纠正预防措施管理 Corrective and Preventive Action Management

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纠正与预防措施管理（Corrective and Preventive Action Management, 简称 CAPA）是质量管理体系（如ISO 9001、ISO 13485、GMP等）中的核心环节。它是一个系统化的过程，旨在识别问题、分析根本原因、实施纠正措施以消除已发生的问题，并采取预防措施以防止潜在问题的发生，从而实现持续改进。

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Corrective and Preventive Action Management (CAPA) is a core component of quality management systems (such as ISO 9001, ISO 13485, GMP, etc.). It is a systematic process designed to identify issues, analyze root causes, implement corrective actions to address existing problems, and take preventive measures to avoid potential issues, thereby achieving continuous improvement.

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核心概念区分

概念

定义

目的

触发条件

纠正 (Correction)

针对已识别的不合格或缺陷，采取的直接、即时的修正行动。

“灭火”——让问题不再可见。

问题发生后，如发现不良品、客户投诉。

纠正措施 (Corrective Action)

为消除已发生不合格或其它不期望情况的根本原因而采取的措施。

“治本”——防止问题再次发生。

问题发生后，需进行根本原因分析。

预防措施 (Preventive Action)

为消除潜在不合格或不期望情况的根本原因而采取的措施。

“防火”——防止问题首次发生。

通过风险评估、趋势分析等预测潜在风险。

举例说明：

• 现象：实验室一台天平读数不准。
• 纠正：将这台天平从使用区移除，并用另一台合格的天平替代。
• 纠正措施：分析发现是因未按计划进行校准。措施：修订校准计划并确保严格执行。
• 预防措施：检查所有实验室设备的校准计划，确保全部覆盖且执行到位，防止其他设备出现同样问题。
  

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Core concept differentiation
Concept definition, purpose, triggering conditions
Correction is a direct and immediate corrective action taken for identified nonconformities or defects. 'Extinguish the fire' - make the problem no longer visible. After the problem occurs, such as discovering defective products or customer complaints.
Corrective Action is a measure taken to eliminate the root cause of non conformities or other unexpected situations that have occurred. Root cause "- prevent the problem from happening again. After the problem occurs, a root cause analysis is required.
Preventive Action is a measure taken to eliminate the root causes of potential nonconformities or unexpected situations. Fire prevention - preventing problems from happening for the first time. Predict potential risks through risk assessment, trend analysis, and other methods.
For example:

Phenomenon: One balance in the laboratory has inaccurate readings.
Correction: Remove this balance from the usage area and replace it with another qualified balance.
Corrective action: Analysis revealed that the issue was due to failure to calibrate as planned. Measure: Revise the calibration plan and ensure strict implementation.
Preventive measures: Check the calibration plan of all laboratory equipment to ensure full coverage and proper execution, and prevent other equipment from experiencing the same problem.

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CAPA管理流程（八步法）

一个完整的CAPA流程通常包括以下步骤：

• 问题识别与报告 (Identification & Reporting)

  • 来源：内部（内审、过程监控、不合格品、客户投诉、员工反馈）和外部（客户投诉、监管检查、市场反馈）。
  • 要求：建立畅通的报告渠道，鼓励全员参与。
    

• 初步评估与分类 (Initial Assessment & Triage)

  • 评估问题的严重性、紧急程度和影响范围。
  • 决定是否需要启动正式CAPA流程，或可通过简单纠正处理。
  • 分配优先级（高、中、低）。
    

• 启动CAPA (Initiate CAPA)

  • 填写CAPA申请单或在系统中创建CAPA记录。
  • 指定负责人（CAPA负责人）和团队。
  • 设定完成时限。
    

• 根本原因分析 (Root Cause Analysis, RCA)

  • 这是CAPA成功的关键！ 必须找到真正的原因，而非表面现象。
  • 常用工具：
    • 5 Why分析法：连续追问“为什么”，直到找到根本原因。
    • 鱼骨图（石川图）：从人、机、料、法、环、测（5M1E）六个方面系统分析。
    • 失效模式与影响分析（FMEA）：用于预防措施，预测潜在失效。
    • 故障树分析（FTA）：逻辑化分析导致事件发生的各种路径。
      
    
    

• 制定纠正与预防措施 (Develop Actions)

  • 基于根本原因，制定具体的、可操作的、可衡量的措施。
  • 措施应能有效消除根本原因。
  • 进行风险评估，确保新措施不会引入新的风险。
    

• 措施审批与实施 (Approval & Implementation)

  • CAPA计划需经相关管理层审批。
  • 由责任人执行措施，如：修订SOP、培训员工、调整工艺参数、更换设备等。
  • 记录实施过程和证据。
    

• 效果验证 (Effectiveness Verification)

  • 在措施实施后的一段时间（如3-6个月），通过数据监控验证问题是否真正解决。
  • 验证方法：检查相关KPI（如不良率、投诉率）是否改善；进行过程审核；收集客户反馈。
  • 关键：必须有客观证据证明措施有效。
    

• 关闭与归档 (Closure & Archiving)

  • 效果验证通过后，由发起人或质量部门批准关闭CAPA。
  • 所有相关记录（问题描述、RCA、措施、证据、验证结果）完整归档，保存期限符合法规要求。
  • 
    
    

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CAPA Management Process (Eight Step Method)
A complete CAPA process typically includes the following steps:

Identification&Reporting
Source: Internal (internal audit, process monitoring, non-conforming products, customer complaints, employee feedback) and external (customer complaints, regulatory inspections, market feedback).
Requirement: Establish a smooth reporting channel and encourage full participation from all staff.
Initial Assessment&Triage
Assess the severity, urgency, and scope of impact of the problem.
Deciding whether to initiate a formal CAPA process or to address it through simple corrective actions.
Assign priority (high, medium, low).
Initiate CAPA
Fill out the CAPA application form or create a CAPA record in the system.
Designated responsible person (CAPA responsible person) and team.
Set a deadline for completion.
Root Cause Analysis (RCA)
This is the key to the success of CAPA! We must find the real reason, not the surface phenomenon.
Common tools:
Why analysis method: Continuously ask "why" until the root cause is found.
Fishbone diagram (Ishikawa diagram): a systematic analysis from six aspects: human, machine, material, method, environment, and measurement (5M1E).
Failure Mode and Effects Analysis (FMEA): Used for preventive measures and predicting potential failures.
Fault Tree Analysis (FTA): Logical analysis of various paths leading to the occurrence of events.
Develop Corrective and Preventive Actions
Develop specific, actionable, and measurable measures based on the root cause.
The measures should be able to effectively eliminate the root cause.
Conduct a risk assessment to ensure that new measures do not introduce new risks.
Approval&Implementation of Measures
The CAPA plan requires approval from relevant management.
The responsible person shall implement measures such as revising SOP, training employees, adjusting process parameters, replacing equipment, etc.
Record the implementation process and evidence.
Effectiveness Verification
After the implementation of the measures for a period of time (such as 3-6 months), verify whether the problem has been truly resolved through data monitoring.
Verification method: Check whether the relevant KPIs (such as defect rate and complaint rate) have improved; Conduct process audits; Collect customer feedback.
Key: There must be objective evidence to prove the effectiveness of the measures.
Closure&Archiving
After the effectiveness verification is passed, the initiator or quality department approves the closure of CAPA.
All relevant records (problem description, RCA, measures, evidence, verification results) shall be fully archived and retained for a period in accordance with regulatory requirements.

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CAPA管理的关键成功因素

因素

说明

高层承诺

管理层必须重视CAPA，提供资源和支持，营造“不责备”的文化。

全员参与

鼓励一线员工报告问题，因为他们最了解现场。

数据驱动

基于事实和数据做决策，避免主观臆断。

及时性

快速响应，避免问题扩大。

闭环管理

确保每个CAPA都经过完整流程，直至验证有效后才关闭。

趋势分析

定期回顾CAPA数据，识别系统性问题或重复发生的主题，推动更高层次的改进。

培训

对员工进行CAPA流程、RCA工具的培训。

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Key success factors of CAPA management
Factor Explanation
The senior management promises that they must attach importance to CAPA, provide resources and support, and create a culture of 'no blame'.
Encourage all frontline employees to report issues, as they have the best understanding of the site.
Data driven decision-making is based on facts and data, avoiding subjective speculation.
Timely and rapid response to prevent the problem from escalating.
Closed loop management ensures that each CAPA goes through a complete process until it is validated as valid before being closed.
Trend analysis regularly reviews CAPA data, identifies systemic issues or recurring themes, and drives higher-level improvements.
Train employees on CAPA process and RCA tools.

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Common Challenges and Responses of CAPA
Challenge response strategy
Treat headaches with the head, treat feet with the feet
Mandatory requirement to use RCA tools (only for correction, not for root cause analysis); The quality department conducts strict audits.
Insufficient in-depth root cause analysis
(Staying at the surface reason) Training 5 Why, fishbone diagram and other methods; Establish an expert review mechanism.
Conduct risk assessment before implementing ineffective measures or introducing new risks; Small-scale pilot; Strengthen effectiveness verification.
The process is cumbersome and the execution is slow. Optimize the process and distinguish between high/low-risk CAPA; Use electronic CAPA system to improve efficiency.
Lack of standardized validation templates and checklists for effectiveness verification; Set clear verification cycles.

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纠正与预防措施管理（CAPA）不是一次性的“救火”行动，而是一个持续改进的循环。它体现了质量管理的精髓——从被动应对转向主动预防。

一个高效的CAPA系统能够：

减少重复性问题，降低质量成本。
提升客户满意度，增强品牌信誉。
满足法规要求，通过审计检查。
驱动组织学习，积累知识资产。
实现真正的持续改进。
记住：没有问题才是最大的问题。优秀的组织不是没有CAPA，而是能通过CAPA不断发现并解决问题，从而变得越来越强大。