GA 431 | Implementing a Quality Management System with Dereck Williams

It seems like there's a struggle sometimes between the quality management system and the cost savings initiatives and the lean best practices. So we don't really think that there should be that conflict. We think the two should complement one another. And I think when they're implemented appropriately, they do complement each other pretty well. So we try to help companies implement with that filter in place.

Today, I'm excited to welcome Derek Williams to the show. Now, Derek has a quality management system and lean background. And so today we spend some time talking about quality management system and how lean plays an important part in the things that folks with QMS are trying to accomplish. We then spent some time talking about how to seek, you know, the various certifications, whether it's ISO or some aerospace certifications or medical equipment, and just talking about, you know, how you. How folks can go about that and some. Some things to look out for and some traps to not fall into. So, really good episode. I think you're going to enjoy it. Show notes can be found over@gembapodcast.com just look for episode 431. Again, gembapodcast.com and look for episode 431. Okay, enough from me. Let's get to the show. Derek, welcome to the show. How are you?

I'm good, Ron. Thank you for having me on today.

Yeah, I'm excited to have you on. So, Derek, I know you've listened to the show, and as you know, we do like to get things rolling with our guest sharing a quote. So do you have one?

Yeah, you know, it's, whatever you are, be a good one. Abraham Lincoln.

Yeah, what's that? I mean, pretty straightforward, but what's that? There's some pretty deep meaning to that. What's it mean to you?

You know, I think it really just sets the tone to kind of guide you to be the best at whatever you're doing. Right. And when we apply that to our lives and our industries and the things we do, like, it should be very empowering to encourage you to just take ownership of whatever you're doing. And that can apply to the graveyard janitor who's sweeping the floors. Right. I mean, the floors need to be swept perfectly. Or the CEO of the Fortune 500 company who just keeps trying to push that bar. Shouldn't matter who you are, you can always take a little bit more and try to be the best that you can.

I love it. Do your job, do your best. Right?

Exactly.

Yeah. Very good, man. Very good. All right, well, hey, Derek, tell us a little bit about yourself, about your Background how you first got involved in all this quality and continuous improvement stuff and then tell us what you're up to these days.

You know, I kind of stumbled into manufacturing by accident, if you will. My, you know, as an 18 year old kid, you know, knew everything but had no idea where I was going. Like every 18 year old, right?

Yeah.

And my, my girlfriend's dad at the time had this job in this factory and said, you know, said, hey, you know, you want to stop flipping burgers and get a real job? So I, you know, I showed up and applied, fell in love with it immediately. I mean, just, you know, the process of seeing things be made. Yeah. The benefit of it being a larger company, so we got to see some pretty advanced stuff for the time. And you know, I had no idea I was going to get into quality or management systems or anything like that, but because I, you know, loved it so much and soaked it right in As a young kid, I just kind of, kind of moved through that and I always kind of had the, you know, the mindset of, you know, double checking, verifying, you know, seeing why we're doing these things. And that kind of drove me to the standards. Right. Like, you know, whether it be as 9100 or an internal procedure or whatever, just, you know, through growing more and more comfortable with that, it was kind of a natural progression. And then, you know, once I realized, hey, that's, that's what I like, then I just said, let's, let's follow that road and see where it takes us.

Yeah. And what are you up to these days?

These days? I own a company called Gamma Group. We're a consulting company. We help, we help manufacturers specifically who want to work in certified spaces like aerospace, defense, medical device manufacturing. We help them, you know, get all their certifications in place, understand the standards, you know, incorporate those processes that are, you know, expected from their, you know, from their types of customers. We help them incorporate them into their processes. But we, we keep lean in the forefront of that. Right. Because, you know, a lot of the companies, it seems like there's a struggle sometimes between the quality management system and the cost savings initiatives in the lean best practices. So we don't really think that there should be that conflict. We think the two should complement one another. And I think when they're implemented appropriately, they do complement each other pretty well. So we try to help companies implement with that filter in place.

Got it. All right, well, let's dive in a little bit. So you mentioned Quality Management System or QMS for short for folks who might not be familiar with just a quality management system, just real high level. Like what is it?

Well, one, you know, one thing that's really not always understood about it is it's a management system. Right? It says it right in the name, but people don't always pull that out. And specifically a quality management system is a management system that is customer focused. Now you know, that's very top level. But really what it is, it's a set of standards or it's a set of guidelines, if you will, that are culminated in a standard like ISO9001 or AS9100 that really define at a very high level the minimum expectations to have a system that is customer focused. Now each industry, you know, has their own segment or their own version of the standard. For instance, ISO 9001 is kind of general manufacturing. You know, whether, you know, it doesn't matter if you're making washers or playground equipment or whatever. ISO9001 can apply to your industry. When you get into things like medical devices, for instance, there's, you know, the ISO 13485, which has some medical device manufacturing specifics in that. And then likewise aerospace, defense, you know, they're going to point you more towards like an AS9100 which has the aerospace specific requirements. And there's, you know, there's a mile long list of QMSs or standards that could apply. So understanding, you know, which one is the right one for your business is key.

That's helpful. Okay, so then you mentioned Lean. So how does Lean play a part in a qms?

Well, so what often happens is the Lean and your QMS often aren't considered at the same time. What I typically find is when people are starting to approach their qms, they're being either directed by a customer or some business decision that's saying, hey, you need to implement this qms. And oftentimes at the beginning stages when you get those QMSs implemented, you haven't even necessarily approached Lean as a business. Right? Because most companies don't start out day one with Lean manufacturing implemented. So they put in the QMS and then they come in with Lean and it's almost like they try and force the two together. And if you don't really understand either of them well enough, there's going to be that conflict quality management system again. That initial interpretation of it is for most people is that you have to document everything, you have to dot all your I's and cross all your t's and, and a lot of companies look at that as a quality function rather than a management system function. And as we know, with Lean. Right. With Lean, it's a, it's a system. It's something that you have to implement as a function across your processes that, you know, holistically, it's, you can't just have a, a guy who's your lean guy who's doing all the lean stuff by himself. Right. And not incorporating system. So, you know, we, we kind of marry those two together. We, we teach, you know, and we coach that, you know, when you take, when you take your lean best practices, you know, like taking, taking as many, you know, you know, reducing your, your waste and reducing your, your touch time and things like that, those are the kind of things that you should document into your quality management system so that they support one another. Right. Your QMS is, you know, you don't have to document every single step that you do, but you should document the steps that are effective for your process. Right, right, right. And I think that's, that's a big part of the confusion there.

Yeah, yeah. I mean, and some would say Lean's a management system. Right. Done correctly.

I absolutely agree that it is. Yeah, yeah. And typically companies who adopt Lean tend to think of it as a system approach because they see that it applies to process and they see that it helps them achieve their strategic goals. Right. For some reason, when they, when companies first approach quality management systems especially, they see it as a quality function because they hear that word quality, they often assign this to whoever their inspector is. Right. I've literally walked into a company once that the quality management system representative, the person who was in charge of implementing this was the guy who spoke the best English and Spanish and that was what qualified him for the job because he could communicate this to both English and Spanish speaking people, but he didn't understand the standard was actually a written text. Yeah, right.

Yeah.

So, you know, how do you incorporate that as a system? Yeah. If, if it's one guy, you know, who doesn't even know it's a document. Right.

So a question I have for you. So like in, you know, over my career, I've seen, I've seen Lean done really badly. I've seen QMS done really badly. And so it's not the pick on one or the other, but if I focused in on QMS and what I've seen done poorly or badly, it would be that, you know, there's been times where I've seen like, let's say someone's got the auditors coming in, you know, next week. Right. You know, to audit their ISO or whatever it might be.

Right.

And so, you know, I've literally seen situations to where you'd be like, hey, Johnny, at three o' clock on Wednesday you need to be on break and Susie, you need to be at your desk because that's when the auditor is rolling through. So like, how do you ensure. And again, it's not to pick on QMS because the same thing can happen in Lean, but like, how do you ensure that it doesn't become this sort of, like, I don't know, pencil whip kind of exercise and that you're just trying to pass the audit and take the auditor out for a big dinner and you know, you're going to get your two or three minor infractions or whatever because you know what I'm saying? Like, how do you make it real? And because done correctly, it can transform a company, but done poorly can just be a poster up on the wall, you know what I'm saying?

Well, ideally you should not have to prepare for an ISO audit or an AS audit.

Yeah.

You should be, this should be incorporated into your processes day in and day out. And I think the way that you get that starts with awareness, right? So first your, your leadership team has to be aware and they have to, they have to adopt the, the, you know, the fundamental foundation that they are going to be a compliant company.

Right.

That whether it be ISO or AS or 1345 or whatever it is, they have to, you know, take the responsibility as a management team to say, hey, we're going to do this because it aligns with our strategic direction.

Yeah, right. Well, some of them have to do it right, like do regulations and whatnot. Don't, don't you like in aerospace in particular?

Absolutely. Yeah. Your aerospace customers are going to tell you, hey, you have to be as 9100 certified, for instance. And again, that's usually what gets the ball rolling towards certification. But once you know that that's your customer's expectation of you, right. As an organization, you really should have a decision to say, hey, you know, what is this one customer that sells me one, you know, that buys one part a year for me for $100. And if so, is it really worth committing to that standard? Right. Maybe that's, you know, if that's the case, maybe it's the wrong business. Maybe you should say, hey, we're not going to quote that. But if you're pursuing that right, then, then you should understand as an organization that that is the expectation of your industry and of your customers. And when we talk about lean. Right, you know, what is, what is value? Value is what your customer is willing to pay for. Right. And your customer is willing to pay for you to be ISO compliant or as compliant or whatever. And if they're buying that product. Right.

Yeah.

You should be making it the best product that you, you know, that you can make it.

Yeah.

You know, meet me. And by best, I mean, I don't mean take it to the nth degree. I mean meet all of the minimums and make sure that it, you know, that the product you sell, which is this as certified product now.

Yeah.

You know, it meets all the minimums and it performs as intended.

Yeah. So what are some of the challenges when you're going for these certifications? Because, you know, some of them are extremely difficult from what I know. And you know, some, some are easier than others. But like, how do you go about it? What are some of the challenges?

I mean, I mean they all have their level of difficulty. Right. I mean, I couldn't cram 13485 into, you know, Bob's garage shop that him and his kid just decided to do on a weekend very easily without changing some mindsets. So I think the biggest challenge is making sure that you understand what the requirements are and making sure that they actually do align to your strategic direction because you won't get the benefit out of it if you're trying to force something for this minimal gain. It needs to be, it needs to benefit your organization. So awareness is probably the first challenge. The second one is navigating the waters of the registrar process and understanding what exactly you need to have in place. So if you understand the requirements of the standard, then you should be able to decipher that and say, okay, this standard says I have to have X, Y and Z. Put those in place, try them, make sure that they fit, you know, do your whole deal or however you want to implement these processes and verify that they're effective and then, you know, pursue your registrar. Typically you're going to go through what's called a stage one implementation. So that's, that's going to be a very top level audit. You know, your registrar is going to come in more and more. They're doing this remote, given the.

Yeah.

Nature of the world. But, but they're just going to come in and they're just going to check a few boxes and say, do you have this kind of process? Do you have, you know, these documents in place, so on and so forth. If, you know, if you do, then they're going to greenlight you for your stage two. Stage two audit is going to be much more in depth. They're actually going to open the documents, they're going to see, hey, does it comply with the standard? Is it effective? And effectiveness is really the key there, right? Because what they're going to measure you on, they're going to use a tool called a pair Process Effectiveness Assessment Report. And it's going to look at your process and see, hey, with this, with the documentation you have with the process that you perform day in and day out, is it effective to achieve your intended results?

How do they verify that? Just look at your quality levels or your, your productivity or.

Yeah, it, at that stage two, it's a, it's a full audit, right? So they're, you know, depending on your auditor, there's a couple of different approaches, but typically they should be, you know, it's a process approach audit. So they should be looking at your process. A lot of them tend to start at the tail end. So they'll look at some product that you shipped, right? And they'll pull the, you know, whether it be, you know, they might start with the PAC slip and say, hey, how did you generate this? Does it have a cert? And they'll work backwards through your process. You know, did you have a work order in place? Did you follow all your work order steps? And they're going to be comparing all this to the sections of the standard to make sure, hey, hey, you said you were going to do it this way and you either did or didn't. The standard says you're going to do it this way, and your document either does or does not align with that. And again, we're talking about documents, so we kind of, we're leaning toward or leaning into that perception that everything needs to be documented. But that can actually be a detriment too, right? You over document, you over detail your procedures and now you're in a position of a gotcha, right? If I, I always use the peanut butter and jelly sandwich example, right? You could tell me how to make a peanut butter and jelly sandwich by saying, you know, take two pieces of bread out, put peanut butter on, put jelly on, smash them together. Most people could follow that instruction and end up with a sandwich. I could say, you know, take one piece of bread out, put it on the left side of your table, use your right hand to use your knife to scoop out one ounce of peanut butter smear. And I can go very detailed. You're still going to get a peanut butter and jelly sandwich at the end. But is everybody, you know, if you, if you lined up 100 people to do that process off memory, are they all going to do it the same way?

Right.

Maybe not. Right. And when they, when you have that misalignment because you've over detailed your process, you're not really doing yourself any benefit. You're not really supporting your lean best practices. Right. You might be doing overkill. Right. Because what if I'm not right handed right now I'm struggling to smear the peanut butter with my right hand and that's not natural for me.

Right, right, right, exactly.

And I've set myself up for an audit yet. Gotcha.

You know, what percentage in your experience of folks that are going for, you know, a registrar comes in and you're going for some level of certification, what percentage? Don't get it.

I really don't see a lot of companies that don't get it if they have made it through their stage one. Right. I have seen companies that, they show up for stage one and the stage one, you clearly don't understand the standard. You're not ready to proceed to stage two. But that is, it's very rare case I would say because most, I would hope most companies wouldn't pay for, you know, who knows, you know, 2,000, $3,000 for an auditor to come in and say you don't, you know, you never even opened the standard.

Yeah.

So typically what I do find though is on the initial certification, a lot of findings for companies who aren't prepared or don't have those processes effectively implemented and you know, in alignment with the standard, which can be troubling. You know, it can be painful for a company, especially the first go round to walk away with, you know, five majors and seven minor non conformities that they now have to correct in 30 days. Yeah, right, yeah. And you know, bigger problem that I see is companies do it once and they think that they've achieved a goal so they don't continue to maintain it. That's that second audit that tends to get them, you know, with a lot more findings as well. Right. Right.

Now talk a little bit about if you are a smaller company seeking one of these certifications versus say a big giant fortune, you know, 500 company kind of thing. Like is there a difference in approach? Is it easier, harder, the same?

I mean there's definitely, I don't know if it's easier or harder necessarily based on your size. Obviously a large company has resources so if they say, hey, we are committed, you know, then they can throw bodies at it, they can throw time and money at it. And you know, and outwardly looking in, it can seem like, oh, it was easier for them, right? But the smaller companies, you know, really, they, they, the processes are closer to leadership in smaller companies or leaders are closer to the process, however you want to word that. And because this is a management system, smaller companies typically have more management engagement, which is a, which again, right? If this is a strategic change in your organization or something that's going to support your strategic plan, well, having your leadership involved with that is probably going to make it more likely to be successful than if you don't. So I think smaller companies are actually set up better to be able to pursue this and implement them in an effective, you know, short time frame. But larger companies, again, have the resources. So you can, you can pay somebody to, you know, eight hours a day for the next two weeks to read and understand every clause in the standard if you want. Whereas a small company, you just don't have that time, right?

So a company, let's say a company wants to seek certification and they're at, they're at square zero. Like, they haven't even, they haven't even begun. Like, what are some practical steps or some advice that you might have for those folks?

The first step, I would say, is determine which quality management system is appropriate for your industry. And if you don't know any of them, that's going to take a little bit of research, a little bit looking up. ISO9001 is a good foundation for any kind of company. So if you are doing aerospace or medical, you can always pick up ISO9001 and say, okay, this is what a quality management system looks like. Then once you know your, which industry or which standard applies to the work you do. Because even within aerospace, right, you've got 9001 or 9100, you've got 9110, 9120, and they all apply to different types of aerospace work. But once you figure out which one is your, is the right one for you. Educate yourself, learn, you know, learn what those clauses say, but more importantly, learn what they mean. And it helps to read these in a group setting with your management team. Go through the standard, take a day or four hours, whatever it takes, go through clause by clause and say, hey, how does this apply to us? And then figure out what doesn't apply. Because what doesn't apply is it needs to be communicated. It needs to be documented in Your scope. So that when you approach your registrar, the guys who are going to certify you, you can say, hey, you know, we're going for our 9100, but we don't do design. Right. So don't audit us on design. We're going to take that out of our scope. Yeah. You know, and then, and then the next step is to pick a good registrar, you know, figure out who, you know, I mean, there's a lot of them out there. Some of them have a reputation for being much more strict than others, you know, harder to pass audits than others. And you know, figure out why that is and what and how that applies to your business. If you're going for 9001 and you're making washers, you probably don't need the guy who's, you know, auditing you. Like, it's an ad cap audit to the nth degree and making sure everything is, you know, is so focused on compliance that you struggle to, you know, to incorporate those lean best practices as well. Inversely, if you're doing medical, you're going to put things inside someone's body. You probably want an auditor who knows the stuff, who's really going to make sure that you're not pushing a bunch of liability out there into your product world.

Yeah, yeah, yeah. Like anything. It's like, what problem are we trying to solve? And then how is this going to help us? Right, because so if you're seeking it just because you want to hang a banner, it's probably obviously not the right way.

Right, exactly. Yeah. And you know, I mean to that, you know, having that certification certainly is a nice banner to have. It is a nice advertising tool to have the logo. But if it's not effective, if it, you know, if it's been pencil whipped and it doesn't really mean anything, you know, you're the customers of the world. You know, they, they know, right. When they see one registrar versus another, they go, okay, yeah, we've dealt with these guys before and yeah, they either hold your feet in the fire, make sure you're doing it right, or they don't. Right, right.

Good stuff, man. Well, hey Derek, if folks wanted to connect with you personally, what's the best way?

Well, they can always go to our website. It's www.gamma group.org G A M M A. Right. G A M M A group.org or they can, you know, they can always reach out to our direct line, 97134. Typically that'll land at me. So, you know, we're a small company and but we help all size companies.

Nice.

Yeah.

And then if they want to go to gembacademy.com they can after after Gamba Group, right?

Absolutely.

Awesome. Well, hey man, thanks for coming on. This has been fun and yeah, keep up the great work.

All right, well, I appreciate you having me on today.

All right, take care. Derek. Thanks for listening. Whether you've been on the continuous improvement journey for many years or perhaps you're just getting started, Gemba Academy is here to support you. And while we're best known for our more than 1500 Lean and Six Sigma teaching and virtual tour videos, we also have a team of experienced Lean and Six Sigma practitioners available for one on one coaching as well as available variety of Lean and Six Sigma certification options. To learn more and to schedule a demo, head on over to gembaacademy.com.