Quality Risk Management in the FDA-Regulated Industry

José Rodríguez-Pérez, ASQ Quality Press, 2017, 368 pp., $35 member, $58 list (second edition, book).

The purpose of this book is to provide an updated view of the risk management field as applied to medical products. The book also includes some discussion of medical devices and food products and their respective risk management needs. The book provides Food and Drug Administration-regulated (FDA) manufacturers with a framework in which experience, insight and judgment can be applied to manage risks associated with their products. Others can use this book as a guide in developing an appropriate risk management system.

Risk management refers to the architecture for managing risks effectively. Organizations manage risk by identifying it, analyzing it, and evaluating whether the risk should or may be modified to satisfy allowable risk criteria. Risk management is not a one-time task. It is a continuous, never-ending effort that should focus on multiple organizational aspects. Effective risk management facilitates better and more-informed decisions. It assures the ability to deal with potential adverse possibilities.

The author provides a thorough discussion of tools typically used to assess risk and subsequently mitigate it to an acceptable level. He also identifies and broadly reviews relevant FDA regulations and related standards where risk management plays a prominent role. Many excellent illustrations and charts help summarize and clarify the topic. The appendixes provide examples, case studies, useful websites and more in-depth coverage of several concepts.

I found this book to be a good upper-level overview of what is needed to successfully participate in the current FDA arena. It will be useful to anyone addressing risk management, but it is most applicable to FDA-regulated areas.

Marc A. Feldman

Extreme Teams: Why Pixar, Netflix, AirBNB, and Other Cutting-Edge Companies Succeed Where Most Fail

Robert Bruce Shaw, Amacom, 2017, 256 pp., $27.95 (book).

Teams are judged on their results. The author emphasizes this, but also shows that relationships, culture and risk are equal partners in the success of teams. Teams should be hard and soft. By this, he means that firms will establish the culture of teams from the top and must clarify company culture attributes that are important. Team members must know what is expected, and firms must create formal and informal mechanisms to reinforce these expectations.

The examples from successful teams and how they operate are invaluable. The key starts in hiring for culture, fit and passion, along with qualifications. Firms with employees that strongly believe in the mission of the company, fit the culture, and understand the focus are more likely to feel comfortable taking risks on teams and moving the firm forward. Without this, a team is more likely to stagnate and not develop any new ideas. Discomfort fits in as being able to critique and listen to critiques of ideas without worrying about job security. There is not only one way to accomplish this, and the author’s examples of companies and their differing cultures, yet overwhelming success is both interesting and illuminating.

This is a book about successful company building, entrepreneurship and intrapreneurship as much as it is about teamwork. The author does a good job of connecting these concepts with examples from established companies like Pixar, large companies like Alibaba, and smaller, newer startups like AirBNB. An interesting book and useful for entrepreneurs and new project team leaders.

I. Elaine Allen
San Francisco

Baldrige in Plain English: Understanding Performance Excellence 2017-2018

John Vinyard, ASQ Quality Press, 2017, 160 pp., $18 member, $30 list (second edition, book).

This book focuses on explaining the principles necessary for an organization to achieve performance excellence, as well as describing the important aspects of the Baldrige award in a simple language. The author states that using Baldrige criteria for performance excellence has become common in the world, and such use is not only by manufacturers, but also by organizations in other sectors such as education, health, non-profit and government.

The book is organized by categories pertinent to performance excellence and the Baldrige criteria. The book begins with an introduction to the typical organizational environment. It discusses the importance of the mission, vision and values of the organization, along with the need to clarity the organization’s product offerings.

Each chapter in the book has a section on "Baldrige Excellence Builder Questions" relating to the main topic of that chapter. These thought-provoking questions lead to discussions in the chapter that should help the reader with implementation. A detailed glossary at the end of the book offers many terms pertaining to performance excellence and the Baldrige award.

This book is easy and interesting to read, and does not bore the reader at any given point in time. It provides practical and action-oriented suggestions, which should be helpful to the novice and experienced professional. This book is a must-read for all quality professionals and other employees that are involved in developing performance excellence in their organizations, or for those considering competing for the Baldrige award.

Rangarajan Parthasarathy
Harvard, IL

Agile and Lean Program Management: Scaling Collaboration Across the Organization

Johanna Rothman, Practical Ink, 2016, 256 pp., $44.95 (book).

Rothman presents a holistic approach and roadmap for high technology product development. This book presents an iterative and people-centric approach for software development. Teams and associates are required to think critically, problem-solve, facilitate clear communication and collaborate across the organization. Project developers learn about the dynamics of handling self-organizing teams, overlapping development phases, required multi-learning, product and process evolutions likely and the necessary organizational transfer of all the learnings across the organization. Agile and lean program management can become a reliable vehicle for introducing innovative, creative, market-driven ideas and processes for internal and external customers.

This book is right for today’s times. Organizations are discovering that it takes more than high quality, low cost and differentiation to grow and excel in today’s global competitive markets. Agile and lean management shows a new approach for managing product development with speed and flexibility. It is clear how strategy for product development can act as a change agent for all organizations.

The self-organizing character of the team produces a unique dynamic. The team begins to work as a unit when each member begins to share knowledge about the marketplace and the technical realities. When an individual’s rhythm and team’s rhythm overlap, a new pulse emerges as the driving force and moves the team forward. Employees must work together-continually planning and adapting to service customer requirements that are ever evolving. Scaling agile means scaling collaborative practices—an imperative for effective and successful collaboration in the organization.

Project managers learning and applying agile and lean will appreciate what’s most important. It is having the ability to learn and to think critically. Both are important because the challenges are filled with constant innovation and new technologies. Program managers must be curious with high drive. They will question everything—no matter their level of experience and knowledge.

Although designed originally for the software industry, this book is recommended and can be applied to many industries striving to develop new products and services for competitive advantage. It also can be used in marketing, advertising, construction, education and finance. Agile and lean program management are necessary to keep up with the ever-evolving customer expectations and stay ahead of competition. Therefore, project leaders who use agile and lean program management will have the best approach methods for project execution.

John J. Lanczycki, Jr.
West Springfield, MA

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