Minor or External Deviations with any rating are automatically closed after they receive QA approval and are not routed for further investigation. Therefore, the Impact & Risk Analysis, Investigation Summary & Conclusion, and CAPA Plan sections are all required to be completed before the Deviation is sent for approval. After the QA Approver approves the Deviation, it is automatically closed.
If any CAPA Actions or Effectiveness Checks are required, they are completed by their respective Owners after the Deviation is closed.
Create Extension Requests
The due dates for Deviations, CAPA Actions, and Effectiveness Checks cannot be changed after they are created. Once a Deviation is in the In Assessment status or later, you must create an Extension Request to adjust the due date for any of the above records.
Create Extension Requests as needed for Deviations, CAPA Actions, and Effectiveness Checks. QA Approvers are required to approve Extension Requests before the associated due dates are changed. If an Extension Request is rejected and returned for revision, you can update the Extension Request and resubmit it.
Close a Minor or External Deviation
To close a Minor or External Deviation:
- Access the Deviation from the assigned task. Vault opens the Deviation and displays a task banner with the task due date and instructions.
- Click Complete in the Complete Assessment task banner to open the Complete Assessment dialog and select the appropriate verdict:
- To complete the Minor Deviation and send it for approval, select the Complete verdict and click Complete. Vault updates the Deviation status to In Approval and assigns a Quality Approval task to the Deviation QA Approver.
- To request cancelation of the Deviation, select the Request Cancelation verdict, enter the Cancelation Reason, and click Complete. Vault changes the Deviation status to Pending Cancelation and assigns an Approve Deviation Cancelation task to the QA Approver.