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The analysis for DRBFM is modeled after a linkage between a good design review and FMEA. A comprehensive, well-done FMEA can be considered one of the inputs (plus many other preparations sheets defined in the methodology) to decide the scope of a DRBFM but an FMEA is not required since the focus is based on the changes and interfaces.
With direct failure mode category assignment during the FMEDA, a new FMEDA was required for each new application or each variation in usage. Under the functional failure mode approach, the actual functional failure modes of the product are identified during a DFMEA.
A FMEA is used to structure mitigation for risk reduction based on either failure mode or effect severity reduction, or based on lowering the probability of failure or both. The FMEA is in principle a full inductive (forward logic) analysis, however the failure probability can only be estimated or reduced by understanding the failure mechanism.
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Companies that use DRBFM do not view DRBFM the same as DFMEA. — Preceding unsigned comment added by 2601:4:1B00:1B7:8CC2:B512:58F4:1DF6 14:28, 7 March 2014 (UTC) Both, DFMEA and DRBFM are tools for risk analysis. Nevertheless, they are individual methods on their own, that only have a few overlappings in the approach.
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FTA analysis requires diagramming software. FMEA analysis can be done using a spreadsheet program. There are also integrated medical device risk management solutions. Through a draft guidance, the FDA has introduced another method named "Safety Assurance Case" for medical device safety assurance analysis. The safety assurance case is structured ...