James Culliton, ASQ Quality Press, 2014, 204 pp., $45 member, $75 list (book).
This book was written to give readers an understanding of the clauses and requirements contained within the AS9100C, AS9110 and AS9120 standards. The first chapter provides an overview of aerospace quality management systems as well as definitions for the numerous terms and abbreviations used in the industry. The following chapters cover each of the clauses contained within the standards. There are seven appendixes that provide useful information like the summary of changes from AS9100B to AS9100C, sample procedures and a risk management program.
Although this is a predictably dry subject, the author uses a consistent format that makes for a useful desk reference. Each clause of the standard is broken down into three sections; a discussion section that provides a plain English explanation of the clause followed by sections that outline typical findings and best practices. Potential buyers should know the specific verbiage from the standard is not included in the chapters, and the author recommends readers also purchase a copy of the standard.
The information in this handbook is useful and informative. It is a helpful reference to those in the aerospace industry looking for a convenient, qualified second opinion. Readers can reference it for guidance on the implementation and maintenance of a certified quality management system.
Wisconsin Rapids, WI
Free, Perfect, and Now: A Lean Six Sigma Money Belt Manifesto
Jay Arthur, KnowWare International, 2011, 64 pp., $9.95 (book).
This short book strips away the extras and gets right to the practical core of lean Six Sigma. Additionally, it emphasizes the financial aspects of improvement. The main points made are:
Lean Six Sigma can be applied anywhere and to any business process.
Three silent killers of productivity and profitability are delay, defect and deviation.
You don’t need a lot of training to get into lean Six Sigma.
You don’t have to fix all the problems in your business, or fix them at the same time.
The secret to lean Six Sigma is FISH: focus, improve, sustain and honor.
People only need the right method and tools to find and fix problems.
Arthur details the magnificent seven lean Six Sigma tools and identifies which ones are appropriate for removing delays, defects, deviation and collecting data quickly. He also includes several of his own rules which help point to those potential improvements that will have the most impact.
Every business can benefit from lean Six Sigma if applied properly. Lean Six Sigma won’t fix an inability to innovate, but Arthur’s suggestions will assure innovation is delivered in a fast, affordable manner and make an impact to the bottom line.
Marc A. Feldman
The FDA and Worldwide Current Good Manufacturing Practices and Quality System Requirements: Guidebook for Finished Pharmaceuticals
José Rodríguez-Pérez, ASQ Quality Press, 2014, 396 pp., $60 member, $100 list (book and CD-ROM).
The World Health Organization (WHO)instituted the Good Manufacturing Practices (GMP) requirements in 1975, covering all aspects of a manufacturing process. Countries around the world have since adopted industry-specific regulations under the umbrella of current good manufacturing practices (cGMP). In the United States, the Food and Drug Administration (FDA) enforces cGMP, regulations on drug manufacturers to control the quality, strength and purity of drug products. This book is intended to help pharmaceutical manufacturers understand FDA-enforced and quality system requirements.
With this as the backdrop, the author creates a roadmap of cGMP requirements and implementation in the United States and other countries. Chapters 1 and 2 provide a broad overview of cGMP regulations, and how the U.S. government regulates pharmaceutical products in general. Chapters 3 and 4 review the international landscape and how countries like the European Union (EU) and Canada have implemented their versions of cGMP and are collaborating across geographical boundaries to establish quality guidelines.
Chapter 5 provides a detailed analysis of the U.S. cGMP regulations, with supporting FDA documents. The author also compares the U.S. cGMP regulations with the EU and the WHO. The CD-ROM accompanying the book contains several such documents, statistical data on FDA enforcements, and a copy of the international regulations. The most useful takeaways for the reader are the practical tips and notes the author provides at various points, drawing from over two decades of regulatory and compliance expertise. The cheat sheet with a comparison of the U.S. cGMP, EU cGMP and WHO cGMP is a handy tool for readers involved in cGMP implementations on a global scale.
The last part of the book contains information regarding what is not explicitly covered in the regulations. The author covers the nuances involved in internal audits, purchasing controls, corrective and preventive actions and validations, and explains what inspectors look for during surveillance audits.
This book serves as an outstanding holistic guide for any novice reader seeking knowledge of the pharmaceutical cGMP standards and their enforcement by the FDA. The experienced reader already involved in implementation of cGMP also will benefit from reading this book.
FDC Division and Mark A. Durivage, editor, ASQ Quality Press, 2014, 396 pp., $89 member, $135 list (book).
This book is an excellent introduction, a helpful resource and a thorough examination of the domestic and international regulation of drugs. It describes the management of raw materials, quality systems, finished drugs and the life-cycle management of these complex and highly valued products. The authors’ considerable experiences and knowledge are presented in a useful and consistent format throughout the book.
The book is organized into eight higher-level parts supported through extensive references and detailed supporting chapters. Each chapter addresses specific topics, manufacturing processes or scientific foundations that make up the general part. Additional and supporting sections include a glossary, references, suggested reading, an index, a list of figures and tables, and a listing of abbreviations and acronyms. The primary benefit of the book is that it presents the concepts necessary to pass ASQ’s certified pharmaceutical GMP professional exam. It is extensively researched and that may be the biggest strength as it works for students and professionals.
Potential readers should find the details, logic and clarity to be beneficial to their own work.