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.
bag
fda_public
created
Sun, 22 Jul 2012 13:38:47 GMT
creator
dirkjan
modified
Sun, 22 Jul 2012 13:38:47 GMT
modifier
dirkjan
tags
CFR 21-820.30
Design Controls
FDA
Quality System Requirements
Term
creator
dirkjan