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Table 6 Failure mode and effect analysis for FDC ART/LUM tablet quality attributes

From: Quality of fixed dose artemether/lumefantrine products in Jimma Zone, Ethiopia

Critical quality attributes Failure mode Failure effects Severity Occurrence Detection RPN
Identity No (intended) active ingredient in the sample or mislabelling (incorrect, inadequate or incomplete identification) Treatment failure, death due to untreated disease, toxicity 10 7 4 280
Assay Under-dose, over-dose Treatment failure, toxicity due to over-dose, drug resistance due to under-dose 8 7 7 392
Uniformity of mass Non-uniform distribution of dose/content within the individual dosage units Sub-optimal therapy for a patient taking the sub-standard dosage unit and drug resistance 5 4 2 40
  1. RPN risk priority number