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Failure Mode and Effects Analysis

(FMEA)

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Sequence of System

Drawings and Specification

Feasibility Study

Process Flow Diagram

Process FMEA

Control Plan

Process Sheet and Work


Instruction
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What Is An FMEA?
FMEA is a systematic analytical, logical & progressive
potential failure analysis technique (a paper test) that
combines the technology and experience of several
engineering disciplines in identifying foreseeable failure
modes of a product / process/ system and service and
planning for its elimination.

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Types of FMEA
•System FMEA (System / Sub system / Component)

•Design FMEA (System/Sub System / Component)

•Process FMEA

•Service FMEA

•Machines

•Human Resources

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POTENTIAL
FAILURE MODE AND EFFECT ANALYSIS
(PROCESS FMEA) FMEA NUMBER

PROCESS
ITEM RESPONSIBILTY PAGE OF

MODEL YEAR(S) / VEHICLE(S) KEY DATE PREPARED BY

FMEA
CORE TEAM DATE(ORIG.)

Item / C O D Action Results


Process Potential Current Response &
Potential Potential S l c Process e R
Step Cause(s)/ Recommended Traget S O D R
Failure Effect(s) of e a c Controls t P Action
Mechanism(s) Actions Complete E C E P
Mode Failure v s u e N Taken
Of Failure Date V C T N
s r c
Function Prevent Detect

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FMEA Preparation Vertical
Approach
– Key Elements of Efficient Development
– Identify all functions/process steps
– Identify all failure modes via
brainstorming/data/warranty/COQ
– Identify all effects via brainstorming/data
• Customer focus
– Develop data pools for
• Failure Modes, Effects and Causes for future/ faster FMEA
development

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System/Subsystem/ Design FMEA
– Effect
• Customer view/customers words
• Regulation violation
• Level of dissatisfaction
– Consider All Customers
• End User
• Engineering Community
• Manufacturing Community
• (Operators/Employees)
• Regulatory Body

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Severity Column
Item / C O D Action Results
Process Potential Current Response &
Potential Potential S l c Process e R
Step Cause(s)/ Recommended Traget S O D R
Failure Effect(s) of e a c Controls t P Action
Mechanism(s) Actions Complete E C E P
Mode Failure v s u e N Taken
Of Failure Date V C T N
s r c
Function Prevent Detect

Severity
Column

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Severity Column

An assessment of the seriousness of the effect to

- The next level of operation


- Assembly operation
- End User ( Final Customer)

•Applies to the effect and effect only

•Severity expressed as a number on a scale of 1 to 10

•A reduction in severity ranking can be achieved only through a product


or process design change.

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AUTOMOTIVE EXAMPLE SEVERITY EVALUATION CRITERIA
Criteria: Severity of Effect Criteria: Severity of Effect
The ranking results a potential failure mode results in a The ranking results a potential failure mode results in a final
R
final customer and/or a manufacturing/assembly plant customer and/or a manufacturing/assembly plant defect. The
Effect anki
defect. The final customer should always be considered final customer should always be considered first. If both occur,
ng
first. If both occur, use the higher of the two severities. use the higher of the two severities.
(Customer Effect) (Manufacturing/Assembly Effect )

Hazardous Very high severity ranking when a potential failure mode affects
without safe vehicle operation and/or involves noncompliance with Or may endanger operator (machine or assembly) without warning. 10
warning government regulation without warning.

Hazardous Very high severity ranking when a potential failure mode affects
with safe vehicle operation and/or involves noncompliance with Or may endanger operator (machine or assembly) with warning. 9
warning government regulation with warning.

Or 100% of product may have to be scrapped, or vehicle/item


Very high Vehicle/Item inoperable (loss of primary function) repaired in repair department with a repair time greater than one 8
hour.

Or Product may have to be sorted and a portion (less than 100%)


Vehicle/Item operable, but at reduced level of performance,
High scrapped, or vehicle/item repaired in repair department with a repair 7
Customer very dissatisfied.
time between a half-hour and an hour.

Or a portion (less than 100%) of the product may have to be


Vehicle/Item operable, but comfort/Convenience item(s)
Moderate scrapped with no sorting, or vehicle/item repaired in repair 6
inoperable Customer dissatisfied.
department with a repair time less than a half-hour.

Vehicle/Item operable, but comfort/Convenience item(s)


Or 100% of product may have to be reworked, or vehicle/item
Low inoperable at a reduced level of performance. Customer 5
repaired offline but does not got to repaire department.
somewhat dissatisfied.

Fit & Finish/Squeak & Rattle item does not conform. Defect Or the product may have to be sorted, with no scrap, and a portion
Very Low 4
noticed by most customers (greater than 75%) (less than 100%) reworked.

Fit & Finish/Squeak & Rattle item does not conform. Defect Or a portion (less than 100%) of the product may have to be
Minor 3
noticed by 50% of customers reworked, with no scrap , on-line but out of station.

Fit & Finish/Squeak & Rattle item does not conform. Defect Or a portion (less than 100% of the product may have to be
Very Minor 2
noticed by discriminating customers (less than 25%) reworked, with no scrap, on-line but in-station.

None No discernible effect. Or slight inconvenience to operation or operator, or no effect.


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Classification And Definition
Column
C O D Action Results
Item Potential Response &
Potential Potential S l c Current e R. Recommended
Cause(s) / Target
Failure Effect(s) of e a c Design t P. Actions Actions S O D R.
Mechanism(s) Complete
Mode Failure v s u Controls e N. Taken e c e P.
of Failure Date
Function s r c v c t N.

Classification and
Definition Column

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Failure Mode/Cause Relationship
In Different FMEA Levels
Inadequate
Electrical
Connection
Failure
Cause Mode
Motor
Stops
Failure
Mode Inadequate
Electrical Connection

Inadequate Causes Harness


Locking Too Short
Feature

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Potential Causes of Failures
– A identification of a design weakness
– A root cause, not a symptom
– Actionable, corrective action pointed at this
weakness can reduce the risk
– Carryout root cause analysis as a separate
exercise before listing the causes using Cause
and effect Analysis.
– Continue through all failure modes.
– Note that many causes are recurring.
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Occurrence Column
Item / C O D Action Results
Process Potential Current Response &
Potential Potential S l c Process e R
Step Cause(s)/ Recommended Traget S O D R
Failure Effect(s) of e a c Controls t P Action
Mechanism(s) Actions Complete E C E P
Mode Failure v s u e N Taken
Of Failure Date V C T N
s r c
Function Prevent Detect

Occurrence
Column

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Occurrence Evaluation Criteria
SUGGESTED OCCURRENCE EVALUATION CRITERIA
Probability of Likely Failure Rates Over Design Life Ranking
Failure

≥ 100 per thousand vehicles/items 10


Very High: Persistent failures
50 per thousand vehicles/items 9

20 per thousand vehicles/items 8


High: Frequent failures
10 per thousand vehicles/items 7

5 per thousand vehicles/items 6


Moderate: Occasional failures 2 per thousand vehicles/items 5
1 per thousand vehicles/items 4

0.5 per thousand vehicles/items 3


Low: Relatively few failures
0.1 per thousand vehicles/items 2

Remote: Failure is unlikely ≤ 0.01 per thousand vehicles/items 1

*Note: Zero (0) rankings for Severity, Occurrence or Detection are not allowed

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Occurrence Rating
– If an action would effectively eliminate the
possibility of the cause occurring, the action is
listed as described earlier.
• Occurrence of 1 or 2 require proof using a surrogate
product or mistake proofing.

DATA HARD FACTS 16


Example of Significant/ Critical
SpecialThreshold
Characteristics Matrix

10 POTENTIAL CRITICAL
9 CHARACTERISTICS Safety/Regulatory
S
E 8 POTENTIAL
V 7 SIGNIFICANT
E 6 CHARACTERISTICS
Customer Dissatisfaction
R 5
I 4 ANOYANCE
T 3 ZONE
Y 2 ALL OTHER CHARACTERISTICS

Appropriate actions /
1 controls already in place

1 2 3 4 5 6 7 8 9 10
OCCURRENCE
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*Used by permission of Ford Motor Company
Detection Rating
Inspection
Types
Detection Criteria Suggested Range of Detection Methods Ranking
A B C

Almost Impossible Absolute certainly of non- detection X Cannot detect or is not checked. 10

Very Remote Controls will probably not detect X Control is achieved with indirect and random checks only. 9

Remote Controls have poor chance of detection. X Control is achieved with Visual Inspection only. 8

Very Low Controls have poor chance of detection. X Control is achieved with double visual inspection only 7

Control is achieved with charting methods, such as SPC


Low Controls may detect X X 6
(Statistical Process Control.)

Control is based on variable gauging after parts have left


Moderate Controls may detect X the station, or Go/No Go gauging performed on 100% 5
of the parts after parts have left the station.

Error detection in subsequent operations, OR gauging


Moderately High Controls have a good chance to detect X X performed on setup and first piece check (for set-up 4
causes only.)

Error detection in-station, or error detection in subsequent


High Controls have a good chance to detect X X operations by multiple layers of acceptance: supply, 3
select, install, verify. Cannot accept discrepant part.

Error detection in-station (automatic gauging with automatic


Very High Controls almost certain to detect. X X 2
stop feature). Cannot pass discrepant part..

Discrepant parts cannot be made because item has been


Very High Controls certain to detect. X 1
error-proofed by process/product design. 18
Detection Column
Item / C O D Action Results
Process Potential Current Response &
Potential Potential S l c Process e R
Step Cause(s)/ Recommended Traget S O D R
Failure Effect(s) of e a c Controls t P Action
Mechanism(s) Actions Complete E C E P
Mode Failure v s u e N Taken
Of Failure Date V C T N
s r c
Function Prevent Detect

Detection
Column

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RPN / Risk Priority Number
RPN = Severity x Occurrence x Detection

Top 20% of Failure


Modes by RPN

R
P
N

Failure Modes
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Evaluation by RPN Only
– Case 1
• S=5 O=5 D=2 RPN = 50
– Case 2
• S=3 O=3 D=6 RPN = 54 WHICH ONE IS
– Case 3
WORSE?
• S=2 O=10, D=10 = 200
– Case 4
• S=9 O=2 D=3 = 54

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Example
– Extreme Safety/Regulatory Risk
• =9 & 10 Severity
– High Risk to Customer Satisfaction
• Sev. > or = to 5 and Occ > or = 4

– Consider Detection only as a measure of Test


Capability.

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Example of Significant/ Critical
SpecialThreshold
Characteristics Matrix

10 POTENTIAL CRITICAL
9 CHARACTERISTICS Safety/Regulatory
S
E 8 POTENTIAL
V 7 SIGNIFICANT
E 6 CHARACTERISTICS
Customer Dissatisfaction
R 5
I 4 ANOYANCE
T 3 ZONE
Y 2 ALL OTHER CHARACTERISTICS

Appropriate actions /
1 controls already in place

1 2 3 4 5 6 7 8 9 10
OCCURRENCE
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*Used by permission of Ford Motor Company
Actions
Your Company Name Here Potential
Failure Mode and Effects Analysis
System (Design FMEA) FMEA Number:
Subsystem Page of
Component: Design Responsibility: Prepared by:
Key Date: FMEA Date (Orig.): (Rev.):
Model Year/Vehicle (s):
Core Team:
Item Action Results
c Potential Responsibility
Potential Potential s l o Current D R.
e a Cause (s)/ c P. Recommended & Target Actions
Failure Effect (s) of c Design e
v s Mechanism (s) t N. Action(s) Completion Taken
Mode Failure s u Controls s o D R.
Failure r e Date
c e c e P.
Function v c t N.

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Actions
EXAMPLE:

Project: Date Of
Meeting:

Issue Issue Status/ Issue Action Action Action Person Resp. Completion
Number Open Date Champion Number Date Team Date
143

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Re-rating RPN After Actions Have Occurred
Your Company Name Here Potential
Failure Mode and Effects Analysis
System (Design FMEA) FMEA Number:
Subsystem Page of
Component: Design Responsibility: Prepared by:
Key Date: FMEA Date (Orig.): (Rev.):
Model Year/Vehicle (s):
Core Team:

Item Action Results


Potential Potential S C Potential O Current D R. Recommended Responsibility
e l c e P.
Failure Effect (s) of v a Cause (s)/ c Design t N. Action(s) & Target S O D R.
Actions
Mode Failure s Mechanism (s) u Controls e Completion e c e P.
s r c Taken v c t N.
Failure Date
Function

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Re-rating RPN After Actions Have
Occurred
– Severity typically stays the same.
– Occurrence is the primary item to reduce / focus on.
– Detection is reduced only as a last resort.
– Do not plan to REDUCE RPN with detection actions!!!
• 100% inspection is only 80% effective!
• Reducing RPN with detection does not eliminate failure mode, or
reduce probability of causes
• Detection of 10 is not bad if occurrence is 1

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Summary
– FMEA can be used creatively in continuous processing.

– Linking key customer requirements to process outputs


instead of standard product grade is valuable.

– Future customer requirements will drive new and modified


processes to achieve specialty results as a normal practice

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The FMEA is a living document

and should always reflect the latest

Design level , as well as the latest

relevant actions in production

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Thank you

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