The Certified Quality Engineer Handbook

Sarah E. Burke and Rachel T. Silvestrini, ASQ Quality Press, 2017, 684 pp., $99 member, $145 list (fourth edition, book).

This book is not necessarily a study guide for the certified quality engineer (CQE) exam because it jumps right into the tools a practicing CQE would use on the job. There is a well-designed and usable structure to the book, providing examples of each tool described. For readers somewhat unfamiliar with quality, there is a thorough explanation of the main concepts, in addition to several pages of acronyms and a glossary.

A common theme throughout the text is that listening to the customer is the most important part of a CQE’s role. A CQE plans for teams to perform the work required to make a product to the level or specificity of quality expected by the customer. It stresses the importance of communication, planning and teamwork throughout the product life cycle. If any of these three critical elements is absent from the process, the product may miss expectations.

The text elaborates on the different facets of the quality profession, including the ISO 9000 family of standards and the opportunities presented by each piece of that family. It goes into enough detail to explain those facets, but leaves the reader to determine which standard (or standards) are right for his or her organization. If a CQE wants to pursue ISO 9001 certification for an organization, a planning outline is provided.

The most striking part of the book is the focus on maintenance, sustainability and continuous improvement. Even though a product can be engineered to perfectly meet customer expectations, a CQE should anticipate how the product could be flawed. It might be good enough for the customer, but there’s at a chance that the customer may be disappointed.

Managing quality, dealing with constraints and implementing process control mechanisms all play a part in a CQE’s consideration of quality. The biggest impact a CQE can have on a process is ensuring or maintaining a healthy level of dissatisfaction: not enough to completely reengineer the process, but enough to keep the team innovating toward a higher level of quality. This book is an excellent reference tool for communicating and executing the themes and details of the quality profession from the perspective of the practitioner.

Trevor Jordan
Winter Springs, FL

The Biomedical Quality Auditor Handbook

ASQ Biomedical Division, edited by Heather Crawford, ASQ Quality Press, 2017, 360 pp., $89 member, $135 list (third edition, book).

Heather Crawford and the other 12 contributors have assembled a must-have reference for those working with medical devices. In this third edition, readers will find a unique and comprehensive approach to the following topics: fundamentals, practices and how to conduct an audit, U.S. Food and Drug Administration regulations, European regulations, a review of supporting technical knowledge in the form of standards and device-related topics, and an overview of quality tools and techniques.

These topics are supported by text from the official regulations, and each section is followed by commentary and insights from the various contributors. This last section is unique and helpful because comments are drawn from a substantial amount of industry experience. The contributors identify specifics, peculiarities and items to address with each regulation.

The book is structured into five parts and includes a list of figures, a preface, acknowledgments, three appendixes, extensive endnotes and an index. It also contains 19 tables and figures that supplement the text and commentary.

Published in 2017, it can serve anyone working in the field ranging from a novice through an experienced individual. It should be used as a reference for basic courses as well as courses covering the auditing of medical device facilities and activities.

While I am looking forward to a future edition that covers the recent European issuance of new regulations, this text is well written, balanced and thorough in scope, content and presentation. It’s rare to find such a handy reference, and use of the book should be encouraged.

Frank Pokrop
Carlsbad, CA

Lean Six Sigma for Hospitals: Improving Patient Safety, Patient Flow and the Bottom Line

Jay Arthur, McGraw Hill Education, 2016, 400 pp., $50 (second edition, book).

This book is about how lean Six Sigma (LSS) can be used to simplify systems and processes leading to consistent performance with improvement to patient safety, patient flow and the bottom line. A broad range of topics are covered in the book, including LSS for hospitals, emergency departments (ED) and operating rooms (OR), order and claims accuracy, data mining and analysis, process flow charts and control charts, billing and collection issues, and planning and implementation aspects.

The book is organized into 14 chapters. The beginning includes how to accelerate the patient’s experience of healthcare by developing a faster ED, OR, lab, nursing unit and hospital in general. A case study involving the Virginia Mason Medical Center is discussed.

In chapters three and five, the author discusses simple steps to a better, cheaper and more profitable hospital. Chapters four and six describe the application of Six Sigma principles to hospitals and reduction of defects with Six Sigma. In chapter seven, Excel-based tools for Six Sigma, data collection and analysis are covered. Chapter eight discusses how to identify whether the data point to any improvement projects. Chapters nine and 12 feature sustaining improvement and change management respectively. Chapters 11 and 14 focus on LSS, and discusses specific statistical tools and implementation of LSS in hospitals. Chapter 10 features process innovation along with a Mayo Clinic case study in innovation. Chapter 13 explains the theory of constraints and applications to the healthcare setting.

There are many thought-provoking discussions throughout the book related to the current U.S. healthcare system, ideas for improving the healthcare system, and application of lean and Six Sigma principles. This book is a must-have for every healthcare professional and hospital administrator. Additionally, lean and Six Sigma practitioners will want to read this book to increase their breadth of knowledge.

Rangarajan Parthasarathy
Harvard, IL

Practical Leadership Skills for Safety Professionals and Project Engineers

Gary L. Winn, CRC Press, 2016, 362 pp., $93.95 (book).

Management was the theme of yesterday; leadership is the focus of tomorrow. Leadership is a soft skill not usually taught in most academic curricula, but it can be learned. This book explores the common-sense aspects of what makes an effective leader.

The book is structured into four units: choosing personal development, understanding leadership, applying leadership fundamentals and fine-tuning leadership applications. Each unit is filled with topics contributing to development along the "path to leadership" in the order typically encountered by young professionals.

Some readers may be bothered by the heavy comparisons to the military, but few professions experience similar challenges in the proper execution of their jobs. The coverage is broad—but detailed—and includes many often-disregarded aspects of early career building, such as work culture and ethics, gender issues, toxic leaders or coworkers, stress, travel, unengaged or uncooperative management, peculiarities of the millennial workforce and professionalism. The result will hopefully be a functioning practitioner who was not taught what to think, but how to think and act decisively—and correctly.

There are many references to original sources for further study. The bibliography and index are complete. If you are entrusted with developing young talent, you need this book on your bookshelf for reference. Make sure HR reads and heeds this book—your job will be much easier.

Marc A. Feldman

Having a review of relevant, current books is a huge benefit for ASQ members and QP readers.
My colleague and I have recently published a book which might be of interest to ASQ members - "Agile Methods for Safety-Critical Systems: a Primer Using Medical Device Examples". Would it be possible to get this book reviewed in an issue of Quality Progress?
Thanks very much
--Brian Shoemaker, 06-17-2018

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