The challenges to effective CAPA systems

A disconcerting trend in Quality Management Systems has been revealed during a review of the last 10 years of FDA Warning Letter data. This review of data from 2023 and the 9 years prior shows that a significant average of 37% of organizations have faced criticism for having 'inadequately established' CAPA (Corrective and Preventive Action) systems.

This frequency of 1 in 3 is not just a number — it's a wake-up call for industries to scrutinize and address the weaknesses in their CAPA processes. More importantly, the duration of this data tells us that these problems have challenged effective CAPA systems for over a decade.

Defining Effective CAPA System Standards

CAPA systems are integral to maintaining and improving the quality and safety of products within a myriad of industries. Quality system standards, such as ISO 13485 for medical devices and ISO 9001:2015 for quality management, underscore the necessity of CAPA systems for certification and regulatory compliance. For FDA-regulated industries, these requirements are distinctly laid out in 21CFR 820 Part 100 (a) and (b).

The evolution of quality management systems (QMS), since the release of the 5th edition of ISO9000 in 2015, has broadened the scope of these systems to demand a more profound engagement with improvement management — a domain heavily reliant on the efficacy of CAPA systems. Despite the clear guidelines and the critical role that CAPA systems play, FDA data from the last ten years paints a worrying picture when it exposes that one-third of organizations in the Devices program have been admonished for their insufficient CAPA procedures.

Should you Ignore FDA Findings?

The underpinning value of analyzing FDA data for understanding the challenges to effective CAPA systems lies in its relevance beyond just regulated industries. For those vested in the efficiency and effectiveness of CAPA systems, delving into FDA's data can be significantly revealing. Not only does it highlight where CAPA systems fall short according to FDA standards, but it also provides detailed, reliable, and inexpensive insights to support these findings.

The Value of FDA Data in Supporting Accurate Analysis

Three underlying values render FDA a pivotal source for data on effective CAPA system operation. Firstly, as a governmental entity, FDA data is collected and shared in a manner that encourages additional research and analysis, providing a cost-effective and accessible resource. Secondly, the definitions and expectations for CAPA systems are clearly documented in the Code of Federal Regulations, available publicly, and not restricted to fee-based standards such as ISO. Lastly, the data's reliability is bolstered by the consistent training and procedural rigor employed by FDA in their evaluations.

Insights for Any Industry

The persistence of CAPA-related criticisms in FDA warning letters provides insights for every industry because it demonstrates the inadequacy of change efforts to take hold over time. Consistently, across the decade of data examined, we see that a substantial proportion of organizations receive warning letters that cite a range of CAPA issues. During this time frame, the same issues are reported with the same levels of frequency each year. This year-after-year pattern of re-occurrence suggests strongly that the core issues remain unaddressed and unresolved across a broad range of industries, and that effective CAPA systems remain out of reach.

Additionally, the scrutiny applied by FDA crosses various programs and industries. When we execute analysis tasks such as ranking the frequency of all reported issues across programs, we gain insight into the most prevalent trends. It is then that we see that CAPA-related issues are reported in warning letters at higher volumes than other concerns. This trend accentuates the notion that deficiencies are not an isolated occurrence but a widespread challenge that transcends different industry sectors striving to operate effective CAPA Systems.

These combined insights are invaluable in suggesting that the lessons-learned from FDA's evaluations are not just for those under its jurisdiction but are applicable and beneficial to all industries committed to quality and continuous improvement. These are clear improvement directions for those wishing to operate effective CAPA systems.

Top Three Issues for Effective CAPA Systems

When we examine the data explained in our short 3 minute video, CAPA Issues Exposed, we can see that three issues clearly stand out when trying to operate effective CAPA Systems. They occur every year at high frequency and in none of the years examined do we find that annual frequency of occurrences is dramatically greater or less than the 10-year average.

1. Inadequately established CAPA procedures
   For this citation, the 10-year average value shows 37% of organizations received Warning Letters that included this reference. The citation is based on the definition in 21 CFR part 820 section 100 (a) which defines requirement that organizations establish and maintain CAPA procedures and the scope of such efforts.
2. Lack of or inadequate complaint procedures
   This citation is based on 21 CFR part 820.198. It refers to Complaint Files and has extensive content describing scope of requirements that should be fulfilled. For the last 10 years, an average of 27% of organizations received warning letters that included this citation. It was often the second most-frequently cited issue annually.
3. Inadequate documentation of CAPA activities or results
   This citation is also based on 21 CFR Part 820 section 100, but it applies to the sub section (b) and specifically relates to completeness and adequacy of documentation related to the activities or results of CAPA system efforts. The average rate of occurrence is 10% — quite low relative to the other citations — but it demonstrates that even those organizations that strive to meet part (a) requirements are failing at part (b).

When is Duration Not a Sign of Success?

When examining established processes or systems, it is easy to immediately believe that their demonstrated existence is a strong indicator of their success or effectiveness. Yet this examination of FDA data draws us to an oppositional conclusion. The long-term reporting of the same issues year-after-year clearly demonstrates that there still seems to be a significant gap in getting there, in spite of the long-established need for effective CAPA systems.

Are you struggling to get leadership to see that your established methods for dealing with CAPA requirements are not really moving the needle? Do you have a solution for improving CAPA processes you would like to share?