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This document provides a template for conducting a Potential Failure Mode and Effects Analysis (PFMEA) for manufacturing and assembly processes. The template includes sections for documenting the process function and requirements, potential failure modes and causes, effects of failure, current process controls, likelihood of occurrence, severity, detection methods, and recommended actions. The goal of a PFMEA is to proactively identify potential product and process failures and mitigate risks before they result in defects.
This document provides a template for conducting a Potential Failure Mode and Effects Analysis (PFMEA) for manufacturing and assembly processes. The template includes sections for documenting the process function and requirements, potential failure modes and causes, effects of failure, current process controls, likelihood of occurrence, severity, detection methods, and recommended actions. The goal of a PFMEA is to proactively identify potential product and process failures and mitigate risks before they result in defects.
This document provides a template for conducting a Potential Failure Mode and Effects Analysis (PFMEA) for manufacturing and assembly processes. The template includes sections for documenting the process function and requirements, potential failure modes and causes, effects of failure, current process controls, likelihood of occurrence, severity, detection methods, and recommended actions. The goal of a PFMEA is to proactively identify potential product and process failures and mitigate risks before they result in defects.
POTENTIAL FAILURE MODE AND EFFECTS ANALYSIS IN MANUFACTURING
AND ASSEMBLY PROCESSES (PROCESS FMEA)
FMEA Number: Item: Page of Model Year(s)/Program(s): / Process Responsibility: Prepared by: Core Team: Key Date: FMEA Date (Orig.): (Rev.):
Process C O Current Process D Action Results
Function Potential Potential S l Potential Cause(s) / c e R. Responsibility Failure Effect(s) of Mechanism(s) Controls Recommended & Target e a c t P. Action(s) Actions S O D R. Mode Failure v s of Failure u Prevention Detection e N. Completion Date e c e P. s r c Taken v c t N. Requirements
What are What can
How bad be done? the is it ? effect(s)? Design Changes Step 1 What can Process go wrong? Changes No What are How often Special Function the does it Controls Partial/ Step 2 Cause(s)? happen? Changes Over/ to Stan- What Degraded dards are the Function Procedure Functions, or Guides Features or Inter- How can How good Require- mittent this be is this ments? Function prevented method Uninten- Step 3 and at ded detected? detecting? Effects List: Process FMEA Function Operator Next Down- Machines/ Vehicle Ultimate Compliance safety user stream Equip- operation Custo- with users ment mer Government regulations
Failure Mode
Revision Date: 1/15/2004
PROCESS FMEA Suggested PFMEA Severity Evaluation Criteria Suggested PFMEA Occurrence Evaluation Criteria Suggested PFMEA Detection Evaluation Criteria Criteria: Severity of Effect: This ranking results when a potential failure mode results in a final customer and/or manufacturing/assembly plant defect. The final customer Probability Effect should always be considered first. If both occur, use the higher of the two severities. Ranking Likely Failure Rates Ranking Detection Criteria A B C Suggested Range of Detection Methods Ranking of Failure (Customer Effect) (Manufacturing/Assembly Effect) Hazardous Very high severity ranking when a Or may endanger operator Almost Absolute Cannot detect or is not checked. potential failure mode affects safe (machine or assembly) without 100 per thousand without Warning vehicle operation and/or involves noncompliance with government warning. 10 Very High: Persistent pieces 10 Impossible certainty of non- X 10 regulation without warning. failures detection. Hazardous Very high severity ranking when a Or may endanger operator Very Controls will Control is achieved with indirect or potential failure mode affects safe (machine or assembly) with with Warning vehicle operation and/or involves noncompliance with government warning. 9 50 per thousand pieces 9 Remote probably not detect. X random checks only. 9 regulation with warning. Very High Vehicle/item inoperable (loss of Or 100% of product may have Remote Controls Control is achieved with visual inspection primary function). to be scrapped, or vehicle/ have poor item repaired in repair depart- ment with a repair time greater 8 High: Frequent 20 per thousand pieces 8 chance of detection. X only. 8 than one hour. failures High Vehicle/item operable but at a Or product may have to be sorted and Very Low Controls Control is achieved with double visual reduced level of performance. a portion (less than 100%) scrapped, or Customer very dissatisfied. vehicle/item repaired in repair depart- ment with a repair time between half an 7 10 per thousand pieces 7 have poor chance of X inspection only. 7 hour and an hour. detection. Moderate Vehicle/item operable but Or a portion (less than 100%) of the Low Controls Control is achieved with charting comfort/ convenience item(s) product may have to be scrapped with Moderate: 5 per thousand inoperable. Customer dissatisfied. no sorting, or vehicle/item repaired in re- pair department with a repair time less 6 Occasional pieces failures 6 may detect. X X methods, such as SPC (Statistical Process Control). 6 than half an hour. Low Vehicle/item operable but com- Or 100% of product may have Moderate Controls Control is based on variable gauging after fort/convenience item(s) operable to be reworked, or vehicle/ at a reduced level of performance. Customer somewhat dissatisfied. item repaired off-line but does not go to repair department. 5 2 per thousand pieces 5 may detect. X X parts have left the station, OR Go/No Go gauging performed on 100% of the parts 5 after parts have left the station. Very Low Fit & finish/squeak & rattle item Or the product may have to Moderately Controls Error detection in subsequent operations, does not conform. Defect noticed be sorted, with no scrap, and 1 per thousand by most customers (greater than 75%). a portion (less than 100%) reworked. 4 pieces 4 High have a good chance to X X OR gauging performed on setup and first- piece check (for setup causes only). 4 detect. Minor Fit & finish/squeak & rattle item Or a portion (less than 100%) High Controls Error detection in-station, OR error detec- does not conform. Defect noticed of the product may have to Low: 0.5 per thousand by 50% of customers. be reworked, with no scrap, on-line but out-of-station. 3 Relatively few pieces 3 have a good chance to X X tion in subsequent operations by multiple layers of acceptance: supply, select, install, 3 detect. verify. Can not accept discrepant part. failures Very Minor Fit & finish/squeak & rattle item Or a portion (less than 100%) Very High Controls Error detection in-station (automatic 0.1 per thousand does not conform. Defect noticed by discriminating customers (less than 25%). of the product may have to be reworked, with no scrap, on- line but in-station. 2 pieces 2 almost certain to X X gauging with automatic stop feature). Can not pass discrepant part. 2 detect. None No discernible effect. Or slight inconvenience to Remote: Very High Controls Discrepant parts can not be made operation or operator, or no 0.01 per thousand effect. 1 Failure is unlikely pieces 1 certain to detect. X because item has been error proofed by process/ product design. 1 Inspection Types: A = Error Proofed B = Gauging C = Manual Inspection