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Stephanie Ojeda

Lean

Eight CAPA KPIs You Should Be Measuring Now

Companies should track a range of CAPA metrics

Published: Thursday, December 8, 2022 - 12:02

Corrective and preventive action (CAPA) is a core function in any quality management system (QMS), and a critical piece in the plan-do-check-act process approach. Like any quality process, tracking CAPA key performance indicators (KPIs) 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 isn’t an efficient way to manage quality issues. Rather, tracking CAPA KPIs is a proactive strategy that helps prioritize issues and improve root cause analysis as part of best practices driving quality improvement.

Let’s look at eight 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 of how effective your CAPA system is. A high 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.

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 also depends 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 may take longer to solve due to their complexity. But 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) wasn’t 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, maybe your training program is inadequate. Furthermore, it could 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 cause. For instance, repeat assembly issues could in fact be the result of having out-of-date instructions.

6. CAPA aging

On a related note, it’s also important to have 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

A metric that many organizations don’t track 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 percent. If your KPI shows a first time through rate of 95 percent, it’s time to evaluate why you’re below target.

Furthermore, there’s important data in CAPAs that aren’t first time through. It 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 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.

Conclusion

When presenting data in quality management reviews or internal quality meetings, CAPA is an important metric to report on. More important 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.

First published Nov. 15, 2022, on the AssurX blog.

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About The Author

Stephanie Ojeda’s picture

Stephanie Ojeda

Stephanie Ojeda is the director of product management for the life sciences industry at AssurX.

Comments

8 CAPA KPIs

ISO 9001:2015 nor ISO 14001 nor ISO 45001 say "CAPA". They ONLY have CA. Reason, risks based thinking is embedded throughout these ISO/IEC Directives Annex SL 9 Harmonized Structure 'clauses'.

Secondly, "risks and opportunities" planned actions are required for CONFORMANCE not 'compliance', is required to be "integrated within the organisation's business processes".

CA and PA in medical, automotive, aerospace, food, medical products, oil & gas are some QMS Standards that ADD 'PA' to their QMS requirements. These MS standards have either referenced or included ISO 9001:2015 requirements.

CA and PA must be separated. They are very different and any 'Continual Improvement' (not "Continuous Improvement") methodology like 8D, PDCA, DMAIC, A3, PDSA et al can be used as per the ISO 9001:2015 "Context of the organization". Correctly, PA by say FMEA et al, are most valuable.

Worth re-reading ISO 9000:2015 Vocabulary and terminology as it a "Normative reference" for ISO 9001:2015 and hence embedded within ISO 22000 etc, for explaining CA and PA. Notice - not "CAPA". ISO 31000:2018 Risk Management - Guidelines and directly, ISO 31010:2019 provides a drill deep and wide RM assessment and mitigation tools and techniques.

Valuable information

This article provides some very valuable information, as inadequate CAPA is a major source of ISO 9001 and IATF 16949 findings. This is not a surprise because so many other processes of the quality management system depend on CAPA. E.g. 8Ds (Eight Disciplines) that never get past D3 or D4 mean the the problems never get fixed and continue to make trouble. These KPIs are well worth reading, and I encourage readers to see if they have noticed any of these issues in their own CAPA process.

Too Many

Eight KPI's just for CAPA's?  We only track nine KPI's for the entire 100-person company.  In my opinion this is way too much beauracracy.