Inspection Ready: A Proactive Approach to Compliance

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Tara Holwegner: Hello Get Smartr listeners. Today, we are coming at you live from Life Cycle Engineering’s corporate headquarters in Charleston, South Carolina. So with me today, I got a very special episode for you. We are gonna bring.

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Tara Holwegner: Two topics that we frequently discussed on this podcast together. We’re gonna talk about reliable operations. We’re gonna talk about workforce readiness, and we are gonna talk about what that means for.

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Tara Holwegner: Inspection readiness. Now, inspection readiness is something that is very important and very typical for highly regulated. Technical operations. And I’ve got a guest today with me, Mister Greg Walker. He is a managing principal at Life Cycle Engineering. Greg has a.

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Tara Holwegner: Very deep level of experience with the pharmaceutical and life sciences industry, so he was twenty years as a global leader at Pfizer, and thirty years of industry experience with a focus on high performance teams and improving reliability, improving outputs. Uptime, compliance and really working with those technical highly regulated environments. So thank you Greg, for joining me on the podcast today.

4:00
Greg Walker: No, it’s great to be here. Thanks for having me and I think Tara just to round out, like you said regulated industry, so a lot of people think inspection readiness, we’re gonna go into detail on that, but it really covers when you, if you think about it, it’s pharma, it’s biologicals, it’s mining, it’s food and beverage, so, so if you look at this and and say, hey, listen, I, I don’t have that.

Greg Walker: If you’re regulated, it could be nuclear. I mean there’s gonna be the same things that we’re gonna talk about. So it translates really to many industries what we haven’t covered today. So hopefully get some some input from it also thanks for that.

Tara Holwegner: The industry. So pick up your ears, listeners because we could be talking about you and your operations and something that can help. So let’s let’s discuss this a little bit more, you know, what does inspection readiness mean, Greg?

5:00
Tara Holwegner: What does it really mean?

Greg Walker: I think if you asked me that question, as you mentioned, like thirty years ago, my first my first response would have been it’s, hey, let’s make sure our mechanical rooms are cleaned. No, no leaks out there, no random spare parts let’s make sure that we basically have the paperwork that the agency wants to come in and see.

Greg Walker: Right. And so it was kind of really asset focused.

Greg Walker: You know, same like my earlier days, as I went through and learned more, some things through inspections where I went, oh, that’s a good question. Or just working with really other SMEs account that it’s a much broader perspective then. It’s a really holistic program looking at how do you show that you have a state of control in your engine.

Greg Walker: And operations, you know, space? How do you prove that? And again, we’re gonna go through a little bit later on a lot of different puzzle pieces of that. So it’s bigger than the classic or the assets running well. It’s more about that integrated program that you really want to make sure that you have that state of control and you’re confident you’re delivering right products to your patients and really helping to go forward.

Greg Walker: And, you know, supporting, everybody that’s part of this connected programmer, but we’ll cover that a little more as we go through, ok?

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Tara Holwegner: So this doesn’t sound like something that you could just, you know, when the FD FDA or the joint commission knocks on your door, it doesn’t sound like it’s something that you could just magically make appear.

Greg Walker: You might, you might survive the inspection.

Greg Walker: I think I guess it’s one of those things that we do find, and again, you know, part of my previous experience, we had forty sites across the globe and they were all at different levels of maturity. We did want to get a standardized methodology on how you doing that. So the first thing is inspection rate is, is not a project. It’s not like, hey, you know, they, the inspector.

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Tara Holwegner: That makes sense. And it’s interesting because I think a lot of folks think, “Inspection readiness? Oh, that’s just a paper exercise.” But you’re saying it’s really a mindset and a cultural approach to operations.

Greg Walker: Exactly. And you know, when you implement that culture, you’ll see benefits beyond inspections—fewer deviations, faster issue resolution, and overall improved reliability in operations. It’s a holistic win.

8:00
Tara Holwegner: So how do you start that culture? I imagine it’s not as simple as telling teams to be “inspection ready.”

Greg Walker: Right. You have to start at the leadership level. Leaders need to model the behaviors they want to see. That includes documentation, following procedures, preventive maintenance, and ensuring all teams understand their role in maintaining control.
Greg Walker: Then you cascade it down through training, coaching, and standard work practices that everyone adheres to every day.

9:00
Tara Holwegner: Got it. And it sounds like it ties into reliability as well. If your operations are reliable and your processes are controlled, inspection readiness almost naturally follows.

Greg Walker: Exactly. Reliability is the backbone. If your assets aren’t reliable, if processes are inconsistent, you’re always going to be chasing issues. Inspection readiness then becomes a constant scramble rather than a continuous state.

10:00

Tara Holwegner: But not turning the inspection from an idea of a burden to be scared of into. Making sure that you’re as ready as you can. We are ready for this and then using it instead as an opportunity for continuous improvement. And in seeing it as a learning, you know, instead of a, a slap on the wrist, if you will. So why do you think so many organizations. Fall into that trap of looking at being ready for an inspection as a project? I was like oh we screwed up on this last time. Let’s make sure that that little piece of it is fixed. Or not you were talking about this culture aspect, this mindset of inspection readiness. Why do you think so many organizations fall in the trap. Of that looking at it as a project?

Greg Walker: I think again what we see is it’s an integrated process. It’s an integrated program to really want there, so my thought would be is that you may have a couple stars, maybe, maybe engineering and quality or working very well together, for instance, and you got that strength there, but you want to bring in operations. You want to bring in validation, you want to bring those different groups. So it’s not that they’re not focused on, on we’ll say the right things. They might be focused on a subset, but when you really start to broaden that out and say, hey, listen, let’s make this an integrated approach. Let’s make this part of really our goals. I mean come from site leadership to the shop floor should be part of that. Again, the expectation is that we’re inspection rate. So I think that’s probably the step change that you want to do from, you know, maybe focused on bits and just correcting things that come up to let’s step back and let’s look at, you know, where there are some potential opportunities we can improve.

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Tara Holwegner: I want to talk about. Indications. If, if, if folks may not be self aware that they are not continuously inspection ready, they are, they are reactive to the results of the inspection to fix whatever symptom, if you will. Right. So what are some red flags.
A plant may not be or a site may not be inspection ready, even if the equipment seems to be running just fine, you know, work is getting done, what are some. Signs or symptoms or issues that you could share with our listeners.

Greg Walker: That’s a great question. A lot of examples going to give first of all, the best way to say it I got caught.

Tara Holwegner: Oh, no.

Greg Walker: So in this sense another thing bad, it wasn’t say we were doing things illegally or anything, but a weakness that I wasn’t aware of. So the first one that popped to my mind is your computerized maintenance management system. Okay, so your CMMS, sometimes it’s, you got equipment and then you might have blue mountain or something like that for your calibration, but that particular program. I had inherited I again, hey I got a great promotion, this is fantastic. You now own the CMMS system for the company, that’s fantastic. One of the things that they that got tripped up on, and this is kind of one of those red flags cause I go back to Are you in a state of control? We talked about that a little bit earlier, right? So one of the basic questions was, you know, do you have a list of all the people that currently have access to the CMS system?

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Greg Walker: I’m good I can print that. No problem. Are all those users supposed to be in the system? Oh, what, what do you mean? Well, has somebody maybe I left the company? Right. But they’re still in the system. Has somebody moved to into a different area? Maybe they went from engineering into operations that they don’t use the CMMS anymore. So there’s a lot of changes. That can occur in who has access to that database. Now keep in mind the database is critical, right? We use that to say this is how we run our programs. It’s our one source of truth. It’s ultimately it keeps our history, you know, even if you’re doing paper based, you still use that for scheduling your work orders, your bill of materials, what. What you’re doing on the jobs. That’s, that’s your, your information set there, right? So, the, the, the state of control question is, do you know who’s currently in your system? And are they supposed to still have access to that? And that was one to be very transparent, that one caught me up because we had probably again it was a large site we probably had about seven hundred users in the CMMS system, but when we cleaned it up, there was really supposed to be only about four and fifty because people had moved to different locations, people left the company.

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Greg Walker: There’s no trigger, at least at the time when I was doing it between say the HR system and promotions or people leaving and things like that to notify. That system admin basically that these people are no longer here. So that’s where you proactively have to set up a program. So that’s an example of a, a red flag because your core system that runs your program, you’ve got people in there that shouldn’t be in there anymore. They’re not authorized, but they’re still in there, so.

Tara Holwegner: Prioritized.

Greg Walker: Are you really in a state of control? And I was like, oh, great question.

Tara Holwegner: That’s cybersecurity issue too, but, but you, you know, you had to bring people, together. To be able to make that link, right? Different functional areas had to work together to make that new process. Which I think is, is another, is another learning. Well, so let’s talk about that. Let’s talk about. So it sounds like being in a state of control, in a state of, inspection readiness. Isn’t only about the maintenance and operations. I mean, how can. 14 min

Greg Walker: I think everybody the first thing that came to mind is a hasssle free day.

Tara Holwegner: Yeah, a better, a better work environment, right?

Greg Walker: So, there’s, there’s always a certain amount of stress when you get an agency in, you know, looking at things and again it might be a new product releasing, it might be their annual visit along those lines. It might be a state run agency inspection. So I think that always puts people a little bit anxious, you know, cause you know, they, they, we know what we know, but we don’t know what they.
Maybe asking so that there’s a little nerves there. So I think the first thing that happened a strong program in place is it takes away some of that stress, ok? If you’re, if you know your inspection readiness program is there, it’s part of your culture, you, you got a little more confidence, ok? You’re definitely gonna come in with a different lens saying, Oh my goodness, the inspectors are here to like.
They’re here I’m pretty sure we’re good. But you know, let’s let’s let’s just kind of see where the, what they, what they want to know. Again, it’s it’s not that they’re the enemy, it’s more about they’re trying to make sure that we’re really doing the right thing for our products and our patients out there, right? So I think when you look at probably the the most critical people are really.

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Greg Walker: The operators and the technicians cause they’re closest to the product, right? And one of the things they’d love to see is that partnership between the two of those, we often talk about, you know, operators know how to operate the equipment and technicians know how the equipment operates, ok? So if we can get that cross pollination.
That’s really gonna help us here. And, one of the ones that just came up with me that kind of drove his home was during one of our inspections, we had the agency out, they were looking at, you know, the operations and, you know, a lot of times they’re looking through the glass or something like that and make a long story short. The inspector said, hey, what’s that blinking light over there? Okay. And what was kind of funny was the person that was touring them around, you know, did one of these things like, you know, like, oh my God like what lady are you talking about went up over there? And, you know, we basically the person, you know, we, we had instructed everybody do well listening, you always tell the truth, if you don’t know.
To say I’m not sure, but then escalate it to your supervisor, ok? So this was a an operator that we had asked the question to. He brought out his supervisor and they went through the whole thing and they said, hey, you know, what, what’s that blinking light over there? And he did the same thing. I was like.
I don’t know. Right. So this is almost like the at the keystone cops or something like that. So it happened about three or four times. I mean they brought in, you know, process engineer. Nobody knew what this blinking leg was. Okay, and so, you know, they’re now you’re, are we in a state of control, right? We keep going back to that. The, the inspector moved on and then basically.

16:00

Greg Walker: Behind the scenes, you had a whole storm of people trying to figure out what this planet light was. And what they found out it was, it was like a flow alarm that wasn’t related to direct product, we’ll say contact or anything along those lines. So it was a a non critical alarm, but still nobody knew about what it was.

Tara Holwegner: And it was still an alarm that something was obviously out of, out of tolerances.

Greg Walker: Think about going back to the agency now and saying, hey, listen, we, we weren’t sure what it was, but we looked through all the prints, we figured out what that alarm was. And now basically it’s this. I don’t know if they’re gonna have that confidence, right? They’re gonna be able to say, oh, you didn’t know what your alarm was, now you’re tell me it’s not an important alarm. Is that really gonna work out? So as.

As they say, I told you that story to go back to the point, if we can get operations and, and, and engineering working together. Not only to say, hey, listen, I, I I run the process, but to notice something different to say, hey, listen, that hasn’t been there before. Start that partnership to say, ok, we not only operate, but we know how it operates.

That’s the key thing there I think when you look at the roles, so again, if we can build off those strengths, we get a stronger team and really helps us for success there.

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Tara Holwegner: I love that and I kind of wanna talk about the inspectors for a moment. I I bet if, could you imagine if you’re an inspector and you know that every plant you go to, people are afraid of you, and they’re stressed about you. And I think maybe, and I don’t know.

In your experience, you know, if you, if you have that culture of inspection readiness, you have that confidence, then maybe you can.

Instead of the fear factor, like we said, turn that into, ok, we’re ready for this, but maybe we’re gonna learn something and either that or we’re gonna impress the crap out of this. Inspector, who has a valid job and is there for a reason? You know, so I don’t know.

Greg Walker: Mindset. No, You’re different mindset. And, I think I mean this this is this is deep down and but you know, the other thing is you’re, you’re not alone. I think that’s the other key thing is so if you don’t know the answer, you say you don’t answer, but there’s probably somebody who does. Yeah. So knowing that you have a broader team to back you up is key.

Anytime we go in and talk to the, the inspectors, there was always two people, right? Don’t send one person in alone because if they start getting nervous and they start, you know, kind of spinning out of control, the other person can kind of say, hey, let me let me just kind of talk for a second here. So I think having that complete integrated system, people are kind of your backups is, is a key way.The state of operational readiness or not operational readiness, inspection readiness, I guess in a way it’s operational readiness too, but inspection readiness, how can that benefit different roles in the organization? I mean, what’s in it for them?

18 min

Greg Walker: To lower that stress down there. You know, at the end of the day as we wanna make sure we’re answering the questions truthfully honest, you know, in in a timely manner and that’s part of that program. So what, you know, we talk about it’s not about the assets, it’s that teamwork, it’s that partnership between engineering operations quality, all those teams, knowing each other’s kind of roles.

You know, what, what, you know, where the backup is and I think the other thing I stress I could talk for hours on this topic, but also where does your responsibility stump? Okay, so you might be in there talking about engineering and maintenance and calibrations and things like that. And the conversation starts to drift to the validated state. How is this validated? What was the parameters around that? And again, if that’s not your expertise or in your roles, say, hey, listen, that’s a fantastic question to be honest with you. That’s a different person, you know, we can get them come into answer those questions, so that’s the other thing is knowing kind of like your swim lanes as they say, know that there’s a broader team.

And that’s part of that mindset and culture is, you know, we’re gonna work on this together, we’re gonna grow and learn.

Tara Holwegner: What are some other, I would say that those are core elements knowing your responsibility’s, and, you know, having the organizational structure in place so everybody knows, who’s responsible for what and how far their responsibility goes. But what are some.

19:00

Tara Holwegner: Elements of a healthy inspection ready program? Top five.

Greg Walker: No, I think I think we talked about a common goal for everybody. So first of all, it starts off, it’s a culture, it’s a mindset. The organizational design as you mentioned, but you know, one of the ones that’s interesting, and again, I always wanted to put people, I’ll say kind of at ease, and one of the things that we talk about is, you know, the inspector’s coming in, they want to learn.

What you do, ok? So if you’re in engineering leader, a maintenance leader along those lines, you should have materials already ready to present. Like what, what does your department do? Tell us about your HEPA program. Tell us about your calibration program, right? So these, this shouldn’t be a random new idea for you.

You should also prepare a, I’ll call it, we used to call them basically a program overview deck, ok? No more than four slides. Now let me start with typically you’re not handing this to the inspector, ok? Who, who uses this deck While we talked about how do you get people comfortable? Prior to.

Going in and answering questions when inspector, again, that’s part of our role we go and we talk, we share an ideas like that is just to get people kind of relaxed a little bit, if they say they’re in charge of the calibration program, have them just go through those four slides that talks about their governing procedures, talks about how they handle test.

20:00

Greg Walker: Ratio, how they handle standards, right? It gets some kind of lockdown to say, ok, listen, let’s not go and panicked. I know my program, I’m just gonna refresh kind of like with the details are at, so when I go in, I’m very focused so that I present the best light as to what my program does. So when we talk about design, job descriptions, what those program.

I think are key. Documentation practices, ok? You know, again, a lot of, a lot of industries have this array, but you know, what, what does a good work order completed look like? You know, sometimes in my experience you’d sit there and you’d get these comments from very mindful.

Mechanics, but it might say, you know, this thing’s been broke for years, I hope management’s fixes it someday or something like that, right? You know, like, Oh my goodness, you know, like, it’s probably a really good idea, but maybe don’t put that on the work order.

Tara Holwegner: Right, right.

Greg Walker: What’s this telling people what’s the right information, what’s the right channels to communicate if there are issues, things like that, quality events. This is always a great one is when, when does engineering bend the root cause of a quality issue? Is it the equipment broke down.

Is it we didn’t follow the procedures? Is it something that we thought we fixed the problem? And this, this is the big one is, but it came back again. So we never really got to the right root cause. So that’s a big element of it as well, so make sure that our quality investigations that we partner with quality and engineering together is let’s get to those right root causes there.