TS16949 PPAP APQP FEMA小归纳.docx
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TS16949 PPAP APQP FEMA小归纳.docx
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TS16949PPAPAPQPFEMA小归纳
APQP(Advancedproductqualityplanning)
Plan and Define Program
1.1Voice of the Customer
1.1.1Market Research
1.1.2Historical Warranty and Quality Information
1.1.3Team Experience
1.2Business Plan/Marketing Strategy
1.3Product/Process Benchmark Data
1.4Product/Process Assumptions
1.5Product Reliability Studies
1.6Customer Inputs
1.7Design Goals
1.8Reliability And Quality Goals
1.9Preliminary Bill of Material
1.10Preliminary Process Flow Chart
1.11Preliminary Listing of Special Product and Process Characteristics
1.12Product Assurance Plan
1.13Management Support
Product Design and Development
2.1Design Failure Mode and Effects Analysis (DFMEA)
2.2Design for Manufacturability and Assembly
2.3Design Verification
2.4Design Reviews
2.5Prototype Build – Control Plan
2.6Engineering Drawings (Including Math Data)
2.7Engineering Specifications
2.8Material Specifications
2.9Drawing and Specification Changes
2.10New Equipment, Tooling and Facilities Requirements
2.11Special Product and Process Characteristics
2.12Gages/Testing Equipment Requirements
2.13Team Feasibility Commitment and Management Support
Process Design and Development
3.1Packaging Standards
3.2Product/Process Quality System Review
3.3Process Flow Chart
3.4Floor Plan Layout
3.5Characteristics Matrix
3.6Process Failure Mode and Effects Analysis (PFMEA)
3.7Pre-Launch Control Plan
3.8Process Instructions
3.9Measurement Systems Analysis Plan
3.10Preliminary Process Capability Study Plan
3.11Packaging Specifications
3.12Management Support
Product and Process Validation
4.1Production Trial Run
4.2Measurement Systems Evaluation
4.3Preliminary Process Capability Study
4.4Production Part Approval
4.5Production Validation Testing
4.6Packaging Evaluation
4.7Production Control Plan
4.8Quality Planning Sign-Off and Management Support
Feedback, Assessment and Corrective Action
5.1Reduced Variation
5.2Customer Satisfaction
5.3Delivery and Service
Control Plan Methodology
6.1Table of Contents
6.2Overview
6.3Control Plan Column Descriptions
6.4Process Analysis
6.5Supplements
DesignVerificationPlan&Report(DVP&R)
PPAP(productionpartapprovalprocess)
PSW(Partsubmissionwarrant)
Submission Levels
The supplier shall submit the items and/or records specified by the level as requested by the customer:
Level 1 -Warrant only (and for designated appearance items, an Appearance Approval Report) submitted to thecustomer.
Level 2 -Warrant with product samples and limited supporting data submitted to the customer.
Level 3 -Warrant with product samples and complete supporting data submitted to thecustomer.
Level 4 -Warrant and other requirements as defined by the customer.
Level 5 -Warrant with product samples and complete supporting data available for review at the supplier’smanufacturing location.
See Retention/Submission Requirements Table I.4.1 for exact requirements for each level.
The supplier shall use level 3 as the default level for all submissions unless specified otherwise by the responsiblecustomer product approval activity. A supplier of bulk material only shall use level 1 as the default level for all bulkmaterial PPAP submissions unless specified otherwise by the responsible customer product approval activity.
Acceptance Criteria For Initial Study
The supplier shall use the following as acceptance criteria for evaluating initial process study results for processesthat appear stable:
ResultsInterpretation
Index Value > 1.67The process currently meets customer requirements. Afterapproval, begin production and follow Control Plan.
1.33 ≥ (Index Value) ≥ 1.67
The process is currently acceptable, but may require someimprovement. Contact your customer and review results of thestudy. This will require changes to the Control Plan, if notimproved prior to start of volume production.
Index Value < 1.33
The process does not currently meet the acceptance criteria.Contact the appropriate customer representative for a review ofthe study results.
NOTE:
Cpk can only be used for stable processes.
S=The supplier shall submit to designated customer product approval activity and retain a copy of records or documentation items atappropriate locations, including manufacturing.
R=The supplier shall retain at appropriate locations, including manufacturing, and make readily available to the customer representativeupon request.
*=The supplier shall retain at appropriate locations, and submit to customer upon request
FMEA(Failuremodeandeffectanalysis)
DFEMASeverity(S)(d)
Severityisthevalueassociatedwiththemostseriouseffectforagivenfailuremode.SeverityisarelativerankingwithinthescopeoftheindividualFMEA.
SuggestedEvaluationCriteria
Theteamshouldagreeonevaluationcriteriaandarankingsystemandapplythemconsistently,evenifmodifiedforindividualprocessanalysis.(SeeTableCr1belowforcriteriaguidelines.)
Itisnotrecommendedtomodifycriteriarankingvaluesof9and10.Failuremodeswitharankofseverity1shouldnotbeanalyzedfurther.
Occurrence(O)(g)
Occurrenceisthelikelihoodthataspecificcause/mechanismwilloccurresultinginthefailuremodewithinthedesignlife.
Thelikelihoodofoccurrencerankingnumberhasarelativemeaningratherthananabsolutevalue(SeeTableCr2).
Aconsistentoccurrencerankingsystemshouldbeusedtoensurecontinuity.TheoccurrencenumberisarelativerankingwithinthescopeoftheFMEAandmaynotreflecttheactuallikelihoodofoccurrence.
Detection(D)(i)
DetectionistherankassociatedwiththebestdetectioncontrollistedintheCurrentDesignControlDetectioncolumn.Whenmorethanonecontrolisidentified,itisrecommendedthatthedetectionrankingofeachcontrolbeincludedaspartofthedescriptionofthecontrol.RecordthelowestrankingvalueintheDetectioncolumn.
AsuggestedapproachtoCurrentDesignControlDetectionistoassumethefailurehasoccurredandthenassessthecapabilitiesofthecurrentdesigncontrolstodetectthisfailuremode.
Donotautomaticallypresumethatthedetectionrankingislowbecausetheoccurrenceislow.Itisimportanttoassessthecapabilityofthedesigncontrolstodetectlowfrequencyfailuremodesorreducetheriskofthemgoingfurtherinthedesignreleaseprocess.
DetectionisarelativerankingwithinthescopeoftheindividualFMEA.Inordertoachievealowerranking,generallythedesigncontrol(analysisorverificationactivities)hastobeimproved.
RiskPriorityNumber(RPN)(j)
OneapproachtoassistinactionprioritizationhasbeentousetheRiskPriorityNumber:
RPN=Severity(S)xOccurrence(O)xDetection(D)
Severity(S)(d)
Severityisthevalueassociatedwiththemostseriouseffectforagivenfailuremode.SeverityisarelativerankingwithinthescopeoftheindividualFMEA.
SuggestedEvaluationCriteria
Theteamshouldagreeonevaluationcriteriaandarankingsystemandapplythemconsistently,evenifmodifiedforindividualprocessanalysis(SeeTableCr1forcriteriaguidelines).
Itisnotrecommendedtomodifycriteriaforrankingvalues9and10.Failuremodeswitharankof1shouldnotbeanalyzedfurther
Occurrence(O)(g)
Occurrenceisthelikelihoodthataspecificcauseoffailurewilloccur.Thelikelihoodofoccurrencerankingnumberhasarelativemeaningratherthananabsolutevalue(SeeTableCr2).
Estimatethelikelihoodofoccurrenceofapotentialcauseoffailureona1to10scale.Aconsistentoccurrencerankingsystemshouldbeusedtoensurecontinuity.TheoccurrencerankingnumberisarelativerankingwithinthescopeoftheFMEAandmaynotreflecttheactuallikelihoodofoccurrence.
The“Incidentperitems/vehicles”isusedtoindicatethenumberoffailuresthatareanticipatedduringtheprocessexecution.Ifstatisticaldataareavailablefromasimilarprocess,thedatashouldbeusedtodeterminetheoccurrenceranking.Inothercases,asubjectiveassessmentcanbemadebyusingtheworddescriptionsinthelefthandcolumnofthetable,alongwithinputfromtheappropriateprocessknowledgesourcetoestimatetheranking.
SuggestedEvaluationCriteria
Theteamshouldagreeonevaluationcriteriaandarankingsystemandapplythemconsistently,evenifmodifiedforindividualprocessanalysis.Occurrenceshouldbeestimatedusinga1to10scalebaseduponTableCr2asaguideline;
Detection(D)(i)
DetectionistherankassociatedwiththebestdetectioncontrollistedintheDetectionControlscolumn.DetectionisarelativerankingwithinthescopeoftheindividualFMEA.Inorderto
achievealowerranking,generallytheplanneddetectioncontrolhastobeimproved.
Whenmorethanonecontrolisidentified,itisrecommendedthatthedetectionrankingofeachcontrolbeincludedaspartofthedescriptionofthecontrol.RecordthelowestrankingvalueintheDetectioncolumn.
Assumethefailurehasoccurredandthenassessthecapabilitiesofall"CurrentProcessControls"topreventshipmentoftheparthavingthisfailuremode.Donotautomaticallypresumethatthe
detectionrankingislowbecausetheoccurrenceislow,butdoassesstheabilityoftheprocesscontrolstodetectlowfrequencyfailuremodesorpreventthemfromgoingfurtherintheprocess.Randomqualitychecksareunlikelytodetecttheexistenceofanisolatedproblemandshouldnotinfluencethedetectionranking.
SuggestedEvaluationCriteria
Theteamshouldagreeonevaluationcriteriaandarankingsystemandapplythemconsistently,evenifmodifiedforindividualproductanalysis.DetectionshouldbeestimatedusingTableCr3asaguideline.Therankingvalueofone
(1)isreservedforfailurepreventionthroughprovenprocessdesignsolutions.
SPC(statisticalproces
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