Hi this is rob packard from medical device academy and today's live streaming video is about what is the difference between the document change control process and the design change control process and what do you use which one so one of our clients and not just one .
Multiple clients have made this error in the past they learn the document change control process first and they're implementing a brand new quality system but they've never actually made a device and controlled design changes because this is their first time bringing a medical .
Device to market so they spend all this time learning document control reviewing documents approving documents and it seems intuitive that oh i'm just going to use this same thing to approve all these other things later on as we make changes but when it involves a design change or .
A modification to your device your manufacturing process or even a change in the supplier such as changing a contract manufacturer changing a sterilization provider changing a contract packager those are things that require more control so you don't use the same form now in theory you could use the more .
Complicated form for both but that makes your document change control process not very efficient document changes you want to encourage those to happen frequently you want people to very easily be able to update correct improve their procedures and work instructions and forms so you want a very simple form for that .
The the most complicated part of that process is when you do a brand new rewrite of a procedure or you create your first procedure you might need to do a gap analysis against the standard to make sure all the requirements are met but once you've already got a procedure in place that meets all the requirements the changes are small so .
The process should be very efficient and very quick when you're doing a design change you don't have that luxury when you're making a design change even if it's a labeling change you could potentially have to not only update your uh documents that document how the label should be .
Formatted and what content should be in the label but you also need to update your technical file your device master record or dmr you also might need to update your udi you might need to update your inventory that you have you might need to get approval from a .
Regulator such as health canada notified body or the fda you might also if it's the instruction for use you might need to actually do a summative usability study to verify that the changes to your instruction for use didn't cause some sort of problem with people understanding what you're talking about and how to use your device .
So there's even just something as simple as changing a diagram in your instruction for use you think it's being more clear but if it's instructions and it's a critical part of the instructions on a high-risk device it might be absolutely required by law for you to go out there and redo this testing and resubmit to the fda .
Because it could have an impact on the performance of that device and how well people use it for medium risk devices it might not be required to get approval from the fda but you still probably internally would say this has a risk we should repeat some of that testing or at least do some formative testing and what about our risk management .
Documents we have risks that are identified for use related risk analysis why don't we update those when we're making this change because that is impacted by the instruction for use so there's all kinds of things that have to be updated just because you made a small change in one document that's a labeling document .
And that document has cross references in many other places so in your design change notification or cn is what we call it a change notice you're gonna enter a log just like you would for document changes and you're going to fill out this form the change notice that's very similar to the document .
Change notice but on there you're going to list other supporting documents that also need to be updated and attach them such as your risk management file might need to be updated your labeling might need to be updated your usability testing might need to be updated your dmr certainly will need to be updated your technical file index needs to be .
Updated all these things are going to have to change in addition to the label itself and that's just a labeling change a very simple one if you pick something more complicated it might seem really straightforward no big deal oh we're just going to switch from this sterilizer to a different sterilizer .
They're going to use the same process conditions everything's going to be the same so you know if it's all the same then we don't have to uh notify a notified body right uh not the case because a lot of high-risk devices will actually list that sterilization provider on the certificate itself the ce .
Certificate if you don't have a high risk device you have a moderate risk device let's say a class 2 a device or a class 2 in the us you're still going to have your technical documentation is going to list this critical suppliers that includes a sterilization vendor and you're going to need to provide copies of their iso .
Certification to your notified body if you're working with the fda and this is a 510k cleared product if it's a the exact same sterilization process you're not changing the method of sterilization and it's a class 2 device and you already have 510k clearance then it could be a letter to file .
However you still need to update your registration listing and you need to have that company list your products with them as the contract sterilizer so they have to have an update to their registration even though you may not have an update to your registration so there are always things that need to be updated when you make any kind of a .
Device modification you change your manufacturing process or you change something that's related to that design documentation somewhere even a change in the supplier could trigger changes even though it's this all to the same specifications all the same process you still might have to .
Some more uh elaborate modifications that have to be made to documentation so there's big differences in in how do you know which one to use when well the key here is this just affecting your quality system your quality system procedures your quality manual and it isn't specific to .
Any one product or is this something that's specific to a product and needs to be listed in your device master record dmr or your technical file index um so that's why our company uses the dmr tech file index it's one in the same .
Document we use the same format and time template for both of those because there's no specific requirement for the formatting content of a dmr so you might as well use the formatting content that's required for a technical file and health canada doesn't have any problems with you using the european template in format for a technical file .
They just want in a submission for you to map how your requirements map to the ghtf requirements that health canada has their uh their license application uh requirements specified so that sort of gives you an idea of is this a change to our calibration procedure .
Or is this a change to the device that we're using to measure something that needs to be calibrated so if if it's a measuring process so this is how this is the device that we're using to measure this that's a change in your inspection instructions it's specific to that product it's going to be in your work instructions it's going .
To be in your final inspection report if if it's a high-risk device it's even going to be listed as something that needs a supplement for a pma but if it's just the procedure itself for calibration in general and isn't specific to any one product then it's just going to be an update to that calibration procedure and you can use .
Document control for it now if you make a change to a document uh one of those quality system procedures there's training that's required and you're going to list who needs to be trained on that if you make a change to a design process or a design of a device you're going to have even more training is required and .
It's going to be training of different types in different locations for example we'll take the the calibration example if you're changing the way you're measuring something let's say before you're using calipers it wasn't giving you accurate enough measurement now you want to use a vision system to measure this part .
That's a change in your work instruction on how you're going to measure it you're going to need to train people on the new vision system you're going to need to calibrate that system you probably want to validate the measurement process so maybe a gauge rnr study should be documented somewhere and if it's a high-risk device you're .
Going to have to file a pma supplement or if it's a notified body with a class 3 you're going to have to notify them and that change of the measurement process if it's a moderate risk device you just need to show something like a gauge rnr oh we we made this modification this measurement method but we validated the .
Measurement method and we updated our documentation for the fda a letter to file would be certainly adequate for health canada probably wouldn't be worthy of a supplement or any kind of a device license amendment but if you're talking about a notified body .
Um it depends and so each notified body you would think that would be doing it the exact same way but what we've experienced is they don't so in general my advice to companies is whenever you make any update to your technical file index even if it's something you know you don't need to notify them of you've updated your .
Technical file index so therefore send them a copy of your updated technical file index showing redline saying we believe this is something that doesn't require notification of this change because it's just a measurement method however we're using it for final inspection it's listed in our technical file index so .
Here's a copy of our updated technical file index if there are any documents you want to review approve or sample please let us know so this way you've let them know and let them know while you're doing the validation or just after you finish the validation but before you start see marking product and shipping it that way .
That's really important and it's not because um you know you they'll shut you down and eliminate your or cancel or suspend your ce certificate what's likely to happen is you're going to get a non-conformity probably a minor one but it could be a major one for not adequately notifying your .
Notified body of a significant change they may consider it more significant than you do now why would that be a major instead of a minor non-conformity it could be something you've done before and that would be escalating it um whenever it's a contract manufacturer that's a significant subcontractor a contract .
Sterilizer that's um somebody that they are going to have to be doing unannounced audits of they're going to have to make sure that they have uh listed them as a subcontractor and they've verified that the certificates uh for the quality system for that company are adequate or they're actually .
Going to have to audit that supplier so those would be reasons why you need to notify them in advance so that's the difference between you know we're just measuring this at final inspection we change from calipers to a vision system versus a contract manufacturer or a contract sterilizer those are a little bit .
Different types of changes but if you do this repeatedly and you don't notify the notified body then they can escalate it to a major so those are some examples of of types of things you need to look at another thing that you might be looking at is post market surveillance activities so post market surveillance .
Activities are getting a lot more emphasis now the europeans created a whole new section in your technical file annex 3 is supposed to be all about post market surveillance in your tech file and then the canadians recently made new regulations requiring post-market surveillance summary reports to be submitted .
A lot of times when we're making these design changes they're improvements but they might be associated with a non-conforming product in the manufacturing process that didn't get to the field or it might be a recall or corrective action um related to customer complaints and in those cases you might actually want to .
Be gathering some post-market surveillance data to verify that the change that you made either to the manufacturing process or the supplier or the actual design of the device actually fix the problem so you might have a complaint determine it doesn't require a recall but it is worthy of a kappa you .
Implement the capital you make the design change you validate it now you also should be doing post markets of balance and that's the effectiveness check for the kappa now a better way would be you would have a quantitative validation report that would have um acceptance criteria .
In the area in there that are uh validated and quantitative and then you could use that as your acceptance criteria but not every single change that you make can be validated quantitatively with quantitative acceptance criteria so a labeling change that might be something that's much harder .
For you're trying to make it more clear without some sort of a summative study that's quantitative it might be really hard to show quantitatively that this kappa was effective so in those cases you might decide you know this is really something i need to do post-market surveillance of to make sure the capital is effective whereas other cases you .
Might say no this is something i can validate before he even goes to market in the manufacturing process uh this new measurement method is much more accurate more precise shows better accuracy and precision and therefore i don't need to look at .
Going out there and doing any post market surveillance for this type of change so it depends on what your changes and how you're validating it determines whether you need post-market surveillance done as well so things that i see companies forget to do notifying the regulators as one updating their technical file updating their dmr .
And if you combine both the dmr and tech file index together then you update once instead of twice they don't uh update their uh post market surveillance they don't update their risk management documents and that includes manufacturing process fmeas they don't update their procedures they don't update their training they don't .
Update their calibration they don't update their maintenance and preventative maintenance plans all those things get covered so if you think about it like any process change if we made a manufacturing change why would we do less verification than if we make a document change if i change my calibration .
Procedure because i'm having problems with people not calibrating things correctly and i clarify the procedure i would do training but then i might also do a re-audit of the calibration process to make sure people are using the new procedure properly so that's effectiveness of that cap i .
Changed the procedures and then i did an audit of the procedure to make sure people are using the new procedure and it's working well if i make a change in the manufacturing process why wouldn't i re-audit the manufacturing process and why wouldn't i use the process approach for that because it's a manufacturing process uh look at what are the new .
Inputs to the process what are the new outputs of the process is there any monitoring measuring of of quantitative things for that process change did i update my calibration records my validation records iq oqpq prevented maintenance plans do i need new safety procedures do i need new training for operators all .
Those things should be covered and would be covered in a thorough process approach to auditing so just like we do training records and audits of the process after we make a change in document control you should also be thinking about audits for effectiveness .
Of your design changes in manufacturing process changes too so that's another approach you can take to make sure you're doing this right but i see companies make change after change after change and then they never go back and audit the records to make sure they were updated properly and having an independent auditor they could even do .
It remotely look at those records might really help you out and avoid this situation i hope i answered everybody's uh questions about when to use the document control process and when to use the change control process for design changes but if you have any more questions don't hesitate to look .
Below for the link on how to contact me and schedule a meeting um you might also be interested in the live webinar that we're going to conduct on january 20th 2022 at 11 a.m eastern time where we're actually going to cover this in much more detail we're actually going to show you how to fill in our change control form form 12 and fill in the log and .
We're also going to talk about significant change notification for notified bodies health canada and letters to file for the fda and um if you uh register for the live webinar before february 3rd um you if it's after the 20th you'll get a recording but you can get a discount up until february 3rd and then the price .
Will go up to our normal 129 a month uh uh sorry for the webinar so i hope that answers everybody's question thank you for attending live next friday uh we're going to be doing another live video at 12 30 um on youtube so hope to see you then and let me know if you have any suggestions for .
A new topic have a great weekend bye