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Hazard and Risk
management system
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
Hazard and Risk
management system
This shall be a hazard and risk assessment system,
based on the Annex of Codex Alimentarius General
Principles of Food Hygiene or other applicable
internationally-recognised industry guidelines.
Hazard and Risk
management system
The scope of the Hazard and Risk Management System
shall be defined per product / product category and /
or per process or production step.
Hazard and Risk
management system
The Hazard and Risk Management System shall be
applicable to the site’s scope of activity.
Hazard and Risk
management system
The Hazard and Risk Management System shall be
reviewed regularly, and in case of any change that
impacts food safety.
Management
responsibility
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.
Management
commitment and
food safety culture
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
Management review
The senior management shall review all elements of the
Food Safety Management System, including the Hazard
and Risk Management System HACCP plan or HACCP-
based plans regularly, and in case of any change that
impacts food safety, to ensure their continuing suitability
and effectiveness.
Food safety legislation
Procedures shall be established, implemented and
maintained to ensure compliance with applicable legis-
lation (both countries of production and intended sale).
Food Safety
Management system
The elements of the Food Safety Management System
shall be established, implemented, maintained and con-
tinuously improved and shall have a scope appropriate
to the range of business activities to be covered.
Food safety policy
and objectives
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.
Food defence
A food defence threat assessment procedure shall be
established, implemented and maintained to identify
potential threats and prioritise food defence measures.
Food defence
A documented food defence plan shall be in place spec-
ifying the measures implemented to mitigate the public
health risks from any identified food defence threats.
Food defence This food defence plan shall be supported by the Food
Safety Management System.
Food fraud
A food fraud vulnerability assessment procedure
shall be established, implemented and maintained to
identify potential vulnerability and prioritise food fraud
mitigation measures.
Food fraud
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.
Food fraud This food fraud mitigation plan shall be supported by the
organisation's Food Safety Management System.
Documentation
requirements
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
Documentation
requirements
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
/ Specifications
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
Specified requirements
/ Specifications
A review process of the specified requirements or
specifications shall be in place.
Specified requirements
/ Specifications
The Food Safety Management System shall ensure that
packaging used to impart or provide a functional effect
on the safety of the food to be packed in this packaging,
such as shelf life extension shall, where known, be
effective within its own specified criteria
Specified requirements
/ Specifications
There shall be sufficient data to ensure food contact with
the packaging is safe, and sufficient documentation of
claims, according to the intended use, where recycled
material, plant based material or functional additives are
used
Procedures
Effective procedures and instructions shall be established,
implemented and maintained for all processes and
operations having an effect on food safety.
Resource management
The resources needed to establish, implement, maintain,
review and improve the Food Safety Management
System shall be identified and assigned.
Purchasing and
supplier performance
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.
Purchasing and
supplier performance
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
Purchasing and
supplier performance
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 packaging still conforms to
the specified requirements or specifications, and the
supplier has been evaluated. The results of evaluations,
investigations and follow up actions shall be recorded.
Purchasing and
supplier performance
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
Traceability
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).
Traceability
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 packaging (minimum
one step forward).
Traceability Documented tests of the traceability system shall be
undertaken to ensure this is operating effectively.
Product development
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
Allergen management
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.
Control of measuring
and monitoring
equipment / devices
The equipment / devices used to measure parameters
critical to ensure food safety shall be identified
Control of measuring
and monitoring
equipment / devices
The identified equipment / devices shall be regularly
calibrated; calibration shall be traceable to a national or
international standard or method
Printed material control
Procedures shall be established, implemented and
maintained to manage packaging materials printed with
product ingredient list(s), allergens, identification code
and other critical information and prevent mis-printing.
Testing
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.
Environmental
monitoring
A risk-based approach shall be in place to define the
microbiological environmental monitoring programme
which shall be established, implemented and maintained
to reduce the risk of food contamination.
Internal audit
An internal audit procedure shall be established,
implemented and maintained; it shall cover all elements
of the Food Safety Management System.
Complaint handling
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.
Serious incident
management
An incident management procedure, including product
recall and withdrawal, shall be established, implemented
and maintained. The recall procedure shall be regularly
tested for effectiveness.
Product release A product release procedure shall be established,
implemented and maintained.
Control of non-
conformity
A procedure shall be established, implemented and
maintained to ensure that any non-conformity impact-
ing food safety and any non-conforming products are
clearly identified and controlled to prevent unintended
use or delivery.
Corrective actions
A procedure shall be established, implemented and
maintained for the determination and implementation
of corrective actions in the event of any significant non-
conformity relating to food safety.
Site environment
The site shall be located and maintained to enable the
reception, storage, production and distribution of safe
food and to prevent its contamination.
Site environment
The site shall be located and maintained to enable the
reception, storage, production and distribution of safe
packaging and to prevent its contamination.
Local environment
All grounds within the site shall be maintained to
prevent contamination and enable the production of
safe products.
Site design, construction,
layout and flow
of operations
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
Product contamination
risk and segregation
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.
Product contamination
risk and segregation
Procedures shall be established, implemented and
maintained to ensure printed materials are not mixed or
intermingled with other materials including in-process
and reworked materials
Employee facilities
Employee facilities including hand washing and toilet
facilities, and public facilities where applicable, shall
be provided, designed and operated to minimise food
safety risks.
Personal hygiene,
protective clothing and
medical screening
Documented personal hygiene standards shall be
established, implemented and maintained to minimise
food safety risks
Personal hygiene,
protective clothing and
medical screening
Suitable protective clothing shall be provided to
minimise food safety risks.
Personal hygiene,
protective clothing and
medical screening
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.
Personal hygiene,
protective clothing and
medical screening
The requirements 6.1, 6.2, and 6.3 shall apply to
employees, contractors and visitors commensurate to
their impact on food safety
Training
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
Housekeeping, cleaning
and disinfection
Procedure of housekeeping, cleaning and hygiene
disinfection shall be established, implemented and
maintained. Its effectiveness in minimising food safety
risks of cleaning shall be validated and verified, based
on the risks associated with the product or activity.
Cleaning activities shall not represent a packaging
safety risk
Housekeeping, cleaning
and disinfection
Cleaning facilities, equipment and chemical materials
shall be suitable for their intended use and shall be
stored and used appropriately.
Site inspections / checks
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 and water quality
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
Waste management
A procedure shall be established, implemented and
maintained for the collection, storage and disposal of
waste material, including waste water and drainage.
Waste management A system shall be in place to control the disposal of
trademarked material
Pest control
A procedure shall be established, implemented and
maintained to prevent, monitor and control or eliminate
the risk of pest infestation at the site
Transport
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.
Storage
Packaging shall be held or stored in designated areas
and handled under controlled conditions to minimise
food safety risks.
Stock management
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
Equipment shall be suitable for the intended purpose.
Equipment shall be designed, constructed, maintained,
used and stored to minimise food safety risks.
Maintenance
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.