Change form

A change form announces an action, such as change notice, change request or deviation. You can specify related information such as

  • Whether a change affects the actual release or cancellation of an item
  • Affected items
  • Reviewing groups and observer lists with configurable workflow
  • Cross-references to related changes

Implementing and non-implementing changes

Under legacy paper-based PLM systems, change forms were documents that described the change, listed the items that were affected by the change, and provided for authorized people to approve the change. In an automated PLM system, these functions are still relevant; in addition, the automated system will actually release or cancel items as directed by the change's contents.

An implementing change ("IC") form is the vehicle for executing the release and/or cancellation of a set of affected items. A non-implementing change ("NC") form simply announces a particular fact about the affected items; in this case, a "fact" may be, for instance, that a product needs upgrading ("change request"), or product shipments must be stopped until a defect is corrected ("stop ship"), or an unapproved component can be used as a temporary substitution ("deviation").

An IC form acts upon the items shown on its Affected tab: pending items are released, and released items are canceled. In contrast, an NC form doesn't release or cancel anything.

In order to release and cancel items, your PLM design must include at least one implementing change in its set of change forms. Any other change form is optional.

Common change forms

A change request is the formal notice that an item may require modification. The CR identifies the specific deficiency in enough detail so that the responsible designer can understand the problem. While a proposed solution is usually required, this solution may not be what is ultimately modified. A CR is a non-implementing change form.

The change notice (or change order) defines a set of items being released and/or canceled. That is, a signed-off CO documents that the items listed on it have been updated and may be used in accordance with the effectivity dates listed. The CO also provides information on the cost of the change: for example, the expenses associated with scrapping or reworking old parts, and retooling and implementing new ones. An engineering change notice, or ECN, typically affects design documentation and part release; a manufacturing change order (MCO) may be used to control process documentation and approved vendor parts. A CO is an implementing change form.

A deviation or waiver specifies a temporary suspension of approved items as a result of, typically, an unavailable or incorrectly manufactured part. A deviation proposes the use prior to the acquisition of the parts, while a waiver proposes acceptance of already-produced items that do not conform to the design documentation, but are acceptable for use (or will be acceptable after approved rework is performed). Deviations and waivers are typically limited in quantity or time, and are non-implementing change forms. (You'd release any temporary rework instruction documents using a related implementing change.)

You'd use a stop ship to temporarily halt shipments of products that may not conform to design requirements. A stop ship will typically provide a fixed time, after which it expires or is replaced with a new stop ship or other change (e.g., CR, CO, deviation). A stop ship is a non-implementing change form.

A problem report describes a product issue that requires investigation, validation and possible remediation. Since the PR may be initiated by a customer, regulator, or employee who does not know the product in details, it may not identify an affected item. A PR is a non-implementing change form.

Changes don't have revisions

A change is a "complete thought", and in PDXpert there's only one change revision possible. Any previously-released change that has a significant error should be corrected by issuing a subsequent change.

Some change attributes can be modified by the analyst after release but prior to completion. A completed or rejected change cannot be modified, except when the administrator uses the Administrator Override user preference. A canceled change form can (and should) be deleted.

1106

Learn More
Help Guide Contents [PDF]