Managing Incoming Material and Lot Tracking on Unifize
In this video, Clarissa discusses the challenges and solutions for managing incoming materials and lot tracking using Unifize. They emphasize the difficulties faced in quality assurance, especially when parts or products do not meet inspection standards. The video illustrates how Unifize streamlines this process by enabling easy tracking of lots, keeping essential documents like certificates of conformance and material certificates organized. The speaker highlights the convenience of having all relevant information, such as lot numbers and PO numbers, scanned and stored in Unifize, facilitating efficient tracking and inspection. They conclude by praising Unifize's collaborative features, which significantly enhanced their team's engagement with the new Quality Management System (QMS).
Transcript

[00:00 - 00:14]
Now let's say you have parts coming in and or whatever product you're working on, right? For us, it's manufactured parts or 3D printed parts and you know, not everything is going to be made perfectly to inspection.



[00:14 - 00:35]
So if it's not made to inspection, we need to look at it and say, okay, is this going to be, you know, something that's just esthetic, that doesn't really affect the patient or is it going to be an actual problem? And so rather than, you know, on most manufacturing floors I've worked on in the past, you know, it's okay, throw a sticker on it.



[00:36 - 01:09]
Let me call an engineer. Let me call someone and then get a meeting and I'll look at it and figure out what's going on, what we need to do. And, you know, it's really easy to misstep or forget, like, what does this affect or have that all get lost in an email? So with here, you know, we have the lot process that everything gets put in that receiving you know parts get received a lot process is created so we can also keep the certificate of conformance the material certs, all of those important pieces of paper that are super easy to get lost.



[01:09 - 01:22]
You know, we have that scanned in lot number PO number input there. So we always have a tracking of what that was and what happened to it before we got there. You can also put the inspection in there. That's really helpful.



[01:23 - 01:32]
Really the collaboration aspect of Unifize was what really pulled our whole team in and really sold us on this new QMS.

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

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.
01:52
How Unifize helps save time and get things done faster
In this video, Michael from Harmonic Bionics celebrates the transparency and coherence Unifize offers. He values the platform's ability to keep everyone synchronized, viewing the same documents and chat histories. This clear and shared understanding of processes, from part designs to quality notifications, not only fosters efficiency but also lets Michael concentrate more on his primary responsibilities, enhancing productivity.
03:23
About Denis Machoka and his role as VP of Quality at Harmonic Bionics
Denis Machoka, VP Quality at Harmonic Bionics, shares his evolution from a scientist with a background in chemistry and biology to a Quality Systems expert. He delves into his experiences in laboratories, IT systems implementation, and his expertise in qualifying systems within regulatory frameworks.
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.
01:01
Collaborating right from the shop floor using Unifize
Dave Anderson showcases the power of Unifize's mobile application, revolutionizing real-time collaboration directly from the shop floor. He highlights how team members can instantly join discussions, contribute insights, and make decisions without being tethered to a desktop computer. The introduction of barcodes on paperwork, a minimal but crucial use of paper, allows anyone to scan and immediately access the relevant discussion on Unifize. This feature underscores the platform's commitment to enhancing efficiency and communication across various departments, making it a game-changer for operational workflows.
02:00
What made us switch from MasterControl to Unifize
In this comprehensive narrative, Mikala explores the decisive factors that led to the switch from MasterControl to Unifize. She discusses the limitations and challenges she faced with MasterControl, including its inefficiency and user-unfriendliness. Mikala then delves into the aspects of Unifize that prompted the change, such as its innovative approach, user-centric design, and efficiency, which have significantly improved their operational processes and overall workflow management.
01:28
A paradigm shift in managing quality collaboratively with Unifize
Wilson discusses the significant shift towards collaborative quality management introduced by Unifize. It emphasizes the enhanced cooperation between departments, leading to a more integrated and effective approach to quality control. The speaker credits Unifize for fostering a culture of shared responsibility and streamlined communication, which has been instrumental in improving their product's quality and compliance.
06:33
What it really means to Unifize your information and people
Clarissa Archer shares the transformative impact of Unifize on Harmonic Bionics' operations. Beyond just a QMS, Unifize emerged as a tool that seamlessly connected people and information. Whether dealing with complex scenarios like non-conformances or change orders, the platform ensured they always had a holistic view, enhancing clarity and decision-making.
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.
02:15
Three reasons why Unifize is the easiest QMS- Security, simplicity, compliance
Denis Machoka advocates for Unifize as a QMS, praising its exceptional ease of implementation and intuitive design. Drawing a comparison with other renowned systems, he emphasizes Unifize's simplicity and rapid setup, making it a standout choice in the realm of quality management syst
01:21
Why can't Slack replace a collaborative eQMS
Natalie addresses why communication platforms like Slack cannot replace a collaborative eQMS like Unifize. She points out the challenges and errors that would arise from relying solely on informal communication channels for quality management. Natalie stresses the importance of a dedicated eQMS for proper documentation, tracking, and compliance, highlighting Unifize's capabilities in meeting these specialized needs effectively.
02:03
How Unifize's configurability helped us fight the resistance to change
Tedd Carr highlights the configurable nature of Unifize as a pivotal element in overcoming resistance to change at The Will-Burt Company. He values the software's adaptability, allowing for a familiar feel akin to their previous systems, thus simplifying the transition. The Unifize platform mirrors their old forms but with a new, conversation-driven approach, resulting in a smoother learning curve and quicker adoption among staff, leading to a more relaxed and progressive work environment.
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.
01:33
How to make facing FDA audits easy
Clarissa Archer talks about the daunting experience of preparing for audits, especially from rigorous bodies like the FDA. She stresses the importance of a robust documentation system, serving as a "source of truth" during these audits. With Unifize, they could effortlessly produce, present, and recall documentation, simplifying the audit process and instilling confidence in their decisions and actions.
01:27
How approvals in Unifize helped us collaborate across organizations and get things turned around faster
Mikala discusses how Unifize's approval features have enhanced collaboration across different organizations and expedited turnaround times. She highlights the platform's ability to streamline approvals, improve communication, and facilitate quicker decision-making. Mikala shares specific instances where Unifize's efficient approval processes have led to faster resolutions and better collaboration, underscoring its impact on operational efficiency.
03:22
Comparing Unifize vs QT9
In this detailed comparison, Dave Anderson shares his candid insights on choosing Unifize over QT9 for quality management at Efco. He praises Unifize for its superior collaboration features, emphasizing how it promotes more personal and effective problem-solving through direct conversations and teamwork, unlike QT9's focus on mere record-keeping. Dave highlights the difference in sales delivery and upfront communication about platform capabilities, which made Unifize stand out. This testimonial underscores the importance of collaboration in modern quality management systems and how Unifize excels in creating a more engaged and accountable team environment.
00:45
Why Mikala uses Unifize for 80% of her work
Mikala shares her reliance on Unifize for a significant portion of her work, detailing how the platform supports 80% of her daily tasks. She discusses the diverse functionalities of Unifize that facilitate efficient management of quality processes, documentation, and compliance. Mikala emphasizes how Unifize enhances her productivity, ensures accuracy, and simplifies complex processes, making it an indispensable tool in her professional routine.
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.
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.
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.

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.