In 2005, ISO introduced ISO 22000 – Food Safety
Management Systems (FSMS) to provide a structured global framework that
combined HACCP principles with ISO management system requirements.
However, ISO 22000 alone had key gaps:
- Limited
Prerequisite Programs (PRPs) for sector-specific hazards such as
allergens, microbial risks, and cleaning validation.
- No
standardized third-party benchmarking process, making global
recognition inconsistent.
- Lack
of detailed integration between operational control and management
system requirements.
To address these gaps, the Foundation for Food Safety
Certification (Netherlands) introduced FSSC 22000 in 2009, creating
a GFSI-recognized certification scheme by combining three key elements:
- ISO
22000 – the core FSMS framework for food safety management.
- ISO/TS
22002-x series – sector-specific PRPs to control operational hazards.
- Additional FSSC Requirements – covering management of services, labeling, food defense, food fraud prevention, and other operational safeguards.
FSSC 22000 harmonizes HACCP, FSMS, and PRPs into one
auditable, risk-based framework, helping organizations ensure consistent,
globally recognized food safety across all departments and supply chain
stages.
Table of Contents
- Introduction
to FSSC 22000
- Background
and Evolution
- Core
Concepts of FSSC 22000
- FSMS
Overview
- HACCP,
PRPs, OPRPs, and CCPs
- Risk-Based
Approach
- Roles
and Responsibilities
- Implementation
Structure (Phases 1–3)
- Key
Tools & Documentation
- Non-Conformities
(NC) & CAPA
- Food
Safety Culture
- Common
Challenges & Solutions
- v5.1
→ v6.0 Transition Highlights
- Summary
& Key Takeaways
- Next
Steps / Learning Continuity
1. Introduction to FSSC 22000
Food safety is a critical requirement in all food-related
industries worldwide. The FSSC 22000 (Food Safety System Certification)
framework is a globally recognized standard designed to ensure food
safety across the supply chain. It is aligned with ISO 22000, HACCP
principles, and recognized by GFSI (Global Food Safety Initiative).
- Purpose:
Provide a systematic approach to identify, evaluate, and control food
safety hazards.
- Scope:
Applicable to all organizations in the food supply chain, from primary
production to distribution.
- Audience:
QA/QC professionals, production staff, maintenance, utility teams,
laboratories, and store/warehouse personnel.
2. Background and Evolution
FSSC 22000 was developed to create a robust, auditable,
and globally recognized food safety system.
- ISO
22000 Foundation: Establishes the requirements for a Food Safety
Management System (FSMS).
- HACCP
Principles: Methodology to identify critical control points in
processes.
- GFSI
Recognition: Ensures certification meets global benchmarks.
Version Evolution:
- v1
→ v5.1 → v6.0: Each iteration addresses gaps, clarifies requirements,
and enhances practical usability.
Key Drivers of Change:
- Increased
regulatory requirements
- Industry-specific
risk assessments
- Enhanced
focus on preventive controls
- Integration
of food safety culture
3. Core Concepts of FSSC 22000
3.1 Food Safety Management System (FSMS)
FSMS provides the framework to manage food safety risks
effectively. Key elements include:
- Policy
& Objectives
- Risk
Assessment & HACCP Plan
- Prerequisite
Programs (PRPs)
- Operational
Prerequisite Programs (OPRPs)
- Verification
& Validation Activities
- Continuous
Improvement
3.2 HACCP, PRPs, OPRPs, and CCPs
- HACCP
(Hazard Analysis Critical Control Point): Preventive approach to
identify hazards and control points.
- PRPs
(Prerequisite Programs): General conditions required for safe food
(hygiene, cleaning, equipment maintenance).
- OPRPs
(Operational PRPs): Specific operational measures to reduce
significant hazards.
- CCPs
(Critical Control Points): Points where control is essential to
prevent, eliminate, or reduce a food safety hazard.
Example Table (Structure Only):
Step / Process |
Hazard Type |
PRP / OPRP / CCP |
Monitoring |
Records |
Step 1 |
Physical |
PRP |
Daily check |
Log sheet |
Step 2 |
Biological |
CCP |
Temp monitoring |
Verification record |
3.3 Risk-Based Approach
- Identify
hazards (biological, chemical, physical)
- Assess
severity and likelihood
- Implement
preventive measures
- Document
actions for accountability and traceability
4. Roles and Responsibilities
Function |
Responsibilities |
Management |
Policy, food safety culture, resource allocation |
QA / QC |
Verification, validation, CAPA, internal audits |
Production |
Implement SOPs, monitor CCPs, document compliance |
Maintenance |
Equipment reliability, preventive maintenance |
Utility |
Monitoring utilities affecting safety (steam, water, air) |
Laboratory |
Testing, analysis, support CAPA |
Store / Warehouse |
Traceability, storage, recall readiness |
Key Principle: Everyone contributes to food safety,
from frontline staff to management.
5. Implementation Structure
Three Phases of Operational Application:
Phase 1 – Preparation & Planning
- Management
commitment
- Staff
training in FSMS principles
- Defining
scope and boundaries
- Gap
analysis against FSSC 22000 requirements
Phase 2 – Operationalization & Verification
- Implement
PRPs, OPRPs, CCPs
- Monitoring
and documentation
- Verification
and validation activities
- Internal
audits
Phase 3 – Audit Readiness & Continuous Improvement
- Pre-assessment
audits
- Corrective
and preventive actions (CAPA)
- Root
cause analysis
- KPIs
and food safety culture tracking
- Management
review and continuous improvement
Flowchart Idea: Preparation → Operationalization →
Audit → Continuous Improvement
6. Key Tools & Documentation
- SOPs:
Standard Operating Procedures for critical processes
- Internal
Audit Checklist: Clause-based compliance verification
- CAPA
Templates: Document non-conformities and corrective actions
- IQ/OQ/PQ
Records: Equipment qualification for critical machinery
- KPI
Dashboards: Track performance and food safety culture metrics
7. Non-Conformities (NC) & CAPA
- Types:
Minor, Major, Critical
- Response
Timelines: Containment (24–48h), Root cause (7 days), Closure
verification
- Documentation:
CAPA records, verification, and validation
8. Food Safety Culture
- Leadership
briefings
- Cross-functional
team huddles
- Recognition
of compliance and best practices
- Embedding
food safety mindset into daily operations
9. Common Challenges & Solutions
- Staff awareness and training gaps
- Utilities affecting product safety
- Supplier management and traceability
- Record-keeping and documentation
10. v5.1 → v6.0 Transition Highlights
Area |
v5.1 |
v6.0 Enhancements |
Practical Impact |
PRPs |
General hygiene requirements |
Expanded sector-specific PRPs |
Better preventive control |
OPRPs |
Less specific |
Clear operational measures for hazards |
Easier monitoring & compliance |
CCPs |
Identified per HACCP |
Integrated with risk-based FSMS |
Stronger hazard control |
Food Safety Culture |
Minimal emphasis |
Formalized leadership & KPI tracking |
Drives proactive safety behavior |
Documentation & Audit |
Focused on record-keeping |
Risk-based verification & validation |
More effective audits |
Food Fraud / Defense |
Not emphasized |
Added preventive measures |
Reduced fraud risk |
11. Summary & Key Takeaways
- FSSC
22000 is a structured, auditable, globally recognized framework
- Cross-functional
collaboration is essential
- Phased
implementation ensures practical compliance and continuous improvement
- Understanding
core concepts (HACCP, PRPs, OPRPs, CCPs, CAPA) is key
- v6.0
strengthens risk-based approach, food safety culture, and preventive
control measures
12. Next Steps / Learning Continuity (To be Linked up
soon)
- After mastering this foundational article, readers can explore real-world applications in sugar refineries, dairy plants, or other FMCG companies.
- Next articles can cover Phase 1 → Phase 3 practical applications, detailed SOPs, RACI, KPI tracking, audit readiness, and lessons learned from transitioning v5.1 → v6.0.
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