SOP Guide for Pharma

SOP for Conducting Post-Incident Investigations

Auditor

SOP for Conducting Post-Incident Investigations

Standard Operating Procedure for Conducting Post-Incident Investigations

1) Purpose

The purpose of this SOP is to establish a systematic process for investigating incidents to identify root causes, prevent recurrence, and enhance safety and operational protocols.

2) Scope

This SOP applies to all incidents occurring within the facility, including workplace injuries, equipment failures, environmental hazards, and near misses. It involves all personnel, supervisors, and investigation team members.

3) Responsibilities

  • Investigation Team: Conduct detailed incident investigations, identify root causes, and propose corrective actions.
  • Supervisors: Report incidents promptly and provide necessary information for the investigation.
  • Safety Officers: Oversee the investigation process, ensure compliance with safety protocols, and verify the implementation of corrective actions.
  • Facility Manager: Allocate resources for investigations and review investigation reports for final approval.

4) Procedure

4.1 Immediate Actions After an Incident

  1. Ensure Safety:
    • Evacuate the area and ensure the safety of personnel involved in the incident.
    • Isolate the incident site to prevent further risks or contamination.

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  2. Provide First Aid:
    • Administer first aid to affected individuals and seek professional medical assistance if necessary.
  3. Report the Incident:
    • Notify the supervisor and the Emergency Response Team (ERT) immediately.
    • Document the incident in the Incident Report Log (Annexure 1).
See also  SOP for Handling and Disposal of Animal Waste from Preclinical Studies

4.2 Investigation Initiation

  1. Assign an Investigation Team:
    • Form a team comprising safety officers, supervisors, and subject matter experts.
    • Ensure the
team is trained in incident investigation techniques.

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  • Secure the Incident Site:
    • Restrict access to the site and preserve evidence for investigation.
    • Take photographs, record videos, and gather relevant physical evidence.
  • Gather Initial Information:
    • Collect initial details, including the time, location, type of incident, and individuals involved.
    • Obtain Safety Data Sheets (SDS) or equipment manuals, if applicable.

    • 4.3 Conducting the Investigation

    1. Interview Witnesses:
      • Interview personnel who witnessed the incident to gather firsthand accounts.
      • Ensure interviews are non-confrontational and focus on facts.

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    2. Analyze Evidence:
      • Review physical evidence, records, and data from monitoring systems.
      • Examine maintenance logs, training records, and incident history for patterns.
    3. Identify Root Causes:
      • Use root cause analysis techniques, such as the 5 Whys or Fishbone Diagram, to identify underlying factors.
    4. Determine Contributing Factors:
      • Evaluate environmental, human, and procedural factors that may have contributed to the incident.

    4.4 Reporting and Documentation

    1. Prepare an Investigation Report:
      • Include a detailed description of the incident, evidence analysis, root causes, and corrective actions.
      • Use the Incident Investigation Report template (Annexure 2).

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    2. Submit the Report:
      • Submit the report to the Safety Officer and Facility Manager for review and approval.
    3. Communicate Findings:
      • Share the investigation findings with relevant personnel to raise awareness and prevent recurrence.

    4.5 Corrective and Preventive Actions

    1. Implement Corrective Actions:
      • Address the immediate causes of the incident by repairing equipment, updating procedures, or providing additional training.

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    2. Develop Preventive Measures:
      • Update policies, improve risk assessments, or enhance safety protocols to prevent future incidents.
    3. Monitor Effectiveness:
      • Evaluate the effectiveness of corrective and preventive actions during routine audits.

    4.6 Review and Improvement

    1. Review Incident Trends:
      • Analyze trends in incident data to identify recurring issues or high-risk areas.

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    2. Update Procedures:
      • Incorporate lessons learned into this SOP and related protocols.

    5) Abbreviations, if any

    • ERT: Emergency Response Team
    • SDS: Safety Data Sheets

    6) Documents, if any

    • Incident Report Log
    • Incident Investigation Report
    • Corrective Action Plan

    7) Reference, if any

    • OSHA Incident Investigation Guidelines
    • ISO 45001 Occupational Health and Safety Standards
    • NFPA Incident Reporting Guidelines

    8) SOP Version

    Version: 1.0

    Annexure

    Template 1: Incident Report Log
    Date Incident Description Location Reported By Immediate Action Taken
    DD/MM/YYYY Chemical Spill Lab 3 Jane Doe Evacuated Area

    Template 2: Incident Investigation Report
    Date Incident Type Root Cause Corrective Actions Preventive Measures
    DD/MM/YYYY Equipment Malfunction Improper Maintenance Repaired Equipment Scheduled Monthly Inspections

    Template 3: Corrective Action Plan
    Date Action Description Assigned To Completion Date Status
    DD/MM/YYYY Update Safety Protocols John Smith DD/MM/YYYY Completed
    See also  SOP for Filing Corrective Action Reports Post-Incident
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