The Cove Business Standards Discussion Forums
Monitor the Elsmar Forum
Courtesy Quick Links

Links Elsmar Cove visitors will find useful in the quest for knowledge and support:

Jennifer Kirley's
Conway Business Services

International Quality Services

Marcelo Antunes'
SQR Consulting, and
Medical Devices Expert Forum

Bob Doering
Bob Doering's Blogs and,
Correct SPC - Precision Machining

Ajit Basrur
Claritas Consulting, LLC

International Standards Bodies - World Wide Standards Bodies

AIAG - Automotive Industry Action Group

ASQ - American Society for Quality

International Organization for Standardization - ISO Standards and Information

NIST's Engineering Statistics Handbook

IRCA - International Register of Certified Auditors

SAE - Society of Automotive Engineers

Quality Digest

IEST - Institute of Environmental Sciences and Technology

Single Post View
Old 24th May 2011, 08:16 AM

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.
Thank You to for your informative Post and/or Attachment!

Sponsored Links

The time now is 04:40 AM. All times are GMT -4.
Your time zone can be changed in your UserCP --> Options.

Misc. Internal Links

NOTE: This forum uses "Cookies"