The goal of quality management in pharma is to ensure that products are manufactured and tested consistently according to the regulations and guidelines set by the regulatory authorities. A quality management system with robust reporting of quality metrics helps pharma companies track and manage quality processes to ensure they are compliant.
But what kind of reports and metrics (or vital signs) are most valuable? We’ve identified several key reporting metrics that are commonly used to measure the effectiveness of a quality system, and we’re sharing them here.
Note: If you like this post, you’ll also like Transforming Quality Management in Pharma: The Seven Core QMS Processes.
The Vital Signs of Quality at a Pharma Company
Batch Failure Rate:
This metric measures the number of batches that fail to meet quality standards as a percentage of the total number of batches produced.
For example, if a pharmaceutical company produces 100 batches of a product and 5 fail to meet quality standards, the batch failure rate would be 5%.
This metric measures the number of deviations from established processes or procedures as a percentage of the total number of processes or procedures performed.
For example, if a company has 100 procedures and 10 deviate from established processes, the deviation rate would be 10%.
Deviation Cycle Time:
This metric measures the time it takes to close and conclude a deviation investigation in a product or process from when the incident is discovered to when it is fully concluded. Usually, the deviation cycle time should not exceed 30 days unless justified for the delay.
Complaints Per Product:
This metric measures the number of critical customer complaints received in a year and the number of valid complaints received for a specific product.
This metric measures the effectiveness of corrective and preventive actions (CAPA) in addressing quality issues. CAPA effectiveness is typically measured by assessing the number of recurring quality issues and the number of CAPAs implemented to address them.
This metric measures the number of findings identified during internal or external audits.
For example, if a pharmaceutical company undergoes an external audit and the auditor identifies 15 findings, the audit findings metric would be 15.
This metric measures the percentage of employees who have completed the required training.
For example, if a company has 100 employees and 90 of them have completed training, the training compliance metric would be 90%.
What About Root Cause Analysis?
Root cause analysis is not typically considered a metric in and of itself. Instead, it is a methodology or process used to identify the underlying causes of quality issues or problems. Root cause analysis involves a systematic approach to identifying the underlying causes of a problem or issue. This may involve asking “why” questions to trace the problem back to its root cause, using tools such as fishbone diagrams or 5 Whys analysis, and gathering data to support the analysis.
The goal of root cause analysis is to identify the underlying causes of the problem, rather than just addressing its symptoms, to prevent the problem from recurring in the future.
For example, if a root cause analysis identifies that a particular deviation is being caused by inadequate training, the training compliance metric may be used to measure the effectiveness of a corrective action aimed at improving training.
The root cause analysis results can be used to inform the development of metrics and measure the effectiveness of corrective and preventive actions. It is an essential tool in developing effective quality metrics and improving the overall effectiveness of a quality system.
Tracking the Right Metrics to Manage Quality
These reporting metrics can provide valuable insights into the effectiveness of a quality system in your company. The metrics help you identify areas for improvement and measure the success of your quality improvement initiatives.
Ready to learn more about tracking these metrics in a quality management system? Request your demo of Scigeniq QMS today.