CAPA effectiveness verification

Open: Quality Events > CAPA. Investigators: authorized Quality Manager, Engineer, Department Manager, or QA Technician. Other authorized roles can open CAPAs. Effectiveness closure: Quality Manager or administrator.

Implement and schedule verification

When the action plan has actually been implemented, enter Implementation note and Verify effectiveness by, then choose Mark implemented. The verification date is required and must be today or later at that step. The CAPA enters Verifying.

Use a meaningful verification interval. “Check the next three production lots after the fixture and instruction change” is more useful than checking immediately before the change has been exercised. The register shows overdue verification when that date passes while the CAPA remains Verifying.

Verify effectiveness

1. Review the evidence against the intended result. Identify the period, sample, records examined, and outcome.
2. Enter a verification note.
3. Select Close as effective only when the evidence supports effectiveness.
4. Select Not effective — reopen if it did not work. The CAPA returns to In progress, retains the failed verification, and clears the verification date so a later implementation can establish a new check.

The normal lifecycle is Open, In progress, Verifying, Closed. A failed check creates a loop; it is not an administrative error. Revise the work under the controls available for the current state, record implementation again, and verify again. The completed structured worksheet remains historical evidence rather than an editable explanation of the past.

Example: CAPA-0004 (rejects from fixture F-12) was marked implemented on 2026-08-20 with Verify by 2026-09-20 — "check the next three lots". Lots 4581, 4590 and 4602 ran clean, so the verification note names those three job numbers and the zero reject count, and the CAPA is closed as effective. Had lot 4590 rejected, Not effective — reopen would have sent it back to In progress with the failed check on record.

Completion check: source, cause, action, implementation, document changes, and effectiveness evidence tell one consistent story. Closing a supplier response, action item, or document revision does not automatically close the CAPA.

In the user guide

This article is part of chapter 25, "Corrective and Preventive Action", of the NormaQMS User Guide (NORMA-UG-001), which is under Help > User guide. Chapter numbers in the text refer to that guide. The same chapter also covers: Open the CAPA from its source; Analyze using free text; Analyze using the root cause worksheet; Manage actions and document changes.