Product Design Safety Evaluations

Aligned with FSSC 22000 – ISO-Based Food Safety Management System (FSMS)

(Supports ISO 22000:2018 Clause 8.5.1 – Control of Product and Process Design)

Requirement Overview

Under FSSC 22000, organizations are expected to control the design and development of products and processes to ensure they are safe, legal, and meet customer expectations. This aligns with ISO 22000:2018 Clause 8.5.1, which requires that changes in products or processes be planned, validated, and controlled to prevent adverse effects on food safety.

A product design safety evaluation is a proactive approach to identifying potential hazards or risks during the development of new or modified food products, ingredients, packaging, or production methods. It supports regulatory compliance, consumer protection, and continuous improvement.

Key Compliance Objectives

  • ✓ Evaluate food safety risks for new or modified products before market release

    ✓ Ensure products meet applicable legal, regulatory, and customer requirements

    ✓ Assess risks related to intended use, misuse, allergens, and consumer interaction

    ✓ Document and retain safety review and approval records

Step-by-Step Compliance Implementation

1. Establish a Product Safety Evaluation Process

  • Process Elements:

    • • Appoint qualified personnel from R&D, QA, and regulatory teams

      • Create a formal product safety evaluation procedure linked to FSMS

      • Integrate safety reviews into product development stage-gates

    Evidence to Maintain:

    • • Documented SOP for product design and safety review

      • Process maps outlining approval flow

      • Assigned roles and responsibilities for evaluation

2. Conduct Risk-Based Safety Assessments

  • Assessment Criteria Should Include:

    • • Intended use, preparation, and end-consumer groups

      • Ingredient safety (e.g., allergens, toxins, raw materials)

      • Process-related hazards (e.g., cross-contamination, CCPs)

      • Labelling accuracy, shelf-life validation, and packaging safety

      • Compliance with applicable legislation (e.g., FDA, EU, Codex, FSMA)

    Evidence to Maintain:

    • • Risk assessment checklists and reports

      • Material Safety Data Sheets (MSDS)

      • Allergen risk analysis and packaging compatibility assessments

3. Approve Product for Market Release

  • Approval Requirements:

    • • Sign-off by QA, food safety team, or authorized manager

      • Verification of hazard controls and process validation

      • Documentation confirming legal and regulatory compliance

    Evidence to Maintain:

    • • Signed design safety evaluation forms

      • Change control and validation logs

      • Certificates of compliance, product specifications, and testing reports

4. Reassess Upon Change or Trigger Events

  • Trigger Events:

    • • Product design changes or reformulation

      • New supplier, raw material, or process changes

      • Recalls, complaints, or regulatory findings

      • Updates in relevant food laws or standards

    Evidence to Maintain:

    • • Updated safety evaluations and risk assessments

      • Records of internal reviews tied to change control

      • Reports from investigations related to consumer safety

Common Audit Findings & Recommended Fixes

Audit Finding Recommended Action
No documented design safety evaluation Create a formal procedure and link it to FSMS clause 8.5.1
Generic or incomplete risk assessments Tailor evaluations to specific product risks and legal markets
Missing proof of compliance Retain up-to-date records of testing and legal certifications
No reassessment after significant change Use your change control process to trigger design reviews

Auditor Verification Checklist (FSSC Context)

During an FSSC 22000 audit, be prepared to present:

  • • A documented product and process design control procedure

    • Risk-based product safety evaluations for new or changed products

    • Regulatory compliance records (FDA, EU, etc.)

    • Evidence of sign-off and validation by qualified personnel

    • Reassessment documentation tied to product or process changes

Implementation Roadmap

Build Your System

  • ✓ Develop SOP for product safety evaluations under FSMS

    ✓ Assign cross-functional review teams

Evaluate and Approve

  • ✓ Perform structured hazard analysis during development

    ✓ Obtain regulatory and internal approvals before launch

Monitor and Reassess

  • ✓ Link change control to product safety re-evaluations

    ✓ Track consumer complaints and incidents for redesign triggers

Document and Retain

  • ✓ Keep records for regulatory defense and audit readinesss

    ✓ Archive safety reports, risk assessments, and approval forms

Why This Matters?

  • ✓ Prevents unsafe or non-compliant products from reaching the market

    ✓ Aligns with ISO 22000 and regulatory expectations

    ✓ Supports proactive risk management and continual improvement

    ✓ Reduces liability, recall exposure, and reputational damage

Support Tools Available

Food Safety Systems provides:

  • ✓ Product safety evaluation templates and workflow guides

    ✓ Risk assessment tools customized for food products

    ✓ Compliance checklists for FDA, EU, Codex, and FSMA

    ✓ Training modules on product design safety and regulatory integration

GET STARTED NOW

Food Safety Systems is an independent consulting provider. We offer support services to help businesses prepare for FSSC 22000 certification but are not affiliated with, endorsed by, or certified by FSSC Foundation or any of its related entities. All trademarks, logos, and brand names are the property of their respective owners and are used for identification purposes only. Use of these names does not imply any official endorsement or partnership.

For official FSSC 22000 requirements and guidance, visit www.fssc.com.