NATIONAL
STANDARD
TCVN
5603:2023
GENERAL
PRINCIPLES OF FOOD HYGIENE
Foreword
TCVN 5603:2023 supersedes
TCVN 5603:2008;
TCVN 5603:2023 is developed by
reference to CXC 1-1969, Revised 2020, General principles of food hygiene;
TCVN 5603:2023 is developed
by the National Technical Committee TCVN/TC/F3 General principles of food
hygiene, requested by the Directorate for Standards, Metrology and Quality
and published by the Ministry of Science and Technology.
Introduction
0.1 People have the right to expect the food
that they eat to be safe and suitable for consumption. Foodborne
illness and foodborne injury can be severe or fatal or have a negative impact
on human health over the longer term. Furthermore, outbreaks of
foodborne illness can damage trade and tourism. Food spoilage is wasteful,
costly, threatens food security and can adversely affect trade and consumer
confidence.
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This document outlines the
general principles that should be understood and followed by FBOs at all stages
of the food chain and that provide a basis for competent authorities to oversee
food safety and suitability. Taking into account the stage in the food chain, the nature
of the product, the relevant contaminants, and whether the relevant
contaminants adversely affect safety, suitability or both, these principles
will enable food businesses to develop their own food hygiene practices and
necessary food safety control measures, while complying with requirements set
by competent authorities.
While it is the FBOs’ responsibility to provide safe food,
for some FBOs this may be as simple as ensuring that the WHO five keys to safer
food1 are adequately implemented. The five keys are: “keep
clean, separate raw and cooked, cook thoroughly, keep food at safe temperatures
and use safe water and raw materials”.
FBOs need to be aware of
hazards that may affect their food. FBOs need to understand the
consequences of these hazards for consumer health and should ensure that they
are properly managed.
Good hygiene practices (GHPs) are the foundation of any
effective control of hazards associated with their businesses. For
some FBOs, effective implementation of GHPs will be sufficient to address food
safety.
The sufficiency of the
implemented GHPs to address food safety could be determined through conducting
a hazard analysis and determining how to control identified hazards. However,
not all FBOs have the expertise to do this. If the FBO is not able to
conduct a hazard analysis, the FBO may rely on information on appropriate food
safety practices from external sources such as those provided by competent
authorities, academia or other competent bodies (e.g. trade associations or
professional societies) that have been based on the identification of relevant
hazards and controls.
For example, requirements in regulations for production of
safe food are based on hazard analysis often conducted by competent
authorities.
Similarly, guidance documents from trade associations and
other organizations that describe food safety procedures are based on hazard
analyses conducted by experts about the hazards and controls needed to ensure
the safety of specific types of products. When external generic
guidance is used, the FBO should make sure that the guidance corresponds with
the activities of the establishment and ensure all relevant hazards are
controlled.
All GHPs are important but
some GHPs have a greater impact on food safety. Thus, for some GHPs, based
on safety concerns with food, greater attention may be needed to provide safe
food. For
example, the cleaning of equipment and surfaces which come into contact with
ready-to-eat food should warrant greater attention than other areas such as the
cleaning of walls and ceilings, because if food contact surfaces are not
properly cleaned, this could lead to direct contamination of food. Greater
attention may include a higher frequency of application, of monitoring and of
verification.
In some circumstances, the
implementation of GHPs may not be sufficient to ensure food safety due to the
complexity of the food operation and/or specific hazards associated with the
product or process, technological advances (e.g. extending shelf-life through
modified atmosphere packaging) or end use of the product (e.g. products
destined for a special dietary purpose). In such cases, when there
are significant hazards identified through hazard analysis as not being
controlled by GHPs, they should be addressed in the hazard analysis critical
control point (HACCP) plan.
Section 6 of this document
deals with GHPs, the basis of all food hygiene systems to support the
production of safe and suitable food. Section 7 deals with HACCP
principles that can be applied
throughout the food chain from primary production to final consumption and
whose implementation should be guided by scientific evidence of risks to human
health. Table 1 in Annex I provides a comparison of control measures applied as
GHPs and those applied at critical control points (CCPs) with examples.
0.2 Objectives
The general principles of
food hygiene: GHPs and the HACCP system aim to:
- provide principles and
guidance on the application of GHPs applicable throughout the food chain to
provide food that is safe and suitable for consumption;
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- clarify the relationship
between GHPs and HACCP; and
- provide the basis on which
sector and product-specific codes of practice can be established.
0.3 Use
0.3.1 General
The document is intended for
use by FBOs (including primary producers, importers, manufacturers/processors,
food warehouse/logistics operators, food service operators, retailers, and
traders) and competent authorities, as appropriate. It
provides basic information to meet the needs of food businesses, irrespective
of the nature of product and size of food business, in the context of food
trade. However,
it should be noted that it is not possible for the document to provide specific
guidance for all situations and specific types of food businesses and the
nature and extent of food safety risks associated with individual
circumstances.
There will be situations
where some of the specific recommendations contained in this document are not
applicable.
The fundamental question for each FBO in every case is: “what
is necessary and appropriate to ensure the safety and suitability of food for
consumption?”
The text indicates where
such questions are likely to arise by using the phrases “where necessary” and
“where appropriate”.
In deciding whether a measure is necessary or appropriate, an
evaluation of the likelihood and severity of the hazard towards establishing
the potential harmful effects to consumers should be made, taking into account
any relevant knowledge of the operation and hazards, including available
scientific information.
This approach allows the measures in this document to be
flexibly and sensibly applied with a regard for the overall objectives of
producing food which is safe and suitable for consumption. In
so doing, it takes into account the wide diversity of food chain operations and
practices and varying degrees of risk to public health involved in producing
and handling food.
0.3.2 Roles of competent
authorities, food business operators, and consumers
Competent authorities are
responsible for deciding how these general principles are best applied through
legislation, regulation or guidance to:
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- ensure FBOs implement an
effective control system so that food is safe and suitable for consumption;
- maintain confidence in
domestically and internationally traded food; and
- provide information that
effectively communicates the principles of food hygiene to FBOs and consumers.
FBOs should apply the
hygienic practices and food safety principles set out in this document to:
- develop, implement, and
verify processes that provide food that is safe and suitable for its intended
use;
- ensure personnel are
competent as appropriate to their job activities;
- build a positive food safety
culture by demonstrating commitment to providing safe and suitable food and
encouraging appropriate food safety practices;
- contribute to maintaining
confidence in domestically and internationally traded food; and
- ensure that consumers have
clear and easily understood information to enable them to identify the presence
of food allergens, protect their food from contamination, and prevent the
growth/survival of foodborne pathogens by storing, handling, and preparing food
correctly.
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GENERAL PRINCIPLES OF
FOOD HYGIENE
1
Scope
This document provides a
framework of general principles for producing safe and suitable food for
consumption by outlining necessary hygiene and food safety controls to be
implemented in production (including primary production), processing,
manufacturing, preparation, packaging, storage, distribution, retail, food
service operation and transport of food, and where appropriate, specific food
safety control measures at certain steps throughout the food chain.
2
Normative references
The following referenced
documents are indispensable for the application of this document. For
dated references, only the edition cited applies. For undated references, the
latest edition of the referenced document (including any amendments) applies.
TCVN 7087:2013 (CODEX STAN
1-1985, with Amendment 2010), Labelling of prepackaged foods
CXG 60-2006, Principles for
traceability/product tracing as a tool within a food inspection and certification
system
3
Definitions
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3.1
Acceptable level
A level of hazard in a food
at or below which the food is considered to be safe according to its intended
use.
3.2
Allergen cross-contact
The unintentional
incorporation of an allergenic food, or ingredient, into another food that is
not intended to contain that allergenic food or ingredient.
3.3
Cleaning
The removal of soil, food
residues, dirt, grease, or other objectionable matter.
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Competent authority
The government authority or
official body authorized by the government that is responsible for the setting
of regulatory food safety requirements and/or for the organization of official controls
including enforcement.
3.5
Contaminant
Any biological, chemical or
physical agent, foreign matter or other substances not intentionally added to
food that may compromise food safety or suitability.
3.6
Contamination
The introduction or
occurrence of a contaminant in the food or food environment.
3.7
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when used as a noun: the
state wherein correct procedures are being followed and any established
criteria are being met
3.8
Control
when used as a verb: to take
all necessary actions to ensure and maintain compliance with established
criteria and procedures.
3.9
Control measure
Any action or activity that
can be used to prevent or eliminate a hazard or reduce it to an acceptable
level.
3.10
Corrective action
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3.11
Critical control point
CCP
A step at which a control
measure or control measures, essential to control a significant hazard, is/are
applied in a HACCP system.
3.12
Critical limit
A criterion, observable or
measurable, relating to a control measure at a CCP which separates
acceptability from unacceptability of the food.
3.13
Deviation
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3.14
Disinfection
Reduction by means of
biological or chemical agents and/or physical methods in the number of viable
microorganisms on surfaces, in water or air to a level that does not compromise
food safety and/or suitability.
3.15
Flow diagram
A systematic representation
of the sequence of steps used in the production or manufacture of food.
3.16
Food business operator
FBO
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3.17
Food handler
Any person who directly
handles packaged or unpackaged food, equipment and utensils used for food, or
surfaces that come into contact with food and that is expected, therefore, to
comply with food hygiene requirements.
3.18
Food hygiene
All conditions and measures
necessary to ensure the safety and suitability of food at all stages of the
food chain.
3.19
Food hygiene system
Prerequisite programmes,
supplemented with control measures at CCPs, as appropriate, that when taken as
a whole, ensure that food is safe and suitable for its intended use.
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Food safety
Assurance that food will not
cause adverse health effects to the consumer when it is prepared and/or eaten
according to its intended use.
3.21
Food suitability
Assurance that food is
acceptable for human consumption according to its intended use.
3.22
Good hygiene practices
GHP
Fundamental measures and
conditions applied at any step within the food chain to provide safe and
suitable food.
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HACCP plan
Documentation or set of
documents, prepared in accordance with the principles of HACCP to ensure
control of significant hazards in the food business.
3.24
HACCP system
The development of a HACCP
plan and the implementation of the procedures in accordance with that plan.
3.25
Hazard
A biological, chemical or
physical agent in food with the potential to cause an adverse health effect.
3.26
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The process of collecting
and evaluating information on hazards identified in raw materials and other
ingredients, the environment, in the process or in the food, and conditions
leading to their presence to decide whether or not these are significant
hazards.
3.27
Monitor
The act of conducting a
planned sequence of observations or measurements of control parameters to
assess whether a control measure is under control.
3.28
Primary production
Those steps in the food
chain up to and including storage and, where appropriate, transport of outputs
of farming.
This would include growing crops, raising fish and animals,
and the harvesting of plants, animals or animal products from a farm or their
natural habitat.
3.29
Prerequisite programme
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3.30
Significant hazard
A hazard identified by a
hazard analysis, as reasonably likely to occur at an unacceptable level in the
absence of control, and for which control is essential given the intended use
of the food.
3.31
Step
A point, procedure,
operation, or stage in the food chain, including raw materials, from primary
production to final consumption.
3.32
Validation of control
measures
Obtaining evidence that a
control measure or combination of control measures, if properly implemented, is
capable of controlling the hazard to a specified outcome.
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Verification
The application of methods,
procedures, tests, and other evaluations, in addition to monitoring, to
determine whether a control measure is or has been operating as intended.
4
General principles
4.1 Food
safety and suitability should be controlled using a science-based preventive
approach, for example a food hygiene system. GHPs should ensure that food
is produced and handled in an environment that minimizes the presence of
contaminants.
4.2 Properly
applied prerequisite programmes, which include GHPs, should provide the
foundation for an effective HACCP system.
4.3 Each
FBO should be aware of the hazards associated with the raw materials and other
ingredients, the production or preparation process, and the environment in
which the food is produced and/or handled, as appropriate to the food business.
4.4 Depending on the nature of the food,
food process, and the potential for adverse health effects, to control hazards
it may be sufficient to apply GHPs, including, as appropriate, some that
require more attention than others, as they have a greater impact on food
safety. When
the application of GHPs alone is not sufficient, a combination of GHPs and
additional control measures at CCPs should be applied.
4.5 Control
measures that are essential to achieve an acceptable level of food safety, should
be scientifically validated 1).
4.6 The
application of control measures should be subject to monitoring, corrective
actions, verification and documentation, as appropriate to the nature of the
food product and the size of the food business.
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4.8 Appropriate
communication about the food and food process should be maintained among all
relevant parties to ensure food safety and suitability across the entire food
chain.
5
Management commitment to food safety
Fundamental to the
successful functioning of any food hygiene system is the establishment and
maintenance of a positive food safety culture acknowledging the importance of
human behaviour in providing safe and suitable food. The
following elements are important in cultivating a positive food safety culture:
- commitment of the management
and all personnel to the production and handling of safe food;
- leadership to set the right
direction and to engage all personnel in food safety practices;
- awareness of the importance
of food hygiene by all personnel in the food business;
- open and clear communication
among all personnel in the food business, including communication of deviations
and expectations; and
- the availability of
sufficient resources to ensure the effective functioning of the food hygiene
system.
Management should ensure the
effectiveness of the food hygiene systems in place by:
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- maintaining the integrity of
the food hygiene system when changes are planned and implemented;
- verifying that controls are
carried out and working and that documentation is up to date;
- ensuring that the
appropriate training and supervision are in place for personnel;
- ensuring compliance with
relevant regulatory requirements; and
- encouraging continual
improvement, where appropriate, taking into account developments in science,
technology and best practice.
6
Good hygiene practices
6.1
Introduction and control of food hazards
The development,
implementation, and maintenance of GHPs provide the conditions and activities
that are necessary to support the production of safe and suitable food at all
stages of the food chain from primary production through to handling of the
final product.
Applied generally, they assist in controlling hazards in food
products.
Knowledge of the food and
its production process is essential for the effective implementation of GHPs. Section
6 provides guidance for effective implementation of GHPs, including appropriate
location, layout, design, construction and maintenance of premises and
facilities, and should be applied in conjunction with sector and
product-specific codes.
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As previously noted, all
FBOs should be aware of and understand hazards associated with their
businesses, and the control measures required to manage these hazards, as
appropriate.
FBOs should consider (using external resources as needed)
whether the application of GHPs alone is sufficient to manage some or all of
the hazards associated with the operation through control of their sources,
such as:
- control of water quality –
minimizes the presence of many potential hazards (e.g. biological, chemical,
physical);
- control of faecal
contamination – minimizes the potential for contamination with many foodborne
pathogens such as Salmonella, Campylobacter, Yersinia, pathogenic
strains of E. coli;
- control of food handler
practices and hygiene – prevents many potential communicable diseases that
could be foodborne; and
- control of food contact
surfaces by cleaning – removes bacterial contaminants, including foodborne
pathogens, and allergens.
After consideration of the
conditions and activities in the business, it may be determined that GHPs alone
may be sufficient to manage the hazards. However, it may also be determined
that it is necessary to place greater attention on some GHPs that are
particularly important for food safety (e.g. increased stringency of cleaning
of a mincer for producing minced meat for raw or lightly cooked consumption
compared to equipment used for producing meat to be cooked prior to
consumption; increased monitoring and/or verification of disinfection of food
contact surfaces).
Hazards that occur or are
present at levels such that GHP procedures are not sufficient to provide safe
food, should be managed by an appropriate combination of control measures that
are capable of preventing occurrence of hazards or eliminating or reducing them
to an acceptable level.
The control measures can be identified in one or more steps
throughout the production process. Where significant hazards
are identified that need to be controlled after the implementation of GHPs, it
will be necessary to develop and implement a HACCP system (see Section 7).
6.2
Primary production
Objectives
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- an assessment of the
suitability of water used where it may pose a hazard, for example, crop
irrigation, rinsing activities, etc.;
- avoiding the use of areas
where the environment poses a threat to the safety of food (e.g. contaminated
sites);
- controlling contaminants,
pests and diseases of animals and plants, to the extent practicable, to
minimize the threat to food safety (e.g. appropriate use of pesticides and
veterinary drugs); and
- adopting practices and
measures to ensure food is produced under appropriately hygienic conditions
(e.g. cleaning and maintaining harvest equipment, rinsing, hygienic milking
practices).
Rationale
To reduce the likelihood
of introducing a contaminant which may adversely affect the safety of food,
or its suitability for consumption, at all stages of the food chain.
The types of activities
involved in primary production may make eliminating or reducing some hazards
difficult.
However, by applying prerequisite programmes such as good
agricultural practices (GAPs) and/or GHPs, steps can be taken to minimize the
occurrence and levels of hazards in the food chain, e.g. at milking for dairy
production, steps taken in the hygienic production of eggs, or the controls on
irrigation water used for growing salad crops. Not all provisions apply for
all primary production situations and consideration will need to be given by
the FBO on the appropriateness of the measures to be taken.
6.2.1 Environmental control
Potential sources of
contamination from the environment should be identified. In
particular, primary production should not be carried out in areas where the
presence of contaminants would lead to an unacceptable level of such
contaminants in food, e.g. using polluted areas2), locating near
facilities emitting toxic or offensive odours which could taint foodstuffs or
near sources of contaminated water such as discharge of wastewater from
industrial production or runoff from agricultural land with high faecal
material or chemical residues, unless there is a measure to reduce or prevent
the contamination of food.
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The potential effects of
primary production activities on the safety and suitability of food should be
considered at all times.
In particular, this includes identifying any specific points
in such activities where a high probability of contamination may exist and
taking specific measures to minimize and, if possible, eliminate that
probability.
Producers should as far as
practicable, implement measures to:
- control contamination from
soil, water, feedstuffs, fertilizers (including natural fertilizers),
pesticides, veterinary drugs or any other agent used in primary production;
- protect food sources from
faecal and other contamination (e.g. zoonotic foodborne agents);
- control plant and animal
health so that it does not pose a threat to human health through food
consumption, or adversely affect the suitability of the product (e.g. observe
the withdrawal period of veterinary drugs and pesticides, keeping records where
applicable); and
- manage waste and store harmful
substances appropriately.
6.2.3 Handling, storage and
transport
Procedures should be in
place to:
- sort food to remove material
which should not be used for human consumption;
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- protect food from
contamination by pests, or by chemical, physical or microbiological
contaminants or other objectionable substances during handling (e.g. sorting,
grading, washing), storage and transport. Care should be taken to
prevent deterioration and spoilage through appropriate measures which may
include controlling temperature, humidity, and/or other controls.
6.2.4 Cleaning, maintenance
and personal hygiene
Appropriate facilities and
procedures should be in place to ensure that:
- Cleaning and maintenance are
carried out effectively and do not compromise food safety (e.g. ensuring
equipment used in harvest is not a source of contamination); and
- an appropriate degree of
personal hygiene is maintained to ensure personnel are not a source of
contamination (e.g. by human faeces).
6.3
Establishment – Design of facilities and equipment
Objectives
Depending on the nature of
the operations and the associated risks, premises, equipment, and facilities
should be located, designed and constructed to ensure that:
- contamination is
minimized;
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- surfaces and materials, in
particular those in contact with food, are non-toxic for their intended use;
- where appropriate,
suitable facilities are available for temperature, humidity, and other
controls;
- there is effective
protection against pest access and harbourage; and
- there are sufficient and
appropriate washroom facilities for personnel.
Rationale
Attention to good hygienic
design and construction, appropriate location, and the provision of adequate
facilities is necessary to enable contaminants to be effectively controlled.
6.3.1 Location and structure
6.3.1.1 Location of
establishment
Food establishments should
not be located where there is a threat to food safety or suitability and
hazards cannot be controlled by reasonable measures. The
location of an establishment, including temporary/mobile establishments, should
not introduce any hazards from the environment that cannot be controlled. In
particular, unless sufficient safeguards are provided, establishments should
normally be located away from:
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- areas subject to flooding;
- areas prone to infestations
of pests; and
- areas where waste, either
solid or liquid, cannot be removed effectively.
6.3.1.2 Design and layout of
food establishment
The design and layout of
food establishments should permit adequate maintenance and cleaning. The
layout of premises and the flow of operations, including the movements of
personnel and material within the buildings, should be such that
cross-contamination is minimized or prevented.
Areas having different
levels of hygiene control (e.g. the raw material and finished product areas)
should be separated to minimize cross-contamination through measures such as
physical separation (e.g. walls, partitions) and/or location (e.g. distance),
traffic flow (e.g. one-directional production flow), airflow, or separation in
time, with suitable cleaning and disinfection between uses.
6.3.1.3 Internal structures
and fittings
Structures within food
establishments should be soundly built of durable materials, which are easy to
maintain, clean and, where appropriate, easy to disinfect. They
should be constructed of non-toxic and inert materials according to intended
use and normal operating conditions. In particular, the following
specific conditions should be satisfied, where necessary, to protect the safety
and suitability of food:
- the surfaces of walls,
partitions and floors should be made of impervious materials that are easy to
clean and, where necessary, disinfect;
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- floors should be constructed
to allow adequate drainage and cleaning;
- ceilings and overhead
fixtures (e.g. lighting) should be constructed to be shatterproof where
appropriate, and finished to minimize the build-up of dirt and condensation and
the shedding of particles;
- windows should be easy to
clean, be constructed to minimize the build-up of dirt and, where necessary, be
fitted with removable and cleanable insect-proof screens; and
- doors should have smooth,
non-absorbent surfaces, be easy to clean and, where necessary, disinfect.
Work surfaces that come into
direct contact with food should be in sound condition, durable, and easy to
clean, maintain and disinfect. They should be made of smooth, non-absorbent materials, and
inert to the food, to detergents and to disinfectants under normal operating
conditions.
6.3.1.4 Temporary/Mobile
food establishments and vending machines
Establishments and
structures covered here include market stalls, street vending vehicles, vending
machines and temporary premises such as tents and marquees.
Such premises and structures
should be located, designed, and constructed to avoid, as far as reasonably
practicable, the contamination of food and the harbouring of pests. Adequate
facilities for toileting and washing hands should be provided, where
appropriate.
6.3.2 Facilities
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Adequate drainage and waste
disposal systems and facilities should be provided and well maintained. They
should be designed and constructed so that the likelihood of contaminating food
or the water supply is avoided. For plumbing, steps should be taken to prevent backflow,
cross-connections, and backup of sewer gases. It is important that
drainage does not flow from highly contaminated areas (such as toilets or raw
production areas) to areas where finished food is exposed to the environment.
Waste should be collected,
disposed of by trained personnel and, where appropriate, disposal records
maintained.
The waste disposal site should be located away from the food
establishment to prevent pest infestation. Containers for waste,
by-products and inedible or hazardous substances should be specifically
identifiable, suitably constructed and, where appropriate, made of impervious material.
Containers used to hold
hazardous substances prior to disposal should be identified and, where
appropriate, be lockable to prevent intentional or accidental contamination of
food.
6.3.2.2 Cleaning facilities
Adequate, suitably
designated facilities should be provided for cleaning utensils and equipment. Such
facilities should have an adequate supply of hot and/or cold water, where
required.
A separate cleaning area should be provided for tools and
equipment from highly contaminated areas like toilets, drainage and waste
disposal areas.
Where appropriate, facilities for washing food should be
separate from facilities for cleaning utensils and equipment, and separate
sinks should be available for hand washing and food washing.
6.3.2.3 Personnel hygiene
facilities and toilets
Adequate washing and toilet
facilities should be available so that an appropriate degree of personal
hygiene can be maintained and to avoid personnel contaminating food. Such
facilities should be suitably located and should not be used for other purposes
such as storage of food or items that contact food. They
should include:
- adequate means of washing
and drying hands, including soap (preferably liquid soap), wash basins and,
where appropriate, a supply of hot and cold (or suitably temperature
controlled) water;
- hand washing basins of an
appropriate hygienic design, ideally with taps not operated by hands; where
this is not possible, appropriate measures to minimize contamination from the
taps should be in place; and
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Handwashing basins should
not be used for washing food or utensils.
6.3.2.4 Temperature
Depending on the nature of
the food operations undertaken, adequate facilities should be available for
heating, cooling, cooking, refrigerating and freezing food, for storing
refrigerated or frozen foods, and, when necessary, controlling ambient
temperatures to ensure the safety and suitability of food.
6.3.2.5 Air quality and
ventilation
Adequate means of natural or
mechanical ventilation should be provided, in particular to:
- minimize airborne
contamination of food, for example, from aerosols and condensation droplets;
- help control ambient
temperatures;
- control odours which might
affect the suitability of food; and
- control humidity to ensure
the safety and suitability of food (e.g. to prevent an increase in moisture of
dried foods that would allow growth of microorganisms and production of toxic
metabolites).
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6.3.2.6 Lighting
Adequate natural or
artificial lighting should be provided to enable the food business to operate
in a hygienic manner
Lighting should be such that it does not adversely impact the
ability to detect defects of, or contaminants in, food or the examination of
facilities and equipment for cleanliness. The intensity should be
adequate to the nature of the operation. Light fittings should, where
appropriate, be protected to ensure that food is not contaminated by breakages
of lighting elements.
6.3.2.7 Storage
Adequate and, where
necessary, separate facilities for the safe and hygienic storage of food
products, food ingredients, food packaging materials and non-food chemicals
(including cleaning materials, lubricants, fuels), should be provided. Storage
should allow for segregation of raw and cooked foods or allergenic and
nonallergenic food.
Food storage facilities
should be designed and constructed to:
- facilitate adequate
maintenance and cleaning;
- avoid pest access and
harbourage;
- enable food to be
effectively protected from contamination, including allergen cross-contact,
during storage; and
- where necessary, provide an
environment which minimizes the deterioration of food (such as by temperature
and humidity control).
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6.3.3 Equipment
6.3.3.1 General
Equipment and containers
coming into contact with food should be suitable for food contact; designed,
constructed and located to ensure that they can be adequately cleaned (other
than containers which are single use only); disinfected (where necessary); and
maintained or discarded as necessary to avoid the contamination of food,
according to hygienic design principles. Equipment and containers
should be made of materials that are non-toxic according to intended use. Where
necessary, equipment should be durable and movable or capable of being disassembled
to allow for maintenance, cleaning, disinfection and to facilitate inspection
for pests.
6.3.3.2 Food control and
monitoring equipment
Equipment used to cook,
heat, cool, store or freeze food should be designed to achieve the required
food temperatures as rapidly as necessary in the interests of food safety and
suitability, and to maintain food temperatures effectively.
Such equipment should also
be designed to allow temperatures to be monitored, where necessary, and
controlled.
Where appropriate, monitoring equipment should be calibrated
to ensure that temperatures of food processes are accurate.
Where necessary, such
equipment should have effective means of controlling and monitoring humidity,
airflow and any other characteristics likely to have an effect on the safety or
suitability of food.
6.4
Training and competence
Objective
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Rationale
Training is fundamentally
important to any food hygiene system and the competence of personnel.
Adequate hygiene training,
and/or instruction and supervision of all personnel involved in food-related
activities contribute to ensuring the safety of food and its suitability for
consumption.
6.4.1 Awareness and
responsibilities
Food hygiene training is fundamentally
important to the food business. All personnel should be aware of their role and
responsibility in protecting food from contamination or deterioration. Personnel
should have the knowledge and skills necessary to enable them to handle food
hygienically.
Those who handle cleaning chemicals or other potentially
hazardous chemicals should be instructed in proper use to prevent contamination
of food.
6.4.2 Training programmes
Elements to take into
account in determining the extent of training required include:
- the nature of hazards
associated with the food, e.g. its ability to sustain growth of pathogenic or
spoilage microorganisms, the existence of potential physical contaminants or
known allergens;
- the manner in which the food
is produced, processed, handled and packed, including the likelihood of
contamination;
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- the conditions under which
the food will be stored;
- the expected length of time
before consumption of the food; and
- the use and maintenance of
instruments and equipment associated with food.
Training programmes should
also consider the knowledge and skill levels of the personnel being trained. Topics
to be considered for training programmes could include the following as
appropriate to a person’s duties:
- the principles of food
hygiene applicable to the food business;
- the measures relevant to the
food business that are used to prevent contaminants in food;
- the importance of good
personal hygiene, including proper hand washing and wearing, when needed,
appropriate clothing, for food safety;
- the GHPs applicable to the
food business; and
- appropriate actions to take
when food hygiene problems are observed.
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6.4.3 Instruction and
supervision
The type of instruction and
supervision needed will depend on the size of the business, the nature of its
activities and the types of food involved. Managers, supervisors and/or
operators/workers should have sufficient knowledge of food hygiene principles
and practices to be able to identify deviations and take necessary action as
appropriate to their duties.
Periodic assessments of the
effectiveness of training and instruction programmes should be made, as well as
routine supervision and verification to ensure that procedures are being
carried out effectively.
Personnel tasked to perform any activities used in food
control should be trained adequately to ensure that they are competent to
perform their tasks and are aware of the impact of their tasks on the safety
and suitability of the food.
6.4.4 Refresher training
Training programmes should
be routinely reviewed and updated where necessary. Systems
should be in place to ensure that food handlers and personnel associated with
the food business, such as maintenance staff, remain aware of all procedures
necessary to maintain the safety and suitability of food. Records
should be kept of training activities.
6.5
Establishment maintenance, cleaning and disinfection, and pest control
Objective
To establish effective
systems that:
- ensure appropriate
establishment maintenance;
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- ensure pest control;
- ensure waste management;
and
- monitor effectiveness of
cleaning and disinfection, pest control and waste management procedures.
Rationale
To facilitate the
continuing effective control of food contaminants, pests, and other agents
likely to compromise food safety and suitability.
6.5.1 Maintenance and
cleaning
6.5.1.1 General
Establishments and equipment
should be maintained in an appropriate condition to:
- facilitate all cleaning and
disinfection procedures;
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- prevent contamination of
food, such as from pests, metal shards, flaking plaster, debris, chemicals,
wood, plastic, glass, paper.
Cleaning should remove food
residues and dirt which may be a source of contamination, including allergens. The
cleaning methods and materials necessary will depend on the nature of the food
business, the food type and the surface to be cleaned. Disinfection may be
necessary after cleaning, especially for food contact surfaces.
Attention should be paid to
hygiene during cleaning and maintenance operations so as not to compromise food
safety and suitability. Cleaning products suitable for food contact surfaces
should be used in food preparation and storage areas.
Cleaning and disinfection
chemicals should be handled and used carefully and in accordance with
manufacturers’ instructions, for example, using the correct dilutions and
contact times, and stored, where necessary, separate from food, in clearly
identified containers to avoid contamination of food.
Separate cleaning equipment
and utensils, suitably designated, should be used for different hygiene zones
e.g. food and non-food contact surfaces.
Cleaning equipment should be
stored in an appropriate place and in such a manner to prevent contamination. Cleaning
equipment should be kept clean, maintained, and replaced periodically so as not
to become a source for cross-contamination of surfaces or food.
6.5.1.2 Cleaning and
disinfection methods and procedures
Cleaning can be carried out
by the separate or the combined use of physical methods, such as heat,
scrubbing, turbulent flow, and vacuum cleaning (or other methods that avoid the
use of water), and chemical methods using solutions of detergents, alkalis, or
acids. Dry
cleaning or other appropriate methods for removing and collecting residues and
debris may be needed in some operations and/or food processing areas where
water increases the likelihood of microbiological contamination. Care
should be taken to ensure cleaning procedures do not lead to contamination of
food, e.g. spray from pressure washing can spread contamination from dirty
areas, such as floors and drains, over a wide area and contaminate food contact
surfaces or exposed food.
Wet cleaning procedures will
involve, where appropriate:
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- applying an appropriate
detergent solution to loosen soil; and
- rinsing with water (hot
water where appropriate) to remove loosened material and residues of detergent.
Where necessary, cleaning
should be followed by chemical disinfection with subsequent rinsing unless the
manufacturer’s instructions indicate that, on a scientific basis, rinsing is
not required.
Concentrations and application time of chemicals used for
disinfection should be appropriate for use and applied according to
manufacturers’ instructions for optimal effectiveness. If
cleaning is not done effectively to remove soil to permit the disinfectant to
contact microorganisms or if sub-lethal concentrations of the disinfectant are
used, the microorganisms may persist.
Cleaning and disinfection
procedures should ensure that all parts of the establishment are appropriately
clean. Where
appropriate, programmes should be drawn up in consultation with relevant
experts.
Written cleaning and
disinfection procedures should be used, where appropriate. They should specify: They
should specify:
- areas, items of equipment
and utensils to be cleaned, and, where appropriate, disinfected;
- responsibility for
particular tasks;
- method and frequency of
cleaning and, where appropriate, disinfection; and
- monitoring and verification
activities.
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Application of cleaning and
disinfection procedures should be monitored for effectiveness and periodically
verified by means such as visual inspections and audits to ensure the
procedures have been applied properly. The type of monitoring will
depend on the nature of the procedures, but could include pH, water
temperature, conductivity, cleaning agent concentration, disinfectant
concentration, and other parameters important to ensure the cleaning and
disinfection programme is being implemented as designed and verify its
effectiveness.
Microorganisms can sometimes
become tolerant to disinfecting agents over time. Cleaning and disinfection
procedures should follow the manufacturers’ instructions. Periodic
review with disinfectant manufacturers/suppliers, where feasible, should be
conducted to help ensure the disinfectants used are effective and appropriate. Rotation
of the disinfectants could be considered to ensure inactivation of different
types of microorganisms (e.g. bacteria and fungi).
While effectiveness of
cleaning and disinfecting agents and instructions for use are validated by
their manufacturers, measures should be taken for sampling and testing the
environment and food contact surfaces (e.g. protein and allergen test swabs, or
microbiological testing for indicator organisms) to help verify that cleaning
and disinfection programmes are effective and being applied properly. Microbiological
sampling and testing may not be appropriate in all cases and an alternative
approach might include observation of cleaning and disinfection procedures,
including the correct disinfectant concentration, to achieve the necessary
results and to make sure protocols are being followed. Cleaning
and disinfection and maintenance procedures should be regularly reviewed and
adapted to reflect any changes in circumstances and documented as appropriate.
6.5.2 Pest control systems
6.5.2.1 General
Pests (e.g. birds, rodents,
insects, etc.) pose a major threat to the safety and suitability of food. Pest
infestations can occur where there are breeding sites and a supply of food. GHPs
should be employed to avoid creating an environment conducive to pests. Good
building design, layout, maintenance, and location, along with cleaning,
inspection of incoming materials and effective monitoring, can minimize the
likelihood of infestation and thereby limit the need for pesticides.
6.5.2.2 Prevention
Establishments should be
kept in good repair and condition to prevent pest access and to eliminate
potential breeding sites.
Holes, drains and other places where pests are likely to gain
access should be covered.
Roll up doors should close tightly against the floor. Wire
mesh screens, for example on open windows, doors, and ventilators, will reduce
the problem of pest entry. Animals should, wherever possible, be excluded from the
grounds of food-processing establishments.
6.5.2.3 Harbourage and
infestation
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Landscaping surrounding a
food establishment should be designed to minimize attracting and harbouring
pests.
6.5.2.4 Monitoring and
detection
Establishments and
surrounding areas should be regularly examined for evidence of infestation. Detectors
and traps (e.g. insect light traps, bait stations) should be designed and
located so as to prevent potential contamination of raw materials, products or
facilities.
Even if monitoring and detection are outsourced, FBOs should
review monitoring reports and, if necessary, ensure they or their designated
pest control operators take corrective action (e.g. eradication of pests,
elimination of harbourage sites or invasion routes).
6.5.2.5 Control of pest
infestation
Pest infestations should be
addressed immediately by a qualified person or company and appropriate
corrective action taken.
Treatment with chemical, physical, or biological agents
should be carried out without posing a threat to the safety or suitability of
food. The
cause of infestation should be identified, and corrective action taken to
prevent a problem from reoccurring. Records should be kept of
infestation, monitoring and eradication.
6.5.3 Waste management
6.5.3.1 General
Suitable provision should be
made for the removal and storage of waste. Waste should, as far as possible, be
collected and stored in covered containers and should not be allowed to
accumulate and overflow in food handling, food storage, and other working areas
or the adjoining environment in a manner that compromises food safety and suitability.
Personnel responsible for waste removal (including hazardous waste) should be
properly trained so they do not become a source of cross-contamination.
Waste storage areas should
be easily identifiable, be kept appropriately clean, and be resistant to pest
infestation.
They should also be located away from processing areas.
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Objective
To ensure that those who
come directly or indirectly into contact with food:
- maintain appropriate
personal health;
- maintain an appropriate
degree of personal cleanliness; and
- behave and operate in an
appropriate manner.
Rationale
Personnel who do not
maintain an appropriate degree of personal cleanliness, who have certain
illnesses or conditions or who behave inappropriately, can contaminate food
and transmit illness to consumers through food.
Food businesses should
establish policies and procedures for personal hygiene. FBOs
should ensure all personnel are aware of the importance of good personal
hygiene and understand and comply with practices that ensure food safety and
suitability.
6.6.1 Health status
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It may be appropriate for
personnel to be excluded for a specific time after symptoms resolve or, for
some illnesses, to get medical clearance before returning to work.
6.6.2 Illness and injuries
Some symptoms of illnesses
that should be reported to management so that the need for possible exclusion
from food handling and/or medical examination can be considered include:
- jaundice;
- diarrhoea;
- vomiting;
- fever;
- sore throat with fever;
- visibly infected skin
lesions (boils, cuts, etc.); and
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Personnel with cuts and
wounds should, where necessary, be assigned to work in areas where they will
have no direct contact with food. Where personnel are
permitted to continue working, cuts and wounds should be covered by suitable
waterproof plasters and, where appropriate, gloves. Appropriate
measures should be applied to ensure plasters do not become a source of
contamination (e.g. plasters of contrasting colour compared to the food and/or
detectable using a metal detector or X-ray detector).
6.6.3 Personal cleanliness
Personnel should maintain a
high degree of personal cleanliness and, where appropriate, wear suitable
protective clothing, head and beard covering, and footwear. Measures
should be implemented to prevent cross-contamination by personnel through
adequate hand washing and, where necessary, the wearing of gloves. If
gloves are worn, appropriate measures should be applied to ensure the gloves do
not become a source of contamination.
Personnel, including those
wearing gloves, should clean their hands regularly, especially when personal
cleanliness may affect food safety. In particular, they should
wash hands:
- at the start of food
handling activities;
- when returning to work after
breaks;
- immediately after using the
toilet; and
- after handling any
contaminated material, such as waste or raw and unprocessed foods where this
could result in contamination of other food items.
In order not to contaminate
food, personnel should wash hands with soap and water and rinse and dry them in
a manner that does not recontaminate the hands. Hand sanitizers should not
replace hand washing and should be used only after hands have been washed.
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When engaged in food
handling activities personnel should refrain from behaviour which could result
in contamination of food, for example:
- smoking or vaping;
- spitting;
- chewing, eating, or
drinking;
- touching the mouth, nose, or
other places of possible contamination; and
- sneezing or coughing over
unprotected food.
Personal effects such as
jewellery, watches, pins, or other items such as false nails/eye lashes should
not be worn or brought into food handling areas if they pose a threat to the
safety and suitability of food.
6.6.5 Visitors and other
persons from outside the establishment
Visitors to food businesses,
including maintenance workers, in particular to food manufacturing, processing
or handling areas, should, where appropriate, be instructed and supervised,
wear protective clothing and adhere to the other personal hygiene provisions
for personnel.
Visitors should be guided through a hygiene policy of the
business prior to visits and encouraged to report any type of illness/injury
that may pose crosscontamination issues.
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Objective
To produce food that is
safe and suitable for human consumption by:
- formulating design
requirements with respect to raw materials and other ingredients, composition/formulation,
production, processing, distribution, and consumer use to be met as
appropriate to the food business; and
- designing, implementing,
monitoring and reviewing effective control systems as appropriate to the food
business.
Rationale
If operations are not
controlled appropriately, food may become unsafe or unsuitable for
consumption.
Control of operation is
achieved by having an appropriate food hygiene system in place. The
following section describes practices that can assist in the identification and
application of appropriate controls, as well as activities that should take
place to ensure the operation is under control.
6.7.1 Description of
products and processes
After consideration of the
conditions and activities of the food business it may be necessary to pay
greater attention to some GHPs that are particularly important for food safety. In
this case, the following provisions could be considered.
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An FBO that is producing,
storing, or otherwise handling food should have a description of the food.
Products may be described individually or in groups in a manner that does not
compromise the awareness of hazards or other factors such as suitability of the
products for the purpose intended. Any
grouping of food products should be based on them having similar inputs and
ingredients, product characteristics (such as pH, water activity (aw)), process
steps and/or intended purpose.
The description could
include, as appropriate:
- the intended use of the
food, e.g. whether it is ready-to-eat or whether it is intended for further
processing either by consumers or another business, for example raw seafood to
be cooked;
- products intended for
specific vulnerable consumer groups, e.g. infant formula or food for special medical
purposes;
- any relevant specifications,
e.g. ingredient composition, aw, pH, type of preservation method used (if any),
or important characteristics associated with the food, such as nay allergens
present;
- any relevant limits
established for the food by the competent authority or, in the absence thereof,
set by the FBO;
- instructions provided for
further use, for example keep frozen until cooking, cook to a specified
temperature for a specified length of time, product shelf-life (use-by date);
- storage of product (e.g.
refrigerated/frozen/shelf stable) and transport conditions required; and
- food packaging material
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The FBO should consider all
steps in the operation for a specific product. It may be helpful to develop a
flow diagram, which shows the sequence and interaction of all processing steps
in the operation, including where raw materials, ingredients and intermediate
products enter the flow and where intermediate products, byproducts and waste
are released or removed. The flow diagram could be used for a number of similar
food products that are produced using similar production or processing steps,
to ensure all steps are captured. The steps should be confirmed as accurate by
an onsite review of the operation or process. For example, for restaurants, the
flow diagram could be based on the general activities from the receipt of
ingredients/raw material, storage (refrigerated, frozen, room temperature),
preparation before use (washing, defrosting), and cooking or preparation of
food.
6.7.1.3 Consideration of the
effectiveness of GHPs
Having considered the
product and process descriptions, an FBO should determine (using information
relevant to hazards and controls from various sources as appropriate) whether
the GHPs and other programmes they have in place are sufficient to address food
safety and suitability or if some GHPs need greater attention. For example, a
cooked meat slicer may require specific and more frequent cleaning to prevent
the build-up of Listeria spp. on its meat contact surfaces, or a conveyor belt
used in direct contact with the food, such as in sandwich production, may
require an increased frequency of cleaning or a specific cleaning programme.
When such increased attention on GHPs is insufficient to ensure food safety, it
will be necessary to implement a HACCP system (see Hazard Analysis and Critical
Control Point [HACCP] System and Guidelines for its Application).
6.7.1.4 Consideration of the
effectiveness of GHPs
The FBO should monitor the
hygienic procedures and practices as relevant to the business and as applicable
to the hazard being controlled. Procedures could include defining methods of monitoring
(including defining responsible personnel, frequency, and sampling regime if
applicable) and monitoring records to be kept. The frequency of monitoring
should be appropriate to ensure consistent process control.
When monitoring results
indicate a deviation, the FBO should undertake corrective action. Corrective
action should consist of the following actions, as appropriate:
- bringing the process back
into control by, for example, altering temperature or timing, or concentration
of disinfectant;
- isolating any affected
product and evaluating its safety and/or suitability;
- determining proper disposition
of affected product that is not acceptable to market;
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- taking steps to prevent
reoccurrence.
Records of corrective
actions should be retained.
6.7.1.5 Verification
The FBO should undertake
verification activities as relevant to the business, to check that GHP
procedures have been implemented effectively, monitoring is occurring, where
planned, and that appropriate corrective actions are taken when requirements
are not met:
Examples of verification activities could include the
following, as appropriate:
- review of GHP procedures,
monitoring, corrective actions, and records;
- review when any changes
occur to the product, process and other operations associated with the
business; and
- assessment of the efficacy
of cleaning.
Records of GHP verification
activities should be kept, where appropriate.
6.7.2 Key aspects of GHPs
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6.7.2.1 Time and temperature
control
Inadequate time and
temperature control, e.g. during cooking, cooling, processing and storage, are
among the most common failures of operational control. These allow survival or
growth of microorganisms that may cause foodborne illness or food spoilage.
Systems should be in place to ensure that temperature is controlled effectively
where it impacts the safety and suitability of food.
Time and temperature control
systems should take into account:
- the nature of the food, e.g.
its aw, pH, and likely initial level and types of microorganisms, such as
pathogenic and spoilage microflora;
- the impact on the
microorganisms, e.g. time in growth/dangerous temperature zone;
- the intended shelf-life of
the product;
- the method of packaging and
processing; and
- how the product is intended
to be used, e.g. further cooking/processing or ready-to-eat.
Such systems should also
specify tolerable limits for time and temperature variations. Temperature
control systems that impact safety and suitability of food should be validated,
and as appropriate, monitored and recorded. Temperature monitoring and
recording devices should be checked for accuracy and calibrated at regular
intervals or as needed.
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There are many individual
processing steps for specific foods which contribute to the production of safe
and suitable food products. These vary depending on the product and can include key steps
such as cooking, chilling, freezing, drying, and packaging.
The composition of a food
can be important in preventing microbial growth and toxin production, e.g. in
its formulation by adding preservatives, including acids, salts, food additives
or other compounds.
When formulation is used to control foodborne pathogens (e.g.
adjusting the pH or aw to a level that prevents growth), systems should be in
place to ensure that the product is formulated correctly and that the
controlling parameters are monitored.
6.7.2.3 Microbiological3)
physical, chemical and allergen specifications
Where microbiological,
physical, chemical and allergen specifications are used for food safety or
suitability, such specifications should be based on sound scientific principles
and state, where appropriate, sampling parameters, analytical methods,
acceptable limits, and monitoring procedures. Specifications can help
ensure that raw materials and other ingredients are fit for purpose and
contaminants have been minimized.
6.7.2.4 Microbiological
contamination
Systems should be in place
to prevent or minimize contamination of foods by microorganisms.
Microbiological contamination occurs through a number of mechanisms, including
the transfer of microorganisms from one food to another, e.g.:
- by direct contact or indirectly
by food handlers;
- by contact with surfaces;
- from cleaning equipment;
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- by airborne particles.
Raw, unprocessed food, where
not considered ready-to-eat, which could be a source of contamination, should
be separated from ready-to-eat foods, either physically or by time, with
effective intermediate cleaning and, where appropriate, effective disinfection.
Surfaces, utensils,
equipment, fixtures and fittings should be thoroughly cleaned and where
necessary disinfected after raw food preparation, particularly when raw
materials with a potentially high microbiological load such as meat, poultry,
and fish have been handled or processed.
In some food operations,
access to processing areas may need to be restricted or controlled for food
safety purposes. For example, where the likelihood of product contamination is
high, access to processing areas should be via a properly designed changing
facility.
Personnel may be required to put on clean protective clothing
(which may be of a differentiating colour from that worn in other parts of the
facility), including head and beard covering, footwear, and to wash their hands
and where necessary sanitize them.
6.7.2.5 Physical
contamination
Systems should be in place
throughout the food chain to prevent contamination of foods by extraneous
materials, such as personnel belongings, especially any hard or sharp
object(s), e.g. jewellery, glass, metal shards, bone(s), plastic, wood
fragments, that could cause injury or present a choking hazard. In manufacturing
and processing, suitable prevention strategies such as maintenance and regular
inspection of equipment, should be undertaken. Detection or screening devices
which are appropriately calibrated should be used where necessary (e.g. metal
detectors, X-ray detectors). Procedures should be in place for personnel to
follow in the case of breakages (e.g. breakage of glass or plastic containers).
6.7.2.6 Chemical
contamination
Systems should be in place
to prevent or minimize contamination of foods by harmful chemicals, e.g.
cleaning materials, non-food grade lubricants, chemical residues from
pesticides and veterinary drugs such as antibiotics. Toxic
cleaning compounds, disinfectants, and pesticide chemicals should be
identified, safely stored and used in a manner that protects against
contamination of food, food contact surfaces, and food packaging materials. Food
additives and food processing aids that may be harmful if used improperly
should be controlled so they are only used as intended.
6.7.2.7 Allergen management4)
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6.7.2.8 Incoming materials
Only raw materials and other
ingredients that are fit for purpose should be used. Incoming materials
including food ingredients should be procured according to specifications, and
their compliance with food safety and suitability specifications should be
verified, where necessary. Supplier quality assurance activities, such as
audits, may be appropriate for some ingredients. Raw materials or other
ingredients should, where appropriate, be inspected (e.g. visual examination
for packages damaged during transportation, use-by-date and declared allergens,
or temperature measurement for refrigerated and frozen foods) for appropriate
action before processing. Where appropriate, laboratory tests could be
conducted to check food safety and suitability of raw materials or ingredients.
These tests may be conducted by a supplier that provides a certificate of
analysis, the purchaser, or both. No incoming material should be accepted by an
establishment if it is known to contain chemical, physical, or microbiological
contaminants which would not be reduced to an acceptable level by controls
applied during sorting and/or processing where appropriate. Stocks of raw
materials and other ingredients should be subject to effective stock rotation.
Documentation of key information for incoming materials (e.g. supplier details,
date of receipt, quantity etc.) should be maintained.
6.7.2.9 Packaging
Packaging design and
materials should be safe and suitable for food use, provide adequate protection
for products to minimize contamination, prevent damage, and accommodate proper
labelling.
Packaging materials or gases, where used, should not contain
toxic contaminants, and not pose a threat to the safety and suitability of food
under the specified conditions of storage and use. Any
reusable packaging should be suitably durable, easy to clean and, where
necessary, to disinfect.
6.7.3 Water
Water, as well as ice and
steam made from water, should be fit for its intended purpose based on a
risk-based approach5). They should not cause contamination
of food.
Water and ice should be stored and handled in a manner that
does not result in their becoming contaminated, and the generation of steam
that will contact food should not result in its contamination. Water that is
not fit for use in contact with food (e.g. some water used for fire control and
for steam that will not directly contact food) should have a separate system
that does not connect with or allow reflux into the system for water that will
contact food. Water recirculated for reuse and water recovered from e.g. food
processing operations, by evaporation and/or filtration should be treated,
where necessary, to ensure that the water does not compromise the safety and
suitability of food.
6.7.4 Documentation and
records
Appropriate records for the
food business operation should be retained for a period that exceeds the
shelf-life of the product or as determined by the competent authority.
6.7.5 Recall procedures -
removal from the market of unsafe food
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Provision should be made for
removed or returned products to be held under secure conditions until they are
destroyed, used for purposes other than human consumption, determined to be
safe for human consumption, or reprocessed in a manner to reduce the hazard to
acceptable levels, where permitted by the competent authority. The cause and
extent of a recall and the corrective actions taken should be retained by the
FBO as documented information.
6.8
Product information and consumer awareness
Objectives:
Appropriate information
about food should ensure that:
- adequate and accessible
information is available to the next FBO in the food chain or the consumer to
enable them to handle, store, process, prepare and display the product safely
and correctly;
- consumers can identify
allergens present in foods; and
- the lot or batch can be
easily identified and removed/returned if necessary.
Consumers should be given
enough information on food hygiene to enable them to:
- be aware of the importance
of reading and understanding the label;
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- prevent contamination and
growth or survival of foodborne pathogens by storing, preparing and using
food correctly.
Rationale
Insufficient product
information, and/or inadequate knowledge of general food hygiene, can lead to
products being mishandled at later stages in the food chain. Such
mishandling can result in illness, or products becoming unsuitable for
consumption, even where adequate hygiene control measures have been
implemented earlier in the food chain. Insufficient product
information about the allergens in food can also result in illness or
potentially death for allergic consumers.
6.8.1 Lot identification and traceability
Lot identification or other
identification strategies are essential in product recall and also help
effective stock rotation.
Each container of food should be permanently marked to
identify the producer and the lot. TCVN 7087:2013 (CODEX STAN
1-1985, with Amendment 2010) applies.
A traceability/product
tracing system should be designed and implemented according to the CXG 60-200),
specifically to enable the recall of the products, where necessary.
6.8.2 Product information
All food products should be
accompanied by or bear adequate information to enable the next FBO in the food
chain or the consumer to handle, prepare, display, store, and/or use the
product safely and correctly.
6.8.3 Product labelling
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6.8.4 Consumer education
Consumer education
programmes should cover general food hygiene. Such programmes should
enable consumers to understand the importance of any product label information
and following any instructions accompanying products, and to make informed
choices.
In particular, consumers should be informed of the
relationship between time/temperature control, cross contamination and
foodborne illness, and of the presence of allergens Consumers
should also be informed of the WHO five keys to safer food and educated
to apply appropriate food hygiene measures (e.g. proper hand washing, adequate
storage and cooking and avoiding cross contamination) to ensure that their food
is safe and suitable for consumption.
6.9
Transportation
Objectives
During transportation,
measures should be taken where necessary to:
- protect food from
potential sources of contamination, including allergen cross-contact;
- protect food from damage
likely to render the food unsuitable for consumption; and
- provide an environment
which effectively controls the growth of pathogenic or spoilage
microorganisms and the production of toxins in food.
Rationale
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6.9.1 General
Food should be adequately
protected during transport6). The type of conveyances or containers
required depends on the nature of the food and the most appropriate conditions
under which it should be transported.
6.9.2 Requirements
Where necessary, conveyances
and bulk containers should be designed and constructed so that they:
- do not contaminate foods or
packaging;
- can be effectively cleaned
and, where necessary, disinfected and dried;
- permit effective separation
of different foods or foods from non-food items that could cause contamination
where necessary during transport;
- provide effective protection
from contamination, including dust and fumes;
- can effectively maintain the
temperature, humidity, atmosphere, and other conditions necessary to protect
food from harmful or undesirable microbial growth and deterioration likely to
render it unsafe or unsuitable for consumption; and
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6.9.3 Use and maintenance
Conveyances and containers
for transporting food should be kept in an appropriate state of cleanliness,
repair and condition.
Containers and conveyances for bulk food transport should be
designated and marked for food use and used only for that purpose unless
controls are taken to ensure that the safety and suitability of the food are
not compromised.
Where the same conveyance or
container is used for transporting different foods, or non-foods, effective
cleaning and, where necessary, disinfection, and drying should take place
between loads.
7
Hazard analysis and critical control point (HACCP) system and guidelines for
its application
7.1
Introduction to HACCP
In the second part of this
document, section 7.2 sets out the seven principles of the HACCP system. Section
7.3 provides general guidance for the application of the HACCP system and
section 7.4 describes its application in 12 successive steps (Figure 1), while
recognizing that the details of application may vary and a more flexible
approach to application may be appropriate depending on the circumstances and
the capabilities of the food business operation. The HACCP system, which is
science-based and systematic, identifies specific hazards and measures for
their control to ensure the safety of food. HACCP is a tool to assess
hazards and establish control systems that focus on control measures for
significant hazards along the food chain, rather than relying mainly on
end-product testing. Development of a HACCP system may identify the need for
changes in processing parameters, in processing steps, in manufacturing
technology, in end product characteristics, in method of distribution, in the
intended use or in the GHPs applied. Any HACCP system should be capable of accommodating
change, such as advances in equipment design, processing procedures or
technological developments.
HACCP principles can be
considered throughout the food chain from primary production to final
consumption, and their implementation should be guided by scientific evidence
of risks to human health. Although it is not always feasible to apply HACCP at
primary production, some of the principles can be applied and may be
incorporated into good practices programmes (e.g. GAPs, etc.). It is recognized
that implementation of HACCP may be challenging for some businesses. However,
HACCP principles can be applied flexibly in individual operations, and
businesses may use external resources (e.g. consultants) or adapt a generic
HACCP plan provided by the competent authority, academia or other competent
bodies (e.g. trade or industry associations) to the specific site
circumstances. As well as enhancing food safety, implementation of HACCP can
provide other significant benefits, such as more efficient processes based on a
thorough analysis of capability, more effective use of resources by focusing on
critical areas, and fewer recalls through identification of problems before
product is released. In addition, the application of HACCP systems can aid
review by competent authorities and promote international trade by increasing
confidence in food safety.
The successful application
of HACCP requires the commitment and involvement of management and personnel
and the knowledge and/or training in its application for the particular type of
food business. A multidisciplinary approach is strongly recommended; this
multi-disciplinary approach should be appropriate to the food business
operation and may include, for example, expertise in primary production,
microbiology, public health, food technology, environmental health, chemistry,
and engineering, according to the particular application.
7.2
Principles of the HACCP system
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Principle 1
Conduct a hazard analysis
and identify control measures.
Principle 2
Determine the critical
control points (CCPs).
Principle 3
Establish validated critical
limits.
Principle 4
Establish a system to
monitor control of CCPs.
Principle 5
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Principle 6
Validate the HACCP plan and
then establish procedures for verification to confirm that the HACCP system is
working as intended.
Principle 7
Establish documentation
concerning all procedures and records appropriate to these principles and their
application.
7.3
General guidelines for the application of the HACCP system
7.3.1 Introduction
Prior to application of a
HACCP system by any FBO in the food chain, that FBO should have in place
prerequisite programmes, including GHPs established in accordance with Section
6, Good Hygiene Practices, of this document, the appropriate product and
sector-specific Codex codes of practice, and in accordance with relevant food
safety requirements set by competent authorities. Prerequisite programmes
should be well-established, fully operational and verified, where possible, in
order to facilitate the successful application and implementation of the HACCP
system. HACCP application will not be effective without prior implementation of
prerequisite programmes including GHPs.
For all types of food
businesses, management awareness and commitment to food safety are necessary
for implementation of an effective HACCP system. The effectiveness will also
rely upon management and personnel having the appropriate HACCP training and
competency. Therefore, ongoing training is necessary for all levels of
personnel, including managers, as appropriate to the food business.
A HACCP system identifies
and enhances control of significant hazards, where necessary, over that
achieved by the GHPs that have been applied by the establishment. The intent of
the HACCP system is to focus control at CCPs. By specifying critical limits for
control measures at CCPs and corrective actions when limits are not met, and by
producing records that are reviewed before product release, HACCP provides
consistent and verifiable control beyond that achieved by GHPs.
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The HACCP system should be
reviewed periodically and whenever there is a significant change that could
impact the potential hazards and/or the control measures (e.g. new process, new
ingredient, new product, new equipment) associated with the food business.
Periodic review should also be conducted when the application of the HACCP
principles has resulted in a determination that no CCPs are needed, in order to
assess whether the need for CCPs has changed.
7.3.2 Flexibility for small
and/or less developed food businesses7)
The application of the HACCP
principles to develop an effective HACCP system should be the responsibility of
each individual business. However, it is recognized by competent authorities
and FBOs that there may be obstacles that hinder the effective application of
the HACCP principles by individual food businesses. This is particularly
relevant in small and/or less developed food businesses. Barriers to the
application of HACCP in small and less developed businesses (SLDBs) have been
acknowledged, and flexible approaches to the implementation of HACCP in such
businesses are available and encouraged. Some approaches may provide ways to
adapt the HACCP approach to assist competent authorities in supporting SLDBs,
for example, development of a HACCP-based system which is consistent with the
seven principles of HACCP but does not conform to the layout or steps described
in this section. While it is recognized that flexibility appropriate to the
business is important when applying HACCP, all seven principles should be
considered in developing the HACCP system. This flexibility should take into
account the nature of the operation, including the human and financial
resources, infrastructure, processes, knowledge and practical constraints, as
well as the risk associated with the produced food. Applying such flexibility,
i.e. recording only monitoring results when there is a deviation instead of
every monitoring result to reduce unnecessary burden of record keeping for
certain types of FBOs, is not intended to impact negatively on the efficacy of
the HACCP system and should not endanger food safety.
Small and/or less developed
food businesses do not always have the resources and the necessary expertise
onsite for the development and implementation of an effective HACCP system. In
such situations, expert advice should be obtained from other sources, which may
include trade and industry associations, independent experts and competent
authorities. HACCP literature and especially sector-specific HACCP guides can
be valuable. HACCP guidance developed by experts relevant to the process or
type of operation may provide a useful tool for businesses in designing and
implementing a HACCP plan. Where businesses are using expertly developed HACCP
guidance, it is essential that it is specific to the foods and/or processes
under consideration. A comprehensive explanation of the basis for the HACCP
plan should be provided to the FBO. The FBO is ultimately responsible for
elaboration and implementation of the HACCP system and the production of safe
food.
The efficacy of any HACCP
system will nevertheless rely on management and personnel having the
appropriate HACCP knowledge and skills, therefore ongoing training is necessary
for all levels of personnel, including managers, as appropriate to the food
business.
7.4
Application
7.4.1 Assemble HACCP team
and identify scope (Step 1)
The FBO should ensure that
the appropriate knowledge and expertise are available for the development of an
effective HACCP system.
This may be achieved by assembling a multidisciplinary team
responsible for different activities within the operation, e.g. production,
maintenance, quality control, cleaning, and disinfection. The
HACCP team is responsible for developing the HACCP plan.
Where relevant expertise is
not available in house, expert advice should be obtained from other sources,
such as trade and industry associations, independent experts, competent
authorities, HACCP literature and HACCP guides (including sector-specific HACCP
guides). It may be possible that a well-trained individual with access to such
guidance is able to implement a HACCP system in house. A generic HACCP plan
developed externally may be used by FBOs where appropriate but should be
tailored to the food operation.
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7.4.2 Describe product (Step 2)
A full description of the
product should be developed, including relevant safety information such as
composition (i.e. ingredients), physical/chemical characteristics (i.e. aw, pH,
preservatives, allergens), processing methods/technologies (i.e.
heat-treatment, freezing, drying, brining, smoking, etc.), packaging,
durability/shelf life, storage conditions and method of distribution. Within
businesses with multiple products, it may be effective to group products with
similar characteristics and processing steps for the purpose of development of
the HACCP plan. Any limits relevant to the food product already established for
hazards should be considered and accounted for in the HACCP plan, e.g. limits
for food additives, regulatory microbiological criteria, maximum allowed
veterinary medicines residues, and times and temperatures for heat treatments
prescribed by competent authorities.
7.4.3 Identify intended use
and users (Step 3)
Describe the use intended by
the FBO and the expected uses of the product by the next FBO in the food chain
or the consumer. The description may be influenced by external information,
e.g. from the competent authority or other sources on ways in which consumers
are known to use the product other than those intended by the FBO. In specific
cases (e.g. hospitals), vulnerable groups of the population may have to be
considered. Where foods are being produced specifically for a vulnerable
population, it may be necessary to enhance process controls, monitor control
measures more frequently, verify controls are effective by testing products, or
conduct other activities to provide a high level of assurance that the food is
safe for the vulnerable population.
7.4.4 Construct flow diagram
(Step 4)
A flow diagram that covers
all steps in the production of a specific product, including any applicable
rework, should be constructed. The same flow diagram may be used for a number
of products that are manufactured using similar processing steps. The flow
diagram should indicate all inputs, including those of ingredients and food
contact materials, water, and air, if relevant. Complex manufacturing
operations can be broken down into smaller, more manageable modules and
multiple flow diagrams that link together can be developed. The flow diagrams
should be used when conducting the hazard analysis as a basis for evaluating
the possible occurrence, increase, decrease or introduction of hazards. Flow
diagrams should be clear, accurate and sufficiently detailed to the extent
needed to conduct the hazard analysis. Flow diagrams should, as appropriate,
include but not be limited to the following:
- the sequence and interaction
of the steps in the operation;
- where raw materials,
ingredients, processing aids, packaging materials, utilities and intermediate
products enter the flow;
- any outsourced processes;
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- where end products,
intermediate products, waste, and by-products are released or removed.
7.4.5 On-site confirmation
of flow diagram (Step 5)
Steps should be taken to
confirm the processing activities against the flow diagram during all stages
and hours of operation and amend the flow diagram, where appropriate. The
confirmation of the flow diagram should be performed by a person or persons
with sufficient knowledge of the processing operation.
7.4.6 List all potential
hazards that are likely to occur and associated with each step, conduct a
hazard analysis to identify the significant hazards, and consider any measures
to control identified hazards (Step 6/Principle 1)
Hazard analysis consists of
identifying potential hazards and evaluating these hazards to determine which
of them are significant for the specific food business operation. An example of
a hazard analysis worksheet is provided in Figure 2. The HACCP team should list
all potential hazards. The HACCP team should then identify where these hazards
are reasonably likely to occur at each step (including all inputs into that
step) according to the scope of the food business operation. Hazards should be
specific, e.g. metal fragments, and the source or reason for presence should be
described, e.g. metal from broken blades after chopping. The hazard analysis
can be simplified by breaking down complex manufacturing operations and
analysing steps in the multiple flow diagrams described in Step 4.
The HACCP team should next
evaluate the hazards to identify which of these hazards are such that their
prevention, elimination, or reduction to acceptable levels is essential to the
production of safe food (i.e. determine the significant hazards that have to be
addressed in the HACCP plan).
In conducting the hazard
analysis to determine whether there are significant hazards, wherever possible,
the following should be considered:
- hazards associated with
producing or processing the type of food, including its ingredients and process
steps (e.g. from surveys or sampling and testing of hazards in the food chain,
from recalls, from information in the scientific literature or from
epidemiological data);
- the likelihood of occurrence
of hazards, taking into consideration prerequisite programmes, in the absence
of additional control;
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- identified acceptable levels
of the hazards in the food e.g. based on regulation, intended use, and
scientific information;
- the nature of the facility
and the equipment used in making the food product;
- survival or multiplication
of pathogenic microorganisms;
- production or persistence in
foods of toxins (e.g. mycotoxins), chemicals (e.g. pesticides, drug residues,
allergens) or physical agents (e.g. glass, metal);
- the intended use and/or
probability of product mishandling by potential consumers that could render the
food unsafe; and
- conditions leading to the
above.
The hazard analysis should
consider not only the intended use, but also any known unintended use (e.g. a
soup mix intended to be mixed with water and cooked but known to commonly be
used without a heat treatment in flavouring a dip for chips) to determine the
significant hazards to be addressed in the HACCP plan (see Figure 2 for an
example of a hazard analysis worksheet.)
In some cases, it may be
acceptable for a simplified hazard analysis to be carried out by FBOs. This
simplified process identifies groups of hazards (biological, physical,
chemical) in order to control the sources of these hazards without the need for
a comprehensive hazard analysis that identifies the specific hazards of
concern. There can be drawbacks to such an approach, as the controls can differ
for hazards within a group, e.g. controls for pathogenic spore-formers versus
vegetative cells of microbial pathogens. Generic HACCP-based tools and guidance
documents provided by external sources, for example, by industry or competent
authorities, are designed to assist with this step and mitigate concerns about
different controls needed for hazards within a group.
Hazards which are such that
their prevention, elimination or reduction to acceptable levels is essential to
the production of safe food (because they are reasonably likely to occur in the
absence of control and reasonably likely to cause illness or injury if present)
should be identified and controlled by measures designed to prevent or
eliminate these hazards or reduce them to an acceptable level. In some cases,
this may be achieved with the application of GHPs, some of which may target a
specific hazard (for example, cleaning equipment to control contamination of
ready-to-eat foods with Listeria monocytogenes or to prevent food allergens
being transferred from one food to another food that does not contain that
allergen). In other instances, control measures will need to be applied within
the process, for example at CCPs.
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7.4.7 Determine the critical
control points (CCPs) (Step 7/Principle 2)
The FBO should consider
which among the available control measures listed during Step 6, Principle 1
should be applied at a CCP. CCPs are to be determined only for hazards
identified as significant as the result of a hazard analysis. CCPs are
established at steps where control is essential and where a deviation could
result in the production of a potentially unsafe food. The control measures at
CCPs should result in an acceptable level of the hazard being controlled. There
may be more than one CCP in a process at which control is applied to address
the same hazard (e.g. the cook step may be the CCP for killing the vegetative
cells of a pathogenic spore-former, but the cooling step may be a CCP to
prevent germination and growth of the spores). Similarly, a CCP may control
more than one hazard (e.g. cooking can be a CCP that addresses several
microbial pathogens). Determining whether or not the step at which a control
measure is applied is a CCP in the HACCP system can be helped by using a
decision tree or a CCP determination worksheet. A decision tree should be flexible,
given whether it is for use in production, slaughter, processing, storage,
distribution, or other processes.
Other approaches such as
expert consultation may be used.
- To identify a CCP, whether
using a decision tree or other approach, the following should be considered:
+ Assess whether the control measure can
be used at the process step being analysed:
+ If the control measure can
be used at the step being analysed, but can also be used later in the process,
or there is another control measure for the hazard at another step, the step
being analysed should not be considered as a CCP.
- Determine whether a control
measure at a step is used in combination with a control measure at another step
to control the same hazard; if so, both steps should be considered as CCPs.
The CCPs identified could be
summarized in tabular format, e.g. the HACCP worksheet presented in Figure 3,
as well as highlighted at the appropriate step on the flow diagram.
If no control measures exist
at any step for an identified significant hazard, then the product or process
should be modified.
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Critical limits establish
whether a CCP is in control, and in doing so they can be used to separate
acceptable products from unacceptable ones. These critical limits should be
measurable or observable. In some cases, more than one parameter could have a
critical limit designated at a particular step (e.g. heat treatments commonly
include critical limits for both time and temperature). Criteria often used
include minimum and/or maximum values for critical parameters associated with
the control measure such as measurements of temperature, time, moisture level,
pH, aw, available chlorine, contact time, conveyor belt speed, viscosity,
conductance, flow rate, or, where appropriate, parameters that can be observed,
such as a pump setting. A deviation from the critical limit indicates that it
is likely that unsafe food has been produced.
Critical limits for control
measures at each CCP should be specified and scientifically validated to obtain
evidence that they are capable of controlling hazards to an acceptable level if
properly implemented9). Validation of critical limits may
include conducting studies (i.e. microbiological inactivation studies). FBOs
may not always need to conduct or commission studies themselves to validate
critical limits. Critical limits could be based on existing literature,
regulations or guidance from competent authorities, or studies carried out by a
third party, e.g. studies conducted by an equipment manufacturer to determine
the appropriate time, temperature and bed depth for dry roasting tree nuts.
Validation of control measures is further described more fully in TCVN
12947:2020.
7.4.9 Establish a monitoring
system for each CCP (Step 9/Principle 4)
Monitoring of CCPs is the
scheduled measurement or observation at a CCP relative to its critical limits.
The monitoring procedures should be able to detect a deviation at the CCP.
Further, the monitoring method and frequency should be capable of timely
detection of any failure to remain within critical limits, to allow timely
isolation and evaluation of the product. Where possible, process adjustments
should be made when monitoring results indicate a trend towards a deviation at
a CCP. The adjustments should be taken before a deviation occurs.
Monitoring procedures for
CCPs should be capable of timely detection of a deviation from the critical
limit to allow isolation of the affected products. The method and frequency of
monitoring should take into account the nature of the deviation (e.g. a drop in
temperature or a broken sieve, rapid drop in temperature during pasteurization,
or a gradual increase in temperature in cold storage). Where possible,
monitoring of CCPs should be continuous. Monitoring of measurable critical
limits such as processing time and temperature can often be monitored
continuously. Other measurable critical limits such as moisture level and
preservative concentration cannot be monitored continuously. Critical limits
that are observable, such as a pump setting or applying the correct label with
appropriate allergen information are rarely monitored continuously. If
monitoring is not continuous, then the frequency of monitoring should be
sufficient to ensure to the extent possible the critical limit has been met and
limit the amount of product impacted by a deviation. Physical and chemical
measurements are usually preferred to microbiological testing because physical
and chemical tests can be done rapidly and can often indicate the control of
microbial hazards associated with the product and/or the process.
The personnel doing the
monitoring should be instructed on appropriate steps to take when monitoring
indicates the need to take action. Data derived from monitoring
should be evaluated by a designated person with knowledge and authority to
carry out corrective actions when indicated.
All records and documents
associated with monitoring CCPs should be signed or initialled by the person
performing the monitoring and should also report the results and timing of the
performed activity.
7.4.10 Establish corrective
actions (Step 10/Principle 5)
Specific written corrective
actions should be developed for each CCP in the HACCP system in order to
effectively respond to deviations when they occur. When critical limits at CCPs
are monitored continuously and a deviation occurs, any product being produced
at the time the deviation occurs is potentially unsafe. When a deviation in
meeting a critical limit occurs and monitoring was not continuous, then the FBO
should determine what product may have been impacted by the deviation.
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External experts may be
needed to conduct evaluations regarding the safe use of products when a
deviation occurs. It may be determined that the product could be reprocessed
(e.g. pasteurized) or the product could be diverted to another use. In other
situations, the product may need to be destroyed (e.g. contamination with Staphylococcus
enterotoxin). A root cause analysis should be conducted where possible to
identify and correct the source of the deviation in order to minimize the
potential for the deviation to reoccur. A root cause analysis could identify a
reason for the deviation that limits or expands the amount of product impacted
by a deviation.
Details of the corrective
actions, including the cause of the deviation and product disposition
procedures, should be documented in the HACCP records. Periodic review of
corrective actions should be undertaken to identify trends and to ensure
corrective actions are effective.
7.4.11 Validation of the
HACCP plan and verification procedures (Step 11/Principle 6)
7.4.11.1 Validation of the
HACCP plan
Before the HACCP plan can be
implemented, its validation is needed; this consists of making sure that the
following elements together are capable of ensuring control of the significant
hazards relevant to the food business: identifying the hazards, critical
control points, critical limits, control measures, frequency and type of
monitoring of CCPs, corrective actions, frequency and type of verification and
the type of information to be recorded.
Validation of control
measures and their critical limits is performed during the development of the
HACCP plan. Validation could include a review of scientific literature, using
mathematical models, conducting validation studies, and/or using guidance
developed by authoritative sources10).
Where HACCP guidance
developed by external experts, instead of the HACCP team, has been used to
establish the critical limits, care should be taken to ensure that these limits
fully apply to the specific operation, product, or groups of products under
consideration.
During the initial
implementation of the HACCP system and after verification procedures have been
established, evidence should be obtained in operation to demonstrate that
control can be achieved consistently under production conditions.
Any changes having a
potential impact on food safety should require a review of the HACCP system,
and when necessary, a revalidation of the HACCP plan.
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After the HACCP system has
been implemented, procedures should be established to confirm that the HACCP
system is working effectively. These include procedures to verify that the
HACCP plan is being followed and controlling hazards on an ongoing basis, as
well as procedures that show the control measures are effectively controlling
the hazards as intended. Verification also includes reviewing the adequacy of
the HACCP system periodically and, as appropriate, when changes occur.
Verification activities
should be performed on an ongoing basis to ensure the HACCP system functions as
intended and continues to operate effectively. Verification, which includes
observations, auditing (internal and external), calibration, sampling and
testing, and records review, can be used to determine if the HACCP system is
working correctly and as planned. Examples of verification
activities include:
- reviewing monitoring records
to confirm that CCPs are kept under control;
- reviewing corrective action
records, including specific deviations, product disposition and any analysis to
determine the root cause of the deviation;
- calibrating or checking the
accuracy of instruments used for monitoring and/or verification;
- observing that control
measures are being conducted in accordance with the HACCP plan;
- sampling and testing, e.g.
for microorganisms 11) (pathogens or their indicators),
chemical hazards such as mycotoxins, or physical hazards such as metal
fragments, to verify product safety;
- sampling and testing the
environment for microbial contaminants and their indicators, such as Listeria;
and
- reviewing the HACCP system,
including the hazard analysis and the HACCP plan (e.g. internal and/or
third-party audits).
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The frequency of
verification activities should be sufficient to confirm that the HACCP system
is working effectively. Verification of the implementation of control measures
should be conducted with sufficient frequency to determine that the HACCP plan
is being implemented properly.
Verification should include
a comprehensive review (e.g. reanalysis or an audit) of the HACCP system
periodically, as appropriate, or when changes occur, to confirm the efficacy of
all elements of the HACCP system. This review of the HACCP system should
confirm that the appropriate significant hazards have been identified, that
control measures and critical limits are adequate to control the hazards, that
monitoring and verification activities are occurring in accordance with the
plan and are capable of identifying deviations, and that corrective actions are
appropriate for deviations that have occurred. This review can be carried out
by individuals within a food business or by external experts. The review should
include confirmation that various verification activities have been executed as
intended.
7.4.12 Establish
documentation and record keeping (Step 12/Principle 7)
Efficient and accurate
record keeping is essential to the application of a HACCP system. HACCP
procedures should be documented. Documentation and record keeping should be
appropriate to the nature and size of the operation and sufficient to assist
the business to verify that the HACCP controls are in place and being
maintained. Expertly developed HACCP guidance materials (e.g. sector-specific
HACCP guides) may be utilized as part of the documentation, provided that those
materials reflect the specific food operations of the business.
Examples of documentation
include:
- HACCP team composition;
- hazard analysis and the
scientific support for the hazards included or excluded from the plan;
- CCP determination;
- critical limit determination
and the scientific support for the limits set;
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- modifications made to the
HACCP plan.
Examples of records include:
- CCP monitoring activities;
- deviations and associated
corrective actions; and
- verification procedures
performed.
A simple record-keeping
system can be effective and easily communicated to personnel. It may be
integrated into existing operations and may use existing paperwork, such as
delivery invoices, and checklists to record, for example, product temperatures.
Where appropriate, records can also be maintained electronically.
7.4.13 Training
Training of personnel in
food businesses, government and academia in HACCP principles and applications
is an essential element for the effective implementation of HACCP. As an aid in
developing specific training to support a HACCP plan, working instructions and
procedures should be developed which define the tasks of the operating
personnel in charge of each CCP. Training programmes should be designed to
address the concepts at a level appropriate for the knowledge and skill level
of the personnel being trained. Training programmes should be reviewed
periodically and updated where necessary. Re-training may be needed as part of
corrective actions for some deviations.
Cooperation between food
business operations, trade groups, consumer organizations, and competent
authorities is vitally important. Opportunities should be provided for the
joint training of FBOs and competent authorities to encourage and maintain a
continuous dialogue and create a climate of understanding in the practical
application of HACCP.
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Annex A
(informative)
Comparison of control measures with examples
Control
measures applied as good hygiene practices (GHPs)
Control
measures applied at critical control points (CCPs)
Scope
General conditions and
activities for maintaining hygiene, including creating the environment
(inside and outside the food business) so as to ensure production of safe and
suitable food.
Generally, not specific to
any hazard but results in reduction of likelihood of hazards occurring.
Occasionally a GHP activity may target a specific hazard, and this may be a
GHP that requires greater attention (e.g. cleaning and disinfection of food
contact surfaces for control of Listeria monocytogenes in a ready-to-eat food
processing environment).
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When
identified?
After consideration of the
conditions and activities necessary to support the production of safe and
suitable food.
After a hazard analysis
has been completed, for each hazard identified as significant, control
measures are established at steps (CCPs) where a deviation would result in
the production of a potentially unsafe food.
Validation
of the control measures
Where necessary, and
generally not carried out by FBOs themselves (TCVN 12947:2020). Validation
data provided by competent authorities, published scientific literature,
information provided by manufacturers of equipment/food processing technology
etc. is adequate e.g. cleaning compounds/products/equipment should be
validated by the manufacturer and it is generally sufficient for the FBO to
use cleaning compounds/products/equipment according to manufacturers’
instructions. The FBO should be able to demonstrate it can follow
manufacturers’ instructions.
Validation should be
carried out (TCVN 12947:2020).
Criteria
GHPs may be observable
(e.g. visual checks, appearance) or measurable (e.g. ATP tests of equipment
cleaning, concentration of disinfectant), and deviations may require an
evaluation of the impact on safety of the product (e.g. whether the cleaning
of complex equipment such as meat slicers is adequate).
Critical limits at CCPs
which separate acceptability from unacceptability of the food:
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- observable (e.g. visual
checks of conveyor belt speed or pump settings, ice covering product).
Monitoring
When appropriate and
necessary, to ensure procedures and practices are applied properly.
Frequency dependent on the
impact on the product’s safety and suitability.
Necessary to ensure
critical limit is met:
- continuously during
production; or
- if not continuous, at
appropriate frequency that ensures to the extent possible the critical limit
has been met.
Corrective
actions when deviation has occurred
- For procedures and
practices: necessary
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- For products: necessary
pre-determined actions.
- For procedures and
practices: necessary corrective actions to restore control and prevent
reoccurrence.
- Specific written
corrective actions should be developed for each CCP in the HACCP plan in
order to effectively respond to deviations when they occur.
- The corrective actions
should ensure that the CCP has been brought under control and food that is
potentially unsafe is handled appropriately and does not reach consumers.
Verification
When appropriate and
necessary, usually scheduled (e.g. visual observation that equipment is clean
before use).
Necessary: scheduled
verification of implementation of control measures, e.g. through record review,
sampling and testing, calibration of measuring equipment, internal audit.
Record
keeping (e.g. monitoring records)
When appropriate and
necessary, to allow the FBO to assess whether GHPs are operating as intended.
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Documentation
(e.g. documented procedures)
When appropriate and
necessary to ensure GHPs are properly implemented.
Necessary to ensure the
HACCP system is properly implemented.
Figure
1 - Logic sequence for application of HACCP
Figure
2 - Example of hazard analysis worksheet
Step*
Identify
potential hazards introduced, controlled, or enhanced at this step
B
= biological
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P
= physical
Does
this potential hazard need to be addressed in the HACCP plan?
Justify
your decision for column 3
What
measure(s) can be applied to prevent or eliminate the hazard or reduce it to
an acceptable level?
Yes
No
(1)
(2)
(3)
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(5)
B
C
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P
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B
C
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P
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B
C
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P
* A hazard analysis should
be conducted on each ingredient used in the food; this is often done at a
“receiving” step for the ingredient. Another approach is to do
a separate hazard analysis on ingredients and one on the processing steps.
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Critical
control points (CCPs)
Significant
hazard(s)
Critical
limits
Monitoring
Corrective
actions
Verification
activities
Records
What
How
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Who
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BIBLIOGRAPHY
Foreword
Introduction
1 Scope
2 Normative references
3 Definitions
4 General principles
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6 Good hygiene practices
6.1 Introduction and control
of food hazards
6.2 Primary production
6.3 Establishment – Design
of facilities and equipment
6.4 Training and competence
6.5 Establishment maintenance, cleaning and
disinfection, and pest control
6.6 Personal hygiene
6.7 Control of operation
6.8 Product information and
consumer awareness
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7 Hazard analysis and
critical control point (HACCP) system and guidelines for its application
7.1 Introduction
7.2 Principles of the HACCP
system
7.3 General guidelines for
the application of the HACCP system
7.4 Application
Annex A (informative)
Comparison of control measures with examples
1) See TCVN 12947:2020, Guidelines for the Validation of Food
Safety Control Measures. TCVN
12947:2020 corresponds
to CXG 69-2008 Guidelines
for the validation of food safety control measures in terms of
specifications.
2) See TCVN 10168:2013 (CAC/RCP 49-2001) Code of Practice Concerning
Source Directed Measures to Reduce Contamination of Food with Chemicals.
3) Refer to TCVN 9632:2016 (CAC/GL
21-1997, Revised 2013) Principles
and Guidelines for the Establishment and Application of Microbiological
Criteria Related to Foods
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5) See Microbiological Risk Assessment
Series 33: Safety and quality of water used in food production and processing.
6) TCVN 10167:2013 (CAC/RCP 47-2001) Code of Hygienic Practice for
the Transport of Food in Bulk and Semi-Packed Food.
7)
FAO/WHO Guidance to governments
on the application of HACCP in small and/or less-developed food businesses.
8) FBOs may take advantage of
risk assessments and risk management matrices established by a competent
authority or by international expert groups such as JEMRA.
9)
See
TCVN 12947:2020, Guidelines for the Validation of Food Safety Control
Measures.
10)
See
TCVN 12947:2020, Guidelines for the Validation of Food Safety Control
Measures.
11) TCVN 9632:2016 (CAC/GL 21-1997,
Revised 2013) Principles
and Guidelines for the Establishment and Application of Microbiological Criteria
Related to Foods