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1、纠正预防措施(CAPA）法规解读和经验分享第一章第一章 CAPA概述概述CAPA相关法规/标准概览；为什么要做CAPA？CAPA对于制造商有何好处？第二章第二章 CAPA法法规详规详解解（QSR）术语和定义法规要点各国法规的主要差异第三章第三章 CAPA流程流程详详解解数据分析定义问题纠正根因分析制定纠正预防措施措施实施前的验证和确认实施措施和沟通有效性确认管理评审CAPA相关法相关法规规概概览览中国医疗器械生产质量管理规范CAPA相关法相关法规规概概览览YY/T 0287-2017 (ISO 13485-2016 IDT)8.5改进CAPA相关法相关法规规概概览览PART 820 QUALI
2、TY SYSTEM REGULATION（QSR 820）ISO 13485:2016QSR 820QSR 820比ISO13485和医疗器械生产质量管理规范要求更多；QSR 820比ISO13485和医疗器械生产质量管理规范要求更详细；从审核角度来说，FDA审核对于CAPA关注度更高，要求也更高。医疗器械生产质量管理规范CAPA相关法相关法规规概概览览三大区三大区域域CAPA法法规对规对比比为为什么要做什么要做CAPAFDA对于中国制造商越来越“照顾”为为什么要做什么要做CAPA历年FDA开出的不 符合项（483）， CAPA子系统排名稳 居前二为为什么要做什么要做CAPA为为什么要做什么要
3、做CAPAFDA开出的警告信， CAPA子系统也一直是 前二位第一章第一章 CAPA概述概述CAPA相关法规概览；为什么要做CAPA？CAPA对于制造商有何好处？第二章第二章 CAPA法法规详规详解解（QSR）术语和定义法规要点法规的主要差异第三章第三章 CAPA流程流程详详解解数据分析定义问题纠正根因分析制定纠正预防措施措施实施前的验证和确认实施措施和沟通有效性确认管理评审第四章第四章 迈迈瑞瑞CAPA流程流程简简介介Correction纠纠正正Corrective Action纠纠正措施正措施Preventive Action预预防措施防措施Definition(ISO 9000:2015
4、)action to eliminate a detected nonconformityaction to eliminate the cause of a nonconformity and to prevent recurrence.action to eliminate the cause of a potential nonconformity or other potential undesirable situation.定定义义（GBT 19000:2016）为消除已发现的不合格 所采取的措施为消除不合格的原因并 防止再发生所采取的措 施为消除潜在不合格或其 他潜在不期望情况的
5、原 因所采取的措施举举例例家中着火扑灭火焰可能的纠正措施：其他报警装置；不让在家中吸烟；更换导致起火的线路可能的预防措施：定期检查和维护家中电 器，排查火灾隐患；术语术语和定和定义义QSR 820.100关关键键字字(a) Each manufacturer shall establish and maintain procedures for implementing corrective and preventive action. The procedures shall include requirements for:建立程序并实施程序(1) Analyzing processes,
6、 work operations, concessions, quality audit reports, quality records, service records, complaints, returned product, and other sources of quality data to identify existing and potential causes of nonconforming product, or other quality problems. Appropriate statistical methodology shall be employed
7、 where necessary to detect recurring quality problems;使用适宜的统计技术进行数据分析，以识别重复发生的质 量问题2) Investigating the cause of nonconformities relating to product, processes, and the quality system;调查不合格的原因法法规规要点要点820.100关关键键字字(3) Identifying the action(s) needed to correct and prevent recurrence of nonconforming
8、 product and other quality problems;识别防止不合格再次发生所 需要采取的措施(4) Verifying or validating the corrective and preventive action to ensure that such action is effective and does not adversely affect the finished device;验证或确认纠正预防措施， 确保措施有效且不会对最终 产品产线不良影响5) Implementing and recording changes in methods and pr
9、ocedures needed to correct and prevent identified quality problems;实施并记录方法和程序的更 改(6) Ensuring that information related to quality problems or nonconforming product is disseminated to those directly responsible for assuring the quality of such product or the prevention of such problems; and确保质量问题传递到相
10、关负 责的人员(7) Submitting relevant information on identified quality problems, as well as corrective and preventive actions, for management review.提交管理评审法法规规要点要点法法规规的主要差异的主要差异ISO13485:20168.5.2 Corrective actionThe organization shall take action to eliminate the cause of nonconformities in order to prev
11、ent recurrence. Any necessary corrective actions shall be taken without undue delay. Corrective actions shall be proportionate to the effects of the nonconformities encountered.应应无不当拖延无不当拖延e) verifying that the corrective action does not adversely affect the ability to meet applicable regulatory req
12、uirements or the safety and performance of the medical device;应验证纠应验证纠正措施正措施对对于于满满足适用的法足适用的法规规要求的能力要求的能力总结总结The purpose of the corrective and preventive action is to collect information, analyze information, identify and investigate product and quality problems, and take appropriate and effective co
13、rrective and/or preventive action to prevent their recurrence. Verifying or validating corrective and preventive actions, communicating corrective and preventive action activities to responsible people, providing relevant information for management review, and documenting these activities are essent
14、ial in dealing effectively with product and quality problems, preventing their recurrence, and preventing or minimizing device failures.QSIT Purpose of CAPA纠正和预防措施的目的是收集信息，分析信息，识别和调查产品和质量问题，并 采取适当，有效的纠正和/或预防措施，防止其再次发生。 验证或确认纠正和预 防措施，并向负责人传达纠正和预防措施活动，提供有关信息至管理评审，并记 录这些活动，对对于于有有效效处处理理产产品品和和质质量量问问题题，防防
15、止止其其再再次次发发生生，防防止止或或最最小小化化设设 备备故障至关重要。故障至关重要。第一章第一章 CAPA概述概述CAPA相关法规概览；为什么要做CAPA？CAPA对于制造商有何好处？第二章第二章 CAPA法法规详规详解解（QSR）术语和定义法规要点各国法规的主要差异第三章第三章 CAPA流程流程详详解解数据分析定义问题纠正根因分析制定纠正预防措施措施实施前的验证和确认实施措施和沟通有效性确认管理评审第四章第四章 迈迈瑞瑞CAPA流程流程简简介介4.0 Phase I Planning4.1 Plan for Measurement, Analysis and Improvement Pr
16、ocesses7.1 Report to Management and 7.2 Management ReviewExamples of defined Data Sources5.1 Measure and 5.2 Analysecoordination / linkage of data / data sources / “horizontal analysis”Within each data source4.2 Establish Data Sources and CriteriaFeedbackComplaintsService ReportsSpare parts usageQuality Audits (internal / external)Supplier Performance/ControlsProcess ControlsReturned ProductMarket / customer surveyImprovement6.1 Investigate6.2 Identify Root Cause6.3 Identify Actions6.4 Verify id
