Potential Failure Mode &

Effects Analysis FMEA

DESIGN FMEA
ISO TS 16949:2002 Lead Auditor Course
Course Objectives
• By the end of the course the
participant should be able to;
 Understand how to audit DFMEA’s
 Understand link between DFMEA and
other ISO TS 16949 documentation
 identify the two types of FMEA’s
 complete a Design FMEA for a project
 understand how to determine the RPN
and its implication
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Failure Mode and Effects Analysis

• ISO TS 16949 requires FMEA’s to be

generated and revised during the following
stages;
– Advanced Product Quality Planning - before or at
design concept finalisation/prior to tooling for
production
– Design reviews
– As a result of customer complaints
– As as result of customer/field returns
• FMEA’s are LIVING DOCUMENTS
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Failure Mode and Effects Analysis

• What is an FMEA?
– An FMEA is a structured process used to
analyse design and/or process activities and
to assure that potential failure modes have
been addressed and effects analysed.

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Failure Mode and Effects Analysis

• An FMEA is a
team process not a
single person

 
process
                    
                  
                  

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Failure Mode and Effects Analysis

• Benefits of FMEA’s

– 1. Utilises previous history and

associated failure modes to assist
in developing quality products
during design - better
understanding of the product

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Failure Mode and Effects Analysis

• Benefits of FMEA’s

– 2. An objective evaluation of the

design or process - not subjective. It
forces an organisation to quantify

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Failure Mode and Effects Analysis

• Benefits of FMEA’s

– 3. Cost & time savings - The process

identifies potential
causes/mechanisms of failure before
they occur

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Failure Mode and Effects Analysis

• Benefits of FMEA’s

– 4. Provides a system for establishing

design and process improvements
and for identifying Special
Characteristics

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Failure Mode and Effects Analysis

• Benefits of FMEA’s

• 5. A structured proactive system that

aims to provide for Customer
Satisfaction

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Failure Mode and Effects Analysis

• There are two types of FMEA’s

• 1. Design FMEA
– Cooling system for vehicle, spoiler assembly,
wiring harness etc..
• 2. Process FMEA
– Injection moulding, welding, assembling etc...

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Failure Mode and Effects Analysis

• Definition of a Design FMEA

– A design FMEA is a structured process
used by Design Responsible companies to
ensure, to the extent possible, that possible
failure modes and their associated causes
and mechanisms have been considered
during the design process.

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 Failure Mode and Effects Analysis
• Examples of when Design FMEA’s may be used;
– A company may be responsible for the complete
design of the cooling system of a vehicle.
– A company may be responsible for designing a
complete trimmed seat assembly
– A company may be responsible for developing and
designing a material to reduce Noise and Vibration in a
vehicle

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Failure Mode and Effects Analysis

• Definition of a Process FMEA

– A process FMEA is a structured process
used by a manufacturing company to
identify potential failure modes and their
associated causes and mechanisms for the
manufacture and assembly of product.

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Failure Mode and Effects Analysis

• Examples of when Process FMEA’s

may be used;
– A company has been provided with all of
the technical information to manufacture;
• An injection moulded interior door handle
• A metal pressed bracket
• A family of fasteners

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How to Complete a
Design FMEA
 Design Failure Mode and Effects
Analysis

• How to complete a Design FMEA

1. FMEA number
• A number used for tracking and identifying the
Design FMEA

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Design Failure Mode and Effects
Analysis

– How to complete a Design FMEA

2. System, Sub-system or Component name &
number
• Indicate the type of analysis and enter the name and
number of the system, sub-system or component

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Design Failure Mode and Effects
Analysis
– How to complete a Design FMEA
3. Design Responsibility
• Indicate the OEM, department and/or group
which is responsible for the design of the
product

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Design Failure Mode and Effects
Analysis
– How to complete a Design FMEA
4. Prepared by:
• Enter the contact details of the person
responsible for preparing the Design FMEA.
This is typically the Design Engineer

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Design Failure Mode and Effects
Analysis
– How to complete a Design FMEA
5. Model Year(s)/Vehicle(s)
• Enter the intended model year(s) and vehicle
lines that will utilise and/or be affected by the
design being analysed, if known

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Design Failure Mode and Effects
Analysis
– How to complete a Design FMEA
6. Key Date
• The key date is defined as the due date for the
design FMEA. This date should not exceed the
scheduled design release date.
• Typically this is the Design freeze date

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Design Failure Mode and Effects
Analysis
– How to complete a Design FMEA
7. FMEA Date
• This date is defined as the original date the
Design FMEA was compiled and the latest
revision date.

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Design Failure Mode and Effects
Analysis
– How to complete a Design FMEA
8. Core Team
• List the names of the responsible individuals
and departments who have participated in the
generation of the design FMEA.

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Design Failure Mode and Effects
Analysis
– How to complete a Design FMEA
9. Item/Product Function
• Enter the name of the item and the product
function. It is important to be as concise as
possible. Use the same terminology as per any
reference documents.Be sure to use all
intended functions and unintended functions

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Design Failure Mode and Effects
Analysis
– How to complete a Design FMEA
10. Potential Failure Mode
• Enter the potential failure mode(s) for that
item. Examples of failure modes might be, but
not limited to;
– Fracturing, Leaking, Cracking, Fading,
Peeling, Breaking, Deformed, Oxidised,
Slips, sticks etc…

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Design Failure Mode and Effects
Analysis
– How to complete a Design FMEA
11. Potential Effects of Failure
• What if the failure occurs, what are the potential
effects? These need to be written from the customers
perspective
• Examples
• inoperable, unsatisfactory appearance, noisy because
of vibration, uncomfortable, regulatory
noncompliance, erratic operation etc..

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Design Failure Mode and Effects
Analysis
– How to complete a Design FMEA
12. Severity
• Enter the severity rating as described in
Appendix 1. The severity is an assessment of
the seriousness of the problem

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Design Failure Mode and Effects
Analysis
– How to complete a Design FMEA
13. Classification
• Enter the special characteristic symbol as per
customer requirements for any critical,
significant, major, safety or Key characteristic.
ISO TS Section II should define the type of
symbol required.
ISO TS requires that all special characteristics
are addressed during the FMEA stage.

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Design Failure Mode and Effects
Analysis

– How to complete a Design FMEA

14. Potential Cause(s)/Mechanism(s) of Failure
• Enter any potential reasons for these failures
• Examples are:
• Specification incorrect ie. formulation, material etc.
• Insufficient testing
• Inadequate product design
• Over stressing
• Incorrect assumptions, Fatigue, creep, wear etc..

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Design Failure Mode and Effects
Analysis
– How to complete a Design FMEA
15. Occurrence
– Enter the Occurrence as per Appendix 2.
The Occurrence is defined is the
probability or the likelihood that the
specific cause or mechanism will occur.
This may be based on previous field
history, similar products and experience

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Design Failure Mode and Effects
Analysis
– How to complete a Design FMEA
16. Current Design Controls
• Enter the current design verification/validation
activities that will assure the adequacy of the
design
• Typical examples may be, environmental
testing, Engineering test, reliability studies,
design reviews, FEA etc..

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Design Failure Mode and Effects
Analysis
– How to complete a Design FMEA
16. Current Design Controls
• There are two type of controls to consider

Prevention Detection

A pro-active method Detecting the failure

to reduce rate of using analytical or
occurrence physical testing

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Design Failure Mode and Effects
Analysis
– How to complete a Design FMEA
17. Detection
• Enter the detection probability as per Appendix
3. Detection is defined as the ability of the
proposed design controls to detect any design
weakness or potential failure.

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Design Failure Mode and Effects
Analysis
– How to complete a Design FMEA
18. Risk Priority Number (RPN)
• The Risk Priority Number is defined as the
Severity multiplied by the Occurrence
multiplied by the Detection. The RPN is a
measure of the design risk. The RPN will be
between 1 and 1000. It is the responsibility of
the group to define what a high RPN is and
take the appropriate actions.

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Design Failure Mode and Effects
Analysis
– How to complete a Design FMEA
19. Recommended Action(s)
• When high RPN’s are established corrective
action should be incorporated with a focus on
reducing the design risk

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Design Failure Mode and Effects
Analysis
– How to complete a Design FMEA
20. Responsibility
• Enter the name of the person(s) or organisation
who has the responsibility for implementing
the corrective action(s). This should also
include a target date for completion.

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Design Failure Mode and Effects
Analysis
– How to complete a Design FMEA
21. Actions taken
• Enter the effectiveness and the results of the
actions taken

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Design Failure Mode and Effects
Analysis
– How to complete a Design FMEA
22. Severity
• Re-enter the severity rating as described in
Appendix 1. The severity is an assessment of
the seriousness of the problem.

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Design Failure Mode and Effects
Analysis
– How to complete a Design FMEA
23. Occurrence
• Re-enter the Occurrence as per Appendix 2.
The Occurrence is defined as the probability or
the likelihood that the specific cause or
mechanism of failure will occur. This may be
based on previous field history, similar
products and/or experience.

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Design Failure Mode and Effects
Analysis
– How to complete a Design FMEA
24. Detection
• Re-enter the Detection probability as per
Appendix 3. Detection is defined as the ability
of the proposed design controls to detect any
design weakness or potential failure.

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Design Failure Mode and Effects
Analysis
– How to complete a Design FMEA
25. Resulting RPN
• Based on the corrective action, calculate the
RPN and record this result. If further action is
required repeat the corrective action steps in
order to reduce the RPN.

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Appendix 1
Severity rating for Design FMEA
Effect Criteria: Severity of Effect Ranking
Hazardous- Very high severity ranking when a potential failure mode affects safe vechicle 10
without operation and/or involves noncompliance with government regulation without warning
warning
Hazardous Very high severity ranking when a potential failure mode affects safe vechicle 9
with operation and/or involves noncompliance with government regulation with warning
warning
Very High Vechicle/item inoperable, with loss of primary function 8

High Vechicle/Item operable, but at reduced level of performance. Customer very 7

dissatisfied
Moderate Vechicle/item operable, but comfort/convenience items inoperable. Customer 6
dissatisfied
Low Vehiclle/item operable, but comfort/conveinience items operable at reduced level of 5
performance. Customer somewhat dissatisfied
Very low Fit and Finish/squeak and rattle item does not conform. Defect noticed by most 4
customers, greater then 75%
Minor Fit and Finish/squeak and rattle item does not conform. Defect noticed by 50% of 3
customers
Very Fit and Finish/squeak and rattle item does not conform. Defect noticed by 2
Minor discriminating customer, less then 25%
None No discernable effect 1

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Appendix 2
Occurrence rating for Design FMEA
Probability of failure Possible failure rates Ranking
Very High - Persistent Failures ≥ 100/thousand vehicles/items 10

50/thousand vehicles/items 9
High - Repeated Failures 20/thousand vehicles/items 8
10/thousand vehicles/items 7
Moderate - Occasional failures 5/thousand vehicles/items 6

2/thousand vehicles/items 5
1/thousand vehicles/items 4
Low - Relatively Few Failures 0.5/thousand vehicles/items 3
0.1/thousand vehicles/items 2
Remote - Failure is unlikely ≤ 0.01/thousand vehicles/items 1

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Appendix 3
Detection rating for Design FMEA
Detection Criteria: Likelihood of detection by design Ranking
Absolute control
Design control will not and/or cannot detect a potential 10
uncertainty cause/mechanism and subsequent failure mode; or there is
no design control
Very remote Very remote chance that the design control will detect a 9
potential cause mechanism and subsequent failure mode
Remote Remote chance that the design control will detect a potential 8
cause mechanism and subsequent failure mode
Very Low Very Low chance that the design control will detect a 7
potential cause mechanism and subsequent failure mode
Low Low chance that the design control will detect a potential 6
cause mechanism and subsequent failure mode
Moderate Moderate chance that the design control will detect a 5
potential cause mechanism and subsequent failure mode
Moderately High Moderately High chance that the design control will detect a 4
potential cause mechanism and subsequent failure mode
High High chance that the design control will detect a potential 3
cause mechanism and subsequent failure mode
Very High Very high chance that the design control will detect a 2
potential cause mechanism and subsequent failure mode
Almost certain Design control will almost certainly detect a potential 1
cause/mechanism and subsequent failure mode

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Auditing DFMEA’s
1. Is the DFMEA conducted by a cross functional
team?
2. Has the Key date been defined
3. Is it consistent with the customer’s design freeze
date?
4. Does the organisation consider the intended and
unintended functions?
5. Has the organisation defined what constitutes a
high RPN
6. Does the organisation follow the definition of a
high RPN
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Auditing DFMEA’s
7. Are recommended actions completed prior to the
Key date
8. Do the sequence of dates make sense?
9. How are revisions recorded?
10. Does the organisation ensure the DFMEA is a
living document?
11. Verify the occurrence rankings are based on
objective evidence

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