FDA & ISO 13485 on Corrective and Preventive Action (CAPA)

24 Dec 2024

Among the many challenges faced by the medical device industry, CAPA (Corrective and Preventive Action)-related challenges pose the most problems. These challenges can be related to CAPA approach, closures, effectiveness, and so on. In this blog, we will explore some of these challenges and see how TSQ &Engineering can help medical device manufacturers overcome those.

CAPA and its Related Regulations

From the regulatory point of view, the importance of CAPA cannot be undermined. For instance, device manufacturers are always evaluated on their CAPA processes during FDA inspections. Similarly, these processes are also scrutinized during ISO 13485 audits.

Even though this process is important, the top reason for device manufacturers to receive FDA observations are due to CAPA and its related processes. Moreover, manufacturers also receive CAPA related warning letters from FDA. And yes, these warning letters are mostly about quality system aspects concerned with CAPA.

Now that we have built a ground on understanding the seriousness of CAPA-related compliance, let’s understand this requirement of implementing “Corrective and Preventive Actions” from a regulatory point-of-view.

CAPA According to FDA

FDA has defined its CAPA requirements in 21 CFR Part 820.100 as well as in its FDA QSIT Guide.

CAPA Requirements in 21 CFR Part 820.100

Manufacturers must have procedures established and maintained to implement CAPA. These procedures will include the requirements for:

1. Analysis of concessions, processes, work operations, returned products, quality audit reports and quality records, complaints and service records. This will help with the identification of any present and potential causes of quality problems and nonconforming products. Whenever there is a need to identify recurrent quality problems, then appropriate statistical methods will be employed.

1. Investigations for the causes of nonconformities concerned with processes, products, and quality system.

1. Identification for the actions required for correcting and preventing recurrence of a nonconforming product and other quality problems.

1. Verification and validation of CAPA to ensure their effectiveness. This will also help ensure that these actions do not affect the finished device adversely.

• Implementing changes in methods and procedures to correct and prevent the identified problems. Such changes will also be recorded.

• Ensuring that information concerned with nonconforming products and quality problems reaches to those who assure quality of these products and prevent quality-related problems.

• Submitting correct information and corrective and preventive actions on the identified quality-related problems so that they can be reviewed by the management.

CAPA Requirements in FDA QSIT Guide:

FDA QSIT Guide describes multiple purposes of CAPA i.e.

• It collects and analyzes information.
• It identifies and investigates product and quality system related problems

According to the QSIT Guide, verification, validation, and communication of CAPA

to responsible persons are effective in dealing with quality-related problems.

CAPA from the Perspective of ISO 13485:2016

ISO 13485 standard addresses CAPA in its two separate clauses:

Corrective Action – 8.5.2

The organization must take necessary actions to eliminate causes of nonconformities prevent them from recurring. Any required corrective actions must be taken without any delay. Moreover, these actions should be of the same intensity of the nonconformities encountered.

In this regard, the organization must document procedures to define the requirements regarding:

• Reviewing nonconformities and determining their causes
• Determining the need for corrective actions to ensure that nonconformities do not happen
• Planning, documenting, and implementing the required actions and updating the documentation accordingly
• Ensuring that the corrective actions do not have any adverse effect on fulfilling the regulatory requirements of safety performance of the medical devices
• Reviewing effectiveness of the actions taken

Whatever the actions are taken by the organizations, they will be documented.

Preventive Actions – 8.5.3

The organization must define the action required to eliminate the causes of nonconformities to prevent them from recurring. These actions must correspond to the magnitude of the problems encountered.

Here, the organization will be required to document a procedure that documents requirements to

• Determine any potential nonconformities and their causes
• Evaluating the need to take action to prevent nonconformities from recurring
• Planning and documenting the actions required and implementing them (the documentation must be updated accordingly, if required)
• Ensuring that the corrective actions do not have any adverse effect on fulfilling the regulatory requirements of safety performance of the medical devices
• Reviewing effectiveness of the actions taken

The Main Problems with CAPA

The reasons why most of the manufacturers have problems with CAPA are listed as follows:

Taking a Reactive Approach

Many medical device manufacturers automatically assume that preventive actions can only be taken after a corrective action i.e. first, a non-conformity should occur, then the organization should take corrective action to mitigate it, and lastly, take a preventive action to prevent its recurrence.

However, this undermining of CAPA by organizations can take a toll on them. Therefore, the best approach for medical device manufacturers is to have a system that can proactively identify issues for them before they get converted to nonconformities.

Lacking Cross Functionality

The quality division of medical device manufacturing organizations mostly look after the CAPA management. However, if there is no proper communication and facilitation between the quality division and other departments of the organization, then CAPA will most likely be rendered useless.

Not Determining the Root Cause Properly

CAPA and root cause are closely linked. While organizations may invest their time performing CAPA, they may feel less interested in determining the root cause. This approach can lead to different problems. Thus, it is safe to say that if the organizations want to correct or prevent a nonconformity, they must define the root cause properly.

Miscellaneous Problems

Apart from the problems mentioned above, medical device manufacturers often face of the following three problems:

1. They do not follow their own defined CAPA process
2. Their CAPA process is non-compliant with the regulations
3. They do not have a defined CAPA process to begin with.

Having such problems at hand is the main reason why CAPA management and its related problems land medical device manufacturers in trouble with FDA and other regulatory bodies every year. But with expert consultancy from TSQ & Engineering s regulatory experts, there is no need for you to worry.

Of course, as a medical device manufacturer, one of your biggest worries would be to ensure that your CAPA system fulfills all the applicable requirements, primarily those of FDA and ISO 13485. But without proper consultation, this can be very difficult. And this is why, you should read our blogs and get a consultation session booked right away!