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.
Financial Measures for Strategic Implementation of Quality Management
Author: Douglas C. Wood
Publisher: ASQ Quality Press
Category: Business & Economics
The last decade has seen wide changes in how quality standards are applied in industry. We now have two functions: quality assurance and process improvement. Quality assurance focuses primarily on product quality, while process improvement focuses on process quality; the principles of quality cost support both. The purpose of this book remains the same as the third edition: to provide a basic understanding of the principles of quality cost. Using this book, organizations can develop and implement a quality cost system to fit their needs. Used as an adjunct to overall financial management, these principles will help maintain vital quality improvement programs over extended timeframes. This fourth edition now includes information on the quality cost systems involved with the education, service, banking, and software development industries. You'll also find new material on ISO 9001, cost systems in small businesses, and activity based costing. Additional information on team-based problem-solving, customer satisfaction, and the costs involved with the defense industry are also offered.
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.
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.
A Comprehensive Guide to Designing a Process-Based Document Control System
Author: Stephanie L. Skipper
Publisher: ASQ Quality Press
Category: Business & Economics
This book explains the requirements for compliance with FDA regulations and ISO standards (9001/13485) for documented information controls, and presents a methodology for compliance. The document control system (DCS), or documented information control system (DICS), is the foundation of a quality management system. It is the first quality system element that must be implemented because the establishment and control of documented processes and information in a quality-controlled environment is dependent on the ability to proactively manage access to documents and the movement of documents through the document life cycle. A well-developed document control system benefits business by: Improving knowledge retention and knowledge transfer within and across business units Improving access to knowledge-based information Improving employee performance by providing standardized processes and communicating clear expectations Improving customer communication and satisfaction by providing documented information from which common understanding can be achieved Providing traceability of activities and documentation throughout the organization Improving organization of and access to documents and data Sample documents are included in the appendixes of this book to help clarify explanations, and a full set of formatted procedures and document templates are available for download to get you off to an even faster start. This book provides a process-based approach that can be used for controlling all forms of documented information that are required to be managed under the quality management system.
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.
This handbook is a comprehensive reference source 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 the technological and societal concerns of the new millennium. The content of this fourth edition has been revised to reflect a more current global perspective and to match the updated Body of Knowledge (BoK) of ASQ’s Certified Manager of Quality/Organizational Excellence (CMQ/OE). In order to provide a broad perspective of quality management, this book has specifically been written to address: • Historical perspectives relating to the evolution of particular aspects of quality management, including recognized experts and their contributions • Key principles, concepts, and terminology relevant in providing quality leadership, and communicating quality needs and results • Benefits associated with the application of key concepts and quality management principles • Best practices describing recognized approaches for good quality management • Barriers to success, including common problems that the quality manager might experience when designing and implementing quality management, and insights as to why some quality initiatives fail • Guidance for preparation to take the CMQ/OE examination. Organized to follow the BoK exactly, throughout each section of this handbook the categorical BoK requirements associated with good quality management practices for that section are shown in a box preceding the pertinent text. These BoK requirements represent the range of content and the cognitive level to which multiple-choice questions can be presented. Although this handbook thoroughly prepares individuals for the ASQ CMQ/OE exam, the real value resides in post-exam usage as a day-to-day reference source for assessing quality applications and methodologies in daily processes. The content is written from the perspective of practitioners, and its relevance extends beyond traditional product quality applications.
This handbook serves as a reference source for the application of quality auditing principles to the biomedical industry, including coverage specifically pertaining to medical devices. The book focuses on the understanding of domestic and international concepts and principles of biomedical quality auditing, and includes information on related regulations, directives, standards, and guidance. The book covers a wide range of subjects that have specific interpretations unique to the biomedical industry. In addition to being a peerless reference for ASQ's Biomedical Auditor certification (CBA), this book is a valuable reference for biomedical professionals who want to execute better audits for medical devices and gain basic knowledge of biomedical technical areas and regulatory requirements.
ASQ’s Certified Quality Improvement Associate (CQIA) certification is designed to introduce the basics of quality to organizations and individuals not currently working within the field of quality. This book and the Body of Knowledge (BOK) it supports are intended to form a foundation for further study and application of proven quality principles and practices worldwide. The book follows the CQIA BoK in both content and sequence. The intent is that this book will serve as a guide to be used in preparation to take the CQIA examination given by ASQ. Each chapter stands alone, and the chapters may be read in any order. Some material reaching beyond the content of the BoK has been added. Supplemental reading suggestions are provided. An online, interactive sample exam and a paper-and-pencil sample can be found on the ASQ website (http://asq.org/cert/quality-improvement-associate/prepare).