Medical Device Manufacturing Process Development
Ranfac continuously improves our processes in order to mitigate as much risk as possible to our customers. We utilize Statistical Process Control, Process Failure Mode and Effects Analysis, ANOVAs, DOEs, and other methods to identify processes requiring attention, and ensuring changes that are made result in positive results with no adverse effects. We utilize Operational and Performance Qualifications to document these changes and show that the change has a positive impact.
All processes at Ranfac are documented in a Control Plan, which identifies all of the Standard Operating Procedures and work instructions required to standardize each process.