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.

*An email notification will also be sent to alert them of the task. For more information on email notifications and their role in the application, click here.

Clicking on either the subject in Pending Tasks or the button 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.

*For guidance on common form functions, please refer to the dedicated section in the manual.

1. Comment: This field allows users to add comments or notes relevant to the quality event.
   

   **The Comment control functions similarly to a discussion board, enabling collaborative discussions with stakeholders involved in the workflow.

2. Send the Issue to CAPA?: This is a single-select dropdown field that determines whether the issue should be escalated to a CAPA. 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 Management workflow and initiate the CAPA Management workflow.
         
         *

         The assigned reviewer will automatically receive the Review CAPA task, which includes details about the quality event.

         • For more information on the CAPA Management workflow, refer to the CAPA Application User Manual.
   • If No is selected, the page will remain unchanged.
3. Save Form: This button allows users to save the form.
   • It will remain in the Pending Tasks folder.
4. Correct Issue Immediately with Actions: This button allows users to submit the issue for immediate correction with actions.
   • If there are no actions linked to the quality event, selecting this button will simply close the event and conclude the workflow.
   • If actions are linked, the assigned owners (whether internal team members, external parties, or supplier representatives) will be responsible for executing them.
     
     *

     If the action item involves a Supplier Corrective Action Request (SCAR), the workflow will bypass the standard execution; instead, the supplier representative will be assigned the task of investigating the SCAR.

     • For more information on the Action Item Management workflow and its connection to the SCAR Management workflow, refer to the Action Items Application User Manual.