In 2015 the US Food and Drug Administration (FDA) had started an initiative in order to use so-called quality metrics for the planning of their risk-based inspections. The FDA wishes that, after it has come into force, manufacturers will convey defined quality scores to the FDA via an electronic portal. The FDA plans to use these to calculate specific statistics which are supposed to allow for risk-based management and planning by the FDA. The Quality Metrics Initiative then started with a voluntary phase and a revised draft guidance was published in November 2016. However after this it became a little quite. Since the initiative started, a lot of feedback was given by industry; they feared additional efforts and expenses.
2015年，美國食品藥品監(jiān)督管理局（FDA）啟動了一項新方案，使用所謂的質(zhì)量量度來規(guī)劃其基于風(fēng)險的檢查。FDA希望，在其生效后，制藥企業(yè)可以通過電子門戶向FDA遞送規(guī)定的質(zhì)量量度分?jǐn)?shù)。FDA計劃使用這些數(shù)據(jù)來計算特定的統(tǒng)計數(shù)據(jù)，這些統(tǒng)計數(shù)據(jù)應(yīng)該考慮到FDA基于風(fēng)險的管理和規(guī)劃。隨后，質(zhì)量量度方案從自愿階段開始，并于2016年11月發(fā)布了修訂后的指導(dǎo)草案。然而，在這之后，它似乎再無大的動作了。自該方案啟動以來，業(yè)界給予了大量反饋，他們擔(dān)心會產(chǎn)生額外的工作量和開支。
In 2018 FDA announced two updated programmes: the Quality Metrics Feedback Program and the Quality Metrics Site Visit Program. FDA now also wants to focus on the benefits for industry, saying that with implementing a quality measurement program, 'companies improve their overall quality systems'and finally product quality.
2018年，F(xiàn)DA宣布了兩個更新的計劃：質(zhì)量量度反饋計劃和質(zhì)量量度實地考察計劃。FDA現(xiàn)在也希望把重點(diǎn)放在對行業(yè)的益處上，說通過實施質(zhì)量量度計劃，“企業(yè)來改善他們的整體質(zhì)量體系”，最終保證產(chǎn)品質(zhì)量。
And FDA is right: Quality Metrics are useful and beneficial!
Quality Metrics have already been used in pharmaceutical industry for years- mainly internally to measure operational performance. But quality can be measured on different levels and for many processes. Done in the right way, Quality Metrics can enable companies to reach a high quality performance. They will benefit from a continuous improvement in both operational performance and GMP compliance. And both are important for the continuity of business and product supply.
FDA是對的：質(zhì)量量度是大有裨益的！
質(zhì)量量度已經(jīng)在制藥行業(yè)使用了很多年，主要是在內(nèi)部衡量運(yùn)行業(yè)績。但是質(zhì)量可以在不同的層次和許多過程中進(jìn)行量度。以正確的方式完成，質(zhì)量量度可以使公司達(dá)到高質(zhì)量業(yè)績。他們將受益于運(yùn)行業(yè)績和GMP合規(guī)性的持續(xù)改進(jìn)。兩者對于業(yè)務(wù)和產(chǎn)品供應(yīng)的連續(xù)性都很重要。
Quality Metrics Definitions
質(zhì)量量度的定義
Let's start with some definitions:
Metric: a measure against a standard (standards of measurement by which efficiency, performance, progress, or quality of a plan, process, or product can be assessed)
Indicator: provides indication of performance (qualitative or quantitative), e.g., to evaluate success of an organisation or activity
KPI: key performance indicator; target critical areas of performance (not all indicators are key)
They all should help to develop, collate and analyse information that provides current performance feedback, anticipates future needs and enable sactions. For this, data must be accurate, timely appropriate, correctly analysed and meaningful.
讓我們從一些定義開始：
量度：根據(jù)標(biāo)準(zhǔn)（可評估計劃、過程或產(chǎn)品的效率、性能、進(jìn)度或質(zhì)量的量度標(biāo)準(zhǔn)）進(jìn)行的量度。
指標(biāo)：對性能進(jìn)行指示（定性或定量），例如評估組織或活動的成功程度。
KPI：關(guān)鍵性能指標(biāo)；性能的目標(biāo)關(guān)鍵領(lǐng)域（并非所有指標(biāo)都是關(guān)鍵的）
它們都應(yīng)該有助于對提供當(dāng)前性能反饋、預(yù)測未來需求和采取行動的信息進(jìn)行開發(fā)、整理和分析。為此，數(shù)據(jù)必須是準(zhǔn)確、及時、適當(dāng)、分析正確和并有意義的。
Points to be considered in Metricsand KPIs Development:
在制定指標(biāo)和KPI時要考慮的要點(diǎn)：
So the following points should be considered when developing Metrics and KPIs:
Quantitative vs.qualitative data
Normally data is required to be SMART (Specific Measurable Accepted Realistic Time Bound) although data 'for information' can be useful, especially when starting, to establish a baseline
Measure product specific/operational quality performance, the performance of the overall quality system and Quality Culture
Adequate indicators to show compliance with regulations
Only a few selected KPIs for senior management, more for local management
Measure performance(s) in all areas with resources invested for quality activities
Quality metrics and KPIs which should be common across global sites and offices to allow visual information and data sharing
所以在制定指標(biāo)和KPI時，需要考慮以下幾點(diǎn)：
定量和定性數(shù)據(jù)的區(qū)分
通常情況下，數(shù)據(jù)必須是符合SMART原則：具體的 (Specific)、可度量的(Measurable)、可接受的 (Accepted)、實際的 (Realistic)、有時限的 (Time Bound)。盡管數(shù)據(jù)“對于信息”可能有用，尤其是在開始建立基線時。
衡量產(chǎn)品特定的/質(zhì)量，評估全部質(zhì)量狀態(tài)和質(zhì)量文化；
充分的指標(biāo)來展現(xiàn)法規(guī)符合性；
僅僅一部分特定選擇的KPI來做高級管理，更多是用來本地管理；
利用為質(zhì)量活動投入的資源衡量所有領(lǐng)域的績效；
質(zhì)量量度和KPI應(yīng)在全球各地和辦公室通用，以實現(xiàn)信息可視化和數(shù)據(jù)共享。
Possible Pitfalls
可能存在的問題
And where are the pitfalls?
Too many metrics, complex and time-consuming
Driving wrong behaviours and actions can lead to unintended consequences in order to achievemetrics target
Actions without understanding the context surrounding the results
Not all have same value - determine the crucial few!
Metrics alone will not deliver. Metrics not meeting targets should lead to actions
The outputs of process performance and product quality monitoring are thekey for continual improvement. The necessary changes can be identified,introduced, monitored and controlled to continually improve processes and systems,
In the end Quality Metrics will enable companies and regulators to benefitfrom a continuous investment in GMP to guarantee a high quality performance andthe continuity of quality product supply.
Source: presentation by Ann McGee, PharmaLex Ireland, at the ECA event KPIs and Quality Metrics
易犯的錯誤有哪些？
指標(biāo)太多，復(fù)雜且耗時；
為實現(xiàn)指標(biāo)目標(biāo)，采取錯誤的行為，可能導(dǎo)致意想不到的后果；
不理解結(jié)果的來龍去脈而采取行動
并非所有指標(biāo)都有相同的價值-確定關(guān)鍵的那幾個！
能僅交付指標(biāo)。未達(dá)到目的的指標(biāo)應(yīng)采取行動。
過程績效和產(chǎn)品質(zhì)量監(jiān)控的輸出是持續(xù)改進(jìn)的關(guān)鍵?？梢宰R別、引入、監(jiān)控和控制必要的變更，以持續(xù)改進(jìn)程序和系統(tǒng)，最終，為確保高質(zhì)量運(yùn)行和優(yōu)質(zhì)產(chǎn)品的連續(xù)供應(yīng)，質(zhì)量量度將使公司和監(jiān)管機(jī)構(gòu)受益于對GMP進(jìn)行持續(xù)投資。
資料來源：愛爾蘭制藥公司Ann McGee在ECA活動關(guān)鍵績效指標(biāo)和質(zhì)量量度上的陳述。
