Our Technical File was prepared by our V.P. of Operations/Engineering and is currently being maintained and updated by him. However, he feels that this should be a QA/RA function. I am curious as to what has been the experience of most as to what function normally maintains this document in a medical device company?

Thanks!
Rick

Our Technical File was prepared by our V.P. of Operations/Engineering and is currently being maintained and updated by him. However, he feels that this should be a QA/RA function. I am curious as to what has been the experience of most as to what function normally maintains this document in a medical device company?

Thanks!
Rick

It's really up to your organization. It can be someone in documentation, quality assurance, reg affairs, quality engineering... The person who is willing to maintain it, and able to maintain it, should maintain it.

Our Technical File was prepared by our V.P. of Operations/Engineering and is currently being maintained and updated by him. However, he feels that this should be a QA/RA function. I am curious as to what has been the experience of most as to what function normally maintains this document in a medical device company?

Thanks!
Rick

Unless you have a documentation department then it is usually QA who gets stuck with maintaining technical files - in my limited experience. I don't think it is the right solution, but that is the way the chips tend to fall. A lot of people don't like to maintain documentation, feeling that it provides no value, and it is not a part of the KPI's they are being measured against (especially in R&D), so it is not highly prioritized either. :nope:

Ditto here. My boss, the RA/QA Manager, is the lucky guy who puts together the Technical Files and our doc control clerk maintains them under his direction.

It's really up to your organization. It can be someone in documentation, quality assurance, reg affairs, quality engineering... The person who is willing to maintain it, and able to maintain it, should maintain it.

:agree1:
I agree with Linda. I've seen the Quality department be responsible for it, when there is little buy in from other contributing areas, resulting in a weak documentation package. The best situation I have worked with had the Manufaccturing Engineers being responsible for all documentation for their product lines. This was driven by Senior Management who monitored the Engineering KPI's closely to evaluate their performance.

I also agree with lindal.

While we are not a medical device company……..
Unfortunately for me it falls squarely on my desk.
This may actually be a good thing.
We have in excess of 3000 technical manuals from more than 40 manufacturers.
They are kept in a master library in our central office. That is the easy part.
The 9 or so technicians each have their own files of duplicates or copies carried on their trucks (mobile labs). Each man has only what he needs according to his experience with each manufacturer. Needless to say nothing is uniform.
Once the system was put together, it took me about a year, it has been a relatively simple thing to maintain. The guys are really very good about telling me when they add or delete a manual. :whip:
Once the challenge was met to be on the same page so to speak maintenance has not been an issue.

I mirror the sentiment that it's up to the company.

Before I came here it was the President who is also Chief Engineer.

Part of the reason I was hired was to get this off his plate so, in creating a more ISO worthy D&D process, I (QA Dir) am responsible for assembling new, and maintaining existing, technical files.
I'm also the "responsible person" for the quality system.

Our Technical File was prepared by our V.P. of Operations/Engineering and is currently being maintained and updated by him. However, he feels that this should be a QA/RA function. I am curious as to what has been the experience of most as to what function normally maintains this document in a medical device company?

Thanks!
Rick

I would imagine your V.P. has other matters to attend to.

Many medical device mfg's have identified the Regulatory Affairs Specialist as the employee who maintains the Technical files. In addition they handle the international submissions.:)

Someone needs to be responsible for the activity of ensuring that the quality/technical documentation for the product is adequately maintained.

That would typically be a QA/RA function.

But RA/QA would not necessarily have the expertise to do anything other than act as a fancy editorial team, except for their own areas of specialist knowledge. It is Engineering / Clinical / Design etc etc that must supply that data.

Thus there should be clear procedure, signed up to by all the relevant parties, that ensures that the these relevant parties supply the data in the appropriate format and in good time.


And do ensure your Internal Audit programme covers this....;)