Dirkjan: Created page with "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 r..."

2020-08-25T07:19:04Z

Created page with "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 r..."

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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|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.
[[Category:fda]]

[[Category:CFR 21-820.30]]

[[Category:Design Controls]]

[[Category:FDA]]

[[Category:Quality System Requirements]]

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Change Control - Revision history

Dirkjan: Created page with "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 r..."