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Establishing Quality Metrics and Key Performance Indicators (KPIs)

Establishing quality metrics and key performance indicators (KPIs) is essential for monitoring and improving pharmaceutical quality assurance processes. Quality metrics and KPIs provide valuable insights into the effectiveness of quality systems and processes and enable you to identify trends, measure performance, and drive continuous improvement initiatives.

In 2012, with the passage of the Food and Drug Administration Safety and Innovation Act, FDA was given the authority to collect pharmaceutical manufacturing records and information from regulated industry as part of FDA’s risk-based oversight. The FDA has been working with industry experts to develop a Quality Metrics Reporting Program. In 2018 two pilot programs into metrics reporting was established, with FDA issuing in 2022 a Federal Register docket for considerations for refining the Quality Metrics Reporting Program based on lessons learned from the pilot programs. While next yet encased in the CFR regulations, Quality Metrics are a focus item for FDA.

The minimum standard for ensuring that a manufacturer’s products are safe, effective and of sufficient quality is compliance with current good manufacturing practice (CGMP) requirements. But CGMP compliance alone does not indicate whether a manufacturer is investing in improvements and striving for sustainable compliance, which is the state of having consistent control over manufacturing performance and quality. Sustainable compliance is difficult to achieve without a focus on continual improvement. 

 Quality metrics, such as Key Performance Indicators (KPIs) play an important role in supplier selection and the oversight of contract activities and material suppliers. Key Performance Indicator (KPI) is a measurable value that shows the progress in meeting a specific goal. The KPIs should be specific, measurable, achievable, relevant, and time-bound. 

Quality-focused KPIs specifically measure the performance and effectiveness of processes, products, or services. The following are examples of Quality-focused performance KPIs and manufacturing metrics that can measure the effectiveness and efficiency of drug manufacturing operations.

• Process Capability/Performance Indices (CPK/PPK): Process capability and performance indices are measures of how well a process is performing relative to its specification limits.

• Lot Acceptance Rate (LAR): The lot acceptance rate is the proportion of lots that were accepted in each period.

• Right-First-Time Rate (RFT):The right-first-time rate is a measure of the proportion of lots manufactured without the occurrence of a deviation or nonconformance.

• Repeat Deviation Rate:The repeat deviation rate is a metric of the deviations that occur multiple times. A high repeat deviation rate KPI indicates that a particular deviation is occurring frequently and that corrective action needs to be taken.

• Unplanned Maintenance: Unplanned maintenance is the tracking of maintenance that is not planned or scheduled in advance. It is often caused by unexpected equipment failures.

Tracking quality KPIs and metrics helps companies to ensure the effectiveness of the quality management system.