Manufacturing Site Medical Devices: Florida

QSCS was hired to conduct an in depth QSIT audit for a manufacturer of mechanical medical devices.  During the audit, the QSCS consultant observed a welding operation that was experiencing less that acceptable yields.  Over the next month, the QSCS consultant worked with the site and uncovered a strong relationship between the thickness of their raw material and the outgoing process yields.  A thorough statistical analysis was performed, a recommendation was made, proper quality documentation was put in place, and training was conducted.

Although the result lead to an increase in annual raw material costs of $60K, they were more than offset by an increase in annual yield of $365K.

Scroll to Top