FMEA Training v1.1

Scope and Target Group for Training
Target Group of this training

Executive Management to Plant Level Management
People who are not perfoming FMEA today and have a possibility to
use preventive (FMEA) approach for their products/processes, for
example: questions during TG Reviews, in daily operations, paying
attention to the importance of FMEA, designing new/revised
products/processes to minimize the risks of concerns.
ALV-TS/SC/Feb2012/FMEA Training v 1.1 - 1
Copyright Autoliv Inc., All Rights Reserved
Failure Mode and

Effects Analysis
Training Managers
Standard training
initiated by Q5
Owner: Engineering & Manufacturing/AHO

Author: T. Saitoh & S. Carlson
Feb 2012
This training includes guiding

notes in the notes page
Why this training?

During this training you will learn:
What is FMEA?
Why we need FMEA?
Where to apply FMEA?
When & How to create, document & review an FMEA?
How to behave when involved in FMEA activities?
Content
What is FMEA?
Why do we need FMEA?

When shall FMEA be performed?
How shall FMEA be created?
How to do FMEA? The 7 Steps
How to document FMEA?
What makes FMEA efficient?
Who is responsible for FMEA?
What did you learn from this training?
References
What is Master FMEA?

How to apply Master FMEA?
More information - Links
What is FMEA ?
A brief history of FMEA
During WW2, although extensively implemented, Quality

Control was unable to catch all problems
Errors / corrective iterations were too costly and time

consuming
Preventive methods required evaluation in advance and action

to prevent/eliminate problem occurrence
In the late 1940s, FMEA was introduced by the US Army and then used
extensively for aerospace/rocket development (Apollo Space program)
In the late 1970s it was extended to the automotive industry by Ford.
Further development / refinement of FMEA has been done by Toyota with

the DRBFM approach (Design Review Based on Failure Mode)
Nowadays FMEA methodology is applied by various industries, (e.g.

semiconductor industry, software suppliers, healthcare, etc.)
What is FMEA?
And what is the purpose?

A risk prediction and prevention method
FMEA = Failure Mode and Effects Analysis

FMEA is a structured team driven process to:
Identify functions
Identify potential failure modes
Create preventive designs/processes/actions
Minimize/Mitigate potential risks
What is FMEA?
And what is the purpose?
.create a robust final product

To know the risks related to a product or a process prior to start of
operation
How can my product/process fail?

How often? What is the probability of occurrence?
What would be the consequences/effects?
To drive actions to prevent/mitigate the risk before occurrence
Activities that prevent or detect the cause of failure mode

For example verification/validation and limit/margin tests to confirm potential
risks are eliminated, for example redesign to make failure less likely, less severe
To capture knowledge on product & process dysfunctioning by:
Creating Master FMEAs as a basis for future similar products

Retaining Lessons Learned from development and serial production via FMEA
update

Current applications areas are:
Product and/or system concept (Concept FMEA)
(Sub) System design (System FMEA) w/customers
Product design (Design FMEA)
Manufacturing process including logistics (Process FMEA)
Machine/tool (Machine FMEA)
Software (Software FMEA)
Other potential applications are:

Any process with potential high risk, for example HR, maintenance,
finance, marketing processes, ...
When should FMEA be performed and updated?
FMEAs
updated
Risk Analysis
for Concept Selection
Pre-APDS
Process
AS 108
FMEAs
updated
Phase 0
Phase 1
Phase 2
Phase 3
Phase 4
Project
Concept
Planning
Product &
Process
Validation
Product
Launch
Definition
Product &
Process
Development
Risk
Assessment
by Concept
FMEA
FMEAs
started
FMEAs
updated
Serial
Production
FMEA update
continuously,
For example Customer
concern
(8 D), changes,
When should FMEA be performed and updated?

FMEA should be started as early as possible when
adjustments are still possible
FMEA methodology has always to be applied before building

or modifying a product/process
FMEA is a living document which should be:

Reviewed whenever a product/process is changed
Reviewed / updated every time a quality concern occurs
(internal/external)
Concerns raised through Go&See activities or daily work
How should FMEA be created?

If an Applicable Product / Process
is
a copy / paste
of an existing
product / process
uses
an existing concept
BUT
with change on
some functions or
components design
is
a new concept
and/or process for
example
manufacturing,
logistics,
administration, etc.
Review and update an

existing FMEA or Master
FMEA
Identify changing points

and update an existing
FMEA / Master FMEA
Create a new FMEA
Preparation
Preparation
Process Flow/
Structure
System Analysis/
Structure
Process Analysis
Function Analysis
Failure Mode Analysis
Risk Assessment and Controls
Optimization
Maintain along daily life
FMEA
form
Risk Assessment and Controls

Optimization
Maintain along daily life

Step 1 - Preparation Work
Definition of System Borders = Scope, for example interface

diagrams, Bill of Materials (BOM), ...
Collection of important information (for example DGD,
specifications, drawings, similar samples/processes, system
descriptions, existing test results etc.)
FMEA needs to be done in the best conditions for the phase:
Early phase cross functional team with the best available data
When first parts/mock-up line ready Do it with parts on mock-up line
Later phases serial parts/line installed To be done on Gemba

Step 1 - Preparation Work
Master FMEAs, if applicable

Lessons learned (AS 65)
Quality input, for example field, COP, internal, supplier and customer
data
Build a Team:
Make everyone participate: gather everyones skills
All team members shall be trained in FMEA methodology
Team members may come from various origins but are required to be
competent in their field of activity.
Step 2/3 - System and Function Analysis

Define System
A system can be considered to be made up of various sub-systems / system
elements
Example DFMEA: PAB Module

Definition of System Borders
Example PFMEA: Process

Flow Structure
Based on the defined system structure, describe the function of the

item which is necessary to meet the design intent based on customer
requirements/end users needs

175
Function
Requirement
Describe the function/process of the

item which meets the design intent.
These are coming from the system
and function analysis.
List and describe requirements
Function Analysis
Step 2/3 - System and Function Analysis - Example PAB Cushion
Function
Requirement

Function Analysis
Step 2/3 - System and Function Analysis Example PFMEA
Function
Requirement

Function Analysis

Example PFMEA, IQ software
Function / Requirement

Function Analysis

Step 4 - Failure Mode Analysis
175
Potential Failure Mode
Potential Effect
Potential Cause
Define what happens if a

system/process could not meet the
design intent/process
requirements.
Starting w/Lessons Learned review
is recommended
Define Potential Effects of failure

perceived by the customer
(internal/external customers and
end users)
Use standard description as much
as possible. (See page-36 and
37)
Potential Effect shall be aligned in
DFMEA and PFMEA
Define Potential cause of

failure
Potential cause of failure is
indications of design/process
weaknesses.

Step 4 - Failure Mode Analysis - Example PAB Cushion
Potential Effect
Potential Cause

requirements.
Starting w/Lessons and learneds
review is recommended

end users)
DFMEA and PFMEA

failure
weaknesses.

Step 4 - Failure Mode Analysis Example PFMEA
Potential Effect
Potential Cause

requirements.
is recommended

end users)
DFMEA and PFMEA

failure
weaknesses.

Step 4 - Failure Mode Analysis - Example PFMEA, IQ software
Potential Effect
Potential Cause

requirements.
is recommended

end users)
DFMEA and PFMEA

failure
weaknesses.

Step 5 - Risk Assessment & Controls
175
Severity
Classification
Occurrence
Detection
Risk Priority No.
Assessment
of the level of
impact at the
customer
Classify any product

characteristics (Critical= [CC],
Significant = [SC]) for
system/process that may
require additional design or
process controls
How often the

cause of a
failure may
occur.
A assessment of
how well the
product or
process controls
detect the cause
of the failure or
the failure mode.
The Risk Priority

Number (RPN) is the
product of severity,
occurrence and
detection rankings.
RPN =(S) x (O) X (D)
Risk Assessment
Risk Assessment is one of the important steps in the FMEA process
Step 5 - Risk Assessment & Controls - Example PAB Cushion
Severity
Classification
Occurrence
Detection
Risk Priority No.
Assessment
of the level of
impact at the
customer

process controls
How often the

cause of a
failure may
occur.
A assessment of
how well the
product or
process controls
detect the cause
of the failure or
the failure mode.
The Risk Priority

Number (RPN) is the
occurrence and
detection rankings.
Risk Assessment
Step 5 - Risk Assessment & Controls Example PFMEA
Severity
Classification
Occurrence
Detection
Risk Priority No.
Assessment
of the level of
impact at the
customer

process controls
How often the

cause of a
failure may
occur.
A assessment of
how well the
product or
process controls
detect the cause
of the failure or
the failure mode.
The Risk Priority

Number (RPN) is the
occurrence and
detection rankings.
Risk Assessment
Step 5 - Risk Assessment & Controls - Example PFMEA, IQ software
Severity
Classification
Occurrence
Detection
Risk Priority No.
Assessment
of the level of
impact at the
customer

process controls
How often the

cause of a
failure may
occur.
A assessment of
how well the
product or process
controls detect the
cause of the failure
or the failure mode.
The Risk Priority

Number (RPN) is the
occurrence and
detection rankings.
Risk Assessment
Step 5 - Risk Assessment & Controls
Risks in a FMEA are ranked by using

Risk Prevention Number (RPN)
RPN is calculated based on multiplying
Severity of problem x
Occurrence of failure mode x
Detection of failure mode
Step 5 - Risk Assessment & Controls - Special Characteristics
During FMEA potential [CC]/[SC] = [pCC]/[pSC] are identified

*p=Potential
Severity of 9 or 10 indicates a potential Critical Characteristic [pCC]
Severity of 7 or 8 indicates a potential Significant Characteristic [pSC]
A [pCC] or [pSC] can become a [CC] or a [SC] after application of the
following criteria:
The criteria shall be used to determine which characteristic does not lead
to a [CC] or [SC]:
Occurrence 1 for a [pCC] or 1 or 2 for a [pSC]
High factor of safety margin or reliability or Poka-Yoke
Capability data (continuous Cpk > 1.67 for more than 100 days) from equivalent design,
equipment and process not older than 12 months

Reliability testing (DOE, etc.) showing this characteristic is not a major contributor to the
failure mode
Product and process expertise with documented evidence / experience
Step 6 - Risk Control & Optimization
175
Current Controls
Activities that prevent

or detect the cause of
the failure mode.
Prioritize preventive
controls at first
Recommended
Actions
Responsibility
& timing
List actions to reduce overall

risk and likelihood that the
failure mode will occur.
Record responsible
person and timing to
complete the
recommended
actions.
Controls and Optimization

Actions Results
Record the updated

ratings based on the result
of the actions
If result is not the expected
one, then create a new line
to further improve.
Step 6 - Risk Control & Optimization Example PAB Cushion
Current Controls

the failure mode.
controls at first
Recommended
Actions
Responsibility
& timing

Record responsible
complete the
recommended
actions.

Actions Results
Record the updated

of the actions
to further improve.
Step 6 - Risk Control & Optimization Example PFMEA
Current Controls

the failure mode.
controls at first
Recommended
Actions
Responsibility
& timing

Record responsible
complete the
recommended
actions.

Actions Results
Record the updated

of the actions
to further improve.
Step 6 - Risk Control & Optimization - Example PFMEA, IQ software
Mr.XY
Mr.XY
Current Controls
Recommended Actions
(Preventive-Detection Action)
Activities that prevent or

detect the cause of the
failure mode.
Prioritize preventive controls
at first

Responsibility
& timing
Record responsible
complete the
recommended
actions.

Actions Results
Record the updated

of the actions
to further improve.
Step 6 - Risk Control & Optimization
Confirm the link After finalized [CC] and/or [SC]

Drawings
D-FMEA and P-FMEA (internal/external)
[CC]/[SC]-List
Control Plan (internal/external)
SWI (internal/external)
Promote Go&See FMEA (internal/external)
To be conducted by cross-functional team with fresh eyes involvements
Go on the Gemba when line is stopped with actual samples
Challenge each machine / Try to create bad products at each station
to verify the efficiency of Poka-Yoke Assess above link!

Step 7 - Maintain along life cycle
175
Anytime after quality concern/Yokoten information has been analyzed or

product/process has been changed:
is the failure mode included in FMEA or could new failure mode occur?
Is occurrence reflecting actual/new condition?
Is detection reflecting actual/new condition?
Review and update if required. Implement action to reduce risk as part of FMEA activity management
on site.
Step 7 - Maintain along life cycle - Example PAB Cushion

is the failure mode included in FMEA or could new failure mode occur?
on site.
Step 7 - Maintain along life cycle Example PFMEA

Is the failure mode included in FMEA or could new failure mode occur?
on site.
Step 7 - Maintain along life cycle (IQ FMEA software)
Mr.XY
Mr.XY

Is the failure mode included in FMEA or could new failure mode occur?
on site.

FMEA effectiveness relies on:
Project team members knowledge

FMEA methodology
Product and process experiences
Management involvement and support

during product lifecycle
(from Development to End of life)
Effective learning circle of lessons

From end users, manufacturing, customers
back to development
Smart application of Master FMEA

Desired behavior:
Train the right people
Assign skilled team leaders
Set direction and expectation
Provide resources
Review (Go and See)
Check it reflects actual condition
Close the lessons learned
circle review and update
FMEA Master FMEA with LL
from users
Create/apply Master FMEA
and focus on changing points
Management owns the FMEA process

Select and apply resources
Ensure an effective risk management process including
timing
Provide direct support to the team through on-going
reviews
Eliminate roadblocks
Incorporate Lessons Learned (according to AIAG FMEA 4th edition)
Management responsibility and involvement in

FMEA & Risk Management is key along the project
Expectations on how to work with FMEA

Autoliv Standard AS 104 defines the common requirements for
FMEA
DFMEA (Design)
PFMEA (Process)
In Autoliv Standards AS 100 and AS 108 it is also described how

to work with FMEA in projects
FMEA is a living document and shall be updated continuously by

a cross-functional team after TG 4
(until End of life)
Involvement from Management In reviews & through active

support!

Ask questions and pay attention to
Design Reviews, Tollgate review Boards
and while visiting plants /suppliers
What are the Top 5 problems/concerns in your products/process?
What are Potential Failure Modes/Effects/Causes ?

How much Risks do we have? Can you show me these RPNs?
What preventive/corrective actions will be taken?
Can you show me FMEA with these problems/concerns/actions?
Should we share these actions with other areas? - Need for master FMEA
update?
How do we confirm these actions are effective enough?

When do we complete all actions?

Ask questions and pay attention to Tollgate review Boards,
Design Reviews and when visiting plants/ suppliers
Use Engineering Cue Card

Ask questions and pay attention to Tollgate review Boards,
Design Reviews and when visiting plants/ suppliers
Use Engineering Cue Card
Summary
FMEA is the State of the Art Risk Management
Method:
To identify potential failure and its consequences
To prevent potential failure modes at an early stage
To mitigate consequence by driving corrective action to reduce
risk
To capture Lessons Learned and manage knowledge
To reduce non-quality costs
To support Do it right at the first time!
To drive Customer satisfaction
FMEA requires YOUR involvement!
How to involve myself?
?
?
?
?

Can you answer these questions:
What is an FMEA?
What does FMEA stand for?
Why do we do FMEA?
What are the application areas of FMEA?
When shall FMEA be created?
How to create FMEA in a efficient way?
What does RPN stand for? What does RPN include?
How to control and optimize the RPN?
How and where do you perform a Go&See FMEA?
What shall you do to make FMEA efficient?
What could be an alternative method to FMEA?
FMEA application - questions
Is a Master FMEA available and considered?

Is an update of the Master FMEA necessary?
Is LL from customer claims, production problems, CCRTs, ...available?
Is LL confirmed/ validated?
Is FMEA updated with the latest LL?
Does FMEA reflect the latest 8Ds?
Are attendees trained /experienced in FMEA method?
Do you involve the Gemba and actual (similar) samples?
Is FMEA done in a cross-functional team?
Are all concerned regions involved in FMEA process?
Is a system definition and/or a block diagram (all relevant modules, components, interfaces)
available?
Is a function requirement analysis done?
Did you consider the 6Ms in the failure mode analysis?
Are failure effects with severity ratings consistent?
Does a customer FMEA checklist or customer FMEA requirement exist?
Is the customer FMEA timing plan considered?
Are management presentations planned/done? (Pareto analysis with Top Ten list at APDS
phase 2 and 3 at least)
Reference
Reference - What is Master FMEA?

Master FMEA
Is a way to capture and manage know-how related to the effect of a
failure mode of a product or process
Is a way to reuse efficiently existing knowledge from similar concept of
product and process (Yokoten from previous experiences)
Is to save time and thus focus on the areas of the product / process that
are new and not included in Master FMEA (MUDA elimination)
Is created for a preferred design/process (likely to be duplicated, even
several time) as a guideline to control risks.
Master FMEAs empower team members

to focus on modifications / new functions and
to raise awareness on known risks to confirm
Reference - What is Master FMEA?

Master FMEA
IS NOT an opportunity to do quick and Cut and Paste FMEA to show
that APDS task is done (NOT ticking the box attitude)
IS NOT applicable in all conditions but requires thorough analysis to
confirm applicability to the product or process studied
IS NOT an opportunity to consider that FMEA is not required because it
already exists for similar products
IS NOT an opportunity to mitigate risk since product process is identical
to the concept studied in Master FMEA but to warn of potential / actual
proven risk Global management support is required to establish
and improve level of Master FMEA
Master FMEAs should be applied carefully by

experienced engineers. Need to avoid misleading
and overconfidence detrimental to the project
Reference - How to apply Master FMEA?

Identify the Master FMEAs that are applicable
(product/process equipment concept)

Focus on changing points including the interface (Fit for Use)
Review the Master FMEA vs. current design/process
Assess ranks/risks as starting point for your project
Carry out FMEA on the changing points (Gap/Master FMEA)
and manage as new FMEA
Feedback of new failure modes discovered in development or
serial production (LL) to the owner of the Master FMEA
Ensure that new failure mode discovered and documented in
Master FMEA is cascaded to other FMEAs
YOKOTEN ensure both good and bad Lessons Learned are shared
and applied to all possible products and processes
References/Links - Further information FMEA

AS 52
Autoliv Corporate Standards Special Characteristics Classification
AS 104
Autoliv Corporate Standards Lotus Notes Database - Link
AS 100
AS 108
AIAG 4th edition
http://www.aiag.org
Guidelines for the trainers
Adjust the content of this training according to the

audience:
Regional Management Staff training

Managers (General)
Team leaders/staff members/staff engineers
Example: Staff members / Staff engineers

What to train?
What is FMEA?
What to follow-up? / Accountability:

Ensure expected behaviors are practiced at local level in plant
Example: Team Leaders

What to train?
What is FMEA?
What to follow-up?
/ Accountability:
Ensure that the expected behavior is followed
Ensure that Team Leader is applying FMEA as expected by the management.
Example: Team leaders / staff members / staff

engineers

engineers

engineers

engineers
Example: Managers (General)

What to train?
What is FMEA?
What to follow-up? / reinforce Accountability:

Ensure that the expected behavior is followed:
Managers take the habit to ask for FMEA anytime during products/projects/sites/process reviews
Managers use FMEA in a proactive way. Manager is asking for problem prevention with FMEA
Managers are seeking for advice on applicability of FMEA
Managers are giving priorities in FMEA and support teams as much as possible
Example: Regional Management
What to train?
What is FMEA?
What to follow up? / Accountability:
Ensure that the expected behavior is followed:
Top Management takes the habit to ask for FMEA anytime during products/projects/sites/Cat A
problem reviews / etc.
Top Management is expecting teams to carry out FMEA for all possible outputs/products/processes
FMEA is used effectively under leadership of Regional Management. (function regional VP)
Selection of slides for training

Regional Management

Regional Management

Regional Management

Regional Management
Modification Index
Feb 2012:Slides 17, 21, 25, 31, 42 are updated with new
FMEA picture, containing correct calculation of RPN number

FMEA Training v1.1

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Scope and Target Group for Training

Target Group of this training

ALV-TS/SC/Feb2012/FMEA Training v 1.1 - 1

Copyright Autoliv Inc., All Rights Reserved

Failure Mode and

Owner: Engineering & Manufacturing/AHO

This training includes guiding

Copyright Autoliv Inc., All Rights Reserved

Why this training?

ALV-TS/SC/Feb2012/FMEA Training v 1.1 - 3

Copyright Autoliv Inc., All Rights Reserved

Why do we need FMEA?

What is Master FMEA?

Copyright Autoliv Inc., All Rights Reserved

A brief history of FMEA

During WW2, although extensively implemented, Quality

Errors / corrective iterations were too costly and time

Preventive methods required evaluation in advance and action

In the late 1970s it was extended to the automotive industry by Ford.

Further development / refinement of FMEA has been done by Toyota with

Nowadays FMEA methodology is applied by various industries, (e.g.

ALV-TS/SC/Feb2012/FMEA Training v 1.1 - 5

Copyright Autoliv Inc., All Rights Reserved

And what is the purpose?

FMEA = Failure Mode and Effects Analysis

ALV-TS/SC/Feb2012/FMEA Training v 1.1 - 6

Copyright Autoliv Inc., All Rights Reserved

And what is the purpose?

.create a robust final product

ALV-TS/SC/Feb2012/FMEA Training v 1.1 - 7

Copyright Autoliv Inc., All Rights Reserved

Why do we need FMEA?

How can my product/process fail?

To drive actions to prevent/mitigate the risk before occurrence

Activities that prevent or detect the cause of failure mode

To capture knowledge on product & process dysfunctioning by:

Creating Master FMEAs as a basis for future similar products

ALV-TS/SC/Feb2012/FMEA Training v 1.1 - 8

Copyright Autoliv Inc., All Rights Reserved

Where to apply FMEA?

Other potential applications are:

Copyright Autoliv Inc., All Rights Reserved

When should FMEA be performed and updated?

for Concept Selection

ALV-TS/SC/Feb2012/FMEA Training v 1.1 - 10

Copyright Autoliv Inc., All Rights Reserved

When should FMEA be performed and updated?

FMEA methodology has always to be applied before building

FMEA is a living document which should be:

ALV-TS/SC/Feb2012/FMEA Training v 1.1 - 11

Copyright Autoliv Inc., All Rights Reserved

How should FMEA be created?

Review and update an

Identify changing points

Create a new FMEA

ALV-TS/SC/Feb2012/FMEA Training v 1.1 - 12

Copyright Autoliv Inc., All Rights Reserved

How to do FMEA? The 7 Steps

Failure Mode Analysis

Risk Assessment and Controls

How to document FMEA?

Definition of System Borders = Scope, for example interface

ALV-TS/SC/Feb2012/FMEA Training v 1.1 - 14

Copyright Autoliv Inc., All Rights Reserved