HAZARD
A review
Definition
Hazard is defined as or a biological, chemical or
physical agent in, or condition of , food with potential
to cause adverse health
Or
A biological, chemical or physical agent that is
reasonably to cause illness or injury in the absence
of control
Categories of Hazards: Biological Hazards,
Chemical hazards and Physical hazards.
Assemble HACCP Team
CATEGORIES OF HAZARDS
Biological Hazards
Chemical Hazards.
Physical Hazards
Origin of Hazards:
From naturally occurring substances (afflatoxin, allergans)
From Deterioration or Decomposition of foods
Contamination of foods with hazards at various stages of their
production., harvesting , storing at processing, Distribution;
preparation and utilisation.
Biological Hazards and Chemical
hazards
Bacteria(gram negative pathogenic bacteria (eg : C. Botulinum, C. Perifringes, Bacillus cereus. Non
spore forming :Salmonella, Shigella Staph.aureus, V. Cholerae, V. Parahemolyticus etc )
Parasites : (eg Trichinella spralis)
Viruses (eg: Hepatits. Norwalk virus Rotavirus)
Fungus or mould (eg:Aspaergillus flavus)
Chemical Hazards:
Chemical hazards are grouped in to three categories
1 Unintentional or incidental chemical contaminants (eg Sanitizers)
2 Naturally occurring chemicals(eg: Aflatoxin,allergans,mushroom toxins,PSP,DSP. ASP and
Ciguatoxin)
3 Intentionally added chemicals (eg Sodiumnitrite, Sodium polyphosphate,antibiotics, pesticides,
growth hormones food additives)
Naturally occurring chemicals
Allergens (eg:egg, milk,nuts , sea foods etc)
Mold Toxins(eg:Aflatoxin)
Toxic compounds(eg: Mushroom, algae)
Intenionally added chemicals
a Direct additives –Preservatives (eg; sodium benzoate and sulfting agents
Nutritional Additives, Calcium, Vitamins, colour additives
b Indirect
Packing materials
Processing plant chemicals like lubricants and sanitizers
Physical Hazards
Glass : Bottles, jars, light fixtures, thermometers, gauge covers
Plastic :Bottle jars packaging equipment and packaging materials
Metal :Machinery, wire staples, building materials, employees personal effects
like jewellery, pen,pencil etc,
Definition of terms
Hazard plan: A document prepared in accordance with the principles of HACCP to
ensure control of hazards which are significant for food safety in the segment of
food chain under consideration is termed as Hazard plan
Hazard Analysis : The process of collecting and evaluating information on hazards
and condition leading to these pressure to decide which are significant for food
safety and therefore should be added in the HACCP plan.
Sanitaion : is the removal of soil, food residue , dirt ,grease or other objectionable
matter.
Food Hygiene : All conditions and measures necessary to ensure the safety and
suitability of foods and all stages of food chain is termed as FOOD HYGIENE
Food Chain-Primary production to Consumer
Control -To take all necessary actions to ensure and made compliance with criteria as
labeled in the HACCP plan.
Corrective Action: Any action to be taken with the results monitoring at the CCP
indicate loss of control.
Definition
Deviation: Failure to meet a critical limit
Verification: The application methods, procedures , tests and other
evaluation, in addition to monitoring to determine compliance
with the HACCP plan activities include
HACCP plan validation, HACCP system audit
Equipment Calibration, Targeted sample collection and testing
Microbiological end product testing
Regulatory inspection/audit
Verification
Validation: Obtaining the evidence that the elements HACCP plan
are effective,
Codex General principles of Food hygiene
Principles of food hygiene- 8 hygiene principles
Primary production
Design and Facilities
Control of operation
Maintenance and Sanitation
Personal Hygiene
Transportation
Product information and consumer awareness
Training of Personnel
Objectives of GHP
Identify the essential principles of food hygiene applicable
through out the food chain
Recommend a HACCP-based approach as a means to
enhance food safety
Indicate how to implement those principles.
Scope and Use of GHP
Protect consumers adequately from illness or injury
caused by food ; policies need to consider the
vulnerability of different groups with in the population.
Provide assurance that food is suitable for human
consumption
Maintain confidence in internationally traded food.
Provide health education programme which effectively
communicate the principles of food hygiene on
industry and consumers
Food safety objectives Established
At relevant functions and levels
They be consistent with policy
They be smart.
Primary production
1.1 Environmental Hygiene
1.2 Hygiene production of Food source
1.3Handling Storage and transport.
1.4 Cleaning ,maintenance and personnel hygiene
2 Establishment, Design& Facilities
2.1 Location and Establishment
2.2 Premises and Rooms
2.2.1 Design and layout
2.2.2 Internal structures and fittings
2.2.3 Temporary / mobile premises and vending machines
2.3 Equipment
2.3.1 Equipment and containers coming in to contact with food
2.3.2 Food control and monitoring equipment
2.3.3 Containers for waste and inedible substances.
2.4 Facilities
2.4.1 Water supply
2.4.2 Drainage and waste disposal
2.4.3 Cleaning
2.4.4 Personnel hygiene facilities and toilets
2.4.5 Temperature control
2.4.6 Air quality and ventilation
2.4.7 Lighting
2.4.8 Storage
2.4 Facilities
2.4.1 Water supply
2.4.2 Drainage and waste disposal
2.4.3 Cleaning
2.4.4 Personnel hygiene facilities and toilets
2.4.5 Temperaturecontrol
2.4.6 Air quality and ventilation
2,4.7 Lighting
2.48 Storage.
3 Control of operations
3.1 Control of food hazards
3.2 Key aspects of hygiene and control systems
3.2.1 Time and temperature control.
3.2.2 Specific process steps
3.2.3 Microbiological and other specifications
3.2.4 Microbiological cross contamination
3.2.5 Physical and chemical contamination
3.2.6 Incoming material requirements
3.2.7 Incoming material requirements
3.2.8 water.
3.2.9 Water
3.2.9.1In contact with food
3.2.9.2 As an ingredient
3.2.9.3
Ice and steam
3.3 Management and Supervision
3.4 Documentation and Records
3.5 Recall procerdures.
4 Establishment , Maintenace & Sanitation
4.1 Maintenance and cleaning
4.1.2 Cleaning procedures and methods
4,2 Cleaning Programmes
4.3 Pest Control Systems
4.3.1 Preventing access
4.3.2 Harborage and infestation
4.3.3 Monitoring and detection
4.3.4 Eradication
4.4 Waste Management
4.5 Monitoring Effectiveness
5 Establishments :Personal Hygiene
5.1 Health status
5.2 Illness and Injury
5:3 Personal cleanness
5:4 Personal behaviour
5:Visitors
Transportation
6:1 Requirements
6:2 Use and Maintenance
7 Product Information and Consumer awareness
7:1 Lot identification
7:2 Product Information
7:3 Labelling
7:4 Consumer Education
8 Training
8:1 Awareness and Responsibilities
8:2 Training Programme
Inhibitory chemicals present
Many naturally occurring antimicrobial compounds in foods have
fungistatic activity , but they are rarely present in amounts sufficient to
prevent growth of moulds
Environmental conditions: The majority of fungi associated with foods
are mesophilic, psychrotrophicor psychrophilic.
Hazard Assessment
Severity of hazard
Risks associated with hazards identified at
various stages of the operation.
The points, steps or procedures at which
control can be applied and foods safety
hazard can be prevented, eliminated or
reduced to an acceptable level ie. critical
control point.
Severity
Severity if the magnitude of a hazard or the degree
of consequences that can result when a hazard exit.
Disease causing hazards can be categorised
according to their severity.
High (life threatening) examples include illness
caused by Clostridium botulinum, Salmonella typhi,
Listeria monocytogenes, E.coli 0157: H 7, Vibrio
cholerae, Paralytic shellfish poisoning .
Severity.
Moderate (severe or chronic) examples include
illness caused by Brucella spp, Camylobacter spp,
Salmonella spp, Shigella spp, Streptococcos type A,
Hepatitis A virus, mycotoxins.
Low (moderate or mild)-examples include illness
caused by Bacillus spp.Clostridium perifringens,
Staphylococcus aureus, most parasites, histamine-
like substances and most heavy metals that caused
mild acute illness.
Risk of Hazard
Risk is a function of the probability of an
adverse effect and magnitude of that effect,
consequential of a hazard in food.
Degrees of risk can be categorise as High
(H), Moderate (M) and negligible (N)
Determine Critical Control Point
The codex guidelines define a critical control point
(CCP) as
“A step at which the step can be applied and is
essential to prevent or eliminate a food safety
hazard or reduce it to an acceptable level”.
The determination of a CCP in the HACCP system
can be facilitated by the application of a Decision
tree which indicates a logical reasoning approach.
Critical Control point
Question 1: Do Control measures exist?
Control measures could include , for example ,
temperature control, visual examination or use of a
metal detector.
If the response is “yes”, proceed to the question 2 in
the decision tree.
If the response is “no”, indicate how the identified
hazard will be controlled before and after the
manufacturing process, for example: Salmonella in
raw poultry is controlled by the end user.
Critical Control Point
Q2 Is the step specifically designed to eliminate or reduce the likely
occurrence of the identified hazard to an acceptable level?
Eg : The retorting operation in a canning plant
Pasteurisation, Metal detector to a process line.
A particular sanitation procedure performed by the operator to clean
contact surface with out which the line would be stopped and the
product would be contaminated to be defined with in the over all
objectives in identifying the CCPs of the HACCP plan.
Acceptable and unacceptable level need to be defined with in the over
all objectives in identifying the CCPs of the HACCP plan
Critical Control Point
If the answer is Yes the step automatically
becomes a CCP.
If the answer is No proceed to the next
question.
Critical Control Point
Q3: Could contamination with the idetified hazards occur in
excess of acceptable levels or increased to unacceptable level.
This question refers to both probability seriousness.
If the answer is “Yes” proceed to the next question in the
decision tree.
If the contamination is known to represent the a substantial
threat to human health or is not likely to occur, answer “no”
(not a CCP) and proceed to the next identified hazard in the
process
Critical Control Point
Q4:Will a subsequent step eliminate the identified hazard or
reduce likely occurrence to an acceptable level.?
This question is designed to identify those hazards that are
known to represent a human health threat or that could
increase to an unacceptable level, and that will be controlled by
a subsequent process operation.
If no subsequent operation in the process answer “no” and this
becomes a CCP.
If there is sub the sequent operation that will eliminate the
identified hazard or reduce it to an acceptable level, answer
“yes” this step not a CCP.
Questions
Qn no: 1 Do not control preventive measure (s) exist at this step?
Qn no1A: Is control at this step is necessary for safety?
Qn no 2: Is the step specifically designed to eliminate or reduce the
likely occurrence of a hazard to an acceptable level?
Qn no 3:Could contamination with identified hazard occur in excess
of acceptable level(s) or could these increase to acceptable levels ?
Qn no 4:Will subsequent step eliminate identified hazard (s) or
reduce likely occurrence to an acceptable level
Determination of CCp& OPRP
Sl no Process Idenified Q1no 1A Q.2 Q3 Q4 CCP/OPRP
step hazard
1 Reception of Biological N N - - - N
raw milk
2 R milk Biological N N - - - -
storage
3 Pasteurisatio Biological Y - Y - - CCP-01
n
4 Cold storage Biological Y - N Y N OPRP-1)
of pouched
milk
5 Tanker filling Biological Y - N Y N OPRP-02
&despatch
Establish critical limits for each
CCP (step 8/Principle 3)
Critical limits are defined as criteria that separates acceptability from
unacceptability
Eg: of Critical limits are temperature/time/physical product dimension,
water activity, moisture level,pH, titrable acidity,salt content, available
chlorine, viscosity, preservatives, or sensory information such as
aroma, and visual appearances. Eg:Production of beef pattice ,ccp is
heating at 155F for 16 seconds., critical limits are Oven temperature,
time, rate of heating and cooling. (belt speed in feet/inch. Patty
thickness, patty composition, oven humidity) second example
Pasturisation of milk at 72oC for 15 seconds, etc,
These parameters ,if maintained with in boundaries, will confirm the
safety of the product.
Sources of limits information on critical limits
Scientific publications/research data
Regulatory requirements and guidelines.
Experts (thermal process authorties, consultants,
food scientists, microbiologists, equipment
manufactures, sanitarians and academics
Experimental studies (eg. In house experiments,
contract laboratories studies.
Examples of Criteria limits
Hazard CCP Critical limits
Bacterial pathogens (non- Pasteurisation 72 oC
spoulating)
Metal fragments Metal detector Metal fragments larger than
0.5mm
Bacterial pathogen Drying oven Aw- 0.85for controlling growth
in dried food products
Excessive nirtite Curing room,brining Max. 200ppm sodium nitrite
in finished product
Bacterial pathogens acidification step Max. pH of 4.6 to control
Clostridium botulinum in
acidified food.
Food allergens Labelling Label that is legible and
contains a listing correct
ingredients.
Histamine receiving Max. of 25 ppm histamine
levels in evaluation of tuna
Critical limits Vs Operating limits
process Critical limits operating limits
Acidification pH 4.6 pH 4.3
Drying 0.84 0.80 Aw
Hot fill 80oC 85oC
Slicing 2 cm 2.5 cm
* The point at which action to prevent loss of control of the CCP taken is
called operating limits.
Establish monitoring system for
each critical control point (step 9)
Codex HACCP system for each its
application defines monitoring as .
“The act of conducting a planned sequence
of observations or measurements of control
parameters to assess whether a CCP is
under control .
Purpose
To measure the performance level of the system’s
operation at the CCP ( trend analysis).
To determine when the performance level of the
system results in a loss of control at the CCP
eg:when there is a deviation from the critical limit.
To establish record that reflects performance level
of the system’s operation at the CCP to comply with
the HACCP plan.
Designing a monitoring system.
What will be monitored?
How critical limits and preventive measures will be monitored?
Frequency of monitoring.
Who will monitor?
What will be monitored : Measurement of time & temperature of a
thermal processing
Measurement of cold storage temperature
Measurement of pH, Aw.
Visual examination of sealed cans.
Verification of vendor’s certificate of analysis
Who will Control Limits and Preventive measured
be monitored
Effective monitoring depends up on proper selection
and calibration of measuring equipment eg:
Thermometers.
Clocks.
Scales.
pH Meters, Water activity meters, Analytical
equipment.
Who will monitor
Linepersonnel
Equipment operators
Supervisors
Maintenance personnel
Quality assurance personnel
Establish Corrective action Step- 10 principle 5
Codex defines Corrective action as “Failure
to meet a Critical limit”
Root Cause analysis.
Corrective action procedures are necessary
to determine the cause of the problem, take
action to prevent recurrence and follow up
with monitoring and reassessment to
ensure that the action taken is effective.
Corrective action programme should include the
following
Investigation to determine the cause of the deviation
(non conformance)
Effective measures to prevent recurrence of the
deviation.
Verification of the effectiveness of corrective action
taken and record the corrective action that have
been taken place.
Step 11: Principle 6, Establish Verification
The Codex guidelines define verification as:
The application of methods, procedures, tests and other
evaluations, in addition to monitoring to determine compliance
with HACCP plan.
Validation another important aspect of verification is the initial
validation of the HACCP plan to determine that the plan is
scientifically and technically sound, that all hazards have been
identified and that if the HACCP plan is properly implemented
these hazards will be effectively controlled.
Verification
activities include:
HACCP plan validation.
HACCP system Audit.
Equipment calibration.
Targeted sample collection and testing.
Microbiological and product testing.
Regulatory inspection and audit
HACCP Plan Validation
Examples: Review of Hazard Analysis, CCP
determination.
Justification for critical limit, based for example . On
current food science and regulatory requirements.
Determination of whether monitoring activities ,
corrective actions. Record keeping procedures are
appropriate and adequate.
HACCP system audit
Audits are systematic and independent examinations involving
on site observations, interviews and review of records.
Calibration: Involves checking instruments or equipment
against a standard to ensures accuracy.
At a frequency sufficient to assure continuous accuracy.
According to procedures established in the HACCP plan.
By checking accuracy against a recognised standard.
Under condition similar or identical to those under which the
instrument or equipment will be used.
Targeted Sampling and Testing
Targeted Sampling and Testing involves taking
product samples periodically and testing them to
ensure that critical limit are appropriate for product
safety.
Targeted sampling may be carried to check vendor
compliance when receipt of material is a CCP and
purchase specification are relied on as critical
limits ,eg: sulphite levels less than 100 ppm in
cooked shrimp.
Verification frequency
Frequency may be decided when:
Online observation that CCPs may not be operating
with in critical limits.
Records reviews indicating in consistent monitoring.
Records reviews indicationg that CCps are
repetitively operated outside critical limits.
Consumer complaints or products rejections by
customers. New scientific data.
Records of Verification
Verification activities should be documented in the
HACCP plan which include:
Method,
Date,
Individual responsible,
Results and Findings and action taken.
Deviation Procedures and Root cause Analysis
Establish Documentation and Record Keeping Step
12/ Principle 7
Four types of records as part of the HACCP
programme.
Support documents
Records generated by the HACCP system.
Documentation of methods and procedures used.
Records employee training programme.
Support documents
Product description and intended use
Flow diagram
Hazard analysis
Identification of CCPs
Identification of critical limits for each CCPs
Documented deviation and corrective action plans
Planned verification activities and procedures.
Identification of the preventive measures for each
hazard.
Records Generated by the HACCP system
This include:
Monitoring records for all CCPS
Deviation and Corrective action records.
Verification/validation.
Documentation of methods and procedure used.
Description of the monitoring system for the critical limit of each
CCP, including: the methods and equipment used for
monitoring, the frequency of monitoring and the person
performing the monitorings..
Plans for corrective actions for critical limit violations or
situations resulting in potential hazards.
Description of record keeping procedures, including copies of
all record forms
Description of verification and validation procedures.
Records of employee training programme
Employees involved in in monitoring critical limits for
CCPS.
Those involved in with deviation review.
Those involved in corrective actions and verification.
Completion of HACCP records.
References
HACCP, Principles and Applicatio Guide lines, The National Advisory Committee on Microbiological
criteria for food (NACMCF) J. Food Production Adapted 1997
HACCP Principles and application guidelines The National Advisory Committee on Microbiological
criteria for food (NACMCF) J. Food Production Vol.61, No 9, 1998.
International HACCP Alliance.” International HACCP Alliance”PDF 12 th October 2007.
Quality Assurance in Sea food Processing (2001) Edited by
T.S Gopalakrishna Iyer, M.K Kandoran, Mary Thomas and P.T Mathew. Published by The Director,
Central Institute of Fisheries Technology, Cochin and The Secretary, Society of Fisheries
Technologist’s( India) , Cochin 682029.
Product Development and Seafood Safety,
Edited by Dr P.T Mathew et al. 2003.
published by The Director Central Institute of Fisheries Technology, Cochin. -682029
Bryan, F.L 1992 Hazard Analysis and Critical control Point Evaluation, A guide to identifying hazards and
assessing risks associated with food preparation and storage published by WHO p 72 :
Codex1991 Draft Principles and application of HACCP system. Alinorm 93/13 Appendix VI FAO, Rome.
Food Safety Management, 2014 A Practical guide for the Food Industry.
Edited by Yasmine Motarjemi and Huub Lelieveld
Published by Academic Press Elsevier Inc ,London.