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

CAPA實(shí)施確認(rèn) VS CAPA有效性確認(rèn)，如何實(shí)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(gè)良好的CAPA過程包括10個(gè)不同的階段，如下圖所示。

anagement review 管理評(píng)審	CAPA Phases CAPA階段	Improvement 改進(jìn)
	Problem identification and CAPA initiation 發(fā)現(xiàn)問題并CAPA啟動(dòng)
	Risk analysis 風(fēng)險(xiǎn)分析
	Investigation/Root cause analysis 調(diào)查/根本原因分析
	Corrective/preventive action（s） 糾正/預(yù)防行動(dòng)
	Implementation 實(shí)施
	Verification of implementation 實(shí)施確認(rèn)
	Verification of effectiveness plan 有效性確認(rèn)計(jì)劃
	Verification of effectiveness 有效性確認(rèn)
	Closure 關(guān)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(guī)定:“應(yīng)使用CAPA，并評(píng)估CAPA的有效性。”因此，質(zhì)量部門必須對(duì)其CAPA計(jì)劃進(jìn)行有效性檢查——測(cè)量并確定CAPA是否已經(jīng)消除了該問題。

 

Verificationof Implementation

CAPA實(shí)施確認(rèn)

 

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(rèn)被定義為通過提供客觀證據(jù)來(lái)確認(rèn)已滿足所指定的要求。實(shí)施確認(rèn)階段記錄糾正和預(yù)防措施的實(shí)際實(shí)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(shí)施確認(rèn)(VOI)階段經(jīng)常與有效性確認(rèn)(VOE)階段相混淆，它們是相互獨(dú)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(shí)施確認(rèn)用于確認(rèn)糾偏、控制、糾正措施和預(yù)防措施確實(shí)按照承諾和計(jì)劃實(shí)施。

 

Examples of VOIsinclude:

CAPA實(shí)施確認(rèn)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(xùn)或再培訓(xùn)

 

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(rèn)計(jì)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(jì)劃階段用于建立和定義既定標(biāo)準(zhǔn)，以確認(rèn)糾正和/或預(yù)防措施確實(shí)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(qǐng)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(shuí)來(lái)測(cè)量（CAPA有效性）？該任務(wù)應(yīng)分配給質(zhì)量部門或組織內(nèi)的其他小組，以確保所有質(zhì)量體系問題按照規(guī)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(biāo)準(zhǔn)是什么？測(cè)量可以呈現(xiàn)許多不同的表現(xiàn)。可以衡量采取CAPA后出錯(cuò)的數(shù)量與CAPA前進(jìn)行對(duì)比?？梢院饬坎扇APA后發(fā)生的偏差的類型/數(shù)量，或者也可以衡量特定產(chǎn)品上新工藝的有效性。還可以測(cè)量培養(yǎng)后超出標(biāo)準(zhǔn)的環(huán)境監(jiān)測(cè)結(jié)果的數(shù)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(shù)情況下，測(cè)量可以使用CAPA表格或電子跟蹤系統(tǒng)進(jìn)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(shí)候衡量？衡量的時(shí)間取決于缺陷的嚴(yán)重程度。針對(duì)低嚴(yán)重性缺陷的CAPA，對(duì)患者無(wú)害，可以放在“停車場(chǎng)”。而更嚴(yán)重的缺陷，如那些可能導(dǎo)致危及病人生命的傷害，應(yīng)立即調(diào)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(biāo)準(zhǔn)操作程序(SOP)或培訓(xùn)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(shù)量來(lái)監(jiān)測(cè)員工的表現(xiàn)和對(duì)SOP修訂的準(zhǔn)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(jié)果？質(zhì)量部門進(jìn)行衡量分析，以確定CAPA是否有效，CAPA計(jì)劃是否可以關(guān)閉。例如，質(zhì)量人員可以通過到車間來(lái)進(jìn)行測(cè)量，以確定是否遵循了糾正措施，以及它們是否確實(shí)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(shù)據(jù)分析將傳達(dá)給誰(shuí)？就像在大多數(shù)組織中一樣，這個(gè)數(shù)據(jù)分析應(yīng)該被討論，并以月度指標(biāo)的形式提交給質(zhì)量單位執(zhí)行管理團(tuán)隊(duì)。當(dāng)然，分析也應(yīng)該傳達(dá)給CAPA計(jì)劃的所有者。

 

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

George T. Doran被認(rèn)為是第一個(gè)使用SMART術(shù)語(yǔ)的人:

 

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

具體-有效性確認(rèn)計(jì)劃（VOEP）是否明確、清晰、有針對(duì)性?

 

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

可測(cè)量-是否使用可量化數(shù)據(jù)來(lái)評(píng)估有效性確認(rèn)計(jì)劃（VOEP）

 

Achievable — Is the VOEP     feasible or practical?

可實(shí)現(xiàn)- 有效性確認(rèn)計(jì)劃（VOEP）是否可實(shí)行或貼合實(shí)際?

 

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

相關(guān)- 有效性確認(rèn)計(jì)劃（VOEP）是否與風(fēng)險(xiǎn)級(jí)別想適應(yīng)?

 

Time bound — Does the VOEP     have a realistic deadline?

時(shí)效性- 有效性確認(rèn)計(jì)劃（VOEP）有實(shí)際的最后期限嗎?

 

Examples of aVOEP’s checks include:

有效性確認(rèn)計(jì)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(gè)生產(chǎn)批次都沒有出現(xiàn)過此問題

 

The problem has not recurred in the last three     months

此問題在過去三個(gè)月沒有再發(fā)生過

 

The first pass yield is >99 percent

一次合格率達(dá)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(rèn)(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(rèn)階段包括對(duì)有效性驗(yàn)證計(jì)劃中確定的既定標(biāo)準(zhǔn)進(jìn)行回顧并記錄。有效性的成功確認(rèn)應(yīng)證明問題的真正根本原因已被正確識(shí)別，糾正措施和/或預(yù)防措施是有效的。

 

Examples of aVOE’s checks and corresponding verifications include:

有效性確認(rèn)（VOE）的檢查和相應(yīng)的確認(rèn)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(gè)生產(chǎn)批次都沒有出現(xiàn)此問題。確認(rèn)內(nèi)容：對(duì)批次為#123、#456、#789的產(chǎn)品進(jìn)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(gè)月沒有再發(fā)生過此問題。確認(rèn)內(nèi)容：對(duì)投訴臺(tái)賬和不合格報(bào)告(NCR)臺(tái)賬進(jìn)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(dá)到> 99%。確認(rèn)內(nèi)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(rèn)內(nèi)容：不合格品率為9.5%，證明CAPA是有效的。