Improving Steroid Out Of Specification (OOS) Trending on Pacemaker Lead

Abstract

The purpose of this project is to identify a roots cause and potential factors that influencing Steroid Out Of Specification Results (OOS) on pacemaker lead model XYZ. Project involves Define, Measure, Analyze, Improve and Control (DMAIC) problem solving methodology. The objective of the study is to decrease Failure Test Rate from 15% to 10%. The contribution will allow the optimization of the steroid application process, by control the potential factors that contribute the (OOS) results. This project might be used as benchmark to implement similar problem solving techniques around the manufacturing plant or as a model for other educational needs. Key Terms ⎯ Combination Products, Out of Specification Trending, Pacemaker Lead, Steroid.