Product Development Process

Aligned with SQF Code Edition 9 – System Element 2.3.3

Requirement Overview

SQF Code Edition 9, System Element 2.3.3, outlines the following:

“Where product development is conducted, documented procedures shall be established and maintained to ensure food safety and quality requirements are met.”

A structured approach to product development ensures safe, compliant, and market-ready products.

Disclaimer: Food Safety Systems is not affiliated with or endorsed by the Safe Quality Food Institute (SQFI). This article references SQF Code for educational purposes only. For official SQF documentation, visit www.sqfi.com.

Key Compliance Objectives

  • ✓ Create a formalized development procedure from concept to launch

    ✓ Include risk assessments and validations at all phases

    ✓ Integrate regulatory and food safety controls into workflows

    ✓ Maintain approval checkpoints and documented decisions

Step-by-Step Implementation Guide

1. Establish a Phase-Gate Development Process

  • Each stage of product development should follow a gated process, including:

    Phase Activities
    Concept Marketing brief, preliminary food safety evaluation
    Formulation/Design Ingredient sourcing review, allergen and label impact analysis
    Prototype Testing Shelf-life testing, process capability validation
    Commercialization Final specification sign-off, HACCP integration, production approval

    Evidence to Maintain:

    • • Documented product development procedure

      • Phase completion forms and approval checklists

2. Implement Food Safety Controls in Development

  • Risk Evaluation Areas:

    • • Ingredient risks (e.g., allergens, novel ingredients)

      • Changes to processing methods or equipment

      • Migration risks from new packaging materials

    Evidence to Maintain:

    • • Risk assessment documentation

      • Test data from validation activities (e.g., microbial, shelf life, thermal)

3. Create an Approval Workflow with Sign-Offs

  • Roles for Approval at Key Stages:

    Gate Required Approvers
    Concept R&D, QA, Marketing
    Formulation Regulatory, Food Safety Team
    Commercialization SQF Practitioner, Operations/Plant Manager

    Evidence to Maintain:

    • • Signed approval records (manual or electronic)

      • Change control logs and revision summaries

4. Train Team and Review Post-Launch Performance

  • Training Topics:

    • • SQF Code requirements for product development

      • Risk analysis and documentation practices

      • Regulatory awareness and compliance checkpoints

    Evidence to Maintain:

    • • Completed training logs and certifications

      • Post-launch review summaries and “lessons learned” reports

Common Audit Findings & Recommended Fixes

Audit Finding Suggested Solution
No documented development process Develop and approve a formal phase-gate procedure
Incomplete or missing risk reviews Include food safety risk analysis in each stage
Product changes without approval Require documentation and sign-off for all modifications
Missing validation evidence Implement a validation checklist for each development stage

Auditor’s Checklist for SQF 2.3.3 Compliance

Auditors will often review:

  • • The product development procedure and revision history

    • Project documentation and test results

    • Records of approvals and responsible personnel

    • Employee understanding of development responsibilities

Implementation Roadmap

Design the Process

  • ✓ Create a phase-gate workflow customized to your products

    ✓ Define roles, sign-off points, and validation stages

Train Key Teams

  • ✓ Conduct e-learning or live walkthroughs for R&D, QA, and Regulatory

    ✓ Review SQF compliance impacts on product design

Execute and Monitor

  • ✓ Pilot the process on a new product

    ✓ Record risk assessments, testing, and approvals

Improve Continuously

  • ✓ Hold quarterly reviews of the development system

    ✓ Update procedures based on post-launch insights

Why This Matters?

A structured product development process:

  • ✓ Ensures food safety and regulatory compliance at every stage

    ✓ Minimizes costly reformulations or recalls

    ✓ Accelerates time-to-market with built-in checks

    ✓ Satisfies certification body and retailer expectations

Need Help Formalizing or Auditing Your Product Development Workflow?

Food Safety Systems offers:

  • ✓ Customizable development procedure templates

    ✓ Risk assessment and validation tools

    ✓ Team training modules focused on SQF compliance

    ✓ Internal audit checklists for product innovation processes

GET STARTED NOW

This document is for internal training and compliance use only. It is not affiliated with or endorsed by the Safe Quality Food Institute (SQFI).

Please refer to www.sqfi.com for official certification requirements.