Streamlining FDA Compliance with Automated Maintenance and Reporting Processes
Cook Medical is a medical device manufacturing company headquartered in Bloomington, Indiana. Founded in 1963, Cook Medical produces more than 16,000 products for a variety of specialties, ranging from anesthesiology to plastic surgery to transplant surgery
With thousands of products produced daily and assets spread across the manufacturing plant, Cook Medical needed a way to track work order status and requests from the floor. A paper-based system caused headaches for everyone from the compliance operator to the manufacturing technicians.
- A time-consuming 100% paper-based maintenance management process
- The need to comply with strict FDA and other government agency regulations
- An inefficient and tedious auditing process that involved digging through filing cabinets to find the paper trail of reports
After implementing Maintenance Connection, Cook Medical was able to create an organized database of all assets, past equipment failures, and service history. The company was also able to create a preventive maintenance (PM) schedule, including automated work orders based on historic asset data.
- Work order details on one screen rather than a stack of papers
- Digital calendars to gauge maintenance staff availability and manage labor assignments
- Reporting on every asset that comes into contact with a medical device during the manufacturing process
As a result of using Maintenance Connection, Cook Medical has improved work order tracking, automated maintenance procedures, and ensured compliance with FDA requirements. The company has also streamlined reporting processes, significantly reducing the time spent searching and processing reports. Additionally, the new PM schedule has reduced downtime by alerting technicians that service is needed before equipment failure.
- A reduction in reporting time by 3 to 4 hours due to automated reporting
- Preventive maintenance schedules and alerts that diminish downtime
- Seamless compliance with FDA and other requirements
- Improved efficiencies that help create a better, simpler and more efficient way to treat patients