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Gage R&R

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utqc

Bioengineer
Aug 5, 2014
1
I'm new to gage r&r studies and I have a beginner question. When performing a gage r&r, is it required to record the lot/serial# of the parts being used? More importantly, for the medical device industry, is it required or just good practice?
 
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I have performed a few Gage R&R for some of our parts going to the autoindustry as part of a PPAP. I had to GR&R for each of the tools we were going to be using. I used 3 operators, 10 trials each. We measured gage pins that were of similar size to the parts (to ensure that they were round).

All we were required to record was the tool ID, standards we were measuring, and our results. This was submitted with paperwork that had our manufacturing lot numbers, customer part number, and our part number.

Sorry I am not exactly sure what your customer is requiring, but I dont think it would hurt anything. My customers have required it on the forms that they gave me to fill out.

________________________________
Ryan M
Quality Engineer
3d Printer Hobbyist
 
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