Standard Operating Procedure for Health and Safety in Maintenance

1) Purpose

The purpose of this SOP is to establish guidelines for maintaining health and safety standards during maintenance activities in pharmaceutical manufacturing facilities to prevent injuries, ensure compliance with regulations, and promote a safe working environment.

2) Scope

This SOP applies to all maintenance personnel, contractors, and employees involved in maintenance activities within pharmaceutical manufacturing facilities.

3) Responsibilities

The Health and Safety Department is responsible for implementing and adhering to this SOP. The Maintenance Manager oversees health and safety in maintenance activities.

4) Procedure

1. Risk Assessment and Hazard Identification
   1. Conduct risk assessments for all maintenance tasks to identify potential hazards and assess risks to personnel, equipment, and the environment.
   2. Document hazard identification findings and risk mitigation measures.
2. Personal Protective Equipment (PPE)
   1. Provide appropriate PPE based on the results of the risk assessment and nature of the maintenance activities.
   2. Ensure maintenance personnel are trained in the proper use, maintenance, and disposal of PPE.
3. Safe Work Practices
   1. Develop and implement safe work procedures (SWPs) for common maintenance tasks, including lockout/tagout procedures, confined space entry, and working at heights.
   2. Train maintenance personnel on SWPs and ensure compliance with established procedures.
4. Emergency Preparedness
   1. Establish emergency response procedures specific to maintenance activities, including procedures for responding to spills, fires, and medical emergencies.
   2. Conduct regular drills and training exercises to ensure readiness in emergency situations.
5. Incident Reporting and Investigation
   1. Require prompt reporting of all incidents, near misses, and accidents related to maintenance activities.
   2. Investigate incidents to determine root causes and implement corrective actions to prevent recurrence.

5) Abbreviations, if any

SOP: Standard Operating Procedure, PPE: Personal Protective Equipment, SWP: Safe Work Procedure

6) Documents, if any

Risk Assessment Reports, PPE Inventory and Inspection Records, Safe Work Procedures, Emergency Response Plans, Incident Investigation Reports

7) Reference, if any

Occupational Safety and Health Administration (OSHA) regulations, local health and safety laws, and industry standards for health and safety in maintenance activities.

8) SOP Version

Version 1.0