3 Best Practices for Establishing Quality Performance Indicators (QPIs)

Quality performance indicators (QPIs) are a tool that pharmaceutical companies employ to track excellence, regulatory compliance, and efficiency across products and processes. The value of QPIs has been recognized by the U.S. Food and Drug Administration (FDA), which encourages their use as they promote continuous improvement. This article describes three best practices organisations can implement to establish QPIs that align with current good manufacturing practices (CGMP).

Provide context for each indicator

One common mistake while establishing quality performance indicators is to approach them as simple metrics, as they can become meaningless or even misleading when the time to make critical decisions arises. Tracking the numbers related to deviation frequency or batch rejection rates needs contextualization, as the person who reads the information needs to know what influences these figures or how they relate to the goals that the company currently has. 

For example, if a company wants to identify quality issues, they need to complement their OOS (Out of Specification) rate data with a process change log. If an OOS spike happens, the data is more helpful, as stakeholders can go back to the log and see which actions were taken beforehand. 

Quality performance indicators can be tied to either site-specific goals, performance objectives, or quality standards. Regardless of their purpose, QPIs should be complemented with explanatory notes, documents, or metadata that add process-specific information, explain why the metrics matter, describe what ‌is being measured, or list certain considerations that impact the metric.

Ensure that indicators are measured consistently

To prove that the data from quality performance indicators is trustworthy, it is necessary to ensure that the indicators are tracked in a transparent and explainable fashion. Beyond demonstrating that the methods used to track performance are consistent, it enables organisations to standardize their metrics and reproduce them across different sites. 

Clearly defining ‌calculations enables companies to avoid discrepancies between different departments and establish the same quality standards across the organisation. Besides digital internal documentation systems, this explanation can be included in FDA submissions, helping the agency ‌understand the reported metrics and confirm their validity. 

The explanation of the calculation should include its mathematical logic, the formulas and data sources used (such as electronic batch records or paper-based logs), the frequency in which data is updated, and the actions taken to deal with missing or irregular data.

Build a robust QPI system

The way quality performance indicator data is collected, processed, and evaluated plays a key role in establishing a culture of continuous improvement. Beyond creating a dashboard that measures quality, pharmaceutical companies should strive to build internal processes that leverage this information and respond effectively to the data reported in order to maintain best practices and deal with quality issues before a crisis arises.

Some actions pharmaceutical companies can take to ensure robustness is to upkeep data integrity, make insights more accessible through business intelligence systems and visualization tools, integrate the metrics into broader quality systems like CAPA (Corrective and Preventive Actions), define standards, establish escalation procedures, and promote root cause analysis and process evaluation across departments. By doing so, organisations can create a feedback loop in which quality metrics result in decisions that affect quality, and so on. 

Thus, measuring QPIs entails addressing the full life cycle of each indicator: from data collection to decision-making. From the organisational perspective, it should be clear which systems are involved in performance tracking, who the internal stakeholders are that review the data, and how actions can be triggered.

The benefits of creating QPIs

Organisations can leverage quality performance indicators to establish a system that can measure, analyse, and monitor the lifecycle of their products and internal processes. This leads to maintaining and/or improving safety, efficacy, and performance. 

Quality performance indicators are also useful from a bigger perspective. The FDA can use the data from QPIs systems to develop better inspection policies and practices, mitigate future drug shortages, and promote innovative approaches to quality management. As of January 2025, the FDA planned to create a reporting program to support the monitoring of quality metrics and evaluate the QPI data shared by companies in their submissions.

QPIs are metrics that are contextualized, trustworthy, and practical, which shifts quality management from being reactive to preventive. Thus, quality performance indicators can cause actions that promote a proactive quality culture both internally and industry-wide.