For some people, audits are terrifying. But today’s guest says you need to learn to love the audit process, and she shares information that can help you do that.
Sara Adams is a Medical Device Guru at Greenlight Guru. Medical Device Gurus are part of Greenlight Guru’s “Guru Edge.” Medical Device Guru’s help customers onboard to their new software and guide them through the various regulatory requirements and challenges unique to MedTech companies and Medical Device Professionals.
Listen to the episode to hear Sara share some of her wisdom about audits. She talks about what happens when you don’t accept the finding of an audit, the different types of rules and approaches to different kinds of audits, and the kinds of problems she consistently sees from people when they’re learning to do audits. She also shares details about her own first audit!
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Some of the highlights of this episode include:
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Sara’s background and experience with audits
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How Sara trained other people to audit
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How to build a culture of collaboration
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Sara’s first audit experience
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What the process of negotiating an audit finding looks like
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What’s unique about each audit
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The partnership in a supplier audit
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Consistent problems people face during audits and how to overcome them
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What’s important to know about getting ISO certification
Links:
Memorable quotes from Sara Adams:
“In an internal audit, you need to avoid a conflict of interest. Like I don’t need to be auditing my own work.”
“Quality is everyone’s responsibility and not just the quality department’s.”
“We all have a first day. Everybody has a first day.”
“Never look at something as just a checkbox.”
Transcript:
Etienne Nichols: Hey everyone. Glad you're back with us today. With me is Sarah Adams. Sarah, how are you doing? So, so pumped to be with you today.
Sara Adams: I am pumped to be with you too. Etienne doing well.
Etienne Nichols: So, guys, she's not actually pumped because I sort of sprang this on her last minute, but she's a really good sport, and, you know, when she got on the call, she didn't even know we were doing a podcast. However, the good part about this is Sarah has done so many audits in her life, she could probably do them in her sleep.
And I'm guessing she can talk about them in her sleep.
Sara Adams: I can talk about my sleep. Sometimes I dream about them. Is that weird? Yes. I'm okay with that.
Etienne Nichols: So, you were just telling me about the. The number of audits you've done. Can. Can you give us a little bit of your background and your experience with audits?
Sara Adams: Yeah. So, before I came to Greenlight, I worked in the medical device industry.
I started with a very small company that grew very large across my 10 years at that company. I was a quality engineer. And essentially, I didn't tell you this part, but I was very young and green and.
And didn't know, and I had a very seasoned director at the time, and so I was included in all of the audit rooms when she left.
That was kind of like Etienne calling and saying, hey, let's do a podcast and I'll just record it. Right? Like, it was like, hey, the auditors are coming. Can you lead these?
And so, I had observed plenty to. To be able to do that and so stepped in and kind of assumed that role for my company of hosting all of our audits.
And I hosted a lot of them over my time at that company.
Etienne Nichols: And so, when you say when she says hosted a lot, I mean, we're talking, like you said, 25 a year, something like that.
Sara Adams: Yeah, yeah. So, we. We were a contract manufacturer, so we hosted our suppliers coming in to do all of those supplier audits.
We were also ISO certified, so we hosted recertification surveillance audits.
We facility moved. So, we hosted those audits when all the regulatory agencies came. We were also registered with both CDRH and CBER, so Biologics and Dev.
So that was two branches of the FDA that would come in to audit us. So, yeah, it usually wound up being about 25 audits where I was responsible for managing the front room in front of the audit or the.
In front of the audit team to be able to produce. Produce what was needed. I also was responsible largely for our internal audit. So, we had two locations, and I would travel to our other location and facilitate as the lead auditor of that internal audit as well.
Etienne Nichols: So, I'm curious. So, for internal audits, the. I, I've heard different things about how you audit different departments, and I assume your quality, I mean, your quality department has to be audited by someone. Did you train other people how to audit or how did that work?
Sara Adams: Yeah, so we did. We had a training, you know, laid out in our, our procedure about what you had to have to be on the audit team, what you had to be. Have to be a lead auditor at the company.
So, yeah, it was comprised of our quality department. So, some quality people would sit in on that audit on the audit team.
We also leveraged other departments. And I think that's really important to remember that like in an internal audit, you don't. You need to avoid a conflict of interest. Like, I don't need to be auditing my own work.
Which was why it was important that the lead auditor for us traveled to the other location. Right. So that I was, I'm. I'm based in Memphis, so I would travel up north and conduct lead that audit.
But not forgetting like that, you can leverage some people in other departments to assist in that audit process.
Training them to understand what they need to look for, how they need to audit was important in our, in our group as well.
Etienne Nichols: How do you. So, one of the questions that pops into my mind is how do you kind of build a culture of collaboration instead of just thinking that, oh, they're coming to audit me?
Because I, I just remember when, when my department was audited, we, we, we closed up. We're like, oh, no, you know, lock your desk, everything like that. I don't know.
Sara Adams: Quality's coming.
Etienne Nichols: That. To where people are a little more collaborative.
Sara Adams: Yeah, it's hard. Like, just transparently. Can I say that? Like, it is not this magic. I don't have this magic button or this magic pill that you can take and make it all better.
I think, you know, we talk a lot about green light about this, just this culture of quality, of true quality. And I think that's part of the importance is one, it starts at the top.
That like, quality is everyone's responsibility and not just the quality departments.
But I think that starts to help you see that the purpose of the audit is not like, so that the quality police can come in and check, you know, say, Etienne, your group's doing all these bad things, all these things that are wrong.
The purpose of the internal audit is for you to find them so that other auditors don't find them. Like, let's do our job, let's do it well so that we find these things and fix them before the 25 other audits that are going to come in at our facility take place.
And they find them and then it's not a real fun task.
And I think just setting the groundwork of my, like my team in an internal audit situation, different than external audit situation, but it gave our employees like we knew what happened at audits. Does that make sense? Like we knew what was expected. We knew, okay, we're going into audit mode.
But I say that and like, I think the clearest picture that we can paint is like we're in audit mode all the time.
Like there may not be an auditor standing over our shoulder and making sure that we're doing things right, but like if we're doing our jobs and following our processes and we have a very good quality system, one that we're living and breathing, then we're ready for the audit. And it doesn't feel like a different day, right? Like it just feels like, oh yeah, we're just doing what we usually do.
Etienne Nichols: So, I, I was at the ASQ conference in Minneapolis last week and I heard somebody say something that I thought was really good. He asked the question, what is the job of a QC inspector or an auditor?
And you know, people would say find defects. Or some people say to pass lots. You know, you got those two ends of the spectrum to find the defects or to ignore the defects and get them through.
But he gave a really good definition. I thought this was great. The job of a QC inspector or an auditor is to seek the truth and report the truth.
Sara Adams: And I, I think that's so good. And I, like, I cut you off on that. So, there may be more. But when you first said to find the non-conformances or whatever, that first one was, like, how negative, right?
Like if that's all we're out for, like how negative. Why, why do you. Everybody else is going to see us that way too, right? On the. And I say us like the quality team, we're going to see the auditor that way.
But yeah, to seek, like you said, to seek the truth, right. And to, to report back what that, what you find, right. What's the evidence to do A big dive into.
Here's what you say you do now. Show me that you do it right. And if we're already, if we're doing those things, then showing you is real easy.
Etienne Nichols: Yeah.
So. Okay, I'm gonna go back a little bit to when you were talking about how your director, when they left, basically it was Sarah, Sarah's gets to run the show.
I want to hear the story of the first one you ever did. Was that. How did that go?
Sara Adams: Oh, my goodness. You had to ask this question. So, here's a funny story.
I was terrified, first of all, when she left. Like, she knew she was a great director, love her dearly, still talk to her occasionally. And she left me, which is we at the time, we're in a paper-based system. We migrated to an eQMS during my time there, which I was on that team to help do.
But she handed me this huge, like, filing box, you know what I'm talking about, like where it's got file hanging folders. She was like, here's everything you need and slid it under my desk.
When I left my company, it was still there.
It was like my security box. Like, and I didn't use it anymore. Right. We were in an eQMS procedures change. They get revised. Like, it was severely outdated, but it's just my reminder, like, you can do this kind of thing.
And so that first audit was a customer audit. And they came in and they. He was, he was a tough auditor, but not because he was a good auditor, and I shouldn't say it that way, but like, he was just a tough auditor.
Like, he asked hard questions and I'm terrified. Right. I have our, our VP of quality. I know I can call her. She's at a different site, but I know I can call her.
And our headquarters was on Eastern time. We were in central time. And so, they, they quit an hour before us. Right.
So, we get to the closing meeting and. Or no, no, right before the closing meeting. And he asked me to show him prevent, preventative maintenance. Preventive maintenance on our forklifts, which was not a part of our quality management system, which is what I should have said. We aren't required to do preventive maintenance on our forklifts. They're not a part of our quality management system.
We did not. Let me like, clarify for the people who are listening. We did not do anything with forklifts that was a part of our process or product. We use them as tools to lift product to the top and off of the racks.
Right. For space, savers and so anyway, I didn't know that answer and I didn't know why we didn't have one. And my engineering manager didn't know why we didn't have one.
And so, I got to the closing meeting, accepted the finding, and the next day had to go back and like to or not that I had to send the email because we would send the email out to upper management and the VP of quality.
She was wonderful, she was so nice, but she was like, that's not a part of our quality management system. We're not accepting that audit finding. And so, we put together like a very nice response and things like that.
But, you know, I think, like, if I could just say anything, I love audits and you guys have heard me say that said in on a lot of them. We all have a first day.
Like there's. Everybody has a first day.
And you know, I accepted the preventive maintenance finding and we wrote a response, and we got it. I mean, not removed. It was still a part of the audit. Right.
But of no action required on our part because everything else that they checked on our preventive maintenance log was there and present and we had everything that we needed to have.
So, it gave. It boosted my confidence to be able to walk into the other audits and be like, you've seen enough of these. You know what they need, you know what they're asking for, and you can get them what they need to get them out the door.
Etienne Nichols: I've heard you talk about accepting a finding or not accepting a finding. And it's funny because you know, every, everybody who works with Sarah knows Sarah's. Sarah's so nice, but she will not accept nonsense.
And I respect that.
Sara Adams: Accept nonsense. I will not.
Etienne Nichols: So, I, I almost wanted to name this, this episode.
Sara Adams: You can name it.
Etienne Nichols: What was, what was the name? I can't remember.
Mom'd by Sarah or something. I will pull this car over; I will audit you. I don't, I don't remember. But anyway, so what does that negotiation look like when you decide to not accept a finding or if you do accept a finding.
And what if I assume they have to accept your acceptance or not acceptance?
Sara Adams: Yeah, I think that depends on when it happens in the audit. Like that one happened post-closing meeting. Right. And the point of the closing meeting is for an auditor to convey like, here's the finding.
And then to get that acceptance from the oddity like to say to like, so there's an agreement at the end of that. There may not be. You may have some dis disagreeing disagreements on that still at the closing.
Closing meeting. But I think that you know, as far as if an if a finding, if you feel strongly and, and differently.
I, I did have those situations where it was like this is not a. A finding at a closing meeting.
There are questions that you can ask. Etienne is getting that he's heard me say this. I will ask, I, I will ask what, what are you, what regulation are you citing? And that was something that a different quality director taught me. It fell at the time. I do not like an argumentative audit room at all.
But it was true, right? Like sometimes auditors get on a, you know, they believe one way and so they're going to go down that path. And so, I think like recentering that like okay, what are you citing? Is a good question to ask in that moment if there is a disagreement so that you can rationalize and have a conversation in a non-argumentative way.
I think respecting that an auditor has a job to do is. And you also as an auditee have a job to do or you know, if you're a lead auditor, vice versa, kind of the same thing.
As far as like a response to one of those that there's not an agreement on that auditor still has to accept your response. Right. They still have to agree with you.
So, you have to do a good job of telling the story. I used to joke with my team that I would absolutely give and take. I don't know that I would absolutely rather do this.
But when you are disagreeing, like when you're saying we're not going to accept this and you're going to say it nicer than that. But when you're saying that you actually you have to tell a better story.
You have to rationalize a lot better. Like those were the ones that you had to give a lot of details and context so that there was no room for doubt or issue if it came back in the future.
Etienne Nichols: So that when I picture doing that, I guess the thing that I worry about myself it's like well do I know the regulation well enough to. To. To just come up with refute it off the top of my head or just I, I'm trying to think of an example, you know, maybe and you were talking about how the auditor maybe they, you know, they, they want to go down a certain way. Maybe they've seen it done a certain way, the best practices and so they just assume you're going to do that maybe give you a finding when really it's not necessarily in the regulation.
Yeah, I don't know that. Was that ever a concern as far as, you know, what regulations should, should I say?
Sara Adams: Yeah, well. So, like, as a lead auditor. Yes. There was times where it was like, what regulation do I cite for this? Right. Like a lead auditor in an internal audit situation.
Like, okay, what am I going to cite for this? I get there's parts that I could cite, but is that really explicitly what it says? That kind of thing?
So, rationalizing where.
What. What clause? And I'm talking ISO 1345 language, but what clause I'm going to cite. We also related it back to the QSR.
We were auditing all the parts in those internal audits, but I think like the biggest thing. So, I had this happen once, too.
This is probably the first time that I learned, like to use that as a tool in my toolbox, in my audit toolbox. But my boss asked the, I don't even.
The finding was good. Like, it was a real finding. I don't, I remember what it was, but it was, it was a real finding. Like, we didn't, we didn't, we weren't, our objective evidence was off. We were not doing what our process said.
And my boss asked them what they were citing, and they told him traceability.
And he, like, I remember sitting on like, like the, the message conversation between the two of you. He's like, they can say whatever they want to, but they are not citing traceability.
We have not lost traceability.
And so, you don't know what answer they're going to give you. Right? But when you tell me traceability, and I wish I could remember the explicits, I don't want to divulge any of that.
But, but like, when you tell me traceability and it's not traceability, then I can, I don't like the word argue, but I can have a conversation about why it's not traceability.
Now, if you want to come back and give me something else, you know, but it leads to more of a conversation because not all the time does the auditor know, to your point, what, what they should be citing. And then sometimes they're really good auditors and they do know.
Etienne Nichols: That's a really good point. So, it is a conversation. Even if they're right, if they got there incorrectly, then maybe you can still even argue that and, you know, backing off and zooming in, obviously the goal is to deliver safe and effective product.
Sara Adams: Right.
Etienne Nichols: You know, so maybe you would have a parking lot or you, you know, have additional items that you pursue later. But, but it's Just a little bit better to do it internally, I assume, than to.
Sara Adams: Absolutely. I. I mean, as long as you have that culture of quality to do it internally. Right. Like, you don't want to be met with. You don't want to have the opinion of; we're going to sit in the audit room.
And I want to, like, use the term parking lot. Not everybody knows what that that is. So I want to clarify with that.
So, parking lot, where I'm collecting OFIS opportunities for improvement on the side.
You and I both listened to something recently where it was, where we talked about, like, having the…
Not all auditors go deep enough because they don't know our processes the way that we know our processes or the way that you know your processes. And so having, like stepping to the side and being able to collect those so that you can go back and do something about them.
Right.
What I found is sometimes that parking lot is the lowest on the totem pole, like the lowest priority. And so, it's good to take those and to do. But you got to actually act on them.
Right. Like, we've got to go back and follow up, though, on those items. Yeah, you're right. Like a great opportunity. Every audit is an opportunity for improving your quality management system, even if they don't have findings, even if you have those parking lot items that you find.
Etienne Nichols: Yeah. So, in your introduction, you talked about.
Well, I don't know if you sit. You mentioned sitting across on the FDA and how many times you did that versus notified bodies versus recertification or. Or supplier audits. I mean, customer audits.
I'm curious if you could kind of maybe go through what's unique about each audit if. If anything pops in your mind.
Sara Adams: Yeah.
So. And I'll just say, I said in lots and lots of audits, but 8, 8 FDA audits every year. BSI notified body audits and customer audits all, all the time.
Unique things. Right.
All of them are. All of them have uniquenesses. But this story sticks out.
Early in my FDA auditing experience, I was across the room from an auditor. I did. When the FDA comes, your VP of quality comes too. Right? Like, that's, that's what happens. I used to tell my husband, it's the super bowl, like, I'm a football player.
I'm not. But, like, this is the Super Bowl. I don't know how better to describe that to you. It's like the moment you've been waiting for. Right. The FDA shows up.
And so, we're sitting there, she leaves the room to get something from the back room.
And the auditor asked me in that moment, she says, can I see your internal audit report and your findings? And I look at her and I go, I don't think that you can see that, but I'd like to confirm with my boss when she comes back in the room. And she was like, I know, I can't see that.
I was just checking to see. You knew I couldn't see that. So, I thought that was a unique moment. Like, of, of her. Like, you know, she knew she couldn't, but she didn't.
I mean, if I gave it to her, she could look at it, right?
So just knowing like when FDA comes in, when a regulatory agency comes in, that they can't see everything, that there are things that you don't have to show them, right?
But they'll try. Like nothing stopped her from asking the young girl in the room if, if she could see that.
Whereas with, when you have a notified body come in, you're doing a 1345 certification, research, surveillance, stage one, whatever, they can really see everything, right? Like that you're paying them to audit your quality management system so they can they get to see everything.
And that's what you want them to do, right? Same thing in an internal audit where you want your internal audit to go to look at every piece of this. No one knows your quality management system better than you do.
And then those customers, those supplier audits, I think probably for your listeners, more of them are going to do the supplier audit than maybe receiving the supplier audit.
But one thing that stood out to me, Etienne, you know this about, but I'm going to tell them I'm about to sit for my lead audit certification, which has been a professional goal of mine forever.
And one of the things that just really stood out in a lot of my pre work is that second party audits, those supplier audits that you're going to do. Man, I had the stretch of type of auditor like re. Like as I'm going through this pre work, I'm like, man, that was that auditor. That was that auditor.
So, if you're listening to this and you ever audited me, yes, I totally typed you on the list on the like the scale of lead auditor and so much that like they can just, they can be everything, right? When you're doing a supplier audit, like being mindful that we need to do a good job auditing, like we need to thoroughly vet this supplier so that they're giving us the product that we need, and we like let's talk about what the goals of that as a supplier.
Or if you're auditing your supplier, you don't want recalls because of the supplier. You don't want quality issues. You don't want complaints like those things.
You want to do your due diligence to get that. Also, at the same time, like, if you're a quality supplier, quality department, you want the business relationship. Right. You want this to go well.
And so that's kind of the uniqueness there. So talked about, like, FDA, they can't see everything. Like, that's the Super Bowl. Then we've got our notified body where they can see everything.
And also, kind of like, maybe the grand championship, I don't know, like to throw a name on that.
Etienne Nichols: Yeah, that's good.
Sara Adams: Airbag them. And then the supplier audit, like, there's that. That tandem relationship that you're kind of working through as well.
And so, they can't see everything either. Since I've commented on that, let's just throw that out there. Like, I don't have to show my supplier audit every piece. They can see things.
Or your forklift.
Yeah, or my forklift.
Rolling my eyes on that one. But, yeah, so those are just some of the uniquenesses that stand out. Like the FDA, you're. You're nervous. I mean, you just are. It's like an adrenaline rush of, like, they could shut you down. Like, and I don't know if any of your listeners have ever had an FDA inspector show up with a gun, but, like, they can show up with a gun.
Like, they show up in full uniform.
And so, it's just kind of intimidating. Intimidating. Whereas, like, you kind of go down, like, the. The notified body. Like, I want this to go well. The lead, the internal audit. Like, I want you to uncover things. I want this.
I want you to find stuff. We're doing this for a reason. Right. And then the supplier, like that, that tandem of, like, I. I want you to not make me have recalls.
And I also want this business relationship to work. And I'm going to conduct an honest and fair audit and look at everything. But. But still.
Etienne Nichols: Yeah, I think you highlighted the philosophical differences really well because I, you know, we could talk about exactly what to do in each scenario, but going in with the right mindset is probably pretty important because, like, internal audits, for example, you want to uncover, like, together so that you can truly improve and make the next time the. The real. The real audit, the real one just ironclad. It makes me think of a.
I don't Remember who said this? But the more you sweat in peace, the less you bleed in war.
Maybe that's a little extreme.
Sara Adams: So true though. No, I mean, I think there's truth to that. Like, I had some. I saw something the other day of. I shared it on LinkedIn. But, like, where you've got a road and this is the road before the audit, and it's like this bumpy, cratery, like bad picture.
And then in the middle it's like this smooth black top. I kind of made the Disney cars analogy. And yes, I have a five-year-old who loves the movie cars, all three of them.
And then on the end you've got like the bumpy road again. And the smooth part being like where Lightning McQueen comes in and like paves the really smooth new road.
But the point being, like, before the audit, we're really bumpy because we just do it whatever we, however we want to, we don't pay attention, we don't. We don't follow our procedures. We're not doing things like we've built, right? And then we get really, really good for the audit. We, like pave our way. We rock the facility.
We change all the status control signs, we get all the cobwebs out and we clean it up, right?
And then afterwards everything goes right back. That's not what you want, right? Like, to your point, you want to sweat, you don't want to bleed, you want to make sure that you've got the foundation laid in a way that's just gonna lightning McQueen style. That, that audit and beyond.
I'm mixing my Pixar movies, Etienne.
Etienne Nichols: No, no, I know what you mean, because I've seen it myself a million times. I'll probably watch it tonight, but. Yeah, so just to kind of run through the others, the partnership with a supplier audit, I think sometimes we just see them as a vendor. But you've been on the other side now and you know, that's, that's that you want that to work out. You want it to be a partnership.
And there's other things too.
They may not just be looking, you know, almost like with an FDA inspection type. Like if I'm the customer and I come and you're manufacturing my product and I'm going to inspect.
I also want you to make sure that you understand what it is that I want from you. So, there's. They're both of those things. So that it is really a partnership.
I respect that.
Sara Adams: Like, even when you said that, it made me think there were times in supplier audits, if you had a really good auditor that could look like they're almost auditing themselves in a way as well.
So, like, you're auditing your supplier, but you're also auditing, like, you're looking at. If they're using your documents, you're looking at your documents like, have I given you all the information that you need to be successful at this?
And sometimes we had auditors who could see that, and sometimes we had auditors who could not, right? Like, where they could be, like, man, we only gave you those three pieces of paper to know what to do, to inspect, whatever.
And so, I think that that's really valuable to be in that audit situation where it can go both ways and, like, look at it both ways.
Etienne Nichols: You. You made me think of a video someone showed me recently where the guy, he. He says to his kids, he's like, hey, guys, if you could write down the instructions.
I'd like you to write down the instructions for me on how to make a peanut butter sandwich. Have you seen this video?
Sara Adams: No, not at all.
Etienne Nichols: A peanut butter jelly san. It is so good. It's. They say, put the peanut butter jelly on the piece of bread, so he puts it on the side of the bread.
Sara Adams: It just kind of illustrates, like, if.
Etienne Nichols: You’re not really explicit in your work instructions, then someone is going to mess it up. It will happen eventually.
Sara Adams: Every time.
We actually did something similar, not peanut butter and jelly, but in our training program at my previous facility, one of the ways we had process trainers, like people who are identified as being the trainer for individuals, and we would give them Lego sets and we would tell them to explain how to put the Lego together right?
Or we would give them instructions and leave out a step, or we would remove some of the Legos, like, all those challenges that come up. But kind of similarly where it was like, well, I can't do this if I don't have all the pieces or if I don't have the right process in front of me.
Etienne Nichols: So, what kind of pr. What kind of training was that that you.
Sara Adams: We were just mean at the end? No, we. We had process trainers. So, we had. And we did have a very big manufacturing floor, so we had all these different processes going. So, when we brought in new employees and trained new employees, they had that normal. Like, you and I both referenced it. The huge thick stack of papers that, like, make you learn how to drink black coffee, right?
And so, reading. Also, I drink black coffee. So, I'll add that.
And reading those procedures, and then they would move into, like an on-the-job type training. And those process trainers would train them on the job. So, to make sure that we had good trainers, right?
Because we want to make sure that we have effective trainers, we would train our trainers. And to do that, we. We did real training too. We, we obviously did on the job training with them, making sure they could explain the process.
But one of the starting point points was Lego sets with sometimes Legos that had missing pieces and sometimes processes for assembling those Legos that had missing steps. But they would have to then teach someone, put those Legos together and just kind of like to assess if they could explain and train.
And in a way that worked.
Etienne Nichols: That is fantastic. I love the tactile learning because, I mean, everybody learns a little bit differently. Some people absorb it a little bit better that way.
So, one of the things. So, you are working with a lot of customers now who may be there, you know, as a medical device guru, we didn't really talk about what that was, and that's okay.
But you work with people who, maybe they're just setting up a quality management system. Maybe they've not gone through an audit. Maybe they have.
What.
I'm curious if you see any pitfalls or consistent problems that people face and how to overcome those. Any, any advice you find yourself giving over and over again?
Sara Adams: Yeah, yeah, I think so. Customers that I work with run across the spectrum, right? I'm a little one. I have no med device experience. I need help here. And then we have others that need help in other ways, but they're a lot larger.
And I think, like talking about this, this group kind of that you described, where maybe I'm, you know, pursuing ISO certification, I'm going to a stage one audit, or I'm not doing that yet.
I'm just trying to set up my quality management system so that I can get my 510k right. So, I can go that route, I think, over and over.
And we kind of touched on this a little bit. But that grouping, not choosing, let me see, how to phrase this, like, choosing to not see that the quality management system is ever evolving.
Right. It's not this thing that I put in one time, and I never touch it again. Like, I don't release a document control procedure and then I leave it for 15 years or 15 months, or like maybe even three months, right?
Like, things change, and we get better and we change. Like someone asked me to today, actually on a customer call, like, can I put this in and then change it later?
Like, can I?
And they didn't mean, I should clarify. They didn't mean like, can I just put this in and not follow it and then change it later. That's not what they meant.
Can I put this in like I think it's going to be.
And then later go back and change it if something doesn't align? And I'm like, yes, and every auditor in the world wants you to do that. Right. So go back to, go back to the question that you asked. Like pitfalls.
Not seeing this as something that is going to be ever changing, ever evolving, putting it in place and, and then be like, okay, we did that, we put procedures in place. Let's go design our project design inputs. What do we think? Right. Like not looking at it as just this like one and done thing is what I would encourage.
That's a pit. Well, that's a pitfall that I see. They're looking at it as a one and done type thing and we're not going to ever return to it. Yay, we checked that box.
Never look at something even like with your background, you would say like the same thing. Like never look at something as just a checkbox. Yay, we checked that box. Let's move on and do the next thing.
You're always going to be going back and ever evolving and making things better.
Etienne Nichols: I mean, so my background is product development. You get to verification. Everybody says, fingers crossed, it's done and you know, you.
But at the same time, you have to be willing to iterate. Suppose you, you realize something. You know, a typical test that you expected to fly through. You see a few failures.
Well, you may need to tweak your design. So, you need to go back and iterate. Yeah, I'm totally with there with you. One thing that you were talking about with the document not being perfect.
Sara Adams: Yeah.
Etienne Nichols: So, if, if that document is, well, I just lost it. I had something that I wanted.
Sara Adams: That's okay. I can go apart as a part of that. Like if that document is not perfect, kind of what, what I hear in that is like, we want to.
I guess. And now I'm not doing a good job of saying it. Did it come back?
Etienne Nichols: It came back to me before it.
Sara Adams: Yes.
Etienne Nichols: Training.
Sara Adams: And then I'll.
Etienne Nichols: So, because you mentioned that stack of documents, we plopped down on that hire's desk. So, when you go through that training, one of the things that I always loved was if, if I, if there was an SOP I had written and somebody was training on it, they came to me and they said, Etienne, I didn't want to Bother. Dot control. I was just curious what you meant here. I'm like, well, you know, it's not clear.
Maybe I should update that.
Sara Adams: Maybe we should revise this.
Etienne Nichols: You don't want to update every SOP Every time you hire someone. But what I almost think it's a good exercise, is to take that feedback from that new hire, which we are usually not interested in.
Sara Adams: But we used to always treat quality new hires like they were auditing our procedures because of what you just said. Or if we had a new process that we were launching and people didn't like, this is new.
We've put all these new work instructions together. We're going to again, contract manufacturer. So, we had new things coming in all the time. Be like, hey, Etienne, you just started here.
Can you go watch them do this and follow this procedure and see if anything is, you know, we need to highlight anything. We need to change anything. Because they're like a.
A blind new person, right? They. They don't know your processes. There’re no assumptions.
There's not that tribal knowledge of this is just the way that we do things. I hate that word. I don't know why I said it. Like, I'd be fine if I never heard the words tribal knowledge ever again.
Etienne Nichols: I want to give you an example of tribal knowledge that I.
This just popped in my head, and it's okay.
Maybe this is right. Maybe not as far as the timing to put this in here, but I remember a time where we had a manufacturer or a machinist who left the company.
We hired a new machinist.
Sara Adams: Of course.
Etienne Nichols: No big deal. We had 20 years. This guy runs this machine for 20 years, never had an issue.
And it was an internal working part. You assembled it, moved it on, all that sort of thing.
After this new guy came on, it just did not work.
We're like, what in the world? So, we took all the parts he made. They. They were perfect. Everything was just right.
What's the deal? You know, just still couldn't figure it out. We finally realized that part had never been made, per. Correctly. Phil. I'll just use the name Phil. The guy who had made it 20 years ago, he said, man, this part ain't right.
And he changed the machine and never told anyone. It's that tribal knowledge. And so, for 20 years, that was. That was a mess. That was really.
Sara Adams: Yeah, that was a good, fun Kappa at the end of the day, right?
Etienne Nichols: Yeah, but. But what made me think of that is that relationship. You send them out there, go audit this process. Do you Understand what's going on if you don't have that relationship too.
You know, they're not gonna. They're not gonna verbalize some of those things that pop up, like, hey, fix this.
Sara Adams: Or if it. If they're new and they verbalize it, and then it's met with like a. And this is not what happened. But if it were to be met with like, oh, that's just what we do, or, oh, that's just how it is.
Right? Like, then you're not really, like, why one of my. My one of my least favorite things. And this is across all the boards. This is like, across friends, family, anything.
I cannot stand when you ask me for feedback. And then, like, why did you ask me if you're not. Like, if you're not gonna listen, like, why did you. Why did you bother to ask me?
Right? Like, I just wasted my time and energy talking, answering, giving my thoughts. And then you just did something completely different. And so that's. You know, I think when you ask somebody to do that, like, being receptive to what they.
What feedback they have and really listening to.
Because again, we could paint those connotations all the way back to the auditor, too. I could hate my auditor.
But even still, I need to be receptive to some of the feedback or at least do my due diligence to see.
To see it from a different eyes. Because I think one of the traps, I felt guilty in was I do these 25 times a year. You got nothing new for me, trust me.
You know what I'm saying? Like, in that. In that, like, no, you don't. I do this all the time.
And so, I think just being receptive to that and being willing to look into that, that what they're saying.
Etienne Nichols: Yeah. Well, thank you for getting us back on track after I got us off track.
Sara Adams: All of it relates back together. All paints. You know, if I say it once, all this big circle. Right.
Etienne Nichols: I promised I'd give you 10 minutes. So, thank you so much for this impromptu episode. It's always a pleasure to talk to you. Sarah, any last words for, you know, for our listeners?
Sara Adams: Man, this is not really a parting thought, but you asked. The last question you asked me was about what think pitfalls that I see. And one thing I'll say is for people who are looking to get that ISO certification, needing to do that stage one and stage two audit, I think they have this, like, preconceived. Oh, I'll just call my notified body, and then they'll get me in next week.
And that is not what happens. So being early in starting that path of getting a notified body involved, you don't have to wait. You, you do need to be ready when they come.
You don't have to have all the things in place when you start pursuing that. Meaning like calling them and saying when can we schedule this? Because sometimes they'll tell you like six months down the road and or you know, so sometimes they'll say faster than that.
It just another guru and I have a saying which is the best notified body you get that question, the one that will audit you and give you a certificate. That's the best one. Like meaning who will get you on the calendar? So, if you are considering that if audits are on your radar, start now rather than later.
Etienne Nichols: Great advice. Awesome. Thank you so much, Sarah. I'll let you get back to your next thank you. Those of you who've been listening, you've been listening to the Global Medical Device Podcast, and we will see you all next time.
Sara Adams: Bye guys.
Etienne Nichols: Thanks for tuning in to the Global Medical Device Podcast. If you found value in today's conversation, please take a moment to rate, review and subscribe on your favorite podcast platform. If you've got thoughts or questions, we'd love to hear from you.
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About the Global Medical Device Podcast:
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.
