Comprehensive Food Safety System Management Guide

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. Sanitation • 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. Employee Training • 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 sởFacility 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 sởFacility 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. Equipment Design and Maintenance • 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. Pest Control • Prevention is key (design, maintenance and sanitation) • Rodent control • Insect control • Bird / Bat Control

19. Traceability and Product Recovery

20. Traceability and Product Recovery • 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