8.5生产和服务提供

8.5.1.1、设备、工装和软件程序的控制

生产设备、工装和用于生产过程自动化和控制、监视或测量的软件程序在最终放行用于生产前应进行确认，并维护。

对储存的生产设备或工装必须确定储存要求，包括任何必要的定期进行防护和状况检查。

8.5.1.2、特殊过程的确认和控制

对于导致输出不能由后续的监视或测量加以验证的过程，组织应规定确认这些过程的安排，适用时包括：

a. 为过程的评审和批准所规定的准则；

b. 维持批准的条件的确定；

c. 设施和设备的认可和

d. 人员资格的鉴定；

e. 为实施和监视过程使用特定的方法和程序；

f. 形成文件的信息得以保留的要求。

8.5.1.3、生产过程的验证

组织应实施生产验证活动以确保生产过程能够生产满足要求的产品

注：这些活动可以包含风险评估，产能研究，能力研究，和控制计划。

组织应使用从首批生产的新零件或组件中确定的有代表性的项目来验证生产过程、生产文件和工装能够生产满足要求的零件和组件。当发生使原来验证结果无效的更改时，应再次验证过程（如工程更改,生产过程更改,工具更改）。

注：此项活动通常被称为首件检验。

组织应保留关于生产过程验证结果的形成文件的信息。

8.5.1.1、Control of Equipment, Tools, and Software Programs

Equipment, tools, and software programs used to automate, control, monitor, or measure production processes shall be validated prior to final release for production and shall be maintained.

Storage requirements shall be defined for production equipment or tooling in storage including any necessary periodic preservation or condition checks.

8.5.1.2、Validation and Control of Special Processes

For processes where the resulting output cannot be verified by subsequent monitoring or measurement, the organization shall establish arrangements for these processes including, as applicable:

a. definition of criteria for the review and approval of the processes;

b. determination of conditions to maintain the approval;

c. approval of facilities and equipment;

d. qualification of persons;

e. use of specific methods and procedures for implementation and monitoring the processes;

f. requirements for documented information to be retained.

8.5.1.3、Production Process Verification

The organization shall implement production process verification activities to ensure the production process is able to produce products that meet requirements.

NOTE: These activities can include risk assessments, capacity studies, capability studies, and control plans.

The organization shall use a representative item from the first production run of a new part or assembly to verify that the production processes, production documentation, and tooling are able to produce parts and assemblies that meet requirements. This activity shall be repeated when changes occur that invalidate the original results (e.g., engineering changes, production process changes, tooling changes).

NOTE: This activity can be referred to as First Article Inspection (FAI).

The organization shall retain documented information on the results of production process verification.