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Table 2 Traditional FMEA scale for severity.

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

Effect Criteria: severity of effect Rank
Hazardous Failure is hazardous, and occurs without warning. It suspends operation of the system 10
Serious Failure involves hazardous outcomes and/or noncompliance with government regulations or standards 9
Extreme Product is inoperable with loss of primary function. The system is inoperable 8
Major Product performance is severely affected but functions. The system may not operate 7
Significant Product performance is degraded. Comfort or convince functions may not operate 6
Moderate Moderate effect on product performance. The product requires repair 5
Low Small effect on product performance. The product does not require repair 4
Minor Minor effect on product or system performance 3
Very minor Very minor effect on product or system performance 2
None No effect 1