Manufacturing change control is usually implemented using a set of standardized procedures similar to the following: * A change request identifies a design problem which the requester believes should be corrected ** It might be originated by a developer, manager, reviewer, marketing representative, user, customer, quality assurance representative, or production personnel ** Change requests are typically reviewed following the manufacturer’s prescribed review process, and the request might be rejected, deferred, or accepted. * If a change request is accepted and corrective action is straightforward, a [[Change Order]] might be issued on the spot to implement the change. * It may not be practical to immediately revise documents affected by a change order. Instead, the common practice is to distribute and attach a copy of the change order to each controlled copy of the original document. * Change control procedures should incorporate review and assessment of the impact of the design change on the design input requirements and intended uses. • A mechanism should be established to track all change requests and change orders to ensure proper disposition. * Change control procedures are usually administered by the document control staff !Project size * For a ''Small development project'' ** an adequate process for managing change involves little more than documenting the design change, performing appropriate verification and validation, and keeping records of reviews. ** The main objectives are ensuring that: *** corrective actions are tracked to completion; *** changes are implemented in such a manner that the original problem is resolved and no new problems are created; or if new problems are created, they are also tracked to resolution; and *** design documentation is updated to accurately reflect the revised design. * For projects involving ''more than two persons'' ** Coordination and communication of design changes become vitally important. ** Manufacturers should take steps to avoid the common situation where, for example, Jon and Marie agree to a make a change but neglect to inform Pat of their decision. ** Medical device manufacturers are usually quite comfortable with the processes of document control and change control with respect to managing manufacturing documents.