CAPA：Verificationof Implementation VS Verificationof Effectiveness , How to do?

CAPA實施確認 VS CAPA有效性確認，如何實施？

 

參考：

A SMART Approach To CAPA Effectiveness Checks, By Mark Durivage, Quality Systems Compliance LLC

The 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.

一個良好的CAPA過程包括10個不同的階段，如下圖所示。

anagement review 管理評審	CAPA Phases CAPA階段	Improvement 改進
	Problem identification and CAPA initiation 發現問題并CAPA啟動
	Risk analysis 風險分析
	Investigation/Root cause analysis 調查/根本原因分析
	Corrective/preventive action（s） 糾正/預防行動
	Implementation 實施
	Verification of implementation 實施確認
	Verification of effectiveness plan 有效性確認計劃
	Verification of effectiveness 有效性確認
	Closure 關閉

 

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規定:“應使用CAPA，并評估CAPA的有效性。”因此，質量部門必須對其CAPA計劃進行有效性檢查——測量并確定CAPA是否已經消除了該問題。

 

Verificationof Implementation

CAPA實施確認

 

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.

確認被定義為通過提供客觀證據來確認已滿足所指定的要求。實施確認階段記錄糾正和預防措施的實際實施情況。

 

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

CAPA的實施確認(VOI)階段經常與有效性確認(VOE)階段相混淆，它們是相互獨立的、不同的階段。

 

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

實施確認用于確認糾偏、控制、糾正措施和預防措施確實按照承諾和計劃實施。

 

Examples of VOIsinclude:

CAPA實施確認的示例包括：

 

Procedures, work instructions, forms, and/or templates were updated.

程序、操作SOP、記錄和/或模板已得到更新。

 

A changeorder was processed

變更已得到處理

 

Theindividual(s) were trained or retrained

人員已得到培訓或再培訓

 

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

可疑部分已被隔離

 

Verificationof Effectiveness Plan (VOEP)

CAPA 有效性確認計劃

 

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

有效性計劃階段用于建立和定義既定標準，以確認糾正和/或預防措施確實有效。

 

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

為了幫助確定最合適的有效性檢查方法，請回答以下問題:

 

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.

誰來測量（CAPA有效性）？該任務應分配給質量部門或組織內的其他小組，以確保所有質量體系問題按照規定得到解決。

 

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.

衡量的標準是什么？測量可以呈現許多不同的表現。可以衡量采取CAPA后出錯的數量與CAPA前進行對比。可以衡量采取CAPA后發生的偏差的類型/數量，或者也可以衡量特定產品上新工藝的有效性。還可以測量培養后超出標準的環境監測結果的數量。

 

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？在大多數情況下，測量可以使用CAPA表格或電子跟蹤系統進行記錄。

 

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.

什么時候衡量？衡量的時間取決于缺陷的嚴重程度。針對低嚴重性缺陷的CAPA，對患者無害，可以放在“停車場”。而更嚴重的缺陷，如那些可能導致危及病人生命的傷害，應立即調查和檢查。

 

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？有效性檢查的衡量可以定性或定量地完成?；诙攘康臋z查可以解釋定量方面，而定性方法可以包括修訂標準操作程序(SOP)或培訓受影響的員工。例如，一旦SOP被修改，可以通過跟蹤該過程的偏差數量來監測員工的表現和對SOP修訂的準守程度。

 

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.

如何分析衡量結果？質量部門進行衡量分析，以確定CAPA是否有效，CAPA計劃是否可以關閉。例如，質量人員可以通過到車間來進行測量，以確定是否遵循了糾正措施，以及它們是否確實有益于該過程。

 

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.

數據分析將傳達給誰？就像在大多數組織中一樣，這個數據分析應該被討論，并以月度指標的形式提交給質量單位執行管理團隊。當然，分析也應該傳達給CAPA計劃的所有者。

 

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

George T. Doran被認為是第一個使用SMART術語的人:

 

Specific — Is the VOEP     unambiguous, clear, and focused?

具體-有效性確認計劃（VOEP）是否明確、清晰、有針對性?

 

Measurable — Is quantifiable     data being used to assess the VOEP?

可測量-是否使用可量化數據來評估有效性確認計劃（VOEP）

 

Achievable — Is the VOEP     feasible or practical?

可實現- 有效性確認計劃（VOEP）是否可實行或貼合實際?

 

Relevant — Is the VOEP     appropriate for the level of risk?

相關- 有效性確認計劃（VOEP）是否與風險級別想適應?

 

Time bound — Does the VOEP     have a realistic deadline?

時效性- 有效性確認計劃（VOEP）有實際的最后期限嗎?

 

Examples of aVOEP’s checks include:

有效性確認計劃（VOEP）檢查的示例包括:

 

The problem has not recurred in the last three     production lots

最近的三個生產批次都沒有出現過此問題

 

The problem has not recurred in the last three     months

此問題在過去三個月沒有再發生過

 

The first pass yield is >99 percent

一次合格率達到> 99%

 

The scrap rate will decrease by 5 percent (say,     from 15 percent to 10 percent)

不合格品率下降5%(例如從15%下降到10%)

 

Verificationof Effectiveness (VOE)

CAPA 有效性確認(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.

有效性確認階段包括對有效性驗證計劃中確定的既定標準進行回顧并記錄。有效性的成功確認應證明問題的真正根本原因已被正確識別，糾正措施和/或預防措施是有效的。

 

Examples of aVOE’s checks and corresponding verifications include:

有效性確認（VOE）的檢查和相應的確認示例包括:

 

The problem has not recurred in the last three     production lots. Verification: Lots #123, #456, #789 were reviewed to     demonstrate the CAPA was effective.

最近三個生產批次都沒有出現此問題。確認內容：對批次為#123、#456、#789的產品進行了審核，以證明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.

在過去三個月沒有再發生過此問題。確認內容：對投訴臺賬和不合格報告(NCR)臺賬進行了審核，以證明糾正措施是有效的。

 

The first pass yield is >99 percent.     Verification: The first pass yield is 99.25, percent, which demonstrates     the CAPA was effective.

一次合格率達到> 99%。確認內容：一次合格率為99.25%，證明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%(從15%下降到10%)。確認內容：不合格品率為9.5%，證明CAPA是有效的。