7 Principles of HACCP7 Principles of HACCP
HAZARD ???HAZARD ???A biological, chemical, or physical agent in food A biological, chemical, or physical agent in food
with the potential to cause an adverse health with the potential to cause an adverse health effect (Codex, 1997).effect (Codex, 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 atau agen yang masuk ke oleh mikroba atau agen yang masuk ke dalam tubuh melalui makanan yang didalam tubuh melalui makanan yang dikonsumsi (WHO).konsumsi (WHO).
Principle 1: Hazard analysisPrinciple 1: Hazard analysis
The process of collecting and The process of collecting and evaluating information on hazards evaluating information on hazards and conditions leading to their and conditions leading to their presence to decide which are presence to decide which are significant for food safety and should 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 analysisanalysis
the agents that could be present in the the agents that could be present in the food under studyfood under study
the severity of the effects and the the severity of the effects and the likelihood of their occurrencelikelihood of their occurrence
the levels that could cause adverse the levels that could cause adverse health effectshealth effects
the conditions that could lead to the conditions that could lead to unacceptable levelsunacceptable levels
Microbial HazardsMicrobial Hazards
Dangerous microorganisms that Dangerous microorganisms that cause food-borne disease (FBD):cause food-borne disease (FBD):– Bacteria Bacteria – Moulds Moulds – VirusesViruses– ParasitesParasites
Patogenic microorganismsPatogenic microorganisms are theare the MAJOR SOURCESMAJOR SOURCES of food of food
contamination!!!contamination!!!
Major bacteria causing FBDMajor bacteria causing FBD
• Aeromonas sppAeromonas spp• Bacillus cereusBacillus cereus• Brucella spp.Brucella spp.• Camphylobacter jejuniCamphylobacter jejuni• Clostridium botulinumClostridium botulinum• Clostridium Clostridium
perfringensperfringens• Escherichia coliEscherichia coli• Listeria Listeria
monocytogenesmonocytogenes
• Mycobacterium bovisMycobacterium bovis• Salmonella spp.Salmonella spp.• Shigella spp.Shigella spp.• Staphylococcus Staphylococcus
aureusaureus• Vibrio choleraeVibrio cholerae• Vibrio Vibrio
parahaemolyticusparahaemolyticus• Vibrio vulcanificusVibrio vulcanificus• Yersinia enteroliticaYersinia enterolitica
Some toxigenic moulds causing Some toxigenic moulds causing FBDFBD
Aspergillus sppAspergillus spp Fusarium spp.Fusarium spp. Penicilium sppPenicilium spp
Producing mycotoxins, such as Producing mycotoxins, such as aflatoxin, ochratoxin, etc.aflatoxin, ochratoxin, etc.
Main sources: fruits, nuts and grainsMain sources: fruits, nuts and grains
MycotoxinsMycotoxins
Major viruses causing FBDMajor viruses causing FBD
Hepatitis A and E virusesHepatitis A and E viruses Small round structured viruses (e.g. Small round structured viruses (e.g.
Norwalk)Norwalk) Rotavirus Rotavirus Polio virusPolio virus
• AnisakisAnisakis• AscarisAscaris• Clonorchis sinensisClonorchis sinensis• CryptosporodiumCryptosporodium• Cyclospora Cyclospora
catetanensiscatetanensis• DiphyllobothoriumDiphyllobothorium• EchinococcusEchinococcus• Entamoeba Entamoeba
histolyticahistolytica
• Fasciola hepaticaFasciola hepatica• GiardiaGiardia• Opisthorcis felineusOpisthorcis felineus• Opisthorcis Opisthorcis
viverriniviverrini• SarcosporodiumSarcosporodium• TaeniaTaenia• ToxoplasmaToxoplasma• TrichinellaTrichinella
Major parasites causing FBDMajor parasites causing FBD
Bacterial growth curveBacterial growth curve
Food-Borne Disease Food-Borne Disease BacteriaBacteria
• InfectionInfection• Invasion of bacteria and theirs multiplication Invasion of bacteria and theirs multiplication
within the body.within the body.• E.g.: E.g.: Salmonella, Campylobacter, E. coli, Salmonella, Campylobacter, E. coli,
V. parahaemolyticus, V. cholerae, V. parahaemolyticus, V. cholerae, Y. enterolitica, L monocytogenes Y. 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, Bacillus cereus, C. botulinum, S. aureus,
E. coliE. coli
Example:Example: 1. Salmonella1. 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 Persons at high risk: young, old, pregnant
woman, underlying disease states.woman, 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 C for 2 min) is sufficient to
kill Salmonella in high moisture foods.kill Salmonella in high moisture foods.
2. Camphylobacter2. Camphylobacter
• Causing camphylobacteriosisCausing camphylobacteriosis• Symptoms: fever, nausea, diarrhea, Symptoms: fever, nausea, diarrhea,
abdominal crampabdominal cramp• Person at high risks: babies, debilitated Person at high risks: babies, debilitated
peoplepeople• 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 doseMinimum infective dose
L. monocytogenesL. monocytogenes High (100/g of High (100/g of food)food)
Salmonella Salmonella (excluding (excluding S. S. typhityphi))
101066
Salmonella typhiSalmonella typhi 10 – 10010 – 100
CamphylobacterCamphylobacter About 500About 500
Minimum toxic doses of Minimum toxic doses of bacterial toxinsbacterial toxins
• S. aureusS. aureus : 10: 1066 (cells/g) (cells/g)• C. botulinumC. botulinum : 10: 1044 - 10 - 1055
• B. cereusB. cereus : 10: 1077 – 10 – 1088
Temperature range for the growth Temperature range for the growth of patogenic bacteriaof patogenic bacteria
Temperature range for the growth Temperature range for the growth of toxigenic mouldsof toxigenic moulds
Prevention of FBDPrevention of FBD
Chemical HazardsChemical 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 DeterminationHazard 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
NOHAZARD
Menentukan signifikansi Menentukan signifikansi bahayabahaya
Tingkat keseriusan bahaya (Tingkat keseriusan bahaya (severityseverity):):– SeveritySeverity dapat ditetapkan dengan dapat ditetapkan dengan
melihat seberapa jauh dampaknya melihat seberapa jauh dampaknya terhadap kesehatan konsumen dan terhadap kesehatan konsumen dan dampak terhadap pencitraan industri.dampak terhadap 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 bahayabahaya
Matrix Risk
(UNEP, 2002)
Matriks Risiko Boevee (Hermawan, Matriks Risiko Boevee (Hermawan, 2005)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)
UnlikelyUnlikely 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 Medium (2)(2)
33 44 55 66
Low (1)Low (1) 22 33 44 55
Mikroorganisme PatogenMikroorganisme Patogen
Bahaya Bahaya TinggiTinggi
Bahaya Bahaya SedangSedang
Bahaya Bahaya RendahRendah
• Clostridium Clostridium botulinumbotulinum• Shigella dysenteriaeShigella dysenteriae• Salmonella typhySalmonella typhy• Salmonella Salmonella paratyphyparatyphy• Trichinella spiralisTrichinella spiralis• Vibrio choleraeVibrio cholerae
• Listeria Listeria monocytogenesmonocytogenes• Camphylobacter jejuniCamphylobacter jejuni• Salmonella spp.Salmonella spp.• Shigella spp.Shigella spp.• Streptococcus Streptococcus pyrogenespyrogenes• Yersinia enterolyticaYersinia enterolytica• Hepatitis A dan EHepatitis A dan E• Aeromonas spp.Aeromonas spp.• Rotavirus NorwalkRotavirus Norwalk• Vibrio Vibrio parahaemolyticusparahaemolyticus
• Bacillus cereusBacillus cereus• Clostridium Clostridium perfringensperfringens• Staphylococcus Staphylococcus aureusaureus• Taenia saginataTaenia saginata
Sumber: Winarno & Suroto (2002)
Contoh Produk dengan Berbagai Contoh Produk dengan Berbagai Tingkat RisikoTingkat Risiko
Risiko TinggiRisiko Tinggi Risiko SedangRisiko Sedang Risiko Risiko RendahRendah
• DagingDaging• Ikan mentahIkan mentah• Produk-produk Produk-produk olahan olahan
susu. susu. • Produk dengan nilai Produk dengan nilai pH pH
4.6 atau diatasnya4.6 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, telur, sayuran, serealia)serealia)• Sandwich, pie dagingSandwich, pie daging• Produk berbasis Produk berbasis lemak lemak
(margarine, coklat, (margarine, coklat,
mayonaise, salad mayonaise, salad
dressing)dressing)
• Produk dengan pH Produk dengan pH di di
bawah 4.6 (asam)bawah 4.6 (asam)• Produk dengan Produk dengan kadar kadar
gula tinggi (selai, gula tinggi (selai, sirup, sirup,
dll)dll)• Produk – produk Produk – produk
konfeksionerikonfeksioneri• MinyakMinyak
Principle 2: determine the CCPsPrinciple 2: determine the CCPs
CCP:CCP:
a step at which control can be applied 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 and eliminate a food safety hazard or reduce it to an acceptable level reduce it to an acceptable level (Codex 1997).(Codex 1997).
CCPs relate to control of CCPs relate to control of significant significant food safety hazardsfood safety hazards only. only.
2. Determination of CCPs2. 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 treeCritical 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 CCPCCP for the raw materials for this hazard
QuestionQuestions to be s to be asked for asked for each each process process stagestage
(SNI, 1998)(SNI, 1998)
Control MeasureControl Measure
Any Any factor or activityfactor or activity which can be which can be usedused to prevent, eliminate, or reduceto prevent, eliminate, or reduce food safetyfood safety hazardshazards to an acceptable to an acceptable level.level.
Control measures are specific for Control measures are specific for each hazard and can be either each hazard and can be either process or activities.process or activities.
Control MeasuresControl Measures
Biological HazardsBiological Hazards Control MeasuresControl Measures
Vegetative pathogens: Vegetative pathogens: Salmonella, Listeria Salmonella, Listeria monocytogenes, E.colimonocytogenes, E.coli..
Heat stable pre-formed Heat stable pre-formed toxins: toxins: S.aureusS.aureus, , B. B. cereuscereus
- Lethal heat treatment Lethal heat treatment during packagingduring packaging- Temperature controlTemperature control- Intrinsic factors: pH, awIntrinsic factors: pH, aw- Intact packagingIntact packaging- Secure building, etc.Secure building, etc.
- effective supplier effective supplier process and testingprocess and testing- hand wash procedureshand wash procedures- control of timecontrol of time
Control MeasuresControl Measures
Chemical HazardsChemical Hazards Control MeasuresControl Measures
Cleaning chemicalsCleaning chemicals
Chemical additivesChemical additives
- Use of non-toxic, food Use of non-toxic, food compatible cleaning compatible cleaning compoundscompounds- separate storageseparate storage- covered containerscovered containers
-Safe operating practices Safe operating practices - written additive written additive instructionsinstructions- validation of levels validation of levels through usage rates, through usage rates, sampling and testingsampling and testing
Control MeasuresControl Measures
Physical HazardsPhysical Hazards Control MeasuresControl Measures
Glass, wood, metal, etc Glass, wood, metal, etc in raw materials.in raw materials.
Physical process cross-Physical process cross-contaminants: pestscontaminants: pests
- inspection – electronic inspection – electronic or humanor human- WashingWashing- Air separationAir separation- X-ray detectionX-ray detection- Metal detector, etc.Metal detector, etc.
- Pest controlPest control- Extermination (electric Extermination (electric pest killers, poisoning, pest killers, poisoning, bait boxes, etc).bait boxes, 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 Operational limits are often set a more stringent levels to provide a buffer or action stringent levels to provide a buffer or action zone for process management.zone for process 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
texturetexture
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 If in a heat process the critical limit is 7272ooC for 2 minutes, the operating limit of C for 2 minutes, the operating limit of 7575ooC for 10 min may be set.C for 10 min may be set.
Critical Limit(s)Critical Limit(s)
CL harus spesifik dan jelas baik batas CL harus spesifik dan jelas baik batas maksimum maupun minimum.maksimum maupun minimum.
Harus berkaitan dengan tindakan Harus berkaitan dengan tindakan pengendalian (monitoring) dan mudah pengendalian (monitoring) dan mudah dipantau.dipantau.
Perusahaan harus memastikan bahwa CL Perusahaan harus memastikan bahwa CL dapat diaplikasikan pada operasi atau dapat diaplikasikan pada operasi atau produk secara spesifik.produk secara 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 ensuring that control measures are working.working.
Codex (1997) defined monitoring as “ the Codex (1997) defined monitoring as “ the act of conducting a planned sequence of act of conducting a planned sequence of observations or measurements of control observations or measurements of control parameters to assess whether a CCP is parameters to assess whether a CCP is under control”.under control”.
Monitoring of the CCPs is carried through tests Monitoring of the CCPs is carried through tests or observationsor observations
The frequency and responsibility for monitoring The frequency and responsibility for monitoring will be appropriate to the control measure.will 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 nature of the CCP and must be determined as part of the control system.part of the control system.
All personnel responsible for monitoring must All personnel responsible for monitoring must be trained and have a clear understanding of be trained and have a clear understanding of their role.their role.
MonitoringMonitoring
Equipment and methods:Equipment and methods: Physical parameters:Physical parameters: temperature, temperature,
time, moisture levels, metal detection, X-time, moisture levels, metal detection, X-ray detection, inspecting sifters, and ray detection, inspecting sifters, and sieves.sieves.
Chemical test:Chemical test: chlorine analysis, pH, chlorine analysis, pH, aw, pesticide residue analysis, allergen aw, pesticide residue analysis, allergen residue testing, heavy metals analysis.residue testing, heavy metals analysis.
Sensory test:Sensory test: visual appearance, visual appearance, texture.texture.
MonitoringMonitoring
The equipment used for monitoring The equipment used for monitoring must be:must be: Accurate:Accurate: needs to be calibrated.needs to be calibrated. Easy to useEasy to use Accessible:Accessible: having the equipment having the equipment
close to the point of testing and must be close to the point of testing and must be quick in terms of providing results. quick in terms of providing results.
MonitoringMonitoring
People assigned monitoring duties People assigned monitoring duties should be:should 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 Trained in the corrective action
procedures: what to do when monitoring procedures: what to do when monitoring indicates loss of controlindicates loss of control
MonitoringMonitoring
– The action should be taken when the result shows a The action should be taken when the result shows a deviation from the critical limitdeviation 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 Deal with the material produced under the deviation periodperiod 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 Clarify to all personnel involve (what to do and how to do it)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)
VerificationVerification
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
VerificationVerification
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
VerificationVerification