Noncompliance in the CAPA system is the leading area for findings in FDA inspections. Not just recently but year after year. There are similar trends seen in audits by registrars. Why is this?
Frequent FDA Findings
A look at some of the frequent findings gives a few clues:
- True root causes are not identified – companies stop when they find a cause (but not the root cause) or just repeat the finding as the root cause.
- CAPAs not processed in a timely manner – companies get focused on product and forget to manage their CAPAs. Sufficient resources are not applied or the company doesn’t consider CAPAs a priority.
- The CAPA process is not understood and/or applied properly – companies set up a system that is not in compliance.
- Effectiveness is not assessed – once changes (corrections) have been implemented, companies may close the CAPA and not follow through with effectiveness assessment.
- Management doesn’t give CAPA its due – considers it just a time suck and a drain on resources.
Management Commitment
We’ll talk about ways to address these issues throughout. If management, though, does not understand or support the process, good intentions may not be enough. A solid CAPA system, like pretty much any other process, has to start with management commitment.