From Root Cause to Roadmap: Rethinking CAPA with Attrayee Chakraborty

Transcript

[00:01:13] Josh: Our next guest may be early in her career, but she’s already making a name for herself in the world of manufacturing quality. She’s worked across startups and global companies to help build and manage quality systems that meet the demands of medical device and digital health production.

[00:01:29] Josh: At Analog Devices, she leads Kappa Investigations, conducts supplier audits and supports product lines under ISO 13,485 and FDA regulations, bringing a hands-on systems driven approach to ensuring product reliability and compliance. Her cross-functional work spans engineering operations and regulatory teams, and she was recently named Quality Magazine’s 2025 Rookie of the Year, as well as a rising star.

[00:01:57] Josh: By the Regulatory Affairs Professionals Society. Please welcome to the show, Atty Chakraborty.

[00:02:03] Josh: Atty, thanks so much for being here.

[00:02:06] Attrayee: Thanks, Josh. it’s great to be here. Thanks for the invite.

[00:02:09] Josh: Yeah, we’ve been going back and forth for a while now. We got connected originally through the A SQ conference earlier this year, and it’s been a game of tag and rescheduling since then. So I’m really excited to lock you down and get you here and, pick your brain on a couple of topics.

[00:02:25] Attrayee: Yeah. thanks for, the invite and like it’s, again, it’s great to be here.

[00:02:30] Josh: Yeah. Yeah. today we’re talking about Design Quality Kappa and the intersection between the two. But before we go any further, we got a quick disclaimer here. The perspectives that Atty shares today, those are hers and hers alone. Isn’t that right? Atty?

[00:02:45] Attrayee: Yep. Yep. They don’t represent any organization I’m part of.

[00:02:49] Josh: That’s right. So keep that in mind. Don’t at Atty and claim that she said something on behalf of someone else. ’cause that’s not true. She’s, everything she shares is on behalf of Atty, so don’t add her. In fact, I think that there’s maybe a tagline there for you don’t at Atty or maybe at Atty. Just think

[00:03:08] Attrayee: I came up with something new. Yeah.

[00:03:10] Josh: I know. Okay, great. we’re gonna start the show, like we start all of our shows. We really want to establish what does a day in the life look like for you? Now, you’re a quality system engineer. I’d love for you to share with us what does a typical day in your life look like?

[00:03:26] Attrayee: Yeah. I typically answer this, pretty like. In a very standard way for everyone, which is, it depends on which organization you’re part of and like what the general maturity of the organization is. in my current state, I keep wearing multiple hats in one day, which is very exciting. sometimes I work on Kappas, sometimes I work on training.

[00:03:52] Attrayee: sometimes it’s on like the tools that we use for EQMS. And also, the o other projects that I’m associated with when it comes to, from the quality standpoint. so there’s a lot of like miscellaneous stuff that I do. there’s things about like process improvement, about system integration, about capturing user needs and like defining an EQMS system, which works for us.

[00:04:16] Attrayee: it’s been, a rollercoaster journey. So because, initially like when I started it was like, very, things need to get done right now kind of thing. So more reactive. And right now I’m going into that phase where I’ve, most of my work is more proactive in nature,there’s also audits and stuff like that, which, I support as well.

[00:04:36] Attrayee: So it’s pretty, like exciting. every day is different, so yeah.

[00:04:42] Josh: that’s a very common theme in as an answer. To this question is that every day is different, and while you have some things, you are fairly confident that you’re gonna have to work on the demands of the day really kinda pull you in a variety of different directions. So you broke down a lot of things.

[00:05:00] Josh: We also used some acronyms, I think that’s the right word, acronyms, because we said Kappa, we said EQMS. Just wanna make sure that we’re all on the same page as to what we’re referring to. Kappa Corrective action, preventative Action. Correct.

[00:05:14] Josh: Yep. Okay. And EQMS, electronic Quality Management System.

[00:05:20] Attrayee: yep.

[00:05:20] Josh: Okay, great.

[00:05:21] Josh: See, it’s a quiz, for myself as well. multiple hats Kappa training. Looking at the tools that you use for EQMS, process improvement, gathering user feedback, you mentioned audits, et cetera. you said that you’ve also, have moved from reactive to more proactive. Now that’s. A pretty interesting thing.

[00:05:42] Josh: A lot of people that we talk to very much describe that reactive state. I’d love if you could share that concept a little bit more about that concept of how you helped move from a reactive to a proactive state.

[00:05:59] Attrayee: Yeah, that’s like a very interesting question. And, I think, it’s something which I value a lot when I reflect upon, all the experiences I’ve had. mostly it’s. If I were to summarize it in one sentence, it would be teaching someone to fish rather than getting the fish for them, which is like this very, very popular, proverb.

[00:06:19] Attrayee: and,in the reactive state, I found myself a lot where I was, facilitating people in certain senses to get things done, but when I was understanding why they were not getting something done, for example. Or they needed support on something. It’s mostly because they didn’t have enough clarity on what they were doing or why they were doing it and the best way to do it.

[00:06:42] Attrayee: so those,while I was in the reactive state, I was able to get those inputs that these are the things which let’s say engineers or,whichever the individuals I’m dealing with they are having a problem with. And those were. Like very good feedback for me to incorporate in the processes that I was driving.

[00:07:02] Attrayee: So what happened was that I started implementing those things and trying to find out ways to, create those, systems that would support those user needs. And what happened was that, everyone like, It was very easy to get stakeholder buy-in and like it was very easy for me to demonstrate why we should be sure,changing a process, for example, or justifying it to even my management of why we need to do something.

[00:07:30] Attrayee: And, it became a situation where I could get buy-in from the stakeholders as well as management. And it was a well-balanced situation where,I could drive process improvement. Thinking about compliance of course, but also thinking about the user, the fin, the final user of that tool or something like the engineer, for example.

[00:07:50] Attrayee: So it, it was, a very exploratory and reflect reflective experience in that sense. But that’s usually like how my experience has been. Yeah.

[00:08:01] Josh: If you had to. Estimate. I’m sure this is gonna be a hard question to pinpoint, but if you had to estimate that timeline of that transition of moving from a reactive state to a proactive state, how long would you say it, it took you to really help shepherd that transition?

[00:08:19] Attrayee: Yeah. I think around six months, honestly. ’cause when I initially joined,you have these set of deliverables which you need to do because, they are urgent. And, I often use this Eisen power matrix, which is like you, decide which tasks are important, and which are.

[00:08:40] Attrayee: Must like, which you must do, which you can do later, which are nice to haves. And it was easy for me to categorize those things in that matrix and present it to management or even other stakeholders and ask them that, are they aligned with what I’m thinking? Because that was helping me to prioritize which things should be driven as process improvements versus which things are, urgent need to be done asap.

[00:09:08] Attrayee: And yeah.

[00:09:10] Josh: I have never heard of the Eisenhower Matrix. I’m gonna have to look that up because my system of prioritization is a to-do list that I’ll take a look at and I’ll say, I’m gonna drag this one to the top, but then I forget about some other ones. So that sounds like something that could help. Me out in my own day to day.

[00:09:28] Josh: okay. Six months. that’s, to some, a long time to others, a short time. Particularly when we start thinking about larger organizations. Six months is actually pretty fast to make a change. I imagine you’re having to balance throughout this situation where you’re still having to solve certain headaches and problems that have popped up during that, that you’re.

[00:09:51] Josh: Trying to correct over the course of that six months, but you’re still having to like deliver some sort of res resolution to in the meantime because it can’t wait the full six months.

[00:10:01] Attrayee: Yep. Yep. I would, I definitely agree with that statement, and there’s always a balance where, let’s say, you know that something needs to be done and, but you are in this reactive fire mode where things pop up and they have to be handled immediately, which kind of, pushes out your timeline when it comes to doing those proactive things.

[00:10:26] Attrayee: It’s very important to like plan things accordingly. So for example, quality plans, they can be like really good ways to, demonstrate that that you have thought about those process improvements. And, you are, like you have certain solutions in the back of your mind, but you estimate a certain time for that.

[00:10:46] Attrayee: And it really helps in audits as well, because. let’s say you know that you have a process, which is probably not the best, but it is getting you by in terms of compliance. Probably not the most user friendly way, but, it’s still getting you by through audits. But, if you have the quality plan to show that, you’ve thought about it and or if it’s there in the management reviews in some way or shape or form, then it demonstrates your commitment to improving it.

[00:11:13] Attrayee: And, I’ve seen the psychological changes as well because, initially people would think that, oh,these are, there are so many problems in this thing and why are these not getting solved? And even though in the back of my mind I knew that I will work on this in the next time I have a chance.

[00:11:29] Attrayee: it’s easier to point to the quality plan even to stakeholders and say that, listen, like these are things that we have incorporated. Please be patient like we are doing this, we are getting through it. And, also winding down the existing systems as well. So whenever, let’s say I’ve had a tool change where, I proposed a different way of doing something.

[00:11:49] Attrayee: it was more about like, how do we put the legacy system down? Like how do we wind down that legacy process that we were using? And how do we adapt ourselves to move into the new process? there’s a lot of questions which come around that as well, and how do we transition smoothly into the second phase or the second process improvement that we were talking about?

[00:12:12] Attrayee: yeah, I hope I answered your question. It was very long winded answer, but Yeah.

[00:12:16] Attrayee: Oh, I love long-winded answers because they give me so much more to ask questions about. Have you ever noticed that? Like you never get a final answer unless you’re on who wants to Be a Millionaire, Yeah.

[00:12:29] Josh: But any answer you get, at least for me, there’s often another question that comes from it, and your answer gave me plenty of questions, and so I’m gonna throw another one at you.

[00:12:39] Josh: You mentioned quality plans, and to me it sounds like that’s your roadmap. Here’s where we’re gonna prioritize our time, our efforts, here’s why, et cetera. What would you say makes a strong quality plan?

[00:12:53] Attrayee: Yeah, that’s again, a great question. most importantly, just like any other quality process, it’s very important to know what the problem statement is. And this is again, where the user feedback plays a huge role. in my experience, like there was a certain process I was working on, which. Again, it was meeting our compliance needs, but not the best to work with.

[00:13:15] Attrayee: and I was, whenever I used to go in, people used to tell me, Hey,this is not the best thing, or that is, that might be improved. So instead of listening to people, I started making a spreadsheet and I circulated it all across the business unit I was associated with.

[00:13:30] Attrayee: And I said that, you know what, why can’t, why don’t you put your thoughts here? And then let’s, and talk to the tool owner and let’s come up with some solutions which can address it. And based on the business unit’s priority, we can decide which to tackle first. And that kind of gave, a lot of like clarity into what the, what the different asks were.

[00:13:54] Attrayee: And also it gave the sense of, being heard. From the stakeholder perspective. So it wasn’t as if we were defining the problem statement in silos. that really worked out well. And once the problem statement was there, the obvious question was that how do we solve this? again,there can be different ways to do this.

[00:14:11] Attrayee: Some people prefer to just have a blank sheet of paper and go in and discuss with the team. some people would like to, propose certain solutions like a draft. And then discuss them with stakeholders as they go on. again, it depends on where, what the culture of the organization is and how, peeved are they with that particular process.

[00:14:33] Attrayee: If they’re, if they are in a situation where they can think of contributing, directly, then a blank sheet of paper is probably better. But, if they are in a situation where they want an answer immediately. Better to just come up with some draft solutions and go in and then just review with them and think about the timelines, think about, whether they would accept them or not.

[00:14:54] Attrayee: Is there something else that they would want? And, while executing those quality plans, like I’ve had multiple stakeholder meetings, like not just at the kickoff when I used to just start the project, but also every month I, I did this very religiously every month I used to have these stakeholder calls.

[00:15:11] Attrayee: Like over a week where I would just show the solutions that we have, the status update and also like just to hear any concerns that they might have or any comments or anything that they would like to share. And that would again, help solidify the quality plan even more, or give us more ideas, which we didn’t think about.

[00:15:31] Attrayee: it’s in, in my experience, it’s very difficult to maintain the stakeholder engagement, but it’s. Extremely important. And the only way to do it is to just show up all the time and show that you are, thinking about them and that you are taking effort on the user needs, which they are communicating to you.

[00:15:55] Attrayee: So it’s a lot about structure eventually. Yeah.

[00:15:58] Josh: Yes. Sounds like you brought a process overall of here’s the quality plan, here’s the roadmap of the things that we’re gonna work on. And a lot of it is made up of what you’re telling me, the things that you’re saying need to be addressed or fixed, which I imagine is like the number one requirement to get stakeholder buy-in.

[00:16:17] Josh: You’re not coming to them saying, we’re gonna change this thing, we’re gonna change it this way. We’re gonna do it because Atty says, so don’t add Atty. Which I should really consider trying in your next stakeholder meeting, one of the things that you called out was it can be difficult to maintain stakeholder engagement.

[00:16:36] Josh: Why is that?

[00:16:38] Attrayee: Yeah. I think it comes down to the question of what’s in it for me? And also, it depends on the priorities of the business unit, right? Because. like I work in quality, but there are so many other folks in engineering who are working on other kinds of problems and they might get pulled into all of that.

[00:16:55] Attrayee: And that’s something which is a bit difficult because,if you look at the typical Six Sigma process,you would think that like it’s easy to get resources and that he would commit to the resources before starting the project. However, in reality, it depends again, on the organization, high chance that it will change, people will get moved into more urgent things, and then you might be, stuck in your progress.

[00:17:18] Attrayee: that’s why it’s important to show the role of the stakeholder and like what value they would add. that’s where again, going back to the Eisenhower Matrix, which I was talking about, like if you can break down the actions in your quality plan as to like the priority and What role does that person have in executing that high priority task?

[00:17:38] Attrayee: Then it’s much more easier to convince to management why they should be on your plan instead of doing something else. that’s one major thing. And the other thing is the interest as well. Initially when people feel that, they are being heard. And that, their user needs are being incorporated in future process improvements.

[00:17:57] Attrayee: They might lose interest there. they might trust you and say that, okay, they’ve heard us, it’s fine. Like they’ll sort it out and then they might just drop there and, which is fine. it’s just that, you just need to keep them informed and in the loop as you go ahead and, so that they don’t feel that the project is stagnating.

[00:18:16] Attrayee: and a lot of the things of a successful project is actually the impression of it also, like in the sense that, of course you will meet the deliverables, you will plan it accordingly. Everything will be done. But it’s also how it’s executed in terms of communication or even about, how do stakeholders feel about the project?

[00:18:37] Josh: do they feel confident about it? Or do they feel that it’s just, a bandaid and you probably do something more. So honest feedback is very difficult to obtain and it’s a lot of trust gets associated with it. Yeah, because perception makes reality and the perception doesn’t even have to be. Accurate, right? You could be completely off base, but if that is the perception that people are left with, then that’s what they’re gonna remember. That’s what they’re gonna think is gonna be true, because you see that all the time, at least with the folks that I talk to, a lot of times. 

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[00:20:11] Josh: One of the things when, when I am able to go to factories and talk with folks, one comment that I hear a lot, and this is both from operators working with the machines to even supervisors and managers that are responsible for leading them, is this comment of,nobody listens to me.

[00:20:31] Josh: I report something. Nobody does anything about it. And when I bring that up to the leadership, they, they’re not surprised, one by that sentiment. It’s never a surprise. But the other part is oftentimes people are doing stuff based on that feedback, but they’re not following up with folks saying that thing, you called out, here’s what we did, or here’s what we decided.

[00:20:56] Josh: In a lot of cases, the decision might be, it’s a good idea. We want to do it. We, it’s just not a business priority right now. And even that helps. but when it feels like nobody is responding, that’s where breakdowns occur. ’cause then the next part of that is, that’s why I don’t say anything. And you can’t have that.

[00:21:15] Attrayee: Yeah,

[00:21:15] Josh: cannot have that. Now there’s a lot that you called out that I want to. Touch on, and we got onto this topic because we were talking about that transition from reactive to proactive. And as I was asking those questions, I couldn’t shake this thought of my mind, which was, man, that sounds.

[00:21:33] Josh: Like a lot of work, a lot of time, a lot of effort when maybe it could feel a little bit easier in the moment to, really just say I’m just gonna fix the problem that’s been brought up. here’s that reactive approach. It’s very tempting because in the moment that might be the quickest and fastest solution.

[00:21:52] Josh: But I love that you took a little bit of a longer term perspective of okay, how can I save myself time in the future? so that these issues don’t come up. We’re not repeating these same issues over and over again. Your perspective that you broke down, teaching someone to fish, really helping them understand how to either tackle the situations or working together with them to make sure that.

[00:22:14] Josh: They don’t even, it’s not even possible for them to get into the situation to begin with. one of the themes that you came up with pretty consistently was this idea of buy-in, stakeholder buy-in. I need stakeholders of the people who are gonna be participating. I need buy-in from the folks who are going to be signing off on the decisions, especially if there’s any sort of expenditure needed in order to make the improvement.

[00:22:37] Josh: so I love that you really focused on. Soliciting the feedback directly from the folks who would be involved. Hey, I need your help. I need your help because you’re the only person that can do this aspect or can provide this guidance, and here’s also how it’s gonna better your role or your peer’s role.

[00:22:55] Josh: So you’re tying it to something that they care about, and then you’re going to the business and say, team. If we do this, if we tackle this, here’s the expected result. What’s the business priority? Do we wanna prioritize X or Y? Okay, this actually aligns with Y, so you’re on board with us pursuing it.

[00:23:14] Josh: Great. I’ve got it in writing. And then to f. Bring this all home. You’re constantly informing everyone and reminding them, Hey guys, we’re working on this. We’re working on this because we agreed to work on this. let me know if that priority has changed for anyone. It doesn’t sound like it’s changed, so let’s work together to get this.

[00:23:32] Josh: Hey, I know you couldn’t join. Here’s the latest updates. That’s a lot of work. That’s a lot of effort. That’s a lot of project management. But look at the payoff transitioning in six months from reactive to proactive. Boy, that sounds like a recipe that a lot of people would wanna follow.

[00:23:50] Attrayee: Yeah. Thank you for that.

[00:23:52] Josh: Yeah. you started off the conversation, we talked about, what the day in the life looks like.

[00:23:57] Josh: It ebbs and it flows. You mentioned multiple hats, Kappa training tools for EQMS, process improvement, user feedback. previously when we had, started talking, one of the things that you had mentioned was. Design quality and design quality being something about your role that gets you excited. I’d love for you to share how you define design quality and what exactly excites you about working with it.

[00:24:24] Attrayee: Yeah, that’s again, a great question. as part of the Kapa process, like I get. Drawn into design quality quite a bit because, of how, let’s say there was a failure and that triggered a cappa and then, as part of the corrective actions, the preventive actions, that’s where the improvement would most likely, manifest itself. so for me, I think I would not say it’s design quality. I would rather term it as general product quality because, it’s. Mostly like it’s a cumulative effort of everyone in quality, and the only metric for its success is a successful product on the field. with like acceptable failure rates or like less failure rates.

[00:25:11] Attrayee: I, it’s sometimes difficult to explain, that concept, but I’ll try my best. the way I. Interpret it or the way I’m involved with it is, let’s say like you have a certain capa about, let’s say a certain component in a device or something. And, you are working with engineers who are the SMEs in that process.

[00:25:34] Attrayee: And, they should technically know the best about that particular aspect of the product. But you are also like guiding them in terms of thinking about the product as well. And, many of those are related to the design as well. it’s interesting because, many times during these Kapa investigations, when I review material or I help go through the investigations with the folks I work with,it’s sometimes very.

[00:26:00] Attrayee: Easy for me to understand why something went wrong, but it’s more because I am probably a fresh set of eyes who’s looking at this from the get go, like from this, from, a new perspective. and it’s sometimes, very evident to me why something went a certain way. And, sometimes these changes are very hard to commit to.

[00:26:19] Attrayee: And there’s a lot of Layering when it comes to thinking about a problem. And, it’s again, not intentional, but when there are changes to design, people freak out ’cause they’re like, oh my God, there is this CPA who just triggering this design change. I don’t know what else I need to fix.

[00:26:37] Attrayee: And is this gonna be a regulatory submission? Is this gonna be like a huge deal? People like freak out, but, Eventually when you go through the whole process and you come up with the corrective action and the effectiveness checks as well, that’s when you affect the quality culture in a sense as well, because you are holding people accountable to a higher standard of quality in a sense.

[00:27:03] Attrayee: So what probably, let’s say there was, a certain component in a device which had a certain. certain failure rate, and it wasn’t like a big deal to most engineers, but maybe for some reason a couple was triggered. And then you go through the whole process and then in the effectiveness check you have this standard where like that, 95% should, let’s say, not have failures or like something like that.

[00:27:28] Attrayee: And then it makes people think about it because. Why are we holding ourselves accountable to such a high number? For example, people start asking those questions and then it comes down to like, why are we not doing that? And also it starts, you start like engineers would start to think about like how the design can be improved to ensure that is met instead of going with a design and hoping it works.

[00:27:58] Attrayee: Is it, the question becomes more of, is this adequate to, is this gonna help customers be satisfied? it’s a mental transition where you see people saying that, is this just enough to get us out into the market? Versus is this something that is gonna make us stand out? and it’s beautiful to see that because engineers start thinking about other things that they can change and.

[00:28:24] Attrayee: That’s why the preventive action also comes in place because when a defect arises, you can think about the other places where it has arisen and you start getting them thi to think about where those other potential failure failures might also occur. which can again, spur a number of other design changes.

[00:28:41] Attrayee: in that sense it is like a very nice transition to see that. Where people go to okay, this was the requirement. I met the requirement to, how can I elevate that requirement to make it, make it more robust?

[00:28:55] Josh: Yeah, it’s this mental transition of moving from requirements as they check the box. We have to check the box on these requirements to, really embracing the whole point of the requirements, right? Because what’s the point of the requirements? It’s to ensure. Ultimately customer satisfaction.

[00:29:17] Josh: Really, if the customer doesn’t like your product because it was poorly designed,to a point you made earlier. There’s really no product quality if there’s poor design. Quality, right? It affects the whole product, which affects the whole customer experience, which affects whether or not you’re going to have a product that people are going to want to buy.

[00:29:38] Josh: ’cause your goal is not to bring the product to market. Your goal is for the customer to buy it, use it, love it, want more. Tell your, tell their friends about it. at Atty, I love this product kind of thing.

[00:29:55] Attrayee: Yeah.

[00:29:56] Josh: So I’m imagining in this process you have to make sure that the engineers are a part of the kappa, or are you bringing them the results of the Kappa?

[00:30:04] Josh: How? How does that work?

[00:30:06] Attrayee: Yeah, it’s, it depends on the problem statement, of course, but, at the beginning, right at right at the beginning when a cappa is being initiated or triggered, that’s the best time to identify the stakeholders. of course you need to think about the containment and correction. That’s like the number one priority, but when you’re going into the investigation before even going in, that’s what has worked out for me that identifying, very clearly identifying who the stakeholders are and what their role is in that process, not just the designation.

[00:30:39] Attrayee: So let’s say someone is a principal engineering lead. so what am I doing here? So it’s very clear to understand that, to make the person understand what role they have,that they’re probably an SME in packaging or in manufacturing and so on and so forth. And then, basically that would, ensure that people are aligned and you can even have RACI charts to establish that, that, to what level of involvement would you like the engineers to be with?

[00:31:07] Attrayee: And, usually it starts off with the leads, like the engineering leads who are there. And, they usually have their own subteams who like, let’s say they, they want to test a certain, certain aspect of the component. Their teams probably do most of the, like actual testing, but they report out to the larger team sometimes.

[00:31:27] Attrayee: So that’s just a way depends on the organization, how things are. In certain cases, the actual engineers who are doing the testing are fully involved. So again, it depends on the comfort level of the organization, but, what is important to establish is who would be the DRIs and, what roles would they have to play and to keep, updating that time to time as well.

[00:31:50] Attrayee: Because investigations can be lengthy and they can be like, pretty, long winded sometimes, but. Things might change in the process. So it’s important to keep revisiting that and ensure that is there and it’s very key to have that, especially from engineering standpoint because, it like prevents you to make a decision without them.

[00:32:13] Attrayee: There so many a times there has been there, the people might fi find themselves in the situations where, decisions are made. But, One or two stakeholders, were not there. And it’s sometimes unclear that do we really need these two folks in the room? Like we have eight more people.

[00:32:31] Josh: do we really need those two people? So again, going back to the RACI and like ensuring that they are there and like why they need to be there in that discussion. That’s where,that’s what makes a key difference. Yeah, it seems like Kappa is something that. It gets you a little excited. I can hear the enthusiasm and just in the way that, that you speak about it, what exactly about Kappa is resonates with you so much?

[00:32:59] Attrayee: Yeah. it, it’s act you pointed out correctly. I do feel very excited by it. so I think the major thing is that. when there is a systemic breakdown or there are certain trends of certain, inputs of the Kapa process, which, would trigger initiation, et cetera, and all of that, people feel like their hair is on fire and they feel that, oh my God, there’s such a huge problem and the, this needs to be done asap and that’s it.

[00:33:29] Attrayee: Certain things need to be done asap, of course. that’s where the containment and correction come in play. But a lot of critical thinking is involved in the investigation part itself, and sometimes because it’s very, I find it a very psychological, skill as well where you are hearing these different standpoints and these different opinions of these really, like top senior management folks, That these might have contributed to, let’s say, a defect. And, how do you remain objective and, calm in those situations without disrupting the emotional, aspects as well. So it’s difficult to, because sometimes it’s very evident that some things have happened, but it’s framing that in a positive sense is very difficult.

[00:34:20] Attrayee: And, Again, a lot of the culture as well is involved in this. I have seen teams who are very proactive and they feel that Kapa is a way to improve their processes and they do not shy away from it. And that’s a much more easier team to work with versus some individuals who feel that it’s unwarranted and like, why are we even discussing this?

[00:34:42] Attrayee: sometimes that mindset shift also like. it’s beautiful to watch because, I’ve seen people who initially feel it’s not a problem and why are we even discussing this to be like, when they’re going through this whole thought process or they’re going through brainstorming or any of the quality tools that you use, like Ishikawa or Five Wise, that’s when things open up and it’s very easy to shy away from the real root cause.

[00:35:09] Attrayee: Not because you don’t know it, but because it’s hard to accept. getting them to acknowledge that is again, a very psychological dance, I would say, because, you don’t wanna, point out certain flaws, which you can clearly see, but you also wanna respect the individual and acknowledge that the work they do is important.

[00:35:32] Attrayee: And it’s not that. They messed up or something, but something in the process broke down probably. So it’s again, like it’s a mix I feel of critical thinking a lot. And also the psychological and emotional regulation which plays into this role. and eventually you are guiding engineers to think about uncharted territory, which they’ve not thought about before.

[00:35:57] Attrayee: And it’s. It’s just a very, yeah, I would just say it’s a very beautiful thing to witness.

[00:36:04] Josh: Yeah, there’s elements that I’m picking up on of you mentioned critical thinking and then just the general psychology of change management and getting people on board with doing something differently, especially if they’ve been doing something the same way for a long time, which is certainly another topic that comes up often with people that, Come on the show here. thinking about that idea of remaining calm and objective when everyone else is freaking out about this issue, is there a secret? What do you do to remain calm? Remain objective. Find your sinner.

[00:36:43] Attrayee: Yeah. honestly, I’m still working on it. I’m not the perfect person, but I try my best. And, I think it’s be, it’s, one thing I’ve learned, which I really exercise now, is defining the problem very succinctly, which is exactly what I have seen across multiple carpas get blown out of proportion.

[00:37:05] Attrayee: again, when people, especially senior management,they start saying that, oh,this is a problem. This is a downstream effect. This is all of this. It’s very important to. Establish what is the actual defect? Is the defect something which, like how is it even labeled as a defect?

[00:37:22] Attrayee: Is it deviating from a regulation or a specification? What is it deviating from? That’s like the first question, which helps center the objectivity back. And then also,talking about, how do we, how do we. Limit the scope of this problem statement, like how much does it affect, what’s the quantity, the general, five w two edge questions, which you have about like defining a problem statement.

[00:37:47] Attrayee: But basically what I’ve seen is when initial discussions happen and people throw their ideas out there,it’s very, good and a good practice to document those things as they’re speaking. And then select the parts which are relevant to the problem statement. And then again, in the larger group, you can share your screen or if you’re in a room, you can write it on the board where you tell everyone to take a pause for five minutes and just read the problem statement and no one speaks. And then after that happens, you start opening up discussion that you know, okay, is this really what happened? Is that really what happened? Or is this as aspect of the ment a bit? like too specific, stuff like that. So that helps center objectivity back. And I know like emotions can be very high sometimes, especially when problems happen and.

[00:38:43] Attrayee: Downstream impacts might be high. again, sometimes it’s good to like just take a break from those situations and it’s good to even, ask if that individual would like to delegate the activity to someone else. for example’s, if it’s a directory position and they have delegates, like other SMEs in their team, would they be willing to discuss it?

[00:39:03] Attrayee: Because that person may not be in the best situation to talk about it. So that also helps in, putting the objectivity together and also the decision tree of it as well. That when you go through a process, like from start to finish, I’ve been trying to, do this as well where half decision trees because engineers are very visual and they really wanna see okay, so is you’re telling me if the trend is above this metric, then it would lead to a cappa.

[00:39:31] Josh: Or if the risk is above this, then that would lead to a cappa. Again, like being very visually, like appealing, like a process wise to an engineer, that also helps a lot to maintain the objectivity. Yeah. Yeah. The way I think about what you just described is understanding your audience, right? Here’s the people that I need to work with. Here’s how they prefer to receive information, consume information, go through it, and so you are adapting your approach to. The different individuals that make up the team so that together everyone can work well and collaborate and pursue the common goal.

[00:40:06] Josh: I like that you also, you in this emotional state, right? ’cause it’s how do we get back to that calm, objective approach? And as humans, what are we known for? Being calm and objective. Just kidding. that’s the,oh my gosh. What are they called? I’m blanking on it. Live on air. From Star Trek, Spock, do you know what he is?

[00:40:30] Attrayee: I don’t, but yeah. But.

[00:40:32] Josh: man. Spock. Okay. Anyway, I’m going to derail this. But the point that I was making is us as humans, we are not centered by default. We’re emotional by default. So I love that you bake in a moment of calm and quiet. We’ve done all this work. It may have been a little stressful getting here. Let’s pause.

[00:40:51] Josh: Take a minute, read this, be quiet, and you introduce an element of calm, and I bet that has such an impact on the conversation.

[00:41:03] Attrayee: Yeah,it works out well sometimes, and, but you, yeah, you’re right. You have to read the room,

[00:41:09] Josh: Yeah. And for everyone listening, Spock was half Vulcan, so I was looking for

[00:41:15] Attrayee: Oh yeah. Paul can, yeah.

[00:41:16] Josh: I had to close that out. We can do a whole Kappa on why I didn’t know. star Trek as well as some people do. okay. So Kappa,just one last question on this topic of Kappa. From your experience, what do you think people are typically getting wrong in their approach to Kappa?

[00:41:35] Attrayee: Yeah, I think there are multiple,first is like not doing the root cause investigation the way it should have been. That’s a big thing. And then also like being comfortable with the root cause instead of like really going in at it and un unning different layers to it. it’s, again, it’s a psychological shift which happens.

[00:41:56] Attrayee: I have been in a position where I have had to push back multiple times and not like in a,in a like uncooperative way, but more like asking the person to think more as to why that. Why the root cause may not be the real root cause, and that’s the most important thing. And also the cappa triggers and the initiation, that’s where most quality engineers face a lot of pushback that they feel that, why is this even a CAPA to begin with?

[00:42:22] Attrayee: defining those criteria, like being very risk approached, in, in terms of that and like having solid criteria that can be flexible enough, but. At least giving a guiding principle or a north star to engineers that this is the basis on which we make decisions. So that’s something which people, do that and the other stuff are pretty standard.

[00:42:43] Attrayee: Like of course, like your CAPAs should be open until you are fully confident that your effectiveness checks have been met, verification is done, all of that. So yeah, I think those are the top three that I would say.

[00:42:55] Josh: One of the things I love that you called out, you’re essentially having to challenge certain assumptions or certain quote unquote truths and really push back on it. how do we know? How do we know? Why is that true? Are we sure that’s the right thing? And that can lead to some areas of discomfort for people, because people don’t, they don’t like to be, I.

[00:43:17] Josh: Challenge. we all like to be challenged in the right way, but it has to be on our terms and all of that. It can be very complicated. okay. Great. one last final question before I let you go, Atty, we talked a lot about what’s going on in your world. What are the things that you focus on? I’m curious when we think of the broader, broader industry, when we think about quality management, quality management systems, or just the world of manufacturing in general.

[00:43:44] Josh: what’s getting you excited these days?

[00:43:47] Attrayee: Yeah, again, great question. I think. The most, and pretty cliche answer would be of course, ai. But again, it’s not just AI in everything, it’s more of like, how can we use it for critical thinking as well. most people say that, oh,it can replace, let’s say investigations or it can, if I give it a database of all the CAPAs, that at the end the system, it can come up with the probable root cause.

[00:44:14] Attrayee: That’s not how you do it. I think the thing which gets me excited more is the increasing importance of critical thinking in the world of ai. That’s probably what gets me excited because, even if you upload all the videos of the plant facility or everything, or images,it can just infer what you want it to infer and challenging the thought is what is.

[00:44:38] Attrayee: I think it takes guts and you have to be a bit thick skinned as well. I think that is what gets me excited that the newer generation that is coming up, how do we challenge the status quo? How do we challenge the, things that are going on and like, how do we ensure that we don’t, fall victim to over relying on AI when critical thinking can make or break a product?

[00:45:03] Attrayee: yeah.

[00:45:04] Josh: I love that you brought up. That AI is not replacing critical thinking. If anything, it’s highlighting the importance of the need to have that, especially in the world of ai ’cause ai. If you haven’t used any of the LLMs or AI features that people are putting out there, there’s things that are impressive, don’t get me wrong, but there’s times where you’re gonna be like, what are you talking about?

[00:45:28] Attrayee: Yeah.

[00:45:29] Josh: what do you mean? So I love that AI Stark reminder focus on those things that are,as old as time itself, critical thinking and using AI to support. Critical thinking, help it, use it to help you get to certain conclusions faster. But you’re the one in charge. The person’s the one in charge AI supporting you.

[00:45:48] Josh: I think that’s a, an astute

[00:45:50] Attrayee: Yeah. But AI can do a lot of documentation and that’s what they can have the engineers like. you let them do the critical thinking and then when it comes to documentation, definitely it can help. yeah.

[00:46:01] Josh: All the non-value added activities. if I don’t have to spend time trying to put on paper what makes sense in my head? that’s how I use a lot of AI is I’m help, help me make this make sense. Atty, this has been a great conversation. I appreciate your candid perspectives on all the topics that we covered today.

[00:46:20] Josh: I certainly walked away with some tips and tricks of my own. I love that moment of calm. I love the way that you’re engaging in different stakeholders to ultimately get him on board. I. Love the idea of keeping in mind that AI is there to support us. It doesn’t replace us in the turn, in the critical thinking and the Eisenhower Matrix.

[00:46:38] Josh: I’m gonna look that up and get a template for that today after this call. But thank you so much for joining us today.

[00:46:45] Attrayee: Yeah, same here. It was great talking to you. Thank you so much, Josh, for the invite.

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