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7 Principles of HACCP. HAZARD ??? A biological, chemical, or physical agent in food with the potential to cause an adverse health effect (Codex, 1997).

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Presentation on theme: "7 Principles of HACCP. HAZARD ??? A biological, chemical, or physical agent in food with the potential to cause an adverse health effect (Codex, 1997)."— Presentation transcript:

1 7 Principles of HACCP

2 HAZARD ??? A biological, chemical, or physical agent in food with the potential to cause an adverse health effect (Codex, 1997). Hazard: MicrobiologicalMicrobiological ChemicalChemical PhysicalPhysical Food-borne disease (FBD): penyakit menular atau keracunan yang oleh mikroba atau agen yang masuk ke dalam tubuh melalui makanan yang di konsumsi (WHO).

3 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. 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.

4 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

5

6 Microbial Hazards Dangerous microorganisms that cause food-borne disease (FBD): Dangerous microorganisms that cause food-borne disease (FBD): –Bacteria –Moulds –Viruses –Parasites

7 Patogenic microorganisms are the MAJOR SOURCES of food contamination!!!

8 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  Aspergillus spp  Fusarium spp.  Penicilium spp Producing mycotoxins, such as aflatoxin, ochratoxin, etc. Main sources: fruits, nuts and grains

10 Mycotoxins

11 Major viruses causing FBD Hepatitis A and E viruses Hepatitis A and E viruses Small round structured viruses (e.g. Norwalk) Small round structured viruses (e.g. Norwalk) Rotavirus Rotavirus Polio virus Polio virus

12 AnisakisAnisakis AscarisAscaris Clonorchis sinensisClonorchis sinensis CryptosporodiumCryptosporodium Cyclospora catetanensisCyclospora catetanensis DiphyllobothoriumDiphyllobothorium EchinococcusEchinococcus Entamoeba histolyticaEntamoeba histolytica Fasciola hepaticaFasciola hepatica GiardiaGiardia Opisthorcis felineusOpisthorcis felineus Opisthorcis viverriniOpisthorcis viverrini SarcosporodiumSarcosporodium TaeniaTaenia ToxoplasmaToxoplasma TrichinellaTrichinella Major parasites causing FBD

13 Bacterial growth curve

14 Food-Borne Disease Bacteria InfectionInfection Invasion of bacteria and theirs multiplication within the body.Invasion of bacteria and theirs multiplication within the body. E.g.: Salmonella, Campylobacter, E. coli, V. parahaemolyticus, V. cholerae, Y. enterolitica, L monocytogenesE.g.: Salmonella, Campylobacter, E. coli, V. parahaemolyticus, V. cholerae, Y. enterolitica, L monocytogenes IntoxicationIntoxication Caused by consuming toxin produced in food.Caused by consuming toxin produced in food. E.g.: Bacillus cereus, C. botulinum, S. aureus, E. coliE.g.: Bacillus cereus, C. botulinum, S. aureus, E. coli

15 Example: 1. Salmonella Causing SalmonellosisCausing Salmonellosis Main symptoms: diarrhea, fever, vomiting, abdominal cramps.Main symptoms: diarrhea, fever, vomiting, abdominal cramps. Persons at high risk: young, old, pregnant woman, underlying disease states.Persons at high risk: young, old, pregnant woman, underlying disease states. Incubation period: 12 – 36 hIncubation period: 12 – 36 h Sources: meat, poultry, milk, eggs, vegetables, shellfish, spices and herbs, untreated water.Sources: meat, poultry, milk, eggs, vegetables, shellfish, spices and herbs, untreated water. Salmonella is heat sensitiveSalmonella is heat sensitive Pasteurization (70 o C for 2 min) is sufficient to kill Salmonella in high moisture foods.Pasteurization (70 o C for 2 min) is sufficient to kill Salmonella in high moisture foods.

16 2. Camphylobacter Causing camphylobacteriosisCausing camphylobacteriosis Symptoms: fever, nausea, diarrhea, abdominal crampSymptoms: fever, nausea, diarrhea, abdominal 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 poultry).Major sources: frozen foods (meats and poultry).

17 Minimum infective dose L. monocytogenes High (100/g of food) Salmonella (excluding S. typhi) 10 6 Salmonella typhi 10 – 100 Camphylobacter About 500

18 Minimum toxic doses of bacterial toxins S. aureus: 10 6 (cells/g)S. aureus: 10 6 (cells/g) C. botulinum: C. botulinum: B. cereus: 10 7 – 10 8B. cereus: 10 7 – 10 8

19 Temperature range for the growth of patogenic bacteria

20 Temperature range for the growth of toxigenic moulds

21 Prevention of FBD

22 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 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 No Hazard NO HAZARD

24 Menentukan signifikansi bahaya Tingkat keseriusan bahaya (severity): 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

25 Menentukan signifikansi bahaya Matrix Risk (UNEP, 2002)

26 Matriks Risiko Boevee (Hermawan, 2005) Risk ranking scheme based upon severity of risk (S) and probability of hazard (P) Severity of hazard (S) Probability of occurrence (P) UnlikelyOccasionallyProbableCommon (1)(2)(3)(4) Very High (4) 5678 High (3) 4567 Medium (2) 3456 Low (1) 2345

27 Mikroorganisme Patogen Bahaya Tinggi Bahaya Sedang Bahaya Rendah Clostridium botulinum Clostridium botulinum Shigella dysenteriae Shigella dysenteriae Salmonella typhy Salmonella typhy Salmonella paratyphy Salmonella paratyphy Trichinella spiralis Trichinella spiralis Vibrio cholerae Vibrio cholerae Listeria monocytogenes Listeria monocytogenes Camphylobacter jejuni Camphylobacter jejuni Salmonella spp. Salmonella spp. Shigella spp. Shigella spp. Streptococcus pyrogenes Streptococcus pyrogenes Yersinia enterolytica Yersinia enterolytica Hepatitis A dan E Hepatitis A dan E Aeromonas spp. Aeromonas spp. Rotavirus Norwalk Rotavirus Norwalk Vibrio parahaemolyticus Vibrio parahaemolyticus Bacillus cereus Bacillus cereus Clostridium perfringens Clostridium perfringens Staphylococcus aureus Staphylococcus aureus Taenia saginata Taenia saginata Sumber: Winarno & Suroto (2002)

28 Contoh Produk dengan Berbagai Tingkat Risiko Risiko Tinggi Risiko Sedang Risiko Rendah Daging Daging Ikan mentah Ikan mentah Produk-produk olahan Produk-produk olahan susu. susu. Produk dengan nilai pH Produk dengan nilai 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 dan Produk-produk kering dan produk beku (ikan, daging, produk beku (ikan, daging, telur, sayuran, serealia) telur, sayuran, serealia) Sandwich, pie daging Sandwich, 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 Minyak Minyak

29 Principle 2: determine the CCPs CCP: 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. CCPs relate to control of significant food safety hazards only.

30 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 Questions to be asked for each raw material used Questions to be asked for each raw material used YES NO YES Not CCP CCP for the raw materials for this hazard

31 Questions to be asked for each process stage (SNI, 1998)

32 Control Measure Any factor or activity which can be used to prevent, eliminate, or reduce food safety hazards to an acceptable level. 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 are specific for each hazard and can be either process or activities.

33 Control Measures Biological Hazards Control Measures Vegetative pathogens: Salmonella, Listeria monocytogenes, E.coli. Heat stable pre-formed toxins: S.aureus, B. cereus - 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

34 Control Measures Chemical Hazards Control Measures Cleaning chemicals Chemical additives - Use of non-toxic, food compatible cleaning compounds - separate storage - covered containers - Safe operating practices - written additive instructions - validation of levels through usage rates, sampling and testing

35 Control Measures Physical Hazards Control Measures Glass, wood, metal, etc in raw materials. Physical process cross- contaminants: pests - inspection – electronic or human - Washing - Air separation - X-ray detection - Metal detector, etc. - Pest control - Extermination (electric pest killers, poisoning, bait boxes, etc).

36 Critical Limit(s) CL are the criteria that differentiate between ‘safe’ and ‘unsafe’  safety boundaries. CL are the criteria that differentiate between ‘safe’ and ‘unsafe’  safety boundaries. Codex (1997): “a criterion which separates acceptability from unacceptability.” Codex (1997): “a criterion which separates acceptability from unacceptability.” Defined by regulations, safety standards and scientifically proven values. 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. Operational limits are often set a more stringent levels to provide a buffer or action zone for process management.

37 Critical limits can be: 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)

38 Buffer or action zone, for example: Buffer or action zone, for example: If in a heat process the critical limit is 72 o C for 2 minutes, the operating limit of 75 o C for 10 min may be set. Critical Limit(s)

39 CL harus spesifik dan jelas baik batas maksimum maupun minimum. CL harus spesifik dan jelas baik batas maksimum maupun minimum. Harus berkaitan dengan tindakan pengendalian (monitoring) dan mudah dipantau. Harus berkaitan dengan tindakan pengendalian (monitoring) dan mudah dipantau. Perusahaan harus memastikan bahwa CL dapat diaplikasikan pada operasi atau produk secara spesifik. Perusahaan harus memastikan bahwa CL dapat diaplikasikan pada operasi atau produk secara spesifik. CL harus terukur dan dapat divalidasi. CL harus terukur dan dapat divalidasi. Critical Limit(s)

40 When is deviation from normality unacceptable? ( i.e. establishment of Critical Limits )

41 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”.

42  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

43 Equipment and methods: 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

44 The equipment used for monitoring must be: 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

45 People assigned monitoring duties should be: 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 Monitoring

46 –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) 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

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

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


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