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Failure Mode & Effect Analysis

Learning Bites

• Understand the concept of FMEA

• Identify the terminologies of FMEA

• Determine steps in measuring and analyzing the potential failure modes

• Define steps in measuring the critical points of failure.

• Deploy the concept in your workplace to reduce the potential failures.

• FMEA stands for Failure Mode & Effect Analysis.

• An Advanced Quality Planning Tool used to evaluate Potential Failure Modes andtheir Causes.

• Prioritizes potential failures according to their risk and drives action to eliminate orreduce their likelihood of occurrence

• Provides a disciplined methodology for documenting this analysis for future use andcontinuous process improvement

• By itself, an FMEA is NOT a problem solver. It is used in combination with otherproblem solving tools.

What is FMEA

QualityBusinessObjectives

QualityBusinessObjectives

ProblemPrevention

ProblemSolving

SpecialCharacteristics

SpecialCharacteristics

ControlPlan

ControlPlan

SPCToolsSPCTools

8 - D8 - D

Q O SQ O S

ProcessImprovement

ProcessImprovement

D O ED O E

F M E AF M E A

A P Q PA P Q P

F T AR F T AF T A

R F T A

Q F DQ F D

Role of FMEA in Quality System

Design & Process FMEA

FMEA

Design FMEA

Process FMEA

Involves study of product

Involves study of processes

DFMEA is an analytical technique utilized primarily to ensurepotential failure modes and their associated causes areidentified, considered, and addressed in the design phase.

PFMEA is an analytical technique utilized primarily forcontinuous analysis of potential failure modes and theirassociated causes during the processes.

• CAUSE - cause of a failure mode is a deficiency that results in a failure mode. It isdescription of how the process could result in a failure.

• SEVERITY - is an assessment of the seriousness of the effect of the potential failuremode to the customer. Severity applies to the effect only.

• OCCURRENCE - the number of times the cause has resulted in the failure modebefore any additional process control are applied.

• DETECTION - is rating corresponding to the likelihood that current process will detectthe failure mode before it gets to the customer.

• RPN (Risk Priority Number) - is a measure of process risk and should be used to rankorder the risks/concerns.

RPN = SEVERITY x OCCURRENCE x DETECTION

Important Terms in FMEA

POTENTIAL FAILURE MODE

EFFECT

CAUSE

CURRENT CONTROLS

DETERMINE OCCURRENCE

DETERMINE SEVERITY

DETERMINE DETECTABILITY

ACTIONS LEADING TOCONTINUOUS IMPROVEMENT

DETERMINE RPN

FMEA Roadmap

SEVERITY

OCCURRENCE

DETECTION

Changing design(material,geometry, etc)

Changing designor process

Adding/improvingcontrols/methods

Eliminatingfailuremode

Preventing orreducingoccurrences ofoneor more causes

Improvingabilityto detect thefailure mode

FMEA Priority Actions

FMEA Process Steps

Step 8: Develop Action Plan

Step 7: Calculate RPNs

Step 6: Assign Detection Ranking

Step 5: Assign Occurrence Ranking

Step 4: Assign Severity Ranking

Step 3: List Potential Effects ofFailure

Step 2: Brainstorm Potential FailureModes

Step 1: Review the Process

Step 10: Calculate Resulting RPN

Step 9: Take Actions

PEOPLE

METHODS

MACHINERY

ULTIMATECUSTOMER

MATERIALSFAILUREMODE

DOWNSTREAMUSER

NEXTOPERATION

ENVIRONMENT

POTENTIAL EFFECTS

Potential Causes & their Effects

POTENTIAL CAUSES

Standard PFMEA Detection Ranking

Detection Criteria: Likelihood of Detection by Process Control Rank

AlmostImpossible

No known Controls available to detect Failure Mode or Cause 10

Very Remote Very remote likelihood current Controls with detect Failure Mode or Cause 9

Remote Remote likelihood current Controls with detect Failure Mode or Cause 8

Very Low Very low likelihood current Controls with detect Failure Mode or Cause 7

Low Low likelihood current Controls with detect Failure Mode or Cause 6

Moderate Moderate likelihood current Controls with detect Failure Mode or Cause 5

ModeratelyHigh

Moderately high likelihood current Controls with detect Failure Mode or Cause 4

High High likelihood current Controls with detect Failure Mode or Cause 3

Very High Very high likelihood current Controls with detect Failure Mode or Cause 2

Almost CertainCurrent Controls almost certain to Failure Mode or Cause. Reliable detection controls areknown with similar processes.

1

FMEA Worksheet

Summary

• FMEA is created to satisfy a customer or third party requirement, NOT to improvethe process.

• FMEA is developed too late in the process and does not improved theproduct/process development cycle.

• The FMEA is perceived either as too complicated or as taking too much time.

Thank you very much!

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