The CAPA report is a critical documented ingredient you'll need in your quality management system to ensure good corrective and preventive action (CAPA) compliance.
You'll need to show off your CAPA report and your CAPA management system in audits for compliance with FDA’s 21 CFR Parts 210 and 211 for finished pharmaceuticals, and to the 21 CFR 820 regulation for medical devices.
And if you do get a warning letter or Form 483 for CAPA non-compliance, the best way to respond to the FDA is with a letter that includes a CAPA report showing how you'll put things right.
A robust and holistic CAPA management system is essential for continuous improvement and for grabbing firm hold of your quality issues - and the CAPA report is at the center of how you'll execute it day-to-day.
Let's dive into what a CAPA report is, and show you how to write one with a CAPA report example.
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.
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.
The FDA has specific requirements for CAPA reports.
All CAPA reports must be filed in a centralized database - either physically on paper or, preferably, in dedicated CAPA management software. This helps to ensure that all quality personnel are aware of the issue and can take appropriate collaborative 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.
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.
Need to learn how to write a CAPA report without gaps? Follow these key steps:
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:
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.
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.
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.
The corrective preventive action report is ultimately about ensuring this critical step is taken: that all elements of your CAPA action are properly documented and traced.
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.
Need a CAPA report example structure for inspiration?
If you're unsure how to make a CAPA report of your own, here's a sample CAPA report format you can steal:
Report Number: [Insert Report Number]
Date: [Insert Date]
Prepared by: [Insert Name]
1.1. Description of the Problem:
1.2. Date of Occurrence:
1.3. Detection Method:
2.1. Method of Analysis:
2.2. Root Cause:
3.1. Immediate Action Taken:
3.2. Corrective Actions:
| Action Item | Description | Responsible Person | Due Date | Status |
|---|---|---|---|---|
| Action 1 | [Description of corrective action] | [Name] | [Date] | [Not Started/In Progress/Complete] |
| Action 2 | [Description of corrective action] | [Name] | [Date] | [Not Started/In Progress/Complete] |
4.1. Preventive Actions:
[Not Started/In Progress/Complete]
5.1. Verification Method:
5.2. Verification Results:
6.1. Reviewed by:
| Name | Title | Date | Signature |
|---|---|---|---|
| [Name] | [Title] | [Date] | [Signature] |
6.2. Approved by:
| Name | Title | Date | Signature |
|---|---|---|---|
| [Name] | [Title] | [Date] | [Signature] |
Simply populate this sample of a corrective and preventive action report with your own information, and ensure each report is stored in a logical, structured way with ALCOA+ data integrity principles in mind.
We hope our guide to CAPA reports proved useful for you.
As you look to get your CAPA processes set up, it's worth considering the tools you'll use to manage them in the long run.
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 platforms, like Qualio, come with pre-built templates for CAPA reports and other quality documents to eliminate the hard work of document creation for you.
And with fully configurable action workflows, automatic prompts and reminders, and powerful CAPA analytic dashboards, you can ensure no steps in your CAPA report are missed along the way.
Want to make CAPA and non-conformance management stress-free? With a suite of CAPA report example templates and total visibility of your nonconformances in one place, Qualio’s eQMS helps you create comprehensive world-class CAPA processes - all underpinned by automatic, fully compliant CAPA report generation.
Meg has amassed over a decade of experience as a QA/RA and compliance professional, with a range of cross-functional skills and knowledge spanning from non-profits to medical device start-ups.
Meg is Senior Quality Specialist at Qualio, a member of the Qualio+ expert team, and a certified auditor for both ISO 9001 and ISO 13485.