KakkoL GMP in Food PDF

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Leila Kakko

Tampere University of Applied science


TRADITIONAL FOOD IN COMBATING FOODBORNE
PATHOGENS 2011
World Food Programme
Food quality control is necessary to ensure that food
aid supplies are safe, of good quality and available in
adequate amounts, in time, at affordable prices to
ensure an acceptable nutritional and health status for
all population groups
Food Quality Systems - HACCP, GMP, ISO & Codex
Alimentarius
Terms
GMP (Good Manufacturing Practice) is a system to
ensure that products meet food safety, quality and
legal requirements.
HACCP (Hazard Analysis and Critical Control Point)
can be part of GMP and is a systematic program to
assure food safety.
GMP video
http://www.youtube.com/watch?v=4wTIP-q2-sw
GMP
Water
Facilities for personal
hygiene
Air quality and ventilation
Lighting
Storage
Operation controls
Time and temperature
control
Cross contamination
Raw materials
Packaging
Product information
Traceability
Pest control
Personal hygiene
No blower!
Transportation
Training
Food marketing
Food services
Verification
GMP
GMP contains ten principles that introduces
employees to critical behaviors established by FDA
and industry leaders to maintain good manufacturing
practices in plants.
Ten GMP Principles
1. Writing procedures
2. Following written procedures
3. Documenting for traceability
4. Designing facilities and equipment
5. Maintaining facilities and equipment
6. Validating work
7. Job competence
8. Cleanliness
9. Component control
10. Auditing for compliance
HACCP
HACCP is an acronym for Hazard Analysis and
Critical Control Point
Food safety program
Developed in 1960s for NASA
To ensure the safety of food products that were to be
used by the astronauts in the space program.
HACCP
A systematic process control system designed to
determine potential hazards and implement control
measures to reduce or eliminate the likelihood of their
occurrence
Focus is on hazard prevention, rather than hazard
detection
HACCP
Basically:
Determining the step or steps that the really serious
problems occur or could occur in your production
process
Monitoring these steps so you know there are problems
Fixing any problems that arise
How to make HACCP work?
Must make the commitment
Must let everyone get involved
Must be able to document all production steps
Must be able to monitor simple / validate
Prerequisite Programs
Applicable to the overall manufacturing environment
Includes Good Manufacturing Practices
Foundation for an effective HACCP program
Prerequisite Programs
Prerequisite programs to have in place before starting
HACCP
Procedures, including GMPs, that address operational
conditions providing the foundation for the HACCP
system
Examples of Common Prerequisite Programs
Facilities
Production equipment
Standard operating procedures
Supplier controls
Production specification
Personnel policies
Traceability and recalls
Eight Key Sanitation Conditions and
Practices:
Safety of water
Condition and cleanliness of food-contact
surfaces
Prevention of cross-contamination
Maintenance of hand-washing, hand-sanitizing
and toilet facilities
Protection from adulterants
Labeling, storage and use of toxic compounds
Employee health conditions
Exclusion of pests
HACCP process 1
Preliminary Steps:
Task 1 - Establish a HACCP team
Task 2 - Describe the product
Task 3 - Identify the product's intended use
Task 4 - Draw up the commodity flow diagram
Task 5 - On site confirmation of flow diagram
Basic Flow Diagram Example
Incoming materials
Processing
Packaging
Storage
Distribution
HACCP process 2
Task 6 - Identify and analyse hazard(s) - (Principle 1)
Task 7 - Determine the critical control points (ccps) -
(Principle 2).
Task 8 - Establish critical limits for each ccp - (Principle 3)
Task 9 - Establish a monitoring procedure - (Principle 4)
Task 10 - Establish corrective action - (Principle 5)
Task 11 - Verify the HACCP plan - (Principle 6)
Task 12 - Keep record - (Principle 7)
1. Conduct a Hazard Analysis
Hazard identification
Hazard evaluation
Likelihood of occurrence
Severity
Safety concerns must be differentiated from
quality concerns.
Hazard Identification
List potential hazards at each operational step in
the process from receipt of raw materials through
release of the finished product
All potentially significant hazards must be
considered
Hazards List
Biological Hazards
Pathogenic microorganisms (e.g., bacteria, viruses)
Parasites
Chemical Hazards
Natural toxins
Chemicals
Pesticides
Drug residues
Unapproved food and color additives
Decomposition (safety only, e.g., histamine)
Physical Hazards
Metal, glass, etc.
Hazard Analysis
A hazard must be controlled if it is:
Reasonably likely to occur, and
Likely to result in an unacceptable risk to
consumers
e.g., Listeria monocytogenes in ready-to-eat
food
Control Measures
Actions and activities that can be used to prevent
or eliminate a food safety hazard or reduce it to an
acceptable level
Bacterial Hazards
Time/temperature control
Heating and cooking processes
Cooling and freezing
Fermentation and/or pH control
Addition of salt or other preservatives
Drying
Source control
2. Determine the Critical Control Points
A point, step or procedure at which control can be
applied and is essential to prevent or eliminate a
food-safety hazard or reduce it to an acceptable
level
Control Point
Any point, step or procedure at which biological,
physical or chemical factors can be controlled
CCPs vs. Control Points
Control Points
Points where quality factors can be controlled
Points where non-HACCP regulatory
requirements can be controlled
CCPs
Points where food-safety hazards can be
controlled
CCPs are product- and process specific
They may change with differences in:
Plant layout
Formulation
Process flow
Equipment
Ingredient selection
Sanitation and support programs
CCP Decision Tree
Q1: Does a control measure(s) exist at this step or
subsequent steps in the process flow for the identified
hazard?
Q2: Does this step eliminate or reduce the likely occurrence
of a significant hazard to an acceptable level?
Q3: Could contamination with an identified hazard or
hazards occur in excess of acceptable levels, or could these
increase to unacceptable levels?
Q4: Will a subsequent step eliminate the identified
hazard(s) or reduce the likely occurrence to an acceptable
level?
3. Establish Critical Limits
Critical Limit
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 to an acceptable level, the occurrence of a
food-safety hazard
Options for Controlling Hazards
Often a variety of options exist for controlling a
particular hazard
The selection of the best control option and critical
limit is often driven by practicality and experience
4. Critical Control Point Monitoring
To conduct a planned sequence of observations or
measurements to assess whether a CCP is under
control and to produce an accurate record for
future use in verification
Purpose of Monitoring
To track the operation of the process and enable
the identification of trends toward a critical limit
that may trigger process adjustments
To identify when there is loss of control (a
deviation occurs at a CCP), and
To provide written documentation of the process
control system
Monitoring
What: Usually a measurement or observation to
assess if the CCP is operating within the critical limit
How: Usually physical or chemical measurements (for
quantitative critical limits) or observations (for
qualitative critical limits). Needs to be real-time and
accurate.
When (frequency): Can be continuous or intermittent
Who: Someone trained to perform the specific
monitoring activity
What will be Monitored?
Measuring a characteristic of a product or
process to determine compliance with a
critical limit
Cold-storage temperature
pH of an acidifying ingredient
Line speed
Monitoring
Must provide rapid results
Microbiological testing is seldom effective
Physical and chemical measurements are
preferred monitoring methods
Time and temperature
Water activity
Acidity (pH)
Sensory examination
Monitoring
Examples of monitoring equipment
Thermometers
Clocks
pH meters
Water activity meters
Monitoring Frequency
Continuous monitoring is preferred:
Continuous monitoring procedures:
Temperature recording chart
Metal detector
Dud detector
Continuous records need to be observed
periodically
Monitoring Frequency
Non-continuous Monitoring :
Non-continuous monitoring must be used when
continuous monitoring is not possible
Frequency of non-continuous monitoring
How much does the process normally vary?
How close are normal values to the critical limit?
How much product is the processor prepared to risk if
the critical limit is exceeded?
Who will Monitor?
Those responsible for monitoring should:
Be trained in CCP monitoring techniques
Fully understand the importance of CCP
monitoring
Have ready access to the monitoring activity
Accurately report each monitoring activity
Immediately report critical limit infractions so
that immediate corrective actions can be taken
5. Establish Corrective Actions
Procedures to be followed when a deviation
occurs
Options Include:
Isolating and holding product for safety
evaluation
Diverting the affected product or ingredients to
another line where deviation would not be
considered critical
Reprocessing
Destroying product
Corrective Action Components
To correct and eliminate the cause of
the deviation and restore process
control
Bring CCP back under control
Determine cause of deviation to prevent future
recurrence
To identify the product that was produced
during the process deviation and determine
its disposition
6. Establish Verification Procedures
Those activities, other than monitoring, that
determine the validity of the HACCP plan and that
verify the system is operating according to the plan
Only marked is done
Verification provides a level of confidence that the
HACCP plan:
is based on solid scientific principles,
is adequate to control the hazards associated with the
product and process, and
is being followed
Elements of Verification
Validation
CCP verification activities
Calibration of monitoring devices
Calibration record review
Targeted sampling and testing
CCP record review
HACCP system verification
Observations and reviews
Microbiological end-product testing
Regulatory agencies
Validation
The element of verification focused on collecting and
evaluating scientific and technical information to
determine if the HACCP plan, when properly
implemented, will effectively control the hazards
Who validates the HACCP plan?
HACCP team
Individual qualified by training or experience
What does validation involve?
A scientific and technical review of the rationale behind
each part of the HACCP plan from hazard analysis
through each CCP verification strategy
Validation Frequency
Initially
When factors warrant, e.g.,
Changes in raw materials
Changes in product or process
Adverse review findings
Recurring deviations
New information on hazards or control measures
On-line observations
New distribution or consumer handling practices
Verification of CCPs
Calibration
Calibration record review
Targeted sampling and testing
CCP record review
HACCP System Verification
Determines if the HACCP plan is being followed
Annually
Occurrence of a system failure or significant change in
product or process
Verification Activities of the HACCP System
Check the accuracy of the product description and
flow chart
Check that CCPs are monitored as required by the
HACCP plan
Check that processes are operating within
established critical limits
Check that records are completed accurately and at
the time intervals required
Verification Procedures by an Agency Include:
Review of the HACCP plan and any modification
Review of CCP monitoring records
Review of corrective action records
Review of verification records
Visual inspection of operations to determine if
the HACCP plan is followed and records are
properly maintained
Random sample collection and analysis
7. Establish record-keeping and
documentation procedures
1. HACCP plan and support documentation used in
developing the plan
2. Records of CCP monitoring
3. Records of corrective action
4. Records of verification activities
Four Kinds of HACCP Records:
CCP Monitoring Records
Kept to demonstrate control at CCPs
Used to determine if critical limits have been violated
Verification Records
Modifications of the HACCP Plan
Audits of supplier compliance with guarantees or
certifications
Calibration records
Microbiological tests
In-house, on-site inspections
Equipment evaluation tests
Record Monitoring Information
Monitoring information should be recorded at the
time the observation is made
Computerized records: Include controls to ensure that
records are authentic, accurate and protected from
unauthorized changes
Review: All monitoring records of critical control
points shall occur within 1 week of the day the records
are made
Advantages of HACCP
Focus on identifying and preventing hazards from
contaminating food
Based on sound science
Permits more effective and efficient government
oversight
Places responsibility for ensuring food safety on
the processor or distributor
Helps companies compete more effectively in the
marketplace
Benefits of HACCP
The main benefits of HACCP are:
S aves your business money in the long run
A voids you poisoning your customers
F ood safety standards increase
E nsures you are compliant with the law
F ood quality standards increase
Organises your process to produce safe food
Organises your staff promoting teamwork and efficiency
Due diligence defence in court.
HACCPEuropa.com 2010
Some links
http://foodquality.wfp.org/FoodSafetyandHygiene/tab
id/118/Default.aspx
http://www.foodallergens.info/Manufac/GMP.html
HACCP - Making Food Products Safe, Part 1
http://www.youtube.com/watch?v=7nbjd_TnU8o
HACCP -Making Food Products Safe, Part 2
http://www.youtube.com/watch?v=gRJ7q_2Vkrc&fe
ature=related

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