Managing your Design History File on Unifize
In this video, Clarissa talks about the transformative experience of managing Design History Files (DHF) using Unifize. She contrasts the challenges of traditional DHF management with the streamlined, intuitive approach offered by Unifize. Clarissa details how the platform efficiently links various documents, processes, and reports, facilitating a smoother review process for manufacturing readiness and design transfers, a feature she finds exceptionally beneficial for product development.
Transcript

[00:00 - 00:08]
Honestly, when I was looking at different options, one of the first things that I tried to imagine is kind of the end product.



[00:08 - 00:30]
So when I was looking at any of these programs, I wanted to know what is my design history going to look like and how difficult or easy is it going to be to manage You know, because in my past I have seen binders, huge, huge, huge binders full of documentation that, you know, is really difficult to organize and keep together and connected.



[00:30 - 00:56]
And so in a lot of different programs that we looked at, the way of creating a DHF was not intuitive. It was kind of difficult to navigate through. And so being able to see and Unifize that, I could configure a DHF and organize it in an intuitive in an intuitive way was really helpful and really a big point for me.



[00:56 - 01:06]
So in order to create DHS, you know, one of the strongest points of Unifize is being able to link to other processes.



[01:06 - 01:39]
So a DHF is the design history file that contains everything. So being able to organize by phase one, face to face to or whatever, and being able to just connect all the processes that I need is really important and really helpful. For example, we have, you know, your Gate one business case where you're developing the plans of how you're going to make money, you know, developing the risk plan and the way that you're going to approach risk and approach a regulatory strategy.



[01:40 - 02:05]
You know, all of those are different documents, several different documents in some cases. And so being able to, you know, have them each as a document and being able to link them in Unifize to show my DHF contains all of these things instead of having to print out thousands of pieces of paper and put them in the binder, you're able to connect to those processes and see what you need.



[02:05 - 02:34]
You know, being able to also connect prints and parts is something that not many programs are able to do because of, again, the connection that Unifize has. So not only can I have a binder full of documents, I can also have the prints in there. I can also have, you know, a list of NCs and deviations and a list of all connected reports so that when we're having our final manufacturing review and we're saying, you know, for design transfer.



[02:34 - 02:55]
Yes, this product can be manufactured and we're at a place where we're ready to move forward through design, transfer into manufacturing. We can see the history really easily in that DHF to say, okay, yes, we are ready to move forward or no, we have these issues that we need to address with the manufacturing side prior to moving forward.



[02:55 - 03:16]
And what I really enjoyed about Unifize is the fact that we could configure the program to be what we needed it to be rather than trying to work against a program to make it fit into what, for example, we'd want a Design History File to look like we were able to configure Unifize to design it, how we needed it and how we wanted it.

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Faster time-to-market
Map Unifize to your processes and streamline workflows, process automation
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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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