Using Unifize to track Non-Conformances and Deviations
Clarissa delves into the intricacies of tracking production deviations and non-conformances through Unifize. She sheds light on the platform's adeptness in generating quality notifications, seamlessly linking them to specific parts, suppliers, and relevant processes. Clarissa underscores how this functionality not only aids in pinpointing recurring quality issues but also streamlines the management of corrective actions. Her enthusiasm is evident as she details Unifize's role in enhancing quality tracking and review processes.
Transcript

[00:00 - 00:06]
And then okay, so now we have that part, out of specification, so you don't want to throw it away.



[00:06 - 00:10]
You can't just throw it away all the time, you know, You know, we can't all be perfect.



[00:10 - 00:45]
So you get that part and you're able within Unifize to create a deviation or a non conformance or even we created something called a quality notification where, you know, not everybody is an expert in quality system. And so you know, they might not be sure, like, is this a non conformance or is this within the acceptable specifications, especially again, if you don't have Unifize and you can't just pull up your print or material specification or any type of description to show, Oh yeah, it is within here and here.



[00:45 - 01:05]
So you can create a quality notification to say, Hey, I'm not sure about this, but I think this is important. I just want to let you guys know or hey, this is within specification, but it's something that we should look out for, you know, for the future with this vendor. And you can connect non-conformists deviations, corrective and preventative actions (CAPAs).



[01:06 - 01:33]
You can connect those all to each other and to the suppliers and to the lot and to the device itself or the parts itself. So you can see, oh, how many times has the supplier incorrectly machined or made this part? And you can easily go to the supplier process and see, okay, here all the entries or non conformances or deviations that we've had to have with this vendor for various parts.



[01:33 - 01:37]
Or if you want to go by part, you can look at one part and you can.



[01:37 - 02:15]
Okay. This part has had several non conformances or several deviations. Maybe that's something that we internally need to look at and see. You know, if something wrong with our specifications. So it's really huge for lot or not lot tracking for quality, tracking for management review to be able to you'll look at trending you know that's something that we're using it for as well because when you have hundreds or thousands or however many parts that are coming in constantly, you know, if there's a consistent non conformance, it's not necessarily something that you will see right away.



[02:16 - 02:49]
But with Unifize you can and so you can describe the non conformance and then go into the MRB, which is material review board and that can all happen within a conversation and Unifize. So you can have management and other people, you know, come and look at all of the evidence of the non nonconforming specification within Unifize and say, you know, okay, this is acceptable because of this or it's not acceptable and we can rework it.



[02:49 - 03:11]
And, you know, instead of having to go through another meeting or another round of discussions regarding rework processes, you can have that in Unifize where they say, Hey, we can rework it in X, Y or Z way, here's the documentation and it's all within that conversation so that you can move forward really quickly and efficiently

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Unifize accelerates compliance, delivering 10x faster regulatory approval for medical devices
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Faster time-to-market
Map Unifize to your processes and streamline workflows, process automation
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Fewer meetings
Less meetings with in-app collaboration, real-time updates, and decision logs
Transcript

But what we've known from what I experience was, is we were able to get there with the system. We still there with the system. The system has what is needed to provide us what we're looking for, because every company, admittedly, is trying to get compliant. If we educate people, if we get people the education that they need and to get over the fear factor, I think 90% of those things can be resolved because most people will go to what they're most familiar with.What I worked with from a different company, but they're not willing to sit down and look at what the demographics are saying. People are into social media now. People are moving fast into fast paced world. But technologies are still antiquated. So there's a disconnect here, right? So while we're moving at a fast pace at home with dragging at work, so why can't we continue that speed while we at work?If your supplier has issues and you're not informed on time, you want to have an alternate supplier in place. If your suppliers are not qualified, you may not know that that needs to happen. And so when you have an integrated system that speaks to itself and is giving you all this data, you literally have the pulse of the organization in your hands as an executive at a money bound access.

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