Activity 1: FMEA Team Roles and Responsibilities

Management (Project Manager)

Lead Design/Process Engineer

(Technical Lead)
Responsibilities

Technical responsibility for the FMEA contents

Authority to make decisions about the acceptability of identified risks and
the execution of actions
Coordination and organization of the workflows in the FMEA
Contribution of additional information about special topics
Defines the persons responsible for pre-work activities, FMEA facilitation,
and the design/process engineer responsible for implementation of
actions resulting from the analysis
Definition of elements, functions, requirements and interfaces
Mitigation of conflicts
Participation in the team formulation
Participation in the Preparation for the rough schedule
Responsible for selecting and applying resources and ensuring an
effective risk management process is implemented within scheduled
project timing
Participation in the invitation to the 1st team meeting for the analysis
phase
Contribute knowledge from relevant product and process experience
Contribute of necessary information about the product or process that is
the focus of the FMEA
Participation in the Preparation of the decision guidelines/criteria
Method competence (FMEA) and familiarization of participants in the
FMEA method
Contribution of existing experiences from previous FMEAs already known
Contribution of additional information about the product or process that
is the focus of the FMEA
Social skills, able to work in a team
Procurement of the necessary documents and information
Responsibility and ownership for development and maintenance of the
FMEAs
Competent moderator, ability to convince, organization and presentation
skills
Providing direct support to the teams through on-going reviews and
eliminating roadblocks
Managing execution of the 7 steps of FMEA method
Participation in the execution of the 7steps of FMEA
Preparation or wrap-up of FMEA meetings
Moderation of the FMEA workgroup
Incorporating lesson learned
 FMEA Facilitator

Core Team Members

Extended Team Members / Experts

Activity 3: Prepare a flow chart for a selected production process
STRUCTURE ANALYSIS (STEP 2)
FUNCTION ANALYSIS (STEP 3)
FAILURE ANALYSIS (STEP 4)

Process Item

EXAMPLE:

Electric Motor Assy

Your Plant:
Assembly of shaft into pole housing
assembly
Ship to Plant (next process / customer):
Assembly of motor to vehicle door
End User:
Window raises and lowers

Your Plant:
Clearance too small to assemble shaft
without potential damage
Ship to Plant:
Assembly of motor to vehicle door requires
additional insertion force with potential
damage
End User:
Comfort closing time too long
 Process Step

[OP 30] Sintered bearing press-in process

Function:
Press in sintered bearing to achieve axial
position in pole housing to max gap per
print

Axial position of sintered bearing is not

reached

Dented on surface
 Process Work Element

Operator

Function:
Operator press the button of machine for
releasing the press-in process when loading
is completed

Operator releases the press-in button too

soon

Press Machine

Function:
Machine presses sintered bearing into the
pole housing seat until the defined axial
position

Machine stops before reaching final

position
STRUCTURE ANALYSIS (STEP 2)
FUNCTION ANALYSIS (STEP 3)
FAILURE ANALYSIS (STEP 4)

Process Item
Process Step
Process Work Element
Activity 6: Identify the correct examples for each FE, FM and FC

Failure Causes
Failure Modes
Failure Effects
Examples

Unable to assemble at next operation X

Yard hold
Hole too deep
Rework and repair
Wrong material used
Endangers operators at customer facility
Noise
Label missing
Lighting inadequate
Unable to attach at customer facility
Line shutdown
100% product scrapped
Connector not fully inserted
Safety effect on end user
Misaligned shaft insertion
Cannot bore at next operation X
Decreased line speed
Added manpower to maintain required line rate
Supply hose blockage
Wrong parts applied
Causes excessive tool wear at next operation X
Damage equipment at next operation X
Barcode not readable
Surface finishing over specifications
Stop shipment
Parts loaded incorrectly
Regulatory system function reduced or failed
Machine set up data entered incorrectly
 Process Failure Mode and Effects Analysis (Process FMEA)
PLANNING & PREPARATION (STEP 1)

Company Name: Subject: PFMEA ID Number:

Plant Location: PFMEA Start Date: Process Responsibility:
Customer Name: PFMEA Revision Date: Confidentiality Level:
Model Year / Program: Cross-Functional Team:

CONTINUOUS
STRUCTURE ANALYSIS (STEP 2) FUNCTION ANALYSIS (STEP 3) FAILURE ANALYSIS (STEP 4) RISK ANALYSIS (STEP 5) OPTIMIZATION (STEP 6)
IMPROVEMENT

Detection (D) of FC/FM

Special Characteristics

Special Characteristics
Filter Code (Optional)
Occurrence (O) of FC
Severity (S) of FE
1. Function of the Process 2. Function of the Process

Occurrence (O)
1. Process Item

Detection (D)
Severity (S)
History / Change 2. Process Step Item Step and Product

PFMEA AP

PFMEA AP
3. Process Work Element 3. Function of the Process Target Action Taken
Issue #

Authorization (as Characteristics 2. Failure Mode (FM) of the 3. Failure Cause (FC) of the Current Prevention Control Current Detection Control Responsible
System, Subsystem, Part Work Element and Process 1. Failure Effects (FE) Prevention Action Detection Action Completion Status: with Pointer to Completion Date Remarks
applicable) (This column is Station No. and Name of Function of System, Process Step Work Element (PC) of FC (DC) of FC or FM Person's Name
Element or Name of 4M Type Characteristic Date Evidence
optional) Focus Element Subsystem, Part Element, (Quantitative value is
Process
or Process optional)
Activity 9: Prevention and detection controls

5 examples for Prevention Controls and detection control

No. Prevention Controls

5
ntion Controls and detection controls
Detection Controls
Activity 14: Prepare a report for the scope and result of an FMEA

FMEA Report Summary

Subject:
Customer Name:
Model Year / Program:

1. FMEA Project Overview – Final Status

2. Summary of scope of analysis and what is new

3. Summary of how the functions were developed

4. Summary of High-Risk failure

5. Summary of actions taken and status

6. Plan and commitment for ongoing actions

Review & Approved By

Date
ult of an FMEA

MEA Report Summary

FMEA ID:
Confidentiality Level:
Reported by:
 Process General Evaluation Criteria Severity (S)

Potential Failure Effects rated according to the criteria below

Impact to Ship-to-Plant
S Effect Impact to Your Plant
(when known)

Failure may result in health and/or Failure may result in health and/or
10 safety risk for the manufacturing safety risk for the manufacturing
High or assembly worker or assembly worker

Failure may result in in-plant Failure may result in in-plant

9 regulatory noncompliance regulatory noncompliance

Line shutdown greater than full

100% of production run affected
8 may have to be scrapped.
Moderately
high
Product may have to be sorted
and a portion (less than 100%)
7 scrapped; deviation from primary
process; decreased line speed or
added manpower
production shift; stop shipment
possible; field repair or
replacement required (Assembly
to End User) other than for
regulatory noncompliance.
Line shutdown from 1hour up to
full production shift; stop
shipment possible; field repair or
replacement required (Assembly
to End User) other than for
regulatory noncompliance

100% of production run may have

6 to be reworked off line and Line shutdown up to one hour
accepted

Less than 100% of product

A portion of the production run
affected; strong possibility for
5 Moderately may have to be reworked off line
additional defective product; sort
low and accepted
required; no line shutdown

Defective product triggers

100% of production run may have
significant reaction plan; additional
4 to be reworked in station before it defective products not likely; sort
is processed
not required

Defective product triggers minor

A portion of the production run
reaction plan; additional defective
3 may have to be reworked in-
products not likely; sort not
station before it is processed
required
Low
 Low
Defective product triggers no
Slight inconvenience to process, reaction plan; additional defective
2 products not likely; sort not
operation, or operator
required; requires feedback to
supplier
1 Very low No discernible effect No discernible effect or no effect
ria Severity (S)
Blank until filled
ria below
in by user

Impact to End User Corporate or

Product Lines
(when known)
Examples

Affects safe operation of

the vehicle and/or other
vehicles, the health of
operator or passenger(s) or
road users or pedestrians

Noncompliance with
regulations

Loss of primary vehicle

function necessary for
normal driving during
expected service life

Degradation of primary
vehicle function necessary
for normal driving during
expected service life

Loss of secondary vehicle

function

Degradation of secondary
vehicle function

Very objectionable
appearance, sound,
vibration, harshness or
haptics

Moderately objectionable
appearance, sound,
vibration, harshness or
haptics
 Slightly objectionable
appearance, sound,
vibration, harshness or
haptics

No discernible effect
 Occurrence Potential (O) for the Process
Potential Failure Causes rated according to the criteria below. Consider Prevention Controls when determining
the best Occurrence estimate. Occurrence is a predictive qualitative rating made at the time of evaluation and
may not reflect the actual occurrence. The occurrence rating number is a relative rating within the scope of the
FMEA (process being evaluated). For Prevention Controls with multiple Occurrence Ratings, use the rating that
best reflects the robustness of the control.

Prediction of Failure
O Type of Control
Cause Occurring

10 Extremely high None

9
Very high Behavioral
8
7
High
6 Behavioral or
5 Technical
Moderate
4
3 Low Best Practices;
Behavioral or
2 Very low Technical

1 Extremely low Technical

Prevention Control Effectiveness: Consider if prevention controls are technical (rely on machines, tool life, tool ma
use best practices (fixtures, tool design, calibration procedures, error-proofing verification, preventive mainten
instructions, statistical process control charting, process monitoring, product design, etc.) or behavioral (rely on ce
certified operators, skilled trades, team leaders, etc.) when determining how effective the prevention contro
Occurrence Potential (O) for the Process
ng to the criteria below. Consider Prevention Controls when determining
ence is a predictive qualitative rating made at the time of evaluation and
Blank until filled
The occurrence rating number is a relative rating within the scope of the in by user
revention Controls with multiple Occurrence Ratings, use the rating that
reflects the robustness of the control.

Corporate or
Prevention Controls Product Line
Examples
No prevention controls
Prevention controls will have little effective in preventing
failure cause
Prevention controls somewhat effective in preventing failure
cause

Prevention controls are affective in preventing failure cause

Prevention controls are highly effective in preventing failure

cause

Prevention controls are extremely effective in preventing

failure cause from occurring due to design (e.g. part
geometry) or process (e.g. fixture or tooling design). Intent
of prevention controls - Failure Mode cannot be physically
produced due to the Failure Cause

ider if prevention controls are technical (rely on machines, tool life, tool material, etc.), or
sign, calibration procedures, error-proofing verification, preventive maintenance, work
charting, process monitoring, product design, etc.) or behavioral (rely on certified or non-
, team leaders, etc.) when determining how effective the prevention control will be.
 PFMEA Occurrence (O) with Incidents per Thousand Values
Occurrence Potential (O) for the Process
Potential Failure Causes rated according to the criteria below. Consider Prevention Controls when determining
the best Occurrence estimate. Occurrence is a predictive qualitative rating made at the time of evaluation and
may not reflect the actual occurrence. The occurrence rating number is a relative rating within the scope of the
FMEA (process being evaluated). For Prevention Controls with multiple Occurrence Ratings, use the rating that
best reflects the robustness of the control.

Prediction of Failure
O Type of Control
Cause Occurring

≥ 100 per thousand

10 None
>/= 1 in 10

9 50 per thousand
1 in 20
Behavioral
8 20 per thousand
1 in 50
10 per thousand
7
1 in 100

6 2 per thousand
1 in 500 Behavioral or
0.5 per thousand Technical
5
1 in 2000
0.1 per thousand
4
1 in 10,000

3 0.01 per thousand

1 in 100,000 Best Practices;
Behavioral or
< 0.001 per thousand Technical
2
1 in 1,000,000

Failure is eliminated
1 through prevention Technical
control

Prevention Control Effectiveness: Consider if prevention controls are technical (rely on machines, tool life, tool m
use best practices (fixtures, tool design, calibration procedures, error-proofing verification, preventive mainten
instructions, statistical process control charting, process monitoring, product design, etc.) or behavioral (rely on c
certified operators, skilled trades, team leaders, etc.) when determining how effective the prevention contr
ence (O) with Incidents per Thousand Values
Occurrence Potential (O) for the Process
g to the criteria below. Consider Prevention Controls when determining
nce is a predictive qualitative rating made at the time of evaluation and
Blank until filled
The occurrence rating number is a relative rating within the scope of the
in by user
evention Controls with multiple Occurrence Ratings, use the rating that
reflects the robustness of the control.

Corporate or
Prevention Controls Product Line
Examples

No prevention controls

Prevention controls will have little effective in preventing

failure cause

Prevention controls somewhat effective in preventing failure

cause

Prevention controls are affective in preventing failure cause

Prevention controls are highly effective in preventing failure

cause

Prevention controls are extremely effective in preventing

failure cause from occurring due to design (e.g. part
geometry) or process (e.g. fixture or tooling design). Intent
of prevention controls - Failure Mode cannot be physically
produced due to the Failure Cause

der if prevention controls are technical (rely on machines, tool life, tool material, etc.), or
gn, calibration procedures, error-proofing verification, preventive maintenance, work
charting, process monitoring, product design, etc.) or behavioral (rely on certified or non-
team leaders, etc.) when determining how effective the prevention control will be.
 PFMEA Occurrence (O) with Time Based Failure Predication Va
Occurrence Potential (O) for the Process
Potential Failure Causes rated according to the criteria below. Consider Prevention Controls when determining
the best Occurrence estimate. Occurrence is a predictive qualitative rating made at the time of evaluation and
may not reflect the actual occurrence. The occurrence rating number is a relative rating within the scope of the
FMEA (process being evaluated). For Prevention Controls with multiple Occurrence Ratings, use the rating that
best reflects the robustness of the control.

Prediction of Failure
O Type of Control
Cause Occurring

10 Every time None

9 Almost every time

Behavioral
More than once per
8
shift

7 More than once per day

More than once per

6
week Behavioral or
More than once per Technical
5
month
More than once per
4
year

3 Once a year Best Practices;

Behavioral or
2 Less than once per year Technical

1 Never Technical

Prevention Control Effectiveness: Consider if prevention controls are technical (rely on machines, tool life, tool m
use best practices (fixtures, tool design, calibration procedures, error-proofing verification, preventive mainten
instructions, statistical process control charting, process monitoring, product design, etc.) or behavioral (rely on c
certified operators, skilled trades, team leaders, etc.) when determining how effective the prevention contr
e (O) with Time Based Failure Predication Values
Occurrence Potential (O) for the Process
g to the criteria below. Consider Prevention Controls when determining
nce is a predictive qualitative rating made at the time of evaluation and
Blank until filled
The occurrence rating number is a relative rating within the scope of the
in by user
evention Controls with multiple Occurrence Ratings, use the rating that
reflects the robustness of the control.

Corporate or
Prevention Controls Product Line
Examples
No prevention controls

Prevention controls will have little effective in preventing

failure cause

Prevention controls somewhat effective in preventing failure

cause

Prevention controls are affective in preventing failure cause

Prevention controls are highly effective in preventing failure

cause

Prevention controls are extremely effective in preventing

failure cause from occurring due to design (e.g. part
geometry) or process (e.g. fixture or tooling design). Intent
of prevention controls - Failure Mode cannot be physically
produced due to the Failure Cause

der if prevention controls are technical (rely on machines, tool life, tool material, etc.), or
gn, calibration procedures, error-proofing verification, preventive maintenance, work
charting, process monitoring, product design, etc.) or behavioral (rely on certified or non-
team leaders, etc.) when determining how effective the prevention control will be.
 Detection Potential (D) for the Validation of the Process Design
Detection Controls rated according to the Detection Method Maturity and Opportunity for Detection

Ability to
D Detection Method Maturity
Detect

No testing or inspection method

10 has been established or is
known.
Very low
It is unlikely that the testing or
9 inspection method will detect
the failure mode

8 Test or inspection method has

not been proven to be effective
and reliable (e.g. plant has little
Low or no experience with method,
gauge R&R results marginal on
comparable process or this
7 application, etc.).

6
Test or inspection method has
been proven to be effective and
reliable (e.g. plant has experience
Moderate with method; gauge R&R results
are acceptable on comparable
5 process or this application, etc.).

System has been proven to be

effective and reliable (e.g. plant
has experience with method on
identical process or this
application, gauge R&R results
are acceptable, etc.).
High
3
 Detection method has been
proven to be effective and
2 reliable (e.g. plant has experience
with method, error-proofing
verifications, etc.).

Failure mode cannot be physically produced as-designed or processed, or detection metho

1 Very high
proven to always detect the failure mode or failure cause.
ential (D) for the Validation of the Process Design
Blank until filled
to the Detection Method Maturity and Opportunity for Detection
in by user
Corporate or
Opportunity for Detection Product Line
Examples

The failure mode will not or cannot be detected.

The failure mode is not easily detected through random or

sporadic audits.

Human inspection (visual, tactile, audible), or use of manual

gauging (attribute or variable) that should detect the failure
mode or failure cause.

Machine-based detection (automated or semi-automated

with notification by light, buzzer, etc.), or use of inspection
equipment such as coordinate measuring machine that
should detect failure mode or failure cause.

Human inspection (visual, tactile, audible), or use of manual

gauging (attribute or variable) that will detect the failure
mode or failure cause (including product sample checks).

Machine-based detection (semi-automated with notification

by light, buzzer, etc.), or use of inspection equipment such as
coordinate measuring machine that will detect failure mode
or failure cause (including product sample checks).

Machine-based detection automated detection method that

will detect the failure mode downstream, prevent further
processing or system will identify the product as discrepant
and allow it to automatically move forward in the process
until the designated reject unload area. Discrepant product
will be controlled by a robust system that will prevent
outflow of the product from the facility.

Machine-based detection automated detection method that

will detect the failure mode in-station, prevent further
processing or system will identify the product as discrepant
and allow it to automatically move forward in the process
until the designated reject unload area. Discrepant product
will be controlled by a robust system that will prevent
outflow of the product from the facility.
 Machine-based detection method that will detect the cause
and prevent the failure mode (discrepant part) from being
produced.

be physically produced as-designed or processed, or detection method

ven to always detect the failure mode or failure cause.
 Action Priority (AP) for DFMEA and PFMEA
Action Priority is based on combinations of Severity, Occurrence, and Detection ratings in order to
prioritize actions for risk reduction.

Prediction of
Effect S Failure Cause O Ability to Detect D
Occurring
Low - Very low 7-10
Moderate 5-6
Very high 8-10
High 2-4
Very high 1
Low - Very low 7-10
Moderate 5-6
High 6-7
High 2-4
Very high 1
Low - Very low 7-10
Product or Plant
9-10 Moderate 5-6
Effect Very high
Moderate 4-5
High 2-4
Very high 1
Low - Very low 7-10
Low 2-3 Moderate 5-6
High 2-4
Very high 1
Very low 1 Very high - Very low 1-10
Low - Very low 7-10
Moderate 5-6
Very high 8-10
High 2-4
Very high 1
Low - Very low 7-10
Moderate 5-6
High 6-7
High 2-4
Very high 1
Product or Plant
7-8 Low - Very low 7-10
Effect High
Moderate 5-6
Moderate 4-5
High 2-4
Very high 1
Low - Very low 7-10
Moderate 5-6
Low 2-3
High 2-4
Very high 1
Very low 1 Very high - Very low 1-10
Low - Very low 7-10
Moderate 5-6
Very high 8-10
 Very high 8-10
High 2-4
Very high 1
Low - Very low 7-10
Moderate 5-6
High 6-7
High 2-4
Very high 1
Product or Plant
Effect Moderate 4-6 Low - Very low 7-10
Moderate 5-6
Moderate 4-5
High 2-4
Very high 1
Low - Very low 7-10
Moderate 5-6
Low 2-3
High 2-4
Very high 1
Very low 1 Very high - Very low 1-10
Low - Very low 7-10
Moderate 5-6
Very high 8-10
High 2-4
Very high 1
Low - Very low 7-10
Moderate 5-6
High 6-7
High 2-4
Very high 1
Product or Plant
2-3 Low - Very low 7-10
Effect Low
Moderate 5-6
Moderate 4-5
High 2-4
Very high 1
Low - Very low 7-10
Moderate 5-6
Low 2-3
High 2-4
Very high 1
Very low 1 Very high - Very low 1-10
No discernible Very high - Very
1 1-10 Very high - Very low 1-10
Effect low
 PFMEA
ction ratings in order to Blank until filled
in by user

ACTION
Comments
PRIORITY (AP)

H
H
H
H
H
H
H
H RPN =120 -> Recommended action
H
H
H Severity: 10 ;Occurrence: 1; Detecti
M
H Severity: 2 ;Occurrence: 5; Detectio
M
L
L
L
H
H
H
H
H
H
H
M
H
M
M
M
M
M
L
L
L
H
H
M
M
M
M
M
L
M
L
L
L
L
L
L
L
L
M
M
L
L
L
L
L
L
L
L
L
L
L
L
L
L
L
L
ce: 1; Detection: 1 (RPN=10) L

e: 5; Detection: 1 (RPN=10) L