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Old 24th May 2011, 08:16 AM
df_df

 
 
Total Posts: n/a
Re: Risk Management Portal - Beyond ISO 14971 - Incorporate $$ into the risk assessme

We have taken $$ into account in our process FMEAs. We use an RPN system with a 1-10 scale and have assigned all "injury" a severity 9 (minor injury) or 10 (major injury/death). Lower severities generally involve money - either scrap, rework, lost productivity, etc. For these we generally assign higher severities to harms that will cost the firm more $$ and lower severities that will cost the firm less to fix/remedy. We also have a 2-tiered mitigation requirement. For severities of 9 or 10 we mandate risk mitigation for RPNs above a certain threshold. For lower severities (i.e. lost $$) it is up to the team to decide whether to implement mitigations and what is ALARP.

In contrast, our Design FMEA and System Hazard Analysis only have severities based on harms to the patient/user/environment and do not have severities based on any monetary losses to the company.
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