How Unifize helps quality leaders take better decisions on Out of Specs
Jesse Kolstad revisits a challenging situation from his early days at Biovation Labs — a significant backlog of Out of Specifications (OOS) cases. Determined to enhance the OOS process, Jesse embarked on a deep dive into the existing procedures and systems. He emphasizes the value of having a clear understanding and the ability to trend data, showcasing Unifize's instrumental role in bringing clarity and improved decision-making.

[00:00 - 00:35]
Going back to when I first started here at Biovation, I remember one of the internal customers asked me to address a backlog of Out of Specifications going back two years at the time. And frankly, I said no because I wasn't here for those. But I can promise that we're going to streamline those and then I again, second day was digging into an Out of Spec which started me down the path of continuing to look at what is our Out of Spec process, how do we document it, how many do we have, Do we are we able to trend that along the lines of per ingredient, per supplier, per lab, etc.?

[00:35 - 00:51]
And again, no. And they were using, I think at the time about 21 different labs. And the problem with the Out of Specs was they would get an Out of Spec and then they would send it to another lab and they would still get an Out of Spec and they would send it to another lab. And this was time.

[00:51 - 01:22]
This was money because each lab would take approximately 5 to 7 business days at best to get back the results. And at no point were they able to actually discover was it Out of Spec and what to do about it. They just were waiting for results. Now, hopefully I'm not showing too much under the skirt, so to speak, but by being able to dig in there, I saw that that was the best and most valuable place to start to get our product released in a streamlined fashion.

[01:22 - 01:32]
when I started here at Biovation, I remember my interview seeing they had just pumped a lot of money and it's a beautiful state of the art facility.

[01:32 - 01:57]
And then I started on my first day and saw from a quality side it was still very paper based. It was still very chaotic. And could you I mean, there was a lot of early and easy wins. I called them and a lot of people would refer to it as low hanging fruit. But the my second day I remember I solved an Out of Spec and they had spent gobs of money at this point on this one material because it kept failing.

[01:57 - 02:16]
I believe it was vitamin B12. And I said, okay, let's look at the history and the people in my team who I started with here I was like, “Can you pull any other Out of Specs for this ingredient?” And I realized very quickly that pulling that historical data was, if possible, incredibly difficult.

[02:16 - 02:33]
So Out of Specifications, I think it's sort of a multi-headed beast in the sense that people set specs because the regulations say, what is it, 21 CFR 111 subsection E 70 through 75, it says, What's specifications must you establish?

[02:33 - 02:57]
And people interpret that kind of to the letter and they set specifications to have specifications not because of the intent behind them, which is what does your material, what does your product, what does it need to do? And so they're your specifications. And I think speaking to frustrations, a lot of times people aren't comfortable, first and foremost, setting the specifications for what they need, not for what's written.

[02:57 - 03:25]
And then that results in a lack of understanding. I think, in interpreting the results. And then they treat it like it's black and white. So speaking to B12, let's say it, it's supposed to be no less than 85% and they get 84% and they go “well it’s Out of Spec”. Well, is it and with my background in analytical chemistry and method development, I'm afforded the advantage of being able to say, well, there's always uncertainty associated with it.

[03:25 - 03:50]
There's lab performance, there's, you know, digging into the methods. But when I started, they were, as I said, using about 21 labs here, which told me that there was a disconnect between specification and result. And it was kind of a thumbs up, thumbs down situation, whereas it's a little more interpretive than that. But speaking to the frustrations, that interpretation comes from an understanding of your specs and why you're testing it and what you're testing for.

[03:50 - 04:13]
So when I talk about managing specs, let's be frank, I'm talking about managing Out of Specs because specifications, you establish them. And as I said, no news is good news for most people. What Unifize gives me the opportunity to do is when we talk about managing specs, as I said, we're talking about managing Out of Specs is in an instant at the same time

[04:13 - 04:25]
When I first started as I said, I started with out aspects because it was an easy place to start and it's typically where I always start and I realized they were sending to too many labs, they were sending too many samples and too many retests.

[04:25 - 04:55]
And there's there's very real numbers associated with that. So within a month, I think I had not only increased or decreased the time it takes to close out on that aspect, which does increase throughput, but eliminate unnecessary retest, consolidate two labs where then I use that to negotiate better pricing, faster turnaround, more commitments. And I took our testing cost by my second month from roughly $150,000 a month down to about 70.

[04:55 - 05:01]
So that's a 50% savings month on month and that has consistently happened for two years now.

[05:01 - 05:10]
Unifize has giving me the ability to make all of my team more effective so I can do a lot more with less heads because we have we are we have eyes and ears everywhere all the time.

[05:10 - 05:35]
So I don't need to throw a quality person at each layer, at each. They're not at blending, at packaging, at weighing it. They're everywhere. And somebody can just say, Hey, I need you. And in the chat environment and they're over there ready to look at Non-Conformance is to deal with the problem. And so the delays the rough spots immediately start smoothing out and I, I encountered that right away.

Unifize Results

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

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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