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