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ISO 22000 Food Safety Hazard & Risk Assessment

Identify food safety hazards, evaluate significance, determine CCPs/OPRPs and manage PRPs โ€” ISO 22000:2018 and HACCP compliant

ISO 22000:2018 Auto-Save HACCP Principles CCP / OPRP / PRP CSV ยท TXT ยท JSON ยท PDF Allergen Tracking

New Food Safety Hazard Entry

General Information
Hazard Details
Hazard Significance Assessment (ISO 22000 Cl. 8.5.4.2)

Significance Score = Severity ร— Likelihood. Significant hazards (score โ‰ฅ threshold) must be controlled by CCPs or OPRPs. Acceptable levels per Codex Alimentarius must be defined.

Control Measure & CCP / OPRP Determination

Food Safety Hazard Categories โ€” ISO 22000:2018 Cl. 8.5.4.1

ISO 22000 requires identification of all food safety hazards associated with the product, process and facility. Hazards must be identified based on preliminary information, experience, legislation, and scientific/technical literature.

Biological Hazards

Pathogenic microorganisms, viruses, parasites, prions and their toxins.

Examples: Salmonella, Listeria monocytogenes, E. coli O157, Campylobacter, Norovirus, aflatoxins, histamine

Control: Cooking, pasteurisation, pH control, water activity, HTST, fermentation, refrigeration

Chemical Hazards

Naturally occurring or added substances at harmful levels.

Examples: Pesticide residues, veterinary drugs, mycotoxins, heavy metals, cleaning agents, PAHs, acrylamide

Control: Supplier specifications, ingredient testing, cleaning validation, GMP, process controls

Physical Hazards

Foreign bodies or hard/sharp objects that could cause injury.

Examples: Metal fragments, glass, bone, plastic, wood, stones, personal effects, packaging material

Control: Metal detection, X-ray, sieves/screens, visual inspection, GMP, maintenance controls

Allergen Hazards

14 major allergens (EU) โ€” intentional or unintentional inclusion causing allergic reactions.

Examples: Gluten, milk, eggs, peanuts, tree nuts, fish, shellfish, sesame, mustard, soy

Control: Allergen management programme, labelling control, dedicated equipment, scheduling, cleaning validation

Radiological Hazards

Radioactive contamination from environmental or industrial sources.

Examples: Radioactive fallout from nuclear incidents, natural radioactivity in some minerals

Control: Supplier verification, geographic sourcing controls, regulatory monitoring

Food Fraud (EMA)

Economically motivated adulteration (EMA) โ€” deliberate substitution, dilution or misrepresentation.

Examples: Honey adulteration, species substitution, undeclared ingredients, fake organic status

Control: VACCP, supplier qualification, origin verification, DNA testing, audit trail

Prerequisite Programmes (PRPs) โ€” ISO 22000:2018 Cl. 8.2

PRPs are the foundation conditions and activities necessary to maintain a hygienic environment throughout the food chain suitable for the production, handling and provision of safe end products. They must be documented, implemented and verified.

Infrastructure & Design

Construction and layout of buildings, equipment design and accessibility, hand-washing facilities, segregation of raw/cooked areas, traffic flow control (people/materials).

Water, Air & Utilities

Potable water supply & quality, water contact surfaces, compressed air quality, steam quality (culinary/non-culinary), ice quality monitoring.

Cleaning & Disinfection

Cleaning and disinfection schedules (SSOP), approved chemicals and dilutions, verification of cleaning effectiveness, CIP/COP procedures, equipment dismantling.

Pest Control

Pest management programme, pest monitoring (rodent traps, fly units), external contractor management, proofing of building, chemical storage and use restrictions.

Temperature Control

Refrigeration monitoring and calibration, cold chain management, freezer performance, hot-holding requirements, delivery vehicle temperatures.

Personnel Hygiene

Personal hygiene rules, protective clothing, handwashing procedures, illness/exclusion policy, jewellery rules, food handler health declarations, visitor controls.

Allergen Management

Allergen register, scheduling (allergen-free first), dedicated equipment or colour-coded utensils, cleaning validation, supplier ingredient declarations, labelling review.

Training & Competence

Food hygiene training (induction and refresh), HACCP awareness, food handler Level 2/3, records of training, competency assessment, allergen training.

Traceability & Labelling

Batch/lot coding, traceability systems, mass balance records, withdrawal & recall procedures, labelling accuracy checks, date coding verification.

PRP vs OPRP vs CCP: PRPs manage general hygiene conditions. OPRPs manage specific food safety hazards that are significant but not controlled at a CCP โ€” monitored but without a critical limit. CCPs are steps where a critical limit can be applied and verified, the violation of which would result in unacceptable health risk (e.g. pasteurisation temperature, metal detection sensitivity).

ISO 22000:2018 โ€” Key FSMS Clauses

8.5.4 โ€“ Hazard Analysis

Identify all hazards in preliminary info, evaluate severity and likelihood, determine acceptable levels, select control measures (PRP/OPRP/CCP). Must be conducted by the food safety team.

8.6 โ€“ HACCP Plan

Identify CCPs, establish critical limits, implement monitoring system, determine corrective actions for deviations, define verification activities, maintain records per 7 HACCP principles (Codex).

8.9 โ€“ Nonconforming Product

Corrections and corrective actions for deviations from critical limits/action criteria. Evaluation of products for release, reprocessing, destruction, or use for other purposes. Withdrawal/recall procedures.

8.8 โ€“ Verification

Verification activities confirm PRPs are implemented effectively, hazard analysis is valid, OPRP/HACCP plans are implemented and effective, hazard levels meet acceptable limits.

8.3 โ€“ Traceability

Product and ingredient traceability one step back/forward. Batch records, supplier documentation, processing records. Must be able to identify and withdraw product within a defined timeframe.

8.4 โ€“ Emergency Preparedness

Procedures for potential emergency situations with food safety implications โ€” power failures, water supply contamination, pest infestations, flood, fire, product tampering.

Significance Scoring Guide (S ร— L):
1โ€“4: Negligible โ€” PRP sufficient 5โ€“8: Low โ€” PRP/enhanced controls 9โ€“12: Medium โ€” OPRP likely 15โ€“16: High โ€” CCP or OPRP 20โ€“25: Critical โ€” CCP required

Catastrophic severity (S=5) is always treated as a CCP or equivalent โ€” the potential for death or mass illness cannot be accepted without a critical control point.

Food Safety Hazard Register

All recorded food safety hazards โ€” filter, edit, export. Auto-saved in browser.

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IDDateProcess StepHazard TypeSpecific Hazard DescriptionSLScoreSignificance Control TypeCritical LimitStatusOwnerVerify DateActions

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Food Safety Hazard Significance Matrix

Severity ร— Likelihood โ€” ISO 22000:2018 Cl. 8.5.4.2 hazard significance evaluation

5ร—5 Significance Matrix (Severity ร— Likelihood)

Significance Score = Severity ร— Likelihood. Significant hazards must be addressed by CCPs, OPRPs or a combination of control measures. The threshold for significance must be defined by the food safety team.

L=1
Very Unlikely
L=2
Unlikely
L=3
Possible
L=4
Likely
L=5
Certain
Negligible (1โ€“4): PRP sufficient Low (5โ€“8): Enhanced PRP Medium (9โ€“12): OPRP likely High (15โ€“16): CCP or OPRP Critical (20โ€“25): CCP required

Negligible / Low โ€” PRP

Managed by standard PRPs (GHP/GMP). Document in hazard register. Verify PRP effectiveness at defined intervals. No specific HACCP control point required. Monitor through general hygiene audits.

Medium โ€” OPRP

Operational PRP required with documented action criteria, monitoring method and frequency, corrective actions and verification. Not a critical limit but must be measured and recorded. Review regularly.

High / Critical โ€” CCP

Critical Control Point: define critical limits, continuous or batch monitoring, immediate corrective action if limit breached, records retention (typically 2ร— shelf life), validation of critical limit, verification schedule.

Catastrophic (S=5) โ€” Always CCP

Any hazard with catastrophic severity (potential for death or mass illness) must be controlled at a CCP regardless of likelihood. Pathogens in ready-to-eat foods, Clostridium botulinum in low-acid canned goods โ€” these require a validated kill step.

HACCP Principles & ISO 22000 Integration

7 HACCP principles as integrated in ISO 22000:2018 โ€” the food safety management system framework

HACCP Principle 1 โ€” Hazard Analysis

ISO 22000 Clause 8.5.4: Conduct a hazard analysis to identify all food safety hazards that may be present in relation to the product type, process and facilities. Assess the likelihood of occurrence before control measures and severity of adverse health effects.

Include in your hazard analysis:
โ€ข All process steps (flow diagram verified on-site)
โ€ข All raw materials, ingredients and packaging
โ€ข Environmental conditions (temperature, humidity)
โ€ข Personnel-related hazards
โ€ข Reasonably foreseeable misuse
โ€ข Consumer vulnerability (vulnerable groups)

HACCP Principle 2 โ€” Identify CCPs

ISO 22000 Clause 8.6.2: Determine which control measures are CCPs using a decision tree (Codex) or other validated methodology. A CCP is a step where a control measure can be applied to prevent, eliminate or reduce a significant hazard to an acceptable level.

CCP Decision Questions:
Q1: Do control measures exist for this hazard?
Q2: Is this step designed specifically to eliminate/reduce?
Q3: Could contamination reach unacceptable levels?
Q4: Will a subsequent step eliminate/reduce the hazard?

HACCP Principles 3 & 4 โ€” Limits & Monitoring

Principle 3 โ€” Critical Limits: Establish validated critical limits for each CCP. Must be measurable (temperature, pH, time, water activity, metal detection sensitivity).

Principle 4 โ€” Monitoring System: Establish monitoring procedures. Define: what is monitored, how, frequency, who is responsible, and when action is required.

Monitoring must be capable of detecting loss of control in a timely manner. Calibrated equipment required.

HACCP Principle 5 โ€” Corrective Actions

ISO 22000 Clause 8.9.2 / 8.9.3: Pre-define corrective actions for each CCP deviation. Actions must: restore process control, determine disposition of affected product, identify root cause, prevent recurrence.

Product fate decisions:
โ€ข Release โ€” if deviation doesn't affect safety
โ€ข Reprocess โ€” if additional processing can make safe
โ€ข Destroy โ€” if safety cannot be assured
โ€ข Divert โ€” to non-food use if appropriate
โ€ข Hold & evaluate โ€” pending testing

HACCP Principle 6 โ€” Verification

ISO 22000 Clause 8.8: Establish verification procedures to confirm the HACCP system is working effectively.

Verification activities:
โ€ข Microbiological testing of product/environment
โ€ข CCP records review
โ€ข Equipment calibration verification
โ€ข Internal HACCP audits
โ€ข Complaints and illness data review
โ€ข Shelf-life studies
โ€ข Challenge testing (for critical limits)

HACCP Principle 7 โ€” Documentation & Records

ISO 22000 Clause 7.5 / 8.6.2: Maintain documented information for the HACCP system. Records demonstrate control and provide evidence of due diligence.

Required records include:
โ€ข Hazard analysis and justification
โ€ข CCP/OPRP determination rationale
โ€ข Critical limits and scientific validation
โ€ข Monitoring records (temperature logs, etc.)
โ€ข Corrective action records
โ€ข Verification records
โ€ข Training records
โ€ข Calibration records

ISO 22000 vs HACCP: ISO 22000:2018 incorporates all 7 HACCP principles within its structure and adds requirements for: PRPs (Clause 8.2), traceability (8.3), emergency preparedness (8.4), interactive communication across the food chain (7.4), documented FSMS with management system structure (aligned with ISO High Level Structure), and explicit requirements for validation and verification. Organisations certified to Codex HACCP will find ISO 22000 builds on this foundation with a more comprehensive management system approach.

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Common Questions

ISO 22000 Food Safety Risk & Hazard Assessment Tool โ€” Frequently Asked Questions

Quick answers about the ISO 22000 Food Safety Risk & Hazard Assessment Tool gap analysis tool, data privacy, audit preparation, and ISO Xpert consulting.

What is the ISO 22000 Food Safety Risk & Hazard Assessment Tool gap analysis tool and how does it work?
The ISO 22000 Food Safety Risk & Hazard Assessment Tool gap analysis tool is a free browser-based checklist that compares your current management system against the clauses of ISO 22000 Food Safety Risk & Hazard Assessment Tool. You answer clause-by-clause questions and rate each requirement as Compliant, Partial or Non-compliant. The tool calculates a live compliance score, highlights gaps on a heat-map, captures evidence and corrective-action notes, and exports the full assessment as JSON, CSV, TXT or print-ready PDF for management review and Stage 1 / Stage 2 audit preparation.
Is the ISO 22000 Food Safety Risk & Hazard Assessment Tool gap analysis tool really free to use?
Yes โ€” the ISO 22000 Food Safety Risk & Hazard Assessment Tool tool is 100% free with no sign-up, no email capture, no credit card, no watermarks, and no usage limits. It runs entirely in your browser; nothing is transmitted to ISO Xpert servers. You can clear or export your data at any time.
Where is my ISO 22000 Food Safety Risk & Hazard Assessment Tool assessment data stored?
All ISO 22000 Food Safety Risk & Hazard Assessment Tool assessment data is stored locally in your browser’s storage. Nothing is uploaded to our servers. This makes the tool GDPR-friendly and suitable for confidential audit data classified up to Restricted. Export anytime as JSON (re-importable), CSV (Excel-pivotable), TXT (executive summary) or PDF (audit-trail evidence).
Can I use this tool to prepare for ISO 22000 Food Safety Risk & Hazard Assessment Tool certification or surveillance audits?
Yes. The ISO 22000 Food Safety Risk & Hazard Assessment Tool gap analysis is designed to support preparation for certification by UKAS-, IAS- or ANAB-accredited bodies. Use the exported report as evidence of internal audit, feed it into management review, and prioritise high-severity non-conformities ahead of Stage 1 / Stage 2 visits. ISO Xpert consultants can assist with documented information, internal audits and full implementation if required.
How long does a ISO 22000 Food Safety Risk & Hazard Assessment Tool gap analysis typically take?
Most users complete an initial ISO 22000 Food Safety Risk & Hazard Assessment Tool gap analysis in 60 to 120 minutes for a single site, depending on system maturity and clause depth. The tool auto-saves continuously, so you can pause, switch devices via JSON export/import, and resume at any time. Re-assessments after corrective action usually take 20 to 40 minutes.
Does ISO Xpert offer ISO 22000 Food Safety Risk & Hazard Assessment Tool consulting or training?
Yes. ISO Xpert Ltd (London, UK) provides ISO 22000 Food Safety Risk & Hazard Assessment Tool gap analysis consulting, internal audits, Stage 1 and Stage 2 certification preparation, lead auditor / internal auditor training, and full management-system implementation. Contact info@iso-xpert.com or WhatsApp +44 7853 109840.

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