S&V Siu Associates helped a client resume production 6 weeks after a voluntary recall of a surgical device. We were able to determine the root cause of the product's failure and qualify a new vendor to resume production.
A spike in surgeon complaints led to sample testing of product inventory. A confirmation of the failures resulted in S&V Siu being asked to assess the severity of the problem - our analysis showed that greater than 75% of the product in inventory was questionable leading to a voluntary recall. We were then asked to determine the root cause of the failures and to fix the problem.
ROOT CAUSE ANALYSIS
We used Scanning Electron Microscopy (SEM) to visually determine the characteristics of the failed component. The manufacturing process for the critical component was then analyzed as well as a determination made into when failures started to occur. Our investigation showed that the date failures started corresponded to the day the component vendor transferred the key processing step to a new operator. We also determined that the quality monitoring process was inadequate as there was no standard functionality test to properly qualify this key device component (only a visual test was used).
S&V Siu helped develop a standard test methodology coupled with a sample testing methodology for that critical component. At our client's request, we worked with a new vendor using DOE to develop a robust manufacturing process. Once the new supplier was also qualified, statistical process control was implemented by S&V Siu at the vendor and client sites, and production was resumed within 6 weeks.