Greetings,
I have a few questions pertaining to the control over R&D parts/equipment.
Currently, we state in our Design Control procedure that units built for V&V must use the intended manufacturing processes and should have DHRs. We'd like to not require part inventory and lot histories before V&V. Is this acceptable and why?
For suppliers who provide us with R&D parts do they have to be on the approved supplier list if those parts won't be part of design V&V?
Basically, how much control over equipment is required if not used for design V&V or assessing quality of finished devices?
Any assistance/feedback would be most appreciated.
Tonia
I have a few questions pertaining to the control over R&D parts/equipment.
Currently, we state in our Design Control procedure that units built for V&V must use the intended manufacturing processes and should have DHRs. We'd like to not require part inventory and lot histories before V&V. Is this acceptable and why?
For suppliers who provide us with R&D parts do they have to be on the approved supplier list if those parts won't be part of design V&V?
Basically, how much control over equipment is required if not used for design V&V or assessing quality of finished devices?
Any assistance/feedback would be most appreciated.
Tonia