2024年6月14日发(作者:)
8 运行
8.5生产服务提供
8.5.2.1标识和可追溯性---补充
可追溯性的目的在于支持对顾客所收产品的开始点和停止
点的清楚识别,或者用于发生质量和/或安全相关不符合的
情况。因此,组织应按照下文描述实施标识和可追溯过程。
组织应对所有汽车产品的内部、顾客及法规可追溯性要求
进行分析,包括根据风险等级或失效对员工、顾客的严重
程度,制定可追溯性计划并形成文件。这些计划应按产品、
过程和制造位置明确适当的可追溯系统、过程和方法,应:
a) 使组织能够识别不合格品和/或可疑产品;
b) 使组织能够隔离不合格品和/或可疑产品;
c) 确保组织能够满足顾客要求和/或法规对响应时间
的要求;
d) 确保保留了成文信息,保留的形式(电子、硬拷贝、
档案)使组织能够满足响应时间要求;
e) 确保各单个产品的序列化标识,如顾客或监管标准
有所规定;
f) 确保标识和可追溯性要求被扩展应用至外部提供的具
有安全/监管特性的产品。
8 Operation
8. 5 Production and service provision
8. 5.2.1 Identification and traceability—supplemental
The purpose of traceability is to support identification of clear
start and stop points for product received by the customer or
in the field that may contain quality and/or safety-related
nonconformities. Therefore,the organization shall implement
identification and traceability processes as described below.
The organization shall conduct an analysis of internal,
customer,and regulatory traceability requirements for all
automotive products,including developing and documenting
traceability plans,based on the levels of risk or failure
severity for employees,customers,and consumers. These
plans shall define the appropriate traceability systems,
processes,and methods by product,process,and
manufacturing location that:
a) Enable the organization to identify nonconforming and/or
suspect product;
b) Enable the organization to segregate nonconforming
and/or suspect product;
c) Ensure the ability to meet the customer and/or regulatory
response time requirements;
d) Ensure documented information is retained in the format
(electronic,hardcopy,archive) that enables the
organization to meet the response time requirements;
e) Ensure serialized identification of individual products,if
specified by the customer or regulatory standards;
Ensure the identification and traceability requirements are
extended to externally provided products with
safety/regulatory characteristics.
(1)标示主要包括良品及不良品的标示、特采标示、呆滞
品标示、待处理标示。
(2)区域标示:报废品区、不良品区、退货区、已加工区、
待加工区。
(3)追溯:批号追溯、标签追溯、报表追溯。生产日报表、
领料单、发货记录、入库记录、生产记录要填写产品名称、
规格、数量、批号、相关人员,以便能够追溯。
(4)当客户投诉时,要能追溯到材料批次、设备编号、检
验仪器和人员、生产人员和日期、工装。当生产中发现不良
时,要能把已发的货追回。
(5)审核时容易出现的错误:成品没办法追溯到原材料生
产日期及厂家。现场不良品没有标示和隔离。半成品没有标
示加工状态。
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