Quality KPIs

Quality KPIs in Life Sciences (Quality KPI & Metric Examples)

by | Nov 24, 2023 | QMS

Key Performance Indicators (KPIs) are quantifiable measures of progress towards a specific goal. Quality KPIs are the metrics used to measure the quality of a product, service, or process.

Quality KPIs are essential in the Life Science industry, where products and services can have a direct impact on human health and well-being. Tracking quality KPIs allows companies to measure their performance, uphold rigorous requirements, and ensure that their products, services, and processes are safe, effective, and reliable.

This article discusses quality key performance indicators, the most important quality metrics to track, how to set and measure KPIs, and the benefits of quality KPI monitoring. It also discusses the role of quality KPI monitoring software.

Recognizing the critical role of quality assurance, Life Science companies are now moving towards adopting QMS software solutions, seeking to streamline their processes and improve the precision in monitoring quality KPIs.

SimplerQMS offers comprehensive eQMS software equipped with quality KPI tracking capabilities designed for the unique needs of Life Science companies. You can book a free demo to learn how our eQMS solution can help your company achieve its quality goals.

This article covers the following topics.

What Are Quality KPIs (Key Performance Indicators)?

Quality KPIs (Key Performance Indicators) are specific, measurable, and relevant metrics that track and evaluate the quality of work, processes, services, or products in a company.

The specific quality KPIs for a company to monitor will vary depending on its industry, compliance requirements, and specific goals.

It is important to regularly review and analyze these KPIs to make informed decisions and continuously improve the quality management of products, services, and processes.

What Is the Difference Between Quality KPIs and Quality Metrics?

Quality KPIs and quality metrics both measure performance, but they serve different functions.

Quality metrics are measurements used for monitoring and controlling specific processes, such as defect rates or inspection counts. Metrics are mostly used internally for operational improvements.

In contrast, quality KPIs are a focused selection of metrics that directly reflect the organization’s strategic goals. KPIs are critical indicators, for example, customer satisfaction or return rates, that influence business decisions and are used to communicate performance to stakeholders and top management.

Quality KPIs VS Quality Metrics

What Are the Most Important Quality KPIs and Metrics to Track?

The most important quality KPIs and metrics to track are those that offer clear insights into the aspects of performance that matter most to the specific quality goals of the company.

The choice of quality KPIs and metrics to monitor can vary significantly based on the stage and size of a company.

Below are some examples of KPIs and metrics that Life Sciences companies could track to measure quality and performance across five key focus areas.

  • Risk
  • Issue response
  • Cost of poor quality
  • Process efficiency
  • Resource maturity
Quality KPI Tracking


Risk-related quality KPIs and metrics help measure the effectiveness of the risk management process in mitigating potential risks to product quality and compliance.

Overdue Training

Overdue training is any training that an employee is required to do but has not yet completed, exceeding the deadline.

Tracking overdue training is essential to help ensure that employees are trained on time and have the skills and knowledge they need to perform their jobs safely and effectively.

Audit Findings

Audit findings are factual statements that document divergences from requirements or procedures identified during an audit.

Audit findings identify compliance issues, operational inefficiencies, and risks. They can lead to corrective and preventive actions that improve process performance and compliance.

Compliance Issues

Compliance issues are any violations of applicable requirements. These issues can be caused by a variety of factors, such as human error, poor communication, lack of awareness of requirements, insufficient resources, unclear or outdated procedures, or lack of training.

Measuring compliance issues helps to identify and address compliance gaps before they lead to fines, penalties, or other legal consequences. It also helps companies to prevent similar compliance issues from happening in the future.

Overdue Risk Assessments

Risk assessment is a systematic process to identify, evaluate, and mitigate the potential risks to patient safety and product efficacy at all stages of development, manufacturing, and distribution. Overdue risk assessments are risk assessments that have not been completed on time or reviewed in connection with change requests, nonconformance, deviation, audit findings, customer complaints, CAPA, etc.

This can include risk assessments for new products or processes, as well as periodic risk assessments for existing products and processes.

Tracking and monitoring overdue risk assessments helps ensure that potential risks are evaluated and mitigated promptly, maintaining compliance and safeguarding product quality and safety.

High Number of Changes

A high number of changes is any situation where a product or process is undergoing a significant number of changes in a short period. This can increase the risk of errors and quality problems.

Measuring the number of changes helps companies identify areas where there is a high risk of errors and quality problems to minimize the impact of changes on product quality and customer satisfaction.

Overdue CAPA

Corrective and preventive action (CAPA) is a systematic approach to identifying, investigating, and solving quality issues and preventing them from happening again. Overdue CAPAs are CAPAs that have not been completed on time.

By tracking and monitoring overdue CAPAs, companies can improve their CAPA process and reduce the risk of regulatory compliance issues.

Issue Response

Issue response KPIs and metrics are quantitative measures used to assess the effectiveness of a company’s process for addressing and resolving issues.

Customer Satisfaction Scores

Customer satisfaction scores are a measure of how satisfied customers are with a product, service, or company. This data can be collected through surveys, customer interviews, or other feedback mechanisms.

Tracking customer satisfaction scores is essential since customer satisfaction is one of the key drivers of business success.

Churn Rate

The churn rate is the percentage of customers who stop using a product or service within a given period. The churn rate is calculated by dividing the number of customers who churned by the total number of customers at the beginning of the period.

Measuring churn rate helps to identify and address areas where companies are losing customers. By understanding why customers are churning, companies can take steps to improve their products or services.

Customer Complaints

Customer complaints are any expressions of dissatisfaction that customers make about a product, service, or company. Customer complaints can be received through a variety of channels, such as phone calls, emails, social media, and customer surveys.

Tracking customer complaints is essential to identify and address issues that are impacting customers.

Overdue Issues

Overdue issues are any issues that have not been resolved within the agreed-upon timeframe. Overdue issues can include customer complaints, technical support tickets, and product warranty claims.

Monitoring overdue issues helps companies ensure that issues are being resolved promptly and efficiently.

Time To Solve Issues

Time to solve issues is the average amount of time it takes to resolve an issue. It is calculated by dividing the total time spent resolving issues by the number of events resolved.

Tracking the time to solve issues helps companies to identify and address areas where issues are taking too long to resolve. By reducing the average time, companies can improve responsiveness and effectiveness.

Time To Respond to Customers

Time to respond to customers is the average amount of time it takes to respond to a customer inquiry or request.

Measuring the time to respond to customers ensures that customers are being responded to promptly and efficiently. Long response times can lead to customer frustration and dissatisfaction.

Corrective Actions Effectiveness

Corrective actions are steps taken to correct the root cause of an issue. Corrective action effectiveness is the degree to which corrective actions are successful in solving issues.

By tracking corrective action effectiveness, companies can identify and address areas where their corrective actions are not effective.

Cost of Poor Quality

KPIs measuring the cost of poor quality track the financial and non-financial costs from defects and errors associated with failing to meet requirements, such as rework, scrap, warranty claims, and lost customers.

Defect Rates

The defect rate is the percentage of products or services that do not meet the applicable requirements.

Tracking defect rates helps companies identify and address areas where quality issues are occurring.

Rework Needed

Rework needed is the amount of work that needs to be done to correct defective products or services. Rework can include fixing defects, replacing defective parts, or re-performing services.

Rework can be a significant expense, both in terms of direct costs, such as labor and materials, and indirect costs, like lost productivity and delayed deliveries.

By tracking the rework needed, companies can identify areas where they need to improve their quality processes to reduce costs.


Nonconformances are any events where a product, service, or process does not meet the applicable requirement.

Measuring nonconformances is important to help prevent quality issues and ensure that products and services are meeting customer and regulatory requirements.


Right-first-time is a measure of how often products or services are completed correctly and without defects the first time around.

Tracking right-first-time is essential since it is a key indicator of the effectiveness of a company’s processes.

High rates indicate that the company is producing uniform and high-quality products and services. Low rates indicate that the company needs to improve its processes to reduce the number of defects and rework.

Wasted Product and Time

Wasted product and time are the costs associated with defects and rework. This can include the cost of the materials used to produce defective products, the cost of labor to rework defects, and the cost of lost productivity.

Measuring wasted product and time helps companies to quantify the impact of quality issues. This information can be used to make informed decisions about investing in quality improvement initiatives.

Process Efficiency

Process efficiency KPIs measure the degree to which a process uses resources effectively by converting inputs, such as time, money, and materials, into valuable outputs to achieve its desired outcome.

Overdue Activities

Overdue activities are any tasks that are not completed on time. This can include audit responses, equipment calibration tasks, maintenance tasks, training assignments, and many others.

By tracking overdue activities, companies can identify and address bottlenecks and other inefficiencies in their processes.

Response Time To Audit Findings

Response time to audit findings is the amount of time it takes to investigate and address audit findings.

Tracking response time to audit findings is essential, as it measures the effectiveness and responsiveness in resolving compliance issues. For example, a delayed response to audit findings could result in additional nonconformances.

Completed Training

Completed training is the percentage of employees who have completed the required training programs on time.

Tracking completed training helps companies ensure that their employees are up to date with the latest procedures.

Resource Maturity

Resource maturity KPIs and metrics measure the development and competency levels of a company’s workforce and systems, including personnel training adequacy, equipment, and technology.

Training Scores

Training scores are the results that employees achieve on training assessments, such as quizzes.

By tracking training scores, companies identify how well the training was understood, areas where their training plans need to be improved, and employees who may need additional training support.

Read & Understood Assignments

Read and understood assignments are the number of assignments that employees have read and understood, as evidenced by their signature upon completion.

Measuring read and understood assignments helps to ensure compliance, safety, and quality processes within the company, as it helps to ensure that employees are aware of and understand their responsibilities and the procedures they must follow.

Number of Change Requests

Number of change requests is the number of requests for changes to products, services, or processes.

The number of change requests can be used to measure the level of continuous improvement initiatives, identify potential areas of inefficiency, and ensure that the organization can adapt to new information, technology, and market demands to maintain competitiveness and compliance.

Improvement Acceptance Ratio

The improvement acceptance ratio is the percentage of improvement suggestions that are accepted and implemented by the company.

Measuring the improvement acceptance ratio helps measure how supportive a company is of innovation and continuous improvement. A high improvement acceptance ratio indicates that the company is open to new ideas and is committed to improving its products, services, and processes.

How to Set Quality KPIs?

The first step in setting quality KPIs is to identify the company’s quality goals. Afterward, companies can start to identify specific KPIs that will measure progress toward those goals.

Using the SMART criteria is a widely recognized approach to setting meaningful and actionable KPIs.

SMART stands for Specific, Measurable, Achievable, Relevant, and Time-bound. Below is a more detailed explanation of each of these criteria:

  • Specific: The KPI should be specific and clearly defined.
  • Measurable: KPIs should be quantifiable, allowing for objective assessment of progress.
  • Achievable: Quality KPIs should be realistic and attainable, considering the available resources, time, and capabilities.
  • Relevant: The KPI should be aligned with the company’s overall strategy, mission, and vision.
  • Time-bound: Quality KPIs should have a specific timeframe or deadline for achievement.

Once quality KPIs have been set, companies must diligently track and measure their quality KPIs to analyze the data and ensure that processes are working as intended.

How to Measure Quality KPIs?

There are several ways to measure quality KPIs. Defining the most effective approach to measuring quality KPIs necessitates a comprehensive understanding of a company’s specific requirements and available resources.

The following are some of the most common methods.

Manually Recorded or Spreadsheet-Based

The manual recording of quality KPIs in spreadsheets is a cost-effective initial approach, particularly for businesses with simpler processes. Companies often start with a quality KPI template in a spreadsheet to ensure organized data entry.

However, while this method provides a simple start, it requires careful attention to detail to avoid human error and can be time-consuming. As companies evolve, they should consider transitioning to more modern systems to improve efficiency, reduce errors, and allow more complex analysis.

Periodic Reviews

Periodic reviews are essential for effectively monitoring quality KPIs in systematic evaluations of performance data at regular intervals.

These reviews, which can be conducted weekly, monthly, or quarterly, require that companies actively interpret the data, allowing the identification of trends, deficiencies, and areas for improvement.

Such regular analysis is critical in maintaining an ongoing awareness of quality performance, enabling informed strategic decision-making.

One common type of periodic review is the management review. A quality management review is a formal assessment held by top management to review the company’s quality management system. Management reviews typically include a review of the quality KPIs.

Real-Time Monitoring and Analytics Tools

Automated dashboards and real-time analytics, such as business intelligence (BI) tools, are the most efficient and effective way to measure quality KPIs.

These digital solutions automatically collect and process data as it happens, providing immediate insights into quality-related parameters.

One example is SimplerQMS, a QMS software that streamlines quality processes and facilitates data access. SimplerQMS allows the seamless export of data in CVS format for further analysis or request periodic quality KPI reports.

What Are the Main Benefits of Quality KPI Monitoring?

The main benefit of quality KPI monitoring is to improve evidence-based decision-making. By regularly tracking and analyzing quality KPIs, companies can identify areas where their QMS has performance gaps and develop and implement improvement initiatives.

Moreover, quality KPI monitoring provides several significant benefits for companies.

Here are some more benefits of KPI monitoring:

Better Decision-Making

Quality KPIs provide objective data that supports informed decision-making. When employees have access to accurate and up-to-date KPIs, they can make timely and effective choices that are aligned with the company’s goals.

Improve Efficiency and Effectiveness of the QMS

An effective quality management system is a system that allows a company to reliably provide products and services that comply with customer and regulatory requirements.

KPI monitoring helps identify areas of inefficiency in processes or workflows, improving the efficiency and effectiveness of the QMS.

By analyzing KPI data, companies can streamline operations, reduce waste, and optimize resource allocation, leading to cost savings and improved productivity.

Enhance Customer Satisfaction

Monitoring customer-centric KPIs allows companies to measure how well they meet customer expectations. This information enables them to make improvements that directly impact customer satisfaction.

Increased Visibility

Quality KPI monitoring provides companies with increased visibility into their processes, which helps companies identify and address problems early on and make better decisions about allocating resources.

Identify and Manage Risks

By tracking relevant KPIs, companies can identify trends and patterns related to potential risks. Implementing a proactive approach to risk enables companies to develop mitigation strategies.

Benchmark Company Performance

KPI monitoring allows companies to compare their performance against industry benchmarks and competitors. The benchmarking process provides valuable insights into areas where the company excels and where improvements may be needed to stay competitive.

To fully leverage the potential of quality KPI monitoring, companies can implement quality KPI monitoring software.

What Is the Role of Quality KPI Software?

The role of quality KPI software is to streamline the process of tracking and reporting quality KPIs in real-time while providing a centralized platform for gathering data on various quality parameters.

Nowadays, modern QMS software solutions offer quality KPI tracking capabilities as an integral component of their feature set.

SimplerQMS offers an eQMS software solution that facilitates access to quality KPI data.

Our software provides Life Science companies access to real-time KPI data, allowing for timely decision-making and proactive quality management.

SimplerQMS also provides periodic KPI reports that could be tailored according to the company’s needs.

SimplerQMS software supports Life Science companies to comply with a variety of regulatory requirements, including ISO 9001:2015, ISO 13485:2016, FDA 21 CFR Part 11, 211, and 820, EU GMP Annex 11, and EU GMP.

SimplerQMS solution provides comprehensive QMS process support for document management, employee training management, CAPA management, customer complaint management, audit management, supplier management, and more.

To assess the value of an eQMS for your company, we recommend downloading our eQMS Business Case template.

Our template can help you evaluate the benefit of implementing an eQMS for your company and communicate your findings to management. By analyzing potential efficiency increases, cost reductions, and compliance efforts, you can make a strong case for implementing an eQMS.

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Final Thoughts

Quality KPIs are specific and measurable metrics that companies use to track the quality of their products, services, or processes. By measuring quality KPIs, companies can identify areas where they need to improve and ensure that they are meeting their quality goals.

Nowadays, many eQMS software simplify access to KPI data, including SimplerQMS.

SimplerQMS is a fully validated (GAMP 5) eQMS solution designed specifically for the needs of Life Science companies. The software includes a dashboard that automatically tracks and displays users’ personal tasks and assignments.

The system allows the creation of personalized views to monitor quality KPI data that accurately reflects the company’s current state. For example, a QA manager could track the number of overdue training or CAPAs that have remained open within the last 30 days.

Discover how SimplerQMS can help your company manage quality. Book a free demo and speak with our quality experts to learn more about how our QMS software can streamline your quality management processes.

eQMS Business Case Template

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