Failure mode effect analysis

Dr. Ir. Muhammad Sabri

Failure mode and effects analysis
A procedure in product development and
operations management for analysis of
potential failure modes

within a system for classification by the

severity and likelihood of the failures.
Failure mode and effects analysis
Objective:
To identify potential failure modes based on
past experience with similar products or
processes.
To design those failures out of the system
with the minimum of effort and resource
expenditure.
Reducing development time and costs.
To estimate qualitative risk trough quantify
numbers of evaluation and show preventive
measures of potential failure
FMEA
What can go wrong and Where can
variation come from
prevent occurrence of failure modes and
to reduce variation
What should be included in the FMEA
◦ warranty experience
◦ customer wants, needs, and delights
◦ performance requirements
FMEA USAGE
To determine possible design and process
failure modes and sources of potential
variation in manufacturing, assembly,
delivery, and all service processes
To detect variations in customer usage;
potential causes of deterioration over useful
product life; and potential process issues
such as missed tags or steps, shipping
concerns, and service misdiagnosis.
FMEA USAGE
To modify product design and processes
to prevent the failure
To redesign of processes to reduce
product variation
To error proofing of designs and
processes
To anticipate failure modes and sources of
variation
DFMEA Steps
 FMEA Preparation steps
Form column Work steps
Systems/Features Structure analysis
Potential failure
Potential following failure Failure analysis
Cause of potential failure
Current condition
Structure analysis
Provided test measures
 
Risk number 'occurrence'
Risk number 'concern'
Risk assessment
Risk number 'detection'
Risk number precedence
 
Recommended correction
Liability
System improvement
Improve condition
Measures taken
 
Risk number 'occurrence'
Risk number 'concern'
Risk assessment
Risk number 'detection'
Risk number precedence
 
FMEA
Effect Severity of effect defined Rating
None No effect 1
Very minor Minor disruption to production line; a portion (100%) of the product may 2
have to be reworked on line but in station; fit/finish/squeak/rattle item does
not conform; defect noticed by discriminating customers
Minor Minor disruption to production line; a portion (100%) of the product may 3
have to be reworked on line but out of station; fit/finish/squeak/rattle item
does not conform; defect noticed by average customers

Very low Minor disruption to production line; product may have to be sorted and a 4
portion (100%) reworked; fit/finish/ squeak/rattle item does not conform;
defect noticed by most customers

Low Minor disruption to production line; 100% of product 5

may have to be reworked; vehicle/item operable, but some
comfort/convenience item(s) operable at reduced level of performance;
customer experiences some dissatisfaction
Moderate Minor disruption to production line; a portion (100%) may have to be 6
scrapped (no sorting); vehicle/item operable, but some comfort/convenience
item(s) inoperable; customers experience discomfort

High Minor disruption to production line; product may have to be sorted and a 7
portion (100%) scrapped; vehicle operable, but at a reduced level of
performance; customer dissatisfied
Very high Major disruption to production line; 100% of product may have to be 8
scrapped; vehicle/item inoperable, loss of primary function; customer very
dissatisfied
Hazardous: with May endanger operator; failure mode affects safe vehicle 9
warning operation and/or involves noncompliance with govern-ment regulation;
failure will occur with warning
Hazardous: May endanger operator; failure mode affects safe vehicle 10
without warning operation and/or involves noncompliance with government regulation;
failure will occur without warning
Probability of failure Occurrence Rating

Very high—persistent failures 100 per 1000 vehicles/items (10%) 10

50 per 1000 vehciles/items (5%) 9

High—frequent failures 20 per 1000 vehicles/items (2%) 8

10 per 1000 vehicles/items (1%) 7

Moderate—occasional failures 5 per 1000 vehicles/items (0.5%) 6

2 per 1000 vehicles/items (0.2%) 5

1 per 1000 vehicles/items (0.1%) 4

Low—relatively few failures 0.5 per 1000 vehicles/items (0.05%) 3

0.1 per 1000 vehicles/items (0.01%) 2
Detection Likelihood of detection Rating
Almost certain Design control will almost certainly detect a potential 1
cause/mechanism and subsequent failure mode
Very high Very high chance design control will detect a potential 2
cause/mechanism and subsequent failure mode
High High chance design control will detect a potential 3
cause/mechanism and subsequent failure mode
Moderately high Moderately high chance design control will detect a 4
potential cause/mechanism and subsequent failure mode
Moderate Moderate chance design control will detect a potential 5
cause/mechanism and subsequent failure mode
Low Low chance design control will detect a potential cause/ 6
mechanism and subsequent failure mode
Very low Very low chance design control will detect a potential 7
cause/mechanism and subsequent failure mode
Remote Remote chance design control will detect a potential 8
cause/mechanism and subsequent failure mode
Very remote Very remote chance design control will detect a potential 9
cause/mechanism and subsequent failure mode
Absolute Design control will not and/or cannot detect a potential 10
uncertainty cause/mechanism and subsequent failure mode; or
there is no design control
The fundamentals of an FMEA inputs
 FMEA Form
Company Part Name Part Number
Failure mode and effects analysis
FMEA Construction FMEA Process  
Model/System/Manufacture Technical
modification status
                 
confirmation by concerned Name/Dept./ created by Date revised date
departments and/or Supplier
supplier  
   
Systems Failure Consequences D Cause of current condition recommended responsibility Improved condition
features potential potential failure potential measurement
failure place

Risk priority numbers (RPN)

Risk priority numbers (RPN)

Intended measurement

Intended measurement
Consequence

Consequence
Occurrence

Occurrence
Detection

Detection
 

                               
PFMEA
is used to analyze manufacturing, assembly, or any other
processes such as those identified as transactional
focus is on process inputs. Software FMEA documents and
addresses failure modes associated with software functions.
Identifying potential manufacturing/assembly or production
process causes in order to place controls on either increasing
detection, reducing occurrence, or both
Prioritizing the list of corrective actions using strategies such
as mitigation, transferring, ignoring, or preventing the failure
modes
Documenting the results of their processes
Identifying the special potential process variables (PVs), from
a failure standpoint, which need special controls
DFMEA
Design Failure Mode Effects Analysis (DFMEA) is the
disciplined analysis of potential failures in the design
The DFMEA is a team effort usually conducted by a
facilitator who collects the team's input and guides the
processes.
the process will identify the key functional items, potential
failure modes, their root causes and any corrective action.
The process leads to a better design and can help guide the
testing and validation process. If used correctly, it can
provide context to the data that physical testing will
produce so the behavior of the company can be influenced.
DFMEA
is used to analyze designs before they are
released to production
should always be completed well in
advance of a prototype build
input to DFMEA is the array of functional
requirements
The outputs are (1) list of actions to prevent
causes or to detect failure modes and (2)
history of actions taken and future activities
DFMEA
Function
◦ Estimating the effects on all customer segments
◦ Assessing and selecting design alternatives
◦ Developing an efficient validation phase within the
DFSS algorithm
◦ Prioritizing the list of corrective actions using
strategies such as mitigation, transferring, ignoring,
or preventing the failure modes
◦ Identifying the potential special design parameters
(DPs) in terms of failure
◦ Documenting the findings for future reference
Basic DFMEA parts:

Functional Item: The functional feature

or design feature from the Bill of Material
(BOM).
Potential Failure Mode: Key word is
potential. What failure modes could the
feature experience? Source for this is
engineering experience, warranty data and
pure imagination.
Basic DFMEA parts
Potential Effect(s) of Failure" What are the results of
the failure on the function or behaviour of the
product? Often the failure itself is not visible, but the
functional effect will be apparent. For example, a
sealed bearing may have excessive wear, but the
failure is not visible externally. The effect of
increased friction is a slowing of the motor or an
increase in the power draw. The effects are key to
designing instrumentation and operational checks for
tests to verify the existence of failure modes.
Severity" How bad are the consequences of the
failure?
Basic DFMEA parts
Criticality: How critical to the function of
the device is the failure mode?
Potential Causes: The key word here is
mechanism. What can break the product?
Basic DFMEA parts
Occurrence: What is the likelihood of
failure?
Controls: What is the current design
effort to prevent the design from failing?
Detectability: How well can the failure
mode be detected if it exists?
Basic DFMEA parts
RPN: Risk Priority Number is the
multiple of all four ratings: Severity x
Criticality x Occurrence x Detectability.
Responsibility: Who will take
responsibility for implementing the
recommended action?
Target Date: When will the recommended
action be completed?
Basic DFMEA parts
Process of DFMEA should start at the
conceptual design process
should be kept current throughout the
process and lead into the Process Failure
Mode Effects Analysis (PFMEA)
Use as a foundation for any follow on
development process
Good practice of DFMEA
Initiation:
A DFMEA should start as soon as the design
development process starts. At this stage, the
details of specific design features may not be
available and the potential failure modes will be
naturally broad. Going through the disciplined
process of capturing all potential failure modes at
this stage will help to drive the development more
efficiently. The DFMEA at this point can be used
to develop the general outline of the validation
plan.
Good practice of DFMEA
Design Iteration:
As the design is iterated, the DFMEA
should be kept current. This will include
adding details as design features are
developed and changing details as design
changes are made. The DFMEA at this
point should be used to begin planning the
details of the validation plan.
Good practice of DFMEA
Design Validation:.
At this point the design should be nearly
complete The DFMEA should reflect all the
details of the design and the corresponding
potential failure modes. Most of the changes
to the DFMEA should now be reflecting the
closing of recommended actions. The
validation plan should reflect checks on all
the key assumptions in the DFMEA.
Good practice of DFMEA
Production Validation:
The DFMEA should still reflect minor
changes implemented to improve or
correct production problems. Since many
DFMEA's are used as the basis for the
next project, this step is critical.
Validation should reflect checks on the
changes.
Good practice of DFMEA
Production Run:
The DFMEA should still reflect minor
changes implemented to improve or
correct production problems. Since many
DFMEA's are used as the basis for the
next project, this step is critical.
Validation should reflect checks on the
changes.
Why is it important to have the DFMEA fit
with the validation plan? Remember that
the DFMEA is based on the individual's
assumptions of what the potential failures
are. The design will be developed based on
these assumptions. The purpose of
validation is to validate that the design will
behave in the real world as well as it does
in the designer's mind
Hypothesis and the DFMEA
If you consider the DFMEA from the
viewpoint of the scientific method,
a couple of key points about the structure and
use of the DFMEA becomes obvious. The
Failure Mode is actually the Null Hypothesis.
In other words, the potential failure mode is
what the design assumes will not happen.
What is not clear in the standard DFMEA
format is how the accuracy of the assumptions
(Hypothesis/Null Hypothesis) are tested.
Hypothesis and the DFMEA
The recommended action should contain the
method by which the hypothesis and null
hypothesis is verified.
The second thing that is missing from the
DFMEA is what to do if the hypothesis is
false.
Using the modified format, the recommended
action contains the key steps for the validation
plan. The actions that determine the accuracy
of the assumptions define the test plan.
The recommended actions may also
contain other action items relevant to
design changes and other issues.
However, every assumption should have
objective evidence clearly documented to
support the use of the design control or
the implementation of any contingency.
a toothbrush
 Hypothesis and the DFMEA
Functional item

Hypothesis: Toothbrush bristles will stay in toothbrush head.

Null Hypothesis: Bristles will fall out under some circumstances.

H = No bristle loss determined?

Failure mode
Ho = Bristle loss
Where/how is this
If Ho then reject H
determined
If Not (Ho) then accept H

Where is this

Assumed outcomes
 Item

Function Item

Potential of failure mode

Potential effect of failure

Severity

Criticality

Potential Causes(s)/Mechanism(s) of Failure

Occurrences

Current design control

Contingency

Detect ability

RPN

Recommended action

Responsibility

Target date
Else Design Control is accepted
If Ho is true based on information Then Contingency

1
2
H = Functional Item will not Fail because Current Design Controls work
3
Ho = Functional Item will fail due to Mechanism causing Failure Mode
Ho is accepted or rejected based on Recommended Action
One logical failure mode to be considered
is that the insert area causes the handle to
split.
The effect of this could be the loss of the
rubber insert, separation of neck and
cutting or hurting the consumer's hand.
There are many potential causes: impact,
thermal cycle, chemical attack/material
incompatibility, fatigue and Sharp radius.
The critical part of this example is the detection methods. For
each potential failure, there is an effect, a mechanism and a
corresponding method of detection.
The method of detection should reflect the suspected
mechanism and take advantage of the potential effect to design
a test that will impose the mechanism and monitor for the
effect. For example, the loss of rubber due to impact can be
tested by imparting an impact and monitoring for rubber loss.
DFMEA could lead to a very large number of discrete tests.
Just in a brief look at one failure in one design feature results
in four tests. Two of the tests are relatively quick (FEA model,
load testing), and two of them could take a significant amount
of time (thermal cycle, chemical exposure).
it will result in a very exhaustive list of discrete testing.
To make the DFMEA more effective and tied
more closely to the validation plan, add a column
called Contingency next to the Current Design
Controls column.
This clearly shows that if the hypothesis is
correct, the Current Design Controls will remain;
if the null hypothesis is true, then the Contingency
will be tried.
Clearly declaring the contingency allows the
development timeline to reflect the actual
decision based on the information.
 Function Item

Occurrences
Criticality
Severity
Potential Potential
Potential of
Item

effect of Causes(s)/Mechanism( Current design control

failure mode
failure s) of Failure

1 Handle split in grip Loss of 3 impact 8 Impact resistant FEA

insert area rubber plastic model of
impact
from 3
likely
direction
2 3 3 Thermal cycle 8 Thermal set plastic Thermal
with stable cycle
material properties testing
from -30 deg c to
100 deg c
3 3 Chemical attack/material 8 Chemically inert Chemical
incompatibility plastic to mild exposure
alkali’s and acids
4 3 Sharp radius 5 All radius must be
greater than 1 mm
5 Cutting or 8 8
hurting
consumers
hand
Exercise
Fill up all the functional item for the tooth
bush for the rest of the part
What conclusion can you grab from the
table analysis
Is the RPN give you a good measurement
on intended design
Can you eliminated all failure causes
using this technique?