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SAE AS 9100:2000 Aerospace Quality Standard SAE AS 9100：2000 航空航天质量标准 (Rev.A,Aug.2001) （A 版，2001年8月） BVQi China 中文译稿 documents, including key characteristics where required.
The organization shall ensure the adequacy of specified requirements prior to their communication to the supplier.
7.4.3 Verification of purchased product
The organization shall establish and implement the inspection or other activities necessary for ensuring that purchased product meets specified purchase requirements.
Verification activities may include
a. obtaining objective evidence of the quality of the
product from suppliers ( e.g., accompanying documentation, certificate of conformity, test reports, statistical records, process control),
b. inspection and audit at supplier’s premises,
c. review of the required documentation,
d. inspection of products upon receipt, and
e. delegation of verification to the supplier, or supplier
certification.
Purchased product shall not be used or processed until it has been verified as conforming to specified requirements unless it is released under positive recall procedure.
Where the organization utilizes test reports to verify purchased product, the data in those reports shall be acceptable per applicable specifications. The organization shall periodically validate test reports for raw material.
Where the organization delegates verification activities to the supplier, the requirements for delegation shall be defined and a register of delegations maintained.
Where the organization or its customer intends to perform verification at the supplier’s premises, the organization shall state the intended verification arrangements and method of product release in the purchasing information.
Where specified in the contract, the customer or the customer’s representative shall be afforded the right to verify at the supplier’s premises and the organization’s premises that subcontracted product conforms to specified requirements.
Verification by the customer shall not be used by the organization as evidence of effective control of quality by
在合同中指定的地方，提供顾客或顾客代表权利，在供应商处和组织处验证分合同产品是否符合规定的要求； 顾客的验证不应该由组织用作为供应商有效控制质量的证据。顾客的验证既不能减轻杂志提供合格产品的责任，也不能排除其后顾客的拒收。 7.5 生产及服务提供
7.5.1 生产及服务提供之控制
适用时，策划必须考虑：
- 建立过程控制并且在关键特性已经识 别的方面形成控制计划； - 在实现的较后阶段不能充分验证符合 性时，识别过程中的验证点； - 工装的设计、制造和使用使得可以进 行易变的测量，特别对于关键特性； 及 - 特殊过程（见7.5.2)。
组织必须策划并在控制状态下进行生产和提供服务。控制状态必须包括下列应加以采用的项目
a) 提供描述产品各种特性的信息，
b) 必要时，提供作业指导书，
c) 使用合适的设备，
d) 具备并使用监控和量测设备，
e) 实施监控与量测，和
f) 实施放行、交付与售后之活动。
g）制造时，对所有的产品负有责任（例 如，零件数、分组生产、不合格品）；
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SAE AS 9100:2000 Aerospace Quality Standard SAE AS 9100：2000 航空航天质量标准 (Rev.A,Aug.2001) （A 版，2001年8月） BVQi China 中文译稿 the supplier and shall not absolve the organization of the responsibility to provide acceptable product, nor shall it preclude subsequent rejection by the customer.
7.5 Production and service provision
7.5.1 Control of Production and Service Provision
Planning shall consider, as applicable,
- the establishment of process controls and
development of control plans where key characteristics have been identified,
- the identification of in-process verification points
when adequate verification of conformance cannot be performed at a later stage of realization,
- the design, manufacture, and use of tooling so that
variable measurements can be taken, particularly for key characteristics, and
- special processes (see 7.5.2)
The organization shall plan and carry out production and service provision under controlled conditions. Controlled conditions shall include, as applicable
a) the availability of information that describes the characteristics of the product,
b) the availability of work instructions, as necessary,
c) the use of suitable equipment,
d) the availability and use of monitoring and measuring devices,
e) the implementation of monitoring and measurement, and
f) the implementation of release, delivery and post-delivery activities,
g) accountability for all product during manufacture (e.g., parts quantities, split orders, nonconforming product),
h) evidence that all manufacturing and inspection operations have been completed as planned, or as otherwise documented and authorized,
i) provision for the prevention, detection, and removal of foreign objects,
j) monitoring and control of utilities and supplies such
h）所有已经按策划完成的生产和检验的
证据，或以其他的文件或公认的方式；
i）提供对外来物的防止、检测和去除；
j）监测和控制公用事业和供应，诸如， 水、压缩空气、电及化学产品，它们 在一定程度上影响产品的质量；和
k）制造工的准则必须以最清楚实用的方 式来规定（例如，书面的标准、代表 性的样品或图例）。
7.5.1.1 生产文件化
生产运行必须按批准的资料进行。按需要，资料必须包括：
a. 图纸，零件目录，过程流程图包括检 查指令，生产文件（例如，制造计 划，零件流程，厂房路线，工作指 令，工艺卡片）；及检查文件（见 8.2.4.1),和
b. 特殊或非特殊工装目录和所要求的数 控机床项目及任何与其使用有关的特 殊仪器。
7.5.1.2 生产工艺更改的控制
必须确定授权批准生产工艺更改的人员。
组织必须按合同或法规性要求确认要求顾客和/或法规性机构认可的更改并获得 其对更改的接收。
影响工艺、生产设备、工装和项目的更改必须文件化。必须有控制更改执行的程序。
对生产工艺更改的结果必须加以评估以确认期望的影响已达到而对产品质量没有不利的影响。
7.5.1.3 生产设备、工装和数控机床的控 制
生产设备、工装和数控机床在使用前被确认并按文件规定的程序周期性地进行维护和检查。 在生产使用前的确认必须包括按设计数据或技术规范生产的首件产品的确认。
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SAE AS 9100:2000 Aerospace Quality Standard SAE AS 9100：2000 航空航天质量标准 (Rev.A,Aug.2001) （A 版，2001年8月） BVQi China 中文译稿 as water, compressed air, electricity and chemical products to the extent they affect product quality, and
k) criteria for workmanship, which shall be stipulated in the clearest practical manner (e.g., written standards, representative samples or illustrations).
7.5.1.1 Production Documentation
Production operations shall be carried out in accordance with approved data. This data shall contain as necessary
a. drawings, parts lists, process flow charts including
inspection operations, production documents (e.g., manufacturing plans, traveler, router, work order, process cards); and inspection documents (see8.2.4.1), and
b. a list of specific or non-specific tools and numerical
control (NC) machine programs required and any specific instructions associated with their use.
7.5.1.2 Control of Production Process Changes
Persons authorized to approve changes to production processes shall be identified.
The organization shall identify and obtain acceptance of changes that require customer and/or regulatory authority approval in accordance with contract or regulatory requirements.
Changes affecting processes, production equipment, tools and programs shall be documented. Procedures shall be available to control their implementation.
The results of changes to production processes shall be assessed to confirm that the desired effect has been achieved without adverse effects to product quality.
7.5.1.3 Control of Production Equipment, Tools and Numerical Control (N.C.) Machine Programs
Production equipment, tools and programs shall be validated prior to use and maintained and inspected periodically according to documented procedures. Validation prior to production use shall include verification of the first article produced to the design data/specification.
Storage requirements, including periodic preservation/condition checks, shall be established for production equipment or tooling in storage.
对储藏的生产设备或工装必须建立储存要求，包括周期性的防护和状况检查。
7.5.1.4 在组织设施外临时的工作转移的 控制
当组织策划临时地将工作转移到组织设施外的场所时，组织必须确定控制和确认工作质量的过程。
7.5.1.5 服务运行的控制
当服务是一种特殊要求时，服务运行过程必须提供：
a. 收集和分析服务过程中数据的方法；
b. 在交付后确认有问题时应采取的措 施；包括调查，报告活动以及有关与 合同和/或法规要求一致的服务信息 的措施；
c. 技术文件的控制和更新；
d. 修理计划的批准、控制和使用；
e. 现场外工作所央求的控制（例如，组织在顾客处承担的工作）。
7.5.2 生产与服务提供过程的确认
凡是无法对过程的结果输出通过后续的监控或量测进行验证的生产和服务提供过程，组织必须加以确认。这种过程包括过程的缺陷唯有在产品使用时或者服务已经提供以后才会显现的任何过程。
注：这些过程通常被认为是特殊过程。 过程的确认必须展示这些过程具有达成策划所要达到结果的能力。
组织必须为这些过程做好下列安排，其中，按实际应加以采用的，包括
a)规定过程评审与批准所用的判别准则，
－在使用前鉴定并批准特殊过程；
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SAE AS 9100:2000 Aerospace Quality Standard SAE AS 9100：2000 航空航天质量标准 (Rev.A,Aug.2001) （A 版，2001年8月） BVQi China 中文译稿 7.5.1.4 Control of Work Transferred, on a Temporary
Basis, Outside the Organization’s Facilities b) 设备的批准与人员的资格鉴定；
When planning to temporarily transfer work to a location c) 使用特定的方法和程序，
outside the organization’s facilities, the organization －按文件化的工艺规范控制特殊过程 shall define the process to control and validate the 的重要操作和参数； quality of the work. 7.5.1.5 Control of Service Operations d) 各种记录要求 (见4.2.4)，和
Where servicing is a specified requirement, service e) 再确认。 operation processes shall provide for 7.5.3 标识与可追溯性 a. a method of collecting and analyzing in-service data,
b. actions to be taken where problems are identified 当必需采用时，组织必须在产品实现的整个过
after delivery, including investigation, reporting 程对产品采用合适的标识。 activities, and actions on service information
consistent with contractual and/or regulatory 为了识别产品实际技术状态与合同要求技术状requirements, 态之间的任何差别，组织必须保持对产品技术c. the control and updating of technical 状态的识别。 documentation, d. the approval, control, and use of repair schemes,
and 组织必须对产品所处量测与监控要求的各种状e. the controls required for off-site work (e.g., 态加以标识。
organization’s work undertaken at the customer’s 当使用授权接收媒体时（例如，印章、电子签facilities). 名、密码），组织必须对媒体建立文件化的控制。 7.5.2 Validation of processes for production and service provision 凡是可追溯性是一项要求时，组织必须控制及 记录用于识别产品的唯一性标识 (见4.2.4)。 The organization shall validate any processes for production
and service provision where the resulting output cannot be 按照合同、法规或其他确立的要求所需追溯性verified by subsequent monitoring or measurement. This 水平，组织的体系必须提供： includes any processes where deficiencies become apparent only after the product is in use or the service has been a. 整个寿命期要维持识别； delivered. b. 要追溯的从同一批原材料或同一制造批生NOTE These processes are frequently referred to as 产的所有产品，也包括所有同一批产品的目special processes. 的地（交付品、报废品）； Validation shall demonstrate the ability of these processes to c. 对于装配件，识别其部件及要追溯的 achieve planned results. 下一步较高层次装配件的部件；
The organization shall establish arrangements for these d. 对一个所给的产品，要能找到其生产 processes including, as applicable 的结果记录（制造、装配、检查）。
a) defined criteria for review and approval of the processes, 注：在某些行业中，技术状态管理是一种用于- qualification and approval of special processes prior 维持产品标识和可追溯性的方法。（见4.3） to use, 7.5.4 顾客资产 b) approval of equipment and qualification of personnel, 组织必须注意受组织控制的或者组织正在使用c) use of specified methods and procedures, 的顾客资产。组织必须标识、验证、保护和安- control of the significant operations and parameters 全防范好顾客所提供使用的或者结合到产品中of special processes in accordance with documented 去的资产。任何顾客资产如发生遗失、损坏或
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