Streamlining Change Control on Unifize
In this video, Clarissa shares her experience with Unifize, emphasizing its impact on change control and document management in quality management systems. She highlights the challenges of maintaining up-to-date engineering drawings and documentation, particularly in a traditional pen-and-paper environment. Clarissa illustrates how Unifize streamlines these processes, ensuring engineers access the latest revisions, understand changes, and comply with FDA requirements. She praises Unifize's integrated checklist feature and approval process, which simplifies change orders and prevents delays, even when key personnel are unavailable. Clarissa's testimonial underscores Unifize's efficiency, detailing how it transformed their change control process from a lengthy endeavor to a more manageable and efficient system.
Transcript

[00:00 - 00:10]
Because when you're really starting a QMS, you know, one of the first things that you approach is change, control and document management because, you know, your QMS has to be your source of truth.



[00:10 - 00:40]
So we primarily started with documentation and parts and those sorts of things because one of our pain points was, you know, we'd have an engineer send a engineering drawing to a vendor and it wasn't the most recent, you know, and that's really easy to do when you have pen and paper and then that's downloaded or scanned and saved onto your computer versus being able to go into Unifize and say, okay, yes, this is the most recent revision.



[00:40 - 00:57]
And being able to say, you know, okay, here's what the changes happened, you know, having change control so that you can see the description of change and the reason for change, which are required by the FDA to be able to kind of remind the engineers to be compliant.



[00:57 - 01:53]
So, for example, you know, yeah, let's make this print change, let's make this drawing change, let's make this document change. And then, you know, it's really exciting. But then, you know, not every engineer is going to pull up the work instruction that says, okay, does this effect verification and validation? Does this affect any of our risk documentation? Does this affect this? You know, a a regular engineer isn't going to, you know, always have their work instructions at hand. Right. And so one they can with Unifize just go to the document, pull that up if they need it. But also being able to have a checklist and create that within Unifize. So our change control process does say, okay, what's your description? What's your reason? You know, is this going to affect training? And it's really great to be able to, you know, have a yes or no and then have something else pop up where if it's a yes, when they now have to fill out another questionnaire.



[01:53 - 02:03]
If they say no, for example, then you don't have this huge mess of other questions that they just have to put N.A., N.A., N.A., N.A. They can just say, no, move on.



[02:03 - 02:35]
Okay. Now, does this affect verification of validation? Yes. Okay. Well, which ones? And now you can link it in Unifize to say, Oh, yes, you know, my engineering change will affect these test reports and here's why. It's okay. Or do we need to redo testing? And so it's really cool to have all of those connected processes to be able to show, you know, not only here's the change I'm going to do and here's why I'm doing it, but being able to see what it could affect, what it will affect.



[02:35 - 02:45]
And if that's going to be a problem or not. And I feel like you miss a lot of that when you don't have those connections because it's easy to forget, You know, we're not perfect.



[02:45 - 02:48]
And another important thing is getting approvals.



[02:48 - 03:11]
You know, you can describe a change order all you want, but you need to make sure that you're getting the proper approvals. So being able to go with advanced approvals and say, okay, here are the options of people that I need to have approve and being able to say, you know, I don't care necessarily who it is, you know, sometimes you might have a problem where, you know, oh, somebody is on vacation.



[03:11 - 03:35]
And in typical other programs, I would see, okay, well, you know, that person was requested as a signature and they either need to, you know, log in on vacation, which nobody wants to do, or completely cancel that change order and go back to the preliminary, which, again, huge waste of time. You know, that can add several days on to a simple change order.



[03:35 - 04:04]
But with Unifize, I can say, okay, I need this to be from a group of product development, create a group with all those users in it. And then in that and then in that in that program say, okay, I need somebody from product development to sign here. So I worked with, but I can also have these other people who can look at the conversations and look at everything and Unifize and understand what's going on to sign if I need to as well.



[04:04 - 04:32]
And so it's so simple to be able to just drag and drop as many times as you need and you can add in processes. You know, one of the things that we like to do is create forms within Unifize, which again is super easy. And so you're able to add in, you know, connections to apart and say, okay, here is here is the connection of, okay, I want to make this change.



[04:32 - 04:58]
I want to pull this process into here. And from there you can also see. So I'm going through it in my head. Yeah, you can see that process. And you can also say, Oh yeah, you know, from a document, I also want to include the revision or the description or these other things. And so within Unifize, you can say that yes, I want to connect this process into a change order to deviation to whatever.



[04:59 - 05:33]
And here's the information from that other process that I want to include, because it's important for this process, and that's huge so that you don't have to click and open it and go through everything you can choose. Here are the things that are important. When I'm looking at this particular process that I want to be able to see every time without necessarily opening a new window, You know, a lot of these things take years to happen, whereas with Unifize, we were able to get it done with about four weeks in order to start utilizing our change controls and our documentation controls

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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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