Corrective and preventive action (CAPA) is a core function in any quality management system (QMS) and critical to the Plan-Do-Check-Act process approach. Like any quality process, tracking CAPA KPIs (key performance indicators) is crucial to continuous improvement. It’s also a focus of regulators and auditors, and is consistently highlighted in the more than 500 warning letters issued to date in 2022 by the U.S. Food and Drug Administration (FDA).
Many companies take a reactive approach to corrective actions. Unfortunately, reacting to issues that get the most attention is not an efficient way to manage quality issues. A proactive strategy of tracking CAPA KPIs to help prioritize issues and improve root cause analysis are best practices to drive quality improvement.
Below we look at 8 CAPA KPIs that can help manufacturers achieve these goals, plus best practices for setting targets.
1. Number of Open Issues
The number of open issues is a rough measure that gives you a sense of how effective your CAPA system is. A large number of open issues can indicate that people aren’t prioritizing corrective actions. On the other hand, there may be some other barrier, for example, a lack of quality resources. Only a thorough analysis of open CAPAs can determine the source(s).
Alternatively, too few issues can mean that people aren’t logging issues in the QMS. Any auditor that visits your facility will want to see consistent entries in the CAPA system. Being able to provide a view of your CAPA KPIs and drill-down as requested provides visibility that auditors value.
2. Average Time to Closure
CAPA KPIs provide insight into your organization’s efficiency and commitment to quality. The average number of days to close out a CAPA is a measure of the efficiency of your corrective action process. For example, if your average time to closure is consistently exceeding targets, it may indicate a bottleneck in the process.
The average time to closure is also dependent on the number of overdue issues of varying criticality, which brings us to our next measure.
3. Number of Overdue Issues
When looking at overdue issues in your CAPA system, it’s important to differentiate between minor, major and critical issues. While neither ISO 9001 nor 21 CFR define these categories or timeline to closure, risk should be a key factor in prioritizing CAPA. A sample target used in many organizations is:
- Minor issues: 30 days
- Major issues: 45 days
- Critical issues: 60 days
At first glance, it seems counterintuitive to set a longer deadline for critical issues. However, these issues can be more complex and take longer to solve. No matter how you define your targets for CAPA closure, auditors will expect to see your definitions in your SOP and whether you’re sticking to it.
4. Number of New Controls Implemented
Another interesting report that some manufacturers may have in their CAPA KPIs is the number of new controls implemented over a given period of time. For example, you may find that as the number of new controls declines, a rise in quality issues may follow. Conversely, a steady pace of newly implemented controls can indicate a healthier CAPA system where problems are being solved with new solutions.
For instance, an additional supplier may be added to mitigate recurring late deliveries. However, production time still runs behind goals. An effectiveness check confirms that the control (new supplier) was not an effective control measure. As a result, a CAPA is opened to investigate the issue for true root cause.
5. Number of Repeat CAPAs
Looking at the number of CAPA KPIs for repeat corrective actions can provide insight into problems you may need to revisit. In some cases, this can identify areas where you need to do a deeper dive with root cause analysis.
For example, if you attribute a number of repeat issues to employee training failure, your training program may be inadequate. Furthermore, it may indicate that people aren’t going far enough during root cause analysis.
However, human error or training failures are often a symptom rather than a true root cause. For example, you may find repeat assembly issues are in fact the result of having out-of-date instructions.
6. CAPA Ageing
Related to the number of overdue CAPAs is having an idea of how old all of your corrective actions are. Specifically, you want to know how long they have been open. Have any been open longer than 90 days, and if so, how many?
A best practice guideline used in many organizations is to make sure CAPAs are closed within 60 days. If you have many open past 90 days—or worse, for nearly a year—that’s a problem you must address. Without a KPI for age, the amount of time a CAPA remains open can easily surpass your objectives. Unfortunately, at that point, it’s very difficult to defend to the FDA.
7. CAPA First Time Through
Our final metric is one many organizations don’t track, and that is CAPA first time through rate. Among CAPA KPIs, this is a measurement of the competence of the team in getting CAPAs right the first time. For example, your target first time through rate may be greater than >99%. If your KPI shows a first time through rate of 95%, it’s time to evaluate why you’re below target.
Furthermore, there is important data in CAPAs that are not first time through. It may may be wise to open a new CAPA referencing those CAPAs to find the root cause.
Action report rejections due to incomplete information or insufficient investigation may signal a need for retraining. In particular, you may need to provide better training on corrective action and/or root cause analysis.
8. CAPAs by Issue Type
Similar to looking at repeat issues, manufacturers should categorize issues by issue type. This allows you to see the distribution of corrective actions across different process areas, for example. Capturing issue types can help with root cause analysis and making sure you focus your efforts in the right areas.
For instance, you may find more issues happening at the beginning or end of the production process. The important thing is to focus on the most frequent issues and make sure you address them first. That means one-off issues that are major or critical should be lower priority than minor issues you see frequently.
When presenting data in quality management reviews or internal quality meetings, CAPA is an important metric to report on. More than just the number of corrective actions or high-profile items, however, companies should track a range of CAPA metrics.
Understanding the distribution of issue types as well as the relative ages of overdue CAPAs is key. Digging deeper into your data is essential to preventing product quality issues, and ensuring the effectiveness of your CAPA system.
About the Author
Stephanie Ojeda is Director of Product Management for the Life Sciences industry at AssurX. Stephanie brings more than 15 years of leading quality assurance functions in a variety of industries, including pharmaceutical, biotech, medical device, food & beverage, and manufacturing.