QMS NC整改

gaowenhua

NC的主要问题：



不符合项整改在质量管理体系认证和实施过程中有着重要的作用和地位。


现场审核的结束并不意味认证的通过，认证审核所开具的不符合项关闭不了，受审核方不具有整改能力，就不能通过认证审核，也无法获得认证证书。


有的受审核方不符合项整改生搬硬套、流于形式、整改不到位、整改效果不理想，造成不符合项重复发生，使受审核方质量管理体系运行有效性、认证机构实施审核的有效性大打折扣，同时也带来质量风险

gaowenhua

The main issues with NC are:



The rectification of non conformities plays an important role and status in the certification and implementation process of the quality management system.



The end of the on-site audit does not mean that the certification has been passed. The non conformities issued by the certification audit cannot be closed, and the audited party does not have the ability to rectify, so it cannot pass the certification audit or obtain the certification certificate.



Some of the audited parties' rectification of non conformities is rote, formalistic, inadequate, and ineffective, resulting in the recurrence of non conformities, which greatly reduces the effectiveness of the audited party's quality management system operation and the effectiveness of the certification agency's implementation of audits, and also brings quality risks

gaowenhua

不符合项整改一般包括对不符合项整改工作的策划、对不符合项进行纠正、对不符合项的产生原因（一个不符合事实可以有若干个原因）进行分析、针对不符合项产生的原因采取纠正措施、针对开具的不符合项进行举一反三，并提供相应整改的证据材料等活动

gaowenhua

The rectification of non conformities generally includes planning for the rectification work of non conformities, correcting non conformities, analyzing the causes of non conformities (a non conformity fact can have multiple reasons), taking corrective measures for the causes of non conformities, drawing inferences about non conformities issued, and providing corresponding evidence materials for rectification, and other activities

gaowenhua

指定专人对整改工作进行协调、指导、督促、检查和跟踪。

召集各职能部门相关人员召开不符合项整改工作会议，根据审核组提出的对不符合项的整改要求，对不符合项产生的背景及事件的因果关系进行分析、研究，确定不符合项产生的过程和原因、责任部门（出现不符合项的部门不一定是主要责任部门，应综合分析、合理确定）。


制定不符合项整改工作实施计划，对整改工作做出具体而又详尽的安排，明确不符合项整改的具体要求、责任部门和负责人、整改完成期限、实际完成时间


责任部门应明确采用何种方式解决，想要达到的目标，由谁执行，在哪执行，何时完成，具体如何完成。

gaowenhua

Designate a dedicated person to coordinate, guide, supervise, inspect, and track the rectification work.



Convene a meeting of relevant personnel from various functional departments to rectify non conformities. Based on the rectification requirements proposed by the audit team for non conformities, analyze and study the background and causal relationship of the occurrence of non conformities, determine the process and causes of non conformities, and the responsible department (the department where non conformities occur may not necessarily be the main responsible department, but should be comprehensively analyzed and reasonably determined).




Develop an implementation plan for the rectification of non conformities, make specific and detailed arrangements for the rectification work, clarify the specific requirements for the rectification of non conformities, the responsible department and person in charge, the completion deadline for rectification, and the actual completion time




The responsible department should clarify the methods used to solve the problem, the goals they want to achieve, who will execute them, where they will execute them, when they will complete them, and how they will achieve them.

gaowenhua

整改效果验证没有达到纠正措施的目的，受审核方应继续整改，重新制订整改工作计划，实施后再次进行效果验证。

受审核方应及时提炼、总结不符合项整改工作中存在的问题，不断优化整改工作管理过程，以深入、有效地推进整改工作的持续改进。

gaowenhua

If the verification of the rectification effect does not achieve the purpose of the corrective measures, the audited party should continue to rectify and formulate a new rectification work plan. After implementation, the effectiveness verification should be conducted again. The audited party should promptly extract and summarize the problems that exist in the rectification work of non conformities, continuously optimize the management process of rectification work, in order to deeply and effectively promote the continuous improvement of rectification work.