Fmea design la

Potential Failure Mode &
Effects Analysis FMEA
DESIGN FMEA
ISO TS 16949:2002 Lead Auditor Course

2
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

3
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

4
• 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.

5
• An FMEA is a
team process not a
single person
process

6
• 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

7
– 2. An objective evaluation of the
design or process - not subjective.
It forces an organisation to
quantify

8
– 3. Cost & time savings - The
process identifies potential
causes/mechanisms of failure
before they occur

9
– 4. Provides a system for
establishing design and
process improvements and
for identifying Special
Characteristics

10
• 5. A structured proactive system that
aims to provide for Customer
Satisfaction

11
• 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...

12
• 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.

13
• 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

14
• 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.

15
• 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

17
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

18
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

19
Analysis
3. Design Responsibility
• Indicate the OEM, department and/or group
which is responsible for the design of the
product

20
Analysis
4. Prepared by:
• Enter the contact details of the person
responsible for preparing the Design FMEA.
This is typically the Design Engineer

21
Analysis
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

22
Analysis
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

23
Analysis
7. FMEA Date
• This date is defined as the original date the
Design FMEA was compiled and the latest
revision date.

24
Analysis
8. Core Team
• List the names of the responsible individuals
and departments who have participated in the
generation of the design FMEA.

25
Analysis
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

26
Analysis
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…

27
Analysis
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..

28
Analysis
12. Severity
• Enter the severity rating as described in
Appendix 1. The severity is an assessment of
the seriousness of the problem

29
Analysis
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.

30
Analysis
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..

31
Analysis
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

32
Analysis
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..

33
Analysis
16. Current Design Controls
• There are two type of controls to consider
Prevention
A pro-active method
to reduce rate of
occurrence
Detection
Detecting the failure
using analytical or
physical testing

34
Analysis
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.

35
Analysis
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.

36
Analysis
19. Recommended Action(s)
• When high RPN’s are established corrective
action should be incorporated with a focus on
reducing the design risk

37
Analysis
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.

38
Analysis
21. Actions taken
• Enter the effectiveness and the results of the
actions taken

39
Analysis
22. Severity
• Re-enter the severity rating as described in
Appendix 1. The severity is an assessment of
the seriousness of the problem.

40
Analysis
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.

41
Analysis
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.

42
Analysis
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.

43
Appendix 1
Severity rating for Design FMEA
Effect Criteria: Severity of Effect Ranking
Hazardous-
without
warning
Very high severity ranking when a potential failure mode affects safe vechicle
operation and/or involves noncompliance with government regulation without warning
10
Hazardous
with
warning
Very high severity ranking when a potential failure mode affects safe vechicle
operation and/or involves noncompliance with government regulation with warning
9
Very High Vechicle/item inoperable, with loss of primary function 8
High Vechicle/Item operable, but at reduced level of performance. Customer very
dissatisfied
7
Moderate Vechicle/item operable, but comfort/convenience items inoperable. Customer
dissatisfied
6
Low Vehiclle/item operable, but comfort/conveinience items operable at reduced level of
performance. Customer somewhat dissatisfied
5
Very low Fit and Finish/squeak and rattle item does not conform. Defect noticed by most
customers, greater then 75%
4
Minor Fit and Finish/squeak and rattle item does not conform. Defect noticed by 50% of
customers
3
Very
Minor
Fit and Finish/squeak and rattle item does not conform. Defect noticed by
discriminating customer, less then 25%
2
None No discernable effect 1

44
Appendix 2
Occurrence rating for Design FMEA
Probabilit y of failure Possible failure rat es Ranking
Very High - Persistent Failures ≥ 100/thousand vehicles/items 10
50/thousand vehicles/items 9
High - Repeated Failures 20/thousand vehicles/items 8
Moderate - Occasional failures 5/thousand vehicles/items 6
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

45
Appendix 3
Detection rating for Design FMEA
Detection Criteria: Likelihood of detection by design
control
Ranking
Absolute
uncertainty
Design control will not and/or cannot detect a potential
cause/mechanism and subsequent failure mode; or there is
no design control
10
Very remote Very remote chance that the design control will detect a
potential cause mechanism and subsequent failure mode
9
Remote Remote chance that the design control will detect a potential
cause mechanism and subsequent failure mode
8
Very Low Very Low chance that the design control will detect a
7
Low Low chance that the design control will detect a potential
6
Moderate Moderate chance that the design control will detect a
5
Moderately High Moderately High chance that the design control will detect a
4
High High chance that the design control will detect a potential
3
Very High Very high chance that the design control will detect a
2
Almost certain Design control will almost certainly detect a potential
cause/mechanism and subsequent failure mode
1

46
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

47
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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