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Hazard and Risk
management system
A Hazard and Risk Management System including
prerequisite programmes shall be implemented to
identify and conrol food safety hazards, including
allergens.
This system shall be systematic, comprehensive and
shall take into consideration relevant law.
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 legislation (both countries of production and intended
Food Safety
Management system
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
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 specifying 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
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
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
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 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
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,
and labelling of the food in compliance with the allergen
labelling legislation in the country of intended sale
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.
Product labelling and
product information
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
Product labelling and
product information
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.
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
environmental monitoring programme which shall be
established, implemented and maintained to reduce the
risk of food contamination.
nternal 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 nonconformity
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
Control of nonconformity
This procedure shall include provisions for food that is
found to be damaged and / or returned from customers.
Corrective actions
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
Site environment
The site shall be located and maintained to enable the
reception, storage, production and offering of safe food
and to prevent its contamination.
Local environment All grounds within the site shall be maintained to prevent
contamination and enable the offering 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 maintain product integrity and regulatory
compliance regarding the disposal, resale, donation, restocking or reuse of product bein
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
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 safet
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 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
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.
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
Reception of
purchased materials
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.
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
Food 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,
and 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