title: Potential use of the scan statistic for quality control in blood product manufacturing.
abstract: 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.
authors.affiliation: Division of Biostatistics, FDA/CBER/OBE, Rockville, MD 20852, USA. lachenbruch@cber.fda.gov
authors.forename: Peter A
authors.initials: PA
authors.lastname: Lachenbruch
authors.forename: Mary A
authors.initials: MA
authors.lastname: Foulkes
authors.forename: Alan E
authors.initials: AE
authors.lastname: Williams
authors.forename: Jay S
authors.initials: JS
authors.lastname: Epstein
mesh_terms: 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
chemical_list: D001688:Biological Products