The Art of Integrating Strategic Planning, Process Metrics, Risk Mitigation, and Auditing

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Publisher : Quality Press
ISBN 13 : 0873899253
Total Pages : 171 pages
Book Rating : 4.8/5 (738 download)

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Book Synopsis The Art of Integrating Strategic Planning, Process Metrics, Risk Mitigation, and Auditing by : J.B. Smith

Download or read book The Art of Integrating Strategic Planning, Process Metrics, Risk Mitigation, and Auditing written by J.B. Smith and published by Quality Press. This book was released on 2016-03-08 with total page 171 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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 opportunities Use of process metrics as feedback mechanism in the discovery of hidden factories and risks Concepts 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.

The Art of Integrating Strategic Planning, Process Metrics, Risk Mitigation, and Auditing

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Author :
Publisher : Quality Press
ISBN 13 : 1953079644
Total Pages : 174 pages
Book Rating : 4.9/5 (53 download)

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Book Synopsis The Art of Integrating Strategic Planning, Process Metrics, Risk Mitigation, and Auditing by : Janet Bautista Smith

Download or read book The Art of Integrating Strategic Planning, Process Metrics, Risk Mitigation, and Auditing written by Janet Bautista Smith and published by Quality Press. This book was released on 2016-03-10 with total page 174 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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 opportunities Use of process metrics as feedback mechanism in the discovery of hidden factories and risks Concepts 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.

How to Audit ISO 9001:2015

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Publisher : Quality Press
ISBN 13 : 087389927X
Total Pages : 136 pages
Book Rating : 4.8/5 (738 download)

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Book Synopsis How to Audit ISO 9001:2015 by : Chad Kymal

Download or read book How to Audit ISO 9001:2015 written by Chad Kymal and published by Quality Press. This book was released on 2016-04-22 with total page 136 pages. Available in PDF, EPUB and Kindle. Book excerpt: ISO 9001:2015 includes many changes that not only affect the companies aiming to achieve certification to it, but also auditors. This book is the resource auditors need to fully understand ISO 9001:2015 and help them perform audits to it. This book integrates two different types of audit strategies, conformance audits and performance audits, into one process approach audit. Conformance audits confirm that the organization is meeting the requirements of the standard, while performance audits confirm that the QMS is achieving its intended results. The book includes: An introduction to ISO 9001:2015 An auditing strategy for ISO 9001:2015 How to conduct a Stage 1 audit for ISO 9001:2015 How to conduct a Stage 2 on-site audit for ISO 9001:2015 Appendices include an introduction to process focus, an assessment report template for Stage 1 audits, a confidential assessment report template for Stage 2 audits, and an ISO 9001:2015 conformance checklist.

Quality Risk Management in the FDA-Regulated Industry

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Publisher : Quality Press
ISBN 13 : 1953079326
Total Pages : 252 pages
Book Rating : 4.9/5 (53 download)

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Book Synopsis Quality Risk Management in the FDA-Regulated Industry by : José Rodríguez-Pérez

Download or read book Quality Risk Management in the FDA-Regulated Industry written by José Rodríguez-Pérez and published by Quality Press. This book was released on 2017-02-21 with total page 252 pages. Available in PDF, EPUB and Kindle. Book excerpt: The purpose of this new edition is to offer an updated view of the risk management field as it applies to medical products. Since the publication of the first edition (2012), the emphasis on risk-based processes has growth exponentially across all sectors, and risk management is now considered as significant as quality management. ISO 9001 was revised and now requires that top management promote the use of risk-based thinking. ISO 13485:2016, which specifies the requirements for a quality management system specific to the medical devices industry, also now shows a greater emphasis on risk management and risk-based decision making. In addition, the FDA Food Safety Modernization Act (FSMA) is the most important reform of U.S. food safety laws in more than 70 years. This indispensable book presents a systematic and comprehensive approach to quality risk management. It will assist medical and food product manufacturers with the integration of a risk management system or risk management principles and activities into their existing quality management system by providing practical explanations and examples. The appropriate use of quality risk management can facilitate compliance with regulatory requirements such as good manufacturing practice or good laboratory practice. All chapters have been updated and revised, and a new chapter has been added to discuss some of the most common pitfalls and misunderstandings regarding risk management, specifically those related to the use of FMEA as the only element of risk management programs. One of the appendices includes 12 case studies, and the companion CD-ROM contains dozens of U.S. FDA and European guidance documents as well as international harmonization documents (ICH and GHTF-IMDRF) related to risk management activities, as well as a 30-question exam (with answers) on the material discussed in the book.

The Biomedical Quality Auditor Handbook, Third Edition

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Author :
Publisher : Quality Press
ISBN 13 : 0873899628
Total Pages : 271 pages
Book Rating : 4.8/5 (738 download)

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Book Synopsis The Biomedical Quality Auditor Handbook, Third Edition by : Heather Crawford

Download or read book The Biomedical Quality Auditor Handbook, Third Edition written by Heather Crawford and published by Quality Press. This book was released on 2017-09-08 with total page 271 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Biomedical Quality Auditor Handbook was developed by the ASQ Biomedical Division in support of its mission to promote the awareness and use of quality principles, concepts, and technologies in the biomedical community. This third edition correlates to the 2013 exam Body of Knowledge (BoK) and reference list for ASQ’s Certified Biomedical Auditor program. It includes updates and corrections to errors and omissions in the second edition. Most notably it has been re-organized to align more closely with the BoK.

Managing Organizational Risk Using the Supplier Audit Program

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Publisher : Quality Press
ISBN 13 : 1953079202
Total Pages : 116 pages
Book Rating : 4.9/5 (53 download)

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Book Synopsis Managing Organizational Risk Using the Supplier Audit Program by : Lance B. Coleman

Download or read book Managing Organizational Risk Using the Supplier Audit Program written by Lance B. Coleman and published by Quality Press. This book was released on 2018-04-06 with total page 116 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Beyond Compliance Design of a Quality System

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Publisher : Quality Press
ISBN 13 : 1951058259
Total Pages : 141 pages
Book Rating : 4.9/5 (51 download)

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Book Synopsis Beyond Compliance Design of a Quality System by : Janet Bautista Smith

Download or read book Beyond Compliance Design of a Quality System written by Janet Bautista Smith and published by Quality Press. This book was released on 2020-03-01 with total page 141 pages. Available in PDF, EPUB and Kindle. Book excerpt: Next Level Results for Your QMS You 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

Human Error Reduction in Manufacturing

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Publisher : Quality Press
ISBN 13 : 1951058860
Total Pages : 191 pages
Book Rating : 4.9/5 (51 download)

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Book Synopsis Human Error Reduction in Manufacturing by : José Rodríguez-Pérez

Download or read book Human Error Reduction in Manufacturing written by José Rodríguez-Pérez and published by Quality Press. This book was released on 2018-08-27 with total page 191 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

ISO Lesson Guide 2015

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Publisher : Quality Press
ISBN 13 : 0873899032
Total Pages : 83 pages
Book Rating : 4.8/5 (738 download)

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Book Synopsis ISO Lesson Guide 2015 by : J.P. Russell

Download or read book ISO Lesson Guide 2015 written by J.P. Russell and published by Quality Press. This book was released on 2016-07-18 with total page 83 pages. Available in PDF, EPUB and Kindle. Book excerpt: The ISO Lesson Guide translates ISO 9001 into easy-to-understand words. This pocket guide was designed as a quick reference for anyone to carry around conveniently. Each element containing requirements is discussed and key concepts are highlighted at the beginning of each section. In the ISO Lesson Guide: Quality is defined The ISO process approach is explained Key concepts are accompanied by an illustration Risk-based thinking is introduced Concepts are described in easy-to-understand words A brief conspectus summarizes ISO 9001 requirements Quality management principles are described in easy-to-understand words An entertaining fable explains the difference between ISO 9001 and ISO 9004 Ideal for handing out to existing and new employees, this pocket guide can also be used as supplemental study material for ISO 9001 training courses.

The ISO 45001:2018 Implementation Handbook

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Publisher : Quality Press
ISBN 13 : 1953079377
Total Pages : 138 pages
Book Rating : 4.9/5 (53 download)

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Book Synopsis The ISO 45001:2018 Implementation Handbook by : Milton P. Dentch

Download or read book The ISO 45001:2018 Implementation Handbook written by Milton P. Dentch and published by Quality Press. This book was released on 2018-06-05 with total page 138 pages. Available in PDF, EPUB and Kindle. Book excerpt: Guidance on how an organization can build and use a management system to both control and improve its safety or occupational health and safety performance in alignment with the requirements of ISO 45001:2018.

Musings on Internal Quality Audits

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Publisher : Quality Press
ISBN 13 : 087389958X
Total Pages : 154 pages
Book Rating : 4.8/5 (738 download)

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Book Synopsis Musings on Internal Quality Audits by : Duke Okes

Download or read book Musings on Internal Quality Audits written by Duke Okes and published by Quality Press. This book was released on 2017-06-02 with total page 154 pages. Available in PDF, EPUB and Kindle. Book excerpt: For over 20 years, Duke Okes has spoken and published articles on internal auditing, and trained an estimated 2,000 internal quality auditors. This insightful book is intended for those who understand the basics and are looking for ideas for how to improve what their organization gets out of the internal quality audit process. It is broken into three parts. Section 1 is a summary of the basic quality audit and intentionally does not include things such as training of auditors, basic auditor competencies, and so on. However, it does look at some of the more recent changes in the audit process driven by changes in standards, technology, and globalism. Section 2 includes several concepts and methods that organizations can choose to use if they want to make their quality audits more robust from a standpoint of achieving the intended purpose. Section 3 then intentionally pushes back from the standard perspective of auditing as a technical process for control and looks at softer issues that an audit program might leverage. It also tries to project a bit into the future as to how the audit role/process might change. Appendices include example audit situations to spur discussion, a SIPOC form for audit planning, and examples of quality risk management audit questions.

Cracking the Case of ISO 9001:2015 for Service, Third Edition

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Publisher : Quality Press
ISBN 13 : 0873899083
Total Pages : 135 pages
Book Rating : 4.8/5 (738 download)

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Book Synopsis Cracking the Case of ISO 9001:2015 for Service, Third Edition by : Charles A. Cianfrani

Download or read book Cracking the Case of ISO 9001:2015 for Service, Third Edition written by Charles A. Cianfrani and published by Quality Press. This book was released on 2016-09-08 with total page 135 pages. Available in PDF, EPUB and Kindle. Book excerpt: This guide is intended to help everyone in a service organization participate in creating and sustaining a foundation of integrity, meet requirements and customer expectations, and support robust processes, to the advantage of everyone in the organization and to each of its customers. It provides a simplified explanation of the clauses of ISO 9001:2015, including: - What’s required - Why to do it - Implementation tips - Questions to ask to assess conformity Also included is a chapter that answers the question “Why do ISO 9001:2015?” and a chapter that summarizes the key differences with past editions of ISO 9001. To assist the user in implementation of QMS processes, this guide also includes a chapter that describes 12 quality tools. For each tool, the authors describe (1) what it is, (2) where it’s used, (3) how it’s done, and (4) cautions to be considered when using the tool. The contents of this book can help organizations save time in achieving compliance with the ISO 9001 requirements and also facilitate effective implementation. This has the potential to lower internal costs and to improve customer satisfaction.

Cracking the Case of ISO 9001:2015 for Manufacturing, Third Edition

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Author :
Publisher : Quality Press
ISBN 13 : 0873899075
Total Pages : 135 pages
Book Rating : 4.8/5 (738 download)

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Book Synopsis Cracking the Case of ISO 9001:2015 for Manufacturing, Third Edition by : Charles A. Cianfrani

Download or read book Cracking the Case of ISO 9001:2015 for Manufacturing, Third Edition written by Charles A. Cianfrani and published by Quality Press. This book was released on 2016-09-08 with total page 135 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Actionable Strategies Through Integrated Performance, Process, Project, and Risk Management

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Author :
Publisher : Artech House Publishers
ISBN 13 : 9781596931190
Total Pages : 261 pages
Book Rating : 4.9/5 (311 download)

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Book Synopsis Actionable Strategies Through Integrated Performance, Process, Project, and Risk Management by : Stephen S. Bonham

Download or read book Actionable Strategies Through Integrated Performance, Process, Project, and Risk Management written by Stephen S. Bonham and published by Artech House Publishers. This book was released on 2008 with total page 261 pages. Available in PDF, EPUB and Kindle. Book excerpt: Presenting new, actionable strategies that offer innovative ways to control essential business operations through integration of key aspects of management, this book explains how to integrate performance, process, portfolio, project, and risk management so companies can respond more effectively in a highly competitive environment.

Beyond Compliance Design of a Quality System

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Publisher : ASQ Quality Press
ISBN 13 : 9781951058234
Total Pages : 0 pages
Book Rating : 4.0/5 (582 download)

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Book Synopsis Beyond Compliance Design of a Quality System by : Janet Bautista Smith

Download or read book Beyond Compliance Design of a Quality System written by Janet Bautista Smith and published by ASQ Quality Press. This book was released on 2020-03 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: Next Level Results for Your QMS You 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

Risk-Based Performance Management

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Author :
Publisher : Springer
ISBN 13 : 113736730X
Total Pages : 323 pages
Book Rating : 4.1/5 (373 download)

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Book Synopsis Risk-Based Performance Management by : A. Smart

Download or read book Risk-Based Performance Management written by A. Smart and published by Springer. This book was released on 2013-10-31 with total page 323 pages. Available in PDF, EPUB and Kindle. Book excerpt: Pulling together into a single framework the two separate disciplines of strategy management and risk management, this book provides a practical guide for organizations to shape and execute sustainable strategies with full understanding of how much risk they are willing to accept in pursuit of strategic goals.

eAuditing Fundamentals

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Publisher : Quality Press
ISBN 13 : 0873898486
Total Pages : 185 pages
Book Rating : 4.8/5 (738 download)

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Book Synopsis eAuditing Fundamentals by : J.P. Russell

Download or read book eAuditing Fundamentals written by J.P. Russell and published by Quality Press. This book was released on 2013-01-15 with total page 185 pages. Available in PDF, EPUB and Kindle. Book excerpt: The purpose of this book is to provide hands-on guidelines for using electronic communication tools as part of the auditing process. The pros and cons of conducting e-audits and their consequences will be reviewed. There are situations when e-auditing techniques are more efficient, and other times they may be less efficient and even lead to questionable audit report conclusions. In this book we provide proven techniques for conducting remote audits (eAudits) and explore eAuditing practices to help organizations make informed decisions regarding their use. A ten point eAudit program implementation checklist is included with the book. Combined, the two authors have over 20 years’ experience conducting remote audits and using virtual communication technologies.