Data is Power: Metrics that Quality teams can track to drive continuous improvement and prove ROI

Quality metrics matter

Quality metrics matter – and they matter to more than just the Quality team.

Why? Data analysis and improvement go hand in hand, and few teams have access to more GxP critical data than the Quality department. From trend data on deviations to reports on quality practices and compliance, Quality teams get an inside look at what’s working and what’s not in their GxP regulated organizations.

And with the right quality management metrics, they provide leadership with actionable insights on where to invest more resources, where efforts are paying off, and where potential problems may be hiding... before they impact operations.

Plus, for Life Sciences investors conducting due diligence, these metrics can indicate a company’s commitment to quality, a low tolerance for risk, and ultimately, its long-term stability, making it a more attractive asset for investment, partnerships, and more.

In fact, Quality teams are more than just compliance gatekeepers, they’re the driving force behind a culture of continuous improvement for the entire organization. Music to the C-suite’s ears.

What metrics should Quality teams track?

When it comes to continuous improvement, figuring out the right metrics to track for improvement is half the battle. For Quality teams, metrics can be broadly divided into two main categories: quality-specific and organizational metrics.

Quality-Specific Metrics

Quality-specific metrics are those directly under the control of the Quality team. They reflect the effectiveness of quality processes and provide insight into how well the Quality team performs its core functions. These are important not just for showcasing your team’s wins, but they’re also particularly useful when making the case to leadership for adding personnel to the team, updating quality processes, or getting more robust quality management tools – like a QMS software – to make your job easier. Some key quality-specific metrics could include:

• Document Accessibility: How quickly and easily can team members find the documents they need? Document accessibility has a direct impact on audit speeds and overall productivity. Track the time it takes to locate any given document and use this data to determine if it’s time to invest in a better document management system, like an eQMS.
• Audit Efficiency: How many audits does your Quality team host and/or conduct? How long does it take your team to navigate through them? If your team is drowning in audits or each one is taking an unusually long time, it could indicate it’s time to hire or invest in better tools.
• Document Approval Time: How long does it take for a document to go from draft to final approval? What’s the average time between when a signature is requested and received? Delays in document approval can bottleneck operations across the entire organization.
• Audit Observations: How many major and minor observations did the company receive this year? How long did it take to address audit findings? Tracking the number and severity of audit findings can serve as a pulse check for the overall health of the company’s quality practices.
  
  

Organizational Metrics

Organizational metrics are those which are technically under the control of other departments. As a secondary owner of these metrics, the Quality team plays a crucial role in tracking, reporting, and providing insights to help drive continuous improvement, but it’s ultimately up to each individual department to act on these insights.

Which organizational metrics you track will heavily depend on your specific company operations – a CMO won’t track the same exact data as a Biopharma organization – but some examples could include:

• Training Compliance: Your HR department may oversee training, but Quality can track company-wide training compliance percentages, spot patterns that lead to overdue assignments, and make suggestions for improvement, such as utilizing quality management software for training management.
• Batch Failure Rates: Monitoring the number of batches that fail to meet quality standards is crucial. While the root cause may lie outside the Quality department, such as in manufacturing or supply chain, the Quality team can help identify trends and support corrective actions.
• CAPA (Corrective and Preventive Action) Effectiveness: Tracking CAPAs ensures that issues are addressed quickly and that preventive measures are actually successful in mitigating future risk. Take a look at your CAPA management data, such as time taken to implement corrective actions, the recurrence rate of similar issues, and the percentage of CAPAs deemed effective.
  
  

An example of the Insights module dashboard within ZenQMS. Easy-to-read dashboards make tracking and reporting on quality data simple and impactful.

Tips for better quality data reporting

Reporting out on data can be a whole separate beast entirely. Here are some tips to help ensure your tracking efforts actually make an impact:

• Set benchmarks: Before you can judge whether or not quality efforts are improving, you have to have a baseline to measure against. How long does it currently take you to find a document? What percentage of employees are training compliant right now? Don’t forget to examine your problem log to determine additional metrics your organization should track. What patterns or consistent issues do you see? Are there specific actions that are frequently delayed? For example, a lengthy document approval time could mean you need to track the time between signature request and completion, or a long list of outdated documents might signal it’s time for a document up-versioning project.
• Move away from paper and spreadsheets: Excel or Google Spreadsheets might seem good enough for tracking metrics, but they come with big drawbacks, like the potential for human error and tedious manual data entry. An electronic quality management system can automate the tracking of key metrics and generate reports that are not only more accurate but also more timely.
• Add context to your reports: Data is only as valuable as the insights it provides, so don’t just paste four different graphs in a presentation and press send. When you present reports to leadership, provide context by explaining the trends you’re seeing, the potential future impacts, and recommendations for action. Most importantly, frame your insights in terms of business outcomes. For example, instead of just stating that the average deviation resolution time has decreased, explain how it has shortened production downtime and reduced costly market delays.

Want to learn more about quality management data security, QMS software validation, and quality management metrics? Check out our eQMS 301 eBook: Best practices for eQMS revalidation, data security, and quality ROI.