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.

When a linked document hasn't changed yet. When a CAPA links a document it changes, the Effectiveness verification card lists each one and whether the change went effective:

• SOP-7 Rev D: effective since 2026-10-05: the new revision is in use.
• SOP-7 Rev D: effective from 2026-10-05, later superseded: it went effective, and a later revision has since replaced it. This still counts.
• SOP-7 Rev D: not effective yet (In review): there's a new revision, but it isn't effective yet.
• SOP-7: no new revision since it was linked: nobody has started a new revision of the document since you linked it.

Only revisions created after you linked the document count. The revision that was already in use when you linked it doesn't, because linking a document to a CAPA says it's going to change.

You can still select Close as effective while a linked change isn't effective. The CAPA might be effective because of other actions, such as the containment. The close form names each document that's not there yet and asks Why this CAPA is effective anyway. Write the reason, up to 2,000 characters, then close. The reason is saved under your verification note, after Linked revision not effective:, and on the record history. Not effective — reopen never needs a reason. If you forget the reason, Norma says so and keeps the verification note you typed.

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; Link change requests; Answer a customer with an 8D.