How to Audit ISO 9001:2015: A Handbook for Auditors

Chad Kymal, ASQ Quality Press, 2016, 156 pp., $36 member, $60 list (book).

This book is intended to help auditors understand the ISO 9001:2015 standard and successfully perform audits to this standard. It integrates two different types of audit strategies—conformance audits and performance audits—into one integrated approach: process audits.

The book is organized into four chapters. The first chapter is extremely useful because it provides a detailed explanation of various aspects of the ISO 9001:2015 standard and where appropriate, relates it to the older versions of the standard to clearly bring out what has changed in the newer standard. It discusses the requirements of the newer standard from the perspective of becoming process focused.

In the second chapter, the auditing strategy for ISO 9001:2015 is discussed. The topics covered include document review or a documented information review and audit planning, details of conducting an audit, audit trails and audit approach, and a detailed discussion on conducting a process performance audit. Examples of forms such as the risk sampling sheet, quality objectives sampling sheet, and the process analysis worksheet enable the reader to translate the theory into action items immediately.

The third chapter dives deeper into conducting a stage one audit for ISO 9001:2015. The minimum requirements for a stage one audit, which include document review, performance analysis, audit plan, feasibility review and process analysis, are discussed in detail. The sequences and interactions with the process are discussed. Chapter four discusses on-site audits. There are relevant discussions pertaining to the auditing of remote supporting functions, opening and closing meetings, conducting facility tours and auditing organizational processes. There is a section that covers how to evaluate root cause analysis and systemic corrective actions.

The book contains several appendixes with useful information such as an introduction to the process focus, writing the assessment report for stage one, and writing the confidential assessment report for stage two. The author uses pictorial representations—such as diagrams, process maps, flow diagrams, sampling sheets and examples of forms throughout the book—to help the reader understand the concepts from various perspectives. This is a useful feature of the book because these forms can be photocopied and used as templates to perform audits, which can simplify the auditing process and reduce workload.

Considering the book's features, it is no exaggeration to say that this is a must-read for all newcomers to the auditing profession. It will also serve as a valuable resource for ASQ certification exams.

Rangarajan Parthasarathy
Harvard, IL

The ISO 14001:2015 Implementation Handbook: Using the Process Approach to Build an Environmental Management System

Milton P. Dentch, ASQ Quality Press, 2016, 132 pp., $30 member, $50 list (book and CD-ROM).  

This book provides guidance in building an organization's environmental management system (EMS) and linking the EMS to the requirements of the new version of ISO 14001 to support third-party certification. Included in the text are best practices and common pitfalls that the author has encountered when auditing various organizations.

For organizations with an EMS certified to ISO 14001:2004, the book highlights and explains what is needed to satisfy ISO 14001:2015. Included in the book is also a CD-ROM with comprehensive check sheets to be used when auditing an EMS's conformance to ISO 14001:2015.

As a whole, I really like this book. It is well structured, easy to read, contains ​​many helpful real-life examples and a lot of hints to support the creation of a supporting EMS. The book also discusses how an organization can use the EMS to control and improve its environmental performance.

Bengt Klefsjö

Handbook of Investigation and Effective CAPA Systems

José Rodríguez-Pérez, ASQ Quality Press, 2016, 234 pp., $37 member, $61 list (book).

This book simply explains the importance of root cause analysis in the implementation of an effective corrective and preventive action (CAPA) system. The first chapter starts with a definition of a quality system and the importance of a strong quality management system (QMS).

The concepts and definitions of a CAPA system are introduced effectively throughout this chapter. The author attempted to clarify most common misinterpretations that exist in various regulated industries. The entire book is written in simple language that can be understood by anyone related to QMS.

The author quickly moves to explain investigation and CAPA requirements for life sciences-regulated industries and ISO 9001:2015. The processes involved from problem detection to effectiveness check are described sequentially in chapter four with a strong emphasis on risk assessment score matrix and trend analysis. CAPA planning and management of corrective actions are summarized effectively, and the templates can be directly used for any industry’s QMS.

One of my favorite chapters in the book is chapter five: "Human Error Investigation and Reduction." The main focus of this chapter is the human side of quality and manufacturing errors. The psychology behind different human errors and classification of these errors gives the readers a fresh perspective on combating human factors in implementation of quality systems.

The rest of the book is loaded with different effective CAPA system procedures, forms and checklists that can be used in any regulated industry. The book also explains curriculum to develop an internal investigation and CAPA expert certification program. The CAPA plans taken from real world examples provide insight into effective implementation of CAPA systems in various industries.

The author succeeded in providing comprehensive information to understand and improve CAPA systems. I recommend this book to anyone interested in root cause analysis and learning to implement effective CAPA systems in regulated industries.

Suresh Anaganti
Palmyra, PA

Card-Based Control Systems for a Lean Work Design: The Fundamentals of Kanban, ConWIP, POLCA, and COBACABANA

Matthias Thurer, Mark Stevenson and Charles Protzman, Productivity Press, 2016, 210 pp., $39.95 (book).

Efficient and effective flow of products in a manufacturing setting to ensure the correct quantity of quality products reaches the customer on time while maintaining an optimum level of inventory has been the main challenge facing operations management in an organization seeking just-in-time and lean manufacturing. This book provides a detailed description of several types of card-based control systems, their benefits, disadvantages, and guidance in selecting and applying the most effective system or systems.               

The book is structured in a way that the types of production control problems experienced in a typical manufacturing setting are identified first, followed by problem diagnosis. The first part of the book covers the basic relevant concepts of card-based control systems. Midway through the book details the three more commonly known card-based control systems and their applicability: kanban, constant work in process (conWIP) and paired-cell overlapping loops of cards with authorization (POLCA).

Chapters eight and nine cover a lesser known and more recently developed control of balance by card-based navigation (COBACABANA) system, which is most suitable for the high variability in routing and processing times seen in high-variety job shop settings. Chapter 10 and the appendix provide useful guidance on selecting the appropriate card-based control systems and their differences. 

The need for and use of card-based control systems have been recognized and realized during recent decades. This book provides valuable information to those who are new to the concept, planning to implement one of the systems, or are unsatisfied with the results of the systems they have implemented.  

Herzl Marouni

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