Failure Modes Effect Analysis

(FMEA)

Enas Khaled
 Learning Objectives
To understand the use of Failure Modes Effect
Analysis (FMEA)
To learn the steps to developing FMEAs
To summarize the different types of FMEAs
To learn how to link the FMEA to other Process
tools

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 What Can Go
Wrong?

What Is A Failure Mode?

A Failure Mode is:
The way in which the component, subassembly, product,
input, or process could fail to perform its intended
function
Failure modes may be the result of upstream
operations or may cause downstream operations to fail
Things that could go wrong

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 Examples

History of FMEA
First used in the 1960’s in the Aerospace industry
during the Apollo missions
In 1974, the Navy developed MIL-STD-1629
regarding the use of FMEA
In the late 1970’s, the automotive industry was
driven by liability costs to use FMEA
Later, the automotive industry saw the advantages
of using this tool to reduce risks related to poor
quality

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 Benefits
Define
Allows us to identify areas of our
process that most impact our customers
Helps us identify how our process is Measure
most likely to fail
Points to process failures that are most Analyze
difficult to detect

Improve

Control

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 FMEA
A structured approach to:
Identifying the ways in which a product or process can
fail
Estimating risk associated with specific causes
Prioritizing the actions that should be taken to reduce
risk
Evaluating design validation plan (design FMEA) or
current control plan (process FMEA)

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 Application Examples
 Manufacturing: A manager is responsible for moving a
manufacturing operation to a new facility. He/she wants to
be sure the move goes as smoothly as possible and that
there are no surprises.
 Design: A design engineer wants to think of all the possible
ways a product being designed could fail so that robustness
can be built into the product.
 Software: A software engineer wants to think of possible
problems a software product could fail when scaled up to
large databases. This is a core issue for the Internet.

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 FMEA
Why
 Methodology that facilitates process improvement
 Identifies and eliminates concerns early in the
development of a process or design
 Improve internal and external customer satisfaction
 Focuses on prevention
 FMEA may be a customer requirement
 FMEA may be required by an applicable
Quality Management System Standard (possibly ISO)

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 When to Conduct an FMEA
Early in the process improvement investigation

When new systems, products, and processes are being

designed
When existing designs or processes are being changed

When carry-over designs are used in new applications

After system, product, or process functions are

defined, but before specific hardware is selected or
released to manufacturing

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 A Closer Look

The FMEA Form

Identify failure modes Identify causes of the Prioritize Determine and

and their effects failure modes assess actions
10 and controls
Process Potential Potential S O D R Action
Potential Current Section
Step/ Failure Failure E C E P
Causes Controls
Input Mode Effects V C T N 
What is the 0 0
How can 0 0

Effect on the this be If risk is

Outputs?
0 0
found?
0 0 too high,
What can what can
go wrong 0
What are 0 0 0
be done?
with the the
0 0 0 0
Process Potential
Step? 0 Causes? 0 0 0

What is
the How How often is the How well can Estimated
Process serious is cause likely to we detect a risk is “Sev”
Step such an occur and result cause before it x “Occ” x
Effect? in a Failure creates a “Det”
Mode? Failure Mode
and Effect?
 Specialized
Uses

Types of FMEAs
Design
Analyzes product design before release to
production, with a focus on product function
Analyzes systems and subsystems in early concept
and design stages
Process
Used to analyze manufacturing and assembly
processes after they are implemented

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 Team Input
Required

FMEA: A Team Tool

A team approach is necessary.
Team should be led by the Process Owner who is the
responsible manufacturing engineer or technical
person, or other similar individual familiar with
FMEA.
The following should be considered for team
members:
– Design Engineers – Operators
– Process Engineers – Reliability
– Materials Suppliers – Suppliers
– Customers
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 Process Steps

FMEA Procedure
1. For each process input (start with high value inputs),
determine the ways in which the input can go wrong
(failure mode)
2. For each failure mode, determine effects
 Select a severity level for each effect

3. Identify potential causes of each failure mode

 Select an occurrence level for each cause

4. List current controls for each cause

 Select a detection level for each cause

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 Process Steps

FMEA Procedure (Cont.)

5. Calculate the Risk Priority Number (RPN)
6. Develop recommended actions, assign responsible
persons, and take actions
 Give priority to high RPNs
 MUST look at severities rated a 10

7. Assign the predicted severity, occurrence, and detection

levels and compare RPNs

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 Information
Flow

FMEA Inputs and Outputs

Inputs Outputs
C&E Matrix List of actions to
Process Map prevent causes or
Process History detect failure
Procedures FMEA modes
Knowledge
Experience History of actions
taken

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 Analyzing

Severity, Occurrence, Failure &

Effects

and Detection
Severity
 Importance of the effect on customer requirements

Occurrence
 Frequency with which a given cause occurs and
creates failure modes (obtain from past data if possible)
Detection
 The ability of the current control scheme to detect
(then prevent) a given cause (may be difficult to
estimate early in process operations).

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 Assigning
Rating
Weights

Rating Scales
Severity
1 = Not Severe, 10 = Very Severe
Occurrence
1 = Not Likely, 10 = Very Likely
Detection
1 = Easy to Detect, 10 = Not easy to Detect

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 Rating Severity
Severity Occurrence
Occurrence Detection
Detection
High 10 Hazardous without warning Very high and almost Cannot detect
inevitable

Loss of primary function High repeated failures Low chance of

detection

Loss of secondary function Moderate failures Moderate chance of

detection

Minor effect Occasional failures Good chance of

detection

No effect Failure unlikely Almost certain

Low 1 detection

Note : Determine if your company has rating scales and rules.

In some companies, rating a “10” on severity may have legal consequences.
 Calculating a
Composite
Score

Risk Priority Number (RPN)

 RPN is the product of the severity, occurrence, and

detection scores.

Severity X Occurrence X Detection = RPN

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 Key Points

Summary
An FMEA:
Identifies the ways in which a product or process can fail
Estimates the risk associated with specific causes
Prioritizes the actions that should be taken to reduce risk
FMEA is a team tool
There are two different types of FMEAs:
Design
Process
Inputs to the FMEA include several other Process tools
such as C&E Matrix and Process Map.

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 References

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