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analysis
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
Work steps
Structure analysis
Failure analysis
Structure analysis
Risk assessment
Recommended correction
Liability
Improve condition
Measures taken
System improvement
Risk assessment
FMEA
Effect
None
Very minor
Minor
Very low
Low
Moderate
High
Very high
Hazardous: with
warning
Hazardous:
without warning
Rating
1
2
9
10
Probability of failure
Very highpersistent
failures
Highfrequent failures
Moderateoccasional
failures
Occurrence
100 per 1000 vehicles/items (10%)
50 per 1000 vehciles/items (5%)
Rating
10
9
Detection
Likelihood of detection
Almost certain
Very high
High
Moderately high
Moderate
Low
Very low
Remote
Very remote
Absolute
uncertainty
Rating
10
FMEA Form
Company
Part Name
Part Number
Model/System/Manufacture Technical
modification status
created by
Date revised date
FMEA Process
Detection
Consequence
Occurrence
Intended measurement
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
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
a toothbrush
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
Detect ability
Contingency
Occurrences
Potential
Causes(s)/Mechanism(s) of
Failure
Criticality
Severity
Function Item
Item
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
Loss of
rubber
impact
Impact resistant
plastic
FEA model
of impact
from 3
likely
direction
Thermal cycle
Thermal
cycle
testing
Chemical
exposure
Chemical attack/material
incompatibility
Chemically inert
plastic to mild
alkalis and acids
Sharp radius
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?