5 Steps to a Compliant CAPA Process

5 Steps to a Compliant CAPA Process

Roxane Napoli, Marketing Manager, Pilgrim Quality Solutions

The Corrective and Preventive Action (CAPA) process is a requirement for compliance as well as a trigger for continuous improvement activities throughout your quality system. Complying with CAPA requirements and maintaining a reliable CAPA process is a challenge for many Life Sciences organizations. Let’s focus on 5 improvements that will help your organization create a reliable and compliant CAPA process.

1 Document the CAPA Process

Planning and organization lay the foundation for a strong CAPA program. It sounds simple, but lack of CAPA process documentation is a frequent reason for FDA 483 citations, which can damage your brand reputation and even lead to a shutdown. Many details need to be documented prior to implementing a CAPA workflow including processes to be monitored, people to involve, potential failure modes, severity levels, and actions to take. Typical CAPA process steps to include are:

  • Detection
  • Analysis
  • Investigation
  • Verification
  • Validation
  • Change Implementation and Communication
  • Effectiveness Review

Each of these steps should be included in your CAPA documentation, and each step should be logically related to the next.

FDA sources state that it is also important to get a handle on potential CAPA-related data sources. This can include both internal and external data. Internal CAPA data sources include existing quality records and data such as inspection data, nonconformance reports, device history records, training records, and more. External sources of CAPA data include supplier controls, customer complaints, service records, and even similar competitive products. Understanding and documenting these data sources will help you understand which quality system data and records should be monitored as input to your CAPA process, so you can analyze them accordingly.

2 Leverage Trends to Pinpoint Risk

Despite intense regulatory pressures, not every deviation, complaint, audit finding, or supplier defect should trigger a CAPA. Trend analysis and risk management can help to avoid the costly and time consuming “everything is a CAPA” syndrome. Paying close attention to trends determines if a nonconformance is an anomaly or part of a greater concern that should trigger a CAPA process. Trending can also reveal minor problems before they become riskier issues and help you better prioritize nonconformances for further investigation.

3 Solidify Root Cause Analysis

An effective CAPA process hinges on your team’s ability to understand the true cause of each problem you encounter. That’s why a well-defined root cause analysis process is essential to a CAPA system’s effectiveness. Corrective and preventive actions cannot be effective without understanding the fundamental reason for the problem.
The goal of root cause analysis in not only to fix the problem at hand. It is to understand why the problem occurred so the right actions can be taken to prevent that problem from reoccurring. A root cause needs to be specific, and it also needs to be something that can be changed with action. You can learn more about the do’s and don’ts of successful root cause analysis.

4 Maintain Management Involvement

A CAPA process is not effective or compliant without management commitment. Managers who understand CAPA procedures and conduct management reviews of CAPA data and records keep the CAPA process in compliance and reduce their risk of FDA 483s. And forward thinking managers are beginning to leverage best practice CAPA as a tool to increase efficiencies, improve customer satisfaction, and protect their corporate brand.

“FDA emphasizes that it is always management’s responsibility to ensure that all nonconformity issues are handled appropriately.”
Source www.fda.gov

5 Take Action

Change is a natural output of the CAPA process; in fact, change is the purpose of the CAPA regulation. Managing corrective and preventive change keeps you in compliance and also contributes to continuous improvement initiatives. Tying CAPA-related changes back to specific root causes ensures that your action plans are focused on finding the most effective solution to teach nonconformance you encounter. This ensures that appropriate changes are implemented whether the CAPA end result calls for document-based change, retraining, new procedures, or any other type of change. It is also helpful to assign specific action plans to specific individuals to keep your team accountable for each task to be completed.

Bonus Tip:

One of the best ways to ensure that you have a compliant CAPA process is to automate it. Solutions like SmartSolve CAPA Management help you document your CAPA process and results, analyze trends, document root cause analysis, and keep your team accountable for making CAPA-related changes.

What are your challenges in maintaining a compliant CAPA process? Please let us know in the comments below.


Tartal, Joseph (2014). Corrective and Preventive Action Basics.

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Roxane Napoli

Director of Marketing Communications, US Marketing, IQVIA

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