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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.
It was released in 1999 by International Organization for Standardization based on ISO 9001, and the first edition was published in June 1999 as ISO/TS 16949:1999. [1] IATF 16949:2016 replaced ISO/TS 16949 in October 2016 by International Automotive Task Force .
FMEA is a bottom-up, inductive analytical method which may be performed at either the functional or piece-part level. FMECA extends FMEA by including a criticality analysis, which is used to chart the probability of failure modes against the severity of their consequences. The result highlights failure modes with relatively high probability and ...
Created Date: 8/30/2012 4:52:52 PM
The SSA includes quantitative FMEA, which is summarized into FMES. Normally FMES probabilities are used in quantitative FTA to demonstrate that the hazard probability limits are in fact met. Cutset analysis of the fault trees demonstrates that no single failure condition will result in a hazardous or catastrophic event.
As more data becomes available, the component database can be refined and updated. After a few years of research and refinement, [17] the database has been published [18] as required by new technology and new knowledge. The success of the FMEDA technique is supplying needed data in a relatively accurate way has allowed the probabilistic ...
(1st Edition, ISBN 978-0-9807660-0-4, in A4 paperback, 150 pages). D.Smith, K Simpson, "Safety Critical Systems Handbook: A Straightforward Guide to Functional Safety, IEC 61508 (2010 Edition) And Related Standards, Including Process IEC 61511 and Machinery IEC 62061 and ISO 13849" (3rd Edition ISBN 978-0-08-096781-3, Hardcover, 288 Pages).
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.