Program
– Establish a comprehensive facility safety program that includes:
– Safety policies and procedures to prevent workplace hazards.
– Emergency protocols (e.g., fire, electrical, medical emergencies).
– Hazardous material handling procedures.
– Safety equipment and protective measures for employees (e.g., PPE, safety barriers).

4.1.2 Safety Risk Assessment
– Conduct regular safety risk assessments to identify potential hazards within the facility, such as:
– Electrical hazards.
– Chemical exposure.
– Mechanical hazards from equipment and machinery.
– Ergonomic risks associated with manual handling tasks.

4.1.3 Safety Standards Compliance
– Ensure compliance with safety regulations, including:
– Occupational Safety and Health Administration (OSHA) regulations.
– FDA 21 CFR Part 820: Quality System Regulation.
– ISO 13485: Medical Devices – Quality Management Systems.
– Local health and safety regulations.

4.2 Hazard Identification and Control
4.2.1 Identifying Workplace Hazards
– Conduct regular hazard identification activities, such as:
– Routine inspections of the facility for unsafe conditions (e.g., wet floors, exposed wiring).
– Monitoring of equipment for malfunction or safety issues.
– Employee feedback on safety concerns or near-miss incidents.

4.2.2 Risk Control and Mitigation
– Implement control measures to eliminate or reduce identified risks, including:
– Installing safety barriers or guards on machinery.
– Providing proper ventilation and ventilation equipment.
– Using warning signs and safety markings to highlight hazardous areas.
– Implementing ergonomic solutions to prevent musculoskeletal injuries.

4.2.3 Personal Protective Equipment (PPE)
– Ensure that appropriate PPE is provided to employees based on the tasks performed and the identified risks:
– Gloves, goggles, and face shields for handling hazardous materials.
– Ear protection in noisy environments.
– Respirators and masks in areas with airborne hazards.

4.3 Emergency Procedures
4.3.1 Emergency Response Plan
– Develop and maintain an emergency response plan that includes procedures for:
– Fire safety and evacuation routes.
– Medical emergencies and first-aid procedures.
– Chemical spills or hazardous material leaks.
– Electrical or equipment malfunctions.

4.3.2 Emergency Equipment
– Ensure that the following emergency equipment is available and accessible:
– Fire extinguishers and first-aid kits.
– Eye wash stations and emergency showers for chemical exposure.
– Emergency stop buttons on machinery and equipment.
– Spill containment kits for chemical or hazardous material spills.

4.3.3 Employee Training
– Conduct regular emergency response drills for employees, including:
– Fire drills and evacuation practice.
– First-aid and CPR training.
– Chemical spill response drills.
– Safe operation of machinery during an emergency.

4.4 Regulatory Compliance
4.4.1 Compliance with Safety Regulations
– Ensure compliance with local, national, and international safety regulations and standards, including:
– OSHA safety regulations and guidelines.
– Environmental Health and Safety (EHS) standards.
– FDA 21 CFR Part 820: Quality System Regulation.
– ISO 45001: Occupational Health and Safety Management Systems.

4.4.2 Safety Audits and Inspections
– Conduct regular safety audits and facility inspections to ensure compliance:
– Internal safety audits by the QA or safety officer team.
– External audits by regulatory bodies or third-party safety inspectors.
– Document audit findings and track corrective actions taken in the Compliance Audit Log.

4.4.3 Regulatory Inspections
– Provide regulatory authorities with all necessary safety and compliance documentation during inspections, including:
– Safety records, hazard assessments, and corrective action logs.
– Employee training records related to safety procedures.
– Evidence of compliance with safety and environmental regulations.

4.5 Employee Safety Training
4.5.1 Training Program
– Develop an employee safety training program that covers:
– Facility safety policies and hazard identification.
– Proper use of PPE and emergency response procedures.
– Safe operation of equipment and machinery.
– Handling and disposal of hazardous materials.

4.5.2 Training Records
– Maintain comprehensive training records for all employees, including:
– Training dates and topics covered.
– Attendance records for safety training sessions.
– Certifications for specific safety training programs (e.g., first aid, machinery operation).

4.5.3 Ongoing Training
– Provide ongoing safety training and refresher courses to ensure that employees are updated on new safety procedures and regulations.

4.6 Documentation and Record Keeping
4.6.1 Safety Documentation File
– Maintain a file containing all safety and compliance documentation, including:
– Hazard assessments and safety risk evaluations.
– Safety audit and inspection records.
– Employee safety training records.
– Incident and accident reports.

4.6.2 Record Retention
– Retain safety records for a minimum of five years or as required by regulatory authorities.

4.7 Continuous Improvement
4.7.1 Safety Program Review
– Continuously review and improve the facility’s safety program by:
– Analyzing accident and incident reports to identify trends.
– Incorporating feedback from employees regarding safety improvements.
– Updating safety procedures and training programs based on new regulations or technologies.

4.7.2 Corrective and Preventive Actions (CAPA)
– Implement a CAPA process for addressing safety issues:
– Investigate the root causes of accidents or safety failures.
– Develop and implement corrective actions to address identified issues.
– Track the effectiveness of corrective actions over time.

5) Abbreviations

– QA: Quality Assurance
– SOP: Standard Operating Procedure
– OSHA: Occupational Safety and Health Administration
– EHS: Environmental Health and Safety
– CAPA: Corrective and Preventive Actions

6) Documents

– Compliance Audit Log
– Safety Training Records
– Hazard Assessment Reports
– Incident and Accident Reports
– Employee Safety Certification Logs

7) Reference

– OSHA Safety Regulations
– FDA CFR Title 21, Part 820: Quality System Regulation
– ISO 45001: Occupational Health and Safety Management Systems
– ISO 13485: Medical Devices – Quality Management Systems

8) SOP Version

– Version: 1.0
– Effective Date: DD/MM/YYYY
– Approved by: [Name/Title]

Annexure

Annexure 1: Compliance Audit Log Template

Date	Audit Type	Audit Findings	Corrective Actions	Responsible Person
DD/MM/YYYY	Internal Safety Audit	Improper storage of chemicals	Reorganized chemical storage area	Facilities Manager

Annexure 2: Safety Training Records Template

Date	Employee Name	Training Topic	Instructor	Certification
DD/MM/YYYY	John Doe	Fire Safety and Evacuation	Safety Officer	Certified