Working with Multi-Document Change Control (Document Control)

QualityOne Vaults allow you to use the Document Change Request and Document Change Control objects to execute document release and obsolescence in a programmatic, controlled manner.

Depending on your Admin’s configuration, object, field, and section labels may appear differently than the labels mentioned in this article.

Process Overview

If your organization follows the suggested configurations, changing documents under change control will follow a process similar to this:

1. Users log change requests against individual documents by creating Document Change Request object records.
2. A Change Manager creates a Document Change Control record and adds one (1) or more documents to it. The Change Manager can also choose to include change requests (none, some, or all) for each document in the change control. CrossLinks are not supported types of documents for routing via Multi-Document Change Controls.
3. Document Authors edit individual documents included in the change control. If necessary, these users send the documents through a review workflow. Either through a Document Author’s action or through a workflow, each document moves into its lifecycle’s Pending Change Control Approval state.
4. When all documents enter Pending Change Control Approval state, Vault automatically moves the Document Change Control record into Ready for Approval state.
5. The Change Manager initiates an approval workflow on the Document Change Control record. Generally, this workflow involves various reviews. At the end of the review process, the change control moves into Approved state.

When the Document Change Control record enters Approved state, the following actions occur automatically:

• All related Document Change Request records enter the Closed/Cancelled or Closed/Completed state. In this state, they automatically become inactive. When this occurs, Vault releases the related documents from any change control restrictions.
• Vault automatically moves the related Document Change Request records into Approved state.
• Vault automatically updates various fields on the related documents with values from the Document Change Control record. Depending on the action occurring (release or obsolescence) and your configuration, Vault may update Proposed Effective Date, Proposed Obsolescence Date, and Obsolescence Approved.
• Scheduled jobs automatically move the change control’s documents into the appropriate document lifecycle state: Issued for Training, the lifecycle Steady state, or the lifecycle Obsolete state.

Governed Documents

Governed documents are any documents related to an active status Document Change Control record through the document fields Release Change Control and Obsolete Change Control. These fields may not be visible to you, but they control whether documents appear in the Documents to be Released and Documents to be Made Obsolete sections of the Document Change Control detail page.

Viewing Documents Under Change Control

When a document is governed by a change control, Vault displays a banner stating which change control currently governs the document. Only users with at least one (1) of the following permissions can see this banner, as users lacking these permissions can’t update the document:

• Edit Document
• Edit Fields
• Annotate
• Version

How to Create Change Requests

Change Request is an object, so creating a request involves creating a new Document Change Request object record and relating it to the document. To create a new change request:

1. Locate the document for which you’re requesting a change.
2. In a document tab, the Doc Info page, or search results, open the All Actions menu and select a configured Create Related Record user action. The label for this action may be different in your Vault.
3. Fill in request details. When creating a request from the document, you don’t need to fill in the Target Document field. Vault automatically selects the document version you viewed when you initiated the action.
4. Click Save.

You can also create a change request from the Change Requests custom tab. When creating this way, select a specific document (including version) in the Target Document field. You can also create a change request through Business Admin > Objects, if your Admin has granted you the applicable permissions.

How to Include/Exclude Change Requests

Each Document Change Control detail page displays an Associated Change Requests section. This section automatically filters to show change requests on documents linked to the change control through the Documents to be Released or Documents to be made Obsolete sections.

As a Change Manager, you should review the Associated Change Request records. If you remove a change request, Vault changes its status to Active. Change requests listed in Associated Change Requests are in Accepted status.

See How to Create Change Controls for more details.

How to Create Change Controls

To create and set up a change control:

1. Navigate to the custom Document Change Control tab or to Document Change Controls in Business Admin > Objects. Custom tabs may be labeled differently in your Vault.
2. Click Create.
3. Enter a Description.
4. Enter a Reason.
5. Select an Urgency.
6. Optional: Select a Proposed Implementation Date for the change control. When approval occurs, this date will cascade down to the documents and the scheduled job will use it to determine when to implement.
7. Click Save.
8. From the Document Change Control record details page, add documents. Locate the Documents to be Released section and click Add. In the selection dialog, select the checkbox next to a document to add it to the change control and click Close when finished. Repeat this process in the Documents to be made Obsolete section. You should have no more than 100 total documents in your Document Change Control.
9. Optional: From the record details page, add Document Change Request records. Find the Associated Change Requests section and click Add. In the dialog, select a change request to the change control and click Close when finished. The change requests you select should be related to the documents associated with the change control.

Criteria for Documents to be Released

Documents must meet the following criteria for you to add them to a change control as documents for release:

• Cannot be in their lifecycle’s Steady state.
• Cannot be governed by an existing active Document Change Control record; if a document is attached to an inactive record, Vault will automatically unlink it from the inactive record when you attach it to an active record.

Criteria for Documents to be made Obsolete

Documents must meet the following criteria for you to add them to a change control as documents for obsolescence:

• Latest version must be in their lifecycle’s Steady state
• Cannot be governed by an existing active Document Change Control record; if a document is attached to an inactive record, Vault will automatically unlink it from the inactive record when you attach it to an active record.

Restrictions on Documents Under Change Control

If a change control currently governs a document, you cannot add it to Documents to be Released or Documents to be made Obsolete on any other change control. There are no other restrictions on documents under change control, unless configured by your Admin.

How to Approve Change Controls

Before you can approve a change control, every document in Documents to be Released should be in its lifecycle’s Pending Change Control Approval state. When this happens, Vault moves the Document Change Control record to Ready for Approval state. If your change control only includes documents to be made obsolete (no documents to release), you will need to manually move the Document Change Control record into Ready for Approval state.

To approve a change control:

1. Use the approval workflow configured by your Vault’s Admins. You can start a workflow on the Document Change Control record from the Workflow Actions menu on the record details page. Depending on your Admin’s configuration, this action may be in the All Actions menu.
2. Open the multi-document viewer by choosing View All Related Documents in the All Actions menu.
3. Click Complete to approve the change control from the multi-document viewer. You may need to provide an eSignature at this point. This signature may apply to all governed documents if the workflow uses the Cascade eSignatures system action, so be sure to carefully read all instructions provided with the task dialog.