CAPA is a system that was initially used in the American medical industry, and over time it was also used in the food sector. Due to its versatility, it also works well in other industries, especially those related to production. What is CAPA and why should you use it? Welcome to the entry.

CAPA — what is it?

CAPA from English Corrective and preventive action is a register for managing corrective and preventive actions, as well as a tool that helps in meeting the requirements of ISO 9001: 2015. Thanks to CAPA, all corrective and preventive actions for non-compliance are visible in one place. What does it give us? A lot of relevant knowledge about what is happening in the organization.

Conducting CAPA shows what problems appear in our company, what is their source, whether and how they are solved, and whether corrective and preventive actions are implemented. By analyzing CAPA, we can check what the trend is, i.e. whether a given non-compliance still occurs.

What does the CAPA registry look like?

The CAPA record can be kept in any spreadsheet. It has the form of a table in which the columns should be, i.e.:

• no discrepancies
• date of occurrence
• category (product, process, etc.)
• input (complaint, quality control, audit, etc.)
• description of the problem
• the product or process covered by the section
• risk assessment
• impact on the customer
• cause
• corrective actions
• implementation status
• the status of the effectiveness of activities
• non-compliance person
• preventive actions
• end date
• status (completed, pending, canceled, etc.).

The table for keeping the CAPA register can be created by yourself, which is quite laborious. It is much easier to use a ready-made CAPA tool. QMStorm has a dedicated CAPA module that can be linked to other system modules, including the risk management module.

What are corrective actions?

Corrective actions are actions that are taken to eliminate the cause of a given non-conformity. By removing the cause, we prevent the problem from reoccurring. Provided that we properly determine the cause of the discrepancy.

An example of a corrective action can be a fairly well-known situation, during which a chest of drawers from one of the furniture manufacturers fell over on a child. The corrective action that has been introduced is the sale of the chest of drawers together with a kit that allows the chest of drawers to be fixed to the wall so that it does not fall over when the child opens the drawer and starts to pull it.

The source of corrective actions (input column in the CAPA register) may be e.g.

• complaints from customers
• customer satisfaction surveys
• quality control reports
• audit results
• information from suppliers
• equipment calibration
• process monitoring.

What are preventive actions?

Preventive actions, as the name suggests, are actions that are to prevent the occurrence of possible non-compliance, i.e. to prevent a problem from arising. An example of a preventive action may be a situation in which a manufacturer of inflatable pools notices that the bottom of the pool design is hard and quite slippery, which may cause a fall and be uncomfortable to use. It introduces a preventive action, i.e. the redesign of the pool, taking into account the non-slip, inflatable bottom, which is softer and more comfortable.

CAPA registry – why is it worth implementing?

The main purpose of keeping the CAPA register is to increase the quality of the products or services offered by effectively eliminating the causes of non-compliance and preventing them.

Thanks to CAPA:

• all relevant information regarding non-compliances and problems in the company is in one place, which makes it easier to track and analyze what is happening with a given problem and how it is solved you
• monitor how problems are solved – how and with what effectiveness
• you know who solves or does not solve the discrepancies
• you know whether corrective and preventive actions have been implemented and at what stage they are
• you know what the quality trend is – you can verify if non-compliances are repeated
• you meet the requirements of ISO 9001:2015.