Kvalitetssikring og kvalitetsstyring

Etableringen af resultatbaserede ledelsessystemer er blevet en del af de fleste offentlige organisationers hverdag. Der formuleres i stigende grad mål, udvikles indikatorer, indsamles og rapporteres data og mængden af resultatinformation om offentlige organisationers indsatser er vokset markant. Formålene med  resultatbaserede ledelsessystemer og tilvejebringelsen af resultatinformation er mange. Det kan fremme gennemsigtighed og ansvarlighed i den offentlige sektor, skabe fokus og retning i en organisation, have en motiverende effekt på medarbejderne samt skabe et udgangspunkt for bedre styring og kontrol, øget læring, mere oplyste beslutninger og i sidste ende forbedringer af offentlige organisationers indsatserPå trods af de mange gode formål er resultatbaseret ledelse løbende blevet mødt af kritik. Denne kritik kan samles i fem centrale indvendinger. Disse fem indvindinger udgør bogens struktur:  Den offentlige sektors ydelser er så komplekse, at det ikke er muligt at måle resultaterne af indsatserne. Resultatbaserede ledelsessystemer anvendes som udgangspunkt for at kontrollere medarbejderne og kan derved risikere at fortrænge medarbejdernes motivation. En stor del af den information, der tilvejebringes gennem resultatmålingssystemer, bliver aldrig bragt i anvendelse i ledelses- og beslutningssituationer. Resultatbaserede ledelsessystemer fører til en række utilsigtede dysfunktionelle adfærdsmæssige effekter. Resultatbaserede ledelsessystemer har en tendens til at eskalere og miste deres simplicitet over tid.Formålet med denne bog er at dykke ned i kritikken af resultatbaseret ledelse og resultatbaserede ledelsessystemer, forstå baggrunden for kritikken og under hvilke betingelser indvendingerne i særlig grad vil forekomme. På den baggrund diskuteres det, hvordan offentlige ledere kan arbejde med resultatbaseret ledelse med henblik på i højere grad at hæmme eller overkomme udfordringerne.Bogens målgruppe er studerende i statskundskab samt diplom- og masteruddannelser i offentlig ledelse samt andre lederuddannelser, hvor styring og ledelse er centrale temaer.

Principles and criteria for succeeding with Canonical Action Research (CAR) have made it easier to study problems like how to implement Total Quality Management (TQM) in real organisations, where the first requirement of CAR is to get into a position of organisational power. How does one attain power? How should a powerless action researcher manage his interpersonal information flow intelligently? The Management System for Survival (MSS) is based on the idea of gradually developing the necessary and sufficient power as the TQM implementation process develops. The book accounts a five-year study of an academic TQM consultant trying to survive in a public sector organisation.

Health Literacy in Medicines Use and Pharmacy: A Definitive Guide highlights issues related to medication literacy from the context of the pharmacist and other healthcare professionals. This definitive guide will undoubtedly serve as an invaluable resource for healthcare professionals in training and practice, fostering excellence in patient care globally. The book provides a clear explanation of medication literacy, presents different tools to assess health and medication literacy, readability, and comprehensibility of written medicine information (WMI), and elaborates on different approaches to develop customized and patient-friendly WMI. The book also covers health and medication literacy in special populations, including geriatrics, pediatrics, and pregnant/lactating patients. Written by experts in health communication, this book will help pharmacists, other health professionals, educators, students, and regulators, who need to develop customized educational materials that can be understood by a broad range of patients, especially those with low health literacy.

In "The Transformation Curve," Steven Leuschel and Rodger Lewis unveil a revolutionary approach to organizational transformation. Drawing from his rich experiences at Volkswagen, Toyota Georgetown, and General Motors, Rodger introduces the Transformation Curve-a systematic framework for achieving lasting change. The book is co-authored with a consultant who has witnessed the curve's impact firsthand, Steven Leuschel.Readers gain insights into the evolution of the Transformation Curve, its adaptability to diverse industries, and its emphasis on culture, mutual trust, and respect as the bedrock of successful change. The book explores how this approach addresses North America's Lean implementation challenges.Rodger B. Lewis's life journey shapes "The Transformation Curve," a groundbreaking approach to complete organizational transformation. From his early days at Volkswagen to his transformative experiences at Toyota Georgetown and General Motors, Rodger's unique path informs his perspective on the Toyota Production System's North American application.The book outlines the journey that led to the Transformation Curve's development and its expansion across industries. Emphasizing culture as the key driver for sustainable change, it offers organizations a roadmap to shift from tool-focused approaches to comprehensive, culture-driven transformation."The Transformation Curve: A Systematic Approach to Organizational Change" challenges organizations to adopt a systematic, repeatable approach, positioning them for world-class performance across industries.

Modern systems have become increasingly complex to design and build, while the demand for reliability and cost-effective enhancement continues. Robust international competition has further intensified the need for all designers, managers, practitioners, scientists, and engineers to ensure a level of reliability of their products and processes before release at the lowest cost. Developments in Reliability Engineering equips its audience with the necessary information to keep up with the latest original research and state-of-the-art advances in reliability engineering. The volume offers an excursus from historical theories and methods to the present-world practical utility of these concepts with worked-out examples.

Descubre Cómo Triunfar en la Cancha de la Vida¿Estás listo para un verdadero cambio en tu vida? ¿Quieres alcanzar nuevas metas y superar tus límites? Si es así, entonces este libro de superación personal es para ti.En Golazo Mental, Romualdo Hernández te guiará a alcanzar tu máximo potencial. A través de 7 poderosas claves, sabrás cómo vencer limitaciones, superar miedos y alcanzar el éxito en todas las áreas de tu vida.Potencia tu mente y ¡métele un gol!En "Golazo Mental" descubrirás cómo: Alcanzar tus objetivos cultivando una mentalidad competitivaFortalecer los valores de tu equipo y alcanzar resultados sobresalientesLiderar con autoridad y lograr el respeto necesario para triunfarSuperar tus límites con el poder transformador de la feVencer tus miedos para salir de tu zona de confort Seguir instrucciones precisas y optimizar tu rendimientoY mucho más...La característica mayor en GOLAZO MENTAL es que podrás ir al terreno de tu juego interior, combinando estrategias futbolísticas, desarrollo personal y principios de liderazgo, para alcanzar un éxito sin precedentes en la Cancha de la Vida. ¡Tu partido más importante está por comenzar!Si estás buscando buenos libros de superación personal en español o motivación en el trabajo, ordena este libro HOY y Romualdo Hernández te dará las herramientas necesarias para desbloquear tu máximo potencial y así vivir una vida llena de logros constantes.

Are you new to the project sponsor role or want to improve? This book's practical guidance will help you successfully fulfill your role. We understand you are time-challenged. This book is short, direct, and focuses on the most common project issues. The book's guidance is helpful for projects of all sizes and across all sectors.Completing the warp-speed project assessment will assess your project's risks and better understand the topics that need more attention. With our practical actions, you can champion the project for success.

Are you winning the Talent Wars?If you aspire to live life by design and not by default, it's crucial for you to attract and retain incredible people. As a leader, the success of your organization and your own financial prosperity, depends upon your team members.Too often we wonder if: We have the right strategy to build a scalable and profitable business.Team members are truly engaged in their roles and creating maximum value.Employee and customer experience exceeds expectations, producing remarkable results.The truth is most organizations know they're not operating at their full potential. Unfortunately, they're unsure how to solve the problem.Author Sunny Kaila knows how you feel. Growing up in a foreign country, he began in America as a taxi driver. During his 20 years of hands-on entrepreneurial experience, he uncovered the powerful concept of Talentpreneurship(TM) that helped him scale a successful technology company with an ever-expanding team.As you read this book you'll discover how to: Build and grow a profitable business that transforms lives-including your own.Implement the Talent Operating System(TM) (TOS) to align your team with your vision.Leverage the Life By Design framework for true employee engagement.Transform your life and business-starting today.

The book includes tech tips, resource lists, featured tools, and example problems for the healthcare quality professional.

Many UX designers are surprised to learn that much of the job isn't about drawing things. It's about knowing what to draw and how to convince people to build it. Whether you're a one-person design team making products from scratch or a C-level product leader managing many products and strategies, UX for Business is your missing guide to real-world business design. You'll not only learn how to think about design as a professional but also discover how design can move the needle for your entire company. Author Joel Marsh helps you understand stakeholders, business models, the process of designing valuable solutions, dangerous choices that can ruin a product, and how to gain the attention your work deserves. You'll also explore the principles of designing common types of digital products and services, from portfolio sites to social networks to ecosystems. With this book, you'll learn: How to design the right things by understanding value, diagnostics, and probability How to conduct UX research and analysis without the luxury of time or money The most important aspects of common digital business models Methods for getting things done under less-than-ideal circumstances How to avoid common pitfalls caused by inexperience

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.

A crucial element of quality control is inspection, but attempting to inspect every product can be impractical. This book covers both the statistical and practical approaches for selecting a particular sampling plan from the c=0 table. Using the plans found in this book can help ensure that you meet your zero defects objectives while saving your company time and money. Zero Acceptance Number Sampling Plans was originally developed to provide equal or greater consumer protection with less inspection than the Department of Defense's (DoD's) military standard 105 (MIL-STD-105E). This book offers a set of plans for lot-by-lot inspection with the acceptance number in all cases as zero. Although the DoD canceled MIL-STD-105, the c=0 sampling plans have stood the test of time. After years of extensive application by aerospace, defense, medical device, commercial manufacturing, and service industries, these plans are still used today as a standard for many organizations to deliver quality products. This sixth edition includes only the original c=0 table as published in the fourth and all previous editions and eliminates conflicting information in the fifth edition tables.

The purpose of this expanded field guide is to assist organizations, step-by-step, in implementing a quality management system (QMS) in conformance with ISO 13485:2016, whether "from scratch" or by transitioning from variations of the ISO 13485 family. In keeping with ISO 9000:2015's definition of quality as the "degree to which a set of inherent characteristics fulfills requirements," Myhrberg, Raciti, and Myhrberg have identified the requirements and inherent characteristics (distinguishing features) for this expanded field guide. Within the guide, each subclause containing requirements is the focus of a two-page visual spread that consistently presents features that fulfill the requirements listed below.This guide will:Provide a user-friendly guide to ISO 13485:2016's requirements for implementation purposes-Identify the documents/documentation required, along with recommendations on what to consider retaining/adding to a QMS during ISO 13485:2016 implementation-Guide internal auditor(s) regarding what to ask to verify that a conforming and effective QMS exists-Direct management on what it must do and should consider to satisfy ISO 13485:2016's enhanced requirements, as well as on the responsibilities for top management-Depict step-by-step in flowchart form what must occur to create an effective, conforming QMS

This book was written to aid quality technicians and engineers. It is a result of 30 years of quality-related work experience. 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 design of experiments (DOE) for the purpose of process optimization.This is a practical introduction to the basics of DOE, intended for people who have never been exposed to design of experiments, been intimidated in their attempts to learn about DOE, or have not appreciated the potential of this family of tools in their process improvement and optimization efforts.In addition, this book is a useful reference when preparing for and taking many of the ASQ quality certification examinations, including the Certified Quality Technician (CQT), Certified Six Sigma Green Belt (CSSGB), Certified Quality Engineer (CQE), Certified Six Sigma Black Belt (CSSBB), and Certified Reliability Engineer (CRE).

This handbook was developed to help small and medium-sized organizations better understand ISO 9001:2015. It is intended to facilitate implementation and improvement. The establishment, implementation, and maintenance of an ISO 9001-compliant quality management system (QMS) should allow the organization to experience multiple benefits beyond the achievement of certification. Organizations should also see improvements in the quality of products, customer satisfaction, and process effectiveness-all of which ultimately have a positive impact on the bottom line.It is expected that some readers will have already established a QMS. This handbook will serve to reinforce good practices and will help you better understand the intent and value of some of the requirements of ISO 9001. Since the handbook is especially focused on small and medium-sized organizations, the examples that are provided will have greater applicability and will enhance comprehension, again resulting in increased value.Implementing a QMS in a small organization is not easier or harder than it is in a large one. Resources are different; each organization has its own unique challenges, constraints, and advantages. The thing to always bear in mind is that this is your organization and these are your processes.ISO 9001:2015 defines the requirements, but it does not dictate the method of application. Utilizing this handbook should allow you to develop or rejuvenate your QMS so that it is a benefit to both you and your customer.

Quality control has played an important role in the manufacture of goods and the creation of monuments since antiquity. From the development of Heron¿s first robot and the Antikythera mechanism to today¿s Internet of Things (IoT), Industry 4.0, and artificial intelligence, quality control has undeniably come a long way. This book examines quality control in several different scenarios and locations. Chapters discuss quality control of Nigeriäs road network, Ethiopiäs leather industry, Africäs food industry, and Hong Kong¿s construction sector, among other scenarios. The book also discusses quality control of intrusion detection systems, artificial intelligence, complementary metal oxide semiconductors, and more.

Innovation management can provide a competitive edge in the business world, and research shows a major correlation between profitability and innovation. The challenge, however, is how to integrate innovation management with quality management. Enter the ISO 56000 series of standards on innovation management systems (IMS). Specifically, ISO 56002 provides guidance on how to develop a systems approach to managing innovation. In this book, author Peter Merrill shares with readers the thinking behind each of the clauses in the standard. He explains real-life, practical applications of the guidance the standard provides and shows how to integrate an IMS with a quality management system based on ISO 9001 and be prepared for the future. In this book, you will discover how it:Details the strategy and leadership necessary to manage innovation using ISO 56002 and explaining the cultures of creativity and execution that must coexistDefines the competences, tools, processes, and assessments that are needed to build an IMS in your organization in order to succeed at innovationExplains the principles that are the basis of innovation managementShows the vital role of innovation and creativity in the progression of organizations in today's Industry 4.0/Quality 4.0 eraUnderlines the idea that innovation management and quality management must work together from practical and financial standpointsPeter Merrill has been a quality professional for many years and is an expert on simplifying complex ideas. Currently, he helps companies develop their approach to innovation. He writes extensively on innovation, including the Innovation Imperative, column for Quality Progress magazine. His previously published books include Innovation Generation, Innovation Never Stops, Executive Guide to Innovation.

The purpose of this new edition is to offer an updated view of the risk management field as it applies to medical products. Since the publication of the first edition (2012), the emphasis on risk-based processes has growth exponentially across all sectors, and risk management is now considered as significant as quality management. ISO 9001 was revised and now requires that top management promote the use of risk-based thinking. ISO 13485:2016, which specifies the requirements for a quality management system specific to the medical devices industry, also now shows a greater emphasis on risk management and risk-based decision making. In addition, the FDA Food Safety Modernization Act (FSMA) is the most important reform of U.S. food safety laws in more than 70 years.This indispensable book presents a systematic and comprehensive approach to quality risk management. It will assist medical and food product manufacturers with the integration of a risk management system or risk management principles and activities into their existing quality management system by providing practical explanations and examples. The appropriate use of quality risk management can facilitate compliance with regulatory requirements such as good manufacturing practice or good laboratory practice.All chapters have been updated and revised, and a new chapter has been added to discuss some of the most common pitfalls and misunderstandings regarding risk management, specifically those related to the use of FMEA as the only element of risk management programs. One of the appendices includes 12 case studies, and the companion CD-ROM contains dozens of U.S. FDA and European guidance documents as well as international harmonization documents (ICH and GHTF-IMDRF) related to risk management activities, as well as a 30-question exam (with answers) on the material discussed in the book.

If a business expects to be a player in their market segment, their product(s) must have the quality expected by their customers. This can only be accomplished with test equipment that produces repeatable, accurate, and traceable measurements and/or outputs. Without a quality calibration system in place, this cannot and will not happen. This book is about how to design, implement, maintain, and continuously improve a quality calibration system, with all the required documentation, traceability, and known uncertainty for each and every item of test equipment owned and used by any company, large or small. It will benefit companies that want to implement a program and also those that already have one in place. Some industries have tighter requirements than others on how they treat calibration; some are more specific about how their standards are read, while being vague about what is needed to meet calibration. Is there one tried-and-true quality calibration system that every organization can use as a foundation for its personalized program? There certainly is, and The Quality Calibration Handbook describes it. By using the quality calibration system outlined and demonstrated, any organization can put together its own version to meet its specific requirements and/or regulations. Quality calibration systems are the very foundation for improving research and development (R&D), production, and quality assurance arenas through accurate, reliable, and traceable calibrations of their test equipment. By ensuring the calibration of test equipment used in the production of genetic identity kits used by law enforcement at crime scenes, the guilty are often caught and the innocent exonerated. Calibrated test equipment used in support of the airline and automotive industries helps prevent disasters. At pharmaceutical companies, calibration technicians quietly lay the foundation for quality treatments that help keep us healthy, cure diseases, and sometimes prevent death. This book explains why a quality calibration system can be the difference between life and death, success and failure, andmost important to shareholders and boards of directorsprofit and loss. COMMENTS FROM OTHER CUSTOMERS Average Customer Rating (5 of 5 based on 4 reviews) "This book offers me the information I need to upgrade the quality of the service I provide to customers. It makes the quantum leap between the theory and practice in calibration. I needed this applicable and practical information a long time ago." A reader in Anchorage, Alaska "This book is a great and simple reference guide for developing a world class calibration system. If you are thinking about revamping your calibration system or developing one, this book is a must. This book is written by a person sharing his practical experience to less experienced people." A reader in Austin, Texas "Excellent reference for setting up a calibration program or improving your current operations. This book is a must read for anyone working in the metrology field." A reader in Springboro, Ohio "This book is for anyone who wants to learn more about the requirements of a good calibration program. It gives easy to understand guidelines and practical advice to help you make your calibration program world class." A reader in Putnam, Connecticut

Change can be hard. It is often difficult to conceive performing tasks in a different order, in a different place, at a different time, or in a different manner altogether. And this is only for the individual. When we talk about organizational change the difficulty increases exponentially with each individual that is added to the equation.This book uses as its basis a fable - the story is not untrue, but it is not fact either. It is a story in which the group dynamics are real, the problems are valid, and the solutions legitimate. It asks you to consider a complex environment with multiple classes interacting between functional units with requirements that are perceived as exclusive and unique, and personalities that reinforce presumed boundaries. It asks you to follow along as all these individuals work together using the basics of four quality methodologies (Lean, Six Sigma, Theory of Constraints, and Business Process Reengineering) to address the problems they face, discover solutions together, and move forward in their continuous performance improvement journey."Lean Acres is fantastic in its appeal and innovative in its writing style. Jim Bowie introduces an amazing convention by using talking animals on a farm ("Lean Acres Farm") to represent "real" stakeholders and teach Strategy and Process Improvement methodologies (Balanced Scorecard, the StrateTree, Lean Manufacturing, Six Sigma, the Theory of Constraints, and Business Process Reengineering) in ways that are easy to understand and enjoyable to learn. His step-by-step guidance through the each tool and philosophy make this book essential for Leaders, Managers, Quality Professionals, and anyone interested in improving performance in any industry. The message is simple, the illustrations are an excellent complement to the story, and the Reader interaction (Pre- and Post-Tests coupled with Rest, Reflect, and Relate sections at the end of each chapter) reinforce education, application, and relevance. Take a trip to Lean Acres today - you will be better for it." Mikel J. Harry Co-creator of Six Sigma and best-selling author.

In 1917, we split the atom and released an incredible force for destruction. In 2019, we split the DMAIC and released an even bigger force for improvement.There is no doubt that the various improvement methods work. Whether it is PDCA or 7-Step problem-solving or A3 or IIs Not or DMAIC or any other tool, it has been used to great success in many organizations stretching back over decades. But why have some organizations been wildly successful with these and others not?The reason is that much of today's continuous improvement (CI) training is focused on tools. Training includes days or even weeks working through every possible tool a practitioner of CI might need. But rather than teach people about a set of tools that they might or might not use, why not teach them how to accomplish a specific objective? Why not give them a path for solving a particular type of problem that works most of the time? This way, anyone anywhere can make CI work by splitting the DMAIC.This book shows four typical paths through the DMAIC process to accomplish four different objectives: Reduce variability of a characteristic Reduce failures of a machine Reduce waste in a process Reduce the frequency of a defectFor each path, the following is presented: -an overview of the purpose and actual steps through the DMAIC process for that path. -Step Details-a detailed description of each step including specific tools used. -Checklist-a simple one-page sheet that anyone can use as a guide along the path. Think of these as a new app called DMAIC Maps, which helps people get around the DMAIC world the same way Google Maps helps in the real world.Project selection and team management are also discussed, since the choice of projects is crucial to creating context and therefore success.

Six Sigma Green Belts need support in applying new skills after training, yet there is little research about how this works and even less advice about what support looks like in the field. This book is that missing link in providing coaching tips to support Green Belt projects.There is an abundant amount of information on the technical, "hard skills" aspects of Six Sigma, while considerably less about the interpersonal side of DMAIC. Research has shown that desirable Green Belt project outcomes are greatly influenced by collaboration issues between the coach and the Green Belt team member, and therefore this text focuses on tips for effective collaboration practices.Besides being a comprehensive discussion about how to coach Green Belts on their first project, it may also be used to coach subsequent Green Belt projects. A case study of Louisville Metro demonstrates this book's ideas in the field and includes an example of one of its actual Six Sigma Green Belt projects.

Good Manufacturing Practices (GMP) for human pharmaceuticals affects every patient taking a medicine. GMP covers all aspects of the manufacturing process, from defining manufacturing processes to systems for recall and investigation of complaints. Consumers expect that each batch of medicines they take will meet quality standards so that they will be safe and effective.GMPs provide for systems that assure proper design, monitoring, and control of manufacturing processes and facilities. This formal system of controls at a pharmaceutical company, if adequately put into practice, helps to prevent instances of contamination, mix-ups, deviations, failures, and errors. This assures that drug products meet their quality standards.This guidance book is meant as a resource to manufacturers of pharmaceuticals, providing up-to-date information concerning required and recommended quality system practices. It should be used as a companion to the regulations/standards themselves and texts on the specific processes and activities contained within the QMS.As a bonus, this package contains dozens of FDA guidance documents as well as international harmonization documents (WHO, PIC/S, and ICH). A check list for GMP audit is also included based on risk management criteria. An exam complements the extra material.

Foreword by Michael F. Gutzeit, M.D., Chief Medical Officer and Vice President of Quality, Children's Hospital of WisconsinThis practical, how-to book clearly and succinctly takes the reader through six proven "success steps" for implementing lean in any healthcare environment:1. Create physician flowbr2. Support physician value-added timebr3. Visually communicate patient statusbr4. Standardize everyone's workbr5. Lay out the clinic for minimal motionbr6. Change the care delivery modelWhy go through such a transformation? Because it works. Tell a doctor that he can see the same number of patients, offering the same high quality and personal care, and have an extra 90 minutes at the end of his clinic day - and that means something. Tell the staff that they can look forward to actually ending on time, with satisfied patients, no backlog, and having focused their attention completely on quality patient care - and they will listen.These Lean principles and success steps work in clinics ranging from orthopedics to neurology to cardiac care-the specialty doesn't matter. They work in small practices and large hospital settings. Lean methodology provides the tools to address the frustrations patients and doctors alike experience in the clinic process.Included throughout the book is a case study showing the lean transformation undertaken at the Orthopedic Center at Children's Hospital of Wisconsin, with numerous quotes and insights from those actually involved. This transformation resulted in patient wait times being reduced by more than 70 percent, the clinic being able to see 25 percent more patients in less space, patient satisfaction scores sometimes reaching 100 percent, and staff satisfaction scores improving by more than 25 percent.

Has your organization tried Lean already? If so, you surely see and feel the Joy of Lean in your workplace now, right?Don't worry. If you're not quite to joy yet, you're not alone.As it attracts more and more attention as a successful business philosophy that can improve results in any type of organization, lean has still sometimes been misunderstood as a method for just cutting expenses. The useful ideas of eliminating waste and driving greater efficiency can pick up a negative spin, with perceptions of job cuts, employees doing more with less, and managers squeezing more productivity from each person. None of that sounds very joyful.But it doesn't have to be that way. This book will show leaders how to cultivate a positive Lean Culture of Excellence that creates value for customers, profitable growth for businesses, sustainable cost reduction, and fulfilling jobs for employees.Lean Culture means empowerment.Lean Culture means better value for the customer.Lean Culture means better performance for the organization.Lean Culture means a more engaging, rewarding, and yes, even joyful role for each employee.And Lean Culture provides the competitive advantages that a team needs to survive and grow.We call the approach Lean Engaged Team Performance (Lean ETP). It's a purposeful combination of value innovation, process excellence, performance measures, team goals, collaborative norms, organizational structure, enabling technology, and most of all, visionary leadership. And it's hard to achieve and even harder to sustain, but it's worth the journey!Praise for The Joy of Lean"For a young growth company, the self-discipline of Engaged Team Performance and a commitment to process improvement do not initially sound too joyful. But all we needed was one team to try. Our leaders and employees came together… operating at the best service levels we had ever achieved."Jana Schmidt, President and CEO, Ecova, Inc."Life is supposed to be an adventure, and work is a core part of that journey. The Joy of Lean will help you develop a culture where everyone takes joy in coming to work every day to contribute something that will change the world for the better."Dr. Fred Moll, co-founder and CEO, Auris Surgical Robotics, and co-founder of Intuitive Surgical"The Joy of Lean provides practical advice that every organization should follow when pursuing a Lean transformation. Dodd Starbird delivers the content in an easy to understand, even humorous way that makes this an important and enjoyable read for anyone, not just leaders for whom the book is most intended."Drew Locher, author of Lean Office and Service Simplified"Dodd Starbird fixes the limitations of most Lean implementations by shifting focus from eliminating waste to achieving excellence, and it's spot on!"David Marquet, author of Turn the Ship Around!"At its heart,The Joy of Lean is about leaders building relationships: relationships with your customer and with your employees. Engaged Team Performance is all about empowering your employees to demonstrate care while attracting new customers, strengthening client relationships, or delivering products and services every day. The Joy of Lean provides the key to any successful business."Art Bacci, Head Hong Kong Group, Principal International"Business, especially a growing business, is ultimately about people working with people. The Joy of Lean outlines key principles for driving a culture of business performance. Working with Dodd Starbird's ETP principles, we have been able to deliver sustainable value to our business, and our teams remain engaged."Beth Rothwell, President, VfD Companies

The intent of this field guide is to assist organizations, step by step, in implementing a QMS in conformance with ISO 9001:2015, whether "from scratch" or by transitioning from ISO 9001:2008. Within the guide each sub-clause containing requirements is the focus of a two-page spread that consistently presents features that fulfill the requirements listed below. This book examines each sub-clause of clauses 4-10 of ISO 9001:2015, which contain the requirements, with a visual representation provided in flowchart format on the facing page.This field guide will:*Provide a user-friendly guide to ISO 9001:2015's requirements for implementation purposes*Identify the documents/documentation required, along with recommendations on what to consider retaining/adding to a QMS during ISO 9001:2015 implementation*Guide internal auditor(s) regarding what to ask to verify that a conforming and effective QMS exists*Direct management on what it must do and should consider to satisfy ISO 9001:2015's enhanced requirements and responsibilities for top management*Depict step by step what must occur to create an effective, conforming QMSWhat separates this field guide from most other books on ISO 9001:2015 and its implementation are the flowcharts showing the steps to be taken in implementing a QMS to meet a sub-clause's requirements. As the flowcharts themselves can be overwhelming when you first look at them, a text box appears with each flow chart that explains pertinent facts and/or what the flowchart represents and how it is to be used.

¿Author D. H. Stamatis has updated his comprehensive reference book on failure mode and effect analysis (FMEA). This is one of the most comprehensive guides to FMEA and is excellent for professionals with any level of understanding.!--nl--This book explains the process of conducting system, design, process, service, and machine FMEAs, and provides the rationale for doing so. Readers will understand what FMEA is, the different types of FMEA, how to construct an FMEA, and the linkages between FMEA and other tools. Stamatis offer a summary of tools/methodologies used in FMEA along with a glossary to explain key terms and principles. The updated edition includes information about the new ISO 9000:2000 standard, the Six Sigma approach to FMEA, a special section on automotive requirements related to ISO/TS 16949, the "robustness" concept, and TE 9000 and the requirements for reliability and maintainability. Also includes FMEA forms and samples, design review checklist, criteria for evaluation, basic reliability formulae and conversion failure factors, guidelines for RPN calculations and designing a reasonable safe product, and diagrams, and examples of FMEAs with linkages to robustness.

Is your Quality organization holding your business back? Is regulatory compliance seen as more important than product or service quality? Do you feel the needs of your customers are lost in a sea of regulations?Transforming Quality Organizations: A Practical Guide questions whether the current approach to managing quality is fit for purpose and, using the latest organizational thinking provides fresh, practical ways to balance a quality system to: Manage risk for better patient, customer, regulator, and stockholder outcomes.Achieve balance between ensuring compliance and supporting innovation.Transform your Quality organization through a roadmap of change.Applicable to all businesses where quality is paramount, the content is based on practical experience of executing transformational change in the healthcare sector resulting in: Product recall rates cut by 50%.Product development cycle-times cut by 50%.Significant cost savings in quality system execution.This book is invaluable for business leaders who want to transform their Quality organization and increase the value it delivers for their business.