SOP Guide for Pharma

SOP for Filing Corrective Action Reports Post-Incident

SOP for Filing Corrective Action Reports Post-Incident

Standard Operating Procedure for Filing Corrective Action Reports Post-Incident

1) Purpose

The purpose of this SOP is to establish a structured process for documenting and filing corrective action reports (CARs) after an incident to ensure root cause analysis, implementation of corrective actions, and prevention of recurrence.

2) Scope

This SOP applies to all personnel involved in incident management, including safety officers, department supervisors, and compliance teams, ensuring accurate documentation and tracking of corrective actions following workplace incidents.

3) Responsibilities

4) Procedure

4.1 Initiating the Corrective Action Process

  1. Report the Incident:
    • Submit an incident report using the Incident Reporting Form (Annexure 1) to document initial details such as date, location, and nature of the incident.
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  3. Notify Relevant Personnel:
    • Inform the safety officer, department head, and other relevant stakeholders about the incident.
  4. Initiate Root Cause Analysis (RCA):
    • Conduct an RCA to identify underlying causes, contributing factors, and potential corrective actions.

4.2 Preparing the Corrective Action Report

  1. Gather Supporting Data:
    • Collect relevant documents, such as incident reports, witness statements, and inspection findings, to support the corrective action process.
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  3. Use the Corrective Action Report Template:
    • Complete the CAR using the standardized template (Annexure 2) to ensure consistency and comprehensiveness.
  4. Include Key Elements:
    • Ensure the CAR includes the incident description, root cause, corrective actions, responsible parties, and implementation deadlines.
  5. Review the Draft:
    • Submit the draft CAR to the safety officer and compliance team for review and feedback.

4.3 Implementing Corrective Actions

  1. Assign Responsibilities:
    • Delegate specific corrective actions to responsible personnel or departments, ensuring clear accountability.
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  3. Monitor Progress:
    • Track the implementation of corrective actions through regular updates and progress meetings.
  4. Document Completion:
    • Record the completion of corrective actions in the CAR, including supporting evidence such as photos or updated procedures.

4.4 Reviewing and Approving the Report

  1. Conduct a Final Review:
    • Ensure all corrective actions are completed and documented before submitting the CAR for approval.
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  3. Obtain Approvals:
    • Secure approval from the safety officer, compliance officer, and other relevant stakeholders.
  4. Distribute the Report:
    • Share the approved CAR with relevant departments and archive a copy in the central repository.

4.5 Archiving and Retaining Corrective Action Reports

  1. Secure Storage:
    • Store CARs in a secure digital or physical repository with restricted access to authorized personnel.
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  3. Retention Period:
    • Retain CARs for at least five years or as required by regulatory standards.
  4. Audit Readiness:
    • Ensure CARs are readily accessible for regulatory audits or internal reviews.

5) Abbreviations, if any

6) Documents, if any

7) Reference, if any

8) SOP Version

Version: 1.0

Annexure

Template 1: Incident Reporting Form

 
Incident Date Location Description Reported By
DD/MM/YYYY Warehouse A Forklift Collision John Doe

Template 2: Corrective Action Report (CAR)

 
Incident ID Root Cause Corrective Action Responsible Party Completion Date
INC-001 Inadequate Training Conduct Refresher Training Training Team DD/MM/YYYY
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