Starting Out In Quality -Management Matters

In this episode, Diane and I discuss challenges small companies face when developing a quality system, and when it can go wrong. We also interview Stephanie Armstead, Director of Quality at Prairie Aquatec, a growing new company in Brookings, South Dakota (https://www.prairieaquatech.com/).

Transcript

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Aaron Harmon: 0:00

Hi, I'm Aaron Harmon.

Diane Cox: 0:01

And I'm Diane Cox Welcome to Insight out quality.

Aaron Harmon: 0:04

both Dan and I build and implement quality systems in the biotech and medical device industry. But we often get asked, Is this really necessary? Do we know if we are doing too much too early? Or do we even need a quality system?

Diane Cox: 0:17

Our goal is to explore questions like these through real life events and experiences shared by our guests from various regulated industries. We will show you why quality is not just about compliance and how when it's done right, it can help your product and company improve lives and make a difference.

Aaron Harmon: 0:38

Welcome to our first episode of Inside Out quality. In this episode, we want to explore the process of growing a company's quality system from infancy to a fully mature GMP system. Some companies struggled like the one in May, which we will discuss, while others were successful by investing time and resources with us to share their experiences are Doug and Robin model. How did you end up working in the animal health industry?

Robin Mofle: 1:01

For me, it was kind of a natural progression, I guess, I started out in college thinking I wanted to be a veterinarian, pre vet, and ended up with a micro degree, went to work for the South Dakota veterinary diagnostics lab really loved it, and just kind of kept following my husband, wherever he went and animal science for a while.

Doug Mofle: 1:26

And I started just at the vet diagnostic lab with Robin. And then we bounced around, down the center of the US. And then to New Zealand and back. That's how we ended up

Aaron Harmon: 1:39

here. And that's about the time that you guys started working together

Unknown: 1:43

when we came back. Mm hmm.

Aaron Harmon: 1:44

So in your career journey, you both experienced the extremes of quality. So you've worked with companies that have had little to no quality system, to being involved with more complex pharmaceutical GMP. And so with that, can you talk about the transition?

Unknown: 2:01

Well, I think the first part of it is, when we started, it wasn't lacking a quality system, it was lacking a manager that supported a quality system. That's where things got a little flaky. It just seemed like it was kind of gradual. Little things started to have to happen. We always had SOPs in Menard, I started out in quality control in the laboratory. And he always had SOPs, and you followed those. But if you made a change to it, you just wrote it down, you didn't really go through a proper process of that. So it was just things like that were Oh, yeah, you needed to test the next standard, you're going to use to make sure it was the same as the previous one. All of those ideas just kind of gradually came a lot of times because of an issue that you'd had. And you had to go back and try and figure out what was going on. So yeah, it just kind of was a gradual thing. Looking back, I don't remember any like big aha moments that told me we have to do, you know, all of the validation, all of this, all of that, in my first experience, they decided they were going to go down the GMP route, they had no idea what it was nothing, we spent months in training at the Adams Mark hotel and took away nothing except cookies. That was it. That they, they, they didn't know what it was going to take. So they just gave up on it now, and then the next company I went, really did make the commitment initially. And our initial step was to build probably 9090 Build a $50 million production building with nothing to produce there. And then they work from that. And they thought it would take 10 years. But the statement from the management there was or this was a family owned company, a large company and they said, We don't care about 10 years, we're looking for our children's children, you know, down, like 100 years down the road. So they made that commitment. And my job was to develop analytics and then negotiate the animal testing with the European companies. And that one was a pretty pleasant experience it they told me it was going to take six months. My part of it, I think it took six years. And because we had to go and negotiate with every European country that we wanted to deal with. It's not like that anymore. You can pick a rep return state, but yeah, and it was a little shocking the amount of stuff you had to do to get to GMP.

Aaron Harmon: 4:45

The first time I had heard the GMP there was a coworker who had been in a GMP facility before. And their comment was, it's terrible,

Unknown: 4:54

I think. Yeah. But once you're there, it didn't seem as bad you know, once you get there thanks go pretty smoothly. As far as I can tell you work pretty efficiently. Yep, some of the stuff didn't make sense, like the IQ o Q, P Q, where you have to prove that really electricity is coming out of the wall outlet. That didn't make sense to me. But you did it. And once we got there, everything was good. And it drastically increased the number of employees at the company. We started out with, I think, three QA people. And I had to call them up just last week and ask how many QA people are there now? And there's over 50. So

Aaron Harmon: 5:38

yeah, it takes a village, though.

Unknown: 5:40

Yeah, it takes a village. Yep.

Aaron Harmon: 5:42

And maybe along the lines with that question, too, when you're in a space without a really mature quality system, have you seen a difference along that path where the errors got less, I say that. And then also my experiences, when there wasn't much mistake was expected. It was kind of part of the process.

Unknown: 6:03

I guess, from my experience, when you first really start implementing GMP and getting into that mode, you're going to see more errors in the beginning, because people are all of a sudden, I don't know if they're just more focused on what's going on, but you tend to see more. But then as you go along, you do see less and less, because you've also implemented things where humans are no longer able to make mistakes, or as many because you've put in different controls and things like that. But you'll see an increase in the beginning. And in ours, one of the things was ours was an older company. So most of the employees were 45 to 50. And there was some pushback. Those people did not want to be put into that system. No way. I had a lady working for me that told me she wasn't able to learn. Okay.

Diane Cox: 7:05

Your story is absolutely incredible. So tell me what has surprised you the most along your quality journey?

Unknown: 7:12

For me, it's probably How many things have had to become regulations by authorities because of wrongdoing of companies, not because of individual mistakes necessarily of people. But because they blatantly decided this is what they were going to do. For me, that's just do it the right way. Kind of thing. Yeah, that's that was my big. Yeah. Wow.

Diane Cox: 7:40

That's funny. When I give GMP training, I'll often tell people this is this might seem like common sense. This is kind of basic, you know, business operation stuff I'm about to tell you. And I think they're always a little bit shocked when they come away from the training and how much just logical sense the regulations make. And it's really, like you said, it's kind of sad that we have to have those in place to just do good business. Exactly. Yeah. Now, have you noticed any consistent underlying themes related to the quality problems you've experienced and witnessed? For

Unknown: 8:13

me, it's probably been the idea that upper management is more willing to take shortcuts and try to get results immediately. And thinking they're saving money, especially in time. But over the years, it's a consistent if it always makes more work, takes more time and costs a lot more money. If they would have just done it correct the first time instead of trying to take the shortcut. So to me, that's the underlying it has to come from upper management that this is really the way we want to go. And yeah, yeah, to instill that. It really does. It can't start at middle management and below and you know, you'll get so far, but you won't get all the way with a quality system for GMP from the top down, right, exactly.

Aaron Harmon: 9:12

That kind of lines up with the idea of building a company for generations versus building a company for next for q1 q2 results. And

Unknown: 9:20

yeah, yep, there's one of the push backs. I should have said it before. But my boss and vice president of the whole facility, he had come out of Germany, he was a German, two weeks before the wall came down him and his family crawled under the wall. And he told me one day, this is anti quality goes, no one will ever control me again. But he didn't have his finger on the quality systems. Yeah, he's my best boss, Abraham.

Aaron Harmon: 9:51

And maybe that's part of perception as well is that a quality system is about personal infringement on your ability to agree versus the two Words that facilitate the job you need to do.

Unknown: 10:02

Yeah. And that's, that's another way that I think people, depending on how it's presented to them, it's like, oh, my gosh, I, you know, it has to be that it was specific rules, and I can't hold a pin a wrong way or make it. But after they get into it and realize it actually makes their jobs easier, in a lot of ways. Because they know how they have to go about things. And if it's not that way, they need, you know, to raise their hand and say, hey, something's going on here. But yeah, it's it's a mindset. It's, it's changing people.

Aaron Harmon: 10:37

So Doug, you sent me an article about a company, it was main biologics laboratory when they're no longer around. No. So could you elaborate on the on the article? And what happened? Yeah,

Unknown: 10:49

by what I remember and what I read, they isolated a strain of avian influenza in Saudi Arabia, they smuggled that bug back to main biologics. And I don't know who turned them in, but they got caught. And I think all of the upper management went to jail. And some of the lower level that testified against them, I think they got probation or whatever. But yeah, they, I'm guessing that you don't want to smuggle influences around the world, because the judge came down on them pretty hard.

Aaron Harmon: 11:24

Now, there's a normal path for this. So if you want to bring in a virus into the US, you can get a permit. Yeah, that you'd work with USDA, they would make sure your facilities are correct. So that there is a risk for getting out to the general population. It's not a very difficult process. No, I've done this paper. And if they had just follow that procedure, yep. Then it would have been completely legitimate. But they were just shortcutting. Yeah, totally.

Unknown: 11:50

Yep. Get it back and get it back over there. And this is

Aaron Harmon: 11:53

the first story I've heard over someone in quality went to jail. I think

Unknown: 11:56

this is I think it's the only one in animal health that there was a company in Omaha. And I tried to find it. But this is way back. And in USDA, you have the potency test every batch, well, these guys figured out that if you make one big, good batch, you just re label that and have it tested. And I think the owner of that company could no longer participate in animal health. I can't remember the company name and I couldn't find it.

Diane Cox: 12:26

It's no gold star for creativity there.

Unknown: 12:29

No, no. Well, there's a lot of ideas that float around.

Aaron Harmon: 12:34

But that is what that new generates. New laws. Yeah. To become regulation. Yes.

Unknown: 12:39

Yep. Well, the company that Robin I work for. Robin, you go ahead, you know what you can save? She spent 12 years in court. So deposition dress that I work quite often, but there. Yeah, it was basically, probably the most flagrant non quality issue that I can think of. They tried to take a lot of vaccine that had been tested in the quality control lab and found to be contaminated with a bacteria. And they were going to move it and sell it in the interest state system to where, you know, the USDA had nothing to do with those basically. And because I couldn't let that go because I had signed a document said it was going to be destroyed. The USDA was called in and and we ended up going through a lot of as I said, depositions. I was a witness for the justice system. US justice system, I spend a lot of time with lawyers, by children cried when the sheriff comes to our house and serving me with with subpoenas. But yeah, I I was upstairs with our kids. When the sheriff came with one of the subpoenas. And the kids were crying. Why does the police have mom?

Diane Cox: 14:20

It's dramatic. Yeah, it

Unknown: 14:22

was. And, I mean, we had to I ended up having to get my own lawyer. I mean, I left the company and Doug got paid a little extra for that. Apparently. I got some cash and a raise my shoe.

Diane Cox: 14:39

Now just out of curiosity, did were there patient problems with the vaccine or were there? No, it's won the trial.

Unknown: 14:51

We had called the USDA after we found out he was going to move this product that was contaminated and was destined for a destruction. We actually came in the next day. And he had replaced it with something else. So it was actually a fraudulent product that he was going to have us destroy. And but it never got into patients. And this would have been cattle. Yeah. So there was never any adverse reaction or anything like that. Right. We stopped it before it got to that Mecca. Yeah. Yeah.

Aaron Harmon: 15:27

With the with the main company. There is a comment in the news article, where the judge had said during the trial, if any one defendant had done the right thing, no one would be here in this courtroom today. You know, in that case with that company, they've taken someone saying, Yep, you know, wait a minute,

Unknown: 15:47

you were wondering how that came about? Right? Like through peer pressure, right? Yeah. Yeah, I'm guessing there was pressure from above. And from the peers, once one guy agrees to do it.

Aaron Harmon: 16:00

If you're in a company where you have not developed a quality system, you're not familiar with what is the true right and wrong? I think it's easy to get caught up in second guessing yourself and saying, Is it really a big deal? Is there really a rule that we have to do this? Is that really a requirement? Am I over interpreting things? Am I making it more complicated than it has to be? Yeah,

Unknown: 16:22

yeah, I mean, because you can always kind of gloss over it and say, Oh, it was just a document that we missed, or something like that. Whereas it really has long term effects if people don't understand what's really going on.

Aaron Harmon: 16:37

So what does it take for a new company to instill quality in their daily work?

Unknown: 16:40

Well, I think it kind of goes back again, and a new company is is probably a little bit easier, because we've kind of alluded to it that if the top management going down, is willing to make some sacrifices, as far as making sure they take the time and get that instilled in new employees. It's a little bit easier than, you know, maybe starting with a company that's been in business for a few years, and you have the older employees. Because, and I think another thing for me, and I've seen it in a couple of companies, even older ones, but if you get the shopfloor employees involved in quality, and let them make some decisions and see how it affects things and give them some responsibilities. Rather than someone saying, as you say, that I'm controlling you, you have to do it this way, if they can understand why they're doing it, we actually had, and this was not animal health, but we actually brought in patients, for a drug that we were part of it was a medical device company, but we actually brought in patients that used our product. And it was amazing the difference that made for the people that you know, even cleaned in the kitchen and stuff, they were like, wow, we really are making this for an actual patient and understanding that it could be one of their their family members. So it's kind of altruistic saying all that. But it really does. It does make a difference if you get people involved from the very beginning. And I think in hours, you had to have a plan set forth and follow it because the first company, it was just random, no one knew what was coming the next day. And at Bi everything was laid out pretty clearly the steps that we're going to be taken all throughout the company,

Aaron Harmon: 18:55

and that company had been around for quite a while for companies that are yes, this thing and not new. They're trying to improve their system. Yep.

Unknown: 19:03

That company had been, I think, since the early 50s. When was it? Hong Kong or whenever hog cholera broke. That's how they started as a hog cholera treatment. And it was single family owned and that was a wild company. They had tigers and monkeys at the company that had nothing to do with animal health. Yeah. And they still think there's people in the town still think there's monkeys roaming the river. But yeah, they started off a long time ago.

Aaron Harmon: 19:35

Now we'll take a quick break to hear from one of our sponsors.

Unknown: 19:38

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Diane Cox: 20:19

So, Robin, you said that it's, from your perspective, easier for the younger companies to kind of set this quality culture? And, you know, like you said, from the top down, kind of implement quality throughout the organization. Now, for those more established companies, let's say they're having some quality problems, is it too late for them?

Unknown: 20:40

It's not too late. But I they cannot expect an immediate change. And they're really are trying to change. I don't know if you guys have gone through that. Who Moved My Cheese? Exercise?

Aaron Harmon: 20:59

I've heard part of it. Okay. Yeah. So it's

Unknown: 21:01

basically going through an exercise of how how you deal with change whether you know, you're gung ho, I want to get it done, you need all the facts before you can, you know, change. But it was very interesting to see how different people even in the quality department of an older company, you know, some of us were very resistant to change. But if you can get a few of those people on board, it just seems like everything goes a little bit smoother. But there is always a couple of the old regime that you may have to give an ultimatum to, because they just dragged on the rest. But it's, it's never too late. It just is a little bit more difficult. And it takes probably some extra time. But if you can set some goals to where they're small enough, you can see some improvement. And, and I always think of quality as continuous improvement as well as the opposite. So if you can show them that when they're doing something in quality, it's actually making their lives a little bit easier to kind of get that win. And then they start kind of falling into place. Right? Older, yeah.

Aaron Harmon: 22:22

resistance to change is that driven off of some perception that it will just be more difficult than is necessary, or any insight and why people would be resistant?

Unknown: 22:32

I think some of it is but more so there are certain personalities that don't like change. And I think you'll find that a lot of those people are in quality control. Because it's a it's it's a routine, you do this, you do this, you do this. And in production, you do this, you do this, you do this. So for someone to come in and say, Oh, but now if you do it this way, it's gonna work better. I think it's a little bit of prove it to me and no, because I've always done it this way. Not to but a lot of it is you can't make my work harder. So and a lot of ours thought it was going to be a lot harder, because in our production building, everything was computer control everything. And you put somebody my age in there, not me. I go along with a lot of them that just refuse to do that. We had people buying equipment, just because it wasn't computer controlled. So they didn't have to learn it.

Aaron Harmon: 23:32

Mm hmm. This might be a good time to talk with Stephanie Armstead with Prairie Aqua tech. She's here with us today to tell us about prairie Aqua tech.

Unknown: 23:41

Sure. So, Prairie Aqua tech is based out of Brookings, South Dakota and then also in Volga and we have two different divisions currently. And our product development division is located in Brookings at the Ag Tech Center. And there we do research testing and trials on different innovative plant based technologies and how they may assist in aquaculture feeds. They have a full recirculating aquaculture system there where they do different testing. They have a female there, where they can test feed formulation and production. And then there's also a lab there. So that's where the product which is called me Pro that we make at the large scale manufacturing plant over in Brookings was refined and tested. So just over a year ago, in 2018 2019, we concluded production of the manufacturing facility. And there is where we use the technology that was developed at the Ag Tech Center to make me Pro or microbially enhanced protein to include in agriculture diets. All sorts of different salmon, trout shrimp, but then also there are some other applications that we're exploring as well. Wow.

Aaron Harmon: 25:10

That's great. And it's kind of hard to imagine that in Brookings, South Dakota, you would have a seafood producing company that's taking advantage of the resources. And

Unknown: 25:21

yes, a little bit more about how it was developed. We have just a couple of minutes, two professors at SDSU, they're in Brookings, actually develop the technology. One of them is a was a professor in the wildlife and fisheries department and saw a need to replace fish meal as a major protein source in aquaculture diets. And the other gentleman is an industrial microbiologist, and he said, I think maybe I have an organism in mind that could help accomplish that goal. So they used soybean meal is what they ultimately ended up with as the substrate. So they did a bunch of research. And here we are,

Aaron Harmon: 26:02

that's pretty exciting to see a company able to get that product out and grow the way it has you been with pre Aqua tech for three years. Now, I'm assuming you've seen a lot of growth in that time, both in the company and your skills, are there any personal highlights you'd like to share? Sure, I

Unknown: 26:17

guess more of them are probably company highlights than personal highlights, but the two kind of go hand in hand. When I started at Prairie Aqua tech, my background was more in laboratory management and quality control from that aspect. So when I started at Prairie Apotek, as the Director of Quality, we were, you know, we didn't really have a quality control program or feed safety program. So I got to go do a bunch of different training, attend some, some seminars, which was great. And then we kind of grew together, I got to work with the great team that we have there. And we implemented a lot of quality processes and procedures that were honestly already being done, just because they're good. You know, good manufacturing practices, good research practices, as well, you know, making sure all of your calibration equipped or your measurement equipment is calibrated, those types of things, but we got to develop the plan. And continuous improvement is a big part of it. Robin mentioned earlier, maybe that having the production employees and the operators get involved and have their hands in on a lot of the quality control steps can be very beneficial. And it really has been for us. So and for me personally as well,

Aaron Harmon: 27:42

that's something you pointed out is that most of the procedures were already there. And a lot of times, that's how it goes where people have a practice the practices the right practice, and really a quality system, you know, part of that case is is going back and documenting it, the FDA will say you must have a something something established. And that established is is defined as you you have to find the procedure, you have a documented procedure, and then you have implemented the procedure. And with the small companies, somebody, they start with a few people they're developing all these procedures are implementing them right away. But it's just going back and documenting them.

Unknown: 28:23

Yep, you're absolutely right, we had, like I said, a lot of really good practices already in place. We just needed the procedures written from you know, 15 post it notes on the wall next to the equipment to here's an actual standardized procedure. And then you know, the the documentation in the record keeping to go along with all of that just goes to show Robins point earlier about things being generally just good business practices, and how much the GMP s are really just based on that. And most likely because people weren't following those good business practices to be in. That's very true. Yeah, we have, as I mentioned before, an example was calibration of measurement equipment. I've been fortunate enough to have a really good group of production and operations staff that are they're willing to learn, you know, we built a brand new multimillion dollar facility that has all sorts of automation and any equipment and instrumentation that they're just as interested in in learning how it works and how to care for it as we are as and you know how to run it and get good quality product out the at the back end of the planet. So they've been, you know, fortunately for me and for our other management members, they've been willing to learn. You know, earlier we talked about someone mentioned they started with three quality control, staff members and now reached back out and they have over 50 Well Our quality department like actual quality people, is me. And I can't do it all by myself. So fortunately for me, I have a very good group, you know, support staff in, in the other members of management who, who are very, you know, willing to help encourage, you know, the production team and the operations team and also to go out there, you know, by themselves and get their hands dirty, if you will, and, you know, calibrating things, or something needs to be cleaned or, you know, whatever the case might be, to make sure that we have a, a safe quality product.

Aaron Harmon: 30:40

One rule of thumb that I've heard is for a biotech company, if you have 25, employees should have one person in quality. And I think that works, because quality is essentially everyone's job. And I don't know that people really understand that initially, when you're rolling out a quality system. They're the ones that are defining the procedures. And they're the ones that are implementing the procedures. They're the ones making choices on equipment purchases, there, they have so much involved in anyways, that you don't need a large quality staff unless you've really got large as a company. And if you have to have a very large quality staff for a small number of people, it might just be because they haven't thoroughly implemented quality practices across the team. Yeah, it makes sense. If you're a big pharma company, and you have 40,000 people on staff, then you will have

Diane Cox: 31:31

full department makes sense very

Aaron Harmon: 31:32

big department.

Unknown: 31:34

Yeah, I would, I would love to have have, you know, even another person for you know, I don't, I don't live there. But like I do. Um, but like I said, we're very fortunate that the group that we have, you know, when we were hiring our production team, we don't, there's not another prairie Aqua Tech, we couldn't just go to another company, no fuel map a few miles down the road, or you know, the next state over and say, Hey, we're building a new plant just like yours, but ours is shiny and new come work for us. So we have a very diverse background of you know, when it comes to our employees, and a lot of them have some relevant experience, some not so much. But everyone has been eager to learn and help in implementing all of these different quality and food safety initiatives that we do have.

Aaron Harmon: 32:33

Don't get the chairman.

Unknown: 32:35

Yeah. In the quality we're we're you massively increase the employment is everyone in our production unit that did something, had somebody standing behind them watching. Everyone had somebody watching them that right Rahman and yours, they have to initial that I observed you do this, when you get a quality system that people understand and can work with. It doesn't necessarily have to be another quality person. It's a second check. But it especially in human pharmaceuticals, they do expect quality people on the floor, not one to one ratio, but yeah, a larger group. So yeah, it increases. Yeah. And it certainly does, I Yes, I will definitely admit, there's a large difference between a pharmaceutical company and, and pre Aqua tech. But we are, like I mentioned, it's a brand new facility, we have a lot of instrumentation that is automated. So our digital system gives us readouts, real time of pH, temperature, different pressures, and things like that all throughout the plant. And fortunately for us, in our, in our process, a lot of it is I don't want to say hands off, because there's there's always things going on and things to do. But there is a lot of automation. And so a lot of times the the work that we're doing that our operators are doing is the second check, you know, the sample that you pull to run a pH on that is a second check to the inline instrumentation, know, that that type of thing. So that's how we've been able to, to keep that number of quality, quality control team members, you know, to a minimum, I guess. So it's, that's beneficial for you know, for the operation of the company, we want to be efficient, we want to be effective. So I think we're doing a very good job so far.

Diane Cox: 34:37

So Stephanie, it sounds like it is possible to be both efficient and have good quality. It is interesting.

Unknown: 34:46

I know. Strange, right?

Diane Cox: 34:48

So when it comes to ensuring high quality feed, what would you say is the most important thing for the employees to practice? For me

Stephanie Armstead: 34:57

what I try to instill in them from the get go is just sticking to the basics. Like we mentioned before, a lot of good manufacturing practices and, and kind of quality or feed safety initiatives are centered around those good manufacturing practices. And honestly, common sense practices, good business practices. So, housekeeping is a big one for me, I asked a lot of questions about when was that cleaned what to clean it with all those types of things, preventive maintenance is another big one, and then also process control. So, housekeeping, if we can't keep the facility clean, inevitably, there's going to be an issue with something whether a piece of equipment breaks down, we have some sort of a, you know, that those things can lead to contamination issues, all that, that kind of stuff. And, you know, when we we have a brand new state of the art facility, we're going to get requests for tours, we're going to have, you know, all sorts of other people that want to come in and see the facility. And to be perfectly honest, we like to show it off. So it's not fun to show someone a dirty facility. So cleanliness is is a big deal for us. Our preventive maintenance program is equally as important. equipment and facilities that are clean and properly maintained, are going to result in fewer breakdowns, fewer quality, or potentially feed safety issues. So we have a great group of maintenance employees that that work very hard to keep, keep all of our equipment up and running smoothly. And then I mentioned process control. And it's really the most important. But if we don't have a clean facility, and our housekeeping isn't kept up, and we don't have our preventive maintenance program in check, then we're not going to have process control, something's going to happen, you know, our equipment isn't going to function, right. Or we're going to end up with some sort of other issue, you guys have been in quality for a long time, I'm sure you can come up with plenty of options. But something's going to spiral out of control, we're not going to have process control, and then we're going to have quality or feed safety issues with the finished product. So those are kind of the things that I that I preach frequently, for someone like myself, who's starting out in a career in quality, whether you knew that's what you wanted to get into, or not just getting as much diverse experience as you can, whether that be in different types of facilities, whether you go into a pharma company, or a feed manufacturing facility, or someone making medical devices or human food, any of those types of things, or even just different departments within your company, you know, how does the quality control the product impact the finance department? How does the quality control or feed safety of the food, you know, impact, you know, your analytical lab and and all those different aspects of the business and how everything ties together? Because I know it has certainly been enlightening to me, and in some cases helped me see a potential solution to to an issue we were having from a different angle.

Diane Cox: 38:22

Yes, definitely. I love that I think diversity among just within your company, like you said, are going out and seeing how different companies do generally the same things within quality. It can be a really, really good learning experience tonight, I kind of want to echo that, because I think a lot of people are scared to show on their resumes, multiple companies that they worked for. And it might seem as though they've been jumping around. But you know, I'm going to be the first to admit I've got a lot of companies listed on mine. And it was the best learning experience for me. It's a good good point, from my perspective,

Aaron Harmon: 38:57

diversity within your organization also helps you understand the interactions and how adds value. I always think from a sales stance. So I'm not in sales. That's probably a good thing. But I knew there was always someone on the other had to sell our product. And if I didn't do my job, then it made their job way more difficult. And if something impacted, like if we had bad quarters, because we had a quality failure, then that sales personnel has to deal with a problem that I could have prevented. Thank you for being on the podcast with us. Yeah.

Unknown: 39:34

Thank you. Yeah, thanks.

Aaron Harmon: 39:36

You know, Doug had brought up the importance of management involvement, and they really set the pace for the company. It's also a regulatory requirement. So yeah, so yes, yeah, the FDA spells out and for those that aren't familiar, when a laws put in place, that law gets turned in regulations, and the regulations are then found in what we call CFR As the codified federal regulations. And if you go there, no, in this in this space, especially for medical devices, there's a section on management responsibility. And that includes a number of elements. And it starts with management. Management has to be the ones making sure that a quality system is put in place,

Diane Cox: 40:17

there are several materials to the kind of support that regulation. And I remember reading one time that management while they can delegate activities, they cannot delegate their responsibility. They're ultimately responsible for the quality and the effectiveness of the company, in the product, and so on. And so absolutely, management is responsible. Again, it's kind of echoing what Robin had said about how it really starts from the top. And if you really hold those, those regulations in high regard, then you really are practicing and following the top down approach and implementing that within your organization.

Aaron Harmon: 41:01

In the case of the company from Maine, the quality person did end up getting a prison term, but sort of the President, so it was the president of the company, their chief veterinarian, it was all of their leadership, as well.

Diane Cox: 41:15

Well, I think that's more common from what I hear in various stories where, you know, companies are prosecuted for whatever reason, it typically is the CEO, the President, that you'll hear about being handcuffed, maybe, escorted, it's very, very rare for the quality regulatory person. Like you said, that's the first story I've heard where that's, that's been the case,

Aaron Harmon: 41:39

that and quality persons, their job is to ensure that the management's needs, for a quality system to be maintained or maintained. It starts with management management, then would bring in some kind of quality structure, and use that to ensure the company meets those quality requirements,

Diane Cox: 41:59

right. Like you said, one of those main responsibilities of management is to bring on qualified individuals to do the activities within the quality system. And so if they're hiring the right people, those people will then it'll it'll trickle down from there.

Aaron Harmon: 42:16

So companies starting out with no quality system at all, maybe they got technology, they've got enough of an inkling that it's going to become a product, they've got some money now to do this. And they're trying to develop their product to get through a regulatory channel. Quality plans, probably a good place to start

Diane Cox: 42:32

quality plan should always be number one, I think in that kind of a scenario, when you're starting out, quality plans are really meant to help you scope out an endeavor to scope it to plan it to make sure that you're considering what's needed, in order to implement what did whatever it is that you're trying to do, whether it's a change in your production line, or whether it's, in this case, and implementation of a brand new quality system. Quality planning is a really good tool to use to assess what is impacted, what do I need to do, what's my scope of activities, absolutely a great tool to to then also use as a communication to others, including management, you know, that quality plan becomes the structure of what activities will be done, to achieve the ultimate goal.

Aaron Harmon: 43:27

And the quality system takes a lot of work to get in place. It's shared. You can't do it all at once. And so having a plan allows you to break it into Priority. This is the first step, this is the most important thing, we need to get a plan for how we're going to do SOPs, we're going to debt free, try to write a whole bunch. Yeah. And then maybe after we have that, and the next step is, how do we approve SOPs, and maybe what a template we're going to use, but you're doing steps to get there, and knowing that you're not gonna be able to just overnight, put something solid in place without having gone through a number of small steps over time.

Diane Cox: 44:05

Yeah, yeah. Well, I think that's a common, I'm gonna call it a problem or a potential issue that I see is that people will oftentimes, you know, they'll download there's there's procedures, there all kinds of quality manuals online, they'll download those and use them as kind of their quality system. And I, it could work if you implement it correctly, but I think the problem that happens is a lot of people will take those, and they'll just, you know, basically say, once they have the procedures, their quality system is implemented, when in fact that's not true. They still have a lot of training to do people need to be aware of these procedures, they need to follow these procedures. And so I think that's absolutely the a good point that you make.

Aaron Harmon: 44:50

I had come across this small paragraph in a guidance document from the FDA, and the document is called a systems approach to pharmaceutical CG GMP regulations. And what the paragraph is talking about is that quality assurance, his job is to be independent. So it's as the role in quality you can't oversee or audit stuff that you've done yourself. But there's going to be times in really small companies where there may be only a handful of people and you need someone to go do a task. And that someone happens to be the quality person you have flexibility is what this paragraph saying, to do that as a person and quality, if someone else is able to then check, and so it says something like, under a quality system is normally expected that the product and process development units, the manufacturing units and quality unit remain independent, in very limited circumstances, a single individual can perform both production and quality functions, that person is still accountable for implementing all the controls and reviewing the control results of manufacturer to ensure the party quality standards have been met. Under such circumstances, it is recommended that another qualified individual not involved in the production operation conduct an additional periodic review of the quality unit activities. Yeah. And so having there is some flexibility in it. But the concept remains where it is. You have someone ensuring that the practices that are meant to keep the product made correctly are being followed.

Diane Cox: 46:24

Yeah, yeah, that's very important when it comes to those very small companies that are just getting started with their quality system. You know, maybe they are actually in their design control. Milestone, maybe they've met the design control milestone, but they haven't yet started hiring all of these individuals necessary to really be able to have that true independence. And so this is super important. Another way that I think a lot of companies will achieve that same idea is by outsourcing. And so that's where contractors, qualified individuals that have done this before can be called upon, you have a contract in place with them a service agreement, and they can, as qualified individuals be the second check on those.

Aaron Harmon: 47:12

You hire army of consultants.

Diane Cox: 47:14

And there you go.

Aaron Harmon: 47:16

And ask Dan for help. So was there anything that stuck out about Doug and Robin, as they were talking about their stories? Is there any something specific that you were like, wow,

Diane Cox: 47:28

well, first of all, I just love their dynamic, I love seeing them as a couple, generally, in the same industry, yet, also experiencing the same types of quality journey along the way. And so that was really, really cool to see. But the things that stuck out to me, I mean, again, it's just comes down to the basics of quality and what it is that we're trying to accomplish. And as Robin said, as we've heard from Stephanie, as well, so much of a good quality culture comes from the top. And as much as you can ingrain quality within everyday operations, as Stephanie said, in the production area, having people involved and actually creating and improving the processes. That is my experience as well. And I just love that they they pulled that out. And were able to highlight that on the show today.

Aaron Harmon: 48:29

Having worked with Doug for about 10 years, I him and I were kind of along some of that transition as well. And so the whole employee base moved along with that. And so they were developing skills. And so people who had been in that company for 2030 or more years, have completely transitioned into a really, to almost like experts in how to do it the correct way. Yeah, and ensure that every regulation was being met, and that it was being documented correctly and there. And so those problems very much evaporated. Sure, because the people changed the system change. And there were certainly rough times early on. Yeah. But over the years, it improved dramatically.

Diane Cox: 49:11

Yeah, sure. Those scars don't leave, do they?

Aaron Harmon: 49:14

But they also keep us like a reminder. Yeah, that's why it's important. And yeah, you know, they're they're another cost of it. You know, there is, you know, in the case of the main company, there is quite a bit legally that happened there. But there's also other trickle down maybe lesser thought of elements like wasted product that didn't pass quality control checks, it had to get discarded, right, or race a time on repeat measures. So having to rerun a production ladder, rerun a test or, you know, an animal study that did not work because something had not been done. Right, right. And those won't make the news, but those will definitely impact product availability, profitability, all of those things get hit, and you don't have so everything in place to prevent a lot of unnecessary errors.

Diane Cox: 50:02

Right. Right. And I think it was Robin that mentioned earlier there's from, from the management perspective, there's often this race between time and quality. And it doesn't always have to be that way. I think they can go hand in hand. I think you can build an efficient quality system and still be able to meet timelines that your management team expects. It's a fine balance, certainly. And it's difficult to find, but it's possible. And Perry

Aaron Harmon: 50:31

aquadex Probably a good example things working really well early on.

Diane Cox: 50:35

So very rare story from my perspective, but yes,

Aaron Harmon: 50:39

I had been my graduate work was up at SDSU. And so I know some of the faculty that were involved with that. And just being able to see from my memories of them back in the lab to now having a multimillion dollar production facility. So cool. Very good.

Diane Cox: 50:56

Okay. Well, we want to thank you for joining us for our first episode. Please tune in next time. We hope you enjoyed this episode. This was brought to you thanks to South Dakota biotech Association. If you have a story you'd like us to explore and share, let us know by visiting www.sd bio.org.

Aaron Harmon: 51:14

Other resources for quality include the University of South Dakota is biomedical engineering department where you can find courses on quality systems, regulatory affairs, and medical product development. Also, if you live in the Sioux Falls area, check out QUIBIT a local Quality Assurance Professionals Network. You can find out more about pivot by clicking on the link on our website to the end and I would like to thank several people, but a few who stand out or Nate peple for his support with audio mixing Barbara Durrell, Christian or support with graphics design and web. And lastly, the support from South Dakota bio