E
eileenr
Hello everyone,
I am currently producing a risk management procedure following the ISO 14971 standard. I appreciate that the Risk Management Team who will complete the risk table will be trained and experienced, but I also believe that my procedure should be comprehensive enough that anyone ought to be able to pick it up and use it. Therefore I am wondering, I have my probability of occurrence table and the probability of severity table, however, is there some sort of formula that ought to be used to ensure that the probabilities selected are correct versus estimates? So my question is do other people put guidance at the end of their procedures or equations on how to actually determine the probability of hazard, hazardous situation, harm occurring etc?
Thank you in advance for any feedback
Eileen
I am currently producing a risk management procedure following the ISO 14971 standard. I appreciate that the Risk Management Team who will complete the risk table will be trained and experienced, but I also believe that my procedure should be comprehensive enough that anyone ought to be able to pick it up and use it. Therefore I am wondering, I have my probability of occurrence table and the probability of severity table, however, is there some sort of formula that ought to be used to ensure that the probabilities selected are correct versus estimates? So my question is do other people put guidance at the end of their procedures or equations on how to actually determine the probability of hazard, hazardous situation, harm occurring etc?
Thank you in advance for any feedback
Eileen