Corrective Action Procedure and CAPA

CAPA (Corrective Action / Preventive Action) is often used synonymously with 'corrective action procedure'. A CAPA -- the overall effort to investigate and correct quality issues to prevent recurrence -- is the lynchpin of any quality system. It is a regulatory requirement that both FDA inspectors and ISO auditors consider singularly critical. When implemented properly, a CAPA system improves product quality and safety, increases customer satisfaction, and ensures FDA and ISO compliance.

Steps in a Corrective Action Procedure

A corrective action procedure is not reworking or remaking an item to bring it back into specification. Patching up a mistake doesn't address what made it happen in the first place and it won't prevent a recurrence.
A corrective action procedure can be documented using either a paper or electronic system. Either way, the process is basically the same:

• Document that was specified versus one that was found. Check the functional specifications and any other requirements against the actual result.
• Determine how much time should be allowed for a corrective action procedure (or CAPA response).
• Decide who will investigate the problem, find a solution and perform the corrective action procedure.
• Research and document the cause of the problem.
• Plan how to keep the problem from recurring.
• Communicate the corrective action procedure to everyone involved, at each appropriate level.
• Periodically check to ensure the problem is solved and that the corrective action procedure was effective.

Automating the above steps greatly facilitates the completion of the corrective action procedure.

How Can MasterControl's CAPA Procedure & Process Help?

MasterControl CAPA™ automates routing, notification, delivery, escalation and approval of CAPAs and all related documentation. It automates management of entire CAPA process, while providing a secure, centralized, and Web-based repository for all CAPA documents.

For More Information on CAPA Procedure & Process

For more information about the corrective action procedure, a corrective action or CAPA, please feel free to contact a MasterControl representative.