8 运行
8.3产品和服务的设计和开发
8.3.3.3特殊特性 【SI-06:2017-10】
组织应采用多方论证方法来建立、形成文件并实施用于识别特殊特性的过程,包括顾客确定的以及组织风险分析所确定的特殊特性,应包括:
a) 将所有特殊特性记录进产品和/或生产文件图纸(按要求)、相关风险分析(例如过程FMEA)、控制计划和标准的工作/操作说明书;特殊特性用特定的标记进行标识,并且贯穿这些文件中的每一个; 记录在为创造或控制这些特殊特性所需的制造文件中;
b) 为产品和生产过程的特殊特性开发控制和监视策略; c) 顾客规定的批准,如有要求;
d) 遵循顾客规定的定义和符号或组织的等效符号或标记,如符号转换表所示。如有要求,应向顾客提交符号转换表。
8 Operation
8. 3 Design and development of products and services 8. 3. 3.3 Special characteristics 【SI-06:2017-10】 The organization shall use a multidisciplinary approach to establish,document,and implement its process(es)to identify
special characteristics,including those determined by the customer and the risk analysis performed by the organization,and shall include the following:
a) documentation of special characteristics in product and/or manufacturing documents drawings (as required), relevant risk analysis (such as Process FMEA), control plans, and standard work/operator instructions; special characteristics are identified with specific markings and are cascaded through each of these documents; documented in the manufacturing documents which show the creation of, or the controls required, for these special characteristics;
b) development of control and monitoring strategies for special characteristics of products and production processes;
c) customer-specified approvals,when required; d) compliance with customer-specified definitions and symbols or the organization's equivalent symbols or notations,as defined in a symbol conversion table. The symbol conversion table shall be submitted to the customer,if required.