What are the biggest issues with your CAPA System? (Medical Devices Quality System)


– Welcome to Medical Device School. So, here we have a small short episode from the Medical Device made Easy Podcast. Just to explain you a small topic. So today we choose the topic of what are the frequent issues on CAPAs? You have mainly CAPAs on your
Quality Management System. If you are using ISO
13485 and also FDA QSR. So then, what are the frequent issues that you have on CAPAs. And for that I have also
with me Stefan Bolleininger who will tell us his
experience about that. And then we can discuss
about the different or potential issues
that we have experienced in our companies or with our customers. So Stefan, tell us more. What are the different issues
that you find on your CAPAs? – Well, most issues I found, missing verification, lack of efficient evidence, and a real root cause. These are the things which are mostly in all models listings I
found to do with the audits. And that is, wow, it’s easy, it’s easy. A root cause analysis, a method for root cause
analysis should be everywhere, and you have a plenty of
them, Poka-Yoke, Ishikawa, whatever it take, FMEA. Plenty of them, but gives
your auditor at least one. – Yeah I think the auditor is just looking for seeing some kind of professional way to find the root cause analysis, so as you said, (chuckles)
just give him one. – Yeah, absolutely and it’s simple ones that you need to give him something to tell him you look at more
than just the first thing you thought about, that’s all. – One thing from you that
I see usually on CAPAs is the fact that, at the end we always use the root cause as human error. So we just say that it’s human error, which is an easy thing to say (chuckling). This is the problem of the person, but in reality maybe
it’s more of a problem of place of work, a problem of method, a problem of tools to
provide to this person, so my advice is you need
to use human error really as the last, last, last root cause, if you really have nothing
else that you identified. – Absolutely, human errors and root cause, it’s easy to fix. Either you fire the people,
or you train the people. – Yeah, this is also the thing so, usually when we have this root cause, usually the action is train the people. I call it awareness training
so it’s fun when I hear that, because it’s more like
showing slide deck telling, here is the procedure that
you already read normally, showing him the thing that
you already know normally. So it’s more making it to
make it so it’s something that can also show to the auditor that yeah you don’t have a really solid CAPA system. – Yes, and that’s the thing. Because when you only say, you train because the people are
doing something wrong. Maybe they have the wrong tools, so if you can say in a root cause analysis everything is fine it’s
really human error, okay go the way, but if you say, ah! It’s a human error and you know by heart that there is something different because it’s maybe a
production tool or whatever. Then you should change that, and that’s the second problem
because you need to verify your root cause. That’s the second thing, second
issue I’ve seen very often. That you have a root cause
not correctly analyzed then you come to the wrong root cause, then you’ve missed the rest of it. And then you get in the wrong direction and the auditor, be fair, the auditor is not
experienced in the product, but experienced in the process
and he sees or she sees, plenty of things, so they can
imagine what is really wrong. So, clear claim, clear instruction, and if needed change
tools, change the process, change the product. – And one thing also is, if you go in the right direction
and the wrong direction, you should also know about it so, Effectiveness Monitoring,
I think is one thing that people are not really using on CAPA, to see if really there is some, collateral damage of what you have done with this CAPA or if you have
really solved the problem. – Yes and effectiveness
check does not mean if you go for human
errors and you train them, training is not sufficient. You need to then take the
time afterwards, a period, to make sure that issue
does not happen again. That’s one thing, you
need to use effectiveness, you need to tackle on a timeframe. And which timeframe and
which method you’ll use to evaluate the problem afterwards. So if the CAPA is not closed
once you have initiated and did everything on the problem, but you need to look after,
if it’s really solved, that is also a key message. – Okay, so we analyzed
the root cause actions, and the effectiveness monitoring. I think we made really a tour of what are the frequent
issues that we have on CAPAs. – I have one additional one and that is, the point when you rise are CAPA. – [Monir] Okay. – Yeah, most companies don’t take predefined specials of venues. They think okay, oh this
issue happens now three times, three times now take the CAPA. That’s not the process! – Yeah. – You need a process,
and a process includes acceptability and threshold. – [Monir] Yep. – And by the threshold if
you pass it, your a CAPA. So by complaint CAPAs. And then there are the real big one CAPAs, that say, oh my God,
I have a real problem. Then you don’t need a threshold anymore. Yeah, it’s an OMG factor,
if you see a problem, you go oh My God, CAPA. – (chuckles) Okay something
else from your side Stefan? – On CAPAs? Ah well, only be true, and honest about it and don’t try to ride some crap in it. Every auditor will find
it as fast as he can look. (upbeat music) – Okay, good, thank you Stefan, and I hope the audience did heard that and is
now ready for their CAPA. So thank you.

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