Hi everyone,
I am supporting a small US medical device manufacturer (for the US market) that wishes to not have an independent final inspector for the finished device.
They would like the final inspection to be performed by the same individuals that manufactured the device (CNC, AM, so on).
Furthermore, the manufacturing facility will not have a quality representative on-site, but remote at the US HQ. Therefore, I am also concerned about NC reporting (for QMS and product), scrap, containment, and so on.
I've reviewed 21 CFR 820 and I can't really find enough defense in the regulation against the operator also being the final inspector.
Can someone give me some thoughts into this situation? Do you think these two situations are a problem? Do you think they aren't problem? Both are making me uncomfortable.
Thank you for any feedback and advice!
I am supporting a small US medical device manufacturer (for the US market) that wishes to not have an independent final inspector for the finished device.
They would like the final inspection to be performed by the same individuals that manufactured the device (CNC, AM, so on).
Furthermore, the manufacturing facility will not have a quality representative on-site, but remote at the US HQ. Therefore, I am also concerned about NC reporting (for QMS and product), scrap, containment, and so on.
I've reviewed 21 CFR 820 and I can't really find enough defense in the regulation against the operator also being the final inspector.
Can someone give me some thoughts into this situation? Do you think these two situations are a problem? Do you think they aren't problem? Both are making me uncomfortable.
Thank you for any feedback and advice!