EHS – Environmental, Health & Safety Business Process
The Environmental, Health & Safety (EHS) business process governs the identification, assessment, control, and monitoring of workplace, environmental, and personnel safety risks to ensure safe, compliant, and sustainable operations.
EHS Operating Model
The EHS Operating Model below illustrates how hazards are identified, controlled, monitored, and escalated to protect personnel, facilities, and the environment while supporting uninterrupted GMP operations.
Regulatory and legal requirements
Workplace activities and hazard sources
Incident data and risk assessments
Identification of chemical, physical, biological, and ergonomic hazards
Engineering, administrative, and PPE controls
Inspections, exposure monitoring, and compliance verification
Documentation, investigation, and corrective action for EHS events
Controlled work environments
Incident and investigation records
Compliance and risk mitigation evidence
EHS activities apply continuously across all operational areas and are not limited to batch execution or specific process families.
Process Interfaces & Boundaries
- Upstream: Regulatory requirements, site activities, and risk identification inputs
- Downstream: All operational and support process families – safe execution of work
- Governance: Enterprise management system defines EHS requirements; EHS executes risk prevention and response
Quality Control Requirements Supported by Environmental Health & Safety
Environmental Health & Safety (EHS) is classified as a QC-Enabling Domain. EHS activities support defined Quality Control Requirements in accordance with the Quality Control Requirements Index (QC-REQ-IDX) under the authority of Quality Control Operations (QCO).
- QC-FAC-001 – GMP Area Classification & Zoning: EHS supports establishment and maintenance of GMP area classifications and zoning controls to prevent contamination and cross-risk exposure.
- QC-UTIL-003 – Wastewater & Drainage Systems: EHS supports environmental controls governing wastewater handling and drainage system risk management within GMP areas.
- QC-CHG-002 – Impact & Risk Assessment: EHS participates in formal impact and risk assessments where environmental, safety, or facility conditions may affect GMP operations.
EHS does not establish product acceptance criteria or make disposition decisions. EHS provides risk evaluation and environmental control inputs that support Quality Control determinations within defined authority.
EHS incidents, near misses, regulatory findings, or unsafe conditions are documented and escalated in accordance with enterprise EHS and incident management procedures.