2020

FOOTNOTES

Human Error Reduction in Manufacturing

José Rodríguez-Pérez, Quality Press, 2018, 249 pp., $45 member, $75 list (book).

Rodríguez-Pérez is an excellent writer and presents experience-based topics clearly and concisely. The title, however, is slightly misleading because most examples in the book are from the U.S. Food and Drug Administration (FDA)-regulated industry. Even though many of the topics treated in the book can be generalized across industries beyond pharmaceutical, manufacturing shouldn’t be interpreted in the wide sense.

The book chapters provide a comprehensive and integrated view of the treatment of human errors in the pharmaceutical manufacturing environment. Ample references to FDA and other regulatory guidelines are provided, including a list of useful links to relevant webpages. To be even more useful, such a list should be made available on the book’s website.

The author states in the preface that, “Human errors continue to be an epidemic for regulated companies.” Throughout the book’s 10 chapters, he covers what might be labeled classical approaches to human error monitoring and reduction, including risk assessment, root cause analysis (RCA), human error classifications and investigation procedures, and approaches to reduce the probability of human errors.

Given the pervasive condition of human errors, other directions beyond the classical approaches deserve consideration. Specifically, two directions come to mind:

  1. Data-driven approaches. This is barely mentioned in the book. With today’s ubiquitous technology, such as wearable sensors and image tracking systems, many improvements in human error prevention should be achieved. Interested readers should consult other books that cover such aspects.
  2.  
  3. Causality analysis. A more in-depth analysis of RCA related to human errors should involve causality models, such as causality networks and counterfactuals. This is not addressed in the book, either.

However, these two directions could be considered more advanced. With this perspective, the book can be considered a foundation representing current practice.

Overall, this is a well-written practical book that I would recommend as background to practitioners involved in human error monitoring and reduction.

Ron S. Kenett,
Raanana, Israel


Lead Self First Before Leading Others: A Life Planning Resource

Stephen K. Hacker and Marvin Washington, Business Expert Press, 2018, 114 pp., $34.95 (book).

This is an excellent book for reflection on the reader’s self-awareness of his or her leadership style and provides a guide on how to form a life plan that applies to professionals at any level.

The authors expand on IQ and emotional quotient, which are routinely used to reference business and leadership abilities, and introduce spiritual intelligence (SQ). They define SQ not as pertaining to religion, but to a self-awareness of living with a purpose and vision, and an alertness to larger patterns and connections. The book explains why readers should be self-aware and purposeful, and why having their visions and values documented with their life plans is key to leading themselves.

Each chapter contains a section from a master coach who gives his or her insights and guidance on the chapter’s topic. The end of each chapter also contains a workout section with open-ended, challenging self-reflection questions indented to make readers look inward on the chapter’s topic and guide themselves.

The second half of the book is a guide to help readers develop their own life plans. The guide starts with the reader’s personal self-reflection on what his or her big picture is and drills down to actionable plans that can keep the reader on track to leading his or herself.

Overall, this is an excellent read for personal leadership self-reflection.

Conor Leahy
San Diego, CA


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