SOP Guide for Pharma

SOP for Documenting and Reporting Near-Miss Incidents

Auditor

SOP for Documenting and Reporting Near-Miss Incidents

Standard Operating Procedure for Documenting and Reporting Near-Miss Incidents

1) Purpose

The purpose of this SOP is to establish a standardized procedure for documenting and reporting near-miss incidents to identify potential hazards, prevent future accidents, and promote a culture of safety within the organization.

2) Scope

This SOP applies to all employees, contractors, and personnel who observe or are involved in near-miss incidents across all departments and operational areas of the organization.

3) Responsibilities

  • Employees: Report near-miss incidents promptly using the designated reporting channels.
  • Supervisors: Review and verify the reported incidents, and ensure proper follow-up actions are taken.
  • EHS Team: Investigate reported near-miss incidents, analyze trends, and recommend corrective actions.
  • Management: Support the reporting process and allocate resources for implementing corrective measures.

4) Procedure

4.1 Identifying Near-Miss Incidents

  1. Definition:
    • A near-miss incident is an unplanned event that did not result in injury, illness, or damage but had the potential to do so.

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  2. Examples:
    • Objects falling near personnel without causing harm.
    • Malfunctioning equipment detected before causing an accident.
  3. Encourage Reporting:
    • Promote a no-blame culture to encourage employees to report near-miss incidents without fear of repercussions.
See also  SOP for Preparing Compliance Reports for Regulatory Authorities

4.2 Reporting Near-Miss Incidents

  1. Immediate Reporting:
    • Report the near-miss incident to the supervisor or EHS representative immediately after it occurs.

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  2. Complete the Reporting Form:
    • Fill out the
Near-Miss Reporting Form (Annexure 1) with details such as date, time, location, description, and contributing factors.
  • Submit the Report:
    • Submit the completed form to the EHS team within 24 hours of the incident.

    • 4.3 Investigating Near-Miss Incidents

    1. Assign an Investigator:
      • The EHS team assigns a qualified investigator to review the reported incident.

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    2. Conduct a Root Cause Analysis:
      • Analyze the circumstances surrounding the incident to identify underlying causes and contributing factors.
    3. Document Findings:
      • Record investigation findings in the Near-Miss Investigation Report (Annexure 2), including recommendations for corrective actions.

    4.4 Implementing Corrective Actions

    1. Develop Action Plans:
      • Create a corrective action plan to address identified risks and prevent recurrence.

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    2. Assign Responsibilities:
      • Delegate implementation tasks to relevant personnel or departments.
    3. Track Progress:
      • Monitor the implementation of corrective actions and document completion status.

    4.5 Reviewing and Analyzing Trends

    1. Compile Data:
      • Aggregate near-miss reports periodically to identify patterns or recurring issues.

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    2. Prepare Trend Analysis Reports:
      • Summarize trends, root causes, and recommendations in a Near-Miss Trend Analysis Report (Annexure 3).
    3. Share Insights:
      • Distribute findings to management and employees to raise awareness and promote preventive measures.

    4.6 Continuous Improvement

    1. Review Procedures:
      • Regularly review and update this SOP based on lessons learned from near-miss incidents.

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    2. Conduct Training:
      • Train employees on near-miss reporting procedures and the importance of hazard prevention.

    5) Abbreviations, if any

    • EHS: Environmental, Health, and Safety

    6) Documents, if any

    • Near-Miss Reporting Form
    • Near-Miss Investigation Report
    • Trend Analysis Reports

    7) Reference, if any

    • ISO 45001 Occupational Health and Safety Standards
    • OSHA Guidelines for Incident Reporting
    • Internal Safety Policies

    8) SOP Version

    Version: 1.0

    Annexure

    Template 1: Near-Miss Reporting Form
    Date Location Description Contributing Factors Reported By
    DD/MM/YYYY Warehouse A Falling Object Near Miss Loose Shelving John Doe

    Template 2: Near-Miss Investigation Report
    Incident ID Root Cause Corrective Action Assigned To Completion Date
    NM-001 Unsecured Shelves Reinforce Shelving Maintenance Team DD/MM/YYYY
    See also  SOP for Segregation of Incompatible Hazardous Chemicals
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