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
• Aeromonas spp • Mycobacterium bovis
• Bacillus cereus • Salmonella spp.
• Brucella spp. • Shigella spp.
• Camphylobacter jejuni • Staphylococcus aureus
• Clostridium botulinum • Vibrio cholerae
• Clostridium perfringens • Vibrio parahaemolyticus
• Escherichia coli • Vibrio vulcanificus
• Listeria monocytogenes • 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 • Fasciola hepatica
• Ascaris • Giardia
• Clonorchis sinensis • Opisthorcis felineus
• Cryptosporodium • Opisthorcis viverrini
• Cyclospora • Sarcosporodium
catetanensis • Taenia
• Diphyllobothorium • Toxoplasma
• Echinococcus • Trichinella
• Entamoeba histolytica
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 High (100/g of
food)
Salmonella 106
(excluding S. typhi)
Salmonella typhi 10 – 100

Camphylobacter About 500

 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
• 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 Is the presence of agent in

in raw material probable? line or environment probable?

YES NO NO
No Hazard YES

Is an unacceptable survival, YES Is an unacceptable

persistence or increase at contamination at this step
this step probable? probable?

YES NO No Hazard NO

YES
Is reduction, if any at a NO
further step adequate? 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
Unlikely Occasionally Probable Common
hazard (S)
(1) (2) (3) (4)
Very High 5 6 7 8
(4)
High (3) 4 5 6 7
Medium (2) 3 4 5 6
Low (1) 2 3 4 5
 Mikroorganisme Patogen

Bahaya Tinggi Bahaya Sedang Bahaya Rendah

• Clostridium botulinum • Listeria monocytogenes • Bacillus cereus
• Shigella dysenteriae • Camphylobacter jejuni • Clostridium perfringens
• Salmonella typhy • Salmonella spp. • Staphylococcus aureus
• Salmonella paratyphy • Shigella spp. • Taenia saginata
• Trichinella spiralis • Streptococcus pyrogenes
• Vibrio cholerae • Yersinia enterolytica
• Hepatitis A dan E
• Aeromonas spp.
• Rotavirus Norwalk
• Vibrio parahaemolyticus

Sumber: Winarno & Suroto (2002)

Contoh Produk dengan Berbagai Tingkat
Risiko

Risiko Tinggi Risiko Sedang Risiko Rendah

• Daging • Produk-produk kering • Produk dengan pH di
• Ikan mentah dan bawah 4.6 (asam)
• Produk-produk olahan produk beku (ikan, • Produk dengan kadar
susu. daging, gula tinggi (selai, sirup,
• Produk dengan nilai
telur, sayuran, serealia) dll)
pH • Sandwich, pie daging
• Produk – produk
4.6 atau diatasnya • Produk berbasis lemak
konfeksioneri
• Produk-produk yang (margarine, coklat, • Minyak
mengandung ikan, mayonaise, salad
daging, telur, sayur, dressing)
serealia.
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?

NO YES
CCP for the raw Not CCP
materials for this
hazard
 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
Vegetative pathogens:
Salmonella, Listeria
monocytogenes, E.coli.
Heat stable pre-formed
toxins: S.aureus, B. cereus
Control Measures
- 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 Control Measures

Cleaning chemicals - Use of non-toxic, food

compatible cleaning
compounds
- separate storage
- covered containers

-Safe operating practices

Chemical additives
- written additive instructions
- validation of levels through
usage rates, sampling and
testing
 Control Measures
Physical Hazards Control Measures

Glass, wood, metal, etc in - inspection – electronic or

raw materials. human
- Washing
- Air separation
- X-ray detection
- Metal detector, etc.

Physical process cross- - Pest control

contaminants: pests - 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:
 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