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.
Citations listed support WHAT-level governance requirements; full compliance traceability is maintained at the L0 level.
| SOP ID | SOP Title | Purpose (Control Intent) | Scope (Operational Boundary) | Regulatory Anchors |
|---|---|---|---|---|
| SOP-EHS-GEN | General Safety Program | Establishes the foundational safety requirements, hazard controls, and safety behaviors required to protect personnel and maintain a safe GMP operating environment. | Applies to all personnel, contractors, and visitors across all facility areas where safety risks may exist. |
21 CFR 111.10 — Personnel hygiene & contamination prevention 21 CFR 111.15 — Facility & grounds sanitation controls NSF/ANSI 455-2: 4.4 — Facility & personnel safety expectations |
| SOP-EHS-HAZCOM | Hazard Communication & SDS Program | Ensures all chemical hazards are identified, communicated, labeled, and accessible through managed Safety Data Sheets, preventing exposure and ensuring regulatory alignment. | Applies to all personnel handling, storing, or exposed to chemicals, cleaning agents, or hazardous materials. |
21 CFR 111.15 — Chemical storage & sanitation risk controls NSF/ANSI 455-2: 4.4 & 4.5 — Chemical management, SDS access, labeling, and employee hazard awareness |
| SOP-EHS-PPE | Personal Protective Equipment Program | Defines required PPE based on hazard assessment to prevent personnel injury and contamination of components, dietary supplements, and contact surfaces. | Applies to all GMP and non-GMP areas where PPE is required due to chemical, ergonomic, mechanical, or contamination risk. |
21 CFR 111.10(b) — Hygienic practices including protective garments NSF/ANSI 455-2: 4.4 — PPE requirements for GMP operations |
| SOP-EHS-EMER | Emergency Response & Evacuation | Establishes emergency response, evacuation, communication, and preparedness controls to ensure personnel safety during emergency events. | Applies to entire facility, including all employees, contractors, and visitors during emergencies. |
21 CFR 111.15 — Facility safety and contamination protection NSF/ANSI 455-2: 4.4 — Emergency preparedness and response requirements |
| SOP-EHS-INCIDENT | Incident Reporting & Investigation | Ensures all injuries, near-misses, unsafe conditions, and safety violations are documented, escalated, investigated, and corrected to prevent recurrence. | Applies to all personnel across all operations where incidents may occur or be observed. |
21 CFR 111.35(b)(3) — Recordkeeping for safety-related equipment controls NSF/ANSI 455-2: 4.10 — Incident reporting and corrective action expectations |
| SOP-EHS-ERG | Ergonomics & Injury Prevention | Reduces musculoskeletal injuries through ergonomic assessment, safe lifting techniques, workstation design, and repetitive-motion risk mitigation. | Applies to all manual handling, repetitive-motion work, equipment operation, and workstation areas. |
21 CFR 111.10 — Personnel safety & hygienic practice NSF/ANSI 455-2: 4.4 — Injury prevention and ergonomic risk controls |
Checks (CHK) are verification activities used to confirm that required, GMP-critical actions, reviews, or prerequisites have been completed in accordance with the governing SOP or WIN. Checks do not instruct how to perform tasks; they verify that required conditions or outcomes have been met.
Logs provide chronological documentation of repeated or ongoing monitoring activities. Logs in this Process Family must:
Templates provide standardized data fields for recording measurements, quantities, equipment settings, sampling results, or other structured GMP data. Templates in this Process Family must:
Records (FRMs) capture the finalized GMP evidence for this Process Family. All Records must comply with ALCOA+, GDP, Part 11 requirements for electronic records, and the metadata and retention standards defined in L0 Section 16 — AA Governance. Records may incorporate Checks, Logs, and Templates as embedded evidence.
Citations above support WHAT requirements; compliance traceability is maintained at the L0 level.
All personnel, contractors, and visitors operating within or interacting with the Environmental Health & Safety (EHS) Process Family must complete and maintain the following training-related requirements. These statements represent WHAT-level expectations and do not require procedural work instructions.
| Role | Primary Responsibilities | High-Level Controls (WHAT Requirements) |
|---|---|---|
| Executive Leadership |
• Ensures organizational commitment to safety programs and employee protection • Allocates resources necessary to maintain a safe and compliant facility • Supports implementation of EHS policies and organizational safety culture |
• Establishes expectations for safe behaviors and workplace safety standards • Reviews safety performance metrics and ensures continuous improvement • Approves enterprise-level safety initiatives and risk mitigation strategies |
| EHS |
• Oversees all safety, hazard communication, PPE, and emergency programs • Identifies and communicates workplace hazards and mitigation strategies • Provides safety training content and supports incident investigation |
• Maintains hazard assessments and required safety documentation • Ensures availability of SDS, safety signage, and emergency information • Monitors compliance with safety rules and escalates unsafe conditions |
| Operations |
• Ensures operational areas follow applicable EHS requirements • Communicates safety expectations to functional teams • Oversees implementation of EHS controls in day-to-day operations |
• Verifies work areas maintain required safety controls and PPE standards • Ensures timely reporting of incidents and unsafe behaviors • Ensures personnel complete required safety training before work assignment |
| Production |
• Ensures personnel follow posted safety rules and hazard controls • Maintains clean, orderly, and hazard-free production areas • Identifies and reports any unsafe condition or near-miss event |
• Enforces PPE requirements for production activities • Ensures proper handling of chemicals and cleaning agents • Ensures workers follow safe lifting and ergonomic practices |
| Warehouse |
• Ensures safe handling, storage, and movement of materials • Maintains clear aisles and hazard-free warehouse areas • Implements forklift, pallet-jack, and transport safety controls |
• Follows required PPE for material handling and storage zones • Ensures chemical storage follows hazard control requirements • Reports unsafe equipment or conditions immediately |
| Maintenance |
• Ensures maintenance work is performed safely and without creating hazards • Supports facility safety infrastructure and utility reliability • Communicates safety risks related to equipment and utility systems |
• Performs lockout/tagout and other required safety controls • Maintains safe access pathways and hazard-free equipment areas • Ensures safety devices and protective systems remain functional |
| Talent Management |
• Ensures required safety training is assigned and tracked • Maintains training records for personnel working in safety-sensitive operations • Supports annual safety and GMP refresher training |
• Ensures new hires complete required EHS onboarding • Ensures role-based safety requirements are clearly defined • Ensures competency gaps trigger retraining actions |
| IT |
• Supports system access and data integrity related to safety records • Ensures critical safety-related systems maintain availability and security • Supports electronic access to SDS and safety documentation |
• Maintains secure access controls for safety-related systems • Ensures backups protect required safety documentation • Ensures system changes do not disrupt safety workflows |
Quality Unit roles (QA, QC, QA-SOD, QC-SOD) are intentionally excluded from this section.
Their responsibilities are defined globally in the L0 Unified Governance Document and detailed within the QA and QC Family Packs, and therefore apply uniformly across all Process Families.
This section defines the authoritative Auditable Artifact (AA) inventory for the Environmental Health & Safety (EHS) Process Family. Each AA provides objective evidence that EHS SOP requirements are executed and controlled. All AAs listed below are mandatory and traceable to an approved SOP and WIN.
| SOP | WIN | AA Doc ID | AA Name | Type | Purpose |
|---|---|---|---|---|---|
| SOP-EHS-GEN | WIN-EHS-SAFETY | AA-CHK-EHS-GEN-EVT | General Safety Compliance Checklist | CHK | Verifies implementation of site-wide safety controls and hazard awareness. |
| SOP-EHS-HAZCOM | WIN-EHS-HAZCOM | AA-LOG-EHS-SDS-MNT | SDS Inventory & Access Log | LOG | Documents availability, currency, and access to Safety Data Sheets. |
| SOP-EHS-PPE | WIN-EHS-PPE | AA-REC-EHS-PPE-ISSUE | PPE Issuance & Training Record | REC | Records PPE assignment, training, and user acknowledgment. |
| SOP-EHS-EMER | WIN-EHS-EMER | AA-CHK-EHS-EMER-DRILL | Emergency Drill Readiness Checklist | CHK | Verifies preparedness for emergency response and evacuation. |
| SOP-EHS-INCIDENT | WIN-EHS-INCIDENT | AA-FRM-EHS-INC-RPT | Incident Report Form | FRM | Captures incident details for investigation and corrective action. |
| SOP-EHS-ERG | WIN-EHS-ERG | AA-REC-EHS-ERG-EVAL | Ergonomic Assessment Record | REC | Documents ergonomic risk assessments and preventive actions. |
Authoritative versions, retention rules, and system ownership for all EHS AAs are governed by the Enterprise Artifact System of Record (SOR) Register.
AA-CHK-EHS-GEN-EVT (Emergency Use Only)
[ ] Safety signage present and visible [ ] Emergency exits unobstructed [ ] Fire extinguishers accessible [ ] Hazard controls in place [ ] Personnel aware of safety rules Operator: __________ Date: _______ Reviewer: __________ Date: _______
AA-CHK-EHS-EMER-DRILL (Emergency Use Only)
[ ] Alarm system functional [ ] Evacuation routes followed [ ] Assembly points used [ ] Accountability completed [ ] Issues documented Operator: __________ Date: _______ Reviewer: __________ Date: _______
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, documentation, data integrity, and system requirements. All SOPs, WINs, and FORMs within this Family must be created, maintained, and executed in alignment with L0 rules, including:
L0 requirements apply uniformly and supersede all Family-level content. This Family Pack does not replace or modify L0 governance and operates fully within the enterprise-wide QMS architecture.