What would the FDA expect to see when they ask for our QSR?

T

Tim Penrose

#1
I think I'm happy with what is required as far as the DMR goes but just what would the FDA expect to see when they ask for our QSR?

The regulation states:

The QSR shall include, or refer to the location of, procedures and the documentation of activities required by this part that are not specific to a particular type of device(s), including but not limited to the records required by 820.40

A previous employer handed an FDA inspector a list of non product specific documents e.g. Policy documents, Process documents and Work Instructions for activities like Goods Inwards, Training, Purchasing etc. and was told 'That's not a QSR, that's just a list of documents'

So, Just what IS a QSR?
 
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Jen Kirley

Quality and Auditing Expert
Staff member
Admin
#2
I think I'm happy with what is required as far as the DMR goes but just what would the FDA expect to see when they ask for our QSR?

The regulation states:

The QSR shall include, or refer to the location of, procedures and the documentation of activities required by this part that are not specific to a particular type of device(s), including but not limited to the records required by 820.40

A previous employer handed an FDA inspector a list of non product specific documents e.g. Policy documents, Process documents and Work Instructions for activities like Goods Inwards, Training, Purchasing etc. and was told 'That's not a QSR, that's just a list of documents'

So, Just what IS a QSR?
QAR stands for Quality Systems Regulation.

I am not an expert in FDA requirements, but I can send you to sites like this one; Appendix 1 deals with QSR.

Fellow Covers: any more advice out there for Tim?
 

yodon

Staff member
Super Moderator
#3
Jennifer is exactly correct and the link she has provided (21 CFR Part 820) gives you the information you need to know.

Bear in mind that the 'R' in QSR is *REGULATION* - it's a law, something you should take quite seriously. Violations of the QSR have included recall, product lock-up, fines, and jail time.

So they're really not asking to see your QSR, they are asking to see how you have implemented the QSR. For example, one of the requirements is to have design controls. You will need to show that you have procedures that comply with the regulation (e.g., an SOP) and then show evidence that you comply with your SOP (e.g., approved requirements).
 
M

MIREGMGR

#4
In fairness, to get jail time for having an inadequate FDA QSR, you'd also have to either be an out-and-out scumbag who defrauds the sick, old and weak, or have killed one or more end-users through negligent disregard for basic safety.
 
J

Jimmy the Brit

#5
I think I'm happy with what is required as far as the DMR goes but just what would the FDA expect to see when they ask for our QSR?
I think you are referring to a Quality Plan - a document that tracks your QMS documents to the relevant sections of the QSR's as well as other standards you state compliance with. We use these at site level to demonstrate how we comply, but also to justify why we have excluded ourselves from certain sections (instead of just having N/A and having to justify at every inspection).

A well written quality plan helps staff "see" the QMS, as well as providing inspectors/auditors with a guide to the QMS, which in turn stops those moments of confusion concerning version numbers and titles that can be so common in inspections.

:2cents: Just our interpretation, but has been well received by both FDA and NB's

Jimmy
 

Ajit Basrur

Staff member
Admin
#6
I think I'm happy with what is required as far as the DMR goes but just what would the FDA expect to see when they ask for our QSR? .........
DMR covers all product specific documentation but QSR covers all the Quality System Regulations documentation that help maintain your Quality Management System. If FDA asks for QSR, its an audit :)

Btw, agree with Jimmy - are you referring to Quality Plan ?
 

yodon

Staff member
Super Moderator
#7
In fairness, to get jail time for having an inadequate FDA QSR, you'd also have to either be an out-and-out scumbag who defrauds the sick, old and weak, or have killed one or more end-users through negligent disregard for basic safety.
Agreed... my point was that it is a regulation, not to be taken lightly. Maybe that was a bit over the top, but hey, it's election time in the US! :)
 
T

Tim Penrose

#8
Thanks for your comment so far but

QSR 820.186 Quality System Record says:

Each manufacturer shall maintain a quality system record (QSR)

Then the text in my original post with a final sentance:

Each manufacturer shall ensure that the QSR is prepared and approved in accordance with 820.40 (Document control)


Now a 'record' to me means a completed form used to record that an activity has been performed by someone at a particular time.

So from that I'm assuming a QSR is a controlled document that includes details of/reference to all documents held within the Quality System that are NOT product specific, and going by past experience is more than a list of document numbers and titles

Any further comments/advice?


Thanks in advance
 
J

Jimmy the Brit

#9
So from that I'm assuming a QSR is a controlled document that includes details of/reference to all documents held within the Quality System that are NOT product specific, and going by past experience is more than a list of document numbers and titles

Any further comments/advice?
Our Quality System Records are our Site Quality Plans (see below). We consciously changed the name so we would not have confusion between the QSR and the QSR's.

Jimmy
 
T

Tim Penrose

#10
So a document listing the QSR requirements that points to the relevant part of our QMS e.g.
820.20 Management review - OP 21 Management Review Procedure

820.22 Quality Audit - OP 20 Internal & Supplier Audit Procedure

Something along those lines?
 
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