Who is this for?
Quality Event Owner - reopening or archiving the Quality Event
How to do it
When an update is necessary after closure, the Quality Event can be reopened. Reopening retains the Quality Event ID and creates a new version; the approved previous version remains available in Full History.
Open the closed Quality Event, open the three-dot menu and select Reopen. The system retains the same ID, creates version 2 in Assessment, and any previously generated Linked CAPA remains displayed.
Reopening a closed Quality Event as a new version.
đĄTip: Reopen the existing Quality Event rather than creating a new one, when you're correcting or updating the same issue, so the full history stays linked under one ID.
Archiving a Quality Event
An Owner can archive a Quality Event that is no longer needed. Archiving requires a justification, confirmation and an electronic signature, and is recorded in the Audit Trail.
Open the Quality Event as the Owner. If the Quality Event is Closed, reopen it so that Archive is available.
Select Archive and enter the justification.
In Action Confirmation, select Archive Immediately, then enter your account credentials to complete the electronic authentication.
The Quality Event state becomes Archived and appears under the Archived tab of the Quality Events list.
âReopening creates a new version while retaining the ID, and the approved previous version stays in Full History. The record's lifecycle is preserved for traceability rather than overwritten. Archiving is signed and captured in the Audit Trail; archive only in line with your record-retention and retirement procedure.