| Field | Value |
|---|---|
| Effective Date | 03/01/2026 |
| Status | Implemented |
| Document ID | QMS-FP-EHS |
| Version | v1.0 |
| Owner | Quality Unit (QU) |
| Approver | Quality Unit Director |
| Controlled System of Record | GitHub |
| Change Control | QMS-???? |
| Last Review Date | 03/01/2026 |
| Next Review Date | 03/01/2027 |
This Family inherits the governance requirements defined in the Unified Governance Manual (SOP-QMS-GOV), including the Quality Manual, Risk Management Program (RMP), Internal Audit Program (IAP), and Material Review Board (MRB) governance (SOP-QA-MRB). All Family responsibilities and WINs must align with these L2 authorities.
The Environmental Health & Safety (EHS) Process Family governs all programs, controls, and safety infrastructure that protect personnel, facilities, and products during GMP operations. EHS establishes the foundational safety environment required for compliant dietary supplement manufacturing, including:
EHS programs are critical to GMP compliance because they directly affect personnel hygiene, facility sanitation, contamination prevention, and operational safety. These requirements align with:
Major EHS risk themes include:
EHS relies on strong cross-functional interaction with:
Risk Tier Classification: HIGH. Due to regulatory exposure, safety sensitivity, and the systemic impact of failures on personnel and product safety, EHS is a HIGH-risk governance domain. Its programs form the compliance foundation on which safe, controlled, and legally compliant GMP operations depend.
| SOP ID | SOP Title | Purpose | Scope | Regulatory Anchors |
|---|---|---|---|---|
| SOP-EHS-GEN | General Safety Program | Establishes enterprise-wide safety governance, hazard identification, risk mitigation, and compliance monitoring. Defines baseline safety expectations and escalation requirements for unsafe conditions. | Applies to all personnel, contractors, and facility operations. Covers workplace safety, hazard reporting, corrective action, and continuous safety monitoring. | 21 CFR 111.10, OSHA General Duty Clause, 29 CFR 1910 |
| SOP-EHS-HAZCOM | Hazard Communication & SDS Program | Defines controls for chemical hazard classification, labeling, Safety Data Sheet (SDS) management, and employee right-to-know requirements to prevent chemical exposure risk. | Applies to all hazardous chemical storage, handling, transfer, and disposal activities across all operational areas. | OSHA 29 CFR 1910.1200 |
| SOP-EHS-PPE | Personal Protective Equipment | Establishes PPE selection, issuance, usage, and enforcement controls to mitigate exposure to physical, chemical, and biological hazards. | Applies to all personnel operating in controlled or risk-exposed environments where PPE is required. | 21 CFR 111.10(b), OSHA 1910 Subpart I |
| SOP-EHS-EMER | Emergency Response | Defines emergency response protocols including evacuation, communication, containment, and coordination with external responders. | Applies to all emergency conditions including fire, chemical release, medical emergency, and facility evacuation scenarios. | OSHA 29 CFR 1910.38 |
| SOP-EHS-INCIDENT | Incident Reporting & Investigation | Defines controls for immediate reporting, documentation, investigation, root cause analysis, and corrective/preventive action implementation. | Applies to all safety incidents, near misses, injuries, and environmental events. | 21 CFR 111.35, OSHA Recordkeeping |
| SOP-EHS-ERG | Ergonomics Program | Establishes controls to identify, evaluate, and mitigate ergonomic risk factors including repetitive motion, force, and posture. | Applies to all manual handling, repetitive operations, and workstation design activities. | OSHA General Duty Clause |
| # | SOP | WIN | AA Doc ID | Type | Frequency | Description |
|---|---|---|---|---|---|---|
| General Safety Program | ||||||
| 1 | SOP-EHS-GEN | WIN-EHS-SAFETY | AA-CHK-EHS-GEN-AUD | CHK | Periodic | Formal safety inspection verifying compliance with defined controls |
| Hazard Communication | ||||||
| 2 | SOP-EHS-HAZCOM | WIN-EHS-HAZCOM | AA-LOG-EHS-SDS-MNT | LOG | Continuous | Maintain current SDS inventory and accessibility |
| PPE Program | ||||||
| 3 | SOP-EHS-PPE | WIN-EHS-PPE | AA-REC-EHS-PPE-ISSUE | REC | Per Event | Document issuance and assignment of PPE |
| Emergency Response | ||||||
| 4 | SOP-EHS-EMER | WIN-EHS-EMER | AA-REC-EHS-EMER-DRILL | REC | Periodic | Document emergency drills and readiness verification |
| Incident Management | ||||||
| 5 | SOP-EHS-INCIDENT | WIN-EHS-INCIDENT | AA-FRM-EHS-INC-RPT | FRM | Per Event | Capture incident details and initiate investigation |
| Ergonomics Program | ||||||
| 6 | SOP-EHS-ERG | WIN-EHS-ERG | AA-REC-EHS-ERG-EVAL | REC | Periodic | Document ergonomic risk evaluation and mitigation actions |
Trigger Event: Scheduled safety inspection or observed unsafe condition
Trigger Event: Introduction or handling of hazardous chemicals
Trigger Event: Entry into PPE-required area
Trigger Event: Emergency condition or drill activation
Trigger Event: Incident or near miss occurrence
Trigger Event: Ergonomic risk identification or periodic review
This Family Pack inherits all enterprise-level governance defined in the L0 Unified Governance Document (L0-QMS-UGD), which serves as the authoritative source for quality management, documentation control, data integrity, electronic systems governance, and enterprise-wide control architecture.
All SOPs, WINs, and Auditable Artifacts (AAs) within this Family shall be created, maintained, executed, and periodically reviewed in full alignment with L0 governance requirements, including:
The Quality Unit (QU) retains final, non-delegable authority over quality-related decisions affecting compliance, authorization, system controls, and escalation pathways.
L0 governance requirements apply uniformly and supersede all Family-level content. This Family Pack does not replace, dilute, or modify enterprise governance and operates fully within the enterprise-wide QMS architecture.