Bücher veröffentlicht von ASQ Quality Press

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

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

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

Modular kaizen is a development of necessity in our rapidly changing world where improvement has to happen "on the fly". Modular kaizen is the counter point to kaizen blitz, where team members are locked in a room to hammer out a solution to some problem or opportunity. In the hectic, interrupt driven environment of many organizations, it is simply not possible to remove critical players from normal operations for any length of time.Modular kaizen is an improvement approach that integrates quality techniques into the busy schedule of everyday activities. All of the components of an effective kaizen event are planned; however, the activities are scheduled in small segments, or "modules" that fit the rapidly changing time demands of team members and subject matter experts. This approach is complementary to the Plan-Do-Check-Act (PDCA) and Define, Measure, Analyze, Improve, Control (DMAIC) models of quality improvement.The author of this book calls upon a 40 year career to incorporate techniques, innovations and lessons learned in the pursuit of effective continuous and breakthrough improvement and use the resources, people, and schedules already in place to get things done.If you are looking for proven approaches to integrating quality improvement into daily work, this is your book.

This book is primarily meant to aid those taking the ASQ Certified Supplier Quality Professional (CSQP) exam and is best used in conjunction with The Certified Supplier Quality Professional. Section I provides 336 practice questions organized by the seven parts of the 2016 Body of Knowledge (BoK). Section II gives the reader a 150-question practice exam comprising each of the nine parts of the BoK, in a randomized order that simulates the actual certification exam. Unlike other resources on the market, all these questions and solutions were developed specifically to address the 2016 CSQP Body of Knowledge and help those studying for the certification, including considering the proper depth of knowledge and required levels of cognition.

Kaizen Kanban is a guide to creating prioritized project pipelines and setting up improvement boards to maximize business success through the execution of continuous improvement projects. It introduces to the Faster and Better visual facilitation approach that enables you to seamlessly leverage and combine fundamental tools in order to identify improvement opportunities for entire value streams, compile them in a prioritized project pipeline, and set up improvement display boards, or kaizen kanbans, linked to key business objectives.Kaizen kanbans follow the same principles used with traditional kanbans. They are visual communication tools and are visible to all levels of employees within the organization. The difference is that instead of telling operators what to build next or what parts to retrieve, the cards tell improvement teams what pre-approved projects are most relevant to current business needs and are next in line for implementation.This approach is designed to complement and enhance the effectiveness of quality, lean, continuous improvement, and project management initiatives that may already be in place in an organization.

"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 Hickmanbr Director, Customer Quality, ConstelliumIn 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 SigmaWith 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.

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.

¿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.

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.

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 Notes2. A plain-English explanation of the requirements and rationale for each Item3. A table showing the similar requirements of the Criteria4. A summary of the requirements of each Item in flowchart form5. The key linkages between each Item and other Items6. An explanation of some potential adverse consequences7. Examples of effective practicesFeatures 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 QualityMark 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.

Quality has been around for years-why would it need to be unleashed? The truth is, the power of quality comes from actions that stem from behaviors-behaviors that apply to every department within a company. In other words, a company's culture.For years, these behaviors have been restrained. Quality has been focused in segments of a company's population, rather than applied to every department from top to bottom.This is where most companies fail in their deployment of quality-by not treating it as a cultural imperative. The aim of this book is to provide guidance on how to correct that in your organization. Inside, you'll find what you need to implement a cultural transformation that will drive long-term sustainable growth and improvement to your organization's bottom line.You'll start by learning the aspects of a behavior-based quality culture and how to unleash an organization's potential by adopting and promoting the behaviors and actions associated with compliance, prevention and improvement. Once this is unleashed, real sustainable profit generation begins.You'll then move into how to implement a behavior-based quality culture at your organization. This will include: Recommendations on strategy development. Considerations for organizational structure. How to build metrics by department that drive change. How to maintain a behavior-based culture of quality.Who should read this book? There is truly something in here for everyone. Executives: This book provides foundational knowledge and a how-to approach to unleash quality to achieve bottom-line results. Quality professionals: Use this book as instructional material for staff and managers about the power of quality. Managers: Apply the knowledge from this book to set the pace for a behavior-based quality culture at your organization.

Initially developed as a tool for training lead auditors of nuclear quality systems, the Nuclear Auditing Handbook has also been used as a reference by quality managers who plan quality system audits. It provides detailed material in such aspects as the development, administration, planning, preparation, performance, and reporting of quality system audits in energy-related fields. ASQ's Nuclear Committee of the Energy and Environment Division gathered a team of highly seasoned experts in the nuclear auditing field to expand this new edition's content and bring it current to modern-day best practices and standards. This book introduces updated information about requirements and standards, including the 2019 editions of the American Society of Mechanical Engineers (ASME) NQA-1 Quality Assurance Program Requirements for Nuclear Facility Applications and ASME BPVC Sections I; IV; and VIII, Divisions 1 and 2. The authors and editors have also added helpful tools to aid nuclear auditors, including case studies suitable for training auditors, blank forms for convenient use, and samples of completed forms.

This book is a convenient and comprehensive guide to statistics. A resource for quality technicians and engineers in any industry, this second edition provides even more equations and examples for the reader-with a continued focus on algebra-based math. Those preparing for ASQ certification examinations, such as the Certified Quality Technician (CQT), Certified Six Sigma Green Belt (CSSGB), Certified Quality Engineer (CQE), Certified Six Sigma Black Belt (CSSBB), Certified Reliability Engineer (CRE), and Certified Supplier Quality Professional (CSQP), will find this book helpful as well. Inside you'll ­find: ¿ Complete calculations for determining confidence intervals, tolerances, sample size, outliers, process capability, and system reliability ¿ Newly added equations for hypothesis tests (such as the Kruskal-Wallis test and Levene's test for equality of variances), the Taguchi method, and Weibull and log-normal distributions ¿ Hundreds of completed examples to demonstrate practical use of each equation ¿ 20+ appendices, including distribution tables, critical values tables, control charts, sampling plans, and a beta table

Risk elimination. Risk management. Risk mitigation. These terms are an increasingly important part of the lexicon of executive-level management as they strive to succeed in a business environment having global competition, geographically diverse suppliers, and new technologies. In this new, globally expansive marketplace, more than 50 percent of value creation is achieved outside of an organization's walls, or, in other words, through their suppliers. This, too, is where the majority of product realization risk lies. This book defines what risk-based thinking is and how to apply it from the perspective of helping manage organizational risk through the supplier audit process. It provides a detailed and useful discussion of the practical application of risk-based supplier auditing principles. It can be a primer for those new to the profession of supplier auditing, and it also shares tips and best practices that would benefit experienced auditors as well.The first section explores supplier management, supplier auditing, and the supplier audit process. The second section discusses the skills, both traditional and nontraditional, needed to ensure a successful supplier audit. Relevant aspects of ASQs Certified Quality Auditor (CQA) and Certified Supplier Quality Professional (CSQP) Bodies of Knowledge are discussed in detail.The author's friends and colleagues from around the globe shared their own stories in Case in Point-vignettes interspersed throughout the book, providing first-hand case studies from, among others, the medical device, logistics, automotive, and aerospace industries.

Have you ever felt that you had a great insight that would benefit your department, division, or organization and found that you seem to be the only one who can see it? Worse yet, has it ever seemed that while you are struggling to pull your idea into consideration, others are actively holding you back? If you just had the power, you think, great things could be accomplished.What is your reaction? Have you and others who suggest new ideas been so beaten down in the past that you simply let the idea go because it isn't worth the emotional capital to pursue it? If that is the case, and your idea is indeed a good one, who suffers? You? The organization? The organization's customers? The answer is all of the above.This book is designed to help those with limited positional power to find ways to get their ideas seriously considered. It is also designed to help those with positional power create a culture that encourages ideas that will benefit the organization regardless of their source.Inspired by Spencer Johnson's classic fable, Who Moved My Cheese?, the authors of this book decided that there ;was another story that could be told about taking a more proactive, team-based approach to change. We Move Our Own Cheese is about creating change. As in Johnson's book, the cheese is a metaphor for what we have in life and what we believe we want more of. In a business context, it represents the business we are in-our current paradigm-and what it gives us."A cleverly conceived, thought-provoking fable by authors Fair and Sower that provides great insight into how to recognize the need for organizational change, the courage to make changes - and the necessity of taking risks in order for an organization's survival in today's innovative and highly competitive world. A great read for employees at every organizational level in any industry. I hope that this excellent book will have timely and wide distribution."Richard Bozeman, Author and Inventor; Retired Chief of the Propulsion and Power Division Test Facilities, NASA"It was very clever and thought provoking. I think the book could open up numerous opportunities for consulting and seminars."brPeter Birkholz, M.B.A. Managing Partner, Sam Houston Group, LP and Management Consultant, Birkholz Management Co. ZLLC.brbr"The manuscript is very well written. The characters represent very recognizable types in organizations. Their reactions to threat and authority are realistic, making them sympathetic figures. The story is compelling, with exciting plot twists. I couldn't stop reading until the end. The diary entries are a clever way to help the reader understand the story's underlying messages. Your prologue and epilogue are thorough and will be very useful for instructors and trainers, especially the list of discussion questions at the end."brDr. Geraldine Hynes, Ph.D. Professor of Business Communication, Sam Houston State Universitybrbr"I thoroughly enjoyed reading the manuscript. The simple, fun way the fable is written captivates the interest of the reader. I love the way the lessons are weaved into the fable and how they are presented, pulled out for emphasis in a book format. The main lesson and contributing lessons are profound and apply to any organization and individuals at a personal level. The diverse characters seem to come to life and the fable highlights the importance of teamwork leveraging the unique skills of the team. In addition, it points out that leadership among team members is fluid and situational. Such a fable can be used in academic and business settings. Academically, it would be valuable for students learn that they are empowered to create the path in front of them and how to be creative to overcome obstacles. In a business environment, it could reinforce for executives the importance of building a culture of innovation."brJerrine Baker, M.B.A. University Lecturer and President-Owner, Majestic Dreams Travel

The author's lessons learned-during more than 25 years of hands-on quality management experience in environments including manufacturing, medical devices, military, aerospace, automotive, and logistics-are condensed in this book to provide reference material to both beginners and seasoned professionals in the development and sustainability of an effective quality and operational system.Experiences shared in this book include the design from ground zero-to-deployment, risk mitigation, and maintenance of quality standards such as ISO 9001, AS9100, ISO/TS 16949, TL 9000, FDA/GMP and C-TPAT standard, and Lean Six Sigma principles.The main focus of this book is to promote the use of the internal auditing tool as a feedback mechanism not only for compliance verification but also for the measurement and enhancement of the system's effectiveness. The catalysts for this goal are:Auditing beyond compliance to include identification of improvement opportunitiesUse of process metrics as feedback mechanism in the discovery of hidden factories and risksConcepts and models discussed in this book are clearly illustrated using anonymous real-life examples encountered in day-to-day operations. These examples include lessons learned associated with compliance, continuous improvement, and techniques in the conversion of performance metrics as process indicators, savings' generators, and risk mitigation. The examples and models are simple and easy to understand accompanied with templates for quick application on the creation of problem statements, root cause analysis methods, and design of action plans with measurement of success.Workshop modules for 'training the trainers' are included in this book with practical hands-on exercises on the different tools associated with problem solving, development of process metrics for risk mitigations and auditing.

This is an important and timely book. Students of organizational behavior for the last 15 years have been asking how to integrate the technology of data gathering and data analysis with critical organizational challenges. This book shows how to do that, using the field of customer service to illustrate the broader point. This volume allows lay readers to understand telemetry and helps them enhance their data-gathering activities to strengthen customer relations.Author of The Agenda Mover: When Your Good Idea Is Not Enough and Transforming the Clunky Organization: Pragmatic Skills for Breaking Inertia (Cornell University Press)Telemetry is an automated way of collecting data at remote sites or locations, and transmitting it to collectors at receiving site for monitoring, analyzing, and driving improvement actions. This book provides the necessary knowledge and information to understand the telemetry infrastructure and associated details. It will enable readers to implement a telemetry program to address customer experience pain and improve customer experience.The authors of this book have all served in different roles and capacities in one of Silicon Valley's premier technology companies. These roles include software engineering, customer assurance, quality management, technology development, and implementation. Their paths intersected in the area of quality management, and they have witnessed first-hand how the latest technology/market transitions around Internet of Things (IoT), digitization, and telemetry are impacting the company they work, as well as the high-tech industry and global economy as a whole.The real-time nature of data and the advent of machine-learning algorithms have set the stage for a new era that the authors call adaptive customer experience. The premise of this concept is that real-time availability of customer experience data opens the door for real-time responses based on machine-learning algorithms. This creates an unprecedented opportunity to change the relationship between customers and the systems they depend on in their digital world. The proliferation of sensors and improvements in data science capabilities are creating an environment where the possibilities for telemetry are limitless. The book provides several examples of use cases and applications that help bring telemetry to life.

The concept of process monitoring and improvement applies to any type of industry: automotive, textiles, food, pharmaceuticals, biologics, medical devices, electronics, aerospace, banking, educational institutions, service providers, and so on. The focus of this book is to identify and apply different process monitoring and improvement tools in any organization.This book is aimed at engineers, scientists, analysts, technicians, managers, supervisors, and all other professionals responsible to measure and improve the quality of their processes. Many times, these professionals do not have a formal education on the use of these tools but learn about them throughout the different improvement projects in which they are involved in their work environment. This book is intended to fill the gap between the lack of formal education in the tools and the need to implement those tools in an improvement project. The book can also be used as a refresher course for those professionals who did learn about these tools as part of their educational background.

Data integrity is a global mandatory requirement for the regulated healthcare industry. It is more than a mere expectation-it's a basic element of good documentation practices, one of the most fundamental pillars of a quality management system. Robustness and accuracy of the data submitted by manufacturers to regulatory authorities when bringing a medical product to market are crucial.The purpose of this book is to consolidate existing data integrity principles and expectations from several regulatory sources-including the U.S. Food and Drug Administration, World Health Organization, and European Medicines Agency-into a single and handy document that provides detailed, illustrative implementation guidance. It serves as a means of understanding regulatory agencies' position on good data management and the minimum expectation for how medical product manufacturers can achieve compliance.

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

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.

In order to stay competitive, organizations need to continuously improve their processes. The purpose of this book is to provide the practitioner with the necessary tools and techniques with which to implement a systematic approach to process improvement initiatives using the Six Sigma methodology.While there are many self-help books out there, here the topics are discussed in a way so as to remove the fear out of Six Sigma and statistics. This guide takes readers through the five phases of the Six Sigma methodology, Define-Measure-Analyze-Improve-Control (DMAIC), in five clearly written and easy-to-understand sections. You learn each phase's purpose and what activities to perform in each. Numerous examples are included throughout and all statistics are described to the exact level of understanding necessary. Each of the five sections then concludes with a checklist to ensure that all of the phase's activities have been completed.Following the systematic approach outlined in this book will ensure that customer needs and functional area needs are understood and met; knowledge of subject matter experts (SMEs) and team members to improve the process is leveraged; team consensus is reached on the root cause(s) for problems; and risk is managed by addressing all compliance issues.Author Webinar Series:"https://asq.webex.com/asq/lsr.php?RCID=57f5326bc0d05d791507f1b6ad92f99d" as the author provides a thorough introduction to this book and its key deliverables.

"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 SassevilleSustainability Quality Systems DirectorWorthen 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 auditorsA 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 rapid pace of technology often catches organizations unprepared and unable to take advantage of every leading-edge benefit. Cloud technology allows forward-thinking companies to launch products and services rapidly, control costs, streamline processes, and mitigate risks-when done correctly. This book addresses technological basics, as well as practical steps for implementing and fitting the cloud into your overall business strategy-which ultimately benefits your bottom line in delivering the best possible product and services to customers quickly.Capitalizing on their collective years of experience working in Silicon Valley, authors Jarvis, Anand, and Jose share best practices for adopting the cloud, including:¿ Calculating cloud usage and crafting a cost management strategy¿ Breaking down the total cost of ownership (TCO)¿ Optimizing DevOps practices for the cloud¿ Understanding the challenges and risks involved with cloud migration and securityArmed with step-by-step guidance, you can generate a plan of action to meet and exceed your cloud management goals.

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 your organization's innovative thinking. Breaking down silos and driving innovation can lead to greater agility in discovering new opportunities and developing creative solutions. In this book, you'll learn how to design a structure that will help foster innovation, agility, and performance by focusing on organizational structure through the eyes of your customers. You will explore five core structural areas-management, process, product, sales and marketing, and services- that can be used to advance innovation.Structuring Your Organization for Innovation also includes:Key characteristics of each organizational structure, including the pros and consStrategic, operational, and tactical considerationsReal-world case studiesTools and tips for practical applicationJane Keathley provides services to regulated organizations in healthcare related industries, including start-up companies, focusing on developing innovative products and services while maintaining effective and compliant operations. She has published and presented widely in quality and other forums.;H. James Harrington is a quality system expert with more than 60 years of experience. He has been involved in developing quality management systems worldwide, has authored more than 55 books, and is the past president of the American Society for Quality.