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
Systems/Features
Potential failure
Potential following failure
Cause of potential failure
Current condition
Provided test measures

Work steps
Structure analysis
Failure analysis
Structure analysis

Risk number 'occurrence'

Risk number 'concern'
Risk number 'detection'
Risk number precedence

Risk assessment

Recommended correction
Liability
Improve condition
Measures taken

System improvement

Risk number 'occurrence'

Risk number 'concern'
Risk number 'detection'
Risk number precedence

Risk assessment

FMEA

Effect
None
Very minor

Severity of effect defined

No effect
Minor disruption to production line; a portion (100%) of the product may
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

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

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

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

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

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

scrapped; vehicle/item inoperable, loss of primary function; customer very
dissatisfied
May endanger operator; failure mode affects safe vehicle
operation and/or involves noncompliance with govern-ment regulation;
failure will occur with warning
May endanger operator; failure mode affects safe vehicle
operation and/or involves noncompliance with government regulation;
failure will occur without warning

Hazardous: with
warning
Hazardous:
without warning

Rating
1
2

9
10

Probability of failure
Very highpersistent
failures

Highfrequent failures

Moderateoccasional
failures

Lowrelatively few failures

Occurrence
100 per 1000 vehicles/items (10%)
50 per 1000 vehciles/items (5%)

Rating
10
9

20 per 1000 vehicles/items (2%)

10 per 1000 vehicles/items (1%)

5 per 1000 vehicles/items (0.5%)

2 per 1000 vehicles/items (0.2%)

1 per 1000 vehicles/items (0.1%)

0.5 per 1000 vehicles/items (0.05%)

0.1 per 1000 vehicles/items (0.01%)

Detection

Likelihood of detection

Almost certain

Design control will almost certainly detect a potential

cause/mechanism and subsequent failure mode

Very high

Very high chance design control will detect a potential

cause/mechanism and subsequent failure mode

High

High chance design control will detect a potential

cause/mechanism and subsequent failure mode

Moderately high

Moderately high chance design control will detect a

potential cause/mechanism and subsequent failure mode

Moderate

Moderate chance design control will detect a potential

cause/mechanism and subsequent failure mode

Low

Low chance design control will detect a potential cause/

mechanism and subsequent failure mode

Very low

Very low chance design control will detect a potential

cause/mechanism and subsequent failure mode

Remote

Remote chance design control will detect a potential

cause/mechanism and subsequent failure mode

Very remote

Very remote chance design control will detect a potential

cause/mechanism and subsequent failure mode

Absolute
uncertainty

Design control will not and/or cannot detect a potential

cause/mechanism and subsequent failure mode; or

there is no design control

Rating

10

The fundamentals of an FMEA

inputs

FMEA Form
Company

Part Name

Failure mode and effects analysis

FMEA Construction

Part Number

Model/System/Manufacture Technical
modification status
created by
Date revised date

FMEA Process

confirmation by concerned Name/Dept./

departments and/or supplier Supplier

Risk priority numbers (RPN)

Detection

Consequence
Occurrence

Intended measurement

Risk priority numbers (RPN)

Detection
Consequence
Occurrence

Intended measurement

Systems Failure
Consequences D Cause of current condition recommended responsibility Improved condition
features potential potential failure
potential
measurement
failure
place

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?
Ho = Bristle loss

If Ho then reject H
If Not (Ho) then accept H

Failure mode
Where/how is this
determined
Where is this

Assumed outcomes

Target date

Responsibility

Recommended action

Then Contingency

RPN

If Ho is true based on information

Detect ability

Contingency

Current design control

Occurrences

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

Criticality

Severity

Potential effect of failure

Potential of failure mode

Function Item

Item

Else Design Control is accepted

3
H = Functional Item will not Fail because Current Design Controls work
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.

Loss of
rubber

impact

Impact resistant
plastic

FEA model
of impact
from 3
likely
direction

Thermal cycle

Thermal set plastic

with stable
material properties
from -30 deg c to
100 deg c

Thermal
cycle
testing

Chemical
exposure

Current design control

Chemical attack/material
incompatibility

Chemically inert
plastic to mild
alkalis and acids

Sharp radius

All radius must be

greater than 1 mm

Cutting or
hurting
consumers
hand

Potential
Causes(s)/Mechanis
m(s) of Failure

Occurrences

split in grip
insert area

Criticality

Handle

Potential
effect of
failure

Severity

Function
Item

Item
1

Potential of
failure mode

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?