1. Food Safety Systems Management GS TS BS Lê Hoàng Ninh

2. Hazard Analysis Critical Control Point Cách tiếp cận hệ thống để xác định, đánh giá và kiểm soát các mối nguy có ý nghĩa làm mất an toàn thực phẩm. Risk Assessment and Management tool not unlike a FMEA (Failure Modes Effects Analysis).

3. NỀN TẢNG HACCP - Prerequisite Programs

4. Prerequisite Programs  Các chương trình / phương tiện kiểm soát các điều kiện vận hành trong nhá máy sản xuất thực phẩm  Tạo ra môi trường thích hợp để sản xuất thực phẩm an toàn.  Phải tương thích và có hiệu quả.  Phải được giám sát, theo dõi (requires documentation and records) – Internal Audit.  Các sai sót cứ lập lại rõ ràng không ủng hộ cho HACCP.

5. Raw Materials Control

6. Kiểm soát chất liệu thô (Raw Materials Control) Supplier licensing and registration must meet state and federal requirements (e.g. FDA Registration for Bioterrorism Act of 2002) Material Guarantee and Supplier Certificate of Insurance Supplier Food Safety Audit (second or third party) Raw Material Specifications - includes capability assessment on critical parameters Certificate of Analysis – on critical to quality parameters Supplier HACCP Risk Assessment Handling / Shipping Requirements

7. Kiểm soát chất liệu thô (Raw Materials Control Phải có hồ sơ thanh / kiểm tra các công cụ phương tiện tiếp nhận các nguyên liệu thô nầy (temperature, sanitation). Vật liệu được kiểm tra phải có chứng nhận Materials inspected upon receipt. Visual inspection, grading,... as your program has defined. Tồn trử phù hợp để đảm bảo chất lượng (allergen segregation, temperature, protected, chemicals stored separately and secured, etc).

8. Sanitation

9. Effective cleaning procedures for equipment and facility. Documented – SSOP (Sanitation Standard Operating Procedures) Defined frequency Chemicals approved for use in food facilities. Records – concentrations, times, temperatures. Sanitation monitoring – visual inspections, chemical or microbiological testing. Corrective actions for deficiencies.

10. Employee Training

11. Records of training required. Hygienic Practices Disease Control Cleanliness – outer garments, hand-washing, unsecured jewelry and other objects, use of gloves, hair and beard nets, eating, drinking, tobacco use, nail polish, etc. Manufacturing Controls Traffic flow to prevent cross contamination Ingredient / product handling to protect product Control measures (pH, cook time / temp, moisture, etc) Scheduling sequential runs to prevent cross contamination (as for allergens) Food Defense

12. Thiết kế và kiểm soát cơ sở (Facility Design and Control)

13. Thiết kế và kiểm sóat cơ sở Facility Design and Control Mặt đất Eliminate pest harborage areas Properly grade roads, yards, parking lots Tòa nhà Đủ khoảng không gian (Provide sufficient space for placement of equipment and storage of materials) Ngăn nhiễm chéo

14. Thiết kế và kiểm soát cơ sở Facility Design and Control Sàn, tường, trần nhà Floors, walls and ceilings cleaned and in good repair. Prevent condensate Ánh sáng đủ Adequate lighting Thông khí phù hợp Adequate ventilation Chất lượng nước Water Quality (potable, steam, ice, reclaimed water, cooling water, backflow prevention) Nghỉ dưỡng nhân viên / nhà vệ sinh Kiểm soát chất thải Giám sát theo dõi môi trường

15. Equipment Design and Maintenance

16. Designed and of materials and workmanship as to be adequately cleanable – meets standards (e.g. 3A Sanitary Standards). Installed with adequate space to allow for proper cleaning and maintenance and to prevent cross contamination. Properly maintained (records).

17. Pest Control

18. Prevention is key (design, maintenance and sanitation) Rodent control Insect control Bird / Bat Control

19. Traceability and Product Recovery

20. Documented program with written procedures to meet federal requirements. Program should include Product Identification / Lot coding Finished product distribution records retained beyond shelf life of product Responsible individuals and their roles Identification of Key Contacts – Internal, supplier customer Mock Recovery Program One step forward, one step back

21. Prerequisite programs are in place Let’s talk HACCP

22. Steps to HACCP Implementation Assemble the HACCP Team Describe the food and its distribution Describe the intended use and consumers of the food Develop a flow diagram which describes the process Verify the Flow Diagram

23. Multidisciplinary HACCP Team Quality Assurance Sanitation Engineering Microbiology Production Outside experts (if necessary)

24. Describe the Food / Distribution: Cheddar Cheese Formal Product name: Cheddar Cheese Food Safety Characteristics: pH (4.9 to 5.4) Packaging type: 42# Block, Vacuum sealed in ploy bag and stored in corrugated box Length of shelf life/storage temperature: 3-12 months when stored below 45°F Where it will be sold: Food Manufacturer Intended Consumers: Consumers of all ages Labeling instructions: Keep Refrigerated Intended use: Ready to eat product. May be used as ingredient. May be further processed into chunks or shredded.

25. Develop a Flow Diagram

26. Verify the Flow Diagram HACCP Team should perform an on-site review of the operation to verify the accuracy and completeness of the flow diagram. Take the diagram out to the production floor and walk through the steps. Review periodically, modify and update as necessary (annual review or when change to process occurs).

27. 1 - Conduct a Hazard Analysis Identify hazards at each processing step and for each ingredient and material used. Biological – such as pathogen Chemical – such as toxin Physical - such as glass Evaluate hazards to determine severity and likelihood to occur The hazard evaluation provides a basis for determining control measures such as CCP’s

28. 2 - Determine Critical Control Points A critical control point (CCP) is defined as a step at which control can be applied and is essential to prevent or eliminate a food safety hazard or reduce it to an acceptable level. Information from the hazard analysis should enable the HACCP team to identify which steps in the process are CCPs.

29. 3 – Establish Critical Limits A critical limit must be scientifically based and is a maximum and / or minimum value to which a biological, chemical or physical parameter must be controlled at a CCP to prevent, eliminate or reduce the food safety hazard to an acceptable level. Examples: Temperature, time, Water Activity, pH, safe tolerance level for drug residues

30. 4 – Establish Monitoring Procedures Monitoring is a planned sequence of observations or measurements used to assess whether a CCP is under control. Monitoring should produce an accurate record for use in verification. Where there is loss of control (a CCP limit is exceeded) there must be documented corrective action.

31. Monitoring Continuous is desirable (recording chart) but where not possible, frequency for monitoring must be established. Responsibility for monitoring must be assigned - Position title / work station

32. 5 - Establish Corrective Actions Corrective actions are procedures to be followed when a deviation occurs. Corrective actions must be specific. Halt production of product Isolate the affected product Return the process to control Determine the disposition of the product Records must be kept for a reasonable period after the shelf life of the product

33. 6 _ Establish Verification Procedures Establish procedures to verify that the system is working properly. Might include calibration and testing of monitoring equipment, demonstration of system performance, documented record review

34. 7 - Records Identify records that are being used to monitor control points Records of training Records at process step (recording charts, temperature records, etc) Deviation logs Verification and Validation Records Records to show changes to the HACCP Plan

35. Consider our example

36. Identify hazard at each step and for each material

37. 1 – Conduct Hazards Analysis Identify the hazards for each step of the process: Raw milk / receiving Identify the type of hazard: chemical, biological or physical Chemical – β-lactam (antibiotic) residue, pesticide Biological – Vegetative Pathogens, viruses, spoilage organisms Physical – Metal

38. Determine severity of each hazard and likelihood of occurrence Severity: Enteric pathogens such as E. coli 0157H7 and Salmonella cause severe health effects including death among children and elderly. Likelihood to occur: Likely that they will occur in raw milk supply Using this information, determine if this potential hazard is to be addressed in the HACCP Plan

39. Hazards Analysis (severity) Is the hazard identified at this step severe and of sufficient likelihood of occurrence to warrant it’s control? If Yes, go to next question. If no, identify the prerequisite program or procedure step, which reduces the likelihood or severity of the hazard to ensure that control at this step is not necessary.

40. Hazards Analysis (control) Does a control measure exist at this step to prevent, reduce or eliminate the likely occurrence of the hazard to an acceptable level? If yes, this step is a CCP. If no, identify where control exists. (Pasteurization Step – This step is a CCP).

41. Hazards Analysis (justify) Justification - Research or Reference Document that gives credence to your assumptions. Pasteurized Milk Ordinance, 2003 Revision, WDATCP 80.48

42. 2 - Determine Critical Control Points

43. 3 - Establish Critical Limits Critical Limits HTST Limits for raw milk pasteurization are defined in the PMO – minimum 161˚F / 15 seconds

44. 4 - Establish Monitoring Procedures Continuous chart monitoring of temperature and flow rate. Performed by Pasteurizer Operator in the Pasteurizer Room.

45. 5 - Establish Corrective Actions When minimum time or temperature requirement is not met, product automatically diverts to back to the balance tank prior to the HTST Pasteurizer. Forward flow is prevented. Product diversion must be indicated on Pasteurizer Recording chart. These instances should be carefully reviewed by Licensed Pasteurizer Operator.

46. 6 _ Establish Verification Procedures Daily: Proper performance of HTST is demonstrated after sanitation and before product (Cut In / Cut Out) and recorded on the continuous chart. Charts verified Licensed Pasteurizer Operator. Six months: Representative from WDA Tests Pasteurizer / time (maximum allowable flow for specified distance) and temperature. All controls are sealed. Records are retained by facility and state. Daily: Seal check – verify that all seals are intact. Record reviewed by Licensed Pasteurizer Operator.

47. 7 – Establish Records Pasteurizer Charts Seal Check Record WDA Pasteurizer Time / Seal Record. Other Equipment Calibration and testing records.

48. Identify CCP on Flowchart

49. HACCP Description Chart

50. References International Dairy Foods Association – HACCP Plant Manual, 2007 Edition Pasteurized Milk Ordinance, 2003 Revision WDATCP Chapters 60 and 80 USDA-FSIS HACCP Website