Quality Grind Podcast

Applying Lean Principles to Controlled Documents - Part 2

• MEDVACON Life Sciences • Season 1 • Episode 20

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In this episode of the Quality Grind Podcast, host Mike Kent and special guest Jose Mora continue exploring the application of Lean principles to controlled documents in regulated life sciences. Jose uses multiple examples to illustrate how ‘Lean’ works to optimize document effectiveness by creating a hierarchy where the 'why,' the 'what,' and the 'how to' are easily identified and differentiated.

The conversation then explores aligning Lean documentation with operational efficiency and audit readiness, underscoring the benefits of an engaged and informed workforce. Jose rounds out our visit by his sharing insights on starting the transformation journey, emphasizing cultural change, training, and involving the right people at the right time.

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Ep 20 Applying Lean Principles to Controlled Documents Part 2

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! Well, we certainly have covered a lot of ground to this point. Applying Lean principles to our controlled documents starts with thinking about those documents differently. Doing so naturally leads us to think then about our processes and systems differently. And as Jose said many times in different ways, it's not just about reorganizing and trimming. The central theme to me so far is being rigorously intentional about each section or paragraph, or even each sentence in a document.

In part two of our [00:01:00] discussion, Jose offers even more tips for writing lean documents and optimizing workflows. We'll also talk about some clever ways to determine if your efforts to go lean are working to make a real difference out on the floor.  

So let's rejoin the discussion with Jose Mora in part two of Applying Lean Principles to Controlled Documents, here on The Grind. 

Coming back to the documents itself, you mentioned breaking that 50 page document up into the 10 unit operations and each one having the information that's necessary for that unit operation. It occurs to me that you would have to understand that unit operation very, very well. 

Typically there's a subject matter expert that's writing the document, right? You've got somebody with all the years of experience, they developed the process, they know the ins and outs, all of this sort of thing. What can the subject [00:02:00] matter expert do while writing that document to ensure that the individuals who need to use that document every day have what they need, nothing they don't need, and in a way that is going to be easily and efficiently interpreted for them as they go?

What guidance do you give to, SMEs to, do that better?

Jose Mora: I'm glad you mentioned SMEs because in general terms, there are the product experts, they're the process experts, and the DMR is actually at the intersection of two of those. When it comes down to breaking down the modules into the individual components, that's the product expert. That person is gonna understand the product drawing, the product specs, the actual parts. They're going to, they will know that there is a [00:03:00] work instruction that corresponds to that.

Mike Kent: Okay.

Jose Mora: However, the author of that work instruction is not that product person. It's the manufacturing engineer who has actually been on the production floor and has fine tuned that process. So, there is a handoff there. The product expert knows enough to say this is something that requires the expertise of manufacturing engineering. 

Likewise, the inspection, the quality inspection procedure should be authored by the quality engineer or the quality control person. However, the product expert putting that module knows, hey, by the way, I need an inspection procedure here and I know that I can reference it, but that specific procedure should be the quality person.

So, that is really the arena that brings together the different functions. And you have to have one person that understands the overall structure. And that's [00:04:00] typically would be the design engineer.

Mike Kent: I think too often we get into a situation where, okay, I know the process, I know all these aspects, and I'm just gonna write it. And there's so much information that gets put into it. I have authors tell me all the time, well, they have to understand the background of where this process comes from or how it all fits into the overall scheme of things. And, you know, all this fluff. In a lean vernacular we would call that waste, right?

You talked about roles and responsibilities, purpose, scope, those sorts of things. I want to get into the practical nuts and bolts of how we write our procedures. If the operator is involved in how that procedure work instruction gets written, it occurs to me there's an opportunity for it to be very [00:05:00] practical, not a lot of waste, not a lot of fluff, not a lot of things that don't apply to whatever it is that they're doing. Why doesn't that happen? Should it happen? How can individuals make sure that happens if they're the subject matter expert that's writing that document?

Jose Mora: Well, why? The why it doesn't happen is because we don't get the right people involved at the right time.

Mike Kent: Okay.

Jose Mora: While that operator, when they sit down to do their work, they're focused on part A and part B. That person is a human being that goes home and balances budgets and takes, they do a lot of other things. There's nothing wrong with involving maybe a team of 'A operators' in the early stages when they were actually doing some pilot lines. Let them play around a little bit, give them some input so that way they, that team, that core team of operators understands the [00:06:00] bigger picture they are in a much better position to train the other people that come on board that line.

Mike Kent: Yes.

Jose Mora: And I'm glad, I'm so glad you mentioned pharma because even though my background is 80% medical device, I did have an opportunity to do a Lean transformation at a pharmaceutical plant.

Mike Kent: Okay.

Jose Mora: What happens in a pharmaceutical plant is you have these capsules of, you have these miniature clean rooms where you have somebody, one person dressed up in a space suit and they're doing capsules or, they're doing tablet presses. That person is totally detached from the rest of the world.

Mike Kent: Right.

Jose Mora: These people were located in different parts of the building. So the question is, well, how do I link that? So what I did is I ended up creating a card game. And I lifted each one of these processes and I said, okay, let's play a table game and show the flow [00:07:00] of the drug device all the way through.

Well, guess what I did? I invited the operators to that game and I said, play this game, tell me what I missed. They said, well, you left out this step, you left this out. So the operators were now very excited because it was an opportunity to play a game and they, they had input. 

There's nothing wrong with getting them involved as you're designing this. So that way when they do sit down to do that one operation, they're motivated. They, are now part of something bigger.

Mike Kent: Absolutely. Absolutely. 

Jose Mora: That's not a reason to put all this extraneous information in the document.

Mike Kent: Yeah, exactly. If the operator has to flip through a bunch of things that just aren't relevant to them, it becomes incredibly inefficient. And to your point earlier, we've got a huge opportunity for errors to take place, poor decisions to be [00:08:00] made based on assumptions or lack of information, of lack of clarity, all of these sorts of things.

So I'm a big proponent of getting those folks that are doing the work involved early and often through the process. If I'm engaged in that process early on, I'll have much better awareness, much better critical thinking, understand it at a level that's deeper, and I've provided my input into the process to say, this is what's gonna be critically important for me. This sort of information is not going to be critically important for me, so you can leave that out or put that someplace else. 

That gets us to the point where we're able to generate these lean documents that can be highly impactful and highly efficient.

If, we have the support structure in place to, to manage them effectively. Am I tying the, all the threads kind of together here a little [00:09:00] bit?

Jose Mora: You also touched on something that's very near and dear to my heart. Many people, when they're in the early stages of design, they're thinking design output, and in their minds, they're only thinking of the product design.

However, this is one of my pet peeves, when I look at the definition of 'design output', it is both process and product. So yes, when you get into design outputs, that should be a big red bell or red flag, it said, hey, time to bring in the manufacturing engineers and get them involved with the process side of design outputs.

Mike Kent: Right.

Jose Mora: See, and that too often that gets forgotten until it's time to write the device master record. And I've, I won't name names, but I've had people tell me, oh no, the device master record is not a design output. And if you look at the definition of design output, it says, includes the device master record. [00:10:00] So

Mike Kent: -- yeah --

Jose Mora: yes, it is the final design output when you're finished with your design control process and you're transferring. But there's nothing that says that you can't get started on it as soon as you start writing design outputs.

Mike Kent: Absolutely.

Jose Mora: There's all kinds of opportunities to do things, to start things at the right time in the process. And again, process guy again, let's do things in the right order, start at the right time, get the right people involved. And then at the time of design transfer, that should really be transactional. There shouldn't be any controversy. It should be a very seamless handoff.

Mike Kent: How do you know that this approach that you're taking to make your documents more lean and your processes by default more lean, how do you know that it's working? 

Jose Mora: Oh boy, that I'm, you, could, I could have almost asked you to ask me that question. I didn't. But this is there, I've actually written about this. There is the voice of non-Lean, the voices of non-Lean, and there's the voices of [00:11:00] Lean. The voices of non-Lean are saying, we don't have enough space. We don't have enough people. We need more resources, we need more documents, need more money. That's before Lean. 

After Lean is what do we do with all these extra people? What do we do with all this extra equipment? What do we do with all this space that we saved? And I hope people are, the management is, smart enough to know the answer is not to lay 'em off. The answer is that you now have resources that can be developing your next product and taking you further into the market and, helping to develop your processes.

But the language, how do I know? I know by the language they use. As soon as they're saying, oh, I we're, I'm overwhelmed, we need more people. That means the culture does not yet understand Lean. We need more space. They don't understand. So if you really are doing Lean, you just listen to how they're [00:12:00] talking and that's how you know if it's working.

Mike Kent: Okay. That sounds really, really simple, but at the same time, really impactful because we do hear a lot of those things. And applying these Lean principles that we're talking about, not only to documents, but to everything that we do, really can shift. And I, think your point's really well taken around what do we do with all these extra people, equipment, space, et cetera, and put them back in, invest those resources back into the what's next. 

I would also argue that has a double down effect in that these are individuals in the people side that already have this mindset, that already have the benefits of experience. That if they approach problems and situations with this mindset, there are going to be better outcomes.

One of the things that I also [00:13:00] don't wanna lose sight of is, we teed up an example that I think is gonna be really important to talk about. Documents that describe maybe a quality process. 

What are the challenges there with turning those documents into lean documents when you've got, say, four or five different unit operations, or four or five different individuals with different roles and different responsibilities involved in executing that process?

Jose Mora: So when I go to a typical company and what you're describing is the SOP level, and I call that the 'what'. That tells you what to do. Now, the SOP, the problem I run into everywhere is the SOP is a combination of why, what, and how to, and that's how you get into 50 page SOPs that are revisions, EF they're constantly gonna revise.

And then in my [00:14:00] inbox, I have to train on 20 documents and I start opening them up. Oh, we changed the job title of this person. It's the same person, the same job title in three different documents. So that's the only thing that's changed, but I'm training on that. 

So we're constantly updating non-value added information. I really don't care what the job title is. That's something that is an administrative thing. I need to understand the process. We're flooding people with training all the time when the changes are non-essential to the document. 

​

Jose Mora: So to answer your question, if I take that SOP, that it's a big combination of what, why and how to, the first thing is let's extract the 'why'. That belongs at a policy level, and this is a huge gap. People think that we jump from the Quality Policy, which is at the top of Mount Everest, and then all of a sudden go down to the ground [00:15:00] level. The Quality Policy is at a very, it's too high a level. We should have a policy for design controls, for process controls, for environmental. Those are overarching questions as to why are we doing this?

Okay. 

Now, when you get to the SOP level, that is where this is a what, okay? And that is where you say, these are the roles and responsibilities. This is the scope, this is what it covers, and you're describing, in different lists, these are the things that have to happen. You wanna know how to do any one of these, go to the work instruction. Okay? But what you're doing is you're listing the things, the deliverables, the things that have to happen. And that way everybody, that's where you see the roles and responsibilities. I don't like to repeat definitions either. I prefer to point to [00:16:00] the single glossary. Again, single source of truth. Now, if you absolutely have to use a definition, make sure that it's, point to the one in the glossary. So be very selective about that, if you absolutely have to use it. And make sure you're using the same definition as the standard or the FDA. That's embarrassing, when you have redefined what an acceptance criteria is, you've redefined what an OQ is. You're asking for trouble. You're making it easy for the auditor to find non-conformance.

Jose Mora: So, if you have a lean SOP, you're strictly talking about, here's what we're doing. This is a place to put a swim lane diagram of the process, show the handoffs. I keep hearing the devil hiding the details. I like to say the devil hides in the handoffs that were not completely clear.

Mike Kent: Absolutely. So what you're talking about, Jose, is really [00:17:00] taking a document hierarchy and using it intentionally based on the why, the what and the how to. 

And I can hear, and maybe it's just the frame of mind that I'm in right now, but I can hear people screaming, wait a second, I thought Lean was about less. And now what you're telling me is I've got one umbrella document for the process, and then I have three or four work instructions that seemingly I'm building complexity into the process.

And I see that you're laughing and chuckling, but I really wanna understand, how do we respond to and reassure those folks that see this as a numbers game. And there's some truth to that. Absolutely. We're talking about now managing five documents as opposed to one. But address those concerns that well, wait a second. You're [00:18:00] introducing complexity by adding documents. I thought we were reducing. 

What's the value there and what's the balance from a Lean perspective? 

Jose Mora: OK, so this is another good segue into how lean documents works because if you're listening to everything I'm saying is well break everything down into smaller pieces. And if that's all you're hearing is, well, I'm gonna end up with more documents. However, Lean the process, is a two stage process. In one process you are breaking things down, but the magic happens when you put things back together that are actually the same thing. And, there is where you get your real benefit.

In that example where we had the 28 documents, each one for a specific product, if you break apart the product and process, separate those, now you could argue, well, now I've got 56. Well, no. Now [00:19:00] you have 28 identical procedures that are identical. So guess what? That just became one procedure. 

Now, you might think that you have 28 document specific. Maybe you don't. Maybe you have a single drawing with a table that says these are all the parts and these are all the dimensions that are unique to that part. So I went from 28 documents to two.

Now, another example, I, in another part of my life, I was working in a company that broke up into manufacturing cells, to the point that each one had their own purchasing, their own procedures, they became their own little world. So it came time to write a division level process validation. And I had, I don't know how many, let's say I'm gonna pick a number. There were 15 different manufacturing cells. Each one had their own [00:20:00] process validation recipe. What I did is I went to each one of those, I extracted the topic of process validation. I left what else was there. Now I ended up with a large document, admittedly. It had over 40 pages, but the topic was here's how to do a process validation.

Mike Kent: Okay.

Jose Mora: Now you had one single source of truth, here is how you do process validation. And again, that would, as the SOP level, this is what process validation looks like as a process. So once you have that, then you might have work instruction here's how to do an IQ, OQ, PQ. But you've now taken the process validation segment out of all those other documents for the cells. 

So it's a two stage process. First, you have to break everything apart. And yes, you will end up with an explosion of different things. But when you put 'em back [00:21:00] together, I'm gonna say you're gonna end up with less documents and less, repetition, less confusion.

Mike Kent: Yeah, and it seems to me that when people get caught up in lean means less, that equates to a mathematical exercise, and we can't determine success based on, oh, now we have fewer documents. The true measure of success goes back to when I asked you, how do we know this is working? That true measure of success comes in we have everything that we need exactly where we need it.

The other thing that I want to come back to is the audit. If we're doing things to impress an auditor, we're losing sight of the real benefit of the 250 days a year that an individual is going to use this particular document. That's where I think the math comes in. 

Now, I'm not suggesting that audits aren't [00:22:00] important. They absolutely are. But I'm a big believer that if your process is working and if you have everything where you need from an operational standpoint put together, you don't have to worry about an audit. 

And all an audit does is come in and see if our day to day is introducing risk to our process, our product, or our patients, right, so, by spot checking.

Jose Mora: And that that brings back another flashback. I was in a very unfortunate situation. I won't mention names or anything or time. But there was a company that obviously was not doing things in the right order, and the FDA came in and they wrote 'em up for serious, serious process validation issues.

One observation process validation went through A to M in number of observations. It was horrible.

Mike Kent: Wow.

Jose Mora: So I go to a startup company and I'm like, well, I'm not gonna be that guy that's telling the FDA that everything's a mess. So I [00:23:00] used these Lean principles as I was starting to learn them, and I created a process validation, the whole thing. So I get there and the FDA shows up and I'm loaded for bear. I'm like, okay, this guy's, he's, I'm nervous. I hand him my document. He flips through it. It takes him about three nanoseconds to tell if you know what you're doing. And he smiled. Thank you. Let's go look at Doc Control. 

Mike Kent: Boom.

Jose Mora: I was ready for bear. I thought he was gonna rip me to shreds, and he knew that there wouldn't be much to find because I had everything laid out. Here's the master plan, here's the validation, SOP, work instruction. It didn't take 'em very long to realize, okay, they know what they're doing. let's go look somewhere else.

Mike Kent: Yeah, absolutely. And that's, the real benefit, right? 

[00:24:00] What can and should organizations do to get started with integrating these Lean principles into their document management processes? Where's the best place to start and who are the right people to get this ball rolling?

Jose Mora: You have to have the culture in place and there's no substitute for that. So you have to have a management team that truly believes in Lean and really wants to do the right thing. There's no substitute for that. The part of the culture is to want simplify by design. If,

Mike Kent: Okay.

Jose Mora: they are reactive, as they're in silos, you're not gonna get anywhere. So the management has to be open and there has to be a culture where people have at least a certain level of trust in each other. 

You also need to start training people on what Lean looks like, what flow looks like. [00:25:00] So the whole idea of focusing on flow is very important because if they don't understand a quality system process, a manufacturing process, they have to be able to visualize it. So, part of, and what you wanna do is you want to involve them in the, in this mapping. So you might take your existing process and it looks horrible, but map it. Map it so they can see what the mess that they're living in.

Mike Kent: And not the ideal, but the real life. You, mapped the real life process. Yeah.

Jose Mora: Let them vent and let 'em, okay, this is what you're dealing with. Now, you start asking questions. So if they are part of the solution of starting to map these, and you have to have a strong facilitator that knows where we're going. The minute that you give people a chance to vent and they understand that they are being heard, now they become part of the solution. Now they're on board with you. And now you involve [00:26:00] them. Just like that time I brought the operators to play that board game, there was purpose to that. I wanted them to be enthusiastic about it. So they say, hey, we're doing what I was part of. I had my input into this, and guess what? We're gonna do it. So now they own it. And that's an important part. 

The other thing is you have to align with the users. Who is the customer? Who is the one that has to, at the end of the process that's receiving all this and work backwards from there. I not only believe in design controls, I practice design controls. I don't care if I'm installing a washer disinfect system, for example.

I still wanna know what my customer wants. They want clean instruments, they want something that, and, then I work backwards from there. So the process, what does the customer want? They want the product to do this. What does the product want? They want the process to do this. What does the process want? They want the [00:27:00] equipment and facilities and the operators to do this. And if you follow that hierarchy, everything falls in place.

Mike Kent: So internal customers then are equally as valuable as the people who are doing the work. 

Having not only the operators who are gonna be performing the task involved in that process, but having the receivers of the output of that particular unit operation involved in that process.

You mentioned process mapping, getting all the, people together who are involved in that process, and then just asking, all right, this is what this unit operation is intended to do. It's going to go to this group over here. Hey, people in this group, what is it that you need from us, because we're gonna deliver this to you. What is it that you need of us so that we can make sure that we're successful? 

So you mentioned the handoffs and the swim lane diagram [00:28:00] earlier, right? That's where the devil is. So doing the same thing with that process mapping exercise, not just looking at the unit operations, but where those handoffs are and what the expectations are and what the needs are, can go a long way. Is that accurate?

Jose Mora: Absolutely. Absolutely. And it may be as simple as how they want the parts delivered. Maybe you have to take an extra step and break it down into something they can handle or maybe not. So, that's where the, how the quantity and shape and everything that, that makes the overall process flow better. 

In that pharma example on Lean transformation, one of my biggest gratification was I walked into this room, and there was these huge kettle drum bins that had been used to transport pharmaceutical material. There was a whole room full of those, and they were no longer [00:29:00] needed. They had been used to just move stuff around. After doing the Lean process, they didn't need those anymore.

Mike Kent: Okay.

Jose Mora: So, it's like, wow!

Mike Kent: Oh...

Jose Mora: What do I do?

Mike Kent: You can have go-kart races at your picnic. Yeah. 

Jose Mora: What do I do with that? What, do I do with this room? What, you

Mike Kent: exactly.

Jose Mora: I might as well sell them to somebody else. 

Mike Kent: And then with the room you could build a training facility, so you're operators. But that again, that's my own thing getting in the way. 

Let's, put a bow on this. And I guess my last question for you, Jose, is what resources are available to assist companies in starting this process and really beginning this transformation to adopting Lean principles into their, not just their document management processes, but overall?

Jose Mora: There are certainly many resources [00:30:00] out there to talk in generally about the process of Lean. There are many resources to talk about quality systems. Unfortunately, the idea of lean documents, there aren't that many resources currently available. I am. I've seen people adopt it, I've seen people get enthusiastic. I've had people... I show up at a, sometimes at a consulting assignment and I see somebody that hasn't seen me for 20 years. They say, oh, I still have that white book you wrote, white paper you wrote on lean documents and they've been practicing all along. So it is a different mindset. However, if you have been educated on Lean principles and you have understood Value Stream Mapping and you understand quality systems. You can probably come up with this on your own. Naturally I am delighted if I get the opportunity to coach some people and facilitate some of [00:31:00] this. But the resources are out there in different aspects. There aren't that many that bring it all together. That's where it's a very small niche, but it's very valuable. And, I'm hoping to see more people that embrace this and take it on.

Mike Kent: Yeah, absolutely. I want to let our listeners know that, that was somewhat of a loaded question for Jose, in that Jose has been kind enough to author a series of blogs that Medvacon has available on our website, and we'll provide the link to that and those specific blogs. And you can read about the application of Lean principles to all different types of environments, from document management to quality systems, to process optimization [00:32:00] to every aspect of the regulated life sciences industry. 

Jose, I want to take this opportunity to thank you for being a contributing author on those blogs with Medvacon. Certainly if individuals have a need and an interest in exploring this further, you can reach out to us here at Medvacon and we're happy to put you in touch with Jose, to assist you in getting started in this process.

And we're also happy to explore these Lean principles as they apply to different topics in future podcast episodes. So we wanna invite everyone to stay tuned for more information, more clarity, more suggestions, and good information with Jose. We are going to, if you are willing, to have you on. We'd love to have you on as often as we can to talk about this.

Because I think it's really important and a real tremendous [00:33:00] opportunity for organizations to not only streamline what they're doing, but also improve the effectiveness and reduce risk through the process.

Jose Mora: Well, that's asking me to do something that I love to do. So that's, a very easy sell. I am more than happy to talk about this. I love the topic and every time I'm talking about it, it triggers a flashback, it triggers other ideas. So this is actually very helpful because I am constantly working on developing more applications for Lean documents, more ideas, and I, it's really my, it's become my calling. I really enjoy this, so thank you. Thank you for the opportunity.

Mike Kent: I want to thank you very much for a tremendous conversation today, Jose. It's been our pleasure having you here on the Quality Grind Podcast. Thanks so much!

Jose Mora: Thank you, Mike. My pleasure. 

Joe Toscano: If Medvacon can help you and your organization, [00:34:00] 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.