L1 PRODUCT DEVELOPMENT AND INNOVATION

Definition: Researches, designs, and validates nutraceutical products that improve wellbeing while meeting quality, scientific, and sustainability standards.

• L2 Market and Consumer Insights
  • L3 Trend Scanning – identify emerging health, wellness, and nutraceutical trends through scientific and consumer data.
  • L3 Customer Segmentation – analyse practitioner, retail, and online markets.
  • L3 Voice of Customer – capture insights to shape R&D priorities.
• L2 Product Research and Formulation
  • L3 Ingredient Research – assess bioactives, probiotics, and excipients for efficacy and sustainability.
  • L3 Formulation Design – create safe, stable formulations to meet therapeutic goals.
  • L3 Clinical Validation – conduct trials and evaluate evidence for health claims.
• L2 Product Design and Specification
  • L3 Label & Regulatory Compliance – ensure accuracy and alignment with TGA and FSANZ.
  • L3 Packaging Design – select recyclable and functional packaging.
  • L3 Product Lifecycle Review – evaluate product performance for continuous improvement.

L1 SUPPLY CHAIN AND MANUFACTURING

Definition: Converts formulations into high-quality, traceable, and compliant finished goods through sustainable and efficient processes.

• L2 Supplier and Procurement Management
  • L3 Supplier Qualification – audit GMP and ethical sourcing standards.
  • L3 Contract Management – establish terms, SLAs, and sustainable procurement policies.
  • L3 Raw Material Traceability – manage origins and batch-level tracking.
• L2 Production Planning and Control
  • L3 Master Scheduling – align capacity, demand, and inventory.
  • L3 Work Order Management – define and control production orders.
  • L3 Batch Recording – ensure detailed traceability through electronic batch records.
• L2 Manufacturing Execution
  • L3 Mixing and Blending – manage controlled processes and operator accountability.
  • L3 Quality-in-Process – inspect and sample during manufacture.
  • L3 Equipment Cleaning and Validation – uphold cross-contamination controls.
• L2 Maintenance and Engineering
  • L3 Preventive Maintenance – plan work orders for machines and utilities.
  • L3 Calibration Control – ensure instrument reliability and GMP compliance.
  • L3 Asset Performance Monitoring – track downtime and OEE metrics.

L1 QUALITY AND REGULATORY AFFAIRS

Definition: Ensures compliance with national and international regulations, maintaining brand trust and consumer safety.

• L2 Quality Management System (QMS)
  • L3 Document Control – manage SOPs, templates, and controlled records.
  • L3 Deviation and CAPA Management – track corrective and preventive actions.
  • L3 Internal Auditing – schedule and perform quality audits.
• L2 Regulatory Compliance
  • L3 Product Listing and Registration – manage TGA submissions and listings.
  • L3 Adverse Event Monitoring – capture, investigate, and report incidents.
  • L3 Label Claims Validation – ensure advertising aligns with evidence.

L1 DISTRIBUTION AND LOGISTICS

Definition: Manages product movement, storage, and delivery across all distribution channels efficiently and responsibly.

• L2 Inventory and Warehouse Management
  • L3 Batch and Expiry Control – enforce FEFO rotation and recall readiness.
  • L3 Temperature and Condition Monitoring – maintain storage integrity.
  • L3 Stock Reconciliation – ensure physical and system alignment.
  • L3 Product Movement management
    • L4 Storage Location Optimisation
    • L4 Inwards goods management
    • L4  Outwards goods management

 

• L2 Transportation and Fulfilment
  • L3 Route Optimisation – improve transport efficiency and reduce emissions.
  • L3 Export and Import Compliance – handle customs and documentation.
  • L3 Returns and Waste Management – coordinate reverse logistics.

L1 SALES AND CUSTOMER ENGAGEMENT

Definition: Builds relationships with practitioners, retailers, and consumers through value-based selling and service.

• L2 Sales Operations
  • L3 Channel Strategy – design wholesale, practitioner, and D2C models.
  • L3 Order Management – process and track sales orders.
  • L3 Pricing and Discounts – manage tiered pricing structures.
• L2 Customer Relationship Management
  • L3 Customer Support – manage inquiries, returns, and satisfaction surveys.
  • L3 Loyalty Programs – develop retention and referral incentives.
  • L3 Account Performance Review – analyse customer profitability.

L1 SUSTAINABILITY AND ESG MANAGEMENT

Definition: Embeds environmental, social, and governance principles across operations and culture.

• L2 Environmental Stewardship
  • L3 Carbon Accounting – monitor and reduce organisational footprint.
  • L3 Waste Reduction Programs – support circular material flows.
  • L3 Sustainable Procurement – source renewable and recyclable inputs.
• L2 Social Responsibility
  • L3 Community Engagement – support local health and wellbeing initiatives.
  • L3 Workforce Diversity – promote equity and inclusion.
  • L3 Ethical Supply Audits – ensure fair labour practices.
• L2 Governance and Transparency
  • L3 ESG Reporting – publish verified impact metrics.
  • L3 Sustainability Certification – achieve third-party accreditation.

L1 PROGRAM AND PROJECT MANAGEMENT

Definition: Delivers initiatives that align strategy, resources, and outcomes for business improvement.

• L2 Program Governance
  • L3 Portfolio Prioritisation – align programs to strategic objectives.
  • L3 Benefit Realisation – ensure programs deliver expected outcomes.
• L2 Project Delivery
  • L3 Scope and Planning – define goals, milestones, and deliverables.
  • L3 Risk and Issue Management – assess and control uncertainties.
  • L3 Cost and Resource Management – track budgets and utilisation.
• L2 Project Closure and Learning
  • L3 Lessons Learned – capture insights for process improvement.
  • L3 Project Archiving – retain documentation for compliance.

L1 CONTINUOUS IMPROVEMENT (KAIZEN)

Definition: Cultivates a culture of learning and refinement through small, incremental enhancements.

• L2 Process Optimisation
  • L3 Value Stream Mapping – visualise and eliminate waste.
  • L3 Root Cause Analysis – use structured problem-solving methods.
• L2 Employee Engagement
  • L3 Suggestion Schemes – empower staff-led innovation.
  • L3 Kaizen Events – cross-functional rapid improvement workshops.
• L2 Performance Measurement
  • L3 KPI Tracking – measure process efficiency and effectiveness.
  • L3 Benchmarking – compare practices to industry standards.

L1 HUMAN RESOURCES AND TALENT

Definition: Builds an adaptive, capable, and engaged workforce aligned with purpose.

• L2 Workforce Planning
  • L3 Role Profiling – define responsibilities and competencies.
  • L3 Succession Planning – identify future leaders.
• L2 Capability Development
  • L3 Learning Management – deliver technical and leadership programs.
  • L3 Certification Tracking – ensure GMP and safety qualifications.
• L2 Employee Experience
  • L3 Engagement Surveys – assess culture and morale.
  • L3 Recognition and Rewards – align incentives with values.

L1 FINANCE AND ACCOUNTING

Definition: Ensures financial sustainability, accountability, and compliance.

• L2 Financial Management
  • L3 General Ledger – maintain accurate accounting records.
  • L3 Budgeting and Forecasting – plan and monitor fiscal performance.
• L2 Accounts Payable
  • L3 Invoice Verification – match POs to goods receipts.
  • L3 Payment Scheduling – optimise cash flow.
• L2 Accounts Receivable
  • L3 Invoicing – bill customers and track payments.
  • L3 Collections – manage overdue accounts.
• L2 Risk and Compliance
  • L3 Internal Controls – enforce segregation of duties.
  • L3 Audit Coordination – support external and internal audits.

L1 INFORMATION TECHNOLOGY AND DATA MANAGEMENT

Definition: Provides digital capability, security, and information integrity.

• L2 Infrastructure Management
  • L3 Cloud and Network Operations – ensure uptime and scalability.
  • L3 Cybersecurity – protect information assets.
• L2 Enterprise Data
  • L3 Master Data Management – govern core business data.
  • L3 Integration and APIs – connect enterprise systems.
  • L3 Data Quality – monitor consistency and completeness.
• L2 Application Management
  • L3 ERP and CRM Administration – support key business systems.
  • L3 Application Lifecycle – manage deployment and decommissioning.

L1 ASSET AND LOCATION MANAGEMENT

Definition: Oversees physical assets and facilities to optimise cost, safety, and sustainability.

• L2 Asset Lifecycle Management
  • L3 Maintenance Planning – schedule preventive maintenance.
  • L3 Decommissioning and Disposal – retire assets responsibly.
  • L3 Acquisition and Commissioning – plan and procure assets.
• L2 Facilities and Location Planning
  • L3 Site Selection – evaluate logistics, workforce, and cost factors.
  • L3 Environmental Compliance – ensure ISO 14001 adherence.
• L2Facilties Management
  • L3 Work Order Management
  • L3 Asset Testing
  • L3 Asset Risk Management

L1 STAKEHOLDER MANAGEMENT

Definition: Builds and sustains relationships with key external and internal stakeholders.

L2 Stakeholder Identification & Analysis

Definition: Identifies stakeholders and develops an understanding of their roles, influence, expectations, and impact on the organisation.

• L3 Stakeholder Mapping – identifies stakeholders and maps their relationships, influence, and relevance to organisational objectives.
• L3 Stakeholder Classification – categorises stakeholders based on characteristics such as influence, interest, role, and risk to guide engagement strategies.

L2 Relationship & Engagement Management

Definition: Establishes and maintains structured engagement with stakeholders to support collaboration, alignment, and value creation.

• L3 Communication Planning – defines the approach, frequency, and channels for engaging stakeholders in line with organisational priorities.
• L3 Stakeholder Interaction Management – manages ongoing interactions with stakeholders to maintain relationships, alignment, and shared understanding.

L2 Issue & Resolution Management

Definition: Manages stakeholder queries, concerns, and conflicts to maintain trust and ensure timely and effective resolution.

• L3 Query Management – receives, tracks, and resolves stakeholder enquiries and requests.
• L3 Conflict Resolution – identifies, manages, and resolves disputes or misalignments between stakeholders.

L1 GOVERNANCE, RISK, AND COMPLIANCE (GRC)

Definition: Establishes accountability, ethics, and transparency across the enterprise.

• L2 Governance Frameworks
  • L3 Policy Management – create and maintain internal policies.
  • L3 Delegations and Authority – define decision-making boundaries.
• L2 Risk Management
  • L3 Risk Identification – capture and evaluate enterprise risks.
  • L3 Mitigation Planning – implement controls and monitoring.
• L2 Compliance
  • L3 Regulatory Reporting – meet statutory obligations.
  • L3 Ethics and Conduct Management – enforce standards of behaviour.

L1: INNOVATION MANAGEMENT

Definition: Establishes and maintains a systematic framework for identifying opportunities, creating value, and managing uncertainty through innovation.

L2: Strategic Innovation Governance

• L3: Innovation Policy and Principles – Define innovation intent, principles, and alignment to organisational mission and vision.
• L3: Leadership and Culture for Innovation – Build an environment that encourages experimentation, collaboration, and learning.
• L3: Innovation Ethics and Risk Oversight – Balance opportunity with responsible innovation and societal impact.

L2: Opportunity and Idea Management

• L3: Environmental Scanning and Opportunity Identification – Detect emerging trends, technologies, and unmet needs.
• L3: Idea Generation and Capture – Encourage staff and partners to contribute ideas through structured channels.
• L3: Idea Evaluation and Selection – Assess feasibility, value potential, and alignment to strategic priorities.

L2: Innovation Portfolio and Project Management

• L3: Portfolio Prioritisation and Investment Planning – Select and fund innovation projects based on value and risk.
• L3: Experimentation and Prototyping – Conduct controlled trials and pilot studies to test assumptions.
• L3: Scaling and Implementation – Transition validated innovations into operational capabilities.

L2: Knowledge and Learning Integration

• L3: Lessons Learned and Knowledge Capture – Embed SECI cycles to transform tacit learning into explicit knowledge.
• L3: Learning Repository and Knowledge Flow – Maintain an accessible system for innovation insights.
• L3: Collaboration and Partnership Ba – Create spaces (physical and virtual) for co-creation and shared innovation.

L2: Value Realisation and Performance Assessment

• L3: Innovation Metrics and KPIs – Measure outcomes such as adoption rate, impact, and learning value.
• L3: Benefits Realisation and Continuous Feedback – Track realised vs expected benefits to refine future innovation.
• L3: External Benchmarking and Certification – Align with ISO 56002/56004 standards and assess maturity level.

 

 

The following was produced by AI using the AI/Human Business Modelling Guideline:

L3 Capability Example — Product Development & Innovation

L3 Formulation Design

Capability Definition:
Creates and refines product formulations that achieve defined therapeutic outcomes while ensuring safety, stability, manufacturability, and regulatory compliance.

Principal Entity

Product Formulation

Entity Description

Represents the defined composition of a product, including active and inactive ingredients, concentrations, and formulation characteristics required to achieve intended health outcomes.

Core Data Attributes

• Formulation ID
• Product ID
• Ingredient List (active and excipient)
• Ingredient Concentrations
• Dosage Form (capsule, powder, liquid, etc.)
• Stability Profile
• Manufacturing Constraints
• Regulatory Classification
• Version / Revision Number
• Effective Date

KPI

Formulation First-Time-Right Rate

Definition:
Percentage of formulations that proceed from design to production without requiring rework due to stability, manufacturability, or compliance issues.

Data Steward

Head of Product Development / Formulation Lead

Risk if Poor

• Product instability or failure in shelf-life testing
• Manufacturing inefficiencies or batch failures
• Regulatory rejection or reformulation delays
• Increased cost of rework and delayed time-to-market