Creating Change Controls

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.

The following diagram illustrates a high-level overview of the change planning process and when it occurs during the life of the Change Control:

During the change planning process, you can create the following records within your Change Control and assign them to an Owner to complete the relevant tasks:

Impact Assessments: Impact Assessments allow the assigned Owner to document potential impacts that may occur when implementing the change plan. Impact Assessments are completed during the change planning process.
Change Actions: Change Actions allow the assigned Owner to enter information regarding the actions taken to implement the change. Change Actions are completed during the change execution process.
Document Change Controls: Document Change Controls (DCCs) allow the appropriate user to update controlled documentation as a result of the change. Unlike other records within a Change Control, DCCs are not assigned an Owner. DCCs are completed during the change execution process.
Effectiveness Checks: Effectiveness Checks allow the assigned Owner to document whether the change implementation was effective or ineffective, or if the results of the change are inconclusive. Effectiveness Checks are completed after the Change Control is closed.

Complete the following steps to create a new Change Control record:

In Quality Events > Change Controls, click Create.
Enter a Title.
Enter a detailed Description for the change, including the current state and intended final state.
Enter a Justification for why the change is needed.
Select the change Category.
For Change Classification, Routine is selected by default. For emergency Change Controls, select Emergency.
For Temporary Change, select Yes if the change is effective for a set amount of time and is not permanent.
Select the Owning Facility that is responsible for managing the change.
Select the Owning Department that is responsible for managing the change.
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.
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.
Expand the Team section and click Manage Team.
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.
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.

Adding Impact Details

After creating the Change Control record, add the impact details of the change such as impact analyses, risk analyses, and impact assessments.

Adding Impact & Risk Analysis Details

During the change planning stage of a Change Control, you are required to enter impact and risk analysis details before you can complete the change plan and send it for approval.

Complete the following steps to add impact and risk analysis details to a Change Control:

In the Change Control record, expand the Impact & Risk Analysis section.
Click Edit () on the action bar.
In the Impact & Risk Analysis section, enter a comprehensive impact of the change and a description of the risk analysis performed.
Click Save to save the information.

Creating Impact Assessments

Impact Assessments allow you to identify and document potential impacts that may occur when implementing the change plan. For example, if a specific department may be impacted by the change, you can create an Impact Assessment and assign it to the Owner of the department to review potential impacts of the change.

Complete the following steps to create an Impact Assessment:

In the Change Control record, expand the Impact Assessments section.
Click Create to open the Create Impact Assessment page.
Enter the impact assessment Title, enter a Description of the impact assessment to be performed, and select the Category of the type of impact assessment to be performed.
Click Save. Vault creates the Impact Assessment with a status of Define Team and opens the Impact Assessment page.
In the Team section, click Manage Team.
Select the Owner responsible for performing the impact assessment and click Save. Vault assigns a Complete Impact Assessment task to the selected Owner and changes the Impact Assessment status to In Impact Assessment.
Optional: Add Library References or Attachments as needed.

Completing Impact Assessments

When an Impact Assessment is created, Vault assigns a Complete Impact Assessment task to the Impact Assessment Owner. To complete the task, review the Impact Assessment description and document your summary of the assessment.

Complete the following steps to complete an Impact Assessment:

Access the Impact Assessment from the assigned task. Vault opens the Impact Assessment and displays a task banner with the task due date and instructions.
Expand the Assessment Summary section and click Edit () on the action bar.
In the Assessment Summary section, enter the results of the impact assessment, and click Save on the action bar.
Optional: Add Library References or Attachments as needed.
Click Complete in the Complete Impact Assessment task banner, and click Complete in the confirmation dialog to confirm that you have completed the impact assessment. Vault saves the Impact Assessment details and changes its status to Impact Assessment Completed.

Adding Products

Complete the following steps to add an impacted product to a Change Control:

In the Change Control record, expand the Products section.
Click Add to open the Search: Product dialog.
Select the checkbox next to the Product Name of one or more impacted products.
Click OK to add the product to the Change Control.

Adding Organizations

Complete the following steps to add an impacted organization to a Change Control:

In the Change Control record, expand the Organizations section.
Click Add to open the Search: Organization dialog.
Select the checkbox next to the Organization Name of one or more impacted organizations.
Click OK to add the organization to the Change Control.

Adding Change Plan Details

After documenting the potential impacts of the change, create Change Actions, Document Change Controls, and Effectiveness Checks to help implement and monitor the change.

Creating Change Actions

Change Actions allow you to document the various actions required to implement the change. Create the Change Actions during the change planning process and select the appropriate Owner who will receive a Complete Change Action Implementation task to complete the Change Action during the change execution process.

If a document requires updates during change execution, we recommend you create a Document Change Control (DCC) instead of a Change Action, because DCCs follow a different workflow specific to controlled documents.

Complete the following steps to create a Change Action:

In the Change Control record, expand the Change Actions section.
Click Create to open the Create Change Action page.
Enter the Change Action Title and a Description of the activities required to implement the change.
Enter the Current Due Date of the Change Action, which is the date the change execution and approval must be completed. The Current Due Date of the Change Control is selected by default. You can edit this date until the initial plan is approved, after which you must create an Extension Request.
Click Save to save the record and open the Change Action page.
In the Team section, click Manage Team.
Select the Owner responsible for implementing the action and one or more Approvers responsible for approving the action implementation. The QA Approvers of the Change Control are selected by default, but you can select different Approvers as needed. An Approver cannot be the same user as the Owner.
Click Save to save the selected team members. Vault saves the information and updates the Change Action status to Initiated.
Optional: Add Library References or Attachments as needed.

Creating Document Change Controls

Document Change Controls (DCCs) allow you to identify controlled documents to be changed as part of the Change Control. DCCs are created during change planning and completed during change execution.

Complete the following steps to create a Document Change Control:

In the Change Control record, expand the Document Change Controls section.
Click Create to open the Create Document Change Control page.
Enter the Document Change Control information as needed and save the DCC.

Creating Effectiveness Checks

Create Effectiveness Checks as needed during the change planning process.

Effectiveness Checks allow you to monitor the effectiveness of the change after it is implemented. Effectiveness Checks are created during change planning and completed after the Change Control is closed.

Complete Effectiveness Check tasks are not assigned to the Effectiveness Check Owner until the associated Change Control is approved and moved to the In Change Execution state; however, the tasks cannot be completed until after the Effectiveness Check Start Date.

Add the following related records and resources as needed during the change planning process:

Related Events: Allow you to link the Change Control to other Change Controls, Deviations, or Standalone CAPAs.
Library References: Allow you to create references to documents in the Library
Attachments: Allow you to attach files to the Change Control

Completing Change Plans

When a Change Control is created, Vault assigns a Complete Change Plan task to the Change Control Owner. To complete the task, select the appropriate verdict to indicate that the plan is complete or request cancelation of the plan. Selecting Complete for the verdict initiates the change plan approval process.

Complete the following steps to complete a change plan and send it for approval:

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.
Click Complete in the Complete Change Plan task banner to open the Complete Change Plan dialog and select the appropriate verdict:
- To complete the change plan and send it for approval, select the Complete verdict, verify or update the Current Due Date as needed, and click Complete. Vault updates the Change Control status to In Change Plan Approval and assigns Approve Change Plan tasks to the Change Control Approvers.
- To request cancelation of the change plan, select the Request Cancelation verdict, enter the Cancelation Reason, and click Complete. Vault changes the Change Control status to Pending Cancelation and assigns an Approve Change Control Cancelation task to the QA Approver.