ASQ/Infotech

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.

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 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.

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.

The editors included many new textbook and journal article references throughout the entire book. Within the discussion of continuous improvement methods, they added descriptions of and references to several case studies. These case studies, which include applications in the service industry, give the reader a broader context on how to apply many of the methods discussed in a real-life scenario. In particular, some of these case studies are related to quality in the service industry. Additionally, the editors updated discussions of and references to new technology important to the quality professional, such as Industry 4.0.

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.

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.

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 ASQ CSSBB Study Guide

This book is primarily meant to aid those taking the ASQ Certified Six Sigma Black Belt (CSSBB) exam, and is best used in conjunction with The Certified Six Sigma Black Belt Handbook. Section 1 provides 432 practice questions organized by the nine parts of the 2015 Body of Knowledge (BoK). Section 2 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 2015 CSSBB Body of Knowledge and help those studying for the certification, including considering the proper depth of knowledge and required levels of cognition.

The accompanying CD contains 180 supplementary problems covering each chapter and a 150-question simulated exam that has problems distributed among chapters per the scheme published in the BOK. New to this edition, the problems are now fully worked so that readers can more readily follow the problem-solving process.