FMEA Potential Failure Mode and Effects Analysis Design and Process FMEA.

FMEAPotential 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 FMEAsPPAP: 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 FMEAsFord 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 FMEAsFord 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 FMEAsFord 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 FMEAsConcept 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

Severity (S) Occurrence (O) Failure Rate(Ford/ AIAG)

Failure Rate (VDA)

Likelyhood (VDA)Detection (D)

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

500.000 ppm

Factor

100 per 1.000 100.000 ppm

10AbsoluteUncertainty

90%

Very high severity ranking when a potential failure mode affects safe vehicle operation and/ or involves non-compliance with government regulation with warning.

100.000 ppm 50 per 1.000 50.000 ppm

9Very remote 90%

Very high, vehicle/ item is inoperable (loss of primaryfunction).

High:Frequent failures

50.000 ppm 20 per 1.000 20.000 ppm

8Remote 98%

High, vehicle/ item is operable but at reduced level of performance. Customer is very dissatisfied.

10.000 ppm 10 per 1.000 10.000 ppm

7Very Low 98%

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

6Low 99,7%

1.000 ppm 2 per 1.000 2.000 ppm

5Moderate 99,7%

500 ppm 1 per 1.000 1.000 ppm

4Moderately High

99,7%Very low, Fit & Finish/ Squeak & Rattle item does not conform. Defect is noticed by most customers (greater than 75%).

Low, vehicle/ item is operable, but Comfort/ Convenience item(s) are operable at a reduced level of performance. Customer is somewhat dissatisfied.

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

3High 99,9%

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

2Very High 99,9%

None, no discernible effect. Remote: Failure unlikely 1 ppm 10 ppm

1Almost Certain 99,99%HNUHN_QMS

Evaluation Criteria for Prozeß FMEA

Severity (S), final customer Occurence (O) CpkFailure Rate (VDA)

Likelyhood (VDA)

Detection (D)



100.000 ppm

Factor

< 0,33 10Almostimpossible

90%


50.000 ppm 0,33 9Veryremote

90%



20.000 ppm 0,51 8Remote 98%


10.000 ppm 0,67 7Very low 98%



5.000 ppm 0,83 6Low 99,7%

2.000 ppm 1,00 5Moderate 99,7%

1.000 ppm 1,17 4Modeartely high

99,7%Very low, Fit & Finish/ Squeak & Rattle item does not conform. Defect is noticed by most customers (greater than 75%).

Low, vehicle/ item is operable, but Comfort/ Convenience item(s) are operable at a reduced level of performance.



100 ppm 1,33 3High 99,9%


50 ppm 1,50 2Very high 99,9%

None, no discernible effect. Remote: Failure unlikely 1 ppm 1,67 1Almost certain 99,99%

Failure Rate (Ford/ AIAG)

HNUHN_QMS

100 von 1.000 100.000 ppm

50 von 1.000 50.000 ppm

20 von 1.000 20.000 ppm

10 von 1.000 10.000 ppm

5 von 1.000 5.000 ppm

2 von 1.000 2.000 ppm

1 von 1.000 1.000 ppm

0,5 von 1.000 500 ppm

0,1 von 1.000 100 ppm

10 ppm

Handout


Severity (S), Manufacturing/ Assy Occurence (O)Inspection Types

Very high severity ranking when a potential failure mode may endanger operator (machine or assembly)without warning.


Factor

10can/ is notchecked

Very high severity ranking when a potential failure mode may endanger operator (machine or assembly)with warning.

9indirector randomchecks

Very high, 100% of product may have to be scrapped, or vehicle/ item repaired in repair department with a repair time > 1 hour.


8visual inspection

High, product may have to be sorted and portion < 100% scrapped, or vehicle/ item repaired in repair department witha repair time greater 30 min and less than 1 hour.

7

charting(SPC)

Moderate, a portion (less than 100% )of product may have tobe scrapped with no sorting, or vehicle/ item repaired inrepair department with a repair time less than 30 min.


6charting(SPC)

5

detection in subse-quent stat.

4Very low, product may have to be sorted, with no scrap, and a portion (less than 100%) reworked.

Low, 100% of product may have to be reworked, or vehicle/ item repaired off-line but does not go to repair department.

Minor, a portion (less than 100%) of product may have to be reworked, with no scrap, on-line but out-of-station.


3

Very minor, a portion (less than 100%) of product may have to be reworked, with no scrap, on-line but in-station. 2

No effect, or slight inconvenience to operation or operator. Remote: Failure unlikely 1HNUHN_QMS

Cpk

< 0,33

0,33

0,51

0,67

0,83 Low

1,00

1,17

1,33

1,50

1,67

Failure Rate (Ford/ AIAG)

100 von 1.000 100.000 ppm

50 von 1.000 50.000 ppm

20 von 1.000 20.000 ppm

10 von 1.000 10.000 ppm

5 von 1.000 5.000 ppm

2 von 1.000 2.000 ppm

1 von 1.000 1.000 ppm

0,5 von 1.000 500 ppm

0,1 von 1.000 100 ppm

10 ppm

Detection (D)

Almostimpossible

Veryremote

Remote

Very low

Moderate

Modeartely high

High

Very high

Almost certain

Error-prfd. Gauging Man.-Insp.

100%Go/ No gogauging

set-up orfirst-piececheck

selectinstallverify

error-prfddesign

autom.gauging,stopfeature

cannotpassdiscrepantpart

detection in stationmultiple

doublevisual inspection

Handout


Detection (D)F

10can/ is notchecked

9indirector randomchecks

8visual inspection

7

charting(SPC)

6charting(SPC)

5

detection in subse-quent stat.

4

3

2

1HNUHN_QMS

Occ. (O) (PPM)

100.000

50.000

20.000

10.000

5.000

2.000

1.000

500

100

10

Error-prfd. Gauging Man.-Insp.

100%Go/ No gogauging

set-up orfirst-piececheck

selectinstallverify

error-prfddesign

autom.gauging,stopfeature

cannotpassdiscrepantpart

detection in stationmultiple

doublevisual inspection

Severity (S), Manufacturing/ Assy

Very high severity ranking when a potential failure mode may endanger operator (machine or assembly)without warning.

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, product may have to be sorted and portion < 100% scrapped, or vehicle/ item repaired in repair department witha repair time greater 30 min and less than 1 hour.

Moderate, a portion (less than 100% )of product may have tobe scrapped with no sorting, or vehicle/ item repaired inrepair department with a repair time less than 30 min.

Very low, product may have to be sorted, with no scrap, and a portion (less than 100%) reworked.

Low, 100% of product may have to be reworked, or vehicle/ item repaired off-line but does not go to repair department.

Minor, a portion (less than 100%) of product may have to be reworked, with no scrap, on-line but out-of-station.

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.

Severity (S), final customer






Very low, Fit & Finish/ Squeak & Rattle item does not conform. Defect is noticed by most customers (greater than 75%).

Low, vehicle/ item is operable, but Comfort/ Convenience item(s) are operable at a reduced level of performance.



None, no discernible effect.

Special CharacteristicsD FMEA

Classi-fication

Memo Rating Control

potential CCin P FMEA

YC S: 9 or 10 n.a.

potential SCin P FMEA

YS S: 5 - 8O: 4 - 10

n.a.

CC or SCnone S: < 5 n.a.

Special CharacteristicsP FMEA

Classi-fication

Memo Rating Control

critical characteristicCC S: 9 or 10 Control Plan

significant characteristicSC S: 5 - 8;O: 4 - 10

Control Plan

high impact(capable processes)

HI S: 5 - 8;O: 4 - 10

specialcare

Special CharacteristicsP FMEA

Classi-fication

Memo Rating Control

operator safetyOS S: 9 or 10 approvalby SafetyEngineer

notCC or SCHI or OS

none 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

FMEA Potential Failure Mode and Effects Analysis Design and Process FMEA.

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