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 |