Hazard Probability of Occurrence Definition

#11
Hi Nash,

Looking at your original document with the definitions and risk matrix, I would suggest that it may help to add another level to your present 2 for acceptability.

So, at the moment you have a choice between acceptable and not acceptable. I would add an in-between level; something like "Undesirable - Risk is acceptable only if it cannot be reduced by controls which do not reduce the clinical usefulness of the device"

This level (amber?) could occupy the diagonal line of your matrix from P5/A1 to P1/A5.
 
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#12
I must confess that in my initial document the probability definition were missed two zeros, and we agree the assessor is right. based on the definition we mean to say that 1 out of 1000,000 is acceptable. The definition column error we have carried forwarded from risk management OP guideline matrix , when we checked the definition we were ignorant to check our maths skills.:bonk:

Now we have removed the definition column and kept the probability ref with reference to ISO 14971.

Thanks guys all your comments.
 

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