FAO Risk-based inspection Resource Kit

How to design, implement and maintain a risk-based inspection programme

Food safety is crucial to secure public health and economic prosperity. Each year, millions of illnesses caused by food contaminants or foodborne pathogens lead to preventable deaths and significant economic losses. To safeguard consumers and enable fair trade practices, governments must implement and enforce robust national inspection programmes. These should be built on sound data and guided by a documented risk categorization framework that identifies higher-risk activities and products, ensuring efficient use of resources and more effective food control systems. This Resource Kit was developed to meet this need—supporting countries in building coherent, risk-based inspection programmes that strengthen food safety at every level.

Who is the Resource Kit meant for?

This Resource Kit is primarily intended for Competent Authorities responsible for inspection activities across the food chain – from primary production through consumption.

Food safety managers responsible for policy making will find practical guidance on how to develop, implement, review, and enhance a risk-based inspection programme aimed at identifying and targeting high-risk food businesses.

The Resource Kit also offers valuable and hands-on guidance for food safety inspectors, supporting them in conducting field inspections at primary production operations and food processing establishments.

In addition, the Resource Kit may be of use to international agencies, consultants, and experts who support countries in designing, implementing, and evaluating risk-based inspection planning and reporting programmes.

Why is the Resource Kit relevant?

The Resource Kit provides a framework designed to remain relevant and applicable as the food safety field continues to evolve in response to emerging risks, scientific advances and changing regulatory contexts.

This Resource Kit:

  • provides guidance on designing, implementing and refining risk-based inspection programmes to strengthen national food control systems;
  • introduces the concept of risk categorization and presents practical approaches for developing such risk-based inspection programmes, tailored to the data and resources available in different national contexts;
  • serves as a technical reference to support planning and reporting of risk-based inspection activities at local and national levels;
  • highlights the importance of documented planning and reporting procedures, including inspection manuals, standard operating procedures and training programmes, aligned with the risk categorization framework and consistent with FAO and Codex Alimentarius texts;
  • outlines the importance of data analysis in assessing programme delivery and effectiveness, providing the evidence essential for continuous improvement.
How to use the Resource Kit

The Resource Kit is designed as a practical, step-by-step guide that users can navigate according to their specific needs. It can be used to support the design and implementation of new risk-based inspection programmes or consulted selectively to refine existing frameworks.

The Resource Kit is organized in 14 modules based on the four steps involved in the risk-based inspection planning and reporting cycle. The modules provide clear explanations, examples and templates to help users plan, implement, and report on inspection activities in line with FAO and Codex Alimentarius texts.

Please click on the modules below to access the printable pdf document available on the FAO Knowledge Repository.

Introductory modules

2026

Explains the kit’s purpose, audience, and structure, promoting a risk-based approach. It outlines key planning, reporting steps and definitions.

2026

Explains relevant risk-related terminology (risk, risk analysis, and risk ranking) to better understand this Resource Kit.

STEP 1- Risk categorization framework development

2026

Guidance on developing national profiles for risk-based inspections, mapping food businesses and authorities, with emphasis on data quality.

2026

How to define risk factors, assessment criteria and scoring methods for food businesses to support consistent, evidence-based risk categorization.

2026

An overview of four approaches to risk categorization with examples on how to select and tailor risk factors and assessment criteria.

2026

Establishing inspection priorities and frequencies based on the results of the risk categorization process.

STEP 2: Risk-based inspection planning

2026

How to structure the annual inspection plan through review of results, updates to risk profiles, drafting plans, feedback, and finalization.

2026

Overview of Competent Authorities in food inspection systems, highlighting roles, coordination, and communication strategies for stakeholders.

STEP 3: Inspection delivery and quality assurance (on-site)

2026

How to prepare for and conduct on-site risk-based inspections according to food safety risks and relevant background information.

2026

A step-by-step guide on risk-based inspections for primary production operations and food processing establishments.

2026

How to identify, address and follow up on non-compliances and violations found during inspections, emphasizing quality data collection and reporting.

2026

Overview of duties and responsibilities of food safety inspectors emphasizing consistent data collection and verification through quality management activities.

STEP 4: Data analysis and continuous improvement

2026

Five stages of data analysis to evaluate programme delivery and effectiveness, with reporting recommendations for operational performance.

2026

Developing a solid communication strategy tailored to different internal and external stakeholders.

Additional FAO resources
Further readings

The links below refer to online sources relevant to each module of the FAO Risk-based Inspection Resource Kit. The chosen references are typically mentioned within the related module and provide valuable online information to gain more in-depth topical knowledge.

FAO & WHO. 2019. Food control system assessment tool. Food Safety and Quality series No 7. Rome.

FAO & WHO. 2007. Working Principles for Risk Analysis for Food Safety for Application by Governments. Codex Alimentarius Guideline, No. CXG 62-2007. Codex Alimentarius Commission. Rome.

FAO & WHO. 2006. Food Safety Risk Analysis - A Guide for National Food Safety Authorities. Rome.

FAO & WHO. 2016. Risk Communication Applied to Food Safety Handbook. Food Safety and Quality Series No 2. Rome.

FAO elearning Academy - Science and risk analysis in Codex course

FAO. 2017. Food Safety Risk Management: evidence-informed policies and decisions, considering multiple factors. Food Safety and Quality Series No 4. Rome.

FAO. 2020. FAO guide to ranking food safety risks at the national level. Food Safety and Quality Series No 10. Rome.

Australia New Zealand Food Authority (ANZFA). 2013. Food Safety: The priority classification system for food businesses.

Disability-adjusted life years (DALYs)

FAO. 2011. Guidelines for risk categorization of food and food establishments applicable to ASEAN countries. Bangkok.

Food Safety Authority of Ireland (FSAI). 2019. Guidance for the Health Service Executive on the Inspection of Food Businesses.

Ministry of Health and Long-Term Care Ontario (MHLTC). 2019. Operational Approaches for Food Safety Guideline.

Quessy, S., Rabhi, N., Lachapelle, V., Racicot, M., Kopko, C., Leroux, A., Barry, O. & Bessy, C. 2026. Development of a FAO model to support risk categorization of food business operators in low and middle-income countries: from model design to the selection and relative weighting of food-safety related risk factors. Food Control, 181: 111704.

Racicot, M., Zanabria, R., Leroux, A., Ng, S., Cormier, M., Tiwari, A., Aklilu, S. et al. 2018. Quantifying the impact of food safety criteria included in the Canadian Food Inspection Agency risk assessment model for food establishments through Expert Elicitation. Food Control, 92: 450–463.

Racicot, M., Zanabria, R., Paradis, M.-È., Gaucher, M.-L., Arsenault, J., Leroux, A., Letellier, A. et al. 2019. Identification of risk factors to be considered for food establishments’ risk assessment models. Microbial Risk Analysis, 11: 1–10.

US FDA Food Code

Zanabria, R., Racicot, M., Cormier, M., Arsenault, J., Ferrouillet, C., Letellier, A., Tiwari, A. et al. 2018. Selection of risk factors to be included in the Canadian Food Inspection Agency risk assessment inspection model for food establishments. Food Microbiology, 75: 72–81.

Zanabria, R., Racicot, M., Leroux, A., Xucen, L., Cormier, M., Ferrouillet, C., Arsenault, J. et al. 2019. Source attribution at the food sub-product level for the development of the Canadian Food Inspection Agency risk assessment model. International Journal of Food Microbiology, 305: 108241.

FAO & WHO. 2021. Principles and guidelines for the assessment and use of voluntary third-party assurance programmes. Codex Alimentarius Guideline, No. CXG 93-2021. Codex Alimentarius Commission. Rome.

FAO & WHO. 2019. Safety and Quality of Water Used in Food Production and Processing – Meeting report. Microbiological Risk Assessment Series no. 33. Rome.

FAO & WHO. 2021. Safety and quality of water used with fresh fruits and vegetables. Microbiological Risk Assessment Series No. 37. Rome.

FAO & WHO. 2023. General Principles of Food Hygiene. Codex Alimentarius Code of Practice, No. CXC 1-1969. Codex Alimentarius Commission. Rome.

FAO & WHO. 2023. Safety and quality of water use and reuse in the production and processing of dairy products – Meeting report. Microbiological Risk Assessment Series, No. 40. Rome, FAO.

FAO & WHO. 2023. Safety and quality of water used in the production and processing of fish and fishery products – Meeting report. Microbiological Risk Assessment Series, No. 41. Rome.

FAO. 1994. Manual on meat inspection for developing countries. FAO Animal Production and Health Paper No. 0254-6019. Rome.

FAO. 2004. Good practices for the meat industry. FAO Animal Production and Health Manual No. 2. Rome.

FAO. 2019. Technical guidance principles of risk-based meat inspection and their application. Food Safety and Quality Series No. 6. Rome.

FAO. 2025. FAO workshop on the safety and quality of water used in fisheries - Workshop Report. Rome.

Good Hygiene Practices (GHP) and HACCP Toolbox for Food Safety.

FAO & WHO. 1995. Principles for Food Import and Export Inspection and Certification. Codex Alimentarius Guideline, No. CXG 20-1995. Codex Alimentarius Commission. Rome.

FAO & WHO. 1999. Recommended Methods of Sampling for the Determination of Pesticide Residues for Compliance with MRLs. Codex Alimentarius Guideline, No. CXG 33-1999. Codex Alimentarius Commission. Rome.

FAO & WHO. 2003. Assuring Food Safety and Quality. Guidelines for Strengthening National Food Control Systems. Food and Nutrition Paper Series No. 76. Rome.

FAO & WHO. 2008. Principles and Guidelines for the Conduct of Microbiological Risk Management (MRM). Codex Alimentarius Guideline, No. CXG 63-2007. Codex Alimentarius Commission. Rome.

FAO & WHO. 2012. FAO/WHO guide for developing and improving national food recall systems. Rome.

FAO & WHO. 2013. Guidelines for the Validation of Food Safety Control Measures. Codex Alimentarius Guideline, No. CXG 69-2008. Codex Alimentarius Commission. Rome.

FAO & WHO. 2013. Principles and Guidelines for National Food Control Systems. Codex Alimentarius Guideline, No. CXG 82-2013. Codex Alimentarius Commission. Rome.

FAO & WHO. 2014. Guidelines for the Design and Implementation of National Regulatory Food Safety Assurance Programmes Associated with the Use of Veterinary Drugs in Food Producing Animals. Codex Alimentarius Guideline, No. CXG 71-2009. Codex Alimentarius Commission. Rome.

FAO & WHO. 2016. Principles and Guidelines for the Exchange of Information in Food Safety Emergency Situations. Codex Alimentarius Guideline, No. CXG 19-1995. Codex Alimentarius Commission. Rome.

FAO & WHO. 2017. Principles and Guidelines for Monitoring the Performance of National Food Control Systems. Codex Alimentarius Guideline, No. CXG 91-2017. Codex Alimentarius Commission. Rome.

FAO & WHO. 2019. Food control system assessment tool: Introduction and glossary. Food safety and quality series No. 7/1. Rome. Licence: CC BY-NC-SA 3.0 IGO.

FAO & WHO. 2019. Food control system assessment tool: Dimension B – Control Functions. Food safety and quality series No. 7/3. Rome. License: CC BY-NC-SA 3.0 IGO.

FAO & WHO. 2021. Guidelines for Risk Analysis of Foodborne Antimicrobial Resistance. Codex Alimentarius Guideline, No. CXG 77-2011. Codex Alimentarius Commission. Rome.

FAO & WHO. 2025. Codex Alimentarius Commission Procedural Manual – Thirtieth edition. Rome.

FAO. 2008. Risk-based food inspection manual. FAO Food and Nutrition Paper Series No. 89. Rome.

FAO. 2015. Risk based imported food control. Food Safety and Quality Series No 1. Rome.

FAO. 2016. Enhancing Early Warning Capabilities and Capacities for Food Safety. Rome.

Food and Drug Administration (FDA). 2012. Bad Bug Book, Foodborne Pathogenic Microorganisms and Natural Toxins. Second Edition.

Pan American Health Organization (PAHO). 2019. Risk-based food inspection manual for the Caribbean. Washington, D.C.

Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law.

WHO Regional Office for Africa. 2012. Guidelines for Developing and Implementing a National Food Safety Policy and Strategic Plan.

WHO Regional Office for the Western Pacific. 2023. Risk-based food inspection system: practical guidance for national authorities. Licence: CC BY-NC-SA 3.0 IGO.

WHO. 2012. Rapid risk assessment of acute public health events. Geneva.

World Bank Group. 2020. Food Safety Handbook: A Practical Guide for Building a Robust Food Safety Management System. Washington, D.C.

Acknowledgements

The Food and Agriculture Organization of the United Nations (FAO) would like to express its appreciation to the many people who provided advice and guidance during the preparation of this publication.

The overall leadership and coordination were provided by Catherine Bessy, Senior Food Safety Officer, Agrifood Systems and Food Safety Division (ESF) at FAO, who also acted as technical editor for the manual, supported by Christine Kopko, FAO Food Safety Officer.

The Agrifood Systems and Food Safety Division (ESF) would like to express profound gratitude and acknowledge the lead author Mary Ann Green, FAO consultant.

The creation of this Resource Kit was supported by an international benchmarking exercise led by Juliette Soudon during a 5-month internship with FAO in 2018. Early in the process, an evaluation of risk categorization models available in Asean countries, Australia, Bangladesh, Barbados, Canada, France, Ireland, New Zealand, Switzerland and the United States of America contributed to the structure and the content of the manual.

A draft of the manual was peer-reviewed by: Oumou Barry, FAO consultant; Rabia Begum, the United States of America; Dennis Bittisnich, FAO consultant; Robyn Edwards, Canada; Teresa Fox, the United States of America; Alia’a Ghiba, Canada; Suzan Gordon, the United States of America; Erwin Miller, the United States of America; Julie Moss, the United States of America; Manon Racicot, Canada; Laura Reid, Canada; Eric Stevens, the United States of America; Sylvain Quessy, Canada; Samia Zrelli, FAO consultant.

The contribution of many other FAO colleagues, including Markus Lipp (Senior Food Safety Officer) for reviewing the final version of the manual, is also gratefully acknowledged.

The technical materials of the Resource Kit were developed under the overall guidance of Catherine Bessy (FAO), Riccardo Siligato (FAO) and Claudia Trezza (FAO). Coordination and management of toolbox web development: Michela Kranner (FAO), Davide Trebbi (FAO). Graphic design: Fabiana Marafiotti (FAO).

FAO would like to express appreciation to the United States of America Food and Drug Administration (FDA) for partial funding under project GCP/GLO/939/USA and GCP/GLO/520/USA.