How to define Risk Acceptance Criteria?

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Is risk acceptance derived from risk quantification? (severity-occurrence-detectability); if it is so, then the acceptance criteria is pretty much pre-determined!

If it is not so, (i.e., risk acceptance defined specific to each product/process) then what is the relevance of risk-quantification tables?

Need certain guidance in way forward.

ref...
http://www.ghtf.org/documents/sg3/sg3n15r82005.pdf
Implementation of risk management principles and activities within a Quality Management System
 

sagai

Quite Involved in Discussions
Re: How to define the criteria of risk acceptance?

Hi,
risk acceptance depends on its definition in the Manufacturer's risk acceptance policy.
What is it mean?
For product risk evaluation, there is a Manufacturer dependent interpretation what the manufacturer considers as acceptable risk region in the evaluation matrix, the rational for it documented in the above mentioned policy.
Is it correct?
From patient safety prospective, far not, there shall be more exact definition as recently also required by the EU.
br
Sz.
 
E

Elizabeth Rafferty

My understanding of acceptable risk is that it is dependent upon the product. For example, chemotherapy has a high risk of causing damage to a patient, but the benefit potentially outweighs that risk.
 

sagai

Quite Involved in Discussions
That one come from the principle, which says when your residual risk still above the risk acceptability level and there is no way for further mitigation, than you can create a risk benefit analysis, which basically says the medical benefit of the acceptance of that risk outweights the risk on patient safety.
yes, it can depend on product, but I would say product classification.,
br
Sz.
 
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