*NOTE: Guide to evaluate prerequisite programs, based on ISO 22002 4:2014

Norm point Name the prerequisite program

4.1 Establishment
4.2 Design and work spaces
4.3 Basic services
4.4 Waste disposal
4.5 Adaptation, cleaning and maintenance of equipment
4.6 Management of purchased materials and services
4.7 Measures to prevent pollution
4.8 Cleaning
4.9 pest control
4.10 Personal hygiene and facilities
4.11 Reprocessing
4.12 Withdrawal procedure
4.13 Storage and transportation
4.14 Information on food packaging and customer communication
4.15 Food defense and bioterrorism
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4.1 Establishments FULFILLS
4.1.1 General requirements
The establishment must be appropriately designed, constructed and
maintained in accordance with the
nature and purpose of food packaging manufacturing operations and with
the
food safety hazards associated with these operations and the sources
contamination potentials. 1. Request preventive and corrective maintenance program
Buildings must be of durable construction that does not 2. Based on the procedure, request evidence of preventive maintenance of buildings and some
4.1.2 present safety hazards equipment according to the schedule they manage.
of food packaging. 3. Request a map of current facilities or equipment distribution.
EXAMPLE All openings to the outside for auxiliary devices and equipment 4. Request evidence of maintenance to the water supply (cleaning of wells and septic tanks)
must be 5. Request evidence and procedures of new facilities, ask about the current one and inductions to
adequately protected. external personnel.
6. Verify the plan for sealing external openings.

4.1.2 Environment
Potential sources of contamination of the nearby environment must be
considered.
4.1.2 NOTE "Near environment" includes internal and external areas.
1. Request evidence of risk assessment by location of the organization and surroundings

4.1.3 Location of establishments

The boundaries of the establishment must be clearly identified. All
areas within the
Establishment boundaries must be maintained in proper condition. 1. Request within the location map of buildings and equipment, what preventive measures are taken,
4.1.3
suitable to prevent That is, if there is preventive maintenance of buildings and there are weeds, what actions were left out?
pollution. take
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4.2 Distribution of facilities and work areas FULFILLS
4.2.1 General requirements
Internal layout must be designed, constructed and maintained to
facilitate good manufacturing and hygiene practices.
The movement patterns of materials, as well as recycled materials (if
applicable), products and people, and the distribution of equipment
must 1. Request sketches of movement patterns of raw materials, product in process and personnel, this
4.2.2 be designed to protect document must exist.
against sources of contamination, accidental mixing of materials or
products and 2. Contamination points have been identified by work areas or associated risks (this can be seen in the
cross contamination. sketch), maintenance should have the sketches and verify them at least once a year.

4.2.2 Design, layout and internal traffic patterns

Buildings must provide sufficient space to allow the logical flow of
materials,
products and people through the production process.
The openings provided for the transfer of materials and products (for
example hoses and
conveyors) must be designed to prevent the entry of
4.2.2 foreign material and pests, as well
1. In addition to the previously requested movement patterns, what plan exists to close open spaces or
as appropriate to the activities carried out within or in the area of the damaged doors such as the sliding one to the transition area to new looms.
building.

4.2.3 Internal structures and furniture

Walls and floors should be washable or easy to clean, as appropriate, to
prevent
Food safety hazards associated with the manufacturing of food
packaging.
Stagnation of water should be prevented in areas where an impact on
food safety may occur.
Drains should be trapped and covered.
Roofs and overhead structures should be designed to minimize the
accumulation of dirt and
condensation and must be accessible for inspection and cleaning.
Equipment should be covered in areas where routine cleaning of
overhead structures is not possible.
possible or practical and there is potential for introducing a food safety
hazard.
food.
The doors and windows that face the outside, the ducts 1. At the time the efficiency maintenance records are delivered, the maintenance checklist includes:
4.2.3 ventilation and fans in the a) Drains
ceiling in production and storage areas, they must be closed or with b) Walls
barriers (example c) Floors
insect screens, air curtains) appropriate depending on the activity in the d) Roofs
facilities. e) Air extractors?
IMPORTANT – Openings to the outside should be avoided whenever
possible. When it is not, it is preferable to keep them closed.

4.2.4 Equipment
Equipment must be designed and located to facilitate good hygiene
and manufacturing practices and their monitoring.
Equipment must be located in a way that allows 4.2.4
access for operation, cleaning and maintenance
1. Request again, if the equipment distribution plans have not shown it

4.2.5 Temporary or mobile structures

 Temporary structures must be designed, located and constructed to prevent pest nesting and 1. Request that work plans or evidence exist to eliminate temporary repairs (botches within the
contamination. plant?). If there is no plan or schedule, it should be marked as a non-compliance.
4.2.6 Storage
Facilities used to store raw materials, intermediate products, chemicals, or food packaging must
provide protection from dust, condensation, drains, debris, and other sources of contamination.
Internal storage areas must be dry and well ventilated. The monitoring and
Temperature and humidity control should be applied where necessary.
If raw materials, intermediate products, chemicals or food packaging are stored in an external
area, appropriate measures must be implemented to control the
potential contamination. Storage areas must be designed or arranged in
manner that allows the separation of raw materials, intermediate products, products 1. Request evidence or pending work in the raw materials warehouse, roll warehouse, and finished
chemicals and food packaging. Raw materials, intermediate products, products product warehouse.
Chemicals and food packaging suitable for food contact should be separated from
those that are not. 2. A visit can be made to the facilities to determine if there are fallen screens, if exterior openings are
All raw materials, intermediate products, chemicals and food packaging not covered or if there are any elements that could put the safety of the products at risk.
should be stored in a manner that minimizes the potential for contamination and with the
Sufficient distance from walls to allow inspection.
The storage area should be designed to allow for maintenance and cleaning, and prevent
contamination and deterioration.
Chemical products must be labeled appropriately. Hazardous materials and chemicals must be
kept in closed containers and used in accordance with the manufacturer's instructions.
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4.3 Services FULFILLS
4.3.1 General requirements
Service supply and distribution routes to and around processing and
storage areas should be designed to prevent contamination.

1. Request a sketch of the water supply facilities, it must include the supply of
drinking water, the drains and others that may exist in Tecnifibras, SA (septic tank)
must be visible.
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4.3.2 Water supply FULFILLS
The supply of adequate quality water must be sufficient to meet the needs of food packaging
production processes and not cause food safety hazards. The organization must establish
requirements for water (including ice or steam) used for direct contact with food packaging or
cleaning and must monitor them. Non-potable water must have a system of
4.3.2 separate, identified supply, not connected to the water system
potable and prevent backflow into the potable water system.

4.3.3 Air quality and ventilation and constructed so that air does
The organization must not flow from areas
establish requirements for 4.3.3 contaminated to clean areas.
air used in direct contact Ventilation systems must be
with food packaging and accessible for cleaning, changing
these must be monitored. filters and maintenance.
Adequate and sufficient 1. You must request a map of the
ventilation (natural or compressed air network within Tecnifibras,
mechanical) must be SA
provided to remove excess
dust, vapors and unwanted 2. Is there a risk analysis that validates
odors. that air is not a source of contamination for
Where appropriate, the product? They must present evidence to
enclosure supply air quality validate the previous point.
should be controlled to
prevent airborne 3. How do you verify that the work
microbiological environment is not too hot? What
contamination. Ventilation preventive maintenance is carried out on the
systems must be designed air extractors?

4.3.4 Compressed air and other gases

 Compressed air and other gas systems used in the manufacturing of food packaging must be constructed and maintained to prevent contamination.
The organization shall establish requirements for gases used in direct contact with
food packaging (including those used for transporting, blowing or drying materials
raw materials, intermediate products, food packaging or equipment) and should be given
follow-up.
Compressor oil must be food grade when contamination exists.
4.3.4 potential.
The requirements to be met with respect to filtration, humidity and microbiology must be evaluated. This 1. The points described here can be validated with those I described previously
evaluation will determine which control and monitoring measures should be applied. Air filtration should
be as close to the point of use as possible.

4.3.5 Lighting 1. Request a sketch of the location of luminaires.

The lighting provided (natural or artificial) must allow the correct
operation of the food packaging production processes. 2. What is the maintenance procedure in case of ruptures? (do you know him?)
The light intensity should be appropriate to the nature of the operation. 3. What maintenance is given to lamps that have a screen? An on-site visit can be made and if the lamps have
Where a food safety hazard exists, lighting fixtures must be protected to insects it is a non-compliance due to lack of maintenance.
prevent contamination of raw materials, intermediate products,
chemicals, food packaging and equipment in the event of 4. Please randomly select 2 plant people, 2 maintenance people, 2 trash people and ask regarding the procedure
4.3.5 breaking off. in case of glass breakage or any other brittle material
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4.4 Waste disposal FULFILLS 4.4.1
4.4.1 General requirements 1. Please request waste management procedure
Systems must be implemented to identify, collect, remove and
dispose of waste. 2. Choose a waste category and present evidence of disposal.
way to prevent contamination
3. What maintenance is given to the general garbage dump?
4.4.2 Waste management
Waste containers should be emptied as frequently as necessary and
maintained in an adequately clean condition.
Waste should be kept away from production and storage areas. The
trash cans and containers for waste that are not related to production
must be
duly identified, emptied regularly and, if necessary, have lids.
Food packaging that is identified and designated as
..
4 4 2 residue, must be deformed or destroyed so that:
a) trademarks or food ingredient information may not be reused; c) Ask Martha Delgado for her cleaning schedule and verify how the garbage cans are cleaned, randomly
b) will not be able to enter the supply chain again. choose months and request records. In the registry, correct filling must be evaluated.
d) Regarding the internal management of both JN and LG plants, how do they remove their waste and
what evidence do they leave?
e) Are garbage cans identified by some type of code or type of waste they contain? (if you do not have
identification, mark as a finding)
f) Are the on-site garbage cans in good condition? (they have a cover)

4.4.3 Drains and drains

Drains and drains must be designed, located and
constructed to prevent
4.4.3 potential contamination. 1. Verify the cleaning procedure and validate if drains and drains are included
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# TRANSLATED POINT FULFILLS Documents to request Observations Luis García Observations Julio Navas Leo Observations

Equipment suitability, cleaning and maintenance

4.5 General requirements
4.5.1 Equipment used in production and packaging areas must be
designed to prevent contamination.
Where relevant, equipment used for irradiation processes
must comply
with relevant food packaging specifications.

1.Ask Julio Navas, Luis García or Jose Balcarcel for their cleaning instructions. Based on the
instructions, compare cleaning plan TF-GC-IN-019.
2.Randomly verify by requesting records of some machines, if the frequency has been met and the cleaning instructions are not known by the person most critical areas due to age of the machines. Old and missing It is not known where to locate the frequency of cleaning the equipment. If the
4.5.1 responsible and the record exists. they need to be updated. There is no instruction manual for the machines machine cleaning instructions
machine of spare parts.
3.Check if they know where their cleaning plans are and if they are being followed. chinita
4.Please pay a visit to the facilities and verify that physically the technical sheets of
cleaning or other chemicals used are available and in good condition

4.5.2 Hygienic design

All parts of the equipment that come into contact with food
packaging must be designed and constructed to facilitate
cleaning and maintenance. The equipment must comply with
established principles of hygienic design, including:
a)smooth, accessible and easy to clean surfaces when in
contact with the packaging to
food and those that may constitute a possible source of
contamination;
b)own drainage (for wet processes);
c) use of construction materials compatible with food
packaging, lubricants and
intended cleaning or washing agents.
Pipes and ducts should be washable and easy to drain, and 1.Request evidence of how it is fulfilled and how do they know that their areas are
should not cause condensation or leakage that could clean and not dirty?
contaminate food packaging. Valve connections and controls It has been determined that there are some temporary repairs Cleaning instructions, physical for digital. Cleaning records for
4.5.2 must have safety mechanisms to prevent contamination. 2.They must present evidence through daily records or auditor inspections. validate the cleanliness of the plant. In a safe environment. Swab The January and February cleanings were not recorded in the evaluation form
Equipment components containing metals of known toxicity that put the safety of the product at risk. at
(for example, mercury) should not be permitted when they 3.Request an explanation of how the table is guaranteed to contaminate the bag. released surfaces. Analysis of the external sacs.
could compromise the safety of the food packaging.

4.5.3 Surfaces in contact with food packaging

Surfaces in contact with food packaging must be constructed
of materials
appropriate for their intended use, to prevent 1. Ask those responsible for the method in which they verify that the surfaces are in good
4.5.3 contamination. condition. Microbiological analysis of finished products.

4.5.4 Maintenance
A planned maintenance system must be implemented that
includes all equipment.
Maintenance programs must be applied systematically to
minimize potential product contamination from the
equipment. Priority should be given to maintenance requests
where food safety is at risk. A procedure must be in place to
remove any potential contamination after maintenance of
machinery or equipment. Maintenance personnel must follow
established procedures, including, when necessary, hygiene
measures. Temporary repairs and modifications should be The cleaning instructions were not effectively transferred and for
avoided, must be controlled and must not become permanent. this reason they need to be updated. Alejandro will create a
Effective measures must be implemented. cleaning manual for the paper plant, where all the instructions will
1. Having previously verified the preventive maintenance program in the prerequisite be united so that there is a single document. Additionally, it is
programs of 4.1 - 4.3 can serve as evidence to comply with this point. suggested to improve cleaning in areas that are difficult to access.
There is a need to put the pen in good condition and the forklift
cannot be used due to the daily occupancy it has.
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Purchase management of materials and services
4.6
4.6.1
General requirements FULFILLS
The purchase of materials, services and subcontracted activities that may
have an impact on the safety of food packaging must be controlled in
such a way that the selected suppliers have the capacity to meet the
specified requirements.
NOTE Services may include (but are not limited to) third party storage
and reprocessing by subcontractors. The organization must establish
clear requirements for the relevant outsourced processes. There must be
a written contract. 1. Ask the purchasing manager to show the procedure that indicates the evaluation of suppliers. The person in charge of purchasing, format TF-GC-CO-005, CO-020. PR-002. There is a need for evaluation of
2. Based on the document, randomly select suppliers and request their evaluation for 2020 or 2021 if it suppliers of the month of March. In the evaluation of the supplier there has been no claim, nor the price
has already been carried out. It has changed. The person in charge knows how to manage suppliers, however she was instructed
3. How are service providers evaluated? Where does the procedure or manual indicate it? regarding the
4. What procedure is followed when the warehouse detects a material outside of specifications, how is it assessment table that must be followed in order to carry out the evaluation. It has been requested to carry
evaluated? out the
5. Is there a folder per supplier, where the technical sheet, safety requirements, evaluation, and others evaluation regarding masterbatch from February 2021, not being able to support the information of said
appear? supplier. The Clariant supplier evaluation has been done, but the application form has not been found.
information. Last update of supplier information was made in 2019. Today I know
will share the list of suppliers. In the manual it was detected that there is no clause that indicates
How to communicate when there is a non-compliant product.

4.6.2 Supplier selection and management

There must be a documented procedure for evaluating, approving and
monitoring suppliers to ensure compliance. The method used must be
justified through risk assessment and hazard analysis, including the
potential risk to the safety of the food packaging.
The process includes:
a) assessment of suppliers' ability to meet food safety requirements;
b) description of how suppliers are evaluated.
Monitoring may include conformance to specifications, meeting COA
requirements, and satisfactory audit results. 1. Request the supplier evaluation procedure, is there a section that indicates what to ask of each
type of supplier? How do you know which one is of greater or lesser risk? The purchasing manager stated that supplier evaluations have not been done in 2019.
4.6.2 2. Are there supplier audits? What results are there? It was the last evaluation.
3. Is there evidence of communication with suppliers?

4.6.3 Incoming raw materials

Cargo on delivery vehicles must be checked before and during unloading to verify
that the safety and security of raw materials has been maintained during
transport.
When anti-tamper closures (marchamos) are used, a process must be
implemented to verify compliance with relevant customer or regulatory
requirements. All raw materials must be inspected, analyzed or covered by a
COA/DOC for conformity with specified requirements prior to acceptance or use.
The verification method must be documented. There must be sufficient
information available to perform the food contact hazard analysis.
NOTE 1 For example where incoming raw materials are from a recycled source or
are plant-based materials, it is desirable that there are appropriate measures in
place to verify that food safety and traceability requirements are met prior to
acceptance. .
NOTE 2 The frequency and extent of inspections may be based on the risk
presented by the material and the risk assessment of specific suppliers. Raw
materials that do not meet the corresponding specifications must be handled
under a documented procedure that prevents their unintended use. Access 1. Request the warehouse manager's procedure for receiving materials and raw materials. You must have
points to bulk raw material receiving lines should be identified and, if the document available. Likewise, regarding your scheme, ask how the materials are evaluated, that is,
appropriate, covered and secured. Unloading into such systems should be carried the unit that transports them, if they come ok and meet the safety requirements.
out only after approval and verification of the raw materials received. Log of receipt of raw materials. The procedure for receiving TF materials is carried out
2. See the income from previous months and request the record that validates that these raw materials BO-006. Logbook with photographs from April 2021.
meet the requirements in terms of safety.
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4.7 Measures to prevent pollution FULFILLS
4.7.1 General requirements
A hazard analysis must be carried out. If applicable, measures must be implemented to prevent
physical, chemical and microbiological contamination.
When external testing of the product is required, it must be carried out by an accredited entity, or
one that follows international guidelines for testing laboratories. If the product is subjected to an
internal test, calibrations of the equipment must be carried out by comparing against national
standards or other precise means. Mixing of raw materials or intermediate products should be
avoided when hazard analysis reveals a food safety hazard.
Whenever a contamination incident occurs, the 4.7.1 cleaning process or
maintenance must be carried out under the control of a designated person. A
documented release procedure must be followed after cleaning or maintenance
has been performed. 1. Request HACCP plans
Any contaminated product that cannot be cleaned effectively should be discarded. 2. Request evidence of how HACCP plans were validated.
3. Are there critical control points?
4. How the HACCP plan is validated.

4.7.2 Microbiological contamination

Measures must be implemented to prevent or control the danger, when
there is a 1. Request information on how the microbiological point is met.
Potential microbiological contamination.
4.7.2 2. Request microbiological testing schedule.
3. Randomly request a type of exam and ask for evidence
4.7.3
Physical contamination
When glass and/or brittle materials are used in storage or production areas (for applications other
than food packaging production), periodic inspection requirements and defined breakage
procedures must be implemented. Brittle materials (such as hard plastic components in equipment
and sight glasses in storage tanks) should be avoided where appropriate. In production and storage
areas, surfaces in contact with the product must be
free of splinters and any other source of contamination. They must be adequate to be able
perform easy and effective cleaning. A formal procedure for the use of “blades” must be in place.
No sharp objects or loose tools should be left anywhere and on surfaces where product contamination may 1. Ask how you can ensure there is no physical danger or why detectors are not a critical control point?
occur. The use of detachable blade knives should be prohibited. To maintain an acceptable level of
cleanliness, buildings, facilities and equipment must be cleaned to remove dust, cobwebs, chips and 2. How tools and blades are controlled, evidence must be provided.
4.7.3 fragments. 3. Please make an on-site visit to any area and randomly ask to check staff tools.

4.7.4
Chemical contamination
 Printed and coated materials should be handled and stored in their intermediate and final states
such that migration of substances to the food contact side by transfer or other mechanism is
reduced to a safe level, appropriate for these materials such as has been defined by hazard
analysis. Chemicals, including cleaning agents and lubricants, must be evaluated and controlled so
as to prevent contamination of the
4.7.5
product. Lubricants intended to come into contact with the product must be of a grade suitable for
the intended use.
1. Request how the chemical hazard is evaluated.
2. Is there a document that declares the ink limits?
3. How compliance with Tecnifibras, SA inks is demonstrated

4.7.6
Chemical migration

Where there is a potential food safety hazard due to migration or other

transfer mechanism, controls must be implemented to prevent or
control the hazard. The packaging (example: pallets, films, containers)
must be made of suitable material and be clean, and must not 1. Request how the chemical hazard is evaluated.
contaminate the food packaging.
4.7.5 NOTE In some cases, chemical pallet treatment may be necessary (e.g., 2. Is there a document that declares the ink limits?
insecticides, fungicides, pesticides, or other chemicals) to meet
customer or regulatory requirements. 3. How compliance with Tecnifibras, SA inks is demonstrated

4.7.7
Allergen management
When a potential source of food allergen contamination has been identified,
must establish, document and implement controls to
4.7.8
prevent or control hazards, and 1. Request a declaration that there are no allergens
record and label appropriately.
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4.8 Cleaning FULFILLS
4.8.1 General requirements
Appropriate specific cleaning programs must be established in areas to maintain production
equipment and the environment in hygienic conditions.
If cleaning activities are outsourced externally, the
4.8.2 approved supplier must be competent and the 1. Request current cleaning plan.
documentation specified by the organization. 2. Request a list of cleaning chemicals, their technical sheets and ET.
3. Regarding the cleaning schedule, choose months randomly and request the records; the correct filling
must be evaluated in the records.
4.8.3 Cleaning programs
Cleaning programs must specify at least:
a) the areas and items of equipment to be cleaned;
b) responsibility for specified tasks;
c) the method and frequency of cleaning;
d) cleaning monitoring and verification methods.
4.8.2
1. The cleaning program must be clearly defined, the responsibilities, what equipment is going to be
cleaned, and how it is going to be cleaned.
2. Verify if the required aspects are met regarding the cleaning plan.

4.8.3 Cleaning agents and utensils

Equipment must be maintained in conditions that facilitate cleaning. Cleaning agents should be
clearly identified, stored separately, and only used in accordance with the manufacturer's
instructions. Utensils must be of hygienic design and maintained in conditions that do not present a
potential source of contamination.
1. Cleaning chemicals must be identified throughout the plant or those handled by Martha's cleaning staff.
The information must be available to them; this information can be verified by interviewing the cleaning
staff. The cleaning process to be indicated must be as follows:

4.8.3 1.1 Dispose of solid waste

1.2 Carry out cleaning of the area, if it is washed, proceed first to remove residues, wash, rinse with soap
and finally disinfect.
1.3 The correct registration of information.

4.8.4 Monitoring the effectiveness of the cleaning program

Cleaning programs must be monitored according to the frequency 1. Ask those involved how they see the effectiveness of the cleaning program, they can present one of
specified by the the following options:
organization to ensure its continued suitability and effectiveness.
1.1 Scientific information supporting that microbial development will not occur,
1.2 Laboratory analysis that demonstrates compliance.
1.3 Luminescence analysis.
1.4 Other
4.8.4
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4.9
pest control FULFILLS
General requirements
4.9.1 Appropriate measures must be implemented to avoid creating an
environment that contributes to pest activity.
4.9.1 1. Is there an outsourced or internal pest service?
Control programs
4.9.2 The organization must designate a person to manage pest control
activities or hire experts for this purpose. Pest management programs
must be documented and must identify the pests to be controlled and
take into account plans, methods, schedules and, where necessary,
personnel training requirements. Programs must include a list of
chemicals approved for use in defined areas of the establishment.
1. There is a document that indicates who is responsible for pest management at Tecnifibras, SA
4.9.2 2. Are there schedules, chemical documentation, technical sheets, personnel training and others required
by the standard?

4.9.3 Access prevention

Establishments must be kept in good condition. Effective measures must
be established to prevent pests from entering the establishment. Doors,
windows or ventilation openings to the outside should be designed to
prevent the entry of pests. All doors to the outside must be maintained
in good condition and must remain closed when not in use.
NOTE Incoming and outgoing products and materials must be inspected
for the presence of contamination caused by rodents, flying and
4.9.3 crawling insects, birds and other pests. 3. In case of findings in the reports, what measures have been taken to contain the pests?
4. Request visit reports and see if the provider's recommendations have been met

4.9.4
Nesting and infestations
When infested raw materials, intermediate products or food packaging
are found, they must be handled in a way that prevents contamination of
other raw materials, intermediate products, food packaging or the
establishment. Potential pest nests (e.g. burrows, weeds, stored items)
should be eliminated. When using external space for storage, stored
items should be protected from weather and pest damage (e.g. bird
droppings). 5. In case of findings in the reports, what measures have been taken to contain the pests?
4.9.4
6. Request visit reports and see if the provider's recommendations have been met.
7. If pests are detected in the plant, what actions have been taken?

4.9.5
Tracking and detection
Pest monitoring programs should include placing devices and traps in
key locations to identify pest activity. A map of devices and traps must
be maintained. Devices and traps must be designed and placed to
prevent contamination of raw materials, intermediate products, food
packaging, and equipment. Devices and traps must be of robust
construction, resistant to tampering
improper. These must be suitable for the pest to be combated. Devices
and traps should be inspected at the expected frequency to identify new
pest activity. Inspection results should be analyzed to identify trends in
pest activity.
1. Request pest trend analysis, is there a registry? What happens when there is a peak that shows that the
4.9.5 plant is out of control?
 4.9.6 Eradication
Eradication measures should be implemented immediately after
evidence of infestation is reported. The use and application of pesticides
should be restricted to trained personnel and should be controlled to
avoid food safety hazards. Records of pesticide use must be maintained
to demonstrate the type, quantity and concentrations used, where,
when, and how they were applied, as well as the pest to be combated. 1. What evidence exists for pest eradication?
4.9.6
2. Request fumigation records, choose months at random
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4.10
Personal hygiene and facilities FULFILLS
General requirements
4.10.1 Requirements for hygiene and staff behavior proportional to the hazards
related to food packaging should be established and documented. It
should be required of everyone 1. Request good manufacturing practices policy.
staff, visitors and contractors compliance with documented
requirements. 2. Request how good hygiene practices are followed on a daily basis
4.10.1
3. What procedure is followed when any aspect related to good practices is not met?

4.10.2 Staff hygiene, locker rooms and sanitary services

Hygiene facilities must be available for staff to maintain the degree of personal
hygiene required by the organization. The facilities must be located close to the
points where hygiene requirements apply and must be clearly designated.
Depending on their size and complexity, organizations must:
a) provide an adequate number and location of means of washing, drying and,
when required, disinfecting hands (including sinks, supply of hot and/or cold
water or temperature-controlled water and soap or disinfectant);
b) provide an adequate number of toilets of appropriate hygienic design,
sufficiently separated from the production area, each with hand washing and
drying facilities and, where required, facilities for disinfection; toilets and
changing rooms must be kept clean;
c) have adequate dressing rooms and lockers for all personnel working in the
production, packaging and storage areas. These locker room and storage
facilities should be accessible without crossing the areas 1. Request inspection records for:
of production and storage, when it comes from abroad. a) Areas
NOTE Where for safety or other considerations, healthcare facilities cannot be b) Bathrooms
accessed without crossing production areas, this can be managed by using c) Wineries
controlled or designated routes. d) Staff income
4.10.2 e) Café
f) Common areas
g) Surroundings
h) Dressing rooms
i) Workshops

Staff cafeterias and designated eating and smoking areas

4.10.3
Staff cafeterias and areas designated for food storage, consumption and
smoking must be appropriately located and managed to prevent
contamination of production areas. All food, drinks and medications
should be stored in designated areas. Procedures should be established
to control the use of medications to prevent product contamination.
Eating (including the consumption of candy, gum, or chewing tobacco),
drinking (except water), and smoking should only be permitted in
designated areas. Where drinking water is permitted, it should be subject
to control to prevent spills and contamination. All of these areas should
be kept clean. For waste disposal, containers with lids, suitable and easy
to clean, should be used. Suitable containers should be provided for
smoking waste.

4.10.3 This point is fulfilled with what was previously stated in relation to the cafeteria.

4.10.4 Work and protective clothing

 The organization must ensure that personnel working in or entering
production or storage areas are dressed in work clothing suitable for the
purpose, in good condition and without any potential for contamination.
Work clothing must be appropriately segregated from personal clothing.
Where appropriate, work clothing or other suitable protection should
provide coverage
so that hair, sweat, and loose objects cannot contaminate raw materials,
intermediate products, food packaging, or equipment, based on a food
safety hazard analysis. When gloves are used for contact with food
packaging, they must be suitable for the purpose and in good condition.
Personal protective equipment, when required, must be designed to 1. Request uniform policy
prevent contamination and must be maintained in sanitary conditions.
4.10.4 2. Question why administrators do not wear uniforms.
3. Question the use of orange shirts on Saturday

4.10.5 Illnesses and injuries

Personnel must follow the organization's documented guidelines for
injuries and illnesses.
CAUTION – Personnel infected with, or carrying, a disease or condition
transmissible through food should be prevented from handling food
packaging. There may be a procedure for medical checkups.
All injuries, including minor cuts, should be treated immediately and
appropriately.
4.10.5
Dressings should be monitored and changed at appropriate intervals. Adhesive
bandages
They should not contaminate the product. These must be differentiated 1. Request procedure for wounds and injuries
from the product (for example, by color).
2. If a case is presented, how is it recorded and what actions are taken
3. How do you prove that there have been no accidents?

4.10.6 Personal hygiene

Personnel working in production areas must wash their hands:
a) before starting any food packaging handling activity;
b) immediately after using the bathroom, eating, smoking or drinking
(except water);
c) immediately after handling any potentially contaminated materials.
IMPORTANT – Appropriate food safety handwashing products should be
used (for example, without
4.10.6 odor). Personnel should be required to refrain from sneezing or coughing on
raw materials, intermediate products, or food packaging. Spitting
(expectoration) should be prohibited. Nails should be kept clean and 1. How to verify that staff wash their hands
trimmed.
2. Has the soap for hand washing been validated?
3. Request laboratory analysis to verify hand hygiene.

4.10.7 Staff behavior

 The required behavior of personnel in production and storage areas must
be described in a documented procedure. The policy must, at a
minimum, include:
a) permission to smoke, drink (except water), eat and chew only in
designated areas; prohibiting the use of visible jewelry, wristwatches and
piercings, unless they are adequately controlled to minimize
contamination. The organization must clearly define the type of jewelry
permitted as determined by the hazard analysis;
b) permission to have personal items, such as cigarettes and
medications, only in designated areas;
c) prohibition of the use of nail polish, false nails and false eyelashes;
d) control measures to restrict writing implements or loose items in
areas where they could contaminate raw materials, intermediate products or food 1. Indicate and request how the rules are followed in the company.
packaging;
2. Request evidence in cases where any point related to good practices has not been met.
e) keeping personal lockers free of trash and dirty clothing;
4.10.7 f) Prohibition of storage of tools that come into contact with food 3. How deficiencies related to BPM's are communicated
packaging in personal lockers.
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# TRANSLATED POINT Documents to request Observations
NOT
4.11
Reprocessed FULFILLS 1. Ask the person responsible for their reprocessing procedure.
General requirements 2. How is traceability met in reprocessing?
4.11.1 Reprocesses must be stored, handled and used in a manner that 3. How do you know what amount of reprocessing to use?
maintains food packaging safety performance, quality, traceability and 4. Is the customer aware of the use of reprocessing in their
compliance with regulations. product?
4.11.1

4.11.2 Storage, identification and traceability line of origin).

Stored rework must be segregated and protected from contamination. 1. Ask the person responsible for their reprocessing procedure.
Rework must be clearly identified and labeled to allow traceability. 2. How is traceability met in reprocessing?
Rework traceability records must be maintained. The classification of 3. How do you know what amount of reprocessing to use?
the rework or the reason for the designation as rework must be 4. Is the customer aware of the use of reprocessing in their
recorded (e.g., food packaging name, production date, shift, production product?
4.11.2

4.11.3 Using rework

When rework is to be incorporated back into the production process, 1. Ask the person responsible for their reprocessing procedure.
the acceptable quantity, type, and conditions of use of the rework must 2. How is traceability met in reprocessing?
be specified. The addition method must be defined, including any 3. How do you know what amount of reprocessing to use?
necessary pre-processing steps. Measures must be taken to prevent 4. Is the customer aware of the use of reprocessing in their product?
reprocessing activities from allowing raw materials, intermediate 5. What processes are followed to validate that the reprocessing meets the quality parameters?
products or food packaging to be contaminated with materials not
intended for food contact. Validation records must be maintained to
demonstrate that following the specified rework procedure maintains
compliance with customer and legal requirements.
4.11.3
 CU M P LE / NO
TRANSLATED POINT C U M PL E Documents to request Observations
#
4.12

Withdrawal procedure
Systems must be implemented to ensure that products that do not meet required food safety standards can be identified, located and removed from all necessary points in the supply chain. The system
It must be recorded and tested with appropriate frequency. 1. Request traceability procedure.
4.12 Choose modern ones with poly 010321
2. Carry out traceability exercises
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# TRANSLATED POINT Documents to request Observations
NOT
4.13
Storage and transportation
General requirements
FULFILLS
4.13.1 Raw materials, intermediate products and food packaging must be
stored and handled in a manner that avoids contamination, such as dust,
condensation, fumes, odors and other sources. Outsourced storage areas
must meet the requirements of this Technical Specification.

1. Request the procedures associated with the storage and transportation of finished product.
2. What measures or actions are taken to guarantee that the cleanliness of the warehouse is in
compliance?
4.13.1
perfect state?
3. Are there cleaning programs for the finished product warehouse?

4.13.2 Storage requirements

When required by food packaging or storage specifications, effective
controls for temperature, humidity, or other environmental storage
conditions must be provided. Waste and chemicals (cleaning products,
lubricants and pesticides) must be stored separately. Measures
(physical or electronic separation) must be implemented to prevent
non-conforming materials from being released and/or shipped. 1. Request technical specification for the receipt of finished product.
Specific inventory rotation systems should be implemented.
2. Are there any requirements for storage?
4.13.2
3. What happens if the product remains under the sun for a long time?
4. How is it determined that having the loading dock open do not allow pests to enter the unit?

4.13.3 Vehicles, means of transport and containers

Vehicles, means of transport and containers must be maintained in a
state of conservation, cleanliness and condition consistent with the
requirements given in the relevant specifications and contracts. Vehicles,
conveyances and containers must provide protection against damage or
contamination of food packaging. When necessary, temperature and
humidity monitoring should be applied, recorded and readily available.
Transport vehicles must be checked before loading and unloading. They
must be in good condition for use, clean and free of foreign bodies, pests
and undesirable odors. Food packaging must be protected from
contamination during loading operations. When required by the
organization, bulk containers must be designated for a specific food
packaging material. Pallets must be inspected before use. They must be
suitable for their intended use and clean, free of foreign bodies, pests
and undesirable odors. Pallets must not contaminate raw materials, 1. Request a cleaning program for transport units.
intermediate products or food packaging.
2. How the safety of each transport unit is guaranteed.

4.13.3 3. Are there records associated with transportation?

4. You can request a month randomly and request cleaning records for both transportation and
units.
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# TRANSLATED POINT Documents to request Observations
NOT
4.14
Food packaging information and customer communication FULFILLS
The organization must be able to demonstrate compliance with food
safety requirements.
food and agreed specifications. The organization shall obtain the
information necessary to determine that the food packaging to be
supplied is suitable for its intended use and meets food safety
requirements. In the event of changes to food packaging, the
organization must evaluate any implications for food safety and
compliance.
The organization shall provide and update its customers with relevant
food safety information on the applicability and use restrictions of the
product.
NOTE Information may be provided through labeling or other means,
such as company websites and advertisements, and may include storage
and instructions applicable to the product. When information is provided
on food packaging, as part of the food safety process , it must be
complete, legible and controlled to prevent printing errors.
1. Ask the person how they communicate with the client and how this prevents mistakes from being
4.14 made when creating a stamp.
 COMPLY /
# TRANSLATED POINT Documents to request Observations
NOT
4.15 Defense and bioterrorism FULFILLS
Each establishment must assess the danger to products posed by
potential acts of sabotage, vandalism or terrorism and must implement
proportionate protective measures. A procedure must be implemented
for the management of security incidents. This may include, but is not
limited to:
a) construction and design of infrastructure to prevent unauthorized
entry;
b) reference checks for staff;

c) control of confidential information;

d) security of storage and production areas; 1. Request a bioterrorism and adulteration plan.
4.15 e) transportation and distribution. 2. Evaluate whether all the points covered by the rule from a) to e) are met, otherwise mark a non-
The site security assessment must be up to date. He compliance.
Staff must receive training in site security measures.