0305. Facility Readiness: More Than a Checklist

1 00:01:01,229 - > 00:01:03,950 SPEAKER_02: Welcome back to another episode of Lean by 2 00:01:03,950 - > 00:01:04,590 Design Podcast. 3 00:01:04,670 - > 00:01:08,109 I'm your host, Oscar Gonzalez, with my co-host Lawrence Wong. 4 00:01:08,349 - > 00:01:12,829 It has been quite a bit since we did our last podcast episode, 5 00:01:12,909 - > 00:01:17,150 and I have to say I was scrambling a little bit to find 6 00:01:17,789 - > 00:01:21,469 my notes from what we've done in the past to make sure that my 7 00:01:21,469 - > 00:01:23,629 microphone, as you could tell, I'm in a new setting. 8 00:01:23,789 - > 00:01:24,750 It's been a little bit. 9 00:01:24,990 - > 00:01:25,469 SPEAKER_00: How are you? 10 00:01:25,710 - > 00:01:25,950 Good. 11 00:01:26,030 - > 00:01:29,549 Yeah, I think uh this episode's gonna be a little rusty as we uh 12 00:01:29,710 - > 00:01:33,870 like get back into a cadence of having these uh conversations. 13 00:01:34,909 - > 00:01:35,950 SPEAKER_02: Yeah, absolutely. 14 00:01:36,030 - > 00:01:37,549 I'm I'm ready to get back into it. 15 00:01:37,629 - > 00:01:42,109 You know, I've been uh for the past month I was on paternity 16 00:01:42,109 - > 00:01:45,229 leave and also juggling moving homes. 17 00:01:45,390 - > 00:01:49,150 That's quite difficult with uh a bunch of little kids. 18 00:01:49,310 - > 00:01:53,950 And so I had you to thank definitely for helping us get 19 00:01:54,829 - > 00:01:56,990 all of our things moved in and settled. 20 00:01:57,069 - > 00:02:00,829 Um I mean, I I can't stress how important that was for us to 21 00:02:00,829 - > 00:02:03,629 sort of knock out of the park and and you helped us get there. 22 00:02:03,710 - > 00:02:06,750 So we've certainly had some engagements over the last couple 23 00:02:06,750 - > 00:02:10,270 of weeks as we were gearing up into this next phase. 24 00:02:10,509 - > 00:02:14,189 But we're gonna continue on to the discussions that we had 25 00:02:14,189 - > 00:02:19,150 previously, where we're touching on a number of risk areas that 26 00:02:19,150 - > 00:02:22,189 we find related to operations and process. 27 00:02:22,349 - > 00:02:26,430 And today we're we're gonna go back and talk to really your 28 00:02:26,430 - > 00:02:31,229 space within facilities and manufacturing and what it means 29 00:02:31,229 - > 00:02:38,509 to be ready, what it means for a site to be ready, and how our 30 00:02:38,509 - > 00:02:44,030 misconception of what that means really creates this downstream 31 00:02:44,030 - > 00:02:47,310 effect that sometimes you don't see until much later, until an 32 00:02:47,310 - > 00:02:50,669 audit or until scientists move into the space. 33 00:02:50,909 - > 00:02:52,030 Tell us a little bit more about that. 34 00:02:52,270 - > 00:02:55,389 SPEAKER_00: Yeah, I think most project teams, operations teams 35 00:02:55,550 - > 00:02:57,870 believe that they know when an asset is ready. 36 00:02:58,030 - > 00:03:00,590 But what does what does ready actually mean, right? 37 00:03:00,669 - > 00:03:04,110 The problem is that these these definitions of what readiness 38 00:03:04,110 - > 00:03:06,830 means is is different depending on the group that you are in. 39 00:03:06,990 - > 00:03:10,109 And a lot of times there is a misalignment over that 40 00:03:10,109 - > 00:03:14,590 definition, but there's also other things that are enabling 41 00:03:14,829 - > 00:03:16,109 that misalignment, right? 42 00:03:16,269 - > 00:03:20,750 So, you know, if if the timeline is met and nothing has failed 43 00:03:20,750 - > 00:03:22,590 yet, everybody thinks that everything is ready. 44 00:03:22,669 - > 00:03:25,629 But then you'll have, let's say, an audit down the road or some 45 00:03:25,629 - > 00:03:29,629 quality event like a deviation, or even just like early 46 00:03:29,629 - > 00:03:32,989 production runs that start revealing some of these issues 47 00:03:32,989 - > 00:03:37,469 that nobody uh knew was present um inside the facility. 48 00:03:37,789 - > 00:03:41,870 So for this episode, we're going to talk about why uh teams 49 00:03:41,949 - > 00:03:45,789 consistently discover risk associated with their assets, 50 00:03:45,949 - > 00:03:49,150 assets being your facility, your equipment, after they start 51 00:03:49,150 - > 00:03:53,870 using them, and why that usually has nothing to do with your 52 00:03:54,030 - > 00:03:55,310 compliance program. 53 00:03:55,709 - > 00:04:01,629 And it's more about looking at how readiness is perceived by 54 00:04:01,629 - > 00:04:04,269 both the project and the operations team, right? 55 00:04:04,430 - > 00:04:08,189 Um they're not looking at it as a control point for risk, 56 00:04:08,269 - > 00:04:11,870 they're looking at it as a, oh, we've completed a checklist and 57 00:04:11,870 - > 00:04:14,189 now it's handed over to the next group. 58 00:04:14,509 - > 00:04:18,670 And when you approach it that way, you sort of lose the 59 00:04:18,990 - > 00:04:22,750 significance of what this means for the people using the 60 00:04:22,750 - > 00:04:23,550 equipment, right? 61 00:04:23,709 - > 00:04:26,670 When people go to use the equipment when it is live, 62 00:04:26,910 - > 00:04:31,389 they're not asking for, hey, did you fill out the checklist for 63 00:04:31,389 - > 00:04:34,750 this particular piece of equipment or this area? 64 00:04:35,069 - > 00:04:38,509 I think they're expecting the equipment to run safely, to 65 00:04:38,509 - > 00:04:42,110 perform the way that it was designed, and also to be trained 66 00:04:42,110 - > 00:04:45,550 and to have the resources readily available if they have 67 00:04:45,550 - > 00:04:48,829 questions or issues about the machinery that they're about to 68 00:04:48,829 - > 00:04:49,230 operate. 69 00:04:49,389 - > 00:04:52,590 I think this usually that's kind of the end portion of it, and 70 00:04:52,590 - > 00:04:53,230 then the beginning. 71 00:04:53,389 - > 00:04:57,069 Even before the facility is built, you you have to resource 72 00:04:57,069 - > 00:05:01,470 out and budget for those activities and not only from 73 00:05:01,470 - > 00:05:03,389 funding, but also your timeline, right? 74 00:05:03,470 - > 00:05:07,790 So your your project has to have that built in so that that road 75 00:05:07,790 - > 00:05:10,590 to the point where an operator is standing in front of a piece 76 00:05:10,590 - > 00:05:12,750 of equipment and understands exactly what they need to do and 77 00:05:12,750 - > 00:05:13,870 how to do it and when to do it. 78 00:05:14,030 - > 00:05:16,269 That thing doesn't just happen when you hire somebody and you 79 00:05:16,269 - > 00:05:17,230 tell them to go in that room. 80 00:05:17,389 - > 00:05:19,870 Like there's all these things that happen during the project 81 00:05:19,870 - > 00:05:23,949 that enable that person to have that experience when they get to 82 00:05:23,949 - > 00:05:24,829 the end of it. 83 00:05:26,029 - > 00:05:28,829 SPEAKER_02: And these are often groups of people that don't 84 00:05:28,829 - > 00:05:30,430 necessarily work together, right? 85 00:05:30,589 - > 00:05:33,790 Those that are setting up, and when you talk about equipment, 86 00:05:33,870 - > 00:05:36,110 these are the very assets that you're talking about, right? 87 00:05:36,269 - > 00:05:39,550 These are sometimes very large pieces of equipment that may do 88 00:05:39,550 - > 00:05:44,029 very complex science and it's it's simply ordered, purchased, 89 00:05:44,110 - > 00:05:46,829 brought in, and okay, they're gonna set it up, and then I can 90 00:05:46,829 - > 00:05:47,469 start using it. 91 00:05:47,629 - > 00:05:48,990 That's sort of that assumption. 92 00:05:49,149 - > 00:05:52,029 And these are usually different groups of people that are 93 00:05:52,029 - > 00:05:56,670 involved, not necessarily the scientists or not necessarily uh 94 00:05:56,829 - > 00:06:00,750 the facilities engineers or facilities uh personnel, right? 95 00:06:01,389 - > 00:06:01,629 SPEAKER_00: Right. 96 00:06:01,790 - > 00:06:03,790 So it depends on the scenario that you're in. 97 00:06:03,949 - > 00:06:06,509 So you'll have for a new project, for a new building, 98 00:06:06,589 - > 00:06:06,829 right? 99 00:06:06,909 - > 00:06:09,230 Obviously, there is nothing existing going on. 100 00:06:09,310 - > 00:06:12,589 And so in that scenario, you'll have a project team typically 101 00:06:12,589 - > 00:06:15,469 comprised of a bunch of engineers and construction 102 00:06:15,629 - > 00:06:20,829 support personnel, safety, and they're trying to design, 103 00:06:21,069 - > 00:06:24,430 install, and make sure the equipment is commissioned and 104 00:06:24,509 - > 00:06:28,029 sometimes qualified, depending on if it's a GMP facility within 105 00:06:28,029 - > 00:06:30,909 a defined timeline, you know, within a defined budget, and 106 00:06:30,909 - > 00:06:33,310 then with a fixed number of resources, right? 107 00:06:33,550 - > 00:06:35,149 It's sort of like building a house. 108 00:06:35,230 - > 00:06:38,750 You have people designing it, building the walls, moving the 109 00:06:38,750 - > 00:06:41,230 equipment in, but the people living inside the house are not 110 00:06:41,230 - > 00:06:43,149 the same people that are the ones building it, right? 111 00:06:43,310 - > 00:06:46,990 And so here's the problem is that for a new facility, again, 112 00:06:47,069 - > 00:06:48,509 these teams don't exist yet. 113 00:06:48,589 - > 00:06:52,110 So they're not only are you hiring new people, you're trying 114 00:06:52,110 - > 00:06:54,750 to build a culture of how you're gonna run the building. 115 00:06:54,990 - > 00:06:58,829 And so there's a lot of effort being put into onboarding the 116 00:06:58,829 - > 00:07:01,790 team, and then you're developing procedures, trainings to make 117 00:07:01,790 - > 00:07:03,790 sure that things are gonna happen a certain way. 118 00:07:04,029 - > 00:07:07,069 At the same time, none of the people on the operation side 119 00:07:07,069 - > 00:07:10,269 have worked together on physical spaces. 120 00:07:10,349 - > 00:07:12,430 So there's a there's a learning curve there. 121 00:07:12,589 - > 00:07:16,589 And so it's really up to whoever the um the lead is on the 122 00:07:16,589 - > 00:07:19,069 operation side and also the project manager on the capital 123 00:07:19,069 - > 00:07:23,069 project side to really align on what it means when something is 124 00:07:23,230 - > 00:07:23,790 is ready. 125 00:07:23,949 - > 00:07:27,069 So that's that's the scenario for a new building. 126 00:07:27,310 - > 00:07:29,550 For an existing facility, it's a little different. 127 00:07:29,949 - > 00:07:33,469 Again, you'll probably have the same structure for a project 128 00:07:33,469 - > 00:07:37,629 team, but the operations team is they've been there. 129 00:07:37,949 - > 00:07:40,909 They have stuff that they're operating already, and the the 130 00:07:40,909 - > 00:07:43,389 project team, they're actively working, right? 131 00:07:43,550 - > 00:07:47,469 And so the project team needs to understand what they need from 132 00:07:47,790 - > 00:07:53,469 them so that this is not a one-off um asset that's being 133 00:07:53,469 - > 00:07:56,990 introduced into their scope of work, but it it integrates 134 00:07:56,990 - > 00:07:58,509 smoothly with whatever they have going on. 135 00:07:58,829 - > 00:08:00,829 You mean they have to communicate together? 136 00:08:01,149 - > 00:08:01,629 Exactly. 137 00:08:01,870 - > 00:08:02,110 Right. 138 00:08:02,189 - > 00:08:05,389 So it's it's like you think of it as like you're again living 139 00:08:05,389 - > 00:08:07,790 inside of a house and you're you're adding to it rather than 140 00:08:07,790 - > 00:08:09,149 building something from scratch, right? 141 00:08:09,230 - > 00:08:12,430 Obviously, the the logistics are gonna be a lot different. 142 00:08:12,670 - > 00:09:10,659 And if you're adding something on, usually there's some sort of 143 00:09:10,659 - > 00:09:13,300 area that's gonna be sectioned off where there's construction 144 00:09:13,300 - > 00:09:14,100 activities. 145 00:09:14,340 - > 00:09:17,860 And so when we say that things are ready, there's there's 146 00:09:17,860 - > 00:09:20,820 existing operations that have to integrate with the new space. 147 00:09:20,899 - > 00:09:22,899 And so those scenarios are very different. 148 00:09:22,980 - > 00:09:24,100 So you got to think about it that way. 149 00:09:24,180 - > 00:09:26,260 How do you weave it in and start starting from scratch? 150 00:09:26,340 - > 00:09:29,460 And I think again, this this goes back to understanding what 151 00:09:29,460 - > 00:09:32,820 does it mean to be ready on on both sides of it. 152 00:09:32,980 - > 00:09:36,740 And I think there's there's a lot of misunderstanding because 153 00:09:36,980 - > 00:09:40,580 capital projects on that side, you you have a different set of 154 00:09:40,900 - > 00:09:47,060 procedures and policies that you will follow because a lot of it 155 00:09:47,060 - > 00:09:50,900 is is structured around a not controlled space, right? 156 00:09:51,060 - > 00:09:54,180 It's it's essentially a construction site, and there's a 157 00:09:54,180 - > 00:09:56,740 lot less the I'm I'm not gonna say there's less rules and 158 00:09:56,740 - > 00:09:59,460 policies, but they're different than if you had a controlled 159 00:09:59,460 - > 00:10:02,500 environment where it's a manufacturing facility or or 160 00:10:02,500 - > 00:10:03,700 like a lab space, right? 161 00:10:03,860 - > 00:10:08,660 SPEAKER_02: So permitting, not really a regulatory entity. 162 00:10:09,460 - > 00:10:09,940 SPEAKER_00: Exactly. 163 00:10:10,100 - > 00:10:12,980 Think about like the we'll use safety as an example. 164 00:10:13,220 - > 00:10:16,820 I think construction safety is very different than lab safety, 165 00:10:17,140 - > 00:10:20,020 just because the the hazards are going to be different, the 166 00:10:20,020 - > 00:10:21,860 people that you're engaging with are going to be different. 167 00:10:22,020 - > 00:10:25,220 And so you have to look at when the project team says something 168 00:10:25,220 - > 00:10:28,740 is ready versus when the lab personnel thinks something is 169 00:10:28,740 - > 00:10:28,980 ready. 170 00:10:29,060 - > 00:10:31,540 Those are like not the same things, and it's important to 171 00:10:31,540 - > 00:10:33,940 get on the same page about what those things are. 172 00:10:34,500 - > 00:10:37,220 SPEAKER_02: You know, it's I want to go back to this idea of 173 00:10:37,220 - > 00:10:37,940 being ready. 174 00:10:38,020 - > 00:10:41,140 And one thing that I've heard before, and it sort of sticks 175 00:10:41,140 - > 00:10:44,020 with me, is that being ready is a decision. 176 00:10:44,180 - > 00:10:46,420 It's not actually a point in time. 177 00:10:46,740 - > 00:10:50,260 And to the comments that you made earlier, often we will look 178 00:10:50,260 - > 00:10:54,580 at timelines and say once we achieve these checkboxes and we 179 00:10:54,580 - > 00:10:58,100 get to that point in time, we are ready. 180 00:10:58,340 - > 00:11:03,940 When it really is a decision of how full is that readiness, how 181 00:11:04,180 - > 00:11:07,540 complete is that readiness, and making sure that we do have that 182 00:11:07,540 - > 00:11:08,260 dialogue. 183 00:11:08,420 - > 00:11:11,140 You know, in your initial description of what we're going 184 00:11:11,140 - > 00:11:14,900 to talk about today, I heard things like believe, uh, 185 00:11:15,220 - > 00:11:20,580 assumed, inferred, and then those things eventually you 186 00:11:20,580 - > 00:11:24,260 start revealing gaps as you're starting that early production, 187 00:11:24,420 - > 00:11:26,580 as you're starting that early work, and then you're 188 00:11:26,580 - > 00:11:31,060 consistently discovering uh issues with the asset or risks 189 00:11:31,060 - > 00:11:35,220 that are surfacing after you start working in there isn't a 190 00:11:35,220 - > 00:11:35,940 part of that. 191 00:11:36,020 - > 00:11:39,860 I mean, I guess there's always going to be some calibration, 192 00:11:40,100 - > 00:11:44,180 but how an organization decides to use a particular piece of 193 00:11:44,180 - > 00:11:48,580 equipment, they have to create, in some cases, their own 194 00:11:48,580 - > 00:11:51,380 standards, their own protocol, for example. 195 00:11:51,540 - > 00:11:55,380 Do you find that there's a big discrepancy from what these 196 00:11:55,700 - > 00:12:00,100 assets are designed to do and how an organization decides to 197 00:12:00,100 - > 00:12:00,500 use them? 198 00:12:01,060 - > 00:12:04,340 SPEAKER_00: I think so that that goes back to like, you know, 199 00:12:04,580 - > 00:12:07,460 right sizing or buying the right equipment for what it's intended 200 00:12:07,460 - > 00:12:07,620 to do. 201 00:12:07,700 - > 00:12:12,900 And I think normally in most circumstances, I've seen the 202 00:12:12,900 - > 00:12:15,940 operations people on the project team work pretty well when it 203 00:12:15,940 - > 00:12:19,380 comes to procuring the right equipment that they need. 204 00:12:19,460 - > 00:12:22,820 And so they're not, you know, let's let's use uh like a bench 205 00:12:22,820 - > 00:12:24,260 scale as an example. 206 00:12:24,580 - > 00:12:28,340 You're not gonna buy a a zero to ten kilogram scale and then put 207 00:12:28,340 - > 00:12:29,780 something that's 50 kilograms on it. 208 00:12:29,860 - > 00:12:32,740 Like operations knows that this is designed for this weight, and 209 00:12:32,740 - > 00:12:35,220 so therefore going to use it for that purpose, right? 210 00:12:35,460 - > 00:12:41,860 I think what gets lost sometimes is the how precise do you need 211 00:12:41,860 - > 00:12:43,940 the measurement to be on such a scale, right? 212 00:12:44,180 - > 00:12:46,900 You need it to three decimal places, two decimal places. 213 00:12:46,980 - > 00:12:49,780 Like there's um there's different grades of the scales 214 00:12:49,940 - > 00:12:50,260 too. 215 00:12:50,820 - > 00:12:52,500 Some scales are very sensitive. 216 00:12:52,660 - > 00:12:55,300 Like, do you need a containment device over it so there's no 217 00:12:55,300 - > 00:12:57,700 draft, depending on how sensitive the measurement that 218 00:12:57,700 - > 00:12:58,500 you want to be, right? 219 00:12:58,660 - > 00:13:02,820 So really understanding what are you using the scale for and what 220 00:13:02,820 - > 00:13:04,660 is the criticality of the scale, right? 221 00:13:04,820 - > 00:13:08,740 So in in any maintenance program or any facility, the first thing 222 00:13:08,740 - > 00:13:11,140 you do before you build a maintenance program is you have 223 00:13:11,140 - > 00:13:14,820 to do a criticality assessment of the fleet of equipment that 224 00:13:14,820 - > 00:13:16,580 you're going to be using. 225 00:13:16,820 - > 00:13:20,340 And the reason we do this is because it it allows both the 226 00:13:20,340 - > 00:13:23,540 project to understand what's going to be critical to your 227 00:13:23,540 - > 00:13:24,180 operations. 228 00:13:24,340 - > 00:13:27,940 And also on the operation side, you know when something breaks 229 00:13:28,180 - > 00:13:30,820 what is actually more important than other things, right? 230 00:13:30,980 - > 00:13:35,380 Otherwise, if you get a work order for some sort of repair, 231 00:13:35,540 - > 00:13:38,900 the the work order for the bathroom is not as important as 232 00:13:38,900 - > 00:13:42,820 the work order for your a bioreactor that you might have 233 00:13:42,820 - > 00:13:43,620 on a bench, right? 234 00:13:43,700 - > 00:13:46,340 Like the just the levels of importance are going to be very 235 00:13:46,340 - > 00:13:46,660 different. 236 00:13:47,060 - > 00:13:50,740 SPEAKER_01: Some would say that a toilet uh is a is a very high 237 00:13:50,820 - > 00:13:51,860 risk area. 238 00:13:52,820 - > 00:13:53,380 SPEAKER_00: Yeah, yeah. 239 00:13:53,540 - > 00:13:56,740 So it the idea is, you know, you you have to perform this 240 00:13:56,980 - > 00:14:01,380 criticality assessment um to want to be able to prioritize 241 00:14:01,380 - > 00:14:03,940 the asset, uh, both on the project side and on the 242 00:14:03,940 - > 00:14:04,980 operation side, right? 243 00:14:05,140 - > 00:14:10,500 And so people run into trouble when you do the criticality 244 00:14:10,500 - > 00:14:11,700 assessment in a vacuum. 245 00:14:11,860 - > 00:14:15,940 And they look at it as, oh, one of the requirements for me to 246 00:14:15,940 - > 00:14:18,020 hand over the equipment is to perform this assessment. 247 00:14:18,180 - > 00:14:21,380 And what usually happens is a person does the assessment maybe 248 00:14:21,380 - > 00:14:24,740 with some people on the project team, not understanding how 249 00:14:24,740 - > 00:14:27,380 important it is going to be on the operation side. 250 00:14:27,620 - > 00:14:31,060 And then something that was supposed to be very important 251 00:14:31,380 - > 00:14:35,060 now becomes something that gets slipped through the hands of 252 00:14:35,060 - > 00:14:37,940 somebody who doesn't know because of the way that the 253 00:14:37,940 - > 00:14:38,820 assessment was done. 254 00:14:38,980 - > 00:14:41,860 And so that that's a risk there. 255 00:14:42,020 - > 00:14:45,460 And for that, you you have to again, like you said, people 256 00:14:45,460 - > 00:14:48,820 have to communicate, people have to both align on what it is 257 00:14:48,820 - > 00:14:51,380 that's important to both operations and the project so 258 00:14:51,380 - > 00:14:52,500 that you can handle it properly. 259 00:14:52,740 - > 00:14:55,380 But that's just one aspect of building out the maintenance 260 00:14:55,380 - > 00:14:55,700 program. 261 00:14:56,180 - > 00:14:59,300 SPEAKER_02: Yeah, it sounds like this is, you know, the very 262 00:14:59,300 - > 00:15:02,740 first step is you know, making sure that you're not doing this 263 00:15:02,740 - > 00:15:07,220 in a vacuum, that, you know, perhaps just from your personal 264 00:15:07,220 - > 00:15:11,300 stance of of what you might be doing with the the equipment, or 265 00:15:11,300 - > 00:15:13,060 even if you're not the one that's going to be working with 266 00:15:13,060 - > 00:15:14,820 the equipment, you're the one that's handing off the 267 00:15:14,820 - > 00:15:17,860 equipment, understanding, you know, who are the players that 268 00:15:17,860 - > 00:15:20,900 are going to be involved in this, not just hand selecting or 269 00:15:20,900 - > 00:15:24,260 hand picking one or two, where there may be someone that's 270 00:15:24,260 - > 00:15:28,340 using using it in a slightly modified way that requires a 271 00:15:28,340 - > 00:15:31,460 little bit more hand holding to make sure that that you are 272 00:15:31,460 - > 00:15:33,380 producing the data that you need to produce. 273 00:15:33,460 - > 00:15:36,500 You are able to run the experiments or run that next 274 00:15:36,500 - > 00:15:37,540 step in the experiment. 275 00:15:37,780 - > 00:15:38,820 So what's happening here? 276 00:15:38,900 - > 00:15:42,740 We're getting gaps during audits, deviations, issues that 277 00:15:42,740 - > 00:15:47,220 happen during early production, um, which I would imagine can 278 00:15:47,220 - > 00:15:51,860 sort of derail things for for weeks, if not months, especially 279 00:15:51,860 - > 00:15:54,980 if these are, you know, coming from the outside, there's a 280 00:15:54,980 - > 00:15:58,340 specialist that comes in uh to work on that machine in 281 00:15:58,340 - > 00:15:58,820 particular. 282 00:15:58,980 - > 00:16:01,860 Perhaps there's a long lead time for them to get on site. 283 00:16:02,020 - > 00:16:05,220 You know, these are things that can really shut down uh the 284 00:16:05,220 - > 00:16:05,860 operations. 285 00:16:06,260 - > 00:16:11,700 You know, it it's I guess if these uh sort of uh verification 286 00:16:11,700 - > 00:16:15,940 mechanisms are not well disseminated within you know 287 00:16:16,020 - > 00:16:20,020 folks in the operations and and folks that are uh getting these 288 00:16:20,020 - > 00:16:23,060 assets and pieces of equipment, you're gonna find yourself in a 289 00:16:23,060 - > 00:16:26,900 place where ready means something different to every 290 00:16:26,900 - > 00:16:27,140 person. 291 00:16:27,860 - > 00:16:30,660 And that sounds like it's a recipe for a disaster. 292 00:16:30,820 - > 00:16:34,020 You know, I I would like to, you know, hope that people are 293 00:16:34,020 - > 00:16:35,940 learning their lessons as they're doing these. 294 00:16:36,020 - > 00:16:39,460 But as we know, folks love to record lessons learned. 295 00:16:39,540 - > 00:16:43,220 They love to have meetings and hold off sites about lessons 296 00:16:43,220 - > 00:16:43,700 learned. 297 00:16:43,860 - > 00:16:47,140 And you don't always see those things coming through practice, 298 00:16:47,300 - > 00:16:49,780 you know, referring back and saying, what happened in the 299 00:16:49,780 - > 00:16:50,180 last time? 300 00:16:50,340 - > 00:16:52,980 What is it that we can do differently this time? 301 00:16:53,140 - > 00:16:57,940 You know, taking that time to pause and reflect to avoid more 302 00:16:57,940 - > 00:17:01,620 of these sort of lack of readiness when these uh very 303 00:17:01,620 - > 00:17:05,059 expensive, very key pieces of equipment are coming into our 304 00:17:05,059 - > 00:17:06,180 space and our facility? 305 00:17:06,420 - > 00:17:13,059 How do we start to see that we have a uh readiness issue, a 306 00:17:13,059 - > 00:17:17,539 readiness risk associated with any of the assets that come in? 307 00:17:17,779 - > 00:17:22,259 What key points should point us to, hey, this is probably not 308 00:17:22,259 - > 00:17:24,500 going to go in the right direction, or we're probably 309 00:17:24,500 - > 00:17:25,460 missing something? 310 00:17:25,860 - > 00:17:28,019 What are some of those signs that that show us that? 311 00:17:28,340 - > 00:17:30,340 SPEAKER_00: Yeah, I think like you you mentioned lessons 312 00:17:30,340 - > 00:17:30,740 learned. 313 00:17:30,819 - > 00:17:33,779 So I think again, like we'll let's split this conversation 314 00:17:33,779 - > 00:17:36,100 into two parts, one being a new facility. 315 00:17:36,180 - > 00:17:40,340 So if if you're at a company or you're part of a project where 316 00:17:40,340 - > 00:17:45,220 it it is a new facility, I'm gonna assume that the project 317 00:17:45,220 - > 00:17:47,059 team, this is not their first project, right? 318 00:17:47,220 - > 00:17:51,380 It may be the first project for many operations people because 319 00:17:52,180 - > 00:17:56,259 the pool of individuals that typically work on these types of 320 00:17:56,259 - > 00:17:59,619 capital projects, they tend to only work on projects, and the 321 00:17:59,619 - > 00:18:02,099 people that are in operations tend to only do operations. 322 00:18:02,179 - > 00:18:04,899 I'm not saying they don't cross-pollinate, but typically 323 00:18:04,980 - > 00:18:07,619 uh you don't always walk into a fresh building. 324 00:18:07,779 - > 00:18:11,539 SPEAKER_02: You can be in the industry for years and never be 325 00:18:11,539 - > 00:18:14,500 at the very inception of a new build. 326 00:18:15,460 - > 00:18:15,859 SPEAKER_00: Yep. 327 00:18:16,099 - > 00:18:21,859 So I I think on you know, the your point about readiness, I 328 00:18:21,859 - > 00:18:24,980 think it's it's very important for both of these sides, 329 00:18:25,299 - > 00:18:27,220 especially in the very beginning, as these teams start 330 00:18:27,220 - > 00:18:31,059 to grow, is on the project side, okay, what are the things that 331 00:18:31,059 - > 00:18:35,220 usually give you headaches when you try to hand off the 332 00:18:35,220 - > 00:18:37,460 equipment or the building to the owners? 333 00:18:37,699 - > 00:18:40,259 And then on the ownership side, what are the things that are 334 00:18:40,259 - > 00:18:42,579 missing that the project team doesn't give you when they hand 335 00:18:42,579 - > 00:18:43,460 over the project? 336 00:18:43,859 - > 00:18:46,259 And usually there's something in the middle, and from there you 337 00:18:46,259 - > 00:18:48,980 can generate some sort of lessons from everybody's 338 00:18:48,980 - > 00:18:51,299 experience that you could apply to the project going forward. 339 00:18:51,460 - > 00:18:54,259 Now, if you're in a situation where you have an existing 340 00:18:54,259 - > 00:18:57,619 database of lessons learned that relate to your particular 341 00:18:57,619 - > 00:19:00,659 project, you should definitely have both sides review it and 342 00:19:00,659 - > 00:19:04,979 then still do the same exercise because maybe there's things 343 00:19:04,979 - > 00:19:08,259 that people have recommended in the in the past that you don't 344 00:19:08,259 - > 00:19:11,539 have to reinvent the wheel, you could just use what people have 345 00:19:12,979 - > 00:19:15,059 put together in the past for it. 346 00:19:15,219 - > 00:19:18,179 And I I think the other scenario is if you have an existing 347 00:19:18,179 - > 00:19:18,899 facility, right? 348 00:19:19,059 - > 00:19:22,899 So there's there are things that are going on at the operations 349 00:19:22,899 - > 00:19:26,899 level that they're going to suggest for readiness that the 350 00:19:26,899 - > 00:19:28,579 project team may not be familiar with. 351 00:19:28,739 - > 00:19:32,179 And that's really like as as fresh as you can get because we 352 00:19:32,179 - > 00:19:32,899 have stuff going on. 353 00:19:32,979 - > 00:19:35,139 These are the things that we need you to do so that we can 354 00:19:35,139 - > 00:19:36,099 integrate properly. 355 00:19:36,339 - > 00:19:39,859 And so it creates less delays on the project side and also less 356 00:19:39,859 - > 00:19:41,459 headaches on the operation side. 357 00:19:41,619 - > 00:19:45,219 But again, like these lessons learned, it's it's worth having 358 00:19:45,219 - > 00:19:50,099 the session and to not only surface these issues, but also 359 00:19:50,099 - > 00:19:53,779 make them accessible so it's not this like one-time exercise that 360 00:19:53,779 - > 00:19:56,739 you do during the project, and then everybody forgets about it 361 00:19:56,739 - > 00:19:58,259 when they when they leave the meeting. 362 00:19:58,419 - > 00:20:01,779 It's it's definitely something that a lot of projects, again, 363 00:20:01,859 - > 00:20:03,059 it's it's very difficult to do. 364 00:20:03,139 - > 00:20:06,019 And I'm not saying it's easy because you have large groups of 365 00:20:06,019 - > 00:20:08,899 people that are a part of these projects and these activities, 366 00:20:09,059 - > 00:20:09,219 right? 367 00:20:09,539 - > 00:20:11,299 SPEAKER_02: These things don't happen every day, right? 368 00:20:11,459 - > 00:20:14,259 You know, they there's a lot that might be happening in the 369 00:20:14,259 - > 00:20:17,939 beginning, but once you have an established site, I mean, how 370 00:20:17,939 - > 00:20:19,459 much are we talking about here? 371 00:20:19,539 - > 00:20:23,539 You know, less than five a year or or you know, more than fifty. 372 00:20:23,699 - > 00:20:27,379 I imagine in certain instances, these are, you know, there's 373 00:20:27,379 - > 00:20:33,779 very common to see uh very high risk procedures or processes 374 00:20:34,099 - > 00:20:36,339 that only occur once or twice a year. 375 00:20:36,499 - > 00:20:38,979 And those are the ones that you have to pay the most attention 376 00:20:38,979 - > 00:20:41,779 to because who's gonna be walking around throughout the 377 00:20:41,779 - > 00:20:44,739 whole year thinking about, oh, we have to be careful because of 378 00:20:44,739 - > 00:20:47,539 these things that happened last time and it took us forever to 379 00:20:47,539 - > 00:20:48,179 get started. 380 00:20:48,339 - > 00:20:50,099 No one's really thinking about those things. 381 00:20:50,259 - > 00:20:52,739 So I mean, who's responsible for that, right? 382 00:20:53,459 - > 00:20:53,699 SPEAKER_00: Right. 383 00:20:53,779 - > 00:20:58,099 So there's the I think the responsibility comes down to the 384 00:20:58,659 - > 00:21:01,539 I think on the project management side, if if you are 385 00:21:01,539 - > 00:21:05,059 in charge of a project team, that should be one of the things 386 00:21:05,059 - > 00:21:07,379 that you're thinking about because you want the project 387 00:21:07,379 - > 00:21:12,339 team to be as prepared and also aware of the things that the 388 00:21:12,339 - > 00:21:13,779 operations people are concerned about. 389 00:21:13,939 - > 00:21:14,099 Right. 390 00:21:14,259 - > 00:21:17,219 And then whoever the operations lead is going to be, I think 391 00:21:17,219 - > 00:21:19,939 they have the responsibility to communicate those needs to the 392 00:21:19,939 - > 00:21:20,979 project team, right? 393 00:21:21,219 - > 00:21:24,099 And so you asked about like how often these things are done. 394 00:21:24,259 - > 00:21:27,539 I would say they're typically done at the end of the project. 395 00:21:27,619 - > 00:21:30,259 And what you should know what you actually should be doing is 396 00:21:30,259 - > 00:21:32,899 at the very beginning of the project, right before you move 397 00:21:32,899 - > 00:21:35,219 stuff in, and then when the project is over, right? 398 00:21:35,459 - > 00:21:38,819 So the beginning, I think is it's a pretty um, I think 399 00:21:38,979 - > 00:21:41,459 obvious thing to do because you're you want everybody on the 400 00:21:41,459 - > 00:21:44,099 same page before you go off and you know, start doing things. 401 00:21:44,339 - > 00:21:44,419 SPEAKER_02: Yeah. 402 00:21:44,819 - > 00:21:46,579 SPEAKER_00: I think a lot of people don't do it right before 403 00:21:46,579 - > 00:21:49,219 they move stuff in because there's so many things happening 404 00:21:49,219 - > 00:21:51,379 that they're like, we need to meet certain timelines. 405 00:21:51,539 - > 00:21:55,299 And that's where I think a lot of once you lose, just get it 406 00:21:55,299 - > 00:21:55,699 done, right? 407 00:21:55,859 - > 00:21:59,219 And so if you miss the opportunity to have that session 408 00:21:59,219 - > 00:22:01,619 right before you move equipment in, you're gonna miss a lot of 409 00:22:01,619 - > 00:22:04,499 the things that will save you headaches as you're moving stuff 410 00:22:04,499 - > 00:22:07,699 into the building and trying to get the handoff completed. 411 00:22:07,859 - > 00:22:09,699 And then doing it at the very end, right? 412 00:22:09,779 - > 00:22:11,219 So like you've gone through the process. 413 00:22:11,379 - > 00:22:13,779 There's people that you're angry at, there might be people you're 414 00:22:13,779 - > 00:22:17,299 happy with, but it's worth going through what went well, what 415 00:22:17,299 - > 00:22:20,179 didn't go well, so that you can pass it on to the next project. 416 00:22:20,339 - > 00:22:22,899 And even if it's not being passed on to the next project, 417 00:22:23,139 - > 00:22:27,619 everybody on the team is aware of those lessons that they can 418 00:22:27,619 - > 00:22:30,899 carry on, not only with another project, but also with ongoing 419 00:22:30,899 - > 00:22:31,699 operations, right? 420 00:22:31,779 - > 00:22:34,099 So if you're in a new facility, you build one, you do the 421 00:22:34,099 - > 00:22:37,779 lessons learned at the end, there's gonna be facility 422 00:22:37,779 - > 00:22:39,779 renovations and additions in the future. 423 00:22:39,939 - > 00:22:42,579 So you could use those lessons that you learned in that project 424 00:22:42,659 - > 00:22:44,579 and and roll it over to the next one, right? 425 00:22:44,739 - > 00:22:47,939 So I think those three points in time, the beginning, right 426 00:22:47,939 - > 00:22:50,339 before you move your equipment in, and then at the very end. 427 00:22:50,659 - > 00:22:54,179 SPEAKER_02: It's it's funny because going through this move, 428 00:22:54,339 - > 00:22:56,499 I felt like we had that to some degree. 429 00:22:56,659 - > 00:23:00,579 Obviously, in order to move an entire house and to hire movers, 430 00:23:00,739 - > 00:23:03,379 they need to come to make an assessment to say, what are we 431 00:23:03,379 - > 00:23:03,779 dealing with? 432 00:23:03,939 - > 00:23:04,819 How much do we have? 433 00:23:04,979 - > 00:23:08,579 But in a way, there was we were looking at readiness to a 434 00:23:08,579 - > 00:23:08,899 degree. 435 00:23:09,059 - > 00:23:12,099 They came in to see how much have you packed, how much do you 436 00:23:12,099 - > 00:23:14,339 need us to pack to be ready to move? 437 00:23:14,579 - > 00:23:16,899 What type of material do you need to pack? 438 00:23:17,059 - > 00:23:21,779 If I if they came without any boxes to move the televisions or 439 00:23:21,779 - > 00:23:25,859 the mirrors or my my dry erase board, that's a glass dry erase 440 00:23:25,859 - > 00:23:30,339 board, we would have had very vulnerable, important to us 441 00:23:30,339 - > 00:23:31,539 during this move. 442 00:23:31,859 - > 00:23:33,459 And so they did that. 443 00:23:33,539 - > 00:23:36,659 And and what happened when we do you remember what happened when 444 00:23:36,659 - > 00:23:39,779 we got back to the house when we got to to our new home here? 445 00:23:40,019 - > 00:23:43,859 We went through and said, okay, here's how we listed, here's how 446 00:23:43,859 - > 00:23:45,459 we labeled things on the boxes. 447 00:23:45,619 - > 00:23:50,019 And I'm gonna take you and we're gonna do uh uh kind of like a 448 00:23:50,019 - > 00:23:51,219 pre Gemba walk. 449 00:23:51,299 - > 00:23:54,579 Here's how we're going to set up this home, here's where these 450 00:23:54,579 - > 00:23:54,899 things are. 451 00:23:55,219 - > 00:23:55,779 Are going to go. 452 00:23:55,859 - > 00:23:57,779 Here's where I need you to be careful of. 453 00:23:57,939 - > 00:23:59,379 There's an outlet on the ground. 454 00:23:59,459 - > 00:24:00,899 There's chandelier here. 455 00:24:01,059 - > 00:24:03,459 There's, you know, don't block the outlets over here. 456 00:24:03,539 - > 00:24:04,819 Don't block the vents over here. 457 00:24:04,979 - > 00:24:07,059 You know, we sort of went through and this all had to 458 00:24:07,059 - > 00:24:08,739 happen within a single day. 459 00:24:09,059 - > 00:24:11,619 And then at the end, they walked with me through the house. 460 00:24:11,779 - > 00:24:14,179 They said, let's go through the house and you tell us if there's 461 00:24:14,179 - > 00:24:16,179 anything that needs to be moved that wasn't there. 462 00:24:16,339 - > 00:24:18,419 So then going, you know, that wasn't in the right place. 463 00:24:18,579 - > 00:24:23,459 So to a degree, we went into sort of our own little new 464 00:24:23,459 - > 00:24:25,139 homeowner risk assessment. 465 00:24:25,299 - > 00:24:31,379 You know, there's there's also this aspect of an absence of who 466 00:24:31,379 - > 00:24:36,179 is owning this, what is the readiness of the asset and its 467 00:24:36,179 - > 00:24:37,939 relationship to the potential risk. 468 00:24:38,019 - > 00:24:40,099 You know, those conversations need to happen. 469 00:24:40,179 - > 00:24:42,819 They can't tap it in a bubble, and they require the project 470 00:24:42,819 - > 00:24:44,419 team and the operations team. 471 00:24:44,579 - > 00:24:46,979 Because the only people that can tell you what the risk is going 472 00:24:46,979 - > 00:24:49,059 to be like is going to be the operations team. 473 00:24:49,299 - > 00:24:52,979 The only, you know, the the group that can assess how 474 00:24:52,979 - > 00:24:57,779 quickly they can become ready is going to be the project team. 475 00:24:58,099 - > 00:25:02,179 So, you know, it and and this isn't anything new to, I think, 476 00:25:02,259 - > 00:25:06,179 you know, readiness as as we're having the conversation here. 477 00:25:06,339 - > 00:25:10,259 I think in a lot of scenarios where we have two groups of 478 00:25:10,579 - > 00:25:14,979 people, one is doing the handoff and the other one is receiving. 479 00:25:16,259 - > 00:25:18,979 You know, oftentimes there's this assumption that because 480 00:25:18,979 - > 00:25:22,339 we're getting it from them, they know all the things that they 481 00:25:22,339 - > 00:25:23,939 need to do to give to us. 482 00:25:24,339 - > 00:25:25,379 And vice versa. 483 00:25:25,779 - > 00:25:28,259 We just have a checklist here and then we hand it off and 484 00:25:28,259 - > 00:25:28,979 everything's fine. 485 00:25:29,139 - > 00:25:32,019 The the project team, the operations team will figure out 486 00:25:32,019 - > 00:25:32,499 the rest. 487 00:25:32,739 - > 00:25:38,899 I think there's very weak linkages that we form in in not 488 00:25:38,899 - > 00:25:42,419 just in bioforma, just in general, um, where we don't have 489 00:25:42,419 - > 00:25:43,299 enough conversation. 490 00:25:43,539 - > 00:25:49,059 We make too many assumptions, we believe too many things without 491 00:25:49,059 - > 00:25:54,019 having anything concrete or any kind of dialogue that can help 492 00:25:54,019 - > 00:25:57,779 prevent any of these future downstream risks or issues. 493 00:25:57,939 - > 00:26:00,339 And so why, why, why does this matter? 494 00:26:00,499 - > 00:26:02,819 I mean, I think we've we've talked about a few of these 495 00:26:02,819 - > 00:26:08,739 things, but we're talking about being proactive in understanding 496 00:26:08,739 - > 00:26:12,419 the risk prior to this mini project, right? 497 00:26:12,499 - > 00:26:13,539 This is a mini project. 498 00:26:13,619 - > 00:26:15,939 We're going to be moving things in, whether it's in the 499 00:26:15,939 - > 00:26:18,899 beginning, moving a lot of pieces of equipment that happen 500 00:26:18,899 - > 00:26:20,259 kind of at the same time. 501 00:26:20,419 - > 00:26:20,739 Why? 502 00:26:20,899 - > 00:26:25,059 Because you this is a uh an event of moving equipment in, 503 00:26:25,219 - > 00:26:28,179 plugging them in, getting them tested, getting people to come 504 00:26:28,179 - > 00:26:28,419 in. 505 00:26:28,579 - > 00:26:32,979 You know, if you're at an established facility, um you're 506 00:26:32,979 - > 00:26:34,579 doing this around people. 507 00:26:34,819 - > 00:26:36,419 People are moving around you. 508 00:26:36,659 - > 00:26:39,939 People are, you know, taking up assets and taking up space 509 00:26:39,939 - > 00:26:42,259 around you that creates another layer. 510 00:26:42,419 - > 00:26:44,099 How are people moving into their? 511 00:26:44,259 - > 00:26:45,299 I'm gonna be over here. 512 00:26:45,379 - > 00:26:47,859 I need to bring this large piece of equipment between this time 513 00:26:47,859 - > 00:26:48,739 and this time. 514 00:26:49,219 - > 00:26:52,579 That how do you create the least amount of disruption? 515 00:26:53,139 - > 00:26:54,819 So why is this so important? 516 00:26:55,059 - > 00:26:58,579 SPEAKER_00: Yeah, it's and and that like I think balancing of 517 00:26:58,579 - > 00:27:01,939 what the project wants to do and what the operations team is 518 00:27:01,939 - > 00:27:03,779 intending to do once they receive the equipment. 519 00:27:04,019 - > 00:27:06,419 There's a lot of the creativity that has to happen, right? 520 00:27:06,499 - > 00:27:09,779 So uh I'll use an example of when you when you moved, right? 521 00:27:10,179 - > 00:27:15,299 I think the instructions that you had provided were to get the 522 00:27:15,539 - > 00:27:18,179 the kids' rooms ready, obviously, right, and making 523 00:27:18,179 - > 00:27:20,179 sure that the stuff in the kitchen was ready so that when 524 00:27:20,179 - > 00:27:22,339 you guys moved in, the kids would be able to sleep and that 525 00:27:22,339 - > 00:27:25,299 you guys would have your bed set up and be able to make food and 526 00:27:25,299 - > 00:27:29,059 to be able to spend time in some part of the living room while 527 00:27:29,059 - > 00:27:30,819 everything was still not unpacked, right? 528 00:27:30,979 - > 00:27:34,819 I think at a bare minimum, that was the idea of having things 529 00:27:34,819 - > 00:27:37,859 moved in a certain order and to have certain rooms ready. 530 00:27:38,099 - > 00:27:42,339 That same approach is what these projects should be doing, right? 531 00:27:42,499 - > 00:27:46,419 So when a building gets handed off, the expectation is not 100% 532 00:27:46,579 - > 00:27:49,779 of the building is being used all on day one, right? 533 00:27:50,019 - > 00:27:53,779 So typically what happens is these facilities will have these 534 00:27:53,779 - > 00:27:56,899 things called engineering runs, and basically it's a smaller 535 00:27:56,899 - > 00:27:59,699 version of what the actual production run is going to look 536 00:27:59,699 - > 00:27:59,939 like. 537 00:28:00,099 - > 00:28:03,059 And so you need a smaller number of equipment, you need a small 538 00:28:03,059 - > 00:28:04,419 number of raw materials. 539 00:28:04,659 - > 00:28:08,019 But the idea is to just run through the process so that your 540 00:28:08,419 - > 00:28:11,779 one, your staff is getting used to the space and using the 541 00:28:11,779 - > 00:28:12,259 equipment. 542 00:28:12,499 - > 00:28:15,539 Two is to make sure that the procedures that you've written 543 00:28:15,539 - > 00:28:19,059 are actually mimicking reality because you you might have to 544 00:28:19,059 - > 00:28:20,579 make revisions to it. 545 00:28:20,739 - > 00:28:24,259 And I think the other part is to make sure that there's nothing 546 00:28:24,579 - > 00:28:28,099 uh in the facility that the project team may have missed as 547 00:28:28,099 - > 00:28:29,939 they get out other things ready, right? 548 00:28:30,019 - > 00:28:31,059 So that's very important. 549 00:28:31,219 - > 00:28:35,219 And so these engineering runs um require a certain number of 550 00:28:35,219 - > 00:28:39,059 pieces of equipment to be available and to be able for the 551 00:28:39,059 - > 00:28:39,779 team to use. 552 00:28:39,939 - > 00:28:42,979 But that plan needs to be communicated to the project 553 00:28:42,979 - > 00:28:43,379 team, right? 554 00:28:43,459 - > 00:28:44,259 Or else they don't know. 555 00:28:44,339 - > 00:28:46,739 They don't know what you need and they don't know how many of 556 00:28:46,739 - > 00:28:47,859 those things you need. 557 00:28:48,019 - > 00:28:51,699 And so it's it's important for them to understand like, let's 558 00:28:51,699 - > 00:28:54,979 just get everything ready for the engineering runs, and then 559 00:28:54,979 - > 00:28:57,299 we'll stagger the approach for all the rest of the areas 560 00:28:57,379 - > 00:28:59,939 because you won't be using them necessarily in that order. 561 00:29:00,099 - > 00:29:04,019 So in biologics, we have both upstream processes and 562 00:29:04,179 - > 00:29:05,299 downstream processes. 563 00:29:05,379 - > 00:29:08,979 So upstream being mostly cell culture, and then downstream 564 00:29:08,979 - > 00:29:10,419 being purification, right? 565 00:29:10,579 - > 00:29:13,699 So logically, we're not gonna make sure that the downstream 566 00:29:13,699 - > 00:29:17,299 rooms are ready because you operate with the upstream rooms 567 00:29:17,299 - > 00:29:17,539 first. 568 00:29:17,699 - > 00:29:21,299 So like that sort of like order of operations, like you got to 569 00:29:21,299 - > 00:29:23,379 think about making sure that things are ready. 570 00:29:23,539 - > 00:29:27,859 But at the same time, you don't want the operations team ramping 571 00:29:27,859 - > 00:29:31,219 up the upstream rooms to the point where you don't have 572 00:29:31,219 - > 00:29:33,939 enough time to make sure the downstream rooms are ready. 573 00:29:34,179 - > 00:29:37,139 So you kind of have to do a a balance of like what their 574 00:29:37,139 - > 00:29:40,339 production timeline is with when you're starting up the other 575 00:29:40,339 - > 00:29:40,899 equipment. 576 00:29:41,059 - > 00:29:46,419 So it's um it can be very tricky because it it really depends on 577 00:29:46,659 - > 00:29:50,019 how many batches they're gonna be making and what sort of 578 00:29:50,499 - > 00:29:53,219 schedule that that they plan on running for their facility. 579 00:29:53,379 - > 00:29:55,619 But yeah, you start small, you start with the engineering runs 580 00:29:55,699 - > 00:29:57,059 and then you slowly ramp up. 581 00:29:57,139 - > 00:30:00,179 But that greatly reduced the risk rather than like, let me 582 00:30:00,179 - > 00:30:02,339 get one room ready and then another room ready. 583 00:30:02,579 - > 00:30:06,099 But if you do that, you run into the scenario where the 584 00:30:06,099 - > 00:30:08,659 operations people run in there and they go, well, this doesn't 585 00:30:08,659 - > 00:30:08,819 work. 586 00:30:08,899 - > 00:30:12,179 And now people that are getting other rooms ready have to come 587 00:30:12,179 - > 00:30:14,979 back and now fix some of those issues, right? 588 00:30:15,139 - > 00:30:17,459 Rather than why don't you do the engineering runs, let's 589 00:30:17,459 - > 00:30:20,179 straighten out whatever issues you found and then roll those 590 00:30:20,179 - > 00:30:23,299 lessons into getting the other areas ready. 591 00:30:23,619 - > 00:30:26,179 SPEAKER_02: I think that's a fantastic approach to make sure 592 00:30:26,179 - > 00:30:29,379 that you're creating these sort of mini pilots, right? 593 00:30:29,539 - > 00:30:33,619 You're creating mini pilots to learn something of that space, 594 00:30:33,779 - > 00:30:36,819 learn something of maybe you didn't have enough power coming 595 00:30:36,819 - > 00:30:38,419 to the outlet that you thought you did. 596 00:30:38,579 - > 00:30:41,379 And imagine hooking and connecting everything up and 597 00:30:41,379 - > 00:30:42,739 then saying, all right, let's go. 598 00:30:42,899 - > 00:30:46,899 And you don't have the power you thought, you blow a breaker, the 599 00:30:46,979 - > 00:30:51,059 the CO2 line actually has, geez, heaven forbid, has oxygen. 600 00:30:51,219 - > 00:30:51,939 You know what I mean? 601 00:30:52,099 - > 00:30:55,459 You know, so when we moved into our our initial home before we 602 00:30:55,459 - > 00:30:57,059 moved here, that was a brand new build. 603 00:30:57,139 - > 00:30:58,579 And we had to do a walkthrough. 604 00:30:58,659 - > 00:31:00,819 And and it would do a walkthrough very, very often 605 00:31:00,899 - > 00:31:02,819 when you're moving into a new space. 606 00:31:02,979 - > 00:31:06,179 We had to make sure if I flip this switch, what's turning on? 607 00:31:06,339 - > 00:31:07,139 What's turning off? 608 00:31:07,219 - > 00:31:09,699 We actually found out at our previous house they had wires 609 00:31:09,699 - > 00:31:10,099 crossed. 610 00:31:10,259 - > 00:31:13,859 We had a light somewhere in the kitchen, a switch that was 611 00:31:13,859 - > 00:31:18,019 turning off the power to the light on the front doorstep. 612 00:31:18,339 - > 00:31:21,699 Very confusing of how they did that, but that ended up 613 00:31:21,699 - > 00:31:22,259 happening. 614 00:31:22,419 - > 00:31:24,979 Well, perhaps they didn't do all of the checks. 615 00:31:25,139 - > 00:31:29,219 Perhaps they just, I mean, we were down to the minute of like 616 00:31:29,219 - > 00:31:31,939 moving into that home from when we were supposed to be 617 00:31:31,939 - > 00:31:34,419 homeowners and when they were finished building it. 618 00:31:34,659 - > 00:31:37,859 So, you know, I think that there's a lot of similarities in 619 00:31:37,859 - > 00:31:38,019 there. 620 00:31:38,179 - > 00:31:42,739 And oftentimes we, in that scenario, in that situation, we 621 00:31:42,739 - > 00:31:45,539 were not communicating with the project team. 622 00:31:45,699 - > 00:31:50,819 We had to communicate through uh uh an agent who was 623 00:31:50,819 - > 00:31:53,699 communicating with the project manager, who would communicate 624 00:31:53,699 - > 00:31:55,299 with the team, and then it would trickle. 625 00:31:55,539 - > 00:31:57,059 I mean, it was incredibly inefficient. 626 00:31:57,219 - > 00:32:00,419 It would take like four-day turnaround to get the response 627 00:32:00,419 - > 00:32:03,539 on something, which was absurd considering they were building 628 00:32:03,539 - > 00:32:04,979 the home we were about to move into. 629 00:32:05,139 - > 00:32:08,419 But I think you you point to a lot of sort of really great sort 630 00:32:08,419 - > 00:32:13,219 of points to consider when you need to onboard these assets, 631 00:32:13,299 - > 00:32:15,619 when you're bringing something new into a facility, when you're 632 00:32:15,619 - > 00:32:18,339 bringing something new into a laboratory, of you know, making 633 00:32:18,339 - > 00:32:20,739 sure that you have those conversations, making sure that 634 00:32:20,739 - > 00:32:25,299 you're considering not just the basic standard usage of whatever 635 00:32:25,299 - > 00:32:27,859 the piece of equipment's going to be delivering, but what else 636 00:32:27,859 - > 00:32:28,899 are they gonna be using it for? 637 00:32:29,059 - > 00:32:30,819 Where are the where are the important parts? 638 00:32:30,979 - > 00:32:34,419 What's most important to this group for this? 639 00:32:34,579 - > 00:32:36,419 Oh, they need to create their own standards. 640 00:32:36,579 - > 00:32:40,179 Okay, let's bake that into the piloting so that they know and 641 00:32:40,179 - > 00:32:43,379 understand how to create their own standards, you know, and and 642 00:32:43,379 - > 00:32:47,779 making sure that there is sort of that full circle approach 643 00:32:47,859 - > 00:32:49,859 rather than we're just gonna, you know. 644 00:32:50,019 - > 00:32:52,899 I've worked with movers that just sort of drop the stuff off. 645 00:32:52,979 - > 00:32:55,939 You know, uh take it, take this as an example. 646 00:32:56,179 - > 00:32:59,939 When you buy furniture, they're not there to play home makeover 647 00:32:59,939 - > 00:33:01,539 and move your furniture around. 648 00:33:01,699 - > 00:33:05,459 They will deliver your sofa, plop it down if you take off the 649 00:33:05,459 - > 00:33:05,939 wrapping. 650 00:33:06,099 - > 00:33:08,419 If you want to move it anywhere else, that's on you. 651 00:33:08,659 - > 00:33:10,979 So when we had the movers here, that was a little bit different. 652 00:33:11,059 - > 00:33:14,659 But we also pay for that as getting movers to say, hey, I 653 00:33:14,659 - > 00:33:18,419 need you to move this over here, take this over here, because as 654 00:33:18,419 - > 00:33:22,019 much as you want to plan and map things out, you don't always 655 00:33:22,019 - > 00:33:25,939 know how the space is going to move when it's completely empty 656 00:33:25,939 - > 00:33:30,019 versus when it's completely filled with equipment or, you 657 00:33:30,019 - > 00:33:33,779 know, there's desks and chairs, and every scientist has their 658 00:33:33,779 - > 00:33:38,259 own set of pipettes and scales and beakers and uh uh you know 659 00:33:38,499 - > 00:33:39,939 materials, things like that. 660 00:33:40,099 - > 00:33:43,219 So I think that there's a lot that we can learn here about 661 00:33:43,539 - > 00:33:46,979 what does it mean to actually be ready for these things? 662 00:33:47,139 - > 00:33:51,059 These are not just a timeline that's being met, these are not 663 00:33:51,059 - > 00:33:55,139 just a checklist of items to say, yes, this is ready. 664 00:33:55,299 - > 00:33:56,259 This is a decision. 665 00:33:56,899 - > 00:34:00,979 This is a decision that is uh, you know, really should be 666 00:34:00,979 - > 00:34:05,539 between the project team and the operations team to say, hey, 667 00:34:05,939 - > 00:34:09,139 we've had the conversations, we know what we're gonna do. 668 00:34:09,300 - > 00:34:12,420 And uh to your point, doing these things in the beginning, 669 00:34:12,579 - > 00:34:16,259 in the middle, towards the end, I think is a really fantastic 670 00:34:16,259 - > 00:34:19,860 approach to make sure that we're still all on the same page. 671 00:34:20,019 - > 00:34:23,860 And if we've had to make any adjustments, you know that there 672 00:34:23,860 - > 00:34:27,460 is a point in time where you're gonna come together and discuss 673 00:34:27,460 - > 00:34:30,820 those adjustments and discuss what needs to change based on 674 00:34:30,820 - > 00:34:34,259 the pilot, based on, you know, perhaps by the time that you, 675 00:34:34,340 - > 00:34:37,860 you know, wanted to order something or some kind of asset, 676 00:34:38,019 - > 00:34:39,219 the body of it changed. 677 00:34:39,300 - > 00:34:42,659 And now it takes up a little bit more space than initial because 678 00:34:42,820 - > 00:34:46,019 there was a recall and they changed the refrigerant coil or 679 00:34:46,019 - > 00:34:46,980 whatever the case is. 680 00:34:47,139 - > 00:34:50,900 So I think it just it really speaks to a lot of potential for 681 00:34:50,900 - > 00:34:51,219 there. 682 00:34:51,460 - > 00:34:55,139 Um, what's also nice is sometimes you don't know what 683 00:34:55,139 - > 00:34:58,739 you're lacking out of your out of your onboarding program, out 684 00:34:58,739 - > 00:35:00,579 of your facilities and maintenance program. 685 00:35:00,739 - > 00:35:04,740 So what's great about it is that we have developed this 686 00:35:04,740 - > 00:35:09,060 assessment that looks at just these things and we assess the 687 00:35:09,380 - > 00:35:14,420 asset data that you have, the criticality, we test you to see 688 00:35:14,420 - > 00:35:16,900 where you guys are as an organization. 689 00:35:17,060 - > 00:35:20,180 Are you do you have a log that shows you how critical these 690 00:35:20,180 - > 00:35:23,940 pieces of equipment are to your operations, to your delivery of 691 00:35:23,940 - > 00:35:24,660 your facilities? 692 00:35:24,820 - > 00:35:29,380 Is it clear who's handing off and who's receiving the 693 00:35:29,380 - > 00:35:31,060 governance, who's making decisions? 694 00:35:31,220 - > 00:35:34,180 What extra support do you need outside of being ready? 695 00:35:34,340 - > 00:35:37,620 Who do you need to have available to hop in whenever 696 00:35:37,620 - > 00:35:38,980 there's going to be some sort of issues? 697 00:35:39,140 - > 00:35:40,580 Do you have spare parts? 698 00:35:40,660 - > 00:35:42,500 Do you have vendor support established? 699 00:35:42,660 - > 00:35:45,940 You don't want these critical pieces of equipment to just stop 700 00:35:45,940 - > 00:35:48,740 and then say, we don't know who to contact. 701 00:35:48,900 - > 00:35:52,900 And then I think what doesn't get spoken about enough in this 702 00:35:52,900 - > 00:35:54,740 industry is the training. 703 00:35:54,820 - > 00:35:57,620 And it's not just the training, it's the competency. 704 00:35:57,780 - > 00:36:01,380 If you're training without competency, you're training 705 00:36:01,460 - > 00:36:02,660 probably stunk. 706 00:36:02,820 - > 00:36:06,580 You're probably not delivering the training the right way, 707 00:36:06,820 - > 00:36:10,580 where you can ensure the folks on the receiving end are 708 00:36:10,580 - > 00:36:11,860 competent to execute. 709 00:36:12,100 - > 00:36:13,940 SPEAKER_00: Yeah, and I think the training piece is really 710 00:36:13,940 - > 00:36:16,420 important because we I think in especially in our industry, we 711 00:36:16,420 - > 00:36:20,500 have a lot of these uh read and understand, which is like I love 712 00:36:20,500 - > 00:36:21,060 those, right? 713 00:36:21,220 - > 00:36:24,580 You just scroll to the bottom, you scroll to the bottom and hit 714 00:36:24,740 - > 00:36:25,220 I read it. 715 00:36:27,780 - > 00:36:31,620 How is anybody supposed to read and understand a 30-page 716 00:36:31,620 - > 00:36:35,460 document with no pictures and just all text on how to operate 717 00:36:35,460 - > 00:36:37,860 this not even a piece of equipment? 718 00:36:38,180 - > 00:36:40,420 SPEAKER_02: And it might not even be your domain. 719 00:36:40,580 - > 00:36:44,340 I mean, I've had read and understands that were, you know, 720 00:36:44,420 - > 00:36:46,580 this is when I was first starting out. 721 00:36:46,900 - > 00:36:51,940 I was at an organization that was on the brink of their first 722 00:36:51,940 - > 00:36:53,220 phase three trial. 723 00:36:53,380 - > 00:36:56,260 So towards the end, all of these regulatory things started 724 00:36:56,260 - > 00:36:57,220 popping out. 725 00:36:57,460 - > 00:37:00,740 I barely understood the language of pharma at that time. 726 00:37:00,900 - > 00:37:03,540 And it was these read and understands of like 15, 20 727 00:37:03,540 - > 00:37:03,780 pages. 728 00:37:03,860 - > 00:37:06,900 I'm like, I don't understand half of the definitions in this 729 00:37:06,900 - > 00:37:09,300 documentation because this is not my forte. 730 00:37:09,620 - > 00:37:11,460 I was a scientist, I was a bench scientist. 731 00:37:11,540 - > 00:37:14,340 You I'll talk to you about cell culture and protocols and all 732 00:37:14,340 - > 00:37:15,380 that stuff all day. 733 00:37:15,540 - > 00:37:17,860 But then regulatory with the clinical trials. 734 00:37:17,940 - > 00:37:20,900 I mean, this was almost 10 years ago, and I was just sort of 735 00:37:20,900 - > 00:37:24,580 like, okay, I'll just click that I read, that I understand it. 736 00:37:25,220 - > 00:37:26,020 Really don't. 737 00:37:26,100 - > 00:37:28,980 I I don't even know that I would be called upon this. 738 00:37:29,060 - > 00:37:33,060 And that's another thing that we often see is um sort of 739 00:37:33,060 - > 00:37:37,060 recycling what the training requirements are for people, 740 00:37:37,220 - > 00:37:40,500 even if they're not relevant to that person's role. 741 00:37:40,660 - > 00:37:43,620 SPEAKER_00: So yeah, and and unfortunately, I I think because 742 00:37:43,940 - > 00:37:48,420 because there are so many trainings required, I think you 743 00:37:48,420 - > 00:37:51,460 you you really have to pick and choose which ones you're going 744 00:37:51,460 - > 00:37:55,300 to have for in-person trainings, or maybe you're going to develop 745 00:37:55,300 - > 00:37:58,580 a presentation for or video for, because it can't be all of them, 746 00:37:58,660 - > 00:37:58,820 right? 747 00:37:58,900 - > 00:38:01,700 You don't want to bog down people to have to watch 50 hours 748 00:38:01,700 - > 00:38:04,740 of videos because it you want these videos to be concise, but 749 00:38:04,740 - > 00:38:07,940 at the same time enough for the person to be able to do their 750 00:38:07,940 - > 00:38:10,020 job and do their job well, right? 751 00:38:10,100 - > 00:38:13,620 Not just to do the bare minimum, but to understand the reasons 752 00:38:13,620 - > 00:38:15,700 why these instructions are important. 753 00:38:15,860 - > 00:38:17,940 Um, I I think you know, just going back to what you said 754 00:38:17,940 - > 00:38:20,180 before, like those different areas where you're looking at 755 00:38:20,180 - > 00:38:23,380 the asset data, the handoff, support and and the training. 756 00:38:23,540 - > 00:38:28,100 I think in in short, what we want at the end of the day is 757 00:38:28,100 - > 00:38:33,700 for whoever is using the equipment of the facility to be 758 00:38:34,340 - > 00:38:40,820 not only prepared to use it, but feel supported in if they needed 759 00:38:40,820 - > 00:38:43,300 help with something, they know where to go, right? 760 00:38:43,700 - > 00:38:46,500 I think the the worst case scenario is that they they end 761 00:38:46,500 - > 00:38:48,740 up standing in front of something and they start using 762 00:38:48,740 - > 00:38:52,260 it and they get confused and they don't know who to turn to. 763 00:38:52,420 - > 00:38:54,820 And then they start making mistakes where they could be 764 00:38:54,820 - > 00:38:57,540 scary, it could be they could break things, void warranty, 765 00:38:57,700 - > 00:38:59,460 like all these different risks that are. 766 00:39:00,180 - > 00:39:01,220 SPEAKER_02: Void warranties, yeah. 767 00:39:01,300 - > 00:39:02,100 That's exactly right. 768 00:39:02,180 - > 00:39:02,500 Yeah. 769 00:39:02,820 - > 00:39:07,300 So you know it's uh it's a very challenging place, and and and I 770 00:39:07,300 - > 00:39:11,060 have to say, with the technology that's available now, with with 771 00:39:11,220 - > 00:39:15,700 the ability for AI to generate documents, the ability for this 772 00:39:15,860 - > 00:39:16,740 this plethora. 773 00:39:16,820 - > 00:39:20,180 I mean, we use some of these software that allow us to create 774 00:39:20,180 - > 00:39:24,980 training videos very quickly, very seamlessly, with uh photo, 775 00:39:25,380 - > 00:39:28,980 you know, of where I clicked in the system, et cetera. 776 00:39:29,220 - > 00:39:33,940 These are all different tools to support that competency and that 777 00:39:33,940 - > 00:39:34,260 training. 778 00:39:34,420 - > 00:39:37,540 And I think that we need to be a little bit more, we as 779 00:39:37,540 - > 00:39:40,260 organizations need to be a little bit amenable to 780 00:39:40,260 - > 00:39:43,060 introducing those types of things rather than saying we're 781 00:39:43,060 - > 00:39:46,580 just gonna create a PowerPoint and we're gonna hold one session 782 00:39:46,580 - > 00:39:48,740 or two sessions for people to come and check. 783 00:39:48,900 - > 00:39:51,460 We're gonna record it and we're gonna put it in this folder that 784 00:39:51,460 - > 00:39:52,980 no one's ever gonna find. 785 00:39:53,220 - > 00:39:55,780 You know, we have to try a little bit harder than that to 786 00:39:56,020 - > 00:39:57,780 make this actually successful. 787 00:39:58,340 - > 00:40:02,340 SPEAKER_00: Yeah, I think, you know, just shooting out an idea 788 00:40:02,420 - > 00:40:05,700 here is we there are a lot of people that have been using 789 00:40:05,700 - > 00:40:09,300 these meta glasses, right, for streaming purposes and stuff 790 00:40:09,300 - > 00:40:09,620 like that. 791 00:40:09,780 - > 00:40:13,860 There's no reason why we can't use those things to show other 792 00:40:14,180 - > 00:40:18,020 technicians how to calibrate something or how to repair a 793 00:40:18,020 - > 00:40:18,420 pump. 794 00:40:18,580 - > 00:40:21,620 If you just had the classes and you showed the video and you had 795 00:40:21,620 - > 00:40:24,900 the person do it the right way and then watching that, and then 796 00:40:24,980 - > 00:40:28,820 hey, refer back to the the SOP of the work instruction if you 797 00:40:28,820 - > 00:40:32,820 want the thing written out, but go to the video and just look at 798 00:40:32,820 - > 00:40:33,860 how these things are being done. 799 00:40:33,940 - > 00:40:37,540 It's just much more technology is available now that makes it 800 00:40:37,540 - > 00:40:40,500 much more accessible and and just easy to kind of do this 801 00:40:40,500 - > 00:40:42,180 type of training. 802 00:40:42,740 - > 00:40:44,260 SPEAKER_02: Absolutely, absolutely. 803 00:40:44,660 - > 00:40:49,060 I think, I mean we nailed the you nailed the topic. 804 00:40:49,220 - > 00:40:53,380 I think it's incredibly critical for us to understand all these 805 00:40:53,380 - > 00:40:57,460 different layers that come into play when we're talking about 806 00:40:57,460 - > 00:41:00,340 bringing in assets into a facility, whether it's a new 807 00:41:00,340 - > 00:41:03,140 facility or one that has built been been built and you're 808 00:41:03,140 - > 00:41:07,220 introducing one or two more assets into their fleet of 809 00:41:07,620 - > 00:41:12,820 tools, you know, from the criticality to the uh the the 810 00:41:13,140 - > 00:41:17,060 handoffs, the responsibilities, the decision making, where the 811 00:41:17,060 - > 00:41:20,980 support's gonna be, what you surround yourself with to ensure 812 00:41:20,980 - > 00:41:26,340 that you have longevity in your operations from the start, as 813 00:41:26,340 - > 00:41:29,140 opposed to hitting roadblock after roadblock after roadblock, 814 00:41:29,220 - > 00:41:33,780 making sure we're training and uh ensuring that competency and 815 00:41:33,780 - > 00:41:34,900 not just compliance. 816 00:41:35,060 - > 00:41:39,780 Compliance is important, it is, but it's not uh equate 817 00:41:39,780 - > 00:41:40,500 readiness. 818 00:41:40,740 - > 00:41:44,340 So I think as we're evolving our understanding of being ready in 819 00:41:44,340 - > 00:41:49,700 any situation, it's beyond that timeline and and those check 820 00:41:49,700 - > 00:41:53,940 marks and is a decision for us that we need to make and take 821 00:41:53,940 - > 00:41:56,500 seriously in any particular scenario. 822 00:41:56,740 - > 00:42:00,100 So lucky for the folks, for our listeners, uh we have the 823 00:42:00,100 - > 00:42:00,740 assessments. 824 00:42:00,900 - > 00:42:04,660 If you guys resonated with anything that you guys uh have 825 00:42:04,660 - > 00:42:08,340 heard here, please check out our risk assessments at Sigma Lab 826 00:42:08,500 - > 00:42:11,220 Consulting.com slash assessments. 827 00:42:11,380 - > 00:42:14,500 Um, also on sale now, it's available. 828 00:42:14,660 - > 00:42:17,220 I'm back, so you'll be hearing me talk about it a little bit 829 00:42:17,220 - > 00:42:17,380 more. 830 00:42:17,700 - > 00:42:19,060 Predictably broken. 831 00:42:19,220 - > 00:42:23,780 My new book on fixing failures in biopharma operations is on 832 00:42:23,780 - > 00:42:26,180 sale now, and you can find out more about it at Sigma Lab 833 00:42:26,340 - > 00:42:29,620 Consulting.com slash predictably broken. 834 00:42:29,780 - > 00:42:32,900 So if you have an idea, send us a message through our interest 835 00:42:32,900 - > 00:42:32,980 form. 836 00:42:33,220 - > 00:42:35,060 It shows up in our show notes. 837 00:42:36,260 - > 00:42:39,860 Lawrence, I think we did okay coming back from uh a little bit 838 00:42:39,860 - > 00:42:40,740 of a hiatus. 839 00:42:40,900 - > 00:42:42,420 SPEAKER_00: Yeah, this this was uh this was good. 840 00:42:42,500 - > 00:42:44,340 We're we're getting back into it and it was good. 841 00:42:44,580 - > 00:42:46,100 It feels good to flex that muscle. 842 00:42:46,340 - > 00:42:48,660 SPEAKER_02: Yeah, just in time for the summer where everybody 843 00:42:48,660 - > 00:42:49,780 uh goes on vacation. 844 00:42:49,860 - > 00:42:53,380 So hopefully as you go on your vacation, your family might not 845 00:42:53,380 - > 00:42:54,020 appreciate it. 846 00:42:54,180 - > 00:42:56,900 But if you decide on your road trip to listen to these 847 00:42:56,900 - > 00:42:59,540 episodes, we certainly appreciate it. 848 00:42:59,780 - > 00:43:00,820 So thanks a lot. 849 00:43:00,900 - > 00:43:03,780 Thanks, Lawrence, and until next time, see you guys.