FMEA Failure Mode and Effects Analysis DFSS

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Preventing Disaster with FMEA

The tool you use to analyze and prevent disasters is the FMEA - Failure Modes and Effects Analysis (a template in the QI Macros). You can use it to analyze a product (car, x-ray, MRI), part (car door), or process (part stamping process or elective surgery). Analyzing a process uses a PFMEA (another template in the QI Macros).

When you've got a product or a process that can affect human life (e.g., radiology or amputation in a hospital), what do you do to prevent a disaster? You want to anticipate all of the ways that the product or process could go wrong and affect your customer. The automobile and airline industries do this routinely to mitigate and prevent potential problems. Let's face it, if it wasn't pretty safe, none of us would drive or fly. (Of course, no one thought that suicidal terrorists would use a plane as a flying bomb, but now that we know better, airlines are reinforcing doors and cockpits, airports are intensifying screening, and so on.)

Here's how to fill out an FMEA template:

1. Identify each Part or Process Step (e.g., preparation for an MRI-magnetic 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. (e.g., MRIs 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.
4. Rank Severity of the Effect (1-10)- from none to "hazardous without warning" (e.g., tire blow out or fire extinguisher to the skull).
5. Evaluate Potential Cause(s) / Mechanism(s) of Failure - List every potential cause and/or failure mechanism: incorrect material, improper maintenance, fatigue, wear, etc.
6. Rank the Possibility of Occurrence (1-10) - remote (6-sigma) to high (3-sigma).
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) from almost certain to 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.

Here is a sample the FMEA excel template from the QI Macros.

Use the FMEA or PFMEA to analyze and mitigate the effects of potential failures before they happen. Can you afford an injury or a death? Probably not. Can you afford the time and money involved in litigation? Probably not. Is it cheaper to use the FMEA and prevent potential problems? No doubt, especially when the consequences are extreme. Are you going to catch everything? No, because some things are outside of our ability to imagine them.

Save yourself time and money by analyzing the potential causes of failure using the FMEA.

The FMEA template is one of over 60 excel templates in the QI Macros for Excel SPC Software.

Only $139 + $8 S&H (U.S.)

© 2007 KnowWare International Inc. (888) 468-1537
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The QI Macros draws line, pie, bar, pareto, box whisker, histogram (Cp, Cpk), scatter and control charts (with stability analysis).

Templates include the Ishikawa diagram, QFD, DOE, FMEA, PPAP, and Gage R&R for MSA. Performs ANOVA, t-test, F-test, and regression analysis.