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CAPA Chapter I: Understanding Non- Compliance in the CAPA System

Rami.Azulay September 16th, 2019 Posted by Rami Azulay( ) Requirements Management Tool

One of the most recurring issues that the FDA finds during its inspection is the non-compliance to the Corrective Action Preventive Action (CAPA) system. Surprisingly, the non-compliance problem isn’t recent as it continues to be a problem for most companies. The registrars’ audit reveals a couple of factors that contribute to the non-compliance trend. They include:

  • The lack of identification of root causes: Most companies often stop their investigation after finding a cause even if it is not the root cause. While others will repeat their findings as to the root cause for the non-compliance.Not Implementing CAPA Quickly: In the process of focusing on product development, some companies tend to forget to apply CAPA. Likewise, CAPA may not be a priority for some companies or they lack adequate resources to implement CAPA.
  • Lack of Understanding of the CAPA Process: There is a possibility that the company may not understand how CAPA works. As a result, they apply processes that are not in compliance. Also, when they implement CAPA, some lack the drive to follow through with the process and access its effectiveness.

  • Managers Ignoring CAPA: Some managers might not consider CAPA as a realistic solution. There are managers who feel that the application of CAPA will be a waste of resources and time.

One of the ways to address to fix the issue of CAPA compliance is commitment. It is not enough to have good intentions, the management has to demonstrate a willing commitment towards ensuring compliance.

Process Requirements

Here are some factors that ensure compliance based on regulation requirements..

Process Documentation: The idea of documenting the CAPA process is very beneficial to the company. In so doing, the company can be sure that they cover every part of the process while making sure that everyone can follow the same steps. 

Also, the company can ensure that everyone has the same understanding of the CAPA process as most CAPA concepts do not have a specific definition. For example, the FDA maintains a universal set of activities for the CAPA process. Hence, the FDA is able to have a single CAPA process.

On the other hand, ISO 13485 splits the CAPA into different categories the CA and PA. Despite the fact that both processes have different procedures, there is an overlap between 21 CFR 820 and ISO 13485.

FDA Process Requirements

As stated earlier, the FDA has just one single process for CAPA. The process requires the following;

Analysis: Critical analysis of the problem.

Investigation: A thorough search of the root causes of the problem.

Actions: Take steps to both correct and prevent the problem. Therefore, making that they won’t be an issue in the future.

Verification: Proof that the steps taken have an effect on issues. There should be answers to questions like; did the actions taken have the desired result? Are there any adverse effects to the actions taken?

Procedural Changes: Making sure the changes are institutionalized.

Communication: To inform everyone about the changes and make sure that they are aware, they act on it, and they understand it.

Review: Informing the management of the current changes and getting their approval on the changes.

Documentation: Always make sure that everything is documented. As a result, there will be a trail of events for all changes and activities.

All can be achived using Orcanod electronic CAPA system.

ISO 13485 Process Requirments

ISO 13485 has two separate processes for both CA and PA. According to ISO 13485, the processes for CA are as follows:

Review: The review process for CA is similar to the analysis process given by the FDA. It involves the understanding of the problem.

Identification of Causes: It is the same process as the FDA’s identification of the root causes process.

Need for Action: Taking steps to fix the problem and making sure they don’t reoccur.

Determine Actions: While it is similar to the FDA’s requirement to take action, the focus here is ensuring that the actions appropriate.

Record Result: Similar to the process of documentation in the FDA’s process.

Determine Effectiveness: It is the same as going through the verification process on the FDA requirement.

For PA, the procedures overlap with that of CA. However, since preventive action means that there are no non-conformities yet, then there is no need to take any action. The following are the procedures for PA;  Identification of causes, need for action, determine actions, record results, and determine effectiveness.

It should be noted that in the need for action for PA, while it is similar to the procedure for CA, there is no need for correction. Likewise, when determining effectiveness, care should be taken that there is no regression.

In conclusion, it is obvious that there are similarities between CA and PA. Also, there are similarities between ISO and FDA requirements.

In that sense, the Orcanos eQMS system is easily adoptive which allows powerful tools that are easy to use and configure to meet your current and future needs in the same system.


About the author, Rami Azulay

Rami has over 24 years of experience in various software development and QA roles. Using his extensive knowledge of operations and quality, Rami was a main architect of the Orcanos software back in 2005 and later became Orcanos VP sales & marketing. Rami holds an MSC degree in Computer Sciences.

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