8.5生产和服务提供

8.5.1、生产和服务提供的控制

组织应在受控条件下进行生产和服务提供。适用时，受控条件应包括：

a. 可获得形成文件的信息，以规定以下内容：

1. 所生产的产品、提供的服务或进行的活动的特性；

2. 拟获得的结果。

注1：定义产品和服务的形成文件的信息可以包含数字产品定义数据、图纸、零件清册、材料、和过程规范。

注2：执行的活动和达成的结果的形成文件的信息可以包含工艺流程图、控制计划、生产文件（例如：制造计划，周转卡、路线卡、工作指令和过程卡），和验证文件。

b. 可获得和使用适宜的监视和测量资源；

c. 在适当阶段实施监视和测量活动，以验证是否符合过程或输出的控制准则以及产品和服务的接收准则；

1. 对用于产品接收的监视和测量活动，确保形成文件的信息包含：

—— 接收和拒收的准则；

—— 按顺序在何处执行验证操作；

—— 保持测量结果（至少表明接收还是拒收）；

—— 要求的任何专用监视和测量设备及与其使用有关的指导书。

2. 当抽样作为产品接收的方法时，确保抽样计划在公认统计原理基础上应是合理的，并是适于使用（亦即，抽样计划与产品的重要度和过程能力相匹配）。

d. 为过程的运行提供适宜的基础设施和环境；

注：适宜的设备可以包含产品专用工装（例如：夹具、工装、模具）和软件程序。

e. 配备具备能力的人员，包括所要求的资格；

f. 若输出结果不能由后续的监视或测量加以验证，应对生产和服务提供过程实现策划结果的能力进行确认，并定期再确认；

注：这些过程通常被称为特殊过程（见8.5.1.2）。

g. 采取措施防范人为错误；

h. 实施放行、交付和交付后活动。

i. 建立工艺准则（例如：文字标准、代表样件或图示）；

j. 在生产中所有的产品的可说明性（例如：零件数量、分单作业、不合格品）；

k. 根据建立的过程，控制和监视识别的关键项目，包括关键特性；

l. 测量变量方法的确定（例如：工具、在线探测、检验设备）；

m. 当符合性的充分验证不能在后续阶段执行时，过程检验/验证点的识别；

n. 所有生产和检验/验证操作已经按策划完成的证据的可用性，或另有形成文件且授权的。

o. 预防、检测和移除多余物的规定;

p. 根据影响产品要求符合性的程度，对公用事业和供给（如水、压缩空气、电及化学产品）进行监视和控制(见7.1.3);

q. 当产品在等待所有要求的监视和测量活动完成期间被发放用于生产时，应对其进行识别和记录，以便在随后发现产品不符合要求时，对其进行召回和更换。

8.5.1、Control of production and service provision

The organization shall implement production and service provision under controlled conditions. Controlled conditions shall include, as applicable:

a. the availability of documented information that defines:

1. the characteristics of the products to be produced, the services to be provided, or the activities to be performed;

2. the results to be achieved;

NOTE 1: Documented information that defines characteristics of products and services can include digital product definition data, drawings, parts lists, materials, and process specifications.

NOTE 2: Documented information for activities to be performed and results to be achieved can include process flow charts, control plans, production documents (e.g., manufacturing plans, travelers, routers, work orders, process cards), and verification documents.

b. the availability and use of suitable monitoring and measuring resources;

c. the implementation of monitoring and measurement activities at appropriate stages to verify that criteria for control of processes or outputs, and acceptance criteria for products and services, have been met;

1. ensuring that documented information for monitoring and measurement activity for product acceptance includes:

—— criteria for acceptance and rejection;

—— where in the sequence verification operations are to be performed;

—— measurement results to be retained (at a minimum an indication of acceptance or rejection);

—— any specific monitoring and measurement equipment required and instructions associated with their use;

2. ensuring that when sampling is used as a means of product acceptance, the sampling plan is justified on the basis of recognized statistical principles and appropriate for use (i.e., matching the sampling plan to the criticality of the product and to the process capability).

d. the use of suitable infrastructure and environment for the operation of processes;

NOTE: Suitable infrastructure can include product specific tools (e.g., jigs, fixtures, molds) and software programs.

e. the appointment of competent persons, including any required qualification;

f. the validation, and periodic revalidation, of the ability to achieve planned results of the processes for production and service provision, where the resulting output cannot be verified by subsequent monitoring or measurement;

NOTE: These processes can be referred to as special processes (see 8.5.1.2).

g. the implementation of actions to prevent human error;

h. the implementation of release, delivery and post-delivery activities.

i. the establishment of criteria for workmanship (e.g., written standards, representative samples, illustrations);

j. the accountability for all products during production (e.g., parts quantities, split orders, nonconforming product);

k. the control and monitoring of identified critical items, including key characteristics, in accordance with established processes;

l. the determination of methods to measure variable data (e.g., tooling, on-machine probing, inspection equipment);

m. the identification of in-process inspection/verification points when adequate verification of conformity cannot be performed at later stages;

n. the availability of evidence that all production and inspection/verification operations have been completed as

planned, or as otherwise documented and authorized;

o. the provision for the prevention, detection, and removal of foreign objects;

p. the control and monitoring of utilities and supplies (e.g., water, compressed air, electricity, chemical products) to the extent they affect conformity to product requirements (see 7.1.3);

q. the identification and recording of products released for subsequent production use pending completion of all required measuring and monitoring activities, to allow recall and replacement if it is later found that the product does not meet requirements.