Trascrizione completa di 0305. Facility Readiness: More Than a Checklist

00:06:01.790 --> 00:06:03.790 So it depends on the scenario that you're in. 00:06:03.949 --> 00:06:06.829 So you'll have for a new project, for a new building, right? 00:06:06.909 --> 00:06:09.230 Obviously, there is nothing existing going on. 00:06:09.310 --> 00:06:33.310 And so in that scenario, you'll have a project team typically comprised of a bunch of engineers and construction support personnel, safety, and they're trying to design, install, and make sure the equipment is commissioned and sometimes qualified, depending on if it's a GMP facility within a defined timeline, you know, within a defined budget, and then with a fixed number of resources, right? 00:06:33.550 --> 00:06:35.149 It's sort of like building a house. 00:06:35.230 --> 00:06:43.149 You have people designing it, building the walls, moving the equipment in, but the people living inside the house are not the same people that are the ones building it, right? 00:06:43.310 --> 00:06:48.509 And so here's the problem is that for a new facility, again, these teams don't exist yet. 00:06:48.589 --> 00:06:54.750 So they're not only are you hiring new people, you're trying to build a culture of how you're gonna run the building. 00:06:54.990 --> 00:07:03.790 And so there's a lot of effort being put into onboarding the team, and then you're developing procedures, trainings to make sure that things are gonna happen a certain way. 00:07:04.029 --> 00:07:10.269 At the same time, none of the people on the operation side have worked together on physical spaces. 00:07:10.349 --> 00:07:12.430 So there's a there's a learning curve there. 00:07:12.589 --> 00:07:23.790 And so it's really up to whoever the um the lead is on the operation side and also the project manager on the capital project side to really align on what it means when something is is ready. 00:07:23.949 --> 00:07:27.069 So that's that's the scenario for a new building. 00:07:27.310 --> 00:07:29.550 For an existing facility, it's a little different. 00:07:29.949 --> 00:07:37.629 Again, you'll probably have the same structure for a project team, but the operations team is they've been there. 00:07:37.949 --> 00:07:43.389 They have stuff that they're operating already, and the the project team, they're actively working, right? 00:07:43.550 --> 00:07:58.509 And so the project team needs to understand what they need from them so that this is not a one-off um asset that's being introduced into their scope of work, but it it integrates smoothly with whatever they have going on. 00:07:58.829 --> 00:08:00.829 You mean they have to communicate together? 00:08:01.149 --> 00:08:01.629 Exactly. 00:08:01.870 --> 00:08:02.110 Right. 00:08:02.189 --> 00:08:09.149 So it's it's like you think of it as like you're again living inside of a house and you're you're adding to it rather than building something from scratch, right? 00:08:09.230 --> 00:08:12.430 Obviously, the the logistics are gonna be a lot different. 00:08:12.670 --> 00:09:14.100 And

if you're adding something on, usually there's some sort of area that's gonna be sectioned off where there's construction activities. 00:09:14.340 --> 00:09:20.820 And so when we say that things are ready, there's there's existing operations that have to integrate with the new space. 00:09:20.899 --> 00:09:22.899 And so those scenarios are very different. 00:09:22.980 --> 00:09:24.100 So you got to think about it that way. 00:09:24.180 --> 00:09:26.260 How do you weave it in and start starting from scratch? 00:09:26.340 --> 00:09:32.820 And I think again, this this goes back to understanding what does it mean to be ready on on both sides of it. 00:09:32.980 --> 00:09:50.900 And I think there's there's a lot of misunderstanding because capital projects on that side, you you have a different set of procedures and policies that you will follow because a lot of it is is structured around a not controlled space, right? 00:09:51.060 --> 00:10:03.700 It's it's essentially a construction site, and there's a lot less the I'm I'm not gonna say there's less rules and policies, but they're different than if you had a controlled environment where it's a manufacturing facility or or like a lab space, right? 00:10:03.860 --> 00:10:08.660 So permitting, not really a regulatory entity. 00:10:09.460 --> 00:10:09.940 Exactly. 00:10:10.100 --> 00:10:12.980 Think about like the we'll use safety as an example. 00:10:13.220 --> 00:10:21.860 I think construction safety is very different than lab safety, just because the the hazards are going to be different, the people that you're engaging with are going to be different. 00:10:22.020 --> 00:10:28.980 And so you have to look at when the project team says something is ready versus when the lab personnel thinks something is ready. 00:10:29.060 --> 00:10:33.940 Those are like not the same things, and it's important to get on the same page about what those things are. 00:10:34.500 --> 00:10:37.940 You know, it's I want to go back to this idea of being ready. 00:10:38.020 --> 00:10:44.020 And one thing that I've heard before, and it sort of sticks with me, is that being ready is a decision. 00:10:44.180 --> 00:10:46.420 It's not actually a point in time. 00:10:46.740 --> 00:10:58.100 And to the comments that you made earlier, often we will look at timelines and say once we achieve these checkboxes and we get to that point in time, we are ready. 00:10:58.340 --> 00:11:08.260 When it really is a decision of how full is that readiness, how complete is that readiness, and making sure that we do have that dialogue. 00:11:08.420 --> 00:11:35.940 You know, in your initial description of what we're going to talk about today, I heard things like believe, uh, assumed, inferred, and then those things eventually you start revealing gaps as you're starting that early production, as you're starting that early work, and then you're consistently discovering uh issues with the asset or risks that are surfacing after you start working in there

isn't a part of that. 00:11:36.020 --> 00:11:51.380 I mean, I guess there's always going to be some calibration, but how an organization decides to use a particular piece of equipment, they have to create, in some cases, their own standards, their own protocol, for example. 00:11:51.540 --> 00:12:00.500 Do you find that there's a big discrepancy from what these assets are designed to do and how an organization decides to use them? 00:12:01.060 --> 00:12:07.620 I think so that that goes back to like, you know, right sizing or buying the right equipment for what it's intended to do. 00:12:07.700 --> 00:12:19.380 And I think normally in most circumstances, I've seen the operations people on the project team work pretty well when it comes to procuring the right equipment that they need. 00:12:19.460 --> 00:12:24.260 And so they're not, you know, let's let's use uh like a bench scale as an example. 00:12:24.580 --> 00:12:29.780 You're not gonna buy a a zero to ten kilogram scale and then put something that's 50 kilograms on it. 00:12:29.860 --> 00:12:35.220 Like operations knows that this is designed for this weight, and so therefore going to use it for that purpose, right? 00:12:35.460 --> 00:12:43.940 I think what gets lost sometimes is the how precise do you need the measurement to be on such a scale, right? 00:12:44.180 --> 00:12:46.900 You need it to three decimal places, two decimal places. 00:12:46.980 --> 00:12:50.260 Like there's um there's different grades of the scales too. 00:12:50.820 --> 00:12:52.500 Some scales are very sensitive. 00:12:52.660 --> 00:12:58.500 Like, do you need a containment device over it so there's no draft, depending on how sensitive the measurement that you want to be, right? 00:12:58.660 --> 00:13:04.660 So really understanding what are you using the scale for and what is the criticality of the scale, right? 00:13:04.820 --> 00:13:16.580 So in in any maintenance program or any facility, the first thing you do before you build a maintenance program is you have to do a criticality assessment of the fleet of equipment that you're going to be using. 00:13:16.820 --> 00:13:24.180 And the reason we do this is because it it allows both the project to understand what's going to be critical to your operations. 00:13:24.340 --> 00:13:30.820 And also on the operation side, you know when something breaks what is actually more important than other things, right? 00:13:30.980 --> 00:13:43.620 Otherwise, if you get a work order for some sort of repair, the the work order for the bathroom is not as important as the work order for your a bioreactor that you might have on a bench, right? 00:13:43.700 --> 00:13:46.660 Like the just the levels of importance are going to be very different. 00:13:47.060 --> 00:13:51.860 Some would say that a toilet uh is a is a very high risk area. 00:13:52.820 --> 00:13:53.380 Yeah, yeah. 00:13:53.540 --> 00:14:04.980 So it the idea is, you know, you you have to perform this criticality assessment um to want to be able to prioritize the asset, uh, both on the project side and on the operation side, right? 00:14:05.140 --> 00:14:11.700 And so people run into trouble when you do the criticality assessment in a vacuum. 00:14:11.860 --> 00:14:18.020 And they look at it as, oh, one of the requirements for me to hand over the equipment is to perform this assessment. 00:14:18.180 --> 00:14:27.380 And what usually happens is a person does the assessment maybe with some people on the project team, not understanding how important it is going to be on the operation side. 00:14:27.620 --> 00:14:38.820 And then something that was supposed to be very important now becomes something that gets slipped through the hands of somebody who doesn't know because of the way that the assessment was done. 00:14:38.980 --> 00:14:41.860 And so that that's a risk there. 00:14:42.020 --> 00:14:52.500 And for that, you you have to again, like you said, people have to communicate, people have to both align on what it is that's important to both operations and the project so that you can handle it properly. 00:14:52.740 --> 00:14:55.700 But that's just one aspect of building out the maintenance program. 00:14:56.180 --> 00:15:33.380 Yeah, it sounds like this is, you know, the very first step is you know, making sure that you're not doing this in a vacuum, that, you know, perhaps just from your personal stance of of what you might be doing with the the equipment, or even if you're not the one that's going to be working with the equipment, you're the one that's handing off the equipment, understanding, you know, who are the players that are going to be involved in this, not just hand selecting or hand picking one or two, where there may be someone that's using using it in a slightly modified way that requires a little bit more hand holding to make sure that that you are producing the data that you need to produce. 00:15:33.460 --> 00:15:37.540 You are able to run the experiments or run that next step in the experiment. 00:15:37.780 --> 00:15:38.820 So what's happening here? 00:15:38.900 --> 00:15:58.820 We're getting gaps during audits, deviations, issues that happen during early production, um, which I would imagine can sort of derail things for for weeks, if not months, especially if these are, you know, coming from the outside, there's a specialist that comes in uh to work on that machine in particular. 00:15:58.980 --> 00:16:01.860 Perhaps there's a long lead time for them to get on site. 00:16:02.020 --> 00:16:05.860 You know, these are things that can really shut down uh the operations. 00:16:06.260 --> 00:16:27.140 You know, it it's I guess if these uh sort of uh verification mechanisms are not well disseminated within you know folks in the operations and and folks that are uh getting these assets and pieces of equipment, you're gonna find yourself in a place where ready means something different to every person. 00:16:27.860 --> 00:16:30.660 And that sounds like it's a

recipe for a disaster. 00:16:30.820 --> 00:16:35.940 You know, I I would like to, you know, hope that people are learning their lessons as they're doing these. 00:16:36.020 --> 00:16:39.460 But as we know, folks love to record lessons learned. 00:16:39.540 --> 00:16:43.700 They love to have meetings and hold off sites about lessons learned. 00:16:43.860 --> 00:16:50.180 And you don't always see those things coming through practice, you know, referring back and saying, what happened in the last time? 00:16:50.340 --> 00:16:52.980 What is it that we can do differently this time? 00:16:53.140 --> 00:17:06.180 You know, taking that time to pause and reflect to avoid more of these sort of lack of readiness when these uh very expensive, very key pieces of equipment are coming into our space and our facility? 00:17:06.420 --> 00:17:17.539 How do we start to see that we have a uh readiness issue, a readiness risk associated with any of the assets that come in? 00:17:17.779 --> 00:17:25.460 What key points should point us to, hey, this is probably not going to go in the right direction, or we're probably missing something? 00:17:25.860 --> 00:17:28.019 What are some of those signs that that show us that? 00:17:28.340 --> 00:17:30.740 Yeah, I think like you you mentioned lessons learned. 00:17:30.819 --> 00:17:36.100 So I think again, like we'll let's split this conversation into two parts, one being a new facility. 00:17:36.180 --> 00:17:47.059 So if if you're at a company or you're part of a project where it it is a new facility, I'm gonna assume that the project team, this is not their first project, right? 00:17:47.220 --> 00:18:02.099 It may be the first project for many operations people because the pool of individuals that typically work on these types of capital projects, they tend to only work on projects, and the people that are in operations tend to only do operations. 00:18:02.179 --> 00:18:07.619 I'm not saying they don't cross-pollinate, but typically uh you don't always walk into a fresh building. 00:18:07.779 --> 00:18:14.500 You can be in the industry for years and never be at the very inception of a new build. 00:18:15.460 --> 00:18:15.859 Yep. 00:18:16.099 --> 00:18:37.460 So I I think on you know, the your point about readiness, I think it's it's very important for both of these sides, especially in the very beginning, as these teams start to grow, is on the project side, okay, what are the things that usually give you headaches when you try to hand off the equipment or the building to the owners? 00:18:37.699 --> 00:18:43.460 And then on the ownership side, what are the things that are missing that the project team doesn't give you when they hand over the project? 00:18:43.859 --> 00:18:51.299 And usually there's something in the middle, and from there you can generate some sort of lessons from everybody's experience that you could apply to the project going forward. 00:18:51.460 --> 00:19:15.059 Now, if you're in a situation where you

have an existing database of lessons learned that relate to your particular project, you should definitely have both sides review it and then still do the same exercise because maybe there's things that people have recommended in the in the past that you don't have to reinvent the wheel, you could just use what people have put together in the past for it. 00:19:15.219 --> 00:19:18.899 And I I think the other scenario is if you have an existing facility, right? 00:19:19.059 --> 00:19:28.579 So there's there are things that are going on at the operations level that they're going to suggest for readiness that the project team may not be familiar with. 00:19:28.739 --> 00:19:32.899 And that's really like as as fresh as you can get because we have stuff going on. 00:19:32.979 --> 00:19:36.099 These are the things that we need you to do so that we can integrate properly. 00:19:36.339 --> 00:19:41.459 And so it creates less delays on the project side and also less headaches on the operation side. 00:19:41.619 --> 00:19:58.259 But again, like these lessons learned, it's it's worth having the session and to not only surface these issues, but also make them accessible so it's not this like one-time exercise that you do during the project, and then everybody forgets about it when they when they leave the meeting. 00:19:58.419 --> 00:20:03.059 It's it's definitely something that a lot of projects, again, it's it's very difficult to do. 00:20:03.139 --> 00:20:09.219 And I'm not saying it's easy because you have large groups of people that are a part of these projects and these activities, right? 00:20:09.539 --> 00:20:11.299 These things don't happen every day, right? 00:20:11.459 --> 00:20:19.459 You know, they there's a lot that might be happening in the beginning, but once you have an established site, I mean, how much are we talking about here? 00:20:19.539 --> 00:20:23.539 You know, less than five a year or or you know, more than fifty. 00:20:23.699 --> 00:20:36.339 I imagine in certain instances, these are, you know, there's very common to see uh very high risk procedures or processes that only occur once or twice a year. 00:20:36.499 --> 00:20:48.179 And those are the ones that you have to pay the most attention to because who's gonna be walking around throughout the whole year thinking about, oh, we have to be careful because of these things that happened last time and it took us forever to get started. 00:20:48.339 --> 00:20:50.099 No one's really thinking about those things. 00:20:50.259 --> 00:20:52.739 So I mean, who's responsible for that, right? 00:20:53.459 --> 00:20:53.699 Right. 00:20:53.779 --> 00:21:13.779 So there's the I think the responsibility comes down to the I think on the project management side, if if you are in charge of a project team, that should be one of the things that you're thinking about because you want the project team to be as prepared and also aware of the things that the operations people are concerned about. 00:21:13.939 --> 00:21:14.099 Right. 00:21:14.259 --> 00:21:20.979 And then whoever the operations lead is going to be, I think they have the responsibility to communicate those needs to the project team, right? 00:21:21.219 --> 00:21:24.099 And so you asked about like how often these things are done. 00:21:24.259 --> 00:21:27.539 I would say they're typically done at the end of the project. 00:21:27.619 --> 00:21:35.219 And what you should know what you actually should be doing is at the very beginning of the project, right before you move stuff in, and then when the project is over, right? 00:21:35.459 --> 00:21:44.099 So the beginning, I think is it's a pretty um, I think obvious thing to do because you're you want everybody on the same page before you go off and you know, start doing things. 00:21:44.339 --> 00:21:44.419 Yeah. 00:21:44.819 --> 00:21:51.379 I think a lot of people don't do it right before they move stuff in because there's so many things happening that they're like, we need to meet certain timelines. 00:21:51.539 --> 00:21:55.699 And that's where I think a lot of once you lose, just get it done, right? 00:21:55.859 --> 00:22:07.699 And so if you miss the opportunity to have that session right before you move equipment in, you're gonna miss a lot of the things that will save you headaches as you're moving stuff into the building and trying to get the handoff completed. 00:22:07.859 --> 00:22:09.699 And then doing it at the very end, right? 00:22:09.779 --> 00:22:11.219 So like you've gone through the process. 00:22:11.379 --> 00:22:20.179 There's people that you're angry at, there might be people you're happy with, but it's worth going through what went well, what didn't go well, so that you can pass it on to the next project. 00:22:20.339 --> 00:22:31.699 And even if it's not being passed on to the next project, everybody on the team is aware of those lessons that they can carry on, not only with another project, but also with ongoing operations, right? 00:22:31.779 --> 00:22:39.779 So if you're in a new facility, you build one, you do the lessons learned at the end, there's gonna be facility renovations and additions in the future. 00:22:39.939 --> 00:22:44.579 So you could use those lessons that you learned in that project and and roll it over to the next one, right? 00:22:44.739 --> 00:22:50.339 So I think those three points in time, the beginning, right before you move your equipment in, and then at the very end. 00:22:50.659 --> 00:22:56.499 It's it's funny because going through this move, I felt like we had that to some degree. 00:22:56.659 --> 00:23:03.779 Obviously, in order to move an entire house and to hire movers, they need to come to make an assessment to say, what are we dealing with? 00:23:03.939 --> 00:23:04.819 How much do we have? 00:23:04.979 --> 00:23:08.899 But in a way, there was we were looking at readiness to a degree. 00:23:09.059 --> 00:23:14.339 They came in to see how much have you packed, how much

do you need us to pack to be ready to move? 00:23:14.579 --> 00:23:16.899 What type of material do you need to pack? 00:23:17.059 --> 00:23:31.539 If I if they came without any boxes to move the televisions or the mirrors or my my dry erase board, that's a glass dry erase board, we would have had very vulnerable, important to us during this move. 00:23:31.859 --> 00:23:33.459 And so they did that. 00:23:33.539 --> 00:23:39.779 And and what happened when we do you remember what happened when we got back to the house when we got to to our new home here? 00:23:40.019 --> 00:23:45.459 We went through and said, okay, here's how we listed, here's how we labeled things on the boxes. 00:23:45.619 --> 00:23:51.219 And I'm gonna take you and we're gonna do uh uh kind of like a pre Gemba walk. 00:23:51.299 --> 00:23:54.899 Here's how we're going to set up this home, here's where these things are. 00:23:55.219 --> 00:23:55.779 Are going to go. 00:23:55.859 --> 00:23:57.779 Here's where I need you to be careful of. 00:23:57.939 --> 00:23:59.379 There's an outlet on the ground. 00:23:59.459 --> 00:24:00.899 There's chandelier here. 00:24:01.059 --> 00:24:03.459 There's, you know, don't block the outlets over here. 00:24:03.539 --> 00:24:04.819 Don't block the vents over here. 00:24:04.979 --> 00:24:08.739 You know, we sort of went through and this all had to happen within a single day. 00:24:09.059 --> 00:24:11.619 And then at the end, they walked with me through the house. 00:24:11.779 --> 00:24:16.179 They said, let's go through the house and you tell us if there's anything that needs to be moved that wasn't there. 00:24:16.339 --> 00:24:18.419 So then going, you know, that wasn't in the right place. 00:24:18.579 --> 00:24:25.139 So to a degree, we went into sort of our own little new homeowner risk assessment. 00:24:25.299 --> 00:24:37.939 You know, there's there's also this aspect of an absence of who is owning this, what is the readiness of the asset and its relationship to the potential risk. 00:24:38.019 --> 00:24:40.099 You know, those conversations need to happen. 00:24:40.179 --> 00:24:44.419 They can't tap it in a bubble, and they require the project team and the operations team. 00:24:44.579 --> 00:24:49.059 Because the only people that can tell you what the risk is going to be like is going to be the operations team. 00:24:49.299 --> 00:24:57.779 The only, you know, the the group that can assess how quickly they can become ready is going to be the project team. 00:24:58.099 --> 00:25:06.179 So, you know, it and and this isn't anything new to, I think, you know, readiness as as we're having the conversation here. 00:25:06.339 --> 00:25:14.979 I think in a lot of scenarios where we have two groups of people, one is doing the handoff and the other one is receiving. 00:25:16.259 --> 00:25:23.939 You know, oftentimes there's this assumption that because we're getting it from them, they know all the things that they need to do to give to us. 00:25:24.339 --> 00:25:25.379 And vice versa. 00:25:25.779 --> 00:25:28.979 We just have a checklist here and then we hand it off and everything's fine. 00:25:29.139 --> 00:25:32.499 The the project team, the operations team will figure out the rest. 00:25:32.739 --> 00:25:43.299 I think there's very weak linkages that we form in in not just in bioforma, just in general, um, where we don't have enough conversation. 00:25:43.539 --> 00:25:57.779 We make too many assumptions, we believe too many things without having anything concrete or any kind of dialogue that can help prevent any of these future downstream risks or issues. 00:25:57.939 --> 00:26:00.339 And so why, why, why does this matter? 00:26:00.499 --> 00:26:12.419 I mean, I think we've we've talked about a few of these things, but we're talking about being proactive in understanding the risk prior to this mini project, right? 00:26:12.499 --> 00:26:13.539 This is a mini project. 00:26:13.619 --> 00:26:20.259 We're going to be moving things in, whether it's in the beginning, moving a lot of pieces of equipment that happen kind of at the same time. 00:26:20.419 --> 00:26:20.739 Why? 00:26:20.899 --> 00:26:28.419 Because you this is a uh an event of moving equipment in, plugging them in, getting them tested, getting people to come in. 00:26:28.579 --> 00:26:34.579 You know, if you're at an established facility, um you're doing this around people. 00:26:34.819 --> 00:26:36.419 People are moving around you. 00:26:36.659 --> 00:26:42.259 People are, you know, taking up assets and taking up space around you that creates another layer. 00:26:42.419 --> 00:26:44.099 How are people moving into their? 00:26:44.259 --> 00:26:45.299 I'm gonna be over here. 00:26:45.379 --> 00:26:48.739 I need to bring this large piece of equipment between this time and this time. 00:26:49.219 --> 00:26:52.579 That how do you create the least amount of disruption? 00:26:53.139 --> 00:26:54.819 So why is this so important? 00:26:55.059 --> 00:27:03.779 Yeah, it's and and that like I think balancing of what the project wants to do and what the operations team is intending to do once they receive the equipment. 00:27:04.019 --> 00:27:06.419 There's a lot of the creativity that has to happen, right? 00:27:06.499 --> 00:27:09.779 So uh I'll use an example of when you when you moved, right? 00:27:10.179 --> 00:27:30.819 I think the instructions that you had provided were to get the the kids' rooms ready, obviously, right, and making sure that the stuff in the kitchen was ready so that when you guys moved in, the kids would be able to sleep and that you guys would have your bed set up and be able to make food and to be able to spend time in some part of the living room while everything was still not unpacked, right? 00:27:30.979 --> 00:27:37.859 I think at a bare minimum, that was the idea of having things moved in a certain order and to have certain rooms ready. 00:27:38.099 --> 00:27:42.339 That same approach is what these

projects should be doing, right? 00:27:42.499 --> 00:27:49.779 So when a building gets handed off, the expectation is not 100% of the building is being used all on day one, right? 00:27:50.019 --> 00:27:59.939 So typically what happens is these facilities will have these things called engineering runs, and basically it's a smaller version of what the actual production run is going to look like. 00:28:00.099 --> 00:28:04.419 And so you need a smaller number of equipment, you need a small number of raw materials. 00:28:04.659 --> 00:28:12.259 But the idea is to just run through the process so that your one, your staff is getting used to the space and using the equipment. 00:28:12.499 --> 00:28:20.579 Two is to make sure that the procedures that you've written are actually mimicking reality because you you might have to make revisions to it. 00:28:20.739 --> 00:28:29.939 And I think the other part is to make sure that there's nothing uh in the facility that the project team may have missed as they get out other things ready, right? 00:28:30.019 --> 00:28:31.059 So that's very important. 00:28:31.219 --> 00:28:39.779 And so these engineering runs um require a certain number of pieces of equipment to be available and to be able for the team to use. 00:28:39.939 --> 00:28:43.379 But that plan needs to be communicated to the project team, right? 00:28:43.459 --> 00:28:44.259 Or else they don't know. 00:28:44.339 --> 00:28:47.859 They don't know what you need and they don't know how many of those things you need. 00:28:48.019 --> 00:28:59.939 And so it's it's important for them to understand like, let's just get everything ready for the engineering runs, and then we'll stagger the approach for all the rest of the areas because you won't be using them necessarily in that order. 00:29:00.099 --> 00:29:05.299 So in biologics, we have both upstream processes and downstream processes. 00:29:05.379 --> 00:29:10.419 So upstream being mostly cell culture, and then downstream being purification, right? 00:29:10.579 --> 00:29:17.539 So logically, we're not gonna make sure that the downstream rooms are ready because you operate with the upstream rooms first. 00:29:17.699 --> 00:29:23.379 So like that sort of like order of operations, like you got to think about making sure that things are ready. 00:29:23.539 --> 00:29:33.939 But at the same time, you don't want the operations team ramping up the upstream rooms to the point where you don't have enough time to make sure the downstream rooms are ready. 00:29:34.179 --> 00:29:40.899 So you kind of have to do a a balance of like what their production timeline is with when you're starting up the other equipment. 00:29:41.059 --> 00:29:53.219 So it's um it can be very tricky because it it really depends on how many batches they're gonna be making and what sort of schedule that that they plan on running for their facility. 00:29:53.379 --> 00:29:57.059 But yeah, you start small, you start with the engineering runs and then

you slowly ramp up. 00:29:57.139 --> 00:30:02.339 But that greatly reduced the risk rather than like, let me get one room ready and then another room ready. 00:30:02.579 --> 00:30:08.819 But if you do that, you run into the scenario where the operations people run in there and they go, well, this doesn't work. 00:30:08.899 --> 00:30:14.979 And now people that are getting other rooms ready have to come back and now fix some of those issues, right? 00:30:15.139 --> 00:30:23.299 Rather than why don't you do the engineering runs, let's straighten out whatever issues you found and then roll those lessons into getting the other areas ready. 00:30:23.619 --> 00:30:29.379 I think that's a fantastic approach to make sure that you're creating these sort of mini pilots, right? 00:30:29.539 --> 00:30:38.419 You're creating mini pilots to learn something of that space, learn something of maybe you didn't have enough power coming to the outlet that you thought you did. 00:30:38.579 --> 00:30:42.739 And imagine hooking and connecting everything up and then saying, all right, let's go. 00:30:42.899 --> 00:30:51.059 And you don't have the power you thought, you blow a breaker, the the CO2 line actually has, geez, heaven forbid, has oxygen. 00:30:51.219 --> 00:30:51.939 You know what I mean? 00:30:52.099 --> 00:30:57.059 You know, so when we moved into our our initial home before we moved here, that was a brand new build. 00:30:57.139 --> 00:30:58.579 And we had to do a walkthrough. 00:30:58.659 --> 00:31:02.819 And and it would do a walkthrough very, very often when you're moving into a new space. 00:31:02.979 --> 00:31:06.179 We had to make sure if I flip this switch, what's turning on? 00:31:06.339 --> 00:31:07.139 What's turning off? 00:31:07.219 --> 00:31:10.099 We actually found out at our previous house they had wires crossed. 00:31:10.259 --> 00:31:18.019 We had a light somewhere in the kitchen, a switch that was turning off the power to the light on the front doorstep. 00:31:18.339 --> 00:31:22.259 Very confusing of how they did that, but that ended up happening. 00:31:22.419 --> 00:31:24.979 Well, perhaps they didn't do all of the checks. 00:31:25.139 --> 00:31:34.419 Perhaps they just, I mean, we were down to the minute of like moving into that home from when we were supposed to be homeowners and when they were finished building it. 00:31:34.659 --> 00:31:38.019 So, you know, I think that there's a lot of similarities in there. 00:31:38.179 --> 00:31:45.539 And oftentimes we, in that scenario, in that situation, we were not communicating with the project team. 00:31:45.699 --> 00:31:55.299 We had to communicate through uh uh an agent who was communicating with the project manager, who would communicate with the team, and then it would trickle. 00:31:55.539 --> 00:31:57.059 I mean, it was incredibly inefficient. 00:31:57.219 --> 00:32:04.979 It would take like four-day turnaround to get the response on something, which was absurd considering they were building the home we were about to move into. 00:32:05.139 --> 00:32:28.899 But I think you you point to a lot of sort of really great sort of points to consider when you need to onboard these assets, when you're bringing something new into a facility, when you're bringing something new into a laboratory, of you know, making sure that you have those conversations, making sure that you're considering not just the basic standard usage of whatever the piece of equipment's going to be delivering, but what else are they gonna be using it for? 00:32:29.059 --> 00:32:30.819 Where are the where are the important parts? 00:32:30.979 --> 00:32:34.419 What's most important to this group for this? 00:32:34.579 --> 00:32:36.419 Oh, they need to create their own standards. 00:32:36.579 --> 00:32:49.859 Okay, let's bake that into the piloting so that they know and understand how to create their own standards, you know, and and making sure that there is sort of that full circle approach rather than we're just gonna, you know. 00:32:50.019 --> 00:32:52.899 I've worked with movers that just sort of drop the stuff off. 00:32:52.979 --> 00:32:55.939 You know, uh take it, take this as an example. 00:32:56.179 --> 00:33:01.539 When you buy furniture, they're not there to play home makeover and move your furniture around. 00:33:01.699 --> 00:33:05.939 They will deliver your sofa, plop it down if you take off the wrapping. 00:33:06.099 --> 00:33:08.419 If you want to move it anywhere else, that's on you. 00:33:08.659 --> 00:33:10.979 So when we had the movers here, that was a little bit different. 00:33:11.059 --> 00:33:39.939 But we also pay for that as getting movers to say, hey, I need you to move this over here, take this over here, because as much as you want to plan and map things out, you don't always know how the space is going to move when it's completely empty versus when it's completely filled with equipment or, you know, there's desks and chairs, and every scientist has their own set of pipettes and scales and beakers and uh uh you know materials, things like that. 00:33:40.099 --> 00:33:46.979 So I think that there's a lot that we can learn here about what does it mean to actually be ready for these things? 00:33:47.139 --> 00:33:55.139 These are not just a timeline that's being met, these are not just a checklist of items to say, yes, this is ready. 00:33:55.299 --> 00:33:56.259 This is a decision. 00:33:56.899 --> 00:34:09.139 This is a decision that is uh, you know, really should be between the project team and the operations team to say, hey, we've had the conversations, we know what we're gonna do. 00:34:09.300 --> 00:34:19.860 And uh to your point, doing these things in the beginning, in the middle, towards the end, I think is a really fantastic approach to make sure that we're still all on the same page. 00:34:20.019 --> 00:34:39.219 And if we've had to make any adjustments, you know that there is a point in time where you're gonna come together and

discuss those adjustments and discuss what needs to change based on the pilot, based on, you know, perhaps by the time that you, you know, wanted to order something or some kind of asset, the body of it changed. 00:34:39.300 --> 00:34:46.980 And now it takes up a little bit more space than initial because there was a recall and they changed the refrigerant coil or whatever the case is. 00:34:47.139 --> 00:34:51.219 So I think it just it really speaks to a lot of potential for there. 00:34:51.460 --> 00:35:00.579 Um, what's also nice is sometimes you don't know what you're lacking out of your out of your onboarding program, out of your facilities and maintenance program. 00:35:00.739 --> 00:35:16.900 So what's great about it is that we have developed this assessment that looks at just these things and we assess the asset data that you have, the criticality, we test you to see where you guys are as an organization. 00:35:17.060 --> 00:35:24.660 Are you do you have a log that shows you how critical these pieces of equipment are to your operations, to your delivery of your facilities? 00:35:24.820 --> 00:35:31.060 Is it clear who's handing off and who's receiving the governance, who's making decisions? 00:35:31.220 --> 00:35:34.180 What extra support do you need outside of being ready? 00:35:34.340 --> 00:35:38.980 Who do you need to have available to hop in whenever there's going to be some sort of issues? 00:35:39.140 --> 00:35:40.580 Do you have spare parts? 00:35:40.660 --> 00:35:42.500 Do you have vendor support established? 00:35:42.660 --> 00:35:48.740 You don't want these critical pieces of equipment to just stop and then say, we don't know who to contact. 00:35:48.900 --> 00:35:54.740 And then I think what doesn't get spoken about enough in this industry is the training. 00:35:54.820 --> 00:35:57.620 And it's not just the training, it's the competency. 00:35:57.780 --> 00:36:02.660 If you're training without competency, you're training probably stunk. 00:36:02.820 --> 00:36:11.860 You're probably not delivering the training the right way, where you can ensure the folks on the receiving end are competent to execute. 00:36:12.100 --> 00:36:21.060 Yeah, and I think the training piece is really important because we I think in especially in our industry, we have a lot of these uh read and understand, which is like I love those, right? 00:36:21.220 --> 00:36:25.220 You just scroll to the bottom, you scroll to the bottom and hit I read it. 00:36:27.780 --> 00:36:37.860 How is anybody supposed to read and understand a 30-page document with no pictures and just all text on how to operate this not even a piece of equipment? 00:36:38.180 --> 00:36:40.420 And it might not even be your domain. 00:36:40.580 --> 00:36:46.580 I mean, I've had read and understands that were, you know, this is when I was first starting out. 00:36:46.900 --> 00:36:53.220 I was at an organization that was on the brink of their first phase three trial. 00:36:53.380 --> 00:36:57.220 So towards the end, all of these regulatory things started popping out. 00:36:57.460 --> 00:37:00.740 I barely understood the language of pharma at that time. 00:37:00.900 --> 00:37:03.780 And it was these read and understands of like 15, 20 pages. 00:37:03.860 --> 00:37:09.300 I'm like, I don't understand half of the definitions in this documentation because this is not my forte. 00:37:09.620 --> 00:37:11.460 I was a scientist, I was a bench scientist. 00:37:11.540 --> 00:37:15.380 You I'll talk to you about cell culture and protocols and all that stuff all day. 00:37:15.540 --> 00:37:17.860 But then regulatory with the clinical trials. 00:37:17.940 --> 00:37:24.580 I mean, this was almost 10 years ago, and I was just sort of like, okay, I'll just click that I read, that I understand it. 00:37:25.220 --> 00:37:26.020 Really don't. 00:37:26.100 --> 00:37:28.980 I I don't even know that I would be called upon this. 00:37:29.060 --> 00:37:40.500 And that's another thing that we often see is um sort of recycling what the training requirements are for people, even if they're not relevant to that person's role. 00:37:40.660 --> 00:37:58.820 So yeah, and and unfortunately, I I think because because there are so many trainings required, I think you you you really have to pick and choose which ones you're going to have for in-person trainings, or maybe you're going to develop a presentation for or video for, because it can't be all of them, right? 00:37:58.900 --> 00:38:10.020 You don't want to bog down people to have to watch 50 hours of videos because it you want these videos to be concise, but at the same time enough for the person to be able to do their job and do their job well, right? 00:38:10.100 --> 00:38:15.700 Not just to do the bare minimum, but to understand the reasons why these instructions are important. 00:38:15.860 --> 00:38:23.380 Um, I I think you know, just going back to what you said before, like those different areas where you're looking at the asset data, the handoff, support and and the training. 00:38:23.540 --> 00:38:43.300 I think in in short, what we want at the end of the day is for whoever is using the equipment of the facility to be not only prepared to use it, but feel supported in if they needed help with something, they know where to go, right? 00:38:43.700 --> 00:38:52.260 I think the the worst case scenario is that they they end up standing in front of something and they start using it and they get confused and they don't know who to turn to. 00:38:52.420 --> 00:38:59.460 And then they start making mistakes where they could be scary, it could be they could break things, void warranty, like all these different risks that are. 00:39:00.180 --> 00:39:01.220 Void warranties, yeah. 00:39:01.300 --> 00:39:02.100 That's exactly right. 00:39:02.180 --> 00:39:02.500 Yeah. 00:39:02.820 --> 00:39:16.740 So you know it's uh it's a very challenging place, and and and I have to say, with the technology that's available

now, with with the ability for AI to generate documents, the ability for this this plethora. 00:39:16.820 --> 00:39:28.980 I mean, we use some of these software that allow us to create training videos very quickly, very seamlessly, with uh photo, you know, of where I clicked in the system, et cetera. 00:39:29.220 --> 00:39:34.260 These are all different tools to support that competency and that training. 00:39:34.420 --> 00:39:48.740 And I think that we need to be a little bit more, we as organizations need to be a little bit amenable to introducing those types of things rather than saying we're just gonna create a PowerPoint and we're gonna hold one session or two sessions for people to come and check. 00:39:48.900 --> 00:39:52.980 We're gonna record it and we're gonna put it in this folder that no one's ever gonna find. 00:39:53.220 --> 00:39:57.780 You know, we have to try a little bit harder than that to make this actually successful. 00:39:58.340 --> 00:40:09.620 Yeah, I think, you know, just shooting out an idea here is we there are a lot of people that have been using these meta glasses, right, for streaming purposes and stuff like that. 00:40:09.780 --> 00:40:18.420 There's no reason why we can't use those things to show other technicians how to calibrate something or how to repair a pump. 00:40:18.580 --> 00:40:33.860 If you just had the classes and you showed the video and you had the person do it the right way and then watching that, and then hey, refer back to the the SOP of the work instruction if you want the thing written out, but go to the video and just look at how these things are being done. 00:40:33.940 --> 00:40:42.180 It's just much more technology is available now that makes it much more accessible and and just easy to kind of do this type of training. 00:40:42.740 --> 00:40:44.260 Absolutely, absolutely. 00:40:44.660 --> 00:40:49.060 I think, I mean we nailed the you nailed the topic. 00:40:49.220 --> 00:41:34.900 I think it's incredibly critical for us to understand all these different layers that come into play when we're talking about bringing in assets into a facility, whether it's a new facility or one that has built been been built and you're introducing one or two more assets into their fleet of tools, you know, from the criticality to the uh the the handoffs, the responsibilities, the decision making, where the support's gonna be, what you surround yourself with to ensure that you have longevity in your operations from the start, as opposed to hitting roadblock after roadblock after roadblock, making sure we're training and uh ensuring that competency and not just compliance. 00:41:35.060 --> 00:41:40.500 Compliance is important, it is, but it's not uh equate readiness. 00:41:40.740 --> 00:41:56.500 So I think as we're evolving our understanding of being ready in any situation, it's beyond that timeline and and those check marks and is a decision for us that we need to make and take seriously in any particular scenario. 00:41:56.740 --> 00:42:00.740 So lucky for the folks, for our listeners, uh we have the assessments. 00:42:00.900 --> 00:42:11.220 If you guys resonated with anything that you guys uh have heard here, please check out our risk assessments at Sigma Lab Consulting.com slash assessments. 00:42:11.380 --> 00:42:14.500 Um, also on sale now, it's available. 00:42:14.660 --> 00:42:17.380 I'm back, so you'll be hearing me talk about it a little bit more. 00:42:17.700 --> 00:42:19.060 Predictably broken. 00:42:19.220 --> 00:42:29.620 My new book on fixing failures in biopharma operations is on sale now, and you can find out more about it at Sigma Lab Consulting.com slash predictably broken. 00:42:29.780 --> 00:42:32.980 So if you have an idea, send us a message through our interest form. 00:42:33.220 --> 00:42:35.060 It shows up in our show notes. 00:42:36.260 --> 00:42:40.740 Lawrence, I think we did okay coming back from uh a little bit of a hiatus. 00:42:40.900 --> 00:42:42.420 Yeah, this this was uh this was good. 00:42:42.500 --> 00:42:44.340 We're we're getting back into it and it was good. 00:42:44.580 --> 00:42:46.100 It feels good to flex that muscle. 00:42:46.340 --> 00:42:49.780 Yeah, just in time for the summer where everybody uh goes on vacation. 00:42:49.860 --> 00:42:54.020 So hopefully as you go on your vacation, your family might not appreciate it. 00:42:54.180 --> 00:42:59.540 But if you decide on your road trip to listen to these episodes, we certainly appreciate it. 00:42:59.780 --> 00:43:00.820 So thanks a lot. 00:43:00.900 --> 00:43:03.780 Thanks, Lawrence, and until next time, see you guys.