The ASQ Pocket Guide for the Certified Six Sigma Black Belt

T.M. Kubiak, ASQ Quality Press, 2013, 300 pp., $17 member, $29 list (book).

As the author states in his preface, this pocket guide is designed to address specific topics that are—in his experience—commonly problematic for most Black Belts. It assumes the reader has the necessary background and training in lean Six Sigma, is already certified and has access to certain resources. It is not a "tool" guide, nor a test study prep book. That being said, it is a handy reference for a lot of advanced topics.

Key tools for Six Sigma and lean are summarized and discussed. The tools are emphasized with advice on selecting the proper project methods for the situation.

Softer skills such as communicating, coaching, mentoring, engagement and time management are also included. The totality is meant to foster effective, efficient team and project management. The chapters are independent and do not rely on one another.

The book does pack a lot of information into the small space it takes up. Included are an excellent glossary of common Japanese terms used in Six Sigma, a solid bibliography and a useful index.

This book is extremely helpful with lots of illustrations and flow charts accompanied by side-by-side comparisons. It also includes decision points illustrating how failure at that point can add phases to project or send it backward.

While I’m generally not a fan of pocket guides, I did find this one worth having on my shelf for quick reference.

Marc A. Feldman

The Project Management Tool Kit: 100 Tips and Techniques for Getting the Job Done Right

Tom Kendrick, PMP, Amacom, 2013, 288 pp., $19.95 (third edition, book).

Whether you are just getting into project management or are a seasoned manager, this book will guide you through to project success. The structure of the book is what sets it apart from anything else. The 100 tips and techniques are easily defined and explained. For the beginner, the details offer guidance. As a project manager, the book becomes a reference.

The section header for each of the tips becomes more of a checklist to ensure that each of the checkpoints for that activity is met.

Another great feature of the book is that it has two tables of contents. The first is in numerical order as the tips and techniques are written in the book.

The second table of contents organizes the tips and techniques into categories focusing on specific processes such as quality, communication, human resources, procurement and stakeholder management. These categories help direct attention to specific areas of the project.

This book will absolutely add value for anyone executing projects, whether it teaches a new team member or guides a project leader. It is a must-have for any person involved with any project.

Conor Leahy
San Diego

Mastering and Managing the FDA Maze: Medical Device Overview

Gordon Harnack, ASQ Quality Press, 2014, 484 pp., $69 member, $105 list (second edition, book).

Designed for manufacturing, production and storage, this is a thorough reference manual on the requirements for reporting information and analysis to the Food and Drug Administration (FDA). It also examines audit procedures and documentation if ever audited by the FDA.

The chapters begin with a discussion of FDA requirements for medical devices and then cover all types of control mechanisms needed for approval and auditing. Chapter 1 includes a figure showing the oversight of medical devices at the FDA, including the offices that provide oversight to begin the discussion of where to submit and how to submit regulatory information.

The book is very specific to the FDA process and includes details on all forms required and what parts of the Code of Federal Regulations apply specifically to medical device manufacturers. For any new medical device company, this information is invaluable. A specific list of all references to the FDA documents follows the text.

An index includes a listing of all forms by number and the function of the form with a reference to the text description. A glossary of terms pertaining to medical devices and FDA regulations is also included along with a list of frequently used acronyms related to the FDA, to medical devices and to specific quality concepts.

This is a comprehensive volume designed for regulatory professionals and others who need a reference tool and guidebook on the FDA’s policies and procedures for medical devices.

If the author decides to create a third edition, some detailed examples of submissions, approvals and results of audits would make the book more hands-on for all readers.

I. Elaine Allen
University of California
San Francisco

Continuous Permanent Improvement

Arun Hariharan, ASQ Quality Press, 2014, 256 pp., $21 member, $35 list (book).

Companies like Toyota—due to its leadership and quality it has been able to achieve—are living examples of the power of continuous permanent improvement. This book is intended to share experiences and results of organizations that have achieved and sustained substantial business excellence results by focusing on continuous permanent improvements.

Many of the lessons learned are taken from the author’s nearly three decades of working with different companies and businesses.

With senior leaders in mind, the book includes improvement methods and tools such as lean, Six Sigma, root cause analysis, excellence models and suggestion schemes. They are explained effectively, in a simple language and using real world examples.

However, the book is not intended to be a detailed manual on specific tools and techniques. The focus is more motivational and supportive, featuring many convincing examples from real or fictional discussions and meetings. The book also covers challenges related to mindsets and other change management aspects leaders typically grapple with.

The target audience for this book is business, functional and quality leaders. Top managers also should read this book because, in many cases, they are in need of quality leadership training.

Bengt Klefsjö
Luleå University of Technology

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