FMEA Example

* 5th Edition FMEA (AIAG & VDA FMEA 1st Edition) introduced in QI Macros' October 2019 release *

Step by Step Example of How to Complete an FMEA

QI Macros FMEA Excel Template makes this process even easier.


FMEA Example

1. Identify each Part or Process Step Preparation for an MRI - magentic resonance imaging - in a hospital
2. Identify Potential Failure Modes - All of the manners in which the part or process could fail.

Cracked, loosened, deformed, leaking, oxidized, overlooked, etc.

For example, MRI's produce intense magnetic fields. One patient was killed by a flying fire extinguisher pulled off the wall by the MRI.

3. Identify any Potential Effect(s) of Failure - Consequences on other systems, parts, or people.

Noise, unstable, inoperative, impaired, injury, death, etc.

The consequence of a fire extinguisher getting pulled off of the wall is that it could hit someone.

4. Rank Severity of the Effect (1-10)

1 = none or no effect, 10 = "hazardous without warning"

For example: a tire blow out may be rated a 2 while a a fire extinguisher to the skull would be rated a 10.

5. Evaluate Potential Cause(s) / Mechanism(s) of Failure List every potential cause and/or failure mechanism such as Incorrect material, improper maintenance, fatigue, wear, etc.
6. Rank the Possibility of Occurrence (1-10) 1 would be remote while a 10 would be high
7. List Your Current Design Controls. List prevention and detection activities to assure design adequacy and prevent or reduce occurrence.
8. Rank Your Ability to Detect a Failure Using these Controls (1-10) 1 is almost certain to 10 absolute uncertainty.
9. Calculate the risk-priority number (RPN) for each part or step. RPN = severity * occurrence * detection.
10. Design Recommended Improvement Action(s) Design additional actions to reduce severity, occurrence and detection ratings. Severity of 9 or 10 requires special attention.
11. Assign Responsibility & Target Completion Date for implementing designed improvements.  
12. Monitor Actions Taken and effects on RPN.  

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