7 principles of haccp. hazard ??? a biological, chemical, or physical agent in food with the...

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