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How many processes for an FDA Quality System (QSR)?

A

ariannas

#1
OK - let me start off by saying that:

1) this is a somewhat philosophical question, and;
2) I bet it has been asked before in the context of the FDA part 820 forum but I may not be asking the search engine in the right way.

I'm mapping out the number of processes needed for a brand new FDA-compliant quality system. Not only is this for a new company, its the first time I've led this sort of effort. Our plans are to produce only a single class III medical device to start with.

After spending (way too long) working through the regulations and guidance documents, and mapping out an initial path, I'm thinking that we will need to establish about 20 processes to get things going.

I thought I had done a pretty good job keeping the number of processes down. But Some of my colleagues think I have gone SOP-crazy.

So... knowing that the real answer to "how many processes are needed" is a) as many as it takes, and; b) as few as possible, would anyone on this forum be willing to share approximately how many medium-to-high level processes they have in the FDA-oriented quality systems they are involved with? I'd dearly love to get a reality check.
 
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v9991

Trusted Information Resource
#2
while waiting for some of the experts from device industry to chip in....
let me fill in the waiting time....

you are almost right, one of the way of arriving at is have a peek at quality manual for a device industry!!!...hope that gives pretty much insight into the few references to start with...
http: //www. fda. gov /medicaldevices/deviceregulationandguidance/postmarketrequirements/qualitysystemsregulations/medicaldevicequalitysystemsmanual/default.htm- DEAD 404 LINK UNLINKED
http ://www .aami. org/QSConnect/qsfda/mdqs.manual.pdf- DEAD 404 LINK UNLINKED
http: //www .unimedsurgical .com/QUALITY-MANUAL-ISO-13485-2003-REV02.pdf- DEAD 404 LINK UNLINKED
http ://www .adctoday. com/images/PDF/qual_man.pdf- DEAD 404 LINK UNLINKED

hope these are relevant and helpfull
just in case if you have not already seen them!!!
 
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A

ariannas

#3
Thank you v9991!

I have dug into the MDQS (the target of your first two links) pretty heavily.

http :// www. fda .gov/medicaldevices/de...al/default.htm- DEAD 404 LINK UNLINKED
http :// www. aami .org/QSConnect/qsfda/mdqs.manual.pdf- DEAD 404 LINK UNLINKED
To be honest, if I had to do it all over again, I would have started with the regulations and preambles, and used the MDQS as reference. I started off with the MDQS, and found it to be a harder read than the regulations themselves. Possibly other peoples mileage will vary...

However, I have NOT seen the two quality manuals in your second two links, and I definitely will be taking a very close look at them.

http ://www. unimedsurgical. com/QUALIT...2003-REV02.pdf- DEAD 404 LINK UNLINKED
http ://www .adctoday .com/ images/PDF/qual_man.pdf- DEAD 404 LINK UNLINKED
Thanks again!
 
Last edited by a moderator:

Ronen E

Problem Solver
Staff member
Moderator
#4
Hi,

I have done similar things in the past, though mostly for class I and II devices.

20 sounds reasonable, but as a stand-alone figure it doesn't mean much. The term "medium/high level process" is too vague to yield a meaningful figure. If you stick to part 820 and the FDA's QSR manual (first link) you should be fine. If you're the kind of person who likes lots and lots of references and angles, I'm sure that the web is full of them (Elsmar has some goodies, naturally - did you have a look at the attachment list?), but I don't think you'd hit any gold that you haven't already.

To address your colleagues concerns, just refer them to part 820. The original FR publication (1996) preamble provides some useful insights too, and is a "semi-official" text.

Cheers,
Ronen.
 
A

ariannas

#5
The term "medium/high level process" is too vague to yield a meaningful figure.
Yep, I was being a little vague/lazy when I wrote that. It seems like different quality systems have different names for each "level" of documentation. I was trying to convey: "stuff that is lower level than the actual quality manual but higher level than detailed procedures and/or work instructions."

..which is probably what I should have said in the first place. :rolleyes:
 
A

ariannas

#6
Thanks again v9991 for sharing these quality manuals with me; that made for interesting reading.

For those who are cursed with a mind that works the way mine does, I thought I would share the below:

The first quality manual above references roughly the same number of processes (stuff in the documentation tier immediately below the quality manual) that I mapped out -- 20 or so.

The second manual seems to reference 5-6 processes, with another 2 or 3 possibly implied by the numbering but not mentioned. My guess is that this ties into the "one can address ISO with only 5 processes if you really want to" stance that I have seen mentioned sometimes.

Another interesting item of note: both of these documents address FDA as well as ISO and other important regulations/standards. It makes me wonder how similar (or different) a quality manual that addresses only FDA regulations would be from manuals that cover multiple sets of regulations...
 
I

isoalchemist

#7
It makes me wonder how similar (or different) a quality manual that addresses only FDA regulations would be from manuals that cover multiple sets of regulations...
In the beginning... The FDA Regulations and ISO13485 were basically the same document. Over the years they have drifted apart slightly more in format than substance, but if you are compliant to one you would not get in significant trouble with the other. I'm sure a number of maps exist to show the comparison between the standards on the Cove, but I don't have a reference handy however.

However you set up your system I would have independent procedures for MDR and Recall. Officially not really part of 820, but listed as their own sections in 21CFR. Hopefully you never need them, but it's better to have them planned rather than trying to figure them out on the fly IMHO.
 
A

ariannas

#8
However you set up your system I would have independent procedures for MDR and Recall. Officially not really part of 820, but listed as their own sections in 21CFR. Hopefully you never need them, but it's better to have them planned rather than trying to figure them out on the fly IMHO.
Amen to that! :agree1:
 
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