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Doctor bill format for Product quality

[Music] welcome to the global medical device podcast where today's brightest minds in the medical device industry go to get their most useful and actionable insider knowledge direct from some of the world's leading medical device experts and companies hello and welcome to the global medical device podcast this is your host and founder at green light guru john speer joining me is uh co-host etienne nichols etienne how you doing today hey john doing good good to be back well i'm glad to have you back as the green light guru software platform has evolved we are constantly listening to our customers to determine you know what new features or functionality should we incorporate into the software platform and you know we're soon going to be rolling out some functionality around it's going to help you better manage bill of material so i'm pretty excited about that i know you've had a chance to see that a little bit right yeah it's going to be pretty cool revision your bill of materials and so forth i won't give too much away but yeah yeah then it ties into the design control and i think this is one of those things where a lot of folks may not understand there's a direct correlation i don't want to get too ahead of ourselves maybe i should just introduce our guests and then we can dive into it so joining us is a repeat guest mark rukovich with innovize and casilla and mark welcome back and i feel like every time i'm saying your name i'm getting a little bit better at pronouncing it so thanks for bearing with me well thanks john thanks for having me again nice to see you so build materials and maybe this is a good place to start i think a lot of people don't especially newbies to med device don't necessarily understand what a build material is what it is not and i would say they don't understand the correlation or the relationship between a bill of material and the dmr and the design controls so maybe that's a good place to kind of paint the picture for folks that's what i was going to start with too so dive in the quality system the quality system requirements both in iso and fda they've added design controls which is great because it's sort of the front end so as you look at design controls there are design inputs design outputs and verifications on validation design output that is what is your design going to be and so that's the design output now everything that's developed out of design controls is part of what's called the design history file so your design hits files everything associated design now part of the regulation talks about the device master record all the information required to build the product well the dmr is actually an output is a design output so the dmr is actually part of your design history file you can debate this with auditors it doesn't matter as long as you have them you need to have them and they need to be controlled so your design output device master record is everything you need to build the product so what do you need to build the product well all the parts in the product need to be listed and defined and controlled now device master record also though includes the instructions to build the product who are your suppliers for those components and then what operational steps to manufacture that so i mean the bill of materials you can also grow it to be a bill of documents and a bill of operations i mean all that is sort of what's required to build a product so simply saying let's discover the bomb because that's the easiest one to recognize it's like if you know you have i have a catheter i have tubing i have a handle okay those are two parts those are parts that are be on your build material there's a packaging material so there's a pouch that it goes into there's a label that goes on it there's an ifu and it goes in a box okay those are like six components that are beyond your build material now what's interesting is what the design people the designers come up with they're using cad tools to build this out and so using cad tools the cad tool itself you have to create what's called a prt a dot prt file for each part so that just sort of describes each physical part and then they so in the cad they can 3d they can connect them all together and then when they put multiple parts together on a cad drawing they get what's called a dot asm file which is the assembly of all the parts so now you have two parts so if you look in the cad software the assembly has linked to it all the parts which the software automatically can print it out onto a design drawing that's your build materials great i got to build materials well that's good for the designer but how do you manufacture it the designers don't put in the manufacturing process steps right in there so you got manufacturing steps so i've talked about this a lot but that's consistent consulting with companies it's like so that build material i ask how many bills of materials do you have in your company for this product as i start asking questions it's typically seven eight so you have the design document has the build materials on it well it's in the cad yeah and then you create a design document so there's two locations for your bomb and then oh because it's part of your dmr you create a dmr document so your bomb is on your dmr document and you're manufacturing work instruction to find i got to assemble this i got some of this component this component of this component so your build material is defined in your manufacturing work construction well i need a dhr record device history record evidence that i built it per the dmr so you may create a separate form that's your traveler document that has a build material on it so now you've got five documents that if you change is it oh and then you gotta buy the parts so you load it in your erp system yeah and then if you have a quality system tool like you guys you might have a bomb or a plm system or something like that you know pdm system the bomb is there so which one is right well they'll always be the same i mean that's a nightmare that's a recipe for disaster you just gave me a headache no uh walk into any medical i go name medical vice company that i haven't touched and it's like yeah they all sell the same things like yeah why does an eco take 30 days to process part of the reveal the signature processes and that kind of stuff isn't done right begin the front end but the back end is like well the documentation takes a week to process it because they have to change make sure all the other documents are all changed same time it's like okay one source for the truth here's the bomb and this is what's going to be and everything else has to match it right you know and you know you don't need if you have an electronic bomb that has also a bill of documents and the bill of operations then you're sort of got it all in one spot so one of the things i've done for other a lot of companies on your bill of materials here's my materials venue on the bill materials is you put a list of this is the manufacturing work construction document here is all the tooling that's unique for that product is on the billing material too and then you know depending what kind of product you're making to you know erp system might have a traveler may have a standardized one innovize actually since we're a contract manufacturer we're infinitely flexible there because every product is different and so we actually list you know here are all the different operational steps that it goes through and each one each one is different because we make you know 2 000 different products for 200 different customers so it has to be that flexible when i was in the contract you know i was doing implantable heart occluders we basically had three three manufacturing travelers so we just put an identifier saying this is routing a routing b and routing c on the bomb so when the documentation group got the eco to release they would know how to load it into the erp system correct and that's saying that was just showing our controls because our workflows were really simple and manufacturing there because it was the same it was basically the same parts we were making i'm not familiar with that sorry john um no no sorry keep going man keep going so the situation described i'm familiar with that multiple bombs and so the solution you're kind of suggesting is having that one source of truth and then the others point back to it or eliminate those what are you right the biggest thing in the company is you define which one is the master now that's sort of a bad word these days or something say it's like which one well the master is this but then everything else has to copy it so the cad drawing can do this this is released here but then the master is and it really won't apply to have electronic so then if the master's electronic then you can extract it and you know if it's like an xml format then it can be configured to look like a traveler it can be configured to look like a design document it can be configured and it's the same data so it's just applying different style sheets to the data so it'll look what the way you want it for the different users it's almost like the prime we'll use my life as in real estate so they've changed the new term is now the primary so the primary is the source of truth it's where the metadata is and it's almost like if the contract manufacturer needs elements of the bill of material or the design file or the eco it's like pulling from that same data source right right yeah one source right one source so then when you change it you change the source and everybody else says if anybody has an issue they know where to go to say well my document says this well your document's wrong this is right you know i've seen that problem so many times especially like when you have a relationship either with you know some sort of supplier like you could be a contract manufacturer it could be a part supplier you know maybe you're getting an injection molded component yes like who owns the prt and who owns the cat who owns the design and even with that how do you know that the part you're getting is built to the right version of that particular component i mean it could be a nightmare right yeah so yeah in the past a lot of companies use plm systems to help manage it but if you don't have a plm system a lot of companies use document management systems you know pharma is totally you know document management it's like it's a process but med device is devices so bombs make more sense now one of the other things about a bomb if you can add additional metadata to the bomb so when you look at a bill of material of wherever format it's whatever it's a paper or whatever you know each component on it should have a unique identifier so i part number is what everybody does and actually this is based on configuration management training there's a configuration management institute that does training on this i took that training i knew this i was a drafter back in high school so i understood the bomb concept back then but you know with training configuration management like oh yes okay now it all makes sense yeah i always did it this way but now i understand why because they went through you know excruciating detail on how to do it but the build material here's the part number here's the description of the part and here's the quantity and the unit of measure that is really the key of a bill material now you add a fine number up front so if you have a drawing you put the number one two three four five and then you have like a circle or balloon with a number on it and then it points to this is one this is two this is three so that you can tell which ones are which great so the part number creates unique identification the fine number helps organize it now typically most software systems use the find number and filter there if there's no find number it'll sort it by the part number now if you have electronics circuit boards on a circuit board your components also are capacitors and resistors and integrated circuits there's standardized methodology for naming those r1 r2 r3 c1 c2c so then you add another column on your build material that's your reference designators for electronic components you really don't need that for mechanical components now what most companies don't have and i've always tell companies to add another column called your operational step so what operational step in your manufacturing process is that component used now if everything's on one manufacturing step it's all up 10. so something simple you really don't need it but if you have you know it goes through multiple steps you know here here it goes through machining and here it goes through cleaning and here it goes through packaging opt-in up 20 up 30. manufacturing wants the bomb to be organized the way they're going to use it which is different than the way the design people so if you have a table and you know find numbers where design engineers want it the op step is how the manufacturing engineers want to see it and then when you add in tooling and manufacturing work instructions you could say and the op step with that document or forms can be linked to it so then they can sort the bomb by the op step and that's how they want to use it and the design engineer sorts it by here and they don't look at anything below like items one through 100 or fine numbers are what they use and they don't care about anything below it and then that information is then used to load the erp system that's really interesting i mean i guess i really hadn't thought about it from that perspective before because to your point i mean as a design engineer when i think of building material i'm almost thinking about it from the outside in i guess you know i'm oversimplifying here but from a manufacturing standpoint you know they're going to look at it almost from the inside out and they're going to look at what are all the different sub assemblies and how do these different sub assemblies need to be snapped together and that sort of thing so i think that's a good tip to folks is however you build your bill of material make sure you have attributes or metadata defined such that it can accommodate you know the points of view from a design perspective or points of view from a manufacturing perspective because right if you don't speak that language it's going to create some confusion that's why there's multiple documents today i mean most companies have because the manufacturing people want to see it this way because they want it this way and they're not talking to each other and then you get into the concepts of you know design people like here i just i designed this like okay so here i was at when i was like you know cardiac pacemakers were finding implantable pacemakers and stuff you know it and it's how what kind of hierarchy do you have in your build material like where do you create a subassembly do i have one level here's the pacemaker and here's all the components in pacemaker no because you know this is the finished good paste and then if i sterilize it it's a level below that so you create another level oh then the packaging level before it's sterilized i want to give it another part number and then i got the can assembly then i got the hybrid assembly and then i have the computer chip assembly so it's a six to seven level deep build material you know it's where your sub-assembly and the sub-assembly calls another sub-assembly and so you know that's actually they designed it so it matches manufacturing more well when i was at a company doing external defibrillators they blew it out this was like uh wait you can't build it that way so the designer built it laid it out in this cad drawing it's like no so we ended up creating part numbers in between but using the same design drawing because they had it on one picture it's like no we're going to do this as two manufacturing jobs and you know do them differently but using the same design drawing so that's where that comes in and really helps understand things so if you don't have material you really understand from the manufacturing now if you're doing simple parts it's all one and then the other concept on a bill of material that i want to most tell everybody here is like so you got one assembly and you have parts and you have one drawing if you have a raw material a single part this is really simple i got one part the part number and the document numbers so a lot of people make them the same thing it's like well yeah you can but you really should have a part number and a document number two different things because you want to be consistent across your whole company you know one part has one drawing right well if you have a tabulated drawing oh what's i have tubing and i'm buying this tubing from the supplier and i have you know five and six and seven and seven eight long lengths i'm gonna create dash numbers for each length because i want to create one drawing i don't want to create seven different drawings and just only difference is its length i'll tabulate it draw it once and say the length is variable so i have one drawing multiple parts printed circuit boards are just the opposite i got one part you need more than one drawing to describe the circuit board right no what's the electrical schematic what's the board layout what's the hold drawings on it what's the mechanical layout i mean you have four what's the test requirement i've had like seven eight documents that describe oh one part i mean you have multiple you know how many layers are in your board you know it's like it makes them even more complicated so yeah so you need to design a system that's flexible it's like wow but mine's really simple okay then for your company might want to just do it that way but if you design for flexibility then you're never going to have to worry about oh i got to change my quality system because i got this new product right because my quality system can't handle it right well i i think a lot of you know i'm the thinking about how you're going to architect your system you know and i know you know having spoken to you many times in the past and reading your book on casilla so this is really the premise behind that is you've got to be thoughtful about how you're architecting the system don't just you know drop things in place and cross your fingers and hope that it works forever it takes a little bit of thought right yeah and you know so i've been in the industry 35 years and i've seen all kinds of you know startups to multinationals you know being on an acquisition being the other acquisition you know disposable parts to capital systems and it's like the what i put in console so is the concepts and a lot of it's tied to you know concepts of configuration management concepts of lean concepts of system engineering are all what's in there it's all these best practices i sort of put it down like all my experiences in my device this is the best way of doing it and one other thing then with a build material when do you change a part number it's like i'm not gonna change the part number same thing no as things change you need to determine rules of interchangeability this is uh in previous podcasts we talked about you know the udi and there's rules of interchangeability there's rules of interchangeability in your assembly and you know the basic question here is if you change the product it's like could you put them in the same bin in inventory and you don't care when your shipping guy picks it up does he care which one he pulls out if he doesn't care then they're interchangeable it's like no no no that can only go there and this can only go there well then they have two different part numbers they can't have the same part number anymore they need to change your part numbering so that he can't pull the wrong part to ship to a customer so rules of interchangeability and your part numbering on your bomb is really important i mean this is an area a lot of companies get tripped up because you know versioning or you know it's like well we have you know version and how do you plan the obsolescence and all these sorts of things but i like the way you simplified that description like if the distinction does not matter then it is same part number if the distinction is a difference that is important then they're separate you know so i i get that that's a really simple way to think about it yeah and there's you know there's a lot of schemes in my book i actually talk about there's three ways of doing part numbering too i mean there's what most med device most people say is you do a semi smart number you know you have a base number and use dash numbers so that these are associated with it so that's really good i've done it where you have pure sequential numbering everything just gets a new number there's no dashes everything gets in there it works really well trying to find things that are related are is tougher then you get to the other end every digit in the part number means something and then you're gonna run it it will break down marketing can use that for the model number great but don't use it for your part numbering it's going to fail no matter you can't design that so that just use it semi smart numbering yeah smart numbers get dumb pretty fast yeah yeah that's well i think john mentioned the revising or the versioning of the part what about alternate parts within a bomb there yeah absolutely so there's different ways of doing alternate parts depending on what kind of part it is you could have let's just say you know i was doing electrical components on a circuit board even in the military back you know way on the day when before i've gotten the medici we had a spec number a part number for this component you know it was a transistor and it's like it has to do this this and so the spec is generic and then you can have multiple suppliers and here's their part you know so i can buy this from multiple parts suppliers for that part same part number not alternate primary because i can buy the same part from multiple manufacturers alternate primary their parts are different the specs are slightly different between the two so you get two different part numbers you can put them on the bill of material like i mentioned before you want to have give them the same fine number because they're located the same spot on the design drawing and the same quantity then you add another column in your build material alternate primary subcontract actually i actually put three an attribute i've done it with three attributes so this everything defaults says primary you have one but if you put an alternate then you control it in the quality system as your alternate primary now the erp system only wants one number you cannot put all erp systems don't like alternating primaries at all so you can say this is what it is and we've loaded it this way now if the buyer says i can't buy that part okay ing to the quality system i can use the alternate and they can look in the system say oh i can swap it and then you change the erp system for that job whatever and use the alternate part because it's allowed over here so that's how you want to be able to do that and then you know sometimes subcontractors you know i want them to make the part i'm going to give them part of it they're going to return part of it back and so it's sort of subcontracted built so that's typically dealing with all the primaries on the build material so you define it up front it has to be approved through the eco process that makes sense that find column i think is kind of invaluable as well as like you mentioned the primary secondary that's great very cool so we talked about contract manufacturing in a previous episode as well so the bomb i mean it seems obvious i guess but really nothing's obvious who owns the bomb in these different scenarios the device manufacturer owns the bomb you own the dmr you're telling the contract manufacturer to build it for the dmr now the country manufacturer can give you lots and lots of help but you're responsible for it i mean startups come here it's like i need a drawing it's like okay we can make it for you as a service you own it what number do you want i don't know they have to sign it they're the only approver is the medicalized manufacturer is the approver of the document this is your document that we're going to build to you signed it you don't have a quality system yet you need to have one but you know and then it's like well what number i give it well call it this like so the part number is you know wound care dressing it's like okay that's not a number but you don't have any other way of assigning it so you're doing it that way that's fine but device manufacturer owns the bomb because they own the dmr and they own a design history file but let me ask a follow-up to that who owns the suppliers oh well your quality system is i like the connected your quality system needs to define who your suppliers are device master record should define on your build material who is the supplier for each of those parts like i talked about alternative primaries some systems some plm systems you know you have the supplier of the part and you have the part number and you link in on an electronic eco you link in which manufacturer's part number from which manufacturer is approved for that part and if there's one to one then it's only one but that is all part of your device master record and it's sort of tied to the bomb but it's really part of the whole thing and some tools out there have that all linked in there i'm not sure if you're right your new one's going to have there enough but that's what you want to do because that's really if you have it all in one tool then you can run a report and do you know like i said you can have multiple views of your bomb you could run a bomb explode report okay bomb will explode into a documentary and it basically goes down through the multiple levels because you know all here's all the components here's all the parts here's the quantity and here's the supplier that's actually your device master record yeah so there's the listing of your device master recorder and that can be actually in some tools it's like set by effectivity date so this is what did this dmr look like you could say every second of every day as different parts change you can tell you what the dmr is at that point in time yeah again at the end i think we're finding that whenever we have mark on the global medical device podcast we could talk for a long long time on each one of these topics this might be a good point again to put kind of a pin in this topic let me hopefully say the right thing and kind of summarize the bill of material i've used this as an analogy or metaphor whatever the right assembly whatever the right english construct is but the way i think of a bill of material is it's a list of ingredients and by itself it's not super intelligent it doesn't necessarily tell you what order to put those ingredients together per se and this is where the contents of your dmr are more like the recipe let's talk about when to use this ingredient and that ingredient and to combine them do you think that's a probably overly simplistic but do you think that's a good way to sort of think about that really good way that's a really good way yeah and it's like i'm making chocolate chip cookies oh i'm gonna water scotch chips well it's no longer chocolate chip cookies it's not interchangeable with butter sketchy well on that don't know that i'm now thinking about food let's let's call this one a wrap mark rickovich with innovize and castella so mark this has been a great time i'm glad we've had an opportunity to continue conversations with you on a variety of topics and you know we'll hopefully we'll find other opportunities to chat again real soon but thank you so much sure thank you family yeah absolutely and at the end i know you're having a good time so we're kind of getting in a rhythm here so of course thank you as well for co-hosting yeah absolutely and folks again you know i'm sure you've heard me if you've listened to the global medical device podcast which since we're number one i'm guessing you've listened to an episode a time or two and if this is your first time welcome but you know being like we're here to help you we have a medical device success platform a software solution that helps you manage many details of your live as a medical device professional and now we have our assume we'll have functionality on helping you better connect the dots between your design history file your dmr and your bill of materials so pretty exciting if you'd like to see those features of functionality and how they all tie together well just reach out to us go to .greenlight.guru and click a button that says you know you'd like to learn more you'd like to have a call you'd like to have a conversation and we'd love to have that conversation with you we'd love to understand what your needs and requirements are and see if we have solutions that can help you better manage your bill of material and connect that information to your design control and your design history file and be able to convey that information to your manufacturer so check it out as always thank you for listening and until next time this is your host and founder at greenland guru john speer and you have been listening to the global medical device podcast you