Hi
From time to time I encounter having very high severity ratings in both DFMEA and PFMEA (9-10), which of course needs to be mitigated as much as entirely possible, but how to determine when enough is enough in a low volume business where safety is of absolute highest focus.
According to our internal special characteristic procedure, mitigation and Special characteristic classification is required sev.>8 and occurrence > 1 (completely error-proofed), so whatever we do, it will never be enough if the risk cannot be entirely removed.
How do any of you handle this ?
For these high severity risks, do you distinguish between how to mitigated based on occurrence (e.g. occ.=2 --> communicate risk, occ.>3 --> design/process change) ?
Thanks.
From time to time I encounter having very high severity ratings in both DFMEA and PFMEA (9-10), which of course needs to be mitigated as much as entirely possible, but how to determine when enough is enough in a low volume business where safety is of absolute highest focus.
According to our internal special characteristic procedure, mitigation and Special characteristic classification is required sev.>8 and occurrence > 1 (completely error-proofed), so whatever we do, it will never be enough if the risk cannot be entirely removed.
How do any of you handle this ?
For these high severity risks, do you distinguish between how to mitigated based on occurrence (e.g. occ.=2 --> communicate risk, occ.>3 --> design/process change) ?
Thanks.