Failure Mode and Effect Analysis

(FMEA)

What is Failure Mode and Effect Analysis (FMEA)?

FMEA is a quality audit procedure which aims to anticipate failures in a products functional design. Failure may be the result of a design, manufacturing process, or use or the malfunctions of a product or service.
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FMEA
The aim of FMEA is to anticipate in advance: What might fail What effect this failure would have on the overall function, & What might cause the failure
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FMEA

The significance of the failure is assessed against:

The probability of failure occurrence An assessment of the severity and the effect of that failure The probability of existing quality systems spotting the failure before it occurs
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Where Does FMEA Occur in the product life cycle?

Planning Concept Development SystemLevel Design Detail Design Testing and Refinement Production Ramp-Up

Concept FMEA

Design FMEA

Process FMEA

Design Project FMEA

Design FMEAs should cover: all new components carried over components in a new environment any modified components Mandatory on all control and load carrying parts
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Design Project FMEA

Failure - a component or system not meeting or not functioning to the design intent Design intent - may be stated in terms of MTBF, load or deflection, coat thickness, finish quality, etc. Failure need not be readily detectable by a customer
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FMEA Process

Identify a failure mode Determine the possible effects or consequences of the failure Assess the potential severity of the effect Identify the cause of failure (to take action!) Estimate the probability of occurrence Assess the likelihood of detecting the failure

Failure Mode

Failure mode - the manner in which a component or a system, where the failure occurs (doesnt meet design intent) Potential failure modes Complete failure Partial failure Intermittent failure Failure over time Over-performance failure
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Failure Mode

Question to be asked: How could the

component or system fail?

Examples: Consider failure modes of a penlights function that is defined as Provide light at 3 0.5 candela.
No light Dim light Erratic blinking light Gradual dimming light Too bright

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Failure Mode - Identification

List potential failure modes for the particular part or function

assume the failure could occur, however unlikely

Sketch free-body diagrams (if applicable), showing applied/reaction loads. Indicate location of failure under this condition. List conceivable potential causes of failure for each failure mode

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Failure Mode Effects

For each failure mode, identify the potential downstream consequences of each failure mode (the Effects) Procedure for Potential Consequences
Beginning with a failure mode (FM-1) list all its potential consequences Separate the consequences that can result when FM-1 occurs: Effects of FM-1 Write additional failure modes for remaining, depending on circumstances

Add these to list of failure modes

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Failure Mode Effects

Team brainstorms failure modes and effects Example: Analyzing penlight bulb
Premature burnout user could trip, fall, be injured While used in eye examination, bulb might explode, resulting in injury
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Failure Severity

To analyze risk, one must first quantify the Severity of the Effects Assume that all Effects will result if the Failure Mode occurs Most serious Effect takes precedence when evaluating risk potential Design and process changes can reduce severity ratings

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DFMEA Severity Table

Severity of Failure Hazardous No warning: Unsafe operation, without warning Very high: Product inoperable; loss of primary function High: Product operable, but at a reduced level Low: Product operable; comfort or convenience items at reduced level Minor: Fit/finish, squeak/rattle dont conform; average customer notices No effect Rank 10 8, 9 6, 7 4, 5 2, 3 1

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Failure Mode Causes

After the Effects and Severity are addressed, the Causes of Failure Modes must be identified In Design FMEA (DFMEA), design deficiencies that result in a Failure Mode are Causes of failure
Assumes manufacturing and assembly specifications are met

Process FMEA (PFMEA) has similar investigation Causes are rated in terms of Occurrence
Likelihood that a given Cause will occur AND 16 result in the Failure Mode

Failure Mode - Occurrence

Estimate the probability of occurrence on a scale of 1 -10 (consider any failsafe controls intended to prevent cause of failure) Consider the following two probabilities:
probability the potential cause of failure will occur probability that once the cause of failure occurs, it will result in the indicated failure mode
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Failure Occurrence Ranking

Occurrence Criteria Ranking

Remote: unreasonable to expect failure (1) Low: similar designs have low failure rates (2,3) Moderate: similar designs have occasional moderate failure rates (4, 5, 6) High: similar designs have failed in the past (7,8,9) Very high: almost certain failure, in major way (10)
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Example DFMEA Occurrence Table

Probability of Failure Very High: Failure almost inevitable High: Repeated failures Failure Rates > 1 in 2 1 in 3 1 in 8 1 in 20 Moderate: Occasional failures 1 in 80 1 in 400 1 in 2000 Low: Relatively few failures 1 in 15,000 1 in 150,000 Rank 10 9 8 7 6 5 4 3 2

Remote: Failure unlikely

< 1 in 1,500,000

Current Controls

Design controls grouped according to purpose

Type 1: Controls prevent Cause or Failure Mode from occurring, or reduce rate of occurrence Type 2: Controls detect Cause of Failure Mode and lead to corrective action Type 3: Controls detect Failure Mode before product reaches customer
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Detection

Detection values are associated with Current Controls Detection is a measure of Type 2 Controls to detect Causes of Failure, or ability of Type 3 Controls to detect subsequent Failure Modes High values indicate a Lack of Detection Value of 1 does not imply 100% detection
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DFMEA Detection Table

Detection Criteria: Likelihood of Detection Rank

Absolute Uncertainty
Very Remote Remote

Design Control does not detect, or there is no Design Control

Very remote chance Control will detect Remote chance Control will detect

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9 8

Very Low
Low Moderate High Very High Almost Certain

Very low chance Control will detect

Low chance Control will detect Moderate chance Control will detect High chance Control will detect Very high chance Control will detect Control almost certain to detect

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6 5 4 3 2 1

Moderately High Mod. High chance Control will detect

Reducing Risk

The fundamental purpose of the FMEA is to recommend and take actions that reduce risk Adding validation or verification can reduce Detection scoring Design revision may result in lower Severity and Occurrence ratings Revised ratings should be documented with originals in Design History File
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Design Project FMEA Results

Risk Priority Number (RPN)

RPN = Severity x Occurrence x Detection Mathematical product of the seriousness of a group of Effects (Severity), the likelihood that a Cause will create the failure associated with the Effects (Occurrence), and an ability to detect the failure before it gets to the customer (Detection) Note: S, O, and D are not equally weighted in terms of risk, and individual scales are not linear
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Non-Intuitive Statistical Properties of the RPN Scale

Incorrect Assumption
The average of all RPN values is roughly 500 Roughly 50% of RPN values are above 500 (median is near 500) There are 1000 possible RPN values

Actual Statistical Data

The average RPN value is 166 6% of all RPN values are above 500 (median is 105) There are 120 unique RPN values
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Criticality

Criticality = Severity x Occurrence

High Severity values, coupled with high Occurrence values merit special attention Although neither RPN nor Criticality are perfect measures, they are widely used for risk assessment
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Interpreting the RPN

No physical meaning to RPN Used to bucket problems Dont spend a lot of time worrying about what a measure of 42 means Rank order according to RPN Note that two failure modes may have the same RPN for far different reasons: S=10, O=1, D=2: RPN = 20 S=1, O=5, D=4: RPN = 20
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Actions

Actions taken are the important part of FMEA Change design to reduce
Severity (redundancy?) Occurrence (change in design, or processes) Detection (improve ability to identify the problem before it becomes critical)

Assign responsibility for action Follow up and assess result with new RPN

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FMEA

Benefits Systematic way to manage risk Comprehensive Prioritizes

Problems Based on qualitative assessment Unwieldy Hard to trace through levels Not always followed up
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FMEA Levels

CFMEA 1 (Concept)
Failures in the concept (inability to achieve performance) Detection

DFMEA 2 (Design)
Failures in current design (performance) Detection

Highlighting failures during the detail design phase

Ability to find the failures (i.e., use of historical data, early models, etc.)

PFMEA 3 (Process)
Failures in production process Detection

Finding the errors in the production line

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Relationships (CFMEA, DFMEA, PFMEA)

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FMEA

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FMEA

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END

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