Building a knowledge base in a startup with Unifize
Michael delves into the distinctive aspects of working in a compact company setting. He underscores the pivotal role of relationships, whether with colleagues, suppliers, or clients. Highlighting the importance of human-centric approaches in startups, Michael contrasts this with the rigidity and compartmentalization of vast corporations. His reflections shed light on the balance between the personal touch and systematic workflows in different company sizes.
Transcript

00:00 - 00:14
The thing about working at a small company is that it's the you know, it's about relationships, both with your coworkers, but with your suppliers, with your customers.



00:14 - 00:40
Right. When you have your people, the importance of people over systems becomes much more important. There's always there's always that balance, right? You can work for these huge 80,000, 80,000 person companies like Raytheon, where you have a very clearly defined role. It's very rigidly boxed. You only know the information for your particular project that you need to know.



00:40 - 01:07
I mean, literally your design inputs don't tell you anything about what you're actually working on in some cases for for good reasons. At a startup, it is it is very much about, you know, what is my what is my working relationship with my quality engineer, what is my working relationship with my suppliers? Right. Because at the end of the day, for a small company they live and die on, on relationships.



01:07 - 01:44
As far as the that ties into compliance, I mean, the thing is that everybody has to hold everybody accountable, right? We don't have the overhead or the or the systems that accrue over time that a rigidly enforce a set of standards as determined by the company. Right. And, you know, regulations are written from, at least in my opinion, from the sense that if you're doing everything right, everything that you should be doing, if you're doing a good job, you know, you will be very close.



01:44 - 02:07
If not already compliant with most standards. There was very few gotchas I've seen there in a tripped up. But the key thing is, is that you need to communicate right? I don't have a walking corpus of, you know, ISO 60601 in my head, right? I can't know everything about it, but between all the people at this company we do.



02:07 - 02:32
And so being able to communicate clearly with each other and being able to have information in a way that's easily accessible, that is flexible processes, is it is the strategy that you need to maintain, Right? If you try to enforce a rigid system on a start, it's just not going to work. There's no way, right?



02:32 - 02:40
You you know, there are days where I'll put on more of a quality engineering hat and maybe I'll go audit suppliers.



02:40 - 03:17
There are days where, you know, in the old days I'd literally was building robots in back. I was the technician. So I think that, you know, tying it back to regulation and I guess to Unifize is that the system that we have with Unifize reflects the scale and size of our company and the fact that it's so adaptive and we've changed it several times over already as we've learned more how to use the system and as we grow as the company is, that's really, you know, what we need as a company

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.

Related Case Study Videos

02:07
Centralizing master formula and reducing redundancies with Unifize
In this video, Mikala explains the benefits of using Unifize to centralize the master formula and reduce redundancies. She discusses how the platform has streamlined their formulation processes, improved accuracy, and reduced errors. Mikala highlights how this centralization has led to better resource management and efficiency in their operations, emphasizing the role of Unifize in enhancing productivity and reducing waste.
01:51
Handling scrap and rework using Unifize
Seth Bozman reflects on the traditional negative perception of scrap and rework and how Unifize has helped Efco to approach these issues as opportunities for improvement. He appreciates Unifize's ability to provide detailed tracking and analysis, enabling Efco to identify root causes and implement effective solutions. This video illustrates how Unifize has empowered Efco to transform challenges into actionable insights, fostering a culture of continuous improvement.
02:54
What other eQMS are missing- Separating conversations from data
Denis Machoka pinpoints a critical shortfall in many eQMS: the division of conversations and data. He critiques the inefficiencies of navigating isolated data and scattered emails, championing Unifize's innovative fusion of both. By merging discussions with data, Unifize presents a unified, actionable view, streamlining decision-making and collaboration.
00:47
Document revisions made simple with Unifize
Mikala, in this comprehensive video, explains how Unifize has simplified the process of document revisions. She highlights the platform's ability to streamline document management, making revisions more efficient and traceable. Mikala also discusses the impact of these capabilities on improving compliance, reducing errors, and enhancing overall operational efficiency. She emphasizes Unifize's role in facilitating better collaboration and communication, making it easier for teams to manage and revise documents in a cohesive and organized manner.
01:49
Why Slack is not the best system for managing quality
In this detailed video, Erica delves into the unique messaging and document management features of Unifize. She explains how Unifize facilitates specific conversation threads, such as for finished goods, artwork, or ingredients, allowing immediate access to relevant documents within these discussions. Erica contrasts this with Slack, where uploading and sharing documents is more cumbersome and lacks the context provided by Unifize's integrated system. She emphasizes how Unifize's layout enables users to quickly view dialogues and understand ongoing issues without extensive explanations. Additionally, Erica highlights Unifize's ability to hold users accountable and convey urgency in tasks, a feature she finds lacking in Slack. This video effectively showcases how Unifize streamlines communication and document management, enhancing productivity and clarity in workplace collaborations.
03:20
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.
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.
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.
01:02
What are the compliance standards followed at Adaptive Health
In this video, Mikala outlines the compliance standards followed at Adaptive Health. She delves into the various regulatory requirements they adhere to and how maintaining these standards is critical for their operations. Mikala explains how Unifize plays a vital role in ensuring compliance, managing documentation, and streamlining processes to meet these rigorous standards effectively.
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.
01:12
How conversations in Unifize foster better collaboration
Tedd Carr is enthusiastic about how Unifize's conversation-driven platform has revolutionized collaboration at The Will-Burt Company. He observed a significant uptake in engagement following a refresher course, likening the buzz of activity to a lively slot machine. This surge in conversations among varied personnel didn't lead to confusion but rather an organized flow of information. Carr takes pride in witnessing the team's proactive interactions and the smooth progression of tasks, indicating a thriving, collaborative environment.
01:23
About Michael Hogan & Harmonic Bionics
Michael Hogan, a mechanical engineer at Harmonic Bionics, paints a vivid picture of the company's origins. He recounts the early days when it was just a group of grad students from the Renew Robotics Lab passionately working on rehab robotics. Their flagship device, Harmony, emerged from these efforts, aiming to revolutionize the recovery process for stroke patients.
01:56
Handling artwork revisions with Unifize
In this video, Erica describes the artwork management process within her organization and how Unifize plays a crucial role in it. She begins by explaining that the artwork process doesn't start in Unifize but is incorporated once the artwork is approved. Unifize then becomes the repository for the final versions, ensuring that everyone accesses the correct and latest artwork for each product. Erica elaborates on the pre-Unifize procedure, including revisions and approvals from print suppliers. She uses Unifize to verify the currentness of documents, flagging any discrepancies, especially with revisions received from suppliers. This system prevents printing errors and ensures accuracy. Furthermore, Unifize's documentation feature allows Erica to trace back the history of revisions, understanding the reasons behind each change. This video highlights Unifize's effectiveness in managing and tracking artwork revisions, ensuring quality control and accuracy in the production process.
01:30
How important is having a single system for everyone to collaborate on all things quality
In this video, Erica expresses her enthusiasm for the collaborative aspect of Unifize, emphasizing its effectiveness in facilitating smooth teamwork without overlapping efforts. She appreciates the platform's ability to connect various departments, including their contract manufacturer, which she frequently mentions in relation to finished good lots. Erica highlights how Unifize streamlines communication, particularly with the contract manufacturer, offering a quicker and more efficient alternative to email or other methods. She notes that other departments also find value in Unifize for accessing files and information. Erica acknowledges some challenges in getting everyone to adapt to a new system but is optimistic about the ongoing efforts of the quality team to improve collaboration across teams. She believes that embracing Unifize will greatly enhance overall efficiency and productivity within the company. This video showcases Unifize's role in promoting effective inter-departmental collaboration and communication.
00:36
Minimising the impact on IT while implementing Unifize
The Will-Burt Company strategically chose Unifize to alleviate their IT department's workload. Tedd Carr appreciates that Unifize's team handled everything from installation to launch, ensuring minimal IT involvement. This approach not only streamlined the implementation process but also allowed their IT staff to focus on other critical internal tasks, marking a significant internal shift towards efficiency and resource optimization.
01:17
Managing part revisions on Unifize
Michael sheds light on the intricacies of managing part revisions at Harmonic Bionics using Unifize. He describes their systematic approach, where each part is tagged with a specific revision. This setup allows team members, like purchasers, to seamlessly access and review older versions of parts when needed. Michael values Unifize's capability to store and present all relevant information, from product definitions to design files, ensuring a comprehensive understanding of each part's evolution.
01:48
About Tedd and The Will-Burt Company
Tedd Carr, with 40 years at The Will-Burt Company, oversees a broad quality assurance and control remit that spans beyond the traditional confines of the department. His role touches all company areas, emphasizing the diverse and complex quality demands of their varied customer base in sectors such as aerospace and military, which presents a significant challenge in meeting each sector's unique requirements and expectations. The Will-Burt Company, an employee-owned enterprise, prides itself on a century of business, specializing in proprietary products and services for emergency communications, warfare, and payload elevation, as well as offering comprehensive manufacturing services.
02:45
Collaborating with vendors using Unifize
Michael elaborates on Harmonic Bionics' systematic approach to documenting design outputs, emphasizing their reliance on definitive documents such as step files and PDFs. He offers a peek into his daily routine, which frequently involves addressing quality notifications on Unifize, collaborating with vendors, and updating specifications. Through his narrative, the importance of Unifize in streamlining vendor interactions and ensuring accurate design documentation becomes evident.
00:59
They key to configurability- make it simple & easy
Denis Machoka extols the straightforward configurability of Unifize, contrasting it with the complexities of other systems. He appreciates its pre-configured design, likening it to object programming. Denis believes Unifize's inherent simplicity is testament to its creators' deep industry understanding and their aim to simplify user experience.
02:28
Evaluating other eQMS software tools
Denis Machoka delves into the evaluation process of various eQMS tools, citing considerations for present needs and future growth. Comparing Unifize to platforms like Ignite EDMS, Veeva, and Greenlight Guru, he underscores Unifize's ease of implementation and its integrated conversation feature as standout advantages.

Experience the benefits of Unifize

4x Faster time-to-market

Map Unifize to your processes and streamline workflows, process automation, and prioritization

70% Fewer meetings

Less meetings with in-app collaboration, real-time updates, and decision logs

10x Speed to compliance

Unifize accelerates compliance, delivering 10x faster regulatory approval for medical devices

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.