Management responsibility is crucial to the success of a QMS… but what is it? What’s covered by the topic of management responsibility and who’s the responsible party? In today’s episode, you’ll hear from Sara Adams, Lead Auditor, Quality Engineer, and now Medical Device guru, on the subject of management responsibility and all that entails.
Listen to the episode to learn more about the topic of management responsibility. Sara shares her thoughts on quality policy, organizational structure, management review, and quality systems procedures.
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Some of the highlights of this episode include:
- Whether a summary statement is enough, or whether the policy needs to be a paragraph
- Who the management representative is and what they are supposed to do
- Why you need management review even if you’re not selling products
- Getting executive management on board with a culture of quality
- Making management review meaningful
Links:
- Sara Adams on LinkedIn
- Etienne Nichols LinkedIn
- etienne.nichols@greenlight.guru
- Greenlight Guru Academy
- Greenlight Guru
Memorable quotes from Sara Adams:
“The quality policy should be the battle cry, the rally cry, the thing that pumps us up that we remember, not just words on a page.”
“It is really important to have enough resources in the right roles to be able to meet the requirements of this regulation.”
“Don’t just gloss over it. It is something that you have to do, but make it meaningful.”
Transcript
Etienne Nichols
00:00:00.720 - 00:02:14.240
Hey everybody. Welcome back. My name is Etienne Nichols. I'm the host of today's episode and today we get to speak with Sara Adams.
We talked about management responsibility, which, if you ask me, is the most important part of a QMS because without it, everything else is doomed to fail. We covered a lot of ground.
We talked about things like what is management responsibility, how in the weeds should management get, and what is involved with management review. And we talked about a lot of other things. Sara Adams is an ISO 1345 lead auditor. She's a fantastic quality engineer who has led countless audits.
I say that, but knowing Sara, she probably has counted them all.
But she's now working as a medical device guru for Greenlight Guru, where she advises a portfolio of companies on how to set up their quality management system so that it's airtight and audit ready. Sara is one of my favorite people on the planet because she genuinely cares for the people she works with and the customers, she serves and.
And I'm sure you'll see that shine through in today's conversation. We hope you enjoyed this episode with Sara Adams on the most important part of your quality management system, management responsibility.
Hey, everyone, welcome back. This is Etienne Nichols, the host of the Global Medical Device Podcast. I get to speak with Sara again today.
Some of you had reached out and said you loved her last episode and plus her lighting is better. I don't know if you notice if you're on the video. How are you doing, Sara?
Sara Adams
00:02:14.400 - 00:02:16.800
I am doing okay. How about you, Etienne?
Etienne Nichols
00:02:17.060 - 00:02:25.540
Doing great. I'm so glad to get to talk to you about management responsibility. Okay, I had 8.20.20 pulled up. Let me pull. Where did it go?
Sara Adams
00:02:25.620 - 00:02:29.540
It disappeared in the thousands of tabs that you have open right that's right.
Etienne Nichols
00:02:29.940 - 00:02:52.580
Incidentally, there's a Google grouping feature that I have not taken advantage of this time. But whatever.
That aside management responsibility, you recently went through a lot of different training with ISO, lead auditor and other training as well. I know you've lived auditing in the past. We don't necessarily have to go at it from that angle.
But when you think about management responsibility, what comes to mind for you?
Sara Adams
00:02:52.980 - 00:03:42.320
Yeah, so.
Well, I think that's a loaded question because when I said let's do this, let's do a podcast on management Review, that's literally what comes to mind is management review. Because I lived that for so, so long, so many years. That was one of my chief jobs at my previous job. Chief roles, whatever.
My previous job was to create the management review slides.
Now, that's not what comes to mind when you say management responsibility, but just from that perspective, what comes to like immediately is like what is. Does management understand what their responsibility and their role is in this whole big quality management system space? Right.
Like, do you understand what you're supposed to be doing as top management? Do you understand? Or is this just an, Is this just kind of an afterthought to you?
Etienne Nichols
00:03:43.040 - 00:04:36.109
That's a good question because I, and people are going to get tired of me talking about this, but I look at a company basically with three different legs. So, there's the leg of the ethical side of things, which has become more and more prevalent in recent years, obviously.
So, the ethical aspects, there's regulatory and I think that's where a lot of people look at management review. Oh, it's just one of the regulatory requirements.
And then there's the business requirements, you know, the money, building money, because money is the air company's breathe. But we usually lump management responsibility or management review, I guess, in that regulatory.
When in reality it's going to cover all three of those, I would think. And so now we'll get into the nuts and bolts.
I'm going to have to ask about the nuts and bolts of management Review at some point because I'm sure people will be interested to hear how you develop those slides and what is included in those. We'll get to that a little bit later. But you say it doesn't. That's not what comes to mind now. What comes to mind now?
Sara Adams
00:04:36.989 - 00:05:27.730
The management commitment piece. Right. So, I, and I have, I should have mentioned you have 820 pulled up. I have 13485 printed at my desk.
Because if you were, I think I said it last time. But if you Came to my lead audit certification. That's what I took away is have a print did copy.
But man, all of management responsibility is 5, right. It's the fifth clause in ISO 1345.
I think just the summarization of what comes to mind is that it is that management plays a role in this quality management system thing, that they have a responsibility of ensuring that all those three legs, like you said, are functioning and apart working together, if you will. And if you don't have management buy in, we probably should add that to talk about too.
If you don't have management buy in, it gets really hard to do this thing called a quality management system.
Etienne Nichols
00:05:28.210 - 00:05:49.890
Yeah. So, part 820.20 is where you would find it in 21 CFR. Part 820.20, management responsibility. So, the first, first paragraph there is quality policy.
Management with executive responsibilities shall establish its policy and objectives for and commitment to quality. And I haven't compared it to ISO 1345. It's been a little while since I've read that.
Sara Adams
00:05:49.890 - 00:07:42.100
But similar, similar.
Top management shall ensure that the quality policy is applicable to the purpose of the organization, includes a commitment to comply with requirements and to maintain the effectiveness of the quality management system. I could keep going, but I won't read to everybody. The quality policy for me kind of sits at the top, right.
Recently I did a guru workshop with John Collins from Comply Guru, who's one of our partners. And we talked a little bit about the quality policy, and he said something that I absolutely loved.
I'm going to give him credit because I didn't come up with it. And that is that the quality is more than words on a paper, right? Like they're like.
I don't know if you had this at your previous job, but we had the quality policy posted everywhere, right? Like it's in the break room. We didn't put it in the restrooms, but we probably would have if we had thought about it, right? It was everywhere.
Even so much so that because quality policy is one of the things that auditors ask about our employees, when they started with us, got this little card that they would put in the back of their badge, right, that they would swipe to get inside that had the quality policy on it. Okay? It was words on a paper. Now, it was more than that at my previous company, so don't hear that. But it really was words on paper.
At its core though, it is the battle cry of the. That unifies the group. So, like when I hear that I'm. Eddie knows this I'm a huge sports fan. I love baseball.
So, I think of the, like, come, like before the game starts, and we're all in the circle, and we're like, on two, one, two, go. Which is not what you say in baseball. That's what you say in football. But, like, it's the, like, here we go. This is what pumps us up.
And for us, at my previous job, that was quality is everyone's responsibility. I think it was, like, quality matters in everything we do all the time. I clearly don't remember deeply what it was, but it is quality matters.
It's important.
And that, like, the quality policy should be the battle cry, the rally cry, the, like, thing that pumps us up that we remember, not just words on a page.
Etienne Nichols
00:07:42.740 - 00:07:58.520
So, I'm curious, when you think about the battle cry of a company. Well, I don't know. It's easy for me to think of a battle cry that I, or maybe even my department has.
But the entire company having something for an entire company seems tougher. And have you heard any good ones? I mean, I'm kind of putting you on the spot here.
Sara Adams
00:07:58.520 - 00:09:20.970
You are putting me on the spot. I think, you know, quality policy comes back to quality at the end of the day, right?
Like, you can't have a quality policy that says, we're gonna make all the money in the world. Like, I don't think that's gonna go over well. That may be one of your top goals as a company is to make money.
I think, like, why would you have a business if it wasn't? Right. It's one of those legs like you talked about. But it needs to be.
I think I don't have any great examples, because I have some examples in my past. Right. Quality matters. But at its core, I think the quality policy needs to think about the patient. Right?
Because, like, at the end of the day, our jobs impact who do they. Who they impact the patient. Right?
And if that's your family member or if that's somebody else's family member, like, good quality policies, think about the end goal. Good things in life, think about the end goal. Right? But, like, think about the end goal. And so quality matters in everything we do all the time.
Like, why? Because we're not at the end of the day making tennis shoes. Or maybe we are. If that's going to be a medical device, maybe that's a bad example.
But we're not making pens, writing utensils that we're going to write with. You know that any. That's not what we're making. We're making things that change the quality of life for patients.
And so, I think, like a good quality policy, a good battle cry places that at the center.
Etienne Nichols
00:09:22.010 - 00:09:27.210
So, we talked a little bit before about your personal quality policy. Am I allowed to ask about that?
Sara Adams
00:09:27.450 - 00:12:19.120
Yeah, I. You're allowed to ask about that. We talked a little bit about that. I am a nerd at heart of people who listen. Have listened to me before.
I love audits. I told Etienne that I was doing a personal check in with myself. And laughingly, I didn't tell you this. I don't like to journal.
I think my brain goes too fast and faster than the pen, which is kind of bad. I am. It is a practice I am trying to get into because I think there are so many benefits there.
Again, not what we're here to discuss, but as I was doing that, I was like, man, I just check in with myself, I need a quality policy for me. I need a quality policy for me. And so, I sat down, and I wrote a bunch of things of like, who I want to be as a friend, who I want to be as a.
As a parent, who I want to be as a spouse, who I want to be as a. As an employee. Like all of those things. It was really long because I know you've seen some really long quality policies, right?
Our quality policy referenced regulations inside of it. I think that's a good thing.
I didn't have any regulations to reference in my personal quality policy, but I got to the end, and I was like, I need something. I need something that is, like, mine to hold on to. That, like, is the battle cry. I can't recite this to myself in the.
You know, for people who've listened to you, I know we've talked about imposter syndrome before or something like that. I can't repeat this to myself in that moment. It's this long. Maybe I could frame it on my wall, but why would I do that?
Or, like, post it in the restroom? Like I joked about earlier, I need something quick. And so, I'm not going to share what my personal battle cry is. It's.
It's definitely mine. But regardless, it's three words, maybe four, depending on what country you're in and how you hyphenate words.
But it's like that quick, like, this is mine battle cry. And yeah, just from a life perspective, I think I'm. I'm a nerd and did a quality policy and called it that.
But at the same time, I think that that is Valuable. That's. That's the point, right? It's something that you can recall. And, like, in that moment of I don't.
Again, in that moment of I don't want to necessarily do the right thing because we're all humans. Like, I. I'm gonna. I'm gonna cut this.
Like, it's something that is in the back of your mind that, like, just pops into play in that moment where you're like, oh, yeah. Oh, yeah. And so that's what the quality policy should be. It should be that thing that people at your company can come back to that they deeply.
That deeply resonates with them and that they deeply believe. And again, it doesn't need to be words on paper.
So, part of the battle, and I don't know if that's the right word to use, but part of the climb is how do we make this not just words on the paper? How do we make people believe in this? And, you know, there are ways that you can do that there. You can show surgeries.
You can bring patients in to tell their story and things like that.
But what emotion can we associate this with for people so that it's something that they remember, and it's not just something on the back of their name card that they pull out during an audit when an auditor says, what's your quality policy? Oh, it's right.
Etienne Nichols
00:12:19.920 - 00:12:56.930
You know, you're making me think of something that my wife and I did when our first son was born, and that is we came up with a family mission statement. We actually did that. We framed it, put it on the wall. It's probably in storage at the moment, because we. We're still not fully back in.
But if I remember some of it, it was things like we said. We asked questions to probe, not prove, and it ended. And if I was trying to think, because it is a lot of statements I couldn't memorize.
I don't have it memorized. But the last statement maybe is what summarized it, and it said, we are the Nichols family. We are a haven from the world.
And that was what our family mission statement was.
Sara Adams
00:12:57.250 - 00:12:59.250
Ready, Break. Right. Yeah.
Etienne Nichols
00:12:59.410 - 00:13:28.270
We're a haven from the world. We don't. We bring people in. We want to be hospitable. We want to be generous. We want our family to feel safe. We want to be a haven to the world.
But if from a company's perspective. I love what you're talking about here, because let's take a step back.
There do have to be some words on a page, obviously, for when you get audited and so forth.
And, and would you, and I just want to ask you, would you say that would be the longer paragraph to maybe fully encompass it and then you have your summary statement that everybody has memorized and is your battle cry.
Sara Adams
00:13:28.430 - 00:14:15.210
Yep, that's exactly it. And that's my experience at my previous company too, if anybody's listening.
Because that we had the paragraph and then we had the summary statement at the end. And I promise you I, I did audits. I was the one that brought the auditor to the floor to interview the people to say what's your quality policy?
I would coach them. And maybe coach is the wrong word. But like this is the.
If you just say quality is matters in everything, I do all the time, like that little statement, that battle cry, if you will, like yes, that's your quality policy. But you do need the words on the paper, right.
And just like my own personal quality policy, I have the words on the paper like I have it detailed of who I want to be as this and that and this and that in this aspect. And then I've got the summary statement at the end that summarizes all of them kind of like that.
Etienne Nichols
00:14:15.870 - 00:14:22.030
So, if we go back to the standard. This is a question, and you don't necessarily curious if you have a thought on this.
Sara Adams
00:14:22.110 - 00:14:22.590
Yeah.
Etienne Nichols
00:14:22.670 - 00:14:28.750
Does it have to be a paragraph to fulfill the regulatory requirement or is that summary statement enough?
Sara Adams
00:14:29.390 - 00:14:58.010
I feel like for some of the parts, and I'm looking down because I'm looking at the standard for some of the parts here, there's parts of a paragraph, right. A commitment to comply with requirements and to maintain the effectiveness of the quality management system.
A framework for establishing and reviewing quality objectives. Like we had gotten quality objectives yet probably going there next. But it does need some of that meat to it.
Even still though it's that summary of who we are and why we are that while we're doing that.
Etienne Nichols
00:14:58.330 - 00:15:38.070
Okay, so if I'm looking at 820.20, the next. The next paragraph is organization. Each manufacturer shall establish and maintain an adequate organizational structure.
So, an org chart essentially is designed and produced in accordance with the requirements of this part. So just to make sure that the organization has an adequate.
Whether it's service and repair quality department, all the different, I guess depending on how you want to lay out your company just to make sure that you are able to meet all of the requirements of Part 820. Do you have any thoughts on this section and maybe any thoughts on, you know, I don't know if ISO 13485 differs in any way here, but it mentions it.
Sara Adams
00:15:38.070 - 00:16:36.550
Right? It's just at a different part. It does not come immediately after the quality policy.
But I think the big thing here, and we'll get into its kind of when we talk about management review too though, is that you have the right people in the right roles and that it's adequate to make sure that you're meeting that quality policy. Right. That you're. And that's not how it reads. It reads like when you look at 80, 20, it reads in accordance with the requirements, right.
That you're ensuring that your devices are produced in that way. But I think that's somewhere where, man, when you pull that third leg of the stool, we fall down. Right?
Because business needs, and especially in executive management, business needs are important. Like we have to make money at the end of the day, we have to exist.
Like there's no point in having a quality management system if we're not producing a product and paying our bills and things like that. But it is really important to have enough resources in the right roles to be able to meet the requirements of this regulation. And that.
And the standard is very clear, that falls in management's responsibility.
Etienne Nichols
00:16:37.590 - 00:17:20.880
Yeah. And so, resources are the. Is a sub paragraph of organization and part A20. So, it would talk about that too.
Make sure you provide those adequate resources, make sure you have everything, including for internal quality audits and so forth. Responsibility and authority are the first sub paragraph after organization.
And it talks about making sure that you give proper responsibility and authority and interrelation of personnel to manage and perform all these different tasks associated with this.
And I think that's interesting because sometimes I've worked with some people who may not have felt like they had the authority to do what they needed to do. And they might have had the responsibility, but not the authority. And it obviously is both of those things.
Sara Adams
00:17:20.880 - 00:17:23.520
So yeah, you definitely need both of them for sure.
Etienne Nichols
00:17:23.920 - 00:17:26.320
Any comments or anything from ISO?
Sara Adams
00:17:26.960 - 00:17:56.660
Same. Similarly, we've got a responsibility and authority section that says similar thoughts that we need to document and manage it.
Let's see, one other thing. I was going to say, like everything in ISO, you got to define, you got to document, right.
Or it didn't happen but communicated within the organization. Again, I know we're going to get into, into management rep too. That falls kind of in the responsibility piece too.
But the big thing that we have delegated who's responsible for what. Right. Because if we have it, then that's where things fall, fall down, fall through the cracks.
Etienne Nichols
00:17:56.660 - 00:18:24.080
Yeah, yeah. And you mentioned management representative. They have two requirements.
One is to ensure that the quality system requirements are effectively established. And then second one is to report on the performance to the executive.
And I think that's interesting because we were talking before we got on here how important, and maybe even at the beginning how important top management is. They have to be constantly informed of the performance of the quality management system. And that's one of the jobs of the management representative.
So, what, anything to add?
Sara Adams
00:18:24.080 - 00:19:04.420
I was going to laugh and joke. The management representative, that's just the person on the paper who's responsible for management.
Like I just have to have somebody named as the management rep. Right, Etienne? Like we had a nice little chart at the door that identified who our management rep was. But it's deeper than that, right?
It's not just a name on a page like, oh, I got a name management rep. Because that's what I got to do. Right. It's one of those questions they ask and who is your management rep? I don't know, it'd be this person kind of thing.
But yeah, they are responsible. Like when we get to communicating what's going on, if we're hitting things, if we're.
What is happening in the quality management system, they are supposed to tell the management of that and then managements supposed to listen and make decisions accordingly. Right.
Etienne Nichols
00:19:04.420 - 00:19:08.780
And who is that? I mean, I think of the VP of Quality, or so I think of too.
Sara Adams
00:19:08.860 - 00:19:41.560
Yeah. VP of Quality, Quality Manager. If you don't have a VP of Quality, the person who is at.
If you've got multiple sites, like we've got a management rep, someone who is for that site. Maybe we've got a management rep for the whole quality management system over multiple sites.
But yeah, I tend to think that falls in the quality umbrella. I certainly would not necessarily want to see that top. That top management, the CEO having that management rep position.
I don't know that that would be. Well, that would be separation, right?
Etienne Nichols
00:19:42.520 - 00:19:55.620
Yeah, it seems like it makes sense that it would. I don't even know if it could be that person because they're supposed to be reported to really it saying.
I think it's just understood that a CEO is just not going to have time, which is why you need a representative.
Sara Adams
00:19:55.620 - 00:19:57.380
Yeah, very true, very true. Yeah.
Etienne Nichols
00:19:57.700 - 00:20:07.700
Okay. The one you're. We've all been waiting for, Section C in. In part 820.20 is management review. Yes. Okay, let's talk management review.
Sara Adams
00:20:07.940 - 00:23:21.050
It's much longer in ISO 13485 than it is in 820. I know that's surprising, right? But I love management review and I'm probably the nerd. And then here's the other thing.
Like I was the queen of pivot tables, show our data to look at it and now I'm like, I don't remember how to do that, how do I do that? Like, I look back at some of those old spreadsheets and things like that and like, how did I live that life for so long?
But yeah, I think an important part of management review is it is a time for everyone to come together. And by everyone, I mean, like, we're bringing in different, different parts of the company. Right. It's not.
It doesn't have to just be management and quality that's sitting down, but that management role not. Sorry, I should have said it doesn't have to just be this CEO and quality who's sitting down.
But like, you need your person who's in charge of HR because we're going to talk about resources and you need your person who's in charge of finances because we're also going to talk about resources. And you need the CEO there and you need the COO there and if you don't have all those members of your team yet, that's cool.
We need top management to come together, sit down and look at. And in ISO 1345 we define some input.
So, feedback, complaint handling, reporting to regulatory authorities, audits, monitoring and measurement of processes, monitoring and measurement of product, corrective actions, preventive actions, follow up actions from your previous management review, changes that could affect the quality management system, recommendations for improvement, applicable new or revised regulatory requirements. So, we are sitting down, and we are talking about a lot of things. It is not a five-minute meeting.
If it is a five-minute meeting and you sign off on the document, do you meet the requirements? I guess so, because you're not writing down that you only met for five minutes.
But it is meant to be a time that we clear that we clear our plates and we do. I'm gonna tell this story at the end, then I'm gonna get my husband for telling the story.
My husband works at an ISO9001 facility, which is a problem when your wife is a 13,485 guru to give it. I don't know. He has not worked there his whole career.
So, when he changed immediately, immediately wife goes into like, do you do this, do you do that? Do you do this, do you do that? You've got to do this; do you do that? And he's like, my husband is an Enneag 9 for those of you that are Enneagrams.
And so, he's like, stop, I don't care. Like, leave me alone. Right? And then I am an Enneagram one, which is like, there's a right, there's a wrong, there's no in between.
So, it makes for an interesting mix over dinner, right? So, we had recently moved into this house, so, like, use boxes. Well, you probably don't still have boxes everywhere. We have boxes everywhere, yeah.
And my son. Close your ears if you're squeamish, but he got sick on our second night that we're here. And yes, it was that kind of sick, right?
I won't call it what it is, but it was that kind of sick. And, like. Like, I'm just glad we had a roll of paper towels at the house because, like, we didn't. Everything was in boxes.
And so, the next day we wake up and we're trying to shuffle schedules. Like, I've got this, then I've got this. Then my husband goes into work, but he also can work remotely as well. And so, he was like, I.
The only thing on my calendar is at 11, and it's not that important. I can take it remotely. And I was like, what's on your calendar at 11? Thinking he'd be like, oh, just a meeting with one of my reports.
He said, it's just management review. You.
Etienne Nichols
00:23:22.090 - 00:23:22.810
Oh, no.
Sara Adams
00:23:24.170 - 00:25:30.730
Wrong thing to say to your ISO 1345 guru of a wife. Right? It's just. Just management review. I don't have to be there for that, y'. All. I don't know ISO 9001 as deeply as N 13485. I know. Like, if you.
If you're new to this, like, 1345 is 9001 on steroids. Like, we're way more specific in the med device industry.
But I literally was like, oh, over my dead body are you not going to be at management review. You're not calling in for that. I'll rearrange and let my boss know. Whatever. Whatever. That I've got to take care of our son because you.
To be on site for a management review.
Guys, I'm not accusing his company of not making a big deal in management review because this was my husband's first management review to be a part of that. Like, likely it was just him who was like, yeah, it's not a big deal. I don't have to be there for that. He came home at the end.
You'll laugh because this is the other thing I want to talk about, I said, so did you get any action items that are assigned to you for management review? He was like, I'm not talking to you about this. I was like, no, no, I really want to know. Did you? And he was like, yes. I was like, what was that it?
Okay. Because you should have action items for management review. This is not just a pow wow where we sit around and we sing some song together.
Like, we are in the weeds. If the quality policy is your battle cry, this is where we prep, right? And we're looking back and we're looking forward.
Like, one of the things in here are applicable new or revised regulatory requirements. We talked about UDI and manager. We talked about ISO 13.5 transition. Like all of those things are part of your management review.
You come with action items. He did have action items and also his quality wife said, he said it was a supplier. My husband does sourcing. So, it was to do a supplier scorecard.
I was like, hey, I just emailed your resource that you might find helpful. Like, right, like that's just me. And I know I'm annoying him. So, all you enneagram nines who are listening are like, God, that woman's crazy.
Yes, I am completely and will readily admit that. I don't know where I was going with that. But essentially, management review is a big deal. You have inputs.
There are things that you are going to look at. I get this question too, Etienne, and you've just gotten me started, so I'm keeping going. But yeah, what if we don't sell product? We.
We're not there yet. Do we still need a management review, Etienne, what do you think the answer is?
Etienne Nichols
00:25:31.450 - 00:25:32.410
I would say yes.
Sara Adams
00:25:32.890 - 00:26:18.400
Yes, yes. Which I think is an appropriate time to tell you a story. I. I had someone that I was talking to, they had an FDA inspection.
It was unexpected, but they did have notice. And I was talking to them, and I was like, hey, here's the things that I would do before they get here.
And one of them was to have a management review. They had not had. I don't know, they probably had. But my point is like, get one, do it so that it shows this management responsibility. Right?
And they did not get any findings. 483s from that inspection because. Not because they did a management review, but because they had. They showed management responsibility.
They showed this whole executive management responsibility. And part of that is, is doing a management review.
Etienne Nichols
00:26:18.480 - 00:26:28.640
So, wait, let me back up. So, you're, you're saying, you're saying there's a company who, they were expecting to get findings.
But your advice was, okay, since you're expecting this, let's do a management review.
Sara Adams
00:26:29.040 - 00:27:34.820
I don't know that they were expecting to get findings.
I think that there were gaps in some of the things that, that could have been a problem that ended up not being a problem because the inspector was able to say hey, and it's, and it's not, it's deeper than that. Right. They could show procedures; they could show things like that. They didn't always have the objective evidence from it.
And I don't want to generalize for them because I was not a part of that. But the inspector over and over, like they had that they, the man, she would say they.
Things like, I know that you are aware of these, like you have a plan in place. I've looked at this quality plan that you've written.
So, things that like weren't all the way in place that they could show, hey, management is taking this seriously and we are putting plans in place to be able to execute these. Right.
And so, I think like that was hugely telling for them to, to have this management buy in was so important and establish, establish that rapport with the auditor in a way that we all know if you sit in audits is super important.
Etienne Nichols
00:27:35.300 - 00:27:38.420
So, it's almost like if I were to rephrase some of what you're saying is.
Sara Adams
00:27:38.420 - 00:27:39.380
Yeah, rephrase it.
Etienne Nichols
00:27:39.540 - 00:27:44.240
This, the management review, it's almost like a companywide look at your. Almost.
Sara Adams
00:27:44.310 - 00:27:44.550
Almost.
Etienne Nichols
00:27:44.790 - 00:27:59.190
So, a CAPA.
If you, if you look at a CAPA as designed to help your processes make a good device and a good product, the management review is almost looking at it from a companywide perspective to make sure that everything you do is aligned with quality.
Sara Adams
00:27:59.590 - 00:28:43.460
Yeah, and that's a great way to say it. Also, quality objectives, something that you have to have for 1, 3, 4, 8, 5.
So, ways that you're going to measure requirements for product are established at relevant functions and levels within the organization. They have to be measurable and consistent with your quality policy. And so that's a piece of management review.
Yes, we're looking at CAPAs, we're looking at complaints, we're looking at those things. But we're, we're looking, we're grading ourselves. Like that just popped into my head.
But like we are saying here's how we did for a period of time and what do we need to do? Like is it good, is it bad and what do we need to do about it? Do we need to change it? What do we need to do. Yeah, that makes sense.
Etienne Nichols
00:28:43.460 - 00:28:44.500
That's good. Yeah.
Sara Adams
00:28:44.500 - 00:28:50.140
We're doing that cross functionally. We're not. Quality is not just doing that. Right. We're doing that cross functionally.
Etienne Nichols
00:28:50.300 - 00:29:03.100
So, when you put those together, those, the PowerPoints together for management review, what did it look like? I'm curious how long they were. I love hearing the nuts and bolts. The actual. You said pivot tables and my ears very long.
Sara Adams
00:29:03.500 - 00:31:54.610
Lots of slides, Lots and lots of slides to put together charts and graphs that we could look at things and interpret data so that we could say like, like, hey, let's look at this. Where are things headed? We've did we trying to think. So, I'm going to add. We did management review quarterly. That's not a requirement.
We just chose to. I want you to do it annually at a bare minimum. If you can find value and do it like doing it more often. I don't want it to be a checkbox.
Does that make sense? And if quarterly makes it feel like a checkbox, then don't do it quarterly. Do it at a minimum annually.
And so, because we did it quarterly, we were assessing those quarter. Like, did we hit our objectives? If we didn't, why? And do we need to put something in place? Do we need to open a CAPA? Because that's the time.
That was the time for us. And we, we did it other times too, but that was the time for us to look and pull threads of like, hey, we saw, man.
Now that I'm looking at this and this is not a real-life example, this is off the top of my head. We had the like 10 complaints last month because this broke or what, you know, whatever.
We had 10 complaints for this one product code, and we didn't even realize that. Shame on us. Probably should have. Right?
But because we're sitting down and looking at it, were these corrective actions sufficient or do we need to open a CAPA so that we can dive in and dig deeper into this? Right. So that was some of the data, some of the pivot tables we're looking at like what are our root cause failures? What are our defect codes?
What, what's, what's going on with, with non-conformances with CAPAs, with audits. Like, you guys know we had lots of those. So, to talk about what, what we are seeing in audits and then what are we going to put in place?
So that was the bulk of my piece. Now you know this, but there are other inputs that I just went through. So, we're looking at personnel like how many people do we have?
What projected projects do we have coming that are going to impact how many people we have? And if that needs to adjust or change for my putting Greenlight in place. Greenlight guru.
If you've got an eQMS that you're putting in place, that's a change that could affect your quality management system. Right. So, we need to have a plan as part of that. That's. That's something we're going to discuss at management review.
So, there were slides that I prepped that were like, here's the graphs. Minitab was my friend. Oh, yuck. That was a bad, bad memory.
Like, what justifies a trend in your procedure and in minitab and putting those in place so that we could tell the visual story for a bunch of people who like to like graphs and charts. Right. For people who are in the room and then interpreting the data.
So, I was also responsible for like, I couldn't interpret all of it, but like, hey, this is something that we need to consider. And then getting that to our management rep, who could then dive deeper with the appropriate parties before management review.
And then as part of management review as well, if there were action items.
Etienne Nichols
00:31:54.610 - 00:31:58.650
From that, you turned the data into information, and he turned the information into a story.
Sara Adams
00:31:58.970 - 00:32:02.330
There you go. Right? Yep. That's why my life was full of pivot tables.
Etienne Nichols
00:32:02.490 - 00:32:06.720
Yeah. Okay. Okay. Anything else about management review that you wanted to cover?
Sara Adams
00:32:06.960 - 00:32:32.260
I don't think so. I could talk management review all day, every day, but I think like takeaways, like cross functional, not a checkbox. We are sitting down in a room.
I'm. I'm going to encourage you to make it longer than an hour.
Like, I know some of you are small companies and you're like, what would we talk about for an hour? I don't know, bring lunch in. But like, don't just gloss over it. Right. Like it is something that you have to do, but make it be meaningful. Right.
Etienne Nichols
00:32:32.820 - 00:32:42.820
Because. And we'll just use that to lead into the next one.
The next one is quality planning and the one after that is quality system procedures, both of which fall under management responsibility.
Sara Adams
00:32:43.380 - 00:33:30.380
Right. I love that. And quality planning, like, similar to these objectives, right.
We're, we're doing practices, we're doing resources, activities relevant to the device that are designed and manufactured. I hate reading to people, but I need to refresh my memory as I read too, how the requirements for quality will be met.
So, yes, we need to plan and like you said, procedures. Manufacturers will establish quality system procedures and instructions.
An outline of the structure of the documentation used in the quality system shall be established where appropriate. And I'm just laughing because I think nine times out of 10, those procedures are quality's responsibility. Right?
Like that's who's writing the procedures, that's who's telling you where they need to go. But yeah, just as a note, top management is responsible for making sure that we have quality system procedures.
Etienne Nichols
00:33:30.450 - 00:33:45.730
Procedures and that those quality assistant procedures meet the requirements of this part or ISO 1345. And I think that's interesting because we forget sometimes. We forget. Well, that's his problem. You know, he wrote that quality.
Well, you're actually the buck stops at your desk.
Sara Adams
00:33:45.890 - 00:33:48.690
You're the person that they're coming to ask the questions to.
Etienne Nichols
00:33:48.690 - 00:34:00.890
So, which is, which is why if you're a CEO, if you're an executive, if you're the, the president or whatever and these management reviews come around, it's important to ask the, the questions that people probably don't want you to ask.
Sara Adams
00:34:00.890 - 00:34:03.550
But you don' Want to know the answer to. Right.
Etienne Nichols
00:34:03.550 - 00:34:08.270
You're the ultimate auditor because yeah, you're the, you're the one who, who's responsible.
Sara Adams
00:34:08.590 - 00:36:36.750
That made me think, going back to my lead, I think everyone knows this, but like literally my entire perspective around quality management systems, for good or for bad, half the time is the audit, right? It should be the patient, remember the patient that we talked about at the beginning, like, what am I going to show in an audit?
What am I going to say? What.
And so, in that lead audit course, we talked a lot about management responsibility and how as an auditor, to establish that, that there is management responsibility. We talked a lot about. I know we have several people who are listening to this who are going to be doing stage one or stage two ISO audits.
And a part, a piece of that audit is interviewing executive management.
And if you've got a good auditor, it's not just going to be a quick, like, hey, at the end, tell me about why executive management is important to you. How are you meeting these requirements? Right. They need to do a good job of like, let's gauge, let's interview, let's ask, ask.
But a takeaway that I learned from that is that if you as an and I'm putting you in the seat, Etienne, like you're the executive manager, if the executive management is doing a good job and they're doing these things that are outlined in management responsibility, it's evident in everything.
It's evident by the way their people talk to an auditor it's evident in like, if somebody comes up to you and says, hey, do you feel like you have the authority to raise your hand when something is wrong? If somebody's like, well, sometimes our executive management frowns upon that or quality. I don't like it when they do that.
They quality wants us to come to them first and then let them handle. Do you see my point? Like, you can get.
It's like, goes back to that, like with our kids, with my kids specifically, like, they can tell me one thing all they want to. Yes, mom, I'm going to clean up my stuff. Yes, mom, I'm going to not speak that way to you anymore.
Yes, mom, I'm going to pick my dirty clothes up out of the bathroom. I think if you went downstairs, they're still down there. The point is your actions are more important than your words. Right.
And so, in that, that interview, really, like, who cares?
Like, it shouldn't just be the audit while we're doing that, but if you want to pass that live and breathe it and so that your people will live and breathe it. And there's this battle cry, use that word again. That everybody knows what, that they know where executive management stands.
That it's not a question of. Let me ask the right questions in an audit to make sure the auditor should do that. But it's not a.
There's not a question in the auditor's mind because they are seeing actions that mimic the fact that there is management, that management is being responsible to these requirements that have been given to them.
Etienne Nichols
00:36:37.070 - 00:37:12.890
Yeah. And I love your examples because your examples talk about how you. We don't even realize how we're actively working against quality.
Sometimes when we frown upon someone bringing up an issue or whatever, there's another more passive activity that sometimes happens. And that is when management always talks about the sales numbers. We hit these goals, we hit this, we did this, we hit this efficiency.
Our throughput is through the roof. You know, we are a hundred percent max capacity. We got double shifts and third shift on the way and all these different things.
And we're about to expand into other markets. And that's all you talk about. And then, oh, by the way, we should make. Maintain quality by the way.
Sara Adams
00:37:13.050 - 00:37:14.970
Yeah, we don't want to have any recalls. Right.
Etienne Nichols
00:37:15.930 - 00:37:35.730
So, they. Maybe they met the regulation like you said earlier. Maybe they met that requirement by bringing it up and everybody's aware of it.
But what do you emphasize? And that is going to incentivize what your people do, really.
So, I mean, I'm going to be thinking, okay, well really, I got a. Throughput's all I care about right now. And qualities. Yeah.
Sara Adams
00:37:35.730 - 00:37:52.290
I want to make one comment about that. I don't think that it is a bad practice to review numbers with employees. Right.
Like, especially in the world that we live in right now, like there's something to be said of. You do want your management to say, like, hey, we have this coming and this coming and that coming.
Etienne Nichols
00:37:52.370 - 00:37:52.810
Yeah.
Sara Adams
00:37:52.810 - 00:38:36.160
Just from a perspective of like job security. So, I don't want people to hear that that's wrong. Wrong.
But if that is the rally cry of what your people hear, then they're not the front that's not meeting what this is saying. And I'm banging on my desk. Right. That's not meaning what this is saying. So, it's not that that's wrong. It's. Is that what you're always focused on?
Because I tell you something, the FDA didn't care about those business requirements. When you talked about the three legs of the stool, I was like, FDA doesn't care about those. Right.
Like, don't, don't write your user need that we need to make money or that this is going to cost. This needs to cost less than $5 to make. Make like the FDA doesn't care about that. Doesn't care about those businesses.
I understand that it's a leg of the stool, though. So. Yeah, like, that's, that's what I'm saying.
Etienne Nichols
00:38:36.480 - 00:38:46.400
I'm glad you bring that up because that's a great point. It's. It's what you emphasize and how much you emphasize it both being important, they should be at least equally emphasized. So. Absolutely.
Sara Adams
00:38:46.400 - 00:39:12.459
Yeah. Not to relate it back to parents and kids, but. Parents and kids. Right. Like, and you're not in his employer, a parent, so don't mishear that.
But like, if my kids hear me talk about all the time. Time. The laundry that's on the floor in the bathroom and not the other things, like not lying. They only character things. Right.
The character, ethical, moral things. Right, right. I'm trying to raise good humans, and I would like them to pick up their laundry from the bathroom.
Etienne Nichols
00:39:13.980 - 00:39:15.260
It's obviously a plus.
Sara Adams
00:39:15.980 - 00:39:16.380
Right.
Etienne Nichols
00:39:16.940 - 00:39:23.500
What have we missed? Anything else that you want to talk about? I think we, I think we hit all the parts in my side on part 8 22.
Sara Adams
00:39:23.580 - 00:40:04.370
I think we hit the big things in, in ISO 1345 too.
I think like the biggest thing we talk about, like, to, to wrap it up, like, we talk about a culture of quality, and we talk about like how do we get executive management on board? We didn't really dive deep into that because that is a, that is a part of. It is like they need; they have, they have a part to play in this as well.
And I, I'm not, I'm the regulations person, you all know that. But like throwing. Here's read this. Executive management, this is what you're supposed to be doing. That's not the way that you accomplish that.
Right, right. But just you have to have that executive management buy in so that you can really, really have an effective and efficient quality management system.
Etienne Nichols
00:40:04.930 - 00:40:39.970
Yeah, I would echo that because the regulations, while they are designed to restrict and put guardrails in place, they're also designed to help build safe and effective devices. And if you're building safe and effective devices rather than someone with a lot of defects, you are going to be way more profitable. Profitable.
So obviously, money being the air companies breathe, you have to be profitable.
These are the things that help build rapport with your employees and build those strong relationships with your employees so that they work better and faster.
So, there's lots of different stories you can tell about how this is beneficial to the company, that third leg, that business side, the economical side.
Sara Adams
00:40:39.970 - 00:40:41.570
So, love it.
Etienne Nichols
00:40:41.650 - 00:40:51.890
Thank you so much for coming on the podcast. I love all the stories. I really appreciate it. I'll let you get back to it. I know you are one of the most busy people I know.
I'll let you get back to your. To your.
Sara Adams
00:40:52.430 - 00:40:57.710
Everybody tells me that, Etienne. I just, just do lots of things. Right. That's the good part.
Etienne Nichols
00:40:58.590 - 00:41:02.030
Well, thank you so much for coming on the show. Looking forward to next time.
Sara Adams
00:41:03.230 - 00:41:03.710
Bye.
Etienne Nichols
00:41:03.950 - 00:42:47.120
Okay, bye. Thank you so much for listening. If you enjoyed this episode, reach out to Sara Adams on LinkedIn and let her know.
Tell her that we need to get her back on the show because she always resists when I say, hey, it's time to do another episode. She's always got other things to do, and I know she's very busy, but it would be great to get some of that encouragement from the other side.
So also, I'd personally love to hear from you via email.
Etienne Nichols, Greenlight Guru, or look me up on LinkedIn if you're interested in learning more about our software that's specifically built for MedTech.
Whether it's document management system, our CAPA management system, our design controls or risk management system, or electronic data capture for your clinical investigations, this is software built by MedTech professionals for MedTech professionals. And you can check it out at www.Greenlight.Guru lastly, please consider leaving us a review on iTunes.
It helps others find us and it lets us know how we're doing. Love to see what you think. Thanks again. Take care.
Improving the quality of life, I know we say it a lot here at Greenlight Guru, and I'll bet it's something you probably said at your company too. We help babies breathe at night. We give you another day to be a dad. We give you back your eyesight.
Those are some of the things the medical device industry and our customers are able to say because that's what they're doing. They're improving the quality of life for these individuals.
Greenlight Guru is the only quality management software designed exclusively for the medical device industry. We built our software around standards like ISO 13485 and risk-based principles to help you bring safer devices to market three times faster.
We're building the tools that will make it easier for you to build yours. If you're ready to find out how to improve the quality of life, contact Greenlight.Guru today.
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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.
