Reduction and mitigation of foreign matter observed in product ABC

Abstract

During the past three years, a manufacturing company for medical devices on the west side of Puerto Rico has been in the need of evaluating and mitigating the causes behind an increase in complaint incidents reported due to foreign matter in product ABC. A PDCA (Plan, Do, Check, Act) methodology cycle was used to accurately develop the plan for each phase of the project. Following root cause analysis techniques, it was found the possible root causes behind the defects were Method and Materials. A plan to mitigate this was sought out, and after feasibility analysis it was found that by implementing an ionizing air gun plus a particle trap system, the components were cleaned of foreign matter and its static charge was reduced mitigating the ability of the foreign material of returning to the components. With the effectiveness check a surveillance system will be determined to monitor complaints for a determined timeframe. Key Terms ⎯ Effectiveness Check, Feasibility Study, Relationship Matrix, Root Cause Analysis.