CHAPTER 6

INTRODUCTION TO HACCP
 Introduction

 HACCP (Hazard Analysis Critical Control Point)

– is an industry-wide effort
– approved by the
• scientific,
• regulatory and
• industry communities,
– designed to focus on food safety,

 A major focus of the HACCP program is “from farm to

table.”
 HACCP
 is a concept as well as a method of operation,
 applied to all phases of food production, including
 agricultural production,
food handling,
food processing,
food services,
food distribution, and
consumer use.
 In short, everyone is responsible for safe food
products.
 The evolution of the HACCP system,
– second half of the twentieth century, in the
U.S. space program

In addition, a series of formal recognition and

adoption activities by
the food industry,
government regulatory agencies, and
national and international scientific and
professional organizations.
 The development and initial use of an HACCP approach
for food safety can be traced to a joint effort of
– the U.S. National Aeronautic and Space
Administration (NASA),
– the U.S. military, and
– the Pillsbury Company in the late 1950s and
early 1960s.
 One objective of this collaboration was ,
to develop a strategy that would ensure that foods
required for the space program were free of any
unacceptable health risk.
 The Pillsbury Company, in conjunction with NASA and the
U.S. Army Natick Laboratories,
– pioneered the development of the HACCP

 The need for this preventive approach resulted from,

inspection and testing of foods, was neither
practical nor effective for ensuring that
foods for the space program were free of
unacceptable health hazards.

 After the initial success with foods for the space program,
the Pillsbury Company
 pioneered the development of the HACCP system for
food safety in the manufacture of consumer foods
in its food processing plants.
• HACCP offers a number of advantages. Most important,
the program:
• (1) Focuses on identifying and preventing hazards
from contaminating food, based on sound science;

• (2) Allow more efficient and effective government

oversight,
• because record keeping 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;

• (3) Places responsibility for ensuring food safety on

the food manufacturer or distributor;

• (4) Helps food companies to compete more

effectively in the world market;

• (5) Reduces barriers to international trade.

 For a successful HACCP program to be properly
implemented ,
• management must be committed; this indicates
» an awareness of the benefits and costs of
HACCP, and
» will include education and training of all
employees.

 Benefits, in addition to,

– enhanced assurance of food safety,
– are better use of resources and
– timely response to problems.
 6.2 The HACCP Program
 Guidelines for Application of the HACCP Principles
 HACCP Prerequisite program
 Education and Training
 6.2.1 Guidelines for Application of the HACCP Principles

 For successful implementation

 Management must be strongly committed to the HACCP
concept.
– top management provides company employees with
a sense of the importance of producing safe
food.
 Prerequisite programs
such Good Manufacturing Practices (cGMPs)
 6.2.2 HACCP Prerequisite program
 The production of safe food products requires that an
HACCP program be built upon important prerequisites.
 The following are examples of common prerequisites.
• Facilities:
• Supplier Control ,Receiving, Storage, and Shipping:
• Specifications:
• Production Equipment
• Cleaning and Sanitation:
• Personal Hygiene
• Training:
• Chemical Control:
• Traceability and Recall:
• Pest Control:
 Other prerequisite programs include:
• Quality assurance procedures;
• Standard operating procedures for sanitation,
processing, product formulations and recipes;
• Procedures for receiving, storage, and shipping;
• Labeling;
• Employee food and ingredient handling practices.
 6.2.3 Education and Training
 success of an HACCP program depends upon educating
and training management and employees
in their role in producing safe foods.
 include
 information about the control of food borne hazards in all
stages of food manufacturing.
include working instructions and procedures
Personnel must be given the materials and
equipment necessary to perform their
required tasks;
management must provide the time for a
education and training of their personnel.
 Training programs should include
• various aspects of food microbiology and
epidemiology.
• data should be presented
» that increase understanding of how
processes work,
» as well as how HACCP can reduce or
eliminate risks that might be present in these
processes.
 6.3 Development of an HACCP Program

• The format of HACCP programs varies depending upon

several circumstances.
• product and process specific.
• a unit operations approach.
• In the development of an HACCP program,
– five preliminary tasks need to be accomplished
before the application of the HACCP principles to a
specific product and process.
 6.4 The Preliminary Tasks of an HACCP Program
– Choosing the HACCP Team
– Description of the Food Product and Its Distribution
– Description of the Intended Use and Consumers of
the Product
– Development of a Flow Diagram Describing a Food
Product Manufacturing Process
– Verification of the Flow Diagram
• 6.4.1 Choosing the HACCP Team
• The team’s responsibility is to develop the HACCP program.
• The HACCP team must be composed of individuals with specific
knowledge of
• the product characteristics and
• expertise appropriate to its manufacturing process,
and its variability and limitations,
• including individuals from areas such as
• engineering,
• production,
• sanitation,
• QA,
• analytical/food microbiology, and
• personnel involved in the manufacturing
operation itself.
• 6.4.2 Description of the Food Product and Its
Distribution

• The HACCP team describe the food product.

• This includes
• a general characterization of it,
• its ingredients, and
• the processing and
• manufacturing methods.
• method of the product distribution should also be
described, along with information on whether the
food is to be distributed
» frozen,
» refrigerated, or
» at ambient temperature,
• as well as the storage requirements.
• 6.4.3 Description of the Intended Use and Consumers
of the Product

• A description of the normal expected use of the food

product should be outlined.

• The intended consumers may be

• the general public or
• a particular segment of the population,
» e.g., infants;
• immune compromised individuals,
• the elderly, etc.
• 6.4.4 Development of a Flow Diagram Describing a Food
Product Manufacturing Process

• A flow diagram provides a

• clear, simple outline of the steps involved in the
manufacturing process.
• 6.4.5 Verification of the Flow Diagram

• the HACCP team should perform an on-site review of the

manufacturing operation to verify the accuracy and
completeness of the flow diagram.
– For example,
– where there are considerable amounts of raw
materials,
– processing equipment
 6.5 The seven HACCP Principles

• The HACCP system is based on

• a universally recognized set of seven principles
• that are used for the development of an HACCP
plan for a food.
• These principles reflect
• a framework that was developed on the basis of a
combination of recognized,
• science-based,
• food safety considerations and
• quality systems characteristics.
 The universally recognized Seven Principles of HACCP
are:

– Principle 1: Conduct hazard analysis,

– Principle 2: Determine critical control points,
– Principle 3: Establish critical limits,
– Principle 4: Establish monitoring procedures,
– Principle5:Establishcorrective action procedures,
– Principle 6: Establish verification procedures,
– Principle7:Establishrecord-keepingand documentation
procedures.
• 6.5.1 Conduct a Hazard Analysis (principle 1)

• The hazard analysis should be carried out in two stages;

the first stage is
– hazard identification,
– hazard evaluation.
• control measures should be identified at the
completion of the hazard analysis.
• i. Hazard identification
• identification of known potential hazards

• ii. Hazard evaluation

• to determine which of the hazards are
significant,
– occurrence and the severity of the risk that
they present if they are not controlled.
–
• iii. Identification of control measures
• Some Examples of Control Measures for
Biological, Chemical, and Physical Hazards
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
• Testing for the presence of antibiotics
• Testing for the presence of pesticide residues
Control measures for physical hazards:
• Filtering or screening to remove foreign objects
• Detection and removal of metal contaminants
• 6.5.2 Determine critical control points(Principle 2)
• determine the points at which there will be control
of the hazards that present unacceptable risks;
» this will establish the CCPs
• A useful tool for the determination of whether a
raw material or process step is a CCP, is the CCP
decision tree.
» Examples of CCP decision trees have been
proposed by Codex Alimentarius
» The CCP decision trees consist of a set of
either 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
plans, can be determined.
• Example1. Codex Alimentarius Critical Control Point Decision Tree
• Question 1: Do preventive control measures exist?
• (a) If the answer is Yes, go to Question 2.
• (b) If the answer is No, is control at this step necessary for the safety of
the product?
• (i) if the answer is No, this step is not a CCP; proceed to the next identified
hazard in the process
• (ii) If the answer is Yes, modify the steps in the process or the product, and
return to start of Question 1.
• Question 2: Is this step specifically designed to eliminate or reduce the
likely occurrence of the hazard to an acceptable level?
• (a) If the answer is Yes, this step is a CCP
• (b) If the answer is No, go to Question 3.
• Question 3: Could contamination with the identified hazard(s) at this
step, occur in excess of acceptable level(s) or could these hazards
increase to unacceptable level(s)?
• (a) If the answer is Yes, go to Question 4
• (b) If the answer is No, this step is not a CCP; proceed to the next
identified hazard in the process.
• Question 4: Will a subsequent step eliminate the identified hazard(s) or
reduce the likely occurrence to acceptable level(s)?
• (a) If the answer is Yes, this step is not a CCP; proceed to the next
identified hazard in the process
• (b) If the answer is No, this step is a CCP
• At the completion of principle 2,
• the HACCP team should be in a position to
determine at which points in the process,
– the identified hazards associated with the
product will be controlled
• so that the hazard will be eliminated,
prevented, or reduced to an acceptable
level.
• more than one step could be a critical control
point (CCP) for the same hazard (e.g.,
pasteurization and refrigerated storage can be
CCPs for the same microbiological hazard);
• a single CCP could control more than one hazard
(e.g., a screening step in a process can be a CCP for
various physical hazards).
• 6.5.3 Establish critical limits for each CCP (Principle 3)
• critical limits will serve as the criteria for
accepting or rejecting a raw material or
ingredient
• A critical limit is
» a maximum value of a parameter that must not be
exceeded or
» a minimum value of a parameter that must be
reached at a CCP.
• At a CCP, the critical limits (eg. Time and
temperature, etc.) must be respected for the
product obtained at the CCP to be acceptable.

• If the critical limits at a CCP are not respected,

the product obtained at the CCP will not be
acceptable.
• 6.5.4 Establish monitoring procedures for each CCP
(Principle 4)

• used to monitor or measure the parameters at

the CCP to determine whether the critical
limits are being respected.
• It is essential that the monitoring procedures be
reliable;
– if the monitoring procedure involves a
measurement, the reliability of the method
used should be known.
– Visual inspection and physical and chemical
measurements are frequently used as
monitoring procedures.
 Examples of Monitoring Procedures for Some CCPs
 CCPs for biological hazards
• Pasteurization
• Acidification
 CCPs for chemical hazards
Monitoring procedures
• Receiving of raw materials
• Labeling
 CCPs for physical hazards
Monitoring procedures
• Filtering
• Metal detection
 Monitoring procedures
• Monitoring of
temperature and time
• Measurement of pH
• Examination of
certificate of analysis
• Inspection of labeled
products
• Inspection of filter
• Monitoring of product
by metal Detector
 6.5.5 Establish corrective action procedures for each
CCP (Principle 5)
• procedures to be followed if and when the
monitoring of a CCP reveals that the critical
limits are not respected (i.e., a deviation occurs),
and
» therefore there is a loss of control of the
hazard at the CCP.

• The procedures that are established to prevent

unsafe product from reaching the consumer are
the corrective action procedures or deviation
procedures.
• The following points must be addressed in the corrective
action procedures:

• The specific, immediate action to be taken

• Identification of the cause of the deviation
• The actions to be taken to correct the cause of
the deviation
• Determination of the period of time for which the
deviation occurred and the quantity of
nonconforming product that was prepared during
this time,
• The actions to be taken with respect to the
nonconforming product to ensure that it does not
reach the consumer,
• The importance of keeping records of all the
actions taken to address the deviation and the
nonconforming product.
 6.5.6 Establish verification procedures for each CCP
and for the entire HACCP plan (Principle 6)

• This HACCP principle requires measures that will

evaluate
• (a) the effectiveness of the HACCP plan that has
been developed and
• (b) the effectiveness of the HACCP system on an
ongoing basis after its implementation.
 Table 11. Examples of Verification Activities for CCPs

CCPs for Biological

Hazards • Verification activities
• Pasteurization • Review of pasteurization, records,
microbiological testing of product
periodically
• Acidification
• Review of pH measurement records,
microbiological testing of
CCPs for Chemical product periodically
Hazards • Verification activities
• Receiving of raw • Review of certificates of analysis, periodic
material sampling and testing of raw material
• Labeling • Review of labeling inspection records
CCPs for Physical
• Verification activities
Hazards
• Review of filter inspection records
• Filtering
• Review of metal detector records
• Metal detection
 6.5.7 Establish record-keeping and documentation
procedures for the HACCP plan and the HACCP system
(Principle 7)
• This HACCP principle covers
– all records and documents
• that are required for all HACCP plans and for
the entire HACCP system.
• the HACCP team must identify
• which documents will be required and
• which records will be kept as part of the
» monitoring procedures,
» corrective action procedures, and
» verification procedures.
• In addition, the HACCP team must maintain the documentation
that was compiled during the development of the HACCP plan.
• This documentation will be required for any verification and
review of the HACCP plan.
• The documents which are expected to be maintained for an
HACCP plan include:
• The composition of the HACCP team along with assigned
responsibility,
• The description of the food product,
• The identification of the intended use of the product,
• Creation of a process flow diagram,
• The verified process flow diagram,
• A summary of the hazard analysis, along with the
justification for identification and evaluation,
• A summary of the CCP determination, along with the
justification,

CCP Hazard Critical Monitoring Corrective Verification Records

(s) limits actins

• Figure 11. Example of format for a HACCP plan summary

 6.6 Maintenance of the HACCP system
• After an HACCP system has been developed and implemented,
it must be maintained effectively on a continuous basis.
• This means that the
• monitoring procedures,
• the corrective action procedures (when required),
• the verification activities, and
• the record-keeping at each CCP, and
• for all the HACCP plans in the HACCP system, must
operate continuously, and
• in exactly the manner as they were initially developed
and implemented.
• Any change in any of these activities should only take place
after the HACCP coordinator has been informed and has
approved the change.
• For any significant change to the existing HACCP plan
activities, the HACCP team should evaluate the change
using the same guidelines and principles that were used in
the development of the HACCP system.
• The HACCP team should determine whether the HACCP plan
for a product needs to be modified after each of the
following:
• The intended use of the product has changed;
• change in raw materials, ingredients, or
packaging materials used for preparing the
product;
• change in the process for preparing the product;
and
• There is addition, replacement or modification
of equipment used in the process.