Sawgrass Nutra Labs (SNL) — Role Architecture
Purpose & Intent
This Role Architecture defines the enterprise role model used within the Sawgrass Nutra Labs Quality Management System (QMS). Roles are intentionally defined at a structural (L1) level to establish clear authority boundaries, decision rights, segregation of duties, and accountability — independent of job titles, reporting lines, or organizational charts.
The role model ensures that:
- Quality decisions remain independent, objective, and non-delegable
- Operational execution is clearly separated from quality oversight
- System ownership and stewardship responsibilities are explicit
- No role operates outside approved governance or Change Control
This page serves as the authoritative role reference for the SNL Operating Model. Task-level responsibilities, training requirements, and qualification criteria are defined in L2–L4 documents and must never conflict with the role boundaries defined here.
Role Architecture Overview
SNL roles are grouped into four structural categories, each with a distinct purpose within the QMS:
- Enterprise Governance — Sets direction, owns governance, and protects independence
- System Stewardship — Maintains enabling systems, data integrity, and infrastructure
- Operational Execution — Executes work strictly as defined and approved
- Quality Unit — Provides independent oversight and final quality authority
No role may assume responsibilities, authority, or decision rights outside its defined category. Where dual roles exist, Segregation of Duties (SoD) controls must be enforced.
Role Architecture Summary Table
| # | Role Category | Role | WHAT (Responsibilities) | AUTHORITY | MAY NOT (Boundaries) | ACCOUNTABLE FOR |
|---|---|---|---|---|---|---|
| 1 | Enterprise Governance | Chief Executive & Executive Leadership | Provide resources, reinforce quality culture, ensure alignment with QMS. | Approve Quality Policy and major structural changes. | Override QA release or compliance decisions. | Supporting QU independence and regulatory compliance. |
| 2 | Quality Unit Leader (QA) | Own the QMS and governance structure; ensure state of control. | Approve SOPs, deviations, CAPA, MMR/BPR, and product release. | Delegate release authority to non-QA personnel. | Maintaining QMS integrity and compliance. | |
| 3 | Business Relationship Manager (BRM) | Align workflows across Process Families; identify system risks and gaps. | Recommend workflow or structural model changes. | — | System-level alignment across operations and quality. | |
| 4 | Business Process Owner (BPO) | Own L3 WINs and execution readiness; ensure team competency. | Define HOW in WINs; request SOP updates. | Approve SOPs or override QA decisions. | Consistent execution and adherence to QMS rules. | |
| 5 | SOM — Sales Operations Manager | Own customer requirements; define feasibility and acceptance criteria. | Approve requirement interpretations; reject noncompliant inputs. | Bypass QA or technical constraints. | Controlled and accurate requirement translation. | |
| 6 | SOL — Sales Operations Liaison | Capture customer-driven changes and route via Change Control. | Initiate Change Control; request impact assessments. | Approve requirement changes; interpret regulatory feasibility. | Ensuring changes are not implemented outside Change Control. | |
| 7 | System Stewardship | System Owner (Digital Systems) | Maintain system configuration, access control, and validated state. | Grant and revoke user access. | Modify workflows without Change Control. | Data integrity and secure access management. |
| 8 | Training Owner / LMS Administrator | Maintain role-based curricula; implement training assignments. | Publish training modules (after QA approval). | — | Accurate training and competency tracking. | |
| 9 | Supplier Quality Lead | Maintain ASL; evaluate supplier risks; manage supplier documentation. | Approve supplier quality documentation. | Override QA supplier approval decisions. | Supplier compliance and qualification accuracy. | |
| 10 | Procurement Lead | Execute controlled purchasing; support supplier onboarding. | Request new suppliers; propose procurement strategy changes. | — | Purchasing aligned with QMS controls. | |
| 11 | Continuous Improvement Lead | Identify and support workflow and process improvements. | Recommend efficiency and structural improvements. | — | Driving improvements aligned with QMS rules. | |
| 12 | Operational Execution | Production Manager | Oversee readiness; ensure personnel, equipment, and materials meet criteria. | Approve line start readiness; reassign operators. | Approve release or deviation decisions. | Safe and compliant production flow. |
| 13 | Production Supervisor | Daily oversight; ensure WIN adherence; escalate abnormalities. | Stop production for safety or quality risks. | — | Accurate GDP and safe execution. | |
| 14 | Operator / Technician | Execute WINs; maintain GDP; escalate abnormalities. | Request QC checks or supervisor support. | Deviate from WINs; modify controlled documents. | Accurate execution and documentation. | |
| 15 | Warehouse Manager | Own material movement, zoning, storage conditions, and traceability. | Approve internal transfers except QA-held goods. | Release quarantined or QA-held material. | Full traceability and material control. | |
| 16 | Warehouse Technician | Execute receiving, labeling, staging, and transactions. | Move materials within approved zones. | Move QA-held or quarantined material. | Traceability accuracy and timely execution. | |
| 17 | Sanitation & Facilities Lead | Execute sanitation tasks; escalate failures; ensure hygiene. | Restrict access to compromised areas. | — | Facility cleanliness and sanitation documentation. | |
| 18 | Maintenance & Calibration Technician | Perform preventive maintenance and calibrations. | Remove unsafe or out-of-spec equipment from service. | — | Equipment readiness and calibration accuracy. | |
| 19 | Quality Unit | Quality Control Analyst (QC) | Perform sampling, testing, verifications; document data. | Stop operations for quality risks; reject samples. | Approve deviations or release product. | Accuracy and integrity of QC testing. |
| 20 | QC-SOD | Perform limited QC verifications per SOP. | — | Verify work they executed; approve releases. | Accurate execution of permitted QC tasks. | |
| 21 | Quality Assurance Specialist | Review records; support deviation triage and document control. | Reject incomplete or noncompliant documentation. | Make release or deviation approval decisions. | Timely and accurate documentation review. | |
| 22 | QA-SOD | Perform routing, GDP checks, and pre-audit verifications. | — | Sign QA approvals; make release decisions. | GDP verification and timely routing. | |
| 23 | MMR/BPR Author & Reviewer | Develop and maintain MMR/BPR templates. | Submit changes via Change Control. | Approve documents they authored. | Clarity, accuracy, and compliance of documentation. | |
| 24 | Product Release Authority (QU) | Final review of batch documentation and testing. | Make independent release/reject decisions. | Delegate release authority. | Ensuring all release criteria are met. |
How This Role Model Is Used
- L1 Operating Model — structural alignment and RACIs
- L2 SOPs — role-based responsibilities and approvals
- L3 Work Instructions — execution constraints
- L4 Records — signature and review expectations
Conflicts between speed, cost, or commercial pressure and defined role boundaries must always be resolved in favor of Quality Unit authority.
Audit & Governance Notes
- This document defines roles, not people
- Authority cannot be transferred without Change Control
- Release authority is exclusive to the Quality Unit
- Operational roles may stop work but may not approve deviations or releases
- System changes require stewardship ownership and QA approval
Failure to enforce role boundaries constitutes a system-level QMS failure.