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FMEA. Risk Index. - PowerPoint PPT Presentation
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FMEAFMEAComponentComponent Failure Failure
ModeModeEffect on Effect on SystemSystem
Possible Possible HazardsHazards
Risk IndexRisk Index User User Detection Detection MeansMeans
Applicable Applicable Control(s)Control(s)
NeedleNeedle Breaking offBreaking off Injection Injection failurefailure
Emergency Emergency surgery to surgery to remove remove needle from needle from patient’s patient’s abdomenabdomen
1010 Pain, missing Pain, missing needle tipneedle tip
User User instructions, instructions, stress tests, stress tests, revised revised procedure for procedure for injectioninjection
NeedleNeedle BendingBending Injection Injection failure, failure, possible possible incorrect incorrect dosagedosage
Blood sugar Blood sugar fluctuations fluctuations from incorrect from incorrect insulin insulin dosage, dosage, possible possible complicationscomplications
88 Visual Visual inspection of inspection of needleneedle
User User instructions, instructions, stress tests, stress tests, revised revised procedure for procedure for injectioninjection
PlungerPlunger JammingJamming Injection Injection failure, failure, possible possible incorrect incorrect dosagedosage
Insulin under Insulin under dose, coma, dose, coma, deathdeath
88 Visual Visual inspection of inspection of plungerplunger
New design New design (possibly (possibly ejection ejection sensor)sensor)
Risk IndexRisk IndexProbability of OccurrenceProbability of Occurrence Severity I: Severity I:
CatastrophicCatastrophic
(Death, serious injury)(Death, serious injury)
Severity II: Severity II:
SignificantSignificant
(Reversible serious (Reversible serious injury)injury)
Severity III:Severity III:
MarginalMarginal
(Inconvenience)(Inconvenience)
Severity IV:Severity IV:
NegligibleNegligible
FrequentFrequent 11 33 77 1313
ProbableProbable 22 55 99 1616
OccasionalOccasional 44 66 1111 1818
RemoteRemote 88 1010 1414 1919
ImprobableImprobable 1212 1515 1717 2020
Risk Index TableRisk Index Table
Hazard Risk IndexHazard Risk Index Acceptance CriteriaAcceptance Criteria
1-71-7 Intolerable: Must never arise or result in an Intolerable: Must never arise or result in an accidentaccident
8-158-15 As low as reasonably practical (ALARP): Must As low as reasonably practical (ALARP): Must minimize possibility of hazard given cost and minimize possibility of hazard given cost and schedule constraintsschedule constraints
17-2017-20 Acceptable: Consequences of hazard are Acceptable: Consequences of hazard are acceptable and no extra cost should be acceptable and no extra cost should be incurred to reduce hazard probabilityincurred to reduce hazard probability
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