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This book provides a protocol for conducting gauge repeatability and reproducibility (R&R) experiments. Such an experiment is required whenever a new test system is developed to monitor a manufacturing process. The protocol presented here is used to determine if the testing system is capable of monitoring the manufacturing process with the desired level of accuracy and precision. This protocol is not currently available in other books or technical reports. In addition to providing a protocol for testing a measurement system, the book presents an up-to-date summary of methods used to construct confidence intervals in normal-based random and mixed analysis of variance (ANOVA) models. Thus, this comprehensive book will be useful to scientists in all fields of application who wish to construct interval estimates for ANOVA model parameters. It includes approaches that can be applied to any ANOVA model.
This book is primarily meant to aid those taking the ASQ Certified Quality Engineer (CQE) exam and is best used in conjunction with The Certified Quality Engineer Handbook. Section 1 provides 380 practice questions organized by the seven parts of the 2015 Body of Knowledge (BOK). Section 2 gives the reader 205 additional practice questions from each of the seven parts, in a randomized order. For every question in both sections, detailed solutions are provided that explain why each answer is the correct one and also which section of the BOK the question corresponds to so that any further study needed can be focused on specific sections. A secondary audience is those taking exams for ASQ certi...
A comprehensive reference manual to the Certified Quality Technician Body of Knowledge and study guide for the CQT exam.
This book a result of 30 years of quality-related work experience was written to aid quality technicians and engineers. It provides the quality professional working in virtually any industry a quick, convenient, and comprehensive guide to properly conducting measurement systems analysis (MSA). The intent of this book is to provide background and examples on the application of gage R&R methodology (test method validation) for variable and attribute data, help for those who work with devices that dont fit the usual approach, and ideas for measurement devices that require innovation to assess their performance under off-line, static conditions. The ultimate objective is to determine how...
A comprehensive reference manual to the Certified Quality Engineer Body of Knowledge and study guide for the CQE exam.
Fully updated to reflect the 2022 ASQ Certified Six Sigma Black Belt (CSSBB) Body of Knowledge (BoK), The ASQ Certified Six Sigma Black Belt Handbook, Fourth Edition is ideal for candidates studying for the CSSBB examination. This comprehensive reference focuses on the core areas of organization-wide planning and deployment, team management, and each of the DMAIC project phases. The fourth edition of this handbook offers thorough explanations of statistical concepts in a straightforward way. It also reflects the latest technology and applications of Six Sigma and lean tools. Updates you will find in the fourth edition include: • New topics and tools, such as return on investment calculations, the roles of coaching and finance in projects, process-decision program charts, interrelationship digraphs, A3 analysis, maturity models, key behavior indicators, and audit MSA • A new chapter on risk analysis and management • Revamped statistics sections • New tables, figures, and examples to help illustrate key points The ASQ Certified Six Sigma Black Belt Handbook, Fourth Edition is also a valuable addition to any quality practitioner’s library.
The ASQ Certified Quality Engineer Handbook, Fifth Edition, covers a wide range of topics in the quality engineering field and is organized to align with the 2022 ASQ Certified Quality Engineer (CQE) Body of Knowledge (BoK). This handbook is essential for candidates preparing for the ASQ CQE examination. For working engineers, it is a convenient and thorough guide to the profession. In addition to providing detailed explanations of each section of the 2022 CQE BoK, this current edition includes: • An explanation of cost-benefit analysis (CBA) and the RACI matrix; critical to quality as a design input; hazard analysis and FMEA; overall equipment effectiveness (OEE); 5 Whys analysis; data au...
The intent of this book (MDDR, for short) is to present an introduction to, and overview of, the world of medical device regulation by the United States Food and Drug Administration (FDA), and the relationship of this regulatory scheme to the design and development of medical devices. In providing this information, the book covers the broad range of requirements, which are presented within eight major topics: background and regulatory environment, device design control, nonclinical testing, clinical testing, marketing applications, post-market requirements, quality systems/GMPs, and compliance/enforcement. This book provides students and professionals in the medical device industry with a ro...
The intent of this field guide is to assist organizations, step by step, in implementing a QMS in conformance with ISO 9001:2015, whether from scratch or by transitioning from ISO 9001:2008. Within the guide each sub-clause containing requirements is the focus of a two-page spread that consistently presents features that fulfill the requirements listed below. This book examines each sub-clause of clauses 410 of ISO 9001:2015, which contain the requirements, with a visual representation provided in flowchart format on the facing page. This field guide will: - Provide a user-friendly guide to ISO 9001:2015s requirements for implementation purposes - Identify the documents/documentation...