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FMEA Objective, scope and goal(s

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Process ID

FMEA Type: Process
FMEA Number:
Prepared By:
FMEA Date:
Revision Date:

Process Lead
Core Team Members:

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New DET

Actions Taken

New RPN

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Owner

Completion
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New SEV

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Recommended
Action(s)

New OCC

DET

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Current Process Controls

RPN

Potential Failure Mode(s)

Potential Cause(s)/
Mechanism(s) of Failure

OCC

Process Step

SEV

Action Results
Potential Effect(s)
of Failure

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Process FMEA 1 1 Column C 1 1 RPN Value 1 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 Process Step 0 0 0 0 0 0 0 0 0 0 0 .

tooling. soft. ATP seat test. temp. oil quality). corona rework 3 fixtures. incoming and at-station inspection. Impregration line operator. material Swaging hi-pot. water test. oil quality). workmanship. operator skill. Line Supervisor. chassis/cover dimension not specified. contamination Curing dimensions. hi-pot failure. hi-pot. PM. pressure/load cell. cal logs 0 0 2 12 None --- None 2 3 2 12 0 0 0 0 0 0 8. operator Welding leaks. mat'l requirements 2 162 Process capability analysis Review operator certification requirements Owner Completion Date Actions Taken 2 136 Process capability analysis Review operator certification requirements 6S station review PE/QE/Line Spv IE Complete 8 1 2 16 8 gas test. operator Impregnation DF. temp. operator skill. variable pressure.5 315 DOE to optimize parameter settings for robustness 5 180 Review operator certification requirements. fixtures. Quality Engineering. corona scrap 8 fixtures. verification procedure.FMEA Objective. bubble test.5 Helium leak test. humidity. material type. measure capacitance. fixturing. test fixture error 3 software error flag. dinemsions. dimensions New OCC Terminal brazing (cover and cap_) Assembly Current Process Controls RPN Potential Cause(s)/ Mechanism(s) of Failure OCC Potential Effect(s) of Failure Potential Failure Mode(s) SEV Action Results Process Step 8. material (thickness. hi-pot. bubble test. Process Engineering Manager 9 operator error. DF. QC dimension New DET 9 time and temperature scrap New RPN scrap low capacitance New SEV leaks. dimension scrap Testing Pads damage to part Testing false failure 10 Helium leak test. cap variation. chassis/cover dimension not specified. IR scrap 9 overheated dielectric. elongation. oil quality. electrical test DET PE/QE Complete 9 1 2 18 PE/QE/Line Spv PE/QE/Line Spv Complete 9 2 1 18 Complete 9 1.5 1 14 Recommended Action(s) 3. electrical test 2 54 Process capability analysis Review operator certification requirements PE/QE/Line Spv Complete 9 1 2 18 2 51 Process capability analysis Review operator certification requirements PE/QE/Line Spv Complete 3 3 2 18 8 cap measurement. low capacitance scrap 9 machine (time. swage dimensions Welding leaks.5 Helium leak test. material type. Welding line operator. operator quallification. fixtures. QC dimension 0 0 . contamination Impregnation corona rework 5 machine (time. corona. PM. oil quality. dimensions. PM. scope and goal(s): Review capacitor assy/test process for potential failure modes and control/risk mitigation strategy Process ID Fictional Capacitor Assembly/Test FMEA Type: Process FMEA Number: XXXX1 Prepared By: Anybody FMEA Date: 9/18/2006 Process Lead Process Engineering Manager Revision Date: A Core Team Members: Swage line operator. temp. electrical test 2 80 Process capability analysis Review operator certification requirements PE/QE/Line Spv Complete 5 2 1 10 3 gas test. DF scrap or rework 3 variable compression time. damaged. low temp seal. curls) 8 FAV. toolling error 3 visual inspection 2 12 None --- None 2 3 2 12 retest 2 operator error. time Winding capacitance. winding machine. thermal shock 4 can size 9 visual inspection. tooling. water test. feel. operator skill. dimension. low temp seal. Design Engineering. humidity/temp/time 2 48 Process capability analysis PE/QE Complete 3 3 2 18 2 operator error. Process Engineering. dimensions. set-up adjustment 2 32 Process capability analysis PE/QE Complete 2 3 2 12 scrap 2 operator error.

Process FMEA 350 300 Fictional Capacitor Assembly/Test 250 200 RPN Value 150 100 50 0 Process Step .

The product will require sorting and a portion (less that 100%) will require general cosmetic rework. but with significant performance degradation. Product may have to be sorted and a portion (less than 100%) scrapped. May lead to degradation over time. Minor disruption to production line. or end user. or end user. Minor disruption to production line. but with one or more non-critical functions degraded. assembly operator. Production stopped. Defect detected by very discriminate observation. Minor disruption to production line. Significant System Degradation Assembly functional. Moderate System Degradation Assembly functional. Failure will occur with warning. No effect. but some non-critical function operating at reduced performance. Minor Cosmetic Minor cosmetic non-conformance. Very Minor None Very minor cosmetic defect. A portion (less than 100%) of the product may require some rework. Production stopped. assembly operator. A small portion (less than 50%) of the product may require rework. loss of primary function.without warning Failure mode affects safety and may endanger machine. Obvious Cosmetic Significant cosmetic non-conformance. Could pose major disruption to production line. System Failure Item inoperable. system failure. Failure will occur without warning. 100% of product may require repair or may be scrapped.with warning Failure mode affects safety and may endanger machine. Major disruption to production line. Minor disruption to production line. Rework may be required on 100% of product. Hazardous .Product Design Severity Ranking Guidelines Effect Severity of Effect Hazardous . Minor System Degradation Assembly functional. A portion (less than 100%) of the product may have to be scrapped (no sorting). General Severity Ranking Guidelines Effect Severity of Internal/External Effect Liability Failure will affect safety or compliance to law Moderate to major reliability failures End user recalls Premature end-of-life (wear out) Increased early life failures Intermittent functionality Reliability/reputation at risk .

effort or annoyance Unnoticed either internally or externally .Customer quality inconveniences Internal yield or special handling required Unnoticed Minor reliability failures Customer line impact / lines down Impacts the yield of customer Wrong package / part / marking Products performing marginally Involved customer's special handling Damaged the customer's equipment Product assembly error Damage to down stream equipment Major yield hit Significant line yield loss Minor yield hit Low line yield loss Special internal handling.

nes Ranking 10 9 8 7 6 5 4 3 2 1 Ranking 10 9 .

8 7 6 5 4 3 2 1 .

Failures occur less frequently. centered. and contains excellent design margin.Probability of Failure Extreme: Process is out of control and not capable Uncontrolled: Process is generally not capable.000 1 in 15 67.000 1 in 3 310.000 3 . Failure occurrence is common. Outlying variation occurs from time to time. but common and standard variation causes exist and have not been corrected.000 1 in 44 23. Moderate: Process may generally be capable. Low: Defects related to common variation Very Low: Process is capable and well centered.000 1 in 161 6200 1 in 740 1350 1 in 4250 235 1 in 31. Possible Failure Rates DPMO >=1 in 2 500. but not centered. Remote: Process is capable.000 1 in 6 158.250 32 <=1 in 340.

50 >=0.00 >=1.50 >=0.50 1 .61 7 >=3.47 8 >=3.34 9 >=2.33 2 >=6.23 3 >=5.50 >=1.76 6 >=4.00 >=1.00 >=0.00 >=0.Sigma Cpk Ranking <2.00 <0.00 >=0.07 4 >=5.34 10 >=2.50 >=1.91 5 >=4.

Unable to determine reliability of assembly going to end user. Very Capable Process controls capable of detecting failures. Processes have easy detection capability and good reliability. Capable Process controls are capable. Good SPC program exists with data to back up results. Very Remote Very remote likelihood current process controls will detect a failure. Likely Process controls are likely to detect a failure. Remote Remote likelihood current process controls will detect a failure. Room for error substantial. Highly Capable Process controls are highly capable of detecting failures. but leave room for human error. SPC program exists with good results or failures are extremely obvious. Extremely Capable Current process controls will detect the failure nearly without fail. Low Likelihood Low likelihood current process controls will detect a failure.Detection Criteria: Likelihood that an Existing Defect will be Detected by the Indicated Process Controls Before the Assembly is Delivered to the End User No Capability Detection capability unknown. . Poor Likelihood that current process controls will detect a failure is poor.

Detection Rate (likelihood of finding defect) Ranking <30% 10 >30% 9 >40% 8 >50% 7 >60% 6 >70% 5 >80% 4 >90% 3 >95% 2 >99.5% 1 .

failure is almost inevitable Loss of primary function Reduced primary function performance High. repeated failures Loss of secondary function Reduced secondary function performance Minor defect noticed by most customers Minor defect noticed by some customers Minor defect noticed by discriminating customers No effect Moderate. relatively few failures Remote: failure is unlikely . occasional failures Low.AIAG Compiled Ratings Rating 10 9 8 7 6 5 4 3 2 1 Severity of effect Hazardous and without warning Hazardous and with warning Likelihood of Occurrence Very high.

ngs Ability to Detect Cannot detect Very remote chance of detection Remote chance of detection Very low chance of detection Low chance of detection Moderate chance of detection Moderately high chance of detection Almost certain detection .

Generally the Team Leader Production Operators Industrial Engineer Design Engineer Quality Engineer Reliability Engineer Tooling Engineer Maintenance Engineer Project Manager Others including Sales.Potential Team Members 1 2 3 4 5 6 7 8 9 10 Process Engineer . QA/QC. Operations .

Step 1 2 3 4 5 6 7 8 9 10 11 12 .

increasing detail only as needed to accomplish your pu Identify the sequence and the steps taken to carry out the process. using standard flow chart symbols and connecting the Identify key process characteristics as potential sources of failure Is the process standardized.Process Mapping Overview Description Identify the process to map Ask the people most familiar with the process to help construct the map Agree on the start and end points. otherwise the task can becom Agree on the level of detail to use. defining the scope of the process to be mapped is important. it’s better to start out with less detail. or are the people doing the work in different ways? Are steps repeated or out of sequence? Are there steps where errors occur frequently? Are there rework loops? Analyze the results and document potential failure modes at each process step . walk the line if necessary Construct the process map either from left to right or from top to bottom.

Potential Failure Causes 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 Omitted processing Processing errors Errors setting up work pieces Missing parts Wrong parts Processing wrong work piece Mis-operation Adjustment error Equipment not set up properly Tools and/or fixtures improperly prepared Poor control procedures Improper equipment maintenance Bad recipe Fatigue Lack of Safety Hardware failure Failure to enforce controls Environment Stress connections Poor FMEA(s) .

Potential Process Controls: 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 Standardized work instructions/procedures Fixtures and jigs Mistake-proofing tooling and/or product design Mechanical interference interfaces Mechanical counters Mechanical sensors Electrical/Electronic sensors Job sheets or Process packages Bar coding with software integration and control Marking Training and related educational safeguards Visual checks Post process inspection/testing Gage studies Statistical Process Control Design of experiments on the process/Robust process design Preventive maintenance Automation & Real Time Control .