Effectiveness Check

An Effectiveness Check in QMS is a type of action item used to verify whether a CAPA has successfully addressed a problem and that implemented actions have successfully mitigated risks, ultimately preventing recurrence.

Important

To designate an Action Item as an effectiveness check, the Mark as Effectiveness Check checkbox must be checked from Room Settings > Record Types > Action Item record > Profile tab.
To enable the creation of an effectiveness check through a CAPA, the CAPA workflow must include the Initiate Effectiveness Check trigger linked to an action within a specific stage.

To create and process an effectiveness check record, follow the steps below

Create and submit a CAPA record by referring to the steps detailed in the Create CAPA section.
As the authority in the first stage, claim the record and click on the Complete button.
On the Complete Implementation form, select Yes, create Effectiveness Check and click on the Complete button.
On the Effectiveness Check Required form, fill in the mandatory details and click on the Next button.
Upload evidence and click on the Create & Submit For Review button.
Enter a comment on the Submit for Review popup and click on the Submit button.
Choose the appropriate workflow from the Workflows wizard and click on the Select button.
Once the record is successfully submitted, navigate to the Action Items tab from the left-hand navigation pane and view the record.
Approve and close the record by following the steps detailed in the Approve Action Item section. The Close Related Records modal opens.
Mandatorily enter a closure comment and click on the Confirm Closure button.

Important

In the above example, the Close Related Records appears since the CAPA record needs to be closed as the related effectiveness check record is closed.
If the Effectiveness Check record is not closed, users will not be able to close the related CAPA record, depending on the Close Condition configurations in the room settings.