Bøger udgivet af ASQ Quality Press

This book provides tools that are less commonly used and some tools that the author, Nancy Tague, created. Inside you'll find tools for generating and organizing ideas, evaluating ideas, analyzing processes, determining root causes, planning, basic data handling, and statistics. In this third edition, six new tools were added (i.e., DFMEA and PMFEA) along with a section on Quality 4.0 and suggested quality tools that can help facilitate practitioners looking to implement Quality 4.0 concepts. The use of icons with each tool description tells the reader at a glance what kind of tool it is and where it is used within the improvement process.

Brush up on your Black Belt testing skills with this handy study guide, updated to adhere to the 2022 ASQ Certified Six Sigma Black Belt (CSSBB) Body of Knowledge (BoK). It is a valuable resource for candidates preparing for the ASQ CSSBB examination and is best used in combination with The ASQ Certfied Six Sigma Black Belt Handbook, Fourth Edition. These questions have been written to reflect current testing standards, and all include detailed solutions and BoK references for further review of the material.

This handbook explains, in detail, each section of the Certified Supplier Quality Professional Body of Knowledge (updated 2023). It is a handy reference for those already working in the field and is an essential text for those working toward a CSQP certification.

TRIZ is the Russian acronym for theory of inventive problem solving. The basic assumption behind this theory is someone somewhere has already solved your problem or a very similar problem, and all we need to do is apply the same principle to the current problem and solve it similarly." It guides you to think in a specific direction rather than getting lost. The goal of this book is to use some of the simple TRIZ tools to help readers immediately solve problems, innovate, be creative, think, and discover the joy of experiencing the thinking process in new dimensions that you might not have previously. It is specifically focused on helping nonengineering and management professionals to apply the concepts of TRIZ immediately and reap benefits. Interspersed throughout the book are vignettes from the author's round-the-world bicycle tour on a budget of less than five U.S. dollars per day, having conducted close to 50 workshops and training sessions and trained more than 1,000 professionals on TRIZ without any remuneration throughout 21 countries, including Thailand, Laos, Vietnam, China, Kyrgyzstan, Uzbekistan, Turkmenistan, Iran, Turkey, Georgia, Armenia, Greece, Italy, France, Spain, and Portugal.

This study guide is helpful for anyone planning to take the ASQ Certified Quality Engineer (CQE) exam. The book has been developed specifically to address the 2022 CQE Body of Knowledge (BoK). Every practice question includes an explanation of the correct answer along with the corresponding section of the BoK for further study, and over half of the 600+ questions have been revised and improved. New topics include data automation and database integration, cost-benefit analysis, the RACI matrix, assessing risks in auditing, overall equipment effectiveness, critical-to-quality concepts, 5 Whys, and a much more intensive treatment of risk management.

Federal regulatory agencies have embraced Hazard Analysis Critical Control Point (HACCP) as the most effective method to offer farm-to-table food safety and quality in the United States-but it is important to look beyond HACCP. The ASQ Certified Food Safety and Quality Auditor (CFSQA) Handbook serves as a baseline of knowledge for auditors of food safety and quality systems that covers other aspects of food production, including preventive controls. This handbook assists certification candidates in preparing for the ASQ Certified Food Safety and Quality Auditor (CFSQA) examination. Its chapters cover the HACCP audit and auditor, preventive principles, and quality assurance analytical tools. The updated fourth edition also includes: The history of primitive and modern food preservation methods, including the introduction of HACCP methods The evolution of prerequisite programs, such as chemical and microbiological controls The importance of other food system support programs, such as product traceability and recall, facility design, and environmental control and monitoring Preliminary tasks for developing a HACCP plan About the Division The mission of the ASQ Food, Drug, and Cosmetic Division is to achieve increased customer satisfaction and continuous improvement by identifying, communicating, and promoting knowledge and the use of management concepts, technologies, and regulations as they relate to quality principles in all functional areas of the food, drug, and cosmetic industries. The Division holds conferences, confers awards annually, awards scholarships, and provides training and networking opportunities for participants in these industries.

The ASQ Certified Quality Improvement Associate (CQIA) certification introduces the basics of quality to organizations and individuals who are new to quality. This book, and the Body of Knowledge (BoK) it supports, form a foundation for applying proven quality principles and practices that are used around the world. This handbook follows the CQIA span in both content and sequence. Let it serve as your guide in preparing for the ASQ CQIA examination, and refer to it frequently as you learn and implement these ideas and tools in your organization.

In a post-pandemic world, amid environmental crises, and advances in technology, the dynamics of what the average city looks like have called for change, leaving governments and policymakers to reimagine urban planning and development. In Smart Cities: Reimagining the Urban Experience, Paul Doherty shares his organization's "secret sauce" recipe to marry information technology infrastructure-design thinking-with sustainable development goals (SDGs) for building smart cities. Paul dives into strategies, master plans, work templates, and real-world examples. This book will disrupt existing paradigms to offer practitioners, urban developers, and policymakers some solutions to creating greater social responsibility in a human-centric, data-driven world.

Implementing the requirements of ISO 9001 can be a daunting task for many organizations. In an attempt to develop a system that will pass the registration audit, we are tempted to establish processes with the primary purpose of conforming to the requirements of ISO 9001. In doing so, however, it is easy to lose sight of the primary intent of the standard: to continually improve the effectiveness of the quality management system (QMS) implemented at our organization. This book is intended to help managers, quality professionals, internal audit coordinators, and internal auditors implement a practical internal audit process that meets the requirements of ISO 9001:2015 while adding significant, measurable value to the organization. The tools, techniques, and step-by-step guidelines provided in this book can also be used by those organizations that have a well-established internal audit process but are looking for easy ways to make that process more effective.

The ASQ Certified Medical Device Auditor Handbook (formerly The Biomedical Quality Auditor Handbook) was developed by the ASQ Medical Device Division (formerly Biomedical Division) in support of its mission to promote the awareness and use of quality principles, concepts, and technologies in the medical device community. It principally serves as a resource to candidates preparing for the Certified Medical Device Auditor (CMDA) certification exam. The fourth edition of this handbook has been reorganized to align with the 2020 certification exam Body of Knowledge (BoK) and reference list. The combination of this handbook with other reference materials can provide a well-rounded background in medical device auditing. Updates to this edition include: A discussion of data privacy, data integrity principles, and the Medical Device Single Audit Program (MDSAP)Current information about federal and international regulationsNew content regarding human factors and usability engineering, general safety and performance requirements, labeling, validation, risk management, and cybersecurity considerationsA thorough explanation of quality tools and techniques

The value of the ASQ Certified Quality Auditor Handbook, Fifth Edition, is clear. It is designed to help new auditors gain an understanding of the field and prepare for the ASQ CQA exam. In addition, experienced auditors can refer to it as a helpful reference; audit managers and quality managers can rely on it for guiding their auditing programs; and trainers and educators can use it for teaching fundamentals. This in-depth overview of quality auditing represents auditing practices for internal and external applications. It provides practical guidance for both system and process auditors as well. Many current topics have been expanded to reflect changes in auditing practices since 2012, with guidance from the recent 2017 update of ISO 19011. In addition, readers will find example audit situations, stories, and review comments to enhance their understanding of the field. Topics covered include the common elements of all types of system and process audits (quality, environmental, safety, and health): Auditing fundamentals, including types of quality audits, purpose and scope of auditing, terms and definitions, roles and responsibilities of participants, and professional conduct The audit process, from preparation and planning, to performance and reporting, to follow-up and closure Auditor competencies, including resource management, conflict resolution, communication, interviewing, and team dynamics Audit program management and business applications, including staffing, training and development, program evaluation, organizational risk management, and best practices Quality tools and techniques, including problem-solving tools, process improvement techniques, basic statistics, verification, and validation "This book is an encyclopedia of all major bodies of information a new or experienced quality auditor would need. It covers both the qualitative and the quantitative, which is a strength. I can't think of a quality auditor that would not find this work helpful." Kim H. Pries, CRE, CQE, CSQE, CSSBB, CMQ/OE, CQA "This handbook will be helpful to those who are new to auditing or require more in-depth knowledge of the implementation of an audit program. Boxed examples or scenarios provide some of the practical challenges encountered during auditing." Govind Ramu, ASQ Fellow, Co-Author ASQ SSGB Handbook, Author ASQ CSSYB Handbook Lance B. Coleman, Sr. has over 25 years of leadership experience in the areas of quality engineering, Lean implementation, quality, and risk management in the Medical Device, Aerospace, and other regulated industries. He has presented, trained, and consulted throughout the United States and abroad. Lance is currently a Director of Quality for IDEX Health and Science, LLC, in Oak Harbor, Washington.

The importance of a safe, reliable, cost-effective, high-quality, integral, and nimble supply chain cannot be overstated. Equally critical are the supply chain processes (e.g., strategic, procurement, quality assurance, technical, regulatory) that ensure these requirements are met. By extension, then, the supply chain professional is of paramount importance as a creator, driver, and full participant in these business-critical activities. ASQ's Certified Supplier Quality Professional (CSQP) certification provides valuable credentials to quality professionals in the growing field of supplier quality engineering. Due to globalization of the supply chain, supplier quality engineers are becoming more important in a broad spectrum of industries, including manufacturing and service industries. The purpose of this handbook is to assist individuals taking the Certified Supplier Quality Professional examination and provide a reference for the practitioner. Throughout this handbook, several examples are provided based upon the collective experience and knowledge of the authors and editor. However, these examples are not explicitly specified in regulations, leaving decisions to the company, as well as the burden of justifying practices using sound scientific principles that provide the context of the rationale.

This handbook is a comprehensive reference designed to help professionals address organizational issues from the application of the basic principles of management to the development of strategies needed to deal with today's technological and societal concerns. The fifth edition of the ASQ Certified Manager of Quality/Organizational Excellence Handbook (CMQ/OE) has undergone some significant content changes in order to provide more clarity regarding the items in the body of knowledge (BoK). Examples have been updated to reflect more current perspectives, and new topics introduced in the most recent BoK are included as well. This handbook addresses: Historical perspectives relating to the continued improvement of specific aspects of quality management Key principles, concepts, and terminology Benefits associated with the application of key concepts and quality management principles Best practices describing recognized approaches for good quality management Barriers to success, common problems you may encounter, and reasons why some quality initiatives fail Guidance for preparation to take the CMQ/OE examination A well-organized reference, this handbook will certainly help individuals prepare for the ASQ CMQ/OE exam. It also serves as a practical, day-to-day guide for any professional facing various quality management challenges. About the Editors Sandra L. Furterer is an Associate Professor and Department Chair at the University of Dayton in the Department of Engineering Management, Systems, and Technology. She is an ASQ Certified Manager of Quality/Organizational Excellence, an ASQ Certified Six Sigma Black Belt, an ASQ Certified Quality Engineer, an ASQ fellow, and a certified Six Sigma Master Black Belt. Douglas C. Wood is President of DC Wood Consulting, LLC and instructor for ASQ. He is an ASQ Certified Manager of Quality/Organizational Excellence, an ASQ Certified Six Sigma Black Belt, an ASQ Certified Quality Engineer, and an ASQ Certified Quality Auditor.

Lean healthcare is not about being better, but rather becoming the best at getting better. Today's challenge in the healthcare environment is your ability to improve at a greater rate than surrounding competitors. This book focuses on the model, strategy, and lessons learned in implementing lean thinking in a practical way. Using real-world case studies, the book provides approaches and tools to facilitate rapid improvements, along with a bonus section on pandemic preparedness. By following this accessible, user-friendly guide, you can achieve meaningful results right away. Dr. Dennis R. Delisle currently serves as the Executive Director for The Ohio State University Wexner Medical Center's flagship University Hospital. Through the Thomas Jefferson University College of Population Health, Dennis founded and oversees the Master of Science degree program in Operational Excellence, one of the first of its kind in the nation. He is the author of two books about streamlining and transforming healthcare.

The ever-changing fields of science and technology have made huge leaps, thanks in part to improvements in measurements. Without metrology, these areas may not have experienced exponential growth. Developed by experts in the field as a comprehensive and practical reference, The ASQ Metrology Handbook, Third Edition provides a foundation for understanding metrology as well as calibration principles and practices. This handbook is ideal for not only metrology professionals, but also calibration professionals including calibration technicians and technologists, quality professionals, workers in testing laboratories, consultants, and instructors. Whether you are entering a new phase of your career field, investing in your own continuous improvement journey, training your fellow calibration practitioners, or preparing for ASQ's Certified Calibration Technician (CCT) exam, this handbook provides the information, guidance, and knowledge to help you achieve your goals. New to this Third Edition: - A thorough explanation of ISO/IEC 17025:2017 - The 2019 Redefinition of the International System of Units - Updated and expanded chapters, including information about training and competency, software validation, statistics, decision rules and risk, uncertainty in measurement, mass and weighing, force, and chemical and biological measurements and uncertainties

Today's global, complex, and disruptive business environment demands companies to make their organizations more adaptive and agile. It's imperative that organizations upskill their personnel and set their culture intentionally. The companies that develop this culture right will have an incredible, competitive advantage. Leading change is everybody's job; nobody can do it alone. A systemic and collaborative approach is needed: a we culture mentality. The We Culture book will help you create a culture in the future of work to increase employee engagement, agility, quality and innovation through the 12-skills CARE model for hybrid workplaces. You will find: Real-life examples and interviews with company leaders Hands-on exercises in every chapter Opportunities for blended learning with the We Culture platform including videos, blogs, and audio content We Culture is an invitation to co-create a culture of conscious teamwork, where we can bring our whole selves to work, while simultaneously producing more cost-effective products and services to become more customer-oriented.

This updated and expanded edition discusses many different tools for root cause analysis and presents them in an easy-to-follow structure: a general description of the tool, its purpose and typical applications, the procedure when using it, an example of its use, a checklist to help you make sure if is applied properly, and different forms and templates. The examples used are general enough to apply to any industry or market. The layout of the book has been designed to help speed your learning. Throughout, the authors have split the pages into two halves: the top half presents key concepts using brief language-almost keywords-and the bottom half uses examples to help explain those concepts. A roadmap in the margin of every page simplifies navigating the book and searching for specific topics. The book is suited for employees and managers at any organizational level in any type of industry, including service, manufacturing, and the public sector. COMMENTS FROM OTHER CUSTOMERS Average Customer Rating: (4 of 5 based on 1 review) "This book is a good intro to Root Cause Analysis tools. It is easy to read and laid out in a good format, with a picture and/or sample provided for every tool discussed, along with a checklist for its usage. There is the occasional spot of confusing information, and some of the explanations seem over-simplified or under-explained. But this is not highly prevalent, and the book does accomplish giving the reader a great introduction to these tools and techniques. It may be insufficient for those who are looking for more advanced or in-depth information on any of the tools and techniques. Beginners should find this a very helpful book and one that will be referenced often as they start practicing Root Cause Analysis." A reader in Bradenton, Florida

All organizations experience unintended variation and its consequences. Such problems exist within a broad range of scope, persistence, and severity across different industries. Some problems cause minor nuisances, others leads to loss of customers or money, others yet can be a matter of life and death. The purpose of this pocket guide is to provide you with easily accessible knowledge about the art of problem solving, with a specific focus on identifying and eliminating root causes of problems. Root cause analysis is a skill that absolutely everybody should master, irrespective of which sector you work in, what educational background you have, and which position in the organization you hold. The content in this little pocket guide can contribute to disseminating this skill a little further in the world.

This handbook is a helpful guide to Six Sigma process improvement and variation reduction. Individuals studying to pass the ASQ Certified Six Sigma Yellow Belt (CSSYB) exam will find this comprehensive text invaluable for preparation, and it is also a handy reference for those already working in the field. The handbook offers a comprehensive understanding of the Body of Knowledge (BoK), which will allow readers to support real Six Sigma projects in their current or future roles. This handbook, updated to reflect the 2022 BoK, includes: - A detailed explanation of each section of the CSSYB BoK - Essay-type questions in each chapter to test reading comprehension - Numerous appendices, a comprehensive list of abbreviations, and a glossary of useful terms - Online contents, including practice exam questions - Source lists, which include webinars, tools and templates, and helpful publications

This handbook is designed to help candidates preparing for the ASQ Six Sigma Green Belt certification exam. Meant for those who already understand the basic concepts of reducing variation and improving processes, it also serves as a helpful reference to the appropriate materials needed to conduct successful Green Belt projects. The layout of the handbook is mapped to the 2022 version of ASQ's Body of Knowledge (BoK). This revised edition includes new information about: - SMART goals, key process indicators, Takt time, just-in-time processes, and spaghetti diagrams - The Kano model, risk management, business continuity planning, SWOT analysis, and RACI charts - Data collection plans and quality checks - Gap analysis, 5 Whys analysis, and fault tree analysis - Maintaining quality improvements - Document control, audits, training plans, the PDCA cycle, Andon, and Jidoka system

Different types of organizations provide services that require multiple, complex services to produce results. Oftentimes, those complex services morph into a maze of system processes that crisscross, impeding the smooth operation of processes and value creation. So how can you manage multiple services efficiently and effectively? This book outlines the strategy and execution needed to meet your goals. Numerous examples, exercises, and tools are included to help explain and clarify. The revised fourth edition includes a new focus on the impact of artificial intelligence in complex services, as well as links to video clips and podcasts. Professionals, semi-professionals, and technical workers in all areas, from law to medicine, accounting to engineering, social work to architecture, will find this book an invaluable tool in achieving success.

This new and expanded second edition maintains the organizational approach of the first and includes the requirements and guidance contained in the Quality System Regulation (QSReg), the ISO 13485:2003 standard, the ISO/TR 14969:2004 guidance document, and, as appropriate, a number of the FDA and Global Harmonization Task Force (GHTF) guidance documents.This second edition also addresses a number of additional topics, such as the incorporation of risk management into the medical device organization's QMS, QMS issues related to combination products, the key process interactions within a QMS, effective presentation of and advocacy for a QMS during FDA inspections and third-party assessments, and future FDA compliance and standards activities. The organization of the guidebook is based on the order of the requirements in the QSReg. For each substantive requirement section there is: A verbatim statement of the QSReg requirement. A description of the comparable requirement in ISO 13485:2003, focusing on any additions to or differences from the requirements contained in the QSReg.Excerpts of the FDA responses to relevant comment groups contained in the Preamble to the QSReg. Excerpts from various FDA guidance documents related to quality management systems. A description of the relevant guidance contained in ISO/TR 14969:2004, focusing on any additions to or differences from the guidance in the Preamble and other FDA guidance documents, and, if useful, excerpts from relevant GHTF guidances. Authors' notes giving guidance derived from the authors' sixty years of regulatory compliance experience. This guidance book is meant as a resource to manufacturers of medical devices, 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.

Unlike other pocket guides, this guide is designed specifically to address topics that the author has found to cause problems, issues, and concerns for most Black Belts over the years. As such, its primary purpose is to serve as a useful reference guide for the Black Belt throughout his or her busy day, and particularly in meetings. Though not intended to be a tool guide like other pocket guides or a preparation guide for the ASQ certifications, it will nonetheless serve as a useful reference guide for both the ASQ Black Belt and Master Black Belt certification examinations. Black belts will enjoy reading this pocket guide and find it invaluable in their daily work.

Basic quality at a size and price that are easy on your pocket! This pocket guide is designed to be a quick, on-the-job reference for anyone interested in making their workplace more effective and efficient. It will provide a solid initial overview of what "quality" is and how it could impact you and your organization. Use it to compare how you and your organization are doing things, and to see whether what's described in the guide might be useful. The tools of quality described herein are universal. People across the world need to find better, more effective ways to improve the creation and performance of products and services. Since organizational and process improvement is increasingly integrated into all areas of an organization, everyone must understand the basic principles of process control and process improvement. This succinct and concentrated guide can help. Unlike any other pocket guide on the market, included throughout are direct links to numerous free online resources that not only go deeper but also show these concepts and tools in action: case studies, articles, webcasts, templates, tutorials, examples from the ASQ Service Division's Service Quality Body of Knowledge (SQBOK), and much more. This pocket guide serves as a gateway into the wealth of peerless content that ASQ offers.

The ISO Lesson Guide translates ISO 9001 into easy-to-understand words. This pocket guide was designed as a quick reference for anyone to carry around conveniently. Each element containing requirements is discussed and key concepts are highlighted at the beginning of each section. In the ISO Lesson Guide: Quality is defined The ISO process approach is explained Key concepts are accompanied by an illustration Risk-based thinking is introduced Concepts are described in easy-to-understand words A brief conspectus summarizes ISO 9001 requirements Quality management principles are described in easy-to-understand words An entertaining fable explains the difference between ISO 9001 and ISO 9004 Ideal for handing out to existing and new employees, this pocket guide can also be used as supplemental study material for ISO 9001 training courses.

This guide is intended to help everyone in an organization participate in creating and sustaining a foundation of integrity, meet requirements and customer expectations, and support robust processes, to the advantage of everyone in the organization and to each of its customers. It provides a simplified explanation of the clauses of ISO 9001:2015, including+G429: G439: What's required Why to do it Implementation tips Questions to ask to assess conformity Also included are included descriptions of 14 quality tools that may be helpful when you are structuring or deploying processes to effectively comply with ISO 9001:2015 requirements. For each tool, the authors describe (1) what it is, (2) where it's used, (3) how it's done, and (4) cautions to be considered when using the tool.

This best-seller prepares auditors to conduct internal audits against quality, environmental, safety, and other audit criteria. This handy pocket guide covers all the steps necessary to complete an internal audit, from assignment to follow-up. New and updated chapters reflect new techniques to address vague requirements, more illustrations and examples, ISO 19011 thinking, and verification of auditee follow-up actions. This condensed, easy-to-read book is a valuable resource and great tool for training others on how to perform an internal audit. It is appropriate for those who have no prior knowledge of audit principles or techniques.

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.

Disruption impacts every industry, and it is essential for an organization to meet or exceed stakeholder expectations. How an organization manages the ever-changing world of digital evolution in the present will ultimately shape and determine its future. With this field guide, you will learn how to integrate people, processes, and technology to create greater efficiencies and profit. More importantly, you'll realize that digital transformation is a dynamic, ongoing process that allows your organization to not just survive but thrive in the world of digital evolution.This field guide provides insight and guidance by:- Explaining how organizations can embrace digital disruption and redefine how they work and serve employees and customers- Streamlining an ongoing current digital transformation journey while being proactive and envisioning big-picture outcomes- Evaluating three components that are critical to an organization's future and understanding how to incorporate them into strategic and tactical plans- Reviewing lessons learned by global market leaders that have been able to pivot digitally to meet their customer's needsTherese Costich is president and managing partner of the Costich Group. She has spent more than 25 years in the digital transformation, lean six sigma, and continuous improvement world, working with employees from the C-suite to front-line associates, for several Fortune 500 companies.

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.