Proactive CAPA Systems From Compliance to Prevention

Or I'm gonna Hello and welcome. My name is Sean Smith. Today's webinar proactive Kappa systems from compliance to prevention. Let's see, I'd like to start by introducing today's subject matter. Experts we're very pleased to have with us azzam kurshidi, and from Dekra Zahur from Dnv and Anna Spell from Akra team before we begin. I have a few quick housekeeping notes. Please use the Q. And a button for any questions that you have, and we'll answer as many as we can live. The rest will try to follow up by email.

Use the chat if you'd like to comment or request a certificate of attendance. If you request a certificate of attendance, it takes us a couple days to get those out, but we need your name, as you'd like it to appear on the certificate and your email address. So please don't forget that when you put it in the chat, use the chat for that Qa. For questions. slides and replay of this will be available tomorrow as well as shared on Linkedin. And you'll get an email, a follow up email that will have the links in it. other announcements. If you missed last month's Accra team Webinar on Mdsap. Navigating multi regulatory harmonization.

Please. Message me, and I'll send you a link or yeah, the final thing is very, very importantly. September 3rd and 4th in Munich, Germany. Please please attend the quality accelerator program featuring 1717 subject matter experts discussing 360 degree view of quality. This is a tremendous opportunity. Also, I have a promo code for 10% off. And if you'd like a group, discount, message me for promo code or discount offers. And I can get that over to you without further ado. I'm going to introduce Anna, who is going to take over from here. Thank you all for attending.

Yeah. Hi, my name is Anna Spiel, and I hold a degree in biomedical chemistry, and have recently completed a postgraduate in program in toxicology. and before joining the equity team, 2 years ago I gained valuable experience, working with quality management systems across various medical device companies and including product lifecycle management of different medical devices, such as drug device combination products. And I'm excited to be here today and look forward to contributing to this session.

So do we directly start? Or shall we also make an introduction regarding our other subject matters? Ex-expert.

Let's have the other 2 introduce themselves, and then we'll jump in. How's that sound?

Great Idea.

Azang.

Okay, thank you, Shannon. Thank you, Anna. Good day. Everyone. My name is. And I'm a product reviewer with Deckra notified body based in the Netherlands. Prior to work for Decra. I also work as a auditor for another notified body. My background is in Ivd, and I hold degree in molecular, genetic and pathobiology. I'm looking forward to a great discussion today, and I'm glad that you guys could join. Thank you.

Hi. So again, thank you, Machine, and for the invitation to attend this session my name is Zahil farbutly. I am the Mdsap Certification manager at 1345 for Dnv. Our offices are based in Norway. Also, I've been managing this role since 2,016, where we maintain the accreditation, and we reply to the requirements of the Mdsap as a consortium my background. I'm a biomedical engineer. Long term of research and development and then auditing. And now holding this role, looking forward to share with you our experiences when we receive packages, when we receive responses from the manufacturers, how they are evaluated. And again we provide the feedback so that you can have from the 1st round an acceptable submission.

Thank you very much. So again, welcome everyone to today's session on proactive Kappa systems from compliance to prevention in this webinar, we will explore how organizations can shift from simply meeting regulatory requirements to using Kapr as a powerful tool for continuous improvement and risk mitigation before we begin. Please. Note that this presentation is for educational purpose only, and that it reflects the Acro team's interpretation of relevant regulations, guidance documents and standards. And it's not a substitute for the official legal texts or differing interpretations by other regulatory bodies or other organizations.

So here's what we will cover in today's session. We will start with a quick refresher on Kappa fundamentals and highlight. Some common pitfalls, organizations face, and then we will dive into what makes Kapr system truly proactive. So, looking at the critical elements that drive prevention and improvement. And finally, we'll we'll wrap up with the key takeaways. So let me start with a quick, important question. Do you know the difference between the terms correction, corrective action, and preventive action.

These terms are often confused or used interchangeably, but they actually have a distinct meaning, so confusing them can lead to ineffective, to ineffective kaba. Understanding the differences is essential for building a compliant and a proactive cover system. and I don't want to take now a deeper look into these terms and the basics of Capr. But if you are interested in the definitions, please check the displayed regulations, standards, or guidance documents. So let's take a moment and have a look at a critical trend from the FDA. So over the last 4 years Kappa related deficiencies have consistently been on place number one ranked as the most frequently cited issues

in an FDA Forum 483 observations. So, in fact, more than 1 3rd of all, FDA. 480 thirds were related to inadequate Kappa procedures. So this highlights, how essential it is not only to have a Kappa process in place. but to ensure also that it is well documented and also adequately implemented. When we take a closer look cover process, and I believe most of you will be familiar with it. We can generally break it down into 3 key stages. So the 1st one is the investigation phase. The second one is the Kappa planning, followed by the effectiveness check.

And yeah, where do things typically go wrong? This is the question here. even with a structured process. There are crucial points that can hamper the success of a copper. And let's take a closer look at some of the most common pain points that organization face when managing coppers. So, walking through the key stages. we will look now at 4 pivotal steps, and we will highlight the common pitfalls here, which is on the 1st point, the identification of issues. So this is where the issue is 1st recognized.

Often the procedure lacks clarity. There's no clear definition of data sources and analysis methods are escalation criteria. So without this structure. issues may be either missed or misclassified. One other very critical step, and one of the most common failure points is the root cause analysis. Either the true root cause is not identified or the investigation stops at symptom level. This leads to actions that don't actually solve the underlying problem, and it may recur

another common issue. Is dependent on the action, so either no interim actions have been defined or the action plans are dark and overlay broad. and that lacks focus. Or we have poor documentation or follow up. And this makes it hard to track, progress and accountability. And often, as we already yeah, have been talking about previously, actions are taken which only correct the symptoms, but not the root cause. The last point is the effectiveness check. And here sometimes cuprs are closed prematurely before verifying whether the actions actually worked. So it is, and it's often misunderstood as to

that, the effectiveness check is to verify the implementation of action. No, this does not confirm that the taken action was effective in preventing recurrence. So applying, for example, smart, choose the defined effectiveness. Criteria are clear that they are actionable and measurable. One important tool or cornerstone cornerstone, or we can say, key element in the cover system is the risk-based approach.

So it helps, for example, decision making by helping us prioritize actions based on risk. And it also assures that we don't read all issues equally. Instead, we can focus on the highest potential to impact product quality, patient safety, patient safety or compliance. and especially high-risk issues may need immediate action here. So while lower risk ones can follow a standard path here.

Hey. Anna? Sorry to interrupt. Can you move your notes away from your microphone? We're getting a lot of feedback every time you flip the page.

Oh, I'm sorry. Yeah, sorry.

That's okay. Thank you.

Road. So yeah, it can also enhance the focus of of management reviews because you are concentrating on the most significant risks and trends. And it finally leads also to improved risk mitigation strategies. Where? Because we are not only reacting to problems, but we are also yeah anticipating to prevent them. So, as I said, root cause analysis is the most common pain point, and it's the heart of the Kappa process. And

without identifying the real cause of a problem. Any corrective action is just a temporary temporary fix and a common pitfall in yar is that we overuse or abuse the human error as a root cause. So as Per Rodriguez Perez, who published a handbook of investigation and effective coupler systems, 80 to 90% coppers are linked to human factors. So. But the human error is not a root cause, it's a symptom. So here it's a very good tool to use the 5 ys, you don't have to

stop after 5 wives. If you did not identify the root cause, just keep going on. perform the root cause in an interdisciplinary team, including not only quality assurance, but also other departments like production and R&D, and don't stop with the root cause at the step of human Error. But ask why the human made the mistake. So why, for example, why did he did the mistake? Was it the unclear instruction? It was it the training which was insufficient or often. Yeah, you will find that imprecise or unclear procedures are the real problems behind or the real root causes behind.

So don't blame the person for the error but fix the problem. So how does your Kappa system look like? Are you still putting out fires, or are you preventing them already from from starting. So what are one of the most powerful ways to your to strengthen your cuppers is to to be proactive with Kappa systems. So to perform a data trend analysis, for example, and to detect trends in manufacturing like process outputs reaction rates before failing the process revalidation or ending up with product Ncs.

There you have to define action levels to have a look on these process outputs if they are running out of order. Another very important tool is the measurement and analysis within and across data sources so correlate the insights from complaints with process or product nonconformances. So, for example, if you have complaints about a difficulty to open a packaging. and you might see in another production process that your action limits exceeded are exceeded in the ceiling process controls. Yeah.

and one other very important tool is to integrate the copper insights back into product design. So analyze your history historic data and improve your second generation. Product design one of the most powerful tools. Also to strengthen your copper system is to break down silos. That means coppers should not be operated in isolation. but it needs to be seen, or it needs to be performed, cross-functional and fully integrated across your quality system. If you have, on the one hand, feeders which are, for example, post-market surveillance, supplier controls or

complaint handling. On the other hand, Kappas can trigger also change control, and what is also very important is the feedback loop between risk management and cover. So every cabr should inform your risk files and your risk assessments should also guide the cab activities. Here are some. Yeah, let us. Let us focus on some R&D tips to avoid corrective actions. So 1st of all, we have, for example, the knowledge management. So you can integrate copper insights back into product design, for example, by identifying any trends in design, weakness, or supplier issues or process gaps, then you can feed

this insights directly in your product design by, for example, refining design inputs or by choosing better materials or qualifying more reliable suppliers. then it's very important to link also the copr with the risk management. So use copr findings to update your risk files. By that you can mitigate similar risks in product planning. And yeah, what's also very important is to strengthen your design controls by ensuring that every design input is verified by the design output. And

so one, some key milestones to catch issues early are, the design reviews after each design and development phase, and which is also very, very important, is to to apply usability engineering to catch some problems with the Usability interface early before product launch. So the other big thing is, yeah, document preventive actions already, which are already taken during during the development to show how risks were mitigated before product launch and start using fmeas or risk analysis. So if you can use Fmes tools proactively for identifying risks or for identifying potential failure modes.

And so it. The best cover is the one you never have to open because you designed the issue out before it ever occurred. That's not the reality, I know. But yeah, it's also important to involve cross-functional teams to capture diverse perspectives. Here I'm often asked, what is the key indicator to for for an effect, to see that my corporate system is effective. So I think the most important indicator is the recurrence of causes, so not the recurrence of problems.

But there are also other indicators, you might know, like the number of open cuppers, or the number of overdue cuppers or time to closure. But there are these indicators. They might also tell us something about the effectiveness of our system. For example, if there is a lack in clarity in determining the need of covers, or if we have kapas which are taking too long to close here, it might be that we don't have a risk-based prioritization of Kappas or a lack of clear guidance and effective Kappa management.

So the question is, are we solving problems? Or are we just documenting them. Yeah. So if we yeah, look on on Kappa re-imaging. So on a different when we have a different view on Kappa, not only like a reactive, but a proactive tool. Yeah, when then, it becomes a continuous improvement tool. So yeah, check. Are we just checking the box? Or are we using copper to drive decisions and long term value? That's the question. So there are some obstacles, often organizations face why, they are more in a reactive mode than in a proactive mode. Maybe they made the experience that

yeah, they have ineffective covers. and they lost the confidence in a copper system, or they just see it as a compliance requirement, then, as a strategic improvement tool. So if we look at the benefits of the copper system, it can. Yeah, if we use the copper for it and feed it with the insights of Kappa insights, feed into the into the product and development. We can enforce knowledge, manage management, and create a faster time to market. But we also have cost savings by preventing issues that could result, for example, in product recalls.

But what I also like is that we get a deeper knowledge on manufacturing process by trending, for example, and we can improve, for example, maintenance intervals of equipment. There are a lot of more, I think, benefits. So the key takeaways for today is, yeah. Use a risk-based, risk-based approach to make your carpaline and effective and use trend analysis to identify issues before they become a major nonconformance. Yeah. Challenge the human error and ask more wise until you find the true root cause

and shift. Yeah, from measuring closure rates to tracking some yeah key indicators like recurrence of cross. And last, but not least, always think or yeah, that the root cause analysis is the heart of the Kappa process. And it's a team sport. So break up the silo thinking and share the data across all departments, and also very important, ensure competence and sufficient training of personnel. Yeah, thank you very much for your intention.

Thank you. I'm going to go ahead and launch the poll question hopefully. This will go as according to plan. Are you all seeing the poll question now. hopefully, yes, okay, great so while the poll question is running, I would just like to remind everyone. But if they would like a certificate of attendance to please put their name, as they would like it to appear, on the certificate of attendance along with their email in the chat, not the Qa. And we will try to get that to you in the next couple days. Appreciate your patience on this. They're created manually so with that in mind.

Thank you for everyone that's requested one so far. And let's see. And a reminder of the quality accelerator program, September 3rd and 4th in Munich. If you would like details, please write agenda in the chat, and I will send you more information, including promotional discounts. So Anna.

While the poll is running. I will just start with my 1st question to Azim and Zahara. So can you share what you think is one of the most important things to consider when developing a 1st time. Corporate strategy.

Right, I can go first.st so to my opinion, when developing a capital strategy, one of the most important thing is to shift from being purely reactive to become proactive, on which is actually the whole purpose of this webinar. And the point that we want to deliver. So don't waste for the problem to happen if you can anticipate and prevent it, because it's going to be timely like time consuming. And it's expensive. and you can do it by adopting a risk-based thinking. But I think everyone in the room also agree with me that it's not possible and realistic to identify all the issue, and not all of them can be foreseen. So when we do need to react in our capital system, the capital needs to be balanced in that way, meaning that it needs to be a structure enough to drive meaningful improvement, but lean enough to stay practical and efficient.

Thank you.

Yep. Cool.

Yeah. Za, do you have something to add? Yeah, thank you so much.

I'm setting up setting up. Yeah.

Yeah, yeah. But you are. You're right. As I'm so it would be great if we could foresee every issues beforehand. But yeah, that's not real life. So yeah. but I think we make the best out of it.

So the poll is over. Thank you. Everybody who participated. There's going to be a survey at the end of the call. And, Anna, do you have another question?

Yeah, so let's go on as you. You were just giving a very great explanation for the 1st time, capa strategy. So maybe you also have a good answer. Yeah. What what do you think is the most or no? What's what did you experience? Is the most common deficiency observed in manufacturers. Kappa procedures.

I can say that the list is like unlimited. A lot of items can be on the list, but I can categorize the the list of issue in 2, the one category can trigger nonconformance, and the second category is not necessarily a nonconformance, but can indicate that your system is inefficient. So I'll start with the 1st category. So you covered a lot of it through your presentation just quickly. If I want to say most important efficiency, what are they? I can say. The 1st one is the capital triggers that are not defined clearly, and I think there's a question from audience also, and I try to answer that as much as possible. So you have to be balanced again. You have to have a set criteria. What has to go through your capital, what not? And that's very important, because you don't want to be too strict that nothing goes to your capital that way. You miss a lot of the issue.

You don't also want to be too relaxed that everything goes through your Kappa. Then you're going to shoot yourself in the leg, overwhelm your system. So the the whole point is that through a risk-based approach, you set this criteria that define exactly what quality problem should be escalated. So when it comes to non conformance. For example, if it's a 1 off time thing, maybe you can just correct it. Remove the symptom. But if it's happening so many times, then that that's a red flag like for complaints, I can say complaints are a different issue, is usually saying that something is wrong with the performance, especially if it is about the performance of your device on the market. So that requires a deeper investigation, and we can go on on and on on that topic. That's 1 point. The other point is that

the the procedure do not require a documented problem statement. And that's that's a big issue to my understanding, because when you go and sample the records to do the audit of the capital, then you often realize that you don't understand the statement. So what is the issue? So if I don't understand, probably your team member also are having difficulty. So that's very important, because if the problem is not defined properly, then it can lead to like team focusing on something that is completely irrelevant. wasting their time. Or you end up like coming up with solution that is not actually going to help with your actual problem. You also mentioned about the Root Cause analysis, and I can't emphasize enough. That is the most important part at the heart of the cap.

So you need to. You need to have a strong, like critical critical way to go about the the problem to make sure that the problem is not always attributed to the staff. They're not always at fault, so human error are rarely the the reason for the quality issues. And you need to. You need to understand that this part is not done properly. Then you are facing that. The same problem actually can happen again. So then, the next problem that I can mention is that the timeframe are not properly defined in your capital plan, so that the procedure not necessarily. We need to have the time, like you say that we are going to close all the capital within certain time point which is good to have. But again, if you think about the situation and case by case, this approach might not be very effective.

It has to be based on the risk and complexity of the issue that happens. Also, I can mention that the risk evaluation are not integrated in your capital. So if because of the capital, something happens, then you have to go back and evaluate. If that risk has been identified before in your risk assessment. If not, you need to add that additional, then you need to also make sure that your conclusion about the benefit risk of your device is still valid. And then the second category are some of the issue that you can see with the capital procedure which not necessarily can cause, can lead to a nonconformance, and those are including the procedures that are overly complicated, and it's difficult for the staff to follow the logical steps and go to the end of it in a timely manner.

or often the procedure requires excessive signature from different people from different departments. Only people that are involved and or like providing input in the Kappa in data, specific Kappa maybe needs to be involved. As you can see, those getting those signature can significantly delay your your process. The next one is the guidance on prioritizing your like issue, you cannot treat all of the issue the same. So if it is a minor issue, if this is a major issue that needs the immediate attention, so you need to treat them with the priority, and the last one is the lack of flexibility in your procedure that prevents efficient handling of the low risk or a straightforward Kappa.

So those those are the one that I had on on my list, and we tested if he has any comments. Yes.

So what somehow, I'm gonna you made a very big overview of the whole thing. So it's really hard to add anything now. But what is lacking in the procedures. What I find the most is that the challenge, when an external body is issuing a Nonconformity. Normally the quality manager is listening to the no conformity, and trying to write notes based on the auditor who issued the No conformity. What I think is also the process owner needs to be involved, and to challenge that external body that is issuing them conformity. The reason is that this will help the auditor who is issuing it to make sure that they are writing exactly what is the problem rather than just throw out something on you guys which is very generic. And you are under the pressure of your management, which is that conformity is something that you did something wrong, something bad, and you are penalized for that. And this is going to add more stress on you. So

what I'm trying to say here is that if it's an external body, internal body like internal audit, or anybody who is raising conformity. You need to make sure that the process owner is present. You are understanding exactly where is the issue and highlighting from the standard? Not only the clause. plus 7.3 7.4, whatever it is, know what in the standard exactly that I'm missing, or where I was not in compliance. So this 1st step that most people I find that they miss this is the key that will help you identify the root cause. After that I agree with everything as I've said, so I'm not need or go through it.

Right? Thank you. Yeah. Let us come to another question. So yeah, maybe we already answered it a little bit. So what do you see, here is the main challenges here. Manufacturers face with Kappa procedures. So I think we we already yeah. summarized a lot of them. Do you have anything to add here. Or I think so, in addition to yeah, to this special point.

Yeah. So what I covered was the procedural issue. So when it comes to the actual operation of the process. So I I have maybe a few additional point to add. So the there are multiple challenges. But I can highlight the inadequate resources to be the main challenge, especially for the smaller manufacturer, especially about the time personnel and the expertise. So that's why many of the Kappa investigation are rushed or incomplete because the staff are overwhelmed with their daily operational demand. and that that will not going to like end that

close that capital efficiently. We also touched about the weak root, cause analysis, skill. So this is a multidisciplinary thing. It is not a like the problem of the quality team. Only I think that's that's another thing that always in organization, they think that if there is a capital, so the person responsible or people responsible from the quality, I think that mindset is also not true. It should be a teamwork. Another thing is this is again maybe related to the smaller manufacturer is that they are reluctant to tackle systemic issues for them is just, maybe it's just the the profit or benefit of doing an aggressive or a significant change is too much to afford. So instead, they will just say, Okay, we'll just take care of the issue for now and until 6 months. It happens again. We will deal with it later.

This this way is inefficient, but maybe it, it will work for some of the manufacturer that way. For example, I remember that there was this issue with with the, with the device about the performance that is creating like false negative result more than is expected, and it's in only one jurisdiction. and instead of like going and changing the design of the the product and improve, the manufacturer decided not to sell to that part or those customer because they have enough customer in other jurisdiction, and it just doesn't make sense for them profit wise to go and do a significant change. I'm not saying that I agree with that, but I've seen in the industry that there are like resistant to changes.

and also the the trend analysis. Maybe they do it in a separate part. They just do it because of just want to do it, because this is something that they have to do it. But they actually not take into account the outcome of those trend analysis as an input or as a trigger for for their Kappa I do also, see that there are challenges in measuring the effectiveness when it comes to the effectiveness check like you have to have something that is objective and measurable, and you have to have criteria set in your plan. What are you going to do? And how are you going to prove that

this action that you're taking is actually going to get rid of your problem. So those are the thing that I taught in addition, in terms of the the actual capital process that can be wrong.

Yeah, sorry. You have something to add, I see.

Yes, so thank you. Azam again. But there are different companies, different sizes, those that maybe still are paper based. Yeah, I I doubt that. But still there are paper based. Those who are using Microsoft excel to track their Kappas, what they are having there. And they shared it with sharepoints, multiple people working and those that are also having a software that is very sophisticated, that tracks everything that is done. So when we are doing an audit in. Let's say we are in July, the next audit we're going to do next July. We tend to see a lot of those. No conformities raised 2025 are going to be rushed and closed. As I was saying, June July 2026. So why, we see this lump of nonconformities that were identified. Now it took all small 12 month, 11 months to all the close them.

and when we try to do our audit and see the progress. Yes, there could. If the if it's closed, there is verification of effectiveness, everything would be closed. But you can sense that there is a lot of attention came right away before the next schedule audit rather than really dealing with the issue when it happened and when it was identified. So the advice here is that. yeah, nobody would like to have additional workload to do. Yeah, but dealing with it at the earliest, definitely will make your life easier and less messy to deal with and clean up just before the audits. So try to schedule, try to make like a reminder of every Monday at coffee, break, meet with that team and make sure. Okay, even if there's no progress, at least discuss it. Say, well, I'm waiting for this. I'm waiting for that. At least we'll help you to refresh.

And when you have no conformities with multiple disciplinary, when you're talking with different individuals, because I have similar issues at my own organization. I get no conformities from my accreditation body. And I know what I'm sharing with you guys. So it's not easy. It takes time, and that's what we're saying. It takes time, and you need to have that time share with your management that you need time to deal with these Kappa Kappa is not something that is just a paperwork. 3 pages. We write, what is the root cause, corrective action, corrective correction, corrective action, preventive action and effectiveness, check and just throw it out. No, it takes time, and you need to be part of your daily work daily schedule to make sure you are addressing these conformities.

Excellent point. And I just wanted to mention that. Yeah, that's not a good way to go about it. It's just better that you have a documented justification. Why, you couldn't meet the timeline rather than just to rush and close the the issue, because that's actually a red flag.

Yeah, that brings me directly to the next question, Zaha, how can manufacturer ensure that their Kappa documentation aligns with notified bodies, expectations.

You wanna go first, st or would you like me to continue.

Go ahead!

Yeah, I, like.

Yeah. So I don't have much to say. It's just that in in that from the audit perspective reviewing, a capa process is no different than any other process. So it must be documented, implemented, maintained, with the records available to provide the objective evidence of conformity. But in practice what it means is that your process should 1st of all to be logical, traceable back to the problem, detection and investigation and corrective and preventive action, etcetera. In another word, it will be able to deliver what it, what this process is meant to deliver, which is getting rid of your issue, and how we check. That is that if we look at the capital log, if a problem is closed, a capital is closed, and then the same problem is happening. Or you say that this capital is properly closed, and then we see similar issue in your complaint.

I just want to mention about the Mdsap audit. That is, this problem can be more prominent, because in the Mds app everything will be taken a look at at the same time they are interrelated. So you can't really fool the auditor and say, Okay, the catalog is very clean, and nothing is in there to worry about, because the auditor will keep that in mind when reviewing other quality data.

Yeah. So what I would like to add here is when you are writing your Kappa, you are not writing a notes for yourself. So it's not only you who needs to understand it. You are writing a Kappa so that the organization can understand it and can implement it. So when you are authoring a Kappa when you are driving these actions into your quality management system, it needs to be traceable. Okay, so we identified when I issue a no conformity. I really try to help the client with my statement to say, issue number 1, 2, 3, 4, combine them in a way. So they know that now, for every identified issue, they have to have a dedicated actions related to that. So this is raised to the traceability. So the point when you are writing your Kappa. Don't just write nonsense in a way that only you understand. It's also for the

3rd party, even if your colleague, if you are absent, and somebody wants to follow on whatever you have done. Understand what you have, how to draft the actions and to finalize the procedure review. If there's anything. If there's a training that needs to be done. Also, it needs to be identified. So I'm not going to go back to the risk. But you when you are taking specific actions, you need to rationalize why this action is not necessary to be taken. For example, if you need to do a product is in the market. And you are saying, well, you know what? I'm not gonna recall it. I'm not going to issue advisory notice.

We expect you to do an appropriate risk analysis on mitigation, saying, why, I took that decision? Yeah, it has no impact on the safety and effectiveness, while I checked with those that are in the regulatory market that doesn't trigger anything related. So we need to see these things. Yep.

So all refers again back to the risk-based approach. Okay, yeah. Can you recommend any specific templates or tools? For Kappa management?

Well as up. Can I go.

Yes, please.

Okay. So when we talk about tubes, it's really ambitious to find a tool that can solve your problem. Because again, it's your problem, and there's no tool that can solve it for you. There's only tools that help to structure your thoughts in a way that you write it down and help you come up with the appropriate actions that can eliminate the problem. Now, talking about tools. So during the presentation, we spoke about the root cause analysis. So there are different ways. The 5 wise fishbone paleo analysis. Apollo, Rca, so, yeah, open Youtube, go to Udemy and try to find some sort of how to effectively to see a practical example. How this is done. Now, I'm not going to say, recommend, use, chat, Gpt, to do the analysis for you, but also it can give you some sort of a guideline if what this structure it is. But still it's your responsibility to do these use these tools appropriately.

Now we're talking about the risk tools. So there is the Fmea, the FDA all these also as well, and it's out of the scope of this training, but when you are doing we say the word risk. It's just not the thought of thinking like that. I think this is a risky no, you need to have a structured work, thought that you are working with multidisciplinary people that are sitting with you. You are a quality manager. You cannot know all aspects of design or the impact of the design change. It's you have to sit with those who are working on that. If you're working with a sterilization. And again, you are the quality manager, rather writing the root cause analysis.

Go and sit with these people and apply these risk tools. Maybe they don't know it. But it is part of the management responsibility to make sure that you are qualified, and you know how to apply these terms. So there is multiple tools here that have been in ages available, maybe just to mention that there is in the Mdr. There is a template. It's not mandatory that you can look for. It's the Mdcg. And x. 1. i think it has to do about the Capa plan and Mx. 2. From the notified body and the jet assessment assessment templates. So if you Google it, you will find these kind of templates that that you can use.

It's yeah. It's often used by is, it's more in the scope of for notified bodies. But it can also be used for manufacturers. And I like, Yeah.

Yeah, no. Under every sub there is a new tool that they have, that that we are using. It's called the rubric. It does highlight a little bit. What are the expectations of how to write on a conformity, and how to evaluate the response of the manufacturers?

Right? Thank you. So, yeah, what? So what strategies can help prevent missing the initiation of a copper? Any ideas here.

So I think.

Can you repeat what I'm just? You can repeat the question. I I didn't hear very well.

Yeah. So what strategies do you think can help prevent missing the initiation of a cover?

So I can go first.st I can think of 2 thing so we covered it both. 1st is just to have the clear criteria written. So your staff know when exactly to escalate the issue from a simple correction to a full cap of, and then the the number 2 is trend analysis which which we talked about a lot. You looked at your complain on conformance service data audit external. and you can detect anything unfavorable. These are the 2 things that I can think of.

You know. Yeah. So

Then, if I may. we have a number of questions from the audience, and I would just start with. you talk. You guys talked about the 5 y's. and so they there were. There were 2 or 3 questions about that. I understand. You can continue the why questions after 5. If you still did not hit the root cause. Sometimes you feel you hit the mark after 3 times. Why is it okay? So is it okay to stop at 3. If you didn't get to 5. And another person asked, would you agree that we shouldn't just focus on one model to investigate Kappa, such as the 5 ys, we can use fishbone diagrams. Fta fmea. I believe. Kappa.

the Kappa root cause analysis, depth is closely correlated to the number of models used. So do you recommend using more than one model? And can you go beyond the 5? Y's to an infinite number of y's.

So I think you can always use also less 5 wise. I think the experience is most often that with 5 wise you will end up with a root cause, so it can be also earlier. So you don't have to get through all of that. But just also don't stop if you're not at at the end, you know, with 5 wise and regarding the tools, I had the impression, or I met the experience, that sometimes it is only said in a procedure, Kappa procedure, you can choose any tool. Yeah, I think that's not a good choice. So you should recommend and train the people on tools. And maybe yeah, a fishbone

fishbone root cause analysis tool is sometimes better. It depends on. If you do not really know what you are working with. And you have to really see. Is it an environmental aspect, or is it a human aspect? So if you want to include much more categories to find your root, cause anything to it? No.

You covered it pretty much. Very well. I just want to simply say, regardless of what tools you can. You will use as as soon as you hit a cause that is actionable and within your control, then you're good.

Sure.

So here's another interesting question as software, either embedded or standalone, comes more and more into focus. So embedded or standalone software, do you have experiences how to fit defect management process in the known processes like Kappa Nonconformity change management. It's a hard question.

So you have any experiences how to fit defect managed processes. Yeah, I agree. It's a bit but what does it mean? Defect management team. Is it like something different than what we are talking about? I think we need to have more context.

Okay. So maybe the person can provide some more context.

Because as a software, sorry man, just to clarify to Mr. Silk, is that also, if I'm saying wrong. yeah. So we have the quality management systems. These are the fundamentals. We have the quality management system. We have your, the standard 1345. You have the software standard you are talking about. So when you have a full system that you are saying that I'm gonna be in compliance with this combined requirements. And you need to add, and you there. There is a conformity that was identified. This is the classical solution is to issue a Kappa and deal with it. I'm not sure if I'm asking the question. I'm trying just to think in a logical way to make sense of the question.

Right, I'm having trouble understanding it as well. so let's move on to another question, which is perhaps more succinct. If I am a manufacturer. And I receive an email from a client stating that there are experiencing issues with my device. What actions should I take? Should I register the issue as feedback in the Qms. And then link to a Kappa for it to it. What would be the best practice for managing such situations? Now, I suppose that if they're telling you about an adverse event versus a complaint versus. I don't know a product observation that would all come into play here. But let's assume that they're registering an actual issue with the either usage or performance of the product.

It needs to be registered. Somebody has to investigate it. Whoever is receiving the the tip. The information cannot make the call without making up, following the appropriate process that they have in place or recording it down, investigate it to the need to get the device into the facility to make appropriate investigation, to ask for photos, to ask for evidences to make their own experts. Whoever designed the device release the device, go back to the dhf, the MF. Because there might be other devices like those out in the market so definitely it needs to be registered. Now, if it needs to be a Kappa or not. This is going to be the next action. So you receive the complaint so feedback we receive as a complaint. This might trigger a Kappa. If you are going to take actions.

Very good.

So. So we have always to decide or to to rationalize if you take no correction with with a complaint here. So that's I think, important.

I just wanted to. Sorry, Shawn. Just the last sentence. Not all. The complaint necessarily need to be a capital, but they always require an investigation, so depend on the case, and if it is a per performance, the safety of your devices affected, then definitely especially if it if an adverse event happened. Because of that. Then you definitely need a capa initiated on that.

Fantastic. So I'd like to take a moment to thank all of the speakers for giving us their time today so generously is very helpful, very insightful. Learned a lot about Kappa that I did not know. And thank you, Anna, of course, for your slides, which will be available tomorrow by way of email, all the attendees. Thank you for your time and sharing your time with us today. If you have any questions or comments, please feel free to message me on Linkedin or email whatever. I'm happy to help. Everyone want to say goodbye.

Thank you everyone for joining.

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