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Hello,
I have a question about acceptance activities and 21CFR - Part 820.
According to section 820.80:
Finished devices shall not be released for distribution until:
It has been my experience in my last 2 companies that Quality Assurance (or Quality Control) personnel are the people to conduct a DHR review (it has been 100% inspection), but there is talk about changing it to a production function.
My question is: Is there anywhere that I am not seeing that required the DHR to be verified by a certain group?
I would not recommend having people inspect their own work and calling that good, but can a "production" person be the person doing the DHR review, or does it have to be someone who is authorized to do a release as well.
Thanks for the help.
I have a question about acceptance activities and 21CFR - Part 820.
According to section 820.80:
Finished devices shall not be released for distribution until:
- The activities required in the DMR are completed;
- The associated data and documentation is reviewed
- ....
It has been my experience in my last 2 companies that Quality Assurance (or Quality Control) personnel are the people to conduct a DHR review (it has been 100% inspection), but there is talk about changing it to a production function.
My question is: Is there anywhere that I am not seeing that required the DHR to be verified by a certain group?
I would not recommend having people inspect their own work and calling that good, but can a "production" person be the person doing the DHR review, or does it have to be someone who is authorized to do a release as well.
Thanks for the help.