CHICAGO—FMI Inc. has launched a proprietary manufacturing information system for its medical silicone molding operations.
FMI iQ links real-time production data with performance metrics, quality data, employee training, continuous improvement and risk management tools, the firm said in a news release. The tool was created to harness and integrate the power of real-time data during production to help ensure zero defects in silicone molding for medical devices.
The program consists of three critical components that FMI's staff can access using a custom portal, including:
• Robust quality data collection, collected in real time during silicone manufacturing, along with material tracking data and regular reports on key performance indicators;
• Employee performance and resources, including the individual's quality data on all silicone molded parts produced on different types of equipment, as well as company policies and procedures, safety programs and upcoming training programs; and
• Continuous improvement and risk management, which outlines how risk is to be managed for every silicone molding project.
“FMI has made a major investment to ensure the highest quality in medical silicone molding by integrating individual department activities into one interface,” Harold Sant, FMI vice president of operations, said in a statement. “While we have been using these systems independently for many years, FMI iQ for the first time brings together all of our quality data and resources, which allows us to respond immediately to any concerns, as well as surpass our customers' requirements for quality reporting and audits.”
FMI supplies medical grade silicone components designed primarily for use in implantable Class 2 and Class 3 medical devices. The firm operates clean room facilities in Chicago and Suzhou, China. Both are ISO 13485 certified with Class 5, Class 6 and Class 7 clean rooms in the U.S. and a Class 7 clean room in China.
FMI is a wholly owned subsidiary of Chicago-based Flexan Corp.