Top quality KPIs to track your QMS performance and help you succeed in 2025

As we approach the end of the year, it’s a great time to reflect on the bigger picture: how well did we meet this year’s quality KPIs? And, just as importantly, how should we approach next year’s?

Maybe you hit every KPI with flying colors, or perhaps you fell short on a few. Either way, it’s a chance to ask yourself: Were your KPIs realistic? Did you set too many? Were you tracking the right metrics?

In this newsletter, we’ll help you get ready for next year by exploring how to set effective quality KPIs and highlighting some of the most impactful ones to prioritize for your QMS in the life sciences.

What is the difference between quality KPIs and quality metrics?

Before we dive into the top quality KPIs to measure for your QMS, let’s address a common misconception in the life sciences—the difference between quality KPIs and quality metrics.

Quality KPIs

• What they are: Strategic indicators tied to overarching business goals.
• Purpose: To measure how effectively you're achieving critical objectives, often at a high level.
• Example: "Percentage of deviations resolved within 30 days" might be a KPI if it aligns with a strategic objective like improving operational efficiency.
• Scope: KPIs are outcome-focused and often a subset of metrics. They are used to influence business decisions and communicate performance to stakeholders and top management.?

Quality Metrics

• What they are: Quantitative data points used to monitor, control, and evaluate specific processes or activities.
• Purpose: To provide detailed, granular insights into operational performance and improvements.
• Example: "Number of deviations reported per month" or "Average time to close a CAPA."
• Scope: Metrics are broader and operationally focused.

To sum it up, all KPIs are metrics, but not all metrics qualify as KPIs because they don’t necessarily tie back to key objectives. KPIs focus on progress toward strategic goals, while metrics provide the detailed data needed to monitor and manage individual processes.?

Top quality KPIs to track your QMS performance

While we’d love to list every essential quality KPI for your business, the reality is that the right KPIs depend on your company, products, and business priorities.?

That said, while specific Quality KPIs will vary from one organization to another, we can help you pinpoint five broad areas of business performance where measurement indicators that we believe are essential:?

1. Risk?
2. Quality response
3. Cost of Quality?
4. Productivity?
5. Quality culture

1. Risk

Risk is one of the most critical areas to monitor in regulated industries like life sciences. To evaluate the effectiveness of your risk management activities, tracking any of the following quality KPIs can provide valuable insights:

• Number of overdue training or required audit actions
• Overall audit score and risk level findings (both internal and external)?
• Number of outstanding compliance issues/risks
• Number of overdue risk assessments
• Number of recent changes (the number of potential risks goes up when the complexity of the product or the number of process steps of the product increases. Product changes are a frequent culprit of quality issues.)?

A note about CAPAs: Have you ever had to revisit old CAPAs because the underlying issue (non-conformance) remained unresolved, even after they were closed? If so, you already understand how crucial CAPA effectiveness is.

Ensuring CAPAs are effective is just as important as closing them on time—it guarantees you're addressing the root cause, not just ticking off another compliance task. This effectiveness serves as an indirect measure of your risk management efficiency and your dedication to fostering a strong quality culture.

2. Quality Response

Tracking KPIs that measure customer satisfaction is a clear indicator of critical issues and future business success. After all, business reputation and loyalty depend on excellent customer service.

To understand customer satisfaction, likelihood of repeat business, and referrals, you can use direct tools like satisfaction surveys or platforms like Net Promoter Score.

Here are some quality KPIs that offer valuable insights into customer retention:

• Customer satisfaction scores (e.g. Net Promoter Score (NPS))
• Customer churn rate
• Product quality complaint rate / Number of customer complaints
• Number of overdue issues
• Time to solve issues
• Time to respond
• Quality of communication
• Solution effectiveness

3. Cost of Quality

Finance-related quality KPIs help estimate the financial impact of your processes and guide budgeting and strategy for the upcoming years. The Cost of Poor Quality (CoPQ) is a critical metric to track, as it quantifies the losses from internal or external quality issues. Unnecessary overheads caused by poor systems, processes, or practices can significantly reduce business profitability.

Ways to measure CoPQ:

• Number of incidents
• Percentage of defects or rework needed
• Number of nonconformities
• Right-first-time percentage
• Time spent in root cause analyses or to resolve issues
• Amount of ‘wasted’ product/time

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4. Productivity

Productivity is often seen as a measure of individual or team performance—how efficiently they work. However, it actually reflects how well-optimized your company is and can reveal systems or processes that may need streamlining, rather than pointing to underperforming individuals.

KPIs that track productivity help determine the resources needed for processes, identify areas of waste, and reveal how much time a process requires. This area of performance directly impacts budget reviews and delivery schedules, making it essential to monitor KPIs that assess productivity.

Here are some quality KPIs to measure productivity:?

• Number of overdue audit findings/issues/training
• Number of overdue CAPAs
• Speed of response to findings
• Number of completed training
• In manufacturing/operations: metrics such as Lot Acceptance Rate & Invalidated Out-Of-Specification Rate

5. Quality Culture

An often overlooked but crucial aspect that can make or break a business is the health of its quality culture. What exactly is a quality culture? It’s an environment where everyone is actively engaged in and applying good quality practices in their daily tasks—a culture where quality responsibility is shared by all, not just the QA department.?

While the concept can be subjective, it’s typically measured through quality KPIs that reflect engagement with quality, governance, risk, and compliance management. Quantifiable examples include:

• Training scores
• Percentage of policies read & understood
• The time that is taken to resolve issues
• Quality Awareness Metric
• Number of change requests or events
• Improvement Acceptance Ratio - How many business suggestions are actually analyzed and implemented? If ideas are discarded directly, it’s an indicator of less future contribution from employees.

Best practices for setting quality KPIs

Not all quality KPIs need to be tracked

Monitoring too many quality KPIs at once can overwhelm those responsible for managing them, leading to divided attention and a lack of focus on each one. This often results in gaps, errors, or incomplete data in the metrics.

Involve everyone in setting your quality KPIs

Remember, awareness of and commitment to quality KPIs is a shared responsibility across the entire company, not just the quality department. Involving your whole team in the process of defining and setting quality KPIs ensures that you track only the most valuable ones, rather than spreading yourself too thin by trying to monitor everything, which can be counterproductive.

Set quality KPIs that align with your company’s goals

The first step in setting quality KPIs is identifying your company’s quality goals. From there, you can select specific KPIs that measure progress toward those objectives. The key is prioritizing what truly matters. Tracking too many or the wrong quality KPIs can overwhelm your team (including management!) and lead to inaccurate performance conclusions.

Make your Quality KPIs SMART

To set meaningful and actionable KPIs, use the SMART criteria, which stands for Specific, Measurable, Achievable, Relevant, and Time-bound. Here's a breakdown:?

• Specific: The KPI should be clear and well-defined.
• Measurable: KPIs must be quantifiable, enabling objective progress assessment.
• Achievable: Quality KPIs should be realistic and attainable, given available resources, time, and capabilities.
• Relevant: The KPI must align with your company’s overall strategy, mission, and vision.
• Time-bound: Quality KPIs should have a defined timeframe or deadline for completion.

Once your quality KPIs are set, it’s essential to track them closely, analyze the data, and ensure that processes are working as intended.

Conclusion?

When implemented effectively, quality KPIs provide valuable insights into how well your QMS is achieving its objectives and goals. By monitoring the right quality KPIs, you can unlock numerous benefits, such as identifying areas for improvement, making informed decisions, and continuously enhancing the quality of your products or services.?

With these tips on selecting quality KPIs and best practices in mind, you're now ready to start the year on the right track and drive improvements in your QMS! We’re rooting for you!

If you want to take it a step further and analyze the current state of your quality processes to help you set your quality KPIs for next year, then take the Quality Management Maturity scan here.

?? Related articles

• How to set your quality KPIs
• The road to continuous improvement: lean thinking, Six Sigma and Kaizen
• How to assess and enhance your Quality Management Maturity (QMM)

Enjoying these articles? Stay updated on the latest life sciences and quality trends by visiting our Scilife blog.