SICD Terminal Ring Cracks Reduction

Abstract

A medical device manufacturing line of cadioverter/defibrillators utilizes a mechanical process called staking to join two metal components as part of the electrode manufacturing process. The staking process exerts a vertical force into the metal components to deformed them and join them together. In some instances, the deformation experienced during the staking process causes small cracks or fractures on the metal component ring. The objective of this project is to reduce crack yield fallout at the staking process. Utilizing process improvement methodology from six sigma Define, Measure, Analyze, Improve and Control (DMAIC) permanent solution was implemented by reducing variation on metal ring component being staked which resulted in 95% yield improvement on crack defect. The project provided financial benefit to the medical device company reducing annual scrap of manufacturing product. Key Terms ⎯ cracks, DMAIC, wall thickness, yield fallout