集成质量系统环境下基于过程取证的质量体系运行监管模式

Quality system audit based on in-process evidence catching under Integrate quality system environment

为提升制造企业质量体系运行状态管理的能力,提出了集成质量系统环境下基于过程取证的质量体系运行监管模型。该模型将质量体系监管活动与集成质量管理系统相结合,通过在集成质量系统的相关业务节点嵌入取证代理组件,实现对质量体系运行过程的自动取证与监管,以及质量体系运行状态监管活动的日常化与过程化。建立了集成质量系统运行空间向质量体系监管空间的映射模型,构建了基于可配置检查单的监管业务模型,依托某集成质量系统环境开发了原型系统,并在典型工程环境中进行了验证。

To improve the quality system operation audit and realize a daily and in-process management,a quality system audit model based on in-process evidence catching under Integrated Quality System（IQS）was put forward.This model combined quality system audit with integrated quality management system.By embedding a series of evidence-catching-agents in the IQS process,the audit evidence was caught,and the quality system audit became daily and procedural.The mapping model from the IQS functional space to the quality system audit space was set up and a configurable framework of audit check-sheets was constructed.The prototype system was developed based on a typical IQS and a case-study of the system application was given.