FMEA

1
FMEA
Component Failure Mode Effect on System Possible Hazards Risk Index User Detection Means Applicable Control(s)
Needle Breaking off Injection failure Emergency surgery to remove needle from patients abdomen 10 Pain, missing needle tip User instructions, stress tests, revised procedure for injection
Needle Bending Injection failure, possible incorrect dosage Blood sugar fluctuations from incorrect insulin dosage, possible complications 8 Visual inspection of needle User instructions, stress tests, revised procedure for injection
Plunger Jamming Injection failure, possible incorrect dosage Insulin under dose, coma, death 8 Visual inspection of plunger New design (possibly ejection sensor)
2
Risk Index
Probability of Occurrence Severity I Catastrophic (Death, serious injury) Severity II Significant (Reversible serious injury) Severity III Marginal (Inconvenience) Severity IV Negligible
Frequent 1 3 7 13
Probable 2 5 9 16
Occasional 4 6 11 18
Remote 8 10 14 19
Improbable 12 15 17 20
Risk Index Table Risk Index Table
Hazard Risk Index Acceptance Criteria
1-7 Intolerable Must never arise or result in an accident
8-15 As low as reasonably practical (ALARP) Must minimize possibility of hazard given cost and schedule constraints
17-20 Acceptable Consequences of hazard are acceptable and no extra cost should be incurred to reduce hazard probability