Lakhasly

The Hazard Analysis and Critical Control Point (HACCP) system, a science-based approach defined by the Codex Alimentarius Commission (CAC, 1993), identifies and controls manufacturing process hazards, prioritizing prevention over end-product testing. Applicable throughout the food chain, its implementation is guided by scientific risk assessment, enhancing food safety and benefiting regulatory inspections and international trade. Successful HACCP necessitates total management and workforce commitment, a multidisciplinary team (agronomy, veterinary health, food processing, microbiology, medicine, public/environmental health, chemistry, engineering), and a robust Quality Management System (e.g., ISO 9000). Originating in the late 1960s when Pillsbury, contracted by NASA, sought astronaut food safety, HACCP shifted from end-product testing to a preventative system, drawing inspiration from the engineering industry's Zero Defect Programme and the Army's Failure Mode and Effect Analysis (FMEA). Pillsbury's HACCP comprised hazard identification and risk assessment, critical control point (CCP) determination for hazard elimination, and CCP monitoring. A HACCP plan, a product- and process-specific written document based on seven principles, requires six preliminary tasks: assembling a multidisciplinary HACCP team; describing the product (composition, structure, processing, packaging, distribution); identifying intended use and high-risk consumer groups; constructing and verifying an on-site flow diagram; and evaluating prerequisite programs (GMPs). The seven HACCP principles are: conducting a hazard analysis (hazard identification and evaluation); identifying CCPs; establishing critical limits (maximum and minimum values for biological, chemical, or physical parameters); establishing CCP monitoring procedures (tracking system operation, detecting deviations, providing documentation); establishing corrective actions for deviations; establishing verification procedures to ensure system effectiveness; and establishing documentation procedures for all aspects of the HACCP system. Each principle details specific procedures and considerations, including the use of decision trees for CCP identification, the importance of continuous monitoring (preferably physical and chemical, rather than microbiological due to time constraints), corrective action plans for deviations, comprehensive annual verification by an independent expert and plant manager, and detailed record-keeping requirements encompassing the entire HACCP plan and its operational data.

The HACCP system, according to the Codex
Alimentarius Commission (CAC, 1993) is a science-
based and systematic approach to the identification
of both specific hazards in manufacturing processes
and measures for their control. In particular, it is a
tool to assess hazards and establish control systems
that focus on prevention of problems rather than
relying on end-product testing to ensure that a
problem has not arisen.
• HACCP can be applied throughout the food chain
from primary production to final consumption, and
its implementation should be guided by scientific
evidence of risks to human health. As well as
enhancing food safety, HACCP can provide other
significant benefits, e.g. aiding inspection by
Regulatory Authorities and promoting international
trade by increasing the confidence of buyers.
• The successful application of HACCP requires the
full commitment and involvement of management
and work force. It also requires a multi-disciplinary
approach that may include expertise in agronomy,
veterinary health, food processing and
microbiology, medicine, aspects of public and
environmental health, chemistry and engineering,
according to the particular study. Furthermore,
there must be a Quality Management System in
place to ensure that the HACCP system is
maintained 100% of the time. This latter aspect can
be assured by the use of the ISO 9000 series
approach to meeting the control points (Surak and
Simpson, 1994), but the demands of ISO 9000 will
not be considered during the current project.
History of HACCP
• The Pillsbury Company developed HACCP in the late
1960’s when the National Aeronautic and Space
Administration (NASA) contracted the company to
develop a totally safe food to be consumed by
astronauts in space.
• Up until that time, most food safety and quality
systems were based on end-product testing, but it was
realized that this could only fully assure safe products
through testing 100% of the product - a method which
obviously could not have worked as all the product
would have been used. Instead, it became clear that a
preventive system was required which would give a
high level of food safety assurance.
• The Pillsbury Company worked alongside the
engineering industry and looked at its Zero Defect
Programme - in which products are made free of
defects, and also with the Army Research
Laboratories in Natick, Massachusetts to investigate
a concept called Failure, Mode and Effect Analysis
(FMEA), which evaluates those parts of a system
that could fail and applies controls to prevent these
failures.
• Based on the combination of these two
programmes, Pillsbury developed a systematic
approach to assure, with a high degree of
confidence, the safety of food eaten by the U.S.A.
astronauts. Their approach covered the entire
production process from raw material sourcing
through processing and packaging to final use, and
it illustrates the fact that food safety control must
encompass the entire food chain. In practice, this
was achieved by identifying all points in the process
that were critical to the food safety of the product,
and then implementing appropriate controls. This
new approach emphasized the concept of
prevention, and from it the HACCP system was
born.
• The HACCP system developed by Pillsbury consisted
of three major components:
-Identification of hazards and assessment of the
risks associated with the production of a food
product.
-Determination of the critical control points (CCPs)
for eliminating the identified hazard from the end
product.
-Establishment of a system for monitoring the
critical control points.
Application of HACCP
A HACCP plan is a written document based on the
seven principles of HACCP, and is product and
process specific; generic HACCP plans can be used
as an initial guide. Six preliminary tasks need to be
accomplished before a HACCP plan can be
developed and implemented:

1. Assemble a HACCP Team
   The team should represent various disciplines
   appropriate to the product and process and provide
   the technical expertise necessary to develop a
   comprehensive, effective HACCP system. This team
   will have the responsibility for planning,
   implementation and verification of the HACCP Plan.


2. Describe Products
   The team should describe the product, including
   relevant information as composition (food ingredients),
   physical/chemical structure (including Aw and pH),
   processing methods, microbiocidal/static treatments
   (heat-treatment, freezing, brining, smoking), packaging
   and the state in which the food is distributed
   (refrigerated, frozen, shelf-stable).


3. Identify Intended Use
   Consumers of the product should be identified, so that
   any high-risk groups, such as infants, geriatrics and
   nursing home or hospital patients can be noted.


4. Construct Flow Diagram
   The HACCP team should develop a flow diagram
   covering all steps in the operation, and that describes
   the process in a simple block diagram which shows the
   flow of the process.


5. On-Site Confirmation of Flow Diagram
   The HACCP team must verify that all the steps in the
   flow diagram are accurate and listed appropriately.


6. Evaluate Prerequisite Programmes
   Determine that all prerequisite programmes,
   including all GMPs, are functioning properly and are
   adequately maintained and evaluated. Once all of
   these six steps have been completed, the seven
   HACCP principles can be applied as follows:
   The HACCP system consists of the following seven
   principles:

• Conduct a hazard analysis


• Determine the Critical Control Points (CCPs)


• Establish Critical Limits


• Establish CCP monitoring procedures


• Establish the corrective actions to be taken when
  
  monitoring indicates that particular CCP is not
  under control.


• Establish procedures for verification to confirm that
  the HACCP system is working effectively.


• Establish documentation concerning all procedures
  and records appropriate to these principles and
  their application.
  HACCP Principles
  Principle 1: Conduct a Hazard Analysis
  The process of conducting a hazard analysis involves
  two stages: Hazard Identification and Hazard
  Evaluation.

1. Hazard Identification
   The HACCP team reviews all steps of product
   processing, from raw ingredients to consumer use.
   Based on this review, the team develops a list of
   potential biological, chemical, and physical hazards,
   which may be introduced, increased, or controlled
   at each step in the production process.


2. Hazard Evaluation
   The HACCP team then decides which potential
   hazard must be addressed in the HACCP Plan. This
   evaluation is based on the severity of the potential
   hazard and its likely occurrence. The HACCP team
   then considers what control measures could or
   should be applied with respect to each hazard.
   More than one control measure may be required to
   control a specific hazard(s), and more than one
   hazard may be controlled by a specified control
   measure.
   Principle 2: Identify the Critical Control Points
   (CCPs) in the Process:
   A CCP is defined as a step at which control can be
   applied and essential to prevent, or eliminate, a
   food safety hazard or reduce it to an acceptable
   level. The potential hazards that are reasonably
   likely to cause illness or injury in the absence of
   their control must be addressed in determining
   CCPs. To assist in identifying CCPs, decision trees
   (see Figure 2.1) are included in the NACMCF
   document (NACMCF, 1998) and that of the CAC
   (1997).
   To assist in identifying CCPs, decision trees (see
   Figure) are included in the NACMCF document.
   Although application of a CCP decision tree can be
   useful in determining if a particular step is a CCP for
   a previously identified hazard, it is not a mandatory
   element of HACCP. Furthermore, the decision tree
   is not a substitute for expert knowledge.

Principle 3: Establish Critical Limits for Prevention
Associated with each Identified CCP:
• Critical limits are defined as the maximum and minimum
values between 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. These limits are used to distinguish between
safe and unsafe operating conditions at a CCP; critical limits
should not be confused with operational limits that are used
for reasons other than food safety.
• Critical limits should be scientifically based and may include
parameters such as temperature, time, physical dimensions,
humidity, moisture level, water activity, pH, titratable acidity,
salt concentration, available chlorine, viscosity, preservatives
and sensory information such as aroma and visual
appearance. These may be derived from sources such as
regulatory standards and guidelines, literature surveys,
experimental results, and experts (NACMCF, 1998).
Principle 4: Establish Monitoring Procedures
• This principle involves establishing procedures for using
the results of monitoring to adjust the process and
maintain control. Monitoring is a planned sequence of
observations or measurements at each CCP in order to
assess whether the process is under control, and
produce an accurate record for future use in
verification. Monitoring serves three purposes:
-It tracks the system’s operation and, if there is an
indication that there is a trend toward loss of control,
then action can be taken to bring the process back into
control before a deviation from a critical limit occurs.
-It determines when there is a loss of control and a
deviation at a CCP, i.e., exceeding or not meeting a
critical limit.
-It provides written documentation for use in
verification of the HACCP Plan.
• Ideally, monitoring procedures should be
continuous, and monitoring and equipment should
be carefully calibrated for accuracy. For example,
the temperature and time control for the scheduled
thermal process of low acid canned foods is
recorded continuously on temperature recording
charts (NACMCF, 1998).
• Microbiological testing is seldom effective for
monitoring CCPs due to their time-consuming
nature; therefore, physical and chemical
measurements are preferred because they may be
done rapidly and can indicate that microbiological
control of the process is appropriate (FAO, 1997).
• However, now-a-days, CCPs can be monitored
electronically, and the development of polymerize
chain reaction technology may provide real time
monitoring for specific micro-organisms in a
process. Random checks, which may consist of
physical and chemical testing and, as appropriate,
microbiological testing, may be useful for
supplementing the monitoring of certain CCPs. They
may be used to check pre-certified ingredients and
to assess equipment and environmental sanitation,
air-borne contamination, cleaning and sanitising of
gloves, and any place where follow up is needed,
e.g. with microbiologically sensitive ingredients
(Mortimore and Wallace, 1998).
• However, to detect low levels of pathogens, a large
number of samples are needed, and this is seldom
possible. For this reason, microbiological testing has
limitations in a HACCP system, but it is valuable as a
means of establishing and randomly verifying the
effectiveness of control at CCP’s (challenge tests,
random testing or for trouble shooting) (FAO, 1997).
• Personnel who monitor CCPs must be trained in the
monitoring technique for which they are responsible,
must fully understand its purpose and importance, and
must accurately report the results of monitoring.
Training should include the procedures to be followed
when there is a trend toward loss of control so that
adjustments can be made in a timely manner to assure
that the process remains under control. Finally, all
records and documents associated with CCP
monitoring must be signed or initiated by the person
doing the monitoring (Mortimore and Wallace, 1998).
Principle 5: Establish corrective action to be taken
when monitoring indicates there is a deviation from
an established critical limit
• The purpose of corrective action is to prevent food
which may be hazardous from reaching consumers.
When there is deviation from established critical limits,
corrective actions are necessary and should include the
following elements:
-Determine and correct the cause of non-compliance to
assure that the CCP returns to normal.
-Determine the disposition of the non-compliant
product.
-Maintain records of the corrective action that have
been taken..
• Specific corrective action plans must be in place for
each CCP, and these actions must demonstrate that
the CCP has been brought under control. The
identification of the deviant lots and of the
corrective actions taken must be noted in the
HACCP record and remain on file for a reasonable
period after the expiration date or expected shelf
life of the product ( NACMCF, 1998).
Principle 6: Establish Procedures for Verification
that the HACCP System is working correctly
• Verification is defined as those activities, other than
monitoring, that determine the validity of the plan and
that the system is operating according to the plan. An
effective HACCP system requires little end-product
testing, since safeguards are built in early in the
process. Thus, firms should rely on frequent review of
their HACCP plan, verification that the HACCP plan is
being correctly followed, and review of CCP monitoring
and corrective action records. The HACCP Coordinator
should verify the HACCP Plan once a year or after any
changes are made in the plan. The yearly
comprehensive HACCP System verification should
involve an independent expert and a review by the
Plant Manager.
• This review should include a technical evaluation of
the hazard analysis and each element of the HACCP
Plan as well as on-site review of all flow diagrams
and appropriate records from the operation of the
plan. This comprehensive verification is
independent of other verification procedures and
must be performed to ensure that the HACCP plan
is effectively controlling the hazards. If this
comprehensive verification identifies deficiencies,
the team must modify the HACCP Plan as necessary
(NACMCF, 1998).
Principle 7: Establish Effective Record Keeping Procedures that
Document the HACCP System:
It is important that the entire HACCP plan be well documented and
records be kept on file in the food establishment. Well-organized
records provide evidence that food safety is being accomplished
according to the HACCP principles. Records should include the
following:
• The HACCP Plan, including the HACCP team responsibilities,
description of the food, its distribution, intended use and consumers;
verified flow diagram, HACCP plan summary table that includes
information for the steps in the process that are CCPs, as well as the
hazards of concern, critical limits, monitoring data, corrective actions,
verification procedures and schedule and record keeping procedures.
• Records generated during the operation of the plan, such as
(NACMCF, 1998):
(a) ingredients for which critical limits have been established,
(b) processing, storage, and distribution records,
(c) deviation and corrective actions records, and
(d) employee training records.