Overview

Experience, training, and sound procedures in your facility may mean that problems rarely arise. But, what about when they do? CAPA, or corrective action and preventive action, can provide a structure for finding the root cause of problems, solving those problems, documenting the conditions and solutions for the future, and looking for potential problems and their solutions. Corrective actions are often used in HR and other manufacturing contexts, but other industries may also be required by the Food and Drug Administration (FDA) to document CAPA processes and then follow the processes if a problem occurs - especially food processing or pharmaceutical and medical device manufacturing. 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 on 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.

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