SOP Guide for Pharma

SOP for Preparing and Maintaining Audit Trail for EHS Activities

SOP for Preparing and Maintaining Audit Trail for EHS Activities

Standard Operating Procedure for Preparing and Maintaining Audit Trail for Environmental, Health, and Safety (EHS) Activities

1) Purpose

The purpose of this SOP is to establish a systematic process for creating and maintaining an audit trail for Environmental, Health, and Safety (EHS) activities to ensure accountability, transparency, and compliance with regulatory and organizational standards.

2) Scope

This SOP applies to all personnel involved in the execution, documentation, and oversight of EHS activities, including incident management, inspections, training, and compliance reporting.

3) Responsibilities

4) Procedure

4.1 Planning the Audit Trail

  1. Identify Key Activities:
    • Determine which EHS activities require an audit trail, such as inspections, incident reports, training sessions, and waste disposal logs.
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  3. Define Audit Requirements:
    • Outline data points to be recorded, such as activity dates, responsible personnel, and outcomes.
  4. Select Documentation Tools:
    • Use approved tools, such as spreadsheets, software platforms, or physical logbooks, for creating and maintaining audit trails.

4.2 Documenting EHS Activities

  1. Record Activity Details:
    • Log all relevant data for each activity, including date, time, description, and personnel involved, using the Audit Trail Log template (Annexure 1).
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  3. Ensure Timeliness:
    • Enter data into the audit trail immediately after the activity is completed to maintain accuracy.
  4. Assign Unique Identifiers:
    • Assign a unique ID to each entry for easy tracking and reference.
  5. Verify Entries:
    • Have the responsible department head or supervisor review entries for accuracy and completeness.

4.3 Reviewing and Approving the Audit Trail

  1. Conduct Periodic Reviews:
    • Review audit trails monthly or quarterly to ensure compliance with regulatory requirements and internal policies.
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  3. Address Discrepancies:
    • Investigate and resolve discrepancies in recorded data, documenting corrective actions taken.
  4. Obtain Approvals:
    • Submit reviewed audit trails to the EHS Manager or designated authority for final approval.

4.4 Archiving Audit Trails

  1. Organize by Activity Type:
    • Store audit trails in folders categorized by activity type, such as training, inspections, or incidents.
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  3. Secure Storage:
    • Archive audit trails in a secure digital repository or physical storage area with restricted access.
  4. Maintain Retention Period:
    • Retain audit trails for a minimum of five years or as specified by regulatory guidelines.

4.5 Continuous Improvement

  1. Conduct Audit Reviews:
    • Evaluate audit trail practices annually to identify areas for improvement and implement changes as needed.
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  3. Integrate Feedback:
    • Incorporate feedback from audit reviews and stakeholders into updated procedures or templates.

5) Abbreviations, if any

6) Documents, if any

7) Reference, if any

8) SOP Version

Version: 1.0

Annexure

Template 1: Audit Trail Log

 
Activity ID Activity Type Date Personnel Involved Remarks
EHS-001 Inspection DD/MM/YYYY John Doe Inspection Completed

Template 2: Discrepancy Resolution Record

 
Date Activity ID Discrepancy Resolution Verified By
DD/MM/YYYY EHS-002 Missing Data Data Updated Jane Smith
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