Content Library

Jesse Kolstad describes recurring challenges in quality management, from overloaded file cabinets to underutilized QMS systems. He emphasizes the need for observation and understanding before implementing reforms, showcasing his experienced, thoughtful approach to driving meaningful quality enhancements.

Join the discussion

0 comments

Active Here: 0
Be the first to leave a comment.
Loading
Someone is typing
No Name
This is the actual comment. It's can be long or short. And must contain only text information.
Edited
Your comment will appear once approved by a moderator.
No Name
Set
This is the actual comment. It's can be long or short. And must contain only text information.
Edited
Your reply will appear once approved by a moderator.
Load More
Thank you! Your submission has been received!
Oops! Something went wrong while submitting the form.
Load More
Transcript

[00:00 - 00:07]
So one of the most frustrating things about managing quality is and I've been at several companies that it's the same song and dance every time I start.



[00:07 - 00:34]
They have file cabinets, they have labs they use, and they just kind of store even if they have scans or they have an existing QMS, it's there, but you're not letting your data work for you and, and again, stepping in and shoring up ourStandard Operating Procedures. I usually spend the first probably month as a fly on the wall before I before I've made a single move, written a single document.



[00:34 - 00:49]
I want to know where we're at. But I've done it enough now that I can assume some things right away. And Out of Specs have been the easy, low hanging fruit early and often win that I get at every company I've started that.



[00:49 - 01:06]
I think other softwares can if you know how to do it and you have to go in with that intent, it's a little more effortless within Unifize because I can link a supplier to all the ingredients and an ingredient to all the Lots and all the Lots to all the formulas and finished product it goes into.



[01:06 - 01:28]
And it's that's three button clicks if I'm counting right. And it's I don't have to go in with the intent of spending half an hour, an hour compiling and pulling individual records. So I think in that regard, systems do that. If you know that you want to do that. But it it's based on it would be based on me, not based on the system, if that makes sense.



[01:28 - 01:53]
So in my experience with a lot of quality management systems, they hold the data, but they don't connect the data. So if you wanted to, let's say trend specific ingredient, let's go back to vitamin B12. I would have to knowingly go back and look on a case by case basis. And I would, as the user and as the director have to say, I am I am trying to look at vitamin B12 from this supplier.



[01:53 - 02:13]
And it's trending test results. And more often than not, I would then look at each individual result and then I'd put it into Excel and then you do some data processing just using Excel. And I think the connectivity and the streamline trending, in my experience with most quality management systems, isn't there.



[02:13 - 02:33]
So when I say connecting things, what I mean to say is again, using B12 as the example of if I just looking at the ingredient vitamin B12, how quickly can I look at every result and how long does that take? Am I going to file cabinets, Am I going opening record of each individual record?



[02:33 - 02:43]
And what I've seen in some other systems that are out in the market is you have to pull and open each individual record as opposed to a quick dropdown that says Here's everything



[02:43 - 03:00]
and connecting the raw material spec for that. Again, Vitamin B12 to each and every Lot I received and each and every result per Lot that I received, the value of being able to at a high level quickly see all of it is invaluable.



[03:00 - 03:06]
people who are evaluating QMSes think outside the box because Unifize will let you.



[03:06 - 03:33]
You don't don't get a quality management system to manage quality, get it to improve your organization every day. And nobody else can give you that. The way this has it's it's not there to just be there. I mean, a lot of times that I've been at many companies where they'll have one system that they're managing their suppliers and their specs in another, that they're, they're managing their artwork approvals and review and another that they're managing their training and they're paying



[03:33 - 03:42]
a very substantial amount for each individual system, whereas Unifize puts it all together at once and then connects them end to end.



[03:42 - 03:55]
I don't have to even open another screen or another app or another program I can get everywhere in my process. Everything about this bottle, every everything that went into it, I could get there at any point in the process,



[03:55 - 04:18]
I think other systems approach the problem as we have the solution. You want it, use it, Unifize’s philosophy said, We acknowledge you have a problem. Let's help you figure it out and build your system to use it. And I think other systems, I see how they got there. I see why they got their and I see why it gained traction.



[04:18 - 04:38]
But I think I don't think I'm misspeaking when I say most people, when they look backwards and say, Gosh, I wish I would have built it the way I wanted as opposed to down the line going, Well, now I'm kind of not committed to this whole system that's got everything I know I need, but it doesn't work the way I need it to.



[04:38 - 04:54]
And that's kind of been truthfully, that's kind of been my career progression from when I moved up at Nelson to rolling out MasterControl to where I am now. I look backwards and say, I. I know that that's what I would have wanted if I could go back.

Problems with managing quality at nutraceutical companies

Thank you! Your submission has been received!
Oops! Something went wrong while submitting the form.

Unifize Results

10x
Speed to compliance
Unifize accelerates compliance, delivering 10x faster regulatory approval for medical devices
4x
Faster time-to-market
Map Unifize to your processes and streamline workflows, process automation
70%
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.

View More Case Studies
Video icon

Here’s how Biovation Labs reduced testing costs from $146K to $65K in two months

Learn how and why Biovation Labs, an FDA regulated nutraceutical manufacturer based in Salt Lake City, took the decision to transition from MasterControl to Unifize for their product lifecycle (PLM) and quality management (QMS) processes.

Video icon

Here’s how Harmonic Bionics slashed time to market by 80%

Clarissa Archer shares her experience integrating Unifize into Harmonic Bionics, underscoring its value in streamlining change control, facilitating communication, and ensuring robust documentation for regulatory compliance in the medical device sector.

Video icon

Will-Burt's game changing boost to quality process cycle times

Learn how The Will-Burt Company was able to implement and adopt a new quality management system across 8 collaborating teams in less than a day and streamline internal / supplier non-conformances, customer complaints (VOCs), internal / supplier audits, 8D reporting, corrective actions and preventive actions.