Who loves internal auditing? Probably 99.99 percent of medical device professionals answered “not me!” While it may not be everyone’s favorite pastime, internal audits are very important...especially if you have or want a true quality culture and mindset of continuous improvement. 

In this episode of the Global Medical Device Podcast, Jon Speer talks to Sara Adams, a medical device guru at Greenlight Guru.

Sara loves to talk about internal audits. She shares her valuable wisdom of internal audits as well as learnings from leading Corrective and Preventive Action (CAPA) investigations and implementations, process improvements, and supplier and regulatory audits throughout her career in the medical device industry.

 

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Some highlights of this episode include:

  • Internal audits shouldn’t be about checking a box. If you know about problems, fix them first. Internal auditing offers opportunities for improvement. 
  • From a risk perspective, where are the trends and weak areas? Find them before someone else does and causes complaints or extra work. It is valuable to be able to look into those problem areas that need to be fixed. 
  • More medical device companies need to change their mindset by embracing quality as part of their culture, not as an obstacle or barrier. Collaborate with other departments because everyone has to own their process and procedure.
  • Quality auditors may say there’s no choice, this has to be done. If the company has a CAPA or other options to be compliant, management will offer its buy-in. 
  • Misconceptions about internal audits include conducting internal audits on every process and procedure at least once a year, and if there’s any audit finding, you must create a CAPA. 
  • Key Tips: Make a plan/schedule, document and follow internal audit processes, and realize that CAPA’s are only meant for major, risk-based, systemic issues.

 

Links:

Sara Adams

Sara Adams on LinkedIn

ISO 13485:2016

FDA - Medical Device Single Audit Program (MDSAP)

Greenlight Guru Academy

Greenlight Guru YouTube Channel

 

MedTech True Quality Stories Podcast

Greenlight Guru

 

Memorable Quotes from this episode:

“We can always get better. Internal auditing is one method that, done properly, can help us improve our processes and our operations as medical device companies.” Jon Speer

“I like rules. I like boundaries. I like guidelines.” Sara Adams

“You can fix it and not give someone else an opportunity to find that.” Sara Adams

“Your internal audits should be the toughest audits that you ever have.” Jon Speer

“Being able to present options that still will take you into compliance, I think, is huge for getting management’s buy-in.” Sara Adams


Transcript:

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: Okay. Raise your hand, all right? And I'm going to ask you a question, and keep your hand up if it's true. Who loves internal auditing? All right. I'm guessing like 99. 99% of you lowered your hand after I asked you that question. Well, it's important. Really important, actually. Especially if you have a true quality culture, or want a true quality culture, and have a mindset of continuous improvement. We can always get better. And internal auditing is a way, one method that, done properly, it can help us improve our processes and our operations as medical device companies. Joining me today on the Global Medical Device Podcast is one of Greenlight Guru's very own medical device gurus, that's a mouthful, Sara Adams. And she loves internal auditing. And she shares all sorts of wisdom and tips and pointers with respect to that topic. So 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 one of our gurus, one of our medical device gurus, Sara Adams. Sara, welcome back to the Global Medical Device Podcast.

Sara Adams: Hi.

Jon Speer: How's it going?

Sara Adams: So excited to be here, Jon. It's going well, it's going well.

Jon Speer: All right. You're setting looks so regal and that sort of thing. And you said it was quiet today?

Sara Adams: Yeah, it's quiet today. Background, we are having internet struggles at our house, so I have transitioned into the library. So this is not my decor. But it does, it looks very official, right? I look very official here.

Jon Speer: No, no. It's like, I don't know. I don't know. Anything I'm going to say from here on out, it's just going to sound silly. But we should talk about something that's important and that people care about. And I'm sure some are going to roll their eyes, but others are going to be excited about it. For those that are going to roll their eyes, I think after listening to this conversation that we're about to have, they might change their mind a little bit. And the conversation, just kind of frame the context a little bit, is internal auditing. And you've confessed that you love internal audits. I guess maybe that's a good place to start. Why is it that you love internal audits?

Sara Adams: I have confessed. I told Jon that I was a weirdo who liked internal audits. I love audits in general. You know, Jon, I think it's the rule follower in me. I am like, to a tee, I like rules. I like boundaries. I like guidelines. And so to be able to take a checklist, to take here's the standard, here's the regulations, go in and verify that we're following these. That is something that I enjoy. And more than that, I'd rather find it than let somebody else find it. I came from a background where I hosted at least 20 audits, customer audits, supplier audits, regulatory audits a year. And when somebody else finds it, it's really no fun because then I have to work lots of extra hours to fix it. So I'd rather find it on my own.

Jon Speer: The pressure is different too when somebody else finds it, I think, as well.

Sara Adams: Definitely. Definitely.

Jon Speer: All right. So I got a couple of scenarios that I've lived in my past, and that I think relate to this topic, sort of. The first, on your last point, is it's better to find it yourself than to have somebody from outside your company come in and find it. One of the companies I worked with once upon a time, I'll just say our internal auditing program, not very robust. It felt a lot like a checkbox activity. I was in engineering and product development, and we knew that there were a lot of, we'll just say opportunities, for improvement with our processes and our approach. And some of us were hopeful that this would be discovered or uncovered during internal auditing. And when it wasn't, I mean, I remember one internal audit in particular. I'm sitting down with the internal auditor who worked for a company. I felt like I was feeding him all of this opportunity. Look at this. And what about this? Because I wanted something to change. I wanted some improvement. But that never found its way into the internal audit report. And that was a head- scratcher for me. But then a couple of months later, I think we had an ISO audit, and it all got uncovered.

Sara Adams: They found it.

Jon Speer: They found it. Which is a good, bad thing. I mean, some of us were like," Yes, sorry that it took that ISO audit to do this, but finally, we're going to do something about it." Does that story resonate with you in any way, shape, or form?

Sara Adams: Absolutely. When I first started in medical devices, I came from the same. Internal audits were a checkbox. Let's just check it and move on. In fact, just as a side story, we almost missed a deadline just because it wasn't important. It wasn't important to upper management. It wasn't really important to anybody. It was just something that we were checking the box for. Now as we grew, and as we realized we're going to have multiple other people coming in, this is not enjoyable to fix, to sit through. It's not enjoyable to say we knew about these things, but we just... I mean, you would never say that. But internally, right? And so as we went on and as we grew, we started looking at things, one, from a risk perspective. Where are we seeing our trends? Where do we need to dig into? Where do we need to go specifically? And like you said, if you specifically to places, you're going to find more things because you know that's your weak area. But that's also really good because you can fix it and not give someone else an opportunity to find that.

Jon Speer: Yeah. And I always tell people, I think it's important that you have a robust internal auditing program. But also, in addition to that, I try to coach people, your internal audit should be the toughest audits that you ever have.

Sara Adams: I agree.

Jon Speer: Any suggestions on how to make that the case?

Sara Adams: Yeah. I think from my perspective in the beginning, I was unwilling to go to those places to have findings. Because who wants findings period, right? If you find a major finding and open up a CAPA, you're creating extra work for your team. But for me, as we went through, it became a I want to fix this because I am tired of this area causing complaints, or causing extra parts of our time to be able to go back to. So it is valuable to be able to look into those areas that you know you have problems, problems that you need to fix.

Jon Speer: Yeah. Unfortunately I think a lot of companies, in my opinion, they don't embrace quality as part of their culture. I think a lot of companies look at this as almost an obstacle, or an impediment, or a barrier, or something that's preventing people from doing things. Which is unfortunate because when that quality auditor is trying to do his or her job for the benefit of the company, sometimes they're viewed as the bad guy or the bad gal. And I don't know. You've been doing this a bit. So you've seen some good, you probably have seen some things that are not so good. But what are some things that come to mind as to how companies can sort of shift their mindset or their culture with respect to embracing quality?

Sara Adams: That's so funny that you say that. I was going to say change your mindset. As quality we have to change. I had to change my mindset and my experience. But really going into your company, your organization, and focusing... I'm trying to phrase it right, Jon. I think from my experience what helped us grow that culture, what helped me grow that culture of, we need to treat this as something that's valuable, as we took steps in the right direction, we had a lot of findings initially, not from internal audits, from customers, from notified bodies. And seeing the progress that we were making really helped to change that mindset. In other words, as we continue down this path, and we were really making improvements to our quality management system with our internal audit program, management noticed that. And they noticed it because we weren't having as many findings from other audits. And you always want to show well, period. But you don't want other people to know the bad things. You don't want them to find the bad things. You want to find those internally. We want to keep it in the family. Not to use a silly analogy, but let's keep it in the family so that we can fix it internally. The other thing that I'll say to that is I think as quality a lot of times, it's really easy to go in and say," We have to do this." And that is not well received in any part of life. Forget medical devices, if I tell my four year old," You have to do this," he's going to throw up a fight regardless. So to me, there are times that as quality you have to walk in and say," We have no choice. We have to do this." But if there are choices, being able to say," We have this CAPA, we can go this route. We can go this route." Or maybe it's not a CAPA. Maybe it's an internal audit finding. We can go this, we can do this, we can do this. And being able to present options that still will take you into compliance, I think is huge for getting management's buy- in. Because the last thing they want is for you to come back and say," We have to do this. It's going to cost millions of dollars." That's not setting the right mindset for everybody.

Jon Speer: Yeah. I mean, we talk a lot about the culture, how important that is at Greenlight. And I guess a good way to kind of summarize, or paraphrase, or briefly describe that is it's a two way street. It's not like we, as an executive team, can just push the culture down and expect people to say," Yeah, that's awesome." You as a person have to contribute and participate in that as well. So it has to be a two way street. And I like the point that you raised, because that was the other thought that was coming to mind is sometimes the quality auditors inside companies, they give the perception that they're wielding a lot of power. And they're quick to pound their chest and say," Oh, you got to do this because I said so," or," Because the procedure says this," and that sort of thing. And you're right. Sometimes there is a time for that. But you've got to figure out how to collaborate. And I think this is a mistake that some companies make is that each functions don't understand the roles or the jobs to be done of the other functions. I've seen this a few times in my career where quality, trying to do a good job, but they had no idea what we were doing in product development, and vice versa. So what can we do to improve upon that? I mean, do we get people to do a ride along or a shadow, or something like that to kind of see, or how can we better improve that situation? Does that make inaudible?

Sara Adams: Yeah. And speaking in the context of internal audits, and then certainly other as well, but we brought other individuals in. So our internal audits were not just run by quality individuals. Because sometimes it really pays to have a fresh set of eyes. You know what I mean? You don't want someone who's responsible for that role to be auditing their area period. And in a smaller company, you've got to utilize some different individuals. And so I think really, you said it, the collaborating together, bringing in other divisions and other parts within your company so that they can see and understand, and training them what we're looking for in a quality audit, letting them own that, own portions of that, is really helpful. On the other side, certainly not in internal audits because you want that collaboration period. You don't want it just in internal audits. But having round table discussions, bringing them in for bringing other parts of your organization in for the CAPA review, for the manager... I mean, manager review, obviously, you'd have to have other people. But for customer feedback, for different areas, and really treating it like a true collaboration. Because I think quality, certainly from my that ground and my past, there were times that quality was just stuck with it. Like, oh, that's quality's job. They need to do that. And when it actuality, quality is everyone's responsibility. Not just quality's.

Jon Speer: Yeah. And to kind of carry that further, I think generally speaking, all the things that we do, I mean all, not necessarily all, but the majority of the major things that we do, there should be an underlying procedure, or overarching procedure, or work instruction, or something of that nature that defines those major steps and those processes. Quality is going to be auditing against those processes and procedures. But me as the person who needs procedure that applies to my job, I should be knowledgeable and familiar with that. And if I'm reviewing that. I'm like, whoa, this really isn't how we do it-

Sara Adams: It's not what we're doing.

Jon Speer: ...it's probably a good idea for me to raise my hand before an internal audit. Don't just wait until the internal audit and" Hey, whoa, can you explain this? Because we do this, and this says that," and that sort of thing. So I think that's important.

Sara Adams: Yeah. On that note, I can't tell you how many internal audits I was a part of where somebody would say," Oh, that's not how we do it." Because when you go out as an auditor, you take your procedure. You're going to look and watch, and make sure everybody's doing it by that. Oh, I didn't know. And that's a big red flag. You are the owner of your process so you should be raising your hand and saying... Sometimes what you're doing makes more sense, and may still be regulatory acceptable, and there's no issue with it. So yeah, I think, I definitely would reiterate what you said that everyone has to own their process and they're procedure.

Jon Speer: I mean, this is dangerous statement, but don't just accept what's in your procedure as gospel if it's not pragmatic and it doesn't necessarily make sense. There might be a reason why certain things are described the way that they are, and there might not be, but it's at least worth asking the question-

Sara Adams: Yeah, have the conversation.

Jon Speer: Have the conversation. I want to take a brief pause. I want to remind folks I'm talking with Sara Adams. Sara is a medical device guru with Greenlight Guru. Sara, talk a little bit about what is a medical device guru do at Greenlight Guru? How do you work with companies and customers?

Sara Adams: I love that question mainly because I absolutely love being a medical device guru at Greenlight Guru. So I get an opportunity to onboard and train our customers as they're coming in to the software. We get to talk through real examples of my background, their background, the best ways to utilize the software system. Additionally, I have some monthly and bi- monthly sessions with customers who we just sit down and we talk about whatever they want to talk about. So we can talk about how to best use the software. We can go through the quality manual, and I can provide feedback based on my experiences, especially in audit environments and things like that. So if I could summarize it, I get to help people bring their products to market faster and safer. And I'm just really passionate about it if you couldn't tell.

Jon Speer: Yeah. No, I share that passion. And one of the things that Sara believes in wholeheartedly, I believe in wholeheartedly, frankly, anybody you talk to at Greenlight is going to share this sentiment, we have a mission at Greenlight, and that's to improve the quality of lives. And there's lots of layers to improve the quality of life. I'm improving the quality of my life because I get to do things that I love to do. Sara gets to improve the quality of her life for similar reasons. We get to improve the quality of our customer's lives because we're making life a little bit easier to be a medical device professional. And we get the have an influence on improving the quality of life of patients who receive the products and technologies that our customers are bringing to market because they're going to do so in a way that's safer and more effective. And frankly, I can't think of a better mission in the world other than that. So we got lots of job opportunities at Greenlight Guru. If you're curious to see what those opportunities are, just go to our website. There's a careers pages. But also if you're a medical device company, and you're curious about how the Greenlight Guru medical device software platform can be a resource to help you, then I would encourage you to also go to www. greenlight. guru to learn about all the workflows. We have workflows for design and development, for risk, for document management and change, as well as quality events. Including workflows to help you manage audits all in a single source of truth software platform designed specifically and exclusively for the medical device industry. So check that out. All right. So a moment ago, Sara, I mentioned that I had a couple of scenarios or stories, blasts from the past, if you will. Here's another one on the topic of internal audits. It's quite a few years ago, but I was called in as a consultant at this time. The company, a small med device company, I think they had about 15 total people, and they did manufacturing, and all that sort of thing. They had previously, within maybe a month or so prior to calling me, had had an FDA inspection. It went a little sideways. They had quite a few 483 observations. I think we also ended up getting a warning letter. But lots of things to address and mitigate. And so I'm diving in. And it's a little bit later in the calendar year. And I'm going through just trying to familiarize myself as quickly as possible because we had work to do. And one of the things that I uncovered or learned, it's right around Thanksgiving. It's very vivid to me, the time of year. I'd read their internal auditing procedure.

Sara Adams: Internal auditing procedure over turkey. Is that how it was done?

Jon Speer: There was some turkey involved for sure. And their internal auditing procedure basically said every single procedure and process had to be part of an internal audit every calendar year. And here it is late November-

Sara Adams: And they hadn't done it yet.

Jon Speer: ...and they hadn't done a single internal audit during that calendar year.

Sara Adams: That's a lot of work, Jon.

Jon Speer: Yeah. And this was outside of my scope of work for them. And the company decided, and it wasn't necessarily my advice per se, but they decided, nope, we're going to stick to that procedure. And they kind of had, having gone through that recent FDA inspection, some of the observations were you're not following your procedures. So they kind of have this drilled into their head. So they decided to hire another resource to do all internal audits from essentially December 1 through December 31.

Sara Adams: Wow.

Jon Speer: All right? It gets better.

Sara Adams: It can't get better.

Jon Speer: The person doing the internal audits did so, like 95% of the time, was entirely remote. Which I understand there's ways you can do this, but this was a manufacturing facility. And this person spent little to no time onsite, little to no time actually interviewing or interacting with anybody that worked at the company. And wait, it gets better. And then I'm going to give you an opportunity to chime in. But the other thing that their internal auditing procedure mandated is anything found as an issue during an internal audit must result in a CAPA. All right, so I'm going to shut up and just let you digest some of that.

Sara Adams: I feel like I can't even talk over this situation. How miserable for them. Because on top of that, they're dealing with 483s for the FDA, and they just had how many internal audits in crosstalk?

Jon Speer: It was about 30 or so internal audits.

Sara Adams: Jon.

Jon Speer: And let's just say, I guess I'll give you one more little tidbit here, early January, I think they ended up issuing 40 internal CAPAs-

Sara Adams: CAPAs.

Jon Speer: ...on top of all of this, right?

Sara Adams: So first of all, make a plan. What is it they say? Fail to plan, plan to fail. You're required to make a schedule. So we need to make a schedule early on, especially if we know that we have this requirement. Which it sounds like they didn't necessarily know what some of their requirements were, period, if they weren't following their procedure in multiple areas. But make a plan. And don't plan for December. I'll just share this example. The last internal audit I did, I had a death in the family, and we had to reschedule it. If we had scheduled that for December, we would have had issues. Life happens. So make a plan. The next big thing that comes to mind is don't sign yourself up for more work than you need. You need to have a procedure in place, and it needs to tell you what to do in the instance that you find findings. Don't sign yourself up for CAPAs as a result of internal audit findings. Now you may have to. You may have a systemic issue that becomes a major internal audit finding, and that needs to be a CAPA. But why would anyone do that to themselves, Jon?

Jon Speer: I don't know. Not all, but some of these things were as simple as change some verbiage in a procedure. You could have just documented that on a change order. But I think there's a couple of misconceptions, especially in the idea of internal audits. I think misconception one is that I have to conduct internal audits on every process, every procedure in my company, at least once a year. And I'll give you one other misconception, and then I'll get your reaction to it. I think the other misconception is that if I do have an audit finding, that I have to create a CAPA. I think those are pervasive thoughts and conventional wisdom in the industry. So what are your reactions to those?

Sara Adams: Yeah. On your first one, on the first misconception, I would say that as the rule follower who likes to cross all the T's and dot all the I's, in the beginning of my career, I leaned towards that misconception. That we had to look at everything because that was what our procedure said, right or wrong. But we had to go deep in everything. And as we moved, and I really think, Jon, what led us to go down this path was ISO 13485:2016 transition. When we started taking a more risk based approach, you need to rationalize what you're looking at, why you're looking at that, and define that. And it doesn't mean that you have to look at every single thing. We had lots of different areas that did the same process, that followed the same procedure. That you can go to your biggest areas of risk or where you've identified trends, and like you said, I think think that definitely was a misconception to me, and so I can see where that would be a misconception to other like- minded individuals who love audits, like I do. The second part, CAPAs are not meant to be. For the example that you shared. CAPAs are meant to be systemic issues. So yes, it makes sense that if you have major findings, that those would lead to CAPAs, major systemic risk- based, that those would lead you to CAPAs. But as far as requiring that every finding be a CAPA, I think that's a huge misconception.

Jon Speer: Yeah, for sure. Maybe working toward wrapping up our conversation today, let's leave folks with some practical, pragmatic tips and pointers when it comes to internal auditing. And I guess I'll throw one more slight twist in there. I think another thing, maybe I guess before we do that, small companies I think feel encumbered on this topic. And I think sometimes, because maybe you're a startup or a smaller company, maybe you don't have anybody on your staff that is an internal auditor, or maybe you don't have the bandwidth or the resources to do that. What suggestions would you have for folks that are in that situation?

Sara Adams: Yeah, that's tough. Because my number one suggestion is to do it yourself. You want to find your things, you know your processes and procedures better than anybody else. I can't tell you how many times I hosted audits and an auditor doesn't know what they don't know. So you want to steer them in a different direction, it's not that difficult to steer them in a different direction. And so if you want your audit to be valuable, find ways to do it yourself. And if you're a smaller organization, you can do that by utilizing people who are in different areas. And maybe classifying a lead auditor who's a quality member, quality focused, and then pulling from other areas. You may have additional thoughts on that, Jon.

Jon Speer: Well, I was going to offer a couple of things. I do think it's important to be involved in the process. I think it's okay to outsource some of the activities here. Maybe you don't have anybody on your team who has audit experience. And I think this is important to factor. Even if you do do it yourself, it is important that the people who are doing audits have had some sort of training and/ or experience with respect to auditing. So that is important. And there are courses you can take and that kind of of thing. But you can also, maybe to get your internal auditing program a little bit of boost and get it going, if you're a small company, that might be an opportunity to have a consultant come in, help you build a schedule and a plan, provide a little bit of oversight. But don't just expect that person to go off and do it themselves.

Sara Adams: Do it.

Jon Speer: Include people from your team through that process. Because that will be part of training that then the next year you can say," Well, yeah, they were involved in our internal auditing program." So I just wanted to add that, that I think it's really important.

Sara Adams: I love that idea.

Jon Speer: But figure out a strategy or a plan to get the experience and the training so that you can do this on a long- term sustainable approach.

Sara Adams: Yeah, for sure.

Jon Speer: All right. So back to the question that I asked that I put on pause. So to wrap things up today, what are some key tips and pointers that you think are important to leave folks with today?

Sara Adams: Yeah. Key tips, make a plan, make a schedule, stick to your schedule. I think you can do that yearly. If you really want to, you can do it twice a year, quarterly.

Jon Speer: crosstalk. I like quarterly personally. But don't do it yearly.

Sara Adams: I was going to just add, don't do it all the time. Don't schedule one a week because nobody's going to pay attention to it. Like you said, with quarterly, people will focus in. This is my week, or this is the two days that we're going to internal audit, and really utilize that time for audit. So I like that you say quarterly. I also will add, this sounds silly, but document your audit procedure. Have a procedure that you are following. And then really look to change that mindset to value the internal audit. We're in COVID. Who knows what that's going to change? You mentioned, you touched on virtual audits. I did have to do a couple virtual audits because of COVID. If that is somewhere where you are right now, and we hopefully are coming out of that and so it's not going to be an issue, but I think that there are parts that you can do virtually. But I think it's so important, especially in manufacturing, to have someone on the ground who is observing. So even the virtual audits I did, somebody else was carrying the computer around, as an auditor, so that they could say," Hey, this doesn't look right," and send me a picture and things like that. So just as a real quick tip on if you're being forced into virtual environments for auditing.

Jon Speer: Yeah. And I think that's going to be a thing that's going to be around for a bit-

Sara Adams: I do too.

Jon Speer: ...in some way, shape, or form. Even once all the restrictions are lifted and we're back to normal, whatever that now means, I do think that regulatory bodies and auditing organizations, I have to imagine that they've seen some benefit of this, and expect that they're going to incorporate this in some way, shape, or form. But anyway that's-

Sara Adams: I mean, that's one reason that I love Greenlight because it is easy to have everything electronically for your auditors. I've been in a paper- based system. I'm not sure how we would've survived COVID audits without being in a EQMS.

Jon Speer: I totally agree. I mean, even if you're not in COVID, I mean, paper- based audits-

Sara Adams: Period. Painful.

Jon Speer: And some people have this, I think it's a flawed strategy, that, oh, we're going to stay on paper, and we'll make the audit process difficult. And man, I've been an auditor before, both as an employee of a company, as well as somebody brought in from the outside, don't make your auditor's life difficult.

Sara Adams: No. The way I looked at it, let's get out. If it takes you five hours to cover, why would I stall? Let's just get you what you need. And I'll just add, Jon, I did live in that mindset that paper was king. And that even once we went to an EQMS, I still printed everything and slid it across the table. But when you switch, it makes everyone's life easier because they can get what they need faster. They can get out of your hair faster. And wouldn't we all love that to happen.

Jon Speer: Yeah. And we've had many customers of Greenlight that have shared stories about going through audits with Greenlight in place. Some, they had lived that life prior to implementing Greenlight. The one story that comes to mind that's kind of top of mind, there was a smaller startup, and they were achieving definitely ISO certification, and I think MDSAP as well, but don't quote me on that one. The audit was cut short by a day and a half because it was so efficient to go-

Sara Adams: Because they were in Greenlight.

Jon Speer: ...through the audit process because we were using Greenlight. So that makes a real difference. Nobody wants to go through an audit. Or most people don't. Sara might.

Sara Adams: I like audits, but I still want you out as quick as possible. I don't want findings.

Jon Speer: So check it out. Go to www.greenlight.guru, and we'd be happy to have a conversation to understand your needs, and see if we might have some products and solutions to help you out. And you might have an opportunity to work with one of our gurus, including Sara Adams, somebody who loves audits, and would be happy to provide tips, pointers, coaching, all those sorts of things to help you prepare for those situations. Because I think it's one of those things that if you've never been through it, and maybe you're newer to the medical device industry, like that's not going to happen. It will.

Sara Adams: It's coming.

Jon Speer: It will. Whether you think it will or not, it will happen. And so be prepared for it. Don't have to react to it after it's already happened to you. Sara, thank you so much. I appreciate your insights, and I'm glad that you love internal audits, and I'm glad you're having a great time at Greenlight Guru. So thank you so much for being on the Global Medical Device Podcast today.

Sara Adams: Thank you for having me, Jon. It was fun.

Jon Speer: We'll do it again, I'm quite sure. Folks, thank you for making the Global Medical Device Podcast and keeping it as the number one podcast in the medical device industry. If you've been listening to this podcast, thank you. Keep listening to it to wherever you're listening to it. But we also have been adding videos. So I guess maybe I should have mentioned that at the beginning. But check it out, live video, audio, however you wish to consume it. I always appreciate hearing from and having loyal listeners. So let us know what topics you think are important. As always, this is your host and founder at Greenlight Guru, Jon Speer, and you have been listening to the Global Medical Device Podcast.


ABOUT 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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