Monitoring Success: Essential CAPA KPIs for Medical Device Companies
In the highly regulated field of medical devices, effective corrective and preventive action (CAPA) processes are crucial for maintaining product quality and ensuring patient safety. However, simply implementing a CAPA system is not enough. To truly improve and monitor the effectiveness of your CAPA process, it is important to establish key performance indicators (KPIs) that can help you track progress, identify areas for improvement, and demonstrate compliance to regulatory bodies. In this blog post, I will explore some of the essential CAPA KPIs that medical device companies should consider to monitor their success and ensure that their products meet the highest quality standards.
Table of Contents
What are Key Performance Indicators (KPIs)?
A KPI, or Key Performance Indicator, is a measurable value that helps track progress towards specific goals and objectives. KPIs are important in monitoring the performance of a company or organization, as they provide a way to objectively evaluate the success of the company’s strategies and initiatives.
A KPI, or Key Performance Indicator, is a measurable value that helps track progress towards specific goals and objectives.
CAPA KPIs in a Medical Device Company
In a medical device company, monitoring the quality management system (QMS) elements is crucial for ensuring compliance with regulatory requirements, maintaining product safety and efficacy, and meeting customer expectations.
Designing KPIs for monitoring a medical device company’s CAPA system is important for several reasons:
Measure effectiveness: KPIs help measure the effectiveness of the CAPA system in addressing quality issues and reducing the occurrence of non-conformances. By measuring the performance of the CAPA system through KPIs, it is possible to identify areas that require improvement.
Continuous Improvement: KPIs help drive a culture of continuous improvement by highlighting areas where the CAPA system needs improvement. By monitoring and analyzing the data provided by the KPIs, the company can take actions to improve the CAPA system and reduce the likelihood of similar issues in the future.
Compliance: Medical device companies are required to maintain compliance with regulatory standards. By monitoring the performance of the CAPA system through KPIs, companies can ensure that they are meeting regulatory requirements and that their products are safe and effective.
Quality Assurance: KPIs can provide assurance that the company’s CAPA system is effectively addressing quality issues and preventing non-conformances. This helps to build trust and confidence in the quality of the company’s products and services.
In summary, designing KPIs for monitoring a medical device company’s CAPA system is essential to ensure quality, compliance, and continuous improvement. By measuring the performance of the CAPA system through KPIs, companies can take proactive measures to address issues and reduce the likelihood of similar issues in the future.
Regulatory Requirements for CAPA KPIs
The regulations that apply to medical device companies vary by country, but they typically require companies to establish and maintain a quality management system (QMS) that complies with applicable regulatory requirements.
For example, in the United States, medical device companies must comply with the Quality System Regulation (QSR) outlined in 21 CFR Part 820. The QSR requires medical device companies to establish and maintain a CAPA system that includes procedures for identifying, investigating, and correcting product and quality problems. The QSR also requires companies to establish and maintain procedures for monitoring and measuring the effectiveness of the CAPA system.
One way to monitor and measure the effectiveness of the CAPA system is through KPIs. KPIs can help a medical device company track and assess the performance of its CAPA system, identify areas for improvement, and demonstrate compliance with regulatory requirements.
Similarly, in the European Union, medical device companies must comply with the Medical Device Regulation (MDR) and the In Vitro Diagnostic Regulation (IVDR). Both regulations require medical device companies to establish and maintain a QMS that includes monitoring and measurement of product and process performance, and tracking of KPIs.
In summary, while the specific KPIs required may vary depending on the company and regulatory requirements, medical device companies are generally required to have KPIs for their CAPA systems to ensure compliance with regulatory requirements and to continuously improve product quality and patient safety.
Learn more about the Quality System Regulatory CAPA requirements by taking our elearning course 21 CFR 820.100 (Medical Device CAPA).
CAPA KPI: Number of Open CAPSs
One of the first CAPA KPIs that should be monitored is the number of open CAPAs. The number of open CAPAs is a KPI that measures the number of CAPAs that have been raised but not yet completed or closed.
The number of open CAPAs KPI is crucial for medical device companies as it helps to identify the backlog of quality issues that require attention and resources to resolve. A high number of open CAPAs can indicate delays in addressing quality issues, which can result in patient safety concerns, regulatory non-compliance, and financial losses.
For example, let’s say a medical device company has identified 10 quality issues through their CAPA process, but only 6 of them have been resolved, and 4 are still open. The number of open CAPAs KPI would measure the number of open CAPAs, which in this case would be 4. The company would aim to keep this KPI as low as possible to ensure timely resolution of quality issues and maintain regulatory compliance.
The number of open CAPAs KPI can also be broken down by age or priority level to help prioritize resources and ensure timely resolution of high-priority issues. For example, the company might track the number of open CAPAs by age categories such as “less than 30 days,” “30-60 days,” and “more than 60 days,” to ensure that older issues are not being neglected.
In summary, the number of open CAPAs KPI is an important metric for medical device companies to track as it provides insight into the status of their CAPA process and helps to ensure that quality issues are being resolved in a timely and efficient manner.
The number of open CAPAs is a KPI that measures the number of CAPAs that have been identified but not yet completed or closed.
CAPA KPI: Average Time to CAPA Closure
The average time to CAPA closure is another CAPA metric that should be monitored. The average time to CAPA closure is a KPI that measures the average time it takes to complete the corrective and preventive action process for identified quality issues.
The average time to CAPA closure KPI is crucial for medical device companies as it helps to measure the efficiency and effectiveness of their quality management systems. A high average time to CAPA closure can indicate delays in identifying and resolving quality issues, which can result in patient safety concerns, regulatory non-compliance, and financial losses.
For example, let’s say a medical device company discovers that a component used in one of their products is defective, which could potentially harm patients. The company initiates a CAPA process to identify and correct the issue. The average time to CAPA closure KPI would measure the time it takes the company to investigate the issue, implement corrective and preventive actions, and verify their effectiveness. The company would aim to keep this KPI as low as possible to ensure patient safety and maintain regulatory compliance.
The average time to CAPA closure is a KPI that measures the average time it takes to complete the corrective and preventive action process for identified quality issues.
CAPA KPI: Number of Overdue CAPAs
The number of overdue CAPAs is another KPI that should be monitored closely. The number of overdue CAPAs is a KPI that measures the number of corrective and preventive actions that are past their due date for closure.
The number of overdue CAPAs KPI is crucial for medical device companies as it helps to identify quality issues that have not been addressed in a timely manner, which can result in patient safety concerns, regulatory non-compliance, and financial losses.
For example, let’s say a medical device company has identified 10 quality issues through their CAPA process, and each CAPA has a due date for closure. At the end of the quarter, 8 CAPAs have been closed on time, but 2 CAPAs are still open and past their due date. The number of overdue CAPAs KPI would measure the number of overdue CAPAs, which in this case would be 2. The company would aim to keep this KPI as low as possible to ensure timely resolution of quality issues and maintain regulatory compliance.
The number of overdue CAPAs KPI can also be broken down by the severity of the quality issue or the priority level of the CAPA to help prioritize resources and ensure timely resolution of high-priority issues.
In summary, the number of overdue CAPAs KPI is an important metric for medical device companies to track as it provides insight into the status of their CAPA process and helps to ensure that quality issues are being resolved in a timely and efficient manner.
CAPA KPI: CAPA Aging
CAPA aging is another KPI that could be monitored. The CAPA aging would measure the time taken to close CAPAs. It measures the duration between the date of CAPA initiation and the date of closure.
The CAPA aging KPI is important because it helps medical device companies track the progress of their CAPA process and identify potential delays in closing CAPAs. This KPI is particularly useful in identifying and prioritizing CAPAs that have been open for an extended period, indicating a need for additional resources or attention.
For example, let’s say a medical device company had 20 CAPAs initiated during a quarter, and the status of each CAPA was as follows:
5 CAPAs were closed within the quarter, with an average closure time of 30 days.
10 CAPAs were still open at the end of the quarter, with an average aging of 60 days.
5 CAPAs were initiated before the quarter and still open at the end of the quarter, with an average aging of 90 days.
To calculate the CAPA aging KPI, the company would determine the average duration from the date of CAPA initiation to the date of closure for all closed CAPAs and the average duration from the date of CAPA initiation to the current date for all open CAPAs. The average CAPA aging would be calculated by adding up the total aging for all open CAPAs and dividing it by the number of open CAPAs.
In this example, the average CAPA aging would be:
(10 x 60) + (5 x 90) = 750
750 / 15 = 50
So the average CAPA aging is 50 days, indicating that the company may need to focus on improving the closure time for open CAPAs to ensure timely resolution of quality issues.
In summary, the CAPA aging KPI is an important metric for medical device companies as it helps to identify potential delays in closing CAPAs and enables the company to allocate resources effectively to ensure timely resolution of quality issues.
The CAPA aging is a KPI used in the medical device industry to measure the time taken to close CAPAs. It measures the duration between the date of CAPA initiation and the date of closure.
CAPA KPI: CAPA Closure Rate
This KPI measures the percentage of CAPAs that have been closed within the specified timeframe. A higher CAPA closure rate indicates that the CAPA system is effective in resolving issues in a timely manner.
 This KPI measures the percentage of CAPAs that have been closed within a specified timeframe. To calculate the CAPA closure rate, you need to divide the number of closed CAPAs by the total number of CAPAs issued within a specified timeframe and then multiply by 100 to get a percentage.
For example, suppose a medical device company has issued 100 CAPAs in a month, and 80 of them have been closed within 30 days. The CAPA closure rate would be calculated as follows:
CAPA Closure Rate = (Number of closed CAPAs/Total number of CAPAs issued) x 100
= (80/100) x 100
= 80%
In this example, the CAPA Closure Rate KPI shows that 80% of the CAPAs issued were closed within the specified timeframe. This indicates that the CAPA system is effective in resolving issues in a timely manner, which is important for ensuring that quality issues are addressed promptly, and that products are safe and effective for patients.
The CAPA Closure Rate KPI is important because it helps measure the efficiency of the CAPA system. When CAPAs are not closed in a timely manner, it can indicate that the CAPA system is not being effectively managed, or that issues are not being adequately addressed. This can lead to increased risk and potentially impact the safety and effectiveness of medical devices. By tracking the CAPA Closure Rate KPI, medical device companies can identify areas for improvement in the CAPA process and take corrective action to address any issues.
The CAPA closure rate measures the percentage of CAPAs that have been closed within the specified timeframe.
CAPA KPI: Repeat CAPA Rate
This KPI measures the number of CAPAs that have been reopened or require a repeat action due to the initial action being ineffective. A lower repeat CAPA rate indicates that the CAPA system is effective in addressing the root cause of the issue.This KPI measures the percentage of CAPAs that have been issued for the same or similar root cause. To calculate the Repeat CAPA Rate, you need to divide the number of CAPAs that have been issued for the same or similar root cause by the total number of CAPAs issued within a specified timeframe and then multiply by 100 to get a percentage.
For example, suppose a medical device company has issued 100 CAPAs in a month, and 10 of them have been issued for the same or similar root cause. The Repeat CAPA Rate would be calculated as follows:
Repeat CAPA Rate = (Number of CAPAs issued for the same or similar root cause/Total number of CAPAs issued) x 100 = (10/100) x 100 = 10%
In this example, the Repeat CAPA Rate KPI shows that 10% of the CAPAs issued were for the same or similar root cause. This indicates that the root cause was not adequately addressed in the initial CAPA, which resulted in the need for additional CAPAs to be issued. A high Repeat CAPA Rate can indicate that there are underlying issues in the CAPA process, such as ineffective root cause analysis, inadequate corrective actions, or poor documentation.
The Repeat CAPA Rate KPI is important because it helps identify areas for improvement in the CAPA process. A high Repeat CAPA Rate can lead to increased risk, as the same or similar issues are not being effectively addressed. By tracking the Repeat CAPA Rate KPI, medical device companies can identify the root cause of repeat issues and take corrective action to prevent them from occurring in the future. This can help improve product quality, reduce non-conformances, and ensure the safety and effectiveness of medical devices.
This KPI measures the number of CAPAs that have been reopened or require a repeat action due to the initial action being ineffective.
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Collecting, Collating and Communicating CAPA KPIs
The responsibility for collecting, collating, and communicating KPIs for a medical device CAPA system typically lies with the Quality Assurance (QA) department or the CAPA team within the organization. The QA department is responsible for ensuring that the CAPA system is effective, and the CAPA team is responsible for managing the CAPA process.
As part of their responsibilities, the QA department or the CAPA team would typically identify the KPIs that are relevant to the CAPA process and establish a process for collecting and collating the data required to measure those KPIs.Â
Once the data has been collected and collated, the QA department or the CAPA team would typically analyze the data to determine if the CAPA system is effective or if there are areas for improvement. The KPIs would then be communicated to relevant stakeholders, such as senior management, to inform them about the performance of the CAPA system and to help them make informed decisions about the allocation of resources and prioritization of improvement activities.
In summary, the responsibility for collecting, collating, and communicating KPIs for a medical device CAPA system lies with the QA department or the CAPA team within the organization. They are responsible for identifying the relevant KPIs, collecting and collating the data, analyzing the data, and communicating the results to
Mechanisms for Reviewing CAPA KPIs
 Typically, CAPA KPIs are reviewed and discussed at management review meetings, which are usually held at regular intervals (e.g., monthly or quarterly) to evaluate the company’s overall performance.
During management review meetings, senior management typically reviews KPIs related to various aspects of the company’s operations, including CAPA KPIs. The review should include a discussion of the trends and patterns observed in the data, and an assessment of whether the company is meeting its goals and objectives related to CAPA.
It is important that representatives from the relevant departments, such as quality assurance, regulatory affairs, engineering, and manufacturing, participate in the management review meetings to ensure that all perspectives are considered when reviewing the CAPA KPIs. This will help ensure that the company has a comprehensive understanding of its CAPA performance and can take appropriate actions to address any issues identified.
Steps to take when CAPA KPIs are going off track
If the CAPA KPIs in a medical device company go off track, it is important to take prompt action to investigate the root cause of the issue and take appropriate corrective and preventive actions. Establish corrective actions to take when something goes wrong (when a critical limit is breached). Here are some steps that can be taken:
Investigate the root cause: Identify the underlying causes of the off-track KPIs. Conduct a thorough investigation to determine what went wrong, where it went wrong, and why it went wrong.
Develop a corrective action plan: Develop a corrective action plan that addresses the root cause of the off-track KPIs. The plan should outline specific actions that will be taken to address the problem.
Implement the corrective action plan: Implement the corrective action plan in a timely and effective manner. This may involve making changes to processes, procedures, or systems, or providing additional training to employees.
Monitor progress: Monitor progress to ensure that the corrective action plan is effective in addressing the root cause of the off-track KPIs. Monitor the KPIs closely to track progress and identify any further issues that may arise.
Take preventive actions: Take preventive actions to ensure that the issue does not recur in the future. This may involve implementing new procedures or systems, providing additional training, or conducting audits or inspections to ensure compliance.
Communicate with stakeholders: Communicate the issue and the actions taken to address it with stakeholders, including customers, regulatory agencies, and internal teams. This will help build trust and confidence in the company’s commitment to quality and compliance.
Conclusion
In conclusion, monitoring CAPA KPIs is critical to the success of medical device companies. By establishing and tracking these metrics, organizations can identify areas of improvement, ensure compliance with regulatory requirements, and ultimately enhance patient safety. With the right tools and strategies in place, companies can leverage CAPA KPIs to drive continuous improvement and achieve long-term success in the industry. I hope that this article has provided valuable insights into the essential CAPA KPIs that medical device companies should monitor to ensure their success.
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Dr. Fiona Masterson
With over 25 years’ experience in quality management, operations management,
and higher education, Fiona combines technical expertise with highly engaging
training. She has worked in fast-paced manufacturing environments including
medical device companies, and lectures part-time in universities.
She is a lead quality auditor and managed the CAPA programme of a leading
medical device company.
She has Bachelor and Master of Science degrees, and a Doctorate in
Mechanical Engineering. Fiona has published in peer reviewed journals on
topics such as medical device and pharmaceutical regulatory affairs, on-the job
training and innovative training technologies and strategies. .