View source for Corrective and Preventive Actions (CAPA)

=Abstract=
Corrective and Preventive Actions (CAPA) are processes designed to improve quality and handle nonconformity as well as other undesirable situations. The CAPA processes should be well defined to support an effective and efficient project management process. When working with CAPA, corrective actions are defined as actions set in motion to eliminate a nonconformity or other unwanted situations which have already occurred, and preventive actions as actions set in motion to eliminate potential nonconformities or unwanted situations.<ref name="CAPAFDA">Rodríguez-Pérez, José American Society for Quality 2011, CAPA for the FDA Regulated Industry</ref> CAPA is a mandatory part of the Quality Management System (QMS) for any pharmaceutical or medical device manufacturer reporting to the U.S. Food and Drug Administration (FDA). CAPA is also an integrated part of ISO:13485 and Good Manufacturing Practice (GMP) for medical products. The FDA defines the purpose of a CAPA procedure as: collecting and analyzing information, identifying and investigating product and quality problems, and taking appropriate and effective corrective and/or preventive action to prevent their recurrence.<ref name="FDA">FDA website Corrective and Preventive Actions (CAPA). Link: https://www.fda.gov/corrective-and-preventive-actions-capa#page3.</ref> There are not a regulatory defined framework for the CAPA process only different requirements. 

The purpose of this article is to give the reader an overview of the context in which CAPA is used, how to perform a CAPA, and which risks to be aware of. In this article a 7-step framework is presented. The steps include:
#identification of the problem;
#evaluation of the risk;
#preparation of a procedure for the investigation;
#analysis of the root cause(s);
#action plan for corrective and/or preventive actions;
#implementation of action;
#follow-up.