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7 Principles of HACCP

7 Principles of HACCP

(2)

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).

(3)

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.

(4)

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

(5)
(6)

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

(7)

Patogenic microorganisms

Patogenic microorganisms are the are the MAJOR MAJOR SOURCES

SOURCES of food contamination!!! of food contamination!!!

(8)

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

(9)

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

(10)

Mycotoxins

Mycotoxins

(11)

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

(12)

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

(13)

Bacterial growth curve

Bacterial growth curve

(14)

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

(15)

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.

(16)

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).

(17)

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

66

Salmonella typhi

Salmonella typhi 10 – 100 10 – 100 Camphylobacter

Camphylobacter About 500 About 500

(18)

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

88

(19)

Temperature range for the growth of Temperature range for the growth of

patogenic bacteria

patogenic bacteria

(20)

Temperature range for the growth of Temperature range for the growth of

toxigenic moulds

toxigenic moulds

(21)

Prevention of FBD

Prevention of FBD

(22)

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.

(23)

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

(24)

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

(25)

Menentukan signifikansi Menentukan signifikansi

bahaya bahaya

Matrix Risk

(UNEP, 2002)

(26)

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

(27)

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)

(28)

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

(29)

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.

(30)

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

(31)

Questions Questions

to be to be

asked for asked for

each each

process process

stage stage

(SNI, 1998) (SNI, 1998)

(32)

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.

(33)

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

(34)

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

(35)

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).

(36)

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.

(37)

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)

(38)

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)

(39)

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)

(40)

When is deviation from normality When is deviation from normality

unacceptable?

unacceptable?

( i.e. establishment of Critical Limits ) ( i.e. establishment of Critical Limits )

(41)

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”.

(42)

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

(43)

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

(44)

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

(45)

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

(46)

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

(47)

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

(48)

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

(49)

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

Verification

Verification

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