material inventories, safety training, and incident reports.

4) Procedure

4.1 Hazardous Materials Identification and Classification
4.1.1 Identifying Hazardous Materials
– Identify hazardous materials used in the facility, which may include:
– Chemicals (e.g., solvents, cleaners, disinfectants).
– Biological materials (e.g., cultures, specimens).
– Physical hazards (e.g., sharp objects, pressurized gas).

4.1.2 Material Safety Data Sheets (MSDS)
– Ensure that Material Safety Data Sheets (MSDS) are available for all hazardous materials used in the facility, which should include:
– Properties of the material (e.g., flammability, toxicity).
– Handling and storage recommendations.
– Emergency response procedures.
– Personal protective equipment (PPE) requirements.

4.1.3 Risk Assessment
– Conduct a risk assessment for each hazardous material to determine the level of hazard and required safety precautions, such as:
– Assessing potential health risks (e.g., inhalation, skin exposure).
– Identifying potential environmental impacts (e.g., contamination).
– Evaluating the physical properties that could pose risks (e.g., flammable, corrosive).

4.2 Handling Hazardous Materials
4.2.1 Personal Protective Equipment (PPE)
– Ensure that appropriate PPE is worn when handling hazardous materials, including:
– Gloves, goggles, and face shields for chemical handling.
– Lab coats and aprons for protection against spills.
– Respirators or face masks for protection against inhalation hazards.

4.2.2 Handling Procedures
– Establish proper procedures for handling hazardous materials to minimize exposure, such as:
– Using fume hoods and local exhaust systems for chemicals with hazardous vapors.
– Using sealed containers and proper dispensing equipment to prevent spills.
– Avoiding direct contact with chemicals by using tongs, scoops, or automatic dispensers.

4.2.3 Spill and Exposure Control
– Develop procedures to control and manage spills, leaks, and exposure incidents, including:
– Immediate containment and neutralization of spills.
– Reporting exposure incidents to the health and safety officer.
– Providing first aid or emergency medical assistance in case of exposure.

4.3 Storing Hazardous Materials
4.3.1 Storage Area Requirements
– Ensure that hazardous materials are stored in designated areas that meet safety requirements, including:
– Adequate ventilation to minimize the buildup of fumes or vapors.
– Proper containment and segregation of incompatible materials (e.g., acids and bases).
– Temperature and humidity control for materials sensitive to environmental conditions.

4.3.2 Storage Containers
– Use appropriate containers for hazardous materials, such as:
– Secure, leak-proof containers for liquids.
– Ventilated, fire-resistant cabinets for flammable materials.
– Clear labeling of containers to indicate the contents and hazard classification.

4.3.3 Inventory Management
– Maintain an up-to-date inventory of all hazardous materials stored in the facility, including:
– Material name, quantity, and location.
– Expiry dates or re-ordering schedules for materials that degrade over time.
– Regular inspection of materials for leaks, damage, or expiration.

4.3.4 Labeling and Signage
– Label all hazardous materials with appropriate hazard symbols and handling instructions:
– Use clear labels with hazard identification symbols (e.g., flammable, toxic).
– Include emergency contact information and safety instructions on labels.
– Mark storage areas with signage indicating the presence of hazardous materials.

4.4 Emergency Response for Hazardous Material Incidents
4.4.1 Spill Containment and Cleanup
– Develop spill containment procedures that include:
– Providing spill kits with absorbent materials, neutralizers, and protective gear.
– Training personnel to respond quickly and effectively to spills.
– Verifying that clean-up procedures minimize the impact on employees and the environment.

4.4.2 Fire and Explosion Hazards
– In case of fire or explosion risks associated with hazardous materials, follow these emergency procedures:
– Activate fire alarms and evacuate personnel to safe areas.
– Use fire extinguishers rated for chemical or flammable material fires.
– Ensure proper ventilation and isolation of ignition sources in areas where hazardous materials are used.

4.4.3 Exposure to Toxic or Corrosive Materials
– In case of exposure to toxic or corrosive materials, ensure the following:
– Immediate decontamination by washing the exposed area with water.
– Providing emergency eyewash stations and safety showers near hazardous material handling areas.
– Reporting exposure incidents to health and safety officers for further medical assessment.

4.4.4 Reporting and Documentation
– Document all hazardous material incidents, including:
– Date, time, and location of the incident.
– Details of the hazardous material involved and the exposure or spill.
– Corrective actions taken and verification of incident resolution.

4.5 Employee Training and Awareness
4.5.1 Safety Training
– Provide regular training for all employees involved in handling hazardous materials, covering:
– Identification of hazardous materials and their associated risks.
– Proper PPE use and safety procedures.
– Emergency response actions for spills, exposures, or accidents.

4.5.2 Training Documentation
– Maintain records of all safety training sessions, including:
– Training dates, topics covered, and attendees.
– Certifications for specialized training (e.g., hazardous material handling, first aid).

4.5.3 Ongoing Education
– Offer refresher training sessions periodically to keep employees informed about safety protocols and regulatory updates.

4.6 Documentation and Record Keeping
4.6.1 Hazardous Material Handling and Storage Records
– Maintain detailed records of all hazardous material handling and storage activities, including:
– MSDS and inventory logs.
– Inspection and cleaning logs for hazardous material storage areas.
– Incident reports and corrective actions taken.

4.6.2 Record Retention
– Retain all hazardous material handling records for a minimum of five years or as required by regulatory authorities.

4.7 Compliance and Regulatory Requirements
4.7.1 Compliance with Safety Regulations
– Ensure that hazardous material handling and storage practices comply with relevant regulations, such as:
– OSHA regulations for hazardous materials.
– FDA 21 CFR Part 820: Quality System Regulation.
– ISO 13485: Medical Devices – Quality Management Systems.
– Local environmental and health safety regulations.

4.7.2 Regulatory Audits
– Provide necessary documentation for regulatory audits or inspections, including:
– Hazardous material inventories.
– Employee training records.
– Safety inspections and incident reports.

5) Abbreviations

– PPE: Personal Protective Equipment
– MSDS: Material Safety Data Sheets
– OSHA: Occupational Safety and Health Administration
– SOP: Standard Operating Procedure
– ISO: International Organization for Standardization

6) Documents

– Hazardous Material Inventory Log
– MSDS for Hazardous Materials
– Spill Containment and Cleanup Procedures
– Employee Training Records
– Incident Report Logs

7) Reference

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

8) SOP Version

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

Annexure

Annexure 1: Hazardous Material Handling Log Template

Date	Material Name	Quantity Handled	Handling Procedure	Handled By
DD/MM/YYYY	Solvent ABC	5 liters	Disposal	John Doe

Annexure 2: Spill Response Log Template

Date	Spill Location	Material Spilled	Response Action	Follow-up Actions
DD/MM/YYYY	Storage Room A	Solvent XYZ	Contained and neutralized	Checked area, no further spills