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Fundamental and Supporting Elements

World-class food safety program is based on the principles of safe product/process design, prerequisite
programs, and HACCP that is supported by essential management practices, thus controlling the operational,
environmental, and process conditions necessary for consumer health protection through consistent
production of safe food.
Fundamental Elements
 Safe product/process design relies on both the understanding of hazards and formulation/process
control capabilities at the development stage and the application of formal procedures to evaluate and
sign off the safety of each new development prior to its implementation.
 Prerequisite programs (PRPs) are the practices and conditions needed prior to and during the
implementation of HACCP and which are essential to food safety. PRPs provide a hygienic foundation for
the HACCP system by enabling environmental conditions that are favorable for the production of a safe
food.
 HACCP system is essential in creating a world-class safety program, hence deeper focus on the
application of its principles should be established (This will be discussed further in the succeeding weeks).
 Essential management practices are management practices and procedures that support effective
application of safe product/process design, prerequisite programs and HACCP systems, and assure their
ongoing capability to protect the consumer. These are all about making sure that there is ownership and
responsibility throughout the company structure and that resources supporting the fundamental
elements are appropriately administered, supervised, and controlled.
These practices include: management commitment, roles and responsibilities, training and education,
resource management, documentation, supplier-customer partnerships, and continuous improvement.
Supporting Elements
 Quality management systems serves as the framework to manage the food safety program. Quality
systems based on Total Quality Management (TQM) principles are useful in ensuring ongoing
effectiveness and continuous improvement of food safety programs.
 Best practice programs – for example:
o Good laboratory practice – to provide confidence in laboratory results used in monitoring and
verification of the food safety program.
o Good distribution practice – to maintain food safety in transit. This may also be considered as part of
the prerequisite programs.
 Sustainability programs ensure supply chain sustainability through prevention of supply problems and
to promote corporate responsibility in the way that the supply chain is managed.
 Continuous improvement programs such as the ‘Lean’ approach, where tools like process, activity, and
value stream mapping can help understand processes in much more detail, seeing which activities are
adding value in consumer terms, in this case to ensure safe food production. (This will be further discussed
on a separate course called Operations Management).

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Food Safety Program in the Global Food Supply Chain

World-class food safety programs need to be applied to the entire food supply chain. This means that all types
of businesses, be it small or large and based in any link of the chain, i.e. agricultural, manufacturing/processing,
and food service/retail, need to apply and manage effective food safety programs. It also requires that food
products produced for any consumer, human or animal, should be subjected to the same strict control
mechanisms (Wallace, 2011).

Figure 1. Supply Chain

Source: Wallace, 2011

Introduction to Prerequisite Programs

Prerequisite programs (PRPs) provide the hygienic foundations for any food operation. The terms
‘prerequisite program’, ‘good manufacturing practice (GMP)’, ‘good hygiene practice’, and ‘sanitary operating
practices’ are used interchangeably in different contexts but have the same general meaning.
Definitions and Standards
Several groups have suggested definitions for the term ‘prerequisites’ and the most commonly used are:
o Practices and conditions needed prior to and during the implementation of HACCP and which are
essential to food safety (World Health Organization [WHO], 1999).
o Universal steps or procedures that control the operating conditions within a food establishment,
allowing for environmental conditions that are favorable for the production of safe food (Canadian
Food Inspection Agency [CFIA], 1998).
o Procedures, including GMP, which addresses operational conditions, providing the foundation for the
HACCP System (The National Advisory Committee for Microbiological Criteria for Foods [NACMCF],
1997).
A number of groups have published helpful materials on PRPs. However, the internationally accepted
requirements for prerequisites are defined in the Codex General Principles of Food Hygiene (Codex, 2009a).
The PRPs listed below are split down into groupings:
o Primary production
o Food chain
 Establishment: design and facilities  Transportation
 Control of operation  Product information and consumer
 Establishment: maintenance and awareness
sanitation  Training
 Establishment: personal hygiene

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These groupings form the essential areas where PRP elements must be developed, implemented, and
maintained to provide environmental conditions that are favorable to the production of safe food and thus,
the foundations needed for effective HACCP systems.
International Requirements of Codex
Primary Production
At this stage of the food chain, the intention is that food produced is safe and suitable for its intended use and
primary production PRPs are, therefore, based on appropriate hygienic practices; control of contaminants,
pests and diseases; and use of production areas where there are no environmental threats to the production
of food (Wallace, 2011).
PRP Elements for Primary Production
• Environmental hygiene requires the consideration of potential contamination sources from the
environment and prevention of use of areas that could cause the presence of unacceptable levels of
potentially harmful substances in the food produced.
• Hygienic production of food sources relates to the need to identify likely sources of contamination
and implement controls to minimize the risk of contamination, including prevention of contamination
from air, soil, water, and other agricultural agents; controlling animal health to minimize threats to
human health at consumption; protecting food from fecal or other contamination; and managing
wastes and harmful substances appropriately.
• Handling, storage and transport describes the protection, segregation, and disposal requirements
needed to protect food, preventing spoilage and deterioration where possible (e.g., through control
of temperature and humidity).
• Cleaning, maintenance, and personal hygiene at primary production refers to the necessity for
appropriate procedures and facilities for the maintenance of these essential practices.
Establishment: Design and Facilities
PRP Elements for Establishment: Design and Facilities
• The location of food premises is important and care should be taken to identify and consider the risks
of potential sources of contamination in the surrounding environmentally polluted areas. Areas of
heavy industry that could pose contamination risks, areas prone to pest infestation, areas subject to
flooding, or where waste cannot be removed effectively should be avoided when planning food
production facilities. Suitable controls to prevent contamination should be developed and
implemented.
• The design and layout of the premises and rooms should permit good hygiene and protect products
from cross-contamination during operation. Internal structures and equipment should be built of
materials able to be easily cleaned/disinfected and maintained. Surfaces should be smooth and non-
pervious, and able to withstand the normal conditions of the operation.
Other surfaces within the food processing area, like walls, floors, partitions, ceilings and overhead
fixtures, windows and doors, should similarly be designed to minimize the building up of dirt,
condensation, etc., and the shredding of particles or contaminants that might gain access to food
products. Similar standard should be applied to the design, construction, and siting of
temporary/mobile premises and food vending machines.

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• Equipment that will come into contact with food should also be designed and constructed to facilitate
cleaning and disinfection, including disassembly where necessary, and be made of materials that will
have no toxic effects under the intended use.
Containers for by-products, waste, inedible, and dangerous substances must be constructed to protect
food from contamination and should be specifically identifiable, including appropriate security
consideration to prevent accidental discharge or malicious contamination.
• Facilities should be provided to include adequate potable water supplies, suitable drainage and waste
disposal, appropriate cleaning facilities, storage areas, lighting, ventilation, and temperature control.
Suitable facilities should also be provided to promote personal hygiene for the workforce, including
adequate changing areas, lavatories, and hand washing and drying facilities.
Control of Operation
The rationale of operational control listed in Codex (2009a) is ‘to reduce the risk of unsafe food by taking
preventive measures to assure the safety and suitability of food at an appropriate stage in the operation by
controlling food hazards’.
PRP Elements for Control of Operation
• Control of food hazards requires the use of a system such as HACCP throughout the food chain to
identify any steps in food operations that are critical to food safety; implement effective control
procedures at those steps; monitor control procedures to ensure its continuing effectiveness; and
review control procedures periodically, and whenever the operations change.
Key Aspects of Hygiene Control Systems (Codex, 2009a)
o Time and temperature control to prevent common causes of foodborne illnesses.
o Use of specific process steps that can contribute to food hygiene (e.g., chilling or modified
atmosphere packaging).
o Microbiological and other specifications based on thorough scientific principles.
o Management techniques to control microbiological cross-contamination risks (e.g.,
segregation of processes/parts of processes and restricted access procedures).
o Physical and chemical contamination prevention, including the use of suitable detection
or screening devices when necessary.
Effective allergen management requires an integrated approach throughout the product stream/flow.
Each stage of the product lifecycle should be considered.
Stages of Product Lifecycle
 During product design – is the allergen already in use in the plant? Is the allergen already
in use on the same process line?
 Hidden supplier control programs – what allergens are used in the supplier’s plant? Has
the supplier program been verified during an on-site visit?
 During manufacture – to prevent cross-contamination, a basis for sequencing schedules
and rework procedures must be set in place.
This basis refers to a formalized allergen control program that will be developed by
conducting an allergen risk evaluation. Elements of this include:
o Listing all allergenic materials that are on site (raw material specifications).

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o Listing all products manufactured together with the allergenic raw materials that go
into them (matrix of products and ingredients).
o Develop a diagram or use the HACCP documents (allergen process flow).
 Transportation and Labelling – this includes the requirements to protect food from cross-
contamination during transit and the need to ensure that all allergens are clearly and
accurately labelled on the package.
• Incoming material requirements and systems to ensure the safety of materials and ingredients at the
start of processing is necessary to protect an operation and its products. This PRP element covers the
need for appropriate specifications and acceptance procedures to prevent the acceptance of
hazardous raw materials and ingredients that would not be controlled by process, including the use
of appropriate inspection and sorting procedure along with effective stock rotation.
• Suitable packaging design to provide the necessary protection to a product during its shelf life is also
highlighted by Codex (2009a). This embraces the need to ensure that the chosen packaging system is
itself safe and will not pose a threat to a food product, plus the requirement to ensure hygienic
conditions of reusable packaging (e.g., refillable glass bottles).
• Use of potable water is also important for hygienic control especially where water is a food ingredient
and for all food handling and processing operations, with the exception of specific food processes
where non-potable water would not cause a contamination hazard to a food.
The need to treat and monitor any water being recirculated for reuse is also described, as is the
requirement to make ice only from potable water, and to ensure the safety and suitability of steam
for direct food contact. It is sometimes necessary to install an in-plant water treatment system to
ensure a supply of potable water.
• Appropriate management and supervision, reflecting the size of the operation and nature of its
activities and processes, is also highlighted, with the need to ensure personnel have enough
knowledge of food hygiene principles to be able to form a judgment on likely risks and take necessary
actions.
• Documentation and records should also be kept adequate and maintained for a period exceeding the
shelf life of products/food items.
• Recall procedures should also be developed and tested so that the products can be effectively
withdrawn and recalled in the event that a food safety problem is highlighted.
Establishment: Maintenance and Sanitation
This stage is a broad-ranging prerequisite grouping that includes the elements of cleaning and
disinfection/sanitation, pest management and waste management, plus the need to monitor the effectiveness
of these elements in all cases.
PRP Elements for Establishment: Maintenance and Sanitation
• Maintenance and cleaning are both important to keep the processing environment, facilities, and
equipment in a good taste of repair, where it can both function as intended and prevent cross-
contamination with food residues and microorganisms that might otherwise build up.
Maintenance and cleaning are performed normally involving the following:
o Operating facilities with preventive maintenance programs as well as attending to breakdowns
and faults without delay

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o Removing gross debris immediately

o Applying detergent solution/s
o Rinsing with potable water
o Disinfection/sanitation as often as necessary
Dry cleaning or other appropriate methods may be used as appropriate to the specific situation, and
all chemicals used should be handled and stored carefully to prevent contamination of food products.
Principal Sanitation Program Stages (Motarjemi & Lelieveld, 2014):
a. Preparation. All product and unwanted utensils/packaging/equipment should be covered or
removed from the area. Machineries should be switched off and equipment should be
dismantled and stored on racks.
b. Gross soil removal. All loosely adhered or gross soil should be removed by brushing, scraping,
shoveling, vacuuming, etc.
c. Pre-rinse. Surfaces should be rinsed with low pressure cold water to remove loosely adhered
small debris. Hot water can be used for fatty soils (approximately 60°C), but too high a
temperature may coagulate proteins.
d. Cleaning. It is a combination of mechanical or kinetic energy (physical or fluid abrasion),
chemical energy (cleaning chemicals), temperature or thermal energy, and cleaning time.
Water provides the cheapest, readily available transport medium for rinsing and dispersing
soils, has dissolving powers to remove ionic-soluble compounds such as salts and sugars, will
help solubilize proteins below their coagulation point, emulsifies fats at temperatures above
their melting point, and, in high pressure cleaning, can be used as an abrasive. Usually in the
order of drains, walls then floors are cleaned prior to food processing equipment and all food
processing equipment should be cleaned at the same time.
e. Inter-rinse. Both soil detached by cleaning operations and cleaning chemical residues should
be removed from surfaces by rinsing with low pressure cold water.
f. Disinfection. It is undertaken to remove and/or reduce the viability of remaining
microorganisms to a level deemed to be of no significant risk. Elevated temperature is the
best disinfectant as it penetrates into surfaces, is non-corrosive, non-selective to microbial
types, easily measured, and leaves no residue.
g. Post-rinse. Disinfectant residues may or may not be removed by rinsing away with low
pressure cold water of known potable quality.
h. Inter-production cycle conditions. A number of procedures may be undertaken, including the
removal of excess water and/or equipment drying, to prevent the growth of microorganism
on production contact surfaces in the period up until the next production process.
i. Periodic practices. These increase the degree of cleaning for specific equipment or areas to
return them to acceptable cleanliness levels. These include weekly acidic cleans, weekend
dismantling of equipment, and cleaning and disinfection of chillers and sanitation of surfaces,
fixtures and fittings above two (2) meters.
j. Clean the cleaning equipment. Following its use of cleaning, cleaning equipment should itself
be cleaned and disinfected. Such equipment should be visually checked for damage and any
areas where microorganisms could reside. Cleaning equipment should be stored in racks to
dry or kept in disinfectant solution until its use is required.

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• Cleaning programs should be developed to encompass all equipment and facilities as well as general
environmental cleaning, and this may require specialist/expert advice. Cleaning methods need to be
developed that are suitable for an item to be cleaned and should describe both the method and
frequency of cleaning specific areas and items of equipment, and the responsibility for the tasks.
Records of cleaning and monitoring should also be kept.
Types of Cleaning and Sanitizing Systems (Motarjemi & Lelieveld, 2014):
 Clean-in-place (CIP) is the automated cleaning of equipment with minimal dismantling of food
production equipment prior to the cleaning and sanitizing operation.
 Clean-out-of-place (COP) is the removal of food production equipment or portions of the
equipment as well as related food production tools at an external area for cleaning, sanitizing,
and drying prior to reassembly.
 Environmental cleaning is generally accomplished manually but in some cases, automated
cleaning systems have been utilized on environmental surfaces. These surfaces are those
external to food processing equipment within the food production facility.
Cleaning Factors
 Time to clean and sanitize is often misunderstood, especially when chemical cleaning is
involved. Optimizing the time for a cleaning operation to ensure effective soil dissolution and
emulsification is generally a high priority for food producers. Rushing a cleaning operation can
result in poor cleaning and the potential for food contamination.
 Temperature effects on cleaning and sanitizing will vary depending on soil type and water
quality. A rule of thumb is that for every 10°C increase, cleaning chemical doubles resulting in
fatty oils, sugars and starches, and many other types of food soils being more easily removed
with increased temperature.
 Chemical activity is important as cleaning chemistry is built to dissolve soils from the surfaces
to be cleaned and emulsify these soils to avoid redeposition. A sanitizing step will kill or inhibit
microbial contamination that remains after the cleaning step. Chemical activity is impeded
when:
× Cleaning or sanitizing solutions do not reach the soils due to lack of solution flow (dead
zones).
× Chemical concentrations are too low (cannot dissolve soils) or too high (precipitate out or
react with soils).
× Inappropriate chemical systems are used and are not effective at cleaning or sanitizing the
food processing equipment.
 Mechanical action is required to move soils away from a surface. In the absence of manual
cleaning, automated cleaning systems generally rely on pressurized water or air to provide
mechanical force for soil removal.
Common Cleaning Problems in Food Process Environments
 Protein. Protein soils formed can be difficult to remove especially if left behind after other
components (such as fats and starches) are removed by the cleaning operation. Protein
cleaning is usually best done using alkaline oxidizing chemistry at temperatures that support
cleaning without precipitating the protein from the cleaning solution.

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 Fats and Oils. Oily soil from fats or vegetable oils generally will clean better with increasing
temperature and use of appropriate surface-active emulsifying cleaning solutions.
 Starches. Starches from food sources, gum, pectin, and other thickeners are usually water
soluble, but when heated can dry out and become very difficult to rewet. Built alkaline
cleaners with oxidizers are often required to remove these soils effectively and, in some cases,
pretreatment with acid followed by alkaline cleaning may result in more efficient cleaning.
• Pest control systems are important to prevent the access of pests that might cause contamination to
a product and good hygienic practices are necessary to prevent the creation of an environment
conducive to pest infestation.
 Buildings need to be made pest-proof and regularly inspected for potential ingress points. This
will include sealing of holes, drains, etc., to prevent pest access and suitable screening (e.g.
wire mesh on any opening windows, vents, and doors).
 Interior and exterior areas need to be kept clean and tidy to minimize potential food and
harborage sources. All potential food sources (including reuse) should be kept in suitable
containers off the ground and away from walls.
 Suitable interior traps and monitoring devices should also be considered, and any pest
infestations need to be dealt with promptly, without adversely affecting food safety.
Presidential Decree No. 856 (PD No. 856) or the Code on Sanitation of the Philippines specifically
cites provisions regarding vermin control on its Chapter XVI. Vermin pertains to a group of insects or
small animals such as flies, mosquitoes, cockroaches, fleas, lice, bedbugs, mice, and rats which are
vectors of diseases.
Section 70 highlights the following general requirements:
a. A vermin abatement program shall be maintained in place by their owners, operators, or
administrators. If they fail, neglect or refuse to maintain a vermin abatement program,
the local health agency will undertake the work at their expense.
b. Vermin control in public places shall be the responsibility of the provincial, city, or
municipal governments that have jurisdiction over them.
c. The procedure and frequency of vermin abatement program shall be determined and
approved by the local health authority.
The big issue regarding the continued successful use of chemical for control of stored product pests is
the development of resistance. Pests have become resistant to insecticides, insect growth regulators,
fumigants such as phosphine, and even to some bacteria-based sprays (Motarjemi & Lelieveld, 2014).
• Waste management should ensure that waste materials can be removed and stored safely so that
these do not provide a cross-contamination risk or become a food or harborage source for pests.
Waste must not be allowed to accumulate in food handling and storage areas and the adjoining
environment and waste areas must be kept clean at all times.
PD No. 856 specifically cites provisions regarding refuse control on its Chapter XVIII. As stated in
Section 81, refuse is an inclusive term for all solid waste products consisting of garbage, rubbish, ashes,
night soil, manure, dead animals, street sweepings, and industrial wastes.
Section 82 discusses the responsibility of cities and municipalities to provide an adequate and efficient
system of collecting, transporting, and disposing refuse in their areas of jurisdiction in a manner
approved by the local health authority.

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Section 83 provides the following additional requirements:

a. Occupants of buildings and residences shall provide a sufficient number of receptacles for
refuse. Refuse in receptacles shall be protected against vermin and other animals.
b. Refuse shall be disposed through a municipal collection service. If this service is not
available, disposal shall be by incineration, burying, sanitary landfill, or any method
approved by local health authority.
c. Refuse shall not be thrown in any street sidewalk, yard, park, or any body of water. It shall
be stored in a suitable container while awaiting its final disposal.
d. Streets shall be kept clean by occupants or owners of properties lining the street from the
line of the property to the middle of the street and from one (1) property to the other.
e. Parks, plazas, and streets adjacent to public buildings shall be kept clean by the local
government concerned.
There is a need to monitor effectiveness of all maintenance and sanitation systems, and these should
be verified and reviewed periodically, with changes made to reflect operational changes. Audit,
inspection and other tools such as microbiological environmental sampling can be used to facilitate
verification of these prerequisite elements.
Establishment: Personal Hygiene
The objectives for personal hygiene stated in Codex (2009a) are maintaining an appropriate degree of personal
cleanliness, and behaving and operating in an appropriate manner.
PRP Elements for Establishment: Personal Hygiene
• Establishment of health status is important where individuals may be carrying a disease that can be
transmitted through food. Anyone known or suspected to be carrying such disease should not be
permitted in food-handling areas. Food-handling personnel should be trained to report illness or
symptoms to the management, and medical examinations should be done if necessary.
• Consideration of illness and injuries that may require affected staff members to be excluded or wear
appropriate dressings should be done. The following conditions should be reported so that any need
for medical examination or exclusion can also be considered as listed by Codex (2009a):
× Jaundice × Visibly infected skin lesions (e.g. boils and
× Diarrhea cuts)
× Vomiting × Discharges from the ear, eye, or nose
× Fever or sore throat with fever
• Personal cleanliness including effective hand-washing and wearing of adequate protective clothing
and footwear is also highlighted.
• Similarly, the prevention of inappropriate personal behavior such as smoking, eating, or chewing in
food-handling areas should be enforced, and personal accessories should be prohibited in food-
handling areas. Visitors to processing and product-handling areas should be adequately supervised
and required to follow the same standards of personal hygiene as employees.
• Personal protective equipment (PPE), which include visors, face masks, gloves, safety spectacles, ear
defenders, overalls and footwear with non-slip soles and metal toe caps, and head protection like hard
hats and caps, are provided to protect the operator from the food processing environment and specific
safety hazards as appropriate.

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• Protective clothing like hairnets, coats, thermal wear/suits, aprons, wrist and forearm sleeves, and
trousers are provided by the food manufacturer primarily to protect the food from microorganisms.
Transportation
To ensure food safety during transportation, transport facilities need to be designed and managed to protect
food products from potential contamination and damage, and to prevent the growth of pathogens.
PRP Elements for Transportation
• General requirements include the need for protection of food during transit.
• Design requirements include the design of containers and conveyances to facilitate protection during
transit.
• Use and maintenance requirements for vehicles and containers include appropriate standards of
cleanliness and disinfection between loads as appropriate. Containers should be both marked for and
used for ‘food use only’, where appropriate and temperature control devices are used when
necessary.
Product Information and Consumer Awareness
Product information is important both for following links in the food chain and for the final food handler and
consumer. Insufficient information or inadequate knowledge can lead to products being mishandled, and
ultimately, to both foodborne illness and product wastage.
PRP Elements for Product Information and Consumer Awareness
• Lot identification information is easily identifiable on products so that the lot or batch can be
identified for recall purposes, a product can be handled correctly, and that stock rotation is facilitated.
This will include permanent marking to identify the producer and the lot.
• Product information and labelling should be clear and sufficient such that it facilitates the correct
handling, storage, preparation, and use of a food by the next person in the food chain.
• Consumer education is important in following handling instructions and the link between
time/temperature and foodborne illness.
Training
This is the final PRP element described by Codex (2009a), which is highlighted as “fundamentally important to
any food hygiene system”, since inadequate training, instruction, and/or supervision can pose threats to food
safety.
• Food hygiene training is essential to promote awareness in food handling personnel of their roles and
responsibilities for food control.
• Training programs should be developed and implemented by companies. Training is likely to include
details on the type(s) of food handled and produced, and their ability to support the growth of food
pathogens, plus control and monitoring procedures, such as the following:

 Process activities  Labelling and shelf life

 Packaging systems  Specific requirements (e.g.,
 Handling and storage requirements monitoring CCPs under HACCP plans)

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• Instruction and supervision of personnel and ongoing monitoring of food hygiene behavior should be
adequate. Managers and supervisors should have levels of food hygiene knowledge that will allow
them to judge potential food safety risks and take appropriate action.
• Refresher training is also needed for a current training to be evaluated, reviewed, and updated as
necessary.
Prerequisite programs are the basic standards for a food facility, in which a safely designed product can be
manufactured. These form the hygiene foundations on which the HACCP system is built to control food safety
operations every day.

References:
Motarjemi, Y. (Ed.), & Lelieveld, H. (Ed.). (2014). Food safety management: A practical guide for the food
industry. Oxford, UK: Elsevier Inc.
UNICEF. (1998). The Code on Sanitation of the Philippines: Presidential Decree No. 856. Manila: Department of
Health.
Wallace, C. A. (2011). Food safety for the 21st century: managing HACCP and food safety throughout the global
supply chain. Chichester, WS: John Wiley & Sons, Inc.

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