QP REVIEWS

Medical Device Design and Regulation

Carl T. DeMarco, ASQ Quality Press, 2011, 368 pp., $66 member, $110 list (book and CD-ROM)

This book is a comprehensive volume providing everything you need to understand medical devices. It is well organized and starts at the design and regulatory stages, moves through the regulatory system of the U.S. Federal Drug Administration (FDA) and goes further to post-approval marketing and surveillance.

The book can be used as a reference and a teaching text. DeMarco has included interesting and useful exercises at the end of each chapter. These are less on testing and are more informative.

For example, chapter four discusses clinical trials, their use for devices and the certification steps necessary in an application. The exercises following the chapter include searching the Codex website to find out the international regulations for a device—useful information that is not covered in-depth in the chapter.

While there are sections on quality and auditing of devices, and clinical and non-clinical trials for submiting a new device for approval, two chapters focus on this specifically. Chapter seven examines quality systems and current good manufacturing practice (GMP) guidelines. After approval, the FDA can, and often will, inspect manufacturing plants for new medical devices to ensure compliance with GMPs and to enforce this with warning letters or decertifying the facility. Chapter eight, the final chapter, covers all this information in-depth. The author wisely doesn’t try to cover all the statistical methods for designing, testing and evaluating medical devices, which probably would have doubled the book’s size.

Also included are extensive appendixes with websites, references and a wonderful lexicon of all the abbreviations used in the book and by regulatory agencies. A CD-ROM is supplied with supplementary reference material.  

I. Elaine Allen
Babson College
Wellesley, MA

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Insights to Performance Excellence 2011-2012

Mark L. Blazey, ASQ Quality Press, 2011, 384 pp., $56 member, $92 list (book and CD-ROM).

As America’s highest recognition for quality, the Malcolm Baldrige National Quality Award sets high standards. Reaching such lofty levels of performance can be a long and daunting challenge for any organization. Blazey has written a clear and approachable text on the Baldrige award and how to use the criteria to achieve organizational performance excellence.

The book represents far more than just a how-to reference manual on the Baldrige award criteria. The Baldrige framework is well developed; however, translating the criteria into actionable items and honestly evaluating your systems is not easy. This book clearly translates the criteria language, the requirements and provides help in getting started, best practices, implementation and assessments.

Because the criteria are constantly evolving, this edition also addresses criteria changes for 2011-2012. An accompanying CD-ROM references the 2011-2012 changes and provides additional information and tools.

The Baldrige criteria apply to every organization regardless of size or interest in receiving the award. Blazey has compiled a well organized and salient compendium of organizational assessment knowledge that will help organizations improve performance. This is the book’s greatest value.

If you’re planning to go for the Baldrige gold, this is your book. But even if you’re not, this is a good manual on how to improve your organization.

James Kotterman
Michigan Manufacturing
Technology Center
Plymouth, MI

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101 Project Management Problems and How to Solve Them

Tom Kendrick, Amacom, 2010, 272 pp., $19.95 (book).

A project manager can be faced with an infinite number of issues even while working on a small project. Managing project challenges, as well as surviving in today’s world, requires skill, experience and the willingness to listen to other people. This book offers lessons and tips in avoiding issues, problems, overruns, delays and personnel matters. Kendrick offers his own experience and lessons learned in every chapter.

The primary and unexpected feature is the author’s focus on people and human resources. He discusses employees throughout the book; he treats them carefully and with respect and offers tips on motivation, communication and listening skills, and ultimately covers monitoring and performance.

The book is well written. It’s direct and formatted similarly to areas of the project management body of knowledge. Sections open with a project-related question. This additional framing of a question adds a quick way for the reader to gauge how to use the author’s insights and whether to use his advice.

This book is nicely written and unwavering in its focus. Readers will find it to be a useful tool to keep around for a long time.

Frank Pokrop
Carefusion
San Diego

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Quality Function Deployment and Lean Six Sigma Applications in Public Health

Grace L. Duffy, John W. Moran and William J. Riley, ASQ Quality Press, 2010, 195 pp., $38 member, $63 list (book).

The purpose of this book is to introduce quality function deployment (QFD) and lean Six Sigma (LSS) methods to public health professionals so that they can implement quality improvements within their own agencies. The authors have modified the methods so they are aligned with the needs in the public health sector.

Using QFD is a way to translate customer requirements into appropriate features at each development stage. The aim is to ensure that the voice of the customer is fully understood and incorporated throughout the design and development of a product or service. LSS is a natural partner to QFD.

The concepts are illustrated at different levels:

• Macro: Addresses the strategic integration of long-term approaches to meet overall priority outcomes.
• Meso: Contains planning and deployment of programs that translate the strategic vision into specific programs and departments.
• Micro: Encompasses the health department projects and programs instituted at the functional unit level.
• Individual: Uses tools that support the specific task.

Overall, I really like this book, even though it does contain a mistake. For example, the description of the Kano model is not good.

This is a structured and balanced book written on a suitable level and is motivating and inspiring. There are also many examples and illustrations from the public health sector supporting the discussion.

Bengt Klefsjö
Luleå University of Technology
Sweden

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Recent Releases

Lean Management Principles for Information Technology, Series on Resource Management
Gerhard J. Plenert, CRC Press, 2011, 368 pp., $79.95 (book).

A Career in Statistics
Gerald J. Hahn and Necip Doganaksoy, Wiley, 2011, 360 pp., $69.95 (book).