Workmanship Error at Assembly Line in a Medical Device Company

Abstract

Abstract — In a Medical Device Company a production line had an increase of non-conformances in 2011. The category for the increase was workmanship error. These failures result in cost of poor quality due to quality holds. The Failure per Million is 205, the goal for the year is 180, and the objective is a 15% of reduction. These failures impact the company to comply with International Organization for standard (ISO) 13485. To be certified by ISO the manufacture shall demonstrate that investigations are made for each non conformance reported. If an increase is observed it is management responsibility to assure defects are attended and corrective and preventive actions will be generated. The methodology used to obtain a reliable production line was DMAIC (Define, Measure Analyze, Improve and Control). The projects mayor improvement is a new systematic visual aid procedure Process Picture Mapping which would be implemented further to the entire company. Key Terms - DMAIC, PFMEA, Poka Yoke, PPM.