9.1.4. CAPA Triggered from Quality Event Application

During the Review the Issue – Escalate to CAPA? stage of the Quality Event workflow, users can choose to escalate the quality event to CAPA.

Before triggering this escalation, the user must designate a party (user, role, or group) as the reviewer. The selected party will be assigned the Review CAPA task. Details about the quality event will be included in this task.

*For more information on how to trigger a CAPA directly from the Quality Event application, click here. For further guidance on the Quality Event application in general, refer to the User Manual for the Quality Event Application.

In the Review CAPA form, the following automatic configurations will be applied:

• The name of the CAPA will be set to ‘[CAPA ID] from – Quality Event [Quality Event ID],’ indicating its source.
• The ID of the CAPA will incorporate the infix associated with the selected event type.
  • For example, if the chosen event type is Deviation, the CAPA ID will be set as ‘CAPA-DEV-[No.].’
• The event type will match the selected event type for the quality event.
  • The Event Type field will be disabled to prevent further modifications.
• The Quality Event Information accordion will be visible, containing the relevant quality event details.
• Any actions created during the Quality Event workflow will be included in the Associated Action Item(s) accordion.