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ISO 28593:2017: ACCEPTANCE SAMPLING PROCEDURES BY ATTRIBUTES — ACCEPT-ZERO SAMPLING SYSTEM BASED ON CREDIT PRINCIPLE FOR CONTROLLING OUTGOING QUALITY (E-STANDARD)
ISO 28593:2017 specifies a system of single sampling schemes for lot-by-lot inspection by attributes. All the sampling plans of the present system are of accept-zero form, i.e. no lot is accepted if the sample from it contains one or more nonconforming items. The schemes depend on a suitably-defined average outgoing quality limit (AOQL), the value of which is chosen by the user; no restrictions are placed on the choice of the value of the AOQL or on the sizes of successive lots in the series. The methodology ensures that the overall average quality reaching the customer or market-place will not exceed the AOQL in the long run.
ISO TS 16355-6:2019 APPLICATIONS OF STATISTICAL AND RELATED METHODS TO NEW TECHNOLOGY AND PRODUCT DEVELOPMENT PROCESS — PART 6: GUIDANCE FOR QFD-RELATED APPROACHES TO OPTIMIZATION (E-STANDARD)
This document provides guidance for QFD-related approaches to optimization through robust parameter design to ensure customer satisfaction with new products, services, and information systems. It is applicable to identify optimum nominal values of design parameters based on the assessment of robustness of its function at the product design phase. NOTE Some of the activities described in this document can be used at earlier and later stages. Other approaches to solve optimization problems in new technology and product development processes are listed in Annex B.
ISO 16355-1:2021 APPLICATION OF STATISTICAL AND RELATED METHODS TO NEW TECHNOLOGY AND PRODUCT DEVELOPMENT PROCESS — PART 1: GENERAL PRINCIPLES AND PERSPECTIVES OF QUALITY FUNCTION DEPLOYMENT (QFD)
This part of ISO 16355 describes the quality function deployment (QFD) process, its purpose, users, and tools. It is not a management system standard. It does not provide requirements or guidelines for organizations to develop and systematically manage their policies, processes, and procedures in order to achieve specific objectives. Users of this part of ISO 16355 will include all organization functions necessary to assure customer satisfaction, including business planning, marketing, sales, research and development (R&D), engineering, information technology (IT), manufacturing, procurement, quality, production, service, packaging and logistics, support, testing, regulatory, and other phases in hardware, software, service, and system organizations.
ASQ TR2:2024
COQ for development, implementation, and monitoring to improve performance is applicable as needed to all processes performed by the organization, performed on behalf of the organization (e.g., external providers) and the results of the processes experienc
STATISTICAL ENGINEERING (EBOOK). AN ALGORITHM FOR REDUCING VARIATION IN MANUFACTURING PROCESSES
Reducing the variation in process outputs is a key part of process improvement. For mass produced components and assemblies, reducing variation can simultaneously reduce overall cost, improve function and increase customer satisfaction with the product.The authors have structured this book around an algorithm for reducing process variation that they call "Statistical Engineering." The algorithm is designed to solve chronic problems on existing high to medium volume manufacturing and assembly processes. The fundamental basis for the algorithm is the belief that we will discover cost effective changes to the process that will reduce variation if we increase our knowledge of how and why a process behaves as it does. A key way to increase process knowledge is to learn empirically, that is, to learn by observation and experimentation.The authors discuss in detail a framework for planning and analyzing empirical investigations, known by its acronym QPDAC (Question, Plan, Data, Analysis, Conclusion). They classify all effective ways to reduce variation into seven approaches. A unique aspect of the algorithm forces early consideration of the feasibility of each of the approaches.Also includes case studies, chapter exercises, chapter supplements, and six appendices.PRAISE FOR Statistical Engineering"I found this book uniquely refreshing. Don't let the title fool you. The methods described in this book are statistically sound but require very little statistics. If you have ever wanted to solve a problem with statistical certainty (without being a statistician) then this book is for you." - A reader in Dayton, OH"This is the most comprehensive treatment of variationreduction methods and insights I’ve ever seen." - Gary M. Hazard Tellabs"Throughout the text emphasis has been placed on teamwork, fixing the obvious before jumping to advanced studies, and cost of implementation. All this makes the manuscript attractive for real-life application of complex techniques." - Guru Chadha Comcast IP ServicesCOMMENTS FROM OTHER CUSTOMERSAverage Customer Rating: (5 of 5 based on 1 review) "This is NOT a typical book on statistical tools. It is a strategy book on how to search for cost-effective changes to reduce variation using empirical means (i.e. observation and experiment). The uniqueness of this book: Summarizes the seven ways to reduce variation so we know the goal of the data gathering and analysis, present analysis results using graphs instead of P-value, and integrates Taguchi, Shainin methods, and classical statistical approach. It is a must read for those who are in the business of reducing variation using data, in particular for the Six Sigma Black Belts and Master Black Belts. Don't forget to read the solutions to exercises and supplementary materials to each chapter on the enclosed CD-ROM." - A. Wong, Canada
SENIOR MANAGEMENT AND QUALITY (EBOOK). HOW TO LEVERAGE QUALITY FOR PROFIT
"Not just another quality tools book. I wish all senior managers would read this..Anyone who is interested in how quality is embedded in all aspects of business should get this book." Holly Hickman Director, Customer Quality, Constellium In this original and practical book, Fin Rooney strips back the myths surrounding quality. He goes back to original principles in deciding what quality means, and then proceeds to show how it can have a positive influence on all departments. He suggests that every department should have quality objectives in order to generate a quality culture. This book will change how you look at quality. You will see how you can use it to drive improvement, cost savings, and better profitability in your organization. It will look at using quality not just as a tool for making good products or delivering a good service, but as a strategic weapon in the marketplace. Full of helpful questions and thought-provoking ideas, Senior Management and Quality will ensure you have interesting conversations with senior managers and how they view quality. For senior managers, it gives a framework for devising a coordinated quality strategy, involving every department in quality, and showing how an embedded quality strategy can create virtuous circles of improvement. Among many features, this book: Explains how we can turn our quality departments and staff into a strategic, value-adding service Gives a neater definition of ‘quality’ that can be applied to any department in any organization Shows the relationships between quality and suppliers, customers, and internal departments Addresses the issues that can arise with the department that is the most important one in determining product quality: R & D Reassesses our view of company and quality objectives Reviews the role of quality personnel, and how we can use them as internal consultants Investigates how quality can influence training and change management Takes a fresh look at objectives and metrics, and the problems and contradictions with some of the common ones in use Looks at some of the deficiencies with Six Sigma With over 30 years in quality, Fin Rooney has put together the results of that experience in the real business world and come up with a practical approach to using quality as a way to improve your organization’s performance in all areas.
PRINCIPLES AND PRACTICES OF ORGANIZATIONAL PERFORMANCE EXCELLENCE (EBOOK)
Many organizations have realized bona fide reward payoffs using a systematic continuous approach to quality and quality improvement. Divided into two sections, this book begins with an easy overview of quality fundamentals and productivity followed by a more detailed explanation of the key quality improvement tools and techniques.Chapter topics include the evolution of quality, management by commitment and leadership, customer satisfaction, organization planning, partnerships and strategic alliances, need for a systems approach in process improvement, quality costs, current engineering, and much more. Includes many examples and study questions to make it useful as a business reference or text.Principles and Practices of Organizational Performance is the evolution of the author's best-selling book, Principles and Practices of TQM, certain portions of which have been included in this book.Selected as an Outstanding Academic Title by Choice Magazine, 1999.Benefits:Discusses international quality standards(ISO). Provides an overview of the essentials in quality improvement awards - both national and international.Includes a glossary of terms that aid in communicating the language of improvement.Contents:Productivity FundamentalsManagement and Organization ChangeCustomer Satisfaction and FocusEmployee EmpowermentQuality Planning and DeploymentQuality Systems and ImprovementThe New Quality AssuranceSupplier Quality ManagementQuality Costs-Old and NewTools for Continuous ImprovementQuality Standards and AwardsQuality Function DeploymentDesign of Experiments
THE UNCERTAINTY OF MEASUREMENTS (EBOOK). PHYSICAL AND CHEMICAL METROLOGY IMPACT AND ANALYSIS
The uncertainty of measurement results is drawing attention of managers, metrologists and customers. The accuracy of measurements affects all of us in trade, commerce, safety, health care environmental protection and more. The quality of these measurements
EXECUTIVE GUIDE TO IMPROVEMENT AND CHANGE (EBOOK)
There are many techniques and a variety of tools available to improve or change an organization, but how do executives and senior management decide which are right for their organizations? The Executive Guide to Improvement and Change is designed to help managers and executives understand the many different approaches to organizational change and improvement. The book explains that there is not one technique that works best for any organization, but rather that the managers and executives need to develop their own strategies with a blending of different methods. The authors share the tools and techniques that they have used to successfully make changes and improvements in their own organizations, which include examples from manufacturing, healthcare, service, government, telecommunications, education, and more. The Executive Guide to Improvement and Change covers a variety of techniques ranging from auditing to teamwork, Six Sigma to Customer Satisfaction, and more. The book will assist executives and managers lead improvement and change initiatives within the organization and the larger business community, as well as educate those who aspire to senior positions of leadership.
ISO LECCION GUIA 2000, SEGUNDA EDICION
Este manual de lecciones de la ISO explica la norma de calidad 9001 en palabras sencillas y fáciles de entender. Esta edición de bolsillo se diseñó como una herramienta escrita de referencia rápida. Cualquier persona lo puede traer consigo.Al principio de cada sección, se analiza individualmente al elemento normativo que contiene los requisitos de cumplimiento y se resaltan los conceptos clave.Resumen de las caracteristicas de manual:Cada concepto clave está plasmado en una ingeniosa ilustraciónLos conceptos están descritos con palabras sencillasCuenta con la definición de concepto de calidadOfrece una explicación del enfoque del proceso en el que se fundamenta la ISODescribe los principios de gestión de la calidad en un lenguaje claroContiene una práctica tabla sinóptica desprendible, en donde puede consultar con rapidez los requisitos y los conceptos de la norma ISO 9001Utiliza un relato ingenioso y llano, para ejemplificar la diferencia entre las normas ISO 9001 y 9004Este manual de bolsillo es ideal para repartirlo a sus empleados, tanto antigous como de Nuevo ingreso. También puede utilizarlo como material de apoyo para los cursos de capacitación sobre la norma ISO 9001.Benefits:COMMENTS FROM OTHER CUSTOMERSAverage Customer Rating: (4 of 5 based on 3 reviews) "This handy dandy reference guide has proven helpful with our employees who need a quick introduction to the new standard. We used the first and second editions during our initial tansition to the new standard and found them very helpful." Neil Slattery - Fort Worth, TX
LEAN STRATEGIES FOR PRODUCT DEVELOPMENT (EBOOK). ACHIEVING BREAKTHROUGH PERFORMANCE IN BRINGING PRODUCTS TO MARKET
Most companies are under a great deal of pressure to reduce expenses and increase profits. And as the competition continues to increase, these companies are all racing to develop new products and bring them to market as quickly and cheaply as possible. Many of these companies have turned to lean strategies in the manufacturing area to help them improve the process by eliminating waste and helping them gain a competitive advantage. Yet few if any have taken these same strategies beyond the manufacturing environment and into the product development area. This is the focus of Lean Strategies for Product Development, which explains how to use these same lean strategies and principles in non-manufacturing areas which will lead to reduced cycle times and increased profits. Lean Strategies for Product Development highlights problems that are common to companies in terms of developing products cheaply and efficiently. The result is a book based on proven strategies and methodologies that will enable a company to significantly reduce the time necessary to develop new products and dramatically reduce product cost. Companies that have implemented the concepts presented in Lean Strategies for Product Development have achieved dramatic results. In some cases, cycle time reduction by as much as 70% has been achieved. The concepts are presented in the context of a story centered on two key characters – a customer and his supplier. Through the dialog shared between the characters, the concepts are presented and a new business opportunity emerges.
EFFECTIVE WRITING FOR THE QUALITY PROFESSIONAL (EBOOK). CREATING USEFUL LETTERS, REPORTS, AND PROCEDURES
Few skills are more powerful or influential in a company or organization than effective writing skills. A poorly written document, whether letter, memo, email, report, or procedure, can make its reader confused, impatient, and unresponsive. Effective writi
THE SIX SIGMA PATH TO LEADERSHIP (EBOOK). OBSERVATIONS FROM THE TRENCHES
Many organizations have seen dramatic improvements by implementing a Six Sigma system, including better efficiency, reduced errors, and increased profits. But for the individuals charged with implementing this system, it can be a long and arduous journey. The Six Sigma Path to Leadership: Observations from the Trenches was written to serve as a support guide for these individuals who may get lost or frustrated on their journey toward Six Sigma improvement. Author David Treichler has assembled a collection of stories showing how others handled these same situations, including the good and the bad with many how-to (and how-not-to) examples. The book is written for anyone – from senior management to the curious novice, with the intent to encourage and assist everyone, wherever they may be in their own Six Sigma journey. The Six Sigma Path to Leadership is not intended to teach the specific tools or techniques of Six Sigma, but rather to inspire and motivate Six Sigma professionals to lead and teach others in the organization. The stories shared within will spark the readers’ imaginations and help them get the most out of their efforts.COMMENTS FROM OTHER CUSTOMERSAverage Customer Rating: (5 of 5 based on 1 reviews) " The very best hands on Six Sigma book I have ever read. Finally someone is writing about real success at the front end of a program. This book is for people that want to know how real Six Sigma leaders do their work!" • Dean Carr - Malibu, CA
AUTOMOTIVE INTERNAL AUDITOR POCKET GUIDE (EBOOK). PROCESS AUDITING TO ISO/TS 16949:2002
This pocket guide is an essential resource for anyone in the automotive industry. It's designed to be used as a reference manual for conducting internal audits to ISO/TS 16949:2002 using a new process approach. The book will assist internal auditors with p
WORK OVERLOAD (EBOOK). REDESIGNING JOBS TO MINIMIZE STRESS AND BURNOUT
The challenges of a globalized market, increasing customer demands, and changing technologies are making business more complicated and leaving employees feeling overwhelmed. Many feel that this work overload is an unfortunate side effect of success, and one that cannot be avoided. Work Overload: Redesigning Jobs to Minimize Stress and Burnout not only argues that this is entirely untrue, but sets forth a clear and easy to follow guideline for overcoming and then preventing work overload in any business. Renowned best-selling author Frank M. Gryna reasons that much of work overload is due to the waste and the inherent ineffectiveness found in most every position. Gryna maintains that overload is a failure in the design of the work, not the worker. To eliminate and ultimately prevent overload, we must find the areas of waste, eliminate them, and then use the resources that have been freed up to prevent overload from happening again. This is not a psychological book intended to motivate employees to love their job, handle stress, and be more productive. Rather it is intended to create a real system that is more effective and less overwhelming for the employees. Gryna also tackles the issue of getting buy-in from upper management, which is crucial for any successful organizational change.Contents:How Serious is the Work Overload Issue?Causes of Work OverloadWhy Study Waste in a ProcessRedesign Work at the Process Level to Eliminate Work OverloadHow Do the Mental Demands of Work Contribute to Work OverloadRedesign Work at the Job LevelHow Do We Match Work to PeopleParticipation and Empowerment of Employees to Reduce Work OverloadHow Can Middle Managers Handle Work Overload in Daily OperationsRole of Upper Management in Work OverloadWork and Family Issues in Work OverloadWhat Do We Do Next?
ROOT CAUSE ANALYSIS: SIMPLIFIED TOOLS AND TECHNIQUES, SECOND EDITION (EBOOK). SIMPLIFIED TOOLS AND TECHNIQUES
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 i
THE LOGICAL THINKING PROCESS (EBOOK). A SYSTEMS APPROACH TO COMPLEX PROBLEM SOLVING
A major rewrite of Dettmer's classic Goldratt's Theory of Constraints, this new edition presents a whole new approach to building and applying logic trees. The logical thinking process referred to in the title is nothing less than a broadly applicable, systems-level approach to policy analysis. Dettmer has streamlined the process of constructing the logic trees while simultaneously ensuring that the results are more logically sound and closer representations of reality than ever before. He explains an easier, more logically sound way to integrate Current Reality Trees with Evaporating Clouds. His new version of the thinking process "retires" the Transition Tree in favor of the marriage of a more detailed Prerequisite Tree and critical chain project management. This book contains new examples of logic trees from a variety of real-world applications. Most of the diagrams and illustrations are new and improved. Explanations and procedures for constructing the logic trees are considerably simplified. Electronic Books Only: CD-ROM files are available for download. Please contact ASQ Customer Care for download instructions.
PROVING CONTINUOUS IMPROVEMENT WITH PROFIT ABILITY (EBOOK)
The goal of this book is to demonstrate to manufacturing, distributor, and service businesses that there are only seven critical business elements from which continuous improvement projects can be discovered, financially evaluated, and ranked before implem
PROCESS DRIVEN COMPREHENSIVE AUDITING (EBOOK). A NEW WAY TO CONDUCT ISO 9001:2008 INTERNAL AUDITS, SECOND EDITION
This book was written for the novice internal auditor and for the experienced auditor in search of a more meaningful approach. The goal is to provide an easy-to-understand method for conducting a highly effective audit. Process Driven Comprehensive Auditing simplifies a complex series of actions through examination and guided application of Shewhart and Deming’s PDCA Cycle. PDCA—the acronym for Plan, Do, Check, Act—is at the foundation of the ISO 9001:2008 Standard, but until now has been relegated to second-tier status as a basic auditing approach. However, the power of PDCA is first and foremost its ability to be easily understood. When harnessed to the task of training new auditors, PDCA provides an easy-to-follow and consistent model for true process auditing. Process Driven Comprehensive Auditing takes more than its name from the letters of the PDCA cycle: Comprehensiveness is vital to excellence in auditing, and PDCA is a comprehensive approach to improvement of any process. By combining a series of general questions drawn from many elements of the ISO 9001:2008 standard with a cross reference guide to particular elements such as Purchasing, Design, Production Control and Calibration, the methods presented in this book offer a practical and uncomplicated starting point for any first time auditor and also for those already familiar with the details of the standard. COMMENTS FROM OTHER CUSTOMERSAverage Customer Rating: (5 of 5 based on 1 review) "This book is a must for anybody interested in conducting truly value-added audits. I have been using Paul Palmes' method for over 3 years with very good results. The audits conducted following this method have became a management tool. Highly recommended!"A reader in Austin, Texas
LEAN SIX SIGMA FOR THE HEALTHCARE PRACTICE. A POCKET GUIDE
This book is for those in healthcare practices whose customers/payers may be encouraging or requiring them to use Lean Six Sigma in the workplace, or to simply improve the way healthcare is being provided. The book is intended to be a basic, easy-to-read,
CORPORATE SUSTAINABILITY PLANNING ASSESSMENT GUIDE (EBOOK). A COMPREHENSIVE ORGANIZATIONAL ASSESSMENT
Includes the Global Reporting Initiative (GRI) Index. Corporate sustainability planning has risen in prominence over the past few years among leading organizations as a tool to achieve strategic dominance within the global marketplace. This manual is desig
LEAN-SIX SIGMA FOR THE PUBLIC SECTOR. LEVERAGING CONTINUOUS PROCESS IMPROVEMENT TO BUILD BETTER GOVERNMENTS
Organizations are continuously trying to improve by reducing cost, increasing customer satisfaction, and creating an environment of empowered employees who continuously strive for excellence in each process and product. In much the same way, governments are continuously required to do “more with less,” enhance budget and organizational performance, and identify innovative ways to increase their impact. There are challenges to applying the Lean-Six Sigma (LSS) tools in the public sector. Examples of these challenges include hierarchical environments, a lack of common goals, and the complexity of working in the public sector. The information included as part of this book provides over 30 spotlights highlighting project examples, lessons learned, and tips and tricks for using LSS in the public sector. These spotlights are based on interviews facilitated with a robust sampling of senior operations strategy practitioners. The LSS methodology focuses on eliminating waste (lean) and then reducing variation (Six Sigma) in a process or product that contains no waste. The information covered in this book will allow someone to have an immediate impact in any public sector organization. It describes some of the most powerful continuous process improvement tools that can be used, with limited training required. This is further enhanced by showing direct correlations to the LSS tools and the challenges that will be faced. Because the public sector spans such a diverse range of organizational charters (such as transportation, education, and defense), this book does not focus solely on either manufacturing or services. Rather, it provides a balanced approach to utilizing LSS in all environments.
HOW TO AUDIT THE PROCESS-BASED QMS, SECOND ED
This book is intended to help those involved in managing and conducting audits to ISO 9001:2008. It can be used as a guide to establishing a new audit program or for revitalizing one that has been operational for some time. It focuses on achieving an audit
CONTINUOUS PERMANENT IMPROVEMENT (EBOOK)
Forewords by Mikel J. Harry, Ph.D. and Dr. K.K. Nohria Continuous permanent improvement (CPI) is not a new ism. The purpose of this book is not to expound any new theory or tools, but to share experiences in implementing existing methods with a bias toward business results. In fact, one of the important lessons we have learned is that most existing models or methods, if adhered to in the right spirit, will give results. This book is a distillation of experiences and lessons learned from successes and mistakes in nearly three decades of experience, mostly working with business processes, systematic thinking, customer focus, quality, and performance measurements—in a variety of companies and industries as diverse as financial services, telecom, manufacturing, conglomerate, and management consulting. Not being about any specific companies or industries, the contents of this book can be applied in any industry—service or manufacturing or government or education or nonprofit. The target audience of this book is business, functional, and quality leaders. Business schools and students may also use it as a text or reference book for courses on business excellence or quality. It is intended to share the experience and results of organizations that have derived substantial and sustained business results by focusing on continuous permanent improvement. Its aim is to strengthen the belief of the reader in the strategic importance of CPI, because the stronger your belief, the bigger and more sustained will be your results. The book also covers challenges related to mind-sets and other change management aspects that leaders typically will need to grapple with. Some of the very effective improvement methods and tools are explained in simple language with real examples, with senior business leaders in mind.
HOW TO ESTABLISH A DOCUMENT CONTROL SYSTEM FOR COMPLIANCE WITH ISO 9001:2015, ISO 13485: 2016 AND FDA REQUIREMENTS (EBOOK). A COMPREHENSIVE GUIDE TO DESIGNING A PROCESS-BASED DOCUMENT CONTROL SYSTEM
This book explains the requirements for compliance with FDA regulations and ISO standards (9001/13485) for documented information controls, and presents a methodology for compliance. The document control system (DCS), or documented information control system (DICS), is the foundation of a quality management system. It is the first quality system element that must be implemented because the establishment and control of documented processes and information in a quality-controlled environment is dependent on the ability to proactively manage access to documents and the movement of documents through the document life cycle. A well-developed document control system benefits business by: Improving knowledge retention and knowledge transfer within and across business units Improving access to knowledge-based information Improving employee performance by providing standardized processes and communicating clear expectations Improving customer communication and satisfaction by providing documented information from which common understanding can be achieved Providing traceability of activities and documentation throughout the organization Improving organization of and access to documents and data Sample documents are included in the appendixes of this book to help clarify explanations. This book provides a process-based approach that can be used for controlling all forms of documented information that are required to be managed under the quality management system.
THE PROBABILITY WORKBOOK (EBOOK)
The best way to master probability is to work problems—lots of them. Through repeated practice, formerly fuzzy concepts begin to make sense, and solution strategies become clear. The Probability Workbook is a companion to The Probability Handbook, which covers counting techniques, probability rules, discrete probability distributions, and continuous probability distributions. This workbook offers more than 400 problems covering a wide range of probability techniques and distributions. From poker problems, to famous problems by luminaries in the field such as Pascal, Fermat, Bertrand, Fisher, and Deming, this one-of-a-kind book gives detailed numerical solutions and explanations presented in a conversational way. There are general probability questions involving travel itineraries, baseball, and birth orders, as well as more real-world applications such as quality inspection, reliability, statistical process control, and simulation. Problems applicable to the manufacturing, healthcare, business, and hospitality and tourism industries are included. For easy reference, each numbered problem in the workbook is categorized by broad topic area, and then by a more detailed, descriptive title. In addition to the topic and title, the level of difficulty is displayed for each problem using a die icon. This workbook is an invaluable resource for the probability portions of ASQ’s CQE, CSSGB, CSSBB, CSSMBB, and CRE exams. Electronic Books Only: CD-ROM files are available for download. Please contact ASQ Customer Care for download instructions.
THE ISO 14001: 2015 IMPLEMENTATION HANDBOOK (EBOOK). USING THE PROCESS APPROACH TO BUILD AN ENVIRONMENTAL MANAGEMENT SYSTEM
This book explains how an organization can use a management system to both control and improve its environmental performance. It provides guidance in building the environmental management system (EMS) in support of the organization’s operations---linking the management system to the requirements of ISO 14001 to support third-party certification to ISO 14001:2015. Included in the text are best practices as well as common pitfalls and weaknesses the author has observed in various organizations. He is an environmental auditor and EMS internal auditor trainer and consultant. He has audited EMSs of over 100 companies to ISO 14001. For those organizations already certified to ISO 14001:2004, the book highlights the changes required to upgrade to the new 2015 version. In addition, included on an accompanying CD are comprehensive check sheets to be used by internal auditors in auditing an EMS's conformance to ISO 14001:2015. Electronic Books Only: CD-ROM files are available for download. Please contact ASQ Customer Care for download instructions.
PROACTIVE SUPPLIER MANAGEMENT IN THE MEDICAL DEVICE INDUSTRY (EBOOK)
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. Electronic Books Only: CD-ROM files are available for download. Please contact ASQ Customer Care for download instructions.
THE CERTIFIED SOFTWARE QUALITY ENGINEER HANDBOOK, SECOND EDITION (EBOOK)
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. Electronic Books Only: CD-ROM files are available for download. Please contact ASQ Customer Care for download instructions.
THE CERTIFIED SUPPLIER QUALITY PROFESSIONAL HANDBOOK (E-BOOK)
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 t
THE ISO 45001:2018 IMPLEMENTATION HANDBOOK (EBOOK). GUIDANCE ON BUILDING AN OCCUPATIONAL HEALTH AND SAFETY MANAGEMENT SYSTEM
"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. Please contact ASQ Customer Care for download instructions.
THE CERTIFIED QUALITY INSPECTOR HANDBOOK, THIRD EDITION (EBOOK)
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.
CONNECTED, INTELLIGENT, AUTOMATED (EBOOK). THE DEFINITIVE GUIDE TO DIGITAL TRANSFORMATION AND QUALITY 4.0
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 Revolution Chapter 2: Connected Ecosystems Chapter 3: Intelligent Agents and Machine Learning Chapter 4: Automation: From Manual Labor to Autonomy Chapter 5: Quality 4.0 Use Cases Across Industries Chapter 6: From Algorithms to Advanced Analytics Chapter 7: Delivering Value and Impact Through Data Science Chapter 8: Data Quality and Data Management Chapter 9: Software Applications & Data Platforms Chapter 10: Blockchain Chapter 11: Performance Excellence Chapter 12: Environment, Health, Safety, Quality (EHSQ), and Cybersecurity Chapter 13: Voice of the Customer (VoC) Chapter 14: Elements of a Quality 4.0 Strategy Chapter 15: Playbook for Transformation N. M. Radziwill 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 at http://qualityandinnovation.com.
THE ASQ CERTIFIED QUALITY IMPROVEMENT ASSOCIATE HANDBOOK, FOURTH EDITION (EBOOK)
Quality Improvement: Basic Principles and Practices 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 BoK 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. ASQ’s experts help you navigate: Quality terms, benefits, and philosophies Team organization, roles, responsibilities, and dynamics Continuous improvement concepts, processes, and tools Root cause analysis and risk management Supplier and customer relationships This edition features ample material that stretches beyond the content of the BoK, making it useful for any quality practitioner—not just those who plan to become certified. In this book, you’ll find a thorough overview of quality tools and history—presented in an accessible manner and easily understood by non-engineers. Start on your quality path here. Grace L. Duffy is the author of 15 books and over 260 published papers and articles. She is an ASQ Certified Manager of Quality/Organizational Excellence, Quality Improvement Associate, and Quality Auditor. Grace is a certified Lean-Six Sigma Master Black Belt and Manager of Process Improvement. Dr. Sandra L. Furterer is an Associate Professor and Associate 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.
THE ASQ CERTIFIED FOOD SAFETY AND QUALITY AUDITOR HANDBOOK, FOURTH EDITION (EBOOK)
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.
STRUCTURING YOUR ORGANIZATION FOR INNOVATION (EBOOK)
Organizations face many ongoing challenges, which can lead to restructuring— an expensive, disruptive solution that doesn’t always offer successful outcomes or better results. As a business leader in a competitive environment, you must find ways to improve