A Change Control can be closed once all of its Change Actions and DCCs are closed. QA Approvers must review and approve the Change Control before it is closed. After the Change Control is closed, Effectiveness Check Owners can review the change implementation effectiveness after the Start Date of the Effectiveness Check.
The following diagram illustrates a high-level overview of the Change Control closure process and when it occurs during the life of the Change Control:
Approving Change Control Closure
Once all Change Actions and Document Change Controls (DCCs) are closed for a Change Control, QA Final Approval tasks are automatically assigned to the QA Approvers of the Change Control. All QA Approvers must record their final QA approval of the Change Control before it is closed. If at least one QA Approver rejects the Change Control, it is returned to the Owner for revision.
Complete the following steps to approve and close a Change Control:
- Access the Change Control from the assigned task. Vault opens the Change Control and displays a task banner with the task due date and instructions.
- Review the Change Control details and associated Change Actions to ensure that the changes were implemented as needed.
- Click Complete on the QA Final Approval task banner to open the QA Final Approval dialog and select the appropriate verdict:
- To approve and close the Change Control, select the Approve - Close Change Control verdict, select Quality Final Approval as the Electronic Signature Approval Meaning, enter your User Name and Password, and click Complete. Vault changes the Change Control status to Closed and changes the status of related Effectiveness Checks to Pending Start Date.
- To reject the Change Control when further work is needed, select the Reject - Return to Implementation verdict, enter the Rejection Reason for what further work is required, and click Complete. Vault changes the Change Control status back to In Change Execution and notifies the Owner that the Change Control has been returned for revision.
Completing Effectiveness Checks
Effectiveness Checks allow you to record the results of the change implementation. You can indicate whether the change was effective or ineffective, or if the results of the change are inconclusive. If you need additional time to complete an Effectiveness Check, create an Extension Request to request a later due date.
After the Effectiveness Check Start Date, the Effectiveness Check Owner can complete or request cancelation of the Effectiveness Check. The QA Approver can then approve or reject the Effectiveness Check, or approve or reject the cancelation of the Effectiveness Check. If an Effectiveness Check or cancelation request is rejected, the Effectiveness Check is returned to the Owner for revision.
Amending Closed Change Controls
You can amend a Change Control after it is closed to add attachments or comments.
Requesting Change Control Amendment
Complete the following steps to request a Change Control amendment:
- Navigate to the closed Change Control you want to amend.
- From the Workflow Actions menu, select Request Amendment.
- In the Start dialog, select the QA Approver responsible for reviewing the amendment request.
- Click Start. Vault assigns you a Submit Amendment Request task.
- Click Complete on the Submit Amendment Request task banner to open the Submit Amendment Request dialog.
- Enter the Amendment Justification for requesting an amendment to the closed Change Control.
- Click Complete. Vault assigns an Approve Amendment Request task to the selected QA Approver.
Approving Change Control Amendment Requests
When a Change Control Amendment Request is submitted, the selected QA Approver is assigned an Approve Amendment Request task to review the request.
Complete the following steps to approve a Change Control Amendment Request:
- Access the Change Control from the assigned task. Vault opens the Change Control and displays a task banner with the task due date and instructions.
- Review the Change Control details and amendment request to determine whether to approve or reject the request.
- Click Complete on the Approve Amendment Request task banner to open the Approve Amendment Request dialog and select the appropriate verdict:
- To approve the request and reopen the Change Control, select the Approve - Allow Amendment verdict, select Quality Amendment Request Approval for the Electronic Signature Approval Meaning, enter your User Name and Password, and click Complete. Vault updates the Change Control status to In Amendment and assigns a Complete Amendment Actions task to the Amendment Request Owner.
- To reject the request to amend the Change Control, select the Reject - Deny Request verdict, enter the Rejection Reason for denying the request, and click Complete. Vault notifies the Amendment Request Owner that the request was denied.
Amending Change Controls
When a Change Control Amendment Request is approved, the Owner is assigned a Complete Amendment Actions task to add information to the Change Control.
Complete the following steps to amend a Change Control after it has been closed:
- Access the Change Control from the assigned task. Vault opens the Change Control and displays a task banner with the task due date and instructions.
- Expand the Amendment Comments section and click Edit () on the action bar.
- Enter Amendment Comments to provide additional clarity to the closed Change Control and click Save to save the comments.
- Add Attachments as needed.
- Click Complete in the Complete Amendment Actions task banner to open the Complete Amendment Actions dialog.
- Click Complete. Vault updates the Change Control status to In Amendment Approval and assigns an Approve Amendment task to the Amendment Request QA Approver.
Approving Change Control Amendments
When an Amendment Request Owner completes their Change Control amendments, Vault assigns the Amendment Request QA Approver an Approve Amendment task to review and approve the amendment.
Complete the following steps to approve amendments to a Change Control:
- Access the Change Control from the assigned task. Vault opens the Change Control and displays a task banner with the task due date and instructions.
- Review the changes made as part of the amendment to determine whether to approve or reject the amendment.
- Click Complete on the Approve Amendment task banner to open the Approve Amendment dialog and select the appropriate verdict:
- If the amendment is satisfactory, select the Approve verdict, select Quality Amendment Approval for the Electronic Signature Approval Meaning, enter your User Name and Password, and click Complete. Vault updates the Change Control status to Closed.
- If the amendment requires further work, select the Reject verdict, enter the Rejection Reason with the additional work that is required, and click Complete. Vault changes the Change Control status back to In Amendment and assigns a Complete Amendment Actions task to the Amendment Request Owner.