CAPA实施确认VSCAPA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Theinpidual(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。