SOP Guide for Pharma

SOP for Use of Forklifts and Equipment in Receiving Raw Materials – V 2.0

SOP for Use of Forklifts and Equipment in Receiving Raw Materials – V 2.0

Standard Operating Procedure for Use of Forklifts and Equipment in Receiving Raw Materials

Department Warehouse / Logistics / Quality Assurance
SOP No. SOP/RM/042/2025
Supersedes SOP/RM/042/2022
Page No. Page 1 of 15
Issue Date 01/02/2025
Effective Date 05/02/2025
Review Date 01/02/2026

1. Purpose

This Standard Operating Procedure (SOP) outlines the safe and efficient use of forklifts and other material-handling equipment during the receipt of raw materials. It aims to ensure that raw materials are handled properly to prevent damage, contamination, and workplace accidents. This SOP ensures:

  • Safe operation of forklifts and equipment in compliance with safety and regulatory standards.
  • Proper training and certification of personnel handling material-moving equipment.
  • Minimization of material damage and workplace hazards during unloading and transportation.
  • Consistent documentation and reporting of equipment usage and any incidents.

2. Scope

This SOP applies to all forklifts, pallet jacks, hoists, and other equipment used in receiving, unloading, and moving raw materials within the facility. It includes:

  • Standard procedures for operating forklifts and other equipment during material receipt.
  • Responsibilities for equipment maintenance, inspection, and safety compliance.
  • Incident reporting and corrective actions related to equipment usage.

3. Responsibilities

  • Warehouse Personnel:
    • Operate forklifts and material-handling equipment following
standard safety procedures.
  • Inspect equipment before use and report any issues to the Warehouse Manager.
  • Ensure raw materials are unloaded and transported without damage or contamination.
  • Logistics Team:
    • Coordinate the unloading schedule and ensure appropriate equipment is available.
    • Maintain equipment service records and ensure timely maintenance.
    • Verify that only certified personnel operate forklifts and equipment.
  • Quality Assurance (QA) Team:
    • Monitor compliance with safety standards during material receipt.
    • Inspect raw materials after unloading for signs of damage due to improper handling.
    • Approve or reject materials based on handling conditions and report any incidents.
  • 4. Accountability

    The Warehouse Manager is responsible for ensuring that forklifts and equipment are operated safely and efficiently during the receipt of raw materials. The Logistics Manager holds accountability for equipment maintenance and ensuring that only trained personnel handle material-moving equipment. The QA Manager is responsible for monitoring the condition of raw materials and identifying handling-related issues.

    5. Procedure

    5.1 Pre-Operation Equipment Checks

    1. Daily Equipment Inspection
      1. Before operating forklifts or other equipment, perform the following checks:
        • Check tire condition, fluid levels, and hydraulic systems.
        • Inspect forks, lift chains, and safety mechanisms for wear or damage.
        • Ensure all controls, brakes, and warning systems are functioning correctly.
      2. Document the inspection results in the Equipment Inspection Log (Annexure-1).
      3. Report any equipment defects to the Warehouse Manager immediately for corrective action.
    2. Certification of Operators
      1. Ensure that only trained and certified personnel operate forklifts and material-handling equipment.
      2. Maintain up-to-date training records and certifications for all equipment operators.

    5.2 Safe Operation of Forklifts and Equipment

    1. Unloading Raw Materials from Delivery Vehicles
      1. Ensure that the delivery vehicle is secured and parked on level ground before unloading.
      2. Use forklifts to carefully unload materials, ensuring:
        • Forks are correctly positioned under the load, and loads are balanced before lifting.
        • Operators maintain clear visibility and proceed at safe speeds during movement.
        • Materials are handled gently to avoid impact, tipping, or spillage.
    2. Transporting Raw Materials to Storage Areas
      1. Transport materials to the designated quarantine or storage areas using approved routes within the facility.
      2. Ensure that aisles are clear and materials are placed securely on stable surfaces.
      3. Segregate hazardous materials according to regulatory requirements and company policies.

    5.3 Post-Operation Equipment Checks

    1. Post-Use Equipment Inspection
      1. After unloading and transporting materials, perform the following checks:
        • Inspect equipment for any damage or malfunctions incurred during operation.
        • Refill fuel, recharge batteries, and clean equipment as needed.
      2. Document post-operation checks in the Equipment Inspection Log (Annexure-1).
    2. Equipment Storage
      1. Return forklifts and equipment to designated storage areas and ensure they are secured.
      2. Report any operational issues to the Warehouse Manager for maintenance or repair.

    5.4 Incident Reporting and Corrective Actions

    1. Reporting Equipment-Related Incidents
      1. If an incident occurs during the use of forklifts or equipment (e.g., material damage, equipment failure, or accidents):
        • Immediately report the incident to the Warehouse Manager and QA.
        • Document the incident in the Equipment Incident Report (Annexure-2).
    2. Corrective and Preventive Actions
      1. QA and Logistics investigate the root cause of the incident and implement corrective actions.
      2. Conduct refresher training for operators if the incident was due to human error.
      3. Schedule equipment maintenance or repair if the incident was due to equipment failure.

    6. Abbreviations

    • SOP: Standard Operating Procedure
    • GMP: Good Manufacturing Practice
    • QA: Quality Assurance
    • QC: Quality Control
    • PPE: Personal Protective Equipment

    7. Documents

    1. Equipment Inspection Log (Annexure-1)
    2. Equipment Incident Report (Annexure-2)
    3. Forklift Operator Certification Records
    4. Material Receiving Logs and Deviation Reports

    8. References

    • OSHA Forklift Safety Regulations (29 CFR 1910.178)
    • 21 CFR Part 211 – Current GMP for Finished Pharmaceuticals (US FDA)
    • EU GMP Guidelines Part I – Basic Requirements for Medicinal Products
    • Company-Specific Safety and Warehouse Policies

    9. SOP Version

    Version: 2.0

    10. Approval Section

    Prepared By Checked By Approved By
    Signature
    Date
    Name
    Designation
    Department

    11. Annexures

    Annexure-1: Equipment Inspection Log

    Date Equipment ID Operator Name Pre-Use Inspection Status Post-Use Inspection Status Issues Identified Corrective Actions Taken
    01/02/2025 FLK-001 John Doe Passed Passed None N/A
    02/02/2025 FLK-002 Jane Smith Passed Minor Hydraulic Leak Reported to Maintenance Equipment Scheduled for Repair

    Annexure-2: Equipment Incident Report

    Incident Number Date Equipment ID Operator Name Description of Incident Root Cause Corrective Action Status
    INC-001/2025 01/02/2025 FLK-001 John Doe Material Shifted During Transport Load Not Secured Properly Operator Retrained on Load Balancing Closed
    INC-002/2025 02/02/2025 FLK-002 Jane Smith Forklift Hydraulic Leak During Operation Worn Hydraulic Seal Hydraulic System Repaired Closed

    Revision History:

    Revision Date Revision No. Revision Details Reason for Revision Approved By Page No. Ref. Point No. Details of Revision
    01/01/2024 1.0 Initial Version New SOP Creation QA Head All All Established procedures for safe use of forklifts and equipment in raw material receiving.
    01/02/2025 2.0 Included Incident Reporting Procedures Standardization of Document QA Head All All Added detailed incident reporting and corrective action procedures for equipment-related issues.
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