How the DMAIC Methodology was applied under the CAPA System with Effective Results

Abstract

The proximal spacing is an essential design output where the purpose is to have the proper alignment and contact at the battery to provide electrical pulse therapy at the sacral cord stimulation. If the contact to the battery are not well aligned, the patient will not receive the therapy and the pain can be worst. A corrective action event was generated to address the increase on proximal spacing out of specification defect observed on the manufacturing process for the Sacral Cord Stimulation (SCS) Implantable Lead product for pain reliever during the months of May to November fiscal year 2017. The initial baseline established in the measure phase of 0.836% defect rate was improved after the implemented process improvements to 0.016% defect rate and cost reduction. The development of this study demonstrated how the DMAIC methodology was applied under the CAPA system with effective results. Key Terms  CAPA, DMAIC, Proximal Spacing and Effectiveness.