Verify effectiveness and reopen

Last updated August 25, 2026

Effectiveness is the difference between a CAPA and a to-do list. The actions are done; the question is whether the thing that caused the problem is actually gone. That can only be answered with evidence from after the change, which is why the check is scheduled rather than immediate.

Performing the check needs manage_effectiveness_checks. Reopening needs reopen_capa.

Performing the check

Schedule it far enough out that the process has actually run under the new conditions. A check performed the same afternoon proves the paperwork, not the fix.

The effectiveness check card showing the scheduled and performed dates, who performed it, the outcome and an evidence summary.
Planned date, actual date, who checked, and what they found. An effective outcome needs the evidence line to say why.

  • Effective means the cause is gone and stayed gone under real conditions.

  • Not effective is a legitimate result, and the honest one when the problem recurred.

  • The evidence summary is the part an auditor reads - "no recurrence" without a period or a sample size is not evidence.

Reopening

A closed CAPA that turns out not to have worked is reopened, not replaced. The history stays on the same record, so the second attempt can see what the first one tried.

The reopen CAPA dialog with an optional comment field.
Say what came back. Reopening with no comment loses the only thing the next person needs.

If the same CAPA is reopened twice, the root cause analysis is what was wrong - not the actions. Go back to the analysis rather than adding a third round of actions.

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