Standard Operating Procedure for Health and Safety in Maintenance

1) Purpose

The purpose of this SOP is to establish guidelines for ensuring health and safety during maintenance activities within pharmaceutical manufacturing facilities to protect personnel, equipment, and the environment.

2) Scope

This SOP applies to all maintenance activities conducted within the facility premises.

3) Responsibilities

The Health and Safety Department, Facilities Management Department, and all personnel involved in maintenance activities are responsible for implementing and adhering to this SOP.

4) Procedure

1. Risk Assessment and Hazard Identification
   1. Conduct comprehensive risk assessments for each maintenance task to identify potential hazards and assess risks.
   2. Document hazards and risks associated with maintenance activities and prioritize control measures.
2. Safe Work Practices
   1. Develop and communicate safe work procedures for all maintenance tasks, including equipment isolation, lockout/tagout procedures, and use of personal protective equipment (PPE).
   2. Train personnel on safe work practices and ensure understanding of procedures before commencing maintenance activities.
3. Emergency Preparedness
   1. Establish emergency response procedures specific to maintenance activities, including procedures for injuries, spills, equipment failures, and hazardous material releases.
   2. Ensure availability and functionality of emergency response equipment and communication systems.
4. Incident Reporting and Investigation
   1. Implement procedures for reporting maintenance-related incidents, near misses, and hazards.
   2. Conduct thorough investigations of incidents to determine root causes and implement corrective actions to prevent recurrence.
5. Continuous Improvement
   1. Review health and safety performance related to maintenance activities regularly.
   2. Engage in continuous improvement efforts by incorporating feedback, lessons learned, and best practices into health and safety procedures.

5) Abbreviations, if any

SOP: Standard Operating Procedure, PPE: Personal Protective Equipment

6) Documents, if any

Risk Assessment Reports, Safe Work Procedures, Emergency Response Plans, Incident Investigation Reports, Health and Safety Training Records

7) Reference, if any

Occupational safety and health regulations, industry standards for maintenance safety, manufacturer’s safety guidelines for equipment, and local emergency response protocols.

8) SOP Version

Version 1.0