7 Principles of HACCP
7 Principles of HACCP
HAZARD ???
HAZARD ???
A biological, chemical, or physical agent in food with the A biological, chemical, or physical agent in food with the
potential to cause an adverse health effect (Codex, potential to cause an adverse health effect (Codex,
1997).
1997).
Hazard:
Hazard:
• MicrobiologicalMicrobiological
• ChemicalChemical
• PhysicalPhysical
Food-borne disease (FBD):
Food-borne disease (FBD):
penyakit menular atau keracunan yang
penyakit menular atau keracunan yang oleh mikroba oleh mikroba atau agen yang masuk ke
atau agen yang masuk ke
dalam tubuh melalui makanan yang di dalam tubuh melalui makanan yang di
konsumsi (WHO).
konsumsi (WHO).
Principle 1: Hazard analysis Principle 1: Hazard analysis
The process of collecting and evaluating The process of collecting and evaluating information on hazards and conditions information on hazards and conditions
leading to their presence to decide which leading to their presence to decide which
are significant for food safety and should are significant for food safety and should
be addressed in the HACCP plan.
be addressed in the HACCP plan.
Information needed for hazard Information needed for hazard
analysis analysis
the agents that could be present in the food the agents that could be present in the food under study
under study
the severity of the effects and the likelihood of the severity of the effects and the likelihood of their occurrence
their occurrence
the levels that could cause adverse health the levels that could cause adverse health effects
effects
the conditions that could lead to unacceptable the conditions that could lead to unacceptable levels
levels
Microbial Hazards Microbial Hazards
Dangerous microorganisms that cause Dangerous microorganisms that cause food-borne disease (FBD):
food-borne disease (FBD):
– Bacteria Bacteria – Moulds Moulds – VirusesViruses – ParasitesParasites
Patogenic microorganisms
Patogenic microorganisms are the are the MAJOR MAJOR SOURCES
SOURCES of food contamination!!! of food contamination!!!
Major bacteria causing FBD Major bacteria causing FBD
• Aeromonas sppAeromonas spp
• Bacillus cereusBacillus cereus
• Brucella spp.Brucella spp.
• Camphylobacter jejuniCamphylobacter jejuni
• Clostridium botulinumClostridium botulinum
• Clostridium perfringensClostridium perfringens
• Escherichia coliEscherichia coli
• Listeria monocytogenesListeria monocytogenes
• Mycobacterium bovisMycobacterium bovis
• Salmonella spp.Salmonella spp.
• Shigella spp.Shigella spp.
• Staphylococcus aureusStaphylococcus aureus
• Vibrio choleraeVibrio cholerae
• Vibrio parahaemolyticusVibrio parahaemolyticus
• Vibrio vulcanificusVibrio vulcanificus
• Yersinia enteroliticaYersinia enterolitica
Some toxigenic moulds causing FBD Some toxigenic moulds causing FBD
Aspergillus spp Aspergillus spp
Fusarium spp. Fusarium spp.
Penicilium spp Penicilium spp
Producing mycotoxins, such as aflatoxin, Producing mycotoxins, such as aflatoxin,
ochratoxin, etc.
ochratoxin, etc.
Main sources: fruits, nuts and grains
Main sources: fruits, nuts and grains
Mycotoxins
Mycotoxins
Major viruses causing FBD Major viruses causing FBD
Hepatitis A and E viruses Hepatitis A and E viruses
Small round structured viruses (e.g. Small round structured viruses (e.g.
Norwalk) Norwalk)
Rotavirus Rotavirus
Polio virus Polio virus
• AnisakisAnisakis
• AscarisAscaris
• Clonorchis sinensisClonorchis sinensis
• CryptosporodiumCryptosporodium
• Cyclospora Cyclospora catetanensis catetanensis
• DiphyllobothoriumDiphyllobothorium
• EchinococcusEchinococcus
• Entamoeba histolyticaEntamoeba histolytica
• Fasciola hepaticaFasciola hepatica
• GiardiaGiardia
• Opisthorcis felineusOpisthorcis felineus
• Opisthorcis viverriniOpisthorcis viverrini
• SarcosporodiumSarcosporodium
• TaeniaTaenia
• ToxoplasmaToxoplasma
• TrichinellaTrichinella
Major parasites causing FBD
Major parasites causing FBD
Bacterial growth curve
Bacterial growth curve
Food-Borne Disease Bacteria Food-Borne Disease Bacteria
• InfectionInfection
• Invasion of bacteria and theirs multiplication within Invasion of bacteria and theirs multiplication within the body.
the body.
• E.g.: E.g.: Salmonella, Campylobacter, E. coli, V. Salmonella, Campylobacter, E. coli, V.
parahaemolyticus, V. cholerae, Y.
parahaemolyticus, V. cholerae, Y.
enterolitica, L monocytogenes enterolitica, L monocytogenes
• IntoxicationIntoxication
• Caused by consuming toxin produced in food.Caused by consuming toxin produced in food.
• E.g.: E.g.: Bacillus cereus, C. botulinum, S. aureus, E. Bacillus cereus, C. botulinum, S. aureus, E.
colicoli
Example:
Example:
1. Salmonella 1. Salmonella
• Causing SalmonellosisCausing Salmonellosis
• Main symptoms: diarrhea, fever, vomiting, Main symptoms: diarrhea, fever, vomiting, abdominal cramps.
abdominal cramps.
• Persons at high risk: young, old, pregnant woman, Persons at high risk: young, old, pregnant woman, underlying disease states.
underlying disease states.
• Incubation period: 12 – 36 hIncubation period: 12 – 36 h
• Sources: meat, poultry, milk, eggs, vegetables, Sources: meat, poultry, milk, eggs, vegetables, shellfish, spices and herbs, untreated water.
shellfish, spices and herbs, untreated water.
• Salmonella is heat sensitiveSalmonella is heat sensitive
• Pasteurization (70Pasteurization (70ooC for 2 min) is sufficient to kill C for 2 min) is sufficient to kill Salmonella in high moisture foods.
Salmonella in high moisture foods.
2. Camphylobacter 2. Camphylobacter
• Causing camphylobacteriosisCausing camphylobacteriosis
• Symptoms: fever, nausea, diarrhea, abdominal Symptoms: fever, nausea, diarrhea, abdominal cramp
cramp
• Person at high risks: babies, debilitated peoplePerson at high risks: babies, debilitated people
• Incubation: 2-5 daysIncubation: 2-5 days
• Heat sensitiveHeat sensitive
• Major sources: frozen foods (meats and Major sources: frozen foods (meats and poultry).
poultry).
Minimum infective dose Minimum infective dose
L. monocytogenes
L. monocytogenes High (100/g of High (100/g of food)
food) Salmonella
Salmonella (excluding
(excluding S. typhi S. typhi ) ) 10 10
66Salmonella typhi
Salmonella typhi 10 – 100 10 – 100 Camphylobacter
Camphylobacter About 500 About 500
Minimum toxic doses of bacterial Minimum toxic doses of bacterial
toxins toxins
•
S. aureus S. aureus : 10 : 10
66(cells/g) (cells/g)
•
C. botulinum C. botulinum : 10 : 10
44- 10 - 10
55•
B. cereus B. cereus : 10 : 10
77– 10 – 10
88Temperature range for the growth of Temperature range for the growth of
patogenic bacteria
patogenic bacteria
Temperature range for the growth of Temperature range for the growth of
toxigenic moulds
toxigenic moulds
Prevention of FBD
Prevention of FBD
Chemical Hazards Chemical Hazards
• Pesticides: PCBs, organochlorinPesticides: PCBs, organochlorin
• DioxinsDioxins
• Heavy metals: Cd, Hg, PbHeavy metals: Cd, Hg, Pb
• Metals: Al, Se, etc.Metals: Al, Se, etc.
• Food additivesFood additives
• Natural contaminantsNatural contaminants
• DesinfectantsDesinfectants
• MycotoxinsMycotoxins
• Etc.Etc.
Hazard Determination Hazard Determination
Is the presence of agent
in raw material probable? Is the presence of agent in
line or environment probable?
Is an unacceptable survival, persistence or increase at this step probable?
Is an unacceptable
contamination at this step probable?
Is reduction, if any at a further step adequate?
YES
YES
YES
YES
YES No Hazard
No Hazard
NO
NO NO
NO
NO HAZARD
Menentukan signifikansi bahaya Menentukan signifikansi bahaya
Tingkat keseriusan bahaya ( Tingkat keseriusan bahaya ( severity severity ): ):
– SeveritySeverity dapat ditetapkan dengan melihat dapat ditetapkan dengan melihat seberapa jauh dampaknya terhadap
seberapa jauh dampaknya terhadap
kesehatan konsumen dan dampak terhadap kesehatan konsumen dan dampak terhadap
pencitraan industri.
pencitraan industri.
– Frekuensi terjadinya bahaya:Frekuensi terjadinya bahaya:
Risiko tinggi: cenderung terjadiRisiko tinggi: cenderung terjadi
Risiko sedang: dapat terjadiRisiko sedang: dapat terjadi
Risiko rendah: cenderung tidak terjadiRisiko rendah: cenderung tidak terjadi
Menentukan signifikansi Menentukan signifikansi
bahaya bahaya
Matrix Risk
(UNEP, 2002)
Matriks Risiko Boevee (Hermawan, 2005) Matriks Risiko Boevee (Hermawan, 2005)
Risk ranking scheme based upon severity of risk (S) Risk ranking scheme based upon severity of risk (S)
and probability of hazard (P) and probability of hazard (P) Severity of
Severity of hazard (S) hazard (S)
Probability of occurrence (P) Probability of occurrence (P) Unlikely
Unlikely OccasionallyOccasionally ProbableProbable CommonCommon (1)(1) (2)(2) (3)(3) (4)(4) Very High
Very High
(4)(4) 55 66 77 88
High (3)
High (3) 44 5 5 66 77
Medium (2)
Medium (2) 33 44 55 66
Mikroorganisme Patogen Mikroorganisme Patogen
Bahaya Tinggi
Bahaya Tinggi Bahaya SedangBahaya Sedang Bahaya RendahBahaya Rendah
• Clostridium botulinumClostridium botulinum
• Shigella dysenteriaeShigella dysenteriae
• Salmonella typhySalmonella typhy
• Salmonella paratyphySalmonella paratyphy
• Trichinella spiralisTrichinella spiralis
• Vibrio choleraeVibrio cholerae
• Listeria monocytogenesListeria monocytogenes
• Camphylobacter jejuniCamphylobacter jejuni
• Salmonella spp.Salmonella spp.
• Shigella spp.Shigella spp.
• Streptococcus pyrogenesStreptococcus pyrogenes
• Yersinia enterolyticaYersinia enterolytica
• Hepatitis A dan EHepatitis A dan E
• Aeromonas spp.Aeromonas spp.
• Rotavirus NorwalkRotavirus Norwalk
• Vibrio parahaemolyticusVibrio parahaemolyticus
• Bacillus cereusBacillus cereus
• Clostridium perfringensClostridium perfringens
• Staphylococcus aureusStaphylococcus aureus
• Taenia saginataTaenia saginata
Sumber: Winarno & Suroto (2002)
Contoh Produk dengan Berbagai Tingkat Contoh Produk dengan Berbagai Tingkat
Risiko Risiko
Risiko Tinggi
Risiko Tinggi Risiko SedangRisiko Sedang Risiko RendahRisiko Rendah
• DagingDaging
• Ikan mentahIkan mentah
• Produk-produk olahan Produk-produk olahan
susu. susu.
• Produk dengan nilai Produk dengan nilai pH pH
4.6 atau diatasnya 4.6 atau diatasnya
• Produk-produk yang Produk-produk yang mengandung ikan, mengandung ikan, daging, telur, sayur, daging, telur, sayur, serealia.serealia.
• Produk-produk kering Produk-produk kering dan dan
produk beku (ikan, produk beku (ikan, daging,
daging,
telur, sayuran, serealia)telur, sayuran, serealia)
• Sandwich, pie dagingSandwich, pie daging
• Produk berbasis lemak Produk berbasis lemak (margarine, coklat, (margarine, coklat, mayonaise, salad mayonaise, salad dressing) dressing)
• Produk dengan pH di Produk dengan pH di bawah 4.6 (asam)bawah 4.6 (asam)
• Produk dengan kadar Produk dengan kadar gula tinggi (selai, sirup, gula tinggi (selai, sirup, dll) dll)
• Produk – produk Produk – produk konfeksioneri konfeksioneri
• MinyakMinyak
Principle 2: determine the CCPs Principle 2: determine the CCPs
CCP: CCP:
a step at which control can be applied and a step at which control can be applied and
the step is essential to prevent and the step is essential to prevent and
eliminate a food safety hazard or reduce it eliminate a food safety hazard or reduce it
to an acceptable level (Codex 1997).
to an acceptable level (Codex 1997).
CCPs relate to control of CCPs relate to control of significant food significant food safety hazards
safety hazards only. only.
2. Determination of CCPs 2. Determination of CCPs
Q1. Is it likely that the raw material contains the hazard under study at unacceptable levels?
Q2. Will processing, including expected consumer use, eliminate the hazard or reduce it to an acceptable level?
Critical control point decision tree Critical control point decision tree
Questions to be asked for each raw material usedQuestions to be asked for each raw material used
YES
NO
NO
YES
Not CCP
Not CCP CCP for the raw
Questions Questions
to be to be
asked for asked for
each each
process process
stage stage
(SNI, 1998) (SNI, 1998)
Control Measure Control Measure
Any Any factor or activity factor or activity which can be used which can be used to to prevent, eliminate, or reduce
prevent, eliminate, or reduce food safety food safety hazards
hazards to an acceptable level. to an acceptable level.
Control measures are specific for each Control measures are specific for each hazard and can be either process or hazard and can be either process or
activities.
activities.
Control Measures Control Measures
Biological Hazards
Biological Hazards Control MeasuresControl Measures Vegetative pathogens:
Vegetative pathogens:
Salmonella, Listeria Salmonella, Listeria monocytogenes, E.coli monocytogenes, E.coli..
Heat stable pre-formed Heat stable pre-formed toxins:
toxins: S.aureusS.aureus, , B. cereusB. cereus
- Lethal heat treatment Lethal heat treatment during packaging
during packaging
- Temperature controlTemperature control
- Intrinsic factors: pH, awIntrinsic factors: pH, aw
- Intact packagingIntact packaging
- Secure building, etc.Secure building, etc.
- effective supplier process effective supplier process and testing
and testing
- hand wash procedureshand wash procedures
- control of timecontrol of time
Control Measures Control Measures
Chemical Hazards
Chemical Hazards Control MeasuresControl Measures Cleaning chemicals
Cleaning chemicals
Chemical additives Chemical additives
- Use of non-toxic, food Use of non-toxic, food compatible cleaning
compatible cleaning compounds
compounds
- separate storageseparate storage
- covered containerscovered containers
-Safe operating practices Safe operating practices
- written additive instructionswritten additive instructions
- validation of levels through validation of levels through usage rates, sampling and usage rates, sampling and testing
testing
Control Measures Control Measures
Physical Hazards
Physical Hazards Control MeasuresControl Measures Glass, wood, metal, etc in
Glass, wood, metal, etc in raw materials.
raw materials.
Physical process cross- Physical process cross- contaminants: pests contaminants: pests
- inspection – electronic or inspection – electronic or human
human
- WashingWashing
- Air separationAir separation
- X-ray detectionX-ray detection
- Metal detector, etc.Metal detector, etc.
- Pest controlPest control
- Extermination (electric pest Extermination (electric pest killers, poisoning, bait boxes, killers, poisoning, bait boxes, etc).
etc).
Critical Limit(s) Critical Limit(s)
CL are the criteria that differentiate betweenCL are the criteria that differentiate between ‘safe’‘safe’
and and ‘unsafe’‘unsafe’ safety boundariessafety boundaries..
Codex (1997):Codex (1997): “a criterion which separates “a criterion which separates acceptability from unacceptability.”
acceptability from unacceptability.”
Defined by regulations, safety standards and Defined by regulations, safety standards and scientifically proven values.
scientifically proven values.
Operational limits are often set a more stringent Operational limits are often set a more stringent
levels to provide a buffer or action zone for process levels to provide a buffer or action zone for process
management.
management.
Critical limits can be: Critical limits can be:
Values of pH, aw, temperature, timeValues of pH, aw, temperature, time
Absorbed radiation doseAbsorbed radiation dose
Levels of disinfectant or antimicrobial agentsLevels of disinfectant or antimicrobial agents
Level of cleanlinessLevel of cleanliness
Limits of residuesLimits of residues
Limits of contaminantsLimits of contaminants
Limits of microbiological criteriaLimits of microbiological criteria
Sensory parameters: visual appearance and Sensory parameters: visual appearance and texture
texture
Critical Limit(s)
Critical Limit(s)
Buffer or action zone, for example: Buffer or action zone, for example:
If in a heat process the critical limit is 72
If in a heat process the critical limit is 72ooC for C for 2 minutes, the operating limit of 75
2 minutes, the operating limit of 75ooC for 10 C for 10 min may be set.
min may be set.
Critical Limit(s)
Critical Limit(s)
CL harus spesifik dan jelas baik batas maksimum CL harus spesifik dan jelas baik batas maksimum maupun minimum.
maupun minimum.
Harus berkaitan dengan tindakan pengendalian Harus berkaitan dengan tindakan pengendalian (monitoring) dan mudah dipantau.
(monitoring) dan mudah dipantau.
Perusahaan harus memastikan bahwa CL dapat Perusahaan harus memastikan bahwa CL dapat diaplikasikan pada operasi atau produk secara diaplikasikan pada operasi atau produk secara
spesifik.
spesifik.
CL harus terukur dan dapat divalidasi.CL harus terukur dan dapat divalidasi.
Critical Limit(s)
Critical Limit(s)
When is deviation from normality When is deviation from normality
unacceptable?
unacceptable?
( i.e. establishment of Critical Limits ) ( i.e. establishment of Critical Limits )
Monitoring Monitoring
Observation or measurement required to Observation or measurement required to ensure that the process is under control ensure that the process is under control
operating within the defined critical limit operating within the defined critical limit
ensuring that control measures are working.
ensuring that control measures are working.
Codex (1997) defined monitoring as “ the act Codex (1997) defined monitoring as “ the act of conducting a planned sequence of
of conducting a planned sequence of
observations or measurements of control observations or measurements of control
parameters to assess whether a CCP is under parameters to assess whether a CCP is under
control”.
control”.
Monitoring of the CCPs is carried through tests or Monitoring of the CCPs is carried through tests or observations
observations
The frequency and responsibility for monitoring will The frequency and responsibility for monitoring will be appropriate to the control measure.
be appropriate to the control measure.
The frequency of monitoring will depend on the The frequency of monitoring will depend on the
nature of the CCP and must be determined as part of nature of the CCP and must be determined as part of
the control system.
the control system.
All personnel responsible for monitoring must be All personnel responsible for monitoring must be trained and have a clear understanding of their role.
trained and have a clear understanding of their role.
Monitoring
Monitoring
Equipment and methods: Equipment and methods:
Physical parameters:Physical parameters: temperature, time, temperature, time, moisture levels, metal detection, X-ray
moisture levels, metal detection, X-ray detection, inspecting sifters, and sieves.
detection, inspecting sifters, and sieves.
Chemical test:Chemical test: chlorine analysis, pH, aw, chlorine analysis, pH, aw, pesticide residue analysis, allergen residue pesticide residue analysis, allergen residue
testing, heavy metals analysis.
testing, heavy metals analysis.
Sensory test:Sensory test: visual appearance, texture.visual appearance, texture.
Monitoring
Monitoring
The equipment used for monitoring must The equipment used for monitoring must be: be:
Accurate:Accurate: needs to be calibrated.needs to be calibrated.
Easy to useEasy to use
Accessible:Accessible: having the equipment close to having the equipment close to the point of testing and must be quick in
the point of testing and must be quick in terms of providing results.
terms of providing results.
Monitoring
Monitoring
People assigned monitoring duties should People assigned monitoring duties should be: be:
Familiar with the processFamiliar with the process
Trained in the monitoring techniquesTrained in the monitoring techniques
Trained in HACCP awarenessTrained in HACCP awareness
Unbiased in monitoring and reportingUnbiased in monitoring and reporting
Trained in the corrective action procedures: Trained in the corrective action procedures:
what to do when monitoring indicates loss of what to do when monitoring indicates loss of
control control
Monitoring
Monitoring
– The action should be taken when the result shows a The action should be taken when the result shows a deviation from the critical limit
deviation from the critical limit
– Adjust the process to bring it back under controlAdjust the process to bring it back under control
– Deal with the material produced under the deviation periodDeal with the material produced under the deviation period
Hold on the productHold on the product
Rework Rework
Release product after sampling and testingRelease product after sampling and testing
Direct into less sensitive products, e.g. animal feedDirect into less sensitive products, e.g. animal feed
– Clarify to all personnel involve (what to do and how to do it)Clarify to all personnel involve (what to do and how to do it)
Corrective Actions
Corrective Actions
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
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
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