Quality Innovation Tour – North America events in October and November 2022

Flipping CAPA on its Head with Prevention and Understanding the True Root Cause

 

“People have to change their thinking on CAPA. They can’t think that CAPAs are burdensome or take too much time. They have to see how powerful, how proactive this tool is and how it can shape the future of quality in your company.” 

Zillery Fortner, Product Advisor, QA/RA Life Sciences, Sparta Systems, a Honeywell company

Welcome to Forging Connections, a podcast from Honeywell about the convergence of IT and operational technology for industrial companies. We’ll talk about the future of productivity, sustainability, safety and cybersecurity. Let’s get connected.

Michelle Dawn Mooney (00:20):

Hello and welcome to Forging Connections, a Honeywell podcast. This is another installment of the series, Shaping the Future of Quality. I am your host, Michelle Dawn Mooney, and I am thrilled to bring on our two guests. We’re talking about flipping CAPA on its head with prevention and understanding the root cause. To bring more information to that topic, it is my pleasure to bring on Bethany Kearney. She is the Director of Enablement for Sparta Systems, a Honeywell company; and Zillery Fortner, who is product advisor, QA/RA, Life Science for Sparta Systems, a Honeywell company. Thank you both for joining me.

Zillery Fortner (00:54):

Thank you for having us.

Michelle Dawn Mooney (00:56):

So, before we dive right in, let’s get a little bio. Bethany, Zillery—can you give people a little bit of a background?

Bethany Kearney (01:03):

I’ll start with my bio. I’m a life sciences expert. I started in pharma and quality systems, in quality control specifically, and progressed through quality assurance in compliance roles. In clinical, in working with medical devices, I’ve worked with multiple quality systems across my over 15 years of experience and most recently joined Sparta in 2019. I help our customers move from TrackWise to TrackWise Digital, using SaaS solutions and offer my expertise in life sciences to really make sure that the customers get what they need. I most recently joined the services team as a Director of Enablement to make sure that they’re trained appropriately on our software as well.

Zillery Fortner (01:51):

And I am Zillery Fortner. I’m the Product Advisor for the QA/RA life sciences at Sparta Systems. I got my bachelor’s degree in Health Science from South University, and I have over 20 years of experience in the medical device arena related to quality assurance, regulatory affairs, surgical arena and JACHO. In addition, I also served 10 years in the military as a certified surgical tech. I’m actively involved in groups including RQA, RAPS, PDA and ASQ. That’s me in a nutshell.

Michelle Dawn Mooney (02:38):

Very, very lengthy resumes there. A lot of numbers Zillery you’ve got going on and I am really excited to have you both here because you obviously know a lot about the topic at hand. And before we get into that, I guess we could say this is kind of that old saying “an ounce of prevention is worth a pound of cure.” We never want problems to happen, but unfortunately they are often inevitable. And before we go into some ways to hopefully prevent them, let’s take a look at some examples and how costly they can be, not just from a monetary standpoint.

Zillery Fortner (03:10):

So, I can give an example from the medical device side on not looking at the preventive measures and not determining the true root cause of what was going on. We had some products that were constantly getting complaints. A CAPA was opened. There were nonconformances because the product wasn’t wearing well. It was a reusable medical device, like a gown you would wear in surgery to protect you during surgery. The gown would just rip. If it was repaired, patches wouldn’t stay on. They were supposed to last 100 lifecycles. So, it should have been able to be used a hundred times approximately. We were getting like 30 to 40 uses out of this when they would try to repair it, the barrier, which makes it a certain level gown would not meet those criteria anymore. Once we finally took the time to dig into truly what was going on, truly what was happening, we noticed that the complaints or the MDRs that were reported for safety with patients that they really stopped at a high level. They didn’t dig down deep to truly find out what was going on. It was human error, human error, human error. They didn’t inspect something right. They didn’t repair it right. It was never truly looked at, to see what was going on. And there wasn’t a global communication between the different facilities. There were multiple issues going on multiple times. It was closed with CAPA saying it was fixed. And when it actually came down to it, the true root cause was a chemical reaction. So, the chemical was reacting with the material, which degraded in, in the barrier and wouldn’t allow you to repair it. This could have saved millions of dollars if we would’ve just taken six months and done it right and truly, truly understood the problem.

Bethany Kearney (05:25):

I have an example like that from the pharma industry where human error was determined to be the root cause time and time again. The background is that it’s a similar kind of issue with the product itself, but the analytical staff was initially blamed for not mixing the product properly. So, there were OS results that were found and the root cause was determined to be human error, human error, human error. And it wasn’t until it went through manufacturing to the full OS investigation, and then they pushed it back to R&D and they figured out that our API in the product is inadequately distributed. So, it really mattered the way they were collecting the sample from the packaging itself. So, the affinity of the product to the packaging was the true root cause.

And there were numerous human error OS investigations prior to that. Finding the true root cause is very complex. It’s easy to blame a human. And if the firm is a hundred percent focused on metrics, then finding the true root cause is going to be very challenging because in some cases it is costly. But it’s much more costly to not know that true root cause. So, I understand that it’s a paradigm shift for organizations but putting in the time to do it right is really where the value is.

Michelle Dawn Mooney (07:04):

Yeah. Not just costly as we talked about from a monetary standpoint, obviously you mentioned millions of dollars there in that particular example, but just the time and the stress level of trying to figure that out and in hitting your head against the wall of why isn’t this working. I mean, that really takes its toll on your mental state as well. So, let’s move on to how we can reduce these issues to have better safety, better quality, and prevent these things from happening. Is that even possible?

Zillery Fortner (07:35):

It’s very possible. And it’s all about prevention. It’s all about constantly continually improving something. You know, when I look at myself every day, how can I make one improvement, one adjustment to make myself better. Right? You take that same mentality. There’s a simple thing that’s been out there for a while. It’s called plan, do, check, act (PDCA). You have to have support—or like you were saying, you would beat your head against the wall. If you have no support, no involvement from the key and the right stakeholders, you’re going to struggle. They have to promote quality, strong quality, and they have to prioritize improvement plans. And it also has to be cross-functional. Everything might sound great to me. It’s my fault. It’s my plan. Yeah, it’s perfect. But does it sound great to the other team members? To people that actually have to put this in place and not playing the blame game? When you look at CAPAs it’s very easy to point a finger. You can’t do that. You can’t blame Bethany for this problem. I, I really need to understand why it happened and fix it. And you also have to make sure that you’re ensuring what you fixed worked, and that doesn’t mean for a week. That means you kind of stand there and watch and make sure that this isn’t happening yet again, because if it’s happening again, you didn’t figure it out and you need to start over.

Bethany Kearney (09:08):

Yeah, that resonates a lot with me too. And I do want to dig in further with that effectiveness piece that you were just mentioning, because you really do need to ensure effectiveness, making sure that you not only have the right time allocated for an effectiveness check, but your sample size. And is that appropriate to identify when those failures occur? Don’t be so close minded to think that this can only happen for a single product. If it could be something that’s happening that you didn’t initially take into account in your CAPA, but it, it could be across your portfolio. So, yeah, I think one of the things that are challenging to the teams that I work with across different organizations is what to do when your CAPA is not effective. And what I would, what I guide them is don’t hesitate. Don’t delay opening a new CAPA.

You see that there’s a piece of your effectiveness check that failed. Then you don’t have your right root cause, or you didn’t appropriately respond in your actions. So, it’s okay to do it again. And I know there is a big metrics game, but if your effectiveness check didn’t go as expected then open a new CAPA, do new actions that are more meaningful as far as finding resolution to that true root cause. I do get pushback on that sometimes. So, I’m open to feedback on that. I guess the only other thing here is that culture piece that you mentioned with effectiveness checks, you make sure there happen and you have those right stakeholders involved because there is going to be bias. So, if it happens in your manufacturing site, at your lab and your team completed those CAPA actions, make sure you’re accounting for some of that bias. And everyone knows that you want things to work out great and do it right the first time. Sometimes it doesn’t happen. You have to be open to know that the effectiveness check might not pass, and you need to have that clear criteria in that effectiveness check. So, you trust, but you also need to verify.

Michelle Dawn Mooney (11:28):

Yeah, and effective being the key word, because if it’s only 50% or 75%, or even 95%, there’s still that 5% that’s going to come showing its ugly head in there and is, is going to be not what you want to have happen. So, let’s dive a little deeper into this. What specific elements are needed for an effective CAPA process?

Zillery Fortner (11:50):

On paper? This is easy. I mean, and Bethany can kind of dig into them further, but on paper there’s considered to be seven steps to a CAPA process. The first is identify—how did this happen? I’m identifying my problem. Next, I’m evaluating this. I’m basing this on data on history, on the impact of the problems, costs, quality, safety of customers. That’s huge to determine the risk. Then, number three is develop and investigate. Four, analyze the problem. Five, I create my action plan. Six, I implement it. Seven, analyzing the effectiveness. That’s our perfect seven steps to a CAPA. But you know, you have your companies, you have to believe in true quality. They have to promote this. They have to live and breathe these seven steps.

Bethany Kearney (12:52):

Yeah, it’s great that’s on paper. And we like to apply what’s on paper to our electronic systems too. And thanks for covering that, Zillery. I love that it’s the Greenfield’s perfect world version. And we do adapt our quality systems to what it could be. And of course, there’s the differences between pharma and medical device as well. So, I just wanted to kind of backtrack a little bit with the initiation part where some of the initial CAPA steps are determined, or perhaps your predecessor, like you’re out of specification investigation of a quality event or complaint that is capturing your initial information. So, you can expedite through those initial steps of your CAPA process, given that maybe some of that root cause is already determined and jump into CAPA planning and execution. In pharma, this is your typical use case for that, where your investigation step occurs on that initial event.

And what we see in the SaaS solution world is that those will be automated for your CAPA to really make those steps abbreviated so you can jump right into your action once your root cause is known. The other way that we see folks influencing the CAPA process and abbreviating it where possible, is using that Make CAPA Cool program from the MDIC group that was sponsored by the FDA and they’re creating this fast track CAPA. So that’s typically where the product is internally controlled, low risk issues that occur. So internally controlled, meaning didn’t escape to market. So, would it be a customer complaint? And they’re able to get through the process and sometimes justify not having an effectiveness check. So, there we’ve seen different adaptions on the CAPA process depending on risk. So, it’s pretty interesting and dynamic, although we have the regulatory requirements to push us to always to do the right thing and make sure that there isn’t recurrence where possible.

Michelle Dawn Mooney (15:05):

Let’s talk about the flip side for a moment, what happens when CAPA goes wrong? So, what factors contribute to basically the opposite of outcome of what we are hoping to see?

Bethany Kearney (15:19):

So, I see that where issues persist when the quality teams don’t conform or don’t confirm the root cause. So, they can’t address the root cause in the CAPA actions. They’re just not finding the true root cause. So that’s going back to our example with blaming people and this kind of mentality, or issue with the CAPA process that can cause catastrophic harm to a patient and to your product by issuing a recall and causing brand damage to your company. In the case where I talked about earlier, where human error was blamed, this was a major issue in the lab itself that caused people to go on the improvement plans. And they just wanted to leave the company because they knew they were doing it the right way. They were following the procedure and they were still being blamed for something that ended up being a product issue. And that really tarnishes their relationship and their trust with the company. And we’ve lost a lot of great talent from that.

Zillery Fortner (16:22):

And you also have smaller companies that won’t survive. Some of these major CAPAs that have been opened, not finding the true root cause, going through a recall, and suffering from brand damage. They just can’t bounce back like a larger company can. And some CAPAs are very simple and then some of them are very complex. It can be as simple as poor documentation, but then they can come to not tracking and tracing. Maybe you didn’t validate something, your effectiveness plan was poor and you continued, you used that thinking of “I already know the problem.” So, you didn’t look at it deeper. And I go back to the one with poor top management, the understanding true quality.

Michelle Dawn Mooney (17:16):

When we talk about CAPA, obviously every facet of what we’ve discussed here today, involved a lot of time. There’s thinking, there’s planning, there’s replanning, there’s trying to do problem solving repeatedly and bringing the cases up and closing them and bringing more cases up. It’s very, very time consuming. But what is the payoff for taking that time to make sure that CAPA is done right?

Zillery Fortner (17:44):

I think it’s always interesting when people understand how much a recall actually costs. And a recall is just one part of doing something wrong or, or not really truly understanding the problem. And it is a little hard to estimate, but McKinsey gave a statement last year that states a single recall process can cost up to 600 million dollars. We’re not including lawsuits, we’re not including legal. We’re just including fixing that situation. The medical device industry spends around 5 billion dollars a year on recalls. It is expensive. And this expense, we can’t ignore it because lives are literally at risk. Every minute that a defective product stays out on that market is another opportunity for somebody to be injured. I always tell people to think if that was your loved one, would you be quick to act, would you want to do this right? So, the payoff to get a CAPA right? I don’t think you can measure it. It’s huge. It might be time consuming in the beginning, but once you get on this cycle of plan, do, check, act and that continuous improvement, your CAPA should go down, right? You should just be preventing things, finding things you can always do better.

Bethany Kearney (19:25):

The numbers are startling, and I totally agree with you. Consider if that was a device that was implanted. So, I’m not sure how to put a price on sanity or a life for that matter. I guess from my experience, I wanted to just offer that there are so many hidden costs unless you’ve been through it. I was just astonished by all the intricacies and the steps of a recall. When I had to go through this process with the company I was with, where you have your receiving of the recall materials, your processing, you have another team processing refunds, you’re shipping your recalled material, you’re reconciling that material.

And then you have all these other complexities. If the material is DEA controlled well, who’s with it? And when you run out of space in your containment area you have to ship it somewhere for deconstruction. So, it’s very complex. And I can see how these figures are easily in that seven-figure range, just thinking downstream as well. If your inspection didn’t occur already and that might have attributed to why you’re having a recall, you better get ready because this is cause for shutdowns and fines. And of course, once this is on the news, you have brand impact when you your public announcement is launched. So, when the organization moves from that reactive mode to being preventive, there’s a lot of impact with your manufacturing, your lab, your overall supply chain, to make sure that you have materials and products available. So, it really does matter when it comes to that customer experience with your product.

Michelle Dawn Mooney (21:31):

It reminds me of that, I think it was a credit card commercial, that had baseball tickets or an experience and the impact was priceless. And I think about the last answers that you both gave. That’s what we’re really talking about. We’re talking about human lives, potentially. We’re talking about not even just from a business standpoint, but just a real impact from a human standpoint. And then on top of it, you’ve got a huge payout with the business side of things and recovery costs. So, any final thoughts as we wrap this up today?

Bethany Kearney (22:03):

I I’ll just start with saying that simply whatever level you find yourself in, in any position, because there are lives at stake, because you are your company’s livelihood, all of this is at stake. Just make sure you’re doing the right thing. And I think the folks in quality like myself and Zillery, we’re here for the right reasons. If you’ve been in the industry long enough, you’re there for the right reasons. You’re going to do the right thing. It’s hard at lower levels to escalate things. And if you’re being blamed for issues, you don’t want to point the finger at management. I know that’s a tough situation, but it’s worth it. It’s worth flagging that. And calling your compliance helpline or whatever you have in your back pocket to support you to do the right thing. Don’t hesitate to do that. If, if your management team is pressuring you to get through an investigation, as fast as possible to keep their numbers green, that’s not doing the right thing. You need to do it the right way. So, challenge that and then throw the flags when you need to.

Zillery Fortner (23:11):

And then I’ll just add on with something we haven’t said yet—Quality 4.0. Quality 4.0 has to be there for companies to survive in the future. They’re going to need to be able to leverage their analytics, not just quality data, but data from all systems. They’re going to need that connective capability across their organization. And that’s how they’re going to get the transparency that they need. When it comes to Quality 4.0, I think it’s important for people to also remember that it doesn’t replace your traditional methods. The whole point is to harmonize the people, the culture, the technology, and your processes to achieve what your company’s goals are. And the other thing is that people have to change their thinking on CAPA. They can’t think that CAPAs are burdensome or take too much time. They have to see how powerful, how proactive this tool is and how it can shape the future of quality in your company. You have to use your CAPA system for the gains, not just flaws. So you have to look at it for improvement reasons also, not just for the mistakes. And then you remember that a successful corrective and preventive action system is not one size fits all. So, what worked for me, isn’t going to work for Bethany or anything like that. It’s not a reactive, overburdensome process.

Michelle Dawn Mooney (24:49):

A lot of information there. And as Bethany said, once you do the right thing for the right reason, you get the right results. And pretty much every time that happens. And that’s really what the discussion is about. We’re talking about flipping CAPA on its head with prevention and understanding the root cause. And I want to thank you both for joining me today. Bethany Kearney, who is the director of enablement for Sparta Systems, a Honeywell company, And Zillery Fortner, who is product advisor, QA/RA life sciences for Sparta Systems, a Honeywell company. Thank you both for joining me today.

Zillery Fortner (25:22):

Thank you.

Bethany Kearney (22:24):

Thank you.

Michelle Dawn Mooney (25:24):

And thank you so much for listening to Forging Connections, Honeywell podcast, and this is another installment in the series, Shaping the Future of Quality. And of course, if you’d like to learn more about Honeywell and its affiliated businesses and companies, you can go to honeywell.com. I’m your host, Michelle Dawn Mooney. Thanks so much for joining me and we’ll see you soon.

Closing (25:46):

This has been Forging Connections, a podcast from Honeywell. You can follow Honeywell Forge on LinkedIn and download new episodes from our website honeywellforge.ai. Thanks for listening.

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