This Book describes “how” an effective and user friendly corrective actions and preventive actions (CAPA) program can be implemented and how the documentation needed to ensure that all Capa requirements are fulfilled should be prepared. It also advises readers on how they can gain practical investigation experience to create successful root cause analysis. Not only does this book address how to understand the requirements for a closed loop CAPA system, but also covers topics such as organizational dynamics and culture and how to obtain CAPA system user buy-in, engage failure investigators interest, and practical tips for performing effective investigations.

Although many books and articles are there about CAPA programs and tips for performing root cause analysis, these books do not fully address how a company’s current CAPA program can be enhanced, nor how the proper use of root cause analysis tools will ensure for a 100% complete and thorough investigation. This book will help to prepare the personnel involved in the CAPA and investigation process by teaching specific ways for all personnel to gain practical investigation experience. Thus, the book intends to help fill the gap with regard to continuous insufficiencies of investigational practices when it comes to CAPA. The examples included in this book are designed to have a practical and relatable appeal to all readers.

My hope is that this book will serve many purposes, but most importantly to promote an understanding of how to implement an effective and practical CAPA system and to conduct thorough investigations that will facilitate the creation of successful root cause analysis to prevent the occurrence of product and process failures. I hope this book can be used as a guide for creating and conducting ad-hoc instructional sessions on CAPA specific topics.

A compliant CAPA system will include: 

1. Tie-in risk analysis—failure mode, effects, and criticality analysis (FMECA), Fault Tree Analysis (FTA), etc. 

2. Robust investigation, which includes getting to the root cause(s) 

3. Effective corrective action verification 

4. Preventive action program 

5. Tie-in design control procedures 

6. Tie-in process control procedure