TS16949：2009审核总结报告.doc

MANAGEMENT SYSTEM CERTIFICATION 管理体系认证Audit Summary Report 审核总结报告Organisation组织名称Suzhou Yasid Auto Parts Co., Ltd.苏州扬信德汽车零部件有限公司Address 地址No.3 Shuanghu Road. Shuangfeng Town, Taicang City. Suzhou, Jiangsu province, P.R. China中国苏州太仓市双凤镇双湖路3号Standard 标准ISO/TS16949:2009Representative公司代表Mr. Song Yumin 宋育民先生Manuf. Site Audited审核的制造现场No.3 Shuanghu Road. Shuangfeng Town, Taicang City. Suzhou, Jiangsu province, P.R. China中国苏州太仓市双凤镇双湖路3号NACE CodeNACE代码34.30EAC CodeEAC代码22Technical Area code技术领域代码QM22.1Audit date(s)审核日期May 8-10,2013Lead Auditor审核组长Tim BAO Man-days performed执行的审核人天2.83MDCo-Auditor审核组员Dennis Zheng Man-days performed执行的审核人天2.83MDCo-Auditor审核组员Chally Peng Man-days performed执行的审核人天1.83MDThis report is confidential and distribution is limited to the audit team, the company representative, the SGS office and IATF (if requested) 该报告是保密文件,仅限于分发到审核小组,公司代表, SGS办公室，和IATF（如有需要）1.1Audit objectives.The objectives of this audit were to confirm that the management system: 本次审核目的是确认管理体系: conforms with all the requirements of ISO/TS16949:2009 符合ISO/TS16949:2009的所有要求 Confirms with applicable Customer Specific Requirements 符合相关的客户特殊要求 of the organisation has been effectively implemented 已得到有效实施 is capable of achieving the organisations policy objectives 能达成组织的方针目标1.2Scope. 范围Design and manufacture of combination switches used in automobile汽车组合开关的设计和制造Has the scope been amended as a result of this audit审核结束时认证范围是否有所更改？Yes NoIs exclusion 7.3 Product Design applicable 7.3 产品设计是否删减？Yes NoDoes this site have manufacturing site extensions or remote locations(Site extensions or remote locations shall be listed in section 1.9 of this report)此现场是否有扩展的制造现场或远程支持场所？（扩展的制造现场或远程支持场所应该在报告的1.9部分列出）Yes No1.3Current audit findings and conclusions. 本次审核发现和结论The audit team conducted a process based audit. The structure of the audit was in accordance with the Audit Plan and the Audit Planning Matrix. The audit team therefore recommends that:审核小组进行了基于过程的审核。审核的架构符合审核计划及审核策划矩阵的安排。审核小组因此推荐： Letter of conformance to TS 16949/2009 获得ISO/TS16949:2009符合性证明函 Registration to TS 16949/2009 is ISO/TS16949:2009 认证注册 Recommended 获得推荐 Continued 持续有效 Open with non-conformances 不符合项待定状态 Number of non-conformities identified: 识别的不符合项数量：Major严重0Minor轻微7Client acceptance客户接受:Date日期:1.4Previous audit results.前次审核结果The results of the last audit of this system have been reviewed, in particular to assure appropriate correction and corrective action has been implemented to address any nonconformity identified. This review has concluded that: 对上次的审核结果已进行了评审,特别是针对已识别出的不符合项的纠正预防措施已确保实施. 该评审的结论是:All areas of concern in the Stage 1 report have been properly addressed已适当解决了第1阶段报告的所有关注点There were no Non-Conformances raised at the previous audit上次审核中无不符合项提出All Non-Conformances raised at the previous audit were closed during an on-site visitAny nonconformity identified during previous audits (that have already been 100% resolved with an action plan) have now been fully implemented & conclusions detailed in 1.6 of this report以往审核识别的任何不符合项（已经有措施计划并100%解决）现在已全部实施措施，并在本次审核中得到验证，详细描述见报告的1.6部分Additional time has been included at this visit to verify corrective action plan (detailed in audit plan)在本次审核中验证纠正措施计划所需要的额外时间包括（详细见审核计划）The management system has not adequately addressed nonconformity identified during previous audit activities and the specific issue has been re-defined in the nonconformity section of this report.管理体系尚未针对前次审核中识别出的不符合采取有效措施,在本报告中又再提出了具体的纠正措施要求1.5Audit findings. 审核发现Management system effectively implemented, indicated below with Yes or No if non conformities identified: 管理体系得到有效实施，请在下面注明是否识别了不符合项。The management system documentation demonstrated conformity with the requirements of ISO/TS1949:2009 and provided sufficient structure to support implementation and maintenance of the management system.管理体系文件显示符合ISO/TS16949:2009要求, 并提供足够的架构支持管理体系的实施与维持 Yes NoThe organisation has demonstrated effective implementation and maintenance / improvement of its management system组织已表明能有效实施与维持/改进其管理体系 Yes NoThe organisation has demonstrated the established and tracking of appropriate key performance indicators and/or targets and monitored progress towards their achievement组织表明已建立及跟踪其适当的关键绩效指标/目标, 并已监控进展状况 Yes NoThe internal audit programme has been fully implemented and demonstrates effectiveness towards achieving continuous improvement. Audits have been conducted using properly qualified auditors已完整实施内部审核程序, 并且展示出达成持续改进的有效性. 已使用适当的合格审核员进行内部审核 Yes NoThroughout the internal audit process, the management system demonstrated overall conformance with the requirements of ISO/TS16949:2009通过整个内部审核过程, 显示管理体系总体上符合ISO/TS16949:2009要求 Yes NoThe management review process demonstrated capability to ensure the continuing suitability, adequacy and effectiveness of the management system管理评审过程显示有能力确保管理体系的适宜性,充分性和有效性. Yes NoThe organisation has identified & implemented all applicable customer specific requirements 组织已识别并实施了所有有关的客户特殊要求 Yes NoThe client is eligible for transfer as stipulated in 3rd Ed IATF Rules 7.0. This was verified prior to the transfer audit.客户能够按照IATF认证规则第三版条款7.0规定的要求实施转换审核。这已在此转换审核前得到验证确认。 N/A Yes NoCertification claims are accurate and in accordance with SGS guidance认证申明是准确的, 符合SGS指南 N/A Yes No 1.6 OBJECTIVE EVIDENCE SEEN BY PROCESS. 各过程所见客观证据In performing the audit, various audit trails and linkages were developed, including the following audit trails, followed throughout:在整个审核过程中, 已设计了多种审核思路及联接部分, 包括以下审核思路贯穿于整个审核之中:SUPPLIER CODES 供应商代码VWn/aBMWn/aMercedesn/aFordn/aRenaultn/aFiat Auton/aPSAn/aGMn/aChryslern/aAudit Trails审核思路Company Briefing: The company was established in 2010 and it entered the automobile industry in same time. There is one General Manager, 1 VGM and 8 Department Managers structured top management. At present, about 200 employees worked as 2 shifts in company. Currently, the organization has the main auto customer Shanxi Heavy-duty Vehicle Co., Ltd. (陕西重型汽车有限公司), About less than 10% OEM product and others are overseas aftermarket parts. some function was supported by Headquarter Zhejiang Sensen Auto Parts Co., Ltd. The main processes are injection moulding, stamping, CNC and assembly in this site. Outsourced process was acid washing, plating and coating.APQPThe main new product Shanqi project JK364B was reviewed at this visit. The APQP team work was formed by the organization. The APQP activity had been conducted, The relevant documents was established, The FMEA and control plan was reviewed. Relevant CC/SC was identified. The MSA/CPK was implemented according to control plan identified. the organization maintained the PPAP records. Several ECN was checked sampled: JK364J and JK3878B etc. One minor NC was raised in this process.Manufacuring and Delivery / Process mornitoring and measuring/ Product Monitoring and Measuring / identification and traceability/ Non-conforming product control Monthly production plan & daily plan prepared, which was driven by customer order. Main manufacturing processes including injection moulding, stamping, CNC and assembly and package had been assessed. The process parameter monitoring, job set-up verification, and IPQC, FQC & OQC of inspection were structured and implemented. Layout & function inspection had been planned & conducted effectively.And 2 shifts were arranged for injection moulding process. Shift 1 was 8:0020:00, shift 2 was 20:008:00 next day. During this audit, all 2 shifts were covered.Samples: injection moulding process shift 1 sampled: 344 base chassis and shift 2 sampled: 360 short leg etc, stamping process: 905E etc. CNC process: 369 dial pole ,and assembly:JK364B and JK319A etc. One minor NC was raised in this process.Monitoring and Measuring (Internal Audit) Process audit, Product audit & QMS audit planned on 2012 & 2013. auditors were qualified, the checklist used to show that audit was conducted as per requirement.System Audit: Jan 1416, 2013 with 5CARs raised and closed out. Process Audit: Dec 1719,2012Product Audit: JK364B and JK377G etc.Facility/ work environment management/Equipment & Tooling ManagementThe main equipment is plastic injection molding machine, lathe, stamping machine, etc.The key equipment was not identified, spare parts were planned, Annual level 2 maintenance plan was established and conducted, level 1 maintenance plan was not established and conducted, YSB-482-001, YSB-48/008, YSB-48/009 plastic molding machine, YSB-012-001 lathe, YSB-123-001027 stamping machine were sampled.The maintenance objectives of the equipment was not assessed and analyzed.Main tooling is mould, the maintenance plan was scheduled, but not well implemented, the mould standing account was reviewed, plastic injection mould repair record was retained, mould identification was conducted. JK9046 injection mould, JK364-051-24 injection mould, JK364-051-29 injection mould, JK364-L063/064 stamping mould were sampled.HR Management Most on-job needed competence has been defined in the WI. Training needs for some new employees has been identified which generate annual training plan, Y2012 and Y2013 training plan were reviewed, new machining operator Mr. LIN on 31 Dec. 2012 and new material warehouse keeper Ms. XU on 9 Jan. 2013 were sampled, electrician certificate of Mr. ZHANG and forklift driver certificate Mr. YUAN was reviewed.Most training records were maintained, QC seven tools training record in Apr. 2013, IE training record in Apr. 2013, abnormal handling training record in Mar. 2013 were reviewed. Internal auditor competence matrix was reviewed, internal auditor training certificate of Mr. XIANG was sampled.One buyer Ms. LIU was modified as system specialist on 26 Feb. 2013, one assembly operator Mr. YE was modified as final QC on 18 Mar. 2013, but their modified job training request was not identified, audit found Mr. YE did not know TS knowledge.Staff promotion & staff satisfaction related activities were also reviewed.Document ControlTech. Dept. & DCC were responsible for document control, including product drawings, FMEA, control plan, WI, procedures, etc. Basically the TS and customer requirements could be followed in handling with all the QMS documentation, the control of standards, retention of records required by the customers and regulationsSampled documents: drawing, PFMEA, control plan and WI of combination switch, JK364B.ZP-002 A1 WI and distribution record, Shanxi Automobile 81.25509.0124 drawing, QC/T218-1996,etc.QA Dept. was responsible for quality record control, QC record retention time was specified 3 years, product QC record in Dec. 2012 and Jan. 2013 was reviewedProduct requirement identification and verification /Customer Feedback and solving /Monitoring and MeasuringThis process was owned by Sales Dept. The main auto customer is Shanxi Heavy-duty Vehicle Co., Ltd.Currently, some functions of market development, contact review, customer satisfaction survey were conducted by Wenzhou Company.The assessment went through all the concerning activities including customer specific requirements acknowledgement, contract review, satisfaction, complaints disposal, customer property and so on. The order sampled: Shanxi Heavy-duty Vehicle from last year. Departmental performance indicators: customer field return PPM, delivery on time, customer satisfaction rate etc.Customer satisfaction survey was performed per half year. There were no complaint received from auto customer from last year.Purchasing management processMain materials include circuit board, Cu belt, connector, wire hardness etc. Main outsourcing process is plating. New supplier collecting, evaluation, approval, new parts approval, supplier QMS development, supplier performance evaluation etc. procedure were established. Monthly supplier performance evaluation was carried out against quality, delivery and service. Purchasing requirements defined in related purchasing contract. Supplier QMS status was monitored, supplier part II audit was conducted for supplier QMS development. The C/P was required for quality issues raised from supplier, but the verification was not conducted effectively.Sampled: Xintang, Kangxin, Qingmao etc.KPIs in this process include supplier ppm, OTD.Preservation of product/ Product Monitoring and Measuring (IQC) processThere are 1 material warehouse and 1 finishing part warehouse in company. The material & product store requirement was determined, which include identification, handling, packaging, storage and protection etc. sampled: material PCB JK364, 7081B-6.3-212 etc., finishing part DZ9100580076.Incoming material verification was structured and implemented. Control plan and inspection instruction were setup to guide the inspection task. IQC inspector was trained and qualified for process control.Sampled: PCB JK364 on 18 Mar., 7081b-6.3-21 on 20 Feb. 2013 etc.Measuring Device Control processLab control: Lab scope was defined. Currently, some length series measuring devices were calibrated by internal lab, others were calibrated by external lab. Annual calibration was planned and conducted, sampled: TY-834-0003, TY-891-0055, JK344-871-02, TY-891-0007 etc. Some measuring devices were not calibrated.The analysis and traceability for NG measuring device was not conducted effectively.Annual MSA was planned and conducted, sampled: caliper, etc. Some measuring device systems were not analyzed.Continual Improvement processKPI of each process was defined, monitored & measured, which all KPI performance were audited.C/P actions were taken for poor performance, which were sampled the C/P action taken as for customer complaints, internal audit, monthly operation review etc.The Improvement action raised in management review was checked.The poor quality cost was collected and reviewed.The process objective management for stamping parts was not conducted effectively.Conclusion on non-conformities from previous visit 对于上次审核中100%解决的不符合项的结论N/AProcess for gathering, communicating & implementing customer specific requirements 收集、沟通和实施客户特殊要求的过程Generally, for a new customer developed sales dept. organise relevant dept. performing contract review especially for its ttechnology, quality, delivery and resource needed, relevant requirement was transferred during contract/technical or quality agreement review process. The CSR implementation status was monitored by quality. During this audit, CSR was clearly identified as following: Purchasing contract (No:PT12511033 ,Jan-1-2013) and Quality agreement (Dec-12-2012)Site extension or remote location扩展的制造现场或远程支持场所Details see below 1.9 Supporting Activities 支持活动1.7Non-conformities. 不符合项Non-conformities detailed here shall be addressed through the organisations corrective action process, including root cause analysis actions to prevent recurrence and proper maintenance of corrective action records. 对在该处详细列出的不符合，组织必须采取纠正措施，包括根本原因分析、防止再次发生的措施，并适当保留纠正措施的记录。Identified non-conformities cannot be closed during the on-site audit. 不能在现场审核中关闭识别出的不符合项。Major non-conformities issued at surveillances require root cause analysis & action / containment within 20 days. Failure to do so will result in suspension in certificate.在监督审核中发现的严重不符合项要求在20天内完成根本原因分析和措施计划/遏制措施。如果没有做到这些将导致证书暂停。Major non-conformities should require onsite verification within 80 days.严重不符合项应该要求在80天内完成现场验证工作。Minor non-conformities require root cause analysis and action plan to be submitted within 30 days, and evidences for implementation of the actions within 80 days.轻微不符合项要求在30天内提交根本原因分析和措施计划, 在80天内提交措施执行证据 。Minor non-conformity that is verified without an onsite visit shall be verified at the next audit.轻微不符合项如果是非现场验证的话则必须在下次审核中加以验证。ALL non-conformities must be closed in the IATF database within 90 days (Rule 8.2).所有不符合项必须在90天内在IATF数据库中得到关闭（规则条款8.2）。Non-conformity Number不符合项编号Number 编号1of7Classification类别 Major Minor 严重 轻微Process过程APQPISO/TS ClauseISO/TS 条款7.3.2.2/7.3.3.1/7.3.6.3QMS Document referenceQMS参考文件ZT/Y02011-2011Document issue文件版本A0Statement of nonconformity不符合项陈述APQP process was not conducted effectivelyCSR or TS RequirementCSR 或TS 要求7.3.2.2 Manufacturing process design inputThe organization shall identify, document and review the manufacturing process design input requirements, including product design output data, targets for productivity, process capability and cost, customers requirements, if any, and experience from previous developments.7.3.3.1 Product design outputs SupplementalThe product design output shall be expressed in terms that can be verified and validated against product design input requirements. The product design output shall include design FMEA, reliability results, product special characteristics and specifications,7.3.6.3 Product approval processThe organization shall conform to a product and manufacturing process approval procedure recognized by the customer.This product and manufacturing process approval procedure shall also be applied to suppliers.Objective Evidence客观证据For the development of product JK364B :1: The project target was not defined, E.g. Capacity, the production process capability and cost. 项目目标没有明确规定, 如产能，生产过程能力及成本等目标.2: DFEMA was not correctly analyzed in DFMEA; The key