SOP Guide for Pharma

SOP for Preparing Compliance Certificates for EHS Programs

Auditor

SOP for Preparing Compliance Certificates for EHS Programs

Standard Operating Procedure for Preparing Compliance Certificates for Environmental, Health, and Safety (EHS) Programs

1) Purpose

The purpose of this SOP is to establish a standardized procedure for preparing compliance certificates for Environmental, Health, and Safety (EHS) programs to ensure adherence to regulatory standards and demonstrate organizational commitment to EHS practices.

2) Scope

This SOP applies to all personnel responsible for preparing, verifying, and issuing compliance certificates related to EHS programs, including certifications for waste management, workplace safety, training, and environmental protection.

3) Responsibilities

  • EHS Manager: Oversee the preparation and approval of compliance certificates.
  • Compliance Officer: Verify that EHS activities meet regulatory and organizational standards before issuing certificates.
  • Documentation Team: Ensure all supporting records are accurate, complete, and readily available.
  • Department Heads: Provide relevant data and ensure departmental compliance with EHS requirements.
See also  SOP for Disposal of Flammable and Combustible Waste

4) Procedure

4.1 Identifying Certification Requirements

  1. Review Regulatory Standards:
    • Identify specific EHS activities or programs requiring compliance certification, such as hazardous waste disposal, air quality monitoring, or employee safety training.

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  2. Determine Documentation Needs:
    • List the documents required for certification, such as inspection reports, training attendance logs, and waste disposal records.
  3. Create a Checklist:
    • Develop a checklist of certification requirements, including submission deadlines and responsible personnel.

4.2 Preparing the Compliance Certificate

  1. Gather Supporting Data:
    • Collect relevant data from
departmental records, such as audit results, environmental test reports, and compliance logs.

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  • Use Standardized Templates:
    • Prepare the compliance certificate using the approved template (Annexure 1) to ensure consistency in format and content.
  • Include Key Details:
    • Ensure the certificate includes the program name, compliance standards met, date of issue, and validity period.
  • Attach Supporting Documents:
    • Include all required supporting documents, such as inspection reports, approval letters, and test results, as annexures to the certificate.

    • 4.3 Verifying Compliance

    1. Internal Review:
      • Submit the draft certificate to the EHS team and Compliance Officer for review and verification.

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    2. Address Discrepancies:
      • Resolve any discrepancies identified during the review process before finalizing the certificate.
    3. Obtain Approvals:
      • Secure final approval from the EHS Manager and other designated authorities.

    4.4 Issuing the Compliance Certificate

    1. Distribute to Stakeholders:
      • Provide the compliance certificate to relevant stakeholders, such as regulatory authorities, management, and external auditors.

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    2. Maintain a Record:
      • Store a copy of the certificate and its supporting documents in the EHS compliance records system.
    3. Notify Departments:
      • Inform relevant departments about the issuance of the certificate and any subsequent actions required to maintain compliance.

    4.5 Reviewing and Updating Certificates

    1. Monitor Validity:
      • Track the expiration dates of compliance certificates and initiate renewal processes at least 60 days before expiration.

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    2. Conduct Annual Reviews:
      • Review all issued certificates annually to ensure ongoing compliance and update them if necessary.
    3. Archive Expired Certificates:
      • Move expired certificates to a separate archive folder, ensuring they remain accessible for audits and reference.

    5) Abbreviations, if any

    • EHS: Environmental, Health, and Safety

    6) Documents, if any

    • Compliance Certificate Template
    • Inspection Reports
    • Compliance Logs

    7) Reference, if any

    • ISO 45001 Occupational Health and Safety Standards
    • ISO 14001 Environmental Management Standards
    • Local Environmental and Safety Regulations

    8) SOP Version

    Version: 1.0

    Annexure

    Template 1: Compliance Certificate
    Certificate No. Date of Issue Validity Period Issued By Compliance Standard
    CERT-12345 DD/MM/YYYY 12 Months EHS Manager ISO 45001

    Template 2: Certification Checklist
    Requirement Status Remarks
    Inspection Report Completed Attached
    See also  SOP for Maintaining Employee Training Records for EHS Programs
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