Failure mode and effects analysis (FMEA)
Failure mode and effects analysis (FMEA) is a systematic method for identifying how a design or process can fail, scoring each failure mode for severity, occurrence, and detection, and working the highest risks first. A design FMEA (DFMEA) asks how the product can fail in use; a process FMEA (PFMEA) asks how manufacturing can produce a bad part. The output is a ranked worklist, not a report.
Examples
PFMEA line item: A stamping operation lists the failure mode "burr exceeds 0.1 mm" with severity 6, occurrence 4, detection 5: RPN 120. Adding an inline vision check drops detection to 2 and RPN to 48; the fixture change that would cut occurrence is queued for the next tool revision.
Severity overrides the math: A connector's DFMEA scores a retention failure severity 9 because the device loses function in the field. Even with low occurrence, the team designs in a positive lock rather than relying on assembly inspection.
Pre-award review: A buyer requests the PFMEA for a machined housing. The document covers 12 of 30 routing steps and was last revised three years ago, which tells the sourcing team more about the supplier's quality system than the audit slide deck did.
Definition
Each failure mode gets rated 1 to 10 on three scales: severity of the effect, likelihood of occurrence, and likelihood the current controls detect it before it escapes. Multiplying them gives a risk priority number (RPN); the newer AIAG-VDA handbook replaces raw RPN with action priority tables, partly because teams gamed RPN by inflating detection scores. Either way the discipline is the same: list the ways it can fail, rank them, act on the top.
The DFMEA versus PFMEA split matters. A DFMEA drives design for manufacturability decisions while geometry is still cheap to change. A PFMEA examines a specific process at a specific plant, which is why a generic PFMEA copied across sites is a red flag. Both are core deliverables inside APQP, written during development and updated whenever the design or process changes.
For procurement, a supplier's PFMEA is a window into process maturity. Ask for it before award: does it cover every operation, do high-severity items (9 and 10) get design-side action regardless of RPN, and has it been revised after past escapes and root cause investigations? An FMEA written once to pass a quality assurance audit and never touched again predicts exactly nothing.
Previous
Next
*GARTNER is a registered trademark and service mark of Gartner, Inc. and/or its affiliates in the U.S. and internationally, and COOL VENDORS is a registered trademark of Gartner, Inc. and/or its affiliates and are used herein with permission. All rights reserved. Gartner does not endorse any vendor, product or service depicted in its research publications, and does not advise technology users to select only those vendors with the highest ratings or other designation. Gartner research publications consist of the opinions of Gartner’s research organization and should not be construed as statements of fact. Gartner disclaims all warranties, expressed or implied, with respect to this research, including any warranties of merchantability or fitness for a particular purpose.