M
All,
I have been looking deeper into ISO14971 and other risk analysis/management techniques. Everywhere I look, the recommendation is to 1) analyse the risk (hazards leading to harm), 2) evaluate the risk (acceptable or not), and 3) control the risk if not acceptable, in that specific order. I understand the logic of this sequence but it doesn?t make practical sense.
As I fill out my risk chart and contemplate harms, with very rare exception, I am always able to find ways of controlling the risk to either minimize the occurrence or the severity. It makes more sense to me, after analyzing the risk, to directly propose a risk control method and THEN evaluate the risk (severity/occurrence). If a control method is absolutely not available at all for whatever reason then the risk is evaluated with this knowledge directly.
Stated another way, I would be surprised to read a risk analysis document for a medical device (of any practical use) and see the majority of uncontrolled risks being deemed as acceptable.
From what I see right now, to follow 14971, one has to always rate risk twice: once before a control and again after. What?s the point of that? I hope that there are forum members that can explain why it ended up the way that it is.
Thanks!
I have been looking deeper into ISO14971 and other risk analysis/management techniques. Everywhere I look, the recommendation is to 1) analyse the risk (hazards leading to harm), 2) evaluate the risk (acceptable or not), and 3) control the risk if not acceptable, in that specific order. I understand the logic of this sequence but it doesn?t make practical sense.
As I fill out my risk chart and contemplate harms, with very rare exception, I am always able to find ways of controlling the risk to either minimize the occurrence or the severity. It makes more sense to me, after analyzing the risk, to directly propose a risk control method and THEN evaluate the risk (severity/occurrence). If a control method is absolutely not available at all for whatever reason then the risk is evaluated with this knowledge directly.
Stated another way, I would be surprised to read a risk analysis document for a medical device (of any practical use) and see the majority of uncontrolled risks being deemed as acceptable.
From what I see right now, to follow 14971, one has to always rate risk twice: once before a control and again after. What?s the point of that? I hope that there are forum members that can explain why it ended up the way that it is.
Thanks!
