MrTetris
Involved In Discussions
Hello,
I tried to read the faq and first two pages, but I could not find an answer to a probably basic question about the Risk Register.
My company is a manufacturer of imaging SaMD, used to prepare surgical plans.
One of the hazards considered in our Risk Register is the possibility for the clinician to overestimate the precision of our computer guided treatment system, thinking that if the plan is safe he cannot damage the patient. Hazardous situation: the clinician touches with his instruments a nerve of the patient (hazardous situation). The problem here is that two different harms are possible (or the same harm, with different severity): paralyzed muscle (severity: 4) or muscle temporary weakness/tingling (severity: 3).
Case 1:
p1 (probability of occurrence of hazardous situation) = 2
p2 (probability of hazardous situation leading to harm - paralyzed muscle) = 2
SE (severity of harm - paralyzed muscle) = 4
Case 2:
p1 (probability of occurrence of hazardous situation) = 2 (the same as case 1)
p2 (probability of hazardous situation leading to harm - muscle temporary weakness/tingling) = 3
SE (severity of harm - muscle temporary weakness/tingling) = 3
Same hazardous situation, but different probability for consequent possible harms.
Should we include both cases in the Risk Register, or only the second one with the highest severity harm?
I am also thinking about even more extreme cases (for instance, a hospital gas patient-delivery equipment, where the probability p2 decreases with the severity of the caused harm - headache p2=4, loss of balance p2=3, coma p2=2, death p2=1)... how to deal with this kind of situation?
I tried to read the faq and first two pages, but I could not find an answer to a probably basic question about the Risk Register.
My company is a manufacturer of imaging SaMD, used to prepare surgical plans.
One of the hazards considered in our Risk Register is the possibility for the clinician to overestimate the precision of our computer guided treatment system, thinking that if the plan is safe he cannot damage the patient. Hazardous situation: the clinician touches with his instruments a nerve of the patient (hazardous situation). The problem here is that two different harms are possible (or the same harm, with different severity): paralyzed muscle (severity: 4) or muscle temporary weakness/tingling (severity: 3).
Case 1:
p1 (probability of occurrence of hazardous situation) = 2
p2 (probability of hazardous situation leading to harm - paralyzed muscle) = 2
SE (severity of harm - paralyzed muscle) = 4
Case 2:
p1 (probability of occurrence of hazardous situation) = 2 (the same as case 1)
p2 (probability of hazardous situation leading to harm - muscle temporary weakness/tingling) = 3
SE (severity of harm - muscle temporary weakness/tingling) = 3
Same hazardous situation, but different probability for consequent possible harms.
Should we include both cases in the Risk Register, or only the second one with the highest severity harm?
I am also thinking about even more extreme cases (for instance, a hospital gas patient-delivery equipment, where the probability p2 decreases with the severity of the caused harm - headache p2=4, loss of balance p2=3, coma p2=2, death p2=1)... how to deal with this kind of situation?