An Overview of What Device Makers Need to Know About CAPA

Today we will be talking about a topic that seems to be an area of continual concern and, in some cases, struggle – CAPA, the commonly abbreviated term for corrective action, preventive action.

When there’s a problem with a process or a product, certain steps need to be taken so we can identify the issue, find a way to correct it, then determine how to prevent it from happening again.

The process can be overwhelming, and today we’re going to go into in exactly what CAPA is, what the intent is, and some advice for medical device companies who aren’t sure where to start.

Our guest is Mike Drues, who has been on the show frequently. He’s the president of Vascular Sciences and an expert on medical device technology and regulatory affairs. You won’t want to miss today’s show, because it’s chock-full of insights on CAPA.

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Some highlights of this episode include:

• The mechanics of a CAPA investigation or system, and what the results of addressing the problems in a product or process should be.
• Advice for new and existing medical device companies who aren’t sure if their CAPA systems are going to meet FDA requirements.
• Some common mistakes that companies make when developing their CAPA systems and criteria.
• An overview of the CAPA process, including what might trigger a CAPA investigation, ways to get to the root cause of the issue, and the case study approach.
• Why being proactive (rather than reactive) is so important when it comes to CAPA.
• Thoughts on whether CAPA is being overused or underused, with data from the FDA.
• Why the thought and intent behind CAPA is more important than a set of checkboxes on a form. 

Related resources:

Mike Drues on LinkedIn

Vascular Sciences

Fishbone Diagram

The Five Whys

CAPA Data from FDA 

Memorable quotes by Mike Drues: 

“CAPA isn’t based on the letter of the law; what’s more important is the thought process.”

“The set of CAPA criteria is not a static document.”

“Corrective action and preventative action are intimately related. You can’t separate the two.”

Transcription:

Announcer: Welcome to the Global Medical Device Podcast, where today's brightest minds in the medical device industry go to get their most useful and actionable insider knowledge, direct from some of the world's leading medical device experts and companies.

Jon Speer: Ah, yes, the infamous CAPA. Overused, underused, getting to the root cause, all of these things and more are discussed with Mike Drues of Vascular Sciences and me, Jon Speer, the founder and VP of Quality and Regulatory at Greenlight.guru on this next episode of The Global Medical Device Podcast.

Jon Speer: Hello and welcome to the Global Medical Device Podcast this is Jon Speer, the host and founder and VP of Quality and Regulatory at Greenlight.guru. Today I have Mike Drues from Vascular Sciences, good morning Mike.

Mike Drues: Good morning Jon. Thank you for the opportunity to have this discussion with you. Always a pleasure to speak with you and your audience today.

Jon Speer: Well, Mike we're jumping into a topic that, for whatever reason, seems to be a continued area of concern or struggle or whatever the right verb is, and that topic is CAPA. So let's take a few moments, I guess, to describe what CAPA is. There might be some people out there who have heard it, and have used it and maybe it's worked and maybe it hasn't. So I guess Mike I'd be interested to kinda hear your perspective, your overview, of what is CAPA and I'll certainly share my insights as well.

Mike Drues: So, I think that's a great opportunity to start the conversation, Jon. Let's start out with the most basic. And that is that CAPA, obviously, is an acronym, C-A-P-A, for corrective action/preventative action. And what I'll do is I'll offer sort of the quick overview of what it is and why we have it, and you can get into a little bit more of the mechanics for the audience, if you'd like. So the idea of a CAPA is that when we experience a problem, it could be a design problem, it could be a manufacturing problem, it could be a problem in a variety of different types regarding one of our medical devices. One of the things that we as engineers want to do is try to figure out the root cause. Why did the problem happen? In order to try to prevent it from happening in the future. And that brings us to the... Essentially the basis of CAPA, corrective action. Once we identify that root cause try to figure out a way to fix it, but then more longer term, we want to prevent similar problems from happening in the future and that brings us to the second half of CAPA, which is preventative action. So that's sort of at a high level, why we have it and Jon this is obviously an area where you do a lot of work as well as I. So why don't you tell the audience a little more about the mechanics in terms of what goes into a CAPA investigation, or a CAPA system, that type of thing?

Jon Speer: Oh, sure, sure. CAPA is one of those things that, I guess, from a high level, can sometimes be nebulous and overwhelming to people, and I think there are a lot of reasons for that sort of thing that happens to people. And so let me just jump in a little bit and talk from my view of what CAPA is really all about. As Mike said that it's... CAPA is an acronym, so corrective action/preventative action, but it's really a mechanism by which companies identify major issues to address in order to either correct or prevent problems. If you think about it, generally, a CAPA should address and mitigate systemic issues so that they are resolved and... And I think we're gonna get into it a bit here in a few moments and talk about how people maybe overuse or underuse CAPA. But think about that though, CAPA should address and mitigate a systemic issue. So, of course, the obvious, maybe is there might be an issue with a product, and may have a systemic issue with a product and so CAPAs certainly can be product related, but they can also be process related. So think about a company's manufacturing processes, or their quality system procedures, those might also be worthy of a CAPA if there are some systemic issues. So hopefully that gives a little bit more insight to this concept of CAPA. And Mike as they say the devil's in the details, sometimes. So it's probably good for us to get into a little bit of those details on the conversation this morning.

Mike Drues: Well, I agree, Jon. So to me, like most regulation, it's not the letter of the regulation or the letter of the law, that's so important here what's much more important is the message, it's the thought process. So, what would you suggest, what would be your best advice for companies who are either setting up a new device company and they need to implement a CAPA system, or they're working in existing medical device company, they probably have a CAPA system as part of their quality system, their design controls, but how do they know if it meets FDA's sniff test and more importantly, how do they know if it works?

Jon Speer: Yeah, that's a deep question. So first, let me tackle the first part of that. But if I'm a new company, and I'm setting up... I'm developing a device and I'm setting up my quality management system. It's interesting to me, I talk to company... A lot of companies in that situation every week and they're years and years away from a 510K submission and they're asking me about CAPA and I applaud their enthusiasm, but in some respect...

Mike Drues: You mean, they're anticipating having problems in the future, Jon?

Jon Speer: Well, I don't know, I don't know what the emphasis is and I try to educate them like, "Hey, CAPA is something that generally or usually is a post-market type of process. You don't usually worry about that during the design and development process you already have a process for that, or should anyway. And it's called design control it's called risk management. So, that always raises an eyebrow. But I think everyone that's starting a company... Well, that I talk to, they're trying to address this quality management system box, they wanna check the box and say, "Yep we've got a CAPA procedure."

Jon Speer: But let's talk more about the company that already has a product to market and hopefully they have some CAPA process in place. And let's talk about that scenario because that's... This is where the rubber meets the road, and there's all kinds of cliches and metaphors that we can rattle off here, but this is when a company... This is when it gets real. You're making medical devices, you're selling medical devices, there are patients receiving your medical devices in some way, shape or form. If there are issues you need to make sure your quality management system is robust. And it's not just about waiting until something happens, it's about making sure that you have enough early indicators or leading indicators regarding your product, your processes and overall performance and health of your company. And this is where CAPA really can become an asset. Because I think it's one of those dirty words that people hear and they're like, "Oh, CAPA. I've gotta do a CAPA." And it's got a lot of negative baggage and a lot of negative connotations. And I think the reasons for that are because we as an industry, or we as companies, have done a really poor job of defining a robust and systematic approach to addressing CAPAs. Mike, I know you talk to companies all the time that are probably dealing with this in some way, shape, or form, what have you seen?

Mike Drues: I agree, Jon. One of the things that I see almost across the board, and this is one of many areas where I work to try to help companies, is that they don't have a specific system or set of criteria in place as to when to instigate or alternatively not instigate a CAPA. And so one of the things that I often suggest to them is that we put together a list of criteria. I did this just with a company a few weeks ago. We put together a list of criteria to help determine you have an issue come up some issues, if it originates for example, from a customer complaint or an observation on a manufacturing floor maybe a particular group of medical devices does not pass the manufacturing inspection, we need to have some set of criteria in place in order to determine whether or not that situation warrants starting a CAPA investigation. And I also say to these companies that this set of criteria is not a static document. Just like, as you certainly know Jon, in the risk world and other places, we create something, but we have to go back on some periodic basis, and the regulation does not specify how often and, in my opinion, the regulation should not specify how often. That should be up to us. But once a week, once a month, once a quarter, it depends on how new the product is and so on, we go back and we revisit that.

Mike Drues: And I also suggest, and this is not a quality system requirement. But I also suggest, and maybe it should be a quality requirement, that we put that in our quality system, that every X period of time we will go back and revisit our criteria and modify or add to it as necessary. And of course we also have to include in there if obviously something comes up between our review cycles, so to speak, that we will revisit the CAPA criteria under those circumstances as well. So, for better or for worse, the regulation is not that specific to this level of granularity or detail to tell companies to do this. I would like to think that we don't need regulation to that level of detail, that we are professionals, that we all have graduated from engineering school and, quite frankly, that we know what the heck we're doing, but unfortunately, for a variety of reasons, and I think you've seen this yourself, Jon, in your experience in playing this game, not all companies do some of the most basic things that they probably know that they should do.

Jon Speer: Yeah, yeah, you've used the word in past conversations that you and I have had, you've used the words prudent engineering and CAPA is certainly one of those processes that fits under that umbrella of prudent engineering. And I guess for those who may be struggling with or trying to just make sure they have a firm enough grasp on what CAPA... What this process entails. Let me just take a moment or two and from a high level give some perspective on an overview of a CAPA process. As Mike and I have talked about, there can be a number of different origins, if you will, or sources that can contribute to a CAPA investigation. It might be a complaint about a particular product, it might be an audit observation, either internal or external, on a particular process, it could be some sort of nonconformance that you found during the manufacturing; there's a number of sources. But a CAPA first starts with some sort of identification of an issue or some sort of problem statement. This is really about that source. This problem statement should describe the observed issue or problem. Usually you have a few sentences, a few words to go along with that, and then once you've described that problem statement, as I said, there's a systematic method or process to get to a resolution.

Jon Speer: The first thing that's important once you've identified the source is to determine if there are any immediate actions that are required and think of immediate actions or any actions required to immediately contain or prevent the issue from growing. A good scenario would be if you had a complaint on a particular feature or something happened, or what have you, if it was a big deal and say, hopefully not, but say, somebody got hurt you would wanna take immediate action to make sure that that isn't going to happen to another patient. So that's what immediate action is all about. And this might require that you hold product in some sort of quarantine, that you put a process on hold, you may have to do a recall at this point, but those are pretty extreme cases, but do contain the issue from growing out of hand.

Jon Speer: And then really, once you do this now it's about investigation. You've gotta really get to the root of it. You've gotta get kinda down and dirty, so to speak. You've gotta do a thorough proper investigation. And that investigation should identify everything that's involved or impacted that we're driving towards this thing called a root cause. And Mike we're gonna talk about root cause here in a moment, I think, again, I suspect anyway, but root cause is the key to a good CAPA investigation. You've gotta keep drilling down until you get to the true root cause. And it's very easy for people... A common mistake that I see is they... You get to the root cause and they're often times rewording or restating the problem and it's like, "If that's what you're doing, then that's not really a root cause." You should take some sort of analysis or some sort of approach to this.

Jon Speer: There are a lot of tools. Fishbones, Ishikawa diagram, fishbone diagram, fault tree. There's another tool I like, called the 5 Whys. Think about being a three year old who's asking his mom or dad for something and the dad answers and the three year old says, "Why?" And then the dad answers and the three year old says, "Why?" Well, that's kinda like what the 5 Whys are. You keep asking why until you get to the root. And that's a key, key piece of CAPA. And then once you've gotten to the root cause guess what? Now, you can truly take action to correct or prevent this issue from happening. And in a nutshell that is really what a CAPA process is all about.

Mike Drues: Well, Jon, I think you did a terrific job of going over the CAPA process in a general sense. Coming from a medical background myself, I'm a big fan of the case study approach. So let me share with you, in order to illustrate much of what you just described, a specific case study, an example that I was involved with recently and perhaps you can add some of your comments on top of it. But in a nutshell, I was in... One of the medical device companies that I work with got a customer complaint. They manufacture a device that goes inside of a patient, it's a surgical device, and the customer complaint was a hair was found in the device. So obviously this is a problem, it could have caused potentially harm to the patient if it was not noticed. And by the way, part of this, which is outside of the context of our discussion today, was the risk mitigation strategy that had to be modified because of this, but let's focus on the CAPA piece of it.

Mike Drues: So the first part of this process, basically was the corrective action part, and in order to address that, we had to identify, to use that engineering phrase again, the root cause. So where did this hair come from? Well, this was found not as a result of the manufacturing inspection, but it was found just in the surgical procedure just prior to putting the implant in, so there were several possibilities. One possibility is that the hair could have come from one of the people in the company who were manufacturing the product. Another possibility is that the hair could have come from one of the surgical staff, and of course a third possibility is the hair could have come from somebody who handled the product in between. So we had to do some investigation. Believe it or not there was even discussion about doing some DNA analysis to try to identify specifically where that hair came from. We didn't actually do quite that, but the point is, you have to figure out where the problem occurred in order to address it. And then, once you identify where the problem occurred then you can try to take a corrective action and finally a preventative action.

Mike Drues: So, for example, if the hair came from one of the people in our manufacturing environment, one of the first questions is, are they required to wear protective garments, hair nets and so on? In most cases, yes. But to me, that's not good enough. In other words, if somebody is wearing a hair net and yet hair still ends up in the product, that means that something is not working and we need to assess the efficacy of the hair net. In other words, are they putting them on properly, are they somehow maybe taking them off because it gets too hot, or... So the point that I'm trying to make without getting into too much detail, here, is corrective action and preventative action to me are intimately related. You really can't separate the two. You need to get to the root cause, you need to find out what was the original problem. And that's not always an easy thing to do. But most importantly, and you and I have talked about this before, Jon, when it comes to design controls and other things, it's the thinking process that's involved here.

Mike Drues: The late great Carl Sagan said, that science is a way of thinking much more than it is a body of rules... Sorry a body of knowledge. Well, my spin on Dr. Sagan's quote is regulatory affairs, including quality and CAPA and so on, is a way of thinking much more than it is a body of rules and regulations. So that's a specific example that I was involved with recently, Jon. Again I know you work a lot in this area, as well. Is there anything that you would add or perhaps even disagree with in terms of what I suggested with that hair example?

Jon Speer: Well, I liked the example a great deal 'cause I'm a guy that... I'm a visual learner and I like pictures instead of words sometimes. And as you were sharing your case study, I just imagined... Pictured the product with the hair and all the steps that happened. The thing that I wanna play a little bit, or go a little bit deeper on is you talked about you can't really separate corrective action and preventive action. And I guess, specifically, I wanna talk about that because I see companies, they're not doing the PA part of the CAPA and one could argue that they're probably not doing the CA part very well either, at times. And we'll talk a little bit about some of the FDA observations on the topic of CAPA here in a few moments.

Jon Speer: But preventative action is key. We are in a community, an industry right now, that for whatever reason, it seems as though we are... We talk about it. I can remember back 10 years ago, talking... When I first started diving a little bit deeper into CAPA. People always talk about preventative action and, "Boy, we should be more proactive," but the reality is we're reactive, we're corrective, we wait 'til something happens before we do something about it. And to me, that's... If you want a good CAPA process, if you're gonna wait for things to happen and then deal with it, excuse the expression, but man, that's when the shit storm happens. That's when things get hairy, because you're trying to hurry up and fix something and that's why there's a rush at times through a CAPA process because you're reacting and it's never good to be in a reactionary mode.

Mike Drues: Well, Jon, I wish, I sincerely wish I could disagree with what you just said, but regrettably I cannot. It's been my vast experience and I've been playing this game, as you know, about 25 years now, that that is very true, especially today, much more so I think even than it was a couple of decades ago. And this is why I say kudos to the companies like you highlighted at the top of our conversation, who are thinking about a CAPA or putting together a CAPA system even before they have a product on the market, because that's exactly what we should be doing. We should recognize as engineers that although we certainly want to try to design the best product that we can, of course no matter how good we are as engineers, there are gonna be some problems, some problems perhaps within our control, some problems that are not within our control, but some problems and we need a process, ideally a process set up in advance, that we can... And then modify later as necessary. But a process set up in advance that we can follow when these problems occur. And with regard to the CA versus PA, I have said publicly, many times, that I think that the simple reality is our industry has gotten, I would say, pretty good at the CA part of the equation, but not particularly good at the PA for one simple reason, and that is these problems tend to happen over and over and over again.

Jon Speer: Yeah.

Mike Drues: And history... Those who forget their history are doomed to repeat it. It's not good enough, in my opinion, for a company just to be following the rules, just to have a CAPA system in place as part of their quality system, what really matters is, does it work in the real world? And by the way, much to the chagrin of some of my FDA friends, I do not assume, I never assume in fact, that just because something meets the FDA requirements necessarily implies that it works. I don't think those two things are mutually inclusive.

Mike Drues: And another question... I had an interesting discussion with a friend over dinner, who's the VP of Regulatory and Quality for a very large medical device company. He and I got into an interesting discussion about CAPAs and we were talking about what is the ideal number of CAPAs that a company should have. In other words, if you have zero CAPAs is that good? Well, maybe your products are perfect or maybe your CAPA system, your complaint system, is not working. On the other hand if you have tons and tons of CAPAs maybe you have a product that in fact is not as good as it should be, or maybe your criteria for instituting a CAPA is a little too loose because in that case you run the risk of the boy who cried wolf. If you have so many CAPAs, that the ones that are not as significant are gonna sort of take away the emphasis from the ones that are the most significant. So I'm curious, Jon, how would you answer the question, what's the ideal number of CAPAs? Or is the CAPA system overused or underused?

Jon Speer: I was smiling the entire time that you were sharing that. It does seem like people are looking for some sort of magic answer that they have to have... They cannot have more than a certain number of CAPAs or what have you or sometimes people are like, "Maybe this shouldn't be a CAPA." And again, it goes back to the criteria and you really look at the intent behind CAPA and again CAPA process is intended to address systemic issues and correct them if they've happened and certainly prevent them if they've not happened or prevent them from happening again. And as far as a number there is no number of CAPAs. I think though, that a company should certainly monitor how many CAPAs that they have and whether they do so over the course of... On a monthly basis, probably better as a quarterly type of metric, and they should just trend what's happening and they should coordinate the sources of those as well. Are they getting a spike in customer complaints or a lot of NCMRs? And if you get to understand what those true root causes are and the sources of these root cause issues, then the intent behind this CAPA is to be a means or a view into the health of your organization. And so I totally danced around answering your question on the number of CAPAs.

Mike Drues: That's okay, JON, you would make a good politician.

Jon Speer: At least on that topic. But you said something that's important, overuse underuse, and I wanna start to pull in some data, recent data from the FDA. I guess, did you know... You probably knew, but listener did you know that year after year after year the CAPA subsystem is responsible for more... For 83 observations during FDA inspections than any other subsystem conducted during an FDA inspection. In fact, I have the 2016 data open right in front of me right now. The top, number one, most cited issue during 2006 fiscal year, 2016 FDA inspections was CAPA. Specifically, it was lack of or inadequate procedures, procedures for corrected or preventative action have not been adequately established. And this is where when this is a problem, this is year after year after year. We know what the problems are gonna be during FDA inspections because FDA shares the data, "Hey, this is what we found last year." And guess what? It doesn't change that much, and yet the practice doesn't improve.

Jon Speer: So that was a long winded way of getting to, there's two scenarios that I see quite often and that is the extremes, the overuse of CAPA and the underuse of CAPA and both are problems for different reasons. Overuse every little thing that you need to address, change or issue that you discover, some people wanna throw that into CAPA. And I appreciate or applaud the intent for fixing things. But pretty soon, if you do that, you're gonna overburden your CAPA system and you're gonna have CAPAs that are... Have aging problems, they're not gonna get resolved. So you didn't really do any service to throw it into the CAPA, if it was just gonna sit there as a parking lot. You don't get credit for having a certain number of CAPAs open, you get credit for correcting issues.

Mike Drues: Or simply put, as I said earlier, it's the boy who cried wolf. So it's the ubiquitous car alarm that goes off in this crowded shopping mall parking lot that nobody pays attention because it just happens too many times.

Jon Speer: Exactly.

Mike Drues: So, I was just gonna say one other... Those statistics that you shared with us are certainly humbling, but let's just remember that FDA is dinging all of these companies only on what the regulation is requiring and in my opinion, oftentimes, the regulation does not require enough. And let me give you another example.

Jon Speer: Good point.

Mike Drues: I know we're coming to the end of our time together, but this is something that I encourage all of the companies that I work with and as far as I know, Jon, it is not a quality requirement. If it is, please correct me. But one of the things I see is that people don't stop and try to see the forest for the trees. In other words, you have some number of CAPAs that come in over the course of a quarter, or a year, or what have you. Oftentimes, almost all the time, at least in my experience, those CAPAs are looked at individually, but rarely, if ever, do I see a company on some regular basis, whether, it's quarterly or yearly, sit down and look at all of the CAPAs and try to see, "Gee, are there similarities? Are there, in fact, root causes that explain multiple CAPAs?" And so one of the things that I suggest companies put into their quality system as part of their CAPA program is on some basis, again, it could be monthly, it could be quarterly, it could be semiannually or annually. It depends on a lot of things. But on some basis, the team sits down and reviews all of the CAPAs and tries to look for the commonalities. One of the things that I often say in my regulatory work is, we always have to look for similarities where no similarity seem to exist. And there are many examples.

Mike Drues: So this will help us... As we talked about earlier, we don't do as an industry, a particularly good job on the PA side. I think if companies would do some of these, what I consider to be, as you said, prudent engineering or even better common sense if we look at our CAPAs collectively on some regular basis, maybe we can do a little better job of the actual PA when we get closer to that, what is often referred to as the root cause, or the root cause of the root cause and so on. So, Jon, do you see companies implement such practices in your experience?

Jon Speer: Mike one of these days we're gonna find a topic that we're gonna put on some gloves and duke it out in a debate style but however, this is not that topic, I don't think, because I'm like you, I see companies very myopic about it, like you said, they can't see the forest for the trees, they look at each CAPA as this singular event, and as a singular issue to resolve and no, they don't look at an overall system or all the CAPAs that the company has issued over a certain period of time, to do any really sort of trending. The trending that people do when it comes to CAPAs is they look at, "Well, how long our CAPA's open? And how many CAPAs do we have? And do we have a route cause? What was the date that we got root cause?" There's always, usually... Or not always, but often timeline types of trending. And that's not really getting into the depth and detail.

Mike Drues: And in my opinion, Jon, those examples of things that company's trend, and you're right, I see that happen all the time, those are the least important, in my opinion, maybe even totally unimportant, the things that people are focusing on. And at the same time, they're not focusing on the things that are the most important.

Jon Speer: Yeah.

Mike Drues: Perhaps, Jon, we are getting to the end. Maybe we should wrap this up with a few final thoughts, takeaways, from the audience. What do you think, based on the many things that we've talked about today, is the most important for our audience to take away with from?

Jon Speer: Oh, well, and here I thought I was gonna be prepared to answer this deep insightful question, and there's so much. I think CAPA... Let me give two pieces of advice. First piece of advice is to that startup. That early stage company you're developing your first device and you're in the development cycles. I assure you, CAPA is not something that you should really spend a lot of time, effort, and energy on. It's really the least of your worries. Wait until you get a product submitted to a regulatory agency and a little bit closer to market before you're really worrying about CAPA and frankly a lot of those other post-market processes. That's the first piece of advice. For the company that's established, that has products to market, chances are your CAPA process needs some tweaking, and I would say the one piece of advice that I would give you is focus on your root cause piece of your CAPA equation. And there might be other parts of that system that needs some evolution or revolution as well, but chances are your root cause analysis is weak, and it needs to be a little bit more thorough and a little bit more robust.

Mike Drues: Well, I think those are terrific takeaway messages for the audience, Jon. Certainly they resonate with me individually. Just to wrap this up from my side, first of all, I welcome the invitation to participate in a debate. I think that would be a lot of fun for both you and I, as well as our audience. Second of all, I'm sure, I'll mention this for our audience, that you and I will probably be doing a CAPA part two where we can take a deeper dive into some of these issues. But the most important thing, the most important takeaway that I would like to to leave the audience, we've talked a lot about in both general as well as specific detail, I shared with you a couple of actual case studies, but the most important thing is that quote that I shared earlier from Carl Sagan, who said that science is a way of thinking more so than it is a body of knowledge.

Mike Drues: I really believe my spin on Dr. Sagan's quote. They say if you're gonna steal steal from the best. My spin on Dr. Sagan's quote is regulatory affairs and quality, and in this particular case CAPA, should be much more a way of thinking than it is a body of rules and regulations. And so many people... This is not unique to CAPA, but CAPA's a good example. So many people have gotten to the point where regulatory and quality issues like this, like CAPA for example, are nothing more than a series of check box on a form. And in my opinion, when people approach these in that way, they totally miss the intent of what it is that we're trying to do here.

Mike Drues: So I would encourage the audience to... Obviously we have to meet the regulation. Nobody wants warning letters, that's not good for anybody's business. But more importantly, ask yourself, "Does what we do make sense? Is the regulation enough?" I think I mentioned two or three examples of best practices that I encourage companies to do, that are not required. Like, for example, as we talked about at the end, the forest for the trees, sitting down on some regular basis, and looking at all of your CAPAs collectively just to make sure that you're not missing a relationship that you may have not seen when you look at these things individually. Only then, in my opinion, can we truly start to address the PA side of the whole CAPA equation. So that's sort of my takeaway message for the audience. Jon, as always I greatly appreciate the opportunity to share this venue with you and I'm more than happy to answer people's specific questions in the future. They can certainly get a hold of me or Jon. Jon do you wanna wrap this up?

Jon Speer: Yeah, sure, and for those that do have questions for either Mike or myself, you can always go to Greenlight.guru and contact us there, and if it's for Mike I'll certainly forward it to him. But a good way to get hold of Mike is... Frankly it's to look for Mike Drues, D-R-U-E-S, do a search, he's all over the place on LinkedIn and through a lot of industry...

Mike Drues: Be careful what you wish for.

Jon Speer: But certainly reach out to us. And if you're struggling with CAPA in any way shape or form and you want somebody to talk to, or maybe help you figure out some of the problems or the areas of improvement for your CAPA process or other quality management system aspects do reach out to Greenlight.guru we'd be happy to have a conversation with you and see what we can do to help you out. Again I wanna thank Mike Drues from Vascular Sciences and this is Jon Speer, the Founder and VP of Quality and Regulatory, and this has been the Global Medical Device Podcast.

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The Global Medical Device Podcast powered by Greenlight Guru is where today's brightest minds in the medical device industry go to get their most useful and actionable insider knowledge, direct from some of the world's leading medical device experts and companies.

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