The FMEA Process

Training Material
Types of FMEA
FMEA

Design FMEA Process FMEA

1. To assess the risks of the 1. To assess the risks of the

elements of a product or POR elements of a process

2. To quantify the interactions in 2. To quantify the interactions of

terms of product functionality production or business
or POR specifications process in terms of process
requirements

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Design and Process FMEA
DFMEA PFMEA
Element to Elements of a product Process steps of a
be assessed (function/ module) or production process or
process of record (POR) design flow

Potential Deviations caused by the Deviations in the process

failure design of a process or
modes product

Potential Deviations from product Deviations from the

effects of specifications process requirements
the failures

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FMEA Creation Process Team Selection
1. Put the Right Team together
Define and Map Process
2. Define and sequence the
process into digestible Failure Modes
chunks
3. Brainstorm Failure Modes, Determine Severity (S)
Causes, Effects and Controls
4. Assign subjective rankings for Effects Causes
Severity, Occurrence, and
Detection Determine Occurrence (O)
5. Analysis: Calculate metrics and
Pareto Chart the results Controls

6. Take Action on the Top 20% or Determine Protection (D)

top 3-5 issues
7. Regular review the FMEA Analysis (RPN)

Actions

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 Risk Priority Number (RPN) =
Severity (Sev) x Occurrence

FMEA Process Sequence

(Occ) x Detection (Det)

What What can be

are the done?
How
Effects? bad
What are the -Design changes
Functions/ is it?
Features / -Special
Requirements? Controls
How
What often
-Changes to
What can go are the does it
Standards,
wrong? Causes? happen?
Procedures or
Guides
-No function
How can
-Partial/ Over/ this be
prevented How good
Degraded
and is this
Function
detected? method at
detecting
-Unintended
it?
Function

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Step 1 - Specify Part
Function

Example
Mechanical Lid
Thinner Wire Diameter
Material Change to Pb free bump
Longer Wire Length
HHP offset
Cu pillar

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Typical Design
Considerations Start with a list of:
What the design is expected to do
What the design is expected NOT to do
Design Intent
Customer Needs - Can be specified and
measured
Customer Wants - Some cant be explained
Product Requirements
Manufacturing assembly requirements

Quality Function Deployment

Think about what
documents in your
company are used to
define these
Customer Contacts
Competitive Analysis
Known Product Quality
Reliability Requirements
Manufacturing Requirements
Design Block Diagram Example
If the product function is complex, break it down into
smaller sub-systems. Identify Primary Vs Secondary
functions

System Body

Sub Doors Exterior Window Interior

System

Door Sealing
Component Glass With
Latch /
Inner Lock
Panel Strip
Step 2 - Think of Failure
Mode

Consider
Customer
Function
Manufacturing Process

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Step 3 - Consider The Effect of
the Failure

Consider
Customer Use or Inconvenience
Safety or Regulatory
Process Difficulty

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Step 4 - Estimate the Severity of the
Failure

How to rank and rate

the effect on a
standard scale

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Step 5 - Think of the Cause of
the Failure

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Cause and Effects
Cause and effect diagrams are extremely helpful in
analyzing and investigating these complex relationships
Ask why, why, why, why, why

Methods Potential Effects

Potential
Failure Mode
Machinery

Effect 1

Effect 2

Effect 3
Materials

Man

Mother Nature

5M

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Cause and Effects Cascade
Example: Exterior casing of a Penlight
Design
Effect
Cause A series of events will occur during
Environment the life of a disposable penlight
Exposure
Effect
Cause
Moisture
Effect
Cause
Corrosion
Effect
Cause
Poor Contact
Tim
e (High Resistance)
Effect
Cause
Insufficient
Current Effect
Cause
Dim Bulb

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Step 6 - Estimate the
Occurrence of Failure

Likelihood or
probability of
happening

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Step 7 - Assess the Design
Control

Measures to control error in

design 16
Step 8 - Estimate the
Detectability

How likely to be detected

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Occurrence X Severity X
Detectability

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Risk Priority Number
Interpretation
O S D RPN Failure Impact

1 1 1 1 Ideal

1 1 10 10 ??

1 10 1 10 ??

10 1 1 10 ??

1 10 10 100 ??

10 10 1 100 ??

10 10 10 1000 Trouble !

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Step 9 - Calculate and Prioritize
the RPN

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FMEA Framework Recap
Actual FMEA Example
DFMEA Purpose
Identify, quantify, and reduce design
risk - especially for critical systems
Provide a traceable document for

making design decisions

Prioritize which design activities to

pursue next
A DFMEA is not a one meeting

activity - It needs to evolve with the

product
DFMEA - Inputs
Product Design Requirements
Design requirement document (if available from customer or
supplier)
Legal and technical regulations
Bill of Materials (BOM) and Specific Hardware
List of components
Components and/or samples as supplied by the customer
Product Definition
Drawings, sketches, animations, and simulations
Description of systems and components
Previous Experience (Lessons Learned from
Others)
Experience with similar concepts, designs, and DFMEA
Customer and supplier inputs
Design guides and design standards (for example ASME codes)
DFMEA - Outputs
RPN: Risk Priority Number
RPN = (Severity) x (Occurrence) x (Detection)

Identification of both systems and

components with high RPN values =
high risk items.
Identification of Critical and Significant
Characteristics
DFMEA integration into others

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FMEA Format Columns
Design FMEA

Occurrence
Occurrence

Detection

Detention
Severity
Severity
Item- Potential Potential Potential Causes/ Current Recommended Responsible
Function Failure Effects of DESIGN Actions and Activity and

RPN
Mechanism (s) of

RPN
Mode Failure Failures Controls Status Target completion
Date

Process FMEA

Occurrence
Occurrence
Responsible

Detection

Detention
Recommended Activity and

Severity
Severity
Process Potential Potential Potential Causes/ Current
Target Action
Function Failure Effects of PROCESS Actions and

RPN
Mechanism (s) of

RPN
completion Taken
Requireme- Mode Failure Failures Controls Status
Date
nts

Design FMEA Process FMEA

System, Sub-system, Process or Operation Steps
component If numerous operations or process
If > one function with with difference Failure Modes list
different failure modes list all all
Basic function or purpose to
meet
Design vs. Process Failures

Design Failures Process Failures

Insufficient lubrication Insufficient lubrication
capability applied
Incorrect material specified Incorrect material used
FMEA Inter-relations
Failure Mode Effect Cause

System The ramification The Cause(s) of the

of the problem The Problem
FMEA Problem

The Cause(s) of the The effect from the New root causes for
Design Problem from the system FMEA with a the design failure
FMEA System FMEA Better Definition Modes

The Cause(s) of the The Same effect as Specific root Causes

Process Problem from the the Design FMEA for the Process Failure
FMEA Design FMEA Modes
QFD Process
Design
Requirement
Requirements
Customer

Part
Characteristics

Requirements
Design Manufacturing
Product Operations

Characteristics
Part
Production
Part Requirement

Manufacturing
Operations
Process

Production
FMEA to Control Relationship
Identification and Detection and Detection and
Prevention of Removal of Elimination of
Potential defects Internal defects. External defects

SPC

Inspection by
Design Process
SPC

customer
FMEA FMEA PPM

Goods Inwards

Inspection
Inspection

Final
Design and Manufacturing
Development planning
Planning Purchase Manufacturing Usage
Manufacturer Customer
Inputs for PMEA
Process flow diagram
Assembly instructions
Design FMEA
Current engineering drawings and

specifications
Data from similar processes

Scrap
Rework
Downtime
Warranty
PFMEA - Example 1

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PFMEA - Example 2

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Design FMEA Exercise
Performing DFMEA on a pressure cooker

Pressure Cooker Block

Diagram
Pressure Cooker Safety Features

1. Safety valve relieves pressure before it

reaches dangerous levels.

2. Thermostat opens circuit through heating

coil when the temperature rises above
250 C.

3. Pressure gage is divided into green and red

sections. "Danger" is indicated when the
pointer is in the red section.
Pressure Cooker FMEA

1. Define Scope

2. Resolution - The analysis will be restricted

to the four major subsystems (electrical
system, safety valve, thermostat, and
pressure gage).

3. Focus - Safety