Transcript Food Safety Systems Management

Food Safety Systems
Management
Hazard Analysis Critical
Control Point
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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
Materials
Control
Facility
Design
And
Control
Sanitation
Equipment
Design
And
Maintenance
Pest
Control
Employee
Training
Traceability
And
Recall
Prerequisite Programs
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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
Materials
Control
Facility
Design
And
Control
Sanitation
Equipment
Design
And
Maintenance
Pest
Control
Employee
Training
Traceability
And
Recall
Raw Materials Control
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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
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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
Materials
Control
Facility
Design
And
Control
Sanitation
Equipment
Design
And
Maintenance
Pest
Control
Employee
Training
Traceability
And
Recall
Sanitation
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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
Materials
Control
Facility
Design
And
Control
Sanitation
Equipment
Design
And
Maintenance
Pest
Control
Employee
Training
Traceability
And
Recall
Employee Training
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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
Materials
Control
Facility
Design
And
Control
Sanitation
Equipment
Design
And
Maintenance
Pest
Control
Employee
Training
Traceability
And
Recall
Facility Design and Control
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Grounds
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Eliminate pest harborage areas
Properly grade roads, yards, parking lots
Building
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Provide sufficient space for placement of
equipment and storage of materials
Prevent cross contamination
Facility Design and Control
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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
Materials
Control
Facility
Design
And
Control
Sanitation
Equipment
Design
And
Maintenance
Pest
Control
Employee
Training
Traceability
And
Recall
Equipment
Design and Maintenance
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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
Materials
Control
Facility
Design
And
Control
Sanitation
Equipment
Design
And
Maintenance
Pest
Control
Employee
Training
Traceability
And
Recall
Pest Control
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Prevention is key (design, maintenance and
sanitation)
Rodent control
Insect control
Bird / Bat Control
Traceability
and Product Recovery
HACCP
Raw
Materials
Control
Facility
Design
And
Control
Sanitation
Equipment
Design
And
Maintenance
Pest
Control
Employee
Training
Traceability
And
Recall
Traceability
and Product Recovery
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Documented program with written procedures to
meet federal requirements.
Program should include
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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
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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
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Quality Assurance
Sanitation
Engineering
Microbiology
Production
Outside experts (if necessary)
Describe the Food /
Distribution: Cheddar Cheese
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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,
Water
Raw Milk
Receiving
Salt
Drain Table
Whey
Curd
Filter
Raw Milk Storage
Block Press
Bag
HTST
Direct Set Culture,
Enzymes, Color,
Water
Cheese Vat
Vacuum Bagger
Metal Detector
Box
Box
Refrigerated
Storage
Whey
Verify the Flow Diagram
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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.
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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
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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
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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
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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
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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
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Corrective actions are procedures to be
followed when a deviation occurs.
Corrective actions must be specific.
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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
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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
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Identify records that are being used to
monitor control points
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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,
Water
Raw Milk
Receiving
1 – Conduct Hazards Analysis
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Identify the hazards for each step of the
process: Raw milk / receiving
Identify the type of hazard: chemical,
biological or physical
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Chemical – β-lactam (antibiotic) residue,
pesticide
Biological – Vegetative Pathogens, viruses,
spoilage organisms
Physical – Metal
Determine severity of each hazard
and likelihood of occurrence
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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)
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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)
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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)
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Justification - Research or Reference
Document that gives credence to your
assumptions. Pasteurized Milk Ordinance,
2003 Revision, WDATCP 80.48
2 - Determine Critical Control Points
Process Step
Raw Milk
Receiving
Category
Biological
Chemical
Physical
Raw Milk
Storage
(silo)
Biological
Identify the
specific
hazard
Q1. Is the hazard
identified at this
step severe and of
sufficient
likelihood of
occurrence to
warrant it’s
control?
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If “yes”,
proceed to
Q3-Q4
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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?
Q6. Will a
subsequent
step
eliminate
hazard(s) or
reduce the
likely
occurrence
to an
acceptable
level?
CCP#
Justification
Research
reference
document
If no = ccp
If yes = ccp
Vegatative
Pathogens,
Spoilage
organisms
B-lactam
drug
residues
Metal
Yes
No, HTST Pasteurizer
Yes
Yes
2
PMO, 2003
Yes
Yes
Yes
No
1
WDATCP
60.19
No
Filter
Vegetative
Pathogens,
Spoilage
organisms
No
Store at
<42°F,
Chemical
No
Physical
No
3 - Establish Critical Limits
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Critical Limits
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HTST Limits for raw milk pasteurization are
defined in the PMO – minimum 161˚F / 15
seconds
4 - Establish Monitoring
Procedures
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Continuous chart monitoring of temperature
and flow rate.
Performed by Pasteurizer Operator in the
Pasteurizer Room.
5 - Establish Corrective Actions
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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
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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
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Pasteurizer Charts
Seal Check Record
WDA Pasteurizer Time / Seal Record.
Other Equipment Calibration and testing
records.
Identify CCP on Flowchart
Raw Milk,
Water
Raw Milk
Receiving
Salt
CCP 1
Antibiotic Screen
Drain Table
Curd
Filter
Block Press
Raw Milk Storage
Bag
HTST
Vacuum Bagger
Metal Detector
CCP 2
Pasteurization
Direct Set Culture,
Chymosin, Color,
Water
Vat
Whey
Box
Box
Refrigerated
Storage
Whey
HACCP Description Chart
HACCP DESCRIPTION CHART
Cheddar Cheese
CCP/
Process
Hazard/
Step
Concern
CCP1
Chemical
CCP2
Control Point
B-lactam
screening of
raw milk
Microbiological HTST
Pasteurization
Critical
Limit
Below limit
of test
161°F / 15
seconds
Monitoring/
Frequency
Each Milk
Load
received
Records/
Location
Daily Drug
Residue Test
record
Continuous
Chart
Recorder
QA
Pasteurizer
Chart / Chart
Board in QA
Office
Person
Responsible
Corrective Action
Lab Technician Load rejected
Pasteurizer
Operator
Product flow
automatically diverts to
waste if temperature of
product is below set
point or flow increases
beyond maximum set
point.
Verification
Daily - Positive and
negative controls
Calibration of test
equipment
Daily demonstration
of cut in / cut out for
low temperature /
high flow
Person
Responsible
QA Manager
reviews records
QA Manager
reviews Pastuerizer
Chart
Daily seal check
QA Manager
Reviews Seal
Check Record
Six month
Pasteurizer Time &
Seal
WDA conducts
Pasteurizer Test
References
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International Dairy Foods Association –
HACCP Plant Manual, 2007 Edition
Pasteurized Milk Ordinance, 2003 Revision
WDATCP Chapters 60 and 80
USDA-FSIS HACCP Website
Questions?