Who can approve Acceptance Activities?

B

benrubacha

#1
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:
  • The activities required in the DMR are completed;
  • The associated data and documentation is reviewed
  • ....
You know the rest. It does not say who has to complete the data and documentation review.

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.
 
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Stijloor

Staff member
Super Moderator
#2
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:
  • The activities required in the DMR are completed;
  • The associated data and documentation is reviewed
  • ....
You know the rest. It does not say who has to complete the data and documentation review.

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.
Any medical device people that can help?

Thank you!!

Stijloor.
 

somashekar

Staff member
Super Moderator
#3
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:
  • The activities required in the DMR are completed;
  • The associated data and documentation is reviewed
  • ....
You know the rest. It does not say who has to complete the data and documentation review.

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.
Any competent person who has been assigned this authority can do it.
If the apprehension is about that person being in production department, give him a QA tag and take away the production tag.
 

pkost

Trusted Information Resource
#4
I'll start with the caveat that I have only just started looking at FDA regulations so someone else may be able to give you a better answer....

As the regulations do not define who carries out the activity it is left to the company to decide. Obviously that person must be suitably competent and have necessary resource to carry out the activity, otherwise you run the risk of that activity not being carried out correctly.

I personally prefer it that the reviewer has some independence from the process even if it is one production guy checking another production guys work but as that is not stated as a regulations it is not a requirement
 
B

benrubacha

#5
Thank you both very much. I have been working with FDA regluations for 7 years and just have always assigned QA to do the task, because they are independent of production, but when it was asked to have production do the review of documents, I had to look again and found that it really didn't state who MUST do the review.

I will take this into consideration. Thanks again!
 

Ajit Basrur

Staff member
Admin
#6
Thank you both very much. I have been working with FDA regluations for 7 years and just have always assigned QA to do the task, because they are independent of production, but when it was asked to have production do the review of documents, I had to look again and found that it really didn't state who MUST do the review.

I will take this into consideration. Thanks again!
Review could be done by any department but most companies have QA approve the documents.
 
B

benrubacha

#7
Thanks,

I thought that was the case, but wanted to make sure. I didn't know if I missed it anywhere in the regulation.
 
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