Product Monitoring Improvements Migrating from the Infinity Quality System to an Automatic Interface Data Collection

Abstract

This improvement project article is intended to demonstrate how a medical device company can improve its inspection process by developing an Automatic Data Transfer Platform migrating from a platform that does not provides the adequacy to maintain product integrity in terms of failing the qualified inspection process requirements. The success of this migration was achieved following project management and data driven improvement cycle methodologies that concluded with a reduction of the defects by fortyfive percent and with an incidence reduction of the product investigations by the Fail Sampling Plan reject code of more than seventy percent. Key Terms - Automatic Interface Data Transfer, DMAIC, Failed Sampling Plan, Infinity Quality System.