Aversan has provided Out-of-Tolerance analysis for Intuity Medical’s blood glucose monitoring system to accept or reject parts for incoming inspection. A thorough analysis on the failed first article inspection (FAI) was conducted and Aversan provided recommendations on short term and long term solutions to accepting the parts. The analysis was done with mating parts and the device as a whole.
Solutions included: increasing the tolerance, additional QC procedure to add onto WI, and drawing changes. The analysis also indicated if any documentation was affected due to the change such as, PFMEA, DFMEA, WI, assembly equipment specification, FAI and IQC report.
Aversan is currently conducting an FAI evaluation between the current and older versions of the drawings with the completed FAI to indicate the items that need to be re-done to accept the failed part under the current revision.