1.

Gobernanza y compromiso
1.1 Política
1.1.1 La alta dirección desarrollará, aplicará y mantendrá una política corporativa que
incluirá, como mínimo:
- seguridad alimentaria, calidad del producto, legalidad y autenticidad
- orientación al cliente
- cultura de seguridad alimentaria
- sostenibilidad.
Esta política corporativa se comunicará a todos los empleados y se desglosará en
objetivos específicos para los departamentos pertinentes. Los objetivos sobre la
cultura de seguridad alimentaria incluirán, como mínimo:
- comunicación sobre las políticas y responsabilidades en materia de seguridad
alimentaria
- la formación,
- opiniones de los empleados sobre cuestiones relacionadas con la seguridad
alimentaria y
- medición de resultados.

1.1.2 Toda la información pertinente relacionada con seguridad alimentaria, la calidad

del producto, legalidad y la autenticidad deberá comunicarse de forma efectiva y a
su debido tiempo al personal implicado.

1.2 Estructura corporativa

1.2.1 * KO N° 1: La dirección se asegurará de que todos los empleados sean conscientes
de sus responsabilidades respecto a la seguridad alimentaria y la calidad del
producto, y de que se implanten mecanismos para supervisar la eficacia de su
desempeño. Dichos mecanismos deberán estar claramente identificados y
documentados.
1.2.2 La dirección facilitará los recursos apropiados y suficientes para cumplir con los
requisitos del producto y del proceso.
1.2.3 * El departamento responsable de la gestión de la seguridad alimentaria y la
calidad deberá depender directamente de la dirección. Se documentará y
mantendrá un organigrama que muestre la estructura de la compañía.

1.2.4 La dirección deberá asegurarse de que todos los procesos (documentados o no)
sean conocidos por el personal correspondiente y sean ejecutados de manera
consistente.
1.2.5 * La dirección mantendrá un sistema para asegurarse de que la compañía se
encuentra informada de toda la legislación pertinente, desarrollos científico-
tecnológicos, códigos de prácticas en la industria, seguridad alimentaria y calidad
del producto y que están informados de los factores que pueden tener influencia
sobre la defensa de los alimentos (food defence) y los riesgos de fraude
alimentario.
1.2.6 * La dirección se asegurará de que la entidad de certificación esté informada de
cualquier cambio que pueda afectar a la capacidad de la compañía para cumplir con
los requisitos de la certificación. Esto incluirá, como mínimo:

 cualquier cambio en el nombre de la entidad legal,

 cualquier cambio de ubicación del emplazamiento de producción.
Para las siguientes situaciones específicas:
 cualquier recuperación de producto,
 cualquier recuperación y/o retirada de producto por orden oficial debida a
motivos de seguridad alimentaria y/o fraude alimentario,
 cualquier visita de las autoridades que resulte en una acción obligatoria
relacionada con la seguridad alimentaria y/o el fraude alimentario
 se informará a la entidad de certificación en un plazo de tres (3) días
hábiles.
1.3 Revisión por la dirección
1.3.1
* La dirección debe asegurarse de que el sistema de gestión de la seguridad
alimentaria y la calidad es revisado. Esta actividad se planificará en un plazo de 12
meses y su ejecución no excederá de 15 meses. Dichas revisiones deberán incluir,
como mínimo:
• una revisión de los objetivos y políticas, incluyendo elementos de
la cultura de seguridad alimentaria
• resultados de auditorías e inspecciones del emplazamiento
• comunicaciones con el cliente positivas y negativas
• cumplimiento del proceso
• resultado de la evaluación del fraude alimentario
• resultado de la evaluación de la defensa de los alimentos (food defence)
• problemas de cumplimiento
• estado de las correcciones y acciones correctivas
• notificaciones de las autoridades
1.3.2 Las acciones de la revisión por la dirección estarán destinadas a apoyar la mejora.
La revisión por la dirección evaluará las acciones de seguimiento de las revisiones
por la dirección anteriores y cualquier cambio que pueda afectar al sistema de
gestión de la seguridad alimentaria y la calidad. La revisión por la dirección estará
plenamente documentada.
1.3.3
La dirección identificará y revisará (por ejemplo, mediante auditorías internas o
inspecciones in situ) la infraestructura y el entorno de trabajo necesarios para garantizar la
seguridad alimentaria, la calidad del producto, la legalidad y la autenticidad, al menos una
vez dentro de un período de 12 meses o siempre que se produzcan cambios
significativos.
Esto incluirá, como mínimo:
• edificios
• sistemas de suministro
• maquinaria y equipos
• transporte
• instalaciones para el personal
• condiciones ambientales
• condiciones higiénicas
• diseño del lugar de trabajo
• influencias externas (p.e. ruido, vibración).

En base al riesgo, los resultados de la revisión se considerarán para la

planificación de inversiones.

2 Sistema de gestión de la seguridad alimentaria y la

calidad
2.1 Gestión de la calidad
2.1.1 Gestión de documentos
2.1.1.1 Se documentará, implementará y mantendrá un procedimiento para el control de
los documentos y sus modificaciones. Todos aquellos documentos que sean
necesarios para el cumplimiento con la seguridad alimentaria, la calidad, legalidad,
 autenticidad y requisitos del cliente estarán disponibles en su última versión. Se
registrará el motivo de cualquier modificación en los documentos que se
consideren críticos para los requisitos.
2.1.1.2 El sistema de gestión de la seguridad alimentaria y la calidad se documentará,
implementará y mantendrá en un lugar seguro. Esto aplica tanto a los sistemas
físicos y/o a los sistemas digitales documentados.
2.1.1.3 * Todos los documentos deberán ser claramente legibles, exhaustivos y no
presentarán ambigüedades. Deberán estar disponibles en todo momento para las
personas correspondientes.
2.1.2 Registros e información documentada
2.1.2.1 Los registros y la información documentada serán legibles, completados
correctamente y auténticos. Se mantendrán de manera que se evite la revisión o
modificación posterior. Si los registros son electrónicos, se mantendrá un sistema
para garantizar que sólo el personal autorizado tenga acceso a crear o modificar
dichos registros (por ejemplo, protección con contraseña).
2.1.2.2 * Todos los registros e información documentada se conservarán de acuerdo con
los requisitos legales y de cliente. Si no existen tales requisitos, los registros y la
información documentada se conservará durante un mínimo de un año después de
la vida útil especificada. Para productos sin vida útil, el tiempo de conservación de
registros e información documentada se justificará y dicha justificación deberá
quedar documentada.
2.1.2.3 Los registros y la información documentada se conservarán en lugar seguro y de
fácil acceso.
2.2 Gestión de la seguridad alimentaria
2.2.1 Plan APPCC
2.2.1.1 * La base del sistema de gestión de la seguridad alimentaria de la compañía será un
plan APPCC totalmente implantado, sistemático y exhaustivo que esté basado en
los principios del Codex Alimentarius, buenas prácticas de fabricación, buenas
prácticas de higiene y cualquier requisito legal de los países de producción y de
destino que pueda ir más allá de tales principios. El plan APPCC deberá ser
específico y deberá estar implantado en el emplazamiento de producción.
2.2.1.2 * El plan APPCC deberá abarcar todas las materias primas, material de envasado,
productos o grupos de productos, así como todos los procesos, desde la recepción
hasta la expedición de producto final, incluyendo el desarrollo de nuevos
productos.
2.2.1.3 La compañía se asegurará de que el plan APPCC se basa en datos científicos, o
asesoramiento experto obtenido mediante otras fuentes, las cuales pueden incluir:
asociaciones comerciales y de la industria, expertos independientes y autoridades.
Esta información deberá estar alineada con cualquier nuevo desarrollo técnico de
procesos.
2.2.1.4 En el en caso de que haya cambios en las materias primas, materiales de envasado,
métodos de procesado, infraestructura y/o equipos, el plan APPCC será revisado
para garantizar que los requisitos de seguridad del producto se cumplen.

2.3 Análisis APPCC

2.3.1 Equipo HACCP
2.3.1.1 Formación del equipo APPCC:
El equipo APPCC deberá tener conocimiento específico y experiencia, y ser un
equipo multidisciplinar que incluya personal operativo.
2.3.1.2 Las personas responsables del desarrollo y mantenimiento del plan APPCC contarán
con un líder del equipo y habrán recibido formación adecuada en la aplicación de
los principios del APPCC, así como el conocimiento específico de productos y
procesos.
2.3.2 Descripción del producto
2.3.2.1 Se documentará y mantendrá una descripción completa del producto y contendrá toda la
 información relativa a la seguridad del producto, que incluye como mínimo:
• composición
• características físicas, organolépticas, químicas y microbiológicas
• requisitos legales para la seguridad alimentaria del producto
• métodos de tratamiento, envasado, durabilidad (vida útil),
• condiciones de almacenamiento, método de transporte y distribución.
2.3.3 Identificar el uso esperado y los usuarios del producto
2.3.3.1 Se deberá describir el uso previsto del producto, en relación con el uso esperado
del mismo por parte del consumidor final tomando en consideración a los grupos
de consumidores vulnerables.
2.3.4 Elaboración del diagrama de flujo
2.3.4.1 Para cada producto o grupo de productos y cada una de las variaciones de procesos
y subprocesos (incluyendo reelaboración y reprocesado) se deberá documentar y
mantener un diagrama de flujo. El diagrama de flujo identificará cada paso y cada
medida de control definida para los PCCs y otras medidas de control. Será fechado,
y en caso de cualquier cambio, será actualizado.
2.3.5 Confirmación in situ del diagrama de flujo
2.3.5.1 Los representantes del equipo APPCC deberán verificar el diagrama de flujo,
mediante comprobación in situ en todas las etapas y turnos operativos. Si procede,
se corregirá el diagrama.

2.3.6 Realizar un análisis de peligros para cada etapa

2.3.6.1 Se realizará un análisis de todos los peligros físicos, químicos (incluyendo peligros
radiológicos y alérgenos), y biológicos que puedan esperarse. El análisis también
incluirá los peligros relacionados con los materiales en contacto con alimentos,
materiales de envasado y peligros relacionados con el entorno de trabajo. El
análisis de peligros deberá considerar la probabilidad de aparición de los peligros y
la gravedad de sus efectos adversos en la salud. Se considerarán las medidas de
control específicas que se aplicarán para controlar cada peligro pertinente.

2.3.7 Determinar los puntos de control críticos y otras medidas de control

2.3.7.1 Se facilitará la determinación de los PCCs correspondientes y otras medidas de
control mediante la aplicación de un árbol de decisiones u otras herramientas, que
demuestren un planteamiento lógico y razonado.

2.3.8 Establecer límites criticos para cada PCC

2.3.8.1 * Para cada PCC se definirán y validarán límites críticos para identificar cuándo un
proceso está fuera de control.

2.3.9 Establecer un sistema de vigilancia para cada PCC

2.3.9.1 * KO N° 2: Se documentará, implementará y mantendrá para cada PCC,
procedimientos específicos de vigilancia que especifiquen métodos, frecuencia de
medición u observación y registro de resultados, parar detectar cualquier pérdida
de control de dicho PCC. Cada PCC definido deberá estar bajo control. La
vigilancia y el control de cada PCC se demostrarán mediante registros.

2.3.9.2 Los registros de la vigilancia de los PCCs deberán ser verificados por un responsable
de la compañía y ser mantenidos durante un periodo de tiempo adecuado.
2.3.9.3 El personal operativo a cargo de la vigilancia de los PCCs y otras medidas de control
deberá haber recibido una formación / instrucción específica.

2.3.9.4 Las medidas de control distintas de los PCCs se vigilaran, registrarán y controlarán
mediante criterios medibles u observables.
2.3.10 Establecer medidas correctivas
2.3.10.1 En el caso de que el seguimiento indique que una medida de control determinada
definida para un PCC o cualquier otra medida de control, no está bajo control, se
documentarán e implementarán las acciones correctivas. Dichas acciones
correctivas deberán tomar también en consideración cualquier acción en relación a
productos no conformes e identificar la causa raíz de la pérdida de control de los
PCCs.

2.3.11 Validar el plan APPCC y establecer procedimientos de verificación

2.3.11.1 Los procedimientos de validación, incluida la revalidación después de cualquier
modificación que pueda afectar a la seguridad de los alimentos, deberán
documentarse, implementarse y mantenerse para garantizar que el plan APPCC sea
adecuado para controlar eficazmente los peligros identificados.
2.3.11.2 *Los procedimientos de verificación para confirmar que el plan APPCC funciona
correctamente deberán estar documentados, implementados y mantenidos.
Actividades de verificación del plan APPCC, por ejemplo:
• auditorías internas
• pruebas
• muestreo
• desviaciones y no-conformidades
• reclamaciones
se realizará al menos una vez dentro un período de 12 meses o cada vez que se
produzcan cambios significativos. Los resultados de esta verificación serán registrados e
incorporados al plan APPCC.

2.3.12 Establecer documentación y mantenimiento de registros

2.3.12.1 Documentación y registros relacionados con el APPCC, por ejemplo:
•análisis de peligros
•determinación de las medidas de control definidas para los PCCs y otras medidas de
control
•determinación de los límites críticos
•procesos
•procedimientos
•resultado de los PCCs y otras actividades de vigilancia de las medidas de control
•registros de formación del personal encargado del seguimiento del PCC
•desviaciones observadas y acciones correctivas
implementadas. estarán disponibles.

3 Resource management
3.1 Human resources
3.1.1 All personnel performing work that affects product safety, quality, legality and
authenticity shall have the required competence, appropriate to their role, as a
result of education, work experience and/or training.
3.1.2 All personnel performing work that affects product safety, quality, legality and
authenticity shall have the required competence, appropriate to their role, as a
result of education, work experience and/or training.
3.2 Personal hygiene
3.2.1 Risk-based requirements relating to personal hygiene shall be documented,
implemented and maintained and shall include, at a minimum, the following areas:
• hair and beards
• protective clothing (including their conditions of use in staff facilities)
• hand washing, disinfection and hygiene
• eating, drinking, smoking/vaping or other use of tobacco
• actions to be taken in case of cuts or skin abrasions
• fingernails, jewellery, false nails/eyelashes and personal belongings
(including medicines)
• notification of infectious diseases and conditions impacting food safety via
a medical screening procedure.

3.2.2 KO N° 3: The requirements for personal hygiene shall be understood and applied
by all relevant personnel, contractors and visitors.
3.2.3 Compliance with personal hygiene requirements shall be monitored with a
frequency based on risks, but at least once within a 3-month period.
3.2.4 A risk-based program shall be implemented and maintained to control the
effectiveness of hand hygiene.
3.2.5 Visible jewellery (including piercing) and watches shall not be worn. Any exceptions
shall have been comprehensively evaluated based on risks and shall be effectively
managed.
3.2.6 Cuts and skin abrasions shall be covered with a plaster/bandage that shall not pose
contamination risks. Plasters/bandages shall be waterproof and coloured differently
from the product colour.
Where appropriate:
• plasters/bandages shall contain a metal strip
• single use gloves shall be worn.
3.2.7 In work areas where wearing headgear and/or a beard snood (coverings) is
required, the hair shall be covered completely to prevent product contamination.
3.2.8 Usage rules shall be implemented for work areas/activities where it is required to
wear gloves (coloured differently from the product colour).
3.2.9 Usage rules shall be implemented for work areas/activities where it is required to
wear gloves (coloured differently from the product colour).
3.2.10 All protective clothing shall be thoroughly and regularly laundered in-house, by
approved contractors or by employees. This decision shall be documented and
based on risks. Requirements related to laundry shall ensure a minimum of the
following:
• sufficient segregation between dirty and clean clothing at all times
• laundering conditions on water temperature and detergent dosage
• avoidance of contamination until use.
The effectiveness of the laundering shall be monitored.
3.2.11 In case of any health issue or infectious disease that may have an impact on food
safety, actions shall be taken to minimise contamination risks.

3.3 Training and instruction

3.3.1 Documented training and/or instruction programs shall be implemented with
respect to the product and process requirements and the training needs of the
employees, based on their job, and shall include:
• training contents
• training frequency
• employee tasks
• languages
• qualified trainer/tutor
• evaluation of training effectiveness.
3.3.2 The documented training and/or instruction programs shall apply to all personnel,
including seasonal and temporary workers and employees from external
companies, employed in the respective work area. Upon employment, and before
commencing work, they shall be trained/instructed
in accordance with the documented training/instruction programs.

3.3.3 Records of all training/instruction events shall be available, stating:

• list of participants (including their signature)
• date
• duration
• contents of training
• name of trainer/tutor.
A procedure or program shall be documented, implemented and maintained to
prove the effectiveness of the training and/or instruction programs.

3.3.4 The contents of training and/or instruction shall be reviewed and updated when
necessary.
Special consideration shall be given to these specific issues, at a minimum:
• food safety
• product authenticity, including food fraud
• product quality
• food defence
• food related legal requirements
• product/process modifications
• feedback from the previous documented training/instruction programs.

3.4 Staff facilities

3.4.1 Adequate staff facilities shall be provided and shall be proportional in size,
equipped for the number of personnel, and designed and controlled to minimise
food safety risks. Such facilities shall be maintained in a way to prevent
contamination.

3.4.2 Product contamination risks by food and drink and/or foreign materials shall be
minimised. Consideration shall be given to food and drink from vending machines,
canteen and/or brought to work by personnel.
3.4.3 Changing rooms shall be located to allow direct access to the areas where
unpacked food products are handled. When infrastructure does not allow it,
alternative measures shall be implemented and maintained to minimise product
contamination risks. Outdoor clothing and protective clothing
shall be stored separately unless alternative measures are implemented and
maintained to prevent contamination risks.
3.4.4 Toilets shall neither have direct access nor pose contamination risks to areas where
products are handled. Toilets shall be equipped with adequate hand washing
facilities. The facilities shall have adequate natural or mechanical ventilation.
Mechanical airflow from a contaminated area to a
clean area shall be avoided.

3.4.5 Hand hygiene facilities shall be provided and shall address, at a minimum:
• adequate number of wash basins
• suitably located at access points to and/or within production areas
• designated for cleaning hands only.
The necessity of similar equipment in further areas (e.g. packing area) shall be
based on risks.
3.4.6 Hand hygiene facilities shall provide:
• running potable water at an adequate temperature
• adequate cleaning and disinfection equipment
• adequate means for hand drying.
3.4.7 Where the processes require a higher hygiene control, the hand washing
equipment shall provide in addition:
• hand contact-free fittings
• hand disinfection
• waste container with hand contact-free opening.
3.4.8 Where needed, cleaning and disinfection facilities shall be available and used for
boots, shoes and further protective clothing.

4 Operational processes
4.1 Customer focus and contract agreement
4.1.1 A procedure shall be implemented and maintained to identify fundamental needs
and expectations of customers. The feedback from this process shall be used as
input for the company’s continuous improvement.

4.1.2 All requirements related to food safety and product quality, within the customer
agreements, and any revision of these clauses, shall be communicated to, and
implemented by each relevant department.
4.1.3 KO N° 4: Where there are customer agreements related to:
• product recipe (including raw materials characteristics)
• process
• technological requirements
• testing and monitoring plans
• packaging
• labelling
these shall be complied with.

4.1.4 In accordance with customer requirements, the senior management shall inform
their affected customers, as soon as possible, of any issue related to product safety
or legality, including deviations and non-conformities identified by competent
authorities.
4.2 Specifications and formulas
4.2.1 Specifications
4.2.1.1 Specifications shall be documented and implemented for all finished products. They
shall be up to date, unambiguous and in compliance with legal and customer
requirements.
4.2.1.2 A procedure to control the creation, approval and amendment of specifications
shall be documented, implemented and maintained and shall include, where
required, the acceptance of the customer(s).
Where required by customers, product specifications shall be formally agreed.
This procedure shall include the update of finished product specifications in case of
any modification related to:
• raw materials
• formulas/recipes
• processes which impact the finished products
• packaging materials which impact the finished products.
4.2.1.3 KO N° 5: Specifications shall be documented and implemented for all raw
materials (ingredients, additives, packaging materials, rework). Specifications
shall be up to date, unambiguous and in compliance with legal requirements and,
if defined, with customer requirements
4.2.1.4 Specifications and/or their contents shall be available on-site for all relevant
personnel.
4.2.1.5 Where products are requested to be labelled and/or promoted with a claim or
where certain methods of treatment or production are excluded, measures shall be
implemented to demonstrate compliance with such a statement.
4.3 Product development/Product modification/Modification of
production processes
4.3.1 A procedure for the development or modification of products and/or processes
shall be documented, implemented and maintained and shall include, at a
minimum, a hazard analysis and assessment of associated risks.
4.3.2 The procedure shall ensure that labelling complies with current legislation of the
destination country/ies and customer requirements.
4.3.3 The development and/or modification process shall result in specifications about
formulation, rework, packaging materials, manufacturing processes and comply
with food safety, product quality, legality, authenticity and customer requirements.
This includes factory trials, product testing and
process monitoring. The progress and results of product development/
modification shall be recorded.
4.3.4 Shelf life tests or appropriate validation through microbiological, chemical and
organoleptic evaluation shall be carried out and consideration shall be given to
product formulation, packaging, manufacturing and declared conditions. The shelf
life shall be defined in accordance with this evaluation.

4.3.5 Recommendations for preparation and/or instructions for use of food products
related to food safety and/or product quality shall be validated and documented.
4.3.6 Nutritional information or claims which are declared on labelling shall be validated
through studies and/or tests throughout the shelf life of the products.

4.4 Purchasing
4.4.1 A procedure for the sourcing of raw materials, semi-finished products and
packaging materials and the approval and monitoring of suppliers (internal and
external) shall be documented, implemented and maintained.
This procedure shall contain, at a minimum:
• raw materials and/or suppliers’ risks
• required performance standards (e.g., certification, origin, etc.)
• exceptional situations (e.g. emergency purchase)

And, based on risks, additional criteria, for example:

• audits performed by an experienced and competent person
• testing results
• supplier reliability
• complaints
• supplier questionnaire.
4.4.2 The purchased materials shall be assessed, based on risks and suppliers’ status, for
food safety, product quality, legality and authenticity. The results shall be the basis
for the testing and monitoring plans.
4.4.3 The purchasing services, which have, based on risks, an impact on food safety and
product quality, shall be evaluated to ensure they comply with defined
requirements.
This shall take into account, at a minimum:
• the service requirements
• the supplier’s status (according to its assessment)
• the impact of the service on the finished products.
4.4.4 Where a part of the product processing and/or primary packing and/or labelling is
outsourced, this shall be documented in the food safety and quality management
system and such processes shall be controlled to guarantee that food safety,
product quality, legality and authenticity are not compromised. Control of such
outsourced processes shall be identified and documented. When required by the
customer, there shall be evidence that they have been informed and have agreed to
such outsourced process.
4.4.5 An agreement shall be documented and implemented, covering the outsourced
processes and describing any arrangements made in connection with it, including
in-process controls, testing and monitoring plans.
4.4.6 Suppliers of the outsourced processes shall be approved through:
• certification to IFS Food or other GFSI recognised food safety certification
standard, or
• documented supplier audit, performed by an experienced and competent
person, which shall include, at a minimum, requirements for food safety,
product quality, legality and authenticity.
4.4.7 The sourcing of materials and supplier assessments shall be reviewed at least once
within a 12-month period or whenever significant changes occur. Records of the
reviews and the consequential actions of the assessment shall be documented.

4.5 Product packaging

4.5.1 Based on risks and intended use, key parameters for the packaging materials shall
be defined in detailed specifications complying with the current relevant legislation
and other relevant hazards or risks.
Suitability of the food contact packaging materials and existence of functional
barrier(s) shall be validated for each relevant product. It shall be monitored and
demonstrated by test/analysis, for example:
• organoleptic tests
• storage tests
• chemical analyses
• migration test results.
4.5.2 For all packaging materials which could have an impact on products, declarations of
compliance, which attest compliance with legal requirements shall be documented.
In the event that no specific legal requirements are applicable, evidence shall be
maintained to ensure that packaging materials are suitable for use. This applies for
packaging materials which could have an influence on raw materials, semi-finished
and finished products.
4.5.3 Used packaging and labelling shall correspond to the product being packed and
shall comply with agreed customer product specifications.
Labelling information shall be legible and indelible. This shall be monitored and
documented at least at the start and end of a production run as well as at
every product changeover.

4.6 Factory location

4.6.1 Potential adverse impact on food safety and/or product quality from the factory
environment (e.g. ground, air) shall be investigated.
Where risks have been identified (e.g. extremely dusty air, strong smells), measures
shall be documented, implemented and reviewed for effectiveness at least once
within a 12-month period or whenever significant changes occur.

4.7 Factory exterior

4.7.1 All external areas of the factory shall be clean, tidy, designed and maintained in a
way to prevent contamination. Where natural drainage is inadequate, a suitable
drainage system shall be installed.
4.7.2 Outdoor storage shall be kept to a minimum. Where goods are stored outside, it
shall be ensured that there are no contamination risks or adverse effects on food
safety and quality.
4.8 Plant layout and process flow
4.8.1 A site plan covering all buildings shall be documented and maintained and shall
describe, at a minimum, the process flow of:
• finished products
• semi-finished products, including rework
• packaging materials
• raw materials
• personnel
• waste
• water.
4.8.2 The process flow, from receipt of goods to dispatch, shall be implemented,
maintained, reviewed and where necessary, modified to ensure that the
microbiological, chemical and physical contamination risks of raw materials,
packaging materials, semi-finished and finished products are avoided.
The cross-contamination risks shall be minimised through effective measures.

4.8.3 In the case where areas sensitive to microbiological, chemical and physical risks,
have been identified, they shall be designed and operated to ensure product safety
is not compromised.
4.8.4 Laboratory facilities and in-process controls shall not affect product safety.

4.9 Production and storage premises

4.9.1 Constructional requirements
4.9.1.1 Premises where food products are prepared, treated, processed and stored shall be
designed, constructed and maintained to ensure food safety.

4.9.2 Walls
4.9.2.1 Walls shall be designed and constructed to meet production requirements in a way
to prevent contamination, reduce condensation and mould growth, facilitate
cleaning and if necessary, disinfection.
4.9.2.2 The surfaces of walls shall be maintained in a way to prevent contamination and
easy to clean; they shall be impervious and wear-resistant to minimise product
contamination risks.
4.9.2.3 The junctions between walls, floors and ceilings shall be designed to facilitate
cleaning and if necessary, disinfection.
4.9.3 Floors
4.9.3.1 Floor covering shall be designed and constructed to meet production requirements
and be maintained in a way to prevent contamination and facilitate cleaning and if
necessary, disinfection. Surfaces shall be impervious and wear-resistant.
4.9.3.2 The hygienic disposal of water and other liquids shall be ensured. Drainage systems
shall be designed, constructed and maintained in a way to minimise product
contamination risks (e.g. entry of pests, areas sensitive to transmission of odour or
contaminants) and shall be easy to clean.
4.9.3.3 In food handling areas, machinery and piping shall be arranged to allow
wastewater, if possible, to flow directly into a drain.
Water and other liquids shall reach drainage using appropriate measures without
difficulty. Stagnation of puddles shall be avoided.
4.9.4 Ceilings/Overheads
4.9.4.1 Ceilings (or, where no ceilings exist, the inside of roofs) and overhead fixtures
(including piping, cableway, lamps, etc.) shall be designed, constructed and
maintained to minimise the accumulation of dirt and condensation and shall not
pose any physical and/or microbiological contamination risks.

4.9.4.2 Where false ceilings are used, access to the vacant area shall be provided to
facilitate cleaning, maintenance and inspection for pest control.
4.9.5 Windows and other openings
4.9.5.1 Windows and other openings shall be designed and constructed to avoid the
accumulation of dirt and shall be maintained in a way to prevent contamination.
4.9.5.2 Where there are contamination risks, windows and roof glazing shall remain closed
and fixed during production.
4.9.5.3 Where windows and roof glazing are designed to be opened for ventilation
purposes, they shall be fitted with easy to clean pest screens or other measures to
prevent any contamination.
4.9.5.4 In areas where unpackaged products are handled, windows shall be protected
against breakage.
4.9.6 Doors and gates
4.9.6.1 Doors and gates shall be maintained in a way to prevent contamination and be easy
to clean. They shall be designed and constructed of non-absorbent materials to
avoid:
• splintering parts
• flaking paint
• corrosion.
4.9.6.2 External doors and gates shall be constructed to prevent the access of pests.
4.9.6.3 Plastic strip curtains separating areas shall be maintained in a way to prevent
contamination and be easy to clean.

4.9.7 Lighting
4.9.7.1 All production, storage, receipt and dispatch areas shall have adequate levels of
light.

4.9.8 Air conditioning/Ventilation

4.9.8.1 Adequate natural and/or artificial ventilation shall be designed, constructed and
maintained in all areas.
4.9.8.2 If ventilation equipment is installed, filters and other components shall be easily
accessible and monitored, cleaned or replaced as necessary.

4.9.8.3 Air conditioning equipment and artificially generated airflow shall not compromise
product safety and quality.
4.9.8.4 Dust extraction equipment shall be designed, constructed and maintained in areas
where considerable amounts of dust are generated.
4.9.9 Water
4.9.9.1 Water which is used for hand washing, cleaning and disinfection, or as an
ingredient in the production process shall be of potable quality at the point of use
and supplied in sufficient quantities.
4.9.9.2 The quality of water (including recycled water), steam or ice shall be monitored
following a risk- based sampling plan.
4.9.9.3 Recycled water, which is used in the process, shall not pose contamination risks.
4.9.9.4 Non-potable water shall be transported in separate, properly marked piping. Such
piping shall neither be connected to the potable water system nor allow the
possibility of reflux, to prevent contamination of potable water sources or factory
environment.
4.9.10 Compressed air and gases
4.9.10.1 The quality of compressed air that comes in direct contact with food or food
contact material shall be monitored based on risks. Compressed air shall not pose
contamination risks.

4.9.10.2 Gases that come in direct contact with food or food contact materials shall
demonstrate safety and quality for the intended use.
4.10 Cleaning and disinfection
4.10.1 Risk-based cleaning and disinfection schedules shall be validated, documented and
implemented. These shall specify:
• objectives
• responsibilities
• the products used and their instructions for use
• dosage of cleaning and disinfection chemicals
• the areas and timeslots for cleaning and disinfection activities
• cleaning and disinfection frequency
• Cleaning In Place (CIP) criteria, if applicable
• documentation requirements
• hazard symbols (if necessary).
4.10.2 Cleaning and disinfection activities shall be implemented and shall result in
effectively cleaned premises, facilities and equipment.

4.10.3 Cleaning and disinfection activities shall be documented and such records shall be
verified by a responsible designated person in company.

4.10.4 Only competent personnel shall perform cleaning and disinfection activities. The
personnel shall be trained and retrained to carry out the cleaning and disinfection
schedules.
4.10.5 The intended use of cleaning and disinfection equipment shall be clearly specified.
It shall be used and stored in a way to avoid contamination.
4.10.6 Safety Data Sheets and instructions for use shall be available on-site for cleaning
and disinfection chemicals. Personnel responsible for cleaning and disinfection
activities shall be able to demonstrate their knowledge of such instructions.
4.10.7 The effectiveness of the cleaning and disinfection measures shall be verified. The
verification shall rely on a risk- based sampling schedule and shall consider, one or
several actions, like for example:
• visual inspection
• rapid testing
• analytical testing methods. Resultant actions shall be documented.
4.10.8 Cleaning and disinfection schedules shall be reviewed and modified in the event
that changes occur to products, processes or cleaning and disinfection equipment,
if necessary.
4.10.9 Where a company hires a third-party service provider for cleaning and disinfection
activities in production areas, all above-mentioned requirements shall be
documented in the service contract.

4.11 Waste management

4.11.1 A waste management procedure shall be documented, implemented and
maintained to prevent cross contamination.

4.11.2 All local legal requirements for waste disposal shall be met.

4.11.3 Food waste and other waste shall be removed as quickly as possible from areas
where food is handled. The accumulation of waste shall be avoided.

4.11.4 Waste collection containers shall be clearly marked, suitably designed and
maintained, easy to clean, and where necessary disinfected.
4.11.5 If a company decides to separate food waste and to reintroduce it into the feed
supply chain, measures or procedures shall be implemented to prevent
contamination or deterioration of this material.
4.11.6 Waste shall be collected in separate containers in accordance with the intended
means of disposal. Such waste shall be disposed by authorised third parties only.
Records of waste disposal shall be kept by the company.
4.12 Foreign material and chemicals risk mitigation
4.12.1 KO N° 6: Based on risks, procedures shall be documented, implemented and
maintained to prevent contamination with foreign materials. Contaminated
products shall be treated as non-conforming products.
4.12.2 The products being processed shall be protected against physical contamination,
which includes but is not limited to:
• environmental contaminants
• oils or dripping liquids from machinery
• dust spills.

Special consideration shall also be given to product contamination risks caused by:
• equipment and utensils
• pipes
• walkways
• platforms
• ladders.
If, for technological characteristics and/or needs, it is not possible to protect the
products, appropriate control measures shall be implemented.
4.12.3 All chemicals within the site shall be fit for purpose, labelled, stored and handled in
a way not to pose contamination risk.
4.12.4 Where metal and/or other foreign material detectors are required, they shall be
installed to ensure maximum efficiency of detection to prevent subsequent
contamination. Detectors shall be subjected to maintenance to avoid malfunction
at least once within a 12 months period, or whenever significant changes occur.

4.12.5 The accuracy of all equipment and methods designed to detect and/or eliminate
foreign material, shall be specified. Functionality tests of such equipment and
methods shall be carried out on a risk-based frequency. In case of malfunction or
failure, the impact on products and processes shall be assessed.
4.12.6 Potentially contaminated products shall be isolated. Access and actions for the
further handling or testing of these isolated products shall be carried out by
authorised personnel.
4.12.7 In areas where raw materials, semi-finished and finished products are handled, the
use of glass and/or brittle materials shall be excluded; however where the presence
of glass and/or brittle materials cannot be avoided, the risks shall be controlled and
the glass and/or brittle materials shall be clean and pose no risks to product safety.

4.12.8 Risk-based measures shall be implemented and maintained for the handling of
glass packaging, glass containers or other kinds of containers in the production
process (turn over, blow, rinse, etc.). After this process step there shall be no
further contamination risks.
4.12.9 Procedures shall be documented, implemented and maintained to describe the
measures to be taken in case of glass breakage and/or brittle materials. Such
measures shall include identifying the scope of goods to be isolated, specifying
authorised personnel, cleaning and if necessary, disinfection of the production
environment and releasing the production line for continued production.

4.12.10 Breakages of glass and brittle material shall be recorded. Exceptions shall be
justified and documented.
4.12.11 Where visual inspection is used to detect foreign materials, the employees shall be
trained and operative changes shall be performed at an appropriate frequency to
maximise the effective- ness of the process.
4.12.12 In areas where raw materials, semi-finished and finished products are handled, the
use of wood shall be excluded; however where the presence of wood cannot be
avoided, the risks shall be controlled and the wood shall be clean and pose no risks
to product safety.
4.13 Pest monitoring and control
4.13.1 Site premises and equipment shall be designed, built and maintained to prevent
pest infestation.

4.13.2 Risk-based pest control measures shall be documented, implemented and

maintained. They shall comply with local legal requirements and shall take into
account, at a minimum:
• factory environment (potential and targeted pests)
• type of raw material/finished products
• site plan with area for application (bait map)
• constructional designs susceptible for pest activity, for example ceilings,
cellars, pipes, corners
• identification of the baits on site
• responsibilities, in-house/ external
• agents used and their instructions for use and safety
• frequency of inspections
• rented storage if applicable.
4.13.3 Where a company hires a third-party service provider for pest control, all above-
mentioned requirements shall be documented in the service contract. A competent
person at the company shall be appointed to monitor the pest control activities.
Even if the pest control service is outsourced, responsibilities for the necessary
actions (including ongoing supervision of pest control activities) shall remain within
the company.
4.13.4 Pest control inspections and resulting actions shall be documented.
Implementation of actions shall be monitored and recorded.
Any infestation shall be documented and control measures taken.
4.13.5 Baits, traps and insect exterminators shall be fully functioning, sufficient in number,
designed for purpose, placed in appropriate positions and used in a way to avoid
contamination.
4.13.6 Incoming deliveries shall be inspected on arrival for the presence of pests. Any
findings shall be recorded.
4.13.7 The effectiveness of the pest control measures shall be monitored, including trend
analysis, to allow timely actions. Records of this monitoring shall be available.

4.14 Receipt and storage of goods

4.14.1 All incoming goods, including packaging materials and labels, shall be checked for
compliance with specifications and a determined risk-based monitoring plan. The
monitoring plan shall be justified by risk assessment. Records of those inspections
shall be available.

4.14.2 A system shall be implemented and maintained to ensure storage conditions of raw
materials, semi-finished, finished products and packaging materials, correspond to
product specifications, and do not have any negative impact on other products.
4.14.3 Raw materials, packaging materials, semi-processed and finished products shall be
stored to minimise contamination risks or any other negative impact.
4.14.4 Adequate storage facilities shall be available for the management and storage of
working materials, process aids, and additives. The personnel responsible for the
management of storage facilities shall be trained.
4.14.5 All products shall be clearly identified. Use of products shall be undertaken in
accordance with the principles of First In / First Out and/or First Expired / First Out.
4.14.6 Where a company hires a third-party storage service provider, the service provider
shall be certified against IFS Logistics or any other GFSI recognised certification
standard covering the respective scope of activity. If not, all relevant requirements
equivalent to the company's own storage practices shall be fulfilled and this shall be
clearly defined in the respective contract.
4.15 Transport
4.15.1 The conditions inside the vehicles related to the absence of, for example:
• strange smells
• high dust load
• adverse humidity
• pests
• mould
shall be checked before loading and be documented to ensure compliance with the
defined conditions.

4.15.2 Where goods are transported at certain temperatures, the temperature inside the
vehicles shall be checked and documented before loading.
4.15.3 Procedures to prevent contamination during transport, including loading and
unloading, shall be documented, implemented and maintained. Different
categories of goods (food/ non-food) shall be taken into consideration, if applicable.
4.15.4 Where goods are transported at certain temperatures, maintaining the appropriate
range of temperatures during transport shall be ensured and documented.
4.15.5 Risk-based hygiene requirements for all transport vehicles and equipment used for
loading/unloading (e.g. hoses of silo installations) shall be implemented. Measures
taken shall be recorded.
4.15.6 The loading/unloading area shall be appropriate for their intended use. They shall
be constructed in a way that:
• the risks of pest intake are mitigated
• products are protected from adverse weather conditions
• accumulation of waste is avoided
• condensation and growth of mould are prevented
• cleaning and if necessary, disinfection can be easily undertaken.
4.15.7 Where a company hires a third-party transport service provider, the service
provider shall be certified for IFS Logistics or any other GFSI recognised certification
standard covering the respective scope of activity. If not, all relevant requirements
equivalent to the company's own transport practices shall be fulfilled and this shall
be clearly defined in the respective contract.

4.16 Maintenance and repair

4.16.1 A maintenance plan shall be documented implemented and maintained, that
covers all critical equipment (including transport and storage premises) to ensure
food safety, product quality and legality. This applies both to internal maintenance
activities and service providers. The plan shall include responsibilities, priorities and
due dates.
4.16.2 Food safety, product quality, legality and authenticity shall be ensured during and
after maintenance and repair work. Records of maintenance and repair work shall
be kept.
4.16.3 All materials used for maintenance and repair shall be fit for the intended use and
shall not pose contamination risks.
4.16.4 Failures and malfunctions of premises and equipment (including transport) that are
essential for food safety and product quality, shall be identified, documented and
reviewed to enable prompt actions and to improve the maintenance plan.
4.16.5 Temporary repairs shall be carried out to avoid compromising food safety and
product quality. Such work shall be documented and a short-term deadline set for
eliminating the issue.
4.16.6 Where a company hires a third-party maintenance and repair service provider, all
the company requirements regarding material, equipment and operational rules
shall be defined, documented and maintained in the service contract, to prevent
any product contamination.
4.17 Equipment
4.17.1 Equipment shall be suitably designed and defined for the intended use. Before
commissioning new equipment, compliance with food safety, product quality,
legality, authenticity and customer requirements shall be validated.
4.17.2 For all equipment and utensils which could have an impact on the product,
evidence shall be documented to demonstrate compliance with legal requirements.
In case no specific legal requirements are in place, evidence shall be available, for
example:
• certificate of conformity
• technical specifications
• manufacturer's self-declaration
to demonstrate that they are suitable for the intended use.

4.17.3 Equipment shall be located to allow effective cleaning, disinfection and

maintenance operations.
4.17.4 All product equipment shall be in a condition that does not compromise food safety
and product quality.
4.17.5 In the event of changes to equipment, the process characteristics shall be reviewed
to ensure that food safety, product quality, legality, authenticity and customer
requirements are complied with.

4.18 Traceability
4.18.1 KO N° 7: A traceability system shall be documented, implemented and maintained
that enables the identification of product lots and their relation to batches of raw
materials and food contact packaging materials, and/or materials carrying legal
and/or relevant food safety information.
The traceability system shall incorporate all relevant records of:
• receipt
• processing at all steps
• use of rework
• distribution.
Traceability shall be ensured and documented until delivery to the customer.
4.18.2 The traceability system shall be tested on a periodic basis, at least annually and
each time the traceability system changes. The test samples shall represent the
complexity of the company's product range. The test records shall verify upstream
and downstream traceability (from delivered products to raw materials, and vice
versa). The traceability of the finished product shall be performed within four (4)
hours maximum.
4.18.3 The traceability from the finished products to the raw materials and to the
customers shall be performed within four (4) hours maximum. Test results,
including the timeframe for obtaining the information, shall be recorded and where
necessary actions shall be taken. Timeframe objectives shall be in compliance with
customer requirements if less than four (4) hours are required.

4.18.4 Labelling of semi-finished or finished product lots shall be made at the time when
the goods are directly packed to ensure a clear traceability of goods. Where goods
are labelled at a later time, the temporarily stored goods shall have a specific lot
labelling. Shelf life (e.g. best before date) of labelled goods shall be defined using
the original production batch.

4.18.5 If required by the customer, identified representative samples of the manufacturing

lot or batch number shall be stored appropriately and kept until expiration of the
"Use by" or "Best before" date of the finished product and if necessary, for a
determined period beyond this date.
4.19 Allergen risk mitigation
4.19.1 For all raw materials, a risk assessment shall be performed to identify allergens
requiring declarations, including accidental or technically unavoidable cross-
contaminations of legally declared allergens and traces. This information shall be
available and relevant to the country/ies of sale of the finished products and shall
be documented and maintained for all raw materials. A continuously up to date
listing of all raw materials containing allergens used on the premises shall be
maintained. This shall also identify all blends and formulas to which such raw
materials containing allergens are added.

4.19.2 Risk-based measures shall be implemented and maintained from receipt to

dispatch, to ensure that potential cross contamination of products by allergens is
minimised. The potential cross contamination risks shall be considered, related to,
at a minimum:
• environment
• transport
• storage
• raw materials
• personnel (including contractors and visitors)
Implemented measures shall be monitored.
4.19.3 Finished products containing allergens that require declaration shall be declared in
accordance with legal requirements. Accidental or technically unavoidable cross-
contaminations of legally declared allergens and traces shall be labelled. The
decision shall be risk based. The potential cross-contamination with allergens from
raw materials processed in the company shall also be taken into account on the
product label.

4.20 Food fraud

4.20.1 The responsibilities for a food fraud vulnerability assessment and mitigation plan
shall be defined. The responsible person(s) shall have the appropriate specific
knowledge.
4.20.2 A documented food fraud vulnerability assessment, including assessment criteria,
shall be documented, implemented and maintained. The scope of the assessment
shall cover all raw materials, ingredients, packaging materials and outsourced
processes, to determine the risks of fraudulent activity in relation to substitution,
mislabelling, adulteration or counterfeiting.

4.20.3 A food fraud mitigation plan shall be documented, implemented and maintained,
with reference to the vulnerability assessment, and shall include the testing and
monitoring methods.
4.20.4 The food fraud vulnerability assessment shall be reviewed at least once within a 12-
month period or whenever significant changes occur. If necessary, the food fraud
mitigation plan shall be revised/updated accordingly.

4.21 Food defence

4.21.1 The responsibility for the food defence plan shall be defined. Those responsible
person(s) shall have the appropriate specific knowledge.
4.21.2 A food defence procedure and plan shall be documented, implemented and
maintained to identify potential threats and define food defence measures. This
shall include at a minimum:
• legal requirements
• identification of critical areas and/or practices and policy of access by
employees
• visitors and contractors
• how to manage external inspections and regulatory visits
• all other appropriate control measures.
The food defence plan shall be reviewed at least annually, and updated when
appropriate.
4.21.3 The food defence plan shall be tested for effectiveness and reviewed at least once
within a 12-month period or whenever significant changes occur.

5 Measurements, analysis, improvements

5.1 Internal audits
5.1.1 KO N° 8: An effective internal audit program shall be documented, implemented
and maintained, and shall ensure at a minimum that all the requirements of the
IFS Standard are audited.
This activity shall be planned within a 12-month period and its execution shall not
exceed 15 months. The company shall have a risk assessment in place where
activities, which are critical to food safety and product quality shall be audited
more frequently.
It shall also apply to off-site storage locations owned or rented by the company.
5.1.2 The auditors shall be competent and independent from the audited department.

5.1.3 Internal audits shall be documented and results communicated to the senior
management and to persons responsible for the concerned activities. Compliances,
deviations and non-conformities shall be documented and communicated to the
relevant persons.

5.2 Site factory inspections

5.2.1 Site and factory inspections shall be planned and carried out for certain topics, like
for example:
• constructional status of production and storage premises
• external areas
• product control during processing
• hygiene during processing and within the infrastructure
• foreign material hazards
• personnel hygiene.
The frequency of inspections shall be based on risks and the history of previous
results.

5.3 Process validation and control

5.3.1 The criteria for process and working environment validation and control shall be
clearly defined.
5.3.2 Process parameters (temperature, time, pressure, chemical properties, etc.) which
are essential to ensure the food safety and product quality, shall be monitored,
recorded continuously and/ or at appropriate intervals and secured against
unauthorised access and/or change.

5.3.3 All rework operations shall be validated, monitored and documented. These
operations shall not affect the food safety and product quality requirements.

5.3.4 Procedures shall be documented, implemented and maintained for prompt

notification, recording and monitoring of equipment malfunction and process
deviations.
5.3.5 Process validation shall be performed using the collected data that is relevant for
food safety and the processes. If substantial modifications occur, a re-validation
shall be carried out.

5.4 Calibration, adjustment and checking of measuring and

monitoring devices
5.4.1 Measuring and monitoring devices required to ensure compliance with food safety
and product quality requirements shall be identified and recorded. Their calibration
status shall be recorded. Measuring and monitoring devices shall be legally
approved, if required by current relevant legislation.
5.4.2 All measuring devices shall be checked, monitored, adjusted and calibrated at
defined intervals, in accordance with defined, recognised standard/ methods and
within relevant limits of the process parameters values. The results shall be
documented.
5.4.3 All measuring devices shall be used exclusively for their defined purpose. Where
the results of measurements or the status of the device indicate a malfunction, the
device in question shall be immediately repaired or replaced. Where a malfunction
has been identified, the impact on processes and products shall be assessed to
identify whether non-conforming products have been processed.

5.5 Quantity control monitoring

5.5.1 Compliance criteria to control lot quantity shall be defined. A system on frequency
and methodology for quantity control shall be implemented and maintained to
meet the legal requirements of the destination country/ies and customer
specifications.
5.5.2 Quantity control monitoring shall be implemented and recorded, according to a
sampling plan which ensures a proper representation of the manufacturing lot. The
results from these monitoring shall be compliant with defined criteria for all
products ready to be delivered.

5.6 Product testing and environmental monitoring

5.6.1 Testing and monitoring plans, for internal and external analysis shall be
documented, implemented and maintained and shall be risk-based to ensure that
product safety, quality, legality, authenticity and specific customer requirements are
met. The plans shall cover topics, a minimum of:
• raw materials
• semi-finished products (if applicable),
• finished products
• packaging materials
• contact surfaces of processing equipment
• relevant parameters for environ- mental monitoring.
All test results shall be recorded.
5.6.2 Based on risks, the criteria for environmental monitoring program shall be
documented, implemented and maintained.
5.6.3 Analyses, which are relevant for food safety, shall preferably be performed by
laboratories with appropriate accredited programs/ methods (ISO/IEC 17025). If the
analyses are performed internally or by a laboratory without the appropriate
accredited programs/ methods, the results shall be cross- checked with test results
from laboratories accredited to these programs/ methods (ISO/IEC 17025) at least
once within a 12-month period or whenever significant changes occur.
5.6.4 Procedures shall documented, implemented and maintained to ensure the
reliability of the results from internal analyses, based on officially recognised
analysis methods. This shall be demonstrated by ring tests or other proficiency
tests.
5.6.5 Results of analyses shall be evaluated in a timely manner by competent personnel.
Immediate corrections shall be implemented for any unsatisfactory results. Based
on risks and legal requirements, the frequency for review of the testing and
monitoring plan results shall be defined in order to identify trends. When
unsatisfactory trends are identified, the impact on processes and products as well
as the need for actions shall be assessed.
5.6.6 Where internal analyses or controls are undertaken, these shall be carried out in
accordance with defined procedures by competent and approved personnel, in
defined areas or laboratories, using appropriate equipment.
5.6.7 For monitoring of the quality of the finished product, internal organoleptic tests
shall be carried out regularly. These tests shall be in accordance with specifications
and related to the impact on respective parameters of product characteristics. The
results of these tests shall be documented.
5.6.8 The testing and monitoring plans shall be regularly reviewed and updated, based
on results, changes to legislation or issues that may have an impact on product
safety, quality, legality and authenticity.

5.7 Product release

5.7.1 A procedure for quarantine (blocking/ hold) shall be documented, implemented
and maintained to ensure that only raw materials, semi-finished and finished
products complying with food safety, product quality, legality, authenticity and
customer requirements, are processed and delivered.

5.8 Management of complaints from authorities and customers

5.8.1 A procedure shall be documented, implemented and maintained for the
management of product complaints and of any written notification from the
competent authorities -within the framework of official controls-, any ordering
action or measure to be taken when non-compliance is identified.
5.8.2 All complaints shall be recorded, be readily available and assessed by competent
staff. Where it is justified, appropriate actions shall be taken immediately.

5.8.3 Complaints shall be analysed with a view to implementing actions to avoid the
recurrence of the deviations and/or non-conformity.
5.8.4 The results of complaint data analysis shall be made available to the relevant
responsible persons.

5.9 Management of product recalls, product withdrawals and

incidents
5.9.1 KO N° 9: An effective procedure shall be documented, implemented and
maintained, for the management of recalls, withdrawals, incidents and potential
emergency situations with an impact on food safety, product quality, legality and
authenticity. It shall include, at a minimum:
• the assignment of responsibilities
• the training of the responsible persons
• the decision-making process
• the nomination of a person, authorised by the company and
permanently available, to initiate the necessary process in a timely
manner
• an up to date alert contact list including customer information, sources
of legal advice, available contacts
• a communication plan including customers, authorities, and where
applicable, consumers.
5.9.2 The procedure shall be subject to internal testing for recall/withdrawal, by covering
the end-to-end process. This activity shall be planned within a 12-month period and
its execution shall not exceed 15 months. The outcome of the test shall be reviewed
for continuous improvement.
5.10 Management of non-conforming products
5.10.1 A procedure shall be documented, implemented and maintained for the
management of all non-conforming raw materials, semi-finished products, finished
products, processing equipment and packaging materials. This shall include, at a
minimum:
• defined responsibilities
• isolation/quarantine procedures
• risk assessment
• identification including labelling
• decision about the further usage like release, rework/reprocessing,
blocking, quarantine, rejection/ disposal.
5.10.2 The procedure for the management of non-conforming products shall be
understood and applied by all relevant employees.
5.10.3 Where non-conforming products are identified, immediate actions shall be taken to
ensure that food safety and product quality requirements are complied with.
5.10.4 Finished products (including packaging) that are out of specifications shall not be
placed on the market under the corresponding label, unless a written approval of
the brand owner is available.

5.11 Management of deviations, non-conformities, corrections and

corrective actions
5.11.1 A procedure for the management of corrections and corrective actions shall be
documented, implemented and maintained for the recording, analysis and
communication to relevant persons of deviations, non-conformities and non-
conforming products, with the objective to close the deviations and/or non-
conformities and avoid recurrences via corrective actions. This shall include a root
cause analysis at least for deviations and non-conformities related to safety, legality,
authenticity and/ or recurrence of deviations and non-conformities.

5.11.2 Where deviations and non-conformities are identified, corrections shall be

implemented.
5.11.3 KO N° 10: Corrective actions shall be formulated, documented and implemented
as soon as possible to avoid the further occurrence of deviations and non-
conformities. The responsibilities and the timescales for corrective actions shall
be defined.
5.11.4 The effectiveness of the implemented corrections and corrective actions shall be
assessed and the results of the assessment documented.