7.4. Review the Issue – Needs CAPA

Once the Gather Details form has been submitted, the assigned user will receive a notification in their Pending Tasks informing them that they need to review the revised issue.

This version of the Review the Issue form will contain information from the Gather Details form. In this form, however, users will not be able to make any direct modifications. For reviewing purposes, users are allowed to download files, view details inside the supplemental forms, and perform Excel-related activities (i.e., export, import, and create an Excel template).

1. Details
   
2. Gather Details
   
3. Assess Risks
   
4. Action Items
   

At the bottom of the form, there are two important fields to consider:

• Do you want to send it to CAPA?: This is a single-select dropdown field that displays a list of responses (Yes/No) to the question. It is a mandatory field. It allows users to select only one value from the dropdown.
  • If Yes is selected, it will alter the page in the following way:
    
    • Select the User . . . RCA: This is a single-select dropdown field that displays the list of users. It allows you to select only one value at a time from the dropdown. The user selected will be assigned to do the root cause analysis (RCA).
    • Send to CAPA: This button allows users to send the form to CAPA.
      • This button replaces the Immediate Containment button.
      • If any of the action items added in the Gather Details form are external and the quality event is sent to CAPA, users will be tasked with creating SCAR at the same time as the Execute Action Items task.
        • SCAR: Supplier Corrective Action Report

*For more information on CAPA, see the CAPA Application User Manual.

• Immediate Containment: This button allows users to submit the issue for immediate containment.
  • If no action items were added in the Gather Details form and the Immediate Containment button is selected, the workflow will end.
  • If action items were added in the Gather Details form and the Immediate Containment button is selected, users will then be tasked with correcting the issue with actions.
    • If any of the action types are external, users will also 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 form).
      • For more information on SCAR, click here.