CAPA: Corrective and Preventive Actions Introduction Principles – Chapter I

Rami.Azulay July 7th, 2019 Posted by Rami Azulay( ) Requirements Management Tool

Corrective and Preventive Action (CAPA) is a way to improve the company’s processes. They are a series of actions that eliminate unforeseen events and causes of non-conformities. Likewise, CAPA, as a concept falls under several ISO business standards and Good Manufacturing Practice (cGMP).  The primary focus of CAPA is focusing on the root causes of specified problems and risks. In so doing, it can help ensure that they won’t be a need for either corrective action or preventive action in the future. This article aims to help you understand the CAPA process within a regulated environment.

Outline

The outline on the subject of CAPA is as follows;

  •         Background
  •         The current State of CAPA
  •         Process Requirement
  •         Process Analysis
  •         The CAPA status review
  •         Conclusion

Background

Two major forces drive the CAPA system. In the US, there is the Food and Drug Administration, the federal regulations, Title 21 Part 820 Subpart J, and CAPA Section 820.100. Meanwhile, companies in the EU that accept the ISO 13485 standard for the quality system there is the Section 8.5.2 corrective action and Section 8.5.3 preventive action. It is worth mentioning that 820 will be known as 21 CFR 820, and 13485 will be EN ISO 13285:2016. Also, there is not of a difference between the old 13485 standards of 2003 and the updated version of 2013 but there are some changes on the 2016 edition when it comes to CAPA requirement.

It is a requirement for both the US FDA and ISO 13485 that CAPA procedures be documented. In the descriptions for CAPA in both organizations, they both address non-conformities.

Regulatory Confirmation

The eligibility criteria for a CAPA system mandate that a situation of non-conformance or a risk of having it. The common suspects for non-conformance issues are either components, products or something physical. However, processes are also suspect despite being less obvious. Regulations often demand that organizations follow specific processes when collecting or analyzing artifacts. Non-conformities are bound to happen when processes are ignored, and there is no collection of artifacts.

CAPA has two distinct components, namely, corrective action and preventive action. Corrective action is used to address systemic non-conformities when they occur. Meanwhile, preventive actions help to address the risk of non-conformities that are likely to happen. In that sense, an electronic system such as Orcanos must let you conduct traceability to CA/PA activities as well to RISK and its mitigation.  

Image1: Orcanos Traceability from/to CAPA

Only About Compliance?

There are pivotal debates regarding the CAPA system. There is an argument that if there is a systemic non-conformity, then action should be taken to identify why and take action to fix and prevent the occurrence in the future. On the other hand, companies find preventive actions problematic. It is not unusual that companies take precautionary steps frequently in the form of reviews, prototypes and much more. However, rarely do they run the steps through the preventive action process.

Despite CAPA and DR (Design Review) and report topping the list, it is difficult to ascertain the safety and effectiveness of products considering the high rates of recalls. A non-scientific approach to the various findings reveals that there is a lack of understanding when it comes to the CAPA approach. The result leads to a lack of implementation. For example, stating that all CAPA will be closed in 60 days in the CAPA Standard  Operating Procedure (SOP) is wrong. The action further demonstrates a lack of understanding of the CAPA process. Inspectors are left with no choice other than issuing findings to processes that they can’t implement or follow.

Therefore, this article will be highlighting realistic ways to approach the CAPA process. The hope is that it will reduce any form of self-damage when it comes to findings and equip you with tools that will guide the regulatory compliance of your business. Eventually helping you making a choice to move onto some electronic form of system to manage the CAPA complete process.

The Basics of Corrective Action

Corrective Action is the first section of the CAPA. Identification of non-conformities tends to trigger corrective action. Although, the language in 820 when addressing CA is cause for confusion as it stipulates action to eliminate reoccurrence. There will be clarity on the subject further down the line.

The Basics of Preventive Action

Preventive Action (PA) represents the other half of CAPA. It becomes actionable in situations where there is a risk for non-conformities, and no steps are in place to mitigate such risks. IT worth mentioning that while in the 13485 standards, there is a distinction between CA and PA. While in 820, there is no such distinction when it comes to CAPA. 

We stated that PA is a frequent feature as part of a company’s project risk activity. The activities often include design and review for manufacturing, preventive maintenance and much more. However, the challenge is identifying when to apply preventive action.

Key Concept

The inconsistent use of terminologies is to blame for the problems in the findings of the CAPA system. To correct this notion, we will be using some easy to grasp terminologies in the absence of standard definitions.

  • Corrections: They are actions taken to resolve problems like replacing a faulty capacitor in a circuit board. Another example is fixing a software bug that alters the user’s input.
  • Corrective Actions: Actions that helps ensure that a problem will no longer occur. For example, changing your capacitor supplier cause they supply faulty resistors to a more reliable supplier. Alternative, training a programmer on a concept that they made an error while working.
  • Preventive Actions: Actions that will stop a problem from happening. An example is reviewing a capacitor’s rating before use to estimate the likelihood of fault. Alternatively, set up a coding standard that programmers can use to review their code to prevent problems.

Systemic Issues

It would not be efficient to flood the CAPA system with every issue. As an alternative, only system issues should be in the CAPA system. Now, the question becomes, what is a systemic issue? In simple terms, it refers to problems that will keep happening without any intervention. System issues can manifest in the following ways;

  • Quality: Missing procedures in the quality process.
  • Product: Failure that keeps rerepeating.
  • Manufacturing: Out tolerance results that don’t stop.
  • Process: Missing steps or lack of actionable steps.

Non-Systemic Issues

By describing non-systemic issues, we better understand the difference between it and systemic issues. Non-systemic issues are problems that are likely to happen once or possess low reoccurrence probability. When dealing with processes, fallouts are not unusual. Therefore, having fallout that is within the limits of the process makes the problem non-systemic. Checking trends and frequency of a problem occurring is the best way of determining if it is non-systemic. However, if you have a non-systemic and non-conformity problem, the action is required.

Some of the best practices will involve checking the trend of all non-conformities, and assessing non-conformities to determine the disposition. Orcanos eQMS system includes a Non-Conformities eForm that will allow you to report and measure your NCR. 

Systemic Issues Product Examples

Below are a few examples that showcase system issues in products.

  1. Should the door be open, an infusion pump will not prevent free flow. The free flow is a systemic issue as the door opening with a set installation will not stop people from seeing the patient.
  2. Cross-contamination of duodenal scopes is responsible for a spate of infections. The reason is that the scopes were not cleaned properly to prevent infection. The problem might have fallen under non-systemic issues if it happened just once. However, the frequent rate at which the infection keeps occurring makes it a systemic issue.
  3. After several testing, making parts that do not match their corresponding mating part as per specification. The rate at which this error occurs and the fact that it surpasses the process limit makes the error systemic.

Systemic Issues Process Example

Problems can come from other factors like processes rather than the product.

  1. When an audit reveals that the quality system failed to incorporate a CAPA requirement. For example, a means of assessing the effectiveness of corrective action. The problem becomes systemic if the process is already reviewed, approved and documented.
  2. An FDA inspection revealing that a company does not keep a record of customer complaints and then issues them a 483. The problem is systemic if the people responsible for taking the call do not realize that all customer related calls should be recorded.

On our upcoming post about CAPA, we will give more tools and tips about how to improve the handling of the CAPA process and be more effective.


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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