Lean Higher Education

William K. Balzer, Productivity Press, 2010, 312 pp., $49.95, (book).

The purpose of this nine-chapter book is to provide college-level educators with a way to apply lean practices at a higher learning institution.

The first three chapters give an overview of lean, a business case for why lean should be adopted and examples of successful implementations. The next two chapters cover the initial phase of starting a lean initiative and an overview of relevant metrics. The following three chapters cover visual stream mapping, identifying waste and sustaining improvements. The last chapter discusses what the future challenges are to make lean methods more widespread in higher education.

The book does a good job of stating a case for adopting lean methods at the college level and setting up the lean program infrastructure. Where the book is weak is in showing how the lean tools other than value stream mapping could be used in a college setting. One chapter covering 5S, mistake-proofing, visual systems, five whys analysis and eliminating waste is not enough to show a novice how and where lean can be implemented.

In addition, what the book calls value stream mapping would better be described as a hybrid between flow charting and value stream mapping. This could be confusing for a novice.

Overall, the book provides a good case for how processes within a college or university can be improved using lean methods and is suitable as an introduction to lean for administrators. College faculty or staff desiring to further study lean methods should get other materials in addition to this book.

Brian Cocolicchio
New City, NY

The A3 Workbook: Unlock Your Problem-Solving Mind

Daniel D. Matthews, Productivity Press, 2010, 183 pp., $49.95 (book).

Matthews spent time at several organizations within Toyota, where he learned many of the automobile industry’s methods, including the use of the A3 problem-solving tool. Upon his entry into a broader-based consulting role, he realized the power of the A3 process and the focused thinking required to clearly present problems and report on solutions outside the Toyota culture.

This book has three chapters: an introduction, an overview and a problem situation. It also has 22 appendixes answering the sample exercises presented in the first three chapters. The goal of the book is to transfer knowledge through discussion and use examples to explain the benefit of being concise in the application of the plan-do-check-act cycle.

This knowledge transfer focuses on the seven major "blocks" on the A3 form used to explain the problem and solution: theme, problem situation, target, cause analysis, countermeasures, implementation and follow-up. The beauty is how the A3 form, approximately 11-by-17 inches, forces the user to tell the story on a single sheet of paper.

Matthews walks readers through the problem-solving process using the A3 tool to guide the process. This book is written for all management levels and should provide great insight to effective problem identification and resolution.

Bill Baker
Speed to Excellence
Santa Fe, NM

CAPA for the FDA-Regulated Industry

José Rodríquez-Pérez, ASQ Quality Press, 2011, 168 pp., $30 member, $50 list (book).

This how-to book captures the author’s extensive experience in U.S. Food and Drug Administration-regulated (FDA) industries. The chapters provide a comprehensive and integrated view of corrective and preventive action (CAPA) as it applies to drug product manufacturing, biopharmaceuticals and medical devices.

Ample references to the FDA and other regulatory guidelines are provided. An in-depth analysis of the treatment of out-of-specifications makes for interesting reading. Other topics covered are risk assessment and root cause analysis with many illustrative examples. The suggestions on how to plan and document CAPA are useful and could prove very effective for practitioners.

The is an introductory-level book. Additional domains relevant to CAPA are not covered, nor are design of experiments for root cause investigation and the general topic of quality by design. Statistical process control, Six Sigma or other improvement initiatives to eliminate chronic problems are barely mentioned.

Overall, this is a well-written, practical book I would recommend to practitioners involved in CAPA.

Ron S. Kenett
KPA Ltd.
Raanana, Israel

ISO 9001:2008 for Small and Medium-Sized Businesses

Denise E. Robitaille, ASQ Quality Press, 2011, 152 pp., $30 member, $50 list (book, second edition).

Finally, someone has put together a book on ISO 9001:2008 that gets back to the basics of the standard. While this book is titled for small and medium-sized businesses, most companies could benefit from it.

Given that, most professionals reading the book will think, "I already know the basics. Why do I need to go back to them?" Because the basics in this book make perfect sense, and what companies need is to get back to the basics.

Robitaille is distinguished in her own right, serving as the vice chair of U.S. Technical Advisory Group to ISO/TC 176, the entity responsible for updating the ISO 9000 family of standards. The book includes chapters that discuss:

  • The International Organization for Standardization.
  • An overview of the standard.
  • Each section of the standard.

But this is where the similarity to other books on ISO 9001 ends. The author uses simple and practical language to explain the intent of the standard not seen in other books. She starts with a review of the eight quality management principles the ISO 9001:2008 standard is built on and how they need to be incorporated into companies’ quality management systems.

The other important concept she incorporates is ISO 9000:2005—Quality management systems—Fundamentals and vocabulary, which she refers to often for definitions of words that are forgotten even by quality professionals.

This book is valuable for small and medium-sized companies, as well as those companies that need to get back to the basics with their quality management systems.

Wayne Sander
Dove Quality Consulting
Dousman, WI

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