report_VDA DongSheng

QM System AuditPage 1 of 9 1. Overall evaluation of the QM system / Categorisation of companyClient:Scope:VDA code(s): Chemicals/Plastic x Metal Electrical/ElectronicsEAC code(s): Employees: 203Order No.: ZN:QM Representative: Audit date:Lead Auditor: Auditor:QM-Regulations: DIN EN ISO 9001 x DIN EN ISO 9002 QS-9000Audit type: First certification x 2.Surveillance (maintenance) audit Repeat audit Extension audit (adding MS-VDA, if certification exists under ISO 9001 or 9002)FindingsFulfilment Degree: E u= (%) E u=(%)E p= (%) E p= (%) Overall result: E GES= (%) E GES= (%) Comments by company/auditee:The client confirmed all findings.Comments by auditors:Continuation of VDA 6.1 certification is recommended by audit team.Date Lead Auditor Auditor Audit RepresentativeThe TÜV CERT Certification Body hereby grants the audited company permission to pass on the audit resultsto third parties.Approval of Veto Person rejectedName (in printed letters) Date, SignatureApproval of Certification Body Manager rejectedDate, SignatureQM System AuditPage 2 of 92. Summary of resultsNo. of questions No. of marksFulfil-mentFulfilment profile [%]VDA No. DIN EN ISO No.ELEMENTmax. poss. evaluat edmax. poss. At-tained degree E E % 0 20 21 40 41 60 61 80 81 100Part U: Company structure01 4.1 Management responsibility 6 6 60 60 x 02 4.2 QM System6 6 60 60 x 03 4.17 Internal quality audits 4 4 40 40 x 04 4.18 Training, personnel7 7 70 70 x 05 4.21* Fin. considerations on QM Syst. 4 4 40 40 x 06 4.22* Product safety 4 4 40 40 x Z14.23*Master strategy **555050xUTotal fulfilment 1-Z1Part P: Product and Process07 4.3 Contract check, Q. in Marketing 5 5 50 50 x 08 4.4 Design control (product devel.) 7 7 70 70 x 09 4.24* Process planning - Process development7 7 70 70 x 10 4.5 Control of documents and data 5 5 50 50 x 11 4.6 Purchasing7 7 70 70 x 12 4.7 Control of prod's from customer 4 4 40 40 x 13 4.8, 4.9, 4.12 Labelling and tracking, (Process control), inspection status 7 7 70 70 x 14 4.9 Process control 7 7 70 70 x 15 4.10 Inspections6 6 60 60 x 16 4.11 Monitoring of test instruments 5 5 50 50 x 17 4.13 Control of non-conforming prods 4 4 40 40 x 18 4.14 Corrective / preventive measures 4 4 40 40 x 19 4.15 Handling, storing, packing, pre-serving, despatch 6 6 60 60x 20 4.16 Control of Q records4 4 40 40 x 21 4.19 Use phase, maintenance, etc.5 5 50 50 x 224.20Statistical methods666060xPTotal Fulfilment Degree 7-22(%)11elements evaluated of number ∑=z EU EE(%)227elementsevaluated of number ∑=EP EE(%)100⨯=possible points max.attainedpoints of number E Eoverall result: 32PU GES E E E +=*Numbering beyond DIN EN ISO 9001QM System AuditPage 3 of 9 3. Summary of evaluated questions01.1 01.2 01.3 01.4 01.5 01.602.1 02.2 02.3 02.4 02.5 02.603.1 03.2 03.3 03.404.1 04.2 04.3 04.4 04.5 04.6 04.705.1 05.2 05.3 05.406.1 06.2 06.3 06.4Z1.1 Z1.2 Z1.3 Z1.4 Z1.507.1 07.2 07.3 07.4 07.508.1 08.2 08.3 08.4 08.5 08.6 08.709.1 09.2 09.3 09.4 09.5 09.6 09.710.1 10.2 10.3 10.4 10.511.1 11.2 11.3 11.4 11.5 11.6 11.712.1 12.2 12.3 12.413.1 13.2 13.3 13.4 13.5 13.6 13.714.1 14.2 14.3 14.4 14.5 14.6 14.715.1 15.2 15.3 15.4 15.5 15.616.1 16.2 16.3 16.4 16.517.1 17.2 17.3 17.418.1 18.2 18.3 18.419.1 19.2 19.3 19.4 19.5 19.620.1 20.2 20.3 20.421.1 21.2 21.3 21.4 21.522.1 22.2 22.3 22.4 22.5 22.6Comment:ne = the question has not been evaluated. Please state reasons for not evaluating any questions on aseparate sheet of paper.= *- Questions with special importance for process, product- and quality systemQM System AuditPage 4 of 9 4. Explanations relating to present situationon QM element ________________ / question _______________QM System AuditPage 5 of 9 5. Individual activitiesClient/Certification company TÜV Rheinland AnlagentechnikGmbHReport No. ofSystem Audit:Audited supplier /Certified companyDate:No. of QM element Activities Considered opinion of auditedsupplier / certified companyTiming01.3 The management improvementin system was not emphased inthe company, e.g. year 2003and year 2004 continuousimprovement plan.01.6 The review of changes toensure the suitability of thequality system was notemphased in the managementreview.02.3 The control of purchasingdocument and play role inAPQP was not clearly specifiedin the quality manual clause3.12.02.5 In PFMEA of P/N LM501310-1:Ranking of “O”and “D” was notconsist with FMEA manual (3rdEdition).02.6 The sample size and number ofcontrol plan for pre-seriesphase were not suitable.03.1 The qualification of internalsystem auditor was notcompletely specified, e.g. abilityin process approach audit. 04.3 The training of managementskills for managerial staff wasnot organised and planned inyear 2004.05.1 The calculation method of costitem –“Down-time caused byFailures” was not clearlydefined in procedure.06.4 The emergency plan forProduct No. LM501310-1 wasnot clearly defined in relevantprocedure.QM System AuditPage 6 of 9 Z1.1 The issues of health, safetyand environment were notcovered by business plan inyear 2004.09.5 The plan for pre-launch (P/NLM501310-1) was notdocumented and reviewedbefore pre-launchimplementation.Z1.3 The trends analysis of companykey competition indicators wasnot evident.14.1 1. The sample size andnumber of Cmk studywas not comply with therequirements of VDA4.1clause 10.8.1.2. The upper and lowlevels were not markedin Xbar-R chart (OCGand V-5NT processes).14.4 The repair history of SSGmachines was not utilized in the2003 yearly maintenance.14.6 The regular verification ofcleaning process in line 2 wasnot evident.15.6 The type test of bearing15123/15245 had beenreported on Sept. 13, 2003, butthe raw test data could not betraceable.The review of above test resultswas not evident.17.3 The rework instruction of finepolishing had not consideredthe rest and roundness of thisposition.The records of rework of finepolishing were not maintained18.2 The PFMEA and control planhad not been reviewed andupdated after customercomplaint on Dec. 12, 2003about packaging problem.QM System AuditPage 7 of 9 18.3 The root cause of packagingproblem complaint by customeron Dec. 12, 2003 was notdocumented.20.2 Only incoming inspectionrecords were not reviewed byresponsible supervisor in thecompany, e.g. incominginspection report on Apr. 11,2004 for heat treatment ofM12649, quantity 18610, lot040320.QM System AuditPage 8 of 9 6. Summary of corrective measuresVDA No. ELEMENT J F M A M J J A S O N D FurtherInformation onSheet No.01 Management responsibility02 Quality management system03 Internal quality audits04 Training, Personnel05 Financial consideration on QM systems06 Product safetyZ1 Corporate strategy07 Contract check, quality in marketing08 Design control - Product development09 Process planning - Process development10 Control of documents and data11 Purchasing12 Control of products provided bycustomer13 Labelling and traceability of products(process control), inspection status14 Process control15 Inspections16 Monitoring of test equipment17 Management of non-conformingproducts18 Corrective and preventive measures19 Handling, storing, packing, preserving,despatch20 Control of quality records21 Maintenance (work subsequent toproduction)22 Statistical methodsQM System AuditPage 9 of 9 7. Indications of potential for improvement1. The planning of management review activities should be improved.管理评审活动策划应改善。