About Quality System Documents

The quality system document's lifecycle is intricately connected to the change order and change action and their lifecycles.

You can view the lifecycle page for the document, but you cannot promote or demote the document from that page like you can other types of objects. See Controlled Documents Lifecycle for more details.

Change orders and change actions control releases and changes to many types of objects for the apps. This guide only deals with how they are used with quality system documents.

A single change order can manage the release or revise effort for any number of quality system documents and other items. The task to prepare, review, and approve a specific quality system document is associated with a change action. Each change action is initially associated with one document, but you can merge change actions so that one change action can manage the changes for multiple documents. In addition, you can define additional tasks for a change action that must be completed before the change action can be promoted to the In Approval state.

You can create a change order independent of any object and then add the quality system document to it as an affected item. You can also create the change order from the properties page of a specific quality system document.

A change object (Change Order and Change Action) can be created without a file checked in to the qualifty system document, but you must have at least one file checked in when promoting a quality system document from In Work to In Approval. You can only add documents in the Draft, Released, and Superseded states to a change order. The change action specifies the Requested Change value based on the state of the document. For the Released state, you choose the type of change. This type determines what happens to the quality system document when the change action and change order have been approved and released.

The affected items page for the change order, shown on its contents page, lists the change action for each item, such as a quality system document. The affected items page can list multiple change actions for any type of object supported by the change process.

The fast track change process is used to create a change order. The fast track process only uses an optional formal approval. The fast track process does not require a Change Coordinator.

You can use a change request to release a quality system document. You can connect the change request to a change template that has been configured specifically to release quality system documents. For example, the change template can include change questionnaires and impact questionnaires. Use the properties page for the change request to define a CO Template.

When you promote the change request from In Review to the In Process CO state, the app creates a change order. In addition to any change questionnaire or impact questionnaire, the app copies this information from the change template:

• Policy
• Responsible organization
• Change Coordinator
• Distribution List
• Evaluation List
• Formal Approval List

The app copies this information from the change request:

• Description
• Reported Against
• Category of Change
• Severity
• Estimated Completion

If you revise a quality system document, the revised document includes these items:

• Last review date
• Periodic review interval
• Next review date
• Subject Matter Expert
• Temporary Subject Matter Expert (if the document was reassigned)

You need to use a change order to revise a quality system document.

To review and approve change actions and quality system documents, the app uses predefined lists of people and tasks. The lists are defined as route templates. The route base purpose for the route template defines whether the route is used to review or approve the change order.

A change order uses these route templates:

• Evaluation Reviewers List
• Formal Approver List

The Evaluation Reviewers route template defines the people who need to review the change order (and its change actions and content). This route is inserted between the In Review and In Work states of the change order's lifecycle.

The Formal Approvers route template defines the people who need to approve the change order. This route is inserted between the In Approval and Complete states of the change order's lifecycle.

The app creates routes from these templates when the change action, and its associated quality system document, reach the point where the review and approval is required.

The history page records the events, actions, and state changes for a quality system document or document template. See Viewing History for Content for details.

The history page logs these details after an item is created:

• Date the item was created
• Person who created it
• The type of action executed on the item (create)
• The item's lifecycle state in which the action occurred
• A description of the creation (revised from an existing document or created from a template, for example)

When an action is taken that affects the item, it is logged in the item's history. For example, when a Document Center Administrator edits a document template, that person must include a reason for the change. The information is included on the history page for the template.

When your system includes Quality-based Document Control and IP Classification, you can add quality system documents to document families using one of these methods:

• Open the context menu for a quality system document (typically done by right-clicking the document name) and clicking Add to Library and search for the required document family
• View the Documents category for a document family and clicking Add Existing and search for the required quality system document

In either case, the document family must be in the Approved state. The classification path then shows on the properties page for the quality system document.

See IP Classification User's Guide for information on creating document libraries, document families, and using the Documents page.