FMEA Failure Mode Effects Analysis - Quality Support Group · 2021. 4. 20. · AIAG Suggested PFMEA...

FMEA

FMEA

Failure Mode and Effects AnalysisA Risk Assessment and Reliability Improvement Tool

“Keys to Success – Selecting the Criteria”Angelo Scangas

Quality Support Group, [email protected]

1

888-336-1124 | www.qualitysupportgroup.com© 2018

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Quality Support GroupQuality Support Group Inc. (QSG) is a leading international consulting and training firm

delivering organizational continuous improvement. Headquartered in Boston, Massachusetts, QSG has been helping organizations reach their core objectives since 1993.

A Little About

QSG offers on-site training, public workshops, consulting, grant writing and much more.

Areas of Expertise

All Quality System Standards, Lean Six Sigma, Technical Skills (SPC, FMEA, DOE, Problem Solving), Process Improvement, Professional Development, Quality Tools,

Business Management & much more.

Check out our website

www.qualitysupportgroup.comor contact us at

[email protected] find out how we can help you

Always Keep Improving!

FMEA

Angelo Scangas

3

Founder and President of Quality Support Group, Inc., an International

Consulting and Training organization.

Worked in the industry for close to 30 years, holding positions in Operations,

Quality and Engineering.

Six Sigma Black Belt and a certified Lean Instructor. Led clients to AS9100,

ISO 13485, ISO 9001, ISO 14000 and TS 16949/IATF 16949 Certifications.

FMEA

Agenda

• Introduction• FMEA Basic Concepts• Design (Product) & Process FMEA Methodology• FMEA Implementation Techniques

4

FMEA

FMEA

• The goal of FMEA is to prevent quality, reliability and safety problems.

• Most effective when used early during product design and manufacturing process development.

5

FMEA

6

FMEA PurposeF

ailu

res

Time

Elimination of

Failures

Into production

Origin of

Failures

FMEA

FMEA

Key Concepts of Risk• The consequences/severity (S) of the failure

– how severe it might be to the stakeholders

• The probability (O) of occurrence of failure

– how often the failure may occur

• The ability to prevent the failure from occurring or detect the failure (D) followed by corrective action to prevent any effect on the stakeholders

7

FMEA

4/18/2021Quality Support Group, Inc.

All rights reserved 8

Process

PDP Overview

Business

(C&F) Phase MP PhasePP PhaseEB PhaseOT Phase

Concept Developed /

Business Rationale

Product

Design

Concept Verification Validation

Concept Verification Validation

Process

Design Risk Assessment (DFMEA)

Process Risk Assessment (PFMEA)

Design Developed/Tested

with Preliminary Tooling

Design Finalized/

Preliminary Production

Production Equivalent

/ Customer Use Test

Mass Production

Monitor Quality &

Reliability

8

FMEAPotential Failure Mode and Effects Analysis Sequence

Potential Effects S Possible O D R Responsibility S O D R

Failure of E Cause(s) C Current E P Recommended and Action E C E P

Function Mode Failure V of Failure C Controls T N Action(s) Target Date Results V C T N

What are the

Functions,

Features, or

Requirements?

What are

the Effects?

What can go wrong?

No Function

Partial/Over/

Degraded Function

Intermittent Function

Unintended Function

How bad

is it?

What could

have caused

the failure?

How often

does it

happen?

How is it

detected or

prevented?

How good is

this method

at detecting it?

Calculate Risk

Priority Number

(RPN)What can be done?

Design Changes

Process Changes

Special Controls

Changes to Standards,

Procedures, or Guides

9

FMEA

10

DetectPrevent

R

P

N

D

E

T

O

C

C

S

E

V

ActionTaken

Action ResultsResponse &

Traget

Complete

Date

Recommended

Actions

R

P

N

D

e

t

ec

CurrentProcess

Controls

O

c

c

ur

PotentialCause(s)/

Mechanism(s)

Of Failure

C

l

a

ss

S

e

v

Potential

Effect(s) of

Failure

Potential

Failure

Mode

Item /

Process Step

DetectPrevent

R

P

N

D

E

T

O

C

C

S

E

V

ActionTaken


Traget

Complete

Date

Recommended

Actions

R

P

N

D

e

t

ec

CurrentProcess

Controls

O

c

c

ur

PotentialCause(s)/

Mechanism(s)

Of Failure

C

l

a

ss

S

e

v

Potential

Effect(s) of

Failure

Potential

Failure

Mode

Item /

Process Step

Function

11

DESIGN FMEA

Failure Mode: The ways in which the device or

product will NOT FUNCTION.

Effect: Based on nature of DESIGN

(Severity) MALFUNCTION. (Effects of

process stoppage are NOT

considered.)

Detection: Design Verification methods are used

to assure confidence in the DESIGN;

eg., DOE, FEA, field trials, prototype

testing, etc.

A Design FMEA controls the

process of developing a DESIGN.

PROCESS FMEA

Reasons for rejection. NOT MEETING

SPECIFICATION.

Also based on nature of design malfunction.

Severity rating may increase due to effects

of work stoppages, process downtime,

scrap, rework, etc.

Process Control methods are used to assure

that the PROCESS will produce product to

specification; eg., 100% inspection, written

work procedures, inspector training and

certification, etc.

A Process FMEA controls the

PROCESS of producing product

that meets the specification.

p. 2.8

FMEA

12

DetectPrevent

R

P

N

D

E

T

O

C

C

S

E

V

ActionTaken


Traget

Complete

Date

Recommended

Actions

R

P

N

D

e

t

ec

CurrentProcess

Controls

O

c

c

ur

PotentialCause(s)/

Mechanism(s)

Of Failure

C

l

a

ss

S

e

v

Potential

Effect(s) of

Failure

Potential

Failure

Mode

Item /

Process Step

DetectPrevent

R

P

N

D

E

T

O

C

C

S

E

V

ActionTaken


Traget

Complete

Date

Recommended

Actions

R

P

N

D

e

t

ec

CurrentProcess

Controls

O

c

c

ur

PotentialCause(s)/

Mechanism(s)

Of Failure

C

l

a

ss

S

e

v

Potential

Effect(s) of

Failure

Potential

Failure

Mode

Item /

Process Step

Function

Critical

FMEA

13

Process Function & Design Intent

(PFMEA)Design Intent Requirements (5Cs):

– Critical To Quality

– Critical To Application

– Critical To Customer

– Critical To Process

– Critical To Safety/Regulatory Compliance

– MUST QUANTIFY and STANDARDIZE THE REQUIREMENTS

FMEA

14

DetectPrevent

R

P

N

D

E

T

O

C

C

S

E

V

ActionTaken


Traget

Complete

Date

Recommended

Actions

R

P

N

D

e

t

ec

CurrentProcess

Controls

O

c

c

ur

PotentialCause(s)/

Mechanism(s)

Of Failure

C

l

a

ss

S

e

v

Potential

Effect(s) of

Failure

Potential

Failure

Mode

Item /

Process Step

DetectPrevent

R

P

N

D

E

T

O

C

C

S

E

V

ActionTaken


Traget

Complete

Date

Recommended

Actions

R

P

N

D

e

t

ec

CurrentProcess

Controls

O

c

c

ur

PotentialCause(s)/

Mechanism(s)

Of Failure

C

l

a

ss

S

e

v

Potential

Effect(s) of

Failure

Potential

Failure

Mode

Item /

Process Step

Function

FMEA

Quality Support Group, Inc. 15

(D) Manner in which a component, subsystem or product could fail to meet design intent

(P) Manner in which the process could fail to meet the process function and design intent

Using this definition a failure does not need to be readily detectable by a customer to still be considered a failure.

Potential Failure Mode

FMEA

16

DetectPrevent

R

P

N

D

E

T

O

C

C

S

E

V

ActionTaken


Traget

Complete

Date

Recommended

Actions

R

P

N

D

e

t

ec

CurrentProcess

Controls

O

c

c

ur

PotentialCause(s)/

Mechanism(s)

Of Failure

C

l

a

ss

S

e

v

Potential

Effect(s) of

Failure

Potential

Failure

Mode

Item /

Process Step

DetectPrevent

R

P

N

D

E

T

O

C

C

S

E

V

ActionTaken


Traget

Complete

Date

Recommended

Actions

R

P

N

D

e

t

ec

CurrentProcess

Controls

O

c

c

ur

PotentialCause(s)/

Mechanism(s)

Of Failure

C

l

a

ss

S

e

v

Potential

Effect(s) of

Failure

Potential

Failure

Mode

Item /

Process Step

Function

Voice of the Customer

FMEA

17

Potential Effects

Effects of the failure mode internally or the external customer

Let’s list the Effects of the Potential Failure

FMEA

18

Severity Ranking

• Rating of 1 to 10 with 10 being the most severe impact.

– Use a scale.

– Use the same scale throughout.

• To assign this rating, must assume the failure mode has

occurred.

• Assign severity rating for every possible effect.

– Understand customer effects

– Understand internal effects

A Severity 9 or 10 must have preventive action


19

AIAG Suggested PFMEA Severity Evaluation CriteriaSuggested PFMEA Severity Evaluation Criteria

Rank Effect

Criteria:

Severity of Effect on Product

(Customer Effect)

Effect

Criteria:

Severity of Effect on Process

(Manufacturing / Assembly Effect)

9Potential failure mode affects safe Product operation and/or involves

noncompliance with government regulation with warning

May Endanger Operator (machine or assembly) with

warning

10Failure to Meet

Safety and/or

Regulatory

Requirements

Potential failure mode affects safe Product operation and/or involves

noncompliance with government regulation without warningFailure to Meet

Safety and/or

Regulatory

Requirements

May Endanger Operator (machine or assembly)

without warning

7Degradation of primary function (Product operable, but at reduced

level of performance)

Significant

Disruption

A portion of the production run may have to be

scrapped. Deviation from primary process including

decrease line speed or added manpower.

8 Loss or

Degradation of

Primary

Function

Loss of primary function (Product inoperable, does not affect safe

Product operation)Major Disruption

100% of product may have to be scrapped. Line

shutdown or stop ship.

6Loss or

Degradation of

Secondary

Function

Loss of secondary function (Product operable, but comfort /

convenience functions inoperable)High Disruption

100% of production run may have to be reworked off

line and accepted

5Degradation of secondary function (Product operable, but comfort /

convenience functions at reduced level of performance)

A portion of production run may have to be reworked

off line and accepted

4

Annoyance

Appearance or audible Noise, Product operable, item does not

conform and noticed by most customers (>75%) Moderate

Disruption

100% of production run may have to be reworked in

station before it is processed.

3Appearance or audible Noise, Product operable, item does not

conform and noticed by most customers (50%)


in station before it is processed.


conform and noticed by most customers (<25%)Minor Disruption Slight inconvenience to process operation or operator.

1 No Effect No discernible effect No Effect No discernible effect


20

AIAG Suggested DFMEA Severity Evaluation Criteria

Suggested PFMEA Severity Evaluation Criteria

Rank Effect

Criteria:

Severity of Effect on Product

(Customer Effect)

Effect

Criteria:

Severity of Effect on Process

(Manufacturing / Assembly Effect)

9Potential failure mode affects safe Product operation and/or involves

noncompliance with government regulation with warning

May Endanger Operator (machine or assembly) with

warning

10Failure to Meet

Safety and/or

Regulatory

Requirements

Potential failure mode affects safe Product operation and/or involves

noncompliance with government regulation without warningFailure to Meet

Safety and/or

Regulatory

Requirements

May Endanger Operator (machine or assembly)

without warning

7Degradation of primary function (Product operable, but at reduced

level of performance)

Significant

Disruption

A portion of the production run may have to be

scrapped. Deviation from primary process including

decrease line speed or added manpower.

8 Loss or

Degradation of

Primary

Function

Loss of primary function (Product inoperable, does not affect safe

Product operation)Major Disruption

100% of product may have to be scrapped. Line

shutdown or stop ship.

6Loss or

Degradation of

Secondary

Function

Loss of secondary function (Product operable, but comfort /

convenience functions inoperable)High Disruption

100% of production run may have to be reworked off

line and accepted

5Degradation of secondary function (Product operable, but comfort /

convenience functions at reduced level of performance)


off line and accepted

4

Annoyance

Appearance or audible Noise, Product operable, item does not

conform and noticed by most customers (>75%) Moderate

Disruption

100% of production run may have to be reworked in

station before it is processed.


conform and noticed by most customers (50%)


in station before it is processed.


conform and noticed by most customers (<25%)Minor Disruption Slight inconvenience to process operation or operator.

1 No Effect No discernible effect No Effect No discernible effect

FMEA



Process Severity Evaluation Criteria

Effect Severity of effect Ranking

Hazardous, without warning

Hazardous, with warning

Very High

High

Moderate

Low

Very Low

Minor

Very Minor

None

May endanger personnel. Involves non-compliancewith gov’t. regulation without warning.Same as above only with warning

Major disruption to production line; 100% of product scrapped

Minor disruption to production line; customerdissatisfiedProduct operable; not cosmetically satisfactory

100% of product may have to be reworked; some customer dissatisfactionFit/finish defects noticed by most customers

Same as above, but, defect noticed by average customerSame as above, but, defect noticed only by the discriminating customerNo effect

10

9

8

7

6

5

4

3

2

1

FMEA

22

DetectPrevent

R

P

N

D

E

T

O

C

C

S

E

V

ActionTaken


Traget

Complete

Date

Recommended

Actions

R

P

N

D

e

t

ec

CurrentProcess

Controls

O

c

c

ur

PotentialCause(s)/

Mechanism(s)

Of Failure

C

l

a

ss

S

e

v

Potential

Effect(s) of

Failure

Potential

Failure

Mode

Item /

Process Step

DetectPrevent

R

P

N

D

E

T

O

C

C

S

E

V

ActionTaken


Traget

Complete

Date

Recommended

Actions

R

P

N

D

e

t

ec

CurrentProcess

Controls

O

c

c

ur

PotentialCause(s)/

Mechanism(s)

Of Failure

C

l

a

ss

S

e

v

Potential

Effect(s) of

Failure

Potential

Failure

Mode

Item /

Process Step

Function

Root Cause AnalysisData

FMEA

23

What are the potential causes of the failure mode?

A cause and effect (fishbone) diagram may be helpful here.

Potential Causes

Let’s list the Potential Causes for one of the Failure Modes?

FMEA

EFFECT

PEOPLE MATERIAL

METHODS MEASUREMENT

MACHINE

ENVIRONMENT

Cause

Why

Analysis Potential Causes

Low mold vacuum

ContaminatedOperator error

High humidity

Inadequate drying time

24

FMEA

25

DetectPrevent

R

P

N

D

E

T

O

C

C

S

E

V

ActionTaken


Traget

Complete

Date

Recommended

Actions

R

P

N

D

e

t

ec

CurrentProcess

Controls

O

c

c

ur

PotentialCause(s)/

Mechanism(s)

Of Failure

C

l

a

ss

S

e

v

Potential

Effect(s) of

Failure

Potential

Failure

Mode

Item /

Process Step

DetectPrevent

R

P

N

D

E

T

O

C

C

S

E

V

ActionTaken


Traget

Complete

Date

Recommended

Actions

R

P

N

D

e

t

ec

CurrentProcess

Controls

O

c

c

ur

PotentialCause(s)/

Mechanism(s)

Of Failure

C

l

a

ss

S

e

v

Potential

Effect(s) of

Failure

Potential

Failure

Mode

Item /

Process Step

Function

FMEA

26

Occurrence Ranking

• How often will each potential cause occur?– Ignore the severity and the possibility that it will or will not be

detected.

– Rating on a 1 to 10 scale with 10 being the most frequent.

• Define root causes of each failure mode

• Use data where possible– Cpk information.

– Customer complaints.

– Root cause analysis.

• Occurrence - Need to consider the time frame for evaluation (Design Life)


27

AIAG Suggested PFMEA Occurrence Evaluation Criteria

=> 100 per Thousand

=> 1 in 10

50 per Thousand

1 in 20

20 per Thousand

1 in 50

10 per Thousand

1 in 100

2 per Thousand

1 in 500

0.5 per Thousand

1 in 2,000

0.1 per Thousand

1 in 10,000

0.01 per Thousand

1 in 100,000

=< 0.001 per Thousand

1 in 1,000,000

Criteria:

Occurrence of Cause - DFMEA

(Incidents per Item / Products)

Suggested PFMEA Occurrence Evaluation Criteria

RankLikelihood of

Failure

9

High

Very High10

7

8

6

Moderate5

4

3

Low

2

1 Very Low Failure is eliminated through preventive control


28

AIAG Suggested DFMEA Occurrence Evaluation Criteria

FMEA

29

Occurrence Evaluation Criteria

Probability of Possible Failure Cpk Rankings Failure Rates

Very high, failure is

almost inevitable

High, repeated

failures

Moderate, occasional

failures

Low, relatively few

failures

Remote, unlikely

> 1 in 2

1 in 3

1 in 8

1 in 20

1 in 80

1 in 400

1 in 2000

1 in 15,000

1 in 150,000

< 1 in 1,500,000

< 0.33

0.33

0.51

0.67

0.83

1.00

1.17

1.33

1.50

1.67

>

>>

>

>>

>>

>

10

9

8

7

6

5

4

3

2

1

FMEA

30

DetectPrevent

R

P

N

D

E

T

O

C

C

S

E

V

ActionTaken


Traget

Complete

Date

Recommended

Actions

R

P

N

D

e

t

ec

CurrentProcess

Controls

O

c

c

ur

PotentialCause(s)/

Mechanism(s)

Of Failure

C

l

a

ss

S

e

v

Potential

Effect(s) of

Failure

Potential

Failure

Mode

Item /

Process Step

DetectPrevent

R

P

N

D

E

T

O

C

C

S

E

V

ActionTaken


Traget

Complete

Date

Recommended

Actions

R

P

N

D

e

t

ec

CurrentProcess

Controls

O

c

c

ur

PotentialCause(s)/

Mechanism(s)

Of Failure

C

l

a

ss

S

e

v

Potential

Effect(s) of

Failure

Potential

Failure

Mode

Item /

Process Step

Function

Think Prevention

FMEA

Current Design Controls

What are the current design controls (DFMEA) to prevent or detect the cause/mechanism of failure leading to the potential failure mode?

Prevention of failure mode or reduction in occurrence. Detection of cause of failure mode leading to Corrective Actions

Quality Support Group, Inc. 31

FMEA

32

DetectPrevent

R

P

N

D

E

T

O

C

C

S

E

V

ActionTaken


Traget

Complete

Date

Recommended

Actions

R

P

N

D

e

t

ec

CurrentProcess

Controls

O

c

c

ur

PotentialCause(s)/

Mechanism(s)

Of Failure

C

l

a

ss

S

e

v

Potential

Effect(s) of

Failure

Potential

Failure

Mode

Item /

Process Step

DetectPrevent

R

P

N

D

E

T

O

C

C

S

E

V

ActionTaken


Traget

Complete

Date

Recommended

Actions

R

P

N

D

e

t

ec

CurrentProcess

Controls

O

c

c

ur

PotentialCause(s)/

Mechanism(s)

Of Failure

C

l

a

ss

S

e

v

Potential

Effect(s) of

Failure

Potential

Failure

Mode

Item /

Process Step

Function


33

AIAG Suggested PFMEA Detection Evaluation Criteria


34

AIAG Suggested DFMEA Prevention / Detection Evaluation Criteria

FMEA



DETECTION (D) Evaluation Criteria

Detection Criteria: Likelihood of DETECTION by Design Control Ranking

Absolute

Uncertainty

Design Control will not and/or can not detect a potential cause/mechanism

and subsequent failure mode; or there is no Design Control.

10

Very Remote Very remote chance the Design Control will detect a potential

cause/mechanism and subsequent failure mode.

9

Remote Remote chance the Design Control will detect a potential cause/mechanism

and subsequent failure mode.

8

Very Low Very low chance the Design Control will detect a potential


7

Low Low chance the Design Control will detect a potential cause/mechanism


6

Moderate Moderate chance the Design Control will detect a potential


5

Moderately High Moderately high chance the Design Control will detect a potential


4

High High chance the Design Control will detect a potential cause/mechanism


3

Very High Very high chance the Design Control will detect a potential


2

Almost Certain Design Control will almost certainly detect a potential cause/mechanism


1

FMEA

36

6. Risk Assessment

Severity

The impacts) of failure

Occurrence

The likelihood of a failure occurrence from an identified

cause under current controls

Detection

How detectable is the failure at any point?

Potential Risk (RPN) = Severity x Occurrence x Detection

FMEA

37

DetectPrevent

R

P

N

D

E

T

O

C

C

S

E

V

ActionTaken


Traget

Complete

Date

Recommended

Actions

R

P

N

D

e

t

ec

CurrentProcess

Controls

O

c

c

ur

PotentialCause(s)/

Mechanism(s)

Of Failure

C

l

a

ss

S

e

v

Potential

Effect(s) of

Failure

Potential

Failure

Mode

Item /

Process Step

DetectPrevent

R

P

N

D

E

T

O

C

C

S

E

V

ActionTaken


Traget

Complete

Date

Recommended

Actions

R

P

N

D

e

t

ec

CurrentProcess

Controls

O

c

c

ur

PotentialCause(s)/

Mechanism(s)

Of Failure

C

l

a

ss

S

e

v

Potential

Effect(s) of

Failure

Potential

Failure

Mode

Item /

Process Step

Function

FMEA

38

Risk Evaluation

Risk Acceptability Decisions

Intolerable

Region

ALARP

Region

Broadly Acceptable

Region

Increasing severity of harm

Incre

asin

g p

rob

ab

ility

of o

ccu

rre

nce

Decreasing Occurrence of Detectability

FMEASafetySever-

ity

HIGH

RISK

4-10

UNACCEP-

TABLE

LOW

RISK

1-3

10

Occur-

rence

Detect-

ability

Risk Priority

Number

RPN= S*O*D

9

8

7

Health of Design/

Mfg Process

6

5

4

3

1000500

400

300

200199

150

100

2

1

9925

1

10

9

8

7

6

5

4

3

2

1

10

9

8

7

6

5

4

3

2

1

UNACCEPTABLE

Redesign Required

MARGINAL

Action Required

GOOD

39

FMEA

40

By giving every Failure Mode a RPN rating, we can

now prioritize which failure modes to address now

and which failure modes we address later.

So, why do we need tocalculate the RPNs?

FMEA

41

RPN / Risk Priority Number

Top 20% of Failure

Modes by RPN

R

P

N

Failure Modes

FMEA

42

REDUCING THE POTENTIAL RISK:

First line of defense -Eliminate causes of failure so that it does not OCCUR - Implement prevention techniques

Second line of defense -Reduce probability of OCCURRENCE

Third line of defense -Improve DETECTION of the failure

FMEA

43

Priority for Action

• Involve Management to assign resources (human/financial) for action items to reduce the RPN.

• Create a What, Who, How and When Matrix in order to monitor action items.

• The FMEA Team Leader will check the status of the FMEA follow-up and schedule review meetings as necessary.

• Re-calculate the RPN as action items are completed and validated. Calculate savings ($$$) if possible based on the reduction of the potential risk.

FMEA IS A “LIVING” DOCUMENT!!!

FMEA

44

FMEA Output

• Control Plans

• Documentation

../../../Local Settings/Temp/Local Settings/Temp/Temporary Internet Files/Local Settings/Temp/Temporary Internet Files/Local Settings/ascangas/Local Settings/Temporary Internet Files/Local Settings/Temporary Internet Files/Content.IE5/Local Settings/Temporary Internet Files/Local Settings/Temporary Internet Files/Content.IE5/05IR09IR/controlplan.xls

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Disagreements on Ratings?

• Use data where possible.

• Try to come to consensus.

• If consensus fails:

– Team may elect to defer to one of its members.

– Average individual ratings.

• Only average if ratings are close (spread of 2 or 3 points

maximum).

– Get the process expert involved.

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FMEA Pitfalls – A review

No Cross-functionality on the Team

Poor Leadership of the Team

No Data Available / Not Used

No Customer Involvement / Voice of the Customer

Meeting Management problems

S,O,D criteria decisions (too long!)

No supplier involvement

Team Members not committed

No Management Commitment & Support

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In Conclusion

FMEA does take time and effort

It does reduce the risk to your customer

It does reduce the risk to you

It does save time to product launch

It does help with Continuous Improvement

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Wrap-up

Questions?

Thank you!

FMEA Failure Mode Effects Analysis - Quality Support Group · 2021. 4. 20. · AIAG Suggested PFMEA...

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