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Enterprise Business Process Architecture

The Enterprise Business Process Architecture defines how Sawgrass Nutra Labs operates as a structured, governed, and scalable organization. It establishes clear boundaries between commercial activity, regulated execution, and enterprise enablement to ensure value delivery, risk control, and regulatory compliance.

This architecture functions as the enterprise operating system — aligning authority, governance, execution, and oversight across all Process Families.

1. Enterprise Value & Execution Structure

Enterprise activities are organized into structured layers that reflect how value flows from market demand through material control, regulated manufacturing, and supporting enterprise safeguards.

Commercial Value Capture

  • MARKET – Market positioning and demand development
  • SALES – Commercial execution and customer management

These Process Families generate demand and revenue. While not directly GMP-executing, they must not conflict with regulatory commitments or QMS governance.

Material Control & Readiness

  • PROC – Supplier qualification and procurement
  • WH – Receipt, storage, and inventory control
  • MR – Material readiness, sampling, and allocation

This layer governs inbound supply, material integrity, and readiness prior to exposure to manufacturing. These activities operate under defined Quality Control requirements and QMS governance.

GMP Execution Core

  • BENCH – Technical and experimental support
  • PROD – Manufacturing operations
  • PKG – Packaging and labeling execution
  • SAN – Sanitation and contamination control
  • MAINT – Facilities, utilities, and equipment reliability

This is the regulated execution core of the enterprise. Activities within this layer directly impact product quality, safety, labeling accuracy, and regulatory compliance. These Process Families operate under enhanced Quality Management System (QMS) governance and final Quality Unit (QU) authority.

Enterprise Enablement & Safeguards

  • TAL – Training, qualification, and competency governance
  • IT – Information systems and data integrity controls
  • EHS – Environmental, health, and safety risk management

Enablement functions provide structural safeguards that support and constrain regulated execution. These domains do not replace operational ownership but ensure capability, system integrity, and risk mitigation across the enterprise.

2. Quality Governance Within the Architecture

The Quality Management System (QMS) governs Process Families whose activities directly or indirectly impact product quality, consumer safety, data integrity, or regulatory compliance.

QMS governance establishes structured controls, documentation requirements, change evaluation mechanisms, and independent oversight processes to ensure execution remains compliant, traceable, and auditable.

Within this architecture:

  • QC defines technical acceptance criteria and disposition constructs
  • QMS governs system processes and documentation controls
  • QA provides independent system oversight
  • QU retains final, non-delegable authority for quality decisions

3. Governance & Authority Boundaries

Each Process Family operates within defined governance boundaries that determine documentation rigor, change control requirements, oversight expectations, and audit exposure appropriate to regulatory risk.

The Quality Unit (QU) retains non-delegable authority over all QMS-classified activities, including:

  • Approval of quality requirements and acceptance criteria
  • Oversight and approval of quality-impacting changes
  • Final disposition decisions for materials and finished product
  • Regulatory decision authority for GMP-related matters

Quality Assurance (QA) provides independent oversight to verify compliance, system effectiveness, and alignment with regulatory obligations.

Commercial and administrative processes operate outside direct regulatory scope but may not override, bypass, or dilute QMS controls or regulatory commitments.

4. Architectural Outcomes

This Business Process Architecture ensures that:

  • Regulatory scope is explicitly defined and defensible
  • Authority, governance, execution, and oversight are structurally separated
  • Quality-critical activities are visibly controlled and traceable
  • Process ownership and accountability are unambiguous
  • Growth and change occur without erosion of compliance

By structuring the enterprise around defined Process Families governed under the QMS and final Quality Unit authority, Sawgrass Nutra Labs operates a scalable, audit-ready, and risk-controlled business system.