What is CAPA?

The U.S. Food and Drug Administration (FDA) outlines that corrective and preventive action should be used to collect, examine, identify, and investigate any product or quality issues while simultaneously taking necessary measures to avoid any future occurrences of the same problem.

To effectively handle and prevent product or quality issues, as well as the possibility of device malfunctions, it is critical to validate corrective and preventive actions, communicate these activities to applicable personnel, supply pertinent information for management examination, and keep a record of all such transactions.

The U.S. Food and Drug Administration (FDA), in 2006, pioneered Corrective and Preventive Action (CAPA) within their Quality Systems Guidance - the source of ICH Guideline Q10. This process has since been adopted by the EU GMP Guide to effectively manage CAPA processes in pharmaceutical space.

For medical device organizations, CAPA is outlined in ISO 13485. Unlike Q10 which delineates the concept into Corrective and Preventive measures, both of these processes must be documented and assessed to verify that improvement has taken place as well as preventive action has been implemented making CAPA an effective process by bringing them together.

With this understanding we will treat it here as one unit.

What is CAPA used for?

Establishing a CAPA procedure is essential for identifying and preventing future errors, deviations, or problems. This type of assessment should be part of your larger risk management system to ensure all potential risks are properly addressed. By taking the time to analyze any issues that have already occurred as well as their wider effects on operations, you can develop effective strategies that will mitigate these risks and keep your business safe in the long term.

Quality management systems are often the source of CAPA-triggering deviations, be it from customer feedback, internal audits or serious safety and security incidents that lead to faulty products as a result of inadequate controls.

Whenever CAPA is initiated, the initial step should be to take any immediate measures that can stabilize the incident and limit its impact. It is important to conduct an honest and precise evaluation of its magnitude here. In dire cases, this could involve halting production as well as distribution of all affected items right away.

How does a CAPA process usually work?

Generally, the execution of a CAPA follows the same structure as that of any typical PDCA

(Plan-Do-Check-Act) cycle:

1. Prior to initiating corrective action, it is critical that the problem be thoroughly determined and documented. Just like preparing for an operation in the PDCA cycle, start your CAPA with a comprehensive description of the issue at hand; doing so will help guarantee its accuracy.

2. Uncover the source of your issue. Once you've clearly identified the challenge, take a deep dive investigation to uncover its core cause by performing an extensive root cause analysis.

3. By implementing, verifying, validating and documenting corrective measures that address the root cause of the problem, you can be sure future issues will not arise. This could come in the form of a change to your production process or training program which works towards transformative improvement.

4. Assess effectiveness and evaluate success. Once the corrective action is taken, it's time to analyze if what was done was successful or not. If all goes according to plan, that means we can justify why the CAPA process worked out nicely. However, if we find there are still issues in need of fixing then another CAPA cycle will be needed; which could potentially include a re-evaluation or addition to the risk analysis too!

Adhering to the FDA Requirements for Your Corrective

Action and Preventative Actions Process

With the myriad of regulatory observations citing inadequate CAPA procedures, it is critical to reassess what authorities expect from you regarding this process.

In a 2014 presentation, Joseph Tartal of the FDA outlined and discussed key aspects of effective corrective and preventive action. Every business should utilize this resource to assess their processes and make sure they are compliant with regulatory expectations.

For manufacturers, one particularly invaluable detail is that their corrective and preventive action records can illustrate to the FDA that they have a successful quality system in place. This allows them to swiftly identify problems and execute effective corrections/preventative measures accordingly.

By helping manufacturers meet all the necessary criteria for effective CAPA, FDA also offers its own inspectional guide which provides investigators with clear goals when evaluating a device company's CAPA program and relevant documentation.

Use this checklist to ensure your CAPA processes are compliant with FDA regulations and you'll be prepared for any unexpected events.

1. Ensure that the necessary procedures of the CAPA system have been documented to adhere to quality system regulations.

2. Ascertain that the ideal sources of product and quality issues have been identified. Ensure that data from these resources are scrutinized in order to comprehend any current product and quality dilemmas which may necessitate corrective action.

3. Ascertain whether any sources of product and quality data that could showcase undesirable trends have been found. Affirm that the info from these resources is assessed to uncover potential product and quality issues which may necessitate a preventive solution.

4. Examine the quality data information system to confirm that all the data received by the CAPA system are precise, thorough, and up-to-date.

5. Ensure statistical methods are used appropriately to identify consistent quality issues. Compare results between data sources in order to gauge the degree and nature of product or quality problems.

6. Assess whether failure investigation protocols are being followed. Gauge if the level of scrutiny for a quality concern or faulty product is proportionate to its importance and risk.

Validate that investigations occur to try uncovering root causes (when possible). Confirm that measures have been taken in order to stop nonconforming products from distribution.

7. Assess whether meaningful solutions have been applied to major product and quality issues revealed from data records.

8. Assess the effectiveness of corrective and preventive actions, validating them before applying. Ensure that these measures do not negatively affect the completed product.

9. Ensure that the appropriate corrective and preventive measures for product-related and quality issues have been taken, recorded, and documented.

10. Ascertain if the details related to defective products and quality issues, along with corrective actions have been properly distributed throughout all levels of management.

By following these steps and ensuring that your processes are compliant with the rules set out by the FDA, you can be confident that your organization is properly equipped and ready for any challenges or inspections it may face. Remember, your CAPA system is a crucial part of maintaining quality assurance and compliance; making sure your systems are up to regulatory standards is essential for staying compliant.

Finally, quite simply, having an effective CAPA system in place helps you ensure that all product issues are identified and addressed properly. No matter the complexity of the issue, a well-established CAPA system will help you assess the quality of your product and identify any potential problems before they become major issues. With an effective CAPA system in place, you can make sure that you’re always meeting regulatory expectations and delivering high-quality products to customers. Learn about regulatory food laboratory testing.