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.
Approve 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.
Complete 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.