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ISOTS22002-1 Prerequisites Program

This document establishes the requirements for implementing food safety prerequisite programs in accordance with the ISO 22000 standard. It describes the objectives of controlling hazards related to food safety during the production stage. Additionally, it presents key terms and reference normative documents for the application of prerequisite programs.
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0% found this document useful (0 votes)
44 views30 pages

ISOTS22002-1 Prerequisites Program

This document establishes the requirements for implementing food safety prerequisite programs in accordance with the ISO 22000 standard. It describes the objectives of controlling hazards related to food safety during the production stage. Additionally, it presents key terms and reference normative documents for the application of prerequisite programs.
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd

Skills for the Development and Implementation of the System

Food Safety Management, based on FSCC 22000 Vs5

PREREQUISITE PROGRAM
Food Safety

PART 1: FOOD PREPARATION


ISO/TS 22002-1, IDT

Prepared by Eurofins GCL Capacita S.A. - FOR TRAINING PURPOSES 1


Developing Skills for the Implementation of the System
Food Safety Management, based on FSCC 22000 Vs5

1 OBJECTIVE
This standard specifies the requirements for establishing, implementing, and maintaining programs of
prerequisites (PRP) that help control hazards related to safety of the
foods. This standard applies to all organizations, regardless of their size or
complexity, which are involved in the stage of food chain production and
they wish to implement PPR in such a way that the requirements specified in ISO are addressed
22000:2012, chapter 7.

This standard is not designed and is not intended for use by other parts of the supply chain.
of food. The food processing operations are inherently diverse and not all
The requirements specified in this standard apply to a particular establishment or process.

When exclusions are made or alternative measures are implemented, they need to be justified and
documenting through a hazard analysis, as described in ISO 22000:2005, section
7.4. Any exclusions or alternative measures adopted should not affect the ability of the
organization to meet these requirements. Some examples of these exclusions include the
additional aspects relevant to the production operations corresponding to items 1), 2),
3), 4) and 5) listed later. This standard establishes detailed requirements that will be
specifically considered in relation to ISO 22000:2005, section 7.2.3; as indicated in
continuation:

a)the construction and design of buildings and related services;


b)the design of the premises, including the workplace and the facilities for the
employees;
the supplies of air, water, energy, and other services;
d)support services, including waste disposal and sewage;
e)the adjustment of the equipment and its accessibility for cleaning, general maintenance and
quote;
f)the management of purchased materials;
g) the measures to prevent cross-contamination;
h)cleaning and disinfection;
i)pest control;
j) the hygiene of the personnel.

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Developing Skills for the Implementation of the System
Food Safety Management, based on FSCC 22000 Vs5

In addition, this standard includes other aspects that are considered relevant for the
manufacturing operations:

1) reprocessing;
2) product withdrawal procedures;
3) storage;
4) product information and consumer awareness;
5) food defense, biovigilance, and bioterrorism.
NOTE. The preventive measures against malicious contamination are
are outside the scope of this regulation.

NORMATIVE DOCUMENTS FOR


2 CONSULTATION
Any regulatory document mentioned below is essential for the application of
this document.

When the listing refers to regulatory documents in which the year is indicated
publication means that this edit must be applied. Otherwise, the edit must be applied
in force, including all its modifications.

ISO 22000:2018 - Food safety management systems. Requirements for any


organization in the food chain. (ISO 22000:2018, IDT).

Since there is still no NCh ISO TS 22002-1, the following document will be used as a reference.
IRAM-ISO TS 22002-1:2013 from Argentina.

Prepared by Eurofins GCL Capacita S.A. – FOR TRAINING PURPOSES 3


Developing Skills for the Implementation of the System
Food Safety Management, based on FSCC 22000 Vs5

TERMS AND DEFINITIONS


3
For the purposes of this document, the terms and definitions apply.
presented in ISO 22000:2012 and the following:

3.1 pollution Introduction or incidence of a contaminant including a


danger related to food safety, in a
product or in the production environment.
3.2 pollutant (food safety) Any biological or chemical agent,
strange material or other substances not intentionally added
to food, which can compromise the safety or suitability of
the foods. [CAC/RCP 1:2003 [1], 2.3.]
3.3 building and (food safety) Any construction or area in the
installations that handle food, and the surroundings that are under the
control of the same organization. [CAC/RCP 1:2003 [1], 2.3.]
3.4 materials (food safety) General term used to indicate the
raw materials, packaging materials, ingredients,
adjuvants, cleaning materials and lubricants.
3.5 cleaning (food safety) Removal of soil, waste from
food, dirt, grease, or any other objectionable material.
NOTE. Adapted from CAC/RCP 1:2003[1], 2.3.
3.6 contact with it All surfaces that come into contact with the product or with
product the primary packaging during normal operation.
3.7 specification of the
Food safety) Detailed documented description or
material, specification of the enumeration of parameters, including variations and tolerances
product permissible that are required to achieve a defined level of
acceptance or quality.
3.8 food grade Lubricants and heat transfer fluids formulated to be
suitable for use in food processing where
there may be accidental contact between the lubricant and the food.
3.9 disinfection food safety Reduction of the number of
microorganisms present in the environment, through agents
chemicals, physical methods, or both at a level that does not compromise
the safety or suitability of food. NOTE. Adapted from CAC/RCP
1:2003[1], 2.3.
3.10 cleaning in the place Cleaning (see 3.5) of equipment through reaction or circulation of
(“cleaning in place”: CIP) chemical solutions, cleaning liquids, and rinses with water
inside or on the surfaces of equipment or systems, without
disassemble, and designed for that purpose. [ISO 14159:2002[3],
3.3].

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Developing Skills for the Implementation of the System
Food Safety Management, based on FSCC 22000 Vs5

3.11 cleaning outside the system where the equipment is disassembled and cleaned in a
place ("cleaning out a tank or in an automatic washer using a solution
place”: COP). cleaner, maintaining a minimum temperature throughout
cleaning cycle.
3.12 sanitizing NOTE. Both definitions 3.12 and 3.13 of ISO TS 22002-1 are
they unify in the definition 3.13 of this standard, because the
The term 'sanitizing' has no translation into Spanish.
3.13 sanitation (food safety) All actions aimed at
clean and maintain hygienic conditions of a
establishment, which range from cleaning and/or disinfection of
specific equipment up to periodic cleaning activities in
the entire establishment (including infrastructure and surroundings).
3.14 certificate food safety) Document provided by a
analysis (CDA) supplier, which indicates the results of the tests or analyses
specifics, which includes the methodology of the conducted tests
about a specific batch of product provided by the supplier.
3.15 zoning (food safety) Delimited area in an establishment
where specific operations can be applied, activities of
hygiene or other practices, to minimize the potential of
cross microbiological contamination.
NOTE. Some examples of practices include: changing clothes to
entering or exiting, positive air pressure, pattern modification
of circulation flow.
3.16 label or tag (food safety) Printed material that is part of the
packaging or container of the finished product, which conveys
specific information about the contents of the packaging or container,
the ingredients of the food and any requirements regarding
storage and preparation.
EXAMPLE - This term includes the following, among others:
a)the packaging itself, the printed material attached to the
packaging, or label used for overlabeling;
multiple packages that have an internal label about
the individual product, and a combined exterior for
all the content.
3.17 product withdrawal Withdrawal of a non-compliant product from the market, commerce,
deposits, distribution centers or customer warehouses, due to
that does not meet the specified requirements.
3.18 first Inventory rotation based on the principle of dispatching
expire, first to go out, first the products with the closest expiration date.
PCPS, ('first expired, first
out: FEFO).
3.19 first to enter, (food safety) Stock rotation based on the
first out, FIFO principle of dispatching first the products received with greater
(“first in, first out”: FIFO). prioritization

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Developing Skills for the Implementation of the System
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4 BUILDING AND ARCHITECTURAL DESIGN

4.1 General requirements

The building infrastructure must be designed, constructed, and maintained appropriately according to its nature.
from the processing operations carried out, the hazards related to safety
the foods associated with these operations, and the potential sources of contamination of the
surroundings of the plant. The building infrastructure must be of durable construction that does not
present danger to the product.

NOTE. An example of durable construction is self-draining roofs that do not leak.

4.2 Environment

Potential sources of contamination of the environment or surroundings must be considered.

Food production should not take place in areas where they can
introducing potentially harmful substances into the product.

The effectiveness of the measures taken to protect must be reviewed periodically.


foods of potential contaminants.

4.3 Location of the establishments

The boundaries of the establishment must be clearly identified.

Access to all sites must be controlled.

The site must be kept in good condition. The vegetation must be removed and discarded.
The roads, courtyards, and parking areas must be drained to prevent them from
the water tank, and they must be maintained.

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5 DESIGN OF PREMISES AND WORK AREAS

5.1 General requirements

The internal distribution must be designed, built, and maintained in a way that facilitates good
hygiene and manufacturing practices. The flows of materials, products, and people, and the distribution
the equipment must be designed to protect them against potential sources of
pollution.

5.2 Design, distribution, and internal circulation flows

The building infrastructure must provide an appropriate space that allows for a flow.
adequate materials, products and personnel, and physical separation between areas of
raw materials and processed products.

NOTE. Some examples of physical separation include walls, barriers, or divisions, or a


sufficient distance to minimize the risk.

The openings planned for the transfer of materials must be designed to minimize
the entry of foreign material and pests.

5.3 Internal structures and accessories

The walls and floors of the process areas must be washable or easy to clean, according to
are suitable for the processes or the possible hazards for the product. The materials
construction must be resistant to the cleaning system applied.

The joints and corners between floors and walls must be designed to facilitate the
cleaning.

It is recommended that the joints between floors and walls be rounded in the areas of
processing.

Floors should be designed in such a way as to prevent the accumulation of water.

In the wet process areas, the floors must be sealed and drained. The drains must be
have traps and they must be covered.

Ceilings and elevated accessories should be designed to minimize accumulation of


dirt and condensation.

The outward-opening windows, ceiling fans or convectors, must have


protection against insects, where they are present.

The doors with openings to the outside must be closed or protected when not in use.
use.

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5.4 Equipment location

The equipment must be designed and located in such a way as to facilitate good practices.
of hygiene and its monitoring.

The equipment must be located in such a way that access for its
operation, cleaning and maintenance.

5.5 Laboratory facilities

The necessary facilities to carry out line tests ('in-line' and 'on-line') must be
controlled to minimize the risk of product contamination.

Microbiology laboratories must be designed, located, and operated in such a way that they
prevent the contamination of people, the establishment, and the products. They should not
to be open directly to a production area.

5.6 Temporary or mobile installations and vending machines

Temporary structures must be designed, located, and built to avoid nesting.


of pests and the potential contamination of products.

Additional hazards associated with temporary structures must be assessed and controlled.
and vending machines.

5.7 Storage of food, packaging materials, ingredients, and products


non-food chemicals

The facilities used to store ingredients, packaging materials, and others


products must provide protection against dust, condensation, drains, waste, and others
sources of pollution.

Storage areas must be kept properly dry and well ventilated.


When appropriate, temperature and humidity should be monitored and controlled.

Storage areas should be designed or arranged in such a way that it is possible to


separation of raw materials, work in progress, and finished products

All materials and products must be stored off the floor and with sufficient
space between the material and the walls, to allow activities to be carried out
inspection and pest control.

The storage area should be designed in such a way that maintenance is allowed.
and the cleaning, the prevention of pollution, and to minimize its deterioration.

A separate and secure storage area must be available (locked or secured)


with restricted access) for cleaning materials, chemicals and other substances
dangerous.

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Food Safety Management, based on FSCC 22000 Vs5

They must be documented in the food safety management system,


exceptions for bulk storage or agricultural harvest materials.

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AIR, WATER, ENERGY


6
6.1 General requirements

The supply and distribution routes of services for processing areas and
storage and its surroundings must be designed to minimize the risk of
product contamination. The quality of services must be verified to minimize the risk of
product contamination.

6.2 Water supply

The supply of drinking water must be sufficient to meet the needs of the
production processes. The facilities for storage, distribution, and when they
require the control of water temperature, they must be designed to meet the
specified water quality requirements.

Water used as an ingredient in a product, including ice or steam (including the


culinary vapor), or in contact with products or surfaces, must meet the requirements of
quality and specified microbiological standards relevant to the product.

Water for cleaning or for applications when there is a risk of indirect contact with it.
product (for example, jacketed containers, heat exchangers) must comply
the microbiological and quality requirements relevant to the application.

When the water supply contains chlorine, checks must ensure that the level
of residual chlorine at the point of use remains within the established limits in the
corresponding specifications.

Non-potable water must have a separate supply system that is marked and
that is not connected to the drinking water system. Measures must be taken to prevent
the backflow of non-potable water into the drinking water system.

It is recommended that any water that may come into contact with the product circulates through
of pipes that can be disinfected.

6.3 Chemical products for boiler

If chemical products are used for the boiler, they must be the following:

a)approved food additives that meet the corresponding specifications, or


b)additives that have been approved by the relevant regulatory authority as safe
for use in water intended for human consumption.

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Developing Skills for the Implementation of the System
Food Safety Management, based on FSCC 22000 Vs5
Boiler chemicals should be stored in a separate, secure area (enclosed with
key or with restricted access) when not in use.

6.4 Air quality and ventilation

The organization must establish requirements for filtration, humidity (%HR), and air microbiology.
used as an ingredient, which comes into direct contact with the product. When the organization
if temperature or humidity, or both, are critical, it should be implemented and
monitor a control system.

Ventilation (natural or mechanical) must be provided to eliminate steam, dust, or odors.


excessive or unwanted, and to facilitate drying after wet cleaning.

The air supply quality of the premises must be controlled to minimize the risk of
microbiological contamination transported in the air. It must be established
procedures for monitoring and air quality control in areas where
products are exposed to the growth or survival of microorganisms.

Ventilation systems must be designed and constructed so that air does not flow from
contaminated areas or raw materials to clean areas. They must be maintained.
specified air pressure differentials.

The systems must be accessible for cleaning, filter changes, and maintenance.

The outdoor air intakes should be checked periodically to determine their integrity.
physics.

6.5 Compressed air and other gases

Compressed air systems, carbon dioxide, nitrogen, and other gas systems
used in the preparation or filling, or both, must be built and maintained with
the end of preventing pollution.

The gases expected for direct or accidental contact with the product (including those used
for the transport, blowing or drying of materials, products or equipment) must come from
an approved source for use in contact with food, and they must be filtered for
eliminate the dust, oil, and water.

When using oil for compressors and there is a potential risk of air entering
contact with the product, the used oil must be food-grade.

It is recommended to use oil-free compressors.

The requirements to be met regarding filtration, humidity (%RH) must be specified.


microbiology.

It is recommended that air filtration be done as close as possible to the point of use.

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6.6 Lighting

The supplied lighting (natural or artificial) must allow the staff to operate in a
hygienic manner.

It is recommended that the light intensity be appropriate for the nature of the operation.

The fixtures must be protected to ensure that materials, products, or


equipment does not get contaminated in case of breakage.

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7 WASTE DISPOSAL

7.1 General requirements

Systems should be implemented to ensure that waste is identified and collected,


removed and arranged in such a way as to prevent contamination of products or areas of
production.

7.2 Containers for waste and non-edible or hazardous substances

The containers for waste and non-edible or hazardous substances must be:

a) clearly identified according to their intended use;


b) located in the designated areas;
c) built from waterproof material that can be easily cleaned and disinfected;
d) closed when not used immediately;
e) locked when the waste may pose a risk to the product.

7.3 Waste management and its disposal

Provisions must be in place for the separation, storage, and disposal of


waste.

Accumulation of waste in handling and storage areas should not be allowed.


of food. The withdrawal frequencies must be managed to avoid accumulations, and
at a minimum this withdrawal must be made daily.

The labeled materials and products, or the packaging or containers printed with the brands
designated as waste must be destroyed to ensure that they cannot be
reused. The withdrawal must be carried out by approved contractors for disposal
final. The organization must keep records of the destruction.

7.4 Drains and drainage

The drains must be designed, constructed, and located in such a way as to avoid the
risk of contamination of materials or products. The drains must have
sufficient capacity to remove the expected flow loads. The drains must not
cross the production lines.

The drainage should not flow from a contaminated area to a clean area.

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DESIGN, CLEANING AND MAINTENANCE OF


8 THE TEAMS

8.1 General requirements

The equipment that comes into contact with food must be designed and built to
facilitate cleaning, disinfection, and maintenance. Contact surfaces should not affect or
areas affected by the intended product or by the cleaning system.

The equipment that comes into contact with food must be made of a durable material.
resistant to frequent cleaning operations.

8.2 Hygienic design

The equipment must have the capacity to meet the established principles of hygienic design.
that include:

a)smooth surfaces, accessible, removable that can be cleaned and prevent the accumulation of
liquid and solid waste;
b)use of materials compatible with the intended products and with the cleaning agents and
disinfection
Surfaces in contact with food must not have holes, nuts, or screws.

Pipes and ducts must be cleanable, drainable, and should not have dead zones.

The equipment must be designed to minimize contact between the operator's hands and the
products.

8.3 Surfaces in contact with the product

The surfaces that are in contact with the product must be made of materials
designed for food use. They must be waterproof and free from rust or corrosion.

8.4 Temperature control and monitoring equipment

The equipment used for thermal processes must be suitable to meet the conditions of
temperature gradient and its maintenance according to product specifications.

The necessary equipment must be provided for monitoring and controlling the temperature.

8.5 Facilities, utensils, and cleaning equipment

Wet and dry cleaning programs must be documented to ensure that the
facilities, and all utensils and equipment are cleaned with the defined frequency.

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The programs must specify what needs to be cleaned (including drains), the responsibility,
the cleaning methods (for example, CIP, COP), the use of exclusive cleaning tools, the
requirements and methods of withdrawal or disassembly to verify the effectiveness of cleaning.

8.6 Preventive and corrective maintenance

A preventive maintenance program must be implemented.


The preventive maintenance program must include all the devices used for the
Monitoring and/or control of hazards related to food safety.
NOTE. Some examples of these devices include screens and filters (including the
air filters, magnets, metal detectors, and X-ray detectors.

Corrective maintenance must be carried out in such a way that production on the lines
or adjacent equipment is not at risk of contamination.
Maintenance requests that impact should be prioritized.
safety of products.
Temporary repairs should not compromise the safety of the products.
request for replacement due to a permanent repair must be included in the program of
maintenance.
Lubricants and heat transfer fluids must be food grade when
there is a risk of direct or indirect contact with the product.

The procedure for bringing the equipment under maintenance back into production must
include its cleaning or disinfection, as specified in the procedures, and it must
inspect before use.
The PPR requirements of the establishment must be applied in maintenance activities in
process areas. Maintenance personnel must be trained on the hazards
associated with their activities that may affect the products.

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MANAGEMENT OF PURCHASED MATERIALS


9
9.1 General requirements

The purchase of materials that impact food safety must be controlled.


to ensure that suppliers have the capacity to meet the specified requirements.
The conformity of the received materials must be verified according to the purchase requirements.
specified.

9.2 Selection and management of suppliers

There must be a defined process for the selection, approval, and monitoring of suppliers.

The process must be justified by the assessment of hazards, including the potential risk for
the final product, and must include:

a)evaluation of the suppliers' capacity to meet expectations, requirements


and specifications for food quality and safety;
b)description of how suppliers are evaluated;

NOTE: Some examples of a description of how suppliers are evaluated include:

1) auditing the suppliers' premises before accepting the materials for the
production;
2) third-party certification.

monitoring the supplier's performance to ensure an approval status


continuing.

NOTE. The monitoring includes compliance with the specifications of materials or products.
the fulfillment of the requirements of the declaration of conformity, and audit results
satisfactory.

9.3 Requirements for the entry of materials (raw materials / ingredients / packaging)

Delivery vehicles must be examined before and during unloading, to verify that
the quality and safety of the material is maintained during transport (for example, the
integrity of seals, absence of infestation, existence of temperature records.

The materials must be inspected, tested, or validated through a declaration of


compliance to verify adherence to the specified requirements, prior to its
acceptance or use. The verification method must be documented.

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NOTE. The frequency and scope of the inspection can be based on the hazard it presents.
material, and in the risk assessment of specific suppliers.

Materials that do not meet the relevant specifications must be handled.


according to a documented procedure that ensures that measures have been taken to
avoid unintended use.

The access points to the bulk material reception lines must be identified.
cover and lock. The discharge in these systems must occur only after
approve and verify the material to be received.

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MEASURES FOR PREVENT THE


10 CROSS-CONTAMINATION

10.1 General requirements

Programs must be implemented to prevent, control, and detect pollution. They must be
include measures to prevent physical, allergenic, and microbiological contamination.

10.2 Cross microbiological contamination

The areas where potential cross microbiological contamination exists must be identified.
(transported by air or through circulation flow) and a Segregation plan must be implemented.
(zoning). A hazard assessment must be carried out to determine the sources of
potential contamination, the susceptibility of the product, and the appropriate control measures for
these areas, in the following way:

a) separation of unprocessed products from finished or ready-to-consume products;


b) structural separation: physical barriers, separate walls or buildings;
c) access controls with requirements related to changing work clothing according to
correspond
d) circulation flow or separation of equipment: people, materials, equipment and
tools (including the use of specific tools);
e) air pressure differences.

NOTE. Consider personal hygiene requirements.

10.3 Allergen management

Allergens present in products must be declared, whether by design or by contact.


crossed potential during production. The statement must be on the product label
for consumption and on the label or in the accompanying documentation for those products intended for
a post-processing.

Products must be protected from unintentional cross-contact with allergens through practices
cleaning, changes of products in the line, and ordering in the production sequence.

NOTE. Cross-contact during preparation may arise from:

traces of the product from previous production runs that cannot be cleaned
adequately from the production line due to technical limitations;
2. when contact is likely to occur in the normal production process, with
products or ingredients produced in separate lines, or in the same area of
processing or in adjacent areas.

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The reprocessing that contains allergens should only be used:

a) in products that contain the same allergen(s) by design;


b) through a process that demonstrates the removal or destruction of the allergenic material.

NOTE. For the general reprocessing requirements, see 14. It is recommended that employees who
Food handlers receive specific training in allergen knowledge and practices.
associated elaboration.

10.4 Physical pollution

When brittle materials are used, periodic inspection requirements must be implemented and
defined procedures in case of a breach.

As much as possible, it is recommended to avoid brittle materials in the equipment such as


as components of glass and hard plastic.

Records of glass breakages must be kept.

Based on the hazard assessment, measures must be implemented to prevent, control or


detect potential contamination.

NOTE 1. Some examples of these measures include:

a) suitable coverings on the equipment or containers for exposed materials or products;


b) use of meshes, magnets, sieves or filters;
c) use of detection or rejection devices, such as metal detectors or X-rays.

NOTE 2. Potential sources of contamination include pallets and wooden tools, seals.
rubber, clothing, and protective equipment for the personnel.

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SANITATION (CLEANING AND DISINFECTION)


11
11.1 General requirements

Sanitation programs must be established to ensure that the processing equipment


food and the environment are kept in hygienic conditions.

Follow-up must be carried out on the programs to determine their appropriateness and effectiveness.
you continue.

11.2 Agents, equipment, and sanitation utensils

The facilities and equipment must be kept in conditions that facilitate cleaning.
wet, or dry, or the sanitation.

Cleaning and sanitation agents and chemicals must be clearly identified.


They must be food grade, stored separately, and used only
according to the manufacturer's instructions.

The equipment and utensils must have a hygienic design and must be maintained in
conditions such that they do not present a potential source of foreign material.

11.3 Cleaning and sanitation programs

The organization must establish and validate cleaning and sanitation programs to ensure that
all parts of the establishment and equipment are cleaned and/or disinfected, according to a
defined schedule, including cleaning equipment.

The cleaning and sanitation programs must specify at least:

a) the areas, equipment elements, and utensils to be cleaned and/or sanitized;

b) the responsibility for the specified tasks;

c) the method and frequency of cleaning/sanitizing;

d) methods of monitoring and verification;

e) inspections after cleaning or sanitation;

f) previous inspections to production.

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11.4 Cleaning in place (CIP) systems

The CIP system must be separated from the lines that are in production.

The parameters for CIP systems must be defined and verified (including the type,
concentration, contact time and temperature of any chemical product used.

11.5 Monitoring the effectiveness of sanitation

Cleaning and sanitation programs must be monitored according to the frequency specified by
the organization to ensure its continued adequacy and effectiveness.

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PEST CONTROL
12
12.1 General requirements

Hygiene, cleaning, and material inspection procedures must be implemented.


purchased, and follow-up procedures, in order to avoid creating a conducive environment
for pest activity.

12.2 Pest control programs

The establishment must designate a person to manage control activities.


pests, and/or dealing with the designated expert contractors.

Pest management programs must be documented and must identify pests.


objective taking into account plans, methods, schedules, and when necessary,
staff training requirements.

The programs must include a list of approved chemicals for use in


specific areas of the establishment.

12.3 Access prevention

The infrastructure must be kept in good condition. Holes and drains must be sealed.
and other potential ingress points for pests.

The doors, windows, or external ventilation openings should be designed to minimize


the potential entry of pests.

12.4 Nesting and infestations

Storage practices should be designed to minimize availability of


food and water for the pests.

When infested material is found, it should be handled in such a way that it prevents the
contamination of other materials, products, or the establishment.

Potential pest nests must be removed (for example, burrows, weeds,


stored elements.

When using external space for storage, the stored items must be
protect from the weather and the damage that pests may cause (for example, droppings of
birds).

Prepared by Eurofins GCL Capacita S.A. – FOR TRAINING PURPOSES 22


Developing Skills for the Implementation of the System
Food Safety Management, based on FSCC 22000 Vs5

12.5 Tracking and detection

Pest control programs must include the placement of detectors and traps in places
keys to identify pest activity. A map of detectors must be maintained and
traps. The detectors and traps must be designed and placed to prevent the
potential contamination of materials, products, or facilities.

The detectors and traps must be of robust construction resistant to tampering. They must be
suitable for the target pest.

The detectors and traps must be inspected with the intended frequency to identify a
new pest activity. The results of the inspections must be analyzed to identify the
trends.

12.6 Eradication

Eradication measures must be implemented immediately after it is


report evidence of infestation.

The use and application of pesticides must be limited solely to operators.


trained and it should be controlled to prevent hazards related to food safety
food.

Records of pesticide use must be kept to show the type, quantity, and
concentrations used, the location, the date and method of application, and the target pest.

Prepared by Eurofins GCL Capacita S.A. – FOR TRAINING PURPOSES 23


Developing Skills for the Implementation of the System
Food Safety Management, based on FSCC 22000 Vs5

PERSONAL AND FACILITIES HYGIENE


13 FOR EMPLOYEES
13.1 General requirements

Hygiene and conduct requirements for the personnel must be established and documented.
exposed to the dangers that can be introduced into the process area or in the product. It must be
require all personnel, visitors, and contractors to comply with the documented requirements.

13.2 Facilities for hygiene and bathrooms for the staff

There must be facilities available for personnel hygiene to ensure a level of hygiene.
required by the organization. These facilities must be located near the points where
hygiene requirements apply and must be clearly indicated.

The facilities must:

a) provide the quantity, location, and appropriate means for hygienic washing and drying, and
when required, hand sanitation (including sinks, water supply
cold and hot or controlled temperature, and soap and/or sanitation items;
b) to have adequate sinks, with faucets not operated by hand, separated from the
pools for use with food and cleaning stations for equipment;
c) foresee an adequate number of bathrooms with the appropriate hygienic design, each with
facilities for hand washing and drying, and when necessary, facilities for
sanitation;
d) have adequate facilities for employee hygiene, that do not open
directly to the production, packaging, or storage areas;
e) to have appropriate clothing for the staff;
f) to have changing rooms located in such a way that the personnel handling food can move around
to the production area in such a way that minimizes the risk for cleaning your clothes
work.

13.3 Canteens and areas designated for staff meals

The designated areas for food storage and consumption must be located at
in such a way that the potential for cross-contamination of the production areas is minimized.
The cafeterias must be managed in such a way that hygienic conditions are ensured for the
storage of ingredients, preparation, maintenance, and service of food
prepared. The storage, cooking, and conditions and temperatures must be specified,
conservation; and time limitations.

The food brought by the employees themselves must be stored and consumed only in the
designated areas.

Prepared by Eurofins GCL Capacita S.A. – FOR TRAINING PURPOSES 24


Developing Skills for the Implementation of the System
Food Safety Management, based on FSCC 22000 Vs5
13.4 Work and protective clothing

The staff who work or enter areas where products or materials are handled
exposed must wear appropriate work clothing for its purpose, clean and in good condition
conditions (for example, without tears, broken, or made of fraying material).

Clothing intended for the protection of food or for hygienic purposes should not be used.
for no other purpose.

It should not have buttons, nor should it have external pockets above the level of the
waist. Zippers or snap fasteners are considered acceptable.

Work clothes should be washed according to established parameters and at appropriate intervals.
for its intended use.

Work clothing must provide adequate coverage to ensure that the hair,
sweat, among others, cannot contaminate the product.

The hair, beard, and mustache must be protected (that is, completely covered)
through fasteners, unless the risk analysis indicates otherwise.

When gloves are used for contact with the product, they must be clean and in good condition.
conditions. When possible, it is advisable to avoid the use of latex gloves.

Shoes for use in processing areas must be completely closed and


made of non-absorbent materials.

When personal protective equipment is required, it must be designed to prevent


the contamination of the product and it must be kept in hygienic conditions.

13.5 Health status

Subject to the current legislation in the country of operation, employees must comply with a
medical examination before joining the organization for contact operations with
food (including on-site food service), unless a hazard analysis
documented or medical recommendations indicate otherwise.

When additional medical examinations are permitted, the organization must carry them out.
defined intervals.

13.6 Diseases and injuries

When permitted by the applicable and current regulations, employees must be required to
report the following conditions to manage your possible exclusion from areas where
food handlers: jaundice, diarrhea, vomiting, fever, sore throat with fever, lesions
visibly infected skin (boils, cuts or wounds), and ear secretions,
eyes or the nose.

Prepared by Eurofins GCL Capacita S.A. – FOR TRAINING PURPOSES 25


Developing Skills for the Implementation of the System
Food Safety Management based on FSCC 22000 Vs5

It should be prevented that individuals known or suspected to be


infected or carrying a disease or ailment that is transmissible through food, handle
foods or materials that come into contact with food.

In food handling areas, staff with wounds or burns must cover them with
the appropriate elements. Any element of it must be reported immediately to supervision.
protection lost.

NOTE. Protective elements must be of bright colors and made of detectable metal.
when appropriate.

13.7 Personal hygiene

Staff in food production areas must be required to wash their hands, and when they
require, disinfect them:

a) before starting any food handling activity;


b) immediately after using the bathroom or wiping your nose;
c) immediately after handling any potentially contaminated material.

Staff should be asked to avoid sneezing or coughing over materials or products. It should be
prohibit spitting.

Nails should be kept clean and short.

13.8 Staff behavior

A policy of required behavior for personnel in the areas of must be described and documented.
process, packaging and storage. The policy must include, at a minimum:

a) permission to smoke, eat, or chew gum only in designated areas;


b) control measures to minimize the hazards posed by permitted jewelry, such as
those used by personnel in processing and storage areas, taking into account
account for the religious, ethnic, medical, and cultural provisions;
c) permission to carry personal items, such as smoking paraphernalia and medicines, in
designated areas only;
d) prohibition of the use of nail polish, fake nails, and false eyelashes;
e) prohibition of carrying writing implements behind the ear;
f) maintenance of the state of personal lockers, so that nothing is stored
trash and dirty clothes;
g) prohibition of storing tools and equipment that come into contact with the
products, in the personal lockers.

Prepared by Eurofins GCL Capacita S.A. – FOR TRAINING PURPOSES 26


Developing Skills for the Implementation of the System
Food Safety Management, based on FSCC 22000 Vs5

REPROCESSING
14
14.1 General requirements

Reprocessed products must be stored, handled, and used in a way that maintains the
safety, quality, traceability, and compliance with regulatory provisions.

14.2 Storage, identification and traceability

The storage of reprocessed products must be protected from exposure to


microbiological, chemical or foreign material contamination.
The separation requirements for reprocessed products must be documented and fulfilled.
(for example, allergens).
Reprocessed products must be clearly identified and/or labeled to allow for their
traceability. Traceability records must be maintained.
The type of reprocessing or the reason for its handling must be recorded (for example, name
of the product, production date, shift, line of origin, shelf life.

14.3 Use of reprocessed products

When the reprocessed product is incorporated into a product in a step 'during the process', it
must specify the acceptable quantity, type, and conditions of use of the reprocessed product.
The stage of the process and the method of addition must be defined, including any steps of
necessary preprocessing.

When reprocessing activities include re-pulling a product from the full containers or
wrapped, measures must be implemented to ensure the removal and separation of the
packaging materials and to avoid product contamination with foreign material.

Prepared by Eurofins GCL Capacita S.A. – FOR TRAINING PURPOSES 27


Developing Skills for the Implementation of the System
Food Safety Management, based on FSCC 22000 Vs5

WITHDRAWAL PROCEDURES
15 PRODUCTS

15.1 General requirements

Systems must be implemented to ensure that products can be identified and withdrawn.
do not comply with the required safety standards, of all the necessary points in the chain
of supply.

15.2 Product withdrawal requirements

A list of key contacts must be maintained in case of a product recall.

When products are withdrawn due to immediate health hazards, they must be assessed
the safety of other products made under the same conditions. It should be
consider the need for public warnings.

Prepared by Eurofins GCL Capacita S.A.–FOR TRAINING PURPOSES 28


Developing Skills for the Implementation of the System
Food Safety Management, based on FSCC 22000 Vs5

16 STORAGE

16.1 General requirements

Materials and products must be stored in clean, dry, and well-ventilated spaces.
protected from dust, condensation, vapors, odors, or other sources of contamination.

16.2 Storage requirements

Effective control of storage temperature, humidity, and others must be carried out.
environmental conditions, when required by storage specifications or of
product.

It is recommended that when products are stacked, measurements should be considered.


necessary to protect the lowest levels.

Residual materials and chemicals (cleaning products, lubricants and


Pesticides should be stored separately.

A separate area or another means of separating identified materials must be provided.


two as non-conformists.

The inventory rotation systems (FIFO/LIFO) must be followed.

Forklifts powered by gasoline or diesel should not be used in storage areas.


of ingredients or food products.

16.3 Vehicles, means of transport, and containers

Vehicles, means of transport, and containers must be kept in good condition.


clean and in general conditions compatible with the requirements established in the
relevant specifications.

Vehicles, carriers, and containers must provide protection against damages or


product contamination. Temperature controls must be applied and recorded.
humidity when required by the organization.

When the same vehicles, means of transport, and containers are used for products.
food and non-food items, they must be cleaned between both loads.

Bulk containers should be used only for food. When required by the
organization, bulk containers must be intended for a product
specific.

Prepared by Eurofins GCL Capacita S.A.–FOR TRAINING PURPOSES 29


Developing Skills for the Implementation of the System
Food Safety Management, based on FSCC 22000 Vs5

PRODUCT INFORMATION AND


17 CONSUMER AWARENESS
Information must be presented to consumers in a way that allows them to understand it.
importance and making informed decisions.

Information can be provided through labels or other means, such as websites and
company advertising, and may include instructions for storage, preparation and
method of serving, applicable to the products.

FOOD PROTECTION,
18 BIOVIGILANCE AND BIOTERRORISM
18.1 General requirements

Each establishment must evaluate the hazards to the product associated with acts of sabotage.
vandalism or terrorism, and must implement proportional protection measures.

18.2 Access controls

Potentially sensitive areas within the establishment should be identified, made


maps of them and subject them to access controls.

When possible, physical access should be restricted using locks.


electronic security cards or other alternative systems.

Prepared by Eurofins GCL Capacita S.A. – FOR TRAINING PURPOSES 30

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