A corrective and preventive action report is filled out following the identification, documentation, and evaluation of a nonconformance event at a medical device company. Some companies choose to report corrective and preventive actions on the same report and call this document a CAPA report, while other companies separate the CAPA report into two separate items: corrective action reports (CAR) and preventive action reports (PAR).
In either case, the purpose of the report is to initiate a process that will lead to either a corrective or preventive action. Corrective actions are required when a nonconformance event is discovered and the medical device company wishes to avoid repeating the same mistake. Preventive actions are required when the company discovers an issue with a policy or process that could lead to non-conformance events in the future.
A one-page CAPA report can be used to document a CAPA event from beginning to end. The document will be touched several times throughout the process, including by the initiator (the person who decided to initiate the CAPA), the implementer (someone who conducts a root cause analysis to discover what caused the nonconformance and creates an action plan) and the quality manager (the person responsible for reviewing and approving all documents that live in the quality management system (QMS).
CAPA reports must be documented in the medical device QMS in accordance with the document control standards and regulations specified by ISO and the FDA.
CAPA reports are completed in several steps and each CAPA issue can have several people working on it. Here are the general steps for completing a CAPA report for a medical device nonconformance issue:
Corrective and Preventive action reports are not the kind of reports that you write a single time, then file and forget about. These are reports that reflect an ongoing process involving many people at your medical device company. CAPA reports will be separately accessed by the report initiator, the implementer, a quality manager conducting management reviews, your company's CAPA review team, internal and external auditors, financiers and more.
Greenlight Guru's QMS allows medical device companies to maintain secure and up-to-date storage of all documents pertaining to the CAPA process, including the relevant policies and procedures and all CAPA reports and other documentation that are generated. Greenlight Guru helps ensure that medical device companies can produce accurate information for auditors in a timely fashion, helping you get to market even faster.