Example 3: FMEA with detectability
This example adds an additional factor detectability and multiplies the risk factors.
Each risk control is configured to be able to reduce any of the risk factors at the same time.
Code
{ "mitigationTypes": [ { "type": "SPEC", "name": "Specification", "required": "false" } ], "maxGreen": 9, "maxYellow": 18, "method": "*", "factors": [ { "type": "cause", "label": "Cause", "weights": [ { "type": "probability", "label": "Probability", "help": "Probability that event happens.", "values": [ { "shortname": "Improbable", "help": "Unlikely to occur during device lifetime, can be assumed occurrence may not be experienced", "factor": 1 }, { "shortname": "Rare", "help": "Unlikely but possible to occur during device lifetime", "factor": 2 }, { "shortname": "Occasional", "help": "Likely to occur sometime during device lifetime", "factor": 3 }, { "shortname": "Probable", "help": "Will occur several times during device lifetime", "factor": 4 }, { "shortname": "Frequent", "help": "Will occur frequently", "factor": 5 } ] }, { "type": "detectability", "label": "Detectability", "help": "Likelyhood to detect risk.", "values": [ { "shortname": "Low", "help": "A risk that is easy to detect", "factor": 1 }, { "shortname": "Medium", "help": "A risk that can be detected some of the times", "factor": 2 }, { "shortname": "High", "help": "A risk that is very difficult to detect", "factor": 3 } ] } ] }, { "type": "effect", "label": "Effect", "weights": [ { "type": "severity", "label": "Severity", "help": "Severity of effects if event happens.", "values": [ { "shortname": "Negligible", "help": "Inconvenience or temporary discomfort", "factor": 1 }, { "shortname": "Minor", "help": "Results in temporary injury or impairment not requiring professional medical intervention", "factor": 2 }, { "shortname": "Serious", "help": "Results in injury or impairment requiring professional medical intervention", "factor": 3 }, { "shortname": "Critical", "help": "Results in permanent impairment or life-threatening injury ", "factor": 4 }, { "shortname": "Catastrophic", "help": "Results in patient death", "factor": 5 } ] } ] } ], "reductions": [ { "name": "00", "options": [ { "shortname": "no effect", "by": 0 }, { "shortname": "reduces probability by 1", "changes": "probability", "by": -1 }, { "shortname": "reduces probability by 2", "changes": "probability", "by": -2 }, { "shortname": "reduces probability by 3", "changes": "probability", "by": -3 }, { "shortname": "reduces probability by 4", "changes": "probability", "by": -4 } ] }, { "name": "01", "options": [ { "shortname": "no effect", "by": 0 }, { "shortname": "reduces severity by 1", "changes": "severity", "by": -1 }, { "shortname": "reduces severity by 2", "changes": "severity", "by": -2 }, { "shortname": "reduces severity by 3", "changes": "severity", "by": -3 }, { "shortname": "reduces severity by 4", "changes": "severity", "by": -4 } ] }, { "name": "02", "options": [ { "shortname": "no effect", "by": 0 }, { "shortname": "reduces detectability by 1", "changes": "detectability", "by": -1 }, { "shortname": "reduces detectability by 2", "changes": "detectability", "by": -2 } ] } ] }