What the worksheet captures
The workbook has two sheets. An Instructions tab explains when to schedule the check, what counts as evidence, and how to apply the pass/fail logic. The working sheet captures the CAPA identifier, original issue, expected outcome, effectiveness criteria, review date, evidence examined, a recurrence check, the result (with Effective / Not effective / Extend review dropdowns), and the closeout decision — with a worked example row to copy from.
- CAPA identifier and original issue
- Expected outcome and effectiveness criteria
- Review date and evidence examined
- Recurrence check and result dropdown
- Closeout decision and notes
Why effectiveness checks often fail
Teams close actions because tasks are complete, not because the underlying issue has stopped recurring. A structured effectiveness review helps avoid that gap.
How governed workflows improve follow-through
A worksheet helps standardize thinking, but a governed CAPA workflow makes it easier to link effectiveness reviews back to deviations, owners, due dates, and related evidence.
