VDA6 .3Process Audit questionnaire翻译版本(中文对外)_图文_

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2024年1月18日发(作者：)

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Process audit*StarsResult VDA 6.3 Questionaire processauditLocation:t#REF!3

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WeP426

Carrying out the product- andprocess developmentHave the Product FMEA / ProcessFMEA been drawn up? Are they up-dated as the project progresses andare corrective actions laid down?Are the stipulations arising from theplans for product and processdevelopment put into effect?4.127

4.228

4.3Are the personnel resources in placeand qualified?29

4.430

4.5x31

4.632

tIs the infrastructure in place ropriate?.trytextBased on the requirements, are essary evidence and lable for the various phases? the productions control plans the various phases and aretrproduction, test and inspectionydocuments derived from them? a pre-production run been under serial production conditionstrto obtain production approval / release?yAre the planning activities h sourcing outside products ices implemented effectively?ytextIs the transfer of the project duction controlled in order to product launch?ytext4.733

4.834

4.935

P536

Supplier managementx5.1Are only approved/released and able suppliers selected?.trytext37

How is the release procedure for the suppliersdefined (direct and indirect materials)?38

How is the regular support from supplierensured?39

Do you refer to external assessments (selfassessment of your supplier, audit from othercustomers or competitors, certificate likeISO/TS-16949)?40

Is there a regular assessment of the overallperformance (quality, costs, service) of allsuppliers?41

What are your rules for selecting and phasing outof suppliers?Do you perform audits and reaudits on a regularbase?42

5.243

Are the customer's requirements o account in the supply chain?.tryteHow do you make sure all customer requirementsare known to your suppliers?44

5.3Have target agreements for formance been agreed with put into operation?ytext45

Are measurable target characteristics specifiedfor quality, price, service, waste reduction,reduce work in progress, increase customersatisfaction?46

How do you improve supplier performance (ed quality targets)?47

5.4xAre the necessary approvals/releasesavailable for the out-sourced productsand services?48

How do you perform prototype/ trial/ preliminaryreleases?49

According to which standard do you documentthe initial sample reports?50

Do you require capability verifications forimportant characteristics?51

Are the safety data sheets available for alldelivered products/materials and are theyobeyed?52

What kind of reliability assessments / tests / trialsare performed?53

What are the rules for requalification?54

5.5xIs the quality of the out-sourcedproducts and services ensured?55

Do you perform any physical incominginspection tests?56

Which tests are performed internally orexternally?57

How do you ensure that the most recentspecifications are used?58

Which QA agreements are used (generaldelivery contracts, QA contracts, ship to stock,part specific demands, release schedule, newpart quality assessment)?59

Do you perform a failure pareto for incomingmaterial?60

How do you document and track the actions ofquality meetings with the supplier?61

Do you require 8D-reports from your supplier?62

Do you perform improvement programs forproblem suppliers?63

Are there agreements in place for handling ofproducts with quality deviations (rework,warranty)?64

How are control, verification, storage, transport,maintenance of quality and featuresimplemented?65

5.6Are incoming goods storedappropriately?66

Which customer requirements are made and howare they fulfilled?67

Which inventory system (KANAB, JIT) is usedand how is it implemented?68

How are the storage/inventory costs monitored?69

Are there emergency strategies for materialshortages?70

Is the FIFO principle implemented?...for storage,…for storage of returned products?71

Are packaging requirements (type, size, materialet al) determined and are they adhered to?72

Does the storage administration system supportFIFO? Is FIFO also valid for residue material?73

Are storage conditions defined with respect tocleanliness, climate, protection from damage,etc.?Are labelling requirements determined andadhered to? (Traceability, inspection status, worksequence, usage status)75

Is a quarantine store setup and used? Who isresponsible for it?74

76

5.7Are personnel qualified for the varioustasks and are responsibilities defined?77

What are the task-specific qualifications for theemployees (incoming inspection, storage, warehouse) and how are they trained?78

79

P66.1Process analysis / ProductionWhat goes into the process ?(process input)80

6.1.1xHas the project been transferred fromdevelopment to serial production?81

Does a written procedure exist for initial/recurringequipment/process releases and is theredocumentation defining when use is necessary?82

Does a check list exist for the initial/recurringreleases, is it complete and in use?How, where and when does documentationoccur?83

Is all equipment (machines, equipment, tools,etc.) approved according to specification and theprocess requirements?Who is responsible for equipment set-up /releases?Are all open actions scheduled and are theyworked on accordingly?85

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QuestionWill reliability tests for product and purchasedmaterial be carried out according to testingprocedures and scheduled according to projectplan? Please provide plan and 86

Is a product quality plan available?As long as pre- or pilot series are manufactured:is there an appropriate pre-series product qualityassurance plan?87

How does the PQP comply with other productiondocuments (e.g. specification, operationsequence, drawings, production and test/workstation instructions) and how is it assured?88

Is a process flow chart available corresponding tothe control plan?89

Are critical parameters identified in the PQP andhighlighted in the control plan? How are thesecritical parameters derived?90

Does the PQP or corresponding documentscontain requirements on equipment capabilitiesand how are they matched?91

Are specific measures derived from the processFMEA and implemented in the control plan?92

Will the control plan be updated after processchange/supplementation (e.g. because of furtherCIP actions or preventative measures) and canthese changes/revisions be clearly identified inthe control plan revision history.93

6.1.294

Are the necessary quantities /duction batch sizes of rials available at the right time andyat the right place (stores; work-teHow is the logistic concept validated (ort trials, are results documented andactions specified where necessary)?95

Are all purchased parts/materials/supplies forseries production available andqualified/released.96

6.1.397

Are incoming materials ropriately and are transport / packing arrangements suitable for theyspecial characteristics of the incomingteWhere and in which form is information onstored quantity available?How are components protected from damage(mechanical, electrical)?Are the part locations suitable for safe handling?98

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Do the storage areas/bins fulfil the necessaryorder and cleaning requirements? How isoverfilling avoided?101

How are the storage times monitored andrecorded (longest/ shortest interim storage time)?102

How are the components protected fromenvironmental influences?103

6.1.4104

Are the necessary identifications /ords / approvals available cated appropriately to the incomingymaterials?textHow do you ensure capability verifications ofpurchased parts (i.e. certificate of conformance(COC))?105

6.1.5106

Are changes to the product or the course of serial ked and documented?ytextHow is the release and change status fortools/equipment/measuring and test equipmentidentified?107

Are changes to parts/products or processesincorporated in the FMEA and will all processsteps be examined for possiblechanges/supplements?Are influences on purchased componentsconsidered.108

Are actions introduced on a regular basis andare they documented in the FMEA?109

Is a FMEA revision history implemented?110

6.2111

6.2.1xWork content / Process sequence(Are all production processescontrolled)Are all the relevant details listed in theproduction and test/inspectiondocuments, based on the productioncontrol plan?Are process parameters available and completeand how are they determined?112

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Are details (tool and machine number) identifiedfor machines/tools/auxiliary onthe operation sequence/process qualityplan/inspection sheet?114

Are inspection characteristics (on part level),related equipment, employed methods, andinspection frequency defined, and are theyobeyed.115

Are process quality plan, operation sequence,manufacturing instructions available andcomplied with?Are equipment inspection/quality instructionsavailable/complied with? How are theyaccessible?117

116

Are process related control limits specified inprocess control chart or a similar document? Arethey regularly updated?118

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Are equipment manuals available?How is information on current equipment failures/ malfunctions gathered, stored, and distributed?120

6.2.2Are production operations checked /approved and are setting data logged?121

Which quality control charts / monitoring chartsare in use ?t122

6.2.3xCan the customer's specific productrequirements be satisfied with theproduction facilities used?123

tAre any specific requirements (internal orcustomer related) for data recording defined andimplemented? where are these requirementsdocumented124

6.2.4xAre significant characteristicscontrolled in production?125

How are the reliability/function characteristics ofthe manufactured parts identified for eachprocess step?How are necessary equipment data acquired andassessed?127

t126

6.2.5Are scrap, rework and setting partskept separate and identified?128

How is non conformance material storageorganized?129

How are bins for scrap, rework, parts andrecyclable materials labelled?130

How are defective parts labelled? How do markand document rework material?131

tHow is processing of approved parts/rework/scrapidentified and how is the return of unneededparts regulated?132

6.2.6Is the flow of materials and ured against mixing / wrong items?.trytext133

Are bins/parts/material (e.g. wafer, lead frames,solder balls for BGA, mold compound, etc.)sufficient, appropriate and properly labelled?134

Is the process/test status obvious and how is theprocess flow guaranteed?135

How is the lot history documented?136

How do you ensure the expiry dates (e.g. photoresist, mold compound etc.) and max. storagetimes of material and products?137

138

6.3Process support/ Personnel resourcesAre operators given responsibility andauthority to monitor the quality ofproduct and process?Who is allowed to change set up parameters forequipment?6.3.1139

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Who completes initial piece inspection?141

Who performs required testing?142

Who completes quality control charts, and whoassesses?Who has authority to put on hold, and who canrelease?Who is involved in the continuous improvementprocess?Who is responsible for repairs and preventivemaintenance and are employee qualificationand permission plans available?146

147

Who is responsible for calibration of the requiredmeasuring and test equipment?143

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6.3.2x148

the operators able to carry out tted tasks and are theiryqualifications kept up-to-date?textDoes the employee have aninstruction/training/qualification certification forthe process?How are work safety and environmental aspectsincluded in the employee training?149

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QuestionHow are employees trained to perform customerspecific process steps?We151

Are process to increase employee motivationeffectively implemented? (information aboutquality status, CIP, profit, rework, scrap,suggestion system, employee survey andsatisfaction)152

Does the employee have the required trainingcertificate? (forklift license, welder certificate,vision/hearing test etc.)153

6.3.3154

there a personnel employment plan?ytextIs an emergency replacement plan available foreach shift?Is a qualification matrix available?155

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6.4Material resources6.4.1158

are the maintenance and production facilities / toolsycontrolled?textAre the servicing/maintenance statustools/facilities/machines sufficient to ensure thequality of manufactured parts? How are theservice intervals and procedures determined.159

Are set-up/buy-off instructions and productspecific set-up plans available?Are equipment/comparison aids (e.g. goldendevices) available?161

Are test samples (e.g. for all bin classes)available and in use?162

Does a written procedure exist for initial/recurringequipment/process releases and is theredocumentation defining when use is necessary?160

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Does a check list exist for the initial/recurringreleases, is it complete and in use?164

How, where and when does documentationoccur?165

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Who is responsible for equipment set-up /releases?6.4.2x167

Can the quality requirements bemonitored effectively with the test,inspection and measurement facilitiesemployed?Are these reliability/function characteristicsmonitored during production and how often?Is the measurement accuracy of the availablemeasuring and test equipment sufficient(measuring/test equipment capability)?t168

169

How often are the measuring and test equipmentcapability examinations conducted formeasuring equipment? Provide gaugecapability study for all used tools on request.170

Is a measuring/test equipment calibrationcertificate for the measuring equipment validation sticker)?171

How are measuring/test equipment handledwhen errors and damages occur, are the effectson manufactured products examined andnecessary actions specified where necessary (ing customers, part recall)?172

6.4.3173

Are the work-stations andtest/inspection areas suitable forrequirements?Who is responsible for appropriate workenvironment including necessary material foreach work station?Is the employee responsible for organization andcleanliness at the work station?t174

175

Are defined rejection/rework stations available?176

6.4.4177

Are tools, equipment andtest/inspection facilities storedcorrectly?tHow do you ensure damage-free storage(defined locations, protection fromenvironmental influences)?178

Do the storage conditions for the tools complywith the order and cleanliness requirements?How is removing from storageregulated/specified?How are the stored work supplies labelled?179

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6.5182

6.5.1183

Process effectiveness (integrateeffectiveness, efficiency, eliminationof waste)Are target requirements set for process?.trytextWere process capability studies conducted forproduction equipment/tools/machines and arethe production equipment/tools capable?#REF!#REF!184

How are product and process parameterscontrolled/regulated?185

How are deviations from desired specificationsnotified (e.g. light, siren, shut-down or other)?How and when is the function efficiency tested?How are deviations monitored?186

How does the loading/unloading affect thequality of the manufactured parts? How is thesave handling guaranteed?187

Which CIP process specific activities areimplemented (e.g. costs, scrap, rework, increasedprocess safety, setup time optimization,equipment availability, process time reduction,storage time reduction)?188

Which product specific goals are specified ( quantity produced, quality codes such aserror rates, audit results, processing times, errorcosts, process codes (cpk))?189

6.5.2190

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Are quality and process data logged h a way that they can ssed?ytextWhich quality control charts / monitoring chartsare in use ?Are the process data automatically stored in adata base and are these data ready to beevaluated ?192

How is the process capability determined (, SPC values)? What rules are defined () ?193

Which statistical methods are used for the qualityassessment (Defect Density, CD Check, OutlierScreening, Statistical Bin Analysis, Part AverageTest, ….)?194

How are errors classified (e.g. according toimpact on quality, reliability, yield) ? How arecorrective actions defined for each class ?195

Which parameters are assessed and how often?What are the pass/fail criteria (cpk) for theseparameters?196

6.5.3xIn the case of deviations from productand process requirements, are thecauses analysed and the correctiveactions checked for effectiveness?197

tHow are process disturbances identified (whichrules are applied), are corrective actions defined(out of control action plan) and documented ?198

Which methods are implemented for root causeanalysis? Will the 8D method be used?199

How are corrective actions derived and will PQP(Product Quality Planning), process-FMEA revised ?200

How do you define and handle non conformingmaterial (e.g. lot on hold) ? Who decides how tocontinue to process this material (material reviewboard) ? What are the criteria for rework ? Areany customer specific requirements defined ?201

How are deviations from specified processingtimes or specified max waiting times recognizedand documented?202

How frequently and what reliability testing areperformed ? How are actions derived from thereliability testing results ?203

How and how often is the effectiveness of theactions monitored ?204

6.5.4x205

Are processes and products auditedregularly?ch types of audits are conducted? Whoaudits?206

How are identified improvement actionsimplemented ? Who is responsible for thetracking of the corrective actions ?207

Which responsible persons and whichdepartments/divisions/business sectors willreceive the audits reports ?208

6.6209

What should the process produce ?(process result / output)6.6.1x210

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Are the customer's requirements met ms of product and process?.trytextWhich significant characteristics are defined?6.6.2212

Are quantities / production batch gned with requirements and are arded to the next process stage inya targeted manner?textAre parts forwarded using suitable transportmechanisms to the defined storage areas withminimal or no interim storage?213

How is the logistic regulated for the process?214

How is part labelling specified for differentpriorities (like hot lots)?How is product quantity recording and analysisperformed?215

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6.6.3Are products / components stored in ropriate manner and are lities / packing arrangementsysuitable for the special characteristicsteof the products / components?xtWhere and in which form is information onstored quantity available?217

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QuestionHow are components protected from damage(mechanical, electrical)?Are the part locations suitable for safe handling?Do the storage areas/bins fulfil the necessaryorder and cleaning requirements? How isoverfilling avoided?We219

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How are the storage times monitored andrecorded (longest/ shortest interim storage time)?222

223

How are the components protected fromenvironmental influences?6.6.4Are the necessary records / releasescarried out and stored appropriately?224

How do you handle and monitor specialreleases?225

tP7226

Customer support / Customersatisfaction / Servicex7.1227

Are the customer's isfied regarding QM system, (on delivery) and process?ytextWhich quality agreements are signed with thecustomers?(e.g. PPM Agreement, General Spec, DetailSpec)Which product specific goals are specified? (itemquantity produced, quality codes such as errorrates, audit results, processing times, error costs,process codes (cpk)).228

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Are customer requirements implemented andcovered by internal audits ? Is an early warningsystem for the customer installed ?230

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Are qualification tests conducted according tocustomer requirements (Joint Qualification Flow)?Is the performance of logistics fulfilled in termsof quantity and schedule of the delivery ?232

Are only products delivered, that are testedaccording to the customer spec and / or jointlyagreed test flows, instead of delivery of openmarket products ?233

Are the test methods agreed with the customers?(e.g. Electrical test, screening, ApplicationSpecific Test pattern etc.)234

Are revision control tables for all specificationsavailable and are changes highlighted ?235

7.2Is customer support ensured?236

Is a dedicated representative for customerneeds/support available ? Does thisrepresentative have enough capacity to careabout the customer needs ?237

Does the customer service representative haveextensive knowledge of product use/problems?Is implementation of new requirements ensured?t238

239

Is a short term implementation of improvementsguaranteed, when derived from customercomplaints/assessments ?240

Will changes (e.g. product and processchange/relocation - also from subcontractors) becommunicated via PCN in due time to thecustomers? Are these changes onlyimplemented after customer acceptance ?241

Is initial/repeated sampling with the customerregulated?242

Are customers informed of deviations? Is aneffective early warning system implemented ?243

7.3xIs the supply of parts ensured?244

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Is the parts supply and confirmed deliverydeadlines ensured?Are deviations from delivery commitments knownand reported to the customer in due time ?Which corrective measures are implemented?246

Do appropriate short term buffers (die bank) existto overcome delivery bottlenecks ?Do appropriate long term emergency planscome into use, if a delivery bottleneck occurs?247

Are capacities and response times for screeningactions planned and implemented? (e.g. for100% storage verification, possible reworking)t248

Risk management: Is there a guarantee thatunpredicted changes to facilities and/or specialoperating supplies and/or tools will not lead to adelivery bottleneck or stop?249

Is the production planning oriented to thecustomers order? (e.g. daily/weekly comparisonof delivery orders with the customers)250

Are there instructions on how to notify themanagement in the case of deliverybottlenecks?251

7.4If there are deviations from qualityrequirements, are failure analysescarried out and corrective actionsimplemented effectively?252

tAre process FMEA actions implemented?253

How are actions resulting from other correctiveactions initiated?254

Are improvement measures from auditsimplemented and effects examined?255

How are information feed back loops definedback to originator / equipment operator (in termsof equipment related corrective actions)?256

How is information exchanged betweenconsecutive shifts and neighboring shop are external information interfaces defined?257

How are internal/external complaints handled,corrective actions implemented and product history, list of actions)?258

Are corrective actions derived from internal andcustomer requests and how are theyimplemented?259

7.5Is there a process which ensures thatanalysis of defective parts is carriedout?260

tAre internal/external defect characteristicsanalyzed (e.g. pareto analysis, laboratory,validation/test facilities, personnel)? Areimprovement measures implemented and aretheir effectiveness examined? Are all affecteddivisions/manufacturing sites informed?261

Are the automotive specific response times for8D (1-2-10 rule) achieved ?262

7.6263

Are personnel qualified for the スタッフはさまざtasks and are responsibilities defined?trまなタスクの適正.ytextAre the employees qualified for the tasks (e.g.):customer service, product validation/storage andスタッフはタスクにおいて適正をゆうしているか、例えば顧客サービス・製品検transport/logistics and error analysis?264

Do employees have the necessary knowledge ):- product/specifications/special customerrequirements- standards/laws- manufacturing/use- assessment methods (e.g. audit, statistics)- quality techniques (e.g. 8D methods,cause/effect diagram)265

Do the employees have the necessaryqualification/ certification? (e.g. certification ofproduct training, seminar of Q techniques)266

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