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Process Failure Mode and Effect Analysis (Process FMEA)

Preparation (STEP 1)
Company Name: ____________________________ Subject: _______________________________ PFMEA ID Number: _____________________________
Plant location: _____________________________ PFMEA Start date: ______________________ Process responsibility: _________________________
Customer name: ___________________________ PFMEA Rev. date: _______________________ Confidentiality level:___________________________
Model year / Platform: ______________________ Cross-Functional team: ____________________________________________________
__________________________________________________________________________

D F
Structure Analysis (STEP 2) Function Analysis (STEP 3) Failure Analysis (STEP 4) O Risk AnalysisE (STEP 5) I Optimization (STEP 6)
S C T L
# E C E T
V U C E O D
E R T R S c
R R I P e c
e P
1. Function of t
1. Process 3. Process work the process I E O M C v u e M
T Current N N
F O e r
F
Item. System, 2. Process Step. element (4M item. Function 3. Function of the process work Y 2. Failure 3. Failure Prevention C Current D Responsible Target Action taken r r
c
subsystem, Station No. and TYPE, Machine, of the system, 2. Function of the Process Step 1. Failure Mode (FM) of Cause (FC) of E Special Prevention Detection person's t Special E
element and process Control (PC) ofE
Detection ( Characteristic E
Completion Status with pointer Completion i e i Characteristic Remarks
part element name of focus Method, subsystem, part and Product Characteristic. characteristic Effect (FE) ( the process the work Failure Cause ( Controls (DC)
D A classification Action action name. Date to evidence Date
t n o classification A
or name of the element Material and S step. element. ) ( y c n
element or ) (FC) O O e
process Man power) process ) O A P ( A
(
O F P T S ( D P
F O I ) O )
F F O )
F C N
E F / A
C F L
M )

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C2 PFMEA

Process General Evaluation Criteria Severity (S)


Potential Failure Effects rated according to the criteria below

S Effect Impact to your plant Impact to Ship-to Plant (when known) Impact to End User (When known)

Affects safe operation of the vehicle


Failure may result in an acute health Failure may result in an acute health and/or
and/or other vehicles, the health of drive
10 and/or safety risk for the safety risk for the manufacturing or
or passenger(s) or road users or
High manufacturing or assembly worker assembly worker
pedestrians.
Failure may result in in-plant Failure may result in in-plant regulatory
9 regulatory noncompliance noncompliance Noncompliance with regulations.

Line shutdown greater than full production


100% of production run affected may shift; stop shipment possible; field repair or
have to be scrapped. Failure may replacement required (Assembly to End
Loss of primary vehicle function
result in in-plant regulatory User) other than for regulatory
8 necessary for normal driving during
noncompliance or may have a chronic noncompliance. Failure may result in in-plant
expected service life.
health and/or safety risk for the regulatory noncompliance or may have a
manufacturing or assembly worker chronic health and/or safety risk for the
Moderately high manufacturing or assembly worker

Product may have to be sorted and a Line shutdown from 1 hour up to full
portion (less than 100%) scrapped; production shift; stop shipment possible; Degradation of primary vehicle function
7 deviation from primary process; field repair or replacement required necessary for normal driving during
decreased line speed or added man (Assembly to End User) other than for expected service life.
power regulatory noncompliance.
100% of production run may have to
6 Line shutdown up to one hour Loss of secondary vehicle function
be reworked off line and accepted
A portion of the production run may Less than 100% of product affected; strong
Degradation of secondary vehicle
5 have to be reworked off line and possibility for additional defective product;
Moderately low function.
accepted sort required; no line shutdown
100% of production run may have to Defective product triggers significant
Very objectionable appearance, sound,
4 be reworked in station before it is reaction plan; additional defective products
vibration, harshness, or haptics.
processed. not likely; sort not required
A portion of the production run may Defective product triggers minor reaction
Moderately objectionable appearance,
3 have to be reworked in-station before plan; additional defective product no likely;
sound, vibration, harshness, or haptics
it is processed sort not required.
Low
Defective product triggers no reaction plan;
Slight inconvenience to process, Slightly objectionable appearance,
2 additional defective products not likely; sort
operation, or operator sound, vibration, harshness, or haptics.
not required; requires feedback to supplier
1 Very Low No discernible effect No discernible effect or no effect No discernible effect

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C2.2 PFMEA OCCURRENCE C2.3 ALTERNATIVE PFMEA OCCURRENCE (O) TABLE C2.3.2 PFMEA OCCURRENCE (O) with Time Based Failure Prediction values
C2.3.1 PFMEA occurrence (O) with incidents per Thousand Values
Occurrence Potential (O) for the process Occurrence Potential (O) for the process 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
Potential Failure Causes rated according to the criteria below. Consider Prevention Controls when determining the Blank until filled in by user Potential Failure Causes rated according to the criteria below. Consider Prevention Controls when Blank until filled in by user of evaluation and may not reflect the actual occurrence. The occurrence rating number is a relative rating Blank until filled in by user
best Occurrence estimate. Occurrence is a predictive qualitative rating made at the time of evaluation and may determining the best Occurrence estimate. Occurrence is a predictive qualitative rating made at the time of within the scope of the FMEA (process being evaluated). For Prevention Controls with multiple
not reflect the actual occurrence. The occurrence rating number is a relative rating within the scope of the FMEA evaluation and may not reflect the actual occurrence. The occurrence rating number is a relative rating Occurrence Ratings, use the rating that best reflect the robustness of the control
(process being evaluated). For Prevention Controls with multiple Occurrence Ratings, use the rating that best within the scope of the FMEA (process being evaluated). For Prevention Controls with multiple Occurrence
reflect the robustness of the control Ratings, use the rating that best reflect the robustness of the control
Prediction of
Corporate of Product Line Incidents per 1000 Corporate of Product Line Time Based Failure Cause Corporate of Product Line
O Failure Cause Type of Control Prevention Controls O Type of Control Prevention Controls O Type of Control Prevention Controls
Examples. items/vehicles Examples. Prediction Examples.
Occurring

>= 100 per thousand >/=


10 Extremely high None No prevention controls. 10 None No prevention controls. 10 Every time None No prevention controls.
in 10
50 per thousand
9 9 9 Almost every time
Prevention controls will have little effect in 1 in 20 Prevention controls will have little Prevention controls will have little
Very High Behavioral Behavioral Behavioral
preventing failure cause. 20 per thousand effect in preventing failure cause. effect in preventing failure cause.
8 8 8 More than once per shift
1 in 50
10 per thousand
7 7 7 More than once per day
Prevention controls somewhat effective in 1 in 100 Prevention controls somewhat Prevention controls somewhat
High
preventing failure cause. 2 per thousand effective in preventing failure cause. effective in preventing failure cause.
6 6 6 More than once per week
1 in 500
Behavioral or Technical Behavioral or Technical Behavioral or Technical
.5 per thousand
5 5 5 More than once per month
Prevention controls are effective in 1 in 2000 Prevention controls are effective in Prevention controls are effective in
Moderate
preventing failure cause. .1 per thousand preventing failure cause. preventing failure cause.
4 4 4 More than once per year
1 in 10,000
0.01 per thousand
3 Low 3 3 Once per year
Prevention controls are highly effective in 1 in 100,000 Best Practices; Behavioral or Prevention controls are highly Best Practices; Behavioral or Prevention controls are highly
Best Practices; Behavioral or Technical
preventing failure cause. <.001 per thousand Technical effective in preventing failure cause. Technical effective in preventing failure cause.
2 Very low 2 2 Less than once per year
1 in 1,000,000
Prevention controls are extremely Prevention controls are extremely
Prevention controls are extremely effective
Failure is eliminated effective in preventing failure cause effective in preventing failure cause
in preventing failure cause from occurring
1 Extremely low Technical 1 through prevention Technical from occurring due to design (e.g. part 1 Never Technical from occurring due to design (e.g.
due to design (e.g. part geometry) or process
control geometry) or process (e.g. fixture or part geometry) or process (e.g.
(e.g. fixture or tooling design)
tooling design) fixture or tooling design)

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C2.4 PFMEA DETECTION (D)

Detection Potential (D) for the Validation of the process Design


Detection Controls rated according to the Detection Method Maturity and Opportunity for Detection Blank until filled in by user
Corporate of Product Line
D Ability to Detect Detection Method Maturity Opportunity for Detection Examples.
No testing or inspection
10 method has been established The failure mode will not or cannot be detected
or is known.
Very low
It is unlikely that the testing or
The failure mode is not easily detected through random or
9 inspection method will detect
sporadic audits.
the failure mode.

Test or inspection method has Human inspection (visual, tactile, audible), or use of manual
8 not been proven to be gauging (attribute or variable) that should detect the failure
effective and reliable (e.g. plant mode or failure cause
has little or not experience
Low with method, gauge R&R Machine-based detection (automated or semi-automated with
7 results marginal on comparable notification by light, buzzer, etc.) or use of inspection equipment
process or this application, such as a coordinate measuring machine that should detect
etc.) failure mode or failure cause.

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


6 gauging (attribute or variable) that will detect the failure mode or
Test or inspection method has failure cause (including product sample checks).
been proven to be effective
and reliable (e.g. plant has
Moderate experience with method, gauge
R&R results are acceptable on
comparable process or this Machine-based detection (semi-automated with notification by
application, etc.) light, buzzer, etc.) or use of inspection equipment such as a
5 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 to
4 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 product from the
effective and reliable (e.g. plan facility
has experience with method on
identical process or this
application), gauge R&R results
are acceptable, etc.
High Machine-based 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
3 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


proven to be effective and
Machine-based detection method that will detect the cause and
2 reliable (e.g. plant has
prevent the failure mode (discrepant part) from being produced.
experience with method, error-
proofing verifications, etc.)

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


1 Very high proven to always detect the failure mode or failure cause.

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C2.5 ACTION PRIORITY TABLE FOR PFMEA

Action Priority (AP) for PFMEA

Blank until filled in by


Action Priority is based on combination of Severity, Occurrence, and Detection ratings in order to prioritize actions user
for risk reduction
ACTION PRIORITY (AP).
Prediction of Failure
Effect S O Ability to Detect D H= High, M=Medium Comments
Cause Occurring
L=Low
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
discernible 1 Very low-very high 10-Jan Very high-Very low 10-Jan L
effect

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