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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.
The value of the ASQ Certified Quality Auditor Handbook, Fifth Edition, is clear. It is designed to help new auditors gain an understanding of the field and prepare for the ASQ CQA exam. In addition, experienced auditors can refer to it as a helpful reference; audit managers and quality managers can rely on it for guiding their auditing programs; and trainers and educators can use it for teaching fundamentals. This in-depth overview of quality auditing represents auditing practices for internal and external applications. It provides practical guidance for both system and process auditors as well. Many current topics have been expanded to reflect changes in auditing practices since 2012, with guidance from the recent 2017 update of ISO 19011. In addition, readers will find example audit situations, stories, and review comments to enhance their understanding of the field. Topics covered include the common elements of all types of system and process audits (quality, environmental, safety, and health): Auditing fundamentals, including types of quality audits, purpose and scope of auditing, terms and definitions, roles and responsibilities of participants, and professional conduct The audit process, from preparation and planning, to performance and reporting, to follow-up and closure Auditor competencies, including resource management, conflict resolution, communication, interviewing, and team dynamics Audit program management and business applications, including staffing, training and development, program evaluation, organizational risk management, and best practices Quality tools and techniques, including problem-solving tools, process improvement techniques, basic statistics, verification, and validation "This book is an encyclopedia of all major bodies of information a new or experienced quality auditor would need. It covers both the qualitative and the quantitative, which is a strength. I can't think of a quality auditor that would not find this work helpful." Kim H. Pries, CRE, CQE, CSQE, CSSBB, CMQ/OE, CQA "This handbook will be helpful to those who are new to auditing or require more in-depth knowledge of the implementation of an audit program. Boxed examples or scenarios provide some of the practical challenges encountered during auditing." Govind Ramu, ASQ Fellow, Co-Author ASQ SSGB Handbook, Author ASQ CSSYB Handbook Lance B. Coleman, Sr. has over 25 years of leadership experience in the areas of quality engineering, Lean implementation, quality, and risk management in the Medical Device, Aerospace, and other regulated industries. He has presented, trained, and consulted throughout the United States and abroad. Lance is currently a Director of Quality for IDEX Health and Science, LLC, in Oak Harbor, Washington.
This handbook is a comprehensive reference designed to help professionals address organizational issues from the application of the basic principles of management to the development of strategies needed to deal with today’s technological and societal concerns. The fifth edition of the ASQ Certified Manager of Quality/Organizational Excellence Handbook (CMQ/OE) has undergone some significant content changes in order to provide more clarity regarding the items in the body of knowledge (BoK). Examples have been updated to reflect more current perspectives, and new topics introduced in the most recent BoK are included as well. This handbook addresses: • Historical perspectives relating to the continued improvement of specific aspects of quality management • Key principles, concepts, and terminology • Benefits associated with the application of key concepts and quality management principles • Best practices describing recognized approaches for good quality management • Barriers to success, common problems you may encounter, and reasons why some quality initiatives fail • Guidance for preparation to take the CMQ/OE examination A well-organized reference, this handbook will certainly help individuals prepare for the ASQ CMQ/OE exam. It also serves as a practical, day-to-day guide for any professional facing various quality management challenges.
What is Risk Based Auditing (RBA)? International Organization for Standardization (ISO) incorporated Risk Based Thinking (RBT) into ISO 9001:2015 Risk Based Auditing is the first book to address risk based auditing and risk based thinking which are fundamental to first-party, second-party, and third-party auditing in all the new ISO families of standards. Learn what RBA and RBT mean and most importantly understand what you need to do to manage, plan, conduct, and report Risk Based Audits. Everyone who is certified to ISO 9001:2015 or any ISO standard should read this book to understand and implement RBA and RBT. What This Book Can Do for You? + Explains the integration of risk into auditing all ISO Management Systems. + Answers the critical questions you need to know about RBA and risk management. + Explains key risk concepts such as Risk Based Auditing, managing RBA programs, planning, conducting, and reporting Risk Based Audits. + Explains in detail ISO 19011:2018. + Explains in detail the steps for planning, conducting, and reporting Risk Based Audits. + Presents insider tips and tools known to first-party, second-party, and third-party auditors. Bonus Materials/Resources: + Access almost 2,000 risk and quality articles through CERM Academy. + Get Lessons Learned at the end of each key question. + Get free course materials such as using FMEA's in ISO 9001:2015.
"The Operational Audit Blueprint: Definitions, Internal Audit Programs, and Checklists for Success" is an indispensable guide for anyone seeking to improve their organisation's operational processes through operational auditing. This book provides a comprehensive overview of operational auditing, including the tools and techniques used by internal auditors to evaluate operational processes. It also emphasises the importance of audit programs and checklists in achieving success. Contents of the book: FINANCE • Financial reporting • Investments • Accounts payable and receivable • Budgeting & Monitoring • Fixed assets • Tax compliance HR · Human resources · Payroll · Payroll cycle data analytics MANUFACTURING · Planning and production control · Quality control · Maintenance · Safety · ESG SUPPLY CHAIN · Demand Planning · Purchasing · Tendering · Import · Inventory · Third-Party Labour Contractor · Warehouse Management · Purchase-to-Pay Cycle Data Analytics SALES & MARKETING · Sales Management · Sales Performance And Monitoring · Product Development · Pricing And Discount · Promotion And Advertising · Marketing Campaigns · Credit Limits · Export · Order Processing · Customer Relationship Management · Retail · Customer Credit Data Analytics INFORMATION TECHNOLOGY · Business Continuity Management · Data Privacy · Database · It General Controls · It Security Management · It Backup & Recovery · It Vendor Management · It Access Controls · It Asset Management · It Change Management · It Data Management · It Help Desk GENERAL PROCESSES · Contract Management · Project Management · Ethics · Ethical Business Conduct Guidelines · Fraud Prevention Whether you're a business owner, manager, or internal auditor, "The Operational Audit Blueprint: Definitions, Internal Audit Programs, and Checklists for Success" is an essential resource for achieving operational and financial success through improved operational auditing. With this book, you will be able to identify and address potential issues before they become significant problems, ensuring that your organization's are operating at peak efficiency.
Forest management auditing is expanding from its traditional focus on forest management, stewardship and Chain of Custody certification to more innovative topics such as ecosystem services, forest carbon credits, Non-Wood Forest Products, wood energy and Fair Trade certification. Forest managers, auditors and project developers require a new range of skills, capacities and expertise to monitor these issues. This book outlines the market-based tools that are required by such professionals to ensure corporate social responsibility in the forestry sector. It shows how a mutual learning process between established forest certification processes and innovative markets is needed. It addresses key topics such as High Conservation Value (HCV) approaches, the role of independent certification versus due diligence process and the engagement of smallholders and SMEs. Beginning with a market and policy analysis, the book fosters a deeper understanding of standards, methodologies and auditing techniques. Numerous case studies are included from a wide range of contexts, including both temperate and tropical forests in developed and developing countries. Overall, the book analyses all the steps towards forest management and forest products and services certification.
Strengthen your ability to implement, assess, evaluate, and enhance the effectiveness of information security controls based on ISO/IEC 27001/27002:2022 standards Purchase of the print or Kindle book includes a free PDF eBook Key Features Familiarize yourself with the clauses and control references of ISO/IEC 27001:2022 Define and implement an information security management system aligned with ISO/IEC 27001/27002:2022 Conduct management system audits to evaluate their effectiveness and adherence to ISO/IEC 27001/27002:2022 Book DescriptionISO 27001 and ISO 27002 are globally recognized standards for information security management systems (ISMSs), providing a robust framework for information protection that can be adapted to all organization types and sizes. Organizations with significant exposure to information-security–related risks are increasingly choosing to implement an ISMS that complies with ISO 27001. This book will help you understand the process of getting your organization's information security management system certified by an accredited certification body. The book begins by introducing you to the standards, and then takes you through different principles and terminologies. Once you completely understand these standards, you’ll explore their execution, wherein you find out how to implement these standards in different sizes of organizations. The chapters also include case studies to enable you to understand how you can implement the standards in your organization. Finally, you’ll get to grips with the auditing process, planning, techniques, and reporting and learn to audit for ISO 27001. By the end of this book, you’ll have gained a clear understanding of ISO 27001/27002 and be ready to successfully implement and audit for these standards.What you will learn Develop a strong understanding of the core principles underlying information security Gain insights into the interpretation of control requirements in the ISO 27001/27002:2022 standard Understand the various components of ISMS with practical examples and case studies Explore risk management strategies and techniques Develop an audit plan that outlines the scope, objectives, and schedule of the audit Explore real-world case studies that illustrate successful implementation approaches Who this book is forThis book is for information security professionals, including information security managers, consultants, auditors, officers, risk specialists, business owners, and individuals responsible for implementing, auditing, and administering information security management systems. Basic knowledge of organization-level information security management, such as risk assessment, security controls, and auditing, will help you grasp the topics in this book easily.
Systems Engineering for Aerospace: A Practical Approach applies insights gained from systems engineering to real-world industry problems. The book describes how to measure and manage an aircraft program from start to finish. It helps readers determine input, process and output requirements, from planning to testing. Readers will learn how to simplify design through production and acquire a lifecycle strategy using Integrated Master Plan/Schedule (IMP/IMS). The book directly addresses improved aircraft system design tools and processes which, when implemented, contribute to simpler, lower cost and safer airplanes. The book helps the reader understand how a product should be designed, identifying the customer's requirements, considering all possible components of an integrated master plan, and executing according to the plan with an integrated master schedule. The author demonstrates that systems engineering offers a means for aircraft companies to become more effective and profitable. - Describes how to measure and manage an aircraft program - Instructs on how to determine essential input, process and output requirements - Teaches how to simplify the design process, thus allowing for increased profit - Provides a lifecycle strategy using Integrated Master Plan/Schedule (IMP/IMS) - Identifies cost driver influences on people, products and processes
Combination products are therapeutic and diagnostic products that combine drugs, devices, and/or biological products. According to the US Food and Drug Administration (FDA), “a combination product is one composed of any combination of a drug and a device; a biological product and a device; a drug and a biological product; or a drug, device and a biological product.” Examples include prefilled syringes, pen injectors, autoinjectors, inhalers, transdermal delivery systems, drug-eluting stents, and kits containing drug administration devices co-packaged with drugs and/or biological products. This handbook provides the most up-to-date information on the development of combination products, from the technology involved to successful delivery to market. The authors present important and up-to-the-minute pre- and post-market reviews of international combination product regulations, guidance, considerations, and best practices. This handbook: Brings clarity of understanding for global combination products guidance and regulations Reviews the current state-of-the-art considerations and best practices spanning the combination product lifecycle, pre-market through post-market Reviews medical product classification and assignment issues faced by global regulatory authorities and industry The editor is a recognized international Combination Products and Medical Device expert with over 35 years of industry experience and has an outstanding team of contributors. Endorsed by AAMI – Association for the Advancement of Medical Instrumentation.