RBAC Model: Work Order QMS

Document Type: Security & Access Control Specification
Version: 1.0 | Date: 2026-02-13
Compliance: FDA 21 CFR Part 11 §11.10(d), HIPAA, SOC 2 CC6.1

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1. Role Definitions

1.1 Human Roles

Role	Scope	Assignment	Typical Persona
ORIGINATOR	Per-WO	Automatic (creator)	Lab tech, program, vendor system
ASSIGNER	Per-WO	Designated planner or System Owner	Department lead, project manager
ASSIGNEE	Per-WO	Person or team executing	IT technician, lab engineer, vendor
SYSTEM_OWNER	Per-system/asset	Tenant configuration	Quality manager, department head
QA	Per-tenant	Tenant configuration	QA specialist, compliance officer
VENDOR	Per-WO + per-vendor	Contract-based	External vendor representative
ADMIN	Per-tenant	Superuser designation	IT administrator, platform admin
AUDITOR	Per-tenant	Read-only compliance	External auditor, FDA inspector

1.2 Agent Roles (CODITECT-Specific)

Agent Role	Maps to Human Role(s)	Autonomy Level	Human Checkpoint Required
AGENT_ORCHESTRATOR	ASSIGNER (delegated)	High	Architecture decisions only
AGENT_ASSET_MGMT	ASSIGNEE (delegated)	Medium	Status changes to production systems
AGENT_SCHEDULER	ASSIGNER (delegated)	Medium	Resource conflicts
AGENT_VENDOR_COORD	ASSIGNER (delegated)	Low	All vendor interactions
AGENT_DOCUMENTATION	ASSIGNEE (delegated)	Medium	Controlled document updates
AGENT_QA_ASSIST	None (advisory only)	Low	All QA decisions require human

Critical rule: Agents NEVER hold SYSTEM_OWNER, QA, or ADMIN roles. These require human identity and e-signature.

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2. Permission Matrix

2.1 Work Order Operations

Operation	ORIGINATOR	ASSIGNER	ASSIGNEE	SYSTEM_OWNER	QA	VENDOR	ADMIN	AUDITOR
Create WO (DRAFT)	✅	✅	❌	✅	❌	❌	✅	❌
Edit DRAFT fields	✅	✅	❌	✅	❌	❌	❌	❌
Transition DRAFT→PLANNED	✅	✅	❌	✅	❌	❌	❌	❌
Set assignee	❌	✅	❌	✅	❌	❌	❌	❌
Set job plan	❌	✅	❌	✅	❌	❌	❌	❌
Set schedule	❌	✅	❌	✅	❌	❌	❌	❌
Transition PLANNED→SCHEDULED	❌	✅	❌	✅	❌	❌	❌	❌
Acknowledge start (→IN_PROGRESS)	❌	❌	✅	❌	❌	✅*	❌	❌
Update execution details	❌	❌	✅	❌	❌	✅*	❌	❌
Log time entries	❌	❌	✅	❌	❌	✅*	❌	❌
Request review (→PENDING_REVIEW)	❌	✅	✅	✅	❌	❌	❌	❌
Approve (→APPROVED)	❌	❌	❌	✅	✅**	❌	❌	❌
Reject (→REJECTED)	❌	❌	❌	✅	✅	❌	❌	❌
Complete (→COMPLETED)	❌	❌	❌	✅	❌	❌	❌	❌
Cancel (→CANCELLED)	❌	❌	❌	✅	✅	❌	✅	❌
View own WOs	✅	✅	✅	✅	✅	✅	✅	✅
View all WOs (tenant)	❌	❌	❌	✅	✅	❌	✅	✅
View audit trail	❌	❌	❌	✅	✅	❌	✅	✅
Export audit data	❌	❌	❌	❌	✅	❌	✅	✅

* VENDOR: Only on WOs where they are the assigned vendor
** QA: Required for regulatory-flagged WOs; optional for non-regulatory

2.2 Separation of Duties

Constraint	Rule	Part 11 Reference
Self-approval prohibition	ASSIGNEE cannot be APPROVER on same WO	§11.10(g)
Dual approval for regulatory	Both SYSTEM_OWNER and QA must approve	§11.10(c)
Admin cannot override approvals	ADMIN can cancel but not approve/reject	§11.10(d)
Vendor boundary	VENDOR sees only their assigned WOs	Least privilege
Auditor read-only	AUDITOR cannot modify any records	§11.10(e)

2.3 Agent Permission Constraints

Constraint	Enforcement
Agents operate under delegated human authority	Every agent action logged with both agent_id AND delegating_human_id
Agents cannot approve or reject	Hard-coded exclusion from APPROVED/REJECTED transitions
Agents cannot cancel WOs	Requires human e-signature
Agent actions are attributable	Audit trail includes agent identity + human delegation chain
Agent budget limits	Token budget controller prevents runaway agent actions

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3. Multi-Tenancy Isolation

3.1 Row-Level Security

-- Every table includes tenant_id
-- RLS policy ensures complete tenant isolation
CREATE POLICY tenant_isolation ON work_orders
  USING (tenant_id = current_setting('app.current_tenant')::uuid);

-- Applied to ALL tables: work_orders, approvals, audit_trail, 
-- job_plans, schedules, assets, persons, etc.

3.2 Cross-Tenant Rules

Rule	Enforcement
No cross-tenant data access	RLS at database level
No cross-tenant role assignment	tenant_id on role_assignments table
Audit trails are tenant-scoped	RLS + separate partition per tenant
ADMIN role is tenant-scoped	Cannot affect other tenants

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4. Implementation: Permission Check Function

type Permission = 
  | 'wo:create' | 'wo:edit_draft' | 'wo:assign' | 'wo:set_job_plan'
  | 'wo:set_schedule' | 'wo:acknowledge_start' | 'wo:update_execution'
  | 'wo:log_time' | 'wo:request_review' | 'wo:approve' | 'wo:reject'
  | 'wo:complete' | 'wo:cancel' | 'wo:view_own' | 'wo:view_all'
  | 'audit:view' | 'audit:export';

type Role = 
  | 'ORIGINATOR' | 'ASSIGNER' | 'ASSIGNEE' | 'SYSTEM_OWNER'
  | 'QA' | 'VENDOR' | 'ADMIN' | 'AUDITOR'
  | 'AGENT_ORCHESTRATOR' | 'AGENT_ASSET_MGMT' | 'AGENT_SCHEDULER'
  | 'AGENT_VENDOR_COORD' | 'AGENT_DOCUMENTATION' | 'AGENT_QA_ASSIST';

const ROLE_PERMISSIONS: Record<Role, Permission[]> = {
  ORIGINATOR: ['wo:create', 'wo:edit_draft', 'wo:view_own'],
  ASSIGNER: ['wo:create', 'wo:edit_draft', 'wo:assign', 'wo:set_job_plan',
             'wo:set_schedule', 'wo:request_review', 'wo:view_own'],
  ASSIGNEE: ['wo:acknowledge_start', 'wo:update_execution', 'wo:log_time',
             'wo:request_review', 'wo:view_own'],
  SYSTEM_OWNER: ['wo:create', 'wo:edit_draft', 'wo:assign', 'wo:set_job_plan',
                 'wo:set_schedule', 'wo:request_review', 'wo:approve', 'wo:reject',
                 'wo:complete', 'wo:cancel', 'wo:view_all', 'audit:view'],
  QA: ['wo:approve', 'wo:reject', 'wo:cancel', 'wo:view_all',
       'audit:view', 'audit:export'],
  VENDOR: ['wo:acknowledge_start', 'wo:update_execution', 'wo:log_time', 'wo:view_own'],
  ADMIN: ['wo:create', 'wo:cancel', 'wo:view_all', 'audit:view', 'audit:export'],
  AUDITOR: ['wo:view_all', 'audit:view', 'audit:export'],
  // Agents: subset of their mapped human role
  AGENT_ORCHESTRATOR: ['wo:create', 'wo:edit_draft', 'wo:assign', 'wo:set_job_plan',
                       'wo:set_schedule', 'wo:view_own'],
  AGENT_ASSET_MGMT: ['wo:update_execution', 'wo:view_own'],
  AGENT_SCHEDULER: ['wo:set_schedule', 'wo:view_own'],
  AGENT_VENDOR_COORD: ['wo:view_own'],
  AGENT_DOCUMENTATION: ['wo:update_execution', 'wo:view_own'],
  AGENT_QA_ASSIST: ['wo:view_own'],  // Advisory only, no write
};

function checkPermission(
  actor: { id: string; roles: Role[]; tenant_id: string },
  permission: Permission,
  workOrder?: { id: string; originator_id: string; assignee_id: string; vendor_id?: string }
): boolean {
  // 1. Check if any role grants the permission
  const hasPermission = actor.roles.some(role => 
    ROLE_PERMISSIONS[role]?.includes(permission)
  );
  if (!hasPermission) return false;
  
  // 2. Scope checks for VENDOR and ASSIGNEE
  if (actor.roles.includes('VENDOR') && workOrder) {
    if (workOrder.vendor_id !== actor.id) return false;
  }
  
  // 3. Separation of duties
  if (permission === 'wo:approve' && workOrder) {
    if (workOrder.assignee_id === actor.id) return false; // Cannot self-approve
  }
  
  return true;
}

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This RBAC model enforces least-privilege access aligned with FDA 21 CFR Part 11 §11.10(d) requirements for authority checks, and SOC 2 CC6.1 logical access security. Agent roles are explicitly constrained to prevent autonomous compliance decisions.

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Copyright 2026 AZ1.AI Inc. All rights reserved. Developer: Hal Casteel, CEO/CTO Product: CODITECT-BIO-QMS | Part of the CODITECT Product Suite Classification: Internal - Confidential