Semi-Markov Processes: Applications in System Reliability and Maintenance

Franciszek Grabski, Elsevier, 2015, 270 pp., $150 (book).
This is a comprehensive and rigorous research text focusing on continuous time semi-Markov processes (SMP)with a discrete set of states. After a mathematical and statistical introduction to discrete Markov processes and semi-Markov processes, the author expands and generalizes into important cases of these models. Advanced methods are presented with clear applications to quality processes—making this text a good reference for statistical quality professionals.

The first six chapters cover the concepts and equations of SMPs necessary to introduce more advanced models, specifically in the area of reliability and maintenance. These chapters are concise and present the characteristics of SMPs to enable mathematical analyses of the models presented in later chapters.

The most interesting part of this book are the processes that have direct implications for quality-control applications such as multitask operation and failure rate. Included are numeric examples that illustrate the use of the models and descriptions of the algorithms inherent in the models. The final chapter, on semi-Markov decision processes, provides models for the optimal strategies for maintenance operations and renewal processes showing algorithms for optimization based on discrete state changes with concrete applications in industry.

I. Elaine Allen
San Francisco

Innovating Lean Six Sigma: A Strategic Guide to Deploying the World’s Most Effective Business Improvement Process

Kimberly Watson-Hemphill and Kristine Nissen Bradley, McGraw-Hill Education, 2016, 304 pp., $35 (book).
This book is down to earth and practical with many charts and graphics to hold the reader’s attention. The authors draw from their experience, using multiple industries and situations with differing expectations for needed changes as examples.

The content is divided into two parts. Part one is for organizations—in the early stages of their improvement journey—that must understand and apply the building blocks and culture to begin the transformation process.

Part two is for those already well on their way to transformation and want to work on the big problems their organization is facing. Part two was right on target—focusing on customers, culture change and strategy deployment (Hoshin planning) to align at all levels and applying lean to product and process design and redesign.

I really like the last part of chapter five, which addresses project pipeline management by referring to Little’s Law: "The amount of time it takes to complete any single project is affected by the total number of projects that are active at any point in time." For example, a basic rule of lean: minimize work in process to reduce cycle time.

This is a useful book for managers at all levels, but particularly C-suite leaders who want to lead positive change in this competitive, fast-moving world.

Bill Baker
Santa Fe, NM

The Certified Pharmaceutical GMP Professional Handbook

Mark A. Durivage, ASQ Quality Press, 2016, 516 pp., $89 member, $135 list (second edition, book).

This book is a remarkable standout by itself while also representing a significant enhancement of the first edition. This second version is not just a simple "refresh," but an overall revision of content and format. It represents current quality and regulatory thinking about pharmaceutical quality and expands the overall body of knowledge for the certified pharmaceutical good manufacturing practices professional (CPGP) exam. The book incorporates updated sources and regulatory references—domestically and internationally.

While serving as the central resource for ASQ's CPGP exam, it also can be used by industry and research to help address theoretical and practical questions regarding pharmaceutical quality, lab operations, manufacturing and related activities.

The author lists 34 contributors to this edition and he shapes their efforts into a comprehensive examination of what constitutes a safe and effective drug product.

The impact of activities—such as development, technology transfer and manufacturing—are also examined and considered in relation to the many types of drug substances, drug products and related packaging.

The book's format has changed considerably and now includes eight major parts broken into 60 chapters. The book serves as an excellent resource with research presented through a detailed list of tables and figures, acronyms and abbreviations, a preface, acknowledgements, four appendixes, a glossary, a comprehensive list of references and suggested readings and then it closes with an index.

The detail and logic of this organization allows the reader to understand many technicalities in a flawless fashion, while covering a significant number of details, suggestions and potential problems.

The book is easy to read and follow. Most everyone will find something valuable in the writing because it is a useful and valuable tool for every level of experience.

Frank Pokrop
San Diego

The Art of Integrating Strategic Planning, Process Metrics, Risk Management and Auditing

Janet B. Smith, ASQ Quality Press, 2016, 216 pp., $36 member, $60 (book and

Between the covers of this book, there is a course. The course represented by this book is organized into five parts: strategic planning, process metrics and risk mitigation, root causes, auditing, and beyond compliance and sustainability.

The book has 18 chapters with tools and templates, plus a CD-ROM with document files. There is also a chapter offered as a workshop in which tools and procedures explored in the book can be put into practice.

With the threepage glossary and references list, Smith’s book can be shelved with the high-value reference collection.

As a resource tool, the book is focused on outcomes and results—based on knowledge and insights of happenings while the processes building results take place. Though failure is referenced, emphasis is on successes, improvements and systems delivering predictable results.

This book is a recommended resource for those in the broad, quality field including government services, education, healthcare and fields beyond manufacturing.

Part seven of the book presents workshops, or practice exercises, on basic quality and lean tools. These workshops are thinking and activity-based and may be used as a resource for a single reader or a study team—possibly a team of students in a course or training program. The workshops are interesting and provide further understanding and insight for readers.

As a resource for leaders tasked with delivering quality results, Smith’s book is on the recommended list. The book also is a resource for the practitioner on the production line, as well as the program developer, manager and the assessor of results.

Two resources in the book may be of value in the broad field of quality. First are examples of quality processes and resources presented in the list of examples appearing as a section in the table of contents. Second, the book itself is an idea-rich resource for those needing examples of how to present a complex topic. It is full of graphics, reference tables, charts and tools for users. This book is a reliable tool for experienced persons in the field, as well as others new to the field.

Gerald Brong
Ellensburg, WA

I really appreciate the review on my book: The Art of Integrating Strategic Planning, Process Metrics, Risk Management and Auditing".
The concepts and models in this book are in actual implementation in my workplace (ProTrans) with full support from our management and buy-in from our process owners.
--Janet B. Smith, 02-03-2017

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