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Process General Evaluation Criteria Severity (S)

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Potential Failure Effects rated according to the criteria below.
by user
Corporate or
Impact to Ship-to Plant Impact to End User
S Effect Impact to Your Plant Product Line
(when known) (when known)
Examples
Affects safe
operation of the
Failure may result in Failure may result in
vehicle and/or
an acute health and/or an acute health and/or
other vehicles, the
10 safety risk for the safety risk for the
health of driver or
High manufacturing or manufacturing or
passenger(s) or
assembly worker assembly worker
road users or
pedestrians.
Failure may result in in- Failure may result in in-
Noncompliance with
9 plant regulatory plant regulatory
regulations.
noncompliance noncompliance
Line shutdown greater
than full production shift;
stop shipment possible;
100% of production run
field repair or
affected may have to be
replacement required Loss of primary
scrapped.
(Assembly to End User) vehicle function
Failure may result in in-
other than for regulatory
plant regulatory necessary for
8 noncompliance.
noncompliance or may normal driving
Failure may result in in-
have a chronic health during expected
plant regulatory
and/or safety risk for the service life.
noncompliance or may
manufacturing or
Moderately have a chronic health
assembly worker
high and/or safety risk for the
manufacturing or
assembly worker
Line shutdown from 1
Production may have to hour up to full
Degradation of
be sorted and a portion production shift; stop
primary vehicle
(less than 100%) shipment possible; field
function necessary
7 scrapped; deviation from repair or replacement
for normal driving
primary process; required (Assembly to
during expected
decreased line speed or End User) other than for
service life.
added manpower regulatory
noncompliance
100% of production run
may have to be Line shutdown up to one Loss of secondary
6
reworked off line and hour. function.
accepted

Less than 100% of


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

Defective product
100% of production run triggers significant Very objectionable
may have to be reaction plan; appearance, sound,
4
reworked in station additional defective vibration, harshness,
before it is processed products not likely; sort or haptics.
not required
A portion of the Defective product triggers Moderately
production run may have minor reaction plan; objectionable
3 to be reworked in- additional defective appearance, sound,
station before it is products not likely; sort vibration, harshness,
processed not required or haptics.
Defective product
Low triggers no reaction
Slightly objectionable
Slight inconvenience to plan; additional
appearance, sound,
2 process, operation, or defective products not
vibration, harshness,
operator likely; sort not required;
or haptics.
requires feedback to
supplier
No discernible effect or
1 Very Low No discernible effect No discernible effect.
no effect

Table P1 – PFMEA SEVERITY (S)


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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 Blank until filled
occurrence. The occurrence rating number is a relative rating within the scope of the in by user
FMEA (process being evaluated). For Prevention Controls with multiple Occurrence
Ratings, use the rating that best reflects the robustness of the control.
Corporate of
Prediction of Failure Type of
O Prevention Controls Product Line
Cause Occurring Control Examples
10 Extremely high None No prevention controls.
9 Prevention controls will have little
Very high Behavioral
8 effect in preventing failure cause.
7 Prevention controls somewhat
High
6 Behavioral effective in preventing failure cause.
5 or Technical Prevention controls are effective in
Moderate
4 preventing failure cause.
3 Low Best
Practices: Prevention controls are highly
2 Very low Behavioral effective in preventing failure cause.
or Technical
Prevention controls are extremely
effective in preventing failure cause
from occurring due to design (e.g.
part geometry) or process (e.g.
1 Extremely low Technical
fixture or tooling design). Intent of
prevention controls – Failure Mode
cannot be physically produced due
to the Failure Cause.
Prevention 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 behavioural (rely on certified or non-certified operators,
skilled trades, team leaders, etc.) when determining how effective the prevention controls will be.
Table P2 – PFMEA OCCURRENCE (O)

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

Human inspection (visual, tactile, audible),


Test or inspection method or use of manual gauging (attribute or
8
has not been proven to be variable) that should detect the failure
effective and reliable (e.g. mode or failure cause.
plant has little or no Machine-based detection (automated or
Low
experience with method, semi-automated with notification by light,
gauge R&R results marginal buzzer, etc.), or use of inspection
7
on comparable process or equipment such as a coordinate
this application, etc.). measuring machine that should detect
failure mode or failure cause.
Human inspection (visual, tactile, audible),
or use of manual gauging (attribute or
Test or inspection method
6 variable) that will detect the failure mode
has been proven to be
or failure cause (including product sample
effective and reliable (e.g.
checks).
plant has experience with
Moderate Machine-based detection (semi-automated
method, gauge R&R results
with notification by light, buzzer, etc.), or
are acceptable on
use of inspection equipment such as a
5 comparable process or this
coordinate measuring machine that will
application, etc.).
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 automatically
4
move forward in the process until the
designated reject unload area. Discrepant
System has been proven to
product will be controlled by a robust
be effective and reliable
system that will prevent outflow of the
(e.g. plant has experience
product from the facility
High with method on identical
Machine-based automated detection
process or this application),
method that will detect the failure mode in-
gauge R&R results are
station, prevent further processing or
acceptable, etc.
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
reliable (e.g. plant has detect the cause and prevent the failure
2
experience with method, mode (discrepant part) from being
error-proofing verifications, produced.
etc.).
Failure mode cannot be physically produced as-designed or processed,
1 Very high or detection methods proven to always detect the failure mode or failure
cause.

Table P3 – PFMEA DETECTION (D)

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