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Food Safety Systems Management
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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).
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Foundation of HACCP -Prerequisite Programs
HACCP
Raw MaterialsControl
Sanitation
Facility Design
AndControl
EquipmentDesign
And Maintenance
PestControl
TraceabilityAnd
Recall
Employee Training
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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.
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Raw Materials Control
HACCP
Raw MaterialsControl
Sanitation
Facility Design
AndControl
EquipmentDesign
And Maintenance
PestControl
TraceabilityAnd
Recall
Employee Training
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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
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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).
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Sanitation
HACCP
Raw MaterialsControl
Sanitation
Facility Design
AndControl
EquipmentDesign
And Maintenance
PestControl
TraceabilityAnd
Recall
Employee Training
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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.
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Employee Training
HACCP
Raw MaterialsControl
Sanitation
Facility Design
AndControl
EquipmentDesign
And Maintenance
PestControl
TraceabilityAnd
Recall
Employee Training
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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
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Facility Design and Control
HACCP
Raw MaterialsControl
Sanitation
Facility Design
AndControl
EquipmentDesign
And Maintenance
PestControl
TraceabilityAnd
Recall
Employee Training
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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
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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
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Equipment Design and Maintenance
HACCP
Raw MaterialsControl
Sanitation
Facility Design
AndControl
EquipmentDesign
And Maintenance
PestControl
TraceabilityAnd
Recall
Employee Training
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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).
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Pest Control
HACCP
Raw MaterialsControl
Sanitation
Facility Design
AndControl
EquipmentDesign
And Maintenance
PestControl
TraceabilityAnd
Recall
Employee Training
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Pest Control
Prevention is key (design, maintenance and sanitation)
Rodent control Insect control Bird / Bat Control
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Traceability and Product Recovery
HACCP
Raw MaterialsControl
Sanitation
Facility Design
AndControl
EquipmentDesign
And Maintenance
PestControl
TraceabilityAnd
Recall
Employee Training
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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
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Prerequisite programs are in place
Let’s talk HACCP
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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
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Multidisciplinary HACCP Team
Quality Assurance Sanitation Engineering Microbiology Production Outside experts (if necessary)
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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.
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Develop a Flow Diagram
Raw Milk Receiving
Raw Milk Storage
HTST
Cheese Vat
Drain Table
Block Press
Vacuum Bagger
Metal Detector
Box
RefrigeratedStorage
Raw Milk, Water
Filter
Direct Set Culture,Enzymes, Color,
Water
Salt
Bag
Box
Curd
Whey
Whey
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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).
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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
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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.
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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
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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.
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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
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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
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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
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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
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Consider our example
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Identify hazard at each step and for each material
Raw Milk Receiving
Raw Milk, Water
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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
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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
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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.
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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).
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Hazards Analysis (justify)
Justification - Research or Reference Document that gives credence to your assumptions. Pasteurized Milk Ordinance, 2003 Revision, WDATCP 80.48
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Process Step
Category
Identify the
specific hazard
Q1. Is the hazard identified at this step severe and of sufficient likelihood of occurrence to warrant it’s control? If “yes”,
proceed to Q3-Q4
If “no”, stop
and document at Q2.
Q2. 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.
Q3-Q4. 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 = ccp If “no”, indicate where control exists.
Q5. Could contamination with identified hazard(s) occur in excess of acceptable levels or could they increase to unacceptable levels? If yes = ccp
Q6. Will a subsequent step eliminate hazard(s) or reduce the likely occurrence to an acceptable level? If no = ccp
CCP#
Justification Research reference document
Raw Milk Receiving
Biological
Vegatative Pathogens, Spoilage organisms
Yes No, HTST Pasteurizer Yes Yes 2 PMO, 2003
Chemical
B-lactam drug residues
Yes Yes Yes No 1 WDATCP 60.19
Physical
Metal No Filter
Raw Milk Storage (silo)
Biological
Vegetative Pathogens, Spoilage organisms
No Store at <42°F,
Chemical
No
Physical
No
2 - Determine Critical Control Points
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3 - Establish Critical Limits
Critical Limits HTST Limits for raw milk pasteurization are
defined in the PMO – minimum 161˚F / 15 seconds
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4 - Establish Monitoring Procedures
Continuous chart monitoring of temperature and flow rate.
Performed by Pasteurizer Operator in the Pasteurizer Room.
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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.
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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.
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7 – Establish Records
Pasteurizer Charts Seal Check Record WDA Pasteurizer Time / Seal Record. Other Equipment Calibration and testing
records.
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Identify CCP on Flowchart
Raw Milk Receiving
Raw Milk Storage
HTST
Vat
Drain Table
Block Press
Vacuum Bagger
Metal Detector
Box
RefrigeratedStorage
CCP 1Antibiotic Screen
Raw Milk, Water
Filter
Direct Set Culture,Chymosin, Color,
Water
Salt
Bag
Box
Curd
Whey
Whey
CCP 2Pasteurization
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HACCP Description Chart
HACCP DESCRIPTION CHART
Cheddar Cheese
CCP/
Process Step
Hazard/ Concern
Control Point
Critical Limit
Monitoring/ Frequency
Records/ Location
Person
Responsible
Corrective Action
Verification
Person
Responsible CCP1 Chemical B-lactam
screening of raw milk
Below limit of test
Each Milk Load received
Daily Drug Residue Test record QA
Lab Technician Load rejected Daily - Positive and negative controls Calibration of test equipment
QA Manager reviews records
CCP2 Microbiological HTST Pasteurization
161°F / 15 seconds
Continuous Chart Recorder
Pasteurizer Chart / Chart Board in QA Office
Pasteurizer Operator
Product flow automatically diverts to waste if temperature of product is below set point or flow increases beyond maximum set point.
Daily demonstration of cut in / cut out for low temperature / high flow Daily seal check Six month Pasteurizer Time & Seal
QA Manager reviews Pastuerizer Chart QA Manager Reviews Seal Check Record WDA conducts Pasteurizer Test
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References
International Dairy Foods Association – HACCP Plant Manual, 2007 Edition
Pasteurized Milk Ordinance, 2003 Revision WDATCP Chapters 60 and 80 USDA-FSIS HACCP Website
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Questions?