FMEA - Quick Reference Guide

Potential
ITEM: FMEA Number:
Failure Mode and Effects Analysis Page 1 of 1
Year: Process Responsibility: (Green FMEA) Prepared by:
Core Team: Key Date: FMEA Date (orig.):
Process C Potential O Current D Action Results
Potential Potential S l c e R. Responsibility
a Cause(s)/ c Process t Recommended Actions S O D R.
Failure Effect(s) of e P. & Target
v s Mechanism(s) u Controls e N. Action(s) Taken e c e P.
Function Mode Failure s r c Completion Date v c t N.
Failure Prevent Detect
OP#10 must assemble cross FMEA not • Product liability Inadequate FMEA • Mistake Proofing • APQP Checklist Call an FMEA Process engineer team FMEA performed
functional Team and Develop • Customer 10 CC development • Automatic Visual • FMEA Review 5 250 leader or project 1 2
adequately 5 facilitator to under the supervision 10 20
Systems Process
FMEA. performed; dissatisfaction • Cross functional reduce time required manager; and leadership of
• Proximity Switch • Management Review
•SAEJ 1739 Guidelines • Reduced performance team not assembled Process and improve quality ASAP an expert/certified
•APQP Specific Team Members of system or • Facilitation not • Control Plan entries of the FMEA process FMEA facilitator
Must provide an FMEA component used
which determines process • Potential risk of • FMEA expertise is Actions should:
risk and addresses injury limited • eliminate failure • Name of team Brief action Recalculate RPN, after
confirmed significant • Reduce level of • Lack of adequate mode SEV=9/10 member to result action has been
characteristic selection: analysis of process FMEA Training • eliminate causes carry issue. description taken
Detect on CC
Measurable: • Inconsistent product/ Planned • Name of Date action • occurrence
• Torque high return rate • reduce occurrence champion • detection
Customer Evaluation • improve evaluation taken
Brainstorm causes Method to/from “detection • Date action Note: severity will
focus/experience • man • Control Plan reduction last desired likely stay the same
• Verb-noun • end user • material • Tools option” completion unless failure mode is
• measurable Anti function • assembler • method • Mistake Proofing
• machine Note: must have written eliminated
is desirable for functional • maker Instruction
• environment Prevent
• objective approach • regulatory body Determine Root • Reduce Occurrence
• subjective • full • environment cause if CC
• partial
• intermittent
• excess function See Severity See Occurrence See Detection FMEA analysis flowchart
Chart on Chart on
Chart on Define
opposite side opposite side No
opposite side function, Yes Determine No
failure, Severity Severity causes of Occur. 4 End
Actions are Required: Critical & Significant effects and 9 or 10? 5 to 8? failure and or more? process
(by Priority) Characteristics Action Guidelines determine occurrence
severity Yes
Yes No
10 1.) Confirmed Critical Characteristic
1.) Confirmed CC is a Critical Determine
Top 20% of Failure Determine End
mitigating
Characteristic to be addressed on 9
Modes by RPN mitigating process
actions. Cost
Control 8 2.) Confirmed Significant actions. Cost should be
Plan) must not be factored to
7 Characteristic; Action factored into
S Required prioritize actions
solution.
e 6 R
2.) An SC is a confirmed Significant v
5
P
Characteristic to be addressed on e N
ANNOYANCE
Control Plan) r 4
ZONE
i 3
t 3.) RPN-Top 20% by pareto US (248) 280 4800
y 2 CDN (519) 915 0952
1 Failure Modes www.quality-one.com
3.) For the top 20% Failure Modes /
Causes (Pareto by RPN) 1 2 3 4 5 6 7 8 9 10
Occurrence
©Quality Associates International, Inc. 1998 (REV: 04/2001)
 Severity, Occurrence, and Detection Criteria for Process FMEA
SEVERITY EVALUATION CRITERIA SUGGESTED DETECTION EVALUATION CRITERIA
DETECTION CRITERIA SUGGESTED RANGE OF RNK.
EFFECT CRITERIA: Severity of Effect RNK A B C DETECTION METHODS
Almost Absolute certainty of Non -
This ranking results when a potential failure mode results in a final customer and/or a manufacturing/assembly plant defect. Detection
Cannot detect or is not checked. 10
Impossible
The final customer should always be considered first. If both occur, use the higher of the two severities. Controls will probably not Control is achieved with indirect or random
Very Remote detect. checks only. 9
Customer Effect Manufacturing/Assembly Effect Environmental Effect Controls have poor chance
Very high severity ranking when a potential failure Ecosystem structure and function are adversely Remote of detection.
Control is achieved with visual inspection only. 8
Hazardous- Or may endanger operator (machine or assembly) 10
mode effects safe vehicle operation and/or involves affected. Impact is long lasting. Possible severe Controls have poor chance of Control is achieved with double visual inspection
without noncompliance with government regulation without without warning. injuries or death to individuals, population is at Very Low 7
detection. only.
warning warning. risk. Control is achieved with charting methods, such
Very high severity ranking when a potential failure Low Controls may detect.
as SPC (Statistical Process Control). 6
Hazardous- Ecosystem structure and function are adversely 9
mode effects safe vehicle operation and/or involves Or may endanger operator (machine or assembly) with
with affected. Impact is long lasting. Possible severe Control is based on variable gauging after parts
noncompliance with government regulation with warning.
warning injuries to individuals, population is not at risk. have left the station, OR Go/No Go gauging
warning. Moderate Controls may detect.
performed on 100% of the parts after parts have 5
Or 100% of product may have to be scrapped, or left the station.
Very High Vehicle/item inoperable (loss of primary function) vehicle/item repaired in repair department with a repair Ecosystem structure and function/environment are
8 Error Detection in subsequent operations, OR
Moderately Controls have a good chance
time greater than one hour. exposed but impact is intermittent. Ecosystem
to detect.
gauging performed on set-up and first-place 4
Or product may have to be sorted and a portion (less structural and functional integrity are intact. High check (for set-up Causes only).
Vehicle/item operable but at a reduced level of
than 100%) scrapped or vehicle/item repaired in repair Possible injuries to individuals, population is not 7 Error Detection in-station, OR error Detection in
High performance. Customer very dissatisfied. at risk.
department with a repair time between half an hour and Controls have a good chance subsequent operations by multiple layers of
an hour.
High to detect. acceptance; supply, select, install, verify.Cannot 3
Or a portion (less than 100%) of the product may have accept discrepant part.
Vehicle/item operable but Comfort/Convenience to be scrapped with no sorting, or vehicle /item repaired
6
Moderate Ecosystem and function/environment are exposed Error Detection in-station (automatic gauging
item(s) inoperable. Customer dissatisfied. in repair department with a repair time less than half an Controls almost certain to
but impact is temporary. Ecosystem structural and Very High detect.
with automatic stop feature). Cannot pass 2
hour. functional integrity are intact. Possible minor discrepant part.
Vehicle/Item operable but Comfort/Convenience Or 100% of product may have to be reworked, or injuries to individuals, population is at risk. Discrepant parts cannot be made because item
items operable at a reduced level of performance.
5
Low vehicle/item repaired off-line but does not go to repair Full Controls certain to detect. has been error proofed by progress/product 1
Customer somewhat dissatisfied. department. design.
Fit & Finish/Squeak & Rattle item does not conform. Or the product may have to be sorted with no scrap, and Ecosystem structure and function/environment are 4
Very Low Defect noticed by most customers (greater than a portion (less than 100%) reworked. Inspection Types: A = Error Proofed
NOTE: The ranking value of 1 is reserved for “Almost
exposed but impact is temporary. Ecosystem B = Gauging
75%). structural and functional integrity are intact. No Certain.”
C = Manual Inspection
Fit & Finish/Squeak & Rattle item does not conform. Or a portion (less than 100%) of the product may have injuries to individuals, population is at risk. 3
Minor Defect noticed by 50% of customers. to be reworked with no scrap, on-line but out- of-station.
Fit & Finish/Squeak & Rattle item does not conform. Ecosystem structure and function are not exposed SUGGESTED OCCURRENCE EVALUATION CRITERIA
Or a portion (less than 100%) of the product may have
Very Minor Defect noticed by discriminating customers (less
to be reworked with no scrap, on-line but in-station.
to stress, or expression of stress is not measurable 2 Probability of Likely Failure Rates Ranking
than 25%). or adverse.
Or slight inconvenience to operation or operator, or no Ecosystem structure and function are not exposed. Failure Process Product
None No discernible effect. 1
effect. Individuals and populations are not at risk.
≥ 100 per thousand pieces 10
Very High: Once per week
Persistent failures 50 per thousand pieces 9
*Note: COST EVALUATION Recommended use for Cost RPN THRESHOLD
Zero (0) rankings CRITERIA Evaluation Criteria 20 per thousand pieces 8
There is no threshold value High: Frequent Once per month
for Severity, Occurrence Criteria Ranking All critical items (Severity 9 or 10) must have for RPNs. In other words, failures 10 per thousand pieces 7
or Detection are not recommended actions assigned. Cost must not there is no value above which
allowed > $500,000 5 it is mandatory to take a 5 per thousand pieces 6
be utilized when determining action
Recommended Action or Moderate:
requirements. Once per year 2 per thousand pieces 5
$100,000 - $499,999 4 below which the team is Occasional failures
Cost ranking should be used as a method to automatically excused from 1 per thousand pieces 4
$25,000 - $99,999 3 prioritize actions for significant items an action.
(Severity 5 – 8 with an Occurrence of 4 or Low: Relatively few
0.5 per thousand pieces 3
(248) 280 - 4800 Once in 5 years
$3,000 - $24,999 2 greater), and as a means of determining if failures 0.1 per thousand pieces 2
CDN (519) 915 - 0952
www.quality-one.com actions are feasible for non-special
1 Remote: Failure is
<$3,500 characteristics. Once in 10 years ≤ 0.01 per thousand pieces 1
unlikely