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:
Microbiological
Chemical
Physical
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.

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

6. Microbial Hazards
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 spp
Bacillus cereus
Brucella spp.
Camphylobacter jejuni
Clostridium botulinum
Clostridium perfringens
Escherichia coli
Listeria monocytogenes
Mycobacterium bovis
Salmonella spp.
Shigella spp.
Staphylococcus aureus
Vibrio cholerae
Vibrio parahaemolyticus
Vibrio vulcanificus
Yersinia 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
Small round structured viruses (e.g. Norwalk)
Rotavirus
Polio virus

12. Major parasites causing FBD
Anisakis
Ascaris
Clonorchis sinensis
Cryptosporodium
Cyclospora catetanensis
Diphyllobothorium
Echinococcus
Entamoeba histolytica
Fasciola hepatica
Giardia
Opisthorcis felineus
Opisthorcis viverrini
Sarcosporodium
Taenia
Toxoplasma
Trichinella

13. Bacterial growth curve

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

15. Example: 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 h
Sources: meat, poultry, milk, eggs, vegetables, shellfish, spices and herbs, untreated water.
Salmonella is heat sensitive
Pasteurization (70oC for 2 min) is sufficient to kill Salmonella in high moisture foods.

16. 2. Camphylobacter Causing camphylobacteriosis
Symptoms: fever, nausea, diarrhea, abdominal cramp
Person at high risks: babies, debilitated people
Incubation: 2-5 days
Heat sensitive
Major sources: frozen foods (meats and poultry).

17. Minimum infective dose
L. monocytogenes
High (100/g of food)
Salmonella (excluding S. typhi)
106
Salmonella typhi
10 – 100
Camphylobacter
About 500

18. Minimum toxic doses of bacterial toxins
S. aureus : 106 (cells/g)
C. botulinum :
B. cereus : 107 – 108

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, organochlorin Dioxins
Heavy metals: Cd, Hg, Pb
Metals: Al, Se, etc.
Food additives
Natural contaminants
Desinfectants
Mycotoxins
Etc.

23. Hazard Determination HAZARD
Is the presence of agent in raw material probable?
Is the presence of agent in line or environment probable?
YES NO NO
YES
No Hazard
Is an unacceptable survival, persistence or increase at this step probable?
YES
Is an unacceptable contamination at this step probable? NO
YES
No Hazard NO
YES
Is reduction, if any at a further step adequate? NO
HAZARD

24. Menentukan 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 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)
Unlikely
Occasionally
Probable
Common
(1)
(2)
(3)
(4)
Very High (4) 5 6 7 8
High (3) 4
Medium (2) 3
Low (1) 2

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

28. Contoh Produk dengan Berbagai Tingkat Risiko
Risiko Tinggi
Risiko Sedang
Risiko Rendah
Daging
Ikan mentah
Produk-produk olahan
susu.
Produk dengan nilai pH
4.6 atau diatasnya
Produk-produk yang
mengandung ikan,
daging, telur, sayur,
serealia.
Produk-produk kering dan
produk beku (ikan, daging,
telur, sayuran, serealia)
Sandwich, pie daging
Produk berbasis lemak
(margarine, coklat,
mayonaise, salad
dressing)
Produk dengan pH di
bawah 4.6 (asam)
Produk dengan kadar
gula tinggi (selai, sirup,
dll)
Produk – produk
konfeksioneri
Minyak

29. Principle 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.

30. 2. Determination of CCPs Critical control point decision tree
Questions to be asked for each raw material used
Q1. Is it likely that the raw material contains the hazard under
study at unacceptable levels?
YES NO
Not CCP
Q2. Will processing, including expected consumer use,
eliminate the hazard or reduce it to an acceptable level?
YES NO
CCP for the raw materials for this hazard
Not CCP

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.
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.
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.

37. Critical Limit(s) 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

38. Critical 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.

39. Critical 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.

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
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.

43. Monitoring 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.

44. Monitoring 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.

45. Monitoring 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

46. Corrective Actions
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)

47. Verification
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)

48. Verification 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

49. Verification
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