SOP Guide for Pharma

SOP for Preparing Incident and Accident Logs

SOP for Preparing Incident and Accident Logs

Standard Operating Procedure for Preparing Incident and Accident Logs

1) Purpose

The purpose of this SOP is to provide a structured approach for preparing and maintaining incident and accident logs to ensure accurate documentation, support root cause analysis, and comply with regulatory reporting requirements.

2) Scope

This SOP applies to all workplace incidents and accidents, including injuries, near-misses, and property damage, within the organization. It ensures consistent recording and tracking of these events.

3) Responsibilities

  • Incident Reporter: Document the initial details of the incident and notify the appropriate personnel.
  • Safety Officer: Oversee the preparation and maintenance of the incident and accident logs.
  • Supervisors: Verify incident details and ensure employees understand the reporting procedure.
  • EHS Manager: Review logs for accuracy, approve corrective actions, and ensure compliance with regulatory standards.

4) Procedure

4.1 Reporting Incidents and Accidents

  1. Immediate Notification:
    • All incidents and accidents must be reported immediately to the supervisor or safety officer.
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  3. Complete Initial Report:
    • Use the Incident Reporting Form (Annexure 1) to capture details such as date, time, location, description, and involved parties.
  4. Secure the Incident Site:
    • Restrict access to the site to preserve evidence for further investigation, if necessary.

4.2 Documenting Incidents and Accidents

  1. Create Log Entries:
    • Record each reported incident or accident in the Incident and Accident Log
(Annexure 2) with unique identifiers.

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  • Include Key Details:
    • Ensure each entry contains the date, time, location, nature of the event, and immediate actions taken.
  • Update Regularly:
    • Update the log promptly with investigation findings, corrective actions, and status of implementation.
  • 4.3 Reviewing and Analyzing Logs

    1. Conduct Regular Reviews:
      • Review the logs monthly to identify trends, recurring issues, or high-risk areas.
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    3. Perform Root Cause Analysis:
      • Analyze serious incidents to determine root causes and recommend preventive measures.
    4. Prepare Summary Reports:
      • Generate quarterly summaries highlighting key findings, trends, and corrective actions for management review.

    4.4 Reporting to Regulatory Authorities

    1. Identify Reportable Incidents:
      • Determine whether the incident or accident is reportable under local or national regulations.
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    3. Submit Reports:
      • Provide necessary details to regulatory authorities within the stipulated timeframe.
    4. Retain Submission Proof:
      • Maintain copies of submitted reports and acknowledgment receipts in the compliance folder.

    4.5 Maintaining and Archiving Logs

    1. Secure Storage:
      • Maintain logs in a secure location, either digitally or physically, to prevent unauthorized access.
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    3. Retention Period:
      • Retain logs for a minimum of five years or as required by regulations.
    4. Archive Old Records:
      • Archive records older than the retention period in a designated storage system, clearly marked as “Archived.”

    5) Abbreviations, if any

    • EHS: Environmental, Health, and Safety

    6) Documents, if any

    • Incident Reporting Form
    • Incident and Accident Log
    • Summary Reports

    7) Reference, if any

    • OSHA Reporting and Recordkeeping Standards
    • ISO 45001 Occupational Health and Safety Standards
    • Local Workplace Safety and Health Regulations

    8) SOP Version

    Version: 1.0

    Annexure

    Template 1: Incident Reporting Form

     
    Date Time Location Description Reported By
    DD/MM/YYYY 10:30 AM Warehouse Forklift Collision John Doe

    Template 2: Incident and Accident Log

     
    Incident ID Date Type Description Status
    INC001 DD/MM/YYYY Accident Slip and Fall in Break Room Closed
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