Bøker av Mark Allen Durivage

This handbook explains, in detail, each section of the Certified Supplier Quality Professional Body of Knowledge (updated 2023). It is a handy reference for those already working in the field and is an essential text for those working toward a CSQP certification.

The importance of a safe, reliable, cost-effective, high-quality, integral, and nimble supply chain cannot be overstated. Equally critical are the supply chain processes (e.g., strategic, procurement, quality assurance, technical, regulatory) that ensure these requirements are met. By extension, then, the supply chain professional is of paramount importance as a creator, driver, and full participant in these business-critical activities. ASQ's Certified Supplier Quality Professional (CSQP) certification provides valuable credentials to quality professionals in the growing field of supplier quality engineering. Due to globalization of the supply chain, supplier quality engineers are becoming more important in a broad spectrum of industries, including manufacturing and service industries. The purpose of this handbook is to assist individuals taking the Certified Supplier Quality Professional examination and provide a reference for the practitioner. Throughout this handbook, several examples are provided based upon the collective experience and knowledge of the authors and editor. However, these examples are not explicitly specified in regulations, leaving decisions to the company, as well as the burden of justifying practices using sound scientific principles that provide the context of the rationale.

This book was written to aid quality technicians and engineers. It is a result of 30 years of quality-related work experience. To that end, the intent of this book is to provide the quality professional working in virtually any industry a quick, convenient, and comprehensive guide to properly conducting design of experiments (DOE) for the purpose of process optimization.This is a practical introduction to the basics of DOE, intended for people who have never been exposed to design of experiments, been intimidated in their attempts to learn about DOE, or have not appreciated the potential of this family of tools in their process improvement and optimization efforts.In addition, this book is a useful reference when preparing for and taking many of the ASQ quality certification examinations, including the Certified Quality Technician (CQT), Certified Six Sigma Green Belt (CSSGB), Certified Quality Engineer (CQE), Certified Six Sigma Black Belt (CSSBB), and Certified Reliability Engineer (CRE).

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 don't 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 best to improve the control and performance of a process. The reader is assumed to be familiar with basic control charting methodology since assessment of statistical control of the measurement process is important.One may wonder why performing a gage R&R is so important; the simple answers are profit, public health, and safety. Companies that are shipping product that is out of specification can be subjected to expensive litigation, especially in the aviation, pharmaceutical, and medical device industries. This book will be a useful reference when preparing for and taking many of the ASQ quality certification examinations, including the Certified Quality Technician (CQT), Certified Calibration Technician (CCT), Certified Quality Inspector (CQI), Certified Six Sigma Green Belt (CSSGB), Certified Quality Engineer (CQE), Certified Six Sigma Black Belt (CSSBB), and Certified Reliability Engineer (CRE).

For the past decade, process validation issues ranked within the top six of Food and Drug Administration (FDA) form 483 observation findings issued each year. This poses a substantial problem for the medical device industry and is the reason why the authors wanted to write this book. The authors will share their collective knowledge: to help organizations improve patient safety and increase profitability while maintaining a state of compliance with regulations and standards.The intent of this book is to provide manufacturing quality professionals working in virtually any industry a quick, convenient, and comprehensive guide to properly conduct process validations that meet regulatory and certification requirements. It will aid quality technicians, engineers, managers, and others that need to plan, conduct, and monitor validation activities.

This book is primarily meant to aid those taking the ASQ Certified Supplier Quality Professional (CSQP) exam and is best used in conjunction with The Certified Supplier Quality Professional. Section I provides 336 practice questions organized by the seven parts of the 2016 Body of Knowledge (BoK). Section II gives the reader a 150-question practice exam comprising each of the nine parts of the BoK, in a randomized order that simulates the actual certification exam. Unlike other resources on the market, all these questions and solutions were developed specifically to address the 2016 CSQP Body of Knowledge and help those studying for the certification, including considering the proper depth of knowledge and required levels of cognition.

This book is a convenient and comprehensive guide to statistics. A resource for quality technicians and engineers in any industry, this second edition provides even more equations and examples for the reader-with a continued focus on algebra-based math. Those preparing for ASQ certification examinations, such as the Certified Quality Technician (CQT), Certified Six Sigma Green Belt (CSSGB), Certified Quality Engineer (CQE), Certified Six Sigma Black Belt (CSSBB), Certified Reliability Engineer (CRE), and Certified Supplier Quality Professional (CSQP), will find this book helpful as well. Inside you'll ­find: ¿ Complete calculations for determining confidence intervals, tolerances, sample size, outliers, process capability, and system reliability ¿ Newly added equations for hypothesis tests (such as the Kruskal-Wallis test and Levene's test for equality of variances), the Taguchi method, and Weibull and log-normal distributions ¿ Hundreds of completed examples to demonstrate practical use of each equation ¿ 20+ appendices, including distribution tables, critical values tables, control charts, sampling plans, and a beta table

This handbook is fully updated to the 2018 Body of Knowledge for the Certified Reliability Engineer (CRE), including the new sections on leadership, performance monitoring, root cause analysis, and quality triangles. Its purpose is to assist individuals preparing for the examination and to provide a reference for the practitioner. Several typical examples are provided throughout based on the collective experience and knowledge of the authors and editor.The chapters and sections are numbered by the same format used in the Body of Knowledge (BoK) for the CRE examination. It also includes a comprehensive glossary of reliability-related terms and appendices with, among other things, various useful distribution tables.

The purpose of this handbook is to assist individuals for the Certified Pharmaceutical Good Manufacturing Practices Professional (CPGP) examination and provide a reference for the practitioner. The second edition reflects the Body of Knowledge which was updated in 2015. This edition has also incorporated additional information including updated references. The updates reflect the current trends and expectations of the evolving pharmaceutical industry driven by consumer expectations and regulatory oversight.This handbook covers compliance with good manufacturing practices (GMPs), as regulated and guided by national and international agencies for the pharmaceutical industry. It covers finished human and veterinary drugs and biologics, and combination devices, as well as their component raw materials (including active pharmaceutical ingredients (APIs) and excipients), and packaging and labeling operations.