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Hello,
I would like to get some help in understanding if it is true that the new version of ISO 14971 does not allow the concept of ALARP.
Our current SOP for Risk Management refers to ISO 14971:2007 (EN ISO 14971:2012).
Our acceptability matrix has the concept of ALARP. Do we need to change it? Should the acceptability matrix (sevXprob) only have Acceptable and Not-Acceptable ranges?
We assume that if a hazard gets into the ALARP zone after mitigation and there is nothing we can do to change it (imagine the case of Catastrophic X Improbable and we are already in the lowest possible probability) we leave it in the ALARP and we add a rationale to it. Is this acceptable?
For what concerns the P2 (probability of a hazard to cause a harm), is it correct to assume that this probability is independent of the device? Could you please provide an example to help me understand better this concept?
I thought of this example (not sure if it is clear though):
device - infusion pump
hazard - wrong infusion rate
severity outcome - death
P1 - (probability the wrong infusion rate of occurring) to be determined by design (it may depend on what originates the wrong infusion rate)
P2 (the probability of wrong infusion rate to cause a death) - probable
To arrive at this value I should assume that a wrong infusion rate (independently of how it is administered) causes a death, correct?
Thank you in advance for your help!
Emilia
I would like to get some help in understanding if it is true that the new version of ISO 14971 does not allow the concept of ALARP.
Our current SOP for Risk Management refers to ISO 14971:2007 (EN ISO 14971:2012).
Our acceptability matrix has the concept of ALARP. Do we need to change it? Should the acceptability matrix (sevXprob) only have Acceptable and Not-Acceptable ranges?
We assume that if a hazard gets into the ALARP zone after mitigation and there is nothing we can do to change it (imagine the case of Catastrophic X Improbable and we are already in the lowest possible probability) we leave it in the ALARP and we add a rationale to it. Is this acceptable?
For what concerns the P2 (probability of a hazard to cause a harm), is it correct to assume that this probability is independent of the device? Could you please provide an example to help me understand better this concept?
I thought of this example (not sure if it is clear though):
device - infusion pump
hazard - wrong infusion rate
severity outcome - death
P1 - (probability the wrong infusion rate of occurring) to be determined by design (it may depend on what originates the wrong infusion rate)
P2 (the probability of wrong infusion rate to cause a death) - probable
To arrive at this value I should assume that a wrong infusion rate (independently of how it is administered) causes a death, correct?
Thank you in advance for your help!
Emilia