Quality Grind Podcast

Applying Lean Principles to Controlled Documents - Part 1

• MEDVACON Life Sciences • Season 1 • Episode 19

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Welcome to the Quality Grind Podcast presented by Medvacon! Join Mike Kent and special guest Jose Mora as they dive deep into Lean principles and their application to controlled documents in regulated life science industries. Discover strategies to make documents more user-friendly and effective, and explore holistic approaches to optimizing workflows. 

With over 30 years of experience in manufacturing and quality systems, Jose shares his wealth of knowledge on minimizing waste, improving efficiency, and optimizing effectiveness. Tune in to learn how Lean principles can transform your document management and operational practices.

Contact MEDVACON:

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

Thanks for listening! Don't forget to follow us @medvacon on all platforms for updates on blogs and podcasts!

Ep 19 Applying Lean Principles to Controlled Documents, Part 1 - Jose Mora

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 with our special guest, Jose Mora. Jose is here to talk with us a little bit about Lean principles and specifically how those principles can be applied to the bane of our existence in regulated life sciences.

We all have procedures, we all have protocols, we all have documents that we use every day. And more often than not, we have a ton of challenges with those documents. So Jose is here to illuminate us on some [00:01:00] strategies that we can use in order to make those documents much more user friendly. Another buzzword that we love here,   

as well as much more effective and easier to manage overall. 

Jose Mora is a principal consultant specializing in manufacturing, engineering, and quality systems with over 30 years of experience in the medical device and life sciences industry. His expertise lies in manufacturing, process development, tooling and quality systems. Jose holds a bachelor's degree in Mechanical Technology from Purdue University.

Jose Mora, it's great to have you here on the Quality Grind Podcast. Welcome, sir.

Jose Mora: Thank you. Glad to be here. Glad to have the opportunity to talk about one of my favorite topics, if not my favorite topic.

Mike Kent: One of the things we want to be able to do is ensure that people who need to use those documents will actually want to use those [00:02:00] documents. So making them as accessible and user friendly and easy to use as possible is really key. And that's where I'm hoping your familiarity with Lean Principles and how they apply to controlled documents can really help us today. 

Why don't we start with having you tell us a little bit about you, how you got into regulated life sciences, and how you got to the point where you are today.

Jose Mora: So from from the very beginning, I've had a bit of an idealistic aspect to me. But I also, I guess I think of it as having my head in the clouds, but my feet on the ground. It's always been a struggle between my ideal and reality. And I always try to live up to the ideal, but understanding very much the fact, the facts around me. So when I, my career started with, I graduated and then [00:03:00] I wanted to do something that was gonna help humanity, obviously ideal, so that ruled out destructive things. I wanted to do constructive things. So my first thoughts were, it my, also, my first opportunities were either in the field of agriculture or something to do with health.

Those were, seemed pretty logical. My first job was in agricultural equipment and I ended up, because I had studied hydraulics, I learned about hydraulic systems and I ended up in a job designing hydraulic systems for hitches, but for tractor hitches. But I also learned a lot about datums and data and how important it is for things to be properly related. 

Fast forward through the next several decades, I went into medical devices, about a year and a half after my first job. And it was a plant that made surgical instruments, handheld. So I [00:04:00] had taken from the first job how important it is to have datums and how to have things properly dated. So I get into an environment where the whole shtick was about handcrafted instruments and the all these people, and I'm like, okay, wait a minute. You're gonna make an instrument, but where do you start if you're gonna make a pair of scissors? I would think the most important thing as the one common place was just a hole and everything. So I kind of, I immediately started applying the engineering and critical thinking no matter where I was. So at some point I started questioning Why are documents so complicated? are we repeating things so often? Why is it so difficult to communicate? After about half of my career, I came to a startup company and I had had plenty of experience on how the traditional ways. 

[00:05:00] But this startup company, they did something very strange. They, this was a small RD group and of course they were focused on the product. So they had 28 almost identical procedures, except the...

Mike Kent: Wow.

Jose Mora: ...only variant was the product specific parts. Now, from their point of view, that was fine. Okay, I'm gonna look at this product here, so that made perfect sense. But I was brought in to start set up manufacturing. And if I have a manufacturing process and I wanna make a change in a procedure, I don't wanna have to go and change 28 documents. I'll probably miss a couple, and next thing you know, I have a lot of confusion.

Mike Kent: Right.

Jose Mora: I started to say, wow, this is wrong. And then I say, wait a minute, they're onto something. There are pieces of that information that are product specific, the rest is process specific. And I started saying, well, why do we even mix those up? [00:06:00] As I went to set up the manufacturing. I, in a startup, you have to wear many hats. So I had to wear the hat of Purchasing, Receiving, stock boy, setting up the manufacturing line, validation. Sometimes I had to do shipping. One of the benefits of that is when you're wearing those hats, you get to visual, you get to witness every single part of the process.

Mike Kent: Right.

Jose Mora: I started thinking, okay, I'm an operator and I'm going to, I'm gonna do something. So imagine the typical work instruction. Okay, make sure you understand the purpose of why you're doing this. And I'm like, wait a minute. If I'm an operator, I hope by now I know why I'm doing this. The first time shouldn't be in those work instructions. The scope? Well, I hope I know what the scope is. When we get to the document, the real, the part that is really interesting to the operator is probably [00:07:00] section seven, where it's like, okay, pick up part A, pick up part B, and put 'em together, and so forth. So it is really about what the operator's doing. 

Now, I had, because I was wearing many hats, I had the opportunity to witness a process. So first of all, as a planner, if I'm gonna build this particular assembly, I am not asking the operator to find the right document. I hopefully know what is the correct work instruction, what are the parts, what are the components, what are the records that I'm gonna need, and I'm gonna ask the people to set up that production line. So that belongs somewhere else. That information is really, if you think of a regulation that's, here's what you have to do. Here's the objective evidence that you did it. The Device History Record is the objective evidence that you did it. But what feeds into the Device History Record is the Device Master Record. If you're building an assembly, you're taking a subset, you're taking [00:08:00] part of the BOM, not just a BOM of the components, the BOM of the documents that you're gonna need to build that subassembly. So that is the document that is the one that contains all that other information, which in includes, by the way, you need these work instructions to do this. The evidence of that is its mirror image, which says, Hey, here's the evidence that I did what this said. So,

Mike Kent: Right.

Jose Mora: I am the planner, I am using that section of the Device Master Record to set up that line, the shop floor paperwork, all the tools, equipment. That is where that process happens. So they, if you ask a question, well, how do I know I have the right document? Well, hopefully the planner and the person setting up the production line already had those in front. 

Okay. 

The operator's not gonna sit down and then go looking for a document, go looking for a tool, go look for the operator should be sitting down and ready to work. [00:09:00] Now the work instruction kicks in. 

Jose Mora: And that's where it's, now what do you need? First of all, you need a unique identifier, the document number, you need the document title, but that's it. The next step should be pick up part A and part B and put 'em together. So it's a very, it's a very different way of thinking.

Mike Kent: It sounds like it. And there's an awful lot there in that overview. But I think that the take home lessons for me is really, there's an increased focus on not just having the information somewhere, but where's the best place for that information to be. And what I hear you saying is there are options.

Really, how do we structure those documents? How do we write those documents in order to achieve those specific outcomes will be something that we'll want to take a look at. 

So really what we're talking about is a holistic approach [00:10:00] throughout the document lifecycle, from the time that a task is identified as needing to be done, we need a procedure or some set of instructions that tells the person who is going to perform that specific task, how to do that, the sequence of steps, the expectations. And then eventually the process is going to change. We're gonna find opportunities for improvement. We're going to find things that need to be adjusted, tweaked, changed, et cetera. How do we manage those changes? 

So in terms of that life cycle, how can we use Lean principles to really write our documents better? And then how do we manage those control documents more effectively through their life cycle? 

It occurs to me that we've started talking about Lean principles and teed this up, but we haven't at this point gone in and really described what Lean principles are. 

Jose Mora: [00:11:00] So Lean has, it's usually attributed to the Toyota production system in Japan.

Mike Kent: Mm-hmm.

Jose Mora: I'm sure that the principles probably go back to the ancient Greeks. But at that point in time, Toyota, World War II had just finished and Toyota could not afford to have to waste a lot of resources. So Lean really was about the elimination of waste.

And waste comes from defective product, excess inventory, excess motion, overproduction, processing waste. So they identified this seven forms of Lean, but in the context of a manufacturing plant to make cars, okay, that was the context. 

The thing is, I've practiced Lean in the manufacturing context and many times what happens is, well, my manufacturing process is Lean, but I'm [00:12:00] waiting for this document. And I have to wait because this quality system process is, takes too long.

So unfortunately that becomes an excuse for, well, since the quality system process takes so long, let's do these big batches of product. All of a sudden we just undid all the work that we had on Lean, because now we're trying to accommodate the inefficiencies of the quality system process.

Mike Kent: Okay.

Jose Mora: I'm a manufacturing engineer, my heart is in processes. So in the second half of my career when I started getting into quality systems, I'm like, wait a minute, this process is broken. The process of identifying the need for a document and then making that document available to somebody, that's a different set.

So there are actually two forms of waste. There's waste in the document itself, which causes people to do a lot of reading and unnecessary, there's a lot of information that's going along for the [00:13:00] ride. But there's also the process of creating documents, and that's the hidden part because unfortunately, in labor based cost accounting, we're only concerned about what the operators are doing and everything else is in this cloud called 'Overhead'.

Mike Kent: Overhead.

Jose Mora: The real waste happens in the creation of documents. So we have the document errors, we have the document handling time, the amount of work we do, the actual processing, the fact that we have too many documents. 

So in one of my many career situations, I saw a Document Control department getting a, recognized oh, wow, they've really made everything lean. Well, what they really did is they shifted all the responsibilities to everybody else. So basically all they had to do was rubber stamp the document, look how efficient I am. Well, it wasn't so efficient for the design engineer, for the procurement people.

So all they did is they created what's called a local optimum. But what they did is they shifted everything. So the [00:14:00] overall efficiency of the document process was not only not helped, it was actually hindered.

Mike Kent: Oh boy. Okay.

Jose Mora: Too often, a company's management rewards local optimums without understanding what it does to the entire process.

Mike Kent: Sure.

Jose Mora: And...

Mike Kent: So if four or five other people...

Jose Mora: Right?

Mike Kent: Yeah, it...

Jose Mora: When we look at quality systems, we have to look at the quality system processes, and there are many. There's the design control process. There is the process of creating and updating documents. There's the CAPA process. So in my mind, every one of these is fair game for the same Lean principles that I applied on the production floor. So that's, yeah really where it came from.

Mike Kent: Okay. And so when you talk about waste, I think it's important to reemphasize that it's not just about scrap or about excess [00:15:00] material, what we're talking about and what really gets to, you know, efficiency and effectiveness. And let's face it, job satisfaction, right? If it's difficult to do, if it takes a long time or there's so many steps in the process, or there's so much information that I have to sift through to understand what's important to me in my job right now, in this minute,

Jose Mora: Right.

Mike Kent: ...all of that is waste.

And we can get, we can have a focus on being faster which is what we typically refer to as efficiency. We can take this process that used to take a week and now it takes two days. Well, that's great, but at the same time, there may still be opportunities in that two day process that are unnecessary or not value added or, you know, any of those [00:16:00] adjectives.

So I get your point that you're making with the example of the Document Control group made their jobs a lot easier. They take something, stamp it as approved, a batch record, for example, or a device record and, "Oh yeah, we print this out, we sign it, and then we send it off. Look, we can do that in four minutes, so don't blame us for the operator not having the device record when they need it," right? But everything else around that is still full of opportunities. 

In addition to eliminating waste and focusing on efficiency, which again is largely a time-based descriptor, what are some of the other benefits of taking a Lean approach to how we write, use and manage our documents?

Jose Mora: Well, first of all, it, by having what I call a single, well, not just what I call, a [00:17:00] single source of truth. By the very act of not repeating information, you minimize a source of error, because

Mike Kent: -- okay --

Jose Mora: you repeat something, you may repeat it perfectly a first time, but when somebody updates it, they might forget to find all the other place it was repeated. So now you've got discordant information in your quality system.

But also if you have the, if you understand a clean, consistent structure, you're gonna be more better prepared for audits because it, you are able to present a coherent story. And if you have a very structured approach, and I'll talk a little bit about the structure a little bit later, but it's, it actually helps you. And the problem is we try to make things for audit at the expense of the operator and everything else we do. that's a...

Mike Kent: No, that never, that never happens. Wow. I've never seen that, ever.[00:18:00] 

Jose Mora: I know...

Mike Kent: The sarcasm is just, oh, you, you struck a nerve, Jose. Yeah, we've...

Jose Mora: You know, we do everything for the auditor and we give the auditor a...

Mike Kent: -- whew --

Jose Mora: ...mine of opportunities to find the heirs and we are very efficient at creating those errors.

Mike Kent: Absolutely.

Jose Mora: But it's a false choice because if you have a coherent story to tell, then the auditor can start as to ask, why are we doing this? That's the policy. What are we doing? Those are the SOPs and how to do it or the work instructions.

Mike Kent: Mm-hmm.

Jose Mora: Right off the bat, you are, by putting the correct structure, you're avoiding that repetition. Guess what? You also have increased efficiency and productivity because now people can focus on the document is actually meaningful to them. They're not dealing with a lot of extraneous information. Even more importantly, you have, you avoid the risk of somebody doing a job they're not qualified to do, [00:19:00] and that

Mike Kent: -- Right --

Jose Mora: is very risky.

Mike Kent: -- Right 

Jose Mora: You have this agility in design and manufacturing. In that example I gave of the R&D engineers, well, if they're developing a new product, it's easier for them to just change the product design part without having to update all those procedures. And then, the process might be almost identical. So now, it's much easier to make both manufacturing improvements and the product design improvements. Instead of your resources wasting their time with this non-value added activity, they're actually able to get right on and do their jobs. 

Mike Kent: But isn't there value there if, if I may, if isn't there? Didn't we just make the case for writing that 29th version of the same process [00:20:00] document for the 29th product? 

Jose Mora: Yes.

Mike Kent: In that case, I can see the logic, and I think it's important to state what might be obvious, but yet needs to be said. These are opportunities to improve. It's not that we're going about and doing things wrong or that our logic is flawed. There are often very good reasons for why, for example, an individual would say yes. Having a product specific document for this process makes a lot of sense because I've got everything I need for product X in one spot. I don't have to worry about sifting through a bunch of stuff for products A, B, C, and Y and Z to try and get at Product X.

So I just wanted to reemphasize for folks that we're not telling you if you have these systems in place, or are using this logic, that it's flawed. [00:21:00] We want to pose a different way of thinking about things that may be better in a lot of different ways.

Jose Mora: And you, whenever you're talking, you're triggering a lot of flashbacks at different points in my career. 

Mike Kent: I'll bet, I'll bet....

Jose Mora: You said, well, this new piece of equipment. Well, this takes me back to when I was running a maintenance department in a campus of nine buildings. My dispatcher would get a call and say, can you send a mechanic out to fix a regurgitating confabulator? And I'm like, the what? Oh yeah, it was just installed. Well, how come, why am I finding out right now? 

So it really got me thinking about where in the process was the right place for the maintenance department to find out that this equipment was being put there. And obviously it's not when the equipment breaks down. So, I started looking at another quality system process, which has to do with process validation. The correct

Mike Kent: -- okay --

Jose Mora: time is when you're ordering the equipment and you're writing the [00:22:00] installation qualification protocol, not when you're getting ready to install. That's the time to say, "Hey, Maintenance, do you have the spare parts?" So everything, one consistent theme is doing things at the right point in the process, as opposed to waiting until the last minute. 

And if you look at almost every company I've been in, there's a monster change control form with 50 questions, and everybody and its uncle has to sign off because it touches every function in the plant. The question is, why do we, at the very 11th hour, you're asking all these questions? Well, these are questions that should have been answered much earlier in the process.

Mike Kent: Mm-hmm.

Jose Mora: And because those signals weren't there, at the very 11th hour, and this is when the management is saying, Hey, we gotta get this product out the door. We're gonna miss a convention, we're gonna miss a release. And all of a sudden [00:23:00] everybody's asking these questions that had never been asked before, you're scrambling. So nobody is happy with that situation. 

So, so it's really important. It's not so much about how fast you work or how efficiently, but if you do things in the right sequence, you're gonna work at a much more relaxed pace and you have time to, to really think through. 

Mike Kent: And that's really where that process mindset comes from and is valuable. Because if we can think about things a little bit more holistically and preemptively, and ask more questions upfront during the early process, and making sure that the initial parts of whatever process you're going through are rigorous and all the right people are involved at the right stage, can save you time, energy, and headaches later on when when crunch time happens.

Am I hearing that correctly?

Jose Mora: Yes. Yes, [00:24:00] absolutely.

Mike Kent: So getting back to writing those documents. Let's take the example first of you have an operating procedure, like a batch record that's utilized by an operator or a technician that is out on the manufacturing floor. And then maybe our second example could be a procedure that is much more cross-functionally related. 

But from a single point of use, an operator is going to use a work instruction, for example, to assemble or do their part of the assembly process of a medical device. What should that document look like? What are some questions that authors should be asking themselves, and how can they make sure that when they're writing that document, it's as effective, efficient, and lean as possible [00:25:00] so that the operator gets everything they need and nothing they don't?

Jose Mora: So if that brings up a good point. So when you're talking about a single user, one of the things that does not belong in there is 'Roles and Responsibilities'. Because by the time that operator sits down, the roles and responsibilities have been defined. And it is that operator's role, it's understood that their role is to assemble that part. So we can skip the Roles and Responsibility section, also.

 The operator is doing that job, but one of the things, we don't want to just start blindly assembling parts. One of my favorite phrases in the regulation is, 'shall contain or refer to...'. And the operator, it's okay to ask the question, do you have the Device Master Record? Do you have the proper documents in front of you? You don't have to say what it is, but do you have 'em? Is it [00:26:00] there? Does everything match? Do you have the tools? Yes. Yes. Yes. Okay. Okay. Now, pick up part A, pick up part B, and so forth. So, it's okay to ask a few questions. What you don't want to do is fill that up with a whole bunch of cross references that are already handled somewhere else. So if it's --okay-- prompting you to make sure you have your Device Master Record portion, and this is another point, many companies think of the Device Master Record as a 50 page document. The regulations: shall contain or refer to. So there's nothing wrong with breaking your Device Master Record up into a BOM structure where you are focusing on the part that you're assembling, but not only the part, but also what you need for it.

Mike Kent: Okay.

Jose Mora: And there's many different ways to mix information up. 

Mike Kent: Yeah. It occurred, it occurs to me that now you, are you suggesting [00:27:00] that perhaps that 50 page document, that 50 page batch record or Device Master Record gets broken up into, let's say 10 segments, and each segment is five pages, but it's specific to a unit operation. How would you respond to, "Well, Jose, you've just taken, you've just increased the need for me as a document control manager to manage 10 different documents as opposed to one." How does that fit in with this concept of making things lean?

Jose Mora: So you are going to create those documents anyway because you're, you have to account for all those parts in different places.

Mike Kent: Right?

Jose Mora: What I'm suggesting is there's an overarching Device Master Record that has the high level assembly, just like you would in a BOM, and then it's [00:28:00] gonna refer to lower levels. 

Mike Kent: Okay.

Jose Mora: When you're focusing on a particular assembly, you not only have the information on the part, but you also know who the supplier is. So now this becomes a unit of, unit of information that has exactly what you need to manage that particular subassembly.

Mike Kent: Okay, so a unit operation. Each unit operation has its own chunk. And to your point, you're putting 50 pages worth of a document together anyway.

Jose Mora: Right.

Mike Kent: Whether it's ten 5-page segments, or it's a 50 page, you know, you're still creating 50 pages. And I guess we could say, well, maybe you make each one of those segments four pages because you don't have a lot of redundant information. Walk us through the value of really having those unit operations captured in their [00:29:00] own independent, yet related and referred to, uh, chunk, if you will, if that's the way to think about it.

Jose Mora: So one of the things that comes to mind is, well, for that I'm gonna need a database so that I can manage all these things. And unfortunately, when I talk about lean documents, people are already looking for a software solution and I'm telling 'em no. I've configured software and if you have a paper system that is convoluted, the software is gonna make that convoluted system work very efficiently at creating a lot of mess. So you are actually helping yourself to prepare for future software by organizing these documents. 

This manifests itself in many sections. I mentioned that one of the hats I wore was going into the stockroom and picking my parts. Now, most people have a functional mindset. So it's like, okay, all the plates, I'm gonna put them in this part of the [00:30:00] stockroom. All the nuts are gonna go here, all the bolts here and all the other washers. Well, you have four sections of the stockroom, and yet you're gonna set, you're gonna pick the parts for just one assembly. You're gonna spend 30 minutes walking all over the stockroom. So maybe the answer isn't to have that functional mindset. Maybe the answer is in your stock room, you have all the components stocked for that assembly in one place, and then you...

Mike Kent: I just had a flashback to Legos and the individual, and the individual packets...

Jose Mora: That's...

Mike Kent: Wow. Okay. Yeah, absolutely.

Jose Mora: That's one of the things I did in my startup. I rearranged a stock room. So everything, you're gonna set up this part, well guess what? Everything's right there. So now you took 30 minutes and now it takes five minutes to get the batch information, the lot information to make that lot, so that mindset [00:31:00] helps you throughout your process.

It helps you in line clearance, it helps you in document management. But the problem is not software. The problem is that you have to rewire the thinking process that has been drilled into you for decades.

Mike Kent: Right, right. If I pick up that package, that kit, and I take it back to my workstation. At that point, I can verify that I have each one of these parts according to a diagram. That individual bolt or plate or nut or whatever, circuit board, whatever it happens to be, may not have the identifier on it. Or maybe it does, maybe it has a tag on it or something along those lines. But, I'm anticipating the questions that come up in terms of how we've traditionally managed components and the identification of

Jose Mora: -- Yeah --

Mike Kent: components trying to prevent [00:32:00] mix ups. What if the stockroom technician mixes up and puts the wrong bolt into this kit, how is the operator going to know? All of these questions that come up. I imagine that there's a way to do that even in your Lean document for that unit operation. 

Just real quickly, how would you address that particular concern to avoid those mix ups?

Jose Mora: First of all, what is the chance of a stock person picking the wrong bolt? you have wall of kits, of with different types of bolts, and you're saying, oh, pick up this one, and they got interrupted and they picked up the wrong one, that's a mistake right there. However, if you had everything in the stock room already organized by only the bolts that go with that kit, there's very little chance that [00:33:00] he's gonna go and walk and pick a bolt for another kit. So right there at the stockroom level, you already eliminated a potential source of error.

Mike Kent: So you're not necessarily eliminating the organization of the stockroom, you're building two layers of organization into your stockroom. One is the identification and segregation of each individual component, and then the collation of the kit or the, putting together the kit in the Ziploc bag so that the operator or whoever is pulling that kit for that unit operation doesn't have to do the sifting through the bins at that one point, right? They're all there and they're segregated, but the thing that gets grabbed for the unit operation is the one kit that's already been verified by a second individual to contain all of the right things. 

Jose Mora: The [00:34:00] operator can then do a quick check based on diagrams in the unit operation document - lean document - they have and say, yep, I've got this, I've got this, I've got this, I've got that. Maybe it's to scale. All those sorts of things, you know, to verify all the Lego pieces are there, if you will. 

If you're talking about nuts and bolts, there's always a risk somewhere that the wrong one is gonna get attached to the wrong label.

Mike Kent: Mm-hmm.

Jose Mora: It depends on the criticality, and it depends on your tolerance for risk. So if you have those, and... 

I want to correct one thing. I am not putting two layers of organization in my stock room. I am reorganizing along kits. I am no longer concerned about the nuts here, the bolts here and the, and the, all the other stuff. 

If you think about the way Amazon, Amazon tried to organize its [00:35:00] warehouses by, by things, and they finally got, they finally created this generic bin, and the robots, they just go and pick up random parts. It no longer matters. That's something I've read about. I haven't experienced it, but the whole mindset is, you know what, it's just a location. You go to this location and pick up this part.

Mike Kent: Yeah.

Jose Mora: In reality, that location now becomes the location of the kit.

Mike Kent: Okay.

Jose Mora: And by default, the unit, the parts that belong there are in, in that location.

Mike Kent: Okay.

Jose Mora: So now the operator, if it's a really critical part, yeah, you probably want to have the part in a Ziploc bag with a label. Or you want to have something that makes it very difficult to misidentify it.

Mike Kent: Mm-hmm.

Jose Mora: I would say depending on the criticality, you might want to do just that. So that would be, you know, a second [00:36:00] line of defense to have it in a either label or something on the part, and then the operator can verify it. So, -- okay -- so there's many different things. 

In that scenario, we actually found something else. We were working in a clean room and instead of passing the parts through the clean room wall, we actually ended up setting small shelves inside the clean room with the kits already there. So the line clearance, as soon as we're finished, we already had the kit and we're setting up for the next line.

Once you start thinking in terms of Lean, everything lines up in a process. Then you had a dual Kanban system where here's kit A, kit there, kit one, kit two, the same parts. 

As soon as that one's empty, that sends a signal to the stockroom to replace that one while the production line is consuming the first one. So you're setting up a system of signals. 

Mike Kent: Which can [00:37:00] reduce error and improve efficiency, as well, if you have that. And I realized we got into a lot of lean processes and things along those lines. It's all related... 

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 discussion, Jose offers even more tips for writing lien documents and optimizing workflows. We'll also talk about some clever ways to determine if your efforts to go [00:38:00] lean are working to make a real difference out on the floor.

So join us for that and more, next time, here on the Grind.

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.