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Creating Quality System and using it before it is complete

R

Randy-BCEC

#1
It is a two question kind of day for me. We are an old company trying to create a quality system around what we do. As I get deeper, I am finding gaps and I am addressing them in procedures.

The plan is to have all the documentation in place by August 1 so that we have a few months to show evidence that we are using our complete quality system before our next FDA inspection.

So, my second question of the day is, do we need to do anything special to approve a particular procedure for use without having the complete system in place? Should I have written a Control of Documents procedure first? I really want to implement the different segments of the system as they get written instead of waiting until everything is done and approving everything at once.
 
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Jen Kirley

Quality and Auditing Expert
Staff member
Admin
#2
I would htink you'd want to have developed document control earlier, but not having a written procedure doesn't mean you're not doing it.

So, I would start by, in this order:

1) Making sure that all the documents used that could impact quality have some way to know if they are the most current version.

2) Make sure only those current versions are being used, figure our how you will make them available to all who need them, and

3) Find a way to safely store the old ones and for how long, based on the type of loss risk.

4) Find a way to show what's being used has been approved by the right people, and how that will be managed.

5) Figure out how the old records will need to be disposed of.

I hope I haven't missed any.

These things can be done without a written procedure. When you figure out what works best and satisfies the needs, write it down... give yourself enough time to check back and see if the written procedures are being followed.

I hope this helps!
 
R

Randy-BCEC

#3
Fortunately, I am only a few procedures into the 25 or so I think I need. I think I will change gears, get the Document Control procedure in place, then start implementing procedures as they are approved.

It turns out that we are collecting a lot of information based on our last FDA inspection. The problem is that it is just data without a known procedure and without an overall quality system in place. A big piece of what I am doing is documenting the current processes and seeing where they fit in terms of ISO 13485. I have been able to identify a few improvements so far.

The toughest part for me is not having a crystal clear picture of what the finished system will look like. I keep getting stuck on little issues (formatting, completeness of the procedure, keeping it simple, etc...) I feel like I have a plan, but I am not sure that the work is correct.
 

Jen Kirley

Quality and Auditing Expert
Staff member
Admin
#4
Randy, I would start by making a list of the "shall" requirements for these documents and using it as a kind of checklist, to show how it's been covered by a procedure as you write them. In this way you may avoid confusion, gaps or layering. On this list I would nuber each item and put a corresponding number on your procedure. As you go, you can figure out what naming/numbering convention to use but for now you just want to avoid a jumble.
 
F

fuzzy

#5
Fortunately, I am only a few procedures into the 25 or so I think I need. I think I will change gears, get the Document Control procedure in place, then start implementing procedures as they are approved.

It turns out that we are collecting a lot of information based on our last FDA inspection. The problem is that it is just data without a known procedure and without an overall quality system in place. A big piece of what I am doing is documenting the current processes and seeing where they fit in terms of ISO 13485. I have been able to identify a few improvements so far.

The toughest part for me is not having a crystal clear picture of what the finished system will look like. I keep getting stuck on little issues (formatting, completeness of the procedure, keeping it simple, etc...) I feel like I have a plan, but I am not sure that the work is correct.
I used to call some of this "system architecture":notme:, in that it helps to frame how you want your system to look and function. Nothing is in concrete however, so you can continually improve system design too.

I'm not a 13485 expert:tg:, but for 9000 I start my rollout with the six required procedures - they are the vital functions of a QMS, and as you define and implement those processes, the fill-ins and complementary processes / procedures become more clarified over time.:2cents: Good luck with your journey...
 

yodon

Staff member
Super Moderator
#6
Excellent advise so far from everyone (as usual). One thing jumped out at me:

Fortunately, I am only a few procedures into the 25 or so I think I need. I think I will change gears, get the Document Control procedure in place, then start implementing procedures as they are approved
Why do you think you need 25 or so procedures? That's quite a few! Fuzzy's mention of 'system architecture' (generally the Quality Manual) is spot on. Yes, you do need doc control - that's pretty much a standard (separate) procedure for everyone. But DO take a top-down approach. Look at the standard from a top down approach and map out your strategy. Keep it simple and don't add complexity unless and until it's necessary.
 
L

Laura Halper

#7
Randy, I noticed that you said you are collecting information based on your last FDA inspection, and want to be ready for your next FDA inspection. But then you discuss seeing where your procedures fit into ISO 13485.

I would caution you to use 21 CFR 820 as your guide as to what quality system procedures the FDA requires. Although the FDA requirements are similar to ISO 13485 requirements, they are not always identical. Actually, 20 - 25 procedures sounds about right to me, depending on the type of products that you make. If your products/processes are simple, then you may be able to combine some procedures.

Be aware that the FDA explicitly requires some procedures that ISO 13485 does not explicitly require. For example, 21CFR820.20(c) requires that management reviews be done "according to established procedures". ISO 5.6 just requires that they be done and documented. Another example, 21CFR820.120 requires that you establish procedures for control labeling activities, and there are several specific requirements in this section. ISO does not address labeling activities per se.

So I would suggest that you use 21CFR820 as your guide for which procedures are required for your next FDA inspection. Of course, if you are trying to get ISO certification as well, then you'll want to be sure you also have the procedures that ISO requires but that the FDA does not require (yes, here are some of these, too :) ).

Laura
 

Chennaiite

Never-say-die
Trusted Information Resource
#9
Fortunately, I am only a few procedures into the 25 or so I think I need. I think I will change gears, get the Document Control procedure in place, then start implementing procedures as they are approved.

It turns out that we are collecting a lot of information based on our last FDA inspection. The problem is that it is just data without a known procedure and without an overall quality system in place. A big piece of what I am doing is documenting the current processes and seeing where they fit in terms of ISO 13485. I have been able to identify a few improvements so far.

The toughest part for me is not having a crystal clear picture of what the finished system will look like. I keep getting stuck on little issues (formatting, completeness of the procedure, keeping it simple, etc...) I feel like I have a plan, but I am not sure that the work is correct.
I would suggest you to avail(invest on) the services of the folks available in the industry who can establish the Quality System by taking inputs from you.
I am sure you can find a suitable one in this forum:)
 
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