ISO/TS 22002-4:2013 (and the updated ISO 22002-4:2025) specifies the Prerequisite Programs (PRPs) for food safety in the manufacture of food packaging. It serves as a foundational operational framework for organizations seeking FSSC 22000 certification, working in conjunction with ISO 22000 to control food safety hazards. Below is a detailed checklist based on the 15 generic PRP clauses outlined in the standard. Clause 4: Generic PRPs Checklist 4.1 Establishment Environment : Assess potential contamination from internal and external local sources. Location : Clearly identify and maintain establishment boundaries to prevent contamination. Construction : Ensure buildings are durable and protect against entry of auxiliary device hazards. 4.2 Layout and Workspace Traffic Patterns : Design internal layouts to protect against cross-contamination and unintended mixing of materials. Internal Structures : Verify that walls/floors are washable and ceilings minimize dirt build-up. Storage : Segregate food-contact from non-food-contact materials; maintain distance from walls for inspection. 4.3 Utilities Water Supply : Use water of adequate quality and sufficient quantity for operations. Air & Gases : Monitor air quality and ventilation; ensure compressed air and gases do not introduce hazards. Lighting : Provide sufficient lighting for safe operations and maintenance. 4.4 Waste Disposal Waste Handling : Implement procedures for the effective removal and storage of solid and liquid waste. Drainage : Ensure drains are trapped, covered, and flow away from production areas. 4.5 Equipment Suitability Hygienic Design : Equipment must be designed to facilitate cleaning and minimize contamination. Food Contact Surfaces : Verify surfaces are smooth, non-absorbent, and easily cleanable. Maintenance : Maintain a preventive maintenance program for all safety-critical equipment. 4.6 Management of Purchased Materials Supplier Selection : Evaluate and manage suppliers based on their ability to meet food safety requirements. Incoming Raw Materials : Inspect and verify incoming materials against agreed-upon specifications. TECHNICAL SPECIFICATION ISO/TS 22002-4 - iTeh Standards
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 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 Your Food Packaging Safety with the ISO/TS 22002-4 Checklist If you’re in the food packaging industry, you already know that "safe for food" starts long before the ingredients hit the container. ISO/TS 22002-4 is the industry-standard specification for prerequisite programs (PRPs) that ensure your packaging doesn't compromise food safety. Whether you’re gearing up for FSSC 22000 certification or just tightening your internal quality controls, having a clear checklist is non-negotiable. Here are the top categories your ISO/TS 22002-4 checklist must cover to stay compliant. 1. Construction and Layout of Buildings Your facility itself is the first line of defense. A standard checklist includes: Environment & Location: Ensuring the surrounding area doesn't pose a contamination risk (like pests or odors). Establishment Layout: Designing the flow of people and materials to prevent cross-contamination. Internal Structure: Using durable, easy-to-clean materials for walls, floors, and ceilings. 2. Utilities: Air, Water, and Energy Contamination can literally be in the air or water. Your audit should verify: Water Supply: Ensuring any water used in the process (or for cleaning) is of appropriate quality. Air Quality: Proper ventilation and filtration to prevent airborne particles from settling on packaging. Compressed Air & Gases: Ensuring gases used in production are food-grade and filtered. 3. Waste Management and Drainage The checklist must address how you handle what's leaving the facility: Waste Handling: Specific protocols for identifying, storing, and removing waste. Drains: Designing drainage systems that prevent backups or odors from entering production areas. 4. Equipment Suitability and Maintenance Your machines shouldn't be the source of the problem. Key checklist items include: Hygienic Design: Using equipment that is easy to clean and lacks "dead spots" where bacteria can grow. Preventive Maintenance: A strict schedule for repairs to prevent mechanical breakdowns or lubricant leaks. Packaging Contact Surfaces: Verifying that any part of the machine touching the packaging is made of approved, non-reactive materials. 5. Management of Purchased Materials You are only as safe as your suppliers. Checklist priorities here are: Supplier Selection: Assessing suppliers for their own safety standards. Incoming Materials: Inspecting raw materials (like resins or inks) before they enter production. 6. Measures for Prevention of Contamination This is the "catch-all" for active safety: Microbiological/Chemical/Physical Hazards: Identifying and mitigating risks for each. Allergen Management: Strict protocols if your facility handles materials that could trigger allergies. Chemical Migration: Testing to ensure chemicals from the packaging don't "migrate" into the food once it's filled. 7. Cleaning and Pest Control Finally, your day-to-day hygiene must be documented: Cleaning Schedules: Detailed "what, when, and how" for every part of the facility. Pest Control: Regular inspections and preventative measures to keep critters out. Need a ready-made template? Tools like Qvalon offer digital versions of these checklists to streamline your internal audits. New Checklist Available For TS ISO 22002 - Safefood 360
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 220024 checklist top
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).
Part 1: Understanding ISO/TS 22002-1 What is it? ISO/TS 22002-1 is a Technical Specification detailing the specific PRPs required for food manufacturing. It is not a standalone standard; it is designed to be used with ISO 22000 (Clause 7.2 – Prerequisite Programmes). Key Principle: If you comply with ISO/TS 22002-1, you automatically satisfy the PRP requirements of ISO 22000. Scope: All food manufacturing operations (excluding primary production, feed, and retail).
Part 2: The ISO/TS 22002-1 Checklist (18 Clauses) Use this checklist to assess your facility. Mark Compliant (C) , Partially Compliant (P) , or Non-Compliant (NC) . Clause 1: Construction and Layout of Buildings | Check Item | Requirement | Status | Evidence | | :--- | :--- | :--- | :--- | | 1.1 | Buildings are structurally sound and weatherproof. | | | | 1.2 | Interior surfaces (walls, floors, ceilings) are smooth, cleanable, and non-absorbent. | | | | 1.3 | Floors are sloped for drainage (no standing water). | | | | 1.4 | Adequate ventilation & dust control systems exist. | | | | 1.5 | Windows and openings are screened against pests. | | | Clause 2: Layout of Premises and Workspace | Check Item | Requirement | Status | Evidence | | :--- | :--- | :--- | :--- | | 2.1 | Internal layout prevents cross-contamination (raw vs. ready-to-eat). | | | | 2.2 | Adequate workspace for equipment and personnel movement. | | | | 2.3 | Physical separation (walls, airlocks) for high-risk areas. | | | Clause 3: Utilities – Air, Water, Energy | Check Item | Requirement | Status | Evidence | | :--- | :--- | :--- | :--- | | 3.1 | Water (potable) quality meets regulatory standards. | | | | 3.2 | Water distribution system prevents backflow (air gaps, check valves). | | | | 3.3 | Ice and steam are produced from potable water. | | | | 3.4 | Compressed air used with food is filtered (oil-free, dry). | | | | 3.5 | Air filtration (HEPA) in high-care areas is validated. | | | Clause 4: Waste Disposal | Check Item | Requirement | Status | Evidence | | :--- | :--- | :--- | :--- | | 4.1 | Waste containers are leak-proof, covered, and labelled. | | | | 4.2 | Waste is removed regularly to prevent pest attraction. | | | | 4.3 | Waste areas are separate from food handling areas. | | | | 4.4 | Drainage system prevents backflow and is cleanable. | | | Clause 5: Equipment Suitability, Cleaning, and Maintenance | Check Item | Requirement | Status | Evidence | | :--- | :--- | :--- | :--- | | 5.1 | Equipment surfaces (food contact) are stainless steel or non-toxic, smooth material. | | | | 5.2 | Equipment is accessible for cleaning (no dead legs, crevices). | | | | 5.3 | Maintenance is scheduled, using food-grade lubricants. | | | | 5.4 | Temporary repairs (tape, wire) are prohibited. | | | Clause 6: Management of Purchased Materials | 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. | | | Clause 7: Measures for Prevention of Cross-Contamination | Check Item | Requirement | Status | Evidence | | :--- | :--- | :--- | :--- | | 7.1 | Physical separation of allergens, raw, cooked, and RTE. | | | | 7.2 | Colour-coded tools and utensils for different zones. | | | | 7.3 | Personnel flow (dirty to clean) is controlled. | | | | 7.4 | Airflow direction (positive pressure in clean zones). | | | Clause 8: Cleaning and Sanitizing | Check Item | Requirement | Status | Evidence | | :--- | :--- | :--- | :--- | | 8.1 | Documented cleaning schedule (what, how, when, who). | | | | 8.2 | Cleaning chemicals are approved (NSF, food-safe) and stored separately. | | | | 8.3 | Verification of cleaning (visual, ATP, swabs). | | | | 8.4 | CIP (Clean-in-Place) systems are validated. | | | Clause 9: Pest Control | Check Item | Requirement | Status | Evidence | | :--- | :--- | :--- | :--- | | 9.1 | Integrated Pest Management (IPM) plan exists. | | | | 9.2 | Map of bait stations, traps, UV fly killers. | | | | 9.3 | Pest activity log and corrective actions. | | | | 9.4 | Exclusion proofing (gaps sealed, air curtains). | | | Clause 10: Personnel Hygiene and Facilities | Check Item | Requirement | Status | Evidence | | :--- | :--- | :--- | :--- | | 10.1 | Handwashing stations (soap, sanitizer, single-use towels) at entrances. | | | | 10.2 | Separate changing rooms and toilets (not opening directly to production). | | | | 10.3 | Personnel hygiene policy (no jewelry, nail polish, illness reporting). | | | | 10.4 | Appropriate protective clothing (hairnets, beard covers, gloves). | | | Clause 11: Rework | Check Item | Requirement | Status | Evidence | | :--- | :--- | :--- | :--- | | 11.1 | Rework is clearly identified and stored separately. | | | | 11.2 | Rework traceability (batch number, date, original product code). | | | | 11.3 | Rework usage is controlled (no allergen cross-contamination). | | | Clause 12: Product Recall Procedure | Check Item | Requirement | Status | Evidence | | :--- | :--- | :--- | :--- | | 12.1 | Documented recall plan with contact list. | | | | 12.2 | Mock recall performed annually (traceability within 4 hours). | | | | 12.3 | Procedure for quarantining and disposing recalled product. | | | Clause 13: Warehousing | Check Item | Requirement | Status | Evidence | | :--- | :--- | :--- | :--- | | 13.1 | Temperature-controlled storage (monitored and alarmed). | | | | 13.2 | FIFO (First-In-First-Out) inventory system. | | | | 13.3 | Separate storage for chemicals, allergens, and non-food items. | | | | 13.4 | Racking is clean, dry, and away from walls (pest inspection). | | | Clause 14: Product Information and Consumer Awareness | Check Item | Requirement | Status | Evidence | | :--- | :--- | :--- | :--- | | 14.1 | Labels meet legal allergen and ingredient declaration. | | | | 14.2 | Batch/lot coding for traceability. | | | Clause 15: Food Defense, Biovigilance, and Bioterrorism | 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. | | | Clause 4: Generic PRPs Checklist 4
Note: Clauses 16-18 are informational annexes (not auditable requirements).
Part 3: How to Use This Guide (Step-by-Step) Step 1: Gap Analysis
Walk through each clause of the checklist. For each NC or P, record evidence (photo, document reference, interview notes). Assign responsibility and deadline for each gap. Incoming Material Procedure . Recall &
Step 2: Documentation Required (Top 10 PRP Documents) You must have these written procedures:
PRP Manual (cross-referencing ISO/TS 22002-1). Cleaning & Sanitation Schedule (SSOPs). Pest Control Management Plan (with site map). Maintenance Program (preventive and corrective). Personnel Hygiene Policy (including illness reporting). Supplier Approval & Incoming Material Procedure . Recall & Traceability Procedure . Waste Management Procedure . Water Safety Plan (potability testing schedule). Food Defense Plan (vulnerability assessment).