What are Corrective and Preventive Actions in ISO 9001? How are such actions going to guide an organisation into continual improvement?

ISO 9001:2015 is a widely recognized standard for quality management systems that provides organizations with a framework for improving the quality of their products and services. One of the critical components of this standard is the implementation of corrective and preventive actions. These actions play a vital role in ensuring continuous improvement by identifying and correcting problems and implementing preventive measures to avoid similar issues in the future.

The purpose of this article is to provide a comprehensive overview of corrective and preventive actions in ISO 9001. We will discuss the significance of such actions within the quality management system, the steps involved in implementing them, and best practices to have an effective CAPA management. This article will serve as a valuable resource for organizations seeking to improve their quality management processes and achieve certification to ISO 9001.

What are Corrective and Preventive Actions in ISO 9001?

The idea of learning from our failures is undoubtedly one of the most critical aspects conveyed in the ISO 9001 standard. Due to our imperfections as human beings, flaws are bound to occur in any process we design. Clause 10.2 lays forth the framework for identifying errors, fixing them, and keeping an eye on the situation to make sure they don’t happen again.

“Companies that I consult with occasionally do some internal work before engaging me. I have observed that businesses tend to overdo things when attempting to adopt ISO 9001 using their own understanding. They overcomplicate the criteria, produce an excessive number of forms, and most do not meet the standard’s standards. They may have obtained the knowledge on the internet and made general assumptions that might not be correct.” says Luke Desira when asked about continuous improvement and implementing a management system.

Ultimately, companies want a system that works best for them. However, the implementation of ISO is not a DIY project that takes a couple of hours of your time. It is essential to remember that poor systems will work against the company rather than benefit it. Organizations must ensure that the systems being put in place will genuinely assist them in increasing both the levels of quality and efficiency.

Corrective and Preventive Actions in ISO 9001 | Setting an Example

Weaknesses and mistakes must be improved over time to tackle the non-conformity of things, that is, whenever an approach fails to function as it should have. As a result, there came the creation of CAPA, the corrective and preventive action that follows the identification of a mistake. When something that was not planned occurs, a CAPA is launched. The process of corrective action is a methodical means of resolving issues. 

Firstly, the issue is identified, followed by the possible courses of action to ensure that we complete the task. Take, for instance, a delivery to a client, where a car is used to go from A to B. If the vehicle breaks down, you must still go to point B. However, we must take a different course of action. This can be either by fixing the car or loading the material on another vehicle. 

This must then be followed by the evaluation of the problem. What caused the car to stop functioning? This will determine what actions must be taken to help prevent a similar situation from occurring again. Was the vehicle out of fuel, or maybe a fault occurred in the engine? If the car is out of gas, then the corrective and preventive actions must be to ensure that the fuel gauge is working correctly and that the vehicle has enough fuel to perform the delivery.

If the car breaks down due to a fault, a maintenance system must be set up in order to prevent frequent occurrences of such events. This will make the day-to-day operations go smoother without any hitches and delays.

After a while, we can look back at the corrective and preventive actions and check whether these actions prevented any mishaps from happening, thus being either effective or not. 

You may discover your organization’s most pressing difficulties by keeping an eye on the issues that arise, which will help you start noticing trends. A fact-based approach can be used to decide which concerns must be handled right away and which can wait by monitoring the frequency and severity with which these problems arise.