Create, complete and verify CAPA actions

Define corrective and preventive work, record completion and review the result separately.

Define the action

Product location: /qms/capas/{capaId} (fallback: /qms/capas). Open the intended CAPA and the action described below.

Open the CAPA and select Add Action. Choose the type that describes the work:

Creating, editing, completing and verifying actions require Manage CAPA permission. Being named as the assignee does not grant that permission.

Enter an action title of at least five characters and a description explaining the actual work. Add a due date.

Use Related Root Cause to select the saved cause this action addresses. The relationship remains with the action after saving and through its completion and review.

Verification required is initially selected. It makes a Verify action available after completion.

Select Effectiveness check required when a later review must establish whether the action prevented recurrence or achieved a sustained result. This requirement is saved separately from the verification requirement. When the action is verified, an Effectiveness review task is created in the CAPA owner's inbox, or the verifier's when the CAPA has no owner. It falls due after the organisation's configured delay, 90 days by default, and the action shows its due date. Because the review is scheduled at verification, keep Verification required selected for an action that needs an effectiveness review.

Select Add Action, then reopen the CAPA to confirm the saved action, related cause and review requirements. An action linked to a cause shows Addresses root cause with that cause. The action appears under its type. Use the expand arrow to see its description and available actions.

Review and edit pending work

Product location: /qms/capas/{capaId} (fallback: /qms/capas). Open the intended CAPA and the action described below.

Pending or In progress actions provide Edit and Complete when expanded. In Edit, review:

Select Save Changes and reopen the action to confirm the result. Choose the action type, related root cause and verification/effectiveness requirements deliberately when creating the action. Updating its title, description, owner or due date retains the existing cause relationship and review requirements.

If concurrent changes cause a conflict, refresh and compare the current values before saving again. Do not treat a dismissed dialog as sufficient evidence that the change persisted.

Complete the action

Product location: /qms/capas/{capaId} (fallback: /qms/capas). Open the intended CAPA and the action described below.

Expand the action and select Complete. Enter Completion Notes describing what was done and referencing the supporting evidence. The dialog requires at least ten characters after trimming and accepts up to 5,000 characters.

For example: "Updated checklist section 4.2 to require the certificate and register identifiers to match; reviewed change EC-042 against the revised check." Use the actual record identifiers in operational work.

Confirm completion, then check that the action becomes Completed. Completion records the work and its author/date. It does not by itself verify the result or close the CAPA.

Verify the completed action

Product location: /qms/capas/{capaId} (fallback: /qms/capas). Open the intended CAPA and the action described below.

When verification was required, expand the Completed action and select Verify. The dialog shows who completed the action, the completion date and the completion notes, when available.

Examine the relevant evidence before entering verification notes. Explain what was checked and what supports the conclusion. Verification notes have the same ten-character minimum and 5,000-character maximum as completion notes.

When the evidence confirms that the action achieved its expected outcome, keep Verify complete selected under Verification decision, enter the verification notes and select Verify Complete. Reopen the CAPA and check that the action is Verified with its review information. If the organisation requires an independent reviewer, have that reviewer perform the verification.

Return an action for rework

Product location: /qms/capas/{capaId} (fallback: /qms/capas). Open the completed action and its verification review.

If the completion evidence does not demonstrate the expected outcome, return the existing action for rework during verification. Record what was checked, why the result is insufficient and what needs to be corrected.

1. Expand the Completed action, select Verify, and review the completion notes and evidence shown in the dialog.

2. Under Verification decision, choose Return for rework and enter the Reason for return, at least 10 characters.

3. Select Return for rework. Check that the same action is back In Progress, with its assignment and related root cause kept, and that it shows Returned for rework by the reviewer with your reason.

4. Complete the corrective work and record new completion notes on that action.

5. When the action is Completed again, Verify becomes available for a fresh verification decision.

Expand Review history on the action to see every completion, verification and return, numbered by cycle, including the reason for each return. A later completion or review adds to that history. Keep using the same action through further rework cycles so the investigation and decisions remain traceable.

Interpret the saved outcome

Product location: /qms/capas/{capaId} (fallback: /qms/capas). Open the intended CAPA and the action described below.

The demonstrative completion and verification use synthetic records. In operational use, only record those outcomes after the described work and review have actually occurred.