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 The Quality Metrics Initiative then started with a voluntary phase and a revised draft guidance was published in November 2016.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，美国食品药品监督管理局（FDA）启动了一项新方案，使用所谓的质量量度来规划其基于风险的检查。FDA希望，在其生效后，制药企业可以通过电子门户向FDA递送规定的质量量度分数。FDA计划使用这些数据来计算特定的统计数据，这些统计数据应该考虑到FDA基于风险的管理和规划。随后，质量量度方案从自愿阶段开始，并于2016年11月发布了修订后的指导草案。然而，在这之后，它似乎再无大的动作了。自该方案启动以来，业界给予了大量反馈，他们担心会产生额外的工作量和开支。
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，FDA宣布了两个更新的计划：质量量度反馈计划和质量量度实地考察计划。FDA现在也希望把重点放在对行业的益处上，说通过实施质量量度计划，“企业来改善他们的整体质量体系”，最终保证产品质量。
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是对的：质量量度是大有裨益的！
质量量度已经在制药行业使用了很多年，主要是在内部衡量运行业绩。但是质量可以在不同的层次和许多过程中进行量度。以正确的方式完成，质量量度可以使公司达到高质量业绩。他们将受益于运行业绩和GMP合规性的持续改进。两者对于业务和产品供应的连续性都很重要。
Quality Metrics Definitions
质量量度的定义
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.
让我们从一些定义开始：
量度：根据标准（可评估计划、过程或产品的效率、性能、进度或质量的量度标准）进行的量度。
指标：对性能进行指示（定性或定量），例如评估组织或活动的成功程度。
KPI：关键性能指标；性能的目标关键领域（并非所有指标都是关键的）
它们都应该有助于对提供当前性能反馈、预测未来需求和采取行动的信息进行开发、整理和分析。为此，数据必须是准确、及时、适当、分析正确和并有意义的。
Points to be considered in Metricsand KPIs Development:
在制定指标和KPI时要考虑的要点：
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
所以在制定指标和KPI时，需要考虑以下几点：
定量和定性数据的区分
通常情况下，数据必须是符合SMART原则：具体的 (Specific)、可度量的(Measurable)、可接受的 (Accepted)、实际的 (Realistic)、有时限的 (Time Bound)。尽管数据“对于信息”可能有用，尤其是在开始建立基线时。
衡量产品特定的/质量，评估全部质量状态和质量文化；
充分的指标来展现法规符合性；
仅仅一部分特定选择的KPI来做高级管理，更多是用来本地管理；
利用为质量活动投入的资源衡量所有领域的绩效；
质量量度和KPI应在全球各地和办公室通用，以实现信息可视化和数据共享。
Possible Pitfalls
可能存在的问题
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
易犯的错误有哪些？
指标太多，复杂且耗时；
为实现指标目标，采取错误的行为，可能导致意想不到的后果；
不理解结果的来龙去脉而采取行动
并非所有指标都有相同的价值-确定关键的那几个！
能仅交付指标。未达到目的的指标应采取行动。
过程绩效和产品质量监控的输出是持续改进的关键。可以识别、引入、监控和控制必要的变更，以持续改进程序和系统，最终，为确保高质量运行和优质产品的连续供应，质量量度将使公司和监管机构受益于对GMP进行持续投资。
资料来源：爱尔兰制药公司Ann McGee在ECA活动关键绩效指标和质量量度上的陈述。
联系客服
