Change Control Element - s1073pt10059

DOESTD107393

Document control activities deal with current or working documents such as procedures and

drawings. The objective is to ensure that the latest approved revision is available and used

by facility staff in the daily performance of their jobs. Emphasis is placed on identifying,

tracking, and statusing controlled documents.

Records management activities deal with historical records (such as test and calibration results)

retained to ensure auditability and proof of performance. Emphasis is placed on indexing (i.e.,

showing existence and location), storing, and retrieving records for future use.

Since both the working documents and historical records can contain design requirement and facility

configuration information, their availability, consistency, and accuracy need to be maintained in

accordance with the CM document control element.

I-B.4 CHANGE CONTROL ELEMENT

The identification and clear understanding of the mechanisms that can lead to configuration changes is

the first step in the development of an effective change control element. At facilities where

configuration management has been compromised most severely, the primary cause is often

inadequately controlled changes. Particular problem areas noted at DOE facilities include recognition

and control of changes made during maintenance, operational changes, temporary hardware and

procedure changes, and document-only changes. Effective implementation of change control often

entails a culture change within the facility operating organization. Often facility personnel need to be

trained to understand how unapproved configuration changes could be accidentally introduced, why

every change affecting facility configuration needs to be identified and controlled, and what methods

will be used to control them. To ensure completeness in the identification of all potential change

mechanisms, facilities should review their facility work processes for both the change types and their

associated change sources. Change control needs to be established prior to performing other

configuration management activities that involve changes, such as establishing or reconstituting design

requirements, or else the improperly controlled products of these activities can become obsolete.

Types of Changes. Changes can be grouped into three basic types, corresponding to these areas

whose relationship is maintained by the CM program: (1) design changes which involve changes to the

design requirements; (2) physical changes, or hardware changes, which involve changes to the

physical configuration; and (3) document changes, which involve changes to the facility documents.

Although a proposed change can involve each change type (design, physical, and document), each

change type is not necessarily involved in every proposed change. For example, CM document

changes may be made without changing the physical configuration or the design requirements.

Further, physical changes within the established design envelope do not involve design changes. Each

change type is discussed further below.

Design Changes. Design changes are usually prepared to support desired changes in facility

operational capability and often lead to physical changes. Design changes may also be made

based on new design analysis or new information. Field changes, facility physical changes

outside the design envelope, and nonconforming items dispositioned "use-as-is" and "repair"

also involve design changes and need design evaluation. Design changes need to be

approved by the design authority, in accordance with the design process, under appropriate

design control.

A small subset of design changes affects only design documents. However, most design

changes result in both changes to the facility physical configuration and the associated facility

documentation. The control of facility physical changes and facility documentation changes

that result from design changes is covered by this program element.

I-B-9