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Severity, Occurrence, and Detection Criteria For Process FMEA

This document provides criteria for assessing the severity, occurrence, and detection of potential failures in a process FMEA (Failure Mode and Effects Analysis). It rates severity on a scale of 1-10 based on the effect on customers or subsequent processes. Occurrence is also rated 1-10 based on the likelihood of a failure occurring, from remote to very high. Detection is ranked 1-10 based on the confidence of detecting a failure before it's too late, from absolutely impossible to absolute certainty. The document provides definitions and examples for properly assessing severity, occurrence, and detection during a process FMEA.

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100% found this document useful (1 vote)
392 views4 pages

Severity, Occurrence, and Detection Criteria For Process FMEA

This document provides criteria for assessing the severity, occurrence, and detection of potential failures in a process FMEA (Failure Mode and Effects Analysis). It rates severity on a scale of 1-10 based on the effect on customers or subsequent processes. Occurrence is also rated 1-10 based on the likelihood of a failure occurring, from remote to very high. Detection is ranked 1-10 based on the confidence of detecting a failure before it's too late, from absolutely impossible to absolute certainty. The document provides definitions and examples for properly assessing severity, occurrence, and detection during a process FMEA.

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RSS347
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Severity, Occurrence, and Detection Criteria for Process FMEA

SEVERITY OCCURRENCE
“ How serious is the effect on the customer, or the next component or step……?” “what’s the likelihood that this cause will actually happen…..?
Design or Process: Process: MANUFACURING/ RNK Likelihood Either… Or…. CpK
RNK Effect
CUSTOMER EFFECT ASSEMLY EFFECT
Very high severity ranking when a Or may endanger operator (machine or More than 100 per thousand 1 in 10 or less
10 Very High: <0.55
Hazardous potential failure mode affects safe assembly) without warning machine/items (10.00%)
Persistent
10 without vehicle operation and/or involves non- 50 per thousand machines/
9 Failures 1 in 10-20 (5.00%) 0.55 to 0.78
warning compliance with government regulation items
without warning. 20 per thousand machines/
8 1 in 20-50 (2.00%) 0.78 to 0.86
Very high severity ranking when a Or may endanger operator (machine or High: Frequent items
Hazardous potential failure mode affects safe assembly) with warning. Failures 10 per thousand machines/
9 with vehicle operation and/or involves non- 7 1 in 50-100 (1.00%) 0.86 to 0.94
items
warning compliance with government regulation 5 per thousand machines/
with warning. 6 1 in 100-200 (0.50%) 0.94 to 1.00
items
Vehicle/item inoperable (loss of primary Or 100% of product may have to be scrapped, Moderate:
2 per thousand machines/ 1 in 200-500
8 Very High function). or vehicle/item repaired in repair department 5 Occasional 1.00 to 1.10
items (0.20%)
with a repair time greater than one hour. Failures
Vehicle/item operable, but at a reduced Or product may have to be sorted and a
1 per thousand machines/ 1 in 500-1,000
4 1.10 to 1.20
level of performance. Customer very portion (less than 100%) scrapped, or vehicle/ items (0.10%)
7 High dissatisfied. item repaired in repair department with a 0.5 per thousand machines/ 1 in 1,000-2,000
3 1.20 to 1.30
repair time between a half-hour and an hour. Low: Relatively items (0.05%)
Vehicle/item operable, but Comfort/ Or a portion (less than 100%) of the product Few Failures 0.1 per thousand machines/ 1 in 2,000-10,000
2 1.30 to 1.67
Convenience item(s) inoperable. may have to be scrapped with no sorting, or items (0.01%)
6 Moderate Remote:
Customer dissatisfied. vehicle/item repaired in repair department with Less than 0.010 per thousand
a repair time less than a half-hour. 1 Failure is 1 in 10,000 or more >=1.67
machines/item
Vehicle/item operable, but Comfort/ Or 100% of product may have to be reworked, Unlikely
5 Low Convenience item(s) operable at a or vehicle/item repaired off-line but does not
reduced level of performance. go to repair department. DETECTION
Fit & Finish/Squeak & Rattle item does Or product may have to be sorted, with no
4 Very Low not conform. Defect noticed by most scrap, and a portion (less than 100%) “What's our confidence that we will detect/predict the Cause, before it's too late in
customers (greater than 75%). reworked. development?"
Fit & Finish/Squeak & Rattle item does Or a portion (less than100%) of the product Inspection
3 Minor not conform. Defect noticed by 50% of may have to be reworked, with no scrap, on- Types
RNK Detection Criteria Range of Detection Method
customers. line but out-of-station. A B C
Fit & Finish/Squeak & Rattle item does Or a portion (less than100%) of the product Absolutely Absolute certainty
2 Very Minor not conform. Defect noticed by discrimi- may have to be reworked, with no scrap, on- 10 X Cannot detect or is not checked
Impossible of non-detection
nating customers (less than 25%). line and in-station.
Controls will
Or slight inconvenience to operation or Very Control is achieved with indirect or random checks
1 None No discernable effect 9 probably not X
operator, or no effect. Remote only.
detect
Controls have a
8 Remote poor chance of X Control is achieved with visual inspection only.
RPN THRESHOLD detection
Controls have a
Control is achieved with double visual inspection
There is no threshold value for RPNs. In other words, there is no 7 Very Low poor chance of X
only.
detection
value above which it is mandatory to take a Recommended Action or Controls may X X Control is achieved with charting methods, such as
6 Low
below which the team is automatically excused from an action. detect SPC (Statistical Process Control)
Control is based on variable gauging after parts
Consider the following two cases: Controls may have left the station, or Go/No Go gauging per-
5 Moderately X
10(S) x 10 (O) x 1 (D) = 100 (RPN) detect formed on 100% of the parts after parts have left
the station.
1 (S) x 10 (O) x 10(D)= 100 (RPN) Error detection in subsequent operations OR gaug-
Controls have a
Although the RPN value is same in both cases the risk associated 4
Moderately
good chance to X X ing performed on setup and first-piece check (for
High
with both cases is very different. detect set-up causes only).
Error detection in-station, or error detection in
Risk is a function of Severity X Occurrence and does not include Controls have a subsequent operations by multiple layers of accep-
3 High good chance to X X
Detection. detect
tance: supply, select, install, verify. Cannot accept
discrepant part.
Inspection Types: Error detection in-station (automatic gauging with
Controls almost automatic stop feature.) Cannot accept discrepant
2 Very High X X
certain to detect. part.
A Error Proofed
B Gauging Almost Controls almost Discrepant parts cannot be made because item has
1 X been error-proof by process/product design.
C Manual Inspection Certain certain to detect.

Caterpillar: Confidential Green Note: Caterpillar has not yet adopted the AIAG 4th Edition. Rev B 12/9/2008
FMEA Quick Reference Guide
Potential Failure Mode and Effects Analysis FMEA number:______________________________
(Process FMEA) Page:_________of __________________________
Item:______________________________ Process Responsibility:_____________________ Prepared by:________________________________
Model Year(s)/Program(s): Key Date:_______________________________ FMEA Date( Orig):___________________________
Core Team _________________________________________________________________________ Location/Building/Line/Station/machine:___________

Process Step Output Potential Potential S C Potential O Current Control D R Recommended Responsi- Action Results
Step / Require- Failure Effect(s) of e l Cause(s)/ c Process Type e P Action(s) bility and
Actions S O D N
ments Mode Failure v a Mechanism c Control t N Target
s (s) of u e Completion Taken e c e e
v c t w
s Failure r c Date
R
P
N
10 5 Det 2 100 10 2 2 40
Process Description R Or
Prev Name
Step of non con- Max Severity for
Date of
Description. formance of What could Failure Mode x
Describe the controls proposed
that specific cause the Occurrence of
that either prevent Action
operation. Failure Mode. the cause x Min
Indicate the Identify how the Failure mode or Detection
purpose of the each input cause from occurring
process or from SIPOC or detect the failure Actions should be able to be stand alone so Mitigated risk
operation As experienced by the can go wrong. mode and cause that it can be taken out of the FMEA and documented and if
being customer both internal should it occur. should be taken in following order. successful should
analyzed. as well as external. Machine Set up Severity first (Extreme safety/regulatory risk result in lower
Process Effects and SPC Severity of 9 & 10) ratings
Operator Safety also Criticality Matrix Red Zone (S x O)
considered. Use AIAG Ranking Criticality Matrix Yellow Zone (S x O)
Remaining combinations in top 20% RPN
Scale 1– 10 pareto

1E2966 Identification – Special Characteristics


Special Process Characteristics— It is a characteristic for which variation must be con-
trolled to some target value during manufacturing and assembly or those with Severity/
Occurrence (Criticality) combinations in the “Red Zone” (and the “Yellow Zone” if
RPN>100) may be nominated as “potential” Special Characteristics based on team’s as-
sessment of the impact the particular characteristic has on compliance to regulatory re-
quirements, product fit, function, performance, or subsequent processing of the product.

If the feature/characteristic is nominated to be a “potential” Special D P


R
Characteristic by the team, the appropriate Special Characteristic Symbol
(as defined in Caterpillar Specification 1E2966 Identification – Special Characteristics)
shall be placed in the Classification column of the Process FMEA.

The feature/characteristic associated with the failure mode identified in DFMEA shall be
transferred to the Process FMEA for further mitigation.

Proof Required for Occurrence


value of 1, 2 & 3 with Severity of 7
or higher

Caterpillar: Confidential Green Rev B 12/9/2008


Severity, Occurrence, and Detection Criteria for Design FMEA
SEVERITY OCCURRENCE
“ How serious is the effect on the customer, or the next component or step……?” “what’s the likelihood that this cause will actually happen…..?
Design or Process: CUSTOMER Process: MANUFACURING/ASSEMLY RNK Likelihood Either… Or…. CpK
RNK Effect
EFFECT EFFECT
Hazard- Very high severity ranking when a poten- Or may endanger operator (machine or assem-
More than 100 per
1 in 10 or less
ous with- tial failure mode affects safe vehicle bly) without warning 10 Very High: thousand machine/ <0.55
(10.00%)
10 out warn- operation and/or involves noncompliance Persistent items
ing with government regulation without Failures 50 per thousand ma- 1 in 10-20
9 0.55 to 0.78
warning. chines/items (5.00%)
Hazard- Very high severity ranking when a Or may endanger operator (machine or assem- 20 per thousand ma- 1 in 20-50
8 High: 0.78 to 0.86
ous with potential failure mode affects safe vehicle bly) with warning. chines/items (2.00%)
9 Frequent
warning operation and/or involves noncompliance 10 per thousand ma- 1 in 50-100
7 Failures 0.86 to 0.94
with government regulation with warning. chines/items (1.00%)
Very High Vehicle/item inoperable (loss of primary Or 100% of product may have to be scrapped, or 5 per thousand ma- 1 in 100-200
8 function). vehicle/item repaired in repair department with a 6 0.94 to 1.00
chines/items (0.50%)
repair time greater than one hour. Moderate:
2 per thousand ma- 1 in 200-500
High Vehicle/item operable, but at a reduced Or product may have to be sorted and a portion 5 Occasional 1.00 to 1.10
chines/items (0.20%)
level of performance. Customer very (less than 100%) scrapped, or vehicle/item Failures
7 1 per thousand ma- 1 in 500-1,000
dissatisfied. repaired in repair department with a repair time 4 1.10 to 1.20
chines/items (0.10%)
between a half-hour and an hour.
0.5 per thousand ma- 1 in 1,000-2,000
Moderate Vehicle/item operable, but Comfort/ Or a portion (less than 100%) of the product may 3 Low: 1.20 to 1.30
Convenience item(s) inoperable. Cus- have to be scrapped with no sorting, or vehicle/ chines/items (0.05%)
6 Relatively Few
tomer dissatisfied. item repaired in repair department with a repair 0.1 per thousand ma- 1 in 2,000-10,000
2 Failures 1.30 to 1.67
time less than a half-hour. chines/items (0.01%)
Low Vehicle/item operable, but Comfort/ Or 100% of product may have to be reworked, or Remote: Less than 0.010 per
1 in 10,000 or
5 Convenience item(s) operable at a re- vehicle/item repaired off-line but does not go to 1 Failure is thousand machines/ >=1.67
more
duced level of performance. repair department. Unlikely item
Very Low Fit & Finish/Squeak & Rattle item does Or product may have to be sorted, with no scrap,
4 not conform. Defect noticed by most and a portion (less than 100%) reworked. DETECTION
customers (greater than 75%).
Minor Fit & Finish/Squeak & Rattle item does Or a portion (less than100%) of the product may “What's our confidence that we will detect/predict the Cause, before it's too
3 not conform. Defect noticed by 50% of have to be reworked, with no scrap, on-line but late in development?"
customers. out-of-station.
RNK Detection Criteria: Likelihood of Detection by DESIGN control
Very Fit & Finish/Squeak & Rattle item does Or a portion (less than100%) of the product may
2 Minor not conform. Defect noticed by discrimi- have to be reworked, with no scrap, on-line and Design Control will not and/or cannot detect a potential cause/
Absolutely
nating customers (less than 25%). in-station. 10 mechanism and subsequent failure mode; or there is no
Uncertainty
None No discernable effect Or slight inconvenience to operation or operator, Design Control.
1
or no effect. Very remote chance the Design Control will detect a potential
9 Very Remote
cause/mechanism and subsequent failure mode.
Remote chance the Design Control will detect a potential
RPN THRESHOLD 8 Remote
cause/mechanism and subsequent failure mode.
Very low chance the Design Control will detect a potential
There is no threshold value for RPNs. In other words, there is no value 7 Very Low
cause/mechanism and subsequent failure mode.
above which it is mandatory to take a Recommended Action or below Low chance the Design Control will detect a potential cause/
which the team is automatically excused from an action. Consider the fol- 6 Low
mechanism and subsequent failure mode.
lowing two cases: Moderate chance the Design Control will detect a potential
5 Moderately
10(S) x 10 (O) x 1 (D) = 100 (RPN) cause/mechanism and subsequent failure mode.
1 (S) x 10 (O) x 10(D)= 100 (RPN) 4
Moderately Moderately high chance the Design Control will detect a
Although the RPN value is same in both cases the risk associated with High potential cause/mechanism and subsequent failure mode.

both cases is very different. High chance the Design Control will detect a potential cause/
3 High
mechanism and subsequent failure mode.
Risk is a function of Severity X Occurrence and does not include Detection. Very high chance the Design Control will detect a potential
2 Very High
cause/mechanism and subsequent failure mode.
Almost Design Control will almost certainly detect a potential cause/
1 Certain mechanism and subsequent failure mode.

Caterpillar: Confidential Green Note: Caterpillar has not yet adopted the AIAG 4th Edition. Rev B 12/9/2008
FMEA Quick Reference Guide
____ System Potential Failure Mode and Effects Analysis FMEA number:____________________
____ Sub System (Design FMEA) Page:_________of _________________
____ Component Design Responsibility:_____________________ Prepared by:_______________________
Model Year(s)/Program(s): Key Date:_______________________________ FMEA Date( Orig):_________________
Core Team ______________________________________________________________________________________________________

Item Functional Potential Potential S C Potential O Current Control D R Recommended Responsibil- Action Results
Requirement Failure Effect(s) e l Cause(s)/ c Design Type e P Action(s) ity and
Mode of Failure v a Mechanism c Control t N Target
s (s) of u e Completion
s Failure r c Date Actions S O D N
Taken e c e e
v c t w
R
P
N
10 5 Det 2 100 10 2 2 40
R
What is it we are Anti Function Or Name
Prev Mitigated risk docu-
analyzing ·Full Date of ment and if success-
Max Severity
Product ·Partial proposed ful should result in
for Failure
System ·Intermittent ·Mistake Proofing Action lower ratings
Mode x
Sub-System ·Over or ·Design Occurrence of
Component Unintended Verification, plan-
Customer Focused the cause x Min Actions should be able to be stand alone
·Product liability Causes Include: ning & Testing Detection so that it can be taken out of the FMEA
Function should be verb ·Customer dissatisfac- System Interfaces ·Builds
and should be taken in following order.
noun with reference to tion Noise Factors (P- ·Bench Test
Severity first (Extreme safety/regulatory
specification including ·Reduced perform- Diagram) risk Severity of 9 & 10)
measures and metrics. ance of System or Design Errors Use AIAG ranking Criticality Matrix Red Zone (S x O)
Based on customer Component Environment Criticality Matrix Yellow Zone (S x O)
Requirements & team ·Potential risk of 1—10 scale Remaining combinations in top 20% RPN
discussions injury pareto

1E2966 Identification – Special Characteristics


Product Features/characteristics associated with failure mode identified in the Design FMEA
involving possible non-compliance with regulatory requirements or those with Severity/
Occurrence (Criticality) combinations in the “Red Zone” (and the “Yellow Zone” if RPN>100)
may be nominated as “potential” Special Characteristics based on team’s assessment of the
impact the particular characteristic has on compliance to regulatory requirements, product fit,
function, performance, or subsequent processing of the product.

If the feature/characteristic is nominated to be a “potential” Special Characteristic by the team,


the appropriate Special Characteristic Symbol D PR

(as defined in Caterpillar Specification 1E2966 Identification – Special Characteristics) shall be


placed in the Classification column of the Design FMEA and the feature/characteristic associ-
ated with the failure mode shall be transferred to the Process FMEA for further mitigation.

Proof Required for Occurrence


value of 1, 2 & 3 with Severity of 7
or higher

Caterpillar: Confidential Green Rev B 12/9/2008

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