A Hazard and Risk Management System including prerequisite programmes shall be implemented to identify and control food safety hazards, including allergens. This system shall be systematic, comprehensive and shall take into consideration relevant law

The scope of the Hazard and Risk Management System shall be defined per product / product category and / or per process or production step

The Hazard and Risk Management System shall be applicable to the site’s scope of activity.

The Hazard and Risk Management System shall be reviewed regularly, and in case of any change that impacts food safety.

A clear organisational structure identifying the job functions and responsibilities of at least those employees whose activities affect food safety shall be established, implemented and maintained.

Evidence of the senior management’s commitment to establish, implement, maintain and continuously improve the Food Safety Management System shall be provided. This shall include elements of food safety culture, at a minimum consisting of: communication, training, feedback from employees and performance measurement on food safety related activities.

The senior management shall review all elements of the Food Safety Management System, including the Hazard and Risk Management System HACCP plan or HACCPbased plans regularly, and in case of any change that impacts food safety, to ensure their continuing suitability and effectiveness.

Procedures shall be established, implemented and maintained to ensure compliance with applicable legislation (both countries of production and intended sale).

The elements of the Food Safety Management System shall be established, implemented, maintained and continuously improved and shall have a scope appropriate to the range of business activities to be covered.

A clear, concise and documented food safety policy statement shall be in place, as well as measurable objectives specifying the extent of the organisation’s commitment to meet the food safety needs.

A food defence threat assessment procedure shall be established, implemented and maintained to identify potential threats and prioritise food defence measures

A documented food defence plan shall be in place specifying the measures implemented to mitigate the public health risks from any identified food defence threats.

This food defence plan shall be supported by the Food Safety Management System.

A food fraud vulnerability assessment procedure shall be established, implemented and maintained to identify potential vulnerability and prioritise food fraud mitigation measures.

A documented food fraud plan shall be in place specifying the measures implemented to mitigate the public health risks from the identified food fraud vulnerabilities.

This food fraud mitigation plan shall be supported by the organisation's Food Safety Management System.

A procedure shall be established, implemented and maintained for the management and control of documented information required to demonstrate the effective operation and control of processes and the Food Safety Management System

All the above-mentioned documented information shall be securely stored for the time period required to meet customer and legal requirements, or for a period exceeding the shelf-life of the food if customer or legal requirements are not available. It shall be effectively controlled and readily accessible when needed.

Specified requirements or specifications shall be established, implemented and maintained for all inputs to the process, including services that are purchased or provided and have an effect on food safety.

A review process of the specified requirements or specifications shall be in place.

Effective procedures and instructions shall be established, implemented and maintained for all processes and operations having an effect on food safety

The resources needed to establish, implement, maintain, review and improve the Food Safety Management System shall be identified and assigned.

A purchasing procedure shall be established, implemented and maintained to ensure that all inputs to the process, including externally purchased materials and services which have an effect on food safety, conform to specified requirements or specifications as well as food safety and regulatory requirements.

A procedure for the evaluation, approval and continued monitoring of suppliers which have an effect on food safety shall be established, implemented and maintained. The procedure shall address procurement in emergency situations to ensure that food still conforms to the documented specified requirements or specifications, and the supplier has been evaluated. The results of evaluations, investigations and follow up actions shall be recorded.

Outsourced processes that may have an effect on food safety shall be identified and controlled. Such controls shall be documented in the Food Safety Management System.

Procedures shall be established, implemented and maintained to ensure product identification from the supplier (minimum one step back) through any processes undertaken to the recipient of the food (minimum one step forward).

Documented tests of the traceability system shall be undertaken to ensure this is operating effectively

Product design and development procedure shall be established, implemented and maintained for new products and changes to product or manufacturing processes to ensure safe and legal products are produced

An allergen management plan shall be established, implemented and maintained. This shall include a risk assessment of allergen cross contamination, implemented controls to reduce or eliminate that risk, and labelling of the food in compliance with the allergen labelling legislation in the country of intended sale.

The equipment / devices used to measure parameters critical to ensure food safety shall be identified

The identified equipment / devices shall be regularly calibrated; calibration shall be traceable to a national or international standard or method.

Finished product shall be labelled to ensure safe use of food, in compliance with the applicable food safety legislation in the country of intended sale.

When product is unlabelled, all relevant product information shall be made available to ensure the safe use of the food by the customer or consumer.

A procedure shall be established, implemented and maintained to ensure that analyses of food parameters critical to food safety are undertaken by competent laboratories and using appropriate sampling and testing methods and that such analyses are performed in accordance with the applicable requirements of ISO/IEC 17025.

A risk-based approach shall be in place to define the environmental monitoring programme which shall be established, implemented and maintained to reduce the risk of food contamination.

An internal audit procedure shall be established, implemented and maintained; it shall cover all elements of the Food Safety Management System.

A procedure for the management of complaints and complaint data shall be established, implemented and maintained to ensure that complaints are assessed and corrective actions implemented, when necessary

An incident management procedure, including product withdrawal, shall be established, implemented and maintained. Withdrawal procedure shall be regularly tested for effectiveness.

A product release procedure shall be established, implemented and maintained.

A procedure shall be established, implemented and maintained to ensure that any non-conformity impacting food safety and any non-conforming products are clearly identified and controlled to prevent unintended use or delivery.

This procedure shall include provisions for food that is found to be damaged and / or returned from customers.

A procedure shall be established, implemented and maintained for the determination and implementation of corrective actions in the event of any significant nonconformity relating to food safety.

The site shall be located and maintained to enable the reception, storage, production and distribution of safe food and to prevent its contamination.

All grounds within the site shall be maintained to prevent contamination and enable the production of safe products.

The site, both the exterior and the interior, shall be designed, constructed and maintained to minimise food safety risks. The layout and flow of operations shall be suitable for the intended purpose and designed to minimise food safety risks.

Procedures shall be established, implemented and maintained to prevent or minimise risk of contamination and cross-contamination of purchased materials, work in progress, rework, packaging and finished product covering all aspects of food safety

Procedures shall be established, implemented and maintained to maintain product integrity and regulatory compliance regarding the disposal, resale, donation, restocking or reuse of product being salvaged or reclaimed.

Employee facilities including hand washing and toilet facilities, and public facilities where applicable, shall be provided, designed and operated to minimise food safety risks.

Documented personal hygiene standards shall be established, implemented and maintained to minimise food safety risks.

Suitable protective clothing shall be provided to minimise food safety risks.

A medical screening procedure shall be established, implemented and maintained to identify conditions impacting food safety and that any person affected shall immediately report illness or symptoms to management, subject to legal restrictions in the country of operation.

The requirements 6.1, 6.2, and 6.3 shall apply to employees, contractors and visitors commensurate to their impact on food safety

Procedure shall be established, implemented and maintained to ensure that all employees are trained, and retrained as necessary to have an understanding in food safety, commensurate with their activity

Procedure of housekeeping, cleaning and disinfection shall be established, implemented and maintained. Its effectiveness in minimising food safety risks shall be verified, based on the risks associated with the product or activity. Cleaning activities shall not represent a food safety risk.

Cleaning facilities, equipment and chemical materials shall be suitable for their intended use and shall be stored and used appropriately.

A programme of site inspections / checks shall be established, implemented and maintained to ensure the site environment and processing equipment are maintained in a suitable condition to ensure food safety, as applicable to the activity of the site.

Air, compressed gases, and water (including ice and steam) in any form which could impact food safety shall be regularly monitored, and adequately stored and handled in order to minimise food safety risks. Water not intended for use in food production, if available on site, shall be managed to minimise food safety risks.

A procedure shall be established, implemented and maintained for the collection, storage and disposal of waste material, including waste water and drainage.

A procedure shall be established, implemented and maintained to prevent, monitor and control or eliminate the risk of pest infestation at the site.

Appropriate procedures for the reception of purchased materials shall be established, implemented and maintained to assure that only materials that meet food safety requirements are accepted.

All containers and vehicles used for transportation in a way that could impact food safety shall be designed, constructed and maintained to minimise food safety risks. They shall be suitable for the intended purpose.

Food shall be held or stored in designated areas and handled under controlled conditions to minimise food safety risks.

A procedure shall be established, implemented and maintained to ensure that purchased materials, work in progress and finished products are used in the correct order, and within the allocated shelf life when applicable.

Equipment shall be suitable for the intended purpose. Equipment shall be designed, constructed, maintained, used and stored to minimise food safety risks.

Effective planned maintenance shall be in place for the site and equipment to minimise food safety risks. Maintenance activities shall not represent food safety risks