Complaint Reduction Project of Infant Heel Incision Lancets of a Medical Device Manufacturing Plant

Abstract

The purpose of this project was to identify key factors affecting the complaint rate of the infant heel stick lancet related to insufficient blood flow from the incisions and no activation of the lancet after triggered. These two defects drive the complaint rate of this product thus overshadowing other minor complaint categories or defects. The results of this project directly affect the complaint rate of the lancet and therefore increase the product quality and manufacturer’s efficiency. The anticipated outcome of this project was the identification of areas of the assembly process with high potential of incorrect assembly of parts due to process variation, which ultimately leads to customer complaints. Following the DMAIC methodology, it was possible to reduce customer complaint rate from 4.82 to 0.47 CPM. Key Terms - Complaints per Million, DMAIC, Lean Principles, Regulation Classification.