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).

I'M READY TO LEARN!

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.

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.
Monitoring Success:
Essential CAPA KPIs for
Medical Device Companies
Dr. Fiona Masterson
Category:CAPA,Medical Device
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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
1. What are Key Performance Indicators (KPIs)?
2. CAPA KPIs in a Medical Device Company
3. Regulatory Requirements for CAPA KPIs
4. CAPA KPI: Number of Open CAPSs
5. CAPA KPI: Average Time to CAPA Closure
 6. CAPA KPI: Number of Overdue CAPAs
7. CAPA KPI: CAPA Aging
8. CAPA KPI: CAPA Closure Rate
9. CAPA KPI: Repeat CAPA Rate
10.Collecting, Collating and Communicating CAPA KPIs
11.Mechanisms for Reviewing CAPA KPIs
12.Steps to take when CAPA KPIs are going off track
13.Conclusion

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).

I'M READY TO LEARN!

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 b

Corrective Action and Preventive

Action (CAPA) as Key Performance
Indicator (KPI) of the
company excellence.
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“We celebrate failure”- Jon Kaplan, Google’s Vice President of US sales and
operations.
Corrective and preventive actions requirements are essential part of every
quality assurance system. If you are manufacturer in plastic or metal industry,
subcontractor of full turn key solutions to the High tech industry or electronic
factory, you are required by different standards to define and implement an
effective CAPA process.

ISO 9001:2008, ISO 13485:2003, FDA requirements for Medical device 21 CFR
Part 820 requires to determine action to eliminate the causes of nonconformities
and the causes of potential nonconformities in order to prevent their
occurrences. Some standards and regulatory requirements put special
attention on the CAPA effectiveness and appropriate documentation of the CAPA
processes, some of them less.

In medical device field FDA, Notify bodies and certification bodies put especial
accent on the CAPA processes, their review and analysis, appropriate
documentation, statistical tools to approve the CAPA effectiveness.

What the main reason of managing CAPA system in most organizations?

The answer is “it is required by regulation”.
What will happen if regulatory bodies will notify tomorrow that CAPA
requirement is voluntary for all organization?
It will be good simulation of the company excellence. Today every organization,
small company or big corporation measures their performance by definition and
verification of KPI’s (Key Performance Indicators) of the main company
activities. As well as most organization control CAPA system KPIs.

Some of them measure number of CAPA’s opened and closed, some of

them follow up reoccurrences of the failure events in order to evaluate the
CAPA effectiveness.

Otherwise the” time to market” of CAPA definition and implementation may

demonstrate the organization excellence and ability to provide appropriate
resources in order:

 To investigate the problem in the timely manner,

 To close the company gaps in current processes and to raise the

organization ability in quality, operation and marketing.
Good example of taking the company failures to the next stage of company
performance improvement may be demonstrated by Google approach presented
by Jon Kaplan in the interview to McKinsey& Company, “Learning from Google
digital culture”, June 2015. The Google’s” test –and – learn” culture
demonstrates how the company analyzes information of failed products may lead
them to go forward to the next evolution level.

Finally creative implementation of Corrective Action and Preventive Action

system may lead your organization to the next level of the company excellence.