QualityOne Vaults allow you to standardize and track the processes of creating a new draft, moving a draft into its Steady state (releasing it for use), or withdrawing an existing, approved document. When your Admin enables the Single-Document Change Control feature, Vault automatically adds various configurations to your Vault, including a lifecycle, document type, and document fields. Admins can modify many of these default configurations.
Note: If your organization uses Multi-Document Change Control, we do not recommend using this feature.
Depending on your Admin’s configuration, object, field, and section labels may appear differently than the labels mentioned in this article.
About Change Control Terminology
Document Control uses conceptual terminologies to support Change Control:
- Change Control Document: The document created when you start the Single-Document Change Control process. This document serves as a comparison point between the original document and the changing document.
- Changing Document: The document you change using Single-Document Change Control, also called the “target document.”
- Draft Creation Workflow: A workflow configured by your Admin that allows you to begin a new draft using the Create Draft action. See Workflows for more details about workflows under Single-Document Change Control.
- Withdrawal Workflow: A workflow that allows you to withdraw a document from the change control process. See Workflows for more details about workflows under Single-Document Change Control.
About the Change Control Process
The Single-Document Change Control process creates a relationship between two (2) documents. The first document is the document you wish to change. The second document, which uses the standard document type Document Change Control, is created automatically when you open the change control request.
You can also manually establish a change control by creating a document with the Document Change Control type and then establishing a Target of Change relationship.
When you enable change control on a particular document type, the Create Draft action becomes unavailable and the Open Change Control action replaces it. You must have the Version permission to see the Open Change Control action.
Configuration Elements
Vault automatically adds various configuration elements to your Vault when Change Control is enabled. You cannot delete or inactivate these elements, but you can tailor them to your business process. These configuration elements apply only to Single-Document Change Control.
- Document Change Control document type: This document type applies to the change control document. You cannot delete this document type. This is the only document type that can be the source for a Target of Change relationship.
- Document Change Control lifecycle: This lifecycle applies to documents with the Document Change Control type.
- Create Draft requires Change Control setting: This setting appears on each document type (except Document Change Control) and enables change control behavior on that type. By default, Vault does not enable this setting for any document type. This setting mandates the use of change control to create drafts. You may manually create a change control for document types without this setting.
- Target of Change relationship type: When users open a document change control, Vault automatically creates a relationship of this type on the change control document with the changing document as the target of the relationship. Currently, relationship types are not configurable.
- Prior Target of Change relationship type: When a change control is complete, Vault removes the Target of Change relationship and creates this type of relationship, using the last associated version of the changed document as the target of the relationship. You can reopen a change control from a Prior Target of Change relationship. Currently, relationship types are not configurable.
Default Single-Document Change Control Workflows
In addition to the configuration elements above, Vault also provisions default workflows and related settings that you can use as a starting point for tailored configurations.
Workflows
- Change Document Approval: This is the standard change approval workflow, which collects approvals from the Quality team before performing the Create Draft action.
- Emergency Change Document Approval: This workflow bypasses the Quality team approval process and only prompts the Workflow Owner for an eSignature before performing the Create Draft action.
- Withdraw Document Approval: This workflow follows the same approval process as the Change Document Approval workflow, but performs the Withdraw action when the workflow is complete instead.
Note: By default, Document Control provides separate change and withdrawal approval workflows for convenience, but many organizations use an identical workflow for both. A single workflow is often preferable if only minor differences exist in your organization’s process.
Document Fields
Vault applies various default fields to the Document Change Control document type. With the exception of Document Change Action, these fields are only informational. By default, Vault uses the Document Change Action field to determine which workflows are available as user actions and which action to take when the change control is approved.
Workflow Steps
The Change Control Action workflow step, which is only available when the Change Control feature is enabled, allows a workflow on the change control document to perform an action on the target of change document. The actions available are limited to: Create Draft, Set Status to Obsolete State, and Set Status to Steady State. When the workflow step executes, Vault performs the selected action on the target of change document using elevated privileges and special auditing. Admins can also configure the workflow step to notify the affected document’s owner. No action or change occurs on the workflow document during the execution of this step.