SOP Guide for Pharma

SOP for Documenting Routine EHS Audits

SOP for Documenting Routine EHS Audits

Standard Operating Procedure for Documenting Routine Environmental, Health, and Safety (EHS) Audits

1) Purpose

The purpose of this SOP is to provide a standardized process for documenting routine Environmental, Health, and Safety (EHS) audits to ensure compliance with regulatory standards, improve workplace safety, and identify areas for continuous improvement.

2) Scope

This SOP applies to all EHS audits conducted within the organization, including facility inspections, process evaluations, and compliance assessments.

3) Responsibilities

4) Procedure

4.1 Planning the Audit

  1. Define Audit Objectives:
    • Establish the purpose of the audit, such as assessing regulatory compliance, identifying hazards, or verifying corrective actions.
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  3. Develop an Audit Plan:
    • Prepare a detailed plan outlining the scope, schedule, and checklist for the audit.
  4. Assemble the Audit Team:
    • Select qualified personnel with expertise in EHS regulations and practices to conduct the audit.
  5. Notify Stakeholders:
    • Inform relevant departments and individuals about the audit schedule and objectives.

4.2 Conducting the Audit

  1. Perform On-Site Inspections:
    • Inspect facilities, equipment, and processes to identify hazards, non-compliances, and best practices.
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  3. Use Audit Checklists:
    • Follow a predefined checklist to ensure all critical areas are evaluated consistently.
  4. Interview Personnel:
    • Engage employees to understand their awareness of EHS practices and gather insights on potential issues.
  5. Document Observations:
    • Record detailed notes, including photographic evidence, on findings during the audit.

4.3 Documenting Audit Findings

  1. Prepare an Audit Report:
    • Summarize audit findings, including areas of compliance, non-compliance, and opportunities for improvement.
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  3. Include Corrective Actions:
    • List specific corrective actions required to address identified non-compliances and assign responsibilities and deadlines.
  4. Use Standard Templates:
    • Document findings using predefined templates to maintain consistency and clarity.
  5. Review the Draft Report:
    • Have the report reviewed by the EHS manager and relevant stakeholders for accuracy and completeness.

4.4 Communicating Audit Results

  1. Distribute the Final Report:
    • Share the approved audit report with department heads and other relevant stakeholders.
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  3. Conduct Post-Audit Meetings:
    • Organize meetings to discuss audit findings, corrective actions, and timelines for implementation.
  4. Address Questions:
    • Respond to queries and provide clarification on audit findings and recommendations.

4.5 Implementing and Monitoring Corrective Actions

  1. Track Progress:
    • Monitor the implementation of corrective actions through regular updates and follow-ups.
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  3. Verify Completion:
    • Conduct re-inspections to ensure corrective actions have been effectively implemented.
  4. Update Records:
    • Document completed corrective actions in the audit report for future reference.

4.6 Retaining Audit Documentation

  1. Archive Reports:
    • Maintain a repository of audit reports and related documents for the legally mandated retention period.
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  3. Ensure Accessibility:
    • Store audit documentation securely and make it accessible to authorized personnel for future audits and reviews.

5) Abbreviations, if any

6) Documents, if any

7) Reference, if any

8) SOP Version

Version: 1.0

Annexure

Template 1: Audit Checklist

 
Area Item Status (Compliant/Non-Compliant) Observations
Warehouse Fire Extinguishers Compliant All units inspected and tagged.

Template 2: Audit Report Summary

 
Finding Corrective Action Responsible Person Deadline
Blocked Emergency Exit Remove Obstructions John Doe DD/MM/YYYY
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