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

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 Conducting Waste Audits and Inspections

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.
  3. 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.
See also  SOP for Proper Disposal of Laboratory Waste

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.
See also  SOP for Developing E-Learning Modules for EHS Awareness

5) Abbreviations, if any

6) Documents, if any

7) Reference, if any

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
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