Abstract
AbstractBackgroundA hybrid Failure Mode Effect Analysis (FMEA) based on fuzzy logic and multicriteria decision analytics was applied as a post-marketing surveillance tool for troubleshooting potential quality problems of Artemisinin Combination Therapies (ACTs) as a means of aggregating subjective opinions of quality experts in providing vital information for continuous management and improvement of safety and quality standards.Research design and methodsAn FMEA team of five cross-functional quality experts implemented a hybrid fuzzy FMEA model based on Analytical Hierarchy Process (AHP) and Technique for Order of Preference by Similarity to Ideal Solution (TOPSIS) to solve multicriteria decision problems in quality risk analysis of historic quality control data of ACTs.ResultsExpert opinions were captured as triangular fuzzy numbers to represent the linguistic scoring of risk-determining variables for fifteen failure modes. The fuzzy AHP enabled systematic ranking of the variables, while the fuzzy TOPSIS algorithm provided easily understood and configurable computational procedures for ranking the failure modes based on optimal geometric paths to positive and negative ideal solutions.ConclusionsThe quality risk of ACTs could be reliably established using the fuzzy FMEA where aggregated experts’ decisions and risk variables’ weights are of considerable importance to the final ranking of quality failures.
Publisher
Cold Spring Harbor Laboratory
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