Jesse Kolstad is Biovation Labs’ Director of Quality and Compliance. He holds a degree in Biochemistry, an MBA in technology management, and spent much of his career at a CRO for the pharmaceutical industry. He has spent more than 10 years working with eQMS systems at various different companies, including MasterControl, JD Edwards and Ross.
How a quality leader at a nutraceutical manufacturer built a culture of continuous improvement using Unifize
Biovation's Director of Quality, Jesse Kolstad shares his experience with Unifize, emphasizing its impact on enhancing accountability, traceability, and efficiency in less than 60 days. He highlights the platform's role in fostering a culture of continuous improvement, reducing communication breakdowns, and eliminating unnecessary meetings and emails. Jesse elaborates on how Unifize's approval workflows and real-time collaboration features streamlined processes, improved decision-making, and drastically reduced turnaround times for various tasks. His experience reflects the transformative power of Unifize in creating a more collaborative and efficient work environment.
How a quality leader at a nutraceutical manufacturer built a culture of continuous improvement using Unifize
The Challenge
Biovation serves both in-house brands and external giants like Walgreens and CVS, necessitating a robust quality management system. Initially, the company struggled with MasterControl, which was clunky and user-unfriendly, causing data entry hurdles and acting as a mere digital filing cabinet. The old system was inadequate for the company's growing needs, leading to inefficiencies and a fragmented approach to quality assurance.
The Unifize Difference
Unifize was brought in to alleviate these challenges. Unlike other systems that imposed a one-size-fits-all solution, Unifize’s philosophy was to understand Biovation's unique issues and tailor the system to fit their needs. This approach promised a seamless transition without data loss or operational hiccups.
Streamlined Communication
With Unifize, Biovation could centralize its communication, eliminating the need for excessive emails and informal chats. The chat environment allowed quality issues to be addressed promptly, smoothing out delays and operational friction.
Improved Decision-Making
Unifize's all-in-one view enabled the company to analyze all components of a product simultaneously, such as a multivitamin with 42 different ingredients from numerous suppliers. This holistic perspective facilitated instant decision-making, cost savings, and increased throughput.
Enhanced Efficiency
The implementation of Unifize reduced testing costs, shortened lead times, and improved overall throughput. The platform’s efficient collaboration tools allowed for effective supplier negotiation and alternative sourcing, showcasing the system's capacity to drive down costs and enhance productivity.
Results
Biovation quickly realized the benefits of switching to Unifize. The transition was smooth, with no loss of data or need to operate out of two systems. The quality team could do more with fewer resources, as Unifize's visibility made the entire process more transparent and manageable.
Cultural Shift
Beyond operational improvements, Unifize helped foster a culture of quality and continuous improvement at Biovation. The system's real-time collaboration and communication capabilities highlighted the company's proactive steps in quality management, proving that quality does not just prevent problems but can also drive organizational success.
Cost Savings
By leveraging Unifize, Biovation could not only maintain compliance but also identify cost savings opportunities, making quality management a value-adding function rather than a cost center.
Conclusion
Unifize transformed Biovation's approach to quality management. From facilitating effective communication to enabling strategic decision-making, Unifize has proven to be an indispensable asset. The case of Biovation stands as a testament to how the right quality management system can create a proactive, efficient, and quality-driven culture within an organization.
Transcript
[00:00 - 00:10]
Day one, you're engendering a culture of continuous improvement. You don't know it. You don't see it till one day you turn around and say, Wow, everybody is rowing in the same direction.
[00:10 - 00:25]
And those are sort of these unintended, massively helpful consequence of rolling out Unifize that I saw is that communication breakdowns fell away, that visibility and unnecessary meetings and unnecessary emails and unnecessary phone calls went away.
[00:25 - 00:34]
And I genuinely could focus on doing my job better every day. And I truly believe across the organization that's true for everyone at all levels.
[00:39 - 00:46]
I'm the Director of Quality, Compliance and Formulation at Biovation Labs here in Salt Lake City, part of a larger organization, Wellful.
[00:46 - 01:00]
We have both internal and external customers is what I call that. We have the brands that are all under the Wellful umbrella, that we're all part of the same company and we're they're predominant, if not entire manufacturer for capsules and tablets here by Biovation.
[01:04 - 01:30]
At that point it was more about having electronic documentation and this was 2016. SharePoint wasn't great. People didn't weren't apt to use MasterControl and it's a little clunky and arduous for the average user. And what I learned probably most notably was that if it's not designed to be easy for the user, then it's just another hurdle.
[01:30 - 01:46]
A lot of systems out there will offer you the digital signatures and 21 CFR part 11 compliance, which is the set of regulations that applies to digital documentation and signatures and Unifize, has this amazing approval workflows that we've used.
[01:46 - 02:01]
I mean, we use it for raw materials, for suppliers, for formulas, for quotes, for product release, for raw material, what I mean by that is they it's a button click just like a lot of digital signatures work, but built into it is automatic notifications.
[02:01 - 02:09]
Being able to real time collaborate about a Non-Conformance and again, an Out of Spec or even just we use what we've termed Observations.
[02:09 - 02:22]
They may not be a problem, but they could be a leading indicator of a problem and collaborating with decisions right then and there. What used to take days, weeks, sometimes months is seconds and minutes.
[02:22 - 02:41]
The digital signature and approval workflows, streamline my Lot release on finished goods, as I mentioned, because before that was email back and forth. Now my quality supervisor uploads the test, uploads the CoA, clicks a button says, All right, I'm done, and it goes right to the customer because again, something that used to take days at times takes minutes at worst.
[02:45 - 03:01]
One huge advantage of Unifize and the collaborative environment that it has is that you can collaborate about a specific item and you can collaborate about many items simultaneously, and that cuts down time, obviously, but it also increases visibility, communication and effectiveness
[03:01 - 03:14]
because I can be I can knock through three or four things that normally would have taken days, weeks, months sitting at my computer all at once, and I can actually respond to people about that event in the in the environment right then and there and move on to the next one.
[03:18 - 03:24]
Unifize is amazing because it grows with you. It solves problems with you as the problems come up. So if a conversation or process doesn't exist, guess what?
[03:24 - 03:34]
You can make it exist right then and there. So it's more than just quality management. It started there for us, every time there's a problem now, people start coming to me and saying, Hey, could Unifize's do this?
[03:34 - 03:50]
And that's so unique. I've never seen that before in any company where I have people from maintenance or people from receiving or people from warehouse or various other areas coming to us to quality and saying, Hey, do you think that this could be a solution for us? And it's so amazing to be able to say, Yeah, it is, let's do it.
Day one, you're engendering a culture of continuous improvement. You don't know it. You don't see it till one day you turn around and say, Wow, everybody is rowing in the same direction.
[00:10 - 00:25]
And those are sort of these unintended, massively helpful consequence of rolling out Unifize that I saw is that communication breakdowns fell away, that visibility and unnecessary meetings and unnecessary emails and unnecessary phone calls went away.
[00:25 - 00:34]
And I genuinely could focus on doing my job better every day. And I truly believe across the organization that's true for everyone at all levels.
[00:39 - 00:46]
I'm the Director of Quality, Compliance and Formulation at Biovation Labs here in Salt Lake City, part of a larger organization, Wellful.
[00:46 - 01:00]
We have both internal and external customers is what I call that. We have the brands that are all under the Wellful umbrella, that we're all part of the same company and we're they're predominant, if not entire manufacturer for capsules and tablets here by Biovation.
[01:04 - 01:30]
At that point it was more about having electronic documentation and this was 2016. SharePoint wasn't great. People didn't weren't apt to use MasterControl and it's a little clunky and arduous for the average user. And what I learned probably most notably was that if it's not designed to be easy for the user, then it's just another hurdle.
[01:30 - 01:46]
A lot of systems out there will offer you the digital signatures and 21 CFR part 11 compliance, which is the set of regulations that applies to digital documentation and signatures and Unifize, has this amazing approval workflows that we've used.
[01:46 - 02:01]
I mean, we use it for raw materials, for suppliers, for formulas, for quotes, for product release, for raw material, what I mean by that is they it's a button click just like a lot of digital signatures work, but built into it is automatic notifications.
[02:01 - 02:09]
Being able to real time collaborate about a Non-Conformance and again, an Out of Spec or even just we use what we've termed Observations.
[02:09 - 02:22]
They may not be a problem, but they could be a leading indicator of a problem and collaborating with decisions right then and there. What used to take days, weeks, sometimes months is seconds and minutes.
[02:22 - 02:41]
The digital signature and approval workflows, streamline my Lot release on finished goods, as I mentioned, because before that was email back and forth. Now my quality supervisor uploads the test, uploads the CoA, clicks a button says, All right, I'm done, and it goes right to the customer because again, something that used to take days at times takes minutes at worst.
[02:45 - 03:01]
One huge advantage of Unifize and the collaborative environment that it has is that you can collaborate about a specific item and you can collaborate about many items simultaneously, and that cuts down time, obviously, but it also increases visibility, communication and effectiveness
[03:01 - 03:14]
because I can be I can knock through three or four things that normally would have taken days, weeks, months sitting at my computer all at once, and I can actually respond to people about that event in the in the environment right then and there and move on to the next one.
[03:18 - 03:24]
Unifize is amazing because it grows with you. It solves problems with you as the problems come up. So if a conversation or process doesn't exist, guess what?
[03:24 - 03:34]
You can make it exist right then and there. So it's more than just quality management. It started there for us, every time there's a problem now, people start coming to me and saying, Hey, could Unifize's do this?
[03:34 - 03:50]
And that's so unique. I've never seen that before in any company where I have people from maintenance or people from receiving or people from warehouse or various other areas coming to us to quality and saying, Hey, do you think that this could be a solution for us? And it's so amazing to be able to say, Yeah, it is, let's do it.
About Biovation Labs
Biovation Labs is a vertically integrated nutritional supplement contract manufacturing operation specializing in high-quality formulation, blending, encapsulation, and packaging.
Industry
Nutritional Supplements
Location
Salt Lake City, Utah, United States of America
01:53
About Jesse Kolstad
Jesse Kolstad, the Director of Quality, Compliance, and Formulation at Biovation Labs, gives an intimate peek into his role and the company's operations. Located in Salt Lake City and part of the Wellful organization, Biovation Labs plays a pivotal role in manufacturing capsules and tablets. Jesse also highlights their collaboration with prominent industry giants, underscoring Biovation's significance in the dietary supplement sector.
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05:21
Why Biovation moved from MasterControl to Unifize
Jesse Kolstad reminisces about his journey with quality management systems, notably his pivotal role in deploying MasterControl. As he navigates through the landscape of electronic documentation circa 2016, he highlights the challenges presented by platforms like SharePoint. While acknowledging MasterControl's early advantages, Jesse candidly critiques its user interface, shedding light on why a transition to Unifize became essential for Biovation Labs.
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05:44
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.
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05:04
Problems with managing quality at nutraceutical companies
Jesse Kolstad paints a vivid picture of the recurring challenges he's faced in the realm of quality management. From overloaded file cabinets to underutilized QMS systems, he's seen a pattern of data not being harnessed effectively. Jesse shares his thoughtful approach to quality enhancement, highlighting the importance of keen observation and understanding before diving into reforms, reflecting his depth of experience and commitment to excellence.
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05:38
How Unifize helped build our processes efficiently from scratch
In this video, Jesse Kolstad of Biovation Labs contrasts his experience with MasterControl's structured modules to the flexibility offered by Unifize. Reflecting on the early stages of his career, Jesse appreciated the structured guidance, but as his expertise grew, he found immense value in the "blank canvas" approach of Unifize, allowing for tailored and efficient process development.
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01:34
How Biovation uses Unifize to create traceability and take better decisions
In this video, Jesse Kolstad of Biovation Labs highlights how Unifize is instrumental in managing ingredient specifications, formulating products, and monitoring trends. He underscores the platform's ability to seamlessly interconnect various stages of the production process, from ingredients to finished products, allowing for enhanced traceability and informed decision-making.
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07:00
How Unifize's real time collaboration empowers faster and efficient decision making
In this video, Jesse Kolstad of Biovation Labs accentuates the power of Unifize's real-time collaborative environment. He praises its capability to manage multiple tasks concurrently, leading to significant time savings, increased visibility, and enhanced communication. Jesse emphasizes how this real-time collaboration facilitates swift and effective decision-making.
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02:05
How Unifize speeds up approvals around product specifications
In this video, Jesse Kolstad of Biovation Labs elaborates on the intricacies of product specifications, from dosage forms to market presentations. He underscores the comprehensive role Unifize plays in the process, highlighting the platform's capability to manage, collaborate, and monitor all aspects of finished products. Jesse reflects on the transformative shift from traditional email-based approvals to the more efficient system provided by Unifize.
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04:05
How Biovation manages Supplier Quality on Unifize
Jesse Kolstad delves into the challenges of juggling multiple suppliers at Biovation Labs. He candidly shares the complications of dealing with myriad versions of similar products, like green tea extracts. With Unifize, Jesse found a way to seamlessly consolidate suppliers, bringing clarity to ingredient and inventory management, and ensuring quality standards are met consistently.
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03:51
How Unifize helped reduce $60,000 of material cost on just one product
Jesse Kolstad shares a transformative experience at Biovation Labs, emphasizing the power of perspective. With Unifize, he could holistically evaluate their ingredient performance and volumes, enabling him to whittle down from 16 SKUs to just two. This consolidation not only simplified management but also resulted in substantial cost savings for the company.
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02:27
How Unifize ensures everyone is trained on the right version of documents and SOPs
Jesse Kolstad sheds light on the intricacies of document control, a critical component across regulated industries. While debunking common myths, he underscores the importance of more than just maintaining master copies. With Unifize, the emphasis is on ensuring that everyone in the organization is well-trained and aligned with the most recent versions of documents and SOPs, guaranteeing compliance and efficiency.
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01:43
How Unifize helped reduce our training time and costs
Jesse Kolstad discusses the transformative role Unifize played in Biovation Labs' training process. By establishing a cohesive link between SOPs, training modules, job roles, and employees, Unifize brought unparalleled structure. Jesse also introduces a novel approach of integrating QR codes on RFID badges, allowing for on-the-spot verification of an employee's training status. This innovative system streamlined compliance checks and significantly cut down on training costs.
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02:28
Managing the product lifecycle and ensuring efficient traceability with Unifize
Jesse Kolstad underscores the imperative of traceability in regulated industries. Drawing from his experience at Biovation Labs, he illustrates how Unifize seamlessly interlinks finished products, ingredients, formulae, and even packaging artwork. The platform's collaborative nature fosters real-time discussions, merging processes that were once scattered across emails and calls into a unified and efficient workflow.
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00:55
Unifize's lightning fast customer support
Jesse Kolstad lauds the unparalleled responsiveness of the Unifize support team. He recounts instances where he received almost instantaneous assistance, highlighting their record response time of just 12 minutes. Jesse values the platform's collaborative capabilities, allowing him to make real-time changes with both his team and the Unifize support team. The genuine partnership feeling resonates throughout his experience, showcasing their commitment to customer success.
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02:38
How Unifize makes audits easier
Jesse Kolstad highlights the revolutionary change Unifize brought to Biovation Labs' internal audit process. The platform facilitates direct capture and storage of visual evidence like photos, ensuring context and clarity. Drawing a contrast with past practices of manual note-taking and subsequent transcription, Jesse appreciates Unifize's real-time documentation that eliminates back-and-forth and enhances audit efficiency.
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01:28
How I reduced Mock Recall time down to 18 minutes with Unifize
Jesse Kolstad dives deep into the world of Mock Recalls, often perceived as a compliance necessity and a cumbersome task. Highlighting the typical time constraints faced during certification audits, he recounts past experiences where meeting the set time frames was challenging. With Unifize, Jesse experienced a game-changing shift, significantly enhancing the efficiency and speed of the Mock Recall process.
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03:00
Accelerate any process on Unifize: Quotes, Formulas, Lot Release, Raw Material, Specs and Approvals
In a regulated environment, Unifize streamlines processes from raw materials to product releases. Jesse Kolstad highlights its flexible approval workflows, instant quotation transfers, and collaboration features, emphasizing how Unifize instills confidence in approvals and accelerates operations at Biovation Labs.
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01:08
Moving away from CCPs to Preventative Controls with Unifize
Highlighting the shift to preventative controls, Jesse Kolstad values Unifize's visibility and supplier management. Unifize seamlessly aligns with food safety, optimizing supplier evaluations and quality control at Biovation Labs.
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04:27
Near instant implementation and adoption of Unifize
Jesse Kolstad lauds Unifize for its intuitive design and quick adoption. With tools that foster user engagement and autonomy, Unifize integrates smoothly into Biovation Labs' daily operations.
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01:41
How Unifize speeds up change control
Jesse Kolstad emphasizes Unifize's prowess in managing change, navigating the challenges of either over-documentation or under-documentation in some companies. With features like versioning, Unifize ensures comprehensive tracking, offering unparalleled visibility and accountability in change management at Biovation Labs.
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03:13
How Unifize's collaboration empowers continuous improvement
Jesse Kolstad heralds Unifize's transformative impact on collaboration at Biovation Labs, empowering continuous improvement through open communication. By breaking down silos and fostering cross-functional collaboration, Unifize establishes real-time feedback loops, ensuring alignment with company objectives and facilitating rapid growth.
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01:47
Reducing the time to resolve customer complaints on Unifize
Jesse Kolstad highlights how Unifize expedites the resolution of customer complaints. Offering tools for rapid issue identification and fostering team collaboration, Unifize streamlines the complaint resolution process, ensuring accountability and efficiency in addressing customer concerns.
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01:13
Managing retentions with Unifize
Jesse Kolstad underscores Unifize's role in effectively managing product retentions at Biovation Labs. The platform simplifies tracking, ensures adherence to retention policies, and enhances compliance, making retention management more streamlined and reliable.
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00:44
Transitioning from an existing eQMS to Unifize
Highlighting the transition from a traditional eQMS to Unifize, Jesse Kolstad lauds the platform's flexibility and advanced capabilities. With its user-friendly interface and transformative features, Unifize has brought about significant operational improvements at Biovation Labs.
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03:53
The ROI of Quality Management Systems
Jesse Kolstad delves into the significant ROI of quality management systems, underscoring efficiency gains and cost savings. Unifize emerges as a pivotal tool in optimizing the ROI of quality management, demonstrating tangible benefits at Biovation Labs.
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02:51
Starting the transformational journey with Unifize
Detailing the transformational journey with Unifize, Jesse Kolstad emphasizes how the platform catalyzes a culture of continuous improvement. Unifize's adaptability and extensive capabilities underline its role as a game-changer in quality management at Biovation Labs.
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00:48
How Unifize links raw materials to lots, formulas and finished products
Jesse Kolstad highlights Unifize's capability to seamlessly link raw materials to lots, formulas, and finished products. Providing a comprehensive view of the production process, Unifize ensures unparalleled traceability and accountability, enhancing production oversight at Biovation Labs.
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01:41
Understanding trends by connecting data on Unifize
Jesse Kolstad accentuates Unifize's prowess in connecting data to discern trends. With robust data integration and analytical capabilities, Unifize offers valuable insights into operational trends, paving the way for data-driven decisions at Biovation Labs.
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01:51
Breaking organisational silos with Unifize: Centralizing knowledge and achieving organisational alignment
Jesse Kolstad emphasizes Unifize's instrumental role in dismantling organizational silos at Biovation Labs. By centralizing knowledge, the platform promotes a unified information hub, fostering organizational alignment and consistent collaboration, ensuring everyone operates in harmony.
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02:35
How Unifize made me a hero in my company
Jesse Kolstad shares how Unifize has amplified his impact and recognition at Biovation Labs. The platform's transformative capabilities have led to substantial operational enhancements, making its users, like Jesse, pivotal contributors to the company's success.
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01:25
Wear a seatbelt using Unifize to avoid accidents and save money
Drawing a parallel with wearing a seatbelt, Jesse Kolstad elucidates how Unifize serves as a preventive tool, averting operational mishaps at Biovation Labs. Ensuring safety and compliance, Unifize's proactive features lead to significant cost savings by forestalling potential issues.
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01:10
Reducing lot release time down to minutes with Unifize
Jesse Kolstad highlights how Unifize has dramatically curtailed lot release times at Biovation Labs. By optimizing the process, Unifize ensures lot releases are executed efficiently, reducing times to mere minutes.
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01:25
Taking faster decisions on Non-Conformances with Unifize
Jesse Kolstad underscores the agility Unifize brings to decision-making on non-conformances at Biovation Labs. The platform fosters rapid issue identification and enhances collaboration for swift resolutions, ensuring effective and timely corrective actions.
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