Qual_Eng_17
Registered
Hello All,
I am a little out of my knowledge area on this one but ill get to the point. We have a new piece of Inspection Equipment (Cognex) which is going to be measuring product. In past practice rather than using the System Calibration Program, which is supplied by Keyence, we create a program to measure a know artifact that is held to a tolerance significantly tighter (1:10) than what the system is intended for.
With this new equipment it came with a Calibration Artifact and a Pre-Build Program, but the engineers involved in this would rather create their own program to measure a similar artifact to that of above as it is normal practice here.
Is this acceptable in Med Device to do this type and justify by measuring something with a significantly tighter tolerance and repeating or should we be using the manufacturer pre-built programming?
I am a little out of my knowledge area on this one but ill get to the point. We have a new piece of Inspection Equipment (Cognex) which is going to be measuring product. In past practice rather than using the System Calibration Program, which is supplied by Keyence, we create a program to measure a know artifact that is held to a tolerance significantly tighter (1:10) than what the system is intended for.
With this new equipment it came with a Calibration Artifact and a Pre-Build Program, but the engineers involved in this would rather create their own program to measure a similar artifact to that of above as it is normal practice here.
Is this acceptable in Med Device to do this type and justify by measuring something with a significantly tighter tolerance and repeating or should we be using the manufacturer pre-built programming?