CAPA Eligibility

To be eligible for entry in the CAPA system, a nonconformance must have occurred or is likely to occur under the current circumstance.

Product vs. Process Noncomformity

The obvious place a nonconformity can occur is in product (or components). Something physical. The less obvious place is in the process. Regulations require that you follow certain processes, collect and manage certain artifacts, etc. If the processes aren’t followed or if artifacts aren’t collected or managed properly, process nonconformities can be realized.

Corrective Action vs. Preventative Action

There are two distinct components to CAPA: Corrective Action and Preventive Action. Corrective Actions are conducted for systemic nonconformities that have occurred (nonconformance has been realized) and Preventive Actions are conducted in cases where nonconformities are likely to occur but have not (yet) been realized.