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ISO 22000 - Food Safety
Management System and
HACCP Implementation
Who is ISO
• ISO (International Organization for Standardization)
is a network of standards institutes from 164
countries with a central office in Geneva,
Switzerland, that coordinates the system
• Member countries work together to develop and
approve standards
• ISO is a non-governmental organization that forms a
bridge between the public and private sectors and is
the largest standards organization in the world
The ISO system
156 national members
50,000 experts
more than 16,000
published standards
100 new standards each
month
3000 technical bodies
ISO 22000 Family of Standards
• Initiated in 2001
• Standards
ISO 22000:2005 – Food safety management system
– Requirements
ISO 22003:2007 - Requirements for bodies providing
audit and certification of food safety management
systems
ISO TS 22004:2005 - Guidance on the application of
ISO 22000
ISO 22005 – Traceability in the feed and food chain
ISO 22000
• It is a food safety management system (FSMS)
• It is aligned with ISO 9001 to enhance compatibility
with existing management system
• It ensure safety along the food chain, up to the point of
final consumption
• It can be used by any organization directly or indirectly
involved in the food chain
• It is applicable to all organizations
IMPLEMENTING A FOOD
SAFETY PROGRAM
Eight principles of pre requisite
program
Six Preliminary steps of HACCP
Seven principles of HACCP
Review HACCP plans
PRP – Pre Requisite Program
Eight general principles of Food Hygiene - GHP
1. Primary production
2. Establishment Design and Facilities
3. Control of operations
4. Maintenance and sanitation
5. Personal Hygiene
6. Transportation
7. Product information and consumer awareness
8. Training
Primary Production
• Environmental hygiene (where the environment/ surrounding
poses a threat to food safety)
• Hygienic production of Food Sources
(Control contamination from air, soil, water, feed-stock,
pesticides, veterinary drugs or any other agent used in primary
production. Protect food sources from fecal and other
contaminant)
• Handling storage and transport
(Use appropriate storage materials and equipment. Protect
food and food ingredients from contamination by pests,
chemicals, microbiological or physical or other objectionable
substances during handling storage and transportation. Cross
contamination.)
• Cleaning maintenance and personal hygiene
Establishment Design and Facilities
• Location (Potential sources of contamination from
surroundings)
• Internal design, structures and layout of the premises rooms
and equipment (Should facilitate MEASURES THAT
PREVENT CONTAMINATION, durable, movable and
capable of being disassembled to allow for maintenance,
cleaning, disinfecting and monitoring)
• Facilities (Directly or indirectly impact food safety : water
quality, air quality, drainage and waste disposal, temperature
control, personal hygiene, lighting, storage- ensure effective
protection from contamination during storage)
Control of Operations
• Control of food hazards through the use of HACCP system
(Potential sources of contamination from surroundings, Time
and Temperature).
• Key aspects of hygiene control systems (Specific process
steps, Microbiological and other specifications, microbial
cross contamination, physical and chemical contamination).
• Incoming material requirements (specification to be
identified and applied, where possible inspected and sorted
before processing).
Cont…
• Packaging (Design and materials used).
• Water (in contact with food and used as an ingredient
Special care for Ice and steam).
• Management and supervision (Size of the business, nature of
activity and type of food).
• Documentation and records (period that exceeds shelf life).
• Recall procedures (complete recall, handling and
communication).
Maintenance and Sanitation
• Cleaning methods and procedures (Appropriate for the type
of product and type of machine. Hidden residual food/pest
infestation).
• Cleaning Programs (Method, frequency and monitored for
their suitability and effectiveness).
• Pest Control Systems (Preventing access, preventing
harborage and infestation, monitoring and detection,
eradication measures).
• Waste Management (Method, frequency and effectiveness).
• Monitoring Effectiveness (Periodic Audit, microbial
sampling).
Personal Hygiene
• Health Status of Employees.
• Illness and injuries (Communicable diseases and surface
injuries to hands or parts that come in contact with food
items).
• Personal cleanliness-Clothing
• Personal Behavior (smoking, spitting, chewing and eating,
sneezing , personal effects).
• Visitors (Rules and guidelines for entry and access and
safety or protective covering).
Transportation
• Design of conveyances and bulk containers
(Proper segregation to prevent cross contamination, Time,
temperature and humidity controls available and monitored,
Appropriate for type of packaging)
• Use and maintenance
(Mixed and prior usage, appropriate scheduling and corrective
measures)
Product information and consumer
awareness
• Lot identification (Codex standard & FSSA rules)
• Product information (Bear adequate information to enable
the next person in the food chain to handle, display, store
prepare and use the product safely and correctly.)
• Labelling (Codex standards and FSSA rules)
• Consumer education (hygiene, nutrition, label instructions)
Training
• Cause of most food safety Hazards and incidents
• Awareness and responsibility
• Training Programs
 nature of food and its ability to sustain growth of harmful
micro-organisms.
 manner in which food is handled/packed .
 extent/nature of processing or further preparation before final
consumption.
 conditions under which the food will be stored.
 expected length of time before consumption.
• Instructions and supervisions
• Refresher Training
Good Manufacturing Practices- GMPs
Deal with contamination
• by people
• by food materials
• by packaging materials
• by hazardous materials
• by miscellaneous materials
General Employee Hygiene
All employees working in direct contact with food, food contact
surfaces and food packaging must conform to hygienic practices.
This protects against food contamination by microorganisms or
unwanted material
Prevent Contamination
• Careless employee practices can cause product contamination
• The best way to avoid contamination is to prevent it
• Any behavior that could result in food contamination such as
eating, use of tobacco, chewing gum or other unhygienic
practices, is not allowed in food handling areas
Hygiene and Communicable Diseases
• Clothing
• Hair
• Personal habits
• Hand washing
• Personal effects and
• Jewelry
• Illness and disease
• Injuries
• Visitors
Preliminary steps of HACCP
1) Define terms of reference (clearly spells out scope, extent,
resources committed, terms of appointment of outside consultants,
third party auditors, levels of authority and accountability for
implementation)
2) Select the HACCP team
Bring together the HACCP
resources/assemble the HACCP team
Company should bring together
as much knowledge as possible
Assemble written materials and
company documents that relate to food
safety
Assemble a team of individuals that
represent different segments
Team should be multi-disciplinary
and represent all areas of plant HACCP coordinator should
have overall responsibility
for the HACCP program.
3) Describe the product and process
4) Identify intended use
5) Construct a flow diagram (schematic flow that
describes the process)
6) On-site confirmation of flow
diagram (walk through)
HACCP Principles
1. Conduct a Hazard analysis
2. Determine critical control points (CCP’s)
3. Establish Critical Limits
4. Establish a system to monitor & control CCP’s
5. Establish corrective action to be taken when
monitoring indicated that a particular CCP is not
under control
6. Establish procedures for verification to confirm that
HACCP system is working effectively
7. Establish Documentation concerning all procedures
and records appropriate to these principles and their
applications
Conduct a Hazard analysis
• This is a risk assessment of Biological, Chemical and
Physical.
• Preparing list of Hazards
• Describe control measures
Purpose of Hazard Analysis:
• Identify significant hazards and control measures.
• Use to modify a process or products to further assure
or improve safety.
• Basis for determining Critical Control Points (CCP).
Hazard Analysis
• Series of questions to determine factors that affect
the safety of the product.
• Questions vary depending on product and process.
For each hazard identified, an analysis shall
be conducted to determine:
• The likely occurrence of the hazard
• The severity of possible adverse health effect
associated with the hazard
•If the identified hazard is controlled by
prerequisite programs
Determine Critical Control Points
(CCPs)
A point, step, or procedure at which control can be applied and
hazard can be prevented, eliminated, or reduced to acceptable
levels .
The HACCP team should utilize the decision tree to
evaluate each point where hazards can be prevented or
eliminated.
CONTROLMEASURES
PROCESS HAZARD CONTROL
MEASURES
CP/CPP
1.Reception BIO bacterial
contamination
from,
•Truckunloading
•Unclean
equipment
CHEcleaning&
sanitizing solution ,
mycotoxin(aflatoxi
n
)
PHY Foreign
materials
Truckunloading
area&equipment
should beclean
Maintain proper
seperationbetween
cleaningsolution and
product.
Aflatoxin canbe
avoided bysupplier
gaurantee
Useof filter, screen
etc
CP1
PRP9
4.Storage BIOBacterial
contamination.
CHECleaning&
sanitizingsolutions
•Storagevessels&
associatedvalves
should beclean
•Proper
temperature
controlsystem
Properseperation
betweencleaning
solution and
product
CP4
5.Standardisation BIO Bacterial
contamination
CHECleaning&
sanitizingsolutions
•Storage vessel &
associated valves
should beclean
•Properseperation
between cleaning
solution and
product
CP5
6.Pasteurization BIO Survivalof
vegetative
pathogens( Eg
Coxiella burnetti)
CHE
•cleaning&
sanitizingsolution
residues
•Presenceof
allergens
•Boileradditives
•Coolingwater
additives
Temperature
controllingdevice
should bethere.
Properseparation
betweencleaning
solution &product.
Equipmentshould
beclean
Ensurethequality
ofwater
Ensurethequality
ofwater
CCP1
7. Homogenization BIO survival of
vegetative
pathogens
CHEcleaningand
sanitizingresidues
Milk should be
heated to 55 °cto
inactivate lipase
enzyme
Properseperation
between cleaning
solution and
product
CP6
8.packaging
CHE
•cleaning&
sanitizingsolution
•Packaging
materialthatdoes
not meetthe
requirementmay
containnon food
gradesubstances
•Allergens
PHY Glass
Fillingequipment
must becleanable
& inspectable
Packaging
machineryand
associated
piping's mustbe
thoroughly
cleaned
Maintainglass
freezone
Maintain proper
separationor CP7
physicaloutbreak PRP9
betweencircuits
Use of
appropriate
packagematerial
BIO human
illnessoutbreak
9.Coldstorage BIO lackof
temperature
controlincooler
Thermometer
should bethereto
controlthe
bacterialgrowth
rate
CCP2
Establish Critical Limits
• Critical Limits: The maximum or
minimum value to which a physical,
biological, or chemical food hazard
must be controlled at a critical
control point to prevent, eliminate, or
reduce to an acceptable level the
occurrence of the identified food
safety hazard.
• For each CCP, a critical limit is
established to see whether a CCP is
“in” or “out” of control.
• Parameters of CCP: Time,
Temperature, Water activity (Aw),
pH, Salt concentration, Weight and
Visual evaluation
Establish Monitoring Procedures
• Each CCP must be Monitored by a Specific Individual (Line
supervisors, QC personnel, selected line workers,
Maintenance)
• Must be trained, understand the purpose of monitoring,
unbiased in monitoring and reporting
• Report unusual occurrence immediately and take corrective
action
• Determine if the process is operating within the established
critical limits
Establish Corrective Actions
• Deviations in a CCP will result in actual or potential hazard
to the customer
• Actions must be taken to eliminate the hazard.
Corrective actions
The cause of the deviation is identified and eliminated
The CCP will be under control after the corrective action is
taken
Assign specific responsibilities for implementing the
corrective actions and the records that will be maintained
• An individual knowledgeable in CCP control must have the
authority to make quick decisions on the production floor.
• The individual responsible for the action must record on the CCP
data sheet what action was taken and by whom.
CCP Data Sheet
CCP# Pasteurization filter inspection
HACCP Plan No
Monitoring
procedure
Visually inspect the filter to ensure it is intact
Frequency of
monitoring
2x daily at startup and shutdown
Corrective action Replace the filter and contact the operations manager
regarding holding of product
Date and time 1/1/2019
Result Filter was not intact
Action taken Filter was replaced and operation
manager was informed.
Signature
Establish Verification Procedures
• Verification procedures make sure the plan is working
correctly. It is those set of activities other than monitoring
that determine the validity of the HACCP Plan
• It also determines that the plan is scientifically and
technically sound
• Three types of verifications:
Validation ( Based on scientific expertise and knowledge)
Verification
Purpose of Verification:
• Determine if the HACCP plan is implemented.
• Determine if Operations are in Compliance with HACCP
Plan.
Reassessment
Is a thorough review of hazard analysis to address specific
hazards to determine if they are controlled
Establish Record Keeping and
Documentation procedures
Typical records of a HACCP System:
• Ingredients for which critical limits have been
established.
o Monitored CCPs,
o Supplier documentation,
o storage temperature & humidity records,
o Shelf life of ingredients records etc.
• Preparation, processing storage and distribution records
( Monitoring and verification records)
• Packaging records (indicating compliance with
specifications of packaging materials , labeling requirements
and sealing requirements)
• Finished products – storage, delivery, sale.
• Deviation and corrective action records
• Employee training records.
• Documentation of the adequacy of the HACCP procedure
from an authority (certification).
ISO 22000
ISO 22000 Standard
Section 1: Scope
Section 2: Normative Reference
Section 3: Terms & Definitions
Section 4: General Requirements
Section 5: Management Responsibility
Section 6: Resource Management
Section 7: Planning & Realization of Safe Products
Section 8: Validation, Verification & Improvement
• Section 1 to 3 are non auditable
• Sections 4 to 8 contain the requirements
1. Scope
Plan, implement, operate, maintain and update FSMS in order to provide safe food to consumers
Demonstrate compliance with applicable statutory and regulatory food safety requirements
Ensure that the organization conforms to its stated food safety policy
Evaluate and assess costumer requirements and demonstrate conformity with those mutually agreed
costumer satisfaction
Effectively communicate food safety issues
Ensure that the organization conforms to its stated food safety policy and demonstrate it to relevant
interested parties
Seek certification and registration of its food safety management system (external organization or
self assessment)
International Standard specifies requirements to enable an organization to
3. Terms and Definitions
Terms Definitions
Food safety Concept that food will not cause harm to the consumer.
Food Chain Sequence of the stages and operations involved in the production, processing,
distribution, storage and handling of a food and its ingredients.
End product Product that will undergo no further processing or transformation by the
organization.
Control Measure Action or activity that can be used to prevent or eliminate a food safety hazard.
PRP prerequisite
program
Basic conditions and activities that are necessary to maintain a hygienic
environment.
Correction Action to eliminate a detected nonconformity.
Updating Immediate or planned activity to ensure application of the most recent information.
4. General Requirements
4.1 General
• Establish an effective Food Safety Management System
(FSMS)
• Keep it current
4.2 Record and Documentation Requirements
• Document your system
• Control your documents
4.2 Records
• Maintain required records
• Control your records
5. Management Responsibility
•Communicating the importance of
meeting the requirements to the
organization.
•Establishing the food safety policy.
•Conducting management reviews.
•Ensuring the availability of resources.
5.1 Management
Commitment
5.2 Food Safety
Policy
• Management creates for Food Safety
Policy
• Management is responsible for
communicating the policy
• Management is responsible for ensuring
that the policy is implemented
5.3 Food Safety
System planning
• Planning of the food safety management
system is carried out to meet
requirements.
• Integrity of food safety management
system is maintained.
5.4 Responsibility
and Authority
• Define responsibilities and authority
• Communicate them
• Everyone is responsible for reporting
problems with the FSMS - make sure they
know that
5.5 Food Safety
Team Leader
• Manage a food safety team and organize
work
• Ensure relevant training and education of
the food safety team members
• Ensure that food safety management system
is established, implemented and updated.
• Report to top management on effectiveness
and suitability of the FSMS
5.6
Communication
• External communication: suppliers and
contactors, costumers and consumers,
statutory and regulatory authorities and
Other organization
• Internal communication: communicating
with personnel about changes to each aspect
of food plant
5.7 Emergency
Preparedness
 Establish, manage, implement and
maintain procedures to manage potential
emergency situations including
• Fire
• Flood
• Accidents
• Contamination
5.8 Management
Review
• General: Include assessing
opportunities for improvement and the
need for change to the FSM
• Review input: Information on follow-
up actions, analysis of results,
emergency situations, reviewing results
of system-updating, external audits or
inspections
• Review output: Assurance of food
safety, improvement of effectiveness of
FSMS, resource need, revision of the
organization’s food safety policy
6. Resource Management
• Top management is responsible for providing the required
resources
 General
• Competent and educated personnel
• Available records and agreement in case of external
assistance
Competence, Awareness and Training
• Identify necessary competence
• Provide training
• Ensure personnel are trained
• Ensure personnel are aware of relevance and importance of
their activities
• Maintain appropriate records
 Infrastructure
• Resources for establishment and maintenance of infrastructure
should be provided by organization
Work Environment
• Resources for establishment and maintenance of work
environment should be provided by organization
7. Planning & Realization of Safe
Product
• Your organization will need to plan all of the processes that
go into making your product in order to ensure a safe end
product
7.2 Prerequisite Program
Basic Conditions and activities that are necessary to maintain a
hygienic environment throughout the food chain
• The Food safety Team establishes PRPs
7.3 Preliminary Steps
The Food Safety Team
• Identifies product characteristics
• Describe intended use
• Prepare flow diagrams
• Describe process steps and control measures
7.4 Hazard Analysis
The Food Safety Team
• Verifies the accuracy of the flow diagrams
• Conducts hazard analysis to identify potential food safety
hazards
• Selects control measures to prevent or eliminate those
hazards
7.5 Establish Operational PRPs
Operational PRPs:
• Similar to a Critical Control Point, an Operational
Prerequisite Program is a control point where biological,
physical, or chemical hazards identified in hazard analysis
can be controlled.
• The Food Safety Team establishes Operational PRPs
7.6 Establish the HACCP Plan
The Food Safety Team
• Documents the HACCP plan
7.7 Updating
The Food Safety Team
• Updates any preliminary information that may have
changed during or as a result of the hazard analysis
7.8 Verification Planning
• Identify what verification activities are required including
verification of PRPs, the HACCP Plan and other procedures.
• Verification will include internal audits, any food safety or
GMP audits, verification of cleaning records and HACCP
records and other activities that you identify for your system.
7.9 Traceability
A traceability system ensures that the identification of
product is maintained from raw material to delivery.
• Establish the traceability of product
• From supplier to distribution
7.10 Control of Nonconformity
When a control limit is exceeded or a PRP is found to
be out of control affected product must be controlled.
• Corrections
• Corrective actions
• Handling of potentially unsafe product
8.2 Validation
All measuring equipment must be capable of the required
measurements and show calibration to national or
international standards.
8.4 Verification
• Establish and document an internal audit process
• The Food Safety Team evaluates and analyzes
verification results
• The Food Safety Team takes any necessary action
8.5 Improvement
Continually improve the FSMS through the use of:
• Management review
• Internal audits
• Corrective actions
• Verification results
• Validation results

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ISO 22000 - Food Safety Management System and HACCP Implementation

  • 1. ISO 22000 - Food Safety Management System and HACCP Implementation
  • 2. Who is ISO • ISO (International Organization for Standardization) is a network of standards institutes from 164 countries with a central office in Geneva, Switzerland, that coordinates the system • Member countries work together to develop and approve standards • ISO is a non-governmental organization that forms a bridge between the public and private sectors and is the largest standards organization in the world
  • 3. The ISO system 156 national members 50,000 experts more than 16,000 published standards 100 new standards each month 3000 technical bodies
  • 4. ISO 22000 Family of Standards • Initiated in 2001 • Standards ISO 22000:2005 – Food safety management system – Requirements ISO 22003:2007 - Requirements for bodies providing audit and certification of food safety management systems ISO TS 22004:2005 - Guidance on the application of ISO 22000 ISO 22005 – Traceability in the feed and food chain
  • 5. ISO 22000 • It is a food safety management system (FSMS) • It is aligned with ISO 9001 to enhance compatibility with existing management system • It ensure safety along the food chain, up to the point of final consumption • It can be used by any organization directly or indirectly involved in the food chain • It is applicable to all organizations
  • 6. IMPLEMENTING A FOOD SAFETY PROGRAM Eight principles of pre requisite program Six Preliminary steps of HACCP Seven principles of HACCP Review HACCP plans
  • 7. PRP – Pre Requisite Program Eight general principles of Food Hygiene - GHP 1. Primary production 2. Establishment Design and Facilities 3. Control of operations 4. Maintenance and sanitation 5. Personal Hygiene 6. Transportation 7. Product information and consumer awareness 8. Training
  • 8. Primary Production • Environmental hygiene (where the environment/ surrounding poses a threat to food safety) • Hygienic production of Food Sources (Control contamination from air, soil, water, feed-stock, pesticides, veterinary drugs or any other agent used in primary production. Protect food sources from fecal and other contaminant) • Handling storage and transport (Use appropriate storage materials and equipment. Protect food and food ingredients from contamination by pests, chemicals, microbiological or physical or other objectionable substances during handling storage and transportation. Cross contamination.) • Cleaning maintenance and personal hygiene
  • 9. Establishment Design and Facilities • Location (Potential sources of contamination from surroundings) • Internal design, structures and layout of the premises rooms and equipment (Should facilitate MEASURES THAT PREVENT CONTAMINATION, durable, movable and capable of being disassembled to allow for maintenance, cleaning, disinfecting and monitoring) • Facilities (Directly or indirectly impact food safety : water quality, air quality, drainage and waste disposal, temperature control, personal hygiene, lighting, storage- ensure effective protection from contamination during storage)
  • 10. Control of Operations • Control of food hazards through the use of HACCP system (Potential sources of contamination from surroundings, Time and Temperature). • Key aspects of hygiene control systems (Specific process steps, Microbiological and other specifications, microbial cross contamination, physical and chemical contamination). • Incoming material requirements (specification to be identified and applied, where possible inspected and sorted before processing).
  • 11. Cont… • Packaging (Design and materials used). • Water (in contact with food and used as an ingredient Special care for Ice and steam). • Management and supervision (Size of the business, nature of activity and type of food). • Documentation and records (period that exceeds shelf life). • Recall procedures (complete recall, handling and communication).
  • 12. Maintenance and Sanitation • Cleaning methods and procedures (Appropriate for the type of product and type of machine. Hidden residual food/pest infestation). • Cleaning Programs (Method, frequency and monitored for their suitability and effectiveness). • Pest Control Systems (Preventing access, preventing harborage and infestation, monitoring and detection, eradication measures). • Waste Management (Method, frequency and effectiveness). • Monitoring Effectiveness (Periodic Audit, microbial sampling).
  • 13. Personal Hygiene • Health Status of Employees. • Illness and injuries (Communicable diseases and surface injuries to hands or parts that come in contact with food items). • Personal cleanliness-Clothing • Personal Behavior (smoking, spitting, chewing and eating, sneezing , personal effects). • Visitors (Rules and guidelines for entry and access and safety or protective covering).
  • 14. Transportation • Design of conveyances and bulk containers (Proper segregation to prevent cross contamination, Time, temperature and humidity controls available and monitored, Appropriate for type of packaging) • Use and maintenance (Mixed and prior usage, appropriate scheduling and corrective measures)
  • 15. Product information and consumer awareness • Lot identification (Codex standard & FSSA rules) • Product information (Bear adequate information to enable the next person in the food chain to handle, display, store prepare and use the product safely and correctly.) • Labelling (Codex standards and FSSA rules) • Consumer education (hygiene, nutrition, label instructions)
  • 16. Training • Cause of most food safety Hazards and incidents • Awareness and responsibility • Training Programs  nature of food and its ability to sustain growth of harmful micro-organisms.  manner in which food is handled/packed .  extent/nature of processing or further preparation before final consumption.  conditions under which the food will be stored.  expected length of time before consumption. • Instructions and supervisions • Refresher Training
  • 17. Good Manufacturing Practices- GMPs Deal with contamination • by people • by food materials • by packaging materials • by hazardous materials • by miscellaneous materials
  • 18. General Employee Hygiene All employees working in direct contact with food, food contact surfaces and food packaging must conform to hygienic practices. This protects against food contamination by microorganisms or unwanted material
  • 19. Prevent Contamination • Careless employee practices can cause product contamination • The best way to avoid contamination is to prevent it • Any behavior that could result in food contamination such as eating, use of tobacco, chewing gum or other unhygienic practices, is not allowed in food handling areas
  • 20. Hygiene and Communicable Diseases • Clothing • Hair • Personal habits • Hand washing • Personal effects and • Jewelry • Illness and disease • Injuries • Visitors
  • 21. Preliminary steps of HACCP 1) Define terms of reference (clearly spells out scope, extent, resources committed, terms of appointment of outside consultants, third party auditors, levels of authority and accountability for implementation)
  • 22. 2) Select the HACCP team Bring together the HACCP resources/assemble the HACCP team Company should bring together as much knowledge as possible Assemble written materials and company documents that relate to food safety Assemble a team of individuals that represent different segments Team should be multi-disciplinary and represent all areas of plant HACCP coordinator should have overall responsibility for the HACCP program.
  • 23. 3) Describe the product and process 4) Identify intended use 5) Construct a flow diagram (schematic flow that describes the process) 6) On-site confirmation of flow diagram (walk through)
  • 24. HACCP Principles 1. Conduct a Hazard analysis 2. Determine critical control points (CCP’s) 3. Establish Critical Limits 4. Establish a system to monitor & control CCP’s 5. Establish corrective action to be taken when monitoring indicated that a particular CCP is not under control 6. Establish procedures for verification to confirm that HACCP system is working effectively 7. Establish Documentation concerning all procedures and records appropriate to these principles and their applications
  • 25. Conduct a Hazard analysis • This is a risk assessment of Biological, Chemical and Physical. • Preparing list of Hazards • Describe control measures
  • 26. Purpose of Hazard Analysis: • Identify significant hazards and control measures. • Use to modify a process or products to further assure or improve safety. • Basis for determining Critical Control Points (CCP). Hazard Analysis • Series of questions to determine factors that affect the safety of the product. • Questions vary depending on product and process. For each hazard identified, an analysis shall be conducted to determine: • The likely occurrence of the hazard • The severity of possible adverse health effect associated with the hazard •If the identified hazard is controlled by prerequisite programs
  • 27. Determine Critical Control Points (CCPs) A point, step, or procedure at which control can be applied and hazard can be prevented, eliminated, or reduced to acceptable levels . The HACCP team should utilize the decision tree to evaluate each point where hazards can be prevented or eliminated.
  • 28. CONTROLMEASURES PROCESS HAZARD CONTROL MEASURES CP/CPP 1.Reception BIO bacterial contamination from, •Truckunloading •Unclean equipment CHEcleaning& sanitizing solution , mycotoxin(aflatoxi n ) PHY Foreign materials Truckunloading area&equipment should beclean Maintain proper seperationbetween cleaningsolution and product. Aflatoxin canbe avoided bysupplier gaurantee Useof filter, screen etc CP1 PRP9
  • 29.
  • 30. 4.Storage BIOBacterial contamination. CHECleaning& sanitizingsolutions •Storagevessels& associatedvalves should beclean •Proper temperature controlsystem Properseperation betweencleaning solution and product CP4 5.Standardisation BIO Bacterial contamination CHECleaning& sanitizingsolutions •Storage vessel & associated valves should beclean •Properseperation between cleaning solution and product CP5
  • 31. 6.Pasteurization BIO Survivalof vegetative pathogens( Eg Coxiella burnetti) CHE •cleaning& sanitizingsolution residues •Presenceof allergens •Boileradditives •Coolingwater additives Temperature controllingdevice should bethere. Properseparation betweencleaning solution &product. Equipmentshould beclean Ensurethequality ofwater Ensurethequality ofwater CCP1 7. Homogenization BIO survival of vegetative pathogens CHEcleaningand sanitizingresidues Milk should be heated to 55 °cto inactivate lipase enzyme Properseperation between cleaning solution and product CP6
  • 32. 8.packaging CHE •cleaning& sanitizingsolution •Packaging materialthatdoes not meetthe requirementmay containnon food gradesubstances •Allergens PHY Glass Fillingequipment must becleanable & inspectable Packaging machineryand associated piping's mustbe thoroughly cleaned Maintainglass freezone Maintain proper separationor CP7 physicaloutbreak PRP9 betweencircuits Use of appropriate packagematerial BIO human illnessoutbreak
  • 33. 9.Coldstorage BIO lackof temperature controlincooler Thermometer should bethereto controlthe bacterialgrowth rate CCP2
  • 34. Establish Critical Limits • Critical Limits: The maximum or minimum value to which a physical, biological, or chemical food hazard must be controlled at a critical control point to prevent, eliminate, or reduce to an acceptable level the occurrence of the identified food safety hazard. • For each CCP, a critical limit is established to see whether a CCP is “in” or “out” of control. • Parameters of CCP: Time, Temperature, Water activity (Aw), pH, Salt concentration, Weight and Visual evaluation
  • 35. Establish Monitoring Procedures • Each CCP must be Monitored by a Specific Individual (Line supervisors, QC personnel, selected line workers, Maintenance) • Must be trained, understand the purpose of monitoring, unbiased in monitoring and reporting • Report unusual occurrence immediately and take corrective action • Determine if the process is operating within the established critical limits
  • 36. Establish Corrective Actions • Deviations in a CCP will result in actual or potential hazard to the customer • Actions must be taken to eliminate the hazard. Corrective actions The cause of the deviation is identified and eliminated The CCP will be under control after the corrective action is taken Assign specific responsibilities for implementing the corrective actions and the records that will be maintained
  • 37. • An individual knowledgeable in CCP control must have the authority to make quick decisions on the production floor. • The individual responsible for the action must record on the CCP data sheet what action was taken and by whom. CCP Data Sheet CCP# Pasteurization filter inspection HACCP Plan No Monitoring procedure Visually inspect the filter to ensure it is intact Frequency of monitoring 2x daily at startup and shutdown Corrective action Replace the filter and contact the operations manager regarding holding of product Date and time 1/1/2019 Result Filter was not intact Action taken Filter was replaced and operation manager was informed. Signature
  • 38. Establish Verification Procedures • Verification procedures make sure the plan is working correctly. It is those set of activities other than monitoring that determine the validity of the HACCP Plan • It also determines that the plan is scientifically and technically sound
  • 39. • Three types of verifications: Validation ( Based on scientific expertise and knowledge) Verification Purpose of Verification: • Determine if the HACCP plan is implemented. • Determine if Operations are in Compliance with HACCP Plan. Reassessment Is a thorough review of hazard analysis to address specific hazards to determine if they are controlled
  • 40. Establish Record Keeping and Documentation procedures Typical records of a HACCP System: • Ingredients for which critical limits have been established. o Monitored CCPs, o Supplier documentation, o storage temperature & humidity records, o Shelf life of ingredients records etc. • Preparation, processing storage and distribution records ( Monitoring and verification records)
  • 41. • Packaging records (indicating compliance with specifications of packaging materials , labeling requirements and sealing requirements) • Finished products – storage, delivery, sale. • Deviation and corrective action records • Employee training records. • Documentation of the adequacy of the HACCP procedure from an authority (certification).
  • 42. ISO 22000 ISO 22000 Standard Section 1: Scope Section 2: Normative Reference Section 3: Terms & Definitions Section 4: General Requirements Section 5: Management Responsibility Section 6: Resource Management Section 7: Planning & Realization of Safe Products Section 8: Validation, Verification & Improvement • Section 1 to 3 are non auditable • Sections 4 to 8 contain the requirements
  • 43. 1. Scope Plan, implement, operate, maintain and update FSMS in order to provide safe food to consumers Demonstrate compliance with applicable statutory and regulatory food safety requirements Ensure that the organization conforms to its stated food safety policy Evaluate and assess costumer requirements and demonstrate conformity with those mutually agreed costumer satisfaction Effectively communicate food safety issues Ensure that the organization conforms to its stated food safety policy and demonstrate it to relevant interested parties Seek certification and registration of its food safety management system (external organization or self assessment) International Standard specifies requirements to enable an organization to
  • 44. 3. Terms and Definitions Terms Definitions Food safety Concept that food will not cause harm to the consumer. Food Chain Sequence of the stages and operations involved in the production, processing, distribution, storage and handling of a food and its ingredients. End product Product that will undergo no further processing or transformation by the organization. Control Measure Action or activity that can be used to prevent or eliminate a food safety hazard. PRP prerequisite program Basic conditions and activities that are necessary to maintain a hygienic environment. Correction Action to eliminate a detected nonconformity. Updating Immediate or planned activity to ensure application of the most recent information.
  • 45. 4. General Requirements 4.1 General • Establish an effective Food Safety Management System (FSMS) • Keep it current 4.2 Record and Documentation Requirements • Document your system • Control your documents
  • 46. 4.2 Records • Maintain required records • Control your records
  • 47. 5. Management Responsibility •Communicating the importance of meeting the requirements to the organization. •Establishing the food safety policy. •Conducting management reviews. •Ensuring the availability of resources. 5.1 Management Commitment
  • 48. 5.2 Food Safety Policy • Management creates for Food Safety Policy • Management is responsible for communicating the policy • Management is responsible for ensuring that the policy is implemented 5.3 Food Safety System planning • Planning of the food safety management system is carried out to meet requirements. • Integrity of food safety management system is maintained.
  • 49. 5.4 Responsibility and Authority • Define responsibilities and authority • Communicate them • Everyone is responsible for reporting problems with the FSMS - make sure they know that 5.5 Food Safety Team Leader • Manage a food safety team and organize work • Ensure relevant training and education of the food safety team members • Ensure that food safety management system is established, implemented and updated. • Report to top management on effectiveness and suitability of the FSMS
  • 50. 5.6 Communication • External communication: suppliers and contactors, costumers and consumers, statutory and regulatory authorities and Other organization • Internal communication: communicating with personnel about changes to each aspect of food plant 5.7 Emergency Preparedness  Establish, manage, implement and maintain procedures to manage potential emergency situations including • Fire • Flood • Accidents • Contamination
  • 51. 5.8 Management Review • General: Include assessing opportunities for improvement and the need for change to the FSM • Review input: Information on follow- up actions, analysis of results, emergency situations, reviewing results of system-updating, external audits or inspections • Review output: Assurance of food safety, improvement of effectiveness of FSMS, resource need, revision of the organization’s food safety policy
  • 52. 6. Resource Management • Top management is responsible for providing the required resources  General • Competent and educated personnel • Available records and agreement in case of external assistance
  • 53. Competence, Awareness and Training • Identify necessary competence • Provide training • Ensure personnel are trained • Ensure personnel are aware of relevance and importance of their activities • Maintain appropriate records  Infrastructure • Resources for establishment and maintenance of infrastructure should be provided by organization
  • 54. Work Environment • Resources for establishment and maintenance of work environment should be provided by organization
  • 55. 7. Planning & Realization of Safe Product • Your organization will need to plan all of the processes that go into making your product in order to ensure a safe end product 7.2 Prerequisite Program Basic Conditions and activities that are necessary to maintain a hygienic environment throughout the food chain • The Food safety Team establishes PRPs
  • 56. 7.3 Preliminary Steps The Food Safety Team • Identifies product characteristics • Describe intended use • Prepare flow diagrams • Describe process steps and control measures
  • 57. 7.4 Hazard Analysis The Food Safety Team • Verifies the accuracy of the flow diagrams • Conducts hazard analysis to identify potential food safety hazards • Selects control measures to prevent or eliminate those hazards
  • 58. 7.5 Establish Operational PRPs Operational PRPs: • Similar to a Critical Control Point, an Operational Prerequisite Program is a control point where biological, physical, or chemical hazards identified in hazard analysis can be controlled. • The Food Safety Team establishes Operational PRPs
  • 59. 7.6 Establish the HACCP Plan The Food Safety Team • Documents the HACCP plan
  • 60. 7.7 Updating The Food Safety Team • Updates any preliminary information that may have changed during or as a result of the hazard analysis
  • 61. 7.8 Verification Planning • Identify what verification activities are required including verification of PRPs, the HACCP Plan and other procedures. • Verification will include internal audits, any food safety or GMP audits, verification of cleaning records and HACCP records and other activities that you identify for your system.
  • 62. 7.9 Traceability A traceability system ensures that the identification of product is maintained from raw material to delivery. • Establish the traceability of product • From supplier to distribution
  • 63. 7.10 Control of Nonconformity When a control limit is exceeded or a PRP is found to be out of control affected product must be controlled. • Corrections • Corrective actions • Handling of potentially unsafe product
  • 64. 8.2 Validation All measuring equipment must be capable of the required measurements and show calibration to national or international standards.
  • 65. 8.4 Verification • Establish and document an internal audit process • The Food Safety Team evaluates and analyzes verification results • The Food Safety Team takes any necessary action
  • 66. 8.5 Improvement Continually improve the FSMS through the use of: • Management review • Internal audits • Corrective actions • Verification results • Validation results