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El sistema CAPA o gestión de acciones correctivas y preventivas

The CAPA system or management of corrective and preventive actions

The success of a company is closely associated with the quality of its service or production, today it is feasible to have several computerized tools that allow controlled processes. Quality management systems are indispensable for correct performance and to be able to optimize the most satisfactory results at production level with a minimum of risks, higher quality and lower costs.

Nowadays, companies can rely on technology and jointly as a solution apply management systems that allow them to develop an optimal development, as is the case of the CAPA system or management of corrective and preventive actions. In this post we tell you what you should know about this system and the benefits for your company.

El sistema CAPA o gestión de acciones correctivas y preventivas

What is the CAPA system?

The CAPA system or corrective and preventive action management system is the main part of a quality system. This system allows you to both manage and carry out the various actions that can be developed in the scope of your company, whether it is a service or product provider.

The corrective and preventive action management system (CAPA), has become a timely solution that becomes very beneficial for the company, to meet the objective of maintaining adequate control and constant improvement in terms of quality and efficiency, thus achieving total customer satisfaction.

How does this quality process work for your company?

When applying the layer system to your company, it is essential to focus on structuring processes, investigating and understanding potential risks, in order to recognize the causes of any occurrences.

This system is directly related to the incident and nonconformity management process. Therefore, it is necessary to establish a procedure to investigate, analyse and document possible incidents and margin of error, in order to apply corrective actions.

The layer system proposes to anticipate the causes of any incident in order to try to prevent them and, in the same way, to correct the problems that may originate. That is why it is a system based on prevention and correction, so it is understood then that:

Preventive actions: with this system it is possible to eliminate the origin of the problem, through the planning of actions aimed at attacking the probable cause, thus avoiding the generation of difficulty in production. That is why it is essential to know, through a thorough investigation, all the structure and levels of production risks of the company, in order to favour the planning of actions and avoid their subsequent occurrence.

Corrective actions: a premise of this system is the planning of actions that effectively correct any error or problem during the production process, with these actions the necessary quality is also obtained and non-conformities or production deviations are avoided.

5 Advantages of having the Capa system

Among the advantages of the layer system are:

  • This system makes it possible to anticipate any type of difficulty that may arise.
  • Potential risks in production can be minimized by detecting and correcting any existing problems during the process.
  • With the management system, the company will show a considerable cost reduction, if we take into account that by applying corrective actions on time and preventing their recurrence, there will be greater quality control and in turn fewer losses.
  • By having a layered system, complaints, product returns, audits, non-conformities, product recalls, constant inspections… are considerably reduced.
  • The layer system has been developed so that it can be used in any process of any type that involves quality management.

Preventive and corrective action management system steps

The preventive and corrective action management process can be delimited according to the different stages, of which we can highlight the following:

  1. The stage at which an incident or problem occurs affects the quality of production.
  2. Perform detailed risk analysis and identify the cause or origin of the risk.
  3. Identification phase of the affected product and the work equipment involved during the process, such as production machines.
  4. Implement corrective actions to amend or eliminate the risk and its impact.
  5. The documentation stage, in which the incident is recorded and the actions to be taken are documented.
  6. The monitoring or follow-up phase of the correction procedure ensures that it is carried out properly.
  7. The verification stage, in which it is demonstrated that the preventive and corrective actions taken proved to be effective.

Importance of having the CAPA system

The great contribution achieved by implementing the layer system is that by carrying out the corrective actions, relevant information is also acquired for the company, which will function in the future as a precedent and guide for action in subsequent cases of incidents that may arise.

By having a corrective and preventive action management system in place, the company is guaranteed a minimum margin of error, as well as a significant reduction in costs and greater quality control. 

In this way, it is of utmost importance to have the adequate preparation in management processes of preventive and corrective actions, which significantly favours the quality control of production, it is worth mentioning that this tool becomes very useful in the companies of the regulated sector.

It is ideal that this system is managed by all the quality personnel of the company, such as managers, validation technicians or quality control technicians, as well as those responsible for the management of the applications and administrators of the IT infrastructure, and it is also very important that it is applied by the personnel who manage the regulated processes of the company that are computerized.

For all these reasons, it is essential that the company’s personnel, who make up the IT infrastructure, as well as the quality control personnel, have the relevant knowledge of the management of corrective and preventive actions associated with computerized systems in the GxP area.

For that, in Oqotech we have developed an online course, whose objective is that both technical managers of validation or quality assurance have knowledge to be able to implement this quality management system and thus optimize the computerized processes of your business. If you want to know more about this process, please contact us.

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