Lamiaa:

Designs controls, in my opinion, is the most important thing a medical device manufacturer needs to get right. Could you imagine working for a company that never implemented the proper design controls for their product? I recall once working for a company where any change you wanted to push down the line was stonewalled by other managers. Why? Because everyone was afraid of touching the design inputs/outputs. What this led to was a dysfunctional organization that eventually ceased to improve their processes.

I think a properly implemented DHF eliminates that fear and allows a company to grow from a solid foundation. If a process change will reduce waste and increase output but requires an engineering review of the DHF, there should be no issues planning, implementing, and tracking the change.