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The Art Of Integrating Strategic Planning Process Metrics Risk Mitigation And Auditing
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Book Synopsis The Art of Integrating Strategic Planning, Process Metrics, Risk Mitigation, and Auditing by : Janet B. Smith
Download or read book The Art of Integrating Strategic Planning, Process Metrics, Risk Mitigation, and Auditing written by Janet B. Smith and published by . This book was released on 2016 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:
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.
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. This book was released on 2008 with total page 279 pages. Available in PDF, EPUB and Kindle. Book excerpt: This unique resource presents a new look at how the puzzle pieces of corporate dynamics management can fit together to ensure strategic designs are actionable.
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 2016-04-04 with total page 161 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 example of the format for an ISO 9001:2015 conformance checklist.
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.
Book Synopsis Managing Organizational Risk Using the Supplier Audit Program by : Lance B. Coleman, Sr
Download or read book Managing Organizational Risk Using the Supplier Audit Program written by Lance B. Coleman, Sr and published by Quality Press. This book was released on 2018-04-06 with total page 117 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 organizations 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 authors 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.
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 300 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 ASQs 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.
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
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.
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 102 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.
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.
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 296 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: - Whats 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 its used, (3) how its 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.
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 298 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis Strategic Management in Action by : Mary K. Coulter
Download or read book Strategic Management in Action written by Mary K. Coulter and published by Prentice Hall. This book was released on 2005 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: Strategic Management in Action, 3rd Edition is clearly differentiated from other volumes by its conversational writing style, increased use of pedagogy, and emphasis on readers doing strategy. The volume effectively integrates strategy theory and strategy action in an exciting and engaging way. The author examines the foundations of auditing, as well as standards, materiality and risk, management assertions and evidence, client acceptance and audit planning, internal control, revenue and cash receipts transactions, expenditure and cash disbursements transactions, other accounts and transactions, sampling, completing the audit and reporting, ethics and legal liability and assurance and other services. For business professionals involved in strategic planning.
Book Synopsis Strategic Planning by : Edward Robertson
Download or read book Strategic Planning written by Edward Robertson and published by . This book was released on 2019-09-11 with total page 76 pages. Available in PDF, EPUB and Kindle. Book excerpt: Why do so many strategic plans end up collecting dust? Organizational leaders feel they should have good plans - and they are right. Private firms, government agencies and non-profits are all facing an uncertain future, whether the task is to impress potential investors, chart a path towards profitability, or fight for funding. Moreover, lack of planning is shown to be among the top reasons for business failure. And yet strategic planning, if done at all, is often a bland re-hash of familiar issues. It is frustrating when prepared plans set high expectations, but then are not even implemented. Embarrassingly, the effort has produced nothing but a dust collector. I have seen this problem first hand - and solved it - not only as a consultant, but as a senior manager in public and private settings. I facilitated the effective implementation of organization-wide risk management programs (praised by the provincial Auditor General). As innovation specialist and director of strategic planning, I helped lead a manufacturing firm to win the Chamber of Commerce Business of the Year Award. It was knowledge hard won. After years of study, field research and dozens of client engagements, I finally arrived at a refined and careful method, and formulated it for publication to share with others.I am convinced: planners must follow a structured method that takes into account not only the different types and purposes of planning (a distinction rarely made!) but also the principles of effective program implementation. These success factors are proven in studies, but do not seem to be part of management training. And yet strategic planning, properly done and executed, can transform the culture and propel the organization to success. Using this book, you will: - gain clarity about exactly what you're trying to plan, instead of mixing up types of plans; - focus the discussion and streamline the process; - feel confident that your planning steps are in the right order; - engage managers and staff, build teams, and transform a negative culture; - conquer the "implementation gap", link to the real business, and reverse program failure. This book is a fast read, 70 pages, complete with diagrams; templates; references; quotes from industry practitioners; and index. Starting with an iron-clad positive case for doing strategic planning, I then show the practical steps. Take my advice, too, on the role of the planning champion and how to facilitate the process. If you can organize and chair meetings, and if you are motivated to move the organization ahead, you can do this! Strategic Planning: Process, Templates, and Effective Implementation lists lower than the average price in the strategic planning category. Show your colleagues, staff and competitors you can do strategic planning the way it should be done. Order it and start planning for success!
Download or read book The Joy of Lean written by Dodd Starbird and published by Quality Press. This book was released on 2016-11-18 with total page 103 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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
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.
