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APPLICATION OF DOCUMENT AND CHANGE CONTROLS TO DESIGN

12/01/2009

The design control system has to be concerned with the creation and revision of documents, as well as the management of finished documents. Additional mechanisms are required to provide needed flexibility while preserving the integrity of design documentation. These additional mechanisms are embodied in the procedures for review and approval of various documents.
It is important that the design change procedures always include re-verifying and re-validating the design. Fortunately, most design changes occur early in the design process, prior to extensive design validation. Thus, for most design changes, a simple inspection is all that is required. The later in the development cycle that the change occurs, the more important the validation review becomes. There are numerous cases when seemingly innocuous design changes made late in the design phase or following release of the design to market have had disastrous consequences.

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