Professional Documents
Culture Documents
(FMEA)
1
Sequence of System
Feasibility Study
Process FMEA
Control Plan
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Types of FMEA
•System 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
FMEA
CORE TEAM DATE(ORIG.)
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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
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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.
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.
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
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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
*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.
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
Detection
Column
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RPN / Risk Priority Number
RPN = Severity x Occurrence x Detection
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
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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:
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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.
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The FMEA is a living document
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Thank you
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