外包过程作业指导书.docx

外包过程作业指导书(IS09001 : 2015)1. Purpose 目的Establish the instruction to manage subcontract process, including subcontractor selection, assessment, and control. Ensure all subcontract processes in VICTOR within control condition.建立外包过程控制指导书来指导对公司的外包方进行选择，评价与管理控制，确 保外包过程具有满足本公司规定要求的能力。2. Scope适用范围This instruction applicable all subcontract process: a.Plastic&Casting Parts Painting Process; b.AM2000:2008 Dental Unit Assembly Process.适用于公司所有外包过程.本公司的外包过程包括：塑料件与机加工件的喷漆过 程与AM2000:2008牙科治疗机的整机装配过程.3. Responsibility-职责Purchase Department: Research, collect and provided potential qualified subcontractor, conduct subcontractor assessment and audit activities.采购部：收集，搜寻，提供潜在的合格外包方信息，主导外包商的评价与审核过程. Quality Department: Participating subcontractor audit process, leading subcontractor quality system evaluation and subcontract parts quality inspection and verification.质量部:参与外包商的审核，主导外包商的品质保障评价，外包产品质量的检验与 验证.Technical Department: Participating subcontractor audit process, leading subcontractor technical aspect including equipment evaluation. Providing technical support to subcontractor, if necessary.技术部:参与外包商的审核，主导外包商的技术能力与设备的评价.必要时,提供技 术支持给予外包商Production Department: Participating subcontractor audit process, leading subcontractor production capability, material management, production management 生产部:参与外包商的审核，主导外包商的生产能力评价,包括物料管理，生产管理 评定等.Management Representative: Coordinate and planning subcontractor assessment process, summarize audit result and report to GM.管理者代表:协调与策划外包商的评价，汇总评价结果,汇报至总经理Tenns and Definitions术语与定义Potential Subcontractor: Subcontractor which have the potential qualify to provided subcontract service to our company, but not do business with us momently 候选外包方：欲向本公司提供服务，本企业尚未使用的供方Qualified subcontractor: Subcontractor which with the competence to provided subcontract service to our company via our systematical investigation and evaluation 合格外包方：经本公司调查、评价和选择，具有向本企业提供满意服务能力的 外包方4. Procedure-程序Subcontractor selection and evaluation外包方的评价和选择Principle of subcontractor selection外包方的选择原则Have a satisfied performance. Efficient production capability and process capability具有使用满意的历史业绩,充足的生产能力与工艺要求；Solid credit background Including quality management level, service, resources, or quality certification proof etc.良好的企业信用等级.包括质量管理能力、服务、资源配备，或相关的体系认证 等；Similar servicing history to other customer对比类似服务的历史情况或对比其他使用者的使用经历.(a) For dental unit subcontractor, must be obtained SFDA license and guarantee follow the SFDA regulations strictly对于整机的外包商，其必需获得国家药监局的相关许可证,并保证严格遵照国家 医疗行业相关的法规来运作.4.1.1 Regular evaluation of exist subcontractor现有外包商定期评价和确认(a) In principle, VICTOR should do regular assessment of exist subcontractor once a year.原则上，每年应进行至少一次对现有外包商的整体评价Purchase department evaluate the service aspect of thesubcontractor, give a score base its on time delivery,(total 40') cost down perfonnance etc.Fill in "Supplier Regular Assessment Record”.采购部负责对外包商的服务业绩及配合度进行评价，并根据其到料准时，价格因素等方面赋予分值，总分40分，填入供方定期评定表(b) QC department evaluate the quality aspect of the subcontractor, give a score base on its quality performance and complaints responding (total 60' Fill in "Supplier Regular Assessment Record”:质检部根据外包商的质量业绩及市场反馈，整改回复进行评价，总分60分，填入 供方定期评定表WARNING subcontractor if the regular appraisal score lower than 75;STOP order to subcontractor immediately if the regular appraisal score low than 70.当年度评定总分值小于75分时,警告该外包商，并提出整改要求;当年度评定总 分值小于70分时，停止与该外包商合作.(e)After complete the evaluation, pass the records to Operational Director or Management Representative to give approval comments. Purchase department shall keep the record for traceability.评价完成后，将供方定期评定表传至运营总监或管理者代表提出审批意见. 采购部应保存该文档，以便追溯.4.1.2 Evaluation of potential subcontractor候选外包商评价和纳入(a) Purchase department supervise the questionnaires or onsite evaluation of potential subcontractor, get the roughly information of the subcontractor and complete an "supplier evaluation record" or ''supplier onsite audit record,由采购部负责进行书面问卷调查或组织现场考查，对该候选外包商作概略性的 了解，完成供应商评审记录或供应商现场考察表.(b) QC department verify the first article and give a conclusion in "FIRST ATRTICAL INSPECTION SUMMARY".质检部对候选外包商首次加工进行样件确认，完成供应商样件评价表，以确保 产品质量符合公司要求.(C) If necessary, sign a “Quality Contract“ with the subcontractor. The contract usually including:必要时，与其签订质量保证协议，协议一般可以包括以下内容：(1) Quality assurance system requirements;对外包商质量保障体系提出要求；(2) Product quality and inspection criteria对外包商加工产品质量和检验标准提出要求；Quality information communicates or conflict solution.质量信息交换处理和争端处理办法Subcontract Process Control外协加工控制Technical department prepare technical specification of subcontract process including criteria and processing requirements.技术部制订外包加工所需的技术文件，如产品标准、技术要求等Subcontract shall provide evidence to proof its comply with the quality assurance system; aperiodicity onsite audit should be conducted to ensure its processing under control.外包商应能提供符合质量保证体系要求的证据，必要时不定期至外包工厂现场 进行检查，以确认外包过程是在协议规定的条件下进行Verification of subcontract外协加工验证QC inspector check the product according our inspection instruction, or verify the quality report attached.Document Type ： Working Instniction由检验员按照产品检验指导书、对照相应检验标准对外协加工产品进行检验 或对产品的附属检验报告进行验证；5.2.1 If we need do inspection in subcontract's site, shall indicate in purchase order or quality contract, verification in subcontract do not means relieve the quality responsibility of subcontract.当需要对某些产品在供方处验证时，须采购合同中对验证活动（标准和方法） 明确；但顾客验证不免除本企业向顾客提供合格产品的责任。6 .Reference Doc-相关文件产品检验指导书一Product Inspection Instruction. Record-记录供方定期评定表一 “Supplier Regular Assessment Record” .供应商评审记录一 u supplier evaluation record供应商现场考察表一 "supplier onsite audit recordn供应商样件评价表一“FIRST ATRTICAL INSPECTION SUMMARY”