CAPA Software for Medical Device | When and What Should Trigger a CAPA?

 



CAPA

CAPA – Corrective Action and Preventive Action is a technique in the quality management system that investigates and tackles quality concerns by identifying and evaluating fundamental root causes and applying corrective and preventive actions. So the life science industry must understand when to launch a CAPA, how to address it, and what process to follow.

This blog discusses the differences between Corrective Actions and Preventive Actions, their criteria for initiating a CAPA, how to handle CAPA, and the processes to be followed to be compliant.

CAPA (Corrective and Preventive Action) is a methodological strategy for mitigating risk and improving the process. It is done by identifying the sources of potential issues, investigating the root cause, resolving them with corrective actions, defining preventive measures to prevent the issues from recurring, and documenting the entire process to ensure compliance.

When to request CAPA?

The goal of a CAPA is to avoid and resolve difficulties that are detected; however, not every issue justifies the use of a CAPA. It is crucial to understand the conditions for initiating a CAPA and dealing with systemic or systemic issues—the items that signify a system-wide failure.


Criteria for a CAPA Request

 The scenarios listed below will assist in determining whether to open a CAPA.

  1. 1. Is there a risk to patient safety or death because of this issue?

When a product fails, and the issue is severe enough to produce harmful impacts when released to the market or receive negative feedback, it is time to open a CAPA.

  1. 2. Is the issue proven to be systematic, or have there been repetitive occurrences?

Repetitive occurrences are more challenging to assess because “many” can indicate “two” or “hundred,” and the key to determining risk is risk estimate. As a result, the risk assessment will estimate the risk connected with the issue and pave the way for anticipating the amount of investigation that needs to be undertaken, the scope of the issue, and how to handle the issue. This results in the CAPA initiation.

In the initial framework, a sequence of issues or non-conformances initiates a CAPA but can initiate change management to address and improve depending on the severity. As a result, it is unlikely that recurring issues will result in a CAPA. Other techniques in the quality system are ideal for dealing with systemic issues in such cases.


Read More : https://www.complianceg.com/capa-software-for-medical-device/

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