Dealing with non-conformances made simple with Unifize
In this video, Erica recounts a specific incident where a wrong revision of artwork was used, demonstrating how she utilized Unifize to manage the situation effectively. She was tasked with investigating the error, which involved gathering information and creating a non-conformance report in Unifize. Erica describes the ease of initiating this process in Unifize, starting from the affected finished good lot. She mentions that the error was traced back to their supply team and emphasizes the importance of thorough documentation in Unifize for tracking such incidents. Additionally, she highlights Unifize's capability to link specific incidents to affected products and its utility in generating reports. This allows for an efficient overview of non-conformances related to finished goods. Erica's experience showcases how Unifize streamlines the process of handling, documenting, and analyzing quality issues, enhancing organizational efficiency and accountability.
Transcript

00:00 - 00:08
So if something takes place, Like, for example, there was a situation where a wrong revision was utilized for our artwork we had one revision that was current and another revision was used.



00:08 - 00:16
So we had to find out what happened, what caused this. I was responsible for contacting the person to find out.



00:16 - 00:23
Just gather all the information in terms of what actually what happened and creating the non conformance in Unifize is very simple just, just making sure everything is documented.



00:28 - 00:33
I initiated it in Unifize from the finished good lot and then because it wasn't necessarily something that was our responsible we didn't do it the the other our contract manufacturers someone from their team had to actually complete everything.



00:44 - 00:49
Yes. They had to do their on their part. They had to do the investigation and that.



00:49 - 00:52
So it was found out it was, it was an error from our supply team.



00:52 - 00:59
With Unifize, just making sure everything is documented, that that's one of the main things and then finding out what was affected.



00:59 - 01:05
So there was a particular finish good lot that was affected so we linked the finished good lot to that as well.



01:05 - 01:12
Say, for example, we wanted to write a report to see how many non-conformances that we had on our finished good lot, we simply run that report and do that And look that up.

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

01:12
Onboarding and adopting Unifize
This video outlines the swift and efficient onboarding process to Unifize for managing corrective actions, risk assessments, and change control within their quality management system. Highlighting the collaborative effort with the Unifize team, the speaker details how they were able to upload historical data and fully implement these crucial aspects within just three to four weeks—a timeline significantly shorter than anticipated. This rapid deployment, compared to previous experiences with other systems, underscores Unifize's ease of adoption and its immediate impact on enhancing the company's quality management processes.
02:43
About Wilson and Applechem
Wilson introduces Applechem, detailing their focus on innovation in cosmetic ingredients. He emphasizes their commitment to developing high-quality, cutting-edge products that cater to the evolving needs of the cosmetics industry. This introduction sets the stage for understanding Applechem's market position and Wilson's role in steering the company towards its goals.
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
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.
02:38
Why Unifize makes post-market compliance a breeze
In this insightful video, Clarissa tackles the complexities of post-market compliance in risk management, focusing on the medical device sector. She emphasizes Unifize's pivotal role in effortlessly connecting customer complaints to corresponding solutions and risk assessments. Clarissa explains how this integration drastically cuts down the laborious task of complaint analysis, enabling proactive and efficient risk control updates, a feature she finds particularly advantageous.
01:52
How Unifize helped us streamline Change Requests
Mikala shares her experience with streamlining change requests using Unifize. She talks about how the platform has simplified the process, improved tracking, and increased transparency. Mikala emphasizes the importance of efficient change management in maintaining product quality and compliance, and how Unifize has been instrumental in making these processes more manageable and effective.
01:44
How has the definition of collaboration changed before and after Unifize
In this video, Wilson explores how the definition of collaboration has evolved within their organization after implementing Unifize. Previously marked by siloed efforts and miscommunications, the adoption of Unifize has led to a more unified and efficient workflow, significantly improving project outcomes and stakeholder engagement.
01:54
About Efco and their products
Dave Anderson provides an overview of Efco's operations, focusing on their specialization in steel forming equipment for concrete construction projects, from stadiums to bridges. Efco, headquartered in Des Moines, Iowa, with a manufacturing presence in Georgetown, Canada, and strategic locations worldwide, serves the global construction industry. The company has transitioned from coiled to sheet steel, employing advanced manufacturing technologies. Dave highlights Efco's role in major projects, such as the Las Vegas Sphere and Dallas Cowboys Stadium, underscoring its significance in the construction sector.
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.
04:11
Who is Natalie and what is her role at Adaptive Health
Natalie introduces herself and her role at Adaptive Health in this video. She describes her responsibilities in overseeing the quality assurance and compliance aspects of product development. Natalie explains how her role is integral to maintaining the highest standards of product safety and efficacy, and she highlights the importance of leveraging tools like Unifize for effective quality management in a complex and regulated industry.
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.
01:08
Streamlining processes efficiently in a small company with Unifize
In this video, Wilson shares how Unifize revolutionized their small company by significantly enhancing visibility and accountability. Emphasizing it as a major quality of life improvement, they highlight the streamlined processes that now require less personnel involvement. The key efficiency gains were not in manpower reduction but in the quality of communication and process execution. Unifize eliminated the need for repetitive confirmations about document exchanges and validation steps, facilitating a smoother, more transparent workflow that benefitted product leaders, quality control, and their CTO.
01:24
How Unifize already had everything we were looking for
In their quest for a QMS that seamlessly aligns with their operations, The Will-Burt Company found Unifize's platform to be the perfect fit. Tedd Carr lauds its all-in-one capability, which encompassed core needs like internal audits, non-conformances, customer feedback, and corrective actions, eliminating the need for multiple modules. The flexibility to tailor the software to their specific processes and the inherent ease of use ensured Unifize stood out, satisfying their desire for a customizable and user-friendly system.
01:54
Trends in New Product Development
Wilson explores current trends in new product development within the cosmetics industry, focusing on sustainability, consumer-driven customization, and technological innovations. These trends underscore the industry's shift towards more eco-friendly practices and personalized consumer experiences.
03:10
Investigating deviations with Unifize
The video explains Unifize's approach to managing deviations, emphasizing the platform's effectiveness in identifying, analyzing, and resolving discrepancies swiftly. It highlights how Unifize facilitates a comprehensive investigation process, contributing to higher standards of quality and compliance.
02:36
Reducing redundancies and getting things done faster with Unifize
In this video, Wilson highlights how Unifize has transformed their approach to product quality and development processes. By integrating Unifize early in the R&D phase, they've significantly enhanced discussions around quality, compliance, and consumer trends. This centralization has streamlined workflows, reduced the need for excessive meetings, and facilitated better communication across departments. The platform's ability to serve as a single repository for all relevant information has led to a notable improvement in efficiency and quality of life for the team, demonstrating Unifize's impact on eliminating redundancies and speeding up project completion.
00:39
Enabling collaboration across multiple shifts
Dave Anderson highlights Unifize's role in fostering seamless collaboration across multiple shifts at Efco. He introduces a novel discussion process within Unifize that allows for more than just quality action tickets, addressing the challenge off-shifts face without direct engineering support. By initiating discussion boards for any arising issue, supervisors can communicate problems in real-time, ensuring that the first shift can immediately see and decide on the necessary actions. This approach has significantly improved decision-making and problem resolution, enhancing operational efficiency across shifts.
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.
00:30
Speeding up finished good lot process from half a day to 10 minutes
Mikala shares her remarkable experience with Unifize, focusing on its impact in optimizing the finished goods lot process. She illustrates how the process duration dramatically decreased from half a day to a mere 10 minutes, showcasing Unifize's efficiency. She also highlights the reduction in the need for quality personnel by 2 to 4 employees, stressing the software's significant role in streamlining operations, reducing manpower requirements, and enhancing overall 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.

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.