Amit Lunia

QMS India Limited

www.qmsil.co.in

Failure Mode and Effect Analysis

Amit Lunia
QMS India Ltd
1
 Failure Modes and Effects Analysis

Failure
FailureMode
Mode
Cause
Cause Effect
Effect
(Defect)
(Defect)

Amit Lunia
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QMS India Ltd
 Quality of Events.

• For all 23 elements, quality expectations are

defined in the guideline
• Out of these 23 elements, the following 8 elements
are considered as focus elements;
Design FMEA Process FMEA
Design Verification Plan Pre-Launch Control Plan
Prototype Build Control Plan Operator Process Instructions
Manufacturing Process Flow Chart Production Control Plan

• These elements when completed with ‘Quality’ and

“On Time” lay a foundation for Programme success

Amit Lunia 3
QMS India Ltd
 • Rule of Ten

Design Process SPC PPM SPC PPM

FMEA FMEA
COST OF QUALITY

Product Design & Process Design Purchasing Manufacturing Use

Development & Development

POTENTIAL DEFECT INTERNAL DEFECT EXTERNAL

MANUFACTURER CUSTOMER
Rs.1 /- Rs.10 /- Rs.100 /- Rs.1000 /- Rs.10000 /-

Amit Lunia
QMS India Ltd
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 What is FMEA
• A failure modes and effects analysis (FMEA) is a
procedure for analysis of potential failure modes
within a system for classification by severity or
determination of the effect of failures on the system.
It is widely used in manufacturing industries in
various phases of the product life cycle and is now
increasingly finding use in the service industry.
• Failure modes are any errors or defects in a process,
design, or item, especially those that affect the
customer, and can be potential or actual.
• Effects analysis refers to studying the consequences
of those failures.
Amit Lunia
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QMS India Ltd
Amit Lunia
QMS India Ltd
 Potential Failure Mode
• Examples 8 Loose
• Bent 8 Leaking
• Burred 8 Mis-oriented
• Dirty 8 Tool Mark on part
• Cracked 8 Tool worn
• Deformed 8 Handling Damage
• Corroded 8 Improper Set-up
• Paint blistered

Amit Lunia 7
QMS India Ltd
 Potential Effects of Failure
Examples
• Next Operation : Cannot fasten, Cannot bore/tap, Cannot
mount, Does not fit, Does not match, Damages equipment,
Endangers operator
• Customer : Noise, Erratic operation, Poor Appearance,
Unstable, Rough, Inoperative, Unpleasant odor, Operation
impaired, Vehicle control impaired, excessive effort required
• If there is an adverse effect on n environmental
regulation, enter “May not comply with government
regulation XYZ”
Amit Lunia 8
QMS India Ltd
 Potential Cause Mechanism
• Tolerance build up •Yield
• insufficient material
•Fatigue
• insufficient lubrication capacity
• Vibration •Material instability
• Foreign Material
• Interference •Creep
• Incorrect Material thickness specified
• exposed location •Wear
• temperature expansion
•Corrosion
• inadequate diameter
• Inadequate maintenance instruction
• Over-stressing
• Over-load
• Imbalance
• Inadequate tolerance
Amit Lunia
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QMS India Ltd
 Severity
• Severity is an assessment of the seriousness of the
effect of the potential failure mode to the customer
• It applies to the effects only
• Estimated on a “1 to 10” scale
• The severity of the effects on the vehicle and
ultimate customer will be shown in the Design FMEA
for the part
• Team should have consensus on severity of each
effect using the Severity Rating Table
• Rate each effect and put highest severity in next
column

Amit Lunia 10
QMS India Ltd
 Effect Criteria
Severity of effect on product
(customer Effect)
Failure to meet safety and / Potential Failure mode effects safe
or regulatory requirements vehicle operation and/or involves non-
compliance with government
regulation with out warning
Potential Failure mode effects safe
vehicle operation and/or involves non-
compliance with government
regulation with warning
Loss or degradation of Loss of primary function (vehicle
primary function operable ,does not effect safe vehicle
operation)
Loss of primary function (vehicle
operable ,but at reduced level of
performance)
Loss or degradation of Loss of Secondary function (vehicle
secondary function operable, but comfort /convenience
function inoperable)
Degradation of secondary function
(vehicle operable, but comfort
/convenience function at reduced level
of performance )
Annoyance Appearance or Audible noise, vehicle
operable, item does not conform and
noticed by most customer (>75%)
Appearance or Audible noise, vehicle
operable, item does not conform and
noticed by most customer (>50%)
Appearance or Audible noise, vehicle
operable, item does not conform and
noticed by discriminating customers
(<75%)
Amit Lunia
No effect
QMS India Ltd
No discernible Effect
Rank Effect Criteria
Severity of effect on product
(Manufacturing /Assembled Effect)
10 Failure to meet May Endanger Operator (Machine or
safety and / or Assembly) Without Warning
regulatory
requirements
May Endanger Operator (Machine or
9 Assembly) Without Warning
8 Major Disruption 100%of product may have to be scrapped
.line shutdown or stop ship.
7 Significant A portion of the production may have to
Disruption be scrapped .deviation from Primary
process including decreased line speed or
added man power.
6 Moderate 100% of product may have to be
Disruption reworked off line and accepted.
5 A portion of the production run may have
to be reworked off line and accepted
Moderate 100% of product may have to be
4 Disruption reworked in portion before it processed.
A portion of the production run may have
3 to be reworked in portion before it
processed.
2 Minor Slight inconvenience to process,
Disruption operation or operator.
11
1 No effect No discernible Effect
 Potential Cause(s) of Failure

• It is defined as how the failure could occur, described

in terms of something that can be corrected, or can
be controlled
• The failure cause assignable to each potential failure
mode should be listed
• Identify the cause(s) using techniques such as
• Cause & Effect diagram
• ‘Ask Why’
• Fault Tree Analysis
• Do not use terms like operator error, machine
malfunction or improper set up

Amit Lunia 12
QMS India Ltd
 Occurrence
• It is how frequently the specific failure
cause/mechanism is projected to occur
• The occurrence ranking number has a meaning
rather than a value
• Estimated on a “1” to “10” scale
• The failure rate can be based upon historical
manufacturing and assembly failure rates
experienced with similar parts or process
• As far as possible assign occurrence rating to each
cause
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QMS India Ltd
 Like hood Criteria: occurrence of cause –PFMEA RANK
failure (incidents per items vehicle)

>100 Per Thousand

VERY HIGH 10
>1 in 10
50 Per Thousand Suggested
9 PFMEA
1 in 20
>20 Per Thousand Occurrence
HIGH 8 Evaluation
>1 in 50
10 Per Thousand Criteria
7
1 in 100
2 Per Thousand
6
>1 in 500
.5 Per Thousand
MODERATE 5
1 in 2000
.1 Per Thousand
1 in 10000 4
.01 Per Thousand
3
1 in 10,000
LOW
.001 Per Thousand
2
1 in 1,000,000
Failure Is Eliminated Through Preventive
VERY LOW 1
Control
Amit Lunia
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QMS India Ltd
 Current Process Controls
Descriptions of the controls that either prevent the failure mode from occurring or detect the
failure mode should it occur

• Preventive • Detection
– SPC – Functional test
– Inspection verification – Visual inspection
– Work instructions – Touch for quality
– Maintenance – Gauging
– Error proof by design – Final test
– Method sheets
– Set up verification
– Operator training

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QMS India Ltd
 Opportunity for Criteria: RANK Like hood of
Detection Like hood for detection by process control detection
Almost Impossible
No detection opportunity No current process control; cannot or is not analyzed. 10
Very
No likely to detect at any
stage.
Failure mode and/or Error (cause) is not easily detected (e.g. random audits) 9 Remote

Remote
Problem Detection Post
Processing
Failure Mode detection post-processing by operator through visual/tactile/audible means. 8

Very Low
Failure mode detection in station by operator through visual/tactile/audible means or post-
Problem detection at sources
processing through of attribute gauging (go &no go, manual torque check/clicker wrench, etc.) 7

Low
Problem Detection Post Failure mode detection post-processing by operator through of variable gauging or in station by
Processing operator through use of attribute gauging (go &no go, manual torque check/clicker wrench, etc.) 6

Moderate
Failure mode or Error cause detection in station by operator through use of variable gauging or by
Problem detection at sources automated controls in station that will defect discrepant part and notify operator (light, buzzer, 5
etc.). gauging performed on setup and first piece check (for set cause only)

Problem Detection Post Failure mode detection post-processing by automated controls that will detect discrepant part and Moderate high
Processing lock part to prevent further processing. 4
High
Failure mode detection post-processing by automated controls that will detect discrepant part and
Problem detection at sources
lock part to prevent further processing. 3

Very high
Error detection and /or Error (cause) Prevention in station by automated controls that will detect error and prevent
problem Prevention discrepant part from being made. 2

Almost certain
Detection not applicable; Error (cause) Prevention as a result of fixture design machine design part design. Discrepant
Error prevention parts cannot be made because item has been error-proofed by process/product design. 1
Amit Lunia
QMS India Ltd
 Ratings
Ratingsto
toDetermine
Determine
overall
overallRisk
Risk

•• Severity
Severity(SEV):
(SEV): HowHowsignificant
significantisisthe
theimpact
impactofofthe
theEffect
Effectto
tothe
the
customer (internal or external)?
customer (internal or external)?
•• Occurrence
Occurrence(OCC):
(OCC): HowHowlikely
likelyisisthe
theCause
Causeofofthe
theFailure
FailureMode
Modeto to
occur?
occur?
•• Detection
Detection(DET):
(DET): HowHowLikely
Likelywill
willthe
thecurrent
currentsystem
systemdetect
detectthe
theCause
Cause
or Failure Mode if it occurs?
or Failure Mode if it occurs? Each is Scored on a 1(Best)
Each is Scored on a 1(Best)
to
to10
10(Worst)
(Worst)Scale
Scale
Risk
RiskPriority
PriorityNumber
Number
• A numerical calculation of the relative risk of a particular Failure Mode.
• Risk Priority Number (RPN) = SEV x OCC x DET
• This number is then used to place priority on which items need additional quality
planning. Team must undertake efforts to reduce risk through corrective actions,
special attention should be given when severity is high
RPN Directs the Improvement Effort, however The use of RPN
threshold is NOT a recommended practice for determining the need for action.
Amit Lunia
QMS India Ltd
 Responsibility & Target Date
• Enter the individual or organisation responsible for
the recommended action and the target completion
date

Actions Taken
• After an action has been implemented
• Enter a brief description of result of the action
• Effective date for the change
• A tracking programme by process responsible
engineer is necessary to assure implementation
• Critical Characteristics and their special controls must
be identified and included in “Control Plans”
Amit Lunia 18
QMS India Ltd
 Customer Requirements
Design Specifications
Key Product Characteristics
Machine Process Capability

Process Process Operator

Flow Process FMEA Control Job
Diagram Plan Instructions

Conforming Product
Reduced Variation
Customer Satisfaction

Amit Lunia
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QMS India Ltd