Working with Multi-Document Change Control (Quality)

Multi-Document Change Control allows you to use the Document Change Request and Document Change Control objects to execute document release and obsolescence in a programmatic, controlled manner.

Process Overview

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

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 or more documents to its Change Authorization section. The Change Manager can also choose to include change requests (none, some, or all) for each document included in the change control. CrossLinks are not supported types of documents for routing via Multi-Document Change Controls.
3. A document control user specifies whether each document needs revision or should be made obsolete. The user or Change Manager then routes the change control for document impact assessment.
4. During the impact assessment, assessors review Change Authorizations and approve or reject them. Approving a Change Authorization adds the document to the appropriate section.
5. 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.
6. When all documents enter Pending Change Control Approval state, Vault automatically moves the Document Change Control record into Ready for Approval state.
7. 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 Made Effective and Documents to be Made Obsolete sections of the Document Change Control detail page.

Documents to be Made Effective/Obsolete with Workflows Sections

The following special sections, if configured on your Document Change Control page layout by your Admin, allow you to see the status of included documents and to start workflows on them directly from the DCC record details page:

• Documents to be Made Effective with Workflows: Displays documents with the current Document Change Control identified in the document’s Release Change Control field.
• Documents to be Made Obsolete with Workflows: Displays documents with the current Document Change Control identified in the document’s Obsolete Change Control field.

You can select documents with the checkboxes on the left side of the section, then start workflows on the selected documents by clicking Start Workflow and then selecting the workflow you wish to start. Only multi-document workflows that are valid for all of the selected documents will be available. Select all documents in the section by clicking the checkbox at the top of the document list. The Workflow column of the section displays the workflow, if any, that a given document is currently associated with.

Viewing Documents Under Change Control

When a document is governed by a change control, Vault displays a banner stating which change control the document is currently governed under. Only users with at least one 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 were viewing 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, you must select a specific document (including version) in the Target Document field.

Auto-Linking Document Change Requests

If enabled by an Admin, you can relate any Document Change Request records which target the document or documents to be made effective to the Document Change Control as related records by performing the Link Available Document Change Requests action. This action may automatically occur, or only be available in specific states, as determined by your configuration.

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 Made Effective or Documents to be Made Obsolete sections.

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

See details for creating change controls.

How to Create Document 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. Custom tabs may be labeled differently in your Vault.
2. Click Create.
3. Add basic details like Description, Reason, and Urgency.
4. 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.
5. Click Save.
6. From the record details page, add documents. Find the Change Authorization 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. The document list is limited to documents that are not currently in an active Document Change Control or another active Change Authorization. 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.
7. For each Change Authorization record on the control, perform the Edit action. In the Revise or Obsolete field, choose the type of change for the associated document.
8. 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 that you select should be related to the documents associated with the change control.

Authorizing Changes

To route documents within the Document Change Control, assessors provide verdicts for its Change Authorizations. Depending on your organization’s processes, these verdicts may be provided as part of a workflow or via a user action on the authorizations in the Change Authorization section of the control. Upon choosing a verdict, Vault routes documents automatically based on the value of the Revise or Obsolete field:

• Needs Revision: When approved, Vault automatically adds the associated document to the Documents to be Made Effective section of the control and creates a new document version.
• Make Obsolete: When approved, Vault automatically adds the associated document to the Documents to be Made Obsolete section of the control.

By default, Vault takes no action when a Change Authorization is rejected, but this behavior may differ depending on your Vault’s configuration.

Criteria for Documents to be Made Effective

Documents must meet the following criteria for you 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 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 document is currently governed by a change control, you cannot add it to Documents to be Made Effective 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 Admins.

How to Approve Change Controls

Before you can approve a change control, every document in Documents to be Made Effective 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 in 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. From the multi-document viewer, click Complete to approve the change control. 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.

Related Permissions

Vault provides two security profiles that include the required permissions through permission sets: Document User with Change Management is appropriate for Change Managers and Document User with Change Request is intended for any full user allowed to submit change requests. Users with these security profiles still need appropriate document role permissions.

Type	Permission	Description
Security Profile	Objects: Document Change Control: Read, Create, Edit	Allows Change Managers to create and update change controls
Security Profile	Objects: Document Change Request: Read, Create, Edit	Allows users to create change requests on documents if they have access to those documents Allows Change Managers to include or exclude change requests in change controls
Document Role	Edit Fields	Allows users to associate a change request with a document Change Managers must have this permission on all documents related to their change controls
Document Role	View Content	Allows users to see the Viewable Rendition for a document; users responsible for reviewing and approving changes should have View Content permission on every document included in the change control. Admins can ensure correct permissions by including the System Action: Cascade Document Roles step in change control workflows.