Is Your Medical Device Company CAPA Happy?

The medical device industry could be more proactive than reactive when managing systemic issues. We’re talking about the Corrective and Preventive Action (CAPA) process.

In this episode, Jon Speer invites Mike Drues of Vascular Sciences to be his guest as they discuss the importance of the Corrective and Preventive Action (CAPA) process. Is your company CAPA happy?

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Some highlights of this episode include:

• CAPA is a means to formally investigate a systemic issue and properly take actions to prevent it from occurring again.

• Call it PACA, instead of CAPA: Place emphasis on prevention, not correction. Identify and predict issues and trends before they spin out of control.

• FDA “theoretically” defines CAPA by purposefully offering flexible and vague ideas, rather than specific details. Is that good or bad? It depends.

• Data doesn’t lie, companies struggle with CAPA. FDA’s lack of information leads to interpretation.
• When the FDA issues 483s and warning letters, the usual solution is mandatory training to require employees to know and understand design controls.

• CAPA is an indicator or biomarker of the health of a company’s quality management system (QMS).

• Metrics should measure the effectiveness of CAPA. Time constraints and root cause determination need to be addressed. Keep asking, “Why?”

• Companies need to go above and beyond to prevent problems. They should review their CAPA process, evaluate efficacy of QMS, and address root cause.

Links:

CAPA Medical Device Tracking

FDA 21 CFR Part 820.100

ISO 13485

FDA Form 483 Frequently Asked Questions

Global Harmonization Task Force: Quality management system – Medical Devices – Guidance on corrective action and preventive action and related QMS processes

Mike Drues

MedTech True Quality Stories Podcast

Greenlight Guru

Memorable episode quotes:

“CAPA is all about assessing and evaluating a systemic issue that you need to correct or prevent from happening.” Jon Speer 

“Companies, I think they struggle with CAPA...because of the words that are there, or the words that aren’t there, or their interpretation of what’s there.” Jon Speer 

“I find the root cause of many, if not most problems...is what’s between most people’s ears.” Mike Drues

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: CAPA, oh my goodness, Corrective Action Preventive Action continues to be, I think, an area where... Honestly, we as an industry can do a much better job of managing these systemic issues and frankly, be much more proactive rather than reacting to situations. Mike Drues and I dive into some of the details on CAPA, or should I say PACA, and you'll have to listen to understand what I mean when I say PACA. But enjoy this episode of The Global Medical Device podcast.

Jon Speer: Hello and welcome to the Global Medical Device podcast. This is your host, founder, and VP of Quality and Regulatory, Jon Speer. I was talking with Mike Drues of Vascular Sciences the other day and yeah, he's joining me on today's episode. But we were catching up a little bit and one of the things that I mentioned to him is it seems like CAPA is this topic that is really important and we've touched on it briefly a time or two, but it's been a while, and I think it's one of those evergreen topics that is important for us as medical device professionals and as an industry to make sure we've got our finger on the pulse of what's going on and we'll dive into some of the details here a moment. But Mike, welcome to the Global Medical Device podcast.

Mike Drues: Thanks Jon, always a pleasure to speak with you and your audience. And I agree 100% that CAPA's one of these evergreen topics and we should definitely dig into it a little bit further. So I know that there are a lot of very savvy, very experienced medical device professionals in our audience Jon, but I also know that some folks are relatively new and might not be familiar with the Corrective Action Preventive Action or CAPA process. So maybe just a real quick primer, Jon, for our audience on what is CAPA.

Jon Speer: Absolutely. So folks, CAPA is an acronym. CAPA, Corrective Action and Preventive Action. From a regulatory perspective, if you're looking from an FDA standpoint, all the regulations are theoretically defined in FDA 21 CFR 820.100. It's not a lot of stuff there, frankly. If you print it out, it might cover half a page printed. It's a little bit more expansive, but not a whole heck of a lot. If you were referring to ISO 13485 2016 version, this is covered. Actually it splits up Corrective Action and Preventive Action into two different clauses, referenced there is 8.5.2 for corrective action and 8.5.3 for preventive action. But in layman's terms, CAPA is all about assessing and evaluating a systemic issue that you need to correct or prevent from happening. Correction is probably the more common of the approaches because we... The series of events have already happened and that we have to correct them from happening again.

Jon Speer: Whereas the more proactive side of this would be to take some preventive action to see or to identify trends before they become trends. You might have heard Mike and I talk about this in the past, being able to predict issues before they spin out of control. So making informed decisions after a couple of occurrences rather than 10 or 15 occurrences. So, that's sort of the gist of CAPA is a means to formally investigate an issue that's deemed as systemic or a big deal within your company and properly take actions to prevent this from happening again.

Mike Drues: I think Jon that's a terrific synopsis of CAPA, and we'll dig into this in much more detail as we continue here. But I agree with you, Jon, that by calling this CAPA, Corrective Action, Preventative Action. It is the classic retrospective approach. In other words, solving problems after the problems have occurred. What I think, and I've made this suggestion before, we should not call this CAPA. Instead, we should call it PACA, Preventive Action Corrective Action because the emphasis should be on the prevention, not on the correction. But you mentioned in your synopsis, Jon, you gave us a lot of sources to the specific regulation, that we can provide on the website links to those sources, but you also said that this is where this is theoretically defined. I'm just curious, Jon. I think I know what you mean by that, but what did you... For the benefit of the others in our audience, what did you mean by "This is where the regulation is theoretically defined."

Jon Speer: Well, if you go to 820.100 in the FDA website, I didn't do a word count there. But seriously, it is less than a half a page of information if you were to print it out or to look at it. I mean, it's not a lot of words that are there and there is certainly not a lot of details and it's not super prescriptive. It's more ideas or more the "Thou shall" type of statements. There's a lot that is left up to interpretation, so to speak. And historically, companies, I think they struggle with CAPA, and I don't know if they struggle because of the words that are there or the words that are not there or their interpretation of what's there. But nonetheless, there's a lot of details of when it comes to CAPA, a lot of areas where companies are really struggling with this, and I think the data doesn't lie if we were to look at the FDA inspection on all data. The FDA every year, they publish where companies are struggling with respect to 43 observations and warning letters and so on. And CAPA is almost always either at or very near the top of the list of topics where companies are struggling. And so I think, there's something there that we're missing as an industry from that perspective.

Mike Drues: And I'd like to dig into that a little bit more Jon in terms of why, as you pointed out and you're exactly right, that so many companies struggle with this. You made an interesting comment a moment ago that this part of the regulation is only half a page or so long. Well, my question is, is that a good thing or a bad thing? I view it similar to in the preamble to the quality management system on FDA's website and the design controls. These are purposely written to be very non-specific, very nebulous, very vague, because the medical device industry, is a very broad industry, and you know a CAPA procedure for a company making band-aids may be very different than that for making artificial hearts. Right so it's specifically written in my opinion, to give us a lot of flexibility to use our own professional judgment based on our particular technologies, our particular devices. Do you think, Jon, that that is a good thing or a bad thing?

Jon Speer: As a good regulatory or quality professional will often answer a question, it depends, [chuckle] I think it's challenging, like I said, that if the data is an indicator of future results, then one could say that it's a bad thing because, for whatever reason, we as an industry, there's something we're missing, and it might be that earlier point, that we chatted briefly about just a few minutes ago about, should it be CAPA or should it be PACA? You know should we focus on the corrects or should we focus on the prevention that all by itself, could be the challenge is that we're reactive, it seems like we're very reactive, as an industry, we're waiting for the event to happen before we do something about it. And maybe that's the problem all by itself. Maybe the CAPA process, if we just flipped it and had our focus be more on the proactive, the preventive side, maybe we would fix all of our problems all by themselves, if we just did that. I don't know, it's a bit altruistic, I suppose, but maybe there's some weight in that too.

Mike Drues: We're taking it one step further Jon, you made an interesting comment that maybe something is missing here. Well, my question and then perhaps I'll leave this as a rhetorical question is why is it that we in industry, or a particular company are missing something that FDA is not. You know, to me, that's very problematic because to me, that would imply that the FDA knows something that I don't know and if that's the case, then quite frankly, I'm not doing my job. Something to think about. Go ahead.

Jon Speer: No I was just gonna say yeah there's truth to that, I suppose, but if you look at the, and the data it's semi-fascinating, I think, at least from my lens of looking at it because what it often points out is that if you started to drill into CAPA one of the problems, usually the bigger topics that are identified are something about the company's procedures and anytime there is a citation for 43, or a warning letter, they're pointing, the inspector will point out the specific clause of the regulation that it pertains to. But I don't think that tells a very good story, just because 820.100A, that has to do with procedures around CAPA, just because that is the number one citation for CAPA is it doesn't really tell the whole story. So for me, I wanna understand what is it about that process? Do companies not have processes defined, or do they have processes defined, and they're not following them, or is there some other nuance or detail that is sort of buried and not necessarily prevalent in the data, you know.

Mike Drues: I do and actually, maybe if it'll help Jon let me share with you a quick story from my world to illustrate and I would love to hear your thoughts on this. But a couple of years ago, I worked with the company that got a number of 483s. This is a fairly large medical device company and one of the solutions that resulted from the CAPA that was generated from these was increased training. Training is a common solution for a lot of problems. In this particular case it was because not enough people in the company were knowledgeable of the design controls and the design control process so as part of the solution that the company proposed to the FDA, they said, "Alright we're gonna train all of our RND engineers and manufacturing engineers better on design controls." And they invited me to come in and do a series of workshops. But here's the thing, these training sessions were "required" for all RND and manufacturing engineers to attend. In reality about 50% of the people showed up. So what I learned from that was maybe mandatory has different meanings to different people. [chuckle] That learning number one and learning number two, the training involved essentially a one-hour overview of design controls. And I know, Jon, you're a guru when it comes to chip design controls. Just imagine trying to teach somebody everything there is to know about design controls in one hour. It's not an easy thing to do.

Jon Speer: No.

Mike Drues: I would argue it's probably impossible. And I had people coming out of the room telling me they would I'm sure never admit this to their senior management. Never say publicly. This was nothing more than the company just ticking a box on the form saying, "Okay we got these 483s, we gotta do more training. I attended the training, and now the problem is done. The problem is solved. I don't know about you, Jon, does that seem like a good solution?

Jon Speer: No, it doesn't and I would say that that is more times than not unfortunately, I've seen the same sort of scenario many times. And I think this is, I think we're starting to get to maybe some of the reasons why CAPA or PACA however we refer to it for this podcast is a challenge for companies because it seems like an exercise in hand waving, more times than not unfortunately. We oh, it's escalated, this elevated as a CAPA that way it's more serious and that sort of thing, but the actions, the behaviors, the formal investigation, the drilling down to identify the root cause, I think misses the mark and to say that in your example that you can do an hour-long course on design control and voila people are trained. That's not an effective means to address that particular issue.

Mike Drues: And yet, I won't mention which one but this was a major medical device company. Okay, let's dig into this a little bit further. One of the things I've heard you say before Jon is that the CAPA system of a company is an indicator, a biomarker if you will, of the health of the overall company's quality management system. And I think that's a very intriguing observation. I wonder if you can explain what you mean by that for the audience that the CAPA system is an indicator of the health of the company's QMS.

Jon Speer: Yeah and I don't know that I can claim full credit for this. I know it's a pretty good document and I'll provide a link to this as well but the Global Harmonization Task Force, it's now known as IMDRF. I won't get into that. But back quite some years ago they actually published a guidance document on Corrective Accident Preventive Action effect. I think it's kind of funny and this guidance document they even specify the acronym CAPA will not be used in this document because the concept of Corrective Action and Preventive Action has been incorrectly interpreted to assume that a preventive action is required for every corrective action and so and so forth. But I believe that it's this document, I think it might also be the FDA QSIT, the Quality System Inspection Technique Guidance talks about CAPA being sort of the health of your quality system and I think the reason that that's somewhat interesting is, again, if you think about CAPA or Corrective Action and Preventive Action as being reserved for systemic issues, sorta big ticket issues, then if you have a lot of those then that could say there's something that's not effective about the underlying processes and procedures that you have in place from a quality management system.

Jon Speer: Conversely, just because you don't have a lot of them, don't be lulled into believing that there aren't other quality system issues. As they say, the devil is certainly in the details and you'd want to interrogate your CAPAs, or lack thereof a little bit further to tell the true story. But this is certainly... If you go through any FDA inspection or you go through any ISO audit, CAPA, your CAPA process will be evaluated. Certain records will be part of that audit or that inspection and the auditor or the inspector will... They will follow the thread so to speak. They will see all the corresponding and correlating and related items and how they're connected to other quality events or other things that you're doing within your business. So it is the place that almost every single audit or inspection from a quality management system perspective, it's almost always the starting point or it's gonna be evaluated.

Mike Drues: Well, again Jon I could not agree with you more and you gave some great examples of trying to interpret that regulation a moment ago. If I can be even more brutally honest, I think that the root cause of why this is so difficult is because many of these guidances both here in the United States as well as in other parts of the world are written by people quite frankly who have never developed a medical device or manufactured a medical device themselves. And this is indicative of a whole other set of problems but it's like if you needed surgery, would you want it be done by somebody who's never done surgery before but have read about it in a textbook? That's a problem across regulatory and quality across the board. But let's move on 'cause there's two more pieces that I think are very important for our audience to hear to make this as pragmatic, as actionable as possible. We've talked about some of the reasons why many companies struggle with CAPA and the CAPA process. Are there other reasons Jon that you would add to that list of why so many companies have such a difficult time with this?

Jon Speer: Yeah, there are a couple of things that come to mind. And I think first of all when we look at our CAPA process, oftentimes we will assign a KPI or some sort of metric or maybe multiple metrics to determine "effectiveness" of the CAPA process. And I think sometimes we're measuring the wrong things. I think sometimes we are so timeline sensitive that oftentimes that we will put a time constraint or a threshold as a target for when we should be done with a CAPA. And some companies will say, "CAPAs need to be done within 90 days," or they'll assign some sort of arbitrary time constraint to that. I think that's a big problem.

Mike Drues: I think that's one problem and on one hand, I'm not a fan of absolutes of having 30 days or 90 days or 180 days or whatever. But it depends on the situation disparity and so on. But on the other hand, we don't want things lingering on the vine so to speak for too long of a period of time. Okay, so the time concern is one. Any other reasons why you think companies struggle with this?

Jon Speer: I do think of another thing that comes to mind and then I'm gonna... I have a tip that maybe can combine the time constraint and this other item and then I'll offer that here in a moment. But I think the other thing is that we're doing a really poor job of root cause determination. I think I would encourage you all to do a deep dive. Maybe issue... It sounds a little flip but I mean this with seriousness too, that you should probably do a CAPA on your CAPA process probably at least annually and interrogate those records. But the root cause, I would question whether or not we're truly getting to the real root cause. And you know, and I'm gonna confess, early on in my career I was a... I did a poor job of managing CAPAs because a lot of times when we get to the root cause, it's almost... It's a really bad habit but a lot of companies they still do this where they will almost restate the problem whenever they identify the root cause.

Jon Speer: A root cause done properly should be some sort of analysis or some sort... It should be a deploying or using some sort of methodology to get there and there's no one size fits all but there's a lot of good tools that are out there. Cause and effect and fishbone diagrams or Ishikawa diagrams. You could do 5 Whys, sometimes you could do fault trees, sometimes you could do failure mode there's a lot of tools but you should do some sort of analysis to try to drill down. My personal favorite is the 5 Whys to determine a root cause because it's really simple, it's really easy to use. Anybody that's been around a three-year-old will understand how to use the 5 Whys. And it goes like this: Your three-year-old says, "Hey, dad, can I have this?" And you say no. And what is that three-year-old gonna say? "Why?"

Jon Speer: And that process is gonna keep going. And so, the 5 Whys is sort of similar to that. You just keep asking why, why, why, why? Until you get to something that you can hang your hat on as a root cause. But I think again, to wrap that up, we don't do a very good job of root cause determination. And so, if you do a poor job of root cause determination, and you slap something together and make a statement about, "Oh, it's this," and then you proceed to do actions and try to correct those things, the likelihood that you're going to actually address and mitigate and prevent that from happening again is there's no certainty about that. It's just like slapping a Band-Aid on it.

Mike Drues: Well, again Jon, I could not agree more. As a matter of fact, I wish I could disagree with you about your assessment of how well as an industry we do when it comes to identifying root cause. I'll be honest with you, as a biomedical engineer, I hear people talking about root cause all the time. And rarely, if ever, do they get anywhere near to what I think is the true root cause. They're usually just dancing around on the surface, applying Band-Aids to problems. I find the root cause of many, if not most problems, and I love your three-year-old metaphor, Jon, explaining the 5 Whys. I think there probably should be a heck of a lot more than just five. But I think the root cause is what's between most people's ears, what's between most people's ears, if they're thinking about this whole... But anyway, and I loved your suggestion, and this brings us to the last topic of discussion of what companies can do to try to improve, to try to prevent these problems.

Mike Drues: I love your suggestion on instituting a CAPA on our CAPA procedures, let's see if in fact, our CAPA procedure is as good as we think. I've made suggestions, and perhaps you and I have talked about some of these in the past, Jon, in terms of evaluating the efficacy of your QMS by purposely injecting a problem into the system to see if your system is capable of detecting it. So perhaps, that can be thought of as a bit of a riff on the CAPA.

Mike Drues: I've also suggested oftentimes, when a company identifies a problem and starts a CAPA, this goes back to root cause, they're not really addressing the root cause. They're addressing the symptom. So they have CAPA number one, and then they address that. And they have CAPA number two, and then they address that. And CAPA number three, and they address that. But one thing that I've suggested to companies is on a periodic basis, whether it's once a year, or twice a year, or quarterly, take a look at all of your CAPAs collectively and see if these are individual root causes, or if they're really just iterations on the same theme. I don't know if I'm doing a very good job of explaining what I mean by that, Jon, but what are your thoughts in... What other suggestions would you have for companies to improve? We're talking, for our audience, we're talking about going above and beyond what is required because none of the level of detail that Jon and I are discussing today is in that one-half page that Jon just alluded to earlier. So what do you think of those suggestions, Jon; or do you have others?

Jon Speer: No, I like those. And to build upon your you may have multiple CAPAs, and then periodically, evaluating and reviewing each of the CAPAs that have been issued to see if there's any trends within those CAPAs, I think that's key. And it gets back to that point of you may identify... If you're doing a good job and you identify a root cause that's deeper than just addressing a symptom, I think it's important to think about, "Okay, does this... Do we have this sort of issue, or this sort of root cause? Could it be prevalent in other product lines, or other processes, or other parts of our business?" And if even though you might be in a situation where you're correcting or reacting to a situation, and in one particular CAPA, there's an opportunity to be proactive or preventive in applying that sort of lens at other products and processes that may have similar sorts of root cause challenges that are maybe haven't surfaced, but could be there. And so, this gives you an opportunity to be a little bit more proactive with that approach, for sure.

Jon Speer: The other thing I see a lot, way too often, frankly, is that CAPAs, even though we look at them sort of as important as far as the health of our quality system, and we have CAPA files and records, and all that sort of thing, I don't think we do a very good job as an industry of appropriately staffing or resourcing CAPA teams. I don't think we treat CAPAs with the same importance within our organizations as, say a new product development project, or a design change, or a regulatory submission. I think CAPA is... I've seen it all too many times where it is the thing that might have some people assigned to it, but it's the thing that never gets time. It's the thing that people do when they have a few extra minutes here and there.

Jon Speer: And so, it doesn't get the same emphasis as far as actual resource allocation or budget, if you will, of time as maybe some of the other sexier things that we do in companies. And so, I think that's a problem, too. It probably is more important in some cases than a product development project. It's probably more important than a regulatory submission because again, if you think about CAPA as being an indicator or some sort of systemic issue or potential systemic issue, why wouldn't you spend more time, effort and energy on staffing and making sure that resources are allocated to that appropriately?

Mike Drues: Well, I think that's a very interesting observation, Jon. And if I were to speculate, I would probably guess that it's because CAPAs are viewed as a cost of money, as a revenue spender, as opposed to developing a new product or changing an existing product would be a revenue generator. And so, that's obviously... But nonetheless, obviously a CAPA can cross this money in the short term, but we're hoping to spend this time and money to prevent even other problems in the future. So I suspect the answer to your question is that it's easier for marketing to push generation of new products and new submissions and making existing products better, as opposed to trying to fix problems that have happened because maybe we didn't do our job quite as well as we should have and this is why we're having problems to begin with.

Jon Speer: Yeah, absolutely. And I think there's some other things that we should evaluate that can have a opportunity to sort of improve or help your CAPA, and maybe some of the other things. I think I've seen a lot of companies who will... I'll just say, they get a little CAPA happy, where if they get a...

[chuckle]

Jon Speer: For example, a non-conformance or a complain or something like that. They may even have it written into their procedure that that automatically would generate a CAPA. And so, pretty soon, they over-burden their CAPA system. There's a lot of things that are issued as CAPAs, and none of them are getting the time, effort, and energy to be done. So I think just be careful of what triggers a CAPA. And the flip side of that is, why not make sure that your complaint handling process is robust enough to handle complaints? Why not make sure your non-conformance process is robust enough to handle non-conformance? Just because you have a quality event, doesn't mean that it has to necessarily be treated as a CAPA.

Mike Drues: Well, I love your phrase of CAPA happy, Jon, and it reminds me of a discussion I had over dinner with one of my very good friends who's the Senior VP of Quality and Regulatory in a Fortune 100 medical device company. He and I were very good friends in graduate school. And we got into an interesting discussion about what is the ideal number of CAPAs for a particular medical device company. But you're exactly right, if companies issue too many CAPAs, then we run into the boy who cries wolf kind of a phenomenon. People just don't pay attention. Or perhaps a more modern metaphor, imagine walking through a crowded parking lot at a shopping mall and you hear a car alarm going off, most people today don't even pay attention because it just happens so frequently.

Mike Drues: So if we have too many CAPAs, then we run into that kind of a risk. On the other hand, if we don't have enough CAPAs, then we run into the risk of repeating the same problems over and over again. So there's gotta be a middle ground. And this is why I work really hard with companies, and I know you do as well, to develop criteria to determine, in their particular company, given their devices and their technology, under what circumstances to open a CAPA, and then what circumstances not to. And one step further... And I'll give you the final word on this Jon. Once you develop that criteria, that just like a risk management plan, that's not supposed to be something that just... You stick in a file, and you never touch again. You constantly gotta be asking yourself, "Do I need to revise that criteria? Do I need to update that criteria? Do I need to change that criteria?" based on new information as it comes in. So this comes back to what you mentioned, and I'm 100% in favor of this, a CAPA on your CAPA. Philosophically, I think it's a very interesting idea. Jon perhaps we should wrap this up by sharing what we think are maybe the one most important take-away message for our audience to come away with when it comes to CAPAs. What would that be?

Jon Speer: Oh, one. This one single most important thing. I think if it came down to it, frankly, it would be to be more thorough with your root cause, quite frankly. Being more thorough with your root cause determination, being methodical and analytical about that. Well make sure that that particular CAPA is getting the right time, effort, energy attention, action plan, and so on, to address that particular issue. And then if you take it one step further, but a huge opportunity for a business to improve their overall throughput and overall QMS efficiency, would be to look at that root cause that you methodically and analytically determine, and identify if there are other products, processes, or parts of your business where that particular root cause might also be buried and hasn't necessarily reared its ugly head yet. Or maybe it has reared its ugly head. And apply that learning toward those opportunities as well. So I would say one single biggest thing of focus on doing a bang up, thorough job on determining your root cause.

Mike Drues: Yeah. And I agree whole-heartedly. Root cause is a great take away. My take away, in addition, would be to be proactive, not simply reactive. In other words, as we talked about at the beginning, don't think about this as a CAPA, think about it as a PACA. Be more proactive. That's where our emphasis. And I'll make one quick suggestion on how to do that. This is an idea that comes right out of the design controls, Jon, something that I know you're intimately familiar with. And that is, let your outputs become your inputs. So take your existing CAPAs, your existing complaints, and feed them back into your system to see if the criteria that I mentioned a moment ago, that you should set up for determining whether a CAPA should have been instituted or not. If that criteria was sufficient to generate that CAPA, if it was necessary, or alternatively, not to, if it was not necessary, and continue to repeat that process. Periodically, I don't wanna go so far as to say that FDA should say companies should do this once a year or twice a year, or wherever it is. That should be up to the company to decide based on their technology, how well established the technology is, if the device is brand new. That's one thing. If the device has been around 20 years. That's another. But use the outputs and feed them back in as your inputs, and constantly make adjustments to your own systems. Not just your CAPA system, but your entire QMS, overall. So be proactive not just reactive.

Jon Speer: Yeah, that's good.

Mike Drues: So root cause and proactive, I think is two great lessons to be learned. Why don't you wrap this up, Jon?

Jon Speer: Yeah, absolutely. And I like that last point that Mike shared. Because your quality management system, it is a full ecosystem. It is a closed loop system. One process relates to another, relates to another. And so, often, I see companies, they almost treat their Quality Management System as a series of silos and a series of processes. Where quality has this, and regulatory has this, and engineering has that. And yeah, sure, each of these different processes may have different owners but you have to understand the big picture and how one might be the output of one process becomes the input of the other, and so on. And it feeds one another. And in today's world, you really need to make sure that your quality management system is architected in a way that allows that visibility of all this inner relationship. And this is what we've done at Greenlight Guru. We've built an EQMS platform for the medical device industry, that ties all of these processes together in one single source of truth.

Jon Speer: So if you're struggling with CAPA, or you want some guidance and direction on how your design and development activities should be feeding into post-market activities, well go to www.greenlight.guru to learn more about our EQMS software and how it's helping companies all over the world improve their throughput, move beyond just compliance, and focusing on true quality. Speaking of true quality, you've been listening to the Global Medical Device Podcast, but did you know that we, at Greenlight Guru, we recently started a brand new podcast as well? Yes, that's right.

Jon Speer: It's called MedTech True Quality Stories. And for me, it's fascinating. I love it. I love talking to folks like Mike and other guests on the Global Medical Device Podcast. With the MedTech True Quality Stories, it's a little bit of a different lens. We're talking to med device professionals like yourself, people who have been there, done that, and you may be doing it right now. And they're sharing stories about their true quality experience, how they've embraced what a quality management system can do to help them run better businesses, but also improve patient outcomes in the process. So go check that out. Wherever you're listening to this podcast, you'll be able to find MedTech True Quality Stories as well. As always, appreciate you listening, appreciate your comments. Mike and I, all the time, get to hear from a lot of you about how much you enjoy the global medical device podcast. Keep the feedback and the comments and the suggestions coming. And you've been listening to the Global Medical Device Podcast.

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