ASQ/Infotech

In an unconventional and intriguing manner the author addresses the economics of quality, statistical thinking, statistical process control, and inspection efficiency. He provides a useful process model for achieving a continuous improvement state in any organization.

As the author is quick to say, “This is not a cookbook! It is, however, a book about cooking.”

Understanding and improving the CAPA system as a whole is the focal point of this book, the first of its kind dealing exclusively with this critical system within this highly regulated industry. By helping those in this industry improve their CAPA systems, it will be a crucial aid in their mission of producing safe and effective products.

Although similar to these recognized QMS standards, ISO/IEC 17025 serves a unique purpose: laboratory accreditation. It is not unusual for laboratories to retain dual certification to ISO 9001 and ISO/IEC 17025.

This book addresses the needs of:

• Users and organizations seeking a general understanding of the contents of ISO 9001:2015
• Users and organizations desiring guidance to ensure their ISO 9001:2015 QMS meets the new version requirements
• Users and organizations considering the use of ISO 9001:2015 as a foundation for the development of a comprehensive QMS
• Educators who require a textbook to accompany a training class or course on ISO 9001:2015
• Auditors who desire to increase their level of auditing competence

Authors Cianfrani and West, members of the expert group that developed ISO 9001:2015, strive to provide a context for all requirements to enable you to develop and deploy processes that will strengthen your QMS. Getting or retaining a certificate is not the real objective. Satisfied customers and organizational sustainability should be primary objectives for the organization.

Busy executives (CEOs, COOs, and operations managers, whom FDA holds responsible for all regulatory compliance), who also need a desk reference with specific information to quickly assess regulatory compliance, identify potential noncompliance, and review corrective, preventive, and compliance actions

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 book is suited for employees and managers at any organizational level in any type of industry, including service, manufacturing, and the public sector.

The handbook can be used by new auditors to gain an understanding of auditing. Experienced auditors will find it to be a useful reference. Audit managers and quality managers can use the handbook as a guide for leading their auditing programs. The handbook may also be used by trainers and educators as source material for teaching the fundamentals of auditing.

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 answers to each chapter’s questions appear at the end of the chapter. The correct answer is given by letter, along with the location of the topic and page number and paragraph (or other locator) in the second edition of The Certified Six Sigma Green Belt Handbook.

The provided solutions are taken from the same references used by the ASQ Item Writing teams who create the test items used in the formal Six Sigma Yellow Belt Certification examination.

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.