Chapter 13- HACCP - A FOOD SAFETY ASSURANCE SYSTEM

Table of Contents
 Introduction
 Terms used in the context of HACCP
 Need For HACCP
 International Obligations — Agreements on Sanitary and Phytosanitary
Measures HSPS) and Technical Barriers to Trade (TBT)
 Other factors
 Benefits Of HACCP
 Limitations of HACCP
 Food safety hazards
 Sources Of Hazards
 Principles Of HACCP
 Guidelines for Application of HACCP Principles
 The HACCP Status in India
 IndiaHACCP Certification Scheme
 International Organization for Standardization (ISO)
 Introduction Of ISO 22000
Introduction
What is HACCP?
 HACCP is an acronym that stands for Hazard Analysis Critical Control Point, a
systematic, science-based approach used in food production as a means to assure
food safety.
 The concept for HACCP was developed in the 1960's by the Pillsbury Company in
consultation with the US National Aeronautics and Space Administration
(NASA) and the U.S. Army Laboratories at Natick.
 While it was originally developed to ensure microbiological safety of food stuffs,
it has been further broadened to include chemical and physical hazards in foods.
 In 1993, the Codex Alimentarius Commission endorsed the HACCP system as the
most cost-effective approach devised to date for ensuring the safety of food.
 HACCP, therefore, is a preventive system of food control.
 It involves examining and analysing every stage of a food-related operation to
identify and assess hazards, determining the 'critical control points' at which
action is required to control the identified hazards, establishing the critical limits
that must be met at, and procedures to monitor, each critical control point,
establishing corrective procedures when a deviation is identified by monitoring,
documenting the HACCP plan and verifying procedures to establish that it is
working correctly.
 HACCP builds on the foundations of well‐established quality management
systems such as Good Manufacturing Practice (GMP), Good Hygienic Practice
(GHP), Good Agricultural Practice (GAP), and Good Storage Practice (GSP).
 From the definition above, the following points require consideration. HACCP is a
food-related operation to:
o identify and assess hazard at every stage of operation, right from start to
finish
o determine the critical control points
o establish the critical limit and procedures to monitor each critical control
point,
o establish corrective procedures.
 It is obvious, therefore, that HACCP is not just based on end product testing and
inspection.
 It is a preventive and a continuous approach to food safety identifying/
examining, analysing/evaluating and establishing correctives measures and
controlling hazards at every stage of a food-related operation. That is why it is
effective and unique.
Terms used in the context of HACCP:
 Control: a) To manage the conditions of an operation to maintain compliance
with established criteria. b) The state where correct procedures are being
followed and criteria are being met.
 Control Measure: Any action or activity that can be used to prevent, eliminate or
reduce a significant hazard.
 Control Point: Any step at which biological, chemical or physical factors can be
controlled.
 Corrective Action: Procedures followed when a deviation occurs.
 Criterion: A requirement on which a judgment or decision can be based.
 Critical Control Point: A step at which control can be applied and is essential to
prevent or eliminate a food safety, hazard or reduce it to an acceptable level.
 Critical Limit: A maximum and/or minimum value to which a biological, chemical
or physical parameter must be controlled at a CCP to prevent, eliminate or
reduce to an acceptable level the occurrence of a food safety hazard.
 CCP Decision Tree: A sequence of questions to assist in determining whether a
control point is a CCP.
 Deviation: Failure to meet a critical limit.
 HACCP: A systematic approach to the identification, evaluation and control of
food safety hazards.
 HACCP Plan: The written document which is based upon the principles of HACCP
and which delineates the procedures to be followed.
 HACCP System: The result of the implementation of the HACCP Plan.
 HACCP Team: The group of people who are responsible for developing,
implementing and maintaining the HACCP system.
 Hazard: A biological, chemical or physical agent that is reasonably likely to cause
illness or injury in the absence of its control.
 Hazard Analysis: The process of collecting and evaluating information on hazards
associated with the food under consideration to decide which are significant and
must be addressed in the HACCP plan.
 Monitor: To conduct a planned sequence of observations or measurements to
assess whether a CCP is under control and to produce an accurate record for
future use in verification.
 Prerequisite Programs: Procedures, including good manufacturing practices that
address operational conditions providing the foundation for the HACCP system.
 Severity: The seriousness of the effect(s) of a hazard.
 Step: A point, procedure, operation or stage in the food system from primary
production to final consumption.
  Validation: That element of verification focused on collecting and evaluating
scientific and technical information to determine if the HACCP plan, when
properly implemented, will effectively control the hazards.
 Verification: Those activities, other than monitoring, that determine the validity
of the HACCP plan and that the system is operating according to the plan.

Need For HACCP

 While traditional safety assurance programmes focused on identifying problems
in the finished product, HACCP, a recent proactive, preventive technique, focuses
on identifying potential problems and controlling them during the design and the
production process itself, as highlighted in Figure given below:

 HACCP offers a number of advantages over the current system. Most

importantly, HACCP:
o Focuses on identifying and preventing hazards from contaminating food is
based on sound science.
o Permits more efficient and effective government oversight, primarily
because the recordkeeping allows investigators to see how well a firm is
complying with food safety laws over a period rather than how well it is doing
on any given day.
o Places responsibility for ensuring food safety appropriately on the food
manufacturer or distributor.
o Helps food companies compete more effectively in the world market, and
reduces barriers to international trade.
Preventing Food Borne Disease Outbreaks
 Food safety has been of concern to mankind since the dawn of history, and many
of the problems encountered in our food supply go back to the earliest recorded
years.
 Despite progress in food science and technology, foodborne diseases remain one
of the most widespread public health problems in the contemporary world.
 As per WHO, up to one-third of populations of developed countries are affected
by the foodborne illness each year and the problem is likely to be even more
widespread in developing countries.
 Food and waterborne diarrhoeal diseases, for example, are leading causes of
illness and death in developing countries, killing an estimated 2.2 million people
annually, most of whom are children.
 Epidemiological investigations have also indicated that a large proportion of food
borne diseases result from poor hygienic handling of food in small businesses.
 One of the most important challenges is the increasing number of new food
pathogens.
o For example, between 1973 and 1988, bacteria not previously recognized as
important causes of food-borne illness— such as Escherichia coli 0157:H7
and Salmonella enteritidis—became more widespread.
o Worldwide it is now being recognized that the application of HACCP system
mitigates the risks of food borne disease outbreaks.
Ensuring Food Safety
 It is now well-known that the end product inspection and testing does not
provide safety of food.
 It has inherent limitation of mapping the potential hazards that could be present
in a lot of raw material or food product.
 It has been proved that a 100 percent inspection is not a reliable control
technique for this purpose.
 Further, for inspection and testing, a sampling plan is used and it is imperative to
note that no sampling plan can reflect the lot characteristics or ensure absence of
a particular organism.
 Accordingly, there is a need for development of a comprehensive and effective
food system which functions in such a way that food safety considerations are
built into the food chain from production to consumption and that is what
HACCP, actually ensures.

International Obligations — Agreements on Sanitary and Phytosanitary Measures

HSPS) and Technical Barriers to Trade (TBT)
  The SPS Agreement, to which India is a signatory, makes it obligatory for us as a
nation to maintain measures to ensure that food is safe for consumers and to
prevent the spread of pests or diseases among animals and plants.
 The TBT agreement encourages the development of international standards and
conformity assessment systems that facilitate trade and that the technical
regulations do not form non-tariff barriers to trade.
 Both these agreements have wider implications in the International Trade and in
this background the various Codex Standards / Guidelines, including those on
HACCP, Good Handling Practices (GHP) and Good Manufacturing Practices
(GMP), take an unprecedented importance with respect to consumer protection
and international food trade.

Other factors
 Increased worldwide tourism and international trade in foodstuffs, leading to a
greater exposure to foodborne hazards from other areas.
 New food technologies and processing methods, causing concerns either about
the safety pf the products themselves or the eventual consequences due to
inappropriate handling during preparation in households or food service /
catering establishments.
 Increased contamination of the environment.
 Increasing consumer awareness of food safety.
 Lack of or decreasing resources for food safety.
 It is this climate of increasing concern about food safety, the lack of sufficient
resources and the recognition of the limitations of traditional approaches to food
safety assurance which have accentuated the need for a cost-effective food
safety assurance method.
 The HACCP system has proven to be such a system.

Benefits Of HACCP
The benefits of HACCP can be summarized as under.
 Benefits to Consumers
o Reduced risk of food borne diseases
o Increased confidence in food supply
o Increased awareness of basic hygiene
o Increased quality of life (health and socio-economic)
 Benefits to Industry
o Increased market access
o Reduction in production costs through reduced wastage and recall of food
o Increased consumer and government confidence
 o Mitigating the business risk
 Benefits to Governments
o Improved public health
o Reduced public health costs
o Enhanced facilitation of International Trade
o Increased confidence of the community in the food supply
The additional benefits of the HACCP system include:
 The HACCP system overcomes many of the limitations of the traditional
approaches to food safety control (generally based on ‘snap-shot’ inspection and
end product testing), including:
o the difficulty of collecting and examining sufficient samples to obtain
meaningful, representative information, in a timely manner and without the
high cost of end-product analysis
o reducing the potential for product recall
o identification of problems without understanding the causes, and limitations
of ‘snap-shot’ inspection techniques in predicting potential food safety
problems.
 The HACCP system allows for the identification of conceivable, reasonably
expected hazards, even where failures have not previously been experienced. It
is, therefore, particularly useful for new operations.
 The HACCP system is sufficiently flexible to accommodate changes introduced,
such as progress in equipment design, improvements in processing procedures
and technological developments related to the product.
 The HACCP system is applicable to the whole food chain, from the raw material
to the end product, i.e. growing, harvesting, processing or manufacturing,
transport, distribution, preparation, serving and consumption.

Some Limitations of HACCP

 Although it is the best system yet devised for controlling microbial hazards in
foods from the farm to the table, the uniform application of HACCP in the food
manufacturing and service industries will not be without some debate.
 Among the lingering questions and concerns raised by Tompkin are the following:
o HACCP requires the education of nonprofessional food handlers, especially in
the food service industry and in homes; whether this will be achieved remains
to be seen.
 The failure of these individuals to get a proper understanding of HACCP
could lead to its failure.
o To be effective, this concept must be accepted not only by food processors
but also by food inspectors and the public.
  Its ineffective application at any level can be detrimental to its overall
success for a product.
o It is anticipated that experts will differ as to whether a given step is a CCP and
how best to monitor such steps.
 This has the potential of eroding the confidence of others in HACCP.
o The adoption of HACCP by industry has the potential of giving false assurance
to consumers that a product is safe, and, therefore, there is no need to
exercise the usual precautions between the purchase and consumption of a
product.
 Consumers need to be informed that most outbreaks of foodborne illness
are caused by errors in food handling in homes and food service
establishments and that no matter what steps a processor takes, HACCP
principles must be observed after foods are purchased for consumption.

Food safety hazards

 The definition of ‘safe food’ indicates that a number of hazards may damage food
safety and leads to food-borne illnesses.
 These situations or factors are termed as Hazards. In the widely recognized
Hazard Analysis Critical Control Point (HACCP) concept, the term hazard refers to
“a physical, chemical and biological agent or the conditions of food with the
potential to cause an adverse health effect”.
 HACCP offers a systematic approach to the identification of hazards and an
evaluation of the probability of their occurrence during production, distribution
and consumption; it also defines the measures for their control.
 Specifically, food safety hazards could be caused by any of the following:
o Presence of a physical, chemical or biological contaminant in raw materials,
in products that are under process or in even in the finished products.
o Potential for the growth or survival of undesirable microorganisms or the
generation of unwanted or unnecessary chemicals in finished products.
o Contamination of semi-finished or finished products with undesirable
microorganisms, chemicals or by any unknown material.
 In other words, the hazards can be categorized into chemical hazards,
microbiological hazards and physical hazards.
 Among chemical hazards it is important to differentiate between residues such
as pesticides, growth promoters and veterinary medicines and contaminants such
as dioxins, polychlorinated biphenyls (PCBs) and heavy metals.
 In contrast to chemical hazards, microbiological hazards are caused by living
organisms.
o Microorganisms can enter the chain at any stage through various origins like
animals, workers, environmental contamination, etc.
o Microbiological hazards refer to microorganisms such as bacteria, viruses,
parasites, protozoa and fungi. They can be either toxigenic or infectious.
o Despite the long list of potential microbiological hazards, a few species and
genera (Clostridium botulium, Clostridium peifringens, Bacillus cereus,
Staphylococcus aureus, Salmonella, Shigella and Campilobacter), and the
intestinally pathogenic Escherichia coli cause the majority of food-poisoning
cases.

 Physical hazards relate to various foreign particles not normally found in a

product. Examples are metal, pieces of wood and sand (Figure 4).
o The nature of physical hazards in the food chain is rather different from the
nature of other hazards. Besides, compared with chemical or microbiological
hazards, physical hazards are less likely to affect large numbers of people
product, do not multiply, but the product cannot be decontaminated.
 o Till date a complete risk assessment has not been made for many of the
known hazards.
o Due to production, processing, distribution and other practices as well as
international trade (import and export), new hazards may emerge in
addition to the existing hazard.

Sources Of Hazards
Raw Materials
 Raw materials are the primary source of contamination.
 Failure to follow basic quality assurance procedures (identification and labelling,
Storage conditions, Handling requirements, Preparation and processing and
Isolation unsuitable raw materials) on raw materials may lead to food products
that are unsafe for construction.
Processing Steps
 Uncontrolled processing operations can lead to hazardous conditions.
 Failure to maintain processing conditions such as Temperature or Time delay in
processing, incorrect formulations and procedures and following unauthorized
processing techniques may all result in contamination or microbial growth.
 Poor cleaning practices may leave excess cleaning chemical residues on plant and
equipment.
Machinery
 Unclean and unhygienic equipment can easily promote the growth of
microorganisms. Preventive maintenance of machinery is an important aspect
in a safety- management program.
 If safety requirements are ignored, the layout of the machinery and equipment
can be a potential hazard.
 The machinery should be examined at intervals to ensure a safe operation.
Handling of Food
 Personal hygiene is extremely important in any food serving establishment. If
adequate precautions are not taken, food handlers can transmit pathogenic
bacteria.
 Personal articles such as Jewellery can get mixed with foods during preparation.
Environmental Conditions
 Hazards due to Environmental conditions may affect raw materials, processing
and machinery. Pollution of water and soil can have alarming results through the
food chain.
 Environmental contamination may also be due to foreign matter, chemicals such
as sprays and contaminants in water.
Measures To Control Hazards
 Measure at the processing and packaging stages (Raw materials, packaging
materials, processing steps, plant and machinery, storage and Distribution,
premises and personnel).

Method Control parameters

Heat treatment Time, Temperature and Humidity
Filtration Pore, size and filter integrity
Irradiation Dosage and Density of load
Chemical Concentration, pH and Temperature

 Measures at post processing and packaging stages (Retail and Food service)
 The consumer (Food preparation and Food usage)

Principles Of HACCP
The HACCP system involves the following seven principles:
Principle 1. Conduct a Hazard Analysis
 Principle 1 describe where the HACCP team should start. A process flow diagram
is put together, detailing all the steps in the process, from incoming raw
materials to finished product.
 When complete, the HACCP team identifies all the hazards which could occur at
each stage and describe preventative measures for their control.
 The hazard could be biological, such as a microbe, chemical, such as a toxin, or
physical, such as ground glass, metal fragments etc.
 There are three objectives of carrying out hazard analysis:
o First, hazards should be identified along with associated control measures
required for them.
 o The analysis can detect the need for changes to a process or product in order
to ensure or enhance product safety.
o The analysis gives a basis for determining the Critical control point in Principle
2.

Principle 2. Determine the Critical Control Points (CCPs)

 When all the hoards and preventative measures have been described, the HACCP
team establishes, the points where control is critical to managing the safety of
the product.
 These are points in a food’s production — from its raw state through processing
and shipping to consumption by the consumer — at which the potential hazard
can be controlled or eliminated.
 Examples are cooking, cooling, packaging, metal detection etc.
Principle 3: Establish Critical Limit(s)
 The third step establishes preventive measures with critical limits for each control
point.
 For a cooked food, for example, this might include setting the minimum cooking
temperature and time required to ensure the elimination of any harmful
microbes.
 The critical limits describe the difference between safe and unsafe product at the
CCPs.
 These must involve a measurable parameter and may also be known as the
absolute tolerance for the CCP.

Principle 4. Establish a System to Monitor Control of the CCP

 The HACCP team should specify monitoring requirements for management of
the CCP within its critical limits.
 This will involve specifying monitoring actions along with frequency and
responsibility.
 Such procedures might include determining how and by whom cooking time and
temperature should be monitored.

Principle 5. Establish the Corrective Action to be taken when Monitoring Indicates

that a Particular CCP is not Under Control
 Corrective action procedures and responsibilities for their implementation need
to be specified.
 This will include action to bring the process back under control and action to
deal with product manufactured while the process was out of control.
 For example, reprocessing or disposing of food if the minimum cooking
temperature is not met.

Principle 6. Establish Procedures for Verification to Confirm that the HACCP System
is Working Effectively
 Verification procedure must be developed to maintain the HACCP system and
ensure that it continues to work effectively.
 For example, testing time-and-temperature recording devices to verify that a
cooking unit is working properly.

Principle 7: Establish Documentation Concerning all Procedures and Records

Appropriate to these Principles and their Application
  Records must be kept to demonstrate that the HACCP system is operating under
control and that appropriate corrective action has been taken for any deviations
from the critical limits.

Guidelines for Application of HACCP Principles

 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 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 Critical Control Points
(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.
 A HACCP approach should be customized to each food business.
o Hazards, control measures at CCPs and their critical limits, CCP monitoring,
CCP corrective actions and verification activities can be distinctive for a
particular situation and those identified in a Codex Code of Practice or other
appropriate guidelines might not be the only ones identified for a specific
application or might be of a different nature.
 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.

Assemble HACCP
team

Describe the
food and its
distribution

Describe the
inteded use and
consumers of
the food

Construct flow
diagram that
describes the
process

Verify the flow

diagramme

Application of HACCP Principles

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.
 The HACCP team should identify the scope of the HACCP system and applicable
prerequisite programmes.
 The scope should describe which food products and processes are covered.

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 (e.g., aw, pH, preservatives, allergens), processing
methods/technologies (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.

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.
o 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.

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:
o the sequence and interaction of the steps in the operation;
o where raw materials, ingredients, processing aids, packaging materials,
utilities and intermediate products enter the flow;
o any outsourced processes;
 o where applicable reworking and recycling take place;
o where end products, intermediate products, waste and by-products are
released or removed.

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.

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 the Diagram given
below.

 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:
o 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);
o the likelihood of occurrence of hazards, taking into consideration
prerequisite programs, in the absence of additional control;
o the likelihood and severity of adverse health effects associated with the
hazards in the food in the absence of control;
o identified acceptable levels of the hazards in the food e.g. based on
regulation, intended use, and scientific information;
o the nature of the facility and the equipment used in making the food
product;
o survival or multiplication of pathogenic microorganisms;
o production or persistence in foods of toxins (e.g. mycotoxins), chemicals
(e.g. pesticides, drug residues, allergens) or physical agents (e.g. glass, metal);
o the intended use and/or probability of product mishandling by potential
consumers that could render the food unsafe; and,
o 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.
 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 good hygiene
practices, 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,
e.g., at critical control points.

Determine the Critical Control Points (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.
 Critical Control points are to be determined only for hazards identified as
significant as of 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.
 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:
 o Assess whether the control measure can be used at the process step being
analysed:
 If the control measure cannot be used at this step, then this step should
not be considered as a CCP for the significant hazard.
 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, 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.
Establish validated critical limits for each CCP (Step 8/ Principle 3)
 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 implemented.
 Validation of critical limits may include conducting studies (e.g. 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 the Guidelines
for the Validation of Food Safety Control Measures (CXG 69 – 2008).
 Taking the example of liquid milk, the process should be designed to ensure the
production of a safe product.
 The hazard analysis, conducted earlier, identified pathogens (e.g., Streptococcus,
Pseudomonas, Lactobacillus) as significant biological hazards.
 Furthermore, it identified pasteurization and storage of processed milk as the
step in the process at which control can be applied to eliminate the pathogens
(i.e.CCP).
 To ensure that an acceptable level is consistently achieved, accurate
information is needed on the probable number of the pathogens in the raw milk,
their heat resistance, the factors that influence the heating of milk etc.
 Collectively, this information forms the scientific basis for the critical limits that
are established.
 Table illustrates the critical limits for each CCP in the liquid milk process.
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.
o 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.

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.
 The corrective actions taken when a deviation occurs should ensure that the CCP
has been brought under control and food that is potentially unsafe is handled
appropriately and does not reach consumers.
 Actions taken should include segregating the affected product and analysing its
safety to ensure proper disposition.
 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.

Validation of the HACCP Plan and Verification Procedures (Step 11/ Principle 6)
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:
 o 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.
o 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 sources.

Verification Procedures
 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:
o reviewing monitoring records to confirm that CCPs are kept under control;
o reviewing corrective action records, including specific deviations, product
disposition and any analysis to determine the root cause of the deviation;
o calibrating or checking the accuracy of instruments used for monitoring
and/or verification;
o observing that control measures are being conducted in accordance with
the HACCP plan;
o sampling and testing, e.g. for microorganisms (pathogens or their indicators),
chemical hazards such as mycotoxins, or physical hazards such as metal
fragments, to verify product safety;
o sampling and testing the environment for microbial contaminants and their
indicators, such as Listeria;
o reviewing the HACCP system, including the hazard analysis and the HACCP
plan (e.g. internal and/or third-party audits).
  Verification should be carried out by someone other than the person who is
responsible for performing the monitoring and corrective actions.
 Where certain verification activities cannot be performed in house, verification
should be performed on behalf of the business by external experts or qualified
third parties.
 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.

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:
o HACCP team composition;
o hazard analysis and the scientific support for the hazards included or excluded
from the plan;
o CCP determination;
o critical limit determination and the scientific support for the limits set;
o validation of control measures; and
 o modifications made to the HACCP plan.
Examples of records include:
o CCP monitoring activities;
o deviations and associated corrective actions; and
o 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.
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 Critical Control Point.
 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
organisations, and competent authorities is vitally important.
 Opportunities should be provided for the joint training of food business
operators and competent authorities to encourage and maintain a continuous
dialogue and create a climate of understanding in the practical application of
HACCP.
The HACCP Status in India
 The HACCP situation in the overall food industry in India is still very dismissal.
 Whatever small efforts that have been made have been limited to the organized
sector which, as such, has a small share in the overall industry.
 For example, the organized dairy sector, which apply HACCP principles in
providing safe milk to consumers, just constitutes 15-16 percent of the entire
dairy industry.
 Nevertheless, it is heartening to see the progress made in HACCP implementation
by dairy, marine and biscuit making industries.
  In the Indian context, where the food safety management systems is not fully
developed and the resources are scarce, there is a need to develop a strategy for
implementing the HACCP system in a phased manner across all pertinent sectors
and scales of the industry, particularly the unorganized sector.
 The various barriers being faced to the implementation of HACCP include:
o lack of concerted efforts by stakeholders
o lack of customer and business demand
o financial constraints
o human resource constraints, and
o inadequate infrastructure and facilities.

IndiaHACCP Certification Scheme

 The IndiaHACCP Certification Scheme is based on the international best practices
and global standards to ensure internationally acceptable certification.
 This Scheme would not only help provide assurance that food is suitable for
human consumption but also maintain confidence in internationally traded food.
 It would also provide Indian FBOs an alternative to foreign certifications and
outgo of foreign exchange.
 Thus, FBOs are encouraged to implement IndiaHACCP in their operations and
take certification from certification bodies approved under this scheme.

International Organization for Standardization (ISO)

 The International Organization for Standardization (ISO) is a worldwide
federation of national standards bodies from some 140 countries, one from each
country. ISO is a non‐governmental organization established in 1947.
 The mission of ISO is to promote the development of standardization and
related activities in the world with a view to facilitating the international
exchange of goods and services, and to developing cooperation in the spheres of
intellectual, scientific, technological and economic activity.
 ISO's work results in international agreements which are published as
International Standards.

ISO's name
 Many people will have noticed a seeming lack of correspondence between the
official title when used in full, International Organization for Standardization, and
the short form, ISO.
 Shouldn't the acronym be "IOS"? Yes, if it were an acronym – which it is not.
 In fact, "ISO" is a word, derived from the Greek isos, meaning "equal", which is
the root of the prefix "iso‐" that occurs in a host of terms, such as "isometric" (of
 equal measure or dimensions) and "isonomy" (equality of laws, or of people
before the law).
 From "equal" to "standard", the line of thinking that led to the choice of "ISO" as
the name of the organization is easy to follow.
 In addition, the name ISO is used around the world to denote the organization,
thus avoiding the plethora of acronyms resulting from the translation of
"International Organization for Standardization" into the different national
languages of members, e.g. IOS in English, OIN in French (from Organisation
internationale de normalisation).
 Whatever the country, the short form of the Organization's name is always ISO.

How it all started?

 International standardization began in the electrotechnical field: the
International Electrotechnical Commission (IEC) was created in 1906.
 Pioneering work in other fields was carried out by the International Federation of
the National Standardizing Associations (ISA), which was set up in 1926.
 The emphasis within ISA was laid heavily on mechanical engineering. ISA's
activities ceased in 1942, owing to the Second World War.
 Following a meeting in London in 1946, delegates from 25 countries decided to
create a new international organization "the object of which would be to
facilitate the international coordination and unification of industrial standards".
 The new organization, ISO, began to function officially on 23 February 1947.
 The first ISO standard was published in 1951 with the title, "Standard reference
temperature for industrial length measurement".

Who makes up ISO?

 ISO is made up of its members who are divided into three categories: A member
body of ISO is the national body "most representative of standardization in its
country". Thus, only one body in each country may be admitted to membership
of ISO. A member body takes the responsibility for:
o informing potentially interested parties in their country of relevant
international standardization opportunities and initiatives;
o ensuring that a concerted view of the country's interests is presented during
international negotiations leading to standards agreements;
o providing their country's share of financial support for the central operations
of ISO, through payment of membership dues.
 Member bodies are entitled to participate and exercise full voting rights on any
technical committee and policy committee of ISO.
  A correspondent member is usually an organization in a country which does not
yet have a fully developed national standards activity.
 Correspondent members do not take an active part in the technical and policy
development work, but are entitled to be kept fully informed about the work of
interest to them.
 ISO has also established a third category, subscriber membership, for countries
with very small economies.
 Subscriber members pay reduced membership fees that nevertheless allow them
to maintain contact with international standardization.

What are standards?

 Standards are documented agreements containing technical specifications or
other precise criteria to be used consistently as rules, guidelines, or
definitions of characteristics, to ensure that materials, products, processes
and services are fit for their purpose.
 For example, the format of the credit cards, phone cards, and "smart" cards
that have become commonplace is derived from an ISO International
Standard.
 Adhering to the standard, which defines such features as an optimal
thickness (0,76 mm), means that the cards can be used worldwide.
 International Standards thus contribute to making life simpler, and to
increasing the reliability and effectiveness of the goods and services we use.

Introduction Of ISO 22000

 By the early 2000s, a number of standards have been developed by different
private and national organizations around the world.
 This led to complications when companies started using their own in-house
developed codes to audit their suppliers. Different audit criteria made it nearly
impossible for suppliers to fulfill all requirements in the global market.
 In 2001, the International Organization for Standardization (ISO) started
working on an auditable standard for Food Safety Management System (FSMS).
 This international FSMS standard, known as ISO 22000, was finally published on
September 1, 2005.
 It is a framework that combines prerequisite programs, the HACCP principles
and application steps as described by the Codex Alimentarius Commission and
elements of the ISO 9001:2000 standard.
 Within two years, the standard has been implemented by organizations in more
than 50 countries as an alternative to more than 20 food safety schemes
developed by individual companies in the sector for auditing their suppliers.
 ISO 22000 intends to define the Food Safety Management System requirements
that companies need to meet in order to comply with food safety regulations all
over the world.
 ISO 22000:2005 takes a food chain approach to food safety.
 It defines a set of general food safety management requirements that apply not
only to food producers and manufacturers, but to all the organizations that
participate in the food supply chain.
 ISO 22000 specifies the requirements for an FSMS that combines the following
key elements to ensure food safety along the food chain: —
 Interactive communication
o Communication along the food chain is essential to ensure that all relevant
food safety hazards are identified and adequately controlled at each step
within the food chain.
o This implies communication between organizations both, upstream and
downstream in the food chain.
 Management system.
o ISO 22000 can be applied independently of other management system
standards.
o Its implementation can be aligned or integrated with existing related
management system requirements, while organizations may utilize existing
management system(s) to establish a food safety management system that
complies with the requirements of ISO 22000.
 HACCP principles and prerequisite programs. ISO 22000 integrates the principles
of the Hazard Analysis and Critical Control Point (HACCP) system and by means
of auditable requirements, it combines the HACCP plan with prerequisite
programs (PRPs).
 Prerequisite programmes comprise all basic conditions and activities necessary
to maintain a hygienic environment throughout the food chain suitable for the
production, handling and provision of safe end products.