SOP Guide for Pharma

SOP for Managing Training Records and Certifications

Auditor

SOP for Managing Training Records and Certifications

Standard Operating Procedure for Managing Training Records and Certifications

1) Purpose

The purpose of this SOP is to establish a structured process for managing, maintaining, and updating training records and certifications for Environmental, Health, and Safety (EHS) compliance and employee development.

2) Scope

This SOP applies to all departments and personnel responsible for conducting, documenting, and verifying training activities and certifications across the organization.

3) Responsibilities

  • EHS Manager: Ensure that training records are accurate, up-to-date, and meet regulatory requirements.
  • Training Coordinator: Maintain records, update certifications, and provide reports as needed.
  • Supervisors: Verify employee participation and ensure timely renewal of certifications.
  • Employees: Complete required training and submit documentation for certifications as needed.

4) Procedure

4.1 Identifying Training and Certification Requirements

  1. Determine Compliance Needs:
    • Review regulatory guidelines, industry standards, and organizational policies to identify mandatory training and certifications.

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  2. Define Training Categories:
    • Classify training into categories such as safety, technical skills, and role-specific certifications.
  3. Create a Training Matrix:
    • Develop a matrix outlining required training for each job role, including renewal intervals.
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4.2 Maintaining Training Records

  1. Document Training Sessions:
    • Record details of training sessions, including date, trainer name, participants, and topics covered.

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  2. Track Employee Participation:
    • Maintain individual training logs for each employee, including completed sessions and due dates for renewals (Annexure 1).
  3. Use a Digital
System:
  • Implement a Learning Management System (LMS) or database to store and manage training records efficiently.
  • Ensure Data Integrity:
    • Regularly review and update records to ensure accuracy and completeness.

    • 4.3 Managing Certifications

    1. Monitor Certification Expiry:
      • Track certification validity periods and send reminders to employees and supervisors for renewals.

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    2. Renew Certifications:
      • Schedule renewal sessions or examinations in advance to avoid lapses in compliance.
    3. Verify External Certifications:
      • Validate certifications obtained from external providers to ensure authenticity and relevance.
    4. Archive Expired Certifications:
      • Move outdated certifications to an archive folder for historical reference while ensuring they are clearly marked as inactive.

    4.4 Generating Reports

    1. Prepare Training Compliance Reports:
      • Generate periodic reports on completed training sessions, pending certifications, and overall compliance rates (Annexure 2).

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    2. Provide Role-Specific Reports:
      • Offer tailored reports for supervisors to track team compliance and identify gaps.
    3. Submit Regulatory Reports:
      • Compile data for submission to regulatory authorities during audits or inspections.

    4.5 Continuous Improvement

    1. Audit Training Records:
      • Conduct periodic internal audits to verify the accuracy and completeness of training records and certifications.

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    2. Update Processes:
      • Incorporate feedback from audits and employee input to improve record-keeping practices.
    3. Enhance Accessibility:
      • Ensure employees can access their training records and certifications easily for reference or submission.

    5) Abbreviations, if any

    • EHS: Environmental, Health, and Safety
    • LMS: Learning Management System

    6) Documents, if any

    • Individual Training Logs
    • Training Compliance Reports
    • Certification Renewal Records

    7) Reference, if any

    • ISO 45001 Occupational Health and Safety Standards
    • Internal Training Policies
    • Regulatory Requirements for Workplace Training

    8) SOP Version

    Version: 1.0

    Annexure

    Template 1: Individual Training Log
    Date Training Topic Trainer Completion Status Next Due Date
    DD/MM/YYYY Fire Safety Basics John Smith Completed DD/MM/YYYY

    Template 2: Training Compliance Report
    Department Total Employees Training Completed Pending Training Compliance Rate
    Manufacturing 50 45 5 90%
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