The Corrective and preventative actions, or CAPA, system is arguably the most important subsystem of the QMS.

It is the location where issues are documented and tracked including the sources of identification, investigations, the actions taken and the verification that those actions were effective.

Corrective Actions

The definitions for “Corrective Action” and “Preventative Action” are a very common source of confusion.

“Corrective actions are steps that are taken to eliminate the causes of existing nonconformities in order to prevent recurrence.”

Preventative Actions

“Preventative actions are taken to eliminate the cause of a potential non-conformity or undesirable situation.”

This often confuses people because corrective actions are preventative actions, but the subtle difference is that corrective actions are actions taken AFTER a nonconformance has occurred.