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Statistical Engineering to Stabilize Vaccine Supply

Summary: Reliable vaccine supply is a critical public health concern. In this case study, statistical engineering was applied to a complex problem in vaccine production. Statistical techniques ranging from simple graphics to sophisticated time series and variance components models were needed to identify root causes. Custom solutions and monitoring methods were developed to insure long-term success. Stability of the vaccine product has been improved; long-term variability has been reduced by one third so far, with additional improvements underway. The stability of other vaccines could be improved by applying the same analysis, standardization, and monitoring approaches.

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  • Topics: Statistics
  • Keywords: Case study, Biotechnology, Control charts, Cumulative sum control chart (CUSUM), Multivariate analysis, Principal components, Propagation of errors, Random effects, Root cause analysis (RCA), Six Sigma, Statistical engineering, Variance components
  • Author: O'Neill, Julia; Atkins, George; Curbison, Dan; Flak, Betsy; Lucas, James M.; Metzger, Dana; Morse, Lindsay; Shah, Tejal; Steinmetz, Thomas; Van Citters, Kathleen; Wiener, Matthew C.; Wingerd, Byron; Yourey, Anthony
  • Journal: Quality Engineering