There is no doubt that CAPA (Corrective and Preventive Actions) is one of the most important process of any Quality Management System based on ISO 13485:2016.

First of all there is still sometimes confusions on the different between correction, corrective actions and preventive actions. Here below some definitions:

  • Correction is the action taken to correct the non-conformance. 
  • Corrective action is the action taken to eliminate the cause of nonconformities.
  • Preventive action is the action taken to eliminate the cause of potential nonconformities.

Corrective actions are intended to correct and also prevent recurrence of not only nonconforming product but also poor practices (inadequate training, for example). Corrections and corrective actions must always be commensurate with the risk associated with the nonconformity.

If, following an issue, a decision not to implement any action is taken, this should be justified using a risk-bases approach, including a determination that the finished device meets risk acceptability criteria.

General CAPA process

The CAPA (Corrective and Preventive Actions) process for ISO 13485 can be divided in different steps.

1) Planning of Corrective and Preventive Actions

The planning shall include different factors, such as identification of data sources and criteria, measuring and analysis of data sources, improvement plans and input to management.

2) Investigations of Corrective and Preventive Actions

Non-conformities related to product, process or quality system shall be investigated. The level of the investigation shall be commensurate with the significance and risk of the nonconformity. There are different techniques to perform an adequate root-cause analysis, such as Ishikawa diagram, 5Whys, 8D, etc.

3) Identification of the actions to implement

After investigation, the actions to implement shall be identified. These action could be correction, corrective actions or preventive actions. Also in this case, as per FDA guidance, the degree of corrective and preventive action taken to eliminate or minimize actual or potential nonconformities must be appropriate to the magnitude of the problem and commensurate with the risks encountered.

4) Verification/Validation of the Actions to Implement of Corrective and Preventive Actions

The identified actions to implement shall be verified and validated, to ensure that such action is effective and does not adversely affect the finished device. It is important to mention that also preventive actions need verification or validation.

5) Implementation and Communication of Corrective and Preventive Actions

The identified actions need finally to be implemented and communicated to the relevant personnel. Specifically, information related to quality problems or nonconforming products must be communicated to those directly responsible for assuring the quality of such product or the prevention of such problems.

Moreover, relevant information on identified quality problems, as well as corrective and preventive actions, shall be submitted for the management review, in order to be specifically analysed and reviewed.

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