Process Failure Mode and Effects Analysis (Process FMEA)

PLANNING & PREPARATION (STEP 1)

Company Name:
Manufacturing Location:
Customer Name:
Model Year(s) / Program(s):

CONTINUOUS
STRUCTURE ANALYSIS (STEP 2) FUNCTION ANALYSIS (STEP 3)
IMPROVEMENT

2. Function of the
1. Function of the
History / Change 1. Process Item 2. Process Step Process Step and
3. Process Work Process Item 3. Function of the
Authorization (As Product
Issue #

Element Process Work

Applicable) (This System, Subsystem, Station No. and Characteristic
Function of System, Element and Process
column is Part Element or Name of Focus
4M type Subsystem, Part Characteristic
optional) Name of Process Element (Quantitative value is
Element or Process
optional)

Your Plant

Ship to Plant

End User
Subject:
PFMEA Start Date:
PFMEA Revision Date:
Cross Functional Team:

FAILURE ANALYSIS (STEP 4) PFMEA RISK ANALYSIS (STEP 5)

Detection (D) of FC/FM

Occurrence (O) of FC
Severity (S) of FE

PFMEA AP
1. Failure effects (FE) to the Next Current Detection
2. Failure Mode (FM) 3. Failure Cause (FC) Current Prevention
Higher Level Element and/or Controls (DC) of FC or
of the Focus Element of the Work Element Control (PC) of FC
End User FM

Your Plant

Ship to Plant

End User
PFMEA ID Number:
Process Responsibility:
Confidentiality Level:

PFMEA OPTIMIZATION (STEP 6)

Responsible Person's Name

Target Completion Date

Special Characteristics

Filter Code (Optional)

Completion Date
Status
Action Taken with Pointers to
Prevention Action Detection Action
Evidence
 Severity (S)

Occurrence (O)

Detection (D)

Special Characteristics

PFMEA AP

Remarks
HINTS Process Failure Mode and Effects Analysis (Process FMEA)
PLANNING & PREPARATION (STEP 1)
Company Name: Name of company responsible for PFMEA
Manufacturing Location: Geographical location
Customer Name: Name of customer(s) or product family
Model Year(s) / Program(s): Customer application or company model/style

CONTINUOUS
STRUCTURE ANALYSIS (STEP 2) FUNCTION ANALYSIS (STEP 3)
IMPROVEMENT

2. Function of the
1. Function of the
History / Change 1. Process Item 2. Process Step Process Step and
3. Process Work Process Item
Authorization (As Product 3. Function of the Process Work
Issue #

Element
Applicable) (This System, Subsystem, Station No. and Characteristic Element and Process
Function of System,
column is Part Element or Name of Focus Characteristic
4M type Subsystem, Part
optional) Name of Process Element (Quantitative value is
Element or Process
optional)

A description of
A description of A positive description of how
what the Process
what the operation the work is completed includig
Use the 4M's to Item is expected to
or station must the positive process
identify types of achieve broken
The name of the achieve. characteristic related to each
variation that have down into several
process being 4M.
an influence on the categories.
analyzed, e.g. This is the positive
operation or station
electrical motor Product The negative of these positives
being analyzed. Some categories
assembly line which Characteristic and will be used for the Failure
The operation or may be unknown
is the end result of must be detectable / Cause column. The more detail
station to be 4M Types: Man, and listed as Not
all successfully measurable in the used here, more positives, will
analyzed that Machine, Material Applicable (NA).
completed process product after the produce more Failure Causes.
produces the (indirect), Milieu
steps product has been
Process Item (Environment) These expectations
produced. Quantitative value/specification
can be referred to
May also be a non- optional, refer to process
List a single "M" for when completing
direct manufacturing The Failure Mode or documents. Examples: Press
each line. Failure Effects (FE).
process, e.g. Failure Modes will force, machine temperature,
shipping be the negative or wash concentration, speed, etc.
Types may vary by These expected
negatives of the Process characteristics are
company. results may apply for
positive Product measured when the process is
the entire Process
Characteristic. running.
Item

Step 7
PFMEA Step 7 is independently handled by each organization and is not recorded on the PFMEA form sheet.
Subject: Name of PFMEA Project PFMEA ID Number:
PFMEA Start Date: Start date Process Responsibility:
PFMEA Revision Date: Latest revision date Confidentiality Level:
Cross Functional Team: Team roster needed

FAILURE ANALYSIS (STEP 4) PFMEA RISK ANALYSIS (STEP 5)

Detection (D) of FC/FM

Special Characteristics
Occurrence (O) of FC
Severity (S) of FE

PFMEA AP
1. Failure effects (FE) to the Next Current Detection
2. Failure Mode (FM) 3. Failure Cause (FC) Current Prevention
Higher Level Element and/or Controls (DC) of FC or
of the Focus Element of the Work Element Control (PC) of FC
End User FM

How the Vehicle, System or

Subsystem could fail to perform
the Function described at the
Next Higher level.
The Failure Cause is
When considering Effects,
the negative of the
consider items listed in Failure mode must
positive listed in
"Function of the Process Item" be detectable /
"Function of the
and the "Failure Mode" and how measurable in the
Process Work
they can Effect the 3 areas being product (defect). Initial State - Past Initial State - Past
Element and Process
considered (Your Plant, Ship-to- controls proven controls proven H, M, L,
1-10 Characteristic" 1-10 1-10 CC
plant, Process Item, End User) The Failure Mode and/or controls and/or controls NA
will be the negative committed to committed to
Cause must be
It is recommended to list the or negatives of the
detectable in the
Severity Rating next to each of positive Product
process (error) and
the 3 areas (Your Plant, SHip to Characteristic.
lead to the Failure
plant, Process Item, End User)
Mode.
being considered and use the
highest Rating for the Severity
Rank. One area, such as End
User, may not always have the
highest Severity Rating.
 Determined by company
nsibility: Name of PFMEA Owner
Business Use, Proprietary, Confidential

PFMEA OPTIMIZATION (STEP 6)

Responsible Person's Name

Target Completion Date

Special Characteristics
Filter Code (Optional)

Completion Date

Occurrence (O)

Detection (D)
Severity (S)

PFMEA AP
Status
Action Taken with Pointers to
Prevention Action Detection Action Remarks
Evidence

Open, Decision
pending (optional),
Additional Actions Additional Actions Name, not Description of action taken and
mmyy or Implementation mmyy or CC H, M, L,
LL needed to reduce needed to improve title or document number, report name 1-10 1-10 1-10 For PFMEA team use
ddmmyy pending (optional), ddmmyy SS NA
Occurrence Detection department and date, etc.
Completed,
Discarded
EXAMPLE Process Failure Mode and Effects Analysis (Process FMEA)
PLANNING & PREPARATION (STEP 1)
Company Name: Acme Automotive
Manufacturing Location: Plant 6, Saginaw, Michigan
Customer Name: Jackson Industry
Model Year(s) / Program(s): 2020 PX123

CONTINUOUS
STRUCTURE ANALYSIS (STEP 2) FUNCTION ANALYSIS (STEP 3)
IMPROVEMENT

2. Function of the
1. Function of the
History / Change 1. Process Item 2. Process Step Process Step and
3. Process Work Process Item 3. Function of the
Authorization (As Product
Issue #

Element Process Work

Applicable) (This System, Subsystem, Station No. and Characteristic
Function of System, Element and Process
column is Part Element or Name of Focus
4M type Subsystem, Part Characteristic
optional) Name of Process Element (Quantitative value is
Element or Process
optional)

Your Plant Machine presses

Press in sintered
Assembly of shaft sintered bearing into
[OP30] Sintered bearing to achieve
Electrical Motor Assy into pole housing the pole housing
Bearing Press-In Press Machine axial position in pole
Line assembly seat until the
Process housing to max gap
Ship to Plant defined axial
per print
Assembly of motor position
to vehicle door
End User
Window raises and
lowers
Subject: PX123 Manual Column Assembly
PFMEA Start Date: March 19, 2018
PFMEA Revision Date: September 25, 2018
Cross Functional Team: See Team list

FAILURE ANALYSIS (STEP 4) PFMEA RISK ANALYSIS (STEP 5)

Detection (D) of FC/FM

Occurrence (O) of FC
Severity (S) of FE

PFMEA AP
1. Failure effects (FE) to the Next Current Detection
2. Failure Mode (FM) 3. Failure Cause (FC) Current Prevention
Higher Level Element and/or Controls (DC) of FC or
of the Focus Element of the Work Element Control (PC) of FC
End User FM

Your Plant
Clearance too small to assemble Axial position of Machine stops 100% check of motor
shaft without potential damage Force adjusted acc.
8 sintered bearing is before reaching final 5 performance curve 2 M
Ship-to-Plant data sheet
not reached position acc. Spec MRKJ5039
Assembly of motor to vehicle
door requires additional
insertion force with potential
damage
End User
Comfort closing time too lonng
PFMEA ID Number: 654321
Process Responsibility: B. Black
Confidentiality Level: Confidential

PFMEA OPTIMIZATION (STEP 6)

Responsible Person's Name

Target Completion Date

Special Characteristics

Filter Code (Optional)

Completion Date
Status
Action Taken with Pointers to
Prevention Action Detection Action
Evidence

Process
Selected press with
Selected press with Engineer dd.mm. dd.mm.
position control open
force monitoring Mr. Paul yyyy yyyy
sensor
Duncan
8
Severity (S)

3
Occurrence (O)

2
Detection (D)

Special Characteristics

L
PFMEA AP

Remarks
 Process general evaluation criteria severity (S)
Blank until filled
Potential failure effects rated according to criteria below
in by user
Corporate or
Impact to ship-to plant Impact to end user (when
S Effect Impact to your plant product line
(when known) known)
examples

Affects safe operation of the

Failure may result in health Failure may result in health
vehicle and/or other
and/or safety risk for and/or safety risk for
10 vehicles, the health of driver
manufacturing or assembly manufacturing or assembly
or passenger(s) or road users
High working working
or pedestrians

Failure may result in in-plant Failure may result in in-plant Noncompliance with
9
regulatory noncompliance regulatory noncompliance regulations

Line shutdown greater than

full production shift; stop
shipment possible; field Loss of primary vehicle
100% of production run
repair or replacement function necessary for
8 affected may have to be
required. normal driving during
scrapped.
(Assembly to end user) other expected service life
than for regulatory
noncompliance.
Moderately
high
Line shutdown from 1 hour
Product may have to be
up to full production shift;
sorted and a portion (less Degradation of primary
stop shipment possible; field
than 100%) scrapped; vehicle function necessary
7 repair or replacement
deviation from primary for normal driving during
required (assembly to end
process; decreased line expected service life
user) other than for
speed or added manpower
regulatory noncompliance

100% of production run may

Line shutdown up to one Loss of secondary vehicle
6 have to be reworked off line
hour function
and accepted

Less than 100% of product

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

Defective product triggers

Very objectionable
100% of production run may significant reaction plan;
appearance, sound,
4 have to be reworked in additional defective
vibration, harshness or
station before it is processed products not likely; sort not
haptics
required

Defective product triggers

A portion of the production Moderately objectionable
minor reaction plan;
run may have to be appearance, sound,
3 additional defective
reworked in- station before vibration, harshness or
products not likely; sort not
it is processed haptics
required
Low
Defective product triggers
Slightly objectionable
Slight inconvenience to no reaction plan; additional
appearance, sound,
2 process, operation, or defective products not likely;
vibration, harshness or
operator sort not required; requires
haptics
feedback to supplier

No discernible affect or no
1 Very low No discernible affect No discernible effect
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
Blank until filled
the time of evaluation and may not reflect actual occurrence. The occurrence rating number is a
in by user
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.

Corporate or
Prediction of failure
O Type of control Prevention controls product line
cause occurring
examples

10 Extremely high None No prevention controls

9 Prevention controls will have little effect in
Very high Behavioural
8 preventing failure cause
7 Prevention controls somewhat effective in
High
6 Behavioural or preventing failure cause
5 technical Prevention controls are effective in preventing
Moderate
4 failure cause
3 Low Best practices; Prevention controls are highly effective in
behavioural or preventing failure cause
2 Very low technical

Prevention controls are extremely effective in

1 Extremely low
preventing failure cause from occurring due to
design (e.g. part geometry) or process (e.g.
Technical
fixture or tooling design). Intent of prevention
controls – Failure mode cannot be physically
produced due to the failure cause

Preventive Control Effectiveness: Consider if prevention controls are technical (rely on machines, tool life, tool
material, etc.), or use best practices (fixtures, tool design, calibration procedures, error-proofing verification,
preventive maintenance, work instructions, statistical process control charting, process monitoring, product design,
etc.) or behaviour (rely on certified or non-certified operators, skilled trades, team leaders, etc.) when determinig
how effective the prevention controls will be.
Note: Occurrence can drop based on process validation activities.
Optional Table for Occurrence
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 actual occurrence. The occurrence rating number is a relative rating within the Blank until
scope of the FMEA (process being evaluated). For prevention controls with multiple occurrence ratings, use the rating that best reflects the robustness of the filled in by user
control
Corporate or
Prediction of failure Incidents per 1000
O Time Based failure cause prediction Type of control Prevention controls product line
cause occurring items/vehicles
examples

≥ 100 per thousand

10 Extremely high Every time None No prevention controls
>/= 1 in 10

50 per thousand
9 Almost every time
1 in 20
Prevention controls will have little effect in
Very high Behavioural
preventing failure cause
20 per thousand
8 More than once per shift
1 in 50

10 per thousand
7 More than once per day
1 in 100
Prevention controls somewhat effective in
High
preventing failure cause
2 per thousand
6 More than once per week
1 in 500
Behavioural or
technical
.5 per thousand
5 More than once per month
1 in 2000
Prevention controls are effective in
Moderate
preventing failure cause
.1 per thousand
4 More than once per year
1 in 10,000

.01 per thousand

3 Low Once per year
1 in 100,000 Best practices
Prevention controls are highly effective in
behavioural or
preventing failure cause
< .001 per thousand technical
2 Very low Less than once per year
1 in 1,000,000

Prevention controls are extremely effective

in preventing failure cause from occurring
Failure is eliminated due to design (e.g. Part geometry) or
1 Extremely low through prevention Never Technical process (e.g. Fixture or tooling design).
control Intent of prevention controls – Failure
mode cannot be physically produced due
to the failure cause
 Detection potential (D) for the validation of the process design
Detection controls rated according to the detection method maturity and opportunity for Blank until
detection filled in by user
Corporate or
Ability to
D Detection method maturity Opportunity for detection product line
detect
examples

The failure mode will not, or cannot, be

10 No testing or inspection method detected
has been established or is known
Very low
It’s unlikely that the testing or The failure mode is not easily detected through
9 inspection method will detect random or sporadic audits
the failure mode
Human inspection (visual, tactile, audible), or
use of manual gauging (attribute or variable)
8 Test or inspection method has that should detect the failure mode or failure
not been proven to be effective cause
and reliable (e.g. plant has little
Low or no experience with method,
gauge R&R results marginal on Machine-based detection (automated or semi-
comparable process or this automated with notification by light, buzzer
7 application, etc.) etc.), or use of inspection equipment such as a
coordinate measuring machine that should
detect failure mode or failure cause

Human inspection (visual, tactile, audible), or

use of manual gauging (attribute or variable)
6
Test or inspection method has that will detect the failure mode or failure
been proven to be effective and cause (including product sample checks)
reliable (e.g. plant has
Moderate experience with method, gauge Machine-based detection (automated or semi-
R&R results are acceptable on automated with notification by light, buzzer
comparable process or this etc.), or use of inspection equipment such as a
5 application, etc.) coordinate measuring machine that will detect
failure mode or failure cause (including product
sample checks)
 Machine-based automated detection method
that will detect the failure mode downstream,
prevent further processing or system will
identify the product as discrepant and allow it
4 to automatically move forward in the process
until the designated reject unload area.
Discrepant product will be controlled by a
System has been proven to be robust system that will prevent outflow of the
effective and reliable (e.g. plant product from the facility
has experience with method on
identical process or this
application), gauge R&R results Machine-based automated detection method
are acceptable, etc. that will detect the failure mode in-station,
High
prevent further processing or system will
identify the product as discrepant and allow it
3 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

Detection method has been Machine-based detection method that will

2 proven to be effective and detect the cause and prevent the failure mode
reliable (e.g. plant has (discrepant part) from being produced
experience with method, error-
proofing verifications, etc.)
Failure mode cannot be physically produced as-designed or processed, or
1 Very high
detection methods proven to always detect the failure mode or failure cause
 Action priority (AP) for DMFEA and PFMEA
Blank until
Action priority is based on combinations of severity, occurrence and detection ratings in
filled in by
order to prioritise actions for risk reduction.
user
Prediction of ACTION
Effect S failure cause O Ability to detect D PRIORITY Comments
occurring (AP)

Low- very low 7-10 H

Moderate 5-6 H
Very high 8-10
High 2-4 H
Very high 1 H
Low- very low 7-10 H
Moderate 5-6 H
High 6-7
High 2-4 H
Product or Very high 1 H
plant effect 9-10 Low- very low 7-10 H
very high Moderate 5-6 H
Moderate 4-5
High 2-4 H
Very high 1 M
Low- very low 7-10 H
Moderate 5-6 M
Low 2-3
High 2-4 L
Very high 1 L
Very low 1 Very high - Very low 1-10 L
Low- very low 7-10 H
Moderate 5-6 H
Very high 8-10
High 2-4 H
Very high 1 H
Low- very low 7-10 H
Moderate 5-6 H
High 6-7
High 2-4 H
Product or Very high 1 M
plant effect 7-8 Low- very low 7-10 H
high Moderate 5-6 M
Moderate 4-5
High 2-4 M
Very high 1 M
Low- very low 7-10 M
Moderate 5-6 M
Low 2-3
High 2-4 L
Very high 1 L
Very low 1 Very high - Very low 1-10 L
 Low- very low 7-10 H
Moderate 5-6 H
Very high 8-10
High 2-4 M
Very high 1 M
Low- very low 7-10 M
Moderate 5-6 M
High 6-7
High 2-4 M
Product or Very high 1 L
plant effect 4-6 Low- very low 7-10 M
moderate Moderate 5-6 L
Moderate 4-5
High 2-4 L
Very high 1 L
Low- very low 7-10 L
Moderate 5-6 L
Low 2-3
High 2-4 L
Very high 1 L
Very low 1 Very high - very low 1-10 L
Low- very low 7-10 M
Moderate 5-6 M
Very high 8-10
High 2-4 L
Very high 1 L
Low- very low 7-10 L
Moderate 5-6 L
High 6-7
High 2-4 L
Product or Very high 1 L
plant effect 2-3 Low- very low 7-10 L
low Moderate 5-6 L
Moderate 4-5
High 2-4 L
Very high 1 L
Low- very low 7-10 L
Moderate 5-6 L
Low 2-3
High 2-4 L
Very high 1 L
Very low 1 Very high - very low 1-10 L
No
Very low-
discernible 1-10 Very low-very high 1-10 L
Very high
effect 1