2019

FOOTNOTES

A Practical Field Guide for ISO 9001:2015

Erik V. Myhrberg, ASQ Quality Press, 2016, 170 pp., $40 member, $70 list (book).

This practical field guide is an excellent resource as businesses and organizations transition from ISO 9001:2008 to ISO 9001:2015. ISO 9001:2015 is a major revision to the standard and will replace ISO 9001:2008, requiring complete transition before September 2018. It is recommended for management, trainers and implementing engineers.

ISO 9001:2015 is organized into 10 sections. Sections 1 to 3 give context to the document. The actionable sections 4-10 (by subclause) are covered by Myhrberg’s book. At the end of this guide, you will find: ISO 9001:2015 documented information requirements by section, a ISO 9001:2015 to ISO 9001:2008 correlation matrix, a ISO 9001:2008 to ISO 9001:2015 correlation matrix and his sources of information. Rigorous detail is applied to all the sub-clauses from sections 4-10.

Using this guide, organizations will focus on a process systems approach. They will determine the processes needed for the effective implementation of their quality management system (QMS). The organization’s analysis of the processes shall be the driving force for defining the amount of documented information needed for the QMS. ISO 9001 always has required a documented QMS and not a system of documents.

The standard leads to a QMS driving preventive action. This book will help to ensure that an organization has addressed the total ISO 9001:2015 standard.

John J. Lanczycki Jr.
West Springfield, MA


Practical Design of Experiments: A Guide for Optimizing Designs and Processes

Mark Allen Durivage, ASQ Quality Press, 2016, 204 pp., $42 member, $70 list (book).

Design of Experiments (DoE) is a powerful tool for process improvement and optimization. This book provides a great introduction and practical guidelines to implementing DoE in any process environment. The author’s intent is to provide an introduction to the various tools and techniques of DoE. In this book, the author provides basic statistical theory, procedure guidelines, assumptions and limitations, as well as detailed examples.

The book is well written and sequenced in a logical progression. For those new to DoE, the book starts with a detailed chapter introducing the concepts of DoE. The next chapter provides an introduction to basic statistic tools and techniques of DoE. The book progresses from simple to more complex DoE methods including analysis of variance (ANOVA), two factors, three factors, qualitative response, screening and larger factor designs, Taguchi designs and mixture designs. The book's last chapters offer procedural considerations and useful points on applying the book, as well as further reading. Each DoE method chapter provides case studies including data, analysis and conclusions reached from the analysis. The book includes multiple appendixes, a glossary, a bibliography and an index which make it an excellent reference text.

The DoE methods included in this title provide a solid introduction to the subject matter and is a great launching point to more detailed learning. This book would be an excellent resource to anyone engaged in process or product improvement and problem solving. It also would make an excellent text in any educational or training environment where DoE and problem solving are the core subject areas.

Bryan Ruggles
New Orleans


Back to Basics: A Practitioner’s Guide to Operational Excellence

Douglas Sutton, Operations Excellence Services LLC, 2012, 172 pp., $14.99 (book).

This book is a great quick reference for all levels of quality professionals. Sutton does an excellent job covering the main topics of operational excellence. The topics covered include customers, people, leadership, accountability and continuous improvement. Though not a deep dive into each topic, the book includes great best practices. Each chapter features pointers, full-color graphics to emphasize points and a quick synopsis at the end for easy reference.

Additionally, this book offers real-life examples of four companies in different industries to show how these principles can be universally applied. The case studies included feature manufacturing, baking, financial processing and technical reporting industries. The book shows how similar processes for obtaining solutions can be used across different industries.

The book keeps true to its title of returning to the basic principles of operational excellence. It does an excellent job showing that mastery of the basics will result in success in an organization. It is a great resource that will be useful for all levels.

Conor Leahy
San Diego


Proactive Supplier Management in the Medical Device Industry

James B. Shore and John A. Freije, ASQ Quality Press, 2016, 144 pp.,
$60 member, $99 list (book).

Supplier management is important to ensure that every component and service meets all quality requirements. This is all the more important in the highly regulated medical device industry in which investigators from the Food and Drug Administration (FDA) tend to regularly audit organizations and issue Form 483 observations for noncompliance. This book provides a comprehensive overview of supplier management in the medical device industry. This book aims to show readers a process of effectively selecting, evaluating and implementing applicable controls based on the evaluation and ongoing proactive management of suppliers, consultants and contractors in a state of compliance.

The book is organized into seven chapters. The first chapter provides an introduction into the importance of controls, and the FDA and International Organization for Standardization regulations pertaining to the controls. There is an informative discussion on the FDA enforcement trends specific to supplier controls and the importance of establishing an effective purchasing controls process. The second chapter delves deep into the planning phase, with useful tips on who to include in the planning phase, how to plan with respect to the project charter and quality requirements, and how to establish objective evidence.

The third chapter emphasizes supplier selection. It discusses the use of total risk factor approach to compare suppliers and the importance of flexibility in the process to meet changing needs. Control plans that adhere to FDA requirements and supplier performance criteria are discussed. Chapter four covers the best way to perform supplier evaluations.

The fifth chapter deals with establishing and maintaining controls. The authors highlight that implementing controls at the facility by means of inspection activities can be done in different ways. They contend that the cost of quality should be a good gage to measure where the controls have been implemented, as well as a potential leverage for risk and cost reduction. The sixth chapter examines control with respect to contractual agreements and obligations. Supplier quality agreements are discussed; the authors stress that depending on the risk associated with a given product or service, the FDA looks for detailed quality agreements. The last chapter in the book features a process to determine whether to consolidate suppliers for business or performance reasons.

The book has been written in a simple and easy-to-follow manner with the use of appropriate icons for FDA quality system regulation requirements, tools that help the reader understand and achieve the requirement, and lessons from the road. A CD included with the book contains extremely useful information, such as the FDA preamble to 21CFR820, FDA compliance program guidance manual excerpts, a self-assessment tool, a supplier survey example, quality audit information and an example of a supplier change notification form.

This book should serve as a valuable resource for those working in the healthcare industry to implement and improve supplier management. In addition, it also will serve as study material for those taking ASQ certification exams, especially the newly introduced certified supplier quality professional exam.

Anuradha Rangarajan
Harvard, IL


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