Name: QMSR is done. Now what?
Uploaded: 2026-03-18T16:02:07.069Z
Duration: 46 min 16 s
Description: QMSR is done. Now what?

Transcript for "QMSR is done. Now what?": Hello. Hello, everyone. Thank you so much for joining us today. Welcome to the webinar. Just gonna wait for a few more people to hop in before we officially kick things off. Alright. Looks like people are starting to to join. Thank you again for joining us this morning, this afternoon, wherever you are in the world. I wanted to start off with some reminders before we get into our content. We have a lot to get through today, so let's get into it. Before we begin, just reminders to make the most of your webinar experience, please remember to expand to full screen from the bottom right of your screen. If you have any specific questions in relation to today's webinar, please add them by using the q and a tab. If you have any other general questions, please feel free to use the chat tab. I'm really excited to introduce our speakers today. Today, we are joined by Sumatha Kondabolu and Yuan Li. Sumatha brings over twenty years of, quality expertise across the pharmaceutical and medical device industries specializing in quality system implementation and regulatory compliance for startups and scalable org operations. She has helped organizations establish robust quality, management systems aligned with global standards, enabling them to achieve seamless compliance and sustainable growth. Sumatha has built and managed quality management systems meeting the requirements of FDA QSR, Canada's medical device regulations, NIOSH, MD SAP, and The EU's MDR, IVDR, as well as preclinical and clinical frameworks. Doctor Yuan Lee is a medical device regulatory expert with twenty years of experience across academia, industry, and certification. He heads up the North American medical operations at DQS, a global certification body, as well as specializing in orthopedic products. Yuan is an expert on QMS, MDSAP, and and MDR. So thank you so much to both of our speakers for joining us today. So today, we're going to be going over what actually got changed in QMSR and what companies may have missed. We'll talk about moving towards a more continuous risk management model and process based tracking of key metrics, and we'll also go through a new way to meet QMSR requirements. With that said, I'll pass it over to Yuan to go through what the QMSR means for your business. Thank you, Thank. you. And thank you everyone for taking the time and joining us. Once again, QMSR. Well, I mean, we are sitting here in 2020 06/2018. What that means is QMSR is here. As of February 2 year, FDA put this in implementation phase. And what that means is we are officially under QMSR by referencing this ISO thirteen four eighty five two thousand sixteen version. K? If you could go to the next slide. Let's go back to the memory lane. Let's refresh our brain what that that mean. Two years ago, waste publication of final ruling from FDA. You have the list of contents under now that eight twenty, and you have part a, which is general provisions, as well as part b, which is supplement provisions as well. And a lot to be published, to be announced yet. However, we can sort of see from here what is what it means of this change. Next slide, please. All right. So a few new sections were added by FDA with specific incorporation by referencing the thirteen four eighty five. Examples are 08/20 dot seven, the production, and also 08/20 dot 10. Some FDA specific requirements, which focus once again on their post market surveillance mindset, on the medical device reporting, as well as complaint handling. And then with eight twenty dot 35, you will have a stricter requirements than thirteen four eighty five on the control of records as well as 820.45, the new section with focus on the UDI and the new traceability requirements from FDA. Next slide, please. Alright. So once again, refresh the memory, which stays the same. First and foremost, their legal authority and the fact that they are the law enforcement is not gonna change. Like I mentioned earlier, FDA's consistent mindset with focus on the post market activities, which include the medical device reporting, which includes complaint handling requirements. Those are unique. Those stay the same outside of the thirteen thousand four and eighty five requirements. And, also, the traceability increased traceability requirements through UDI requirements, FDA successfully implemented years ago. That's where you have labeling, packaging controls, stays the same, and servicing records, etcetera. Last but not least, even though they're going away from the Qsets inspection method, the risk based inspections will continue as well. Next slide, please. Okay. So risk based approach. This is pretty much the key point of this latest and greatest harmonization with thirteen four eighty five because by referencing directly the thirteen four eighty five, you will establish a reference of ISO fourteen nine seventy one, risk management of medical device, which is pretty much a shared language already, a global regulatory framework for device manufacturers. And with that approach, you will have better control downstream, which means you will have more alignment throughout your product life cycle, including design, documentation, post market activities as well. And the new requirements also included what I mentioned earlier, some of the unique FDA requirements with focus on the packaging, the labeling control, as well as the post market activities. Next slide, please. All right. Not my word. Published a long ways to this FDA final ruling. They actually highlight cost saving opportunities. Okay? So here's my interpretation on that. It's open secret. A lot of The US based manufacturers, especially suppliers, they actually run multiple quality management system. One specifically for a 20, for FDA, as well as one specific for 1785 and international markets. Well, you don't need to do that anymore with this referencing and QMSR. You essentially just need one QMS, which is based on the thirteen four eighty five. That means you will have less duplication in terms of your processes, in terms of your documentations. You will essentially have less internal auditing costs. You don't have to run parallel paths. And last but not least, you don't have to run multiple trainings for your various quality management system. That's one. And, also, by having this QMSR and further alignment with thirteen four eighty five, you can essentially achieve streamlined audits as well as regulatory inspections because, theoretically, FDA should be running essentially the same audit method under thirteen four eighty five just like certification body such as DQS. And with that, you could have push potential savings through fewer late stage design changes because this whole risk based thinking is covering your entire product life cycle compared to the previous QSR requirements. And last but not least, with more of the supplier following essentially the same requirements, thirteen four eighty five, you will have a more efficient supplier in purchasing control. I added a little disclaimer down there by reminding you that having a third party ISO thirteen five thirteen four eighty five certification does not automatically give you FDA compliance by yourself. There are additional requirements from FDA, from QMSR, and also the legal authority part as well. So next slide, please. All right. So obviously compliance is mandatory. As I mentioned earlier, FDA asked the government agency, this QMSR is a legal binding document that makes it mandatory for any companies that's under FDA jurisdiction. However, you also have opportunities because by further alignment with searching for 85 will open doors for you to international markets such as EU, Canada, Japan, just to name a few. Last but not least, even non FDA suppliers may benefit or else be required to comply with ISO thirteen thousand four and eighty five. So next slide, please. Some of the key advantages through the QMSR, essentially the further alignment with ISO 13,485. Like I mentioned previously, global harmonization means further regulatory alignments. Your international registration inspection application will get easier and encourage modern practices, which is essentially the risk based thinking throughout the the entire 1785, and then you will potentially have streamlined audits and documentation, and you will be more ready when you attack global market entrants. Last but not least, you tend to have more efficient FDA inspections, because you are familiar with thirteen thousand four and eighty five already. Next slide, please. And see it as opportunity. What I mean by that is, you know, I know many people, myself back in the days, we have this prescriptive thinking, which we always ask for checklist. We always ask for what's required. What is the deadline, etcetera? And then with this QMSR. If you see it that way, we might have a opportunity to evolve into seeing quality as partner, not as, you know, gatekeeper. Instead, it's a real time risk awareness and dynamic regulatory intelligence coming in place to help your business instead. Next slide, please. And well, I mean, numbers come up with from the research by such evolution from reactive firefighting to upstream strategy, you could potentially save a lot of those preventable changes. And also this by applying this product life cycle risk based thinking, you could achieve a lot of the cost of the poor quality strategy. Next slide, please. Some other benefits. If you do the QMSR rights, you will have stronger credibility, obviously, because you will be more familiar with thirteen forty five and easier due diligence in partnership because you essentially will speak the same language with your global partners. They have been very familiar with ISO thirteen four eighty five already, and you will potentially have faster onboarding for OEMs or any suppliers. Last but not least, you will tend to have more favorable regulatory perception because, like I said, thirteen four eighty five being the new backbone of your quality management system. Next slide, please. Okay. So last but not least, like I said before, third party ISO thirteen four eighty five certification does not guarantee you a successful FDA inspection. However, it can help you navigate by building credibility with FDA inspectors, because essentially we're talking about the same auditor pool they will be using, and you could potentially reduce inspection frequency under the FDA's inspectional authority discretion. And also, like I mentioned before, you could potentially have faster onboarding of supplier OEMs. And last but not least, just to remind everyone, MD SAP is another program or certification you could pursue, which is accepted by FDA in place of routine inspections. So with that, I'm going to turn to my other speaker, Sumasa, and thank you very much. Thank you, Yuan. Hello, everyone. What I'd like to focus on today is a shift in mindset from from simply meeting compliance requirements to actually owning the outcome those requirements are meant to achieve. Because compliance is really just step one. What matters is whether your quality system actually works in practice, whether it consistently delivers safe, effective products, supports good decision making. You'll see here three areas where this mindset really comes to life. One, the external providers and purchasing controls. First, external providers, it's not enough to qualify a supplier and check the box. The real goal is to ensure that this risk is understood and controlled before out before outsourcing decisions, or maybe you are sourcing the decisions that are finalized. That means quality needs to actively define risk based controls, not just review paperwork, but influence decisions. We will move on to the next one that is the product life cycle. So here, the quality shouldn't be something that comes at the end. It needs to be embedded from the beginning, especially during the design. Here, quality defines what risk is acceptable and ensures risk management is integrated throughout the life cycle, not treated as a separate exercise. The third one is the feedback and complaint management. This is where the system proves whether it's actually working. Quality should lead the cross functional and evaluation of complaints and post market signals, not just documenting them, but using them to drive corrective actions and continuous improvement. So across all three areas, the theme is the same. It's not about executing processes. It's not about owning the outcomes. Those processes are meant to deliver. So how do you actually move from checking the box to truly owning the outcomes? Let's look at what that transformation looks like. Here, you can see that building on that idea of co owning outcomes, this really shows up in how we manage suppliers. Traditionally, quality reviews are conducted after procurement selects them, but at that point, it's already reactive. Under QMSR, quality shifts to a co owner role, defining the risk criteria upfront. That means setting expectations like required certifications, quality agreement terms, and performance thresholds before selection happens. And this matters where you can see 61% of organizations say supply chain disruption is their biggest risk. So the shift is simple, from reviewing supply decisions to shaping them early. So let's look at how the same principle applies in the next area. So if we move on to the yes. On the this slide, you will see if you are thinking how do we actually make this shift. Here is a simple three step checklist. First, diagnose your current state, map your current supplier qualification process, and identify where quality is still coming in too late. Second, move quality upstream, define risk based criteria, agreement requirements, and clear performance thresholds before supplier selection. And third, build the evidence tree. Document your risk rationale and link supplier performance to ongoing review. The key is make decisions risk based, make them early, and make them traceable. This same approach applies beyond suppliers, and let's look at the next area. Here, the same shift applies to the design controls as well. In the old model, quality sits at the gate, reviewing decisions after engineering has already made them. That often leads to gaps in traceability, mismatches between design and production, and ultimately, higher recall risk. Under QMSR, quality moves upstream. Quality and engineering defined risk and acceptability criteria together early on so that when trade offs are made, they are made against clear thresholds, not after the fact. And that improves both traceability and communication across the design process. So again, the shift is from reviewing decisions to shaping them early. Let's look at how this plays out in post market feedback. So how do you apply this in the product life cycle? Again, three simple steps. First, diagnose your current state, where is quality entering today. Usually, it's still at formal design reviews. Second, move quality upstream, codifying risk and acceptability criteria at the start of design and make quality part of design planning, not just reviewer at the end. And the third one is build the evidence trail, make sure risk decisions are traceable from input through design, and that post market data feeds back into early design decisions. So finally, the goal is risk informed decisions made early and clearly traceable. Now let's look at the final area of feedback and complaints. The third area is complaint handling, and this is where QMSR adds more depth. Under the ISO thirteen four eighty five, the focus is on having procedures in place, receiving, reviewing investigation complaints, and finally meeting reporting requirements. QMSR builds on what with much more explicit documentation and traceability expectations. For example, documenting evaluations in detail, including UDI and MDR related information, and clearly justifying decisions, especially when investigations aren't repeated. So the shift here is from having procedures to demonstrating consistent, well documented decision making. And this is really where the system shows whether it's working, turning feedback into clear and traceable actions. We will see in the next slide. So finally, how do you op operationalize this in the complaint handling? Again, three steps. First, diagnose your current state, map who is involved end to end, identify where quality is coming into too late or key decision aren't well documented. Second, move quality upstream, align with support teams on what qualifies as a complaint, involve quality early in stage, and make MDR evaluation a front end decision. Next is the third build evidence trail. Ensure consistent UDI capture clear documentation of investigations and explicit justification when justify when investigations aren't repeated. The goal is same. Clear decisions made early and fully traceable. So across suppliers' design and complaints, the pattern is consistent. Quality moves upstream, decisions become risk based, and everything is traceable. That's really the essence of QMSR in practice. And if we see the next continuous risk management. To bring this together, if we see in the other slide, yeah, the two dimensions of the same shift. So to bring this together, this shift really happens along two dimensions. First, organizational position where quality shows up moving upstream before decisions are made across suppliers, design, and complaints. The other one is the second operational cadence. Often, quality engages shifting from periodic or episodic involvement to something more continuous and always on, and both matter because it's not enough to be involved early. You also need to stay engaged throughout. That's what it really means, to co own outcomes not just at that point in time, but across the life cycle. And if you see in the next one here, the co ownership examples we just walked through, the supplier qualification design inputs, change control, are all about where the quality shows up in the process, upstream versus downstream, before decisions are made versus after. So the continuous risk management challenge is the same problem applied to time. Most quality functions operate in periodic cycles. Example, like annual audit cycles, quarterly management reviews, point in time gap assessments, followed by the chemisarts process based model assumes something different. That risk awareness is ongoing, not episodic. Together, these are the two dimensions of the same shift quality operating earlier in decisions and quality operating continuously rather than periodically. One is about organizational position. The other is about operational cadence. Both are required for the model QMSR is pointing toward. And one final shift to highlight is how we measure success. So here you can see, traditionally, we focus on audit readiness metrics, things like training completion, kappa aging, document status. So these are important, but they are lagging indicators. QMSR pushes us toward process health metrics, looking at performance trends across processes to answer a bigger and question that we want to answer is the system actually improving and that the distinction matters. Because it defines whether your quality function is built to demonstrate compliance or to drive it. That's what it really means, to co own outcomes not just at point in time, but across the life cycle. And here, if you see that on the slide, most quality dashboards are built to answer one implicit question. Are we ready for an inspection? On time, training completion, open cover aging, document review status, followed by a mature operating model as a different question. Is our quality system actually working? That means metrics on process performance across related standards like QMSR and ISO thirteen four eighty five. The distinction is the audit readiness metrics tell tell you if you are compliant. Process health metrics tell you if you are improving, and QMSR's continuous improvement requirement actually demands the second set. Sure maturity curve where the basic metrics more advanced, you know, the compliance, intelligence, tracking, kappa effectiveness rates, audit finding trends over the time, complaint patterns is a good start. And, the state is getting to real time visibility across all standards that matter based on live changes within your quality management system and catch when you are drifting. For example, if a customer complaint comes in and there is no corresponding review of the associated risk file, you should have instant visibility that missing traceability step automatically rather than waiting for your next audit to surface it. So the conversation worth having in the next phase of QMSR maturity is not whether you are compliant, but whether you your quality function is structurally capable of the continuous risk awareness the regulation assumes you have. And if we move on to the next slide, this is where Qualio compliance intelligence comes in. Most quality teams are still tracking lagging indicators like Kappa accounts, training completion, audit findings. Compliance Intentions is built to get you beyond that. It continuously monitors your quality management system against ISO, FDA, and EMA frameworks so you're resolving gaps before they become audit findings, not after. The guided remediation keeps quality professionals in control while the platform does the heavy lifting. And for leadership, you get board ready risk reporting, shifting the conversation from are we ready from an inspection to, is our quality system actually working? Customers like SendTech are seeing 80% faster audit prep as a result. So let us show you what that looks like in the product. I'll pass it over to my colleague, Sarah. Thank you, Samantha. Let me get set up here and share screen so I can show you the what Qualio's compliance intelligence looks like in real time. So we've been talking a lot today about what QMSR expects from your quality system. So let me show you what it looks like to actually implement and monitor that in practice. This is what you see here is Qualio's framework library. So out of the box, you get the standards that matter most to medical device manufacturers. There's thirteen forty five in QMSR, 21 CFR part 11, ISO 9,001, MD SAP, and others. And so you're not building these from scratch there, or you're not maintaining multiple spreadsheets of mapping all of these requirements. They're prebuilt, pre mapped controls, and ready to implement. So QMSR is here. As we've been talking about today, it's a current requirement. So if you're a US medical device manufacturer, this is what FDA compliance looks like now. So let's dig in and take a look at what it looks like. So within compliance intelligence, we have this new set of QMSR requirements and gives you that idea of what your current compliance posture is against them. Every requirement here is connected to your actual SOPs, your policies, any records sitting within Qualia. And your requirement status, the gap severity, and even your remediation tasks are all tracked in one place, so you have a one stop shop to see what your compliance posture is at any point in time. So let's look at a specific requirement here. I'm gonna dig in and look at confidential records. So this is one of the areas that QMSR adds specifically building on what ISO thirteen forty five covers on its own. Now here underneath the hood, compliance intelligence has pulled in the relevant SOPs and records. It's read them, and it's assessed whether they actually meet the requirement. It's gone ahead and flagged a gap here, providing a full description of what's missing and a recommendation for how to address it. So compliance intelligence is continuously scanning MyQMS and flagging these gaps in real time. As you make changes, it's always going to be keeping those assessments going so your team doesn't have to wait for those point in time audits or your doc of that documentation or of your CAPA systems to really uncover any of those blind spots. So this makes your overall understanding of risk and process health much more dynamic and proactive across all of your requirements. You can even bring in our AI assistant here to ask for additional guidance or even to help you draft an SOP update directly within Qualio. Now beyond your process documentation, those SOPs, your policies, your work instructions, compliance intelligence can also automatically monitor evidence. So if a record or log that's expected is missing or maybe it's out of date, the system will flag that too. And it's not just gaps on how your procedures are written, but it's actually evidence and how is it actually following and demonstrating your prescribed processes. So compliance intelligence goes beyond just the requirements to actually building out assessment against your own processes. Now you now that you have a gap identified, from here, you actually can assign a remediation task. Now this can go to whoever owns it across your organization. So it's involving teams outside of just quality. And you can set a due date, and you can track that to closure without ever leaving the platform. Now the other great thing is that once Tina here goes and updates this SOP based on this task, where the system is gonna automatically reanalyze it and resolve that gap if it's addressed. So that's what continuous monitoring looks like operationally. Issues are surfaced as they emerge, not months later, once you're actually preparing for an audit. And because these controls actually map across multiple frameworks as you can see here, resolving this gap doesn't just update your QMSR posture. The same control may apply to other standards, so you're managing all of it in one place. You get credit across all of them from that single fix or that single update to your SOP. So what that means is you have one quality system, one update, and you get all of it credit everywhere. So as part of that initial setup, compliance intelligence is going to map your documentation, going to identify any gaps, and it's gonna update all of those requirement statuses so you know where you stand at any point in time. But it's not just a onetime setup. After that gets set up, it runs continuously. So as we mentioned, every time a document is updated, it flows through and gets reassessed in real time. So for teams working through those QMSR compliance requirements, that's the practical answer to what dynamic risk management looks like day to day. Not a separate exercise you've run before an audit, but something that happens as a byproduct of how your team already works. And with that, let me pass that the screen back. Alright. Thank you so much for walking through that, Sarah. We appreciate it. Before we wrap up here, I wanted to get to some q and a. So the first question that we have is on the QMSR ISO relationship. So this is for Yuan. So, Yuan, you mentioned that ISO thirteen forty five alone doesn't equal FDA compliance under QMSR. So for companies that are already certified, what are some of the most common gaps you're seeing in practice, and where do folks think that they're covered but maybe they actually aren't? Okay. Yeah. No. Thank you, Tina. That's a great question. I will say, first off, in the the presentation earlier, as you can see, there are a lot of FDA specific flavor being added into the QMSR, specifically the the post market simulants activities. That's a unique feature of FDA. And the UDI requirements, that's unique. That's on top of the thirteen four eighty five. So those are the two general areas I would highlight. If you are thirteen four eighty five compliant, either through a third party certification or you just been running the QMS for a while. Those are the two areas you need to you need to really spend some time look into. And as far as gap goes, I I don't really think there's any gap necessarily, but more opportunities maybe. End of the day, you have to keep in mind, thirteen four eighty five is like a backbone. Nothing more, nothing less. With QMSR, you are adding on top The US specific requirements just like you would do for Canada, for Japan, for Australia. So it's a good thing that with this harmonization effort from FDA, you will eventually be able to run thirteen four eighty five with add on features of your QMS. But just pay attention to US specific requirements such as labeling, such as reporting, etcetera. So I hope I answered your question. Got it. Thank you. That's very helpful. Our next question is for Sumatha, and it's about this idea of quality as co owner and moving towards that model. So, Sumatha, the presentation frames a shift from quality as gatekeeper to quality as co owner, particularly in areas like supplier qualification and design controls. So for companies where quality might be working more downstream, what's a practical first move to start repositioning upstream without completely restructuring how the team operates from day one? Thank you, Tina. So that's a great question. And honestly, the key is to start small and targeted and not to try to restructure everything that once. So the most practical, first move is to insert quality earlier into one decision point. For example, a single supplier selection or an active design project. Instead of reviewing, after the fact, have quality codifying the criteria upfront, what risk is acceptable, what thresholds matter, and what good looks like. So the that one shift changes the dynamic from approval to influence. At the same time, make sure, the documents have the rationale behind those decisions, and, that builds the evidence of the QMSR is looking for. So it's really like pick one use case, move quality into the decision, and make the thinking visible. Once that works, you can scale it without needing a full reorg. I hope I answered. the question. Yes. Thank you, Sumatha. Next one is actually for you as well. So on this idea of continuous risk management, the presentation that we went through, it draws a distinction between audit readiness metrics and process health metrics, like lagging versus leading indicators. For teams that are mostly tracking lagging indicators right now, what's one process health metric they should add first, and what does it actually tell them that their current metrics don't? That's, that's really a good, question again, I would say. So so if you are, mostly, you know, tracking lagging indicators today, a strong first step is to add a a cycle time metric. For example, from, time from issue detection to closure, whether that's, a complaint deviation or a kappa. And what that tells you is that the lagging metrics don't is how your system is actually performing in real time. Lagging indicators might tell you you are compliant, that KAPAs are closed or training is complete. So by cycle time shows you where things are slowed down or how quickly risks are being processed, whether your process is being improving or if there is any delay over the time. So it shifts the decision, you know, or the the question from, did we complete it, and how well is the system working? And that's the real goal, actually. So, so that's how you can focus on. Got it. Thank you. We have one question here before we wrap up. One last question. So this is from, I believe. I have always seen quality leading the complaints handling before QMSR. I'm not sure if there would be any shift with regards to their involvement except for increasing their scope with regards to UDI and MDR. Am I missing something here? Please explain. I think part of this is just the idea that complaint handling is typically very cross functional. So with more requirements is the opportunity to make sure that the process is working as it should. But I'll pass it over to our speakers to give a little more color to this. Yuan, do you wanna start? I I I don't think there's anything unique based on the the question. No. I I don't I don't think by having QMSR, we added any additional process. Instead, I think that's exactly what it's supposed to. As searching 45 pointed out, it's a it's a whole product life cycle complaint handling being one part of it. It should be interlinked, interconnected with all the different modules. No. I I think it's it it stays the same. Yep. Thank you. Thank you, Yuan. I think maybe I'll add a little bit to that is, as Yuan mentioned, like, many organizations, like, quality has a traditionally led complaint handling. So what QMSR changes isn't who owns it, but how that ownership is exercised. So the shift is really in three areas. Like, you know, you can think of, first, the timing, quality is expected to be involved earlier at an intake and triage or not just, you know, during the investigation process. Second is decision clarity. For example, the MDR evaluation, whether an investigation is required, need to be clearly defined and justified upfront. And then I was also thinking about the depth of documentation and traceability, including, like, for example, like, there are UDI, MDR, and explicit justification when decisions are made. So it's less about changing the ownership, but more about making the process more structured, proactive, and traceable. Awesome. Thank you for walking through that, Sumatha. Appreciate it very much. Before that's all the questions we have time for today. Before we wrap up, I wanted to go through a couple of last reminders of how to get in touch with our speakers. If you need more information, we were joined today by DQS. You can reach them over email at sales.us@dqs.de, or you can visit their website. Yuan, is there anything else you'd like to add? No. I just wanna highlight DQS being a certification body. We we certify ISO thirteen forty five, MD SAP, even MDR. So we will be there every step along the way, being your certification partner just like Qualio. So, nope, nothing to add. Thank you. Awesome. Thank you so much. And to learn more about Qualio and the compliance intelligence solution we walked through today, You can visit us at qualio.com/compliancemanagementsoftware. You can also scan the QR code to go directly to the URL. And we look forward to being in touch soon with more best practices and more insights. Thank you so much everyone. Thank you for joining us today. Thank you. Thank you. Hi.