Medical device quality control testing process time reduction

Abstract

A Medical Device Company has paid, in overtime labor hours for processing raw materials and quality control testing due to inefficient process requirements thus impacting costs on product. The raw material purchasing is performed in small batches due to Supplier Company limitations; nevertheless, Medical Device Company have a larger demand on these raw materials and must purchase those small lots more frequently per month. Improvements on QC testing process will be possible with the purchase of bigger lot sizes of each raw materials, elimination of nonvalue-added activities that will result in a decrease in the total hours of labor and reduce incoming testing for raw materials that will decrease the total labor cost incurred at Main QC Laboratory. These improvements will allow a work standardization on Main QC laboratory which is expecting to have a positive impact on productivity and will reduce Quality Notifications, Out of Specification and human errors. Key Terms - Certificate of Analysis (CoA), Out Of Specifications (OOS), Quality Control (QC), Quality Notification (QN).