Quality Grind Podcast

Lean Principles and Regulated Life Sciences - Part 1

• MEDVACON Life Sciences • Season 1 • Episode 21

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In this episode of the Quality Grind Podcast, host Mike Kent welcomes Jose Mora back to discuss the application of Lean principles in regulated life science environments.

Tune in as they dive deep into the importance and utility of Lean, with plenty of real-life stories from across product development and commercial manufacturing. Learn about situational awareness, visual signals, and how Lean processes can help you navigate challenges, improve quality, and optimize your workflow.

Don't miss out on this insightful discussion and get actionable advice to implement Lean in your organization!


Contact MEDVACON:

  • Message us at @MedvaconLifeSciences on LinkedIn
  • Visit our website at www.medvacon.com/contact
  • Email us at qualitygrind@medvacon.com

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Ep 21 - Applying Lean Principles to Reg Life Sciences, Part 1

Jessica Taylor: [00:00:00] This is the Quality Grind Podcast presented by Medvacon. Conversations that go beyond compliance. Sharing insights geared toward helping you navigate the everyday grind of regulated life science industries. Here are your hosts, Joe Toscano and Mike Kent.

Mike Kent: Welcome back to The Grind, everyone. Mike Kent, along with you today, flying solo, but not alone. As usual, we have a tremendous guest lined up for you, and our first official return guest! Mr. Jose Mora has been kind enough to join us again for a second recording, this time talking a little bit more about Lean Principles and their application to regulated life sciences, specifically product development and commercial manufacturing.

And what we'll do today is go through an overview of [00:01:00] what Lean principles are, how they came about, and why they're important, why we should care about them, and really their utility in our industry. Jose Mora, it's tremendous to welcome you back to the Quality Grind Podcast. Thank you, sir! 

Jose Mora: I'm very excited to be here and honored to be back. Happy to participate in these. 

Mike Kent: Well, we appreciate it tremendously. And the response to your first episode, which we'll point to in the show notes for folks to catch up and get to know you a little bit better - the response has been tremendous, focusing on Lean documents and Lean procedures, which we all struggle with SOPs and documents in our industry.

So, we wanna give a little bit more detail in terms of Lean principles, what they are, how they came about. Can you walk us through just a general overview of, "What is Lean?"

Jose Mora: So, I like to think of Lean in terms of [00:02:00] situational awareness. And some of my favorite quotes, one is, "No man ever steps in the same river twice, for it's not the same river, and he's not the same man." And that dates back to Heraclitus, an ancient Greek. Many times we get into this routine of robot routine and we're just going through the motions, we lose our situational awareness. And especially this is dangerous in manufacturing because you're walking into a situation and you are no longer looking for what changed. You're just going through the motions. So situational awareness is very important because Lean is all about visual signals. And visual signals are necessary to tell you if something has changed. There are always situations that happen, unexpected situations. So part of the idea of Lean is to catch those signals to let you know something has changed so that you can react to it.[00:03:00] 

Lean is really about those personal signals, and we know we all have our personal routines. This is where it becomes comical. Many people think of the Toyota production system, but some of us may remember the movie Cheaper by the Dozen, and I'm not talking about the Steve Martin one. I'm talking about the Gilbreths, many decades earlier where these two industrial engineering couple had their whole family running on, on all kinds of efficiencies and clockwork.

But, if you think about it, in your personal life, you have, you might put signals along your daily path. So have the umbrella next to the door so you don't forget to take it with you, even though it may not be raining right now. You go into the kitchen in the morning and you might not remember that you have to prep some items for tonight's meal because you're in a hurry and you're focused on breakfast.

Well, if you leave some of those food prep [00:04:00] utensils out as a signal, it's like, oh, that's right. I've gotta, you know. And I'll use my personal example, I like to marinate some plantains for tonight, but they need to be soaking. So I left the plantains out there and yeah, that's right. And it only takes five minutes to do it, but if you forget to do it, those are not gonna be part of your meal tonight. So then that could apply to absolutely any food prep item. So, location, sequence, and timing are essential. You want to limit the number of unnecessary trips. So if you happen to live in a multi-level house, maybe a townhouse, one of the things you might do is leave your personal items at the bottom or top of the stairs so that you remember to take them with you on your next trip instead of having to constantly be going up and down the stairs because you forgot something. Have your backpack ready to go so that all you do is put your laptop In and you're on the way. As opposed to, oh yeah, I gotta get my charger, I gotta get my glasses, like all this kind of [00:05:00] stuff. All it takes is one mistake, one forgotten item, and your day is, is ruined. Your trip or your visit to your client is ruined.

Mike Kent: So through all of that, I can't help but have some PTSD around all of the examples that you listed. I'm thinking, well, Jose's been in my kitchen. He's, he's... Where are the cameras all around my house? He's been watching me for signals of all of these things, right? Because it's, oh, yeah, I should have put that out the night before.

It strikes me though, Jose, that this may be more than, or folks may be thinking of Lean now in terms of, well, I just have to prepare better, or I have to remember to prepare better. But Lean really is more than just preparing things in advance, isn't it?

Jose Mora: Correct. That's correct. Because Lean is also about, [00:06:00] and the reason for this example, it's about signals, but signals in the context of a process. In regulated manufacturing, we are dealing with more than one process. It's not just a production line, it's a design control process. It's the CAPA process. It's your QMS processes. And if you are not ready for those, and you don't have the right placement at the right time. For example, when is the best time to capture a CAPA thing? When there's a defect, or when somebody's working and they think, "Oh you know what, we might be able to improve this." Well, if your CAPA catcher is right there to catch the idea and say, "Hey, by the way, here's an opportunity for improvement," it doesn't interfere with the work. The person provides the idea and they keep on working. That, that can be a place to catch those for later processing.

One of the things about Lean is having things in their proper place at the proper time. [00:07:00] Unfortunately, one of the things that happens is when you're introducing a, you're rushing at the last minute to get a prototype out the door, there's been some comical events in my past, more than one. One was the R&D group spent a lot of time in their little isolated lab and they created a pilot line, and nobody thought of checking with manufacturing. And it was very embarrassing when they brought the pilot line out to the production floor and it ran in the opposite direction as all the other lines in the production floor.

Mike Kent: Oh no. 

Jose Mora: That's expensive. 

Mike Kent: Little bit.

Jose Mora: And I'm talking about you had like five of production and here's this fifth line, this new line, and it's going in the opposite direction. 

Mike Kent: Wow.

Jose Mora: I mean, all you have to do is get ask somebody.

The other one was in, and I have many from my maintenance days. A mechanic goes out [00:08:00] to the production floor and says, "Hey, this part, where do I get the replacement part?" I look at this weird part, I said, "where did they get this?" So I find the R&D engineer, and he starts laughing, like rolling on the floor laughing. I said, "why are you laughing?"

"We had to get this done at the last minute and we just picked up this piece of junk, these jerry rigs, and we just threw it in there just to get the equipment out the door."

And, okay, so you're telling me this is not something that is that I could go to a catalog and order. This is some junk that somebody, so that's why he was laughing. Well, it was not funny when production is down and now we have to get somebody to go to the tool room and build this whatever it was, thing, as a replacement part. Sure. These are real life examples. So by doing things at the right time and thinking ahead, that's part of Lean.

But the other principle of Lean, many people [00:09:00] think of Lean as speed and simply production fast versus quality. And in fact, if you think of the sequence of events in Lean, you're trying to do small, frequent lots. Well, in terms of quality, that translates into small frequent feedback on any deviations. So they're actually working in tandem with each other. If you make a hundred and you have a problem, you just have a hundred problems. If you make 10 and you have a problem, you have 10 problems, and then you, the next 10 will be okay. It's a constant feedback loop.

Now that's just on the production line. But when you're talking about a supply chain, it really gets exacerbated because the mentality is, "Oh, I don't know if I trust my supplier. So I'm gonna order three months of inventory just in case." And the supplier is, [00:10:00] and I've been on the supplier side, oh, "I don't know if this customer's reliable, so I'm just gonna build up three months of inventory on my end." So now, unbeknownst, they each have three months. So now you have six months worth of stock hidden from each other of three months. He so all a sudden, "Oh, I need to make a design change." Well, you've got your three months of stock that you have to get rid of. The supplier: "Oh, by the way, um, I, what I had, I can't give you because I have to start over."

So all of a sudden you just set yourself back six months for what should have been a simple change. 

Mike Kent: Sure.

Jose Mora: But, we even create problems for ourselves. And I couldn't, that's just saying I can't make this up.

So we had a certain Engineering director who thought he was gonna be creative and said, "Okay, you know what? We just have this low yield tool. Let's go ahead and do that. Let's use that, [00:11:00] because I need to get my parts going. But I know I'm gonna change the spec later, because this tool needs different specs than the final production tool. So just start giving me some parts." This company actually scheduled daily concession meetings for engineers to come in front of the manager and say, "Oh, I need the spec changed on this part that just came in, because yada yada...".

Well, the reason for it was that policy. And that same director, I can't believe he said, "Well, the solution is that the engineers need to hustle more. They need to be better at hustling." And I, at that point, you know, I didn't even try to reason. I mean it was just so far out there that there was no point. So, you ended up with every single... at final inspection and testing, every part that, every equipment, was a new creation. There no two were alike. And of course, they were full of these components [00:12:00] that were out of spec.

So I was sent out as a production engineer to streamline the inspection process. I very soon learned, you don't have an inspection problem. Your inspection is really a rework shop for all the crap that you've been sending as a result of your policy. I didn't say it that way, but that's the reality. There was nothing wrong with the inspection. It was doing exactly what it was supposed to do, which was to reject the bad parts. In trying to be efficient in the tool or prototype design process, you just shifted the problem to your final inspection at the worst time when you're trying to make product to ship out the door. 

Mike Kent: Sure. So in that particular case, the signal that gave rise to there's something wrong here was the bottleneck created with the inspection process due to the [00:13:00] ineffective or non-optimized steps in the process earlier. And I was careful not to say inefficient because you mentioned earlier that this is not just about efficiency and speed, it's about optimizing your process so you're not, as you put in that last example, pushing the problem further down the line where now it becomes more critical and more urgent given the step where it's eventually found.

So in those earlier steps, what are some of the other signals that people can be on the lookout for that, hey, something may be, again, I'm not gonna say inefficient, but something could be further optimized and where could Lean potentially be applied in those earlier steps. 

Jose Mora: Well, you start, the first signal might be a complaint or a comment from a customer that says, you know what? This handle is really [00:14:00] not user friendly. And unfortunately, that complaint or that comment gets buried in the system and by the time you're acting on it, several months have passed. You have many more complaints, many more issues. But that one signal could have made its way to the R&D group to start working on an improved design and simply have it ready and as part of the new design spec. And there was plenty of time to get the tools made to make the part, design the part. Unfortunately, by the time many complaints have accumulated, then all of a sudden it's, oh my God, we've got a crisis. We've gotta get this out the door, this changed immediately, and then it gets put through as a field corrective action - the worst. And then of course, they didn't think through, oh, this new handle came out, but did you think of how the rest of the workflow works?

So now you've got a solution [00:15:00] that just created five new problems. So by failing, by missing that initial signal and having, by not having a steady flow of signals to the design process, you're simply cluttering up. And it's the batch processing mentality. "Oh, we can't process this complaint right away, so we're gonna let them accumulate and because we wanna be efficient in the Complaint process, and now we'll just enter all these 500 complaints at one time because I'm now being efficient." And all of a sudden you, you know, by the time it gets to Design, it's already a blazing fire. 

If you had your information flow smooth, smoothly coming from the customer to the designer and back to the supply chain, then it, you can smooth that out.

And it's funny because in one of, in the startup company that I, that I put together, I hired some people [00:16:00] and at one time they were working very smoothly. It actually looked like they were moving slowly, but in fact the product was moving very smoothly. And one of 'em said, you know, I'm nervous because the bosses, they're gonna think that we're not working very hard and they're gonna think we're not being productive. 

Mike Kent: Yeah.

Jose Mora: And I, I had to reassure 'em, no, no, the product is moving out the door. It's working just fine. You don't have to look busy. You just work at a comfortable, steady pace. And it, sometimes it's hard because they're so, oh my God, boss is there, I gotta look busy. And unfortunately looking busy may mean building parts, building up inventory that you are not ready to consume yet. 

Mike Kent: I think it's an interesting point you bring up, Jose, in terms of looking busy and how some of those signals get passed into the organization of, you mentioned a director earlier that [00:17:00] the response to his engineers was, well, you just need to hustle more. And the production line workers that feel like they have to look busy, which means moving fast and things like that. We get caught up in speed an awful lot.

And so one of the signals that I might suggest into this is if people in the organizations feel like they have to be doing something other than what they're doing while they're being effective, that may be a signal that something might be wrong. It may not be, but it's worth looking into and exploring. Even if optimizing that process means, as you put it, having that conversation with the workers and saying, you don't have to do anything other than what you're doing... 

Jose Mora: Yeah, yeah. 

Mike Kent: ...which, you know, that's the human end of the process.

Earlier in the Lean [00:18:00] Documents episodes, and again for those of you who haven't heard those, episodes 19 and 20 of the Quality Grind Podcast,

'Applying Lean Principles to Controlled Documents',

Jose gave us a really good set of strategies there. One of the points that you made in those two episodes was a discussion around the 'Voices of Lean' and the 'Voices of Non-Lean' in terms of those signals.

I wonder if you could revisit that concept for us and walk us through in terms of those being signals of when Lean is either working or may need to be applied to improve process effectiveness. 

Jose Mora: And this happens all the time. Whenever I visit a 'non-Lean' place, invariably I could print a t-shirt on this. It's like, we need more space, we need more people, more resources. If we only had the [00:19:00] equipment, if we only had more tooling, if they only spent more. It's always about spending more resources, spending more money. What they're not realizing is if we hire five more people, they're each gonna have to learn, they're each going to introduce their own disruptions. So adding more bodies to it exponentially complicates the situation, especially when it's not necessary.

The struggle with when people are not in Lean, and I, one of my, one of my early mentors was a lady that came to this company and she was good, an excellent world class facilitator. And she had trained a group on Lean, then everybody's like, oh, you should look at that group over there, they really need your help. And she stepped back and said, "They're not ready for me."

And I was shocked. What do you mean they're not ready [00:20:00] for you? They desperately need help. They're not ready. The problem is their mindset wasn't ready to accept these changes. So it...

Mike Kent: Tell me a little bit more about that. What about that mindset? What did she recognize?

Jose Mora: She had to teach them how to do proper brainstorming, how to do a flow map of the current and future process. there was a certain set of behaviors that people had to be encouraged to talk, and so we could capture the ideas. And the facilitation, there were certain tools. They had to learn certain tools, simple tools like Fishbone and Pareto, but also how to diagram the process flows.

And when people are in a desperate situation and they're constantly chasing, chasing their tail basically, it's like, "Oh no, we don't have time for this. We don't have time for [00:21:00] any training because look, we gotta get this product out the door." And I ended up bringing her to another job, and I think I mentioned this, they were getting 25% yields and they were working three shifts. I thought I'm gonna bring this lady in to train the group.

And it was like, oh no, we don't have time for this. Why? Because you're making, you're using 75% of the time making scrap. So finally I convinced the management. She had a three day session with the engineers, the operators. And during dinner, the plant manager, and he was unfortunately very old school, and he's like,

"Well, what immediate benefits are we gonna see from this?"

And she said, "None."

So that's not what he wanted to hear. But what she was trying to tell him is, you need to change your culture. It's not just about the training session. So she went [00:22:00] and left. But just from that visit, the yields crept up from 25% to 50% and eventually to 80%. All of a sudden they had plenty of time because they weren't throwing away 75% of what they made. 

Mike Kent: Sure.

Jose Mora: Now there was plenty of time to do real optimization of the process. 

Mike Kent: Okay.

Jose Mora: The key was there needed to be a strong cultural signal from the management that we're gonna do things differently now. 

Mike Kent: And part of that is communicating openly and directly in all directions. Everyone's encouraged to do that. You know, I've talked with you many times, and you mentioned it during the podcast in your previous visit. The two of us are big fans of getting out on the floor and talking to operators in their environment while the process is going on, best we can, to [00:23:00] understand and view the process from their perspective and just listen. Ask open-ended questions and listen to what they have to say, and the gems that come out of that are immense.

So how do we create those opportunities? And it leads us right into those Lean principles.

We are just getting started with the application of Lean to our industries, having touched on the basics of this powerful mindset for improving the quality and effectiveness of everything we do every day.

And speaking of quality, as we say so long for now, enjoy this sneak peek of what you'll hear in part two of our discussion with Jose around applying Lean principles across the diverse landscape of regulated life sciences, next time here on The Grind.

Jose Mora: So quality and compliance is about meeting standards, meeting [00:24:00] specifications, and also about having the proper feedback when something is deviating. So in a regulated industry, we have the feedback of the customer complaint, but we also have the feedback of the non-conformances. However, the length of time of that feedback has a lot to do with the success of Lean. So if that feedback comes back immediately, you can course correct immediately. The idea of Lean is also about having the smallest, ideally a lot size of one, and immediately sending that to your next step and getting feedback. Was this good? Yes. Was this good? Yes. And that establishes a chain of assurance, of quality assurance. The real quality control is that feedback mechanism. Saving [00:25:00] everything for a final inspection when you've got a huge lot of material, you shouldn't have to do that. By then, you should already know that it's good product. 

Joe Toscano: If Medvacon can help you and your organization, we're happy to do so. We specialize in the following areas: Quality and Compliance, Validation and Qualification Services, Project Management, Tech Transfers, General and Specialized Training Programs, Engineering Services, and Talent Acquisition. If you have general questions as well, feel free to give us a call at any time.

We can easily be reached at 833 633 8226 or via our website at www.medvacon.com. Thanks so much, and we look forward to speaking with you. 

Jessica Taylor: Thank you for listening to the Quality Grind Podcast presented by Medvacon. To learn more or to hear additional episodes, visit us at www.medvacon.com.