Final Device Quality Control Unit Operation Optimization

Abstract

With the intent of achieving cost reduction initiatives, the Quality Control Unit operation regarding the final device release was identified as a labor cost opportunity. Through kaizen events done across site, it was determined a requirement of 20% total cycle time reduction for the final device packaging and release process and, consequently, eliminate the human interaction from the Quality Control Unit technicians. Lean manufacturing principles and DMAIC project methodology was used to develop this project and successfully eliminate the Quality Control Unit operation at the final device release process. With the elimination of the process step, the Unit Record Review was eliminated since it was identified as not required, and the other elements contained on the eliminated step, were moved to the previous step, once this was leaned out. The implementation of this project achieved its objectives, assuring compliance to the applicable regulation agencies requirements and engagement from the employees. Key Terms ⎯ DMAIC, Final Device Release, Quality Control, Regulation Agencies.