How NoMuda VisualFactory transformed Medical Manufacturer Frencken’s FDA Compliance process
5 Minute Read
“NoMuda VisualFactory helps our medical customers in multiple ways. We now keep a digital record of all production data and checks. It also helps us track the traceable items that we have in our products, so we have a clear overview of what has happened to a particular product.”
Frencken Mechatronics specialize in high-mix, low-volume, high-complexity, and high-flexibility production of assemblies and systems for the medical, analytical, and semiconductor markets.
Before NoMuda VisualFactory, Frencken’s process was paper-based with operators often choosing their way of building to avoid sifting through paper work instructions. The production team found it hard to document everything and provide traceability for their products to meet FDA guidelines.
In the search for the right Lean Manufacturing System, they found NoMuda VisualFactory to be, “very intuitive and a lot less rigid than their competitors. VisualFactory had a natural feel that it would do perfectly what we needed it to” says Production Engineer, Jaap Schuit.
“We had a dedicated rollout team to implement NoMuda VisualFactory across our medical device production. It was both exciting and difficult to begin with, but it got easier as we introduced more lines and transferred our paper work instructions to VisualFactory.”
“NoMuda VisualFactory helps our medical customers in multiple ways. We now keep a digital record of all the production data and checks. It also helps us track the traceable items that we have in our products, so we have a clear overview of what has happened to a particular product.”
“Now that it is digitally logged, it takes a matter of seconds to locate what happened in production. If something goes wrong, we have the data to resolve it and help us improve our processes in the future.”
“The benefits for Frencken are the reduction in paperwork and the speed at which we can now release work instructions to the shop floor. There is no manual distribution and sign off and we can ensure that the most recent versions are always being used.”
“We are able to use the VisualFactory vRelease module to support our work instruction authorization. When we make an instruction, it’s sent to a team leader on the shop floor to agree before it is approved by the manufacturing manager to ensure that it meets the needs of the FDA.”
“In my role as a Production Engineer, I have a clear overview of the work instruction changes as we can look back to the oldest version even if it was 2 years ago.”
“VisualFactory makes you write work instructions intuitively with only the information that is required, highlighting tools and other functions. This makes it easier for us and reduces the amount of work we need to do to keep our work instructions up to date.”
“We use VisualFactory dashboards on one production line that works in takts. Every hour the product moves from one station to the next and using the dashboards we can project the tact time and figure out whether we are ahead of schedule.”
“If there is a production issue, it is highlighted on the dashboard instantly for the team leader to resolve, reducing our response times.”
“In the beginning, there was a slight resistance from operators saying, ‘we must work in a different way’ and ‘I must adjust to become a robot and follow the steps’. The feedback now is that VisualFactory isn’t prescribing exactly what they must do, it is additional support to ensure that they don’t miss critical steps. It helps them have a better view of what they are doing.”
“I would recommend NoMuda VisualFactory as it gives you one standard way of working. There is so much data available that we couldn’t register before due to the paperwork. We can now visualize our KPIs and use to improve our production processes.”
Frencken is currently adjusting its work instructions for further compliance with the FDA. Once this is complete, they will be expanding VisualFactory to other lines and areas to help operators in other parts of the business.