2HAZARD ???A biological, chemical, or physical agent in food with the potential to cause an adverse health effect (Codex, 1997).Hazard:MicrobiologicalChemicalPhysicalFood-borne disease (FBD):penyakit menular atau keracunan yang oleh mikroba atau agen yang masuk kedalam tubuh melalui makanan yang dikonsumsi (WHO).
3Principle 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.
4Information needed for hazard analysis the agents that could be present in the food under studythe severity of the effects and the likelihood of their occurrencethe levels that could cause adverse health effectsthe conditions that could lead to unacceptable levels
14Food-Borne Disease Bacteria InfectionInvasion of bacteria and theirs multiplication within the body.E.g.: Salmonella, Campylobacter, E. coli, V. parahaemolyticus, V. cholerae, Y. enterolitica, L monocytogenesIntoxicationCaused by consuming toxin produced in food.E.g.: Bacillus cereus, C. botulinum, S. aureus, E. coli
15Example: 1. Salmonella Causing Salmonellosis Main symptoms: diarrhea, fever, vomiting, abdominal cramps.Persons at high risk: young, old, pregnant woman, underlying disease states.Incubation period: 12 – 36 hSources: meat, poultry, milk, eggs, vegetables, shellfish, spices and herbs, untreated water.Salmonella is heat sensitivePasteurization (70oC for 2 min) is sufficient to kill Salmonella in high moisture foods.
162. Camphylobacter Causing camphylobacteriosis Symptoms: fever, nausea, diarrhea, abdominal crampPerson at high risks: babies, debilitated peopleIncubation: 2-5 daysHeat sensitiveMajor sources: frozen foods (meats and poultry).
17Minimum infective dose L. monocytogenesHigh (100/g of food)Salmonella (excluding S. typhi)106Salmonella typhi10 – 100CamphylobacterAbout 500
18Minimum toxic doses of bacterial toxins S. aureus : 106 (cells/g)C. botulinum :B. cereus : 107 – 108
19Temperature range for the growth of patogenic bacteria
20Temperature range for the growth of toxigenic moulds
22Chemical Hazards Pesticides: PCBs, organochlorin Dioxins Heavy metals: Cd, Hg, PbMetals: Al, Se, etc.Food additivesNatural contaminantsDesinfectantsMycotoxinsEtc.
23Hazard Determination HAZARD Is the presence of agent in raw material probable?Is the presence of agent in line or environment probable?YESNONOYESNo HazardIs an unacceptable survival, persistence or increase at this step probable?YESIs an unacceptable contamination at this step probable?NOYESNo HazardNOYESIs reduction, if any at a further step adequate?NOHAZARD
24Menentukan signifikansi bahaya 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 terjadiRisiko sedang: dapat terjadiRisiko rendah: cenderung tidak terjadi
26Matriks 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)5678High (3)4Medium (2)3Low (1)2
28Contoh Produk dengan Berbagai Tingkat Risiko Risiko TinggiRisiko SedangRisiko RendahDagingIkan mentahProduk-produk olahansusu.Produk dengan nilai pH4.6 atau diatasnyaProduk-produk yangmengandung ikan,daging, telur, sayur,serealia.Produk-produk kering danproduk beku (ikan, daging,telur, sayuran, serealia)Sandwich, pie dagingProduk berbasis lemak(margarine, coklat,mayonaise, saladdressing)Produk dengan pH dibawah 4.6 (asam)Produk dengan kadargula tinggi (selai, sirup,dll)Produk – produkkonfeksioneriMinyak
29Principle 2: determine the CCPs 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.
302. Determination of CCPs Critical control point decision tree Questions to be asked for each raw material usedQ1. Is it likely that the raw material contains the hazard understudy at unacceptable levels?YESNONot CCPQ2. Will processing, including expected consumer use,eliminate the hazard or reduce it to an acceptable level?YESNOCCP for the raw materials for this hazardNot CCP
31Questions to be asked for each process stage (SNI, 1998)
32Control MeasureAny 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.
33Control Measures Biological Hazards Control Measures Vegetative pathogens: Salmonella, Listeria monocytogenes, E.coli.Heat stable pre-formed toxins: S.aureus, B. cereusLethal heat treatment during packagingTemperature controlIntrinsic factors: pH, awIntact packagingSecure building, etc.effective supplier process and testinghand wash procedurescontrol of time
34Control Measures Chemical Hazards Control Measures Cleaning chemicals Chemical additivesUse of non-toxic, food compatible cleaning compoundsseparate storagecovered containersSafe operating practiceswritten additive instructionsvalidation of levels through usage rates, sampling and testing
35Control Measures Physical Hazards Control Measures Glass, wood, metal, etc in raw materials.Physical process cross-contaminants: pestsinspection – electronic or humanWashingAir separationX-ray detectionMetal detector, etc.Pest controlExtermination (electric pest killers, poisoning, bait boxes, etc).
36Critical Limit(s)CL are the criteria that differentiate between ‘safe’ and ‘unsafe’ safety boundaries.Codex (1997): “a criterion which separates acceptability from unacceptability.”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.
37Critical Limit(s) Critical limits can be: Values of pH, aw, temperature, timeAbsorbed radiation doseLevels of disinfectant or antimicrobial agentsLevel of cleanlinessLimits of residuesLimits of contaminantsLimits of microbiological criteriaSensory parameters: visual appearance and texture
38Critical Limit(s) Buffer or action zone, for example: If in a heat process the critical limit is 72oC for 2 minutes, the operating limit of 75oC for 10 min may be set.
39Critical Limit(s)CL harus spesifik dan jelas baik batas maksimum maupun minimum.Harus berkaitan dengan tindakan pengendalian (monitoring) dan mudah dipantau.Perusahaan harus memastikan bahwa CL dapat diaplikasikan pada operasi atau produk secara spesifik.CL harus terukur dan dapat divalidasi.
40When is deviation from normality unacceptable? ( i.e. establishment of Critical Limits )
41MonitoringObservation 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”.
42MonitoringMonitoring of the CCPs is carried through tests or observationsThe 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.
43Monitoring 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.
44Monitoring The equipment used for monitoring must be: Accurate: needs to be calibrated.Easy to useAccessible: having the equipment close to the point of testing and must be quick in terms of providing results.
45Monitoring People assigned monitoring duties should be: Familiar with the processTrained in the monitoring techniquesTrained in HACCP awarenessUnbiased in monitoring and reportingTrained in the corrective action procedures: what to do when monitoring indicates loss of control
46Corrective ActionsThe action should be taken when the result shows a deviation from the critical limitAdjust the process to bring it back under controlDeal with the material produced under the deviation periodHold on the productReworkRelease product after sampling and testingDirect into less sensitive products, e.g. animal feedClarify to all personnel involve (what to do and how to do it)
47VerificationThe 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)
48Verification Review of HACCP system and records Review of unacceptable deviations and their follow upConfirmation that CCPs are controlledReview of consumer complaintsEnd-product testingReview of validation data
49VerificationWhenever 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