Reduce Scrap Loss of a Pacemaker Lead Applying Lean-Six Sigma

Abstract

A pacemaker is an electronic device that is placed under the skin to help control abnormal heart rhythms. It consists of a battery, a computerized generator, and lead (wires) with electrodes on one end. in a pacemaker leads manufacturing plant, the loss related to scraps from May 2008 to December 2008 was $81, 223.92. Sleeve Head Assembly was identified as the loss higher generator related to scraps with a total loss of $49, 765 representing a 61% of the total scrap loss. Appling DMAIC methodology from Lean Six-Sigma, the possible causes and action were evaluated. The major cause for the Sleeve Head Assembly scraps is related to leakage at the sleeve head joint. DOE (Design of Experiments) was use to optimize distal & proximal Sleeve Head Bonding. A factorial experiment 2k (for k > 3 Factors) was run to determine the significant factors. The experiment results appoint to prime with adhesive tab 5, use adhesive. Tab 5 for the 360 and one (1) grove layer. A change on manufacturing process was implemented on April 07, 2009 to reduce leakage defect at the sleeve head joint.