Create a Change Control

Change Control is a systematic approach to managing changes. It ensures that changes are introduced in a controlled manner, and that the impact of those changes is fully understood, reducing potential risks and maintaining compliance with regulatory requirements.

The first step in the change planning process is to create a Change Control. A Change Control record serves as the primary record for your change, to which you can add other records for documenting and tracking information during change planning and implementation.

To create a change control:

1. In Quality Events > Change Controls, click Create. 
2. Enter a Title.
3. Enter a detailed Description for the change, including the current state and intended final state. 
4. Enter a Justification for why the change is needed.
5. Select the change Category.
6. For Change Classification, Routine is selected by default. For emergency Change Controls, select Emergency.
7. For Temporary Change, select Yes if the change is effective for a set amount of time and is not permanent.
8. Select the Owning Facility that is responsible for managing the change.
9. Select the Owning Department that is responsible for managing the change.
10. Select the Current Due Date, which is the date the change execution and approval must be completed. You can edit this date until the initial plan is approved, after which you must create an Extension Request.
11. Click Save. Vault assigns the Change Control a Record Number, creates the Change Control record with a status of Define Team, and opens the Change Control page.
12. Expand the Team section and click Manage Team.
13. Search for and select the Owner responsible for creating the change plan and actions, one or more Approvers responsible for approving the change plan, and one or more QA Approvers responsible for approving the change plan and execution. A QA Approver cannot be the same user as an Owner or Approver. 
14. Click Save to save the selected team members. Vault updates the Change Control status to In Change Planning, and assigns a Complete Change Plan task to the selected Owner.