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).