9.6. Review the Issue – Escalate to CAPA?

If the quality event is submitted for CAPA assessment, the assigned reviewer will receive a notification in their Pending Tasks prompting them to evaluate whether the issue requires an escalation to CAPA.

They will also receive an email notification informing them of the assigned task.

Clicking on either the subject in Pending Tasks or the link in the email will direct users to the Review the Issue – Escalate to CAPA? form. This form, largely mirroring the Gather Details form, presents all fields in a read-only format. Users can review the investigation of the quality event, along with its associated risks and action items, before deciding whether to escalate or submit for correction.

1. Send the Issue to CAPA?: This is a single-select dropdown field that displays a list of responses (Yes or No) to the question. It is a mandatory field.
   • If Yes is selected, it will alter the page in the following way:
     
     • CAPA Reviewer: This is a single-select dropdown field that retrieves the list of users, roles, and groups in the system. It is a mandatory field. It allows for the selection of the user, role, or group responsible for reviewing the CAPA.
     • Send to CAPA: This button allows users to send the quality event to the CAPA application.
       • Selecting this button will conclude the Quality Event workflow and initiate the CAPA workflow.
         • The assigned reviewer will automatically receive the Review CAPA task, which includes details about the quality event.
           

           **For more information on the CAPA workflow, please refer to the User Manual for the CAPA Application.

           !!Please note that if any of the action items added in the Gather Details form are external and the quality event is sent to CAPA, the Create SCAR task will be issued concurrently with the Execute Action Items task—both tasks assigned to the relevant owners.

   • If No is selected, the page will remain unchanged, displaying only the Correct Issue Immediately with Actions button.

2. Correct Issue Immediately with Actions: This button allows users to submit the issue for immediate correction with actions.
   • Upon selecting this button, the outcome varies depending on whether action items are linked to the quality event:
     • If there are no action items linked, the quality event will be closed, bringing the workflow to an end.
     • If there are action items linked, the assigned owners will be tasked with correcting the issue with actions.
       • If any of the action types are external, selecting this button will also trigger the SCAR workflow. The assigned owners will be tasked with creating SCAR.

         **If there is only one action item and it is external, users will only be tasked with creating SCAR—meaning that they will not receive the Correct the Issue with Actions task.