Medical Device and Life Sciences Industry:
Process Improvement


 Client:

A global leader in the processing of human bone and connective tissue for transplantation, with a focus on spinal trauma and total joint revision procedures.

 Problem:Because the company had grown rapidly, its bone and tissue production processes, plus associated documentation and record keeping, were excessively complex and inefficient. Mistakes were occurring in both production and record keeping. Increased production costs created quality problems, and paperwork costs had escalated. Also, the company was adding new products and needed more clean room space for production.

Additionally, workers in the clean rooms were highly skilled and well paid, but worked excessive overtime. Four months of training and on-the-job experience was required before such employees were certified.

 Approach:The entire production process was videotaped and processes and paperwork were flowcharted. Work elements that could be performed in nonclean room space, if the processes were modified, were identified. Work steps were combined and new tools suggested. Duplication of data entries on various forms was noted.

 Results: • Production and administration costs dropped
• Customer complaints decreased
• Production flow was streamlined
• Existing clean rooms handled more volume, but fewer clean room workers were demanded and overtime was cut
• Administrative forms were combined, eliminated or simplified and recording errors were significantly reduced
• New recommended bar coding and scanning equipment was earmarked to further reduce mistakes
   
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