The Research Of Development Process Optimization For New Vaccine Product Project In Company S Based On Lean Six-Sigma

As our country entered the World Trade Organization (WTO), our biopharmaceutical companies have to face more fierce global competition. To gain a foothold in the competition, Chinese biopharmaceutical companies must improve their own competitiveness. Lean six sigma (LSS) management is an organic combination of two management concepts:lean production and six sigma. Now it has been applied successfully to manufacturing industry and become the "best practice" to help biopharmaceutical companies enhance their own competitiveness.S company is a domestic biopharmaceutical enterprise, but its development process of new vaccine products has certain defects, which results in problems such as low pass percentage of product and unstable process control, failing to achieve expected objectives. This research project, through the study and analysis of domestic and foreign LSS theories, based on the general situation of S company and domestic biopharmaceutical companies, improves and optimizes S company’s development process of its new vaccine products by applying the thoughts and tools of LSS management. With problem-solving model "Define-Measure-Analyze-Improve-Control" (hereinafter referred to as DMAIC), it uses Pareto charts to identify specific objectives for improvement in the Define stage; uses failure mode and effects analysis (FMEA) in the Measure stage, and conduct an analysis of quality risk based on the products’technological process to prioritize value-at-risk of all key processes and hence identify main risk factors; in the Analyze stage, it carries out single factor analysis of variances for each main risk factor identified at the previous stage and identify relevant factors and irrelevant factors concerning the problems; conducts design of experiment (DOE) in the Improve stage to find the optimal solution for each relevant factor, namely technological improvement plan; in the Control stage, it applies fishbone diagram and ideas of lean production to optimize and improve existing quality control process for development. Finally, the research project has solved the problems in S company’s vaccine development projects that its products’percentage of pass rises to over 90%, output increases by more than 13% after optimization, and process sigma level rises to 5 and above, achieving the expected standard.S company’s LSS-based optimization project for vaccine development process provides a good reference to other biopharmaceutical companies when implementing projects guided by LSS ideology. The application of LSS provides a set of effective theoretical bases and analytical devices for biopharmaceutical companies to optimize process, increase efficiency, ensure quality, and apply research result to production.