There are many occasions when a project leader will preside over a team meeting that ends up falling short of the desired outcomes. Entering a room full of people who are expecting you to guide them to results can be a source of tremendous pressure, even when you feel fully prepared as a leader. This book offers a deeper understanding of how a workshop needs to be managed, how a team can be guided, and how workshop tools should be deployed to achieve a team's objectives. Notes: Facilitation for Quality offers several updates to traditional quality tools to better suit non-manufacturing environments. If you work in an service, office, non-profit, or professional setting, you will find these tools helpful (and you will use them to achieve real results). This book also offers five new tools invented or refined by the authors for those who practice or promote quality, innovation, and effective workshop management to add to their toolbox.Tracy Owens, CQE, CMQ/OE, is a process improvement consultant in Dublin, Ohio. Tracy holds a masters degree in international business from Seattle University, and he was elected to the 2016 class of ASQ Fellows. He is the author of two previous books from Quality Press: Six Sigma Green Belt, Round 2 (2011) and The Executive Guide to Innovation (2013, coauthor), and several articles in Quality Progress magazine.Therese Steiner, ASQ CSSBB, is the Director of Operational Effectiveness and Customer Experience at LexisNexis, where she has worked for 20+ years since completing her Juris Doctorate degree at the University of Dayton School of Law in 1999. Therese is a 2020-2021 ASQ Board Member and Geographic Communities Council Region Director. Therese has been a speaker on Customer Experience and Quality topics at global and regional conferences, including ASQ WCQI and OPEX World Summit, as well as at local meetings for ASQ and other organizations.
This bestseller can help anyone whose role is to try to find specific causes for failures.It provides detailed steps for solving problems, focusing more heavily on the analytical process involved in finding the actual causes of problems. It does this using figures, diagrams, and tools useful for helping to make our thinking visible. This increases our ability to see what is truly significant and to better identify errors in our thinking. In the sections on finding root causes, this second edition now includes more examples on the use of multi-vari charts; how thought experiments can help guide data interpretation; how to enhance the value of the data collection process; cautions for analyzing data; and what to do if one can't find the causes. In its guidance on solution identification, biomimicry and TRIZ have been added as potential solution identification techniques. In addition, the appendices have been revised to include: an expanded breakdown of the 7 M's, which includes more than 50 specific possible causes; forms for tracking causes and solutions, which can help maintain alignment of actions; techniques for how to enhance the interview process; and example responses to problem situations that the reader can analyze for appropriateness.
Culture IS Everything. As organizational leaders and managers, we can successfully apply all of the Lean Six Sigma principles, quality ideas, and best practices we know and still fail because we have done so within a company culture utterly hostile to such endeavors. In this book, Jeff Veyera shows you how to diagnose your company's culture in terms of its suitability for your preferred quality improvement approach and then offers guidance on how to either tailor your approach to that culture or change the culture to better suit your approach. If you've ever executed a brilliant initiative only to see it chewed up in the prevailing culture of your company, this book is your protection against such soul-crushing setbacks in the future. The first book I've seen that approaches cultural transformation with an emphasis on process improvement, including rational how-to steps that quality geeks can relate to Jeff sharing his personal stories adds a richness to this book and certainly makes it relatable to the quality professional.The author delivers on his initial promise providing a toolkit to help you evaluate, change, and sustain your company culture. Throughout the book the author discusses the concepts and a logical strategy and then provides the & how-to tools for implementation, giving readers actionable benefits from the book, not just theory. Veyera introduces the concept of using guerrilla warfare in the struggle between the culture lived and the culture desired. This is particularly appropriate, as the old culture is geared to protect itself, not to bring about its own demise. Organizations continually fall into the trap of letting the existing culture dictate how culture change will be carried out. Having been involved in a few change efforts, I found the discussion of steps to protect yourself especially valuable. I really could have used that back in the day.
More organizations and their leaders are looking to big data to transform processes and elevate the quality of products and services. Yet, gathering and storing large amounts of data isn't the quick fix often sought after. Without analysts-the human component-to interpret that data, the cost of incorrect or misinterpreted data can greatly impact organizations.In this book, William Mawby examines the claims of big data analysis in detail. Using examples to illustrate potential problems that may lead to inefficient and inaccurate results, Mawby helps practitioners avoid potential pitfalls and offers application methods to incorporate big data analytics into your company that will enhance your analytic efforts.William D. Mawby, Ph.D. has extensive consulting, teaching, and project experience and has taught more than 200 courses on many subjects in statistics and mathematics. He is currently writing, teaching courses on climate change and big data, and volunteering at the American Association for the Advancement of Science and the Union of Concerned Scientists.
Throughout Don Benbow's extensive career, teaching mathematics and statistical courses to college students and corporate employees, one common question always popped up: how do you fix statistical errors in quality? Most textbooks and courses tend to emphasize how to perform statistical analysis and give little attention to errors that can occur in the process. This book intends to teach readers how to avoid common pitfalls by providing examples and scenarios based on similar real-world events. The book also provides caveats (or quick tips) to help readers navigate their way through statistical methodology.
Quality 4.0 is for all industries, and this book is for anyone who wants to learn how Industry 4.0 and Quality 4.0 can help improve quality and performance in their team or company. This comprehensive guide is the culmination of 25 years of research and practice-exploring, implementing, and critically examining the quality and performance improvement aspects of Industry 4.0 technologies. Navigate the connected, intelligent, and automated ecosystems of infrastructure, people, objects, machines, and data. Sift through the noise around AI, AR, big data, blockchain, cybersecurity, and other rising technologies and emerging issues to find the signals for your organization. Discover the value proposition of Quality 4.0 and the leading role for quality professionals to drive successful digital transformation initiatives. The changes ahead are powerful, exciting, and overwhelming-and we can draw on the lessons from past work to mitigate the risks we face today.Connected, Intelligent, Automated provides you with the techniques, philosophies, and broad overall knowledge you need to understand Quality 4.0, and helps you leverage those things for the future success of your enterprise. Chapter 1: Quality 4.0 and the Fourth Industrial RevolutionChapter 2: Connected EcosystemsChapter 3: Intelligent Agents and Machine LearningChapter 4: Automation: From Manual Labor to AutonomyChapter 5: Quality 4.0 Use Cases Across IndustriesChapter 6: From Algorithms to Advanced AnalyticsChapter 7: Delivering Value and Impact Through Data ScienceChapter 8: Data Quality and Data ManagementChapter 9: Software Applications & Data PlatformsChapter 10: BlockchainChapter 11: Performance ExcellenceChapter 12: Environment, Health, Safety, Quality (EHSQ), and CybersecurityChapter 13: Voice of the Customer (VoC)Chapter 14: Elements of a Quality 4.0 StrategyChapter 15: Playbook for TransformationN. M. Radziwillspan is Senior VP of Quality and Strategy at Ultranauts, a professional services firm specializing in quality assurance and quality engineering for software, data science, and digital transformation. Radziwill is editor of the journal, Software Quality Professional, an ASQ fellow, and an ASQ-certified Six Sigma Black Belt. Radziwill is one of ASQ's Influential Voices and blogs.
Next Level Results for Your QMSYou don't just want a compliant quality management system, you want a robust one a QMS that's easy to implement and maintain. Beyond Compliance Design merges two sets of experiencess that of a quality system designer/auditee and that of an external auditor to help you make that possible. Move beyond a focus on checking all the right boxes to the opportunities for continuous improvement, waste reduction, employee engagement, and customer satisfaction and delight.Author Janet Bautista Smith, with the contributions of external auditor, Robert Alvarez, guides you in this process with her models, case studies, lessons learned, and an array of simple tools and templates you can customize for your organization and begin using immediately, including: Implementing layered metrics to align with the auditor's perspective Employing DMAIC analysis to process customer complaints Discovering hidden factories through a Process Grid Walk Addressing common pitfalls of documentation systems with lean solutions Achieving operational compliance and excellence within processes Determining QMS, customer, and auditor satisfaction Fostering synergy among the QMS, customer, and auditor perspectives Engaging management review for critical support
The quality technician is a person responsible for understanding and utilizing quality concepts and tools, statistical techniques, metrology and calibration procedures and protocols, inspection and test techniques, quality auditing, and preventive and corrective action in the context of product/process/service improvement or in correcting problems. Quality technicians frequently work in the quality function of organizations in the various measurement and inspection laboratories, as well as on the shop floor supporting and interacting with quality engineers, mechanical inspectors, and production/service delivery personnel.This book supports individuals preparing for, or those already performing, this type of work. It is intended to serve as a ready reference for quality technicians and quality technicians-in-training, as well as a comprehensive reference for those individuals preparing to take the ASQ Certified Quality Technician (CQT) examination. Examples and problems used throughout the handbook are thoroughly explained, are algebra-based, and are drawn from real world" situations encountered in the quality profession.To assist readers in using the book as a ready reference or as a study aid, the book has been organized so as to conform closely to the 2018 CQT Body of Knowledge (BoK).
This handbook is fully updated to the 2018 Body of Knowledge for the Certified Reliability Engineer (CRE), including the new sections on leadership, performance monitoring, root cause analysis, and quality triangles. Its purpose is to assist individuals preparing for the examination and to provide a reference for the practitioner. Several typical examples are provided throughout based on the collective experience and knowledge of the authors and editor.The chapters and sections are numbered by the same format used in the Body of Knowledge (BoK) for the CRE examination. It also includes a comprehensive glossary of reliability-related terms and appendices with, among other things, various useful distribution tables.
The 2015 edition of ISO 9001 has been modernized to update terminology and content to meet current and anticipated user needs. The major emphasis of ISO 9001:2015 is still consistent provision of products and services that meet customer and applicable statutory and regulatory requirements.This book explains the meaning and intent of the requirements of ISO 9001:2015 and discusses the requirements as they relate to each of the product categories. Where appropriate, it includes an elaboration of why the requirements are important. It also includes typical audit-type questions that an organization may consider to assess conformity to internal needs and ISO 9001 requirements. Recommendations for implementation are also included.This book addresses the needs of:Users and organizations seeking a general understanding of the contents of ISO 9001:2015Users and organizations desiring guidance to ensure their ISO 9001:2015 QMS meets the new version requirementsUsers and organizations considering the use of ISO 9001:2015 as a foundation for the development of a comprehensive QMSEducators who require a textbook to accompany a training class or course on ISO 9001:2015Auditors who desire to increase their level of auditing competenceAuthors Cianfrani and West, members of the expert group that developed ISO 9001:2015, strive to provide a context for all requirements to enable you to develop and deploy processes that will strengthen your QMS. Getting or retaining a certificate is not the real objective. Satisfied customers and organizational sustainability should be primary objectives for the organization.
This book was written to provide guidance for those who need to apply statistical methods for practical use. While the book provides detailed guidance on the use of Minitab for calculation, simply entering data into a software program is not sufficient to reliably gain knowledge from data. The software will provide an answer, but the answer may be wrong if the sample was not taken properly, the data was unsuitable for the statistical test that was performed, or the wrong test was selected. It is also possible that the answer will be correct, but misinterpreted. This book provides both guidance in applying the statistical methods described as well as instructions for performing calculations without a statistical software program such as Minitab.One of the authors is a professional statistician who spent nearly 13 years working at Minitab and the other is an experienced and certified Lean Six Sigma Master Black Belt. Together, they strive to present the knowledge of a statistician in a format that can be easily understood and applied by non-statisticians facing real-world problems.Their guidance is provided with the goal of making data analysis accessible and practical. Rather than focusing on theoretical concepts, the book delivers only the information that is critical to success for the practitioner. It is a thorough guide for those who have not yet been exposed to the value of statistics, as well as a reliable reference for those who have been introduced to statistics but are not yet confident in their abilities.Supplemental files available! If you are an instructor who would like to conduct training with this book, please visit this "https://asqassets.widencollective.com/portals/sybdffda/(H1550)AppliedStatisticsManualAGuidetoImprovingandSustainingQualitywithMinitab" access: Course descriptions for one or two semester university courses Chapter descriptions for standalone sessions A data file containing data sets used in the book
In order for organizations to have high confidence in the reliability of their medical devices, they must ensure that each and every component or service meets requirements, including quality requirements. In that light, supplier management is not only a regulatory requirement but also a business aspect.The intent of this book is to show readers a process of effectively selecting, evaluating, and implementing applicable controls based on the evaluation and ongoing proactive management of suppliers, consultants, and contractors in a state of compliance. These processes can be applied to all suppliers, consultants, and contractors.In writing this book, the authors made sure that readers could immediately apply its content. They provide best practices based on a combined 50+ years of quality and engineering experience, having worked with some of the best medical device companies and contract manufacturers in the world.Four icons use throughout the book help readers navigate and understand the content. The FDA and toolbox icons assist in determining whether it's a requirement or a tool to help achieve compliance. The Lessons from the Road" icon indicates real-life stories and what the authors have learned throughout their careers. Lastly, the check mark icon is used to highlight key thoughts, what they feel are unique takeaways or deserve a special focus.
The focus of this book is to demystify the requirements delineated within ISO/IEC 17025:2017, while providing a road map for organizations wishing to receive accreditation for their laboratories.AS9100, ISO 9001:2015, and ISO 13485:2016 are standards that have been created to support the development and implementation of effective approaches to quality management, and are recognized blueprints for the establishment of a quality management system (QMS) for many diverse industries. Similar to these recognized QMS standards, ISO/IEC 17025:2017 for laboratory accreditation serves a unique purpose. It is not unusual for laboratories to retain dual certification in ISO 9001:2015 and ISO/IEC 17025:2017. However, ISO/IEC 17025:2017 contains requirements specific to the laboratory environment that are not addressed by ISO 9001:2015.This book highlights those differences between ISO 9001:2015 and ISO/IEC 17025:2017, while providing practical insight and tools needed for laboratories wishing to achieve or sustain accreditation to ISO/IEC 17025:2017. For those currently or formerly accredited to the 2005 version of ISO/IEC 17025, an appendix outlines the changes between the 2005 and 2017 versions of the standard.
The quality inspector is the person perhaps most closely involved with day-to-day activities intended to ensure that products and services meet customer expectations. The quality inspector is required to understand and apply a variety of tools and techniques as codified in the American Society for Quality (ASQ) Certified Quality Inspector (CQI) Body of Knowledge (BoK). The tools and techniques identified in the ASQ CQI BoK include technical math, metrology, inspection and test techniques, and quality assurance. Quality inspectors frequently work with the quality function of organizations in the various measurement and inspection laboratories, as well as on the shop floor supporting and interacting with quality engineers and production/service delivery personnel.This handbook supports individuals preparing to perform, or those already performing, this type of work. It is intended to serve as a ready reference for quality inspectors and quality inspectors in training, as well as a comprehensive reference for those individuals preparing to take the ASQ CQI examination. Examples and problems used throughout the handbook are thoroughly explained, are algebra-based, and are drawn from real-world situations encountered in the quality profession.To assist readers in using this book as a ready reference or as a study aid, the book has been organized to conform explicitly to the ASQ CQI BoK. Each chapter title, all major topical divisions within the chapters, and every main point has been titled and then numbered exactly as they appear in the CQI BoK.
The handbook is structured to guide organizations new to ISO 9001 through the process necessary to connect their current practices to the requirements of ISO 9001:2015. For organizations already certified to ISO 9001, it advises how to use your upgrade to ISO 9001:2015 as an opportunity to rebuild your QMS into a helpful asset in managing your business.
Good data is a source of myriad opportunities, while bad data is a tremendous burden. Companies that manage their data effectively are able to achieve a competitive advantage in the marketplace, while bad data, like cancer, can weaken and kill an organization.In this comprehensive book, Rupa Mahanti provides guidance on the different aspects of data quality with the aim to be able to improve data quality. Specifically, the book addresses: Causes of bad data quality, bad data quality impacts, and importance of data quality to justify the case for data quality Butterfly effect of data quality A detailed description of data quality dimensions and their measurement Data quality strategy approach Six Sigma - DMAIC approach to data quality Data quality management techniques Data quality in relation to data initiatives like data migration, MDM, data governance, etc. Data quality myths, challenges, and critical success factorsStudents, academicians, professionals, and researchers can all use the content in this book to further their knowledge and get guidance on their own specific projects. It balances technical details (for example, SQL statements, relational database components, data quality dimensions measurements) and higher-level qualitative discussions (cost of data quality, data quality strategy, data quality maturity, the case made for data quality, and so on) with case studies, illustrations, and real-world examples throughout.About the AuthorRupa Mahanti, Ph.D. is a Business and Information Management consultant and has worked in different solution environments and industry sectors in the United States, United Kingdom, India, and Australia. She helps clients with activities such as business process mapping, information management, data quality, and strategy. Having a work experience (academic, industry, and research) of more than a decade and half, Rupa has guided a doctoral dissertation and published a large number of research articles. She is an associate editor with the journal Software Quality Professional and a reviewer for several international journals."This is not the kind of book that you'll read one time and be done with. So scan it quickly the first time through to get an idea of its breadth. Then dig in on one topic of special importance to your work. Finally, use it as a reference to guide your next steps, learn details, and broaden your perspective."from the foreword by Thomas C. Redman, Ph.D., the Data DocDr. Mahanti provides a very detailed and thorough coverage of all aspects of data quality management that would suit all ranges of expertise from a beginner to an advanced practitioner. With plenty of examples, diagrams, etc. the book is easy to follow and will deepen your knowledge in the data domain. I will certainly keep this handy as my go-to reference. I can't imagine the level of effort and passion that Dr. Mahanti has put into this book that captures so much knowledge and experience for the benefit of the reader. I would highly recommend this book for its comprehensiveness, depth, and detail. A must-have for a data practitioner at any level.Clint D'Souza, CEO and Director, CDZM Consulting
This book is written for the leader or management team of any complex organization attempting to lead an organization-wide change. Successfully leading change has never been easy. Many realities of life in the 21st century have combined to intensify the challenge. This book captures the lessons learned during more than 43 years of experience working in complex, large-scale organizations, 14 years between West Point and the United States Army and more than 29 years in two large, very different American companies. These lessons learned are shared in the hope that it will help others lead change successfully and avoid at least some of the pitfalls that come with it.The principles and questions in this book also benefit leaders making changes in the small organization or those who desire to transform their small organization into a large one. This book is intended to serve as a leaders' guide of things to think about and how to plan for successful change.Many books have been written about management and leadership, as well as the dos and must-dos of leading an organization. But few books discuss what it takes to make changes in today's complex organizations, and those that do are often written by consultants who have not practiced what they propose over any significant period of time. This book, by contrast, draws lessons from a successful long-term change made by leaders who had a personal and financial stake in the organization's success and saw the change all the way through.hr"In my 40 years at Cummins one of the most successful changes made was our adoption of Six Sigma. When I became CEO it was clear that we needed to improve our product and overall business performance. We chose Six Sigma to help us do that. George's book concisely captures many of the things we had to think about when implementing Six Sigma throughout the company. I believe this is a good guide for any leader contemplating making an organization-wide change." Tim Solso former CEO Cummins, Inc."As CEO I have discovered that just saying I want something done doesn't make it happen. Change done well is hard work. George's book is a practical go-to guide for driving lasting change." Tom Linebarger CEO Cummins, Inc."In medicine today ever-higher quality has become an expectation. This expectation is causing us increasingly to transition from volume-based to value-based medicine. As an industry we are quickly adapting to this new value-based world. However, organizations don't transform easily. It requires dedicated and engaged teams to be leaders of change in their industry. I have been waiting for a book like this for years...whether you are a medical student or a senior attending physician...George Strodtbeck's book on Making Change is a must read!!!" James Grant, M.D. Chair, Department of Anesthesiology Beaumont Health System, Royal Oak, Michigan"George Strodtbeck draws on more than three decades of personal experience in planning and executing change in complex organizations. His incisive, fast-paced writing explains, engages and motivates. His guidance is candid about challenges faced but simultaneously practical and actionable in today's organizations. This book is for any leader seeking to accelerate the pace of change, improvement and innovation in their organizations." Mohan V. Tatikonda, PhD Professor of Operations Management Kelley School of Business, Indiana University
This handbook contains information and guidance that supports all of the topics of the 2016 version of the CSQE Body of Knowledge (BoK) upon which ASQ's Certified Software Quality Engineer/(CSQE) exam is based. Armed with the knowledge presented in this handbook to complement the required years of actual work experience, qualified software quality practitioners may feel confident they have taken appropriate steps in preparation for the ASQ CSQE exam.However, the goals for this handbook go well beyond it being a CSQE exam preparation guide. Its author designed this handbook not only to help the software quality engineers, but as a resource for software development practitioners, project managers, organizational managers, other quality practitioners, and other professionals who need to understand the aspects of software quality that impact their work. It can also be used to benchmark their (or their organization's) understanding and application of software quality principles and practices against what is considered a cross-industry good practice baseline. After all, taking stock of strengths and weaknesses, software engineers can develop proactive strategies to leverage software quality as a competitive advantage.New software quality engineers can use this handbook to gain an understanding of their chosen profession. Experienced software quality engineers can use this handbook as a reference source when performing their daily work. It is also hoped that trainers and educators will use this handbook to help propagate software quality engineering knowledge to future software practitioners and managers. Finally, this handbook strives to establish a common vocabulary that software quality engineers, and others in their organizations can use to communicate about software and quality. Thus increasing the professionalism of the industry and eliminating the wastes that can result from ambiguity and misunderstandings.
Perfect for anyone charged with implementing a quality audit program or those performing the audit, this book is an ideal reference on the established techniques of quality auditing. This third edition serves as a guide to learning and applying the basics of quality auditing, and expands on the basic auditing principles by showing how the quality audit can be used to improve business performance. This new edition includes:- An expanded background and history of quality auditing- A general model for auditing any quality management system- Added information on process audits and the system-process-product relationship- Auditor competencies and qualifications- An explanation of audit reports and the role of the auditor after the report- New material on remedial and corrective action- Example audit procedures and a glossary of auditing termsAuthor Dennis Arter addresses both internal and supplier auditing as it relates to any quality management system, including ISO 9001, GMP, automotive, and others. He provides supportive examples and checklists throughout the text to help make this book the best single-source guide on the subject. Quality practitioners, registrars, and those preparing for the ASQ Certified Quality Auditor (CQA) exam will find it to be an invaluable reference.
This book is written for the Six Sigma Black Belt who needs an understanding of many statistical methods but does not use all of these methods every day. It is intended to be used as a quick reference, providing basic details, step-by-step instructions, and Minitab statistical software instructions.Six Sigma Black Belts typically use a statistical program such as Minitab to perform calculations, but an understanding of the underlying statistics is still needed. Anybody can type data into a program; a Black Belt must be capable of understanding which hypothesis test is appropriate for a given use, as well as the assumptions that must be met to correctly perform the hypothesis test.The methods presented here are laid out according to the Six Sigma DMAIC (Define, Measure, Analyze, Improve, Control) phases in which they are typically used. However, these methods can also be applied outside of a Six Sigma project, such as when one simply needs to determine whether there is a difference in the means of two processes producing the same parts.A Six Sigma Black Belt using Statistics for Six Sigma Black Belts will be able to quickly zero in on appropriate methods and follow the examples to reach the correct statistical conclusions.
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.
Worldwide regulatory agencies perform many inspections annually, and all too often investigation and CAPA system violations are at the top of the list of infractions. Life-sciences regulated companies (not only FDA-regulated ones) must ensure their investigation and CAPA systems look beyond the 'usual suspects' to identify other quality issues in order to minimize risks (including safe ones) and reduce costs.Enhancements to this third edition include:A new section linking the investigation and CAPA programs with the overall quality culture of the companyFully updated, current versions of regulations including U.S. FDA, EU, ISO 9001, and ISO 13485Updated inspectional observations from the U.S. FDA and U.K. MHRAA revised investigation and CAPA processes chapter, which has an improved barrier analysis section, including detailed flowcharts describing the barrier analysis processNew charts and information related to the investigation of human errors; the human factor section includes information about training and competenceA new chapter devoted to analytical laboratory investigations, including a section covering the invalidation of testing resultsUpdated forms and examples of the different elements of the investigation and CAPA plan, including new case studies; a revised diagnostic tool used for investigating human errorJose(Pepe) Rodrguez-Perez, PhD, is president of Business Excellence Consulting, Inc., (BEC), a Puerto Rico-based, consulting, training, and remediation firm that focuses on the areas of regulatory compliance, FDA-regulatory training, and risk management. He is a biologist with a doctoral degree in biology from the University of Granada (Spain). Over his career, he has served as an educator, a technical services manager, and as a science advisor to the FDA.
As a quality professional in the medical device industry, you know all too well the importance of a risk management process-and how iterative it can be. Industry regulations and standards-like ISO 14971-help medical device manufacturers define risk management processes, but they don't make them bulletproof, that is, ensure the efficacy of their products while minimizing future liability.This book can help you build a bulletproof, risk process. You will learn how: Designing product and manufacturing processes controls risks Using consistent language in a holistic, closed-loop risk management system leads to greater efficiency Creating useable and audit-ready risk documents can support verification/validation (V/V) sampling plans Developing labels and instructions can help end-users and patients clearly understand the pertinent risks Creating post-market surveillance (PMS) processes is essential to determine if additional clinical/performance studies are necessaryJoe Simon holds an MBA and has been a member of ASQ since 2008. Over his nearly 30-year career, he worked with numerous companies as an employee and a consultant to build or improve complaint analysis, trending, post-market surveillance (PMS), nonconformance (NC), corrective action/preventive action (CAPA), stewardship, and risk management processes.
This handbook is designed as a reference for ASQ's Certified Quality Process Analyst (CQPA) Body of Knowledge (BoK), providing the essential information needed to prepare for the CQPA examination. The handbook is aimed at quality professionals who, in support of and under the direction of quality engineers or supervisors, analyze and solve quality problems and are involved in quality improvement projects. It's ideal for recent graduates and experienced professionals who want to expand their knowledge of quality tools and processes.There are five main sections in the CQPA Body of Knowledge, further subdivided into related subsections. These sections are:Quality Concepts and Team DynamicsQuality Tools and Process Improvement TechniquesData AnalysisCustomer-Supplier RelationsCorrective and Preventive Action (CAPA)This updated edition has been revised and expanded to match the 2020 BoK with enhancements to:tools for assessing training effectivenessbest practices on the Six Sigma DMAIC methodology and process maps with a focus on process architectureexamples of lean and value analysis, Theory of Constraintsrisk management, business process management and lifecycle phasesthe importance of data collection and analysis, data integrity, validity, and reliabilityexamples of gage R&;R and attribute agreement analysisSandra L. Furtererspan, BS, MS, MBA, PhD, is an associate professor at the University of Dayton in the Department of Engineering Management, Systems and Technology. She is an ASQ Certified Six Sigma Black Belt, Certified Manager of Quality/ Organizational Excellence, Certified Quality Engineer, an ASQ fellow, and a certified Six Sigma Master Black Belt. She is also a contributor to ASQ's certification handbooks (CMQ/OE and CQIA) and a prolific speaker.
In today's uncertain times, risk has become the biggest part of management. Risk management is central to the science of prediction and decision-making; holistic and scientific risk management creates resilient organizations, which survive and thrive by being adaptable. This book is the perfect guide for anyone interested in understanding and excelling at risk management.It begins with a focus on the foundational elements of risk management, with a thorough explanation of the basic concepts, many illustrated by real-life examples. Next, the book focuses on equipping the reader with a working knowledge of the subject from an organizational process and systems perspective. Every concept in almost every chapter is calibrated to not only ISO 9001 and ISO 31000, but several other international standards.In addition, this book presents several tools and methods for discussion. Ranging from industry standard to cutting edge, each receives a thorough analysis and description of its role in the risk management process. Finally, you'll find a detailed and practical discussion of contemporary topics in risk management, such as supply chain risk management, risk-based auditing, risk in 4.0 (digital transformation), benefit-risk analyses, risk-based design thinking, and pandemic/epidemic risk management.Jayet Moon is a Senior ASQ member and holds ASQ CQE, CSQP, and CQIA certifications. He is also a chartered quality professional in the U.K. (CQP-MCQI). He earned a master's degree in biomedical engineering from Drexel University in Philadelphia and is a Project Management Institute (PMI) Certified Risk Management Professional (PMI-RMP). He is a doctoral candidate in Systems and Engineering Management at Texas Tech University
Jetzt zum Newsletter anmelden und tolle Angebote und Anregungen für Ihre nächste Lektüre erhalten.
Mit Ihrer Newsletter-Anmeldung erklären Sie sich mit unseren Datenschutzbestimmungen einverstanden.
