* AIAG has released a 5th Edition FMEA Handbook with significant updates to these templates *
* These updates will be a part of 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.
|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.|