FDA’s CAPA Guidelines for 2023
Four in five warning letters issued by the Food and Drug Administration (FDA) are because of poor implementation and documentation of the Corrective Action, Preventive Action (CAPA) process.
The FDA recently released a Definitive Guide for CAPA for 2023, detailing the expectations of the FDA from the CAPA process implemented by organizations. Here’s a quick summary of what the guide entailed:
1. One of the first requirements is that of a clear definition and documentation of CAPA system procedure(s) addressing the requirements of the quality system regulation.
2. Second, a root cause analysis of the problems to determine the appropriate cause must be conducted. Data should be further analyzed to identify problems where corrective action is required.
3. Third, the trends must be identified to determine potential product and quality problems that may occur in the future and the need for preventive action.
4. Data Quality: The data received by the CAPA should be verified for quality, completeness, accuracy, and timeliness.
5. The appropriateness of the statistical methods used for detecting recurring quality problems should be evaluated.
6. Failure investigation procedures must be followed, risk of the quality problem or nonconforming product assessed, root cause investigations conducted, and controls put in place to prevent the distribution of the nonconforming product.
7. Appropriate actions must be taken to address product and quality problems identified from data sources.
8. Corrective and preventive actions have to be verified and validated before implementation and confirmed that it is performing as expected. More importantly, corrective and preventive actions should not adversely affect the final product.
9. A verification of corrective and preventive actions for product and quality problems must be done to ensure CAPAs were properly implemented and documented.
10. Companies must ensure the sharing of information about the nonconforming product, the quality problems, etc. with relevant teams and the management for review.
The FDA also recommends taking a PDCA (Plan-Do-Check-Act) approach to implementing CAPA to meet the above requirements.
10-Step CQ Guide: End-to-End CAPA Workflow
The first part of a PDCA approach is the plan. The CAPA plan must be fool-proof to ensure compliance while correcting a problem and prevent its future recurrence. Some of the best practices in creating a CAPA plan include:
Step 1 - Define the Problem
- Identifying the problem and defining it are the first steps to creating an effective CAPA plan. Detailing the problem will help the users to determine the nature of the defect, establish the degree of variance from the specifications, and whether it is within the tolerance level.
- Establish whether the problem is with one product batch or all batches and take a decision about the next step.
- Based on this, decide whether it needs a CAPA or if there is an alternative solution to mitigate the problem.
- Where possible, specify the affected processes, systems, equipment, and/or software.
- What were the tell-tale signs that helped to identify the problem and the need for further investigation should be specified.
- Delineate the associated risks and the potential impact.
This stage is crucial for setting the tone for the effectiveness of the subsequent CAPA implementation.
Step 2 - Risk Assessment
Document all known information about the issue to understand the associated risks by assessing the following:
- Does it occur frequently?
- What is the impact of the problem?
- Has any CAPA been initiated before and its impact?
- Any investigations that were conducted and their findings
- Assign CAPA risk level based on the frequency and impact
- With appropriate statistical methods, determine if the problem is likely to recur
The severity and frequency will determine whether the problem is high-risk and what kind of action should be taken.
Step 3 - Take Action While Triggering the CAPA
Even as it is being decided whether the problem requires CAPA or not, initiate action to contain the problem based on the risk level to:
- Stop the distribution of the nonconforming or deviant product
- Stop the production of the nonconforming product, or
- Stop the use of a process that is out of control
- Document the short-term measures.
- If required, quarantine the nonconforming product, segregate it in the field to prevent further use, notify the appropriate regulatory authorities, and initiate a recall if needed.
Step 4 - Conduct Root Cause Analysis
This is a crucial investigation that helps establish the real cause of a problem and the appropriate corrective solution. Interestingly, there can be more than one root cause. Therefore, it is important to identify all of them for the CAPA to be effective. There are many tools available to perform root cause analysis, such as:
- Pareto Analysis
- Fish Bones
- Five Why Analysis
- FMECA
- FTA
These should be supported by forensic analysis, interviewing the operators, product testing, replicating failure mode, and comparison of the variant products with other lots or batches. External help from experts or laboratories may also be required to understand the problem.
Step 5 - Plan the Corrective Action
Here, it is important to understand the difference between correcting a mistake and taking corrective action. Correcting may mean adjusting for a particular product or batch. Corrective action has a more far-reaching impact and will prevent the recurrence of the issue. Corrective actions encompass
- Training employees
- Preventing recurrence
- Addressing each Root Cause with an appropriate Corrective Action
- When a root cause is not addressed, documenting the reason along with the impact
Elucidate the deployment strategy for the corrective action and the timelines, assign responsibilities, and establish metrics that should be measured to assess the effectiveness of the measures.
Step 6 - Verify the Corrective Action Before Implementing
CAPA involves many steps and takes time and effort. Therefore, before implementing it at the enterprise level, running a pilot is essential to verify its effectiveness. It should be assessed to ensure that:
- The product meets the approved specifications
- The problem is resolved
- Or that severity or the frequency of the problem or defect reduces.
Step 7 - Validation of Design and Process Changes
Changes to a design or process must be validated through real or simulated use to ensure that the changes have the desired impact and do not introduce new errors or issues. The nature of the test will depend on the type of problem. Appropriate methods should be used for validation, as per pre-approved protocol. It should be supported by documentation.
Step 8 - Communicate the CAPA Action Plan with the Organization
Share the CAPA plan and the action taken along with the reasons for it with the relevant teams who will be impacted by it. Employees should also be made aware of potential problems and defects and encouraged to share their observations with their supervisors and managers.
Based on risk, plan and schedule the implementation of the corrective actions such that there is minimum disruption of operations.
Step 9 - Review CAPA for Effectiveness
Use the metrics established in the planning stage to measure the effectiveness of the CAPA at predetermined intervals. This will help identify any gaps and finetune the process for continuous improvement.
Step 10 - Integrate CAPAs with Management Review
CAPA measures and metrics should be communicated for Management Reviews for data-backed decision-making, identifying and responding to quality-related issues, and providing the resources needed to take corrective action.
Conclusion
For a more detailed document, download our Whitepaper titled ‘A Fool-proof Plan for Building an Effective CAPA Process’ here: https://www.compliancequest.com/whitepaper/fool-proof-plan-for-building-capa-process/
In this paper, we also talk about why leaders and decision-makers must not stop with just CAPA Planning. They need to have an implementation and review strategy as well.
