ISOTS22002-1 Prerequisites Program
ISOTS22002-1 Prerequisites Program
PREREQUISITE PROGRAM
Food Safety
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:
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.
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.
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.
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
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.
4.2 Environment
Food production should not take place in areas where they can
introducing potentially harmful substances into the product.
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.
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.
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.
The openings planned for the transfer of materials must be designed to minimize
the entry of foreign material and pests.
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.
In the wet process areas, the floors must be sealed and drained. The drains must be
have traps and they must be covered.
The doors with openings to the outside must be closed or protected when not in use.
use.
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.
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.
Additional hazards associated with temporary structures must be assessed and controlled.
and vending machines.
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.
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.
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 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.
If chemical products are used for the boiler, they must be the following:
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.
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.
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 that air filtration be done as close as possible to the point of use.
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.
7 WASTE DISPOSAL
The containers for waste and non-edible or hazardous substances must be:
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.
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.
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.
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.
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.
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.
Wet and dry cleaning programs must be documented to ensure that the
facilities, and all utensils and equipment are cleaned with the defined frequency.
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.
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.
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:
1) auditing the suppliers' premises before accepting the materials for the
production;
2) third-party certification.
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.
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.
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.
Programs must be implemented to prevent, control, and detect pollution. They must be
include measures to prevent physical, allergenic, and 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:
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.
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.
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.
When brittle materials are used, periodic inspection requirements must be implemented and
defined procedures in case of a breach.
NOTE 2. Potential sources of contamination include pallets and wooden tools, seals.
rubber, clothing, and protective equipment for the personnel.
Follow-up must be carried out on the programs to determine their appropriateness and effectiveness.
you continue.
The facilities and equipment must be kept in conditions that facilitate cleaning.
wet, or dry, or the sanitation.
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.
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 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.
Cleaning and sanitation programs must be monitored according to the frequency specified by
the organization to ensure its continued adequacy and effectiveness.
PEST CONTROL
12
12.1 General requirements
The infrastructure must be kept in good condition. Holes and drains must be sealed.
and other potential ingress points for 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.
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).
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
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.
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.
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.
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.
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.
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.
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.
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.
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.
Staff in food production areas must be required to wash their hands, and when they
require, disinfect them:
Staff should be asked to avoid sneezing or coughing over materials or products. It should be
prohibit spitting.
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:
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.
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.
WITHDRAWAL PROCEDURES
15 PRODUCTS
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.
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.
16 STORAGE
Materials and products must be stored in clean, dry, and well-ventilated spaces.
protected from dust, condensation, vapors, odors, or other sources of contamination.
Effective control of storage temperature, humidity, and others must be carried out.
environmental conditions, when required by storage specifications or of
product.
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.
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.