Sawgrass Nutra Labs — L1 Operating Model, Roles, and Process Family Hierarchy

Document Control

1. Operating Model

Sawgrass Nutra Labs (SNL) operates under a defined and intentionally narrow manufacturing scope designed to minimize regulatory risk and ensure consistent, compliant operations. The Operating Model establishes what SNL manufactures, what it does not manufacture, and how the Quality Management System (QMS) is structured around this scope.

1.1 Approved Manufacturing Scope

• Dry-process dietary supplements only
• Approved formats:
  • Dry-filled capsules
  • Dry powder blends in bottles, jars, or pouches
• No liquid processing, tableting, granulation, aseptic operations, wet processing, or thermal processing
• No internal chemical or microbiological testing beyond identity verification

1.2 Purpose of Scope Control

The QMS is built around the minimized risk profile of dry-process manufacturing. All SOPs, WINs, training programs, facility controls, sanitation programs, and equipment qualification assumptions are derived from this restricted scope.

1.3 When Scope Changes Apply

Any request for new product formats, new equipment categories, or new processing capabilities outside this defined scope requires formal review and approval. Scope expansion may require:

• Additional validation activities
• New critical control points
• Revised training and competency programs
• Expanded sanitation and environmental monitoring
• New or revised Process Families

1.4 Governance of Operating Model Changes

Scope changes require documented assessment and approval by the Quality Unit and Executive Leadership. No Sales, R&D, or Operations commitments may be made until formal approval is granted.

2. QMS Document Architecture (L0 – L4)

Sawgrass Nutra Labs maintains a structured document hierarchy to ensure clarity, control, and alignment between governance requirements, operational execution, and recordkeeping. Each level serves a distinct purpose and has defined ownership.

2.1 L0 — Governance Documents (Rules & Framework)

L0 documents define the overarching governance model for the QMS. They establish structure, regulatory mapping, document control rules, and the enterprise operating framework that all lower-level documents must follow.

• Define quality governance principles and QMS structure
• Establish document hierarchy, numbering, and control rules
• Map regulatory expectations to QMS requirements
• Define enterprise roles, responsibilities, and accountabilities

Owned by: Quality Control Operations (QCO) with Executive Leadership endorsement

2.2 L1 — Process Families (Organizational Domains)

L1 documents define Process Families — the major organizational domains that group SOPs and workflows under a unified operational or quality function.

• Define the domain purpose and boundaries
• List SOPs belonging to the Process Family
• Provide domain-level orientation for the QMS
• Support organizational alignment and governance

Owned by: QA and Business Relationship Management (BRM)
Supported by: Business Process Owners (BPOs)

2.3 L2 — Standard Operating Procedures (WHAT)

L2 SOPs define the rules, requirements, acceptance criteria, and boundaries for controlled processes. SOPs describe WHAT must be done to remain compliant.

• Define requirements, acceptance criteria, and compliance rules
• Specify prerequisites to execution
• Identify responsible and verifying roles
• Do not include step-by-step instructions (L3 only)

Owned by: QA (sole document approval authority under QCO governance)

2.4 L3 — Work Instructions (HOW)

L3 Work Instructions (WINs) define how tasks are performed. They provide detailed step-by-step execution directly used by operators.

• Provide instruction-level steps
• Include materials, tools, and system pathways
• Incorporate safety, QC, and verification checkpoints
• Translate SOP requirements into executable workflow

Owned by: Business Process Owners (BPOs)
Reviewed and approved by: QA (document governance only; authority delegated by QCO — not applicable to deviation or product disposition decisions)

2.5 L4 — Forms & Records (PROOF)

L4 documents provide the evidence of execution for L3 WINs and L2 SOP requirements. They demonstrate traceability, compliance, and data integrity.

• Logs, checklists, batch records, sampling forms, labels
• Must be completed in real time (GDP)
• Reflect the exact sequence and data elements in L3 WINs
• Serve as audit evidence and historical traceability

Designed and controlled by: QA
Completed by: Operations, QC, and other functional teams

3. Process Families & Hierarchy

Process Families represent the Level 1 (L1) structure of the Sawgrass Nutra Labs QMS. Each Family contains Level 2 SOPs (WHAT) and Level 3 WINs (HOW). SOPs below are listed exactly in the order found in the Master Navigator file and use the intelligent identifier format: [SOP-FAM-ABBR] SOP Name.

3.1 Process Families

1. Commercial & Customer Management (SALES)

• [SOP-SALES-SLSCOMM] Sales Communications
• [SOP-SALES-SLSSPEC] Sales Specifications
• [SOP-SALES-RFQ] Request for Quote
• [SOP-SALES-PMA] Product Manufacturing Agreement
• [SOP-SALES-SOW] Statement of Work
• [SOP-SALES-ROE] Rules of Engagement

2. Procurement (PROC)

• [SOP-PROC-SOURCING] Sourcing
• [SOP-PROC-SUPQUAL] Supplier Qualification
• [SOP-PROC-ASL] Approved Supplier List
• [SOP-PROC-P2P] Procure to Pay
• [SOP-PROC-SUPDOC] Supplier Documentation

3. Warehouse Management (WH)

• [SOP-WH-RACKMAP] Rack Mapping
• [SOP-WH-RECEIVING] Receiving
• [SOP-WH-STORAGE] Storage
• [SOP-WH-INVCNTRL] Inventory Control
• [SOP-WH-SHIPPING] Shipping
• [SOP-WH-MATERIALMOVE] Material Transport / Movement

4. Material Handling (MH)

• [SOP-MH-SEGREGATION] Segregation Control
• [SOP-MH-MATERIALHANDLING] Material Handling

5. Production (PROD)

• [SOP-PROD-HYGIENE] Personnel Hygiene & Illness Control
• [SOP-PROD-FMCONTROL] Foreign Material Control
• [SOP-PROD-PREOP] Pre-Operation Checks
• [SOP-PROD-MMR] Master Manufacturing Record Requirements
• [SOP-PROD-BLENDING] Blending Operations
• [SOP-PROD-ENCAP] Encapsulation
• [SOP-PROD-BATCHRECORD] Batch Record Execution
• [SOP-PROD-WEIGHING] Weighing & Dispensing
• [SOP-PROD-CLEANING] Production Cleaning

6. Packaging (PKG)

• [SOP-PKG-LINESETUP] Packaging Line Setup
• [SOP-PKG-LABELCTRL] Label Control
• [SOP-PKG-PKGEXEC] Packaging Execution
• [SOP-PKG-PKGCLEAN] Packaging Cleaning

7. Sanitation (SAN)

• [SOP-SAN-SANITATION] Sanitation Cleaning
• [SOP-SAN-MASTERPROGRAM] Master Sanitation Program
• [SOP-SAN-ENVIRONMENTAL] Environmental Monitoring
• [SOP-SAN-PESTCTRL] Pest Control
• [SOP-SAN-EMP-HYGIENE] Employee Hygiene & Sanitation Responsibilities

8. Maintenance (MAINT)

• [SOP-MAINT-PM] Preventive Maintenance
• [SOP-MAINT-CALIBRATION] Calibration
• [SOP-MAINT-CALPROG] Calibration Program Management
• [SOP-MAINT-FACILITYMGMT] Facility Management
• [SOP-MAINT-UTILITIES] Utilities Management
• [SOP-MAINT-FACHYGIENE] Facility Maintenance & Hygienic Conditions

9. Quality Control (QC / QCL / QCP)

• [SOP-QC-SAMPLING] QC Sampling
• [SOP-QC-LABTESTING] Laboratory Testing
• [SOP-QC-LABDATA] Laboratory Data Management
• [SOP-QC-IPCTESTING] In-Process Control Testing

10. Quality Assurance (QA)

• [SOP-QA-RELEASE] Release & Disposition
• [SOP-QA-DEVIATION] Deviations & Corrective Action / Preventive Action
• [SOP-QA-CAPA] Corrective & Preventive Actions
• [SOP-QA-DOCCONTROL] Document Control
• [SOP-QA-CHANGECTRL] Change Control
• [SOP-QA-COMPLAINT] Complaint Handling
• [SOP-QA-RECALL] Recall Management
• [SOP-QA-AUDITS] Internal Audits
• [SOP-QA-MGMTREVIEW] Management Review
• [SOP-QA-SPECMGMT] Specification Management Program
• [SOP-QA-NCMR] Nonconforming Material Review
• [SOP-QA-STABILITY] Stability Program
• [SOP-QA-SAMPLINGPROG] Sampling Program
• [SOP-QA-RESERVESAMPLES] Reserve Sample Program
• [SOP-QA-RETURNS] Returned Product, Salvage & Reprocessing

11. Talent Management (TAL)

• [SOP-TAL-TRAINING] Training Program
• [SOP-TAL-COMPETENCY] Competency Program
• [SOP-TAL-QUALIFICATION] Personnel Qualification Program

12. Information Technology (IT)

• [SOP-IT-ACCESS] System Access Control
• [SOP-IT-ELECSIGN] Electronic Signatures
• [SOP-IT-BACKUP] Backup Management
• [SOP-IT-CSV] Computer System Validation

13. Environmental Health & Safety (EHS)

• [SOP-EHS-GENSAFETY] General Safety Program
• [SOP-EHS-HAZCOM] Hazard Communication & SDS Program
• [SOP-EHS-PPE] Personal Protective Equipment Program
• [SOP-EHS-EMERGENCY] Emergency Response & Evacuation
• [SOP-EHS-INCIDENT] Incident Reporting & Investigation
• [SOP-EHS-ERGONOMICS] Ergonomics & Injury Prevention

4. Role Architecture (L1 Structural HOW)

The Role Architecture in this L1 Operating Model defines the structural responsibilities, decision authority, boundaries (“MAY NOT”), and accountability expectations for each role within Sawgrass Nutra Labs. These definitions establish how the organization functions within the Quality Management System and clarify role-to-role interactions across Process Families.

This section does not serve as a job description and does not replace HR-owned role profiles or broader employment expectations. It also does not contain training requirements, competency matrices, or qualification criteria. Those elements are governed by the Talent Management Process Family (SOP-TAL-TRAINING, SOP-TAL-COMPETENCY, SOP-TAL-QUALIFICATION) and are defined at the L2 (requirements) and L3 (execution/training) document levels.

Roles within the Sawgrass Nutra Labs Operating Model are organized into four structural categories: (1) Enterprise Governance Roles,
(2) System Stewardship Roles,
(3) Operational Execution Roles, and
(4) Quality Oversight Roles.
Each role definition in this document is intentionally limited to L1 expectations and must not be used as a substitute for job-level HR documentation or training/qualification tools.

4.1 Enterprise Governance Roles

Chief Executive & Executive Leadership

• WHAT:
  • Provide resources, staffing, systems, and technology needed for stable QMS operation.
  • Reinforce quality culture and organizational compliance expectations.
  • Ensure enterprise initiatives align with regulatory and QMS obligations.
• AUTHORITY:
  • Approve Quality Policy and QMS-level charters.
  • Authorize major structural or strategic organizational changes.
• MAY NOT:
  • Override QU compliance or release decisions.
• ACCOUNTABLE FOR:
  • Ensuring leadership actions support QU independence and regulatory compliance.

Quality Unit Leader (QA)

• WHAT:
  • Own the Quality Management System, governance structure, and L0 rules.
  • Define quality expectations across all Process Families.
  • Ensure regulatory compliance and state of control across the business.
• AUTHORITY:
  • Final approval for SOPs, deviations, investigations, CAPA, MMR/BPR, and product release.
  • Approve system changes, change controls, and supplier quality decisions.
• MAY NOT:
  • Delegate release authority to non-QA personnel.
• ACCOUNTABLE FOR:
  • Maintaining QMS compliance, integrity, and effectiveness.

Business Relationship Manager (BRM)

• WHAT:
  • Align workflows across Process Families to ensure correct systemic handoffs.
  • Identify structural risks, gaps, and inefficiencies across systems.
  • Support cross-functional integration and ensure structural alignment.
• AUTHORITY:
  • Recommend systemic workflow or structural model changes.
• ACCOUNTABLE FOR:
  • System-level alignment across all operational and quality functions.

Business Process Owner (BPO)

• WHAT:
  • Own operational execution within assigned Process Families.
  • Maintain L3 Work Instructions and ensure they align with L2 SOPs.
  • Ensure team competency and readiness to execute their processes.
  • Escalate risks, abnormalities, and process gaps to QA and BRM.
• AUTHORITY:
  • Define execution HOW in L3 WINs.
  • Request SOP updates through Change Control.
• MAY NOT:
  • Approve SOPs or override QA decision authority.
• ACCOUNTABLE FOR:
  • Ensuring consistent execution, training, and adherence to QMS rules.

SOM — Sales Operations Manager (Customer Requirements Owner)

• WHAT:
  • Own the customer requirement lifecycle (specs, formulas, label requirements, claims, regulatory expectations).
  • Translate customer requirements into controlled QMS inputs (PMA, SOW, product requirements).
  • Define feasibility boundaries and acceptance criteria for new or modified customer requests.
  • Ensure customer expectations align with operational and compliance capabilities.
  • Ensure customer-driven changes correctly enter Change Control.
• AUTHORITY:
  • Approve customer requirement interpretations prior to QMS entry.
  • Reject customer inputs that violate regulatory or capability boundaries.
  • Approve or route customer-driven changes requiring technical or QA evaluation.
• ACCOUNTABLE FOR:
  • Ensuring customer requirements are complete, controlled, and accurately translated.
  • Preventing uncontrolled customer-driven changes.
  • Maintaining alignment between customer obligations and QMS capabilities.

SOL — Sales Operations Liaison (Change Control Facilitator)

• WHAT:
  • Act as the liaison between Sales, QA, Production, and Supply Chain.
  • Ensure customer-driven changes are captured and entered into Change Control.
  • Ensure documentation completeness for customer changes (specs, artwork, requirements).
  • Coordinate readiness verification for cross-functional change impacts.
  • Monitor and track Change Control execution for customer-driven actions.
• AUTHORITY:
  • Initiate Change Control and request impact assessments from stakeholders.
• MAY NOT:
  • Interpret regulatory or technical feasibility.
  • Approve requirement changes (belongs to SOM + QA).
• ACCOUNTABLE FOR:
  • Ensuring customer changes are not implemented outside Change Control.
  • Accurate and timely routing of required documentation.

4.2 System Stewardship Roles

System Owner (Digital Systems)

• WHAT:
  • Maintain system configuration, access control, and validated state.
  • Ensure audit trails, data integrity, and secure record retention.
  • Ensure system workflows support operational and QMS requirements.
• AUTHORITY:
  • Grant and revoke user access based on approved RBA matrices.
• MAY NOT:
  • Modify workflows without approved Change Control.
• ACCOUNTABLE FOR:
  • Data integrity, system performance, and secure access management.

Training Owner / LMS Administrator

• WHAT:
  • Maintain training curricula per role and Process Family.
  • Implement training assignments and track team readiness.
  • Ensure retraining occurs after controlled changes.
• AUTHORITY:
  • Publish training modules following QA approval.
• ACCOUNTABLE FOR:
  • Accurate training status records and competency tracking.

Supplier Quality Lead

• WHAT:
  • Maintain ASL and supplier qualification lifecycle records.
  • Evaluate supplier risks and verify compliance documentation.
  • Coordinate supplier corrective actions and improvements.
• AUTHORITY:
  • Approve supplier quality documentation and qualification packages.
• MAY NOT:
  • Override QA decisions on supplier approval or material disposition.
• ACCOUNTABLE FOR:
  • Supplier compliance and accuracy of supplier risk data.

Procurement Lead

• WHAT:
  • Execute controlled purchasing based on ASL and approved specifications.
  • Ensure purchased goods match QMS-defined requirements and supplier category controls.
  • Support supplier onboarding and material risk assessments.
• AUTHORITY:
  • Request new suppliers; propose procurement strategy changes.
• ACCOUNTABLE FOR:
  • Ensuring procurement aligns with QMS purchasing controls.

Continuous Improvement Lead

• WHAT:
  • Identify operational and workflow improvement opportunities.
  • Support BPOs and BRM in developing improved processes.
• AUTHORITY:
  • Recommend structural and efficiency improvements.
• ACCOUNTABLE FOR:
  • Driving improvements aligned with QMS rules and Process Family integrity.

4.3 Operational Execution Roles

Production Manager

• WHAT:
  • Oversee execution readiness for all Production Process Families.
  • Ensure personnel, equipment, and materials meet readiness criteria.
  • Coordinate production schedule alignment with capability and compliance.
• AUTHORITY:
  • Approve line start readiness.
  • Redirect or reassign operators as needed.
• MAY NOT:
  • Approve product release or deviation decisions.
• ACCOUNTABLE FOR:
  • Accurate execution across production teams.
  • Safe and compliant production flow.

Production Supervisor

• WHAT:
  • Provide daily oversight for execution and WIN adherence.
  • Conduct pre-op checks, line clearance, and issue escalation.
  • Ensure operators follow GDP and escalate abnormalities immediately.
• AUTHORITY:
  • Stop production for safety or quality concerns.
• ACCOUNTABLE FOR:
  • Accurate GDP documentation and safe operational execution.

Operator / Technician

• WHAT:
  • Execute tasks exactly per L3 WINs.
  • Document work in real time using GDP.
  • Escalate abnormalities, equipment issues, or deviations immediately.
• AUTHORITY:
  • Request QC checks or supervisor support.
• MAY NOT:
  • Modify documents, skip documentation, or deviate from WINs.
• ACCOUNTABLE FOR:
  • Complete and accurate execution and documentation.

Warehouse Manager

• WHAT:
  • Own all material movement, staging, receiving, labeling, and segregation.
  • Ensure inventory accuracy and traceability integrity.
  • Maintain storage conditions and zoning requirements.
• AUTHORITY:
  • Approve internal transfers except QA-held goods.
• MAY NOT:
  • Release quarantined material or override QA holds.
• ACCOUNTABLE FOR:
  • Full traceability accuracy and proper material control.

Warehouse Technician

• WHAT:
  • Execute receiving, labeling, staging, sampling support, and system transactions.
  • Maintain real-time updates in the system of record for all material movements.
• AUTHORITY:
  • Execute warehouse transactions within approved warehouse zones and workflows.
  • Perform material movements as assigned by Warehouse Manager or Supervisor.
• MAY NOT:
  • Move, relabel, or modify the status of QA-held or quarantined material.
  • Perform QC or QA approval functions, including verifications or dispositions.
  • Authorize or initiate changes to material records outside the system of record.
• ACCOUNTABLE FOR:
  • Accurate and timely execution of material movement tasks.
  • Data accuracy and traceability integrity for all warehouse transactions.

Sanitation & Facilities Lead

• WHAT:
  • Execute sanitation tasks according to the master schedule.
  • Document sanitation activity and escalate failed criteria.
  • Ensure facility hygiene meets QMS requirements.
• AUTHORITY:
  • Restrict access to sanitation-compromised areas.
• ACCOUNTABLE FOR:
  • Facility hygiene and sanitation record accuracy.

Maintenance & Calibration Technician

• WHAT:
  • Execute preventive maintenance and calibrations.
  • Document equipment condition and escalate failures.
• AUTHORITY:
  • Remove equipment from service when unsafe or out-of-spec.
• ACCOUNTABLE FOR:
  • Equipment readiness and accurate calibration records.

4.4 Quality Oversight Roles

Quality Control Analyst (QC)

• WHAT:
  • Perform sampling, testing, verifications, environmental checks.
  • Document all QC data in real time.
  • Escalate out-of-spec or abnormal conditions immediately.
• AUTHORITY:
  • Stop operations for quality risks.
  • Reject samples or results as necessary.
• MAY NOT:
  • Approve deviations or release product.
• ACCOUNTABLE FOR:
  • Accuracy and integrity of QC testing and records.

QC-SOD (Split Operational Duty)

• WHAT:
  • Perform limited QC verifications defined by SOP.
  • Support QC activities without compromising independence.
• MAY NOT:
  • Verify work they personally executed.
  • Perform release or deviation approval.
• ACCOUNTABLE FOR:
  • Accurate execution of permitted verification tasks.

Quality Assurance Specialist

• WHAT:
  • Review L4 records for GDP and completeness.
  • Support deviation triage, routing, and document control functions.
  • Support audit readiness and quality system checks.
• AUTHORITY:
  • Reject incomplete or noncompliant documentation.
• MAY NOT:
  • Make product disposition or deviation approval decisions.
• ACCOUNTABLE FOR:
  • Timely and accurate review of controlled documentation.

QA-SOD (Split Operational Duty)

• WHAT:
  • Perform routing, GDP checks, and pre-audit verifications.
  • Support quality workflows in low-risk areas.
• MAY NOT:
  • Sign any QA approvals or make release decisions.
  • Perform deviation or CAPA approval.
• ACCOUNTABLE FOR:
  • Accurate GDP verification and timely document routing.

MMR/BPR Author & Reviewer

• WHAT:
  • Develop, maintain, and update MMR and BPR templates.
  • Ensure templates reflect regulatory requirements and QMS rules.
  • Ensure BPR templates match approved MMR content.
• AUTHORITY:
  • Submit controlled changes via Change Control.
• MAY NOT:
  • Approve documents they personally authored.
• ACCOUNTABLE FOR:
  • Accuracy, clarity, and compliance of manufacturing documentation.

Product Release Authority (QU)

• WHAT:
  • Perform final review of all batch documentation and testing results.
  • Ensure all release criteria and regulatory requirements are met.
• AUTHORITY:
  • Make independent release, reject, or rework decisions.
• MAY NOT:
  • Delegate release authority to operational roles.
• ACCOUNTABLE FOR:
  • Ensuring product meets all release criteria and quality expectations.

5. Role Architecture Summary Table

5. Career Progression & Competency Framework — Production Operators & Technicians

5.1 Operator vs. Technician — Role Seniority

Within the Sawgrass Nutra Labs Operating Model, the Technician role is more senior than the Operator role. Technicians hold greater technical responsibility, equipment ownership, and abnormality response capability.

• Operator: Executes tasks as written in L3 Work Instructions, documents work using GDP, and escalates abnormalities promptly.
• Technician: Performs equipment setup, adjustments, minor troubleshooting, advanced cleaning, and supports Operators through mentoring and technical oversight.

This hierarchy supports a structured competency pathway and aligns with the Talent Management Process Family (Training, Competency, Qualification).

5.2 Competency Tiers

Tier 1 — Operator I (Entry Level)

• Executes tasks strictly per L3 WINs.
• Demonstrates basic GDP accuracy and escalation discipline.
• Requires direct supervision for equipment setup and adjustments.

Tier 2 — Operator II (Independent Operator)

• Independently performs production operations (weighing, blending, encapsulation, packaging).
• Executes pre-op checks, line clearance, and in-process verifications with limited oversight.
• May assist with training Operator I personnel.

Tier 3 — Technician I (Equipment Specialist)

• Performs equipment setup, basic troubleshooting, and complex cleaning/teardown tasks.
• Supports supervisors in resolving operational interruptions and ensuring readiness criteria are met.
• Acts as a mentor to Operators I and II.

Tier 4 — Technician II (Advanced Technician)

• Executes advanced troubleshooting and works closely with Maintenance and QA when resolving abnormalities.
• Leads equipment changeovers and multi-step setup activities.
• Supports continuous improvement efforts and provides feedback to BPOs on WIN improvements.

Tier 5 — Line Lead (Optional Leadership Path)

• Coordinates daily workflow, verifies team readiness, and supports shift-level issue escalation.
• Trains team members and assists with qualification assessments.
• Ensures documentation completeness prior to QA review.

5.3 Progression Requirements

• Completion of training curricula and qualification sign-offs.
• Demonstrated competency and performance consistency.
• Supervisor and BPO endorsement.
• QA verification where required by the QMS.

5.4 Integration With the Operating Model

This competency framework aligns with L1 Process Families (Production, Packaging, Warehouse) and supports the structural roles defined in Section 4. It ensures readiness, controlled execution, and a clear technical development pathway within SNL's manufacturing scope.

5.5 Document Placement Clarification

To maintain the integrity of the QMS document hierarchy, detailed competency matrices, qualification checklists, and task-level training tools must not be included in this L1 Operating Model document. These detailed artefacts belong in:

• L2 SOPs – defining competency requirements and qualification rules.
• L3 Work Instructions (WINs) – detailing task-specific training steps and qualification pathways.

The content included in this section reflects only the structural, role-level, and competency-tier architecture appropriate for L1. All granular execution-level or evaluative materials must be maintained within the Talent Management Process Family (TAL) at L2 or L3.