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Hello
I'm aware that spiraplan/team can document product risks and there's an FMEA app for FMEA style risks.
We would typically use the FMEA as a tool to evaluate the device design (Design FMEA, Software FMEA, etc) and that would tell us how the device itself would fail (i.e. stop functioning, function at 50%, loss of certain features, etc). These 'hazardous situations' which arise due to various component failure modes, are then fed into a linked hazard analysis to evaluate the harm that each haz. situation can lead to.
As far as I can see, spiraplan can only document risks as the product level (FMEA). Is there a way to set things up so that the risk output can be linked to a second risk evaluation (maybe in a different product that is purely a risk assessment), or perhaps the output can be fed into a project level risk evaluation?
Thanks
Hello,
Thanks for your question. The FMEA app is set up for multiple products to perform independent assessment. But you can set up a cross-project association and connect the secondary risk in a different project with the main risks in the repository.
Please check the KB article that can help you with this.
Spiraplan’s FMEA app focuses on product-level risks, but you can link outputs to a separate hazard analysis by creating a dedicated risk assessment product or using project-level risk items with traceability links. This allows layered evaluation across design and harm impact.
And if you have any questions, please email or call us at +1 (202) 558-6885
