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.

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.

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.

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.

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

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.

As with Milt Dentch's previous ASQ books on ISO management systems (ISO 9001 and ISO 14001), his coverage of ISO 45001:2018 manages to be both concise, yet fully informative. Avoiding fluff, the book's guidance on this new ISO health and safety standard provides a helpful section-by-section digest coupled with implementation examples and changes from the OHSAS 18001 requirements. Dennis Sasseville Sustainability Quality Systems Director Worthen Industries, Inc. This handbook explains how an organization can use a management system to both control and improve its safety or occupational health and safety performance. It provides guidance in building the OH&S management system in support of the organization's operations, linking the management system to the requirements of ISO 45001:2018, to support third-party certification. Included in the text are best practices as well as common pitfalls or weaknesses I have observed in various organizations. For those organizations certified according to OHSAS 18001:2007, the book highlights the changes required to upgrade to the new international standard. The ISO 45001:2018 Implementation Handbook is formatted to describe each clause of ISO 45001:2018 in four sections: Correspondence with the current OHSAS 18001 standard The ISO requirement Guidance on conformance to the requirements Questions for internal auditors A CD included with this handbook contains internal auditor check sheets that can be used to assess conformance to ISO 45001:2018. Electronic Books Only: CD-ROM files are available for download.

The ASQ Certified Software Quality Engineer Handbook, Third Edition contains information and guidance that supports all the topics within the 2023 version of the Certified Software Quality Engineer (CSQE) Body of Knowledge (BoK). Armed with the knowledge in this handbook, qualified software quality practitioners will be prepared for the ASQ CSQE exam. It is also helpful for any practitioner or manager who needs to understand the aspects of software quality that impacts their work

Designed to aid candidates in preparing for ASQ Certified Quality Technician (CQT) certfication exam, this fourth edition aligns with the 2024 ASQ CQT Body of Knowledge (BoK). It also serves as an ideal reference for quality professionals responsible for implementing quality concepts and tools on the job. The editors have included statistical techniques, calibration and metrology procedures, inspection and testing techniques, and corrective and preventive action, as well as examples with algebra-based math throughout the book to show practical application of the material.

This book is ideal for leaders in any type of company. The concepts and principles throughout will guide the reader on a journey toward organizational excellence.

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 regulations
• New content regarding human factors and usability engineering, general safety and performance requirements, labeling, validation, risk management, and cybersecurity considerations
• A thorough explanation of quality tools and techniques

The eight discipline (8D) problem-solving methodology includes the following: Select an appropriate team Formulate the problem definition Activate interim containment Find root cause(s) Select and verify correction(s) Implement and validate corrective action(s) Take preventive steps Congratulate the team This unique book provides an overview of the 8D process, gives guidance on tools for finding root causes, shows 8D in action in eight case studies, and gives five unsolved problems for readers to apply 8D themselves for practice. Anyone who wants to improve quality, regardless of the industry they come from, will benefit from the 8D approach. It has been successfully applied in healthcare, retail, finance, government, and manufacturing.

The ASQ Certified Pharmaceutical GMP Professional Handbook assists candidates preparing for the Certified Pharmaceutical Good Manufacturing Practices Professional (CPGP) examination and serves as a handy reference guide for practitioners in the field. This handbook covers compliance with good manufacturing practices (GMPs) as regulated and guided by national and international agencies for the pharmaceutical industry.

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 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.

For decades, this book has served as a guide to organizations that document their continuous improvement efforts using Baldrige Award-type management systems. Readers will learn what each area of the system means for organizations and how the synergy between process-oriented parts-leadership; strategy; customers; measurement, analysis, and knowledge management; workforce; and operations-can lead to excellent performance results. This book provides a valuable, step-by-step approach to help identify and put in place properly focused continuous improvement systems. Seven types of information are provided in this book for each of the Items in Categories 1 through 7 of the 2021-2022 Baldrige Framework and Performance Excellence Criteria: 1. The actual language of each Item, including Notes 2. A plain-English explanation of the requirements and rationale for each Item 3. A table showing the similar requirements of the Criteria 4. A summary of the requirements of each Item in flowchart form 5. The key linkages between each Item and other Items 6. An explanation of some potential adverse consequences 7. Examples of effective practices Features of this edition include: - A stakeholder matrix table of contents that identifies relevant material within the book for key stakeholder groups: senior leaders, examiners, performance excellence initiative leaders, application writers, and program administrators - Tables for each Criteria Item showing the similar expectations of the Criteria award (and award program administrators) presented only once at the scoring level where the expectation first appears to help examiners determine at what level an expectation belongs - Online resources, including scoring calibration guides for education, healthcare, and business/nonprofit/government organizations, a guide to self-assessment of organizations and management systems, and a guide to the alignment of Baldrige, Six Sigma, Lean, and Balanced Scorecard - A new crosswalk between Baldrige and ISO standards and a set of global performance excellence best practices - Information on other award programs throughout the world such as the European Foundation for Quality Management (EFQM), which has undergone significant changes in the 2020 model, and the China Association for Quality Mark L. Blazey has retired from more than 26 years as president of Quantum Performance Group, a management consulting and training firm specializing in organization assessment and high-performance systems development. Paul L. Grizzell is president of Core Values Partners, a perfor mance excellence consulting firm that helps organizations focus, align, and accelerate their improvement efforts through the use of the Baldrige Framework for Performance Excellence, the EFQM Model, the China Quality Award, and other integrated management systems.

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.

As a companion to The ASQ Certified Six Sigma Yellow Belt Handbook, this study guide offers helpful exercises for anyone planning to take the ASQ Certified Six Sigma Yellow Belt (CSSYB) exam. Unlike other resources, this book has been developed specifically to address the 2022 CSSYB Body of Knowledge (BoK), considering the proper depth of knowledge and required levels of cognition. Every practice question in both sections details solutions that explain the correct answer and the corresponding section of the BoK to the question to facilitate further study as needed.

Inside, you will find:

- SECTION 1, which offers 161 practice questions organized by the five parts of the BoK

- SECTION 2, which offers 139 additional practice questions from each of the five parts

- Updates to the 2022 CSSYB BoK, including new supply chain management, corrective action, preventive action, and work instructions sections

- A list of additional references used by the teams that create the test items for the CSSYB examination.

For many years, we considered human errors or mistakes as the cause of mishaps or problems. In the manufacturing industries, human error, under whatever label (procedures not followed, lack of attention, or simply error), was the conclusion of any quality problem investigation. The way we look at the human side of problems has evolved during the past few decades. Now we see human errors as the symptoms of deeper causes. In other words, human errors are consequences, not causes. The basic objective of this book is to provide readers with useful information on theories, methods, and specific techniques that can be applied to control human failure. It is a book of ideas, concepts, and examples from the manufacturing sector. It presents a comprehensive overview of the subject, focusing on the practical application of the subject, specifically on the human side of quality and manufacturing errors. In other words, the primary focus of this book is human failure, including its identification, its causes, and how it can be reasonably controlled or prevented in the manufacturing industry setting. In addition to including a detailed discussion of human error (the inadvertent or involuntary component of human failure), a chapter is devoted to analysis and discussion related to voluntary (intentional) noncompliance. Written in a direct style, using simple industry language with abundant applied examples and practical references, this book's insights on human failure reduction will improve individual, organizational, and social well-being.

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