Corrective & Preventive Action Tracking (CAPA)

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Chapter :- Safety Management

CORRECTIVE & PREVENTIVE ACTION TRACKING (CAPA)

Identify the Root Cause of Non Conformities & Implement A Permanent Corrective Action Plan

👉IDENTIFICATION

Realizing and Defining a Problem is as crucial as solving it. Hence, to have a robust software system with inbuilt CAPA is a must for organizations.

The first step is to Identify the problem by asking;

• Who
• What
• When

These problems can be the ones which need to be corrected when something went wrong and includes actions to prevent them from happening in the future.

👉ACKNOWLEDGEMENT

The related authorities are required to;

• Review the Request
• Determine the level of investigation

👉INVESTIGATION

• The reviewers do a comprehensive Root Cause Analysis of the raised issue.
• This step is supported by specific root cause analysis techniques.
• The automated safety system helps them relate and identify the root cause of the problem.
• The investigation goes beyond the symptoms of the issue and identifies all potential root causes of the raised issue.

👉IMPLEMENTATION

When an issue is observed and communicated, it requires a systematic process of implementation.

The inbuilt CAPA process helps to;

• Decide whether action plan needs to be corrective or preventive.
• Create and Assign independent tasks for the responsible person.
• Sync efforts & reviews.
• Execute the critical steps in the plan to achieve the desired outcome.

👉VALIDATION

The officer in charge needs to go through the action plan critically to ensure all the action were initiated and acted accordingly. The Safety system with inbuilt CAPA assists the officer to;

• Review every action with precision.
• Brief the team of the changes and implementation of new corrective actions and preventive measures.
• Approve the closure with satisfactory validations and compliances.
• Assurance that the detected conformity is eliminated.

👉CLOSURE

This step seals that the action plan was implemented with effectiveness and necessary standards were met

Herein the system generates a CAPA report with all the supporting documents.

The close out procedure involves learnings of the actions to ensure the problem does not manifest again.

A software based solution for CAPA ensures that the files are archived and saved for future retrieval.

👉MONITORING

• A fully integrated CAPA system provides a 360 degree view of the CAPA reports.
• The CAPA system gives a detailed analysis, KPI dashboard and management information reports.
• The system is inbuilt to monitor and provide information about the open, close, active, and in progress CAPAs.
• This ensures CAPA effectiveness, quality and compliance.