Potential use of the scan statistic for quality control in blood product manufacturing.
There are minimal standards for the processing of whole blood components, and to apply those standards requires a system of quality assurances. Excessive indications of failures in compliance trigger inspections and other remedial actions, but the demarcation of what is excessive is a critical issue. Issues of low volume in some production facilities, low expected frequency of nonconformance, multiple nonindependent statistical tests, and controlling both the false-positive and false-negative rates all complicate quality assurance procedures. The scan statistic is a statistic that computes the number of events in a moving window throughout the period of risk. Monitoring plans based on scan statistics are developed to estimate the probability that a process that is under control.
Lachenbruch
Peter A
PA
Division of Biostatistics, FDA/CBER/OBE, Rockville, MD 20852, USA. lachenbruch@cber.fda.gov
Foulkes
Mary A
MA
Williams
Alan E
AE
Epstein
Jay S
JS
D000465:Algorithms; D001419:Bacteria; D001688:Biological Products / Q000592:standards*; D001769:Blood; D001772:Blood Cell Count; D001803:Blood Transfusion / Q000592:standards; D004340:Drug Contamination; D004345:Drug Industry / Q000592:standards* / Q000706:statistics & numerical data*; D006801:Humans; D007958:Leukocyte Count; D015233:Models, Statistical; D011336:Probability; D011786:Quality Control
D001688:Biological Products