Outsource Component for Quality Improvements

Abstract

In a medical device facility located in Puerto Rico, the process used for the manufacturing of plastic tubes was to have an inhouse extrusion machine to produce tubing of several dimensions. These tubes then follow the normal process and are supplied to the manufacturing line for final assembly and packaging. During the production of plastic tubing using extrusion process there are some characteristics that can deviate the final product specifications, such as wear, environmental variations or operator fatigue. Assessment of the complete process was performed in order to determine the poor quality of the product received at the assembly line. Investigation results shown deterioration of the incumbent machine causing quality defects and delays in the manufacturing line. The senior management team took the decision to outsource the process to an outside supplier. The aim of this paper is to review and summarize all the activities performed to qualify and create a supply chain for the new process established. Key Terms ⎯ Extrusion machine, quality defects, plastic tube, outsource.