A guide to writing Corrective and Preventive Action (CAPA) reports
It’s stressful to receive an observation or warning letter from the Food and Drug Administration for corrective and preventive action (CAPA) noncompliance.
But if you do, you’re not alone—it’s one of the top reasons the FDA issues a noncompliance warning. A majority of the warnings issued stem from audits for compliance to FDA’s 21 CFR Parts 210 and 211 for finished pharmaceuticals, and to 21 CFR 820 regulation for medical devices.
If you do get a warning or observation for CAPA non-compliance, you’ll have to initiate an internal corrective action at your facility for the very thing you have just been told is lacking within your system. The easiest way to respond to the FDA is with a letter that includes a CAPA report, so it’s simple and easy for the FDA reviewer (and those at your facility) to follow the course of action.
Just remember to keep calm and create a thorough corrective action plan to close out the FDA warning and hopefully avoid any further issues in regards to corrective actions. Use this time to gather information, improve your system and implement a more refined CAPA process. This will help you in every other aspect of your quality system, so try and view the process as an opportunity. It should get everyone on board pulling resources to enhance your quality system, utilize your CAPA management software, and overall make your organization run even smoother.
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What is a CAPA report?
A CAPA report is used to document actions taken to correct or prevent non-conformances in products, processes, or systems. CAPA reports are typically initiated in response to customer complaints, internal audits, or other quality events. The purpose of a CAPA report is to document the actions taken to address the issue and prevent it from happening again in the future.
The difference between a CAPA form and a CAPA report is a matter of completion; a CAPA form is used to initiate the CAPA process, while a CAPA report is the documentation of the actions taken to address the issue.
How do you write a CAPA report?
Writing a CAPA report requires a systematic and organized approach. The first step is to assign a CAPA number. This will be used to track the issue throughout the CAPA process. Next, you will need to describe the issue in detail. Be sure to include all relevant information, such as when and where the issue occurred, what product was involved, and who was affected. Third, you will need to perform a root cause analysis to identify the underlying causes of the issue. Once you have identified the root cause, you can develop corrective and preventive actions to address the issue and prevent it from happening again. Finally, be sure to document all actions taken in the CAPA report. This includes the date the issue was reported, the date the corrective and preventive actions were taken, and who was responsible for each action.
What are the FDA requirements for CAPA reports?
The FDA has specific requirements for CAPA reports. All CAPA reports must be filed in a centralized database. This helps to ensure that all quality personnel are aware of the issue and can take appropriate action. CAPA reports must also be reviewed and approved by a designated individual within the organization. This helps to ensure that the corrective and preventive actions are adequate and will actually address the issue. And all CAPA reports must be made available to the FDA upon request.
Essential elements of a Corrective and Preventive Action report
Preparing a CAPA report for the FDA can seem daunting, but following these steps will help to ensure that your report meets all of the necessary requirements. The purpose of a CAPA report is to establish a timeline, identify the issue at hand, determine the root cause, propose corrective action(s), and include proof of effectiveness. The FDA will have to agree that your corrective actions are sufficient to close the warning, and they will check on these at subsequent visits, which could be soon, depending on severity of any other issues they found during their audit.
To avoid holes in your CAPA report, include these key items:
1. Identify and define the issue
Your first step is to define the issue in simple terms—especially when dealing with FDA. It’s always best to keep information simple, as some members of the investigation team may not be quality personnel with a background understanding of quality terms and lingo.
A few questions to ask while defining the problem:
- Is the problem real and not just a perceived problem?
- Can it be defined using simple words?
- What is the scope?
- Are there any stop gap measures we can do now to contain the issue while we figure out the root cause?
2. Determine the root cause
Root cause analysis is the most challenging parts of the CAPA process. Because of the complexity of root cause analysis, there are training courses on multiple different methods used to determine root cause. No matter the method, the bottom line is digging until you identify the underlying problem and not just the surface level issue. We all like to say it was “human error,” but there is certainly more to uncover.
In general terms, the problem could be identified as a lack of qualified personnel, undefined process, lack of resources or a misunderstanding of the importance of the quality system. Thus, determining the root cause of the problem takes dedication as you will need to comb through the data and processes used to create your product to determine probable corrective actions.
Additionally, a cross functional team that has been empowered to operate freely to determine the root cause is critical. It's easy to jump to conclusions in the root cause process, or have a senior manager that ends up leading the team to the wrong conclusion based on their biases. All potential root causes need to be systematically assessed to ensure nothing critical is missed. Assumptions are the death of a good CAPA process.
3. Propose and implement Corrective Action(s)
The most important step is to propose a plan to fix the root cause to ensure the problem doesn’t happen again. There could be more than one thing to fix, as it might entail different areas and different actions to close the loop. With this in mind, you should establish a defined timeline for implementation and follow-up (checks could be set at intervals or have defined dates for correction actions to be completed). In your report, explain exactly how you plan to follow up and what tools you’ll use to measure the effectiveness of the changes.
A key component of implementing the corrective actions is to document how you communicate these changes to everyone involved in the improvement process. This may involve retraining employees, making sure all process owners know what happened and why, changing a supplier, or editing your quality standard metrics. Show the precise steps you’re taking to correct the issue and list out who will be responsible for making sure each step is followed whether it’s internal or third-party. For example, if one action is retraining, the person responsible for this step would include proof of training records with the corrective action.
4. Proof of effectiveness
After the established time has passed, you should follow up and review the effectiveness of your corrective actions. This can be done by a quality manager; unbiased, trained staff; or you could hire a third party to ensure no bias. The latter is especially helpful if the corrective action process is a part of the quality team managed system.
In your report, date and document that you followed each step of the CAPA process and show data that supports your findings. If you still see issues, you can reconvene with the cross functional team assigned to the CAPA to review and develop more corrective actions and effective dates, or simply extend your timeline if timing is not a critical step in the corrective action plan (e.g. deadline missed for having everyone retrained).
The cycle will keep going until the loop is closed. Once closed you should send your CAPA report to the FDA, if that was part of the plan. Otherwise, keep all documentation on hand.
5. Track and document the CAPA in your system
Documentation is very important, since excessive CAPAs, recurrence of process failures and new problems are usually the result of a lapse in quality management processes. Therefore, it’s important to make sure your quality management team has a way to track and trend these issues.
Smaller companies usually start with homegrown tools to track their CAPAs, but as companies grow it is usually better to invest in an eQMS system. The best eQMS solutions come with templates for CAPA reports and other quality documents that could benefit your company.
Some systems are sophisticated enough to send reminders to all internal parties involved, regardless of the department, to ensure timely closure of CAPAs. Thus, with a more robust eQMS, it makes it easier to manage and track CAPAs across your organization. Ultimately, an eQMS could simplify internal and external (FDA) audits of the CAPA system, and ensure no steps are missed along the way.
Want to make CAPA and non-conformance management stress-free? With a suite of templates and visibility across your teams, Qualio’s eQMS can help you create comprehensive CAPA reports. Learn more about Qualio's CAPA management software.