浅析特殊过程确认的常见误区

Analysis of Common Misunderstandings in Special Process Validation

特殊过程对产品和服务的质量有重大影响,在质量管理体系中占有重要地位。由于相关标准对特殊过程确认的要求过于精炼,各组织的质量管理体系策划人员对标准要求的理解差异很大,造成了不同组织的特殊过程确认的水平参差不齐的局面,部分组织所开展的特殊过程确认未起到应有的作用。本文分析列举了特殊过程确认时常见的误区,为组织提高特殊过程确认的质量提供参考。

Special processes have a significant impact on the quality of products and services and play an important role in quality management systems.Due to the over-refined requirements of the relevant standards for special process validation,the quality management systems planners of different organizations have different understandings of the requirements of the standards.As a result,the level of special process validation of different organizations is uneven.The special process validation carried out by some organizations does not play a proper role.This paper analyzes and lists the common mistakes in special process validation,which can provide reference for organizations to improve the quality of special process validation.