Manage the Change / Risk management

Managing changes is an important responsibility for any quality management system. There are inherent risks involved with change. Proper planning, implementation and validation must be part of the manage the change process. It depends on the change, how much effort is needed. You have to manage the risk, of course.

If your customers do not require their approval or notification, there are still risks. A failed change can become very expensive. Risks of change include loss of business, losing your customers, bad press (including newspaper, review sites, etc). A change should start with justifying the business case and a Process FMEA (your risk analysis of the change).

A manage the change checklist must be developed and become part of your quality management systems. You should audit if the change process is followed and needs improvement.

For example Ford Motor Company has a process called SREA (supplier request for engineering approval). This is a good start if you are looking for a manage the change process.

See me a note if I can help you out.