Quality Systems

The FMEA Guide

How to Run Process and Design Failure Mode and Effects Analysis in Manufacturing

Cover of The FMEA Guide

The methodology behind an FMEA program that produces real risk reduction, not a binder that sits on a shelf. Covers PFMEA and DFMEA mechanics, the cross-functional team composition, the rating-scale discipline that survives team turnover, the AIAG-VDA action-priority transition, the action-execution loop, and the FMEA-living-document principle that keeps the analysis current. Walks the failure modes that kill FMEA programs: scoring inflation, single-author worksheets that the team did not actually agree to, actions that are not assigned with target dates, RPN-driven prioritization without strategic judgment. Framed for ISO 9001, ISO 13485, FDA 21 CFR 820, and AIAG-VDA environments. Written for quality managers, manufacturing engineers, and design engineers. Pairs with the FMEA Risk Analysis Workbook by Wade Prescott.

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The methodology behind an FMEA program that produces real risk reduction, not a binder that sits on a shelf. Covers PFMEA and DFMEA mechanics, the cross-functional team composition, the rating-scale discipline that survives team turnover, the AIAG-VDA action-priority transition, the action-execution loop, and the FMEA-living-document principle that keeps the analysis current.

Walks the failure modes that kill FMEA programs: scoring inflation, single-author worksheets that the team did not actually agree to, actions that are not assigned with target dates, RPN-driven prioritization without strategic judgment.

Framed for ISO 9001, ISO 13485, FDA 21 CFR 820, and AIAG-VDA environments. Written for quality managers, manufacturing engineers, and design engineers. Pairs with the FMEA Risk Analysis Workbook by Wade Prescott.