provides the product. The book helps define the key business function as three large business functions that must work as one cohesive and unified team. These functions are: commercial (sales and marketing), R&D (product properties and services), and operations (product quality). Connecting these functions involves many colleagues, and a very effective communication process among the three is vital for the success of the product and customer satisfaction.Understanding the voice of the customer is paramount—not doing so could lead to product performance issues and loss of market share. In addition, repeated customer dissatisfaction permeates internal workplace culture—employees begin to feel that they are producing products disconnected from end users'needs and wants.

La Boîte à outils de la qualité propose 68 outils essentiels et immédiatement opérationnels à toutes les étapes d'une démarche qualité :- pour engager un processus de certification ISO 9001 ou une démarche centrée client ;- pour déployer un management par les processus ;- pour dynamiser un système qualité déjà en place ;- pour assurer la conformité des produits et prestations.Dans cette 4e édition mise à jour, les outils sont regroupés par thématiques, présentés de manière visuelle sur deux ou quatre pages : une représentation graphique, l'essentiel, Pourquoi et Comment l'utiliser, les avantages et les précautions à prendre, et des approfondissements et cas pratiques.

ISO 9000 is a comprehensive set of international standards for quality management and quality assurance. These standards ensure that companies effectively document all aspects of their quality management to show transparency and efficiency within all processes. They are not industry specific and pertain to organizations of any size. Continuous improvement is a key facet of the ISO 9001 standard (the particular standard that specifies requirements for a quality management system), but it does not explain how to implement or maintain this improvement. Lean production methodologies surely provide this crucial and tactical information. Adding Lean production methodologies to quality management systems effectively focuses these improvement activities. In the long run, it will save companies much time and money. This book, written in the novel format, discusses the symbiotic relationship between ISO 9001 and Lean as both can be seamlessly integrated. It shows how Lean provides the process improvements that are required by the ISO 9001 quality management system – Lean is crucial for identifying and removing waste from your processes, which ultimately creates greater customer value. In addition, the book shows the crucial financial benefits of this integration. This novel clearly illustrates that these two systems can function effectively is one understands the complex balance of standardization and change. ISO 9001 is clearly controlled and audited while Lean is often empowering, less meticulously audited, and rarely controlled. While presenting interesting characters and interactions, this fictional story embeds real-life manufacturing speak with a message of the importance of successful synergy between Lean practitioners, production leaders, and quality departments.

Winner of the Walter E. Masing Book Prize 2019 at the International Academy for Quality.Perceptions as to the nature of the Quality Sciences and disciplines vary across the world depending on local industrial history. This can cause problems for global organisations who often want to retain the quality policies of the parent company whilst attempting to embrace the approaches familiar to local people. For example, whilst Western organisations have embraced Six Sigma, Lean and other Japanese management techniques, we have tended to adopt them in a hotchpotch fashion, bolting them on without ever understanding the context behind total quality control. In Japan, these concepts are not considered to be standalone but are all part of a seamless companywide matrix of interactive concepts, which can be summed up as company-wide quality work, of, by and for all. In essence, this means that ‘quality'is everybody's responsibility from the chief executive downwards. David Hutchins has over several decades worked in all of the cultural blocks and has consistently managed to integrate all of these differences into a single companywide approach. When the concepts covered are integrated into a total company-wide programme, the intention is to make that organisation the best in its business; in Japanese terms this implies ‘Dantotsu', which means ‘number one thinking'. Accessible and practical in approach, Quality Beyond Borders is split into short sections, each representing a self-contained idea for the reader to digest and reflect on. It is a valuable resource for business practitioners, students and academics alike that will enable you to reach beyond your own borders to implement new ideas with significant results.

The current economic climate, characterized by growing international competition, is forcing companies to rethink their approach in terms of strategy, the customer and supplier relationship, processes and human resource management. In this context,'quality management'- synonymous with efficiency, effectiveness and competitiveness, becomes essential. Quality Management: Tools, Methods and Standards fills a gap in the current literature by providing an updated overview of the discipline and its boundless fields of application from industry to public administration. Written by authors with both academic and practitioners backgrounds, the book serves as a culmination of the knowledge they have gained as managing directors and chairmen of leading companies. Starting from the history of quality, the authors provide the reader with a review of the main tools and approaches aimed at improving effectiveness and efficiency in organizations. Balanced scorecard, QFD, and FMEA are some of the solutions that are first introduced theoretically and then described in their application. International standards are also broadly discussed: ISO 9001, ISO 14001, ISO 45001, ISO 27001 and SA8000 are described in their essential features and implementation patterns. This book should be considered a must-read for students, academics, and practitioners who are interested in the theory and practice of quality management.

Poka Yoke ist eine Qualitätsmethode zur Fehlervermeidung mit dem Ziel, Null-Fehler-Prozesse zu erreichen. Einfache, effektive Lösungsansätze neutralisieren Fehlerquellen.Dieser Pocket Power-Band stellt das Prinzip und die Techniken von Poka Yoke vor und gibt eine praxisorientierte Anleitung zur Umsetzung, besonders im Rahmen einer bestehenden Qualitätsmanagementsystem- und Methodenarchitektur.Highlights- Fehler von vornherein verhindern- Direkt in Ihre Praxis umsetzbar- Mit vielen Beispielen

من أهم التطورات في مجال إدارة الأعمال بصورة خاصة وإدارة المنظمات بصورة عامة في القرن الماضي والقرن الحالي هو بروز أهمية إدارة الجودة الشاملة ونظم إدارة الجودة بعد أن باتت جميع منظمات الأعمال تناشد الإجادة في جميع أعمالها وبالتالي أصبح القرار الاستراتيجي يضم بين طياته كيفية تحقيق التمايز من خلال جودة المنتج لذلك فإن نظم الجودة أمست غاية وهدف الإدارة الناجحة والجهة الساندة لمواجهة التحديات التنافسية ومسعى اجتماعي وأخلاقي في نفس الوقت.

This book is a crucial resource for Lean practitioners (experienced or not) who are seeking: insight on how to gain more from their Lean efforts, how to overcome resistance to change (that is, to effectively convey'What's in it for me?'to their business associates), and to understand how other companies have overcome the barriers to implementing Lean and incorporated it as the common-sense approach to continuous improvement. The author shares his specific experiences with Lean transformations—some successes and some failures. His insightful perspective shows readers how the understanding of Lean progresses from theory to common sense to common practice. The Lean initiative is not merely a transformation of skills, but the development of a robust continuous-improvement culture. The book includes more than 60 case-in-point examples, across a diversified range of industries, based on the author's hands-on experience with many multinational corporations. These case-in-point examples show transformations that have resulted in $200+ million verified annualized savings for a diversified array of industries. The author details his journey from industry Lean practitioner to a consultant in a top-tier consultancy firm to developing his own consulting practice.

This book introduces fundamental, advanced, and future-oriented scientific quality management methods for the engineering and manufacturing industries. It presents new knowledge and experiences in the manufacturing industry with real world case studies. It introduces Quality 4.0 with Industry 4.0, including quality engineering tools for software quality and offers lean quality management methods for lean manufacturing. It also bridges the gap between quality management and quality engineering, and offers a scientific methodology for problem solving and prevention. The methods, techniques, templates, and processes introduced in this book can be utilized in various areas in industry, from product engineering to manufacturing and shop floor management. This book will be of interest to manufacturing industry leaders and managers, who do not require in-depth engineering knowledge. It will also be helpful to engineers in design and suppliers in management and manufacturing, all who have daily concerns with project and quality management. Students in business and engineering programs may also find this book useful as they prepare for careers in the engineering and manufacturing industries. Presents new knowledge and experiences in the manufacturing industry with real world case studies Introduces quality engineering methods for software development Introduces Quality 4.0 with Industry 4.0 Offers lean quality management methods for lean manufacturing Bridges the gap between quality management methods and quality engineering Provides scientific methodology for product planning, problem solving and prevention management Includes forms, templates, and tools that can be used conveniently in the field

To succeed, an organization must cultivate management systems that effectively align their work and behaviors with principles and direction. These systems should be simple, comprehensible, actionable, and standardized. Establishing alignment in every value stream of an organization will ultimately create value for their customers and produce the desired results. This alignment stems from an understanding of why an organization exists, where it is going, and how it will get there. Enterprise Alignment and Results guides readers to their goal of enterprise-wide alignment by providing a deeper look at the Shingo Model. This book builds upon the previous books in the Shingo Model Series by continuing to define ideal behaviors and the systems that drive them and increasing understanding of fundamental beliefs and how to use behavioral benchmarks. As readers examine the principles of'Create Constancy of Purpose,''Think Systemically,'and'Create Value for the Customer,'they will gain a deeper knowledge of the relationship between behaviors, systems, and principles. This knowledge will foster an understanding of how to create alignment within their organizations, thereby increasing the consistency of delivering ideal results.

Risk is everywhere. It does not matter where we are or what we do. It affects us on a personal level, but it also affects us in our world of commerce and our business. This indispensable summary guide is for everyone who wants some fast information regarding failures and how to deal with them. It explores the evaluation process of risk by utilizing one of the core methodologies available: failure modes and effects analysis (FMEA). The intent is to make the concepts easy to understand and explain why FMEA is used in many industries with positive results to either eliminate or mitigate risk.

Data integrity is a global mandatory requirement for the regulated healthcare industry. It is more than a mere expectation-it's a basic element of good documentation practices, one of the most fundamental pillars of a quality management system. Robustness and accuracy of the data submitted by manufacturers to regulatory authorities when bringing a medical product to market are crucial. The purpose of this book is to consolidate existing data integrity principles and expectations from several regulatory sources-including the U.S. Food and Drug Administration, World Health Organization, and European Medicines Agency-into a single and handy document that provides detailed, illustrative implementation guidance. It serves as a means of understanding regulatory agencies'position on good data management and the minimum expectation for how medical product manufacturers can achieve compliance.

Equipment Qualification in the Pharmaceutical Industry provides guidance and basic information for the preparation of a quality qualification program. It has been noted that there is a general lack of understanding in the industry, especially for those new to the industry, as to what constitutes a compliant qualification program. Even experienced professionals have felt a lack of security in reaching a compliant state. This book outlines a guideline for the preparation and execution of qualification protocols including the installation (IQ), operational (OQ), and performance (PQ) protocols. It discusses the importance of related qualification programs (e.g., quality systems, commissioning, computer system, and cleaning) and how to incorporate them into a fully compliant qualification program. Furthermore, it provides matrices of what could be included in each type of protocol for major types of process equipment. While primarily for people entering the pharmaceutical industry, those established in the field will benefit from the multiple examples and matrices as well as integration of related systems. Equipment Qualification in the Pharmaceutical Industry provides students and pharmaceutical scientists a guideline for the preparation and execution of qualification (installation, operational, and performance) protocols. Incorporates good manufacturing processes into a compliant qualification program Provides examples of protocol layout Includes matrices for major process equipment, installation quality, operational quality, and performance quality requirements

Pharmaceutical Quality by Design: Principles and Applications discusses the Quality by Design (QbD) concept implemented by regulatory agencies to ensure the development of a consistent and high-quality pharmaceutical product that safely provides the maximum therapeutic benefit to patients. The book walks readers through the QbD framework by covering the fundamental principles of QbD, the current regulatory requirements, and the applications of QbD at various stages of pharmaceutical product development, including drug substance and excipient development, analytical development, formulation development, dissolution testing, manufacturing, stability studies, bioequivalence testing, risk and assessment, and clinical trials. Contributions from global leaders in QbD provide specific insight in its application in a diversity of pharmaceutical products, including nanopharmaceuticals, biopharmaceuticals, and vaccines. The inclusion of illustrations, practical examples, and case studies makes this book a useful reference guide to pharmaceutical scientists and researchers who are engaged in the formulation of various delivery systems and the analysis of pharmaceutical product development and drug manufacturing process. Discusses vital QbD precepts and fundamental aspects of QbD implementation in the pharma, biopharma and biotechnology industries Provides helpful illustrations, practical examples and research case studies to explain QbD concepts to readers Includes contributions from global leaders and experts from academia, industry and regulatory agencies

Underline by the importance of sustainable quality management practices to contemporary organizations, this edited book complies best practice cases of leaders who have initiated and facilitated quality practices in their organizations. The cases highlight how these best practices manifested in their work cultures, values, and beliefs. Not only do they address organizational efforts towards implementation of quality practices, but they also discuss the challenges the leaders faced to instill a sense of quality in practices across the hierarchical structures of their organizations. The book highlights the profiles of quality leaders, their journey and their successes in leading quality in their organizations. A book would be an interesting read for those who are eager to integrate quality in their work culture. A key message emerging from these expertise is that ‘passion'is truly behind the quality success!

The book is about applying Lean manufacturing principles to industrial maintenance in order to improve the efficiency and be able to do more with the same (or less) resources. By industrial maintenance we mean the maintenance that takes place in factories and industrial facilities. The book is the result of multiple improvement projects carried out by the authors in various industrial settings and sectors in the past 10 years.The approach works and can be applied in any industry. It yields results without investment. The book is a step-by-step guide that takes the reader through the maintenance process, from equipment failure to finished repair. In each step of the process, the typical inefficiencies are explained and tools are given to improve the process. The book is meant to be used as a guide in an improvement journey. The improvement approach presented in the book is very close to the shop floor and instructs the reader to engage with all team members in the maintenance department in every step of the process, in order to make the improvements sustainable.If one looks at the main market indexes, between one third and one half of companies on those indexes belong to the industrial sector: automotive, power generation, basic materials, chemicals, consumer goods, et cetera. Those companies spend on average 2 – 5% of plant replacement value per year on maintenance. About one third of this cost is maintenance labor.The maintenance work that gets done every day in factories around the world is typically inefficient, from a Lean perspective: time is wasted, different tasks are not properly coordinated, job durations are overestimated and job plans, when they exist, are thus'inflated'to cover up the inefficiency.All this happens because maintenance tends to be the'forgotten'area of efficiency in industrial companies, as much of the improvements are carried out on the (literally) productive areas of the factories. When companies set out to'improve'maintenance, they typically do it through budget cuts that can risk the reliability of the equipment.The authors believe there is a better way to do more with the same resources through a carefulreview of the current way of working and the introduction of Lean.With this book, the authors try to bring to maintenance managers and practitioners the tools theyneed to quickly improve efficiency (in a matter of weeks) without any investment.

This book is the leader among the new generation of text books on quality that follow the systems approach to creating quality in products and services; the earlier generations focused solely on parts of the system such as statistical methods, process control, and management philosophy. It follows the premise that the body of knowledge and tools documented by quality professionals and researchers, when employed in designing, creating and delivering the product will lead to product quality, customer satisfaction and reduced waste. The tools employed at the different stages of the product creation cycle are covered in this book using real world examples along with their theoretical bases, strengths and weaknesses. This textbook can be used for training - from shop floor personnel to college majors in business and engineering to practicing professionals. Graduate students training as researchers in the quality field will also find useful material. The book has been used as the text for a Professional Series Massive Open Online Course offered by the Technical University of Munich on edX.org, through which tens of thousands of participants from all over the world have received training in quality methods. According to Professor Dr. Holly Ott, who chose the book for the course, the text is one of the main factors contributing to success of this MOOC. The Third Edition has been fully revised to be friendly for self-study, reflects changes in the standards referenced such as ISO 9000, and includes new examples of application of statistical tools in health care industry.Features: Reviews the history of quality movement in the U.S. and abroad Discusses Quality Cost analysis and quality's impact on a company's bottom line Explains finding customer needs and designing the product using House of Quality Covers selection of product parameters using DOE and reliability principles Includes control charts to control processes to make the product right-the-first-time Describes use of capability indices Cp and Cpk to meet customer needs Presents problem solving methodology and tools for continuous improvement Offers ISO 9000, Baldrige and Six Sigma as templates for creating a quality system

Lean Production for Competitive Advantage: A Comprehensive Guide to Lean Methodologies and Management Practices, Second Edition introduces Lean philosophy and illustrates the effective application of Lean tools with real-world case studies. From fundamental concepts to integrated planning and control in pull production and the supply chain, the text provides a complete introduction to Lean production. Coverage includes small batch production, setup reduction, pull production, preventive maintenance, standard work, as well as synchronizing and scheduling Lean operations. Detailing the key principles and practices of Lean production, the text also: Illustrates effective implementation techniques with case studies from a range of industries. Includes questions and completed problems in each chapter. Explains how to effectively partner with suppliers and employees to achieve productivity goals Designed for students who have a basic foundation in production and operations management, the text provides a thorough understanding of the principles of Lean. It also offers practical know-how for implementing a culture of continuous improvement on the shop floor and in the office, creating a heightened sense of responsibility in all stakeholders, and enhancing productivity and efficiency to improve the bottom line.In this second edition, the author addresses management's role in Lean production. Early observers of Japanese methods focused on the shop floor to see amazing things unlike anything practiced elsewhere. And the thinking was, if the'methods'could be adopted by companies elsewhere, those companies would experience the success of the Japanese. What the early observers hadn't considered were dramatic differences in the way those companies were managed, both daily and strategically. The'management side'of Lean production is addressed in two new chapters, one devoted to daily management, the other to strategy deployment. Additionally, there is a new chapter that addresses breakthrough improvement and an approach to achieving it called Production Preparation Process.Every chapter has been revised and expanded to better tell the story of Lean production—itshistory, applications, practices, and methods.

Leading Reliable Healthcare describes ‘state of the art'healthcare management systems. The key focus of the publication is ‘reliable'; describing how leadership can ensure never less than reliable standards of care for patients and how excellence can be achieved. The focus throughout is on ensuring that patients and their families can depend on a reliable healthcare system for their needs, fulfilling their expectations that hospitals are trustworthy, stable and capable of dealing with their health, from the simplest to the most complex illnesses.Each of the chapters focuses on a different aspect of building a reliable healthcare system, concentrating on the leadership necessary to deliver and manage the different component elements of the healthcare system. The nominated contributors for this book are recognized leaders from various healthcare systems around the globe, including the UK, USA, Canada and South Korea/Singapore. The contributors have been selected to ensure a wide perspective of healthcare management, building on diverse approaches, practices and experiences, and are currently practicing healthcare management in their respective systems. The book aims to focus on the pragmatic rather than theoretical and will provide a series of practical methodologies and case studies to help improve decision making in healthcare management.With contributions by: Sallie J. Weaver, PhD, MHS, Associate Professor, Armstrong Institute for Patient Safety and Quality and Dept. of Anesthesiology & Critical Care Medicine, John Hopkins University School of Medicine Susan Mascitelli, Senior Vice President, Patient Services & Liaison to the Board of Trustees, New York-Presbyterian Hospital Dr. Sandra Fenwick, Chief Executive Officer, Boston Children's Hospital Martin A. Makary, MD, MPH, Professor of Surgery, Johns Hopkins University School of Medicine; Professor of Health Policy and Management, John Hopkins Bloomberg School of Public Health Frank Federico, RPh, Vice President, Institute for Healthcare Improvement Dr. Hanan Edrees, Manager, Quality Management, KAMC-Riyadh Dr. Hee Hwang, CIO and Associate Professor; Seoul National University Bundang Hospital, Department of Pediatrics, Division of pediatric Neurology, Center of Medical Informatics Dr. M. Andrew Padmos, Chief Executive Officer, The Royal College of Physicians and Surgeons of Canada Professor Richard Hobbs, Professor of Primary Care Health Sciences, Director, NIHR English School for Primary Care Research, Nuffield Department of Primary Care Health Sciences, University of Oxford Ms. Jules Martin, Managing Director, Central London Clinical Commissioning Group Dr. Bruno Holthof, Chief Executive Officer, Oxford University Hospitals Tara Donnelly, Chief Executive, Health Innovation Network, South London Göran Henriks, Chief Executive of Learning and Innovation, Qulturum, County Council of Jönköping, Sweden

Mediante el manual Sistemas de Gestión de Calidad (9001:2015) conocerá los últimos cambios sobre las modalidades Gestión de Calidad. Aprender a valorar el concepto del Sistema de Gestión de Calidad, comprender en qué se basan y en qué consisten las modificaciones que se proponen con los cambios en la norma. Este manual analiza los principales cambios que ha introducido la ISO 9001:2015 ayudando a comprender el nuevo enfoque y dotándoles de las herramientas y conocimientos necesarios para llevar a cabo con éxito la transición a la nueva norma adaptando los Sistemas de Gestión de la Calidad de las empresas a las nuevas directrices.

Søren Bisgaard was an extremely productive and insightful scholar of modern industrial statistics and quality engineering. He was amazing for both his breadth of interests and the depth of his scholarship. Søren was one of the very few people making substantial contributions in so many basic areas in statistics and quality engineering. This compilation collects 31 of his works and is divided into four broad areas: Design and Analysis of Experiments Time Series Analysis The Quality Profession Healthcare Engineering This book provides a comprehensive coverage of essential statistical methods for the 2k-p factorial system and shows the basic principles of time series analysis through examples. Furthermore, this book presents the connection between the application of the scientific method and quality improvement, and it points out the importance of quality improvement to tangible financial results. Finally, this book explains the seemingly paradoxical idea that we can enhance quality while reducing cost of healthcare.

The standard tells you what to implement; this book focuses on how and why. Many organizations implement ISO 9001 and see only mild improvements. This book is a collection of concepts that can assist you in implementing a very successful ISO 9001 quality management system. Its concepts go beyond the basic implementation steps so widely available in the marketplace, instead helping you to use the ISO 9001 standard as a tool for organizational growth and success. Instead of being organized sequentially by the standard's clauses, it is split into three sections that outline how to go about satisfying the standard's requirements: Organize, Scrutinize, and Optimize. Each of these chapters includes sporadic WHAT TO DO action items to transform theory into practice. This book is intended for anyone leading the ISO 9001 implementation effort, including quality managers, management reps, executives, and consultants. It is to be used in addition to ISO 9001 training courses, packages, and consulting assistance. Read this book while you are simultaneously attending ISO 9001 courses, going through purchased how to” packages, or working with a consultant. Review it again as your implementation nears certification. Reread the later sections of the book after certification is achieved.

Author and experienced quality management consultant Carlos Pereira da Cruz has written this book with one goal in mind: to offer you a practical and straightforward way to adapt your quality management system to your business, while meeting the requirements of ISO 9001:2015. Discover ISO 9001:2015 Through Practical Examples is primarily for beginners in quality management systems, and for people with moderate knowledge of ISO 9001. However, if you are an experienced quality practitioner, but are disappointed with bureaucratic side of the standard, this book will show you a practical and relevant method of applying ISO 9001 to your business rather instead of blindly following policies and procedures. The main focus of the book is author's desire to show you a different approach to the QMS. As he says at the beginning of the book, “What I see too often is Quality Management Systems with too few or too many documents, but concentrated on listing tasks that people must perform. And people perform their tasks, and companies remain certified, but nothing else happens.” Rather than looking at the standard that way, da Cruz says, “This book is about how to build a Quality Management System from scratch without looking at ISO 9001; the standard will naturally come afterwards when we show the relationship between sound management practices and ISO 9001 clauses.” Even though this book is written to be short and simple, it has more than 50 case studies, charts, diagrams and tables to help you develop your own QMS. Da Cruz has written the book using plain English, which is easy to understand for beginners. Using practical examples to help you understand the relationship between your regular business operations and ISO 9001:2015, he shows you that you're not just implementing the standard to prove compliance, you're doing it to improve the business.

Here's the quickest and most inexpensive way to learn about the pioneering work of Shigeo Shingo, co-creator (with Taiichi Ohno) of just-in-time. It's an introductory book containing excerpts of five of his classic books as well as an excellent introduction by Professor Robinson.

Although many businesses, organizations, and institutions have currently implemented continuous improvement initiatives that address wants, needs, and challenges at the process and systems level, very few have effectively considered and addressed human factors. Thus, even businesses, organizations, and institutions with the most finely crafted continuous improvement systems face failure from inadequate human factors continuous improvement. Continuous Improvement by Improving Continuously (CIBIC): Addressing the Human Factors During the Pursuit of Process Excellence explains how the frustrating reoccurrence of operating failures are the result of flawed or fragmented business philosophies and principles. CIBIC is designed to promote the pursuit of excellence from mediocrity using an adaptable strategic model that promotes the pursuit of continuous improvement and sustainability in operations, performance management, and personal endeavors. By transforming the pursuit of excellence from a hit-and-miss endeavor to an easily achievable and sustainable continuous endeavor, CIBIC creates value where other systems fail. By addressing gaps, disconnects, and chaotic realities at a fundamental level through the sustained use of frameworks, methods, and analytics, CIBIC promotes the pursuit of excellence across the wide range continuum, eradicating the value and philosophical disconnects that generally plague individuals and collective interests. This book addresses this systemic problem by highlighting an incredibly comprehensive system that promotes continuous improvement and the pursuit of excellence. By highlighting key inner drivers, essential outer qualities, and supporting models and frameworks, the book makes the pursuit of excellence an easily sustainable and logical endeavor.

This book will address key organizational issues that must be considered and addressed when implementing Lean business practices. The book offers solutions for many of the challenges, provides a resource that leaders can use in addressing cultural and regulatory issues, provides means to address the associated people issues and the challenging task of knowledge retention and succession planning. Vignettes are used to illustrate and provide examples of potential issues and solutions that can be considered for resolving issues and a case study demonstrating ways to address the technical and people aspects of implementing Lean to ensure project success.

What is risk based thinking? Do you know how to address risks and opportunities? Did you ever analyzed risks? Are you sure it is that what the ISO 9001 expects? What do you really know about knowledge management? Can you identify the types of knowledge in your organization? How do you maintain knowledge? What is awareness in the eyes of the ISO 9001 Standard? Can you tell the relation between awareness and the effectiveness of the QMS? This book explains in details all the new issues and topics required by the ISO 9001:2015 Standard and gives you the tools and tricks to answer the new requirements. Just read and do. The table of contents in the book are identical to the table of contents of the standard so you can orient yourself quite easily and find the specific advice you are looking for.

This book provides an assorted set of reflections/lessons from the'trenches'of Lean service and brings to fore leadership challenges, new tools, and the known-unknowns (insights that very few know but many in journey of Lean transformation need to know). Lean has the ability to address a wide range of problems faced by service companies, such as: complexity reduction, sales force productivity enhancement, operations risk control, cost leadership, combining scale with flexibility, service excellence and improving employee morale and involvement. Many of the principles discussed in the book are based on the author's first-hand experience in Lean implementation.

Quality is a discipline that focuses on product and service excellence. This book is about improving the quality of products and services. The improved quality and reliability lead to higher perceived value and increased market share for a company, thereby increasing revenue and profitability. The book discusses the concepts and dimensions of quality, costs of poor quality, the importance of quality in this highly competitive global economy, and quality programs-Six Sigma and Lean Six Sigma that focus on improving quality in industries. The text integrates quality concepts, statistical methods, and one of the major tools of quality-Statistical Process Control (SPC)-a major part of Six Sigma control phase. A significant part of the book is devoted to process control and the tools of SPC-control charts-used for monitoring, controlling, and improving the processes by identifying the causes of process variation. The fundamentals of control charts, along with SPC techniques for variables and attributes, and process capability analysis and their computer applications are discussed in detail. This book fills a gap in this area by showing the readers comprehensive and step-wise solutions to model and solve quality problems using computers.

For the past decade, process validation issues ranked within the top six of Food and Drug Administration (FDA) form 483 observation findings issued each year. This poses a substantial problem for the medical device industry and is the reason why the authors wanted to write this book. The authors will share their collective knowledge: to help organizations improve patient safety and increase profitability while maintaining a state of compliance with regulations and standards. This book was written to assist quality technicians, engineers, managers, and others that need to plan, conduct, and monitor validation activities. To that end, the intent of this book is to provide the quality professional working in virtually any industry a quick, convenient, and comprehensive guide to properly conducting process validations that meet regulatory and certification requirements. It provides an introduction and background to the requirements necessary to perform process validations that will comply with regulatory and certification body requirements.

The Lean Anthology: A Practical Primer in Continual Improvement presents operations management case studies that illustrate a Lean process improvement journey. Ideal for non-engineers, adult learners, and corporate or business education settings, this book can help you and your organization understand and apply Lean practices as part of a plan for

Mastering Project Time Management, Cost Control, and Quality Management gives managers powerful insights and tools for addressing the'Triple Constraints'that define virtually every project: time, cost, and quality. This book is part of a new series of seven cutting-edge project management guides for both working practitioners and students. Like all books in this series, it offers deep practical insight into the successful design, management, and control of complex modern projects. Using real case studies and proven applications, expert authors show how multiple functions and disciplines can and must be integrated to achieve a successful outcome. Individually, these books focus on realistic, actionable solutions, not theory. Together, they provide comprehensive guidance for working project managers at all levels, including highly-complex enterprise environments. These books also provide indispensable knowledge for anyone pursuing PMI/PMBOK or PRINCE2 certification, or other accreditation in the field.

Many organizations are looking for that magic tool or methodology that will suddenly transform them into outstanding organizations. Unfortunately, there is no one right answer for all organizations or even for a single organization. Successful organizations skillfully integrate the appropriate improvement approaches with honesty, commitment, and co

The recognition that all well-managed companies are interested in preventing or at least minimizing risk in their operations is the concept of risk management analysis. This pocket guide explores the process of evaluation of risk by utilizing one of the core methodologies available: the failure mode and effect analysis (FMEA). The intent in this “Pocket FMEA” is to provide the reader with a booklet that makes the FMEA concept easy to understand and provide some guidelines as to why FMEA is used in so many industries with positive results. The booklet is not a complete reference on FMEA, but rather a summary guide for anyone who wants some fast information regarding failures and how to deal with them. It covers risk, reliability and FMEA, prerequisites of FMEA, what an FMEA is, robustness, the FMEA form and rankings, types of FMEA, and much more.

Reduced market share, lack of repeat customers, and added costs are just a few ways warranty claims can hurt an organization. Avoiding complex mathematics or accounting terminology, Warranty Claims Reduction: A Modern Approach with Continuous Improvement Techniques explains how to boost profits through the reduction of warranty expenses in your org