Follow Up Reviews
The CAPA Manager conducts follow up reviews to verify that Corrective and Preventive Actions outlined in CAPA Plans have been implemented and documented.
See Link for CAPA Plan Implementation Review Flowchart
Effectiveness Checks
The purpose of an Effectiveness Check is to verify if the CAPA Plan has resolved the observations or non-compliance. Once Corrective and Preventive Actions have been implemented for some time, the CAPA Manager will verify that the observations or non compliance have not recurred.
If the observations have not recurred, the CAPA Plan is considered successful. If however, the observations have recurred, this indicates the CAPA Plan did not resolve the issues and should be revised.
See link for CAPA Plan Effectiveness Check Flowchart
Effectiveness checks will be conducted for;
- Internal Quality Review observations classified as Immediate Action Required
- Federal Audits where a Form FDA 483 or equivalent was issued
- Full CAPA Plans
