کد مقاله کد نشریه سال انتشار مقاله انگلیسی نسخه تمام متن
1222391 1494667 2012 5 صفحه PDF دانلود رایگان
عنوان انگلیسی مقاله ISI
Risk analysis of analytical validations by probabilistic modification of FMEA
موضوعات مرتبط
مهندسی و علوم پایه شیمی شیمی آنالیزی یا شیمی تجزیه
پیش نمایش صفحه اول مقاله
Risk analysis of analytical validations by probabilistic modification of FMEA
چکیده انگلیسی

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.


► FMEA is a valuable addition to analytical validation.
► Traditional FMEA is modified by replacing categorical scores by probabilities.
► Probabilistic modification of FMEA has added values.
► Frequencies of occurrence of undetected failure modes are now quantified.

ناشر
Database: Elsevier - ScienceDirect (ساینس دایرکت)
Journal: Journal of Pharmaceutical and Biomedical Analysis - Volumes 64–65, May–June 2012, Pages 82–86
نویسندگان
, , , ,