Product Design & Development

Aligned with BRCGS Food Safety Issue 9 – Clause 5.1

Requirement Overview

BRCGS Food Safety Issue 9 requires that all products introduced, reformulated, or changed must go through a formal product design and development process to ensure that food safety, legality, quality, and customer expectations are maintained.

Clause 5.1.1: “The company shall have a procedure for new product development, changes to product, or changes to manufacturing processes to ensure that safe and legal products are produced.”

A structured design and development process ensures that risks are assessed, controlled, and communicated before launch. This applies to new products, packaging, process changes, and ingredient substitutions.

Aligned with BRCGS for Storage & Distribution Issue 4 – Clause 4.3.1 & 4.3.3

Requirement Overview

BRCGS for Storage & Distribution requires that products moved via cross-docking are traceable and controlled at all times, even when they are not held in storage for extended periods.

Clause 4.3.1: “The company shall ensure that traceability is maintained at all stages, including during cross-docking operations.”
Clause 4.3.3: “Procedures shall be in place to ensure that all products handled, including those not stored on-site, remain under control and are not subject to contamination or substitution.”

Cross-docking operations must not compromise product traceability, safety, or integrity. Even with minimal handling and temporary presence, each product must be accurately identified, documented, and protected.

Key Compliance Objectives

  • Ensure all new or modified products are safe, legal, and meet customer requirements

    Assess food safety risks related to formulation, packaging, and shelf life

    Conduct trials and validations before commercial production

    Document each stage of development with traceable records

Step-by-Step Compliance Implementation

1. Establish a Product Development Procedure

  • Key Elements to Define:

    • Triggers for initiating product development (e.g., new recipe, reformulation, customer request)

      Roles and responsibilities of the development team

      Stage-gate process for development, testing, and approval

    Evidence to Maintain:

    • Product development SOP

      Cross-functional team assignments

      Documented product development workflow

2. Conduct Product Risk Assessment

  • Evaluation Criteria Include:

    • Ingredient hazards (e.g., allergens, chemical residues, microbiological risks)

      Process-related hazards (e.g., thermal processing, kill steps)

      Intended use and misuse by consumers

      Shelf life and labeling impact

    Evidence to Maintain:

    • HACCP review or new hazard analysis

      Allergen assessment forms

      Risk evaluation report

3. Validate Process and Packaging Suitability

  • Activities to Perform:

    • Trial runs at pilot or production scale

      Packaging material compatibility and integrity tests

      Label and artwork review against regulatory and customer requirements

    Evidence to Maintain:

    • Trial reports and production trial logs

      Packaging validation test results

      Approved label and artwork records

4. Review and Approve Before Launch

  • Actions Include:

    • Final review by QA, food safety, and senior management

      Documented sign-off before the first commercial run

      Internal training and updated SOPs to reflect new product

    Evidence to Maintain:

    • Signed approval documentation

      Updated product specification

      Training logs for affected staff

Common Audit Findings & Recommended Fixes

Audit Finding Recommended Action
No documented development procedure Create and implement a formal product development SOP
Incomplete risk assessments Include allergen, HACCP, and regulatory reviews for all new products
Launch without final approvals Require multi-department sign-off before commercial production
Unvalidated shelf life or packaging Conduct stability and compatibility testing prior to launch

Auditor Verification Checklist

During a BRCGS audit, expect to present:

  • A documented product design and development procedure

    Risk assessments for ingredients, process, and packaging

    Records of trials, validations, and label reviews

    Signed approvals before product release

Implementation Roadmap

Build Your Program

  • Define a cross-functional product development procedure

    Assign development responsibilities and approval authorities

Validate and Review

  • Conduct food safety risk assessments and trials

    Confirm packaging, labeling, and shelf life validation

Document and Launch

  • Obtain all required approvals

    Update FSQMS documents and train operational staff

Improve Continuously

  • Analyze launch performance and customer feedback

    Review procedures after each development cycle

Why This Matters?

  • Prevents launch of unsafe or non-compliant products

    Protects brand reputation and regulatory standing

    Reduces costly recalls due to mislabeling or formulation errors

    Demonstrates strong management commitment to product integrity

Support Tools Available

Food Safety Systems provides:

  • Product development SOP templates

    Allergen and risk assessment forms

    Label and packaging validation checklists

    Trial and sign-off documentation templates