1. Food Safety Systems Management

2. Hazard Analysis Critical Control Point
A systematic approach to the identification , evaluation, and control of significant food safety hazards.
Risk Assessment and Management tool not unlike a FMEA (Failure Modes Effects Analysis).

3. Foundation of HACCP -Prerequisite Programs

4. Prerequisite Programs
Universal programs / procedures for controlling operational conditions of the plant
Create an environment suitable for the production of safe products.
Must be adequate and effective.
Must be monitored (requires documentation and records) – Internal Audit.
Repeated failure of a prerequisite program may indicate that decisions made in a Hazard Analysis are not supported.

5. Raw Materials Control

6. 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. Raw Materials Control
Documented inspection of sealed vehicle (temperature, sanitation) in which materials are received.
Materials inspected upon receipt. Visual inspection, grading, COA receipt, etc. as your program has defined.
Suitably stored to protect quality and integrity of goods. (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. Facility Design and Control

13. Facility Design and Control
Grounds
Eliminate pest harborage areas
Properly grade roads, yards, parking lots
Building
Provide sufficient space for placement of equipment and storage of materials
Prevent cross contamination

14. Facility Design and Control
Floors, walls and ceilings cleaned and in good repair.
Prevent condensate
Adequate lighting
Adequate ventilation
Water Quality (potable, steam, ice, reclaimed water, cooling water, backflow prevention)
Employee welfare / sanitary facilities
Waste control
Environmental monitoring

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: 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
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

51. Questions?