Potential Failure Mode and Effects Analysis (FMEA) Including Design FMEA, Supplemental FMEA-MSR, and Process FMEA
This FMEA standard describes potential failure mode and effects analysis in design (DFMEA), supplemental FMEA-MSR, and potential failure mode and effects analysis in manufacturing and assembly processes (PFMEA). It assists users in the identification and mitigation of risk by providing appropriate terms, requirements, rating charts, and worksheets. As a standard, this document contains requirements—”must”—and recommendations—”should”—to guide the user through the FMEA process. The FMEA process and documentation must comply with this standard as well as any corporate policy concerning this standard. Documented rationale and agreement with the customer are necessary for deviations in order to justify new work or changed methods during customer or third-party audit reviews.
This standard has been revised to emphasize the process of FMEA selection, creation, documentation, reporting, and change management. New additions include the table of contents, supplemental DFMEA for monitoring and system response (DFMEA-MSR) with rating critiera for frequency and monitoring, and an introduction of the action priority method. The standard includes more information about how information flows from DFMEA to validation planning and PFMEA to control planning. Revisions have been made to the rating criteria for severity, occurrence, and detection for both DFMEA and PFMEA. This standard serves as a common starting point for the development of an effective DFMEA and PFMEA.This document contains content from the AIAG and VDA Handbook, First Edition, 2019.
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