1. A change is thought to be necessary (eg, a line operator thinks that changing a manual valve to any automatic valve will not only make his/her job easier but also makes the product more consistent as it will not be dependent on an operator’s decision).

2. The operator writes up his idea and submits it to his/her supervisor.

3. The supervisor decides whether it is a worthwhile idea and sends it to his/her supervisor or to the line manager.

4. The line manager reviews it and sends it to engineering.

5. Engineering reviews it and sends it to QA/regulatory/validation.

6. QA (regulatory and/or validation) approves and sends it to upper management. The GMP status of the requested change is evaluated. If there is an apparent impact of the GMP or compliance status of the requested change it still may be approved, but further consideration is needed (how it can be brought into compliance again).

7. Management reviews and finally approves or rejects. If the change request is approved, then the affected departments will be notified. Usually this means engineering, validation, QA, and the requesting group.