This handbook is intended to serve as a baseline of hazard analysis critical control point (HACCP) knowledge for quality auditors. HACCP is more than just failure mode and effect analysis (FMEA) for food: it is a product safety management system that evolved and matured in the commercial food processing industry allowing food processors to take a proactive approach to prevent foodborne diseases. Both the FDA and the USDA have embraced HACCP as the most effective method to ensure farm-to-table food safety in the United States. This handbook also assists the certification candidate preparing for the ASQ Certified HACCP Auditor (CHA) examination. It includes chapters covering the HACCP audit, the HACCP auditor, and quality assurance analytical tools.
Federal regulatory agencies have embraced Hazard Analysis Critical Control Point (HACCP) as the most effective method to offer farm-to-table food safety and quality in the United States-but it is important to look beyond HACCP. The ASQ Certified Food Safety and Quality Auditor (CFSQA) Handbook serves as a baseline of knowledge for auditors of food safety and quality systems that covers other aspects of food production, including preventive controls. This handbook assists certification candidates in preparing for the ASQ Certified Food Safety and Quality Auditor (CFSQA) examination. Its chapters cover the HACCP audit and auditor, preventive principles, and quality assurance analytical tools. The updated fourth edition also includes: The history of primitive and modern food preservation methods, including the introduction of HACCP methods The evolution of prerequisite programs, such as chemical and microbiological controls The importance of other food system support programs, such as product traceability and recall, facility design, and environmental control and monitoring Preliminary tasks for developing a HACCP plan About the Division The mission of the ASQ Food, Drug, and Cosmetic Division is to achieve increased customer satisfaction and continuous improvement by identifying, communicating, and promoting knowledge and the use of management concepts, technologies, and regulations as they relate to quality principles in all functional areas of the food, drug, and cosmetic industries. The Division holds conferences, confers awards annually, awards scholarships, and provides training and networking opportunities for participants in these industries.
The recognition that all well-managed companies are interested in preventing or at least minimizing risk in their operations is the concept of risk management analysis. This pocket guide explores the process of evaluation of risk by utilizing one of the core methodologies available: the failure mode and effect analysis (FMEA). The intent in this “Pocket FMEA” is to provide the reader with a booklet that makes the FMEA concept easy to understand and provide some guidelines as to why FMEA is used in so many industries with positive results. The booklet is not a complete reference on FMEA, but rather a summary guide for anyone who wants some fast information regarding failures and how to deal with them. It covers risk, reliability and FMEA, prerequisites of FMEA, what an FMEA is, robustness, the FMEA form and rankings, types of FMEA, and much more.
This book is intended for small business owners and non-engineers such as researchers, business analysts, project managers, small non-profits, community groups, religious organizations, and others who want an assessment tool that can provide methods for: - identifying the areas or actions that may be at risk for failure - ranking the risks that they may be facing, and - determining the degree of threat being faced. While an FMEA is a tool of reliability engineering, this book sidesteps the complex approach that reliability engineering can take; therefore, it does not cover all aspects and applications of an FMEA. This book provides sufficient information about FMEAs, without requiring the expertise of an engineer or statistical analyst, to establish specifications and for making cost-effective, informed decisions. FMEAs are valuable for: - developing policies and standard operating procedures (SOPs) - developing system, design, and process requirements that eliminate or minimize the likelihood of failures - developing designs, methods, and test systems to ensure that errors or failures are automatically corrected, errors or failures are flagged for correction, the potential for errors or failures have been eliminated, or risks are reduced to acceptable levels - developing and evaluating of diagnostic systems, and - helping with design choices (trade-off analysis)
Translating promising discoveries and innovations into useful, marketable medical products demands a robust process to guide nascent products through a tangle of scientific, clinical, regulatory, economic, social, and legal challenges. There are so many human and environmental elements involved in shepherding medical advances from lab to launch that the field of medical product development has been referred to as an ecosystem. The purpose of this book is to help provide a shared foundation from which cross-functional participants in that ecosystem can negotiate the product development labyrinth and accomplish the goal of providing both groundbreaking and iterative new medical products. The book is intended for anyone in industry, the public sector, or academia—regardless of functional specialty, workplace, or seniority—who is interested in medical product development. The years since the publication of the previous edition of this book have seen profound changes in the actions and attitudes of patients, insurers, manufacturers, and the Food and Drug Administration regarding the streamlining of medical product development and approval. What those years have not seen is a concomitant increase in innovative treatments with profound benefits to patients. Despite enormous investments in research by both private and public sources and a surge in scientific and technological advances, new medical products barely trickle into the marketplace. For a variety of reasons, applied sciences necessary for medical product development are not keeping pace with the tremendous advances in basic sciences. Not surprisingly, industry and academia are under substantial pressure to transform discoveries and innovations from the laboratory into safe and effective medical products to benefit patients and improve health. This evolution—from bench to bedside—has become known as translational research and development, and this approach is what this book illuminates. "I have been working in medical device design and design assurance for over 10 years...Elaine Whitmore really gets this right...The point is that quality regulations are not going to go away, and those responsible for healthcare product development will have to lead the charge to keep up the momentum in their organizations. I am going to have to buy several copies of this for my clients!" Joseph P. Sener, P.E.
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.
Federal regulatory agencies have embraced Hazard Analysis Critical Control Point (HACCP) as the most effective method to offer farm-to-table food safety and quality in the United States-but it is important to look beyond HACCP. The ASQ Certified Food Safety and Quality Auditor (CFSQA) Handbook serves as a baseline of knowledge for auditors of food safety and quality systems that covers other aspects of food production, including preventive controls. This handbook assists certification candidates in preparing for the ASQ Certified Food Safety and Quality Auditor (CFSQA) examination. Its chapters cover the HACCP audit and auditor, preventive principles, and quality assurance analytical tools. The updated fourth edition also includes: The history of primitive and modern food preservation methods, including the introduction of HACCP methods The evolution of prerequisite programs, such as chemical and microbiological controls The importance of other food system support programs, such as product traceability and recall, facility design, and environmental control and monitoring Preliminary tasks for developing a HACCP plan About the Division The mission of the ASQ Food, Drug, and Cosmetic Division is to achieve increased customer satisfaction and continuous improvement by identifying, communicating, and promoting knowledge and the use of management concepts, technologies, and regulations as they relate to quality principles in all functional areas of the food, drug, and cosmetic industries. The Division holds conferences, confers awards annually, awards scholarships, and provides training and networking opportunities for participants in these industries.
Are you trying to improve performance, but find that the same problems keep getting in the way? Safety, health, environmental quality, reliability, production, and security are at stake. You need the long-term planning that will keep the same issues from recurring. Root Cause Analysis Handbook: A Guide to Effective Incident Investigation is a powerful tool that gives you a detailed step-by-step process for learning from experience. Reach for this handbook any time you need field-tested advice for investigating, categorizing, reporting and trending, and ultimately eliminating the root causes of incidents. It includes step-by-step instructions, checklists, and forms for performing an analysis and enables users to effectively incorporate the methodology and apply it to a variety of situations. Using the structured techniques in the Root Cause Analysis Handbook, you will: Understand why root causes are important. Identify and define inherent problems. Collect data for problem-solving. Analyze data for root causes. Generate practical recommendations. The third edition of this global classic is the most comprehensive, all-in-one package of book, downloadable resources, color-coded RCA map, and licensed access to online resources currently available for Root Cause Analysis (RCA). Called by users "the best resource on the subject" and "in a league of its own." Based on globally successful, proprietary methodology developed by ABS Consulting, an international firm with 50 years' experience in 35 countries. Root Cause Analysis Handbook is widely used in corporate training programs and college courses all over the world. If you are responsible for quality, reliability, safety, and/or risk management, you'll want this comprehensive and practical resource at your fingertips. The book has also been selected by the American Society for Quality (ASQ) and the Risk and Insurance Society (RIMS) as a "must have" for their members.
