Risk analysis of analytical validations by probabilistic modification of FMEA

Publication: Research - peer-reviewJournal article – Annual report year: 2012

  • Author: Barends, D.M.

    National Institute for Public Health and the Environment, RIVM, Centre for Quality of Chemical-Pharmaceutical Products, Netherlands

  • Author: Oldenhof, M.T.

    National Institute for Public Health and the Environment, RIVM, Centre for Quality of Chemical-Pharmaceutical Products, Netherlands

  • Author: Vredenbregt, M.J.

    National Institute for Public Health and the Environment, RIVM, Centre for Quality of Chemical-Pharmaceutical Products, Netherlands

  • Author: Nauta, Maarten

    Division of Microbiology and Risk Assessment, National Food Institute, Technical University of Denmark, Mørkhøj Bygade 19, 2860, Søborg, Denmark

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Risk analysis is a valuable addition to validation of an analytical chemistry process, enabling not only detecting technical risks, but also risks related to human failures. Failure Mode and Effect Analysis (FMEA) can be applied, using a categorical risk scoring of the occurrence, detection and severity of failure modes, and calculating the Risk Priority Number (RPN) to select failure modes for correction. We propose a probabilistic modification of FMEA, replacing the categorical scoring of occurrence and detection by their estimated relative frequency and maintaining the categorical scoring of severity. In an example, the results of traditional FMEA of a Near Infrared (NIR) analytical procedure used for the screening of suspected counterfeited tablets are re-interpretated by this probabilistic modification of FMEA. Using this probabilistic modification of FMEA, the frequency of occurrence of undetected failure mode(s) can be estimated quantitatively, for each individual failure mode, for a set of failure modes, and the full analytical procedure.
Original languageEnglish
JournalJournal of Pharmaceutical and Biomedical Analysis
Publication date2012
Volume64-65
Pages82-86
ISSN0731-7085
DOIs
StatePublished
CitationsWeb of Science® Times Cited: 2

Keywords

  • Analytical validation, FMEA, Human factor, Risk analysis, NIR
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