1. FMEA Potential Failure Mode and Effects Analysis
Design-/ Prozeß-FMEA
FMEA
Potential Failure Mode and Effects Analysis
Design and Process FMEA
Version

2. Design-/ Prozeß-FMEA
Reference Material
Potential Failure Mode and Effect Analysis Reference-Manual (Third Edition, Juli 2001)
VDA 4.2 (1996)
APQP & CP Reference Manual (1994)
APQP Status Reporting Process (Ford, Checklist)
PPAP Third Edition ( )
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3. Design-/ Prozeß-FMEA
FMEA
Definition (QS-9000)
A systemized sequence of activities intended to:
1. recognize and evaluate the potential failure of a product/ process and its effects.
2. identify actions which could eliminate or reduce the chance of the potential failure occuring, and
3. document the process.
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4. Types of FMEAs (DaimlerChrysler/ QZ 5/2002)
Hybrid FMEA
Product and Process or Process and Product
integrate compatible data during Design- and Process planning phase
assure systematic feedback between both planning phases
achieve better elimination of failures using design approach

5. Types of FMEAs PPAP: Third Edition Sept. 1999
FMEA for Bulk Material
Design and Process FMEA
note: special ratings (S,O,D)
significant impact of bulk product characteristic and final product attributes
products: paint, oil, plastics...

6. Types of FMEAs Ford Motor Company (03.2001)
Machinery FMEA
Evaluation criteria (selection)
affects operator, plant or maintenance personnel
non-compliance with government regulation
downtime
defective parts
process parameter variability
MTBF: Mean Time between Failure

7. Types of FMEAs Ford Motor Company (03.2001)
Environment FMEA
Evaluation criteria (selection)
non-compliance with customer standards
non-compliance with legal regulations
fuel economy and recycling
vehicle interior air quality
allergenic materials
light weight material (energy consumption)

8. Types of FMEAs Ford Motor Company (APQP)
Logistik-FMEA
Evaluation criteria (selection)
non-compliance with legal regulations
long lead time and transportation routes
loading and unloading of dangerous goods
packaging

9. Types of FMEAs Concept FMEA
Design-/ Prozeß-FMEA
Types of FMEAs Concept FMEA
Definition (Ford):
Concept FMEAs analyze systems and subsystems and their interrelationships during early phases of the development process
potential failure modes are evaluated in correlation with planned functions and design intentions
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10. Evaluation Criteria for Design FMEA
Design-/ Prozeß-FMEA
Evaluation Criteria for Design FMEA
Failure Rate
(VDA)
Failure Rate (Ford/ AIAG)
Likelyhood
(VDA)
Severity (S)
Occurrence (O)
Detection (D)
Factor
Very high severity ranking when a potential failure mode affects safe vehicle operation and/ or involves non- compliance with government regulation without warning.
Very high: Persistent failures
ppm
³ 100 per 1.000
ppm
Absolute Uncertainty
90% 10
Very high severity ranking when a potential failure mode affects safe vehicle operation and/ or involves non- compliance with government regulation with warning.
ppm
50 per 1.000
ppm
Very remote
90% 9
Very high, vehicle/ item is inoperable (loss of primary function).
High: Frequent failures
ppm
20 per 1.000
ppm
Remote
98% 8
High, vehicle/ item is operable but at reduced level of performance. Customer is very dissatisfied.
ppm
10 per 1.000
ppm
Very Low
98% 7
Moderate, vehicle/ item is operable, but Comfort/ Convenience item(s) are inoperable. Customer is dissatisfied.
Moderate: Occasional failures
5.000 ppm
5 per 1.000
5.000 ppm
Low
99,7% 6
Low, vehicle/ item is operable, but Comfort/ Convenience item(s) are operable at a reduced level of performance. Customer is somewhat dissatisfied.
1.000 ppm
2 per 1.000
2.000 ppm
Moderate
99,7% 5
Very low, Fit & Finish/ Squeak & Rattle item does not conform. Defect is noticed by most customers (greater than 75%).
500 ppm
1 per 1.000
1.000 ppm
Moderately High
99,7% 4
Minor, Fit & Finish/ Squeak & Rattle item does not conform. Defect is noticed by 50% of customers.
Low: Relatively few failures
100 ppm
0,5 per 1.000
500 ppm
High
99,9% 3
Very minor, Fit & Finish/ Squeak & Rattle item does not conform. Defect is noticed by discriminating customers (less than 25%).
50 ppm
0,1 per 1.000
100 ppm
Very High
99,9% 2
None, no discernible effect.
Remote: Failure unlikely
1 ppm
£ 10 ppm
Almost Certain
99,99% 1
HNUHN_QMS
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11. Evaluation Criteria for Prozeß FMEA
Design-/ Prozeß-FMEA
Evaluation Criteria for Prozeß FMEA
Handout
Detection (D)
Failure Rate
(VDA)
Failure Rate
(Ford/ AIAG)
Likelyhood
(VDA)
Severity (S), final customer
Occurence (O)
Cpk
Factor
Very high severity ranking when a potential failure mode affects safe vehicle operation and/ or involves non- compliance with government regulation without warning.
Very high: Persistent failures
ppm
³ 100 von 1.000
ppm
< 0,33
Almost
impossible
90% 10
Very high severity ranking when a potential failure mode affects safe vehicle operation and/ or involves non- compliance with government regulation with warning.
ppm
50 von 1.000
ppm
³ 0,33
Very
remote
90% 9
Very high, vehicle/ item is inoperable (loss of primary function).
High: Frequent failures
ppm
20 von 1.000
ppm
³ 0,51
Remote
98% 8
High, vehicle/ item is operable but at reduced level of performance. Customer is very dissatisfied.
ppm
10 von 1.000
ppm
³ 0,67
Very low
98% 7
Moderate, vehicle/ item is operable, but Comfort/ Convenience item(s) are inoperable. Customer is dissatisfied.
Moderate: Occasional failures
5.000 ppm
5 von 1.000
5.000 ppm
³ 0,83
Low
99,7% 6
Low, vehicle/ item is operable, but Comfort/ Convenience item(s) are operable at a reduced level of performance.
2.000 ppm
2 von 1.000
2.000 ppm
³ 1,00
Moderate
99,7% 5
Very low, Fit & Finish/ Squeak & Rattle item does not conform. Defect is noticed by most customers (greater than 75%).
1.000 ppm
1 von 1.000
1.000 ppm
³ 1,17
Modeartely
high
99,7% 4
Minor, Fit & Finish/ Squeak & Rattle item does not conform. Defect is noticed by 50% of customers.
Low: Relatively few failures
100 ppm
0,5 von 1.000
500 ppm
³ 1,33
High
99,9% 3
Very minor, Fit & Finish/ Squeak & Rattle item does not conform. Defect is noticed by discriminating customers (less than 25%).
50 ppm
0,1 von 1.000
100 ppm
³ 1,50
Very high
99,9% 2
None, no discernible effect.
Remote: Failure unlikely
1 ppm
£ 10 ppm
³ 1,67
Almost certain
99,99% 1
HNUHN_QMS
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12. Evaluation Criteria for Prozeß FMEA
Design-/ Prozeß-FMEA
Evaluation Criteria for Prozeß FMEA
Handout
Detection (D)
Failure Rate
(Ford/ AIAG)
Inspection Types
Severity (S), Manufacturing/ Assy
Occurence (O)
Cpk
Factor
Error-prfd.
Gauging
Man.-Insp.
Very high severity ranking when a potential failure mode may endanger operator (machine or assembly) without warning.
Very high: Persistent failures
³ 100 von 1.000
ppm
< 0,33
Almost
impossible
can/ is not
checked 10
Very high severity ranking when a potential failure mode may endanger operator (machine or assembly) with warning.
50 von 1.000
ppm
³ 0,33
Very
remote
indirect
or random
checks 9
Very high, 100% of product may have to be scrapped, or vehicle/ item repaired in repair department with a repair time > 1 hour.
High: Frequent failures
20 von 1.000
ppm
³ 0,51
Remote 8
visual
inspection
High, product may have to be sorted and portion < 100% scrapped, or vehicle/ item repaired in repair department with a repair time greater 30 min and less than 1 hour.
10 von 1.000
ppm
³ 0,67
Very low
double
visual
inspection 7
Moderate, a portion (less than 100% )of product may have to
be scrapped with no sorting, or vehicle/ item repaired in
repair department with a repair time less than 30 min.
Moderate: Occasional failures
5 von 1.000
5.000 ppm
³ 0,83
Low 6
charting
(SPC)
charting
(SPC)
Low, 100% of product may have to be reworked, or vehicle/ item repaired off-line but does not go to repair department.
2 von 1.000
2.000 ppm
³ 1,00
Moderate
100%
Go/ No go
gauging 5
Very low, product may have to be sorted, with no scrap, and a portion (less than 100%) reworked.
1 von 1.000
1.000 ppm
³ 1,17
detection
in subse-
quent stat.
set-up or
first-piece
check
Modeartely
high 4
Minor, a portion (less than 100%) of product may have to be reworked, with no scrap, on-line but out-of-station.
Low: Relatively few failures
0,5 von 1.000
500 ppm
³ 1,33
High
detection
in station
multiple
select
install
verify 3
Very minor, a portion (less than 100%) of product may
have to be reworked, with no scrap, on-line but in-station.
0,1 von 1.000
100 ppm
³ 1,50
Very high
autom.
gauging,
stop
feature
cannot
pass
discrepant
part 2
No effect, or slight inconvenience to operation or operator.
Remote: Failure unlikely
£ 10 ppm
error-prfd
design
³ 1,67
Almost certain 1
HNUHN_QMS
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13. Evaluation Criteria for Prozeß FMEA
Design-/ Prozeß-FMEA
Evaluation Criteria for Prozeß FMEA
Occ. (O)
(PPM)
Detection (D)
Severity (S), final customer
Severity (S), Manufacturing/ Assy F
Error-prfd.
Gauging
Man.-Insp.
Very high severity ranking when a potential failure mode affects safe vehicle operation and/ or involves non- compliance with government regulation without warning.
Very high severity ranking when a potential failure mode may endanger operator (machine or assembly) without warning.
can/ is not
checked 10
Very high severity ranking when a potential failure mode affects safe vehicle operation and/ or involves non- compliance with government regulation with warning.
Very high severity ranking when a potential failure mode may endanger operator (machine or assembly) with warning.
50.000
indirect
or random
checks 9
Very high, vehicle/ item is inoperable (loss of primary function).
Very high, 100% of product may have to be scrapped, or vehicle/ item repaired in repair department with a repair time > 1 hour.
20.000 8
visual
inspection
High, vehicle/ item is operable but at reduced level of performance. Customer is very dissatisfied.
High, product may have to be sorted and portion < 100% scrapped, or vehicle/ item repaired in repair department with a repair time greater 30 min and less than 1 hour.
10.000
double
visual
inspection 7
Moderate, vehicle/ item is operable, but Comfort/ Convenience item(s) are inoperable. Customer is dissatisfied.
Moderate, a portion (less than 100% )of product may have to
be scrapped with no sorting, or vehicle/ item repaired in
repair department with a repair time less than 30 min.
5.000 6
charting
(SPC)
charting
(SPC)
Low, vehicle/ item is operable, but Comfort/ Convenience item(s) are operable at a reduced level of performance.
Low, 100% of product may have to be reworked, or vehicle/ item repaired off-line but does not go to repair department.
2.000
100%
Go/ No go
gauging 5
Very low, Fit & Finish/ Squeak & Rattle item does not conform. Defect is noticed by most customers (greater than 75%).
Very low, product may have to be sorted, with no scrap, and a portion (less than 100%) reworked.
1.000
detection
in subse-
quent stat.
set-up or
first-piece
check 4
Minor, Fit & Finish/ Squeak & Rattle item does not conform. Defect is noticed by 50% of customers.
Minor, a portion (less than 100%) of product may have to be reworked, with no scrap, on-line but out-of-station.
500
detection
in station
multiple
select
install
verify 3
Very minor, Fit & Finish/ Squeak & Rattle item does not conform. Defect is noticed by discriminating customers (less than 25%).
Very minor, a portion (less than 100%) of product may
have to be reworked, with no scrap, on-line but in-station.
100
autom.
gauging,
stop
feature
cannot
pass
discrepant
part 2
£ 10
error-prfd
design
None, no discernible effect.
No effect, or slight inconvenience to operation or operator. 1
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14. Special Characteristics D FMEA
Design-/ Prozeß-FMEA
Special Characteristics D FMEA
Classi-
fication
Memo
Rating
Control YC
potential CC
in P FMEA
S: 9 or 10
n.a. YS
potential SC
in P FMEA
S: 5 - 8 O:
n.a.
none
CC or SC
S: < 5
n.a.
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15. Special Characteristics P FMEA
Design-/ Prozeß-FMEA
Special Characteristics P FMEA
Classi- fication
Memo
Rating
Control CC
critical characteristic
S: 9 or 10
Control Plan SC
significant characteristic
S: 5 - 8; O:
Control Plan HI
high impact
(capable processes)
S: 5 - 8; O:
special care
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16. Special Characteristics P FMEA
Design-/ Prozeß-FMEA
Special Characteristics P FMEA
Classi- fication
Memo
Rating
Control OS
operator safety
S: 9 or 10
approval
by Safety
Engineer
none
not
CC or SC
HI or OS
other
n.a.
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17. Special Characteristics
Design-/ Prozeß-FMEA
Special Characteristics
Note:
special characteristics are confirmed after completion of D FMEA and P FMEA
include in Design Review with customer (QS-9000, ISO TS , VDA 6.1, ....)
Control Plan and FMEAs must be signed (Ford: CC, for all Control Item Parts (Ñ))
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18. Design FMEA Definition (VDA 4.2):
Design-/ Prozeß-FMEA
Design FMEA
Definition (VDA 4.2):
a Design FMEA (System FMEA Product) evaluates potential failure modes in terms of a potential malfunction of product or systems
potential failure mode is defined as the manner in which a component, subsystem, or system fails to meet design intent
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19. Process FMEA Definition (VDA 4.2):
Design-/ Prozeß-FMEA
Process FMEA
Definition (VDA 4.2):
A Process FMEA (System FMEA Process) evaluates potential failure modes of a product in terms of a potential malfunction of processes (production or assembly, logistics).
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20. FMEA “Overview” Concept FMEA: Design FMEA: Process FMEA:
Design-/ Prozeß-FMEA
FMEA “Overview”
Concept FMEA:
defines functions of design (intent)
Design FMEA:
evaluates a product before release to production
Process FMEA:
“completed“ before process steps are defined and special characteristics are listed in the Control Plan
Version

21. FMEA “Up-Dates” compare PPAP (examples) new laws and regulations
Design-/ Prozeß-FMEA
FMEA “Up-Dates”
compare PPAP (examples)
new laws and regulations
engineering change or new and additional field of product usage
new or changed processes
new location for production of product
as part of 8D Problem Solving (escape point)
customer complaints and nonconformities
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22. Related APQP Elements Design Review Design Verfication Plan
Design-/ Prozeß-FMEA
Related APQP Elements
Design Review
Design Verfication Plan
Prototype Build Control Plan
Manufacturing Process Flow Chart
Pre-Launch Control Plan
Production Control Plan
Operator Process Instructions
Version

23. Timing Prepare FMEAs before: defining systems prototype phase
Design-/ Prozeß-FMEA
Timing
Prepare FMEAs before:
defining systems
prototype phase
selection of material and processes
development of packaging
deciding about logistics
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24. Optimization goal robust design capable processes
Design-/ Prozeß-FMEA
Optimization
goal
robust design
capable processes
reduction of severity (C and D FMEA only!)
reduction of occurence rate (Ford: criticality = S x O)
defect prevention
reduction of RPN = S x O x D
mistake proofing, defect detection
Version