How to Build a QMS for a Medical Device

Where do you begin when building a quality management system (QMS) for a medical device? It’s a task that is often delayed until later stages of development. Don’t wait to implement a QMS; the consequences of waiting too long can lead to irreparable damage to your processes and, in some cases, product failures.

In this episode of the Global Medical Device Podcast, Jon Speer talks to quality and regulatory expert Mike Drues, president of Vascular Sciences. Together they discuss why a QMS is so important to a company as it sets up its business and processes. 

Laying a proper foundation for a QMS to operate at its full capacity is just as critical, which involves a shared mindset and philosophy across the organization that reinforces a culture of True Quality.

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Some highlights of this episode include:

• A QMS is not a system of compliance. It should describe how business is conducted through policies, procedures, processes, and philosophies.
• If a QMS consists of devices not manufactured by the company, it’s an example of the copy-and-past approach to be compliant, but not customized. 
• A QMS is important to describe, document, and demonstrate roles, responsibilities, and rules to make decisions about products for patients.
• A QMS focuses on four key areas: Accountability, traceability, consistency, and continuity.
• Preamble/Introduction: One company’s QMS should not be a carbon copy of another company’s QMS. It should focus on its own mindset and philosophy.
• Every QMS should include complaints, change management, and customer feedback to trigger notifications that affect safety, efficacy, and performance.
• Product Lifecycle: During research and development, conduct post-market surveillance, beta test change management, and review risk management plan.
• Document Management Control: All complaints and conflicts are not created equal. Get it right to make sure it’s effective and efficient.

Links:

ISO 13485:2016

FDA 21 CFR Part 820 

FDA Quality System (QS) Regulation/Medical Device Good Manufacturing Practices

Mike Drues on LinkedIn

Vascular Sciences

The Greenlight Guru True Quality Virtual Summit

Greenlight Guru YouTube Channel

MedTech True Quality Stories Podcast

Greenlight Guru

Memorable Quotes from this episode:

“A QMS is about setting up your business and your processes. It’s also about having the right mindset and the philosophy around building a culture of quality.” Jon Speer

“Your QMS should not be a carbon copy of another company’s QMS.” Mike Drues

“Risk-based approach is sort of in vogue these days.” Jon Speer

“A QMS should be a living entity within an organization. It’s not like you’re going to do it one time and forget about it.” Jon Speer

Transcript:

Speaker 1: Welcome to the Global Medical Device podcast, where today's brightest minds in the medical device industry go to get their most useful and actionable insider knowledge direct from some of the world's leading medical device experts and companies.

Jon Speer: How to build your medical device quality management system, where do you start? Well, it can be a daunting task and it can be one that a lot of people are saying, I'm going to put this off till later. I don't advise that. I don't think that's a good move. I think there's some simple things that you can do from the beginning of your medical device journey that will put you in good shape for your quality management system. Think about it this way. A QMS is about setting up your business and your processes. It's also about having the right mindset and the philosophy around building a culture of quality. So enjoy this episode of the Global Medical Device podcast. Hello, and welcome to another exciting episode of the Global Medical Device podcast. This is your host, founder and VP of quality and regulatory at Greenlight Guru, Jon Speer. A quality management system, if you know anything about Greenlight Guru that we're all about medical device quality management system, and what is it? And those sorts of things. We'll get into some of that today, but there are some stories that are pretty fresh. I'll just read a couple of the headlines and I'll leave the company names out for the moment. But our FDA draws or issues warning for quality failures, IVD manufacturer written up for validation failures, FDA finds company software wasn't validated, breast implant maker lands in hot water with FDA and so on and so forth. And these are all May, June timeframes. So these are fresh stories. So it's clear that something is not connecting. And I don't know what that is, but hopefully today my guests and I can get through some of these things and figure out maybe a path through the woods, so to speak. So joining me a usual voice, familiar voice on the Global Medical Device podcast. It's Mike Drues with Vascular Science. So Mike welcome.

Mike Drues: Thanks John.

Jon Speer: So like you and I often do on these, maybe a good place to start is what is a quality management system? So I have some thoughts and ideas, but I'm curious to hear what your thoughts and ideas are with what a quality management system is.

Mike Drues: Well, John, first of all, once again, thanks for the opportunity to have this discussion with you and our audience on what is I think a very important topic because in spite of the fact that we have tons and tons of regulation and guidance, there are so many resources that you and I have put out, as well as other people have put out with regard to quality management systems in the form of podcasts and webinars and articles. And yet in spite of all of this, or perhaps because of all of this, companies and the people in them, continue to do some of the stupidest things. I can't put it any more politely than that. So I appreciate the opportunity to give you my definition of a quality management system, John. But I'm going to turn the tables on you if you don't mind, but obviously you and your company, Greenlight, this is your bread and butter. So how would you define what a quality management system is?

Jon Speer: Well, sometimes when I'm asked these sorts of questions, I start with what it's not, and then I'll get to what I believe it should be. It's not a system of compliance. And I think this is where the industry still needs to open up their minds and to be willing to think about this in a different way. I think for as long as I can remember my career, a lot of people look at a QMS as a thing we have to do to comply with regulations. And don't mishear me, there is an element where compliance is important, but if that's why you're doing it, then you're missing the mark. And I think that's part of the challenge. What a quality management system should be is in my opinion a way to describe how you conduct business. Your policies, your procedures, how you do things within your company, period. What do you think?

Mike Drues: I think John, that's a terrific start. As a matter of fact, I was going to say almost something exactly the same. First of all, I could not agree with you more. And you and I have talked about this in the past from time to time that it's absolutely not a, to use your phrase, a system of compliance or to use one of my phrases, ticking boxes on a form. Anybody that approaches a quality management system in that regard, in my opinion, and this might sound harsh to some people John, but they should not be in this business because that's not what this is about. Instead, the way I think about this, it's a philosophy of doing business. It's a mindset, it's a way of thinking, it's a way of how you develop your product. What do you do once your product is on the market in terms of keeping an eye on it, like post- market surveillance, like complaint handling, like corrective actions and preventative actions. So it's not just ticking boxes on a form, it's much more than that. So I think you and I are singing exactly the same song, John, just maybe in a very slightly different key, but the challenge for us is, how do we get our colleagues in this industry to get past that ticking boxes on a former system of compliance? What's the minimum that I have to do to make sure that I have a compliance system. What forms do I need in place? You and I both know and we can talk about this later, that there are people that sell forms on the internet for X number of dollars, they will sell you the forms to make your quality management system. But in my opinion, John, and maybe you might disagree, I don't know. But that defeats the whole purpose of having a quality management system. What do you think?

Jon Speer: Well, there's two words that you said that I really, really like. Mindset philosophy. And I think those are important things for those listening to really embrace. I mean, if you have a mindset that I'm doing this for compliance, then buy those cheap forms, check the boxes. And as you've might've heard me say a little tongue in cheek before, let me know if that's your philosophy so that I can alert everyone that I love and care about, about your company, because you got the wrong mindset and the wrong philosophy, but it should be about this. I mean, that mindset and that philosophy, if quality of our products and processes aren't, and I guess even above that, the patients who are going to receive these products is not the center of our universe or our north star, our guiding force, then maybe we're in the wrong industry. So, for what that's worth. And I get a lot of times people are lured or there's an appeal to these inexpensive templates, I get that. Because if I've never built a quality management system before and maybe I'm an inventor, or an engineer, and I don't understand these things called regulations, those templates are appealing to me because I don't have to start with a blank sheet of paper. And the implication is, " Oh, well, this will help make sure that I'm compliant." But if you just take those templates, you spend the few thousand dollars or whatever it is, and you just drop them in and change the logo and you don't embrace what's in there and you don't tailor those to me, how you do business, then you miss the mark period.

Mike Drues: John, may I give you a quick example?

Jon Speer: For sure.

Mike Drues: I think that infiltrates what you just described. So I spent some of my time, I don't market myself as a quality auditor, but I do spend some of my time going into companies and kicking the tires as I like to call it of their quality management system, giving them recommendations on what to add or what to change, where I think that the holes, the gaps are and so on. So in one recent visit, this was a few months ago before COVID when we were still allowed to travel. I was in a company taking a look at their QMS and I happened to see examples of devices that were in their QMS, that that particular company did not in fact even manufacture. Now, if that's not the quintessential example of copying and pasting from these pre- printed forms or some other places, and by the way, it's also an example of a company that has a QMS where it's painfully obvious to me that the people working in the company don't even know what's in their own QMS. So I think you would agree, John, that what's the point of having a quality management system if it's sitting in a three ring binder on somebody's shelf, or just simply residing in a computer when people are not familiar with it and literally living by it every single day.

Jon Speer: There's no point.

Mike Drues: Maybe we should think of, I mentioned earlier it's a philosophy of doing business and you said something very similar. Maybe we should think about it and I don't mean to be too theological here, but maybe we should think about it like the Bible. This is a set of instructions if you will, a set of rules, whatever you want to call it. That were supposed to be very familiar with, that we're supposed to be living by every single day. But with the very recent examples that you cited at the beginning, and I can give lots more for whatever reasons, some companies clearly not all of them, but some companies just don't do this. So why do you think beyond just the regulatory reasons or the quality reasons, what John, why do you think having a quality management system is important?

Jon Speer: Well, I think it's important and I think there's a lot of points of view where the quality management system is important. And you talked about ultimately it's about that patient but coming down a little bit closer to, I guess, to home, so to speak. Within a company, a quality management system is I guess, rules of engagement or how we as an organization interact with one another. It defines the different roles and responsibilities, handoffs, knowledge transfers and that sort of thing. I think you look at a quality management system as a method to describe how you communicate and interact with one another as a business. I think that's really important and making sure we're doing the right things at the right time and documenting the proper information because ultimately what we're trying to, I'll say, demonstrate, but not necessarily from a compliance perspective but to ourselves, is that we're making good decisions about our products and that those products that we're designing, developing, manufacturing, selling, et cetera, that they're as safe and effective as it can possibly be. And that we're gathering data and information throughout the entire total product life cycle to make sure that that's the case and always the case. So to me, hopefully there's a couple of nuggets there that you can wrap your head around with why I think it's important.

Mike Drues: I think those are all great reasons John, but let me just add a couple more to your list. I've summarized it into four words. The first two words are accountability and traceability.

Jon Speer: Yeah.

Mike Drues: So accountability and traceability in the context of the QMS system to me means not just having these procedures in place, but actually following them. And I'll give you a quick example. So as I've mentioned in some of our discussions before, a growing part of my business is working as an expert witness in medical device product liability cases. So if I can show for example, that a company has a particular section in their quality management system, whatever it is, complaints, post- market surveillance, training, I don't care whatever it is. But they're not following what's in their own QMS, then it doesn't take a JD from Harvard law after your name to appreciate cha- ching, cha- ching, cha-ching. Or alternatively, if I can show that the company doesn't have a particular key section in their QMS, they don't have a section on complaints or CAPA or what I find very common John, is criteria in there when a complaint becomes a CAPA or so on. Once again, it doesn't take a JD from Harvard law to appreciate cha- ching, cha-ching, cha-ching. So accountability and traceability are two of my four words. The second two of my four words of why a QMS is important is consistency and continuity. In other words, we want to make sure that not only our procedures are being followed, but our procedures are being followed in a consistent way. In other words, what we're doing today is the same as what we're doing tomorrow and next month, and next year, and so on. If we have multiple employees or maybe multiple facilities where we're manufacturing or developing medical devices, we want to make sure that we're following our QMS, our procedures and protocols, and so on consistently, and also continuity. People do move. If somebody leaves our company and moves to another company, or God forbid somebody walks out the door and gets hit by a bus and somebody comes in and tomorrow and starts to take over, we want to make sure that that new person is doing the same things as the person before them. So accountability and traceability, as well as consistency and continuity. Those are some of the reasons why I think that a QMS is so important.

Jon Speer: Yeah, those are excellent points. And that accountability is really key. I mean I haven't been in a courtroom where you're on the stand as an expert witness, but I'll just say, I know you well enough that I would want you on my team.

Mike Drues: Thank you John.

Jon Speer: For sure, but I think this is one of those things that I think is really important. And I think sometimes people get a little caught up into documentation and that sort of things, and we won't dive into all the nuances in this slippery slope, but it is important that accountability is I guess there's a document or documentation to confirm that accountability and traceability that's really, really key. And I think sometimes people are like, " Oh, I made this decision on such and such." Some of those headlines that I was mentioning on the intro, I'm sure if you ask those companies, they may even say, " Oh, well, we did this, this and this." And it's like, " Yeah, but did you document it and report that?" And that sort of thing. And that might be where the disconnect is. So I know those are some challenges for folks.

Mike Drues: Well, there was example, as a matter of fact, just literally a few days before making this podcast of a warning letter for a company making implants where one of the things FDA cited was exactly what you just said, failure to document complaint investigations. And let me remind you that this is not for a bandaid, this is for a permanent implant. To me, that's just inexcusable. Some other things that FDA said" Lacks record keeping" in another particular warning letter that was issued just a couple of days ago, this particular warning letter was for an in vitro diagnostic. And along with it FDA had problems with their acceptance criteria, with their component specifications, with their process procedures. I mean, to me John, and this is one of the reasons why I wanted to talk about this topic today. It's very unfortunate that we have all of these things in place, but to me, I don't mean to be overly harsh here and I don't mean to overly stereotype because we are not talking about our entire industry that may be crystal clear. There are some people in our industry who quite frankly do know what the heck they're doing and they are doing all the things that they should. But regrettably, there are those that don't. And as I like to joke Jon this to me is all common sense, this is all stuff that we used to teach in engineering school, although I'm not sure that we do anymore. Some of your audience knows that I teach in academia part- time, including I teach at one Ivy league institution and the second near Ivy league institution in their graduate department of biomedical engineering in one case, and in their graduate department of regulatory science in another and regrettably, this is not stuff that we seem to teach anymore. So let's get a little bit more pragmatic, John, if you don't mind. So we've talked a bit about what QMS is and why it's important. Another question that I just got from one of my customers recently is, and I'm going to be honest with you, John. This is a very small startup company. They don't have the resources to use one of the tools like Greenlight offers, at least not right now. They hope as they grow to be able to do that. So what they want to do is they want to like we all used to do back at the day, is start to put together a quality management system, or at least the beginnings of it manually with paper, documentation and so on. And they asked me, so what are some of the most major sections to start with? And I put together for them a list of what I thought was the major sections. And I'll just tick them off real quick. And then you tell me if I'm missing anything. And then we can talk about any of the components going into them. So first of all, the preamble, which by the way, is not required, but it's always something that I like to see in a company because a quality management system is not supposed to be a cookie cutter. Your QMS should not be a" Carbon copy" of another company's QMS. The preamble is an opportunity to explain how you're going to implement the philosophy of quality regulation into your particular company, QMS based on your kinds of devices and technologies and business practices and so on. So that all goes into the preamble.

Jon Speer: And if I can interject right there.

Mike Drues: Please.

Jon Speer: I mean, I think this is an opportunity a term that people may be more familiar with. This might be a great opportunity to put that information in something like a quality manual. To me a quality manual is a great opportunity to be that preamble as Mike described it. Quality manual should be a document that describes your mindset, your philosophy with respect to quality management systems. So that would be if you needed to put a" Title" on your document, capturing this preamble information, I would suggest capturing that within a quality manual.

Mike Drues: I think that's a great idea John, and look, I don't want to argue semantics here because Shakespeare said a rose and the name still smells as sweet. So whether we call it a preamble or a quality manual, I could care less as long as you have that information. And by the way another thing that I usually put into the quality manual or the preamble is a list of terms and definitions for how we are going to define certain things because the way one company might define something might be different than somebody else. The only reason, and this is a very, very minor point John. But the only reason why I tend not to use the phrase quality manual, I know that many people do, is because at least in my experience, a lot of people who are not that familiar with quality or regulatory, like your typical R&D engineer or your manufacturing engineer or something like that. They might assume that the quality manual is synonymous with your quality management system. And therefore they read the quality manual and there's nothing else to do. You know what I mean? So to me, I like the term preamble better because it reemphasizes that this is just the introduction. This is the overview, but it certainly not the entire book, so to speak. But again, very minor point.

Jon Speer: Totally agree.

Mike Drues: Yeah. So other sections that I think are important, and I know John, this is right up your street. So please feel free to agree or disagree or add or change, but some of the other important sections to start with are your complaint handling system, your CAPA system, and by the way as I alluded to earlier, having defined criteria between the two is an area where I see a lot of companies either are very weak or totally omit. In other words, having criteria that will determine when a complaint or a series of complaints becomes a CAPA. Changed management something that your idea crosstalk.

Jon Speer: Can I take one or backs? Can I take one-

Mike Drues: Yeah, yeah, please.

Jon Speer: ...step backwards before diving into change management? I would even broaden that universe just a little bit beyond just complaint handling. I would look at it more as a means to gather customer feedback of which a complaint is a specific type, but I totally agree with you that a lot of times the companies that they haven't defined, okay, when does this issue, this feedback, this complaint, when should it trigger a CAPA? I think it really is in a company's best interest to define those conditions and evaluate those. But yeah, I just wanted to add, I think it's important to look at the bigger picture. All customer feedback just the complaint scenarios.

Mike Drues: I think Jon that's an excellent point and my apologies for my oversimplification here, because you're right. I think broadening it out to customer feedback, not just negative but positive as well is obviously a good thing. However, that reminds me of another fairly recent story. One of the small companies that I work with they got pinged on a manufacturing inspection because FDA said that they did not investigate all of their complaints, including some of the positive stuff equally. And I said to FDA, " That's nuts." I said, " It doesn't make sense to investigate every complaint to the same level, to the same degree. If it's a little cosmetic defect, like there's a scratch or a nick in the paint over the housing of device. Okay, technically that's a complaint, but with all due respect who cares?" You know what I mean? It's not going to impact safety, efficacy, performance. And here's the problem that I have with that Jon is, if we hold a bar to that level, I guarantee that a lot of companies, especially the smaller ones that you and I work with, they're not going to afford to stay in business. So we have to have a system and this is something else that I encourage companies to put in their QMS is to triage these complaints, to figure out which are the ones that are most important and worthy of investigation and which of them we document that we got the complaint, the feedback. We say, " Okay, we're going to have better inspection procedures to make sure that the housing of the device is painted properly or something like that." But beyond that, who cares.

Jon Speer: Yeah, totally.

Mike Drues: I don't need to be overly flippant, but it's just like coming from a medical background the concept of triaging patients when they come into the emergency room. Obviously a person that's having a heart attack is going to be treated we hope sooner than somebody that has a splinter in their finger, right? So the logic is exactly the same here. Would you agree John?

Jon Speer: A hundred percent.

Mike Drues: Okay. So complaint handling, CAPA, those are important sections. The next important section, and by the way, these are in no particular order. Change management. You and I have talked about this topic before Jon I'll just remind my audience that one of the most common reasons why companies get warning letters and 483s from the FDA is because of change management or the lack thereof. So that's a part of the QMS that needs to be prioritized. Now, I'll be honest with you though, if you have a company that doesn't have a clearance or an approval, doesn't have a product on the market yet. Maybe the company can get away with putting the change management on the back burner because they don't have a device on the market yet. So how can they change it? On the other hand, if they do have the resources, I do encourage them to start building out the change management system, because it's a wonderful opportunity while the product is still on R& D. And I would love to hear if you've had any experience doing this John, but this is something that I do. While the product is still under development in R& D, use that as an opportunity to beta test your change management system. In other words, obviously when the device is still under development, you're going through a series of iterative changes that's the nature of device development. So I encourage the company if they want, this is a little more advanced topic of discussion, I think. But use that to help beta test their change management system so that when they do get the product on the market, they're going to be that much more confident that their change management system really works, especially for their particular device. What do you think of that idea John?

Jon Speer: Yeah, I think that could work. I mean, because I think every design and development project I've ever worked on and let's just say off top of my mind, I can't think of a single exception. There are numerous changes that happen throughout the entire design and development process. And also in my 22 years of experience, even post- market, there are going to be significant changes. So yeah, it's a good way to pilot your change management program and make sure that that's robust and thorough. I think this idea of total product life cycle and managing the details of the total product life cycle are something that we can certainly improve upon as an industry. And I think that all starts with change management.

Mike Drues: Couldn't agree more. So continuing on just a few other what I think are key sections, and then again, I would love to hear what you think should be added or deleted. Obviously risk, that's a key area as well. Not just how we handle risks pre- market as part of the clearance or the approval process, but post- market. How do we get that information is directly related to the next key section post- market surveillance. So how do we get the information that we're collecting via post- market surveillance and via complaints and customer feedback and all those different things and incorporate them into our risk management plan. And I don't know about you Jon but one of my frustrations I run into with some people with regard to the risk management plan, they think that the risk management plan is something that they can put together and once everybody signs off on it, they stick it in their file and they never touch it again. And to me, that defeats the whole purpose of having a risk management plan, because a risk management plan like the rest of your quality system, this is supposed to be a living document. It's just supposed to be updated continuously as you learn more information and so on. I mean, back to the product liability piece, if I can show that I have a couple of cases that I'm involved with right now where this is exactly the case that the company didn't know about certain risks associated with their product even though they were well reported in the public domain, in the medical literature and so on. Or, they did know about those risks, but for whatever reasons they did not act upon them in terms of modifying the design of the device, modifying the labeling, putting out dear doctors letters to make them aware of problems and so on. Once again, I don't mean to be overly flippant, but it doesn't think a JD from Harvard law to appreciate cha-ching, cha- ching, cha- ching. So risk and PMS are both important sections in the quality management system, even at the very beginning. Before just ticking off the last couple of sections John, anything that you want to add to what I just said about those sections.

Jon Speer: Just going back to a comment that you mentioned on the FDA investigator saying all complaints needed to be investigated equally. And I think this is an opportunity maybe within your complaint handling and customer feedback processes that you describe your risk based approach for those sorts of scenarios. And that might be, I guess, an asterisk with all of these things. I think risk- based approaches is invoked these days. So incorporating risks throughout all of these different processes is a good idea, but I think it is important to have more of a global risk management your processes described from that perspective as well.

Mike Drues: I could not agree more. So just the last couple of sections that I think are important, and this might surprise some people that I put them on my priority list, the next one being document management or document and control. This sounds like a terribly boring job. I met somebody once on their business card, who their job title was document control expert or something like that. And I basically said, " I'm glad you have your job because that's not a job that I want." But on a more serious note document management is very important and I'll give you a recent example, John, and I'm sure you have lots of similar examples. I happened to be in a company once kicking the tires of their QMS, and we happened to be talking about their document management system and they were going on about, " Oh, we have such a wonderful document management system." Blah, blah, blah. Long story short John, I happened so notice that the rev date that was on the screen from the PowerPoint slide for this particular QMS from this company, was different than the rev date of the hard copy that I had in front of me.

Jon Speer: Oh, no.

Mike Drues: Well, that to me, just totally obliterated not only everything that they said about their document management system, but quite frankly, everything that they told me during that visit. And here's why. Because one of the many things that I've learned in dealing with my attorney firms is that if the opposing counsel can impugn any one aspect of my testimony, in other words, if there's any one thing that I say that's wrong or is inconsistent, then my entire testimony can be thrown away. Similar logic applies here. If they're making this one seemingly trivial mistake. What's the big deal? Even though they told me that they had such a wonderful document management system, but because of this seemingly simple mistake, what other mistakes, problems, inconsistencies, whatever you want to call them, might they be doing that I don't know about? This is something that I tell my companies all the time Jon when they have the FDA come in for an inspection. If everything is going well and everything seems to be kosher and nothing, no smell of rotten fish or anything in the air, then the inspector's probably going to say, " Oh, thank you very much for your time." And you're on your way. On the other hand, once an inspector finds one little trivial thing, like for example, that you can consistency in the rev dates within document control system. That's an opportunity for a good inspector to pounce, to start digging. And so again, some people might think that rev dates would be a trivial thing, but it's not. What do you think of that example John?

Jon Speer: Well, I always describe document management as the foundation of everything that a company does within their business and especially from a quality management system. That's one thing that it's really hard to do, " Get it right" and to make sure it's effective and efficient and all those sorts of things. And it's the easiest opportunity for a slipup and to your point, auditors and inspectors, I mean, they find a document rev conflict it's just going to open a box and they're going to follow that path. And if it happens one time, they'll keep searching for a second or a third or multiple occurrences. So getting document management right is really, really important.

Mike Drues: Absolutely. And so just two other what I would think are important sections to finish up our list of the most important section is when you begin to build a quality management system is training. Now in the example that I shared with you earlier, where I said, I have a company that's a very small company, they can't afford a robust software package. They can't even afford to have a quality manager, or some quality consultant to come in yet. They just want to build themselves. So I said, " Okay, put together a module on training." And because you're literally building your QMS right now John, this is an opportunity not just to build a quality management system on paper, but to talk the talk, but to walk the walk. So I suggested to them, why don't you as part of your implementation of your training, offer a series of trainings, maybe once a month for your employees that will explain to them, okay, we're in the process of building a quality management system and once a week, or once a month, we're going to take one module, whether it's complaints are CAPAs or change management, or any other things that we've talked about and we're going to show you what we got so far, and we want you to give us suggestions on what to change, what to improve in order to make it better. And when I make recommendations like this John, because I'm trying to get companies not just to have this in a three written binder, but to live it every day and to use this as an opportunity to build a stronger QMS. I think that's a very powerful way of using the quality management system to our advantage. Not just as we talked about at the beginning, ticking the boxes and dotting the I's and crossing the T's. And by the way one other thing that I would mention in passing before just mentioning the very last section that I think is key. When a small company starts to build their quality management system and perhaps you might have a different view on this, John, if you do please share, but I don't think it's necessary to be able build out all of these sections completely, in the first pass. I think even if you can put just a page in there on almost as a placeholder on training, and even if you were going to go, this is a bit of an extreme case John, but even if you're going to say, " Well, we don't exactly know how we're going to do training yet, but here are some of our initial thoughts." That will be a reminder for us to go back and beef that section up later once we do get a quality consultant, once we do get Greenlight's software, whatever. Because one thing that I want to make sure is that nothing gets forgotten. What do you think of that suggestion John?

Jon Speer: I totally agree. A QMS should be a living entity within an organization. It's not like you're going to do it one time and forget about it. Some listen-

Mike Drues: And not just forget the spot John, but do you think it's a problem if even in a mid or a large- sized company, here's something to drives me nuts. Have some quality people put together the quality management system almost in a, not unilateral is the right word, but-

Jon Speer: Vacuum.

Mike Drues: ...by themselves, in a vacuum, yeah. And then they send it out to the rest of the company and they say, " Here's our QMS, follow it." I mean Jon that makes really no sense. Of course, you haven't seen that in your experience.

Jon Speer: I mean we're laughing, that happens all the time. Oh, I've seen it so many times. Sorry folks, if you're a quality manager or someone who works within the quality organization and is tasked with writing a quality management system, but for a lot of your QMS procedures, you're probably the last person that should finalize the QMS procedures. You probably should at the very least, you need to make sure that the people doing the job have a strong voice in that and that how they do their roles and responsibilities and that sort of thing that that's factored into the process. If you're throwing it over the wall and saying, " Now folks follow." This is why quality gets a bad name Mike, because this is why people outside of quality are like, " Man, those people do not understand what I do because they just sent this procedure and" Compliant" and it meets the regulations and the requirements, but it does not match up with what we do." And this is where that disconnect happens I think.

Mike Drues: And if I can apply a psychological metaphor, John. My grandson who is four and a half, he's a pretty finicky eater. It's very difficult, it's very challenging to get him to try new things. But one thing that I've learned is if I have him cook something with me, if he's part of the cooking process, he's more likely to at least try it, whether he likes it or not, that's a different story, but at least he'll try it. So I apply the same thing here. If a quality person puts together a quality management system in isolation and then just sticks it out for the rest of the company and say, " Follow this." It's like getting a kid to try something new, it's not easy to do, but if you involve them in the development of the process, call me naïve John, but I think that might make them a little more willing to actually follow it. And let's be honest, what's the point of having a QMS, even if it ticks all the boxes, if nobody follows it.

Jon Speer: Yeah, totally.

Mike Drues: So the last section that I would add to my list of key sections, especially for small companies, is some section along the lines of supplier quality management, because we both know that in all medical device companies, but especially the small ones, they farm out a lot of stuff. Some of the developments, some of the testing, different things. And so we need to have some description in their. Protocols, procedures, whatever the heck you want to call them, I don't care on how we're going to manage those different suppliers, different vendors and so on. So in a high level John, the areas that I usually recommend companies start with are the preamble complaint, handling our customer feedback, CAPAs, change management, risk, post- market surveillance, document management, training, and supplier quality management. Obviously there are other sections that go into a QMS as well, but at least in my experience John, I think these are some of the most important ones that a company should start with from your vast quality experience, what would you add or what would you delete from that list? What suggestions would you make?

Jon Speer: Well, one area and maybe it's because I'm a design control nerd, but some process to describe how we do design and development I think is really important. That's something that I would add to the list.

Mike Drues: As a former R& D engineer I'm a little embarrassed that wasn't like top on my... But in my own defense John, to me as you and I have talked about many times in the past, that's basic engineering. And quite frankly, if you add, this is going to sound very harsh to some people in our audience I'm sure Jon and it's very politically correct hypersensitive society and industry that we work in. But if you have engineers working in R& D or manufacturing or whatever areas, that don't know those things, they probably shouldn't be working for you.

Jon Speer: Wow that's true. The other thing that I would advise people is, I mean, if you go look at 820 and you look at 1345, this is a short list of requirements with respect to those requirements and regulations. So the key thing that I would advise people is, and I think this goes back to almost point number one of our conversation today, you got to make this your own. There's nothing that says, " Thou shall have an individual procedure for clause X and then separate procedure for clause Y." Et cetera, et cetera, et cetera. If you are able to build this into a, it might be a large document. But if you were able to build this into a large document and you can demonstrate through documentation and records that you're following your processes, then you can do that. There's no absolute that says your quality management system has to have 48 procedures and 58 form, there's nothing like that. The idea is that you're meeting the intent and that you're reducing this to practice.

Mike Drues: I couldn't agree more John, and maybe just to wrap this up, one of the things we can post along with this podcast is one of my all time favorite sections of the FDA's website. It's what I call the preamble to the whole quality system regulation. And we'll post it on the website with the podcast, but I'd just like to read two sentences from it. And this is a direct quote from FDA. " Because the regulation," medical device regulation, " Must apply to so many different types of devices, the regulation does not prescribe in detail how a manufacturer must produce a specific device. Rather, the regulation provides the framework that all manufacturers must follow by requiring that manufacturers develop and follow procedures and splendid details that are appropriate to a given device." That's directly off of FDA's website, which is just another way of saying John, I think what you and I saying that your quality management system should not be a cookie cutter approach. It should not be just buy forms off the internet and print them off and put them into a three ring binder and you're done. In my view John, and I think you'd probably agree with me, but anybody that takes that approach, it defeats the whole purpose, the philosophical intent of having a quality management system. It demonstrates nothing more than your ability to tick boxes on a form, but that's not what this is about.

Jon Speer: Absolutely make it your own, right size it, it evolves, revisit your processes from time to time. Mike, I know there's a whole lot more that we can dive into on the topic of quality management system. And I think for today, this is good food for thought for folks that are curious about how to build their quality management system. So we'll dive into some of those other nuances and details and dive into some additional depth and detail on a future episode. But folks, Mike is a great person to have in your corner. Like I said, I wouldn't want him on the stand against me. He has a very pragmatic approach to all things medical device. I'll say his sweet spots are certainly regulatory, but as he shared getting into and evaluating how a company is documenting their policies, processes, and procedures, and he has a lot of experience in helping shape this and work with you. So I would encourage you to reach out to him, Mike Drues, Vascular Sciences. Of course, Greenlight Guru we're in your corner as well, or hopefully we are. I would like you to consider that anyway. So go to www. greenlight. guru. Greenlight has built the only medical device quality management system software solution on the market today. I know some of you listening might be in that situation that Mike described where you're just getting started. We'll be happy to have a conversation with you, even if you're not at a point in time where you're ready to explore Greenlight Guru, you're just getting started. There's some simple tips and pointers that we're happy to provide to you to put you on that right path so that at such a time when you're ready we're there. And even if you choose some other option, that's cool too. We just want to make sure you're focused on quality, that this becomes part of your mindset, part of your philosophy as a business. So like I said, be sure to check us out, www. greenlight. guru. As always thank you for being a listener of the Global Medical Device podcast. We're still the number one podcast and the medical device industry and that's because of you. Be sure to share and spread this to other friends and colleagues. And as always, this is your host, founder and VP of quality and regulatory at Greenlight Guru, Jon Speer. And you have been listening to the Global Medical Device podcast.

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