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FMEA
Potential Failure Mode and
Effects Analysis
Design and Process 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 (09 1999)
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.
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
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...
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
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)
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
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
Evaluation Criteria for Design FMEA
Failure Rate
(VDA)
Failure Rate
(Ford/ AIAG)
Detection (D)
500.000 ppm
 100 per 1.000
100.000 ppm
Absolute
Uncertainty
90%
10
100.000 ppm
50 per 1.000
50.000 ppm
Very remote
90%
9
50.000 ppm
20 per 1.000
20.000 ppm
Remote
98%
8
10.000 ppm
10 per 1.000
10.000 ppm
Very Low
98%
7
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
100 ppm
0,5 per 1.000
500 ppm
High
99,9%
3
50 ppm
0,1 per 1.000
100 ppm
Very High
99,9%
2
1 ppm
 10 ppm
Almost Certain
99,99%
1
Severity (S)
Very high severity ranking when a potential failure mode
affects safe vehicle operation and/ or involves noncompliance with government regulation without warning.
Occurrence (O)
Very high:
Persistent failures
Very high severity ranking when a potential failure mode
affects safe vehicle operation and/ or involves noncompliance with government regulation with warning.
Very high, vehicle/ item is inoperable (loss of primary
function).
High:
Frequent failures
High, vehicle/ item is operable but at reduced level of
performance. Customer is very dissatisfied.
Moderate, vehicle/ item is operable, but Comfort/
Convenience item(s) are inoperable. Customer is
dissatisfied.
Minor, Fit & Finish/ Squeak & Rattle item does not
conform. Defect is noticed by 50% of customers.
Moderate:
Occasional failures
Low:
Relatively few failures
Very minor, Fit & Finish/ Squeak & Rattle item does not
conform. Defect is noticed by discriminating customers
(less than 25%).
None, no discernible effect.
Remote: Failure unlikely
Likelyhood
Factor
(VDA)
HNUHN_QMS
Evaluation Criteria for Prozeß FMEA
Severity (S), final customer
Very high severity ranking when a potential failure mode
affects safe vehicle operation and/ or involves noncompliance with government regulation without warning.
Occurence (O)
Very high:
Persistent failures
Handout
Detection
(D)
Failure Rate Failure Rate
(Ford/ AIAG)
(VDA)
Cpk
 100 von 1.000
100.000 ppm
< 0,33
Almost
impossible
90%
10
100.000 ppm
Likelyhood
Factor
(VDA)
50.000 ppm
50 von 1.000
50.000 ppm
0,33
Very
remote
90%
9
20.000 ppm
20 von 1.000
20.000 ppm
0,51
Remote
98%
8
10.000 ppm
10 von 1.000
10.000 ppm
0,67
Very low
98%
7
5.000 ppm
5 von 1.000
5.000 ppm
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
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
1,17
Modeartely
high
99,7%
4
100 ppm
0,5 von 1.000
500 ppm
1,33
High
99,9%
3
50 ppm
0,1 von 1.000
100 ppm
1,50
Very high
99,9%
2
 10 ppm
1,67
Almost certain
99,99%
1
Very high severity ranking when a potential failure mode
affects safe vehicle operation and/ or involves noncompliance with government regulation with warning.
Very high, vehicle/ item is inoperable (loss of primary
function).
High:
Frequent failures
High, vehicle/ item is operable but at reduced level of
performance. Customer is very dissatisfied.
Moderate, vehicle/ item is operable, but Comfort/
Convenience item(s) are inoperable. Customer is
dissatisfied.
Minor, Fit & Finish/ Squeak & Rattle item does not
conform. Defect is noticed by 50% of customers.
Moderate:
Occasional failures
Low:
Relatively few failures
Very minor, Fit & Finish/ Squeak & Rattle item does not
conform. Defect is noticed by discriminating customers
(less than 25%).
None, no discernible effect.
Remote: Failure unlikely
1 ppm
HNUHN_QMS
Evaluation Criteria for Prozeß FMEA
Failure Rate
Detection
(D)
Handout
Inspection Types
(Ford/ AIAG)
Cpk
 100 von 1.000
100.000 ppm
< 0,33
Almost
impossible
can/ is not
checked
10
50 von 1.000
50.000 ppm
0,33
Very
remote
indirect
or random
checks
9
20 von 1.000
20.000 ppm
0,51
Remote
10 von 1.000
10.000 ppm
0,67
Very low
5 von 1.000
5.000 ppm
0,83
Low
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
1,00
Moderate
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
1,17
Modeartely
high
0,5 von 1.000
500 ppm
1,33
0,1 von 1.000
100 ppm
 10 ppm
Severity (S), Manufacturing/ Assy
Very high severity ranking when a potential failure mode
may endanger operator (machine or assembly)
without warning.
Occurence (O)
Very high:
Persistent failures
Very high severity ranking when a potential failure mode
may endanger operator (machine or assembly)
with warning.
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
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.
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.
Minor, a portion (less than 100%) of product may have to
be reworked, with no scrap, on-line but out-of-station.
Moderate:
Occasional failures
Low:
Relatively few failures
Very minor, a portion (less than 100%) of product may
have to be reworked, with no scrap, on-line but in-station.
No effect, or slight inconvenience to operation or operator.
Remote: Failure unlikely
Error-prfd. Gauging Man.-Insp.
visual
inspection
double
visual
inspection
charting
(SPC)
charting
(SPC)
Factor
8
7
6
100%
Go/ No go
gauging
5
detection set-up or
in subse- first-piece
quent stat. check
4
High
detection select
in station install
multiple verify
3
1,50
Very high
1,67
Almost certain
autom.
gauging,
stop
feature
error-prfd
design
cannot
pass
discrepant
part
2
1
HNUHN_QMS
Evaluation Criteria for Prozeß FMEA
Severity (S), final customer
Severity (S), Manufacturing/ Assy
Occ. (O)
(PPM)
Detection (D)
Error-prfd. Gauging Man.-Insp.
F
Very high severity ranking when a potential failure mode
affects safe vehicle operation and/ or involves noncompliance with government regulation without warning.
Very high severity ranking when a potential failure mode
may endanger operator (machine or assembly)
without warning.
100.000
can/ is not
checked
10
Very high severity ranking when a potential failure mode
affects safe vehicle operation and/ or involves noncompliance 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
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
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
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 set-up or
in subse- first-piece
quent stat. 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 select
in station install
multiple 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
None, no discernible effect.
No effect, or slight inconvenience to operation or operator.
 10
autom.
gauging,
stop
feature
error-prfd
design
visual
inspection
double
visual
inspection
charting
(SPC)
charting
(SPC)
cannot
pass
discrepant
part
8
7
6
2
1
HNUHN_QMS
Special Characteristics
D FMEA
Classification
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: 4 - 10
n.a.
none
CC or SC
S: < 5
n.a.
Special Characteristics
P FMEA
Classification
Memo
Rating
Control
CC
critical characteristic
S: 9 or 10
Control Plan
SC
significant characteristic
S: 5 - 8;
O: 4 - 10
Control Plan
HI
high impact
(capable processes)
S: 5 - 8;
O: 4 - 10
special
care
Special Characteristics
P FMEA
Classification
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.
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 16 949, VDA 6.1, ....)
• Control Plan and FMEAs must be signed
(Ford: CC, for all Control Item Parts ())
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
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).
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
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
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
Timing
Prepare FMEAs before:
• defining systems
• prototype phase
• selection of material and processes
• development of packaging
• deciding about logistics
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