SOP Guide for Pharma

SOP for Conducting EHS Audits by External Agencies

Auditor

SOP for Conducting EHS Audits by External Agencies

Standard Operating Procedure for Conducting Environmental, Health, and Safety (EHS) Audits by External Agencies

1) Purpose

The purpose of this SOP is to provide a structured framework for facilitating Environmental, Health, and Safety (EHS) audits by external agencies to ensure compliance with regulatory standards, identify gaps, and enhance workplace safety and sustainability practices.

2) Scope

This SOP applies to all departments and facilities subject to EHS audits conducted by external agencies, including government regulators, certification bodies, and third-party consultants.

3) Responsibilities

  • Plant Manager: Coordinate with external agencies and ensure readiness for EHS audits.
  • EHS Manager: Act as the primary liaison for external auditors and provide necessary documentation and access to facilities.
  • Department Heads: Ensure departmental compliance and availability of relevant records during the audit.
  • Employees: Adhere to EHS policies and cooperate with auditors during site visits.

4) Procedure

4.1 Preparing for the Audit

  1. Review Audit Scope:
    • Understand the purpose, scope, and criteria of the audit as communicated by the external agency.

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  2. Assign Responsibilities:
    • Designate an audit coordination team, including representatives from relevant departments, to facilitate the audit process.
  3. Conduct Pre-Audit Assessments:
    • Perform an internal EHS audit to identify and address potential non-compliance issues before the external audit.
  4. Organize Documentation:
    • Compile necessary records, including EHS policies, training logs, incident
reports, permits, and monitoring data (Annexure 1).

4.2 Coordinating with External Auditors

  1. Schedule the Audit:
    • Agree on a mutually convenient date and time for the audit and communicate it to all stakeholders.

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  2. Provide Pre-Audit Information:
    • Share preliminary information, such as facility layout, key contacts, and operational details, with the auditors.
  3. Prepare the Site:
    • Ensure all areas are clean, organized, and compliant with EHS standards before the audit.
  4. Host an Opening Meeting:
    • Welcome auditors, introduce the team, and discuss the audit agenda and scope.

4.3 Facilitating the Audit Process

  1. Provide Access:
    • Escort auditors to relevant areas of the facility and ensure they have access to necessary resources and personnel.

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  2. Answer Queries:
    • Respond to auditors’ questions promptly and accurately, supported by documented evidence where applicable.
  3. Document Observations:
    • Record the auditors’ observations, findings, and recommendations during site visits and discussions.
  4. Host a Closing Meeting:
    • Conclude the audit by discussing preliminary findings and agreeing on timelines for addressing any non-conformities.

4.4 Post-Audit Activities

  1. Review Audit Report:
    • Analyze the detailed audit report provided by the external agency, focusing on non-conformities and recommendations.

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  2. Develop Corrective Action Plans:
    • Create a corrective action plan to address identified issues, including responsibilities, deadlines, and required resources (Annexure 2).
  3. Implement Actions:
    • Execute corrective actions promptly and document progress for future reference.
  4. Submit Compliance Reports:
    • Provide evidence of corrective actions and compliance to the external agency within the agreed timeline.

4.5 Continuous Improvement

  1. Conduct Follow-Up Audits:
    • Schedule follow-up internal audits to ensure sustained compliance and prevent recurring issues.

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  2. Update EHS Policies:
    • Revise EHS policies and procedures based on audit findings and industry best practices.
  3. Train Employees:
    • Provide training to employees on updated EHS requirements and corrective measures implemented.

5) Abbreviations, if any

  • EHS: Environmental, Health, and Safety

6) Documents, if any

  • Pre-Audit Checklist
  • Audit Report
  • Corrective Action Plan

7) Reference, if any

  • ISO 45001 Occupational Health and Safety Management Systems
  • ISO 14001 Environmental Management Standards
  • Local Regulatory Requirements for EHS Compliance

8) SOP Version

Version: 1.0

Annexure

Template 1: Pre-Audit Checklist
Area Requirement Status (Compliant/Non-Compliant) Remarks
Documentation EHS Policies and Records Compliant All documents updated

Template 2: Corrective Action Plan
Non-Conformance Action Required Responsible Person Timeline Status
Improper Waste Segregation Train Employees on Waste Management Jane Doe 30 Days In Progress
See also  SOP for Evaluating Training Effectiveness for EHS Programs
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