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7 Principles of HACCP
HAZARD ???
A biological, chemical, or physical agent in food
with the potential to cause an adverse health
effect (Codex, 1997).
Hazard:
• Microbiological
• Chemical
• Physical
Food-borne disease (FBD):
penyakit menular atau keracunan yang
oleh mikroba atau agen yang masuk ke
dalam tubuh melalui makanan yang di
konsumsi (WHO).
Principle 1: 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 should
be addressed in the HACCP plan.
Information needed for hazard
analysis
 the agents that could be present in the
food under study
 the severity of the effects and the
likelihood of their occurrence
 the levels that could cause adverse health
effects
 the conditions that could lead to
unacceptable levels
Microbial Hazards

Dangerous microorganisms that cause
food-borne disease (FBD):
– Bacteria
– Moulds
– Viruses
– Parasites
Patogenic microorganisms are the MAJOR
SOURCES of food contamination!!!
Major bacteria causing FBD
•
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•
•
•
•
Aeromonas spp
Bacillus cereus
Brucella spp.
Camphylobacter jejuni
Clostridium botulinum
Clostridium perfringens
Escherichia coli
Listeria monocytogenes
•
•
•
•
•
•
•
•
Mycobacterium bovis
Salmonella spp.
Shigella spp.
Staphylococcus aureus
Vibrio cholerae
Vibrio parahaemolyticus
Vibrio vulcanificus
Yersinia enterolitica
Some toxigenic moulds causing FBD
 Aspergillus spp
 Fusarium spp.
 Penicilium spp
Producing mycotoxins, such as aflatoxin,
ochratoxin, etc.
Main sources: fruits, nuts and grains
Mycotoxins
Major viruses causing FBD
Hepatitis A and E viruses
 Small round structured viruses (e.g.
Norwalk)
 Rotavirus
 Polio virus

Major parasites causing FBD
Anisakis
Ascaris
Clonorchis sinensis
Cryptosporodium
Cyclospora
catetanensis
• Diphyllobothorium
• Echinococcus
• Entamoeba histolytica
•
•
•
•
•
•
•
•
•
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Fasciola hepatica
Giardia
Opisthorcis felineus
Opisthorcis viverrini
Sarcosporodium
Taenia
Toxoplasma
Trichinella
Bacterial growth curve
Food-Borne Disease Bacteria
• Infection
• Invasion of bacteria and theirs multiplication
within the body.
• E.g.: Salmonella, Campylobacter, E. coli,
V. parahaemolyticus, V. cholerae,
Y. enterolitica, L monocytogenes
• Intoxication
• Caused by consuming toxin produced in food.
• E.g.: Bacillus cereus, C. botulinum, S. aureus,
E. coli
Example:
1. Salmonella
• Causing Salmonellosis
• Main symptoms: diarrhea, fever, vomiting,
abdominal cramps.
• Persons at high risk: young, old, pregnant
woman, underlying disease states.
• Incubation period: 12 – 36 h
• Sources: meat, poultry, milk, eggs, vegetables,
shellfish, spices and herbs, untreated water.
• Salmonella is heat sensitive
• Pasteurization (70oC for 2 min) is sufficient to kill
Salmonella in high moisture foods.
2. Camphylobacter
• Causing camphylobacteriosis
• Symptoms: fever, nausea, diarrhea,
abdominal cramp
• Person at high risks: babies, debilitated
people
• Incubation: 2-5 days
• Heat sensitive
• Major sources: frozen foods (meats and
poultry).
Minimum infective dose
L. monocytogenes
Salmonella
High (100/g of
food)
106
Salmonella typhi
10 – 100
Camphylobacter
About 500
(excluding S. typhi)
Minimum toxic doses of bacterial
toxins
• S. aureus
: 106 (cells/g)
• C. botulinum : 104 - 105
• B. cereus
: 107 – 108
Temperature range for the growth of
patogenic bacteria
Temperature range for the growth of
toxigenic moulds
Prevention of FBD
Chemical Hazards
•
•
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Pesticides: PCBs, organochlorin
Dioxins
Heavy metals: Cd, Hg, Pb
Metals: Al, Se, etc.
Food additives
Natural contaminants
Desinfectants
Mycotoxins
Etc.
Hazard Determination
Is the presence of agent
in raw material probable?
YES
NO
Is the presence of agent in
line or environment probable?
No Hazard
Is an unacceptable survival,
persistence or increase at
this step probable?
YES
NO
Is reduction, if any at a
further step adequate?
NO
YES
Is an unacceptable
contamination at this step
probable?
No Hazard
YES
YES
NO
NO
HAZARD
Menentukan signifikansi bahaya

Tingkat keseriusan bahaya (severity):
– Severity dapat ditetapkan dengan melihat
seberapa jauh dampaknya terhadap
kesehatan konsumen dan dampak terhadap
pencitraan industri.
– Frekuensi terjadinya bahaya:
 Risiko tinggi: cenderung terjadi
 Risiko sedang: dapat terjadi
 Risiko rendah: cenderung tidak terjadi
Menentukan signifikansi
bahaya
Matrix Risk
(UNEP, 2002)
Matriks Risiko Boevee (Hermawan, 2005)
Risk ranking scheme based upon severity of risk (S)
and probability of hazard (P)
Probability of occurrence (P)
Severity of
hazard (S)
Unlikely
Occasionally
Probable
Common
(1)
(2)
(3)
(4)
Very High
(4)
5
6
7
8
High (3)
4
5
6
7
Medium (2)
3
4
5
6
Low (1)
2
3
4
5
Mikroorganisme Patogen
Bahaya Tinggi
Clostridium botulinum
• Shigella dysenteriae
• Salmonella typhy
• Salmonella paratyphy
• Trichinella spiralis
• Vibrio cholerae
•
Bahaya Sedang Bahaya Rendah
Listeria monocytogenes
• Camphylobacter jejuni
• Salmonella spp.
• Shigella spp.
• Streptococcus pyrogenes
• Yersinia enterolytica
• Hepatitis A dan E
• Aeromonas spp.
• Rotavirus Norwalk
• Vibrio parahaemolyticus
•
Bacillus cereus
• Clostridium perfringens
• Staphylococcus aureus
• Taenia saginata
•
Sumber: Winarno & Suroto (2002)
Contoh Produk dengan Berbagai Tingkat
Risiko
Risiko Tinggi
• Daging
• Ikan mentah
• Produk-produk olahan
susu.
• Produk dengan nilai
pH
4.6 atau diatasnya
• Produk-produk yang
mengandung ikan,
daging, telur, sayur,
serealia.
Risiko Sedang
• Produk-produk kering
dan
produk beku (ikan,
daging,
telur, sayuran, serealia)
• Sandwich, pie daging
• Produk berbasis lemak
(margarine, coklat,
mayonaise, salad
dressing)
Risiko Rendah
• Produk dengan pH di
bawah 4.6 (asam)
• Produk dengan kadar
gula tinggi (selai, sirup,
dll)
• Produk – produk
konfeksioneri
• Minyak
Principle 2: determine the CCPs

CCP:
a step at which control can be applied and
the step is essential to prevent and
eliminate a food safety hazard or reduce it
to an acceptable level (Codex 1997).

CCPs relate to control of significant food
safety hazards only.
2. Determination of CCPs
Critical control point decision tree
 Questions to be asked for each raw material used
Q1. Is it likely that the raw material contains the hazard under
study at unacceptable levels?
YES
NO
Not CCP
Q2. Will processing, including expected consumer use,
eliminate the hazard or reduce it to an acceptable level?
CCP for the raw
materials for this
hazard
NO
YES
Not CCP
Questions
to be
asked for
each
process
stage
(SNI, 1998)
Control Measure

Any factor or activity which can be used to
prevent, eliminate, or reduce food safety
hazards to an acceptable level.

Control measures are specific for each
hazard and can be either process or
activities.
Control Measures
Biological Hazards
Control Measures
Vegetative pathogens:
-
Heat stable pre-formed
toxins: S.aureus, B. cereus
-
Salmonella, Listeria
monocytogenes, E.coli.
Lethal heat treatment
during packaging
- Temperature control
- Intrinsic factors: pH, aw
- Intact packaging
- Secure building, etc.
effective supplier process
and testing
- hand wash procedures
- control of time
Control Measures
Chemical Hazards
Cleaning chemicals
Chemical additives
Control Measures
Use of non-toxic, food
compatible cleaning
compounds
- separate storage
- covered containers
-
-Safe
operating practices
- written additive instructions
- validation of levels through
usage rates, sampling and
testing
Control Measures
Physical Hazards
Control Measures
Glass, wood, metal, etc in
raw materials.
-
inspection – electronic or
human
- Washing
- Air separation
- X-ray detection
- Metal detector, etc.
Physical process crosscontaminants: pests
-
Pest control
- Extermination (electric pest
killers, poisoning, bait boxes,
etc).
Critical Limit(s)
CL are the criteria that differentiate between ‘safe’
and ‘unsafe’  safety boundaries.
 Codex (1997): “a criterion which separates
acceptability from unacceptability.”

Defined by regulations, safety standards and
scientifically proven values.
 Operational limits are often set a more stringent
levels to provide a buffer or action zone for process
management.

Critical Limit(s)

Critical limits can be:

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
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Values of pH, aw, temperature, time
Absorbed radiation dose
Levels of disinfectant or antimicrobial agents
Level of cleanliness
Limits of residues
Limits of contaminants
Limits of microbiological criteria
Sensory parameters: visual appearance and
texture
Critical Limit(s)

Buffer or action zone, for example:
If in a heat process the critical limit is 72oC for
2 minutes, the operating limit of 75oC for 10
min may be set.
Critical Limit(s)
CL harus spesifik dan jelas baik batas maksimum
maupun minimum.
 Harus berkaitan dengan tindakan pengendalian
(monitoring) dan mudah dipantau.
 Perusahaan harus memastikan bahwa CL dapat
diaplikasikan pada operasi atau produk secara
spesifik.
 CL harus terukur dan dapat divalidasi.

When is deviation from normality
unacceptable?
( i.e. establishment of Critical Limits )
Monitoring
 Observation or measurement required to
ensure that the process is under control
operating within the defined critical limit 
ensuring that control measures are working.
 Codex (1997) defined monitoring as “ the act
of conducting a planned sequence of
observations or measurements of control
parameters to assess whether a CCP is under
control”.
Monitoring
 Monitoring of the CCPs is carried through tests or
observations
 The frequency and responsibility for monitoring will
be appropriate to the control measure.
 The frequency of monitoring will depend on the
nature of the CCP and must be determined as part of
the control system.
 All personnel responsible for monitoring must be
trained and have a clear understanding of their role.
Monitoring

Equipment and methods:
 Physical parameters: temperature, time,
moisture levels, metal detection, X-ray
detection, inspecting sifters, and sieves.
 Chemical test: chlorine analysis, pH, aw,
pesticide residue analysis, allergen residue
testing, heavy metals analysis.
 Sensory test: visual appearance, texture.
Monitoring

The equipment used for monitoring must
be:
 Accurate: needs to be calibrated.
 Easy to use
 Accessible: having the equipment close to
the point of testing and must be quick in
terms of providing results.
Monitoring

People assigned monitoring duties should
be:





Familiar with the process
Trained in the monitoring techniques
Trained in HACCP awareness
Unbiased in monitoring and reporting
Trained in the corrective action procedures:
what to do when monitoring indicates loss of
control
Corrective Actions
– The action should be taken when the result shows a
deviation from the critical limit
– Adjust the process to bring it back under control
– Deal with the material produced under the deviation
period
 Hold on the product
 Rework
 Release product after sampling and testing
 Direct into less sensitive products, e.g. animal feed
– Clarify to all personnel involve (what to do and how
to do it)
Verification
The application of methods, procedures,
tests, and other evaluations, in addition to
monitoring, to determine conformity with
the HACCP plan.
 Verification is on going activities

(Codex, 1997)
Verification

Review of HACCP system and records
– Review of unacceptable deviations and their
follow up
– Confirmation that CCPs are controlled
Review of consumer complaints
 End-product testing
 Review of validation data

Verification
Whenever a change from the existing situation is
made a new Hazard Analysis needs to be carried
out, the outcome verified and the effectiveness
of changes in the HACCP plan, if any, validated.
 Monitoring records, deviation files, raw material
&end-product test results, customer complaints
etc. need to be reviewed regularly.
 Records should be kept of all activities
