SOP Guide for Pharma

SOP for Documenting Incident Reports and Root Cause Analysis

SOP for Documenting Incident Reports and Root Cause Analysis

Standard Operating Procedure for Documenting Incident Reports and Root Cause Analysis

1) Purpose

The purpose of this SOP is to establish a standardized process for documenting incident reports and conducting root cause analysis (RCA) to identify underlying causes of workplace incidents and implement corrective actions to prevent recurrence.

2) Scope

This SOP applies to all incidents occurring within the organization, including accidents, near-misses, equipment failures, and environmental breaches. It ensures thorough documentation and systematic analysis for improving workplace safety and compliance.

3) Responsibilities

4) Procedure

4.1 Incident Reporting

  1. Immediate Reporting:
    • Employees must report all incidents, including near-misses, to their supervisor or safety officer immediately.
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  3. Complete Initial Report:
    • Fill out an Incident Report Form (Annexure 1) capturing key details such as date, time, location, and a brief description of the incident.
  4. Notify Relevant Authorities:
    • Report significant incidents to management and regulatory bodies, as required by law.

4.2 Incident Investigation

  1. Assemble Investigation Team:
    • Form a team comprising safety officers, supervisors, and subject matter experts to investigate the incident.
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  3. Secure the Incident Site:
    • Restrict access to the incident site to preserve evidence and prevent further harm.
  4. Collect Evidence:
    • Document the site using photographs, videos, and sketches.
    • Interview witnesses to gather additional insights.
  5. Review Records:
    • Examine relevant documents, such as equipment maintenance logs, training records, and standard operating procedures.

4.3 Conducting Root Cause Analysis

  1. Identify Contributing Factors:
    • Analyze evidence to determine immediate and contributing factors, such as unsafe conditions, human errors, or equipment failures.
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  3. Use RCA Tools:
    • Apply RCA techniques such as the 5 Whys, Fishbone Diagram, or Fault Tree Analysis to trace the root cause of the incident.
  4. Document Findings:
    • Summarize the root cause, contributing factors, and associated risks in the Root Cause Analysis Report (Annexure 2).

4.4 Implementing Corrective Actions

  1. Develop an Action Plan:
    • Outline specific corrective actions, timelines, and responsibilities to address identified root causes.
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  3. Implement Controls:
    • Introduce engineering, administrative, or procedural controls to mitigate risks.
  4. Communicate Changes:
    • Inform employees about new controls or procedural changes through training sessions and notices.

4.5 Monitoring and Continuous Improvement

  1. Track Implementation:
    • Monitor the progress of corrective actions and update stakeholders on implementation status.
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  3. Review Effectiveness:
    • Evaluate the effectiveness of implemented controls through periodic inspections and feedback.
  4. Update Procedures:
    • Incorporate lessons learned from the incident into SOPs and training programs.

5) Abbreviations, if any

6) Documents, if any

7) Reference, if any

8) SOP Version

Version: 1.0

Annexure

Template 1: Incident Report Form

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

Template 2: Root Cause Analysis Report

 
Incident ID Root Cause Contributing Factors Corrective Actions Timeline
INC001 Inadequate Operator Training Obstructed View Implement Training Program 30 Days
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