CAPA实施确认 VS CAPA有效性确认，如何实施？

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本文转载自GMP办公室

CAPA：Verificationof Implementation VS Verificationof Effectiveness , How to do?CAPA实施确认 VS CAPA有效性确认，如何实施？

参考：A SMART Approach To CAPA Effectiveness Checks, By Mark Durivage, Quality Systems Compliance LLCThe 10 Phases Of An Effective CAPA, By Mark Durivage, Quality Systems Compliance LLC

A good CAPAprocess consists of 10 distinct phases, as shown in the figure below.

一个良好的CAPA过程包括10个不同的阶段，如下图所示。

Management review 管理评审	CAPA Phases CAPA阶段	Improvement 改进
	Problem identification and CAPA initiation 发现问题并CAPA启动
	Risk analysis 风险分析
	Investigation/Root cause analysis 调查/根本原因分析
	Corrective/preventive action（s） 纠正/预防行动
	Implementation 实施
	Verification of implementation 实施确认
	Verification of effectiveness plan 有效性确认计划
	Verification of effectiveness 有效性确认
	Closure 关闭

Step 3.2.2 ofICH Q10 states: “CAPA should be used and the effectiveness of the actionsshould be evaluated.” Thus, quality units must perform effectiveness checks ontheir CAPA plans — measuring and determining that the corrective action has (orhas not) eliminated the problem.

ICH Q10的第3.2.2规定:“应使用CAPA，并评估CAPA的有效性。”因此，质量部门必须对其CAPA计划进行有效性检查——测量并确定CAPA是否已经消除了该问题。

Verificationof Implementation

CAPA实施确认

Verification isdefined as confirmation, through the provision of objective evidence thatspecified requirements have been fulfilled. The verification of implementationphase documents that corrective and preventive actions were actuallyimplemented.

确认被定义为通过提供客观证据来确认已满足所指定的要求。实施确认阶段记录纠正和预防措施的实际实施情况。

The verificationof implementation (VOI) phase is often confused with the verification ofeffectiveness (VOE) phase of a CAPA, but these are separate, distinct phases.

CAPA的实施确认(VOI)阶段经常与有效性确认(VOE)阶段相混淆，它们是相互独立的、不同的阶段。

VOIs are used toverify that corrections, containment, corrective actions, and preventiveactions were indeed implemented as promised and planned.

实施确认用于确认纠偏、控制、纠正措施和预防措施确实按照承诺和计划实施。

Examples of VOIsinclude:

CAPA实施确认的示例包括：

• Procedures, work instructions, forms, and/or templates were updated.
• 程序、操作SOP、记录和/或模板已得到更新。
• A changeorder was processed
• 变更已得到处理
• Theindividual(s) were trained or retrained
• 人员已得到培训或再培训
• Thesuspect parts were sorted
• 可疑部分已被挑出
• Thesuspect parts were reworked
• 可疑部分已被返工
• Thesuspect parts were quarantined
• 可疑部分已被隔离
  
  

Verificationof Effectiveness Plan (VOEP)

CAPA 有效性确认计划

Theeffectiveness plan phase is used to establish and define predetermined criteriato verify that corrective and/or preventive actions were indeed effective.

有效性计划阶段用于建立和定义既定标准，以确认纠正和/或预防措施确实有效。

To helpdetermine the most appropriate measurement for your effectiveness check, answersome/all of these questions:

为了帮助确定最合适的有效性检查方法，请回答以下问题:

1. Who will measure     it? The task should be assigned to the quality unit or     other group in the organization that ensures all quality system issues are     resolved according to regulations.

谁来测量（CAPA有效性）？该任务应分配给质量部门或组织内的其他小组，以确保所有质量体系问题按照规定得到解决。

2. What will be measured? Measurements can     take on many different appearances. You can measure the number of errors     made once the solution is in place versus the number made prior to its     implementation. You can measure the types/amount of deviations that occur     after the solution is implemented, or you can measure the effectiveness of     a new process on a specific product. You can also measure the amount of     over-the-limit environmental monitoring results after incubation.

衡量的标准是什么？测量可以呈现许多不同的表现。可以衡量采取CAPA后出错的数量与CAPA前进行对比。可以衡量采取CAPA后发生的偏差的类型/数量，或者也可以衡量特定产品上新工艺的有效性。还可以测量培养后超出标准的环境监测结果的数量。

3. Where will it be     measured? In most cases, the measurement can be     documented using the CAPA form or electronic tracking system.

在哪里衡量？在大多数情况下，测量可以使用CAPA表格或电子跟踪系统进行记录。

4. When will it be measured? The timing of the     measurement depends on the severity of the defect. CAPAs with low severity     defects, which are not harmful to the patient, can be put in the “parking     lot.” While more significant defects, such as those that may cause the patient     life-threatening harm, should be investigated and checked immediately.

什么时候衡量？衡量的时间取决于缺陷的严重程度。针对低严重性缺陷的CAPA，对患者无害，可以放在“停车场”。而更严重的缺陷，如那些可能导致危及病人生命的伤害，应立即调查和检查。

5. How will it be measured? Measurement of     effectiveness checks can be done qualitatively or quantitatively, as     discussed in the previous examples. Metric-based checks can account for     the quantitative aspect, whereas the qualitative approach can include     revisions to a standard operating procedure (SOP) or training of impacted     employees. For example, once the SOP has been revised, you can monitor     employee performance and compliance to the SOP revision by tracking the     number of deviations to the step.

如何衡量？有效性检查的衡量可以定性或定量地完成。基于度量的检查可以解释定量方面，而定性方法可以包括修订标准操作程序(SOP)或培训受影响的员工。例如，一旦SOP被修改，可以通过跟踪该过程的偏差数量来监测员工的表现和对SOP修订的准守程度。

6. How will measurements be     analyzed? Analysis of the measurements is conducted by     the quality unit, who will determine if the solution was effective and the     CAPA plan can be closed. For instance, quality staff can conduct     measurements by heading out onto the shop floor to determine if corrective     actions are being followed and if they are indeed beneficial to the     process.

如何分析衡量结果？质量部门进行衡量分析，以确定CAPA是否有效，CAPA计划是否可以关闭。例如，质量人员可以通过到车间来进行测量，以确定是否遵循了纠正措施，以及它们是否确实有益于该过程。

7. Who will data analysis be     communicated to? As in most organizations, this data     analysis should be discussed and presented to the quality unit executive management team in the form of monthly metrics. Of course, the analysis     should also be communicated to the owners of the CAPA plans.

数据分析将传达给谁？就像在大多数组织中一样，这个数据分析应该被讨论，并以月度指标的形式提交给质量单位执行管理团队。当然，分析也应该传达给CAPA计划的所有者。

George T. Doranis credited with first using the term SMART:

George T. Doran被认为是第一个使用SMART术语的人:

• Specific — Is the VOEP     unambiguous, clear, and focused?
• 具体-有效性确认计划（VOEP）是否明确、清晰、有针对性?
• Measurable — Is quantifiable     data being used to assess the VOEP?
• 可测量-是否使用可量化数据来评估有效性确认计划（VOEP）
• Achievable — Is the VOEP     feasible or practical?
• 可实现- 有效性确认计划（VOEP）是否可实行或贴合实际?
• Relevant — Is the VOEP     appropriate for the level of risk?
• 相关- 有效性确认计划（VOEP）是否与风险级别想适应?
• Time bound — Does the VOEP     have a realistic deadline?
• 时效性- 有效性确认计划（VOEP）有实际的最后期限吗?
  
  

Examples of aVOEP’s checks include:

有效性确认计划（VOEP）检查的示例包括:

• The problem has not recurred in the last three     production lots
• 最近的三个生产批次都没有出现过此问题
• The problem has not recurred in the last three     months
• 此问题在过去三个月没有再发生过
• The first pass yield is >99 percent
• 一次合格率达到> 99%
• The scrap rate will decrease by 5 percent (say,     from 15 percent to 10 percent)
• 不合格品率下降5%(例如从15%下降到10%)
  
  

Verificationof Effectiveness (VOE)

CAPA 有效性确认(VOE)

The verificationof effectiveness phase includes reviewing and documenting the predeterminedcriteria established in the verification of effectiveness plan. A successfulverification of effectiveness should demonstrate the true root cause of theissue was properly identified and the corrective and/or preventive actions wereeffective.

有效性确认阶段包括对有效性验证计划中确定的既定标准进行回顾并记录。有效性的成功确认应证明问题的真正根本原因已被正确识别，纠正措施和/或预防措施是有效的。

Examples of aVOE’s checks and corresponding verifications include:

有效性确认（VOE）的检查和相应的确认示例包括:

• The problem has not recurred in the last three     production lots. Verification: Lots #123, #456, #789 were reviewed to     demonstrate the CAPA was effective.
• 最近三个生产批次都没有出现此问题。确认内容：对批次为#123、#456、#789的产品进行了审核，以证明CAPA有效。
• The problem has not recurred in the last three     months. Verification: The complaint log and non-conformance report (NCR)     log were reviewed to demonstrate the CAPA was effective.
• 在过去三个月没有再发生过此问题。确认内容：对投诉台账和不合格报告(NCR)台账进行了审核，以证明纠正措施是有效的。
• The first pass yield is >99 percent.     Verification: The first pass yield is 99.25, percent, which demonstrates     the CAPA was effective.
• 一次合格率达到> 99%。确认内容：一次合格率为99.25%，证明CAPA是有效的。
• The scrap rate will decrease by 5 percent (from     15 percent to 10 percent). Verification: The scrap rate is now 9.5     percent, which demonstrates the CAPA was effective.
• 不合格品率下降5%(从15%下降到10%)。确认内容：不合格品率为9.5%，证明CAPA是有效的。