BIOT 114 |
| Six Sigma can be described as a rigorous, disciplined, data-driven methodology for eliminating defects and reducing variability in any process. The method can be characterized as having five stages: define, measure, analyze, improve and control (DMAIC). The Six Sigma methodology is designed and expected to deliver real, tangible financial results by improving the performance of processes. This talk will describe how this methodology was applied to understand the variability and identify the process drivers associated with a commercial cell culture process. The team was comprised of scientists, engineers and a Six Sigma Blackbelt who employed the DMAIC approach. Initially stakeholders and process owners were identified and the proper support was provided to the project team. A rigorous analysis of historical data was performed to determine process baselines, develop the correct metrics and determine the financial impact of the project. The validity of measurement systems was scrutinized, ensuring data accuracy. Detailed statistical analysis was performed, focusing primarily on special cause variability and the associated root causes. Root cause analysis led to the examination of process drivers, the variables that were found to “drive” the process and have the most direct impact on overall variability and process performance. |
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Commercialization of Biologics: Data Management & Process Modeling in Support of Commercial Processes
3:00 PM-5:20 PM, Monday, August 20, 2007 BCEC -- 107C, Oral
Division of Biochemical Technology |