The ISO/TS 22002-4 checklist is the essential roadmap for food packaging manufacturers looking to secure FSSC 22000 certification and ensure the highest standards of food safety. By focusing on Prerequisite Programs (PRPs), this technical specification helps you control biological, chemical, and physical hazards before they ever reach the consumer.
Below is an in-depth guide and checklist of the top requirements to help your facility stay compliant and audit-ready. 1. Facility Construction and Layout
Your physical site is the first line of defense against external contamination. An auditor will look for:
Clear Boundaries: Are the edges of your facility well-defined to prevent unauthorized access or environmental pollution?
Hygienic Design: Do internal structures (walls, floors, and ceilings) feature smooth, washable surfaces that don't trap dust or moisture?
Traffic Patterns: Is there a logical flow for people and materials that prevents the unintentional mixing of raw materials and finished goods? 2. Utilities and Environment
Utilities like air, water, and energy must be managed to ensure they don't introduce hazards.
Air Quality: Is ventilation sufficient to control dust and condensation, especially in areas where packaging is exposed?
Water Safety: Is water used for cleaning or direct contact monitored for potability? Non-potable systems must be separate and clearly labeled.
Lighting: Are light fixtures protected (shatterproof) to prevent physical contamination in the event of a bulb breaking? 3. Equipment Suitability and Maintenance Equipment used in production must be "food-safe" by design.
Cleanability: Are product-contact surfaces smooth, non-absorbent, and easily accessible for sanitation?
Preventative Maintenance: Is there a documented schedule for all equipment? Maintenance requests that impact food safety must be prioritized.
Food-Grade Lubricants: Are any lubricants that might contact the packaging certified for incidental food contact? 4. Contamination Prevention & Pest Control
The "top" priority in any ISO/TS 22002-4 audit is the active prevention of pollution.
Physical Hazards: Is there a strict policy for glass, brittle plastics, and sharp objects? Retractable "snap-off" knives are typically banned.
Chemical Migration: For printed packaging, are there controls to prevent ink from "offsetting" from the outer surface to the food-contact surface?
Pest Management: Do you have a comprehensive program including regular inspections, bait maps, and documented sighting logs? 5. Personnel Hygiene and Facilities Safety starts with the people on the floor.
Handwashing Stations: Are they located at the entrance to production areas and equipped with hands-free taps and single-use towels?
Protective Clothing: Do workers wear appropriate, clean uniforms without pockets above the waist to prevent items from falling into products?
Health Status: Is there a policy for reporting illnesses and covering open wounds before entering the production zone? 6. Supplier Management & Traceability You are only as safe as the materials you buy.
The ISO/TS 22002-4:2013 standard (recently updated to ISO 22002-4:2025) establishes the prerequisite programs (PRPs) for food safety specifically within food packaging manufacturing. While ISO 22000 provides the broad management framework, ISO 22002-4 offers the "operational foundations" required to control food safety hazards during the production of packaging materials. Core Checklist Components
An effective audit checklist for this standard typically breaks down into several critical operational areas:
Establishment Infrastructure: General requirements for building construction, layout, and workspace design to prevent cross-contamination.
Utilities & Environment: Management of air, water, and energy supplies, as well as waste disposal and drainage systems.
Equipment Maintenance: Standards for the hygienic design of machinery and the maintenance of product contact surfaces.
Contamination Control: Measures to prevent physical, chemical, and microbiological contamination, including rigorous cleaning and pest control programs.
Personnel Hygiene: Requirements for staff facilities, personal cleanliness, and health monitoring to ensure workers do not introduce hazards. Why It Matters
Using a dedicated checklist ensures that packaging manufacturers meet the high-level requirements for FSSC 22000 certification. It moves beyond general manufacturing to address specific packaging risks, such as migration of chemicals or physical defects that could compromise the food's integrity later in the supply chain.
If you are preparing for an audit, it is recommended to use digital tools like the ISO 22002-1/4 Checklists to track compliance and identify non-conformance. ISO-TS 22002-1 checklist - Qvalon
ISO/TS 22002-4 standard specifies the prerequisite programs (PRPs) for food safety in the manufacturing of food packaging . It is a critical component for organizations seeking FSSC 22000 certification ISO/TS 22002-4 Checklist: Key Focus Areas
A comprehensive internal audit checklist for ISO/TS 22002-4 typically covers the following technical requirements to ensure food safety hazards are controlled: Establishment Infrastructure Environment & Location : Is the site located away from potential contaminants? Layout & Workspace
: Are internal designs, traffic patterns, and equipment placement optimized to prevent cross-contamination?
: Are air quality, ventilation, and water supplies monitored and treated as necessary? Waste and Equipment Management Waste Handling
: Are there documented procedures for waste removal and drainage? Equipment Suitability iso ts 220024 checklist top
: Is equipment designed for easy cleaning and maintenance (hygienic design)? Maintenance
: Are preventive and corrective maintenance schedules established and recorded? Operational Controls Purchased Materials
: Is there a selection and management process for suppliers of raw materials? Contamination Prevention
: Are measures in place to prevent microbiological, physical, and chemical contamination? Cleaning & Sanitizing
: Are cleaning schedules and concentrations for sanitizing agents documented and verified? Personnel and Hygiene Personnel Hygiene
: Are facilities for handwashing and changing available and used correctly? Product Information : Is labeling accurate to prevent consumer misuse? How to Write Up Your Checklist Results
When performing a write-up after an audit or for a procedure, follow these steps to ensure clarity and compliance: ISO - International Organization for Standardization Define the Scope
: Clearly state which part of the packaging manufacturing process is covered (e.g., "Extrusion and Printing for Food-Grade Films"). Align with Clauses
: Structure your write-up using the clause numbers of the ISO/TS 22002-4 standard (e.g., Clause 4.7 for Contamination Prevention). Identify Conformance : For each item, indicate (Compliant), (Non-compliant), or Detail Evidence
: Do not just check a box. List specific evidence, such as "Reviewed cleaning records for Line 4 dated March 2026." Draft Corrective Actions
: If a requirement is not met, define a clear, time-bound corrective action to address the gap. Use Plain Language
: Keep sentences short and use active voice to avoid misinterpretation by auditors or staff. ISO - International Organization for Standardization Related Standard Components : Provides the overarching management system framework. HACCP Plan
: Required alongside PRPs to manage critical control points. DNV - Global for a specific section, such as Contamination Prevention Supplier Management how-to-write-standards.pdf - ISO
The ISO/TS 22002-4 standard specifies requirements for prerequisite programs (PRPs) to assist in controlling food safety hazards in the manufacture of food packaging. It is a critical component for organizations seeking FSSC 22000 certification in the packaging sector. Top Checklist Categories for ISO/TS 22002-4
A comprehensive checklist typically covers these primary areas to ensure hygiene and operational safety:
Establishment & Layout: Evaluation of the workspace, including internal structures, workspace flow, and the separation of raw materials from finished products to prevent cross-contamination.
Utilities & Waste: Monitoring air, water, and energy supplies, alongside strict protocols for waste management and disposal.
Equipment Suitability: Ensuring all machinery is designed for easy cleaning and maintenance, and that it is made from materials safe for food-contact packaging.
Management of Purchased Materials: Verification of incoming materials and a robust system for supplier approval and monitoring.
Measures for Prevention of Contamination: Includes physical, chemical, and biological hazard controls, as well as strict allergen management.
Cleaning and Sanitizing: Detailed schedules for cleaning facilities and equipment, including the validation of cleaning effectiveness.
Pest Control: Documented programs for inspection, monitoring, and the safe use of pesticides within the facility.
Personnel Hygiene: Requirements for staff facilities, protective clothing, and health monitoring to prevent human-borne contamination.
Rework & Product Withdrawal: Procedures for handling non-conforming products and effective recall mechanisms.
Storage and Transport: Maintaining appropriate conditions during storage and shipping to preserve the integrity of the packaging material. Key Documentation
For a successful audit, your checklist should verify the existence of: A formal Hazard Analysis for packaging.
Documented Standard Operating Procedures (SOPs) for each PRP. Training records for employees on food safety and hygiene.
The ISO/TS 22002-100 framework can also be used as a reference to consolidate shared PRPs across different sectors.
ISO/TS 22002-4 (now being updated to ISO 22002-4:2025 ) is a technical specification that defines requirements for Prerequisite Programmes (PRPs) specifically for the food packaging manufacturing
industry. It is not a standalone standard but is designed to be used in conjunction with to support a complete Food Safety Management System (FSMS). ISO - International Organization for Standardization Key Objectives of ISO/TS 22002-4 Hazard Control
: It provides detailed requirements for establishing, implementing, and maintaining PRPs to control food safety hazards during the manufacture of packaging. Life Cycle Management
: Focuses on the entire lifecycle of packaging, from initial design and material selection to manufacturing and final distribution. Contamination Prevention
: Sets rigorous standards for hygiene, cleaning, and facilities to prevent chemical, physical, or biological contamination of food via its packaging. ISO - International Organization for Standardization Core Checklist Categories The ISO/TS 22002-4 checklist is the essential roadmap
An effective compliance checklist for ISO/TS 22002-4 typically covers these primary technical areas: foodsmi.com FSSC 22000 Internal Audit Checklist - Safety Culture
Master the ISO/TS 22002-4 Checklist: Your Top Priorities for Food Packaging Safety
If you're in the food packaging industry, you know that safety isn't just about the food itself—it's about the materials that touch it. ISO/TS 22002-4 (often used alongside FSSC 22000
) provides the specific requirements for Prerequisite Programs (PRPs) to control food safety hazards during the manufacture of packaging.
Whether you are preparing for an audit or just tightening up your operations, here is a "top-tier" checklist of the essential areas you must master. 1. Facility Design & Environment
Your building must be more than just a shell; it must be a barrier against contamination.
Assess the surrounding area for potential contamination sources (e.g., nearby industrial pollution or stagnant water). Layout & Workspace:
Ensure the internal design follows a logical flow that prevents cross-contamination between raw materials, intermediate products, and finished packaging. Infrastructure:
Walls, floors, and fittings must be durable, easy to clean, and maintained to prevent the buildup of dust or moisture. 2. Utilities: Air, Water, and Energy What flows your facility is just as important as the facility itself. Air Quality:
Ventilation and dust extraction systems must be adequate to prevent airborne contamination. Compressed Air/Gases:
Any gases that come into direct contact with packaging must be monitored for quality and purity. Water Supply:
Water used in the manufacturing process (like cooling) must meet potable standards if it poses a risk to the final product. 3. Equipment Suitability & Maintenance Your machines should be assets, not hazards. Hygienic Design:
Equipment must be constructed from materials that don't leach chemicals into the packaging. Preventive Maintenance:
Keep a rigorous schedule for lubrication (using food-grade lubricants where necessary) and repairs to prevent physical contamination like metal shavings or oil leaks. 4. Raw Material Management Safety starts with your suppliers. Approved Suppliers:
Only purchase materials (resins, inks, adhesives) from suppliers that meet your specific food safety criteria. Incoming Inspection:
Verify that incoming materials are stored correctly—separate from chemicals and waste—to avoid absorbing odors or moisture. 5. Personnel Hygiene & Facilities The human element is often the hardest to control. Hygiene Standards:
Establish clear rules for handwashing, hairnets, and protective clothing. Facilities:
Staff areas like canteens and locker rooms must be physically separated from the production floor to prevent food or personal items from entering the manufacturing zone. 6. Contamination Prevention This is the "meat" of the ISO/TS 22002-4 requirements. Chemical/Physical Hazards:
Implement strict controls for glass, hard plastics, and chemicals used for cleaning or pest control. Pest Control:
Maintain a proactive system (traps, monitoring, and professional inspections) to ensure your facility remains pest-free. Cleaning & Sanitization:
Use a documented cleaning schedule for both the environment and the equipment. 7. Rework & Product Information Rework Control:
If you reuse scrap or trim, it must be handled, stored, and tracked to ensure it doesn't introduce hazards. Traceability:
Ensure you can track every batch of finished packaging back to the raw materials used.
As of late 2025, the technical specification has been updated to ISO 22002-4:2025
. While the core PRPs remain similar, the new version aligns more closely with modern Food Safety Management Systems (FSMS) like ISO 22000:2018. or a guide on how to transition to the 2025 version of the standard?
ISO/TS 22002-4:2013 (recently updated to ISO 22002-4:2025) establishes the prerequisite programs (PRPs) for food safety specifically for food packaging manufacturing . It is typically used in conjunction with ISO 22000 for organizations seeking FSSC 22000 certification . Top Requirements Checklist
A comprehensive audit checklist for ISO/TS 22002-4 typically includes the following critical areas :
Establishment & Layout: Evaluation of the environment, location, and internal design to ensure traffic patterns and equipment layout minimize contamination risks .
Utilities: Management of water supply, air quality (ventilation/compressed air), and lighting .
Waste Management: Procedures for waste handling and the adequacy of drains and drainage .
Equipment Suitability: Hygienic design of machinery, maintenance schedules, and the safety of food packaging contact surfaces .
Purchased Materials: Selection and management of suppliers and rigorous inspection of incoming raw materials .
Contamination Prevention: Specific measures to prevent microbiological, physical, chemical, and allergen contamination, as well as chemical migration . Clause 6: Management of Purchased Materials | Check
Cleaning & Sanitation: Verification of cleaning schedules and effective pest control programs .
Personnel Hygiene: Requirements for staff facilities, personal cleanliness, and health monitoring .
Rework & Storage: Proper handling of reworked materials, storage conditions, and transport security .
Food Defense: Implementation of biovigilance and bioterrorism prevention measures . Critical Implementation Steps
To successfully review and implement these standards, organizations often follow a structured workbook approach :
Familiarization: Understanding the relationship between ISO 22000 and the sector-specific ISO 22002-4 .
Gap Analysis: Using a checklist to identify current operational gaps compared to the standard .
HACCP Implementation: Integrating hazard analysis specifically for packaging materials .
Internal Audit Training: Ensuring the quality team can effectively use the ISO/TS 22002-4 checklist for ongoing compliance .
For organizations using professional toolsets, resources like the SafetyCulture FSSC 22000 Checklist or the IFSQN Implementation Package provide structured templates for these reviews .
Are you preparing for an internal audit or an official FSSC 22000 certification?
This essay focuses on ISO/TS 22002-4 , the technical specification that outlines prerequisite programs (PRPs) for food safety in the manufacture of food packaging
While ISO 22000 provides the broad framework for a Food Safety Management System (FSMS), it lacks the specific "how-to" for the shop floor. ISO/TS 22002-4 fills this gap, ensuring that packaging—which touches almost everything we eat—doesn't become a source of contamination. The Foundation of Packaging Safety
The core philosophy of ISO/TS 22002-4 is that food safety starts long before the food is processed. If a plastic film, glass jar, or paper carton is contaminated with chemicals or physical hazards, the food inside is compromised. This standard provides a rigorous checklist to prevent such occurrences by focusing on the manufacturing environment. Top Pillars of the ISO/TS 22002-4 Checklist 1. Establishment and Infrastructure
The checklist begins with the physical plant. It requires that the site is designed to prevent cross-contamination. This includes proper layout, internal structures that are easy to clean, and the management of "utilities" like air, water, and energy to ensure they don't introduce hazards into the packaging material. 2. Waste and Sewage Management
Proper disposal systems are critical. The standard mandates clear procedures for identifying, collecting, and removing waste. This prevents the accumulation of debris that could attract pests or lead to the accidental reuse of contaminated materials. 3. Equipment Suitability and Maintenance
Machines used to produce packaging must be designed for food-grade safety. The checklist focuses on "hygienic design"—ensuring equipment is easy to sanitize and maintain. It also covers the use of food-grade lubricants to prevent chemical migration into the packaging. 4. Management of Purchased Materials
Safety starts with the raw materials (resins, inks, adhesives). The standard requires a strict vetting process for suppliers. Manufacturers must ensure that every incoming material has a "Declaration of Compliance" stating it is safe for food contact. 5. Prevention of Contamination This is the "heart" of the checklist. It addresses: Microbiological contamination: Managing humidity and hygiene. Physical contamination: Controlling glass, hard plastics, and metal fragments. Chemical migration:
Ensuring inks and coatings don't "bleed" through the packaging into the food. 6. Cleaning and Pest Control
The standard requires documented cleaning schedules and a proactive pest management program. In a packaging plant, dust and insects are primary threats; the checklist ensures these are managed through regular monitoring rather than just reactive treatment. 7. Personnel Hygiene
Even though workers aren't touching the food directly, their hygiene affects the packaging. The checklist covers handwashing protocols, hairnets, and the prohibition of jewelry or personal items in production areas. Why It Matters
Implementing ISO/TS 22002-4 allows a packaging manufacturer to achieve FSSC 22000 certification
, a globally recognized mark of excellence. It moves a company from a "reactive" stance to a "preventative" one. By checking these boxes, manufacturers protect the end consumer, reduce the risk of costly recalls, and build trust with major food brands. Conclusion
ISO/TS 22002-4 is not just a list of rules; it is a blueprint for integrity in the food supply chain. By standardizing the environment in which packaging is made, it ensures that the "container" is just as safe as the "content." summarized bullet-point version of this checklist to use for an internal audit?
This guide is structured to help you audit, develop, or maintain your Prerequisite Programmes (PRPs) against the specific requirements of ISO/TS 22002-1:2009 (often used in conjunction with ISO 22000).
| Check Item | Requirement | Status | Evidence | | :--- | :--- | :--- | :--- | | 6.1 | Incoming materials are inspected/specified against requirements. | | | | 6.2 | Supplier approval and monitoring program exists. | | | | 6.3 | Bulk silos/tanks are labelled, locked, and cleaned. | | |
The checklist is organized logically, mirroring the clause structure of the standard itself. It moves from high-level organizational requirements to specific operational controls.
In the world of food safety, the focus is often on HACCP (Hazard Analysis and Critical Control Points). However, without a solid foundation, HACCP is like building a house on sand. That foundation is your Prerequisite Programmes (PRPs).
For food packaging manufacturers, the global benchmark for these PRPs is ISO/TS 22002-4. This technical specification works hand-in-hand with ISO 22000 (Food Safety Management Systems) to ensure that the environment where packaging is produced—from a plastic bottle to a cardboard box—does not become a source of contamination.
If you are looking for the top checklist to audit your facility against ISO/TS 22002-4, you have come to the right place. This checklist is structured across the 19 critical clauses of the standard.
| Check Item | Requirement | Status | Evidence | | :--- | :--- | :--- | :--- | | 15.1 | Vulnerability assessment for intentional contamination. | | | | 15.2 | Restricted access to sensitive areas (water, ingredients, control systems). | | | | 15.3 | Employee security screening and visitor control. | | |
Note: Clauses 16-18 are informational annexes (not auditable requirements).