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.

Change Control