Approving Deviations

Different approvals and approval stages are required for Deviations depending on whether their Rating is Minor, Major, or Critical.

When a Minor Deviation is approved, Vault closes the Deviation, and no further action is required.

Major and Critical Deviations require two approval stages: QA Approval and Final QA Approval. The first QA Approval stage occurs after the initial Deviation assessment, and the QA Approver must approve the Rating and other details before investigation can begin. The second Final QA Approval stage occurs once the Deviation investigation is complete. The QA Approver must review all Deviation details and records, and then record their final QA approval. After the final QA approval is received, the Deviation is closed.

Approving Deviations

When a Deviation Owner completes the initial Deviation assessment, the QA Approvers are assigned Quality Approval tasks. All QA Approvers must approve the Deviation before it moves to the next status. If at least one QA Approver rejects the Deviation assessment, it is returned to the Owner for revision.

For Minor Deviations, this QA approval closes the Deviation. For Major and Critical Deviations, this QA approval initiates the investigation process.

Complete the following steps to approve or reject a Deviation as the assigned QA Approver:

1. Access the Deviation from the assigned task. Vault opens the Deviation and displays a task banner with the task due date and instructions.
2. Review the Deviation details and any associated records to determine whether to approve or reject the Deviation.
3. Click Complete on the Quality Approval task banner to open the Quality Approval dialog and select the appropriate verdict:
   • If the Deviation is satisfactory, select the Approve verdict, select the Quality Approval Electronic Signature Approval Meaning, enter your User Name and Password, and click Complete. 
   • If further work is required, select the Reject verdict, enter the Rejection Reason, and click Complete. Vault changes the Deviation status back to In Assessment and assigns the Owner a Complete Assessment task. 

When the QA Approver approves a Minor Deviation, Vault performs the following actions and status changes:

• The Deviation status is updated to Closed.
• The status of each CAPA Action is updated to In Implementation.
• A Complete CAPA Implementation task is assigned to the Owner of each CAPA Action.
• The status of each Effectiveness Check is updated to Pending Start Date.

When the QA Approver approves a Major or Critical Deviation, Vault updates its status to In Investigation and assigns a Complete Investigation & CAPA Plan task to the Deviation Owner.

Completing the Final Approval for Major and Critical Deviations

Major and Critical Deviations must receive a final QA approval before they are closed. When the Deviation Owner completes their Complete Investigation & CAPA Plan task, Vault assigns the QA Approver a Complete Final Approval task. 

To complete the task, review the Deviation details, including the Investigation, CAPA Actions, and Effectiveness Checks, then approve or reject the Deviation. When the Deviation is approved, it is automatically closed. After the Deviation is approved and closed, the respective Owners can complete their assigned Complete CAPA Implementation tasks and Complete Effectiveness Check tasks.

Complete the following steps to record the final QA approval for a Major or Critical Deviation:

1. Access the Deviation from the assigned task. Vault opens the Deviation and displays a task banner with the task due date and instructions.
2. Review the Deviation details, Investigation, CAPA Actions, and Effectiveness Checks to determine whether to approve or reject the Deviation.
3. Click Complete in the Complete Final Approval task banner to open the Complete Final Approval dialog and select the appropriate verdict:
   • If the Deviation is satisfactory, select the Approve verdict, select the Quality Final Approval Electronic Signature Approval Meaning, enter your User Name and Password, and click Complete. Vault performs the following actions and status changes:
     • The Deviation is updated to the Closed status.
     • CAPA Actions are updated to the In Implementation status.
     • CAPA Action Owners are assigned Complete CAPA Implementation tasks.
     • Effectiveness Checks are updated to the Pending Start Date status.
   • If further work is required, select the Reject verdict, enter the Rejection Reason, and click Complete. Vault changes the Deviation status back to In Investigation and assigns a Complete Investigation & CAPA Plan task to the Deviation Owner.

Approving Deviation Cancelation

When the Deviation Owner requests cancelation of the Deviation, the QA Approver is assigned an Approve Deviation Cancelation task. The QA Approver can either approve the cancelation and close the Deviation or reject the cancelation and send the Deviation back to the Owner for revision.

Complete the following steps to approve a request to cancel a Deviation:

1. Access the Deviation from the assigned task. Vault opens the Deviation and displays a task banner with the task due date and instructions.
2. Review the Deviation details to determine whether to approve or reject the cancelation.
3. Click Complete in the Approve Deviation Cancelation task banner to open the Approve Deviation Cancelation dialog and select the appropriate verdict:
   • To approve the cancelation, select the Approve Cancelation verdict, select Cancelation Approval for the Electronic Signature Approval Meaning, enter your User Name and Password, and click Complete. Vault changes the Deviation status to Canceled. 
   • To reject the cancelation, select the Reject Cancelation verdict, enter the Rejection Reason, and click Complete. Vault changes the Deviation status back to In Assessment or In Investigation and assigns the appropriate assessment completion or investigation task to the Deviation Owner.