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ASQ: Handbook of Investigation and Effective CAPA Systems, Second Edition

Handbook of Investigation and Effective CAPA Systems, Second Edition

José Rodríguez-Pérez


234 pages, Published 2016

Dimensions: 6 x 9

ISBN: 978-0-87389-926-0

Item Number: H1504

Member Price: $37.00

List Price: $61.00

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  • CAPA
  • quality system
  • FDA
  • medical devices


Understanding and improving the CAPA system as a whole is the focal point of this book, the only of its kind dealing exclusively with this critical system within highly regulated industries.
Features include:

  • Information about the importance of the CAPA system within the quality system for the medical products regulated industry.
  • Fully updated with current versions of regulations (U.S. FDA,
    EU, ISO 13485, and so on), and a new section covers the regulatory expectation of customer complaint investigations.
  • Investigation and CAPA elements of the 2015 revision of the ISO 9001 standard.
  • New coverage on the investigation plan and the new U.S. FDA quality metric guidance, as well as a section discussing the tight relationship between CAPAs and FMEA.
  • A new chapter fully devoted to human errors and human factors, and their impact in the investigation and CAPA system.
  • Discussion of a dozen of the most common pitfalls commonly
    encountered in the investigation and CAPA world of regulated companies.
  • An example of an investigation and CAPA expert certification program being used for many companies.
  • Forms and examples of the different elements (investigation report, root causes checklist, human error investigation,
    CAPA plan, and so on) covered in the book. Fully usable forms are also included in the companion CD in Microsoft Word format.

While the first edition of this book was aimed solely at the FDA-regulated industry, the title of this second edition reflects the importance of the investigation/root cause analysis stage as the necessary preceding step of any effective corrective and preventive action system. Investigation and CAPA are concepts used in many sectors besides the FDA-regulated industry, such as: automotive, electronics, aerospace, telecommunications, process industry, and many more. This book will become an essential reference for those in these other industries.

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Benchmarking – ASQ™ TV

Today, we’ll learn the basics of benchmarking, review the recommended six phases of a successful benchmarking process, and finally, we’ll get reacquainted with one vital ingredient in benchmarking: metrics.

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Ask the Experts: Standard vs. Specification and Guidance Documents

Standards, specifications, guidance, and research

Q: What is the difference between a standard and a specification?

A: There is no single or simple answer to your question. The answer depends upon the context of the question. Relative to the ANSI/ISO/ASQ Q9000 Series: Quality management standards, I direct you to ANSI/ISO/ASQ Q9000:2005 Quality management systems – Fundamentals and vocabulary.

ISO 9000:2005 defines specification as a document that states requirements. A specification can be related to activities (e.g. procedure document, process specification and test specification), or products (e.g. product specification, performance specification and drawing).

ISO 9000:2005 does not define “standard”. The first part of the ISO 9000:2005 introduction reads:

“The ISO 9000 family of standards listed below has been developed to assist organizations, of all types and sizes, to implement and operate effective quality management systems.

ISO 9000 describes fundamentals of quality management systems and specifies the terminology for quality management systems.

ISO 9001 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide products that fulfill customer and applicable regulatory requirements and aims to enhance customer satisfaction.

ISO 9004 provides guidelines that consider both the effectiveness and efficiency of the quality management system. The aim of this standard is improvement of the performance of the organization and satisfaction of customers and other interested parties.

ISO 19011 provides guidance on auditing quality and environmental management systems.

Together they form a coherent set of quality management system standards facilitating mutual understanding in national and international trade.”

In other words…

ISO 9000 is a standard that describes fundamentals and specifies the terminology.

ISO 9001 is a standard that specifies requirements.

ISO 9004 is a standard that provides guidelines.

ISO 19011 is a standard that provides guidance.

This implies that a standard is a formal document that establishes uniform criteria, methods, processes and practices — which may or may not be requirements.

ISO 9000:2005 also makes a distinction between quality management system requirements and requirements for products using the terms “specifications” and “standards.” It states:

“The ISO 9000 family distinguishes between requirements for quality management systems and requirements for products.

Requirements for quality management systems are specified in ISO 9001. Requirements for quality management systems are generic and applicable to organizations in any industry or economic sector regardless of the offered product category. ISO 9001 itself does not establish requirements for products.

Requirements for products can be specified by customers or by the organization in anticipation of customer requirements, or by regulation. The requirements for products and in some cases associated processes can be contained in, for example, technical specifications, product standards, process standards, contractual agreements and regulatory requirements.”

Joe Tsiakals
Voting member of the U.S. TAG to ISO/TC 176 (ASQ)
Voting member of the U.S. TAG to ISO/TC 210 (AAMI)

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