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.

The CD-ROM has been expanded into two disks, and a layout diagram is available in Appendix R. Given that this is an electronic format, you are encouraged to search the files for any number of forms, examples, templates, videos, and other useful tidbits that can help in running projects and preparing for the exam.

The ASQ CSSGB Study Guide

A team of ASQ Fellows has created this study guide with over 300 new questions predominantly based on the best-selling second edition of The Certified Six Sigma Green Belt Handbook.

The primary audience for this work is the individual who plans to sit for the ASQ Certified Six Sigma Green Belt (CSSGB) examination. The intended purpose of this study guide is to help you determine your readiness for the exam, using the questions as a self-assessment tool.

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 CD-ROM has been expanded into two disks, and a layout diagram is available in Appendix R. Given that this is an electronic format, you are encouraged to search the files for any number of forms, examples, templates, videos, and other useful tidbits that can help in running projects and preparing for the exam.

The CD accompanying the print book and at the end of the e-book versions includes a practice problem set covering each part of the book and a simulated examination that has problems distributed among parts according to the scheme published in the Body of Knowledge.

The ASQ CSSYB Study Guide is primarily meant to aid those taking the ASQ Certified Six Sigma Yellow Belt (CSSYB) exam and is best used in conjunction with The Certified Six Sigma Yellow Belt Handbook. Section 1 provides 151 practice questions organized by the five parts of the Yellow Belt Body of Knowledge (BoK) effective from March 2015 until March 2021. Section 2 gives the reader 136 additional practice questions from each of the five 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. 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.

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.

New software quality engineers can use this handbook to gain an understanding of their chosen profession. Experienced software quality engineers can use this handbook as a reference source when performing their daily work. It is also hoped that trainers and educators will use this handbook to help propagate software quality engineering knowledge to future software practitioners and managers. Finally, this handbook strives to establish a common vocabulary that software quality engineers, and others in their organizations can use to communicate about software and quality. Thus increasing the professionalism of the industry and eliminating the wastes that can result from ambiguity and misunderstandings.

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.

A companion CD contains dozens of FDA guidance documents as well as international harmonization documents (WHO, PIC/S, and ICH). A check list for cGMP audit is also included based on risk management criteria. An exam complements the material included in the CD.

In addition, included on an accompanying CD are comprehensive check sheets to be used by internal auditors in auditing an EMS’s conformance to ISO 14001:2015.

Material from several lean practitioners with differing backgrounds and experience has been gathered to create this handbook, which serves as an ideal starting point for practitioners who want both a holistic view of lean in general and also specifically the BOK of this groundbreaking joint certification program.

Completely new to this edition is a unique graphical software application – Transformation Logic Trees, designed primarily to create thinking process logic trees and only secondarily for other flowcharting uses. Provided on the accompanying CD-ROM is a full-function, unrestricted copy of version 1.0 for new and experienced users of the thinking process alike to use in building their logic trees. Appendix J in the book provides more information on how to install and use the software.

Sponsored by ASQ’s Measurement Quality Division, this handbook serves as an excellent desktop reference for calibration technicians, supervisors, managers, quality inspectors, auditors, those in calibration and/or testing laboratories, consultants, and teachers. Whether you’re changing disciplines in your career field, helping to becoming certified to a new or different standard, accepting more responsibilities as a supervisor or manager, training your fellow calibration practitioners, or using it to prepare for ASQ’s Certified Calibration Technician (CCT) exam, this handbook provides the information, guidance, and knowledge to help you achieve your goals.