HACCP: HAZARD ANALYSIS CRITICAL CONTROL POINT SYSTEM

Objective
• Understand principles and application for addressing the safety of
foods in food processing establishments

 Introduction
 HACCP Prerequisite programs
 The seven HACCP principles
 logical steps in application of HACCP
 Maintenance of HACCP
 HACCP plans

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 Introduction
• The HACCP is a systematic approach to identify and evaluate hazards, and define
measures for their control to ensure the safety of food.
• HACCP is a tool to assess hazards and establish control systems; it focus on
prevention rather than relying mainly on end-product testing
• Classic approaches to food safety rely heavily on end product testing;
• HACCP is Proactive System of Assuring Food Safety.
• It Can be applied throughout the food chain– from Farm to Table

• Successful implementation of HACCP requires management commitment and

involvement of workforce
• Requires a multidisciplinary approach; expertise in agronomy, veterinary,
production, microbiology, medicine, public health, food technology,
environmental health, chemistry and engineering
• The application of HACCP is compatible with the quality management systems,
such as the ISO 9000 series, and is the system of choice in the management of
food safety within such systems.
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 ORIGIN OF HACCP
• HACCP concept dates back to the early 1960s; the Pillsbury Company in
conjunction with the National Aeronautics and Space Administration (NASA)
and the US Army Natic Laboratories pioneered the development of HACCP in
response to the needs of the space program.
• The objective was to develop a strategy that would ensure food for astronauts
were free of unacceptable health hazards
• 1970s, The Pillsbury Company announced the use of the HACCP for the
manufacture of consumer foods; provide expertise, training to the food industry
and to government regulatory agencies in the U.S.
 International recognition;
• In 1987, the International Commission on Microbiological Specifications for
Foods (ICMSF) endorsed the use of the HACCP system
• In 1991, the Codex Alimentarius Committee prepared a draft report on HACCP
for member countries, and recommended the HACCP system as the basis for an
internationally recognized approach for addressing food safety.
• The final version of the HACCP guideline was later incorporated into the Codex
Alimentarius General Principles of Food Hygiene (Annex part).

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Regulatory implications
• The HACCP system has become the basis for official food control and the
establishment of standards applicable to international trade
• HACCP has become part of the mandatory regulations of the food sector In
many countries, such as Australia, Canada, EU, USA
• For example
– USDA (FSIS) implemented mandatory HACCP regulations for meats and poultry;
– FDA HACCP regulations for sea foods and fruit and vegetable juice products ; also
emphasize SSOPs
• Whether requirements are voluntary or mandated, every food establishment
is responsible to produce “safe” products
• Federal governments may have updated Current requirements; so It is very
important for manufacturers and retailers to review current updates and status
of regulations
• Building a HACCP system require
– HACCP prerequisite programs and
– the HACCP plans
• An effective HACCP program is built on the foundation of effective PRPs
• Together, the prerequisite programs and the HACCP plan at a food establishment form the
“House of Product Safety”

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 The HACCP plan is developed on the basis of the seven principles
 HACCP Prerequisite programs
• Procedures, including good manufacturing practices that address operational
conditions providing the foundation for the HACCP system.
• GMPs/ PRPs include measures for :
– requirements for the design of infrastructure and facilities;
– maintenance programmes for facilities, equipment and sanitation;
– control of operations, including food product risk control, hygiene,
pest control, control of raw materials, packing, water quality, temperature
control;
– management and supervision, documentation and records and procedures
for rejects and the recall of unsafe products;
– staff hygiene;
– transport;
– information concerning the product and for the consumer (product
identification and labelling and consumer information);
– staff training etc …

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PRINCIPLES OF THE HACCP SYSTEM
• The Codex Alimentarius recognized set of seven principles that are used for the
development of an HACCP plan.
The universally recognized Seven Principles of HACCP are:
1. Conduct a hazard analysis
2. Determine the critical control points (CCPs)
3. Establish critical limit(s)
4. Establish a system to monitor control of the CCP
5. Establish the corrective action to be taken when monitoring indicates that a
particular critical control point is not under control
6. Establish procedures for verification to confirm that the HACCP system is working
effectively
7. Establish documentation concerning all procedures and records appropriate to
these principles and their application

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 Codex Definition of relevant terms to the HACCP

• Hazard: A biological, chemical or physical agent in, or condition of, food with
the potential to cause an adverse health effect.
• Risk: an estimate of the likely occurrence of a hazard?????
• Control point: a point or procedure where a hazard can be controlled
• Critical Control Point (CCP): Any point or procedure where control can be
applied and is essential to prevent or eliminate a hazard or reduce it to an
acceptable level.
• Critical limit: A criterion that separates acceptability from unacceptability; One
or more prescribed tolerances that must be met to ensure that a CCP
effectively controls a health hazard.
• CCP decision tree: A sequence of questions to assist in determining whether a
control point is a CCP.
• Corrective action: action to be taken when the results of monitoring at the CCP
indicate a loss of control.
• Deviation: Failure to meet a critical limit for a CCP.

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• HACCP: A system that identifies, evaluates and controls hazards that are
significant for food safety.
• HACCP plan: A document prepared in accordance with the HACCP principles to
ensure control of food safety hazards in the segment of the food chain under
consideration.
• Hazard analysis: The process of collecting and evaluating information on hazards
and conditions leading to their presence to decide which are significant for food
safety and therefore should be addressed in the HACCP plan.
• Monitoring: The act of conducting a planned sequence of observations or
measurements of control parameters to assess whether a CCP is under control.
• Verification: methods, procedures, tests and other evaluations, in addition to
monitoring, to determine compliance with the HACCP plan
• Validation: Obtaining evidence that the elements of the HACCP plan are
effective ; i.e., element of verification
• Risk category: prioritizing risk based on food hazards.
• Step: A point, procedure, operation or stage in the food chain, including raw
materials
• Flow diagram: A systematic representation of the sequence of steps or operations
used in the production or manufacture of a particular food item.
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 Development and implementation of a HACCP plan

• the Codex Alimentarius adopted a model consisting of a sequence of twelve steps

for developing and implementing an HACCP plan for a particular food product,
and is referred to as the Logic Sequence for the Application of HACCP.
This set of twelve steps includes
– Five of them are preliminary steps;
– Followed by seven steps that address the seven principles of HACCP

 The successful application of HACCP requires the full commitment and

involvement of management and the workforce.

 The worldwide acceptance of the Codex Alimentarius model has resulted in a

consistent format for developing and implementing HACCP plans in food
establishments around the world, and has contributed to the recognition of
HACCP systems to address food safety issues in bilateral and international trade.
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The Codex Alimentarius Logic Sequence for the Application of HACCP

After these five preliminary tasks have been completed, the seven principles of HACCP are applied.

The twelve steps in the Codex Alimentarius Logic Sequence for the Application of HACCP:
• 5 preliminary tasks & 7 principles 11
Step 1 — assemble an HACCP team
 multidisciplinary
 team should include whole range of specific knowledge and expertise
appropriate to product under consideration, who can contribute knowledge in
– Quality control and quality assurance
– Food microbiology
– Food processing,
– GMPs, and Equipment maintenance
– involve as much as possible higher management levels
– Others ( production, inspection, testing etc.)
– Team will be assisted by (internal and or external) specialists.

• The top management must demonstrate its commitment to provide support

to the HACCP team; must ensure that all members of the team obtain the
required training in HACCP system and are available to work as part of the
team
• The team must be also aware of the requirements of the regulatory agencies.
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Step 2 — describe the food product
Important characteristics relating to safety of the product described include:
• Product name, including common names
• Composition; physicochemical (Aw, pH , preservatives, allergenic ingredients
etc.)
• Treatments (heat, freezing, brining, smoking, etc.)
• packaging ( unit, material, and packaging condition)
• shelf-life; storage conditions and method of distribution(e.g., refrigerated,
frozen)
• Labeling Instructions to customers for handling, storage and use (e.g.,
refrigerated, frozen, cooking etc.)
• The actual use of the product (e.g., ready-to-eat, heat before consumption)

Step 3 — identify the intended use of the product

• Define consumer target groups for which the product is intended.
• Institutional use, the general public, or certain segment of the population (e.g.,
infants, pregnant women, immunocompromised individuals, the elderly, etc.
should be considered.
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Step 4 — Construct a process flow diagram
• A clear, simple logical outline of the steps involved in the manufacture of the
product
• The flow diagram should identify all key steps in the process from,
– receiving of raw materials and ingredients;
– handling, sorting, preparation and storage of raw materials and ingredients;
– all processing treatments (including filters, screens, magnets, metal
detectors);
– all packaging, labeling, and storage steps to shipping of the product

• It should be simple, easy to understand, and sufficiently descriptive.

• the process flow diagram is extremely useful for conducting the hazard analysis
and determining the CCP

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An example of a flow diagram, for the
preparation of a stewed meat product

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Step 5 — on-site verification of the process flow diagram
• the HACCP team should actually perform on-site review of the manufacturing
operation to confirm that each activity and operation identified on the process
flow diagram accurately represents the actual processing operations used to
prepare the product
• Requires sufficient knowledge of the processing operation
• Modifications should then be made, as necessary.

 After Steps 1 to 5 (the five preliminary tasks) have been completed, the HACCP
team can then proceed to develop the HACCP plan for the product.

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Step 6 — conduct a hazard analysis (HACCP Principle 1)
• 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.”
 Hazard Analysis consists stages for hazard identification, hazard evaluation and
Identification of control measures
a. identify all of the hazards that may be reasonably expected to occur at each
step__ for all raw materials, ingredients, processing, manufacture and
distribution to the point of consumption.
b. Next The identified hazards are evaluated to determine which hazards
essentially need to be addressed in the HACCP plan
c. control measures are also identified for the hazards that need to be addressed
in the HACCP plan

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a. Hazard Identification:
• The team develops a list of known potential hazards that are likely to be associated
with the product; this covers:
– ingredients, raw materials, and packaging materials
– aspect of each step of the process (equipment, survival at important steps,
deviations in process etc…)
– Environment

 practices that may be helpful to consider when identifying potential hazards

– Cross-contamination
– Poor employee sanitation practices
– Improper food storage temperatures
– inadequate cleaning and sanitation practices
– poor food manufacturing and handling practices
– Improper refuse storage in food manufacturing
– Improper storage of chemicals and personal items

 read the NACMCF compiled a list of examples of issues that should be considered during a
hazard identification exercise 18
Examples of Some Biological, Chemical, and Physical Hazards in Foods.
** This is not a complete list of all the potential hazards in processed foods
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b. Hazard Evaluation:
• The team decides which of the potential hazards are significant, and therefore
need be addressed in the HACCP plan.

• Assessing their likely occurrence and the severity of the risk for the identified
hazards. The HACCP team should consider:
 methods and procedures of preparation, handling, storage, and distribution
 effects of short-term and long-term exposure to the health of consumers
 persistence, survival or multiplication,
 people potentially exposed, including any particular groups (e.g., infants,
pregnant women, the elderly), and the adverse effects
 epidemiological evidence leading to the above conditions

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Categories of Hazards
• The NACMCF suggested the following six categories for risk assessment:
A. Food intended for consumption by at-risk population
B. Product containing sensitive ingredients
C. No process step to eliminate hazard
D. Recontamination potential before packaging
E. Potential for product abuse
F. No terminal heat process

• Based on these risk factors, food risk categories are assigned as 0–VI
VI: risk factor A- has the highest risk e.g., infant formula or baby food
0: none of the risk factors are assigned
I: Foods with one of the risk factors other than A
II: Those with two factors other than A, and so on

 These food risk categories help in classifying microbiological hazards, but they still do
not aid in identification of chemical or physical hazards, or of CCPs for HACCP

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c. Identification of Control measures
• consider control measures, if any exist, can be applied to each hazard
• general prevention measures (PRP/GMP)
• institute measures to limit risk, such as modification of the process

 Control measures for biological hazards:

– thermal processing to eliminate pathogens
– frozen storage to prevent pathogens
– use of preservatives to prevent pathogens
– testing for the presence of pathogens
 Control measures for chemical hazards:
– formulation control of regulated food additives
– detailed product specifications for chemicals
– Maintaining letters of guarantee from suppliers
– Inspecting trucks used to ship finished product
– Properly labeling and storing all chemicals
– testing for the presence of antibiotics and pesticide residues
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 Control measures for physical hazards:
– accurate specifications for building design and operation
– letters of guarantee for ingredients and product supplies
– Performing random visual examinations of incoming materials
– Using magnets and metal detectors to find metal fragments
– Using stone traps and bone separators to remove
– Keeping equipment well maintained

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Step 7 — determine the critical control points (HACCP Principle 2)
• With the information from the hazard analysis, CCPs are identified.
• a CCP is a point or step at which control can be applied and is essential to
prevent a food safety hazard or reduce it to an acceptable level;
• If control measure may not in place at this step, Later processing steps won’t
correct these safety problems.

• Example of CCPs include:

– Raw materials screening, testing ingredients for chemical
residues/adulterants, metal detection etc.
– Thermal processing (time–temperature relations)
– refrigeration, Freezing and time to freezing, thawing,
– pH, water activity, modified atmosphere
– Packaging,
– product formulation control
– a decontamination step, Employee hygiene, etc.

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 A CCP decision tree- a tool used to determine whether a point or process
step is a CCP.
• The CCP decision trees consist of a set of three or four questions, which are
asked in a particular sequence for each identified hazard so that the point of
control of that hazard within the HACCP plan can be determined.
• The CCP decision trees are proposed by Codex Alimentarius and the
NACMCF.

• Important considerations when using the decision tree:

– The decision tree is used after the hazard analysis.
– The decision tree is used at the steps where a hazard that must be
addressed in the HACCP program has been identified.
– A subsequent step in the process may be more effective for controlling a
hazard and may be the preferred CCP.
– More than one step could be a CCP for the same hazard
– a single CCP could control more than one hazard

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Codex Alimentarius CCP Decision Tree
(Answer questions in sequence)

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If a hazard has been identified at a step where control is necessary for safety, and no
control measure exists at that step, or any other, then the product or process should be
modified at that step, or at any earlier or later stage, to include a control measure

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 Codex CCP decision tree. Source: Adapted from Codex 2009b.
(answer questions in sequence)

* Proceed to the next identified hazard in the described process.

** Acceptable and unacceptable levels need to be defined within
the overall objectives in identifying the CCPs of HACCP plan.
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Step 8 — establish critical limits for each CCP (HACCP Principle 3)
• Once CCPs are identified, critical limits are determined to reduce or eliminate
the hazard at that point.
• A critical limit is a criterion that separates acceptability from unacceptability
o Microbial and chemical limits often set for end products
o At CCP usually equipment parameter limits; process capability
 Critical limits are measurable factors; often include
a. Physicochemical al parameters : temperature, time, pH, Aw, chlorine level,
moisture level, titratable acidity, viscosity, physical dimension etc.
b. Sensory parameters: odour, visual appearance and texture

 In Setting Critical limits

• A number of sources such as regulatory standard and guidelines, literature
surveys, experimental results, and expert advice can be use

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Step 9 — establish monitoring procedures for each CCP (HACCP Principle
4)
• Monitoring is the scheduled measurement or observation of a CCP relative to
its critical limits.
• The monitoring procedures must be able to detect loss of control at the CCP in
time to make adjustments.
• Monitoring procedures include
– Visual inspections
– chemical measurements (e.g. pH, moisture)
– physical measurements (e.g. pressure, time, temperature)
 Microbiological tests are not often preferred for routine monitoring, as it requires too
much time
• monitoring results must be recorded and documented.
– E.g., recording chart to monitor temperature/time for a process

 Importance of Monitoring
• Provide early warning when the parameter tends to deviate the limit at the CCP,
initiating appropriate corrective action.
• It provides written documentation for use in verification of the HACCP plan
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Monitoring procedures must address the following points:
• reliability of the method
• number of samples/measurements, handling
• Whether the method is appropriate for monitoring
• frequency of monitoring
• skill and training of personnel responsible for the monitoring
• reliability of measuring equipment/ maintained and calibrated
Examples of Monitoring Procedures for Some CCPs

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Step 10 — establish corrective actions for each CCP (HACCP Principle 5)
• The when the monitoring of a CCP reveals that the critical limits are not
respected (i.e., a deviation occurs), there should be clearly established
procedures for its restoration, and for the actions to be taken, and recording
the action taken.
 points must be addressed in the corrective action procedures:
– Determine and correct the Cause of Deviation
– Identify the person responsible
– Proper Disposition of nonconforming product/deviation procedures
– Record the Corrective Action
– Reevaluating The HACCP Plan ??

 When a deviation from the critical limits is discovered only after the non-conforming
product has been shipped to the customers, What action must be used to address this
situation?

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Step 11 — establish verification procedures (HACCP Principle 6)
• Verification is the process of checking that the HACCP plan is applied correctly and the
HACCP system is working effectively on an ongoing basis

 Verification of initial HACCP plan: involves validation to ensure that the critical limits,
the monitoring procedures and the corrective action procedures established at each
CCP are indeed capable of controlling the hazard.

 Verification of the HACCP plan on a continuous basis: activities that demonstrate

whether the HACCP system continue to function effectively as intended.
• Verification activities includes:
– observing monitoring activities
– Review of records of monitoring activities and corrective actions
– Conducting independent sampling and analysis to verify the effectiveness of the CCP
to control a hazard
– review of the HACCP plan and its records
– written records of verification inspections
 Extensive microbiological tests are conducted as part of verification

 Verification should be performed by a second or third party audit teams

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Step 12 — establish documentation and record-keeping procedures
(HACCP Principle 7)
• Collection of documents which describes the provisions of the HACCP system,
including records that prove it’s real and effective implementation.
• The HACCP scheme should be fully documented and kept on file at the food
establishment and must be made available to official inspectors upon request.
• Documentation is storing knowledge and information; Record-keeping is storing
data/observations.

 Documentation compiled during the HACCP plan development

– e.g., hazard analysis, CCP determination, critical limit determination etc.
 Records are generated when the HACCP plan is used
– e.g., CCP monitoring activities; deviations and corrective actions;
verification procedures; modifications to the HACCP plan etc.

 establish procedures for the identification, storage, retrieval, maintenance,

protection, and disposition of documents.

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  Maintenance of the HACCP system
• The HACCP system must be maintained effectively on a continuous basis . i.e.,
monitoring procedures , corrective action procedures, verification activities, and the
record-keeping must operate continuously, and in exactly the manner as they were
initially developed and implemented
• Any change of the program should only take place after the HACCP coordinator has
been informed and has approved.
• Modifications to HACCP plan for a product to be determined if:
• The intended use of the product has changed
• There is a change in one or more raw materials, ingredients, or packaging material
• There is a change in the process for preparing the product
• There is addition, replacement or modification of equipment used in the process

 TRAINING
• Training of personnel in industry, government and academia in HACCP principles and
applications and increasing awareness of consumers are essential elements for the
effective implementation of HACCP.
• Joint training among different stakeholders could facilitate dialogue and create mutual
understanding in the practical application of HACCP.
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 Example of HACCP plan
• Establishment of HACCP plan for the
manufacture of frozen, cooked beef
patties
• The answers to the three questions:
A1- Raw ground beef patties are
known to be vehicles for
Escherichia coli 0157:H7,
Toxoplasma gondii, and
salmonellae
A2- This will be achieved in step 5
(cooking)
A3- This can occur in steps 7, 8, and
10.

A flow diagram for the production of frozen cooked beef patties

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Principle 1—Hazards and Risks
• Raw meat is a sensitive ingredient and the cooked product is subject to
recontamination after processing and during distribution
Principle 2—CCPs
• An important concern about step 1 is the overall condition of the beef
carcasses or cuts. GMP is required in the production of the raw beef .
• Step 5 is the indisputable CCP1, since it can eliminate the hazards.
• CCP2s may be assigned to steps 6 and 8,and possibly to step 7.
Principle 3—Critical Limits
• Temperature is the critical parameter from steps 1 to 9. It consists
– proper refrigeration temperature in steps 1 to 4
– proper cooking temperature in step 5
– freezing in steps 6 to 8
– heating in step 9
• The overall objective is to keep the fresh beef at/below 4.4◦C at all times,
cook patties to 71.1◦C, freeze to 0◦C, and store at the same temperature.

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Principle 4—Monitoring HACCP
• Use chart recorders for steps 2 to 4, use thermometers for steps 5 and
6, and temperature recorders for step 8.
• Principle 5—Corrective Actions
• These refer to deviations from critical limits identified during
monitoring of CCPs.
• Specific corrective actions to be taken should be clearly spelled out.
– For example, if the target temperature in step 5 is not reached, will the batch
be discarded, reprocessed, or assigned to another use?
Principle 6—Verification
• Overall assessment of effectiveness of the HACCP system.
• Some microbial analyses are in order—for example,
– were all relevant pathogens destroyed in step 5?
– Have the products in retail stores been contaminated ?

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Principle 7—Record-Keeping
• This should be done by product number in such a way that
records are available to verify the events in steps 1 to 9.
• chart recorder tracings should be kept.

Q. Assignment
• HACCP plan for particular food product
– flow diagrams for the process
– Hazard analysis
– Identify critical control points
– Critical limits etc.
– HACCP plan summary

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Figure: illustration of HACCP for raw
beef. Flow diagram of a process, CCPs;
O, major contamination source.

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Figure: illustration of HACCP for raw
beef. Flow diagram of a process, CCPs;
O, major contamination source.

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Important points
Why to use HACCP?
 Awareness of food-borne illness is increasing and concern throughout the
industry is driving the use of HACCP and HACCP based certification programs
• Global market place
• Increasing incidents of food-borne pathogens
• New pathogens emerging
• Need to protect Brands, control risks
Benefits of HACCP
 The primary purpose of a HACCP system is to protect people from food borne
illness, but the benefits of the system also extend to the company
• guaranteeing the safety of its products;
• using the company’s resources effectively;
• reducing costs and defective products, thereby increasing productivity;
• consolidating the company’s image and credibility among it’s consumers;
• enhancing the company’s capacity to respond to any safety problems
that may arise.
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• HACCP is the globally recognized approach for developing a food safety
management system.
• The HACCP system consisting of the following seven principles: •
1. conduct a hazard analysis
2. • determine the Critical Control Points (CCPs) •
3. establish critical limits
4. • establish a system to monitor control of the CCPs •
5. establish corrective action
6. • establish procedures for verification •
7. establish documentation

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Example of a HACCP worksheet for HACCP plan development

HACCP work sheet

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