Research in the Requirements for Reducing the Blood Transfer Device Complains for Air Bubbles and Leakage

Abstract

An increase on complain trigger a company Quality department raising a flag for further investigation of a product Nonconformance. Using Lean Six Sigma tools and DMAIC methodology a multidisciplinary team work together to found possible root cause that create robust process and brings back customer confident. Following the Existing Process Failure mode analysis and customer experiences, a route to follow was created to pursue some corrective action activities that address the failure study. Design of experiment and process validation prove that there was some process opportunities that’s needs to be implemented. Also during the Analyze phase some recommendation were found to pursue as a long term solution. Key Terms - CAPA, Complains, DMAIC, Lean Principals.