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空管运行质量安全管理手册中_规范性引用文件_的研究
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空管运行质量安全管理手册中_规范性引用文件_的研究
官方公共微信质量管理手册 Quality Management ManualQMM-001 Rev. CSchneider Electric Equipment and Engineering (Xi’an) Co., Ltd 施耐德电气设备工程(西安)有限公司QMM-001 Rev. C 质量管理手册 Quality Management ManualWritten by/编写 Approved by/批准 Updating content/更新内容Help you make the most of your energyHOU Dong-FrankWANG XuOrganization change,site change打印文件不受控!1 / 86 质量管理手册 Quality Management ManualQMM-001 Rev. CTable of Contents/目录1 Scope/范围 2 Normative References/规范性引用文件 3 Terms and definition/术语&定义 4 Quality Management System/质量管理体系 5 Management Responsibility/管理职责 5.1 Quality Commitments and Direction/管理承诺 5.2 Focus on Customer/以顾客为关注焦点 5.3 Quality Policy/质量方针 5.4 Objectives/质量目标 5.5 Responsibility, authority and communication/职责、权限&沟通 5.6 Management Review/管理评审 6 Resource Management/资源管理 6.1 Provision of Resource/资源提供 6.2 Human Resource/人力资源 6.3 Infrastructure/基础设施 6.4 Work Environment/工作环境Help you make the most of your energy打印文件不受控!2 / 86 质量管理手册 Quality Management ManualQMM-001 Rev. C7 Product Realization/产品实现 7.1 Planning for product realization/产品实现的策划 7.2 Customer-related processes/与顾客有关的过程 7.3 Design and Development/设计和开发 7.4 Purchasing/采购 7.5 Production and service provision/生产和服务的提供 7.6 Control of monitoring and measuring equipment/监视和测量设备的控制 8 Measurements, Analysis and Improvement/测量、分析和改进 8.1 The Plan of measurement、analysis and improvement/监视、测量分析改进的策 划 8.2 Monitoring and measurement/监视和测量 8.3 Control of nonconforming product/不合格品控制 8.4 Analysis of data/数据分析 8.5 Improvement/改进 9 CCC Certification/CCC 认证Help you make the most of your energy打印文件不受控!3 / 86 质量管理手册 Quality Management ManualQMM-001 Rev. C1 Scope 范围 1.1 Aims 目的 To express Quality Policy and Objectives/通过该手册传达公司的质量方针和目 标 To Describe the Quality Management System (Abbr.QMS)/通过该手册描述 SEEE 质量管理体系 It is intended for Schneider-Electric Equipment Engineering Co., Ltd (Abbr. SEEE) personnel, SEEE customers and auditors from separate organizations/为 SEEE 的 员工、客户和各审核方提供依据。 1.2 Relationship with Schneider-Electric Corporate Quality Manual 该手册与施 耐德集团质量手册的关系 SEEE quality manual is in-line with Schneider-Electric Corporate Quality Manual in Core Value, Management Concept, Process Model, and Operation Guide-Line has no conflict with Schneider-Electric Corporate Quality M SEEE quality manual and Schneider-Electric Corporate Quality Manual are two separated documents. SEEE的质量手册与施耐德集团质量手册在核心价值观、管理理念、流程模块 和执行手册上是保持一致的,该手册与集团质量手册没有冲突的地方;SEEE质 量手册和施耐德集团质量手册是两个独立的文件。 SEEE quality manual is written in complying with the International Standards ISO
clause sequence, describes the standards those it has cited and theHelp you make the most of your energy打印文件不受控!4 / 86 质量管理手册 Quality Management ManualQMM-001 Rev. Coperation requirements in detail “Further information relating to the SE Corporate Quality Manual and SE Corporate Quality Management System is available on the SE intranet under Customer Satisfaction & Quality website.” -SEEE质量手册编写的依据是ISO对应条款, 该条款所引用的集团 标准要求详见下面链接: http://quality.fr./global/quality/intranet/en/publication.nsf/F?R eadForm&ID=E1D88FDCD285D&1.3 Scope 范围 By now, the scope of SEEE includes 2 addresses, they are: 目前,SEEE 区域范围包括如下两个: 1.3.1 Schneider Electric Equipment Engineering (xi’an )CO.,LTD o ffice center and R&D center, Addressed at: 1-4/F, Building C,GLP I-Park, No.211 Tiangu 8th Road, Hi-tech Zone, Xi'an 710077, P.R.C., 西安办公中心&研发中心:西安市高新区天谷八路 211 号环普科技产业园 C 栋 1-4 层 1.3.2 Schneider Electric Equipment Engineering (xi’an) CO.,LTD Factory,Help you make the most of your energy打印文件不受控!5 / 86 质量管理手册 Quality Management ManualQMM-001 Rev. Caddressed at: No. 26 ZHANGBA 8 Road, Hi-tech Zone, Xi'an, Shaanxi Province P.R.C 工厂:陕西省西安市高新区丈八八路 26 号。 1.3.3 Business scope 业务范围 The research and develop, sales, design, manufacturing and service of medium and low voltage electric a the design, installation, consult and service of electric and atomization solution. 中低压电气及相关设备的研发、销售、设计、生产和服务;电气及自 动化项目方案的设计、安装、咨询及服务。 1.3.4 Product scope 产品范围 Medium and low voltage electric and related equipment/中低压电气及相关设 备 1.4 Introduction of SEEE/SEEE 简介 SEEE is a subsidiary company of Schneider Electric China Co., Ltd (Abbr. SEC), a solely-foreign-owned. It is a part Schneider-Electric’s GO WEST focuses on offering both medium voltage and low voltage equipment and solutions. SEEE 是施耐德电气中国有限公司的一个子公司,外资企业。它是施耐德电气 D西部计划‖战略的一部分,专注于中低压设备和成套解决方案的提供。 2 Normative references参考文件Help you make the most of your energy打印文件不受控!6 / 86 质量管理手册 Quality Management ManualQMM-001 Rev. CISO Quality Management System --Fundamentals and vocabulary(can be found in DMS) ISO
DMS) Schneider-Electric Corporate Quality Manual ISO 质量管理体系―术语和定义(在 SEEE 的 DMS 里可查) ISO 质量管理体系―要求(在 SEEE 的 DMS 里可查) 施耐德电气集团质量手册 All the documents above are the newly effective version when this quality manual is released. /手册发布时,以上文件为最新版本,后续以最新版本为准。 3 Terms and Definition术语和定义 Quality Management system C Requirements (can be found in? SEEE: Schneider-Electric Equipment Engineering Co., Ltd. ? SBMV: Schneider (Beijing) Medium Voltage Co., Ltd. ? SEC: Schneider Electric China Co., Ltd. ? SE: Schneider Electric ? R&D: Research & Development ? PMO: Project Management OfficeHelp you make the most of your energy打印文件不受控!7 / 86 质量管理手册 Quality Management ManualQMM-001 Rev. C? BP: Business Partner ? TA: Technical Antena ? DCC: Document Control Center/文控中心 ? DMS:Document Management System/文件管理系统 ? IQI: Incoming Quality Inspection/来料检验 ? PQC: Process Quality Control/制程检验 ? FQC: Final Quality Control/终检 ? SQE: Supplier Quality Engineer/供应商质量管理工程师 ? PM: Project Management/项目管理 ? SOA: Sale Order Administrator/销售订单管理员 4 Quality Management System质量管理体系 4.1 General requirement/总要求 4.1.1 The company set up QMS and established quality manual, procedure, work instructions, sheet, etc in accordance with ISO standards. SEEE carries out and maintains the system, and continuously improves its effectiveness. And manage following processes in accordance with ISO requirements. 公司建立了质量管理体系并依据 ISO 标准起草了质量手册,程 序书及作业指导书表单等。公司将切实执行手册、程序书及作业标准书并Help you make the most of your energy打印文件不受控!8 / 86 质量管理手册 Quality Management ManualQMM-001 Rev. C不断提高自身的绩效。并依据 ISO 要求管理以下过程:a) Determine the processes needed for the QMS and their application throughout the company. 确定质量管理体系所需的过程及其在整个组织中的应用 b) Determine the sequence and interaction of these processes. 确定这些过程的顺序和相互作用 c) Determine the criteria and method which is needed to ensure that both the operation and control of these processes are effective. 确定所需的准则和方法,以确保这些过程的运行和控制有效; d) Ensure the availability of resources and information that are necessary to support the operation and monitoring of these processes. 确保可以获得必要的资源和信息,以支持这些过程的运行和监视; e) The quality files determine how to monitor、 measure and analyze these processes. 制定质量文件,以确定如何监控、测量及分析这些过程; f) To take action that’s necessary to achieve the planned results and continual improvement of these processes. 实施必要的措施,以实现对这些过程策划的结果和对这些过程的持续改进。4.1.2 The company employs the Dprocess-based quality management system model‖,, also named PDCA model, including the processes related to the management activities, resource supply, product realization, measuring, and controls of these processes in respect with the requirement of ISO9001. PDCA can be briefly described as follows, 公司建立“以过程为基础的质量管理体系模式” ,也称为“PDCA 模式, 包括与管理指责、资源提供、产品实现等过程。并依据 ISO9001 的要求测 量和监控这些过程。 PDCA 模式可简述如下:Help you make the most of your energy打印文件不受控!9 / 86 质量管理手册 Quality Management ManualQMM-001 Rev. CP- Plan: to identify the objective and processes required for delivering results in accordance with the customer’s requirements. P- 策划: 根据顾客的要求和组织的方针,为提供结果建立必要的目标和过程 D- Do: to implement the processes. D- 实施: 实施过程 C- Check: to monitor and measure processes and product against policies, objectives and requirements. C- 检查: 根据方针、目标和产品要求,对过程和产品进行监视和测量,并报告结果 A- Action: to take immediate action to improve process performance continuously. A- 处置: 采取措施,以持续改进过程业绩。4.1.3 The QMS of SEEE is consisting of 6 main processes, each process is supported by r please refer to procedures for the processHelp you make the most of your energy打印文件不受控!10 / 86 质量管理手册 Quality Management ManualQMM-001 Rev. Cdescription. 公司的质量管理体系包括以下六个主要过程, 对各个过程都制定了相应的程序,详细的过程描述请参考相关的程序文件.o Bid and quotation process---- see (PRO-TSC-002)/(PRO-TSC-001) 投标报价及相关要求审核过程 ---- 见《投标程序》/《报价程序》 o Order deal with and production plan control procedure---- see (PRO-SCM-002) 订单评审与生产计划过程 ---- 见《PRO-SCM-002 订单处理与生产计划程序》 o Product Design and Development process ---see(PRO-RD-001)/(PRO-TE-001) 产品设计与开发流程 ----见(PRO-RD-001 设计与开发控制程序)/《设计流程》o Product Continuous Evolution Process (PRO-QM-005)--(PRO-RD-002)/(PRO-TE-003)/持续改进过程 ----见《PRO-RD-002 产品持续改进控制程序》/《PRO-TE-003SEEE PEP 手册》/《PRO-QM-005 纠正与预防措施控制程序》 o Customer complaint Handling Process --- see (PRO-QM-006) 客户投诉处理过程 ---- 见《PRO-QM-006 客户投诉处理程序》 o Customer satisfaction process―see(PRO-QM-009) 客户满意改善流程----见《PRO-QM-009 客户满意改善程序》4.2 Document Structure 文件结构 4.2.1 General/总则4.2.1.1 MR shall identify the process needed for the quality management system and their application throughout the organization. The process shall be documented in Procedure, Working Instruction. And it will show the sequence and interaction of processes. 管理者代表应识别质量管理体系所需的过程及其在组织中的应用。应对这些过 程建立文件化的程序、作业指导书以确定这些过程的顺序和相互作用。Help you make the most of your energy打印文件不受控!11 / 86 质量管理手册 Quality Management ManualQMM-001 Rev. C4.2.1.2Each identified processes shall include measurable criteria and verification methods to monitor the processes and ensure the output can meet customers’ needs, requirements of laws and regulations. 每一个识别出的过程应包含其测量的标准及验证的方法,以便于监控这些过程, 并确保过程的输出可以满足客户的需求及法律法规的要求。4.2.1.3The result of continuous improvement of the processes will be the basis for quality objectives at each Management review meeting (5.6). 过程的持续改进绩效将在管理评审会议中进行评审,并作为目标设定的基础。4.2.1.4In case of discrepancy, the original version of management procedures in Chinese shall prevail. 文件的中英文若有偏差或冲突,将以中文版的管理程序为准。4.2.2 Quality Manual 质量手册 SEEE has establishes and will maintain quality manual. The manual including: SEEE 编制和保持该质量手册,包括 a) The scope of the quality management system 质量管理体系的范围 b) The documented procedure established for the quality management system, or reference to them, and 为质量管理体系编制的形成文件的程序及对其的引用 c) Description of the interaction between the processes of the quality management system 质量管理体系过程之间的相互作用的表达. Please refer to 1 Scope for detailed. 详细见 1 范围 4.2.3 Document control 文件控制Help you make the most of your energy打印文件不受控!12 / 86 质量管理手册 Quality Management ManualQMM-001 Rev. C4.2.3.1The Quality Management System documentation system is based on the quality policy, quality objectives, quality management manual, Procedure, Work Instruction &Instruction of process, Record, as shown: SEEE 的文件管理体系至少由以下内容构成:质量方针、质量目标、质量管理手 册、程序文件、工作指导、流程指导、记录等4.2.3.2Document control 文件控制To ensure the adequacy and suitability of all the documents, SEEE will follow: a).to approve documents for adequacy prior to issue, b). to review and update as necessary and re-approve documents, c). to ensure that changes and the current revision status of documents are identified, d).to ensure that relevant versions of applicable documents are available at points of use. e). to ensure that documents remain legible and readily identifiable, f).to ensure that documents of external origin determined by the organization to be necessary are identified and their distribution controlled, and g). to prevent the unintended use of obsolete documents, and to apply suitable identification to them if they are retained for any purpose.Help you make the most of your energy打印文件不受控!13 / 86 质量管理手册 Quality Management ManualQMM-001 Rev. CDetail requirements follow (Control of Document), and (Control of Record) 为了保证文件的充分性与适宜性,文件控制满足: a).文件发布之前先审批,批准后的文件才生效,以确保文件的充分性与适宜性; b).文件进行评审、更新后的文件需再次批准方可受控; c). 确保文件的更改和现行修订状态得到识别; d). 确保在使用处可获得有效版本的文件; e). 确保文件保持清晰、易于识别; f). 确保SEEE所适用的外来文件的识别,并控制其分发; g). 防止作废文件的非预期使用, 如果有因任何原因而保留的作废文件,要对这些文件进行标 识。 具体要求参见:PRO-QM-001 《文件控制程序》4.2.4 Record control 记录控制4.2.4.1 SEEE establishes and maintain control of appropriate quality records (include data in computer) to demonstrate conformance of finished product to specified requirements and effective operative the Quality Management System. SEEE 建立并保持适当的质量记录(包括电子档的数据记录),以提供产品符合 要求和质量管理体系有效运行的证据。 4.2.4.2 Every department shall ensure the identification, collection, access, filing, maintenance and deposition of quality record. 各部门应确保质量记录的收集、标识、检索、归档、储存及处置符合要求。 4.2.4.3 All the quality records shall be legible and filed. All records shall be kept in an environment free from damage, deterioration. All quality records shall be stored following (record control procedure) 所有的质量记录应保持清晰,易于识别和检索,并妥善存储以防止损坏。所以 质量记录的保存期限见《记录控制程序》。Help you make the most of your energy打印文件不受控!14 / 86 质量管理手册 Quality Management ManualQMM-001 Rev. C4.2.4.4 A Records List shall be drafted and updated. 质量记录清单应被拟定并及时更新。4.3 Clauses and department correspondence/条款与部门对应关系 Can be found in Annex 1/参见附件1 4.4 相关文件No. 1 2 Document (PRO-QM-001) 《文件控制程序》 (PRO-QM-002)《记录控制程序》5 Management Responsibilities管理职责 5.1 Quality Commitments and Direction 管理承诺 5.1.1 SEEE has the following management commitment 我们的管理承诺 ? We commit to be a customer-oriented organization by ensuring the Products and Services that we provide are of a high Quality Standard./我们承诺以客户为导向,确 保所提供的产品和服务满足高品质要求 ? We shall always consider the view of our Quality performance from our customer’s perspective. We consider the customers view point on Quality as the true view of our performance./我们将为客户考虑,以客户对产品的质量要求为要求。 ? We shall continue to improve and implement the Quality System in accordance with ISO9001, ensuring that Quality is considered in every step of our organization./Help you make the most of your energy打印文件不受控!15 / 86 质量管理手册 Quality Management ManualQMM-001 Rev. C我们将以ISO9001为基准,持续改善质量体系,确保在SEEE的每个流程都以质 量为导向。 ? We consider our long-term competitive advantage being linked to our Quality performance. Therefore, we shall endeavor to ensure that appropriate resources are allocated towards our Quality objectives./我们会把质量绩效当作公司的长期竞争 优势之一。因此,我们将全力确保提供合适的资源分配,以满足我们的质量目 标。 ? The Quality initiatives we undertake shall add value which are our Customers, Employees and Shareholder’s./质量导向会是我们的利益相关 方-我们的客户、雇员和股东的价值原则。 ? With this commitment of Quality, we look forward to your support and the continued success of our business./我们希望:该质量承诺获得您的支持,并期望 我们事业的持续成功。General Manager /总经理5.1.2 SEEE will offer the evidence of setting and operating quality management system and continuously improving it to ensure its effectiveness by the following actions/公司通过以下活动, 对建立、 实施质量管理体系并持续改善其有效性的承诺 提供证据:Help you make the most of your energy打印文件不受控!16 / 86 质量管理手册 Quality Management ManualQMM-001 Rev. Ca). 通过会议、培训、文件及各种宣传形式来传达满足客户要求及法律法规要求 的重要性; b).按照标准要求制定公司的质量方针; c).根据质量方针,在公司和各职能部门执行质量目标,并形成文件; d).按照规定的时间进行管理评审; e).确保各质量活动可获得必要的资源。 5.2 Customer Focus 以顾客为关注焦点 Customer orientation is being operated in SEEE. To ensure customer’s requirements get confirmation and met, SEEE monitor and improve the CNPS, PRR and other KPI, handle customer complaints on time with high quality, and offer the customized products and services. We handle the customer complaints following the process (customer complaint handling process). SEEE以客户为中心,通过客户满意度、产品退货率等KPI的监控和改善,通过质 量管理体系实现对过程的管理,以及客户投诉的处理与解决,为客户提供定制化产 品和服务,确保客户的要求得到确定和满足,从而提高客户的满意度。 5.3 Quality Policy 质量方针 We follow the Corporate Quality Policy which can be found at below URL: http://quality.fr./global/quality/intranet/en/publication.nsf /F?ReadForm&ID=E1D88FDCD285D& 我们遵守施耐德集团的质量方针,可通过以下链接访问:Help you make the most of your energy打印文件不受控!17 / 86 质量管理手册 Quality Management ManualQMM-001 Rev. Chttp://quality.fr./global/quality/intranet/en/publication.nsf /F?ReadForm&ID=E1D88FDCD285D&Help you make the most of your energy打印文件不受控!18 / 86 质量管理手册 Quality Management ManualQMM-001 Rev. CHelp you make the most of your energy打印文件不受控!19 / 86 质量管理手册 Quality Management ManualQMM-001 Rev. C5.4 Quality Objectives 质量目标 5.4.1 Quality Objectives 质量目标 5.4.1.1 All quality related KPI YTD target will be reviewed and new KPI will set in the end of every year by top management team. All KPI shall be measurable and consistent with the quality policy. The KPI shall be the input of management review to review the quality management system operation status and effectiveness. Departments shall set separate targets according to the company KPI. All KPI set will be monitored periodically and will be shown in the management review meeting. Actions shall be acted when necessary. 每年年底,管理层对公司的年度质量目标达成情况进行评审,并设定下一 年度的质量目标,目标需要数据化、可测量,并且与公司的质量方针保持 一致。并应作为评价公司质量管理体系运行情况和有效性的依据,作为管 理评审的输入内容之一。所有相关的部门应将公司的目标进行分解,制定 本部门的目标。设定后,所有的质量目标需定期监控,并作数据分析;公 司管理会议上对目标进行汇报,并采取必要的措施以持续改善。 5.4.1.2 For the yearly detailed value of the company’s quality objectives, please refer to the related information issued by the company. 关于公司详细的目标,请参阅公司的 KPI 文件。 5.4.2 Quality management system planning/质量管理体系策划 SEEE ensures that:Help you make the most of your energy打印文件不受控!20 / 86 质量管理手册 Quality Management ManualQMM-001 Rev. Ca). the planning of the quality management system is carried out to meet the requirements stated in clause 4.1 and b). the integrity of the quality management system is maintained when changes to the quality management system are planned and implemented. 公司确保: a). 质量管理体系的策划应得到有效实施,满足标准 4.1 的要求。 b). 在对质量管理体系的变更进行策划和实施时,应保持质量管理体系的 完整性。 5.5 Responsibility, authority and communication 职责、权限&沟通 5.5.1 Top management ensures that the responsibilities and authorities are defined and communicated within SEEE, and authorizes HR department to make up the job description of positions including responsibilities and authorities, and to make sure the communication is effective. So can get the required quality management effective. 公司管理层确保公司级各部门的职责、权限明确规定,并授权人力资源部 编制《岗位职责》 ,对各岗位的职责、权限及其沟通予以明确规定,从而 实现有效的质量管理。 SEEE will review and update the company organization chart per year. Department o-chart will be reviewed and updated accordingly. 公司的组织架构进行评审并更新, 部门根据公司组织架构对应更新本部门Help you make the most of your energy打印文件不受控!21 / 86 质量管理手册 Quality Management ManualQMM-001 Rev. C组织架构. 5.5.1.1 Top management 公司管理层 a).To communicate to the employees the importance of meeting customer as well as statutory and regulatory requirements/向公司员工传达满足客 户和法律法规要求的重要性; b).To issue the quality policy and quality objectives, to approve the quality manual, to appoint the management representative, and to hold the management review work/发布质量方针和公司质量目标,批准颁布质 量手册,授权管理者代表,主持管理评审; c).To hold the top management meeting, to discuss the critical quality issues and make the decision/主持召开公司管理会议,讨论重大质量问 题并作出决定; d).To authorize QM department to execute the authority of quality inspection and control, and ensure their responsibilities could never be interrupted by any department or person, so they can execute the responsibilities of identifying, judging and report the quality issues/ 授权 质量部行使质量监督的职权, ,保证其不受任何部门和个人的干预, 正确行使鉴别、判断、报告的职能; e).To approve the requirement of resources, and ensure the needed resources can be available for quality management system/审批资源的需 求,确保质量管理体系运作获得必要的资源;Help you make the most of your energy打印文件不受控!22 / 86 质量管理手册 Quality Management ManualQMM-001 Rev. Cf).To continuously improve SEEE total performance by quality policy, quality objectives, audit results, data analysis, corrective and preventive actions, management review, customer requirements etc./利用质量方针、 质量目标、审核结果、数据分析、纠正与预防措施及管理评审、客户 需求等,持续改进公司整体业绩。 5.5.1.2 Industry Solution department 工业解决方案部 a) To support Industry Solution department BU to get the continuous growth, control the project risks, add the project
支持工业事业部实现工业解决方案(L2/L3/IDADS) 的持续增长, 控制项目 风险, 提高项目利润及现金流. b) Support Industry Solution department BU on the growth of engineering and the project execution in AP and C 支持工业事业部工程变频业务在亚太区和中国市场的持续增长和项目执 行. c) To be able to manage the team and get more professional, and conduct the large scale in 能够专业化管理和实施大型国际化项目. d) To be the energy management expert of industry area. 成为工业领域能源管理的专家. 5.1.2.1 Bidding department 投标部a) 推广公司形象,依据公司销售政策、策略和确定的目标;Help you make the most of your energy打印文件不受控!23 / 86 质量管理手册 Quality Management ManualQMM-001 Rev. Cb) Support Sales team to organize sales activities, including preparation of materials, product launching and promotion seminars, technical supports and product training and so on. Ensure achieving sales target. 支持销售团队的销售活动,如销售材料的准备,产品的推广研讨 会、产品技术支持、产品培训等,以达成销售目标; c) Communicate with customer, determine and review customer’s requirement, accept customer contract, and manage the internal communication to meet requirements 与客户沟通,确定及评审客户的要求,接收客户合同,并确保相 关要求的内部沟通 d) 收集客户咨询,识别客户需求,并相应地计划投标工作; 根据客户的要求,制定投标方案,并作投标评估分析。 e) Receive and manage customer property 接收并管理顾客财产 5.1.2.2 Project management department 项目管理部a). To take charge of monitoring the execution o b). To organize and plan the processes needed for the product realization, and ensure that projects can finish on ti c).To handle the information added by customer during the execution ofHelp you make the most of your energy打印文件不受控!24 / 86 质量管理手册 Quality Management ManualQMM-001 Rev. Ccontract, and the managemen d). To take charge of the FAT. a).负责监督协调合同条款的全面履行; b).负责组织策划产品实现所要求的过程 , 确保项目按期保质执行完 成; c).处理合同履行过程中客户追加的信息,合同变更管理; d).负责客户工厂验收。 5.1.2.3 Design Department 设计部a). Determine and review the requirement related to the product, ensure to design a product to meet customer’ b). Plan and manage the design of product, including mana c). Control the engineer change of the product. a). 确定及评审与产品有关的要求,确保设计出满足客户要求的产品 b).策划并管理产品的设计及设计的更改 c).控制产品的工程变更 5.5.1.3 R&D 研发部 a). To research and develop new products, and finish the records and docu to take charge of new function improvementHelp you make the most of your energy打印文件不受控!25 / 86 质量管理手册 Quality Management ManualQMM-001 Rev. Cand enhance the R&D b). To lead the whole program and
c). To organize the PEP; d). To lead the new product trial run, and new part qualification, and ensure the product e). To mange the tools using in supplier site for the R&D f). To manage the technical standards and documents for R&D process. a).对本公司新产品的开发和设计, 完成设计开发过程中的相关记录和 文件,新功能改进设计,提高研发水平; b).负责设计和开发全过程的组织和实施工作; c).组织产品的持续改进依据项目; d). 负责对新零部件试制以及当零件和供应商变更时零件认可过程的 控制,确保量产后产品符合质量要求; e). 负责研发过程中供应商处制造产品零部件时所需要使用的模具的 管理。 f).负责技术和技术管理,组织制定和完善公司各类技术标准; 5.5.1.4 TA& Engineering Department 产品工程部 a). To lead the product localization from external R&D center, and get the technical information from France or internal R&DHelp you make the most of your energy打印文件不受控!26 / 86 质量管理手册 Quality Management ManualQMM-001 Rev. Cb). To lead the CCC; c). To approve the technical change in SEEE; d). To receive the information about PEP and material, ensure the PEP e). To lead the transf f). To revise the Internal g). Determine and review the requirement related to the product, ensure to design a product to meet customer’ h). Plan and manage the mechanical design of product, including manage of mecha i). Control the mechanical change of the product. a).从法国研发或国内研发部获得相关产品的技术, 并进行国外产品技 术本土化; b).获取中国强制性产品认证中心的产品资质认证; c).负责 CCC 认证产品的技术变更; d). 接收产品改进信息和材料,负责产品改进在 SEEE 的顺利进行; e).负责 SEEE 转让级零件验证; f).负责编制内部技术指导文件; g). 确定及评审与产品有关的要求,确保设计出满足客户要求的产品Help you make the most of your energy打印文件不受控!27 / 86 质量管理手册 Quality Management ManualQMM-001 Rev. Ch).策划并管理产品的机械设计及机械设计的更改 i).控制产品的机械工程变更 5.5.1.5 Supply chain management department 供应链部 a). To make up the manufacturing plan according to the orders receives, and make up the material purchasing schedule and conduct and follow t b). To take charge of the product label and traceability to make sure the materials pass the inspection can go into th contact with suppliers to handle the non-conforming material according to the non-confor c). To manage the inventory, and optimize the material storage and internal material tr d). To arrange the packaging and delivery of finished goods, and the transportation of WIP materials. a).根据接收的订单,编制生产计划,编制物料采购计划并实施和跟踪 采购订单; b).负责采购产品的标识和可追溯性工作, 确保只有经检验合格的物料 才能进入生产区域,与供应商联系,根据不合格品处置意见处理采购 的不合格物料; c).负责物料的库存管理,对物料的仓储及内部配送过程进行优化;打印文件不受控!Help you make the most of your energy28 / 86 质量管理手册 Quality Management ManualQMM-001 Rev. Cd).安排成品的包装和合同交付的发货及生产过程中物品的运输工作, 并实施跟踪。 5.5.1.6 Workshop 生产部 a). Conduct production according to design requirements and give appropriate identification and preservation. 依据产品设计要求进行生产,并在生产过程中对产品进行适宜的 标识及防护; b).control the internal producing balance, to get the pr 控制、调整和平衡内部生产负荷,实现最优化生产; c). To use the product characteristic information and WI, using the required equipment and arran 根据获得的产品特性信息和作业指导书,使用适宜的设备和工作 组织产品生产; d).To conduct the product self-inspection, get the non-conforming products containment,
负责组织产品的自检,对车间不合格品进行隔离,并报告. e). Analysis and deal with the nonconforming together with Quality, perform the fixed actions for product quality continual improvement.Help you make the most of your energy打印文件不受控!29 / 86 质量管理手册 Quality Management ManualQMM-001 Rev. C与质量一起对不合格产品进行分析处置,执行既定的解决方案, 持续改进产品质量。 5.5.1.7 M&M 工艺与维修部 a).To prepare and follow the budget for invest of equipment, track and support vendor about the equipment installation, including the related training. a).准备和跟踪设备投资预算, 跟踪和协助设备供应商对设备的安装调 试及设备的操作培训; b).Control the following conditions in production and service provision: 生产及服务提供过程中控制以下条件: - Determine appropriate process to instruct the production 确定适宜的工艺过程,以指导生产过程相关环节 - Apply appropriate equipments, maintain the equipment to assure its normal running 使用适宜的设备,对设备进行维护,确保设备的正常运行。 - Develop the technology and equipment to meet the production capability. 同时考虑提高生产工艺或改进设备以满足产能的需求Help you make the most of your energy打印文件不受控!30 / 86 质量管理手册 Quality Management ManualQMM-001 Rev. C5.5.1.8 Quality Management Department 质量管理部 a) Responsible for verification of purchased product 负责采购产品的验证 b) Plan and manage monitoring and measurement of product during product realization process, to verify that product requirement have been met. 策划及管理产品实现过程的监视和测量,以验证产品要求已得到 满足 c) Control nonconforming products and product status identification, 确保不合格品的控制及产品的状态得到有效识别。 d) Organizing the analysis of data for product quality improvement, guide the application of statistical techniques. 分析数据用于质量改进,指导对统计方法的运用; e) Involve in customer satisfaction survey and take actions for boosting customer satisfaction f) 参与客户满意度调查并采取相关的措施提高客户满意度; g) Monitor and measure the implementation of the objectives and program 监视和测量目标、指标及方案的的达成状况;Help you make the most of your energy打印文件不受控!31 / 86 质量管理手册 Quality Management ManualQMM-001 Rev. Ch) Organize relevant department to identify, valuate and communicate the applicable legal 组织相关部门识别评价并沟通适用的法规要求; i) Plan and organize internal audit for management system and follow up the actions which for detected nonconformities. 策划及组织管理体系的内部审核并跟踪发现的不合格的改进; j) Organize management team to review the management system to ensure continuing suitability, adequacy and effectiveness of the management system. 组织最高管理者按策划的时间评审管理体系,确保管理体系持续 的适宜性、充分性和有效性; k) Responsible for management of document and records 负责文件及记录的控制及管理。 5.5.1.9 HRA 人力资源部 a). Work with GM and department managers for effective management of human resources activities & service provisions to support on organization objectives. 与总经理及各部门经理一起对人力资源进行有效的管理,以支持 公司目标的达成。 b) Work out, update, supplement, adjust and communicate personnel management rules and policies 拟定,更新,补充,调整及沟通人事管理的规则及政策。Help you make the most of your energy打印文件不受控!32 / 86 质量管理手册 Quality Management ManualQMM-001 Rev. Cc)Responsible for recruitment, source the right people for the right position 负责公司的招聘,为需求岗位寻找合适的人员d) Work with department managers to determine the necessary competence for personnel and, where applicable, provide training or take other actions to achieve the necessary competence 与各部门经理一起确认人员所需的能力,必要时提供培训或其他 措施以获得所需的能力 e) Personnel including: Who performing work affecting conformity to product requirements 人员包括: 从事影响产品要求符合性工作的人员 f) Responsible for employee satisfaction/ salary & benefits surveys / analysis and actions. 负责员工满意度、薪资福利的调查及分析,并采取相关措施 5.5.1.10 Except for above responsibility and authorization, all departments shall take into account requirements for the activity: Applicable legal and other requirements 各部门除了以上职责及权限外,还应在活动中充分考虑: 适用的法规及其他要求 5.5.1.11 Quality responsibility distribution table 质量职能分解表Help you make the most of your energy打印文件不受控!33 / 86 质量管理手册 Quality Management ManualCharter 条款 Elements 要素QMM-001 Rev. CM&MSCMR&DHRAPRDGMQMIDSMRTE4 4.1 4.2Quality management system 质量管理体系 General requirements总要求 Documentation requirements文件要求* ☆ ☆ * * * * * *** * ☆ * * * * * **4.2.1 General总则 4.2.2 Quality Manual质量手册 4.2.3 Control of documents文件控制 4.2.4 Control of records记录控制 5.1 5.2 5.3 Management commitment管理职责 Customer focus以顾客为关注焦点 Quality policy质量方针☆ * * ☆ ☆ ☆ ☆☆ * ☆ * * * ☆* * * * ☆ * ** * * * ☆ * ** ☆ * * * * ** * * * * * ** * * * * * ** * * * * * ** * * * * * * ** * * * * * * *5.4.1 Quality objectives质量目标5.4.2Quality management planning 质量管理体系 ☆ 策划 Responsibility, authority and communication☆******5.5职责、权限和沟通 Management review管理评审 Resource management资源管理 Provision of resources资源提供 Human resource人力资源 Infrastructure基础设施 Work environment工作环境 Product realization产品实现 Planning of product realization产品实现的策☆******☆**5.6 6 6.1 6.2 6.3 6.4 7 7.1☆☆******* ** *☆******** * ** * ** * ** * ** * ** * ** * *☆ * ** * * ** ☆ ☆ ☆****☆☆☆*Help you make the most of your energy打印文件不受控!34 / 86 质量管理手册 Quality Management Manual划 7.2 7.3 7.4 Customer-related process与顾客有关的过程 Design and development设计和开发 Purchasing management采购 * * * * * * * * ☆ * * * * * ☆ * * * * * * ☆ * * *QMM-001 Rev. C* * * ☆* * * *7.5Production and service provision生产和服务 * 提供 Control of monitoring and measuring devices * 监视和测量装置的控制 Measurement, analysis and improvement 测 * 量、分析和改进 Monitoring and measurement监视和测量 *****☆*7.6 8 8.1 8.2****☆***☆☆***☆* * *** *☆**☆☆** ** *8.3Control of nonconforming product不合格品控 * 制 Analysis of data数据分析 Improvement改进 * ―participate * * in***☆**8.4 8.5* ☆* ** ** *☆ ☆* ** ** ** *☆ ―take in charge5.5.2 Management Representative管理者代表 The management representative shall be appointed by the top management. The responsibility and authority includes the following irrespective of other responsibilities: a).ensuring the processes needed for the quality management system are established, implemented and maintained, b). reporting to top management on the performance of the quality management system and any need for improvement and c). ensuring the promotion of awareness of customer requirements throughout theHelp you make the most of your energy打印文件不受控!35 / 86 质量管理手册 Quality Management ManualQMM-001 Rev. CSEEE. d). liaison with external parties on matters relating to the quality system. 管理者代表由公司最高管理者任命。 管理者代表的职责和权限除其他方面的职 责外,包括: a). 确保质量管理体系所需的过程得到建立、实施和保持; b). 向最高管理者报告质量管理体系的业绩和任何改进的需求; c). 确保在全公司内提高满足顾客要求的意识。 d). 与质量管理体系有关事宜的外部联络。 5.5.3 Internal Communication内部沟通 5.5.3.1 The top management shall ensure that communication between the management and employees is maintained and effective in order to meet the requirement of quality objective and quality policy. 最高管理者应确保在公司内部管理者与员工沟通的有效性,以达成公 司的质量方针及目标; 5.5.3.2 Internal communication channel shall be established in order to increase the work efficiency between departments. Information communication content includes current management status, issue need cross function communication, external information, requirements from SEEE, and employees’ suggestion or ideas.Help you make the most of your energy打印文件不受控!36 / 86 质量管理手册 Quality Management ManualQMM-001 Rev. C应建立内部沟通渠道以提高各部门的工作效率。信息沟通内容包括公 司管理现状、职能部门之间需要沟通或协调的事项、外部信息、公司 提出的要求、员工建议等; 5.5.3.3 The methods of internal communication includes: weekly meeting, monthly management meeting, internal communication board, e-mail, internal magazine, telephone contact.etc to ensure the effective internal communication. 内部沟通的方式有:周会,月度管理会,内部沟通板,电子邮件、公 司简报、内部刊物、电话联系等,以确保有效的内部沟通; 5.5.3.4 Each department shall exchange necessary information with relative department or workers. 每个部门都应就相关信息与相关的部门及人员进行沟通。5.6 Management Review管理评审 SEEE has set the (management review procedure) to standardize the management review. The top management shall review the quality management system at planned intervals, to ensure its continuing suitability, adequacy and effectiveness. Management review shall include assessing opportunities for improvement and the need for changes to the quality management system, including the quality policy and objectives. Inputs to management review shall include information on:Help you make the most of your energy打印文件不受控!37 / 86 质量管理手册 Quality Management ManualQMM-001 Rev. Ca). results of audits, b).customer feedbacks, c).process performance and product conformity, d).status of corrective and preventive actions, e).follow-up actions from previous management reviews, f).changes that could affect the quality management system, and g). recommendations for improvement. Outputs from management review shall include any decisions and actions related to: a). improvement of the effectiveness of the quality management system and its process, b).improvement of product related to customer requirements, c). resource needs, and d).document system improvement. The detail requirements about the Inputs, outputs and records follow the procedure (Management review). SEEE建立了《管理评审》文件以规范管理评审工作。公司高层按照策划的时间 间隔对公司的质量管理体系进行管理评审,以确保其持续的适宜性、充分性和有效 性。评审包括评价质量管理体系改进的机会和变更的需要,包括质量方针和目标。 管理评审的输入应包括:Help you make the most of your energy打印文件不受控!38 / 86 质量管理手册 Quality Management ManualQMM-001 Rev. Ca).审核结果 b). 顾客反馈 c). 过程的业绩和产品的符合性 d). 纠正和预防措施的状况 e). 过往管理评审的跟踪措施 f). 可能影响质量管理体系的变更 g). 改进的建议 管理评审输出应包括与以下方面有关的任何决定和措施: a).质量管理体系及其过程有效性 b). 与顾客要求有关的产品的改进 c). 资源需求 d).文件的改进 管理评审的输入输出和记录详细要求参照《管理评审》程序文件。 5.7Related Document相关文件 No. 1 2 Document/文件 Company Organization chart/公司组织架构图 The appointment of Management representative/管理者代表任命书打印文件不受控!39 / 86Help you make the most of your energy 质量管理手册 Quality Management ManualQMM-001 Rev. C3 4 5 6(PRO-QM-012) 《Internal communication Procedure/内部沟通流程》 (PRO-QM-006) 《customer complaint handling process)/客诉处理流程》 KPI target and actual performance/KPI目标与绩效 (PRO-QM-011) 《Management review/管理评审流程》6 Resource management资源管理 6.1 Provision of resources 资源的提供 6.1.2 SEEE management team will determine and provide resources needed to a). implement and maintain the quality system and continuously improve its effectiveness and b). to enhance customer satisfaction by meeting customer requirements. Note: resources can include human resource, information, vendor information, fundamental, work environment and finance resource. SEEE管理层负责确定并提供以下方面所需的资源: a). 实施、保持质量管理体系并持续改进其有效性; b). 通过满足顾客要求,增强顾客满意。Help you make the most of your energy打印文件不受控!40 / 86 质量管理手册 Quality Management ManualQMM-001 Rev. C其中,资源可包括人员、信息、供方、基础设施、工作环境及财务资源。 6.2 Human resource 人力资源 6.2.2 Human resource management requirement 人力资源管理要求 SEEE set the proper departments to meet the requirements of the processes needed. We identify the positions those can affect the product conformity, and will put the people who can meet the requirements by education, training, and personal experience, to endure that the quality policy and quality objectives can be reached. The processes may affect conformity to product requirements include delivery date of material and finished goods, transportation, storage and product capability. 公司根据生产服务过程的需要,合理设置职能部门。识别出影响产品性能和要 求的岗位,并通过对员工的教育、培训、结合个人技能和经验,安排有能力的人员 从事影响产品要求符合性的工作, 为实现质量方针、 质量目标提供人力资源的保证。 其中影响产品要求符合性的过程可能包括:产品和原材料的交期、运输、储存 及产品性能等。 6.2.3 Competence, training and awareness 能力、培训和意识 SEEE will revise and operate the (training control procedure), and HR department will organize the employee training or other actions to ensure that: a) The ability of the employees whose position can affect the product conform b) The ones affect the product conformity have the competence to meet theHelp you make the most of your energy打印文件不受控!41 / 86 质量管理手册 Quality Management ManualQMM-001 Rev. Crequirements, and people perform c) Assess the effectiveness d) Ensure that the employees have realized the importance of their activities and connection with each others’, and how to contribute for the quality o e) The records of education, training, and skills or experience shall be stored be HR or related departments. 本公司编制并实施《培训控制程序》 ,通过人力资源部组织的员工培训或采取其 他措施,以确保: a)从事影响产品要求符合性工作的人员所必需的能力得到明确; b) 从事影响产品要求符合性工作的人员能胜任本职工作, 对员工绩效进行评估, 发现有不称职、不适应岗位的,通过提供培训或采取其他措施予以满足; c)评价采取措施的有效性; d) 确保组织的人员认识到所从事活动的相关性和重要性,以及如何为实现质量 目标做出贡献; e) 由人力资源部和相关部门保存教育、培训、技能和经验的相关记录。 6.3 Infrastructure 基础设施The top management will determine, provide and maintain the infrastructure needed to ensure product conformity.Help you make the most of your energyM&M department shall manage and maintain the打印文件不受控!42 / 86 质量管理手册 Quality Management ManualQMM-001 Rev. Cinfrastructure. The infrastructure includes: a). buildings, manufacturing workspace, office and related equipment (water, electric, air conditioner, internet, fire-fighting equipment); b). office equipment, equipment for manufacturing, tools for design, inspecting equipment , calibrating equipment, hardware an c) Transportation, communication and information system and other supporting services. And the buildings shall meet the requirements of 6.4 公司会确定、提供并维护所需的基础设施,以确保产品符合要求。工艺与维修 部负责设备的管理与维护保养。这些基础设施包括: a) 厂房、生产流水线、办公室等相关设施 (水、电、空调、电脑网络 、消防器 材等) ; b) 办公设备、生产设备,设计工具、检测设备、仪器仪表、计算机硬件和软件 等; c) 支持性服务, 如运输、通讯、信息系统等。 同时,建筑物需满足6.4 的要求。 6.4 Work Environment 工作环境SEEE has determined the work environment needed to ensure the product requirements conformity can be achieved. The work environment includes lighting,Help you make the most of your energy打印文件不受控!43 / 86 质量管理手册 Quality Management ManualQMM-001 Rev. Ctemperature, humidity, noise, weather, the distance between equipment, the fire-fighting equipment and other environment where working in. All shall meet the national requirements. SEEE确保所提供的工作环境达到产品符合要求所需。这些环境包括:照明、温 度、湿度、噪音、天气、设备间距、消防设备和其他工作环境。所有工作环境满足 国家相关要求。 6.5 No.1 2 3Related Document 相关文件 Document/文件(PRO-HR-002)《Human Resource Policy Procedure人力资源管理程序》 (PRO-HR-001)《Training Control Procedure培训控制程序》 (PRO-ME-001)《Maintenance of Industrial Equipment/工业设备的管理及校核》7 Product Realization产品实现 7.1 Planning of Product Realization 7.1.2 SEEE will plan and develop the processed needed for the product realization in the following situations: a) develop new products or the current product
b) the special project products excluded from the current quality management system.Help you make the most of your energy打印文件不受控!44 / 86 质量管理手册 Quality Management ManualQMM-001 Rev. CTo ensure it can be consistent with the requirements of the other processes of QMS. 公司在具体的产品、项目或合同存在下列情况时,进行产品实现的策划: ? 开发新的产品或现有产品有较大的变更时。 ? 现有质量管理体系未覆盖的特殊项目产品。 以保证确保其与质量管理体系其他过程的要求相一致。 7.1.3 SEEE has determined the following: a). quality objectives and requirements for the product, b). the need to establish processes and documents, and to provide resources specific to the product, c). required verification, validation, monitoring, measurement, inspection and test activities specific to the product and the criteria for product acceptance, d). record to provide evidence to ensure the realization processes and resulting product meet requirements. 策划内容包括: a) 根据顾客和相关法律法规的要求确定产品的质量要求; b) 针对产品、项目或合同确定实现的过程、职能的分配,需建立的文件、配备 的资源及培训; c) 规定产品所要求的验证、确认、监视、测量,检验和试验活动,以及产品接 收准则;Help you make the most of your energy打印文件不受控!45 / 86 质量管理手册 Quality Management ManualQMM-001 Rev. Cd)规定为产品实现和满足要求提供证据所需的记录(见4.2.4)。 7.1.4 The planned output may include: contract rolling plan, procedures, drawing, process, or criterion, production plan, purchase plan, inspection regulation, records, table, report and etc. A document specifying the processes of quality management system (including the product realization processes) and the resources applied to a specific product, project or contract, can be referred to as quality plan. 产品策划的输出应包括: 合同、程序、图纸、过程、准则、产品计划、采购计划、检验规则、记录、 报告等等。质量管理体系(包括产品实现过程)的相关文件以及应用于特 定产品、项目、合同的资源都可认为是质量策划的部分。 7.2 Processes related to customer与客户有关的过程 7.2.1 Determination of requirements related to the product 与产品有关要求的确定 7.2.1.1 Before accepting the contracts or orders, we shall organize relative departments to review the product requirement: 在接收合同或订单前,我们应组织相关部门对客户的要求进行评审: a) requirements specified by the customer, including the requirements for delivery and post-delivery activities,Help you make the most of your energy打印文件不受控!46 / 86 质量管理手册 Quality Management ManualQMM-001 Rev. C顾客规定的要求,包括对交付及交付后活动[(交付后的活动包括保证 条款规定的措施,合同义务(如维修服务) ,附加服务(如回收或最终 处置)等)]的要求; b) requirements not stated by the customer but necessary for specified or intended use, where known, 顾客虽然没有明示,但规定的用途或已知的预期用途所必需的要求; c) statutory and regulatory requirements applicable to the product, and 适用于产品的法律法规要求; d) any additional requirements considered necessary by the organization 本公司认为必要的任何附加要求。 e) All requirements are clearly defined and documented. 所有的要求都得以清晰定义并记录 f) Special requirement shall be resolved and documented. 特殊的要求应被确定并记录 g) Where the customer provides no documented statement of requirement, the customer requirements shall be confirmed before acceptance. h) 若顾客没有提供形成文件的要求,在接受顾客要求前应对顾客要求进 行确认 7.2.1.2 The implementation progress of the contract shall be feed back to the customers in time. In order to improve customer satisfaction, we shall communicate with customers effectively to get relevant information.Help you make the most of your energy打印文件不受控!47 / 86 质量管理手册 Quality Management ManualQMM-001 Rev. C合同实现的过程应及时反馈给顾客。 为了提高顾客满意度, 我们 应有效地与客户沟通以获取相关信息。 7.2.1.3 Any changes, including product requirement changes, shall be informed in time to the relative departments of SST and customers. 任何变更, 包括产品要求的变更, 应及时通知到相关的部门或客 户。 7.2.2 Review of requirements related to the product 与产品有关要求的评审 7.2.2.1 For order from Schneider internal group customer, a frame contract will be signed including FIN items. Supply Chain team carry out contract review with support from plant site manager, mainly focus on delivery time. 来自施耐德内部客户的订单, 通过框架协议实现, 其中包括财务 信息。供应链部负责合同评审,主要评审准时交货方面; 7.2.2.2 For direct bidding order to external customer, TS&C department carry out contract review, Engineering, Supply Chain, Quality department and others can be involved. TS &C take charge of communications with customer in this period. 如果是直投的外部客户,投标报价部负责合同评审,设计、供应 链部、 质量部和其他相关部门共同参与。 投标报价部负责与客户Help you make the most of your energy打印文件不受控!48 / 86 质量管理手册 Quality Management ManualQMM-001 Rev. C的沟通。 7.2.2.3 Any customer changes are also reviewed and studied its impact on the commercial aspect and design and progress plan. 客户的任何变更都需要评审并分析它在商务和设计及流程策划 上的影响。 7.2.2.4 SEEE shall review the requirements related to the product. This review shall be conducted prior to the commitment to supply a product to the customer (e.g. submission of tenders, acceptance of contracts or orders, acceptance of changes to contracts or orders) and shall ensure that SEEE 应评审与产品有关的要求。评审应在向客户作出提供产品 的承诺之前进行,并确保: a) product requirements are defined, 产品要求得到规定; b) contract or order requirements differing from those previously expressed are resolved, and 与以前表述不一致的合同或订单的要求已予解决; c) SEEE has the ability to meet the defined requirements. 公司有能力满足所规定的要求。Help you make the most of your energy打印文件不受控!49 / 86 质量管理手册 Quality Management ManualQMM-001 Rev. C7.2.2.5 Records of the results of the review and actions arising from the review shall be maintained。 评审结果及评审所引起的措施的记录应按要求保存。 7.2.3 Customer communication 客户沟通 SEEE shall determine and implement effective arrangements for communicating with customers in relation to: a) Product information, b) Enquiries, contracts or order handling, including amendments, and c) Customer feedback, including customer complaints. SEEE 对以下有关方面的确定并实施与顾客沟通的有效安排: a) 产品信息; b) 问询、合同或订单处理,包括对其的修改; c) 顾客反馈, 包括顾客抱怨。 7.3 Design &Development设计和开发 7.3.1 Design and development planning 设计和开发策划 7.3.1.1 General Requirement 总要求 The products designed & developed shall be processed on the basis of (PMP Procedure) , (PEP Procedure) , and (design procedure) and be in accordance with the requirements stated in 7.3.2 ~ 7.3.7.Help you make the most of your energy打印文件不受控!50 / 86 质量管理手册 Quality Management ManualQMM-001 Rev. C产品设计及开发依据《设计和开发程序》,《产品持续改进控制 程序》和《设计程序》执行,并与以下条款 7.3.2 ~ 7.3.7 的要求 相一致. 7.3.1.2 SEEE shall plan and manage the design and development of product. SEEE 应策划和管理产品的设计和开发 7.3.1.2.1 During the design and development planning, SEEE shall determine: 在进行设计和开发策划时,公司应确定: a) the design and development stage, 设计和开发阶段 b) the review, verification and validation that are appropriate to each design and development stage. 适合于每个设计和开发阶段的评审、验证和确认活动 c) the responsibilities and authorities for design and development. 设计和开发的职责和权限 7.3.1.2.2 To ensure effective communication and clear assignment of responsibility, SEEE shall manage the interfaces between different groups involved in design and development. 为确保有效的沟通及明确职责分工,公司应对参与设计和开 发的不同小组之间的接口进行管理。 7.3.1.2.3 Planning output shall be updated, as appropriate, as the design and development progresses.Help you make the most of your energy打印文件不受控!51 / 86 质量管理手册 Quality Management ManualQMM-001 Rev. C随着设计和开发的进展,在适当时,策划的输出应予更新。 7.3.1.3 New product development and existing product modification are the two points in the management process of SE. In the process of design management: 在施耐德, 设计和开发分为新产品研发和现有产品的更新。 在设 计管理流程中: 7.3.1.3.1 For new product development and existing productmodification: 对于新产品的开发和现有产品的更新: Develop new products and modify existing products according to product researches, customer requirements and market demands. These designs and modifications will be achieved by R&D center or France Design Institute according to the signed product development contract. They follow ( ProjectManagement Program ) or ( Product Evolution Program process). 根据产品研究、客户要求和市场需求,进行新产品研发和现 有产品的更新。产品的研发由研发部或法国的研发中心根据 产品开发协议进行。遵从《PMP 程序》和《PEP 程序》 。 7.3.1.3.2 For Technical service:Help you make the most of your energy打印文件不受控!52 / 86 质量管理手册 Quality Management ManualQMM-001 Rev. C对于技术服务: R&D center or France Design Institute will inform Engineering department of the information about new product or existing product modification. Engineering department is in charge of tracking and updating all technical documents and drawings and informing other industrial teams & Quality Department convenient for the implementation of these modifications in production. 有关新产品研发或现有产品的更新信息,由研发部或法国的 研发中心通知设计部。设计部负责跟踪并更新所有的技术文 件和图纸,并通知其他工业化部门和质量部,以便执行。 According to the requirements of China CompulsoryCertification (CCC), any modification involved in products which may impact the product safety performance will get the approval of certificate body or the technical representative before implementation. 根据中国强制性产品认证要求,任何可能有产品安全方面的 影响的变更,在执行之前,必须获得相关认证机构或技术负 责人的批准。7.3.2 Design and development inputs 设计和开发的输入Help you make the most of your energy打印文件不受控!53 / 86 质量管理手册 Quality Management ManualQMM-001 Rev. C7.3.2.1 Inputs related to product requirements shall be determined and recorded 应确定与产品要求有关的输入并保持记录 7.3.2.2 These inputs shall include 这些输入应包括: a) function requirements, 产品性能要求 b) applicable statutory, regulatory and standard requirements, 适用的法律法规要求 c) where applicable, information derived from previous similar design 适用时,来源于以前类似设计的信息 d) Other requirements essential for design and development. 设计和开发所必须的其他要求 7.3.2.3 The input shall be reviewed for adequacy. The requirement shall be complete, unambiguous and not conflict with each other. 应对这些输入的充分性及适宜性进行评审,要求应完整、清楚,并 且不能自相矛盾。 7.3.3 Design and development outputs 设计和开发的输出 7.3.3.1 The outputs of design and development shall be in a form suitable for verification against the design and development input and shall be approved prior to release. 设计和开发输出的方式应适合于对照设计和开发的输入进行验 证,并在放行前得到批准。 7.3.3.2 Design and development outputs shall 设计和开发的输出包括以下内容: a) Meet the input requirements of design and developmentHelp you make the most of your energy打印文件不受控!54 / 86 质量管理手册 Quality Management ManualQMM-001 Rev. C满足设计和开发输入的要求 b) provide appropriate information for purchasing, productions and service, 给出采购、生产和服务提供的适当信息 c) contain product acceptance criteria, and 包含或引用产品接受准则。 d) Specify the characteristics of the product that are essential to its safe and proper operation. 规定对产品的安全和正常适用所必须的产品特性。 7.3.4 Design and development review 设计和开发评审 7.3.4.1 At suitable stages, systematic reviews of design and development shall be performed in accordance with planned, so as to 依据策划,在适宜阶段对设计和开发进行系统的评审,以便: a) Evaluate if the results of design and development can fulfill requirements 评价设计和开发的结果满足要求的能力。 b) Identify any problems and propose necessary actions. 识别任何问题并提出必要的措施。 7.3.4.2 Participants in such reviews shall include representatives involved in the design and development. 评审的参加者包括与所评审的设计和开发阶段有关的职能的代 表。Help you make the most of your energy打印文件不受控!55 / 86 质量管理手册 Quality Management ManualQMM-001 Rev. C7.3.4.3 The review result and any necessary actions shall be recorded 评审结果及任何必要的措施的记录应予保持。 7.3.5 Design and development verification 设计和开发验证 7.3.5.1 Verification shall be performed according to the planned arrangements to ensure that the design and development outputs can meet the input requirements. 依据策划的安排, 对设计和开发进行验证, 确保设计和开发的输 出满足输入的要求。 7.3.5.2 The verification result and necessary actions shall be recorded 验证结果及任何必要的措施的记录应予保持。7.3.6 Design and development validation 设计和开发确认 7.3.6.1 According to the planned arrangements, design and development validation shall be performed to ensure that the final product can meet the requirements for the specified application or expected use. 依据策划的安排, 对设计和开发进行确认, 确保产品能够满足规 定的使用要求或已知的预期用途的要求。 7.3.6.2 The verification result and necessary actions shall be recorded 确认结果及任何必要的措施的记录应予保持。7.3.7 Control of design and development changes 设计和开发更改的控制Help you make the most of your energy打印文件不受控!56 / 86 质量管理手册 Quality Management ManualQMM-001 Rev. C7.3.7.1 Design and development changes shall be identified and recorded. The changes shall be reviewed, verified and approved before implementation. The review of design and development changes shall include evaluation of the effect that the changes have on constituent parts and products already delivered. 设计和开发的更改应被识别并保持记录 设计和开发的更改在实施前应被适当的评审、 验证、 确认并得到 批准 。设计和开发更改的评审应包括评价更改对产品组成部分 和已交付产品的影响。 7.3.7.2 The review result and any necessary actions shall be recorded 更改的评审结果及任何必要的措施的记录应予保持 7.3.8 Related documents 相关文件 No. 1 2 3 4 5 Document(PRO-RD-001) 《Control Procedure of Design and Development/设计和 开发控制程序》 (PRO-RD-002) 《Control Procedure of Product Evolution/产品持续改进控 制程序》 (PRO-TE-001) 《DESIGN PROCESS/设计流程》(PRO-TE-002) 《Customer Demand Mechanical Design Procedure》(PRO-TE-002) 《SEEE PEP process execution handbook/SEEE PEP 执行 手册》Help you make the most of your energy打印文件不受控!57 / 86 质量管理手册 Quality Management ManualQMM-001 Rev. C7.4 Purchasing 采购 7.4.1 Purchasing process 采购过程 Purchasing department and supply chain department shall carry out the purchasing according to (purchasing control procedure) to ensure that the purchased product conforms to specified purchase requirements. The type and extent of control applied to the supplier and the purchased product shall be dependent upon the effect of the purchased product on subsequent product realization or the final product. 采购部和供应链按《采购控制程序》实施采购,以确保采购的产品符 合规定的采购要求。对供方及采购的产品控制类型和程度应取决于采 购的产品对随后的产品实现或最终产品的影响。 Purchasing Department is the owner of the purchasing and supplier management process. Supplier Quality Management team are the supporters for supplier selection, validations, audits and quality improvement. Supplier and Supply Quality Management (Abbr. SSQM) system from Schneider Electric Corporation is the guideline for supplier management, selection and assessment of suppliers, which covers Supplier Assessment Management (SAM), Supplier Qualification Management (SQM), Supplier Performance Management (SPM). SEEE will evaluate and select suppliers based on their ability to supply product in accordanceHelp you make the most of your energy打印文件不受控!58 / 86 质量管理手册 Quality Management ManualQMM-001 Rev. Cwith Schneider ’s requirements for selection, evaluation and re-evaluation. Records of the results of evaluations and any necessary actions arising from the evaluation shall be maintained. 采购部是采购和供应商管理的负责部门。SQE 团队负责支持供应商的 选择、确认、审核和质量改善。SEEE 根据集团统一的《供应商认证管 理流程》-SAM\SQM\SPM 来确定选择、评价和重新评价供方的准则, 根据供方按公司要求提供产品和服务的能力选择、评价和再评价供方。 评价结果及评价所引发的必要措施应记录并予以保持. 7.4.2 Purchasing information shall clearly describe the product to be purchased, including: 采购信息应明确表述拟采购产品的信息,包括: a) Requirements for approval of product, procedures, processes and equipment, b) Requirements for qualification of personnel, and c) Quality management system requirements. a) 产品技术质量或服务、程序、过程和设备批准的要求; b) 人员资格的要求; c) 质量管理体系的要求。 SEEE shall ensure the adequacy of specified purchase requirements prior toHelp you make the most of your energy打印文件不受控!59 / 86 质量管理手册 Quality Management ManualQMM-001 Rev. Cthe communication to the supplier. SEEE 在与供方沟通之前,需确保规定的采购要求时充分与适宜的。 7.4.3 Verification of purchased products 采购产品的验证 SEEE shall compile and implement in-coming inspection and testing requirements to ensure that purchased product meets specified purchase requirements. Although the verification is conducted at SEEE side, if necessary, SEEE or customer intends to perform verification at the supplier’ a documented verification procedure or method shall be released in the purchasing information. 公司应确定并实施进料检验或试验,以确保采购的产品满足规定的采 购要求。虽然,产品的验证在公司内执行,如果有需要,公司或顾客 也可在供方的现场实施验证,但应在采购信息中对验证的安排和产品 放行的方法作出规定。 7.4.4 Related document 相关文件 No. 1 2 Document(PRO-PUR-002) 《Purchasing procedure/采购程序》(PRO-ME-001) 《Maintenance of Industrial Equipment/工业设备的管理 及校核》Help you make the most of your energy打印文件不受控!60 / 86 质量管理手册 Quality Management ManualQMM-001 Rev. C7.5 Production and service provision生产和服务提供 7.5.1 Control of production and service provision 生产和服务提供的控制 SEEE supply chain department and workshop departments will carry out production and service by controlling the following: 本公司供应链管理部和生产部门通过以下方面对生产和服务提供进行 控制: a. attain the information that describes the characteristics of the product, 通过技术文件、规范、图纸等获得表述产品特性的信息; b. attain the work instructions for product assembling, 获得产品装配工艺规程等作业指导书; c. the use of suitable equipment,, the availability and use of monitoring and measuring equipment, 使用满足生产要求的设备及工装、夹具等,通过维护、保 养等手段保持其满足要求; d. the implementation of monitoring and measurement, and 获得和使用合适的监视和测量设备,对生产和服务(包括 特殊过程)实施监视和测量;Help you make the most of your energy打印文件不受控!61 / 86 质量管理手册 Quality Management ManualQMM-001 Rev. Ce. theimplementationofproductrelease,deliveryandpost-delivery activities. 产品放行, 交付和交付后活动的实施----质量部按规定实施 成品放行,供应链管理部实施产品的交付,项目部对交付 后活动进行控制,保证放行或交付的产品满足顾客的要 求。 7.5.2 Validation of processes for production and service provision 生产和服务提 供的过程确认 7.5.2.1 We shall validate any process for production and services provision where resulting output cannot be verified by subsequent monitoring or measurement and as consequence, defi

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