Empower Your Business with Cloud Contact Management Systems for Product Quality

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hello and welcome today we're going to be talking about qms in a regulated industry and how to take that qms to the next level and what that really means in today's world quality tends to be in some instances a backroom quality or the ability to document after the case and realistically to expand your quality management system throughout the organization you have to instill cultural quality throughout manufacturing already believes and does produce quality through their craftsmanship supply chain inventory and the real key to expanding a quality management system is focusing on how to generate that culture of quality so what is quality assurance well at the end of the day it's pretty simple did you meet the specifications that you were required of you to develop the product and did that product meet the efficacy and needs of the population it's being sold into hey terence yeah so at the end of the day who owns quality assurance and more specifically the quality management system that we are talking about you know that's a great question you know quality is a responsibility of all of us right so i hope that was a redundant question yeah i mean you know if if done right quality is really owned by everyone that's always challenging but we have several examples of customers who have been very successful with embracing quality initially through the qms but also then expanding it throughout their organization primarily the motivation there is to eliminate the inefficiencies and the inaccuracies that come in when you have a large-scale document system that is mostly paper-based and then there are a few other motivations as well that we will touch on as we go through this quick introduction this is uh i'm rajesh talpade i'm the vp for product at master control my background spans mostly roles in product management and related areas enterprise sas have been at various size companies over the last many years uh and uh now i'm totally excited to be talking about this very important topic especially in these times as a lot of attention is focused on healthcare and hello i am terence holbrook i am the principal director for master controls product i have a multitude of years in manufacturing product development as well as software development for the regulated industry as well as i work with several very large corporations on machine learning and artificial intelligence and today we're going to discuss again how to expand that qms mentality right create that culture and to be able to do that you you have to understand that it already exists for the most part if you go into the manufacturing floor the manufacturing employees produce quality the shipping employees do it it is there and the real key is connecting those dots it's being able to capture that real information that real quality that's being put in so that we can track and trend it and focus on what is really happening in our manufacturing in our production in our development and how the those specifications need to drive that system and really at the end of the day without executives helping us to really transition to that culture of mindset it's extremely difficult to expand the qms to that culture of quality but in today's changing world where quality is instantaneous across you know the csat ratings on mobile and the live interjections we have with tick tock and other platforms we have to be much more responsive and much more embedded into our quality processes yeah and you know the other part about quality is the fact that a lot of data exists today as companies are successful in digitizing their documents and other artifacts this data is typically in the qms and rather than treating the data as a blob it makes sense to leverage and extract relevant and actionable items from it so we'll touch on those as well as we go along but but it's extremely important and beneficial as you think about expanding the qms the fact that the increasing amounts of data can even benefit from that expansion so uh speaking of uh expansion you know we all already know about uh the role that document control plays in a qms uh but it doesn't stop just at document control there's also the very related area of document management it's very important to be able to meet those requirements document control typically is needed by the equality organization while document document management is required by some of the other organizations in the company so for a qms to be successful at expansion it needs to be able to support both those capabilities yeah well and track tracking and trending you know the all the new regulations around udi unit dose specific user implementation needs for the supply chain are really changing the focus of data right we're going from manufacturing for the one instead of manufacturing for the masses which is a unique element in today's world yeah absolutely and again you know we touch on data over there the availability of data in the qms is is super relevant wouldn't it be great if because of the data that you have an operator is prevented from operating operating a piece of machinery or performing an operation on a product since that operator has not completed a required training which might result in an expensive product recall if nobody intervened agreed and and speaking to that point so being able to have that information readily available across the departments helps to feed that quality-minded culture and mindset and helps us really do proactive quality instead of reactive right stuck in that world where we're looking at is that a four or an eight is that a nine or two did so and so sign off did this person miss something we have to wait for their shift to come back if we're capturing information and connecting the dots across the system the data can really be then used and consumed by those that need to impact the quality system yeah and it brings us back to the same question which is you know who exactly owns the qms you love the redundancy questions yes it's it is it is unique right that quality assurance owning the quality management system is very siloed right we have to get past that into the culture of quality and speaking of that not only do we have to get to the culture of quality we really have to start automating and looking at ways to improve beyond just the culture quality inside of the company but expanding it out even further your supply chain is part of your quality your audit your partners your clients all of that is intertwined and being able to bring all that data into a center point where you can use and capitalize on that is crucial to expanding hey terrence just wondering was it intentional or did you really forget about recalls and complaints here yeah those tend to scare companies so i didn't want to talk about them but good point you know you have the worst case scenarios that come out the recalls right and the complaints and the customers not being happy all that information has to loop so that you can have that touch endpoint to end point quality system and speaking of that when you get into that manufacturing realm that realm where at the end of the day they are responsible to produce the specifications ing to those needs and make sure the efficacy applies and to do this with real lifetime quality data funneling through our system through our executive branch we can then really use that information to start capturing on continuous improvement and process controls which really optimizes that and to your point rogers bringing in that postmarket complaints and the recall information connecting that all through gives us the ability to get to a truly data-driven manufacturing environment where we're looking at what's happening and adapting it without silos we're adapting it with the greater good in mind yeah yeah that's true and you know a great uh application is also uh in cases where manufacturing equipment might not be in calibration right oh that is true i forgot about that yes equipment and calibration such a crucial part of manufacturing to help meet those specifications all that data needs to be brought into a continual flow so it's not disparate on paper in boxes in a warehouse yeah and you know speaking of uh uh not keeping it in boxes responsibility goes uh in a similar direction as well right so we talked about quality being relevant on a horizontal uh plane across the organization but clearly it also goes up in the vertical direction and affects everyone in management as well most of the regulations out there not just the ones out of europe but others hold uh specific named people within the organization responsible and have specific penalties uh when those violations are um not in compliance yeah and i notice you're solely focused here on european don't forget i mean i've been in the room and it's nothing like watching an executive be handcuffed and taken out because they falsify documentation to ship a product right management responsibility is a global concern the fda here locally doesn't take too lightly to intentional errors which of course brings us into errors right how do we manage a system effectively well i can tell you it's not by deciding if it's a four or an eight or seeing if an employee was on time or seeing if their training was up to date after they built something right that's that's not a quality assurance that is checking at the end of the fact which we talked about is not ideal review by exception has been adopted as a mentality by the fda and other international regulation based companies as a best practice let's look at what's going wrong and really find out how to improve their the proactive quality approach connecting those dots throughout the system and giving those executives something real to look at what is our trending as far as our quality to specifications what is our scrap rate our yields rate in lifetime information so we can look and capture those imagine being able to stop a line because you know you're trending out saving that material to be able to use in a different lot when the specifications aren't getting met and you've called out instead of that getting to the shelf you realizing it didn't meet quality now you got to go pull it off and not only when you pull it off do you lose all of that product now you've lost all the double time back in manufacturing where you could have been producing high quality product yeah and it's a lot of uh you know i think uh material and uh knowledge to take in but there's help we have several partners that have actually been working with many of our customers a partial list of those are shown on the screen right now please feel free to reach out to any of them they are spread out through north america and europe but there are other partners in other parts of the world as well and of course you can reach out to us if you don't find someone that is specifically in your particular area or industry yeah so in conclusion we've talked about some high-level tools some different ways that you can work to connect those dots and of course moving data into an electronic system is always optimal as one of those tools and one of the key elements is bringing that leadership into that so that you can optimize and truly gain the value and that's how you really expand your quality management system it's creating that culture of quality yeah and data is a big role to play here again quality is all about being able to collect relevant information and make it available in a timely manner and so the the data to support those operations exists today in most qms's um it would be a shame to not take advantage of it to not just support quality needs but also other needs of other organizations such as improving efficiencies or even for that matter improving the revenue enhancement opportunities so data exists make it work for you exactly and bring with that the executives right make sure that it's not a quality system that's paper it's not a quality management in the back room this is providing quality throughout and it saves money the executives are looking for that right it makes a better product it makes clients and customers happier right a culture of quality is really the best way to expand your quality management system is to embed that value of meeting the efficacy and efficiency and delivery of value to the client well thank you so much rogers for joining us today i appreciate you taking the time out of your busy schedule and we look forward to the next session here in a few minutes yeah it was great thanks so much terence take care everyone you