Who is this for?
Quality Event Owner - progressing the Quality Event when a CAPA is not created or not yet closed
How to do it
The intended workflow expects a linked CAPA to be closed before the Quality Event is further processed. The Quality Event Owner can override this expectation and progress the Quality Event without the CAPA being closed, in the following cases:
When no CAPA is created, a justification is required to proceed with the Quality Event workflow. Enter the justification in Justification for not creating a CAPA, select Sign and send for review, and complete the electronic signature to send the Quality Event for review.
When a CAPA has been created but is not yet closed, the system treats continuing as an exception. Complete the electronic signature to proceed with sending the Quality Event for review.
❗Progressing without a closed CAPA is an exception path. When no CAPA is created, a documented justification is mandatory; when a CAPA exists but is not yet closed, continuing is treated as a signed exception. Both justifications become part of the audit trail, so use these overrides only where your CAPA procedure permits and state the reason plainly.
💡Tip: Where you can, close the linked CAPA first. Use the override only when your procedure allows the Quality Event and CAPA to progress in parallel.