Medical device companies must comply with a list of strict requirements throughout the duration of their product's lifecycle. These compliance efforts will be put to the test once an FDA inspection or ISO audit rolls around. As it turns out, there are a few common culprits when it comes to compliance issues for manufacturers.

In this episode of the Global Medical Device Podcast, Jon Speer talks to Tom Rynkiewicz, Vice President of Life Sciences for RA/QA and ASQ Certified Quality Auditor, about the three most common compliance issues and offer answers to questions like, why are the same select areas continuing to cause issues and what’s beyond these recurring compliance issues?

 

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Some highlights of this episode include:

  • Based on FDA data, the same issues are the top issues year after year. Are people simply not paying attention to the observations they receive? Are they intentionally not being compliant? Probably not, but then, what are the reasons?
  • FDA does not require medical device companies to share internal audit results that address components of a quality system. Rather than being dishonest, hire an independent, third-party to conduct internal audits. 
  • Another issue with internal audits is that only individual components of the quality system are audited. However, when FDA performs an inspection, they inspect the entire quality system - all components combined.
  • The corporate management mindset is to manage complaints and CAPAs. However, the entire process should be built upon having zero complaints. Improve the product, make it safer, make it better quality to not get complaints.
  • The CAPA effectiveness measure is not always effective. Some elements may be good to know, but do not actually measure the effectiveness of CAPAs.
  • FDA audits will find something. Nobody’s perfect, including inspectors. Their ultimate goal is to improve products and safety.
  • Human Behavior: Be honest, transparent, and take a system approach to gain efficiency and true quality culture.

 

Links:

FDA - Medical Devices

ISO 13485 - Medical Devices

FDA - Corrective and Preventive Actions (CAPA)

FDA - Case for Quality Program

FDA - Current Good Manufacturing Practices (CGMP) Regulations

Tom Rynkiewicz on LinkedIn

Raland Compliance Partners

The Five Behaviors by Patrick Lencioni

Greenlight Guru Academy

The Greenlight Guru True Quality Virtual Summit

MedTech True Quality Stories Podcast

Greenlight Guru YouTube Channel

Greenlight Guru

 

Memorable quotes from Tom Rynkiewicz: 

“Out of just human behavior, they want to help each other. So, they are not brutally honest.”

“The second issue about internal audits is they’re auditing individual components of the quality system. When the FDA comes in, they inspect the quality system.”

“We all manage our complaints. We manage our CAPAs, and as long as they hit some acceptable threshold, we’re good.”

“Shouldn’t the entire process be built upon having zero complaints? The reason we’re doing this is to improve the product, make it safer, make it better quality, so we don’t have to manage complaints.”

 

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 in companies.

Jon Speer: As many of you probably know, I've been in the medical device industry for gosh, over 23 years now. It's hard to believe, it's been that long time flies and by and large, I've had pretty much a good time most of that duration, but one of the things that's always been a little bit of a head scratcher as I actually scratch my head is compliance, especially on quality assistant things. We know as medical device companies who are in the United States, especially, and even outside the United States, you're going to be subjected to audits whether that be, FDA for US or potentially you have an ISO certification and you're going to have to maintain that compliance as well. Specifically when it comes to FDA year after year, after year, after year, after year, after year, I can go on and on and on same issues are always at the top. And they're usually things like CAPAs complaints design controls and there are a few others. But CAPA complaint design controls, those are almost always in the top five, maybe from the top three issues that medical device companies have. Why is that? Why do we keep struggling with these things? So I have an opportunity to catch up with Tom Rynkiewicz, VP of RAQA at Raland Compliance Partners. And we chat a little bit about that, but then also give you a little bit of food for thoughts, things to think about, what's beyond those big recurring compliance issues. Is there something else that we should be focused on? So I hope you enjoy this episode of the Global Medical Device Podcast. Hello and welcome to the Global Medical Device Podcast. This is your host and founder at Greenlight Guru, Jon Speer and joining me today is Tom Rynkiewicz. Tom is the VP of RAQA at Raland Compliance Partners. Tom, welcome to the Global Medical Device Podcast.

Tom Rynkiewicz: Oh, thanks for having me Jon.

Jon Speer: Oh, absolutely. So we were catching up a little bit before we started the recording today and I think a good thing for us to talk about today. We got a lot of experience, I think from both the device and the pharma side, you've been doing this for a while, you probably lost your hair on the process like I did.

Tom Rynkiewicz: Yeah that's about it. But I didn't pull out, fell out so.

Jon Speer: Oh yeah, and truth be told mine was probably gone many years before I got into the depth of the industry. But you shared with me some of the things that you're observing and I thought today we could talk about, what are some of the current compliance issues that are happening in the med device industry? And I guess the second part of that, why are these things continuing to happen? Because, if you look at data year, after year, after year in large part the same issues are the top issues year, after year, after year. So maybe that'd be a great place to start. What are you seeing in your practice?

Tom Rynkiewicz: Yeah, it is exactly what you said, Jon. It is very interesting. We're sitting here looking at things, it really was a mid 2000 when FDA started really going after the device industry. And some of the first observations they had were, in their quality system CAPA complaints design controls, things like that. And almost every device company, that gets inspected get some observations in one or more of those same areas. And so you got to look at what's going on here. Are people just not paying attention? Do they not want to do these things? Are they intentionally not being compliant? And I don't believe that's the case. So, it's interesting when I look at with the reasons behind it and why don't companies look at what's happening to their peers. Why don't they see that? Why don't they fix that? And while I think there has been some improvement, the one aspect that the companies don't have to share with FDA are the results of their internal audits. Expected to prove that they have an internal audit program, however, they're not required to share that information. So, what I've noticed over the years different projects, different clients, it pretty much goes across the board that what they do internally is they have internal audits that address components of the quality system. So maybe, Mary who is in quality control does her internal audit is over Bob, who is the CAPA guy and the dynamic that doesn't get addressed is Bob and Mary probably know each other fairly well, probably have lunch together, even and out of just human behavior, they want to help each other.

Jon Speer: Sure.

Tom Rynkiewicz: So they're not truly honest. They don't write down the observations to say, Bob knows Mary's going to get in trouble if he points out things and it ends up in the management review which is another interesting aspect of the entire quality system is where that happens into what depth. How complete that management review is. But I think there's a two part issue here is no number one, the internal audit is focused on a component of the quality system and then the human behavior piece of not wanting to help their peer improve. So maybe a point out that, oh, you forgot to sign these documents. You forgot to note all this stuff. And in the end, those things continue to happen. And they happen until an FDA inspector comes by and happens to notice the same thing. The second issue about internal audits is we auditing individual components of the quality system. When FDA comes in, they inspect the quality system. So two different ways around that, what I've done with some of our clients, not all clients willing to bite this off, but some are, is to have an independent company who you contract, you called internal audits but you contract with a company self- serving as a Raland or someone else doing this.

Jon Speer: Sure.

Tom Rynkiewicz: And actually come in without those personal relationship bias. And we've done that for some companies over the years and it's been very successful in finding the problems. Fixing them is a different story because that still takes the company to adjust their processes and their practices. But the other thing is to change the focus the style of the internal audit, which means let's do the internal audit rather than individual components. Let's do it the same way an inspector would. We're all managing CAPAscomplaints and come in digital an inspector, would they yank one out, yank out a CAPA and say," Show me the complaint that went along with this. Show me the investigative. Show me the root cause investigation. Show me where you brought it back to your design control. Show me where you improved your product." So that you don't have that issue. And that to me would be a successful style for doing an internal audit because you're exercising your quality system, as opposed to looking at a piece. To me that can work and should work. Not a lot of companies... Most companies... We actually have had success with small firm doing it because they're not already entrenched with, 10 or 15 or 20 years of doing things the same way we've always done them. But new companies are starting out. They're developing their quality system, because it doesn't have to be as a startup company. You don't have to have everything in place. You have to have the framework in place for the quality system, as you guys know.

Jon Speer: Of course.

Tom Rynkiewicz: So they're much more able to adapt and do the right thing for the right reason. And one of the other interesting observations I see, observations of mine when we're talking with companies is they all have, especially a lot of large companies, we all manage our complaints. We manage our CAPAs. And as long as they hit some acceptable threshold, we're good. Where we, geez, we have a CAPA turnaround of 90 days. That's great because we used to have 120. We only have a small back or 50 cap or complaints backlog instead of 100 who we used to have. You think about it, shouldn't the entire process be built upon having zero complaints. The reason we're doing this is to improve the product, make it safer, make it quality. So we don't have to manage compliance. We don't have to manage CAPAs. But it's interesting because we all fall into this corporate management scheme that we got to have this. And in fact, I'm speaking with someone at a very large company just recently. And he was telling me how their product line is. They've got a 90% of their products that are sold, our research use only and 10% are sold to customers on the market, the filed device yet when they're doing their investigations, looking at complaints, they don't count the 90%, even though it's the exact same product, they don't have to report those because that's research use only. So the opportunity to actually improve their product is only 10% of what it could be. So it's a lot of this is to me is human behavior piece. We get out there in the corporate world, everyone's got a job to do, we've got a complaint handling department that handles calls or a call center that takes them all in from the public or physicians and they fall into this bucket where somebody has a job to do. And they have to do this job eight hours a day. And frankly, they don't want to work themselves out of a job either. So nobody's jumping up and saying," Hey, let's look at this differently to get rid of this aspect." To improve our product, to the point we don't have these. What if instead of having, a 1000 complaints a month come across your desk that have to be then bucketed into different categories. What if it was 50? So now instead of having a team of people, you have one or two people and maybe you're not having the same problem you used to have. So it's interesting when you look at it, that human behavior piece of it.

Jon Speer: Yeah. I jotted down a couple notes. I have a couple of, I guess reactions. Maybe we can dive into a little bit further. I guess the first one you talk about the way we've corporately designed or architected our various processes is oftentimes some KPI or something we're measuring about those individual process. Like you mentioned, number of days a CAPA is open, number of open complaints and things of that nature. Do you feel like maybe we're measuring the wrong things when it comes to these processes?

Tom Rynkiewicz: Definitely, in some cases we are. Instead of, we talk about CAPA effectiveness, a lot of times that effectiveness measure is how long they're open or how many.

Jon Speer: That's right.

Tom Rynkiewicz: It's not effectiveness, that's not-

Jon Speer: It's good to know, but it's not the measure of your effectiveness.

Tom Rynkiewicz: ...It's good to know from a people management. How many people you need and what you have going forward, but it's not really measure your effectiveness of your CAPAs. And because when it breaks comes down to it and it perpetuates, we get down to the internal audit and we look at, did we do a good job on this little bucket? If we do a good job on this one? This aspect of the quality system, not the whole thing. The CAPA effectiveness is only effective if the whole entire process works and springs together.

Jon Speer: The other thing that I want to explore a little bit further is this notion of, I would say the classic or probably the conventional approach, as you've mentioned to internal auditing, is that we break it down element by element and arguably speaking a company probably past somewhere between 20 and 50, give or take, different procedures and they'll schedule internal audits. And I think that, in some respects that could be good because it's really scrutinizing that individual process. But I hear your point. Very few companies actually take that top down overall system view of their audits. So it's like, if you want to do the individual elements, okay, I get that those are opportunities to streamline and fine tune in the process, but you have to take a big picture look. And I know people are going to say, but Jon, Tom, we're struggling to do internal audits as it is. Keep in mind, FDA when they come to do their inspection, generally they're going to take about five days and generally, they're going to be able to cover all of your processes in that system approach. So there's something to be said for that.

Tom Rynkiewicz: Yeah. The thing is when you're only auditing an element of your quality system, exactly what you're doing is you're looking at the procedure. Did we follow this procedure, we do the documentation. And while that is important, we can't deny that somewhere down on the list, maybe four, five, six is documentation as far as audit observations, people not following their own procedures. So there is something to be said for that, but that's really not. When FDA comes in, they're not going to pull out, give your whole list of CAPAs that you've on and start looking for the CAPA document. They're going to pull and look and say, " Did this string follow all the way through?" So-

Jon Speer: And I think taking that-

Tom Rynkiewicz: ...Yes, they still find the documentation procedure. So what are we really doing? We're doing the individual element where it should be a documentation verification, yet they're still finding them because it's still high on the list.

Jon Speer: ...I was just going to say even from a system approach, if I'm taking that approach as an auditor and I pull a CAPA example, I can determine whether or not that CAPA procedure was followed just by looking at that. But then I'm more interested in you didn't use these words exactly. But following the thread, what happened upstream and downstream as a result of that. I mean, understanding these parts connect is really the big picture. It's how we get better as medical device plant.

Tom Rynkiewicz: Yeah. At the end of the day, my opinion, that's what we should be doing because if our focus is compliance to some regulation and the ticking a box, filling out a document, filling out a checklist. If that's the extent of our focus is complying to something instead of a quality system that assures that we're giving safe and effective product to the public, to our patients. So it's quite interesting and I know there's some discussions around that. The case for quality program and FDA is largely right now on the pharma side, but it's a dynamic that device and pharma and near the 20 shall meet. The GMP regs are pharma, we don't talk about those. Let's talk about the eight twenties or ISO 13485, that's that's our side, which it comes to different issues as we go down the line to that so far haven't really been addressed.

Jon Speer: Maybe we'll talk about that in a moment. But in the meantime, I want to take a quick break. I want to remind folks, I'm talking wit Tom Rynkiewicz. Tom is the VP of a RAQA at Raland Compliance Partners. Tom, while we're taking this break, do you mind sharing a few words and sharing with folks a little bit more about Raland and the types of services that you offer?

Tom Rynkiewicz: Sure. So we're a quality and regulatory compliance consulting company. We're not unique in the market. There are a lot of people doing what we do. Our focus is really making sure that we're a service first company. So it's what our client needs. We don't walk in and impose our process. There certainly are plenty of companies who say, here's our best practice and you should follow it. And here's what we do. What we do is we like to focus on what our client needs and sometimes their need is they need a subject matter expert to help establish a strategy or a program for improvement of their company. Some times they need to outsource project. And we're doing a lot of these where it's a computer system validation project, you're implementing a max or some other system or an ERP system. And we do the CSV aspect, everything from a project manager all the way through the end. And sometimes we have a client, they just need some more operational bandwidth. They just need people. They've got a lot of work to do. And especially in this market, good people are hard to find and clients are having a hard time hiring good people, but they usually look in their local market where we have a national reach. We've been around for about 20 years. And all of the main, the principles in the company are all around myself. I got my started at Abbott labs back in the 80s. Cut my teeth there before getting out in the consulting world, the dark side in 2000. But that's really what we do. We really want to make sure that we're not trying to impose our goals onto our clients. We're there to help them and do what they need so.

Jon Speer: And I think that's sadly somewhat level approach it in our industry. And I say, sadly, because you didn't say this exactly, but I've experienced it myself. Both at Greenlight and consulting practice that I have prior to Greenlight is a lot of times the company will hire a consultant because I know they have a need. And consultant will bring their set of processes and procedures and ripping out the old and try to force in their approach. And then the initiative, the project's over consultant leaves and the company is sitting there. They didn't have any ownership. They didn't have any influence on it. And then lo and behold, a couple years later company probably had a bigger problem because now, they've had repeat fractions and that's just not going to work.

Tom Rynkiewicz: Yeah. In fact, that's one of the aspects we do when we're doing a, let's say for instance, a quality system remediation. Where someone has been under enforcement action, need to fix things. And there are a lot of companies who want to come in, bring a team, ran through all these things, get rid of all their complaints, their CAPAs we'll do all this and then we're out the door like you said, our approach is let's have a team where we're mixed. We'll have someone who's going to focus on CAPA. You put your CAPA guy with us. We'll work hand in hand doing this and teach along the way. I don't want to park myself at a client and be there for five years. We want to come in, help them fix the problem, help them improve their process and then get the heck out.

Jon Speer: Yeah. They have to own it at the end of the day. So, if you'd like to learn more about Raland Compliance Partners and their products and services, it's pretty simple go to their website, R- A- L- A- N- D. com, R- A- L- A- N- D. com. I know I said that really fast. Sometimes it gets the best of me, but www.raland.com, certainly Tom is a resource as well as a number of other folks on the Raland team that are very experienced and there to help. So, connect with them. They even if it's for, how should we structure our internal audit program or what's our quality system strategy and those sorts of things. I'm sure any of those type of things-

Tom Rynkiewicz: You have a question you need to bounce it off someone. Does this make sense? Am I barking up the wrong tree? We're all ready to help and do anything to help move things along with people. So.

Jon Speer: ...Absolutely. And while we're taking this break, I want to remind folks about the Greenlight Guru Medical Device Success Platform. It is an all in one software service that is there to help you manage many aspects of your quality management system from design and development, through risk management, through document and record management, through quality events, things like CAPAs and complaints. And it's all in a single source of truth. And what's great about the Medical Device Success Platform, we have gurus people who have medical device experience, who work at Greenlight and we have partners like Tom and Raland Compliance Partners that we partner with to help our customers achieve success when it comes to compliance and true quality and effectively managing a quality management system. So if you'd like to learn more about the Greenlight Guru Medical Device Success Platform, it's very simple go to www.greenlight.guru. You can learn all about the soft for platform. If you'd like to have a conversation, just click the button, request some time. We'd love to talk about your needs and requirements and see if we have products and solutions that can help you. So check that up. All right. So Tom, you've got a lot of experience on both device and pharma. And before we started the recording of the episode today, I almost heard a cautionary tale or a beware tale. And I'm like," Hang on, we're going to get into that when we chat." And what I heard though, is so far from a device perspective, FDA's focus I think has been pretty consistent for the past couple of decades or so at least in device. Now that's a lot different in pharma and part of what I heard you hint at or suggest maybe you can tell me if I misheard, is that in device, we better be prepared because there's an opportunity or there's a good chance that FDA will start to shift to be more pharma like in their inspections. So what are you seeing there? Or what advice do you have there?

Tom Rynkiewicz: Yeah, most definitely. Then this comes from years of, as I transition from my pharma experience at Abbott into consulting and then working on with device companies is that was mentioned earlier. Device is looking at the other eight twenties and 13485 in pharma, that's two, 10 and two 11 GMPs and they don't cross. You've had people who said," We don't want to talk to pharmaceutical consultants because they don't understand our needs." And the truth is, up until now that is been the case, like you mentioned, because the low- hanging fruit. And inspector walks into a device company ask for these same things, a CAPAs a compliance and quality system stuff and they're finding it. And they from an inspector perspective and I know plenty of ex FDA folks, we're going to find something. They can't come in and do an inspection of walkout. Nobody's perfect. They're going to find something. And up until now, they haven't had to dig. I'm sure there are some who've wanted to, I'm sure some who have walked in the door and seen, because they don't only inspect device companies. They inspect companies and they haven't had the opportunity or-

Jon Speer: Much more hanging fruit that needs to be systemic issues that are low hanging fruit.

Tom Rynkiewicz: ...It would seem mean if on top of all that stuff, they also say," Oh yeah, by the way, your finishes and your manufacturing floor are not GMP." But that's, what's coming. In the perfect world, we improve get rid of these, get past these low hanging fruit quality system issues. But then they're going to start taking a walk around your plant. They're going to start looking, they're going to see your equipment. They're going to want to see your equipment validation. They're going to want to see your pest control what you do there, all right, God forbid they find something on the floor and from my pharma days, when it was a planned inspection, I mean, things were painted. Things were, floors left waxed, new terrazo floor, anything but you had to be ready every day in case you don't get that unplanned inspection. Somebody knocks on the door and I've seen companies who have cleared people off the manufacturing floor and turned off the lights and said," We're shut down today. You can't come in and look at our manufacturing area." But the reality is they're going to start doing that. And I know just from physically being in device companies and on their manufacturing floor and they're ware housing space, those things are going to happen. And a lot of companies might not want to believe it, but they are also liable to be compliant to the GMP. That is the rule. That is the way it works. It's not just 820s. There are certainly elements if you look at it, elements of quality systems are required in pharma, even though the 210, 211 don't go into the same level of detail. They don't talk about the same quality system, but pharmaceutical companies are expected to comply with that as well. So it's gone that way where pharma companies are getting scrutinized on their quality system side that is explicitly written in the 820s but the device guys need to start opening their eyes in knowing that even they're going to come walking in the door. And what I see is a big looming presence that's over the horizon right now, but it's going to come. It's going to come one day and it'll be a different world for them.

Jon Speer: And I think we talked about elements versus system and I can hear people, I can imagine the reactions of folks listening to this that like, wait a minute, Tom, Jon, our internal audit team is already stressed and strained as it is. And they probably are doing the best they can, but I think maybe there's some nuggets here that we can suggest to people. First, taking that system approach, but being super thorough with that is one way to gain some efficiency. And then if you're gaining that efficiency here, this might give you another opportunity to dive a little bit deeper into other areas that oftentimes probably don't see the light of day when it comes to auditing things like GMPs.

Tom Rynkiewicz: Yeah. Definitely, and I think by nature because there's this compliance hammer hanging over people's heads, they don't think about, the inspectors are human beings too. And if, as part of the kickoff for an inspection, you say," Listen, we do something a little bit novel on our internal audit process." We don't only audit elements of the quality system. We take a system approach and do the same thing you guys would do. Just by saying that gives an inspector a different attitude. I think from your plan, in your inspection, what they're going to do. When I was with Abbott, it was, don't say anything. They be careful you're in the bathroom. Don't mention anything make jokes you never know when someone's going to overhear you. I know a lot of ex FDA, and I know some FDA inspectors, they're human beings, they're people, their ultimate goal is to improve our products and safety and you or me or anyone. We've got either one of us or our family or someone else we love, or our neighbor are going to be a patient and need these things. Don't you want to be as safe as possible. That's really what it boils down to.

Jon Speer: The other thing, when people ask me about my thoughts, opinions, ideas, et cetera, on auditing and especially internal auditing. My first comment to them is your internal auditing program needs to be the toughest audits that your company has. And clearly if that were true, he would be okay with sharing when Mary-

Tom Rynkiewicz: Yeah, exactly.

Jon Speer: ...Was dropping the ball or something wasn't, being addressed. But clearly we're not getting that message. I mean, clearly their internal auditing as an industry, at least as a whole needs to be tougher a little bit. It needs to be more thorough and it needs to be more complete and it needs to be more detailed and more difficult.

Tom Rynkiewicz: Honest.

Jon Speer: Honest, yeah. Maybe that's it. Maybe it's just honest.

Tom Rynkiewicz: Yeah. Yet, at the same time a human behavior piece. Some people are afraid of it's tough times, especially these COVID times.. Nobody wants to be sitting with a negative review, a negative, losing their job or something. If people are out there hanging, that's a tough one, get people to get past. And it comes down to trust. Does your company attitude, do they really value their people and be transparent internally to do that and value when people truly are trying to improve the product. So.

Jon Speer: Yeah. I'll bring this back. I think what we're talking a little bit about what's the culture within a company, does a company have a true quality culture and culture is one of those or can be one of those esoteric things that can be hard to describe, but hopefully try to make it a little less vague and share an example at Greenlight. One of the things that our team focuses on is this framework, the authors named is Patrick Lencioni. And he has a framework called The Five Behaviors of Cohesive Team. And the base of those five behaviors, that the first thing you have to get right, is vulnerability based trust. And ones you have that, then you can get into conflict and alignment and drive toward results on all these things. I think the other thing that's important that we try to remind our team at Greenlight is, if it seems as though Mary's dropping the ball, assume ignorance and not malicious behavior.

Tom Rynkiewicz: Yeah. Exactly. Exactly. Exactly. And we never know what's going on with someone else. Don't assume someone is doing something wrong on purpose. And it comes down, like you said, comes down to a trust. Internally at your company, whether you're a consulting firm, a software company like yours or where one of the biggest multinationals. People have to know that they're valued and be able to trust that when they do something that might seem unpopular that it's okay if the motivation is right.

Jon Speer: And I think that's key. Motivation is right. If I'm out there on a witch hunt trying to poke holes and just identify something, that's an issue for the sake of calling people out, that's not the right spirit. I mean, all of our goals and objectives within the device company, in my opinion is, we have to do what best for patient. What's the best thing we can do for the quality of that product. If our motives are aligned with that, then good. We can get better as a company, we have opportunities to improve. So Tom, as we were wrapping up our conversation, did any last minute tips, pointers, suggestions that you think it's key for folks to think about on this topic of audits inspection GMP and things of that nature?

Tom Rynkiewicz: Yeah. And it's really what we've talked about, look at your quality system as a system. It's not just a bunch of elements. Not just a bunch of procedures. Not just a bunch of standalone checklists. Look at it as a system. And if any, one of those elements aren't working, it's the weakest is linking the chain concept. Then the whole thing falls apart. So you've got to look at it in that respect. We're not just a bunch of people doing their individual jobs and as long as I'm doing my piece, everything's fine. You got to look at the entire picture.

Jon Speer: Yep. A hundred percent. And the longer we perpetuate this element only approach, it just means our silos are going to grow taller and the walls thick. We have to figure out how to blend. Because we are working in a system of systems in a medical device company. One thing that I do absolutely is going to have upstream and downstream ramifications. So I need to be cognizant of that and make sure that I'm fairly inspecting and auditing my company with that in mind. Tom Rynkiewicz, VP, RAQA at Raland Compliance Partners. Again, you can learn more about Raland very simple, www.raland.com R- A- L- A- N- D. com. Tom, thank you so much for being a guest on The Global Medical Device Podcast.

Tom Rynkiewicz: Thanks Jon, I appreciate it.

Jon Speer: Absolutely.

Tom Rynkiewicz: It's great talking and look forward to talking in the future.

Jon Speer: Absolutely. And folks, I want to thank you for listening to The Global Medical Device Podcast. It's because of you that this is still the number one podcast in the Medical Device Industry. So keep spreading the word to your friends and colleagues. You've probably picked up by now, we're not on iTunes and Spotify and all the places you listen to things, we are on YouTube. You can watch the latest episodes of The Global Medical Device Podcast as well. So thank you so much as always this is your host and founder, Jon Speer, and you have been listening to The Global Medical Device Podcast.


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