Food Safety Systems Management

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).

Foundation of HACCP -Prerequisite Programs

HACCP

Raw MaterialsControl

Sanitation

Facility Design

AndControl

EquipmentDesign

And Maintenance

PestControl

TraceabilityAnd

Recall

Employee Training

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.

Raw Materials Control

HACCP

Raw MaterialsControl

Sanitation

Facility Design

AndControl

EquipmentDesign

And Maintenance

PestControl

TraceabilityAnd

Recall

Employee Training

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

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).

Sanitation

HACCP

Raw MaterialsControl

Sanitation

Facility Design

AndControl

EquipmentDesign

And Maintenance

PestControl

TraceabilityAnd

Recall

Employee Training

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.

Employee Training

HACCP

Raw MaterialsControl

Sanitation

Facility Design

AndControl

EquipmentDesign

And Maintenance

PestControl

TraceabilityAnd

Recall

Employee Training

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

Facility Design and Control

HACCP

Raw MaterialsControl

Sanitation

Facility Design

AndControl

EquipmentDesign

And Maintenance

PestControl

TraceabilityAnd

Recall

Employee Training

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

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

Equipment Design and Maintenance

HACCP

Raw MaterialsControl

Sanitation

Facility Design

AndControl

EquipmentDesign

And Maintenance

PestControl

TraceabilityAnd

Recall

Employee Training

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).

Pest Control

HACCP

Raw MaterialsControl

Sanitation

Facility Design

AndControl

EquipmentDesign

And Maintenance

PestControl

TraceabilityAnd

Recall

Employee Training

Pest Control

Prevention is key (design, maintenance and sanitation)

Rodent control Insect control Bird / Bat Control

Traceability and Product Recovery

HACCP

Raw MaterialsControl

Sanitation

Facility Design

AndControl

EquipmentDesign

And Maintenance

PestControl

TraceabilityAnd

Recall

Employee Training

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

Prerequisite programs are in place

Let’s talk HACCP

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

Multidisciplinary HACCP Team

Quality Assurance Sanitation Engineering Microbiology Production Outside experts (if necessary)

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.

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

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).

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

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.

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

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.

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

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

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

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

Consider our example

Identify hazard at each step and for each material

Raw Milk Receiving

Raw Milk, Water

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

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

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.

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).

Hazards Analysis (justify)

Justification - Research or Reference Document that gives credence to your assumptions. Pasteurized Milk Ordinance, 2003 Revision, WDATCP 80.48

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

3 - Establish Critical Limits

Critical Limits HTST Limits for raw milk pasteurization are

defined in the PMO – minimum 161˚F / 15 seconds

4 - Establish Monitoring Procedures

Continuous chart monitoring of temperature and flow rate.

Performed by Pasteurizer Operator in the Pasteurizer Room.

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.

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.

7 – Establish Records

Pasteurizer Charts Seal Check Record WDA Pasteurizer Time / Seal Record. Other Equipment Calibration and testing

records.

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

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

References

International Dairy Foods Association – HACCP Plant Manual, 2007 Edition

Pasteurized Milk Ordinance, 2003 Revision WDATCP Chapters 60 and 80 USDA-FSIS HACCP Website

Questions?