【体系文件】APISpecQ19th质量管理手册（修订-2015-825张）上海******有限公司 Shanghai** *., Ltd. 质量手册 QUALITY MANUAL (根据API规范Q1:第9版) (According to the API Spec Q1:9th) 文件编号：CY/QM01-2014 Document Number: CY/QM01-2014 版本（Rev）：B/0 0.1 质量手册颁布令0.1 Policy Proclamation of QM质量手册发布令 Policy Proclamation Quality Manual 本公司依据API Spec Q1 9th，并结合公司实际情况建立了质量管理体系，编制了B/0版《质量手册》，现予以批准发布,本手册在2014年5月15日正实施。 本手册是本公司贯彻质量方针、实现质量目标和指导本公司建立、实施质量管理体系并持续改进其有效性的纲领性文件，是实施质量活动的行动准则。我以总经理的名义要求全体员工必须严格遵守执行。 本《质量手册》是我厂质量管理体系运行的依据，也是全体、员工的行为规范，体现了本企业对顾客的承诺。 自本手册实施之日起，要求全体员工充分理解、正确执行公司的质量方针，严格按照《质量手册》的要求落实在质量责任，开展质量管理活动，满足合同要求及顾客期望，达到顾客满意。 This Quality Manual (CY/QM01-2014 B/0) is formulated in accordance with API Spec Q1 9th Specification for Quality Programs, together with the actual conditions of our Company. It is now ratified and shall be implemented since MAY.15,2014 This manual is a program document of the quality management system of the Company, which gives guidance to carry out quality policy, achieve quality objective and establish, implement and improve quality management system. It is also a criterion for the company to build such quality management system. All staff must strictly executes the regulations specified in the quality system documents, and continually improves the effectiveness of quality management system. 总经理： G M: May.10,2014 0.2 目 录0.2 Contents0.0 文件修定记录 1 0.0 Changed record of QM 1 0.1 质量手册颁布令 2 0.1 Policy Proclamation of QM 2 0.2 目 录 3 0.2 Contents 3 0.3 企业简价 7 0.3 Company Profile 7 0.4 质量管理体系组织构图 8 0.4 Organization Chart Quality Management System 8 0.5 品管职责系统 9 0.5 Quality Assurance Department Responsibility 9 0.6 质量管理体系职能分配表 9 0.6 Duty Authority Chart for Management System 10 0.7 质量方针和质量目标批准令 10 0.7 Proclamation of Quality Policy and Quality Objective 11 0.8 管理者代表任命书 11 0.8 Assignment of Management Representative 12 1 范围 12 1 Scope 13 2.0 引用标准 13 2.0 Normative reference 14 3.0 主要术语和定义 14 3.0 Terms and Definitions 15 4.0 质量管理体系要求 15 4.0 Quality Management System Requirements 16 4.1 质量管理体系 16 4.1 Quality Management System 16 4.2 管理职责 18 4.2 Management Responsibility 18 4.3 组织能力 19 4.3 Organization Capability 19 4.4 文件要求 21 4.4 Documentation Requirements 21 4.5 记录控制 24 4.5 Control of Records 24 5.0 产品实现 24 5.0 Product Realization 25 5.1 合同评审 25 5.1 Contract Review 25 5.2 策划 26 5.2 Planning 26 5.3 风险评估和管理 28 5.3 Risk Assessment and Management 28 5.4 设计开发 29 5.4 Design and Development 29 5.5 应急计划 33 5.5 Contingency Planning 33 5.6 采购 33 5.6 Purchasing 33 5.7 生产和服务提供 36 5.7 Production and Servicing Provision 36 5.8 监视、测量和试验设备的控制 44 5.8 Control of Testing, Measuring, and Monitoring Equipment 44 5.9 产品放行 46 5.9 Product Release 46 5.10 不合格品控制 46 5.10 Control of Nonconforming Product 46 5.11 变更管理（MOC） 48 5.11 Management of Change (MOC) 48 6.0 质量管理体系监视、测量、分析和改进 49 6.0 Quality Management System Monitoring, Measurement, Analysis, and Improvement 50 6.1 总则 50 6.1 General 50 6.2 监视，测量和改进 50 6.2 Monitoring, Measuring, and Improving 50 6.3 数据分析 52 6.3 Analysis of Data 53 6.4 改进 53 6.4 Improvement 53 6.5 管理评审 55 6.5 Management Review 55 附录A API会标程序 57 Annex A Use of API Monogram by Licensees 58 Annex B Procedure List 58 0.3 企业简价0.3 Company ProfileShangHai ChengYi Valve Co., Ltd is located at YieXie industrial zone, is an enterprise that collects products science researching, developing, designing, producing and selling into one organ. 上海****有限公司位于叶榭工业区，是集产品科研、开发设计、生产、销售为一体的企业。 The company carries out ISO 9001 international quality system standard strictly and owns digital control processing center, big-size vertical lathe, milling machine and ion arc resurfacing welding equipments. There are also material chemical analysis and of mechanical property testing room, penetration inspection, spectral analysis and various testing. Besides, the company also established CAD valve design center and new products developing center. 公司严格执行ISO 9001国际质量体系标准,拥有数控加工中心、大型立车、铣床和等离子弧堆焊设备。还有化学材料分析室,物理性能实验室、渗透检验、光谱分析和各种测试。除此之外,公司还建立了CAD阀门设计中心和三维固体模拟生产设计系统和新产品开发中心。 The company takes “CREDIT AND QUALITY FIRST” as the strategy idea, successively research and develop high temperature hard airproof ball valve, high pressure forging ball valve, high pressure gate valve, globe valve ,check valve, double eccentric ball valve, V ball valve, whole welding buried ball valve, butterfly valve, generating plant valve and such one series high-new products. The materials are mainly WCB, LCB, WC6, C9, ZGCr5Mo, ZG15Cr1Mo1V, CF8, CF8M, CF3M, 12Cr18Ni9Ti, ZG1Cr18Ni12Mo2Ti etc”. The drive manner of annual, electro motion, liquid operated, pneumatic and electric-liquid operated are adopted; the nominal diameter is from DN10~DN1000mm, NPS3/8~NPS40; The work pressure is from 0.6~40.0Mpa, Class 150~2500Lb; The design and manufacturing standard is according to notational standard, American standard, Japanese standard and Germany standard, and non-standard can be designed according to customers’ requirement. The products has completed specification, credible performance and nice appearance, which is widely used to petrifaction, melting, electric power, paper making, pharmacy, city construction and such industries, welcomed by vast customers. 公司以“诚信天下，一心做好产品”为战略理念,先后研发出高温硬密封球阀、高压锻造球阀、高压闸阀,截止阀,止回阀,双偏心球阀、V型球阀、全焊接埋地球阀,蝶阀,电站阀等一系列高新产品。材料主要有WCB,LCB、WC6 C9,ZGCr5Mo,ZG15Cr1Mo1V、CF8,CF8M、CF3M,12 ZG1Cr18Ni12Mo2Ti等”。采用手动、电动、液动,气动和电液动等多种驱动方式;公称通径从DN10 ~ DN1000mm,NPS3/8 ~ NPS40;工作压力从0.6 ~ 40.0 mpa,150 ~ 2500磅;设计和制造标准按国标、美标、日标、德标，也可以根据客户的要求进行各种非标产品设计。产品规格齐全，性能可靠，外形美观，广泛用于石化，冶炼，电力，造纸，制药，城市建设等行业，深受广大客户的信赖和好评。 We still insist: quality is the base for existence, efficient is the foundation for development, credit is the guarantee for standing, and satisfaction is our basic pursuing, and we also take “Completed system, innovation, exploiting, satisfaction and refulgence creation” as the guideline, Sincerely provide more excellent service for old and new customers. 公司本着：品质使我们生存的根本、效益是我们发展的基础、信誉是我们立足的保障、满意是我们基本的追求！以“健全体系、务实开拓、顾客满意、共创辉煌”为方针。竭诚为新老用户提供更优良的服务！ 0.4 Organization Chart Quality Management System0.5 品管职责系统0.5 Quality Assurance Department Responsibility0.6 质量管理体系职能分配表0.6 Duty Authority Chart for Management System
0.7 质量方针和质量目标批准令0.7 Proclamation of Quality Policy and Quality Objective0.7.1 质量方针 0.7.1 Quality policy: 质量高于一切，信誉就是生命，持续改进产品质量，确保顾客满意。 Quality First, Credit is life, Continuous improvement, Client Satisfaction 本质量方针内涵为： The intension of the Quality policy 明确企业追求的目标，为达成顾客满意，持续改进公司的质量管理体系，设计理念，生产流程。 严格遵守标准规范，保证产品安全。 Clear out our pursuit target, and in order to reach the customers' satisfaction. All staff shall be continually improves the effectiveness of quality management system, design & development and production processes, and meet the regulations specified in the quality system and product standard & specifications to supply customer the safety products. 实现企业追求目标的途径是：以最佳的理念，建立最佳的管理组织，运用科学的管理方法，不断吸收国内外同类产品的优点，以智能系统工程为发展方向，使公司产品更趋完美。 The way of realizing the pursuit target of the Arita is: By the best philosophy, set up the best management organization; By the scientific management method, constantly absorb the advantage of the similar products at world; By the development direction with engineering of intelligent systems, make our products more perfect. 以质量为生命，信誉为根本。不断提高、不断创新，以满足不同顾客的需求，赢得广阔市场，使星承产品走向世界 。 Quality as vital, Reputation as a fundamental; Continually innovate to satisfy the different customers' requirements, then win the huge market, make Arita's products be internationally recognized and expect to be in a leading position. 0.7.2 质量目标 0.7.2 Quality Objectives 1.The satisfaction rate of customers over 92%. 顾客满意度超过92%。 2.The first qualified rate of finished-product over 98%; 成品一次交验合格率超过98% 3.The qualitified rate of finished-product leave the factory reaches 100%. 出厂产品合格率达到100%。 总经理： GM: May.10,2014 0.8 管理者代表任命书0.8 Assignment of Management Representative任命书 Assignment 为了贯彻执行标准API Spec Q1第九版，加强对质量管理体系运作的领导，持续改善本手册和公司的质量管理体系。 In order to implement API Spec Q1:9th strength QMS operation and successful performance and ongoing improvement of this manual and all the quality system in this company. 我在此任命张久展为我公司的管理者代表，负责提升公司质量管理系统，以达成顾客满意。 I hereby appoint Mr. Zhang JIUZHANas Management Representative , to be responsible for the task of upgrading the company’s quality to meet full satisfaction of the customers. 管理者代表的职责： The Responsibility of M.R as follows: 1．确保质量管理体系的过程得到建立、实施和保持； 1．Ensuring that processes needed for the quality management system are established, implemented, improved and maintained; 2．向总经理报告质量管理体系的业绩和任何改进的需求； 2．Reporting to top management on the performance of the quality management system and any need for improvement; 3．确保在整个公司内提高满足顾客要求的意识； 3．Ensuring the promoting the awareness of customer requirements throughout the organization; 4．定期组织内部质量管理体系审核，监督纠正和预防措施的实施情况； 4．Arranging the internal audit, monitoring the implementation of corrective and preventive measurement; 5．负责代表本公司就质量管理体系有关事宜与外部联络。包括认证机构的选择和沟通。 5．Liaising with external parties on matters relating to the quality management system, including the select for the certification agency. 总经理： GM: May.10,2014 1 范围1 Scope1.1 总则 1.1 General A.确保本公司能够稳定地提供满足顾客和适用的法律法规要求的产品； A. Have ability to consistently provide product that meets customer and applicable regulatory requirements B.通过本质量管理体系的有效应用，包括体系的持续改进的过程以及保证符合顾客与适用的法律法规要求，以增强顾客满意。 B. Aims to enhance customer satisfaction through the effective application of the system, including processes for continual improvement of the system and the assurance of conformity to customer and applicable regulatory requirements 本手册所依据标准API Spec Q1 9th规定了本公司的质量管理体系要求，用于石油、石化及天然气工业产品（阀门产品）的设计、开发、制造。 This QM according to API Spec Q1 defines the quality management system requirements for the design, development, manufacture of Valve products for the petroleum, petrochemical and natural gas industries. 1.2 删减 1.2 Exclusions 根据本公司生产情况，本公司对API Spec Q1 9th -5.7.1.2 标准中的条款进行删减。 In accordance with the actual situation of misduts，The clauses 5.7.1.2 of Api Q1(9th) is exclusions . 2.0 引用标准2.0 Normative referenceGB/T19000-2008idtISO9000：2005 质量管理体系—基础和术语 ISO 9000:2008 Quality Management System --- Fundamentals and Vocabulary. GB/T19001-2008idtISO9001：2008 质量管理体系—要求 ISO 9001:2008 Quality Management System --- Requirements. GB/T19004-2008idtISO9004：2008 质量管理体系—业绩改进指南 ISO 9004:2008 Quality Management System ---Guidelines for Performance Improvements, API Spec Q1 9th :2013 API质量纲要规范 第九版 API Spec Q1 9th :2013--Specification for Quality Programs for the Petroleum, Petrochemical and Natural Gas Industry, Ninth Edition, 2013 3.0 主要术语和定义3.0 Terms and Definitions3.1 本手册采用ISO9000：2008--质量管理体系—基础和术语和API Spec Q1 9th中的术语和定义。 3.1 The manual adopts terms and definitions given in ISO9000:2008 Quality Management System --- Fundamentals and Vocabulary and API Spec Q1 9th :2013-- Specification for Quality Programs for the Petroleum, Petrochemical and Natural Gas Industry, Ninth Edition, 2013 4.0 质量管理体系要求4.0 Quality Management System Requirements4.1 质量管理体系4.1 Quality Management System4.1.1 总要求 4.1..1 General 公司按API Spec Q1 9th要求，采用过程方法建立质量管理体系，形成文件，加以实施和保持并持续改进和测量其有效性。提供满足顾客要求，符合产品法律法规要求的产品，以实现顾客、社会、员工及满意。公司质量部具体负责组织质量体系的建立和实施。 The company shall establish, document, implement and maintain a quality management system and continually improve its effectiveness in accordance with the requirements of API Spec Q1 9th, provide product that meets customer and applicable regulatory requirements , realize costumer society employee satisfaction. The Q.A. department shall responsible for establishing, implementing, and maintaining the quality management system. 4.1.2 质量方针 4.1.2 Quality policy 总经理以文件形式制定并批准本公司的质量方针。总经理在年度管理评审时对质量方针进行评审，以保证其适合组织，是质量目标发展的基础，并在所有组织内相关职能和各阶层进行沟通、理解、实施和保持。本公司质量方针包括遵守标准要求和持续改善质量管理体系有效性的承诺。 The general manager shall define, document, and approve the quality policy, and review the quality policy at the management review meeting, to ensure that it is appropriate to the organization, is the basis for the development of quality objectives (see 4.1.3), and is communicated, understood, implemented, and maintained at all relevant functions and levels within the organization. The policy shall include a commitment to comply with requirements and continually improve the effectiveness of the quality management system. 公司质量方针为: 质量高于一切，信誉就是生命，持续改进产品质量，确保顾客满意。 The company Quality Policy as follows:Quality First, Credit is life, Continuous improvement, Client Satisfaction 4.1.3 质量目标 4.1.3 Quality Objectives 公司制定《管理策划控制程序》对质量目标进行策化，保证质量目标符合产品和顾客的需求，保证质量目标是建立在组织内部相关职能和层面上。公司的质量目标是可测量并且和质量方针保持一致。公司的质量目标由总经理批准。 The company shall establish and maintain the “Management planning control program”, control of the quality objectives, ensure that quality objectives, including those needed to meet product and customer requirements, are established at relevant functions and levels within the organization. The quality objectives shall be measurable and consistent with the quality policy. The general manager approved the quality objectives. 4.1.4 策化 4.1.4 Planning 总经理对本公司的质量管理体系进行策划，并确保： the General Manager plans the quality management system to ensure that: a) 运行和控制质量管理体系的准则和方法是明确有效的； a) criteria and methods needed for the operation and control of all quality management system processes are determined, managed, and effective; and b) 执行质量管理体系策划是为了满足本规范的中规定的要求； b) planning of the quality management system is carried out in order to meet the requirements of this specification 公司建立并保持《管理策划控制程序》，实施对质量管理体系策划的控制。 The company shall establish and maintain the “Management planning control program”. The company’s quality management system planning control is described in it, 公司策划过程可用下图表示： and implement it as follows:  4.1.5 沟通 4.1.5 Communication 4.1.5.1 内部沟通 4.1.5.1 Internal 公司应建立并保持适宜的《内外部沟通控制程序》，确保质量管理体系的有效性得到沟通： a）符合顾客，法律和其他适宜要求的重要性在组织内部得到交流和沟通； b）数据分析的结果在组织内部得到沟通； The company shall establish and maintain the appropriate “Internal and External Communication Control Procedure”, ensure the effectiveness of the quality management system is communicated. a) importance of meeting customer, legal, and other applicable requirements is communicated at relevant functions within the organization; and b) results of analysis of data (see 6.3) are communicated at relevant levels and functions within the organization. 4.1.5.2 外部沟通 4.1.5.2 External 为了与外部及顾客的交流，确保有合同履行与产品实现过程中正确的理解规范要求，公司制定了《内外部沟通控制程序》，对以下外部沟通进行控制； The company shall establish and maintain the “Internal and External Communication Control Procedure” for communicating with external organizations, including customers, to ensure requirements are understood throughout contract execution and product realization. The communication process shall address: a）相关顾客要求，合同或订单的处理和变更的执行情况； b）产品信息的提供，包括产品被提交给顾客后被确认的不合格； c）顾客的反馈和抱怨； d）当合同有要求时，提供相关的质量计划，所要求的信息以及后续更改的信息。 a) execution of inquiries, contracts, or order handling and amendments (see 5.1); b) provision of product information, including product nonconformities identified after delivery to the customer (see 5.10.4); c) feedback and customer complaints (see 6.2.1); and d) when required by contract, providing information required by product quality plans and subsequent changes to those plans (see 5.7.2). 4.2 管理职责4.2 Management Responsibility4.1.1 总则 4.1.1 General 总经理应提供有效的基本资源，以保证建立、实施、保持和改进质量管理体系。 注：资源包括：人力资源、特种技术、组织基础设施、财政资源和技术。 总经理应提供以下证据来改进和实施质量体系有效性： a）确保建立质量目标，包括用于数据分析的关键绩效指标(KPI)； b）实施管理评审 The General Manager shall ensure the availability of resources essential to establish, implement, maintain, and improve the quality management system. NOTE: Resources can include human resources and specialized skills, organizational infrastructure, financial resources, and technology. Management shall provide evidence of its commitment to the development and implementation of the quality management system and continually improve its effectiveness by: a) ensuring that quality objectives are established including key performance indicators (kpi )for use in data analysis; and b) conducting management reviews (see 6.5). 4.2.2 职责和权限 4.2.2 Responsibility and Authority 公司建立并保持《职责和权限程序》，确保各部门的职责和权限及其相互关系得到规定和沟通。总经理实施对人员职责和权限的管理。 The company shall establish and maintain the “Responsibilities and authority control procedures”, define and communicate functions and their interrelations within the company, including responsibilities and authorities, in order to facilitate effective quality management. The General Manager implements it 4.2.3 管理者代表 4.2.3 Management Representative 公司总经理任命副总经理为管理者代表，管理者代表实行以下职责和权限： a) 确保质量管制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) 确保采取的措施减小不符合项发生的可能性； d) 确保在整个组织提高满足顾客要求的意识。 The General Manager shall appoint Vice-G.M who, shall have responsibility and authority that includes： a) ensuring that 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; c) ensuring initiation of action(s) to minimize the likelihood of the occurrence of nonconformities (see6.4.3); and d) ensuring the promotion of awareness of customer requirements throughout the organization. 4.3 组织能力4.3 Organization Capability4.3.1 资源的提供 4.3.1 Provision of Resources 公司应确定和分配实施、保持及改进质量管理体系要求的有效性所需的资源。 The company shall determine and allocate the resources needed to implement, maintain, and improve the effectiveness of the requirements of the quality management system. 4.3.2 人力资源 4.3.2 Human Resources 4.3.2.1 总则 4.3.2.1 General 公司制定并执行《人力资源控制程序》，根据组织机构图，确定从事影响产品质量工作人员所必要的能力要求并识别培训要求，或采取其它措施，以达到与质量管理体系有关的员工所必需的能力。程序包括确定和记录所进行的、针对达到所需能力的培训或其它活动的有效性条款。 The company shall establish and maintain the “Human Resource Control Procedure” , according to Organization Chart of Quality Management System, for defining personnel competency and identifying training requirements or other actions to achieve the necessary competency of personnel whose responsibilities fall within the scope of the quality management system. The procedure shall include provisions for determining and documenting the effectiveness of the training or other actions taken toward the achievement of required competency. 4.3.2.2 人员能力 4.3.2.2 Personnel Competence 公司行政部对质量管理体系内所有相关员工包括在岗员工、新进员工和转岗员工提供培训和考核，以保证基于满足产品和顾客要求所需的适当的教育、培训、技能及经经验的人员应是胜任的。 人员能力评价的证据记录应保持。 The human dept provide job training for personnel in any contract or new or modified job affecting product quality. Personnel shall competent based on the appropriate education, training, skill, and experience needed to meet product and customer requirements. Evidence of determination of competence of personnel shall recorded and maintained (see 4.5). 4.3.2.3 培训和意识 4.3.2.3 Training and Awareness 公司应： a) 提供质量管理体系培训及技能培训； b) 若有需求，培训项目应包括客户的特定培训后客户提供的培训； c) 确定培训的内容后频次； d) 确保员工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) 根据法律及相关要求确定并提供培训； f) 保持教育、培训、技能和经验的适当记录。 The organization shall: a) provide for quality management system training and job training; b) ensure that customer-specified training and/or customer-provided training, when required, is included in the training program; c) ensure that the frequency and content of training is identified; d) ensure that its personnel are aware of the relevance and importance of their activities and how they contribute to the achievement of the quality objectives; and e) maintain appropriate records of education, training, skills, and experience (see 4.5). 4.3.3 工作环境 公司制定并保持《设施和工作环境控制程序》，生产部确定、提供、管理并保持为达到产品制造适用的符合性所需的工作环境。工作环境应包括： a）建筑物、工作场所和相关的公工共设施； b）工艺设备及其维护（硬件和软件）（见5.7.8）； c）支持性服务（如：交通、通讯、信息系统）； d）实施工作的条件，包括物质、环境以及其他因素。 4.3.3 Working environment The company shall establish and maintain the “procedure for control infrastructure and work environment” The Manufacturing Dept. shall determine, provide, manage, and maintain the work environment needed to achieve conformity applicable to the manufacture of the product. Work environment shall include： a) buildings, workspace, and associated utilities; b) process equipment and its maintenance (both hardware and software) (see 5.7.8); c) supporting services (e.g. transport, communication, information systems); and d) conditions under which work is performed such as physical, environmental, or other factors. 4.4 文件要求4.4 Documentation Requirements4.4.1 总则 4.4.1 General 本公司质量管理体系文件包括： The quality management system documentation of organization shall include: a)形成文件的质量方针（见本手册0.4章节）和质量目标（见《管理策划控制程序》）； a) statements of quality (see 0.4) and quality objectives (see “Management planning control program”) b)质量手册，质量手册包括下列内容： b) a quality manual that addresses each requirement of this specification and includes: 1）质量管理体系的范围，包括任何删减细节与合理性（见1 章节） 2）对质量管理体系过程之间的顺序和相互作用的描述，见下图 3）公司应该识别需要验证的过程（见本手册5.7.1.5章节），公司这些过程包括：无损检测 4）对为控制质量管理体系过程而形成的文件化程序的引用。 1) the scope of the quality management system, including justification for any exclusions to specific quality management system elements (see Section 1); 2) a description of the sequence and interaction between the processes of the quality management system; see figure below; 3) The company shall indicate the processes that require validation (see 5.7.1.5), The processes of company is NDE; 4) reference to documented procedures that control the quality management system processes.
c)针对质量管理体系制定文件化程序，公司建立的质量系统文件包括 c) documented procedures established for the quality management system, that include
d）确保质量管理休系过程的有效策划、行动、控制以及符合要求的文件和记录； d) documents and records to ensure the effective planning, operation, and control of its processes and compliance with specified requirements; and e）实现产品符合性所需要的法律、法规和其它要求。 e) identification of legal and other applicable requirements to which the organization claims compliance that are needed to achieve product conformity. 4.4.2 程序 4.4.2 Procedures 公司建立了API Spec Q1 9th中涉及的所有程序，形成文件并实施和保持，使其持续适宜。 All procedures referenced within API Spec Q1 9th shall be established, documented, implemented, and maintained for continued suitability. 4.4.3 文件控制 4.4.3 Control of documents 4.4.3.1 通用要求 4.4.3.1 General A）文件控制是管理所有针对文件的行为：编制、审核、批准、识别和作废等。公司建立《文件控制程序》文件和资料进行控制。 A) Document control is the management the all activities of document edit, review, approve, issue, use, change, re-approve, identified, obsolete etc. The company shall establish and maintain the “Document and data control procedure” B) 须建立文件控制总清单或相当的文件控制程序，以确保： B) A master list or equivalent control feature shall be used to: a)识别质理管理系统所需的文件及文件的修订状态； b)有效防止使用失效和/或作废的文件。 a) identify the documents required by the quality management system, and their current revision status; b) prevent the misuse of obsolete documents. 4.4.3.2 文件批准和发布 4.4.3.2 approve, issue 质量手册和程序文件由总经理批准发布，作业指导书和检验规范由管理者代表批准发布。 General Manager approve the issue of quality manual and procedure, Management Representative approve the issue of the working instruction and inspection specification. 文件控制应包含改下内容： Control of documents shall include: a)文件发布前得到批准； b)必要时评审和更新文件并重新批准； c)文件的变更、现行版本状态得到标识； d)适用文件的相应版本在使用处的有效性； e)文件清晰，易读易查； f)外来文件得到识别，分发得到控制； g)防止非预期使用作废文件，因任何原因保留的作废文件应适当标志； h)应保证质量管理体系要求的文件、作业指导书、表单受控。 a) To approve documents for adequacy prior to issue; b) To review an 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 are identified and their distribution controlled; g) To prevent the unintended use of obsolete documents, and to apply suitable identification to them if they are retained for any purpose; h) To ensure that that Procedures, work instructions, and forms required by the quality management system shall be controlled. 4.4.4 外来文件在产品实现中的使用 4.4.4 Use of External Documents in Product Realization When API product or other external specification requirements, including addenda, errata, and updates, are used in the design or manufacture of the product, the organization shall maintain a documented procedure for the integration of these requirements into the product realization process and any other affected processes. 4.5 记录控制4.5 Control of Records本公司建立、实施并保持记录，以提供符合要求和质量管理体系有效运行的证据。记录应保持清晰，易于识别和检索。公司建立并保持《质量记录控制程序》，以规定记录的标识，贮存，保护，检索，保存期限及处置所需的控制。并对质量体系记录的收集和保持的相关职责进行识别。 适用的工业产品标准所要求的记录，应保持不少于工业标准规定的时间周期或10年，甚至更长。 为符合要求和证实质量管理体系有效性提供证据的所规定的记录，保存期限应不少于5年。 质量部负责记录控制的管理工作，各职能部门按《质量记录控制程序》要求实施。 The company shall establish and maintain records to provide evidence of conformity to requirements and of the effective operation of the quality management system. Records shall remain legible, readily identifiable and retrievable. The “Quality record control procedure”, has established to define the controls needed for the identification, storage, protection, retrieval, retention time and disposition of records. The Q.A. Dept. accordance with this documented procedure shall responsible for the collection and maintenance of records. Records required by applicable industry product standards shall be retained for not less than the time period specified by the industry standard or five years, whichever is longer. Records required to provide evidence of conformity to requirements and of the effective operation of the quality management system shall be retained for a minimum of five year. The Quality Dept. is responsible for the management of records control, all function Departments implement it per the “Quality record control procedure” 5.0 产品实现5.0 Product Realization5.1 合同评审5.1 Contract Review5.1.1 总则 5.1.1 General 销售部应建立《与顾客有关的过程控制程序》组织相关部门进行产品和服务的相关规定要求的评审. The Marketing Dept shall establish and maintain the “Process related to control procedure” for the review of requirements related to the provision of products and required servicing. 5.1.2 要求的确定 5.1.2 Determination of Requirements 公司建立并保持《与顾客有关的过程控制程序》，对顾客的产品要求进行识别和确认，以提供满足顾客要求的产品，不断增强顾客和相关方满意。对与产品有关的要求主要确定如下内容： a）顾客规定的要求； b）与产品有关的法律法规，安全技术规范，技术条件要求； c）顾客虽然没有明示，但规定的用途/已知的预期用途所必需的要求。 若顾客提供的要求没有形成文件，公司在接受顾客要求前应对顾客要求进行确认，并保持记录。 The sale Dept. shall determine: a) requirements specified by the customer; b) legal and other applicable requirements; and c) requirements not stated by the customer but considered necessary by the organization for the provision of the product. Where the customer provides no documented statement of the requirements, the customer requirements shall be confirmed by the organization and records maintained (see 4.5). 5.1.3 要求的评审 5.1.3 Review of Requirements 销售部组织相关部门和人员按《与顾客有关的过程控制程序》评审与产品有关的要求。评审应在公司向顾客做出提供产品的承诺之前进行（如：提交标书、接受合同或订单及接受合同或订单的更改），以确保： The sale Dept. shall organize related department and personnel to review the requirements related to the product, including API 609 and/or API 6D requirements, in accordance with the “Process related to control procedure”. This review shall be conducted prior to the company’s 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: a) 产品要求得到规定； b) 与以前表述不一致的合同或订单的要求已予解决； c) 组织有能力满足规定的要求。 a) Product requirements are defined; b) Contract or order requirements differing from those previously expressed are resolved; c) The organization has the ability to meet the defined requirements. 若产品要求发生变更，公司应确保相关文件（如质量计划、设计文件、工艺规程等）得到修改，并确保相关人员知道已变更的要求。 销售部记录并保持评审结果及评审所引起的措施。 Where product requirements are changed, the organization shall ensure that relevant documents (such as quality plan, design documents, and technique procedure) are amended and that relevant personnel are made aware of the changed requirements Records of the results of the review and actions arising from the review shall be maintained by The Marketing Dept. (see 4.5). 5.2 策划5.2 Planning公司应建立《产品实现策划控制程序》，技术部应识别和策划产品实现所需的过程和文件。产品实现策化的要求应与质量管理体系其他过程的要求一致（见4.1.4）。 The company shall establish and maintain the “Procedure for Control of Planning of Product Realization” The Tech.Dept.. shall plan and develop the process needed for product realization. Planning of product realization shall be consistent with the requirements of the other processes of the quality management system (see 4.1.4); 策划时，组织应确定以下内容： In planning, the organization shall address the following: a）所需的资源和工作环境的管理（见4.3）； b）产品要求及顾客指定的要求（见4.3）； c）法律法规及其他适用的要求； d）基于风险评估的意外事件（见5.3和5.5）； e）设计与开发要求（见5.4）； f）针对产品所需的验证、确认、监视、测量、检验和试验活动，以及产品接收准则； g）管理变理（MOC）（见5.11）； h）证明产品实现过程满足要求所需的记录（见4.5）。 a) required resources and work environment management (see 4.3); b) product and customer-specified requirements (see 5.1); c) legal and other applicable requirements; d) contingencies based on risk assessment (see 5.3 and 5.5); e) design and development requirements (see 5.4); f) required verification, validation, monitoring, measurement, inspection, and test activities specific to the product and the criteria for product acceptance; g) management of change (MOC) (see 5.11); and h) records needed to provide evidence that the product realization processes meet requirements (see 4.5). 策化的输出应文件化，并随更改的出现而更新。策划应保持适于组织运营方式的结构。 The output of planning shall be documented and updated as changes occur. The plans shall be maintained in a structure suitable for the organization's method of operations. Planning processes of Product realizing as follows：       Related product realization process as follows 5.3 风险评估和管理5.3 Risk Assessment and Management公司应建立和执行《风险评估和管理控制程序》来识别和控制产品在交付和质量方面的风险，对产品交付的风险评估应包括： The company shall establish maintain the “Risk Assessment and Management Control Procedure” to identify and control risk associated with impact on delivery and quality of product. The procedure shall identify the techniques, tools and their application for risk identification, assessment, and mitigation. Risk assessment associated with product delivery shall include: a)交付中的实施、设备实用性和维护性； b)供方业绩和材料可用性提供。 适用时，对产品质量的风险评估应包括： c)不合格品的交付； d)人员能力的有效性。 a) facility/equipment availability and maintenance; and b) supplier performance and material availability/supply. Risk assessment associated with product quality shall include, as applicable: c) delivery of nonconforming product (see 5.10.1); d) availability of competent personnel. 注：1）风险评估可包括对风险发生的可难性、检测方法以及严重程度的考量。 2）风险评估的输出可用建立应急预案（见5.5） 3）风险评估可以是与纠正措施及预防措施相关的活动。 NOTE：1) Risk assessment can include consideration of severity, detection methods, and probability of occurrence. 2) The output of risk assessment may be used in the development of contingency plans (see 5.5). 3) Risk assessment can be an activity associated with corrective and/or preventive action. 在风险评估过程中所生产的记录（包括采用的纠正和预防）应予以保存。 Records of risk assessment and management including actions taken shall be maintained (see 4.5) 5.4 设计开发5.4 Design and Development5.4.1 设计开发的策划 5.4.1 Design and Development Inputs 公司建立并保持《设计和开发控制程序》，技术部实施对产品的设计和开发进行策划和控制。在进行设计和开发策划时，技术部应确定： The company shall establish and maintain the “Procedure for control of Design and Development”; The Tech.Dept.. shall plan and control the design and development of product in accordance with this procedure. During the design and development planning, the Tech.Dept.. shall determine and control: a）用于设计开发的计划，包括计划的更新； b）设计和开发过程阶段； c）资源、职责、权限及工作接口以确保有效沟通； d）完成每个设计和开发阶段改要的评审、验证和确认活动； e）设计最终评审的要求。 a) the plan(s), including plan updates, used for design development; b) the design and development stages; c) the resources, responsibilities, authorities, and their interfaces to ensure effective communication; d) the review, verification, and validation activities necessary to complete each design and development stage; and e) the requirements for a final review of the design (see 5.4.5). 当设计开发活动在公司内部不同地点进行时，程序应明确控制要求以确保设计符合5.4规定 当设计和开发外包时，公司应确保供方满足5.6.1.6的要求。 When design and development activities are performed at different locations within the same organization, the procedure shall identify the controls required to ensure that the designs meet the requirements of 5.4. When design and development are outsourced, the organization shall ensure the supplier meets the requirements of 5.6.1.6. 5.4.2 设计和开发输入 5.4.2 Design and Development Input 技术部应对输入信息的适当性、完整性和一致性进行确认和评审： Inputs shall be identified and reviewed for adequacy, completeness, and lack of conflict, by the Tech.Dept.. 如适用，输入应包括功能要求和技术要求，以及如下的要求 If applicable, the input of design shall include the function and technical requirements, and other requirements as follows: a）顾客确定的要求（见5.1）； b）相关外部资源要求，包括API产品规范,如API6D 、API608； c）产品的环境和操作条件； d）方法、假设条件、公式和计算； e）以前类似设计提供的信息； f）适用的法律、法规要求； g）设计和开发所必需的其他要求； h）设计输入应包括顾客规定的要求。 a) customer-specified requirements (see 5.1); b) requirements provided from external sources, including API product specifications; c) environmental and operational conditions; d) methodology, assumptions, and formulae documentation; e) historical performance and other information derived from previous similar designs; f) legal requirements; and g) results from risk assessments (see 5.3). 技术部应对这些输入进行评审，以确保输入是充分与适宜的且完整、清楚，没有自相矛盾之处。技术部应确定、形成文件并评审产品设计输入的要求，且应考虑合同评审的结果。 These inputs shall be reviewed for adequacy by the Tech.Dept.. to ensure requirements complete, unambiguous and not in conflict with each other. The Tech.Dept.. shall identify, document and review the product design input requirements, and consider the result of contract review. 5.4.3 设计和开发输出 5.4.3. Design and Development Output 技术部应将设计和开发输出形成文件，且以能够针对设计和开发输入进行验证的方式提出，并应在发放前得到总经理批准。应保持设计输出的记录。 The Tech.Dept.. shall documents the Design and Development Output. The outputs of design and development shall be provided in a form that enables verification against the design and development input and shall be approved by GM prior to release. 技术部应确保设计和开发输出满足以下要求： The Tech.Dept.. shall ensure design and development meets the following requirements: a）满足设计和开发输入的要求（见7.3.2）； b）给出采购、生产和服务提供的适当信息； c）包含或引用产品接收准则(DAC)； d）包括对设计至关重要的产品和/或组年的识别或引用； e）包括适用的计算结果； f）规定对产品的安全和正常使用所必需的产品特性； a) meet the input requirements for design and development; b) provide appropriate information for purchasing, production, and servicing; c) identify or reference design acceptance criteria (DAC); d) include identification of, or reference to, products and/or components deemed critical to the design; e) include results of applicable calculations; and f) specify the characteristics of the product that are essential for its safe and proper use. 5.4.4 设计和开发评审 5.4.4 Design and Development Review 在适宜的阶段，技术部应依据所策划的安排组织相关部门和人员对设计和开发进行系统的评审，以便： a)评价设计和开发的结果的适宜性、充分性和有效必，及满足要求的能力； b)识别任何问题并提出必要的措施； 评审的参加者应包括与所评审的设计和开发阶段有关的职能部门的代表。 技术部应记录应予以保持评审结果及任何必要措施的记录（见4.5）。 At suitable stages, the Tech.Dept.. shall organize relevant department and personnel to perform the systematic reviews of design and development in accordance with planned arrangements a) To evaluate the ability of the results of design and development to meet requirements b) To identify any problems and propose necessary actions Participants in such reviews shall include representatives of functions concerned with the design and development stages being reviewed. Records of the results of the reviews and any necessary actions shall be maintained by the Tech.Dept.. (see 4.5). 5.4.5 设计开发验证和最终评审 5.4.5 Design and Development Verification and Final Review 为确保设计和开发的输出满足输入的要求，技术部应依据所策划的安排（见5.4.1）对设计和开发进行验证和最终评审，并保持验证和评审结果及任何必要措施的记录（见4.5）。通常包括以下内容： Verification and final review shall be performed by the Tech.Dept.. in accordance with planned arrangements (see 5.4.1) to ensure that the design and development outputs have met the design and development input requirements. And maintain records of the results of the verification and any necessary actions (see 4.5). Include one or more of the following: a）输入要求与输出结果进行比较； b）通过变换方法进行计算，来证明设计结果的准确性； c）将新设计与已证实的类似设计进行比较。 a) comparing the input and output; b) confirming the accuracy of design results through the performance of alternative calculations; c) Comparing new design to similar proven designs. 5.4.6 设计和开发确认和批准 5.4.6 Comparing new design to similar proven designs 为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，技术部应依据所策划的安排（见7.3.1）对设计和开发进行确认，并形成文件。只要可行，技术部应在产品交付或实施之前完成确认。技术部应保持确认结果及任何必要措施的记录（见4.5）。最终设计批准人应是与设计项目无关的人员。 Design and development validation shall be performed and filed by the Tech.Dept.. in accordance with planned arrangements (see 4.5) to ensure that the resulting product is capable of meeting the requirements for the specified application or intended use, where known. Wherever practicable, validation shall be completed prior to the delivery or implementation of the product by the Tech.Dept.. records of the results of validation and any necessary actions shall be maintained (see 4.2.4) 设计确认可包括以下一种或多种： Design validation can include one or more of the following: a) 标准试验； b) 试制产品功能和/或运转试验； c) 工业标准和/或法规规定的试验； d) 现场操作试验和评审； a) Prototype tests b) Functional and/or operational tests of mass production product c) Tests specified by industry standards and/or regulatory requirements d) Field performance tests and reviews. 5.4.7 设计和开发更改的控制 5.4.7 Design and Development Changes 技术部应建立并保持《设计开发控制程序》识别设计和开发的更改，并保持记录。技术部应对设计和开发的更改进行评审、验证和确认，并在实施前得到总经理批准。在进行设计和开发更改的评审时，技术部应评价更改对产品组成部分和已交付产品的影响。 技术部应保持更改的评审结果及任何必要措施的记录（见4.2.4）。 设计和开发的更改包括设计文件的更改，应满足和最初原设计开发以及设计证据资料一样的控制要求。 The Tech.Dept.. shall establish and maintain the “Procedure for control of Design and Development ” Design and development changes shall be identified and records maintained by the Tech.Dept.. in accordance with this procedure. The changes shall be reviewed, verified and validated, as appropriate by the Tech.Dept.. and approved before implementation. When review the design and development changes, the Tech.Dept.. shall evaluate the effect of the changes on constituent parts and product already delivered. Records of the result of the review of changes and any necessary actions shall be maintained (see 4.2.4) Design and development changes including changes to design documents, shall require the same controls as original design and development, and design documentation. 5.5 应急计划5.5 Contingency Planning5.5.1 总则 5.5.1 General 公司应制定和执行《应急计划控制程序》，根据风险分析评估的结果制定相应的应急计划，采取有效地措施减少或避免出现产品的交付影响和不合格品。 The company shall establish and maintain the “Contingency Planning Control Procedure” for contingency planning needed to address risk associated with impact on delivery and quality of product. Contingency planning shall be based on assessed risks (see 5.3), and output shall be documented and communicated to the relevant personnel and updated as required. 5.5.2 应急计划输出 5.5.2 Planning Output 应急计划的输出应形成文件和及时更新，同时应转达到相关的应急小组成员，应急计划输出包括； Contingency planning shall be based on assessed risks (see 5.3), and output shall be documented and communicated to the relevant personnel and updated as required. The contingency plan shall include, at a minimum a)相对于重大风险场景下所采取的措施应减轻被破坏事件的影响； b)确定相关的职责和权限，成立应急小组，任命负责人和成员； c)内外部应保持沟通，保证信息畅通。 应保存应急计划实施记录 a) actions required in response to significant risk scenarios to mitigate effects of disruptive incidents; b) identification and assignment of responsibilities and authorities; and c) internal and external communication controls (see 4.1.5). Records of the result of the Contingency planning shall be maintained (see 4.2.4). 5.6 采购5.6 Purchasing5.6.1 采购控制 5.6.1 Purchasing Control 5.6.1.1 程序 5.6.1.1 Procedure 公司应建立和保持《采购控制程序》，确保采购的产品和外包的活动得以控制，满足规定的要求.。程序包括： The company shall establish maintain the “Purchasing Control Procedure” to ensure that purchased products or outsourced activities conform to specified requirements. The procedure shall address: a）活动或产品适用于符合的产品或顾客规范时，确定其关键性； b）供方的首次评估和选择应基于供方提供产品或活动的能力； c）控制供方的类型或范围基于产品或活动的关键特性； d）确定供方再评估的准则、范围和频次以及方法； e）保存供方批准和范围批准的清单； f）外包活动的类型和范围的控制。 a) determination of the criticality of the activities or products as they are applicable to conformance to product or customer specifications; b) initial evaluation and selection of suppliers based on their ability to supply products or activities in accordance with the organization's requirements (see 5.6.1.2 and 5.6.1.3); c) type and extent of control applied to the supplier based on the criticality of the product or activity; d) criteria, scope, frequency, and methods for reassessment of suppliers; e) maintaining a list of approved suppliers and scope of approval; and f) type and extent of control to be applied to outsourced activities (see 5.6.1.6). 5.6.1.2供应商初次评估-关键采购 5.6.1.2 Initial Supplier Evaluation—Critical Purchases 对于关键产品、零件或生产过程的采购，由采购部会同质量部必要时汇同技术部对供应商进行初次评估，对供方初次评估准则应视每个供方的现场具体确定，应包括以下内容 For purchase of critical products, components or activities, the criteria for the initial evaluation of suppliers by the Purchasing Dept, the Q.A Dept and the R&D Dept (in necessary) shall be site-specific for each supplier and shall include the following: a）供方的质量管理体系验证，应符合公司规定的质量体系要求； b）评审供方并确保按企业要求提供合格产品能力； 1）实施相关活动的场所评估； 2）实施首次样机检验确保符合声明的要求； 3）当受到所有权、法律或契约安排的限制，应表明怎样使供方质量满足声明的要求； a) verification that the supplier’s quality management system conforms to the quality system requirements specified for suppliers by the organization; and b) assessment of the supplier to ensure its capability to meet the organization’s purchasing requirements by: i) performing an on-site evaluation of relevant activities, or ii) performing first article inspection to ensure conformance to stated requirements, or iii) identifying how the supplied product conforms to stated requirements when limited by proprietary, legal, and/or contractual arrangements. 5.6.1.3 供应商初次评估-非关键采购 5.6.1.3 Initial Supplier Evaluation—Noncritical Purchases 对于非关键产品、零件或生产过程的采购，由采购部必要时会同质量部和技术部对供应商进行初次评估，评估准则应满足5.6.1.2或满足下列一项或多项内容: For purchase of noncritical products, components, or activities that impact product realization or the final product, the criteria for evaluation of suppliers by the Purchasing Dept, the Q.A Dept and the R&D Dept (in necessary) shall meet the requirements of 5.6.1.2 or satisfy one or more of the following: a）供方的质量管理体系验证应符合公司规定的质量体系要求； b）符合采购要求的供方评估； c）产品交付或活动完成能力的评估。 a) verification that the supplier’s quality management system conforms to the quality system requirements specified for suppliers by the organization; or b) assessment of the supplier to meet the organization’s purchasing requirements; or c) assessment of the product upon delivery or activity upon completion. 5.6.1.4 供应商再次评估 5.6.1.4 Supplier Reevaluation 公司规定按照5.6.1.3章节要求，每年对相对应的供应商进行一次评估，确保采购的产品能满足公司规定要求。 Supplier evaluation will be performed once a year, the requirements of 5.6.1.3 shall apply. 5.6.1.5 供应商评估记录 5.6.1.5 Supplier Evaluation—Records 采购部应做好供方的首次评估和年度评估记录且予以保存。 Records of the results of all evaluations and any necessary actions arising from the evaluations shall be maintained (see 4.5) by the Purchasing Dept. 5.6.1.6 外包 5.6.1.6 Outsourcing 当公司选择外包其质量管理体系中的任何活动时，应确保其质量管理体系中所有适用的要素被满足，并且对产品符合规定的要求，包括与产品实现相关的适用的API产品规范，承担其责任。 Where the company chooses to outsource any activity within the scope of its quality management system, the company shall ensure that all applicable elements of its quality management system are satisfied and shall maintain responsibility for product conformance to specified requirements, including applicable API product specifications, associated with product realization. 公司规定无损探伤为外包过程，公司制定并保持《采购控制程序》这些外包进行控制，外包的记录应予以保存。 The Non-destructive Examination is outsourced process in our company. The company has established and maintained the “Purchase Control Procedure” Control of such outsourced processes Records of outsourced activities shall be maintained (see 4.5). 5.6.2 采购信息 5.6.2 Purchasing Information 采购部在与供方沟通前应确保规定的采购信息的充分性。提供给供方的采购信息应形成文件，并充分描述采购的产品或服务，包括接收准则，适当时要包括： The Purchasing Dept shall ensure the adequacy of specified purchasing information prior to their communication to the supplier. Purchasing information provided to the supplier shall be documented and adequately describe the product or activity to be purchased, including acceptance criteria, and where appropriate: a）对供应商程序、工艺和设备的批准要求； b）适用版本的规范、图纸、过程要求、检验指南、可追溯性以及其他相关技术数据； c）人员资格的要求； d)质量管理体系要求。 a) requirements for approval of supplier’s procedures, processes, and equipment; b) applicable version of specifications, drawings, process requirements, inspection instructions, traceability, and other relevant technical data; c) requirements for qualification of supplier’s personnel; and d) quality management system requirements. 5.6.3 采购产品或活动的验证 5.6.3 Verification of Purchased Products or Activities 质量部应建立和执行《过程和产品的监视和测量程序》, 确保采购的产品和活动符合规定的采购的要求，检验记录应维持和保存。 The Quality Dept. shall establish and maintain the “Procedure for monitoring and measurement for procedures and product” for the verification or other activities necessary for ensuring that purchased products or activities meet specified purchase requirements。The Quality Dept. shall maintain records of verification activities (see 4.5). 如果公司或顾客要求在供应商的场所进行检验，采购部应和供应商就检验安排和产品放行方法达成一致。 Where the company or its customer intends to perform verification at the supplier’s premises, The Marketing Dept and the purchasing Dept shall state the intended verification arrangements and method of product release in the purchasing information. 5.7 生产和服务提供5.7 Production and Servicing Provision5.7.1 生产和服务的控制 5.7.1 Control of Production and Servicing 5.7.1.1 生产 5.7.1.1 Production 生产部建立和实施《生产和服务提供控制程序》。应保证各项工作活动处于受控状态，建立并保持必要的作业文件，以平价过程能力发现潜在的问题，并制定相应的措施，该程序应包括； The Manufacture Dept shall establish and maintain the “Production and service provision control procedures”. The Manufacture Dept plans and describes the control of production and service activities performed, ensuring the provision of production and service under control. The procedure shall address the following: a）工艺文件上规定产品的特性； b）当需要时，执行产品质量计划（见5.7.2）； c）适用时，确保设计要求及相关变更得到满足（见5.4）； d）使用适宜的生产、试验、监视和测量设备并保持使用性； e）适宜的作业指导书； f）工艺控制文件（见5.7.1.3）； g）实施监视和测量活动； h）实施产品放行（见5.9），包括交付和交付后的活动。 a) the availability of information that describes the characteristics of the product; b) implementation of the product quality plan, when applicable (see 5.7.2); c) ensuring design requirements and related changes are satisfied, when applicable (see 5.4); d) the availability and use of suitable production, testing, monitoring, and measurement equipment; e) the availability of work instructions, when applicable; f) process control documents (see 5.7.1.3); g) implementation of monitoring and measurement activities; and h) implementation of product release (see 5.9), including applicable delivery and post-delivery activities. 5.7.1.2 服务 5.7.1.2 Servicing 不适用 N/A 5.7.1.3 过程控制文件 5.7.1.3 Process Control Documents 过程控制应按工艺路线，转移卡，过程卡片或其他控制点形成编制文件并包括检验符合质量策划（见5.7.2），控制点和参考标准、API产品规范和顾客的要求，过程控制文件包括或参照有关工序，试验，检验和顾客规定的停检或见证点所用的说明书，制造工艺和验收准则。 Process controls shall be documented in routings, travelers, checklists, process sheets, or equivalent controls required by The Manufacture Dept and shall include requirements for verifying conformance with applicable product quality plans (see 5.7.2), API product specifications, customer requirements, and/or other applicable product standards/codes. The process control documents shall include or reference instructions and acceptance criteria for processes, tests, inspections, and required customer’s inspection hold or witness points. 5.7.1.4 产品实现能力文件 5.7.1.4 Product Realization Capability Documentation 公司应编制和保持产品实现过程文件和评估、验证、确认、监视、测量、检验和试验活动的见证记录，同时包括公司有能力满足产品及服务要求的产品按接收标准。 注：产品实现文件是公司有能力制造产品或系列产品的证据，并不涵盖每个工作订单工制造的单个产品。 The company shall develop and maintain documentation that includes but is not limited to product realization plans (see 5.2) and records of review/verification, validation, monitoring, measurement, inspection, and test activities, including criteria for product acceptance that demonstrates the capability of the organization to satisfy specified product and/or servicing requirements. NOTE：Product realization documentation is evidence of the capability of the organization to manufacture products or families of products and does not extend to every work order or individual product manufactured. 5.7.1.5 生产和服务过程确认 5.7.1.5 Validation of Processes for Production and Servicing 当生产和服务提供过程的输出不能由后续的监视或测量加以验证时，质量部应对任何这样的过程实施确认。公司建立并保持《生产和服务提供控制程序》，由质量部主导实施对生产和服务提供的人员资格和特殊过程的确认,包括要求确认的外包过程也要按此要求进行确认。这也包括在产品使用或服务已交付之后问题才显现的过程。质量部应通过确认证实这些过程能圆满实现所策划的安排。 质量部应对这些过程做出安排，适用时包括; The Quality Dept. shall validate any processes for production and service provision where the resulting output cannot be verified by subsequent monitoring or measurement. The company shall establish and maintain the “Production and service provision control procedures”, The Q.A Dept implements the validation of personnel qualification and special processes for production and service provision. Where the company chooses to outsource a process that requires validation, the organization shall require that the supplier conform to these requirements (see 5.6.1.6). This includes any processes where deficiencies become apparent only after the product is in use or the service has been delivered. The Quality Dept. shall validate and demonstrate the ability of these processes to achieve planned results. The Quality Dept. shall establish arrangements for these processes including, as applicable a）为过程的评审和批准所规定的准则； b）设备的认可和人员资格的鉴定； c）使用特定的方法和程序； d）记录的要求《见记录控制》； e）再确认。 a) Define criteria for review and approval of processes; b) Approval of equipment and qualification of personnel; c) Use of specified methods and procedure; d) Requirements for records (see 4.2.4); e) Revalidation. 公司必须按要求确认适用的产品规范识别的需确认的过程，本公司的特殊过程是：焊接，热处理，无损探伤，技术部应其过程按《生产和服务提供控制程序》进行确认。在生产过程中应对其进行连续监控，确保符合规定要求。 The organization shall validate those processes identified by the applicable product specification as requiring validation. Our special processes are heat treatment, welding and NDE The Q.A Dept shall validate and implement these special processes accordance with the “Production and service provision control procedures”, and to ensure and keep control with these requirements and procedures. 5.7.2 产品质量计划 5.7.2 Product Quality Plans 若合同规定，组织应开展产品质量计划来详细规定质量管理体系过程，（包括产品实现过程）及产品应用的资源，公司建立并保持《产品实现策划控制程序》，产品质量计划应至少包括： When required by contract, the organization shall develop a product quality plan that specifies the processes of the quality management system (including the product realization processes) and the resources to be applied to a product. The company shall establish and maintain the “ Product Realization Plan Control Procedure”. The product quality plan required by contract shall address each of the following as a minimum: a）生产产品描述； b）要求的过程及文件，包括记录； c）控制外包活动的识别参考； d）每项活动中所使用参考的过程、规定或其它文件的识别； e）所需持有，证据，监视及文件评审关键点的识别。 a) description of the product to be manufactured; b) required processes and documentation, including required inspections, tests, and records, for conformance with requirements; c) identification and reference to control of outsourced activities; d) identification of each procedure, specification, or other document referenced or used in each activity; and e) identification of the required hold, witness, monitor, and document review points. 该质量计划及其它任何校订都应该存档并得到公司及客户的批准，质量计划及其修订版应该传达给顾客。 These product quality plans and any revisions to them shall be documented and approved by the organization to ensure customer requirements are met. These product quality plans and any revisions shall be communicated to the customer. 注1：一个产品质量计划可以包含一个或几个不同的文件。 注2：产品质量计划有时有其他的说法，如：质量计划（QP）、检验与试验计划（ITP）、制造过程规范（MPS）、过程控制计划（PCP）、质量活动计划（QAP），而且会经常引用质量手册或者程序文件的部分内容。 NOTE 1: A product quality plan may be comprised of one or several different documents. NOTE 2: A product quality plan is sometimes referred by other terms—such as quality plan (QP), inspection and test plan (ITP), manufacturing process specification (MPS), process control plan (PCP), and quality activity plan (QAP)— and often makes references to parts of the quality manual or to procedure documents. 5.7.3 标识和可追溯性 5.7.3 Identification and Traceability 公司建立并保持实施《生产和服务提供控制程序》。适用时，生产部应在产品实现的全过程使用中适宜的方法识别产品。生产部应针对监视和测量要求识别产品的状态。在有可追溯性要求的场合，生产部应控制并记录产品的唯一性标识。 The company shall establish and maintain the “Production and service provision control procedures”. Where appropriate, the manufacture Dept shall identify the product by suitable means throughout product realization. The manufacture Dept shall identify the product status with respect to monitoring and measurement requirements Where traceability is a requirement, The Manufacture Dept shall control and record the unique identification of the product. 生产部应确保与API 6D、API608要求有关的承压件材料和产品，从接收到最终试验得到适当的标识和追溯。对主要承压件应保持材料炉批号标识，必要时，对产品应以产品系列号予以标识。 The manufacture Dept shall ensure to get the identification and trace-ability of API 6D or API608 relevant material and product from the final test. The products shall be marked by the serial number when necessary. 公司应按自身，顾客和采用产品规范要求制定合适的产品标识和可追溯性控制特征。标识和可追溯性的要求适用于接收，生产，交付和安装的所有阶段。控制特征应包括标识和可追溯性标志及记录的保持和更换要求 生产部应按《生产和服务提供控制程序》建立产品状态标识的控制特征及其可追溯性。 标识和可追溯性的记录应保持（见4.5）。 The company shall establish control features for identification and traceability of the product by suitable means from receipt and during all stages of production, delivery and installation, as required by the company, the customer, and the applicable product specifications. Control features shall include requirements for maintenance or replacement of identification and traceability marks, and records. The manufacture Dept shall establish control features for the identification of product status, according to the “Production and service provision control procedures”. Records (see 4.5) of identification and traceability shall be maintained 5.7.4 产品检验/试验状态 5.7.4 Product Inspection/Test Status 质量部应建立和保持《生产和服务提供控制程序》，标明整个产品实现过程中的合格和不合格状态，必须确保产品符合规定的要求下放行或在授权让步情况下放行。 The Q.A Dept shall establish and maintain the “Production and service provision control procedures” for the identification of product inspection and/or test status throughout the product realization process that indicates the conformity or nonconformity of product with respect to inspections and/or tests performed. The Q.A Dept shall ensure that only product that meets requirements or that is authorized under concession (see 5.10.3), is released. 检验状态是指：待检、合格、报废、返修。 Inspection status include: waiting for inspection, qualified, scrap, rework, 5.7.5 顾客财产 5.7.5 Customer property 公司建立并保持实施《生产和服务提供控制程序》，确保在本公司控制下或使用的顾客财产得到爱护，并识别、验证、保护和维护供其使用或构成产品一部分的顾客财产，包括知识产权。若顾客财产发生丢失、损失或发现不适用的情况时，销售部应报告顾客，并保持记录。 The company shall establish and maintain the “Production and service provision control procedures”. The Marketing Dept shall exercise care with customer property while it is under the company’s control or being used by the company. The company shall identify, verify, protect and safeguard customer property provided for use or incorporation into the product. If any customer proper is lost, damaged or otherwise found to be unsuitable for use, this shall be reported to the customer and records maintained 5.7.6 产品防护 5.7.6 Preservation of Product 5.7.6.1 总则 5.7.6.1 General 生产部应建立并保持实施《生产和服务提供控制程序》，以规定在公司内部处理和交付到预定的地点期间，公司应针对产品的符合性提供防护，这种防护应包括标识、搬运、包装、贮存和保护，且适用于产品的组成部分。 The Manufacture Dept shall establish and maintain the “Production and service provision control procedures”, and preserve the conformity of product during internal processing and delivery to the intended destination. This preservation shall include identification, handling, packaging, storage and protection. Preservation also applies to the constituent parts of a product. 5.7.6.2 贮存与评估 5.7.6.2 Storage and Assessment 生产和服务提供控制程序应识别贮存和评估的要求，公司应使用指定的贮存区域或库房以防止产品损坏或变形、暂停使用或发运。 为发现变异，应按照程序规定，定期对库存产品或组件的状态进行评估。时间间隔应适于评估的产品或组件。 评估结果的记录应予以保持。 The “Production and service provision control procedures” shall identify the requirements for storage and assessment. The organization shall use designated storage areas or stock rooms to prevent damage or deterioration of product, pending use or delivery. In order to detect deterioration, the condition of product or constituent parts in stock shall be assessed at specified intervals identified by the procedure. The interval shall be appropriate to the products or constituent parts being assessed. Records of the results of assessments shall be maintained (see 4.5). 程序应规定以下内容 The procedure shall address the following: a) 生产部负责执行产品防护控制程序； b）生产部应根据产品特点和客户合同要求，明确搬运、贮存、包装、防护的方法； c）生产部分别提供为防止产品在生产中和已交付产品损坏、碰伤或变质的方法和手段； d）生产部提供安全贮存产品的场地或仓库，以防止产品在使用前或交付前的损坏、碰伤等，并按规定期限检查库存产品状况和保存条件（保存期限），及时发现不合格产品出现； e）规定采用尽可能缩短库存物资周转时间和确保库存周转的库房管理制度，保证物资的“先进先出”； f）生产部根据客户对产品的合同要求，应提供特殊的运输和包装防护方法； g）生产部对完工的产品进行适当的包装，并在外包装上做好标记，使用防护和隔离存放的合适方法。 The company shall use an inventory management system to optimize inventory turns over time and assure stock rotation, such as “first-in-first-out” FIFO a) The manufacture dept is in charge of the implementation of “procedure for control of product preservation”; b) The manufacture dept define the method of handling, storage, packaging, and preservation, in accordance with the product characteristics and contract requirements; b) The manufacture dept shall provide method for the prevention of product damage, scratch and loss in the process of production and delivery; d) The manufacture dept provides warehouses and storage areas for safe storage to prevent products from damage, scratch and so on before the usage and delivery; and inspect the storage product condition and preservative term to prevent the nonconformity; e) The company shall use an inventory management system to optimize inventory turns over time and assure stock rotation, such as “first-in-first-out” FIFO; f) The manufacture dept shall provide method for special transportation and package, in accordance with the contract requirements; g) The manufacture dept shall provide appropriate package for the finished products, make marks on the package, and use the ways of protection and isolation storage. 5.7.7 检验和试验 5.7.7 Inspection and Testing 5.7.7.1 总则 5.7.7.1 General 质量部建立并保持《过程和产品的监视和测量程序》,实施对产品的特性进行监视和测量，以验证产品要求已得到满足。产品的监视和测量应在产品实现过程的适当阶段依据所策划的安排进行，这些活动可包括采购产品的验证、工序产品的监视和测量、最终产品的监视和测量。应保持检验和实验的记录。 The company shall establish and maintain the “monitoring and measur controe Procedure for procedures and products ”,The Quality Dept. shall monitor and measure the characteristics of the product to verify that product requirements have been met. This shall be carried out at appropriate stages of the product realization processes in accordance with the planned arrangements. These actions shall include: the verification of purchasing products, the in-process inspection and testing of technique products, the in-process inspection and testing of final products. Records of required inspection and testing shall be maintained per documented procedures (see 4.5) 5.7.7.2 生产过程中的检验和试验 5.7.7.2 In-process Inspection and Testing 公司应依据产品质量计划（见5.7.2），过程控制文件（见5.7.1.3），和/或文件化的程序，按照计划的阶段检验和试验产品。符合接收准则的证据应予以保持。 The organization shall inspect and test the product at planned stages as required by the product quality plan (see 5.7.2), process control documents (see 5.7.1.3), and/or documented procedures. Evidence of conformity with the acceptance criteria shall be maintained. 5.7.3 最终检验与试验 5.7.3 Final Inspection and Testing 公应依据产品质量计划（见5.7.2）和/或文件化的程序实施所有最终检验，以证明最终产品的确认文件能证明产品是符合规定要求的。 最终的接收和产品的放行应由与材料生产或产品生产的操作或直接监督无关的人员来执行。品检员进行产品的最终检验和放行。 质量部应保存符合接收准则的证据。产品的监视和测量记录应指明有权放行产品的人员。 The organization shall perform all final inspection and testing in accordance with the product quality plan (see 5.7.2) and/or documented procedures to validate and document conformity of the finished product to the specified requirements. Personnel other than those who performed or directly supervised the production of the product shall perform final acceptance inspection at planned stages of the product realization process. The Q.A. Personnel shall perform final acceptance and product release. The Quality Dept. shall maintain the evidence of conformity with the acceptance criteria. Records shall indicate the persons authorizing release of product 5.7.8 预防维护 5.7.8 Preventive Maintenance 生产部应建立《设施和工作环境控制程序》，确定和提供和维护符合产品实现过程中要求的设备的维护，生产部负责生产设备的维修、维护和其它管理。程序规定以下内容 a)要求维护的设备的型号； b)设备的维护频率； c)负责维护的人员。 预防性维护的记录应予以保存。 注：预防性维护可以以风险、系统可靠性、使用历史、经验、工业推荐活动、相关规范和标准、原始设备生产指南或应用要求进行制定和实施。 The Production Dept. shall establish and maintain the “Infrastructare and work environment control procedure” for the establishment of preventive maintenance for equipment used in product realization. The procedure shall identify requirements for: a) type of equipment to be maintained; b) frequency; and c) responsible personnel. Records of preventive maintenance shall be maintained (see 4.5). NOTE: Preventive maintenance can be based on risk, system reliability, usage history, experience, industry recommended practices, relevant codes and standards, original equipment manufacturer’s guidelines, or other applicable requirements. 5.8 监视、测量和试验设备的控制5.8 Control of Testing, Measuring, and Monitoring Equipment公司建立并保持《监视和测量装置控制程序》，质量部确定需实施的监视和测量以及所需的监视和测量装置，规定装置类型、唯一性标识、使用场合、检查频次、检查方法和可接收准则，控制、校准和维护监视和测量装置，以确保监视和测量活动可行并以与监视和测量的要求相一致的方式实施，为产品符合确定的要求提供证据。 The company shall establish and maintain the “Procedure for control of Monitoring and Measuring Devices”. The Quality Dept. shall determine the monitoring and measurement to be undertaken and define the device type, unique identification, location, frequency of checks, checks method, and acceptance criteria and control, calibrate and maintain monitoring and measuring devices to ensure that monitoring and measurement can be carried out and are carried out in a manner that is consistent with the monitoring and measurement requirements. The monitoring and measuring devices needed to provide evidence of conformity of product to determined requirements Where necessary to ensure valid results measuring equipment shall: 程序应包括以下内容： The procedure shall include requirements for the specific equipment type that addresses: a）设备唯一标识； b）可识别的校准状态； c）对照能溯源到国际或国家标准的测量标准，按照规定的时间间隔或在使用前进行校准或检定。当不存在上述标准时，应记录校准或检定的依据（见4.5）； d）检定/校准的频率，在规定的时间间隔或在使用前； e）检定/校准的方法，包括进行调整或必要时再调整； f）接收准则； g）为防止非预期使用，对检定不合格的设备要进行标识； h）当发现设备不符合要求时，质量部应按此程序对以往测量结果的有效性进行评价和记录。质量部应对该设备和任何受影响的产品采取适当的措施。质量部保存校准和验证结果的记录。 a) unique identifier; b) calibration status; c) equipment traceability to international or national measurement standards; where no such standards exist, the basis used for calibration or verification shall be recorded (see 4.5); d) frequency of calibration, at specific intervals or prior to use; e) calibration or verification method, including adjustments and readjustments, as necessary; f) acceptance criteria; g) control of equipment identified as out-of-calibration in order to prevent unintended use; and h) when the equipment is found to be out of calibration, an assessment of the validity of previous measurements and actions to be taken on the equipment and product, including maintaining records 监视、测量和试验设备应受到以下控制 Testing, measuring, and monitoring equipment shall: a）根据测量标准进行检定或校准； 注1：对照指定的接收准则，对不可调整的设备实施校准。 b）针对所有实施的活动，具备用户可识别的校准状态； b）防止可能使测量结果失效的调整； c）在搬运、维护和贮存期间防止损坏或失效； d）应确保实施校准、检验、测量和试验相适应的环境条件。 a) be calibrated or verified, or both, against measurement standards; NOTE 1: Verification against identified acceptance criteria is performed on nonadjustable equipment. b) have the calibration status identifiable by the user for the activities being performed at all times; c) be safeguarded from adjustments that would invalidate the measurement result or the calibration status; d) be protected from damage and deterioration during handling, maintenance, and storage; and e) be used under environmental conditions that are suitable for the calibrations, inspections, measurements, and tests being carried out. 当计算机软件用于规定要求的监视和测量时，质量部应确认其满足预期用途的能力。确认应在初次使用前进行，必要时再确认。 注2：对专利测量设备的适用性的验证以及其对5.8要求符合性的证据可能会受到合同或会标协议的限制，但是，会标持有者需要出示合同给予的限制以符合5.8 c)、5.8 e)和5.8 f) 的要求。 When used in the monitoring and measurement of specified requirements, the ability of computer software to satisfy the intended application shall be confirmed by The Q.A. Dept, this shall be undertaken prior to initial use and reconfirmed as necessary NOTE 2: Verification of the suitability of proprietary measurement equipment and evidence of its conformity to the requirements of 5.8 may be limited by contract or licensing agreement; however, the licensee is required to demonstrate the limitations imposed by the contract in order to meet 5.8 c), 5.8 d), 5.8 e), and 5.8 f). 当设备由公司外部资源提供时，包括第三方、专利持有者、雇员和顾客所有的设备，公司应验证设备适合并提供满足本条要求的证据。 When the equipment is provided from a source external to the organization, including third-party, proprietary, employee- and customer-owned equipment, the organization shall verify that the equipment is suitable and provide evidence of conformity to the requirements of this section. 公司必须登记用于确定产品符合性所需的试验，测量和监视设备，且予以唯一标识，特别是设备的每一个测量仪器。 保存设备校准和检定记录（见4.5）。 The organization shall maintain a registry of the required testing, measurement and monitoring equipment used to determine product conformity to requirements that includes a unique identification, specific to each piece of equipment. Records of the results of calibration and verification shall be maintained (see 4.5). 5.9 产品放行5.9 Product Release公司应制定和实施《产品放行控制程序》确保除非得到有关授权人员的批准，适当时得到顾客的批准，否则在策划的安排（见5.7）均已圆满完成之前，不得向顾客放行产品。 要保存能够标明单个放行产品的记录 The company shall establish and maintain the “Product Release Control Procedure” to ensure release of product to the customer shall not proceed until the planned arrangements (see 5.7) have been satisfactorily completed, unless otherwise approved by a relevant authority and, where applicable, by the customer. Records shall be maintained to enable identification of the individual releasing the product (see 4.5). 5.10 不合格品控制5.10 Control of Nonconforming Product5.10.1 总则 5.10.1 General 质量部应制定《不合格品控制程序》，确定控制方法和规定对不合格品进行评审的职责和处置的权限。应包括： The Quality Dept. shall establish and maintain the “Procedure for Control of Nonconforming Product” and define the controls and related responsibilities and authorities for dealing with nonconforming product. The procedure for addressing nonconforming product identified during product realization shall include controls for: a）不合格品应被标识，以防非预期的使用或交付； b）描述发现的不合格（见5.10.2）； c）采取措施，以防非预期的使用或交付； d）经有关授权人员批准，适用时经顾客批准，让步使用、放行或接受不合格品（见5.10.3）。 a) product identification to prevent unintended use or delivery; b) addressing the detected nonconformity (see 5.10.2); c) taking action to preclude its original intended use or delivery; and d) authorizing its use, release, or acceptance under concession by relevant authority and, where applicable, by the customer (see 5.10.3). 交付之后出现的不合格品应按以下方法控制 The procedure for addressing nonconforming product identified after delivery shall include controls for: a）标识信息、原始文件、报告或产品交付后的故障； b）确保对产品不符合或故障进行分析，提供证据确定不符合的原因； c）当在交付后发现产品不符合，应采取与不符合的影响或潜在影响的程度相适应的措施。 a) identifying, documenting, and reporting nonconformances or product failure identified after delivery; b) ensuring the analysis of product nonconformance or failure, provided the product or documented evidence supporting the nonconformity is available to facilitate the determination of the cause (see 6.4.2); c) taking action appropriate to the effects, or potential effects, of the nonconformance when nonconforming product is detected after delivery. 5.10.2 不合格品 5.10.2 Nonconforming Product 公司应对不合格品进行评审，规定不合格品的处置方式，采用以下一种或几种方法： The organization shall address nonconforming product by performing one or more of the following: a）返工或返修后应进行后续的检验来满足规定的要求； b）降级使用； c）让步放行（见5.10.3）； d）拒收或报废； a) repair or rework with subsequent inspection to meet specified requirements; b) re-grade for alternative applications; c) release under concession (see 5.10.3); and/or d) reject or scrap. 5.10.3 不合格品的让步放行 5.10.3 Release of Nonconforming Product Under Concession 对不符合制造接受准则（MAC）的不合格品，当公司有关授权人员和顾客（如适用）已经授权的情况下，可以进行评估和让步放行，但须满足一下条件： The evaluation and release under concession of nonconforming product that does not satisfy manufacturing acceptance criteria (MAC) shall be permitted when the organization’s relevant authority and the customer (where applicable) have authorized the release provided that: a）产品持续的满足设计接受准则（DAC）要求或客户的准则； b）违反的制造接收准则被列为设计接收准则的非必需项； c）产品符合修改的设计接受准则（DAC）和制造规范要求（MAC）。 a) products continue to satisfy the applicable DAC and/or customer criteria; or b) the violated MAC are categorized as unnecessary to satisfy the applicable DAC and/or customer criteria; or c) the DAC are changed and the products satisfy the revised DAC and associated MAC requirements. 5.10.4 顾客通知 5.10.4 Customer Notification 公司对发现不符合设计规范的产品且已经发给客户的，必须及时通知客户，采取适宜的纠正措施，并保存记录（见4.5）。 The organization shall notify customers of product not conforming to DAC or contract requirements, that has been delivered. The organization shall maintain records of such notifications (see 4.5). 5.10.5 记录 5.10.5 Records 对不合格品，公司应采取措施（包含让步放行）记录并保存。 Records of the nature of nonconformities and any subsequent actions taken, including concessions obtained, shall be maintained (see 4.5). 5.11 变更管理（MOC）5.11 Management of Change (MOC)5.11.1 总则 5.11.1 General 公司建立并保持《管理变更控制程序》 公司应确保完整的质量体系管理体系，当质量管理体系在策划和实施中发生变更时，也应该保持其它的完整性。对任何变更，应标明更改和任何更改前需要认可的潜在风险，保持变更记录。 The company shall establish and maintain the “Change Management Control Procedure” The organization shall maintain a process for MOC. The organization shall ensure that the integrity of the quality management system is maintained when changes to the quality management system are planned and implemented. For MOC, the organization shall identify the potential risks (see 5.3) associated with the change and any required approvals prior to the introduction of such changes. The organization shall maintain records of MOC activities (see 4.5). 5.11.2 变更管理实施 5.11.2 MOC Implementation 公司应运用变更管理过程来评价可能造成产品质量负面影响的以下方面： The organization shall use the MOC process for any of the following that may negatively impact the quality of the product: a）组织机构的变更； b）关键或重要人员的变更； c）主要供应商的变更； d）管理体系程序变更，包括纠正和预防措施的提出的变更。 a) changes in the organizational structure (see 4.2.2); b) changes in key or essential personnel (see 4.3.2); c) changes in critical suppliers (see 5.6.1.1); and/or d) changes to the management system procedures, including changes resulting from corrective and preventive actions (see 6.4). 5.11.3 变更管理的通知 5.11.3 MOC Notification 公司应将发生的变更告知相关人员（当合同有要求时，包括客户），还应告知变更之后的贵留风险以及带来的新风险，这些变更可能是公司自身产生的或是由客户要求的。 The organization shall notify relevant personnel, including the customer when required by contract, of the change and residual or new risk due to changes that have either been initiated by the organization or requested by the customer. 6.0 质量管理体系监视、测量、分析和改进6.0 Quality Management System Monitoring, Measurement, Analysis, and Improvement6.1 总则6.1 General公司应策划并实施所需的监视、测量、分析和改进过程，确保质量管理体系对本规范的符合性以及持续改进质理管理体系的有效性。 The organization shall plan and implement the monitoring, measurement, analysis, and improvement processes needed to ensure conformity of the quality management system to the requirements of this specification and to continually improve the effectiveness of the quality management system. 质量管理体系监视、测量、分析和改进应包括数据分析技术在内的适用方法及其应用范围的确定。 Quality management system monitoring, measurement, analysis, and improvement shall include determination of applicable methods, including techniques for the analysis of data, and the extent of their use. 在测量、监视、分析和改进过程中应使用适当的统计技术。分析结果和改进活动作为管理评审输入。 6.2 监视，测量和改进6.2 Monitoring, Measuring, and Improving6.2.1 顾客满意 6.2.1 Customer Satisfaction 公司销售部建立和保持《顾客满意度控制程序》来测量顾客满意度，程序中明确规定测量的频率、获得顾客的反馈、关键绩效指标（KPI），以及组织用来决定是否在满足规定要求方面，令顾客满意的其它信息，顾客满意信息结果的记录应保存（见4.5）。 The Marketing shall establish and maintain the “Customers Satisfaction Control Procedure” to measure customer satisfaction. The procedure shall address the frequency of measurement, obtaining customer feedback, key performance indicators (KPIs), and other information that the organization uses to determine whether the organization has satisfied customers in meeting identified requirements. Records of the results of customer satisfaction information shall be maintained (see 4.5). 信息获取：销售部和质量部通过顾客投诉、支持服务、调查表和顾客访问等信息收集渠道获取顾客满意和不满意信息； 信息利用：销售部和质量部对收集到的顾客满意和不满意信息进行分析，至少每年一次（必要时应用统计技术）。分析结果提交管理评审，作为改进的依据。 Information obtaining： The Marketing Dept and the Quality Dept. obtain the customer satisfaction and dissatisfaction information by customer complains, service, survey paper, visit etc. Information Utilizing： The Marketing Dept and the Quality Dept. shall analysis (apply statistics technique if necessary) the customer satisfaction and dissatisfaction information once a year at least. The analysis result shall be submitted to management review as a basis of follow-up improvement action. 6.2.2 内部审核 6.2.2 Internal Audit 6.2.2.1 总则 6.2.2.1 General 公司质量部建立和保持《内部审核控制程序》，明确规定策划、实施审核、内审文件化的职责。审核应验证质量管理体系有效实施并保持，且符合API Spec Q19TH 的要求。内审的策划应考虑到以往审核的结果以及审核过程的重要性。 The Quality Dept. shall establish and maintain the “Internal Audit Control Procedure” to define responsibilities for planning, conducting, and documenting internal audits. Audits shall verify that the quality management system is effectively implemented and maintained and conforms to the requirements of API Spec Q1 9th specification. The planning of internal audits shall take into consideration the results of previous audits and criticality of the process being audited. 公司应识别审核准则、范围、频率和方法，确保声称符合要求的管理体系的所有过程每12个月至少被审核一次。 The organization shall identify the audit criteria, scope, frequency, and methods to ensure that all processes of the quality management system claiming conformity to the requirements of this specification are audited at least every 12 months. 影响产品质量且在公司场所实施的外包活动应包含在公司内审的范围内。 Outsourced activities that impact the quality of the product and that are performed at the organization’s facility shall be included as part of the internal audit of the organization. 6.2.2.2 内部审核实施 6.2.2.2 Performance of Internal Audit 审核应由独立于被审核活动或为非直接监督审核活动的胜任人员（见4.3.2.2）实施，以确保审核过程的客观公正。审核记录应提供质量管理体系 被实施和保持的证据。 Audits shall be performed by competent personnel (see 4.3.2.2) independent of those who performed or directly supervised the activity being audited to ensure objectivity and impartiality of the audit process. Records of the audits shall provide objective evidence that the quality management system is implemented and maintained (see 4.5). 质量管理体系所有要求满足API Spec Q1 9th要求的过程，应在声明其符合API Spec Q1 9th之前被审核 All processes of the quality management system required to meet this specification shall be audited prior to claiming conformance to the requirements of API Spec Q1 9th specification. 注：产品规范要求可以涵盖于整个质量管理体系过程，并与一个或多个质量管理体系过程配合被审核。 NOTE：Product specification requirements may be embedded throughout the quality management system processes and audited in conjunction with one or more quality management system processes. 6.2.2.3 审核评审与关闭 6.2.2.3 Audit Review and Closure 发现不符合项的相关责任人应采取纠正措施并确定响应时间，并确保所有必要纠正的纠正措施符合6.4.2要求，质量部对内审结果和纠正措施的执行进行追踪、监视、检查，其结果要在管理评审中进行输入。应保持内部审核的记录。 The organization shall identify response times for addressing detected nonconformities. The management responsible for the area being audited shall ensure that any necessary corrections and corrective actions follow the requirements of 6.4.2. The results of internal audits and the status of corrective actions shall be reported in the management review (see 6.5). Records of internal audits shall be maintained 6.2.3 过程评价 6.2.3 Process Evaluation 公司应采用适宜的评估方法来证明质量管理体系的能力达到所策划的结果和产品要求的符合性，当未实现所策划的结果，应采取纠正和纠正措施。 The organization shall apply suitable evaluation methods to demonstrate the ability of the quality management system processes to achieve planned results, including conformity to product requirements. When planned results are not achieved, correction and corrective action shall be taken (see 6.4.2), as appropriate. 注：实施内部审核和管理评审满足该要求。 NOTE：Performance of internal audits and management reviews satisfy this requirement. 详细职责如下： The detailed responsibility is as follows: a) 质量部对各职能部门的过程的监视和测量的实施情况进行评估； b) 质量部对本部门的产品的监视和测量过程进行评估； c) 销售部对本部门的与顾客有关的过程、交付和交付后活动过程及顾客满意进行评估； d) 生产部对本部门的采购及生产和服务提供过程进行评估； e) 人力资源部对本部门的人力资源控制过程进行评估； f) 生产部对公司的持续改进过程进行评估。 有关部门应保持有效的过程参数更改的记录。 a) The Quality Dept. shall evaluate the implementation of the monitoring and measurement of processes in all functional departments; b) The Quality Dept. shall evaluate the product monitoring and measurement of processes; c) The Marketing Dept shall evaluate the processes related customers, delivery and after-delivery action, and customer satisfaction; d) The Manufacturing Dept shall evaluate the processes of purchasing and product and service provision; e) The human resource dept shall evaluate the processes for control of human resources; f) The manufacture Dept shall evaluate the processes of continual improvement. The relevant department shall maintain the records of valid process parameter change 6.3 数据分析6.3 Analysis of Data质量部建立并保持《数据分析控制程序》，识别并应用数据分析技术。 公司各部门确定、收集适当的数据，质量部分析适当的数据，以证实质量管理体系的适宜性和有效性，并评价在何处可以持续改进质量管理体系的有效性。这应包括来自监视和测量的结果、内审、管理评审以及其他有关来源的数据。 The Quality Dept. shall establish and maintain the “Data Analysis Control Procedure”. The Quality Dept. shall identify and use statistical analyzing technique. All departments shall determine and collect appropriate data, and The Quality Dept. shall analyze appropriate data to demonstrate the suitability effectiveness of the quality management system and to evaluate where continual improvement of the effectiveness of QMS can be made. This shall include data generated as a result of monitoring and measurement and from other relevant sources. 数据分析应提供以下有关方面的信息： The analysis of data shall provide information relating to: a）顾客满意（见6.2.1）； b）与产品要求的符合性； c）交付或使用后发现的产品不符合或失效，提供产品或文件化的证据帮助确定原因； d）过程和产品的特性及趋势，包括采取预防措施的机会； e）供方业绩； f）质量目标。 a) customer satisfaction (see 6.2.1); b) conformity to product requirements; c) nonconformities and product failures identified after delivery or use, provided the product or documented evidence is available to facilitate the determination of the cause (see 5.10); d) characteristics and trends of processes and products including opportunities for preventive action (see 6.4.3); e) supplier performance (see 5.6); and f) quality objectives (see 4.1.3). 数据分析的结果应提交管理评审，公司应使用数据评价实施对质量管理体系有效性的持续改进的地方。 The result of data analysis shall be submitted to management review. The organization shall use data to evaluate where continual improvement of the effectiveness of the quality management system can be made. 6.4 改进6.4 Improvement6.4.1 总则 6.4.1 General 公司通过质量方针、目标、审核结果、数据分析、纠正和预防措施和管理评审，持续改进质量管理体系的有效性。 The organization shall continually improve the effectiveness of the quality management system through the use of the quality policy, quality objectives, audit results, analysis of data, corrective and preventive actions, and management review. 注：纠正、纠正措施和预防措施见 ISO 900 NOTE: See ISO 9000 for definitions of correction, corrective action, and preventive action. 6.4.2 纠正措施 6.4.2 Corrective Action 公司质量部建立实施《纠正措施程序》和《预防措施程序》，在内部和供应链内纠正不符合的采取纠正措施，消除不符合的原因以尽可能降低不符合再次出现的可能性，纠正措施应与发生的不合格的影响程度相适应。 The Quality Dept. shall establish and maintain the “Corrective actioncontrol procedure”and “Preventive actioncontrol procedure” to correct nonconformities and to take corrective actions, both internally and within the supply chain, to eliminate the causes of nonconformities in order to minimize the likelihood of its recurrence. Corrective actions shall be appropriate to the effect(s) of the nonconformity encountered. 注：纠正措施可同时适用于质量管理体系过程和不合格品趋势。 NOTE: Corrective action can apply to both quality management system processes and nonconforming product trends. 程序包括以下内容： The procedure shall identify requirements for: a）质量审核的不符合（包括顾客投诉）； b）确定和实施纠正措施； c）识别不符合的根源和评价采取纠正措施的需求； d）-实施纠正措施来减少不符合项的再次发生； e）明确实施纠正和纠正措施的时间和责任人； f）评定和检查纠正和纠正措施的有效性； g）纠正措施要求的质量体系的变更。 纠正措施的记录和有效性验证结果应保存 a) reviewing a process nonconformity (including customer complaints); b) determining and implementing corrections; c) identifying the root cause of the nonconformity and evaluating the need for corrective actions; d) implementing corrective action to reduce the likelihood that a nonconformity recurs; e) identifying the timeframe and responsible person(s) for addressing corrections and corrective action; f) verification of the effectiveness of the corrections and corrective action taken; and g) MOC (see 5.11) when the corrective actions require new or changed controls within the quality management system. Records of the activities for control of a nonconforming process shall be maintained (see 4.5). Records shall identify the activities performed to verify effectiveness of the corrective actions taken. 6.4.3 预防措施 6.4.3 Preventive Action 公司质量部制定《纠正措施程序》和《预防措施程序》，在内部和供应链内制定和实施预防措施，消除不符合的原因以尽可能降低不符合再次出现的可能性，预防措施应与潜在问题的影响程度相适应。 The Quality Dept. shall establish and maintain “Corrective actioncontrol procedure”and “Preventive actioncontrol procedure”to determine and implement preventive actions, both internally and within the supply chain, to eliminate the causes of potential nonconformities in order to minimize the likelihood of their occurrence. Preventive actions shall be appropriate to the effect(s) of the potential problems. 注：预防措施可同时适用于质量管理休系过程和产品分析。 NOTE: Preventive action can apply to both quality management system processes and product analysis. 程序包括以下内容： The procedure shall identify requirements for: a）识别改进的机会； b）识别潜在的不合格品，查明原因； c）评估采取预防措施的必要性，包括任何立即或短期的措施及长期措施； d）标明回复时间和负责人； e）评定和检查预防措施的有效性； f）当预防措施要求在质量管理体系内有新的控制或者更改控制时的管理变更(见5.11)。 预防措施的记录和有效性验证结果应保存 a) identifying opportunities for improvements; b) identifying a potential nonconformity and its potential cause(s); c) evaluating the need for preventive action, including any immediate or short-term action required, to prevent occurrence of a nonconformity; d) identifying the timeframe and responsible person(s) for implementing a preventive action; e) reviewing the effectiveness of the preventive action taken; and f) MOC (see 5.11) when the preventive action require new or changed controls within the quality management system. Records of the activities for control of potential process nonconformities shall be maintained (see 4.5). 6.5 管理评审6.5 Management Review6.5.1 总则 6.5.1 General 公司质量部建立和保持《管理评审控制程序》，总经理每12个月主持质量管理体系评审以保证其连续可行，适宜有效。评审应考虑变更和改进公司质量管理体系的必要性，包括质量方针和质量目标。 The Quality Dept. shall establish and maintain the “Management Review Control Procedure”. The GM shall hold review meeting of the quality management system, at planned interval of every 12 months, to ensure its continuing suitability, adequacy and effectiveness. The review shall evaluate the need for changes and improvement to the company quality management system, including quality policy and quality objectives. Records of management reviews are maintained. The MR maintains the record of management review 6.5.2 评审输入 6.5.2 Input Requirements 管理评审至少包括以下输入信息： a）前一次管理评审的实施结果的有效性； b）审核结果，包括内审和外审； c）能够影响质量体系的变更，包括法律，法规和其他工业标准的变更； d）顾客满意度分析，包括顾客反馈； e）过程业绩； f）风险评估的结果； g）纠正和预防措施的状态； h）供方业绩的分析； i）产品符合性分析的评审，包括交付或使用出现的不合格； j）改进的建议。 a) effectiveness of actions resulting from previous management reviews; b) results of audits (see 6.2.2); c) changes that could affect the quality management system, including changes to legal and other applicable requirements (such as industry standards); d) analysis of customer satisfaction, including customer feedback (see 6.2.1); e) process performance [see 6.2.3 and 6.3 d)]; f) results of risk assessment (see 5.3); g) status of corrective and preventive actions (see 6.4.2 and 6.4.3); h) analysis of supplier performance (see 5.6); i) review of the analysis of product conformity, including nonconformities identified after delivery or use (see 5.10); and j) recommendations for improvement. 6.5.3 评审输出 6.5.3 Output Requirements 管理评审的输出包括以下各相关的结果和措施: a) 质量管理体系运行的适宜性、有效性和充分性； b) 过程，决定和活动的更改； c) 符合顾客要求的产品改进； d) 资源适宜性和需求。 管理者代表做好管理评审记录，形成报告，经总经理批准后下发至相关部门。 管理者代表负责评审输出的计划和实施，并将结果报告总经理. The outputs from the management review shall include results and actions related to: a) Conformance，sufficiency and effectiveness of the quality management system performance; b) Improvement of the quality management system and its processes; c) Improvement of product related to customer requirements; d) Resource suitability and needs including personnel and resource requirements. The MR should write management review report according to related record and/or minute, after approval by GM, the results of management reviews shall be informed to related departments. Management Representative shall have responsibility and authority for the plan and implementation of review output and report the result to General Manager. 附录A API会标程序Annex A Use of API Monogram by Licensees1 目的 本公司建立并保持《API 会标控制程序》，确保会标的使用符合API SPEC Q1 9th附录一的要求。 1 Purpose The company shall establish and maintain the “API Monogram Control Procedure” to ensure that the product used the API monogram meets API requirements. 2 范围 适用于使用API会标的产品。 2 Scope This chapter is applicable to the management and control of the use of the API monogram on the product which meets API standard. 3 职责 质量部负责API会标使用的控制。 3 Responsibilities The Quality Dept. is responsible for applying and removing the API monogram. 4 概述 4.1 质量部根据API产品规范中规定的标准程序在合格产品上标识会标、许可证Number及制造期。 4.2 当产品不符合API规范时，检验人员应将会标去掉并记录。 4.3 API产品规范要求的记录按《质量记录控制程序》执行。 4.4 公司有责任向API报告使用会标产品所遇到的问题。 4 Control Requirement 4.1 The Quality Dept. shall apply the monogram, license number, and date of manufacture to monogrammed products in accordance with a marking procedure as specified by the applicable API product specification. 4.2 The monogram shall be removed if the product is subsequently found to be in nonconformance with API specified requirements. 4.3 Records required by API product specifications shall be maintained in accordance with “ Procedure for control of Quality Record”. 4.4 The company shall report to API any question in application of API monogram. Annex B Procedure List
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