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 • Illness and disease

• Hair • Injuries
• Personal habits • Visitors
• Hand washing
• Personal effects and
• Jewelry
 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.
 CONTROL MEASURES
PROCESS HAZARD CONTROL CP/CPP
MEASURES
1.Reception BIO bacterial Truck unloading
contamination area&equipment
from, should be clean
•Truckunloading
•Unclean
equipment
CHE cleaning & Maintain proper CP1
sanitizing solution , seperation between PRP9
mycotoxin(aflatoxi cleaning solution and
n product.
) Aflatoxin can be
avoided by supplier
gaurantee
Use of filter, screen
PHY Foreign etc
materials
4.Storage BIO Bacterial •Storage vessels& CP4
contamination. associated valves
should beclean
•Proper
temperature
controlsystem

CHECleaning & Properseperation

sanitizingsolutions between cleaning
solution and
product

5.Standardisation BIO Bacterial •Storage vessel & CP5

contamination associated valves
should be clean

CHECleaning & •Proper seperation

sanitizing solutions between cleaning
solution and
product
6.Pasteurization BIO Survival of Temperature CCP1
vegetative controllingdevice
pathogens( Eg should bethere.
Coxiella burnetti)

CHE Proper separation

•cleaning & between cleaning
sanitizingsolution solution &product.
residues
•Presenceof Equipmentshould
allergens beclean
•Boileradditives Ensure thequality
of water
•Coolingwater Ensure the quality
additives of water
7. Homogenization BIO survival of Milk should be CP6
vegetative heated to 55 ° c to
pathogens inactivate lipase
enzyme
CHEcleaning and Proper seperation
sanitizing residues between cleaning
solution and
product
 Filling equipment
BIO human
8.packaging must becleanable
illness outbreak
& inspectable
CHE
•cleaning & Maintain proper
sanitizingsolution separation or CP7
physical outbreak PRP9
betweencircuits
•Packaging
material thatdoes Use of
not meet the appropriate
requirement may packagematerial
contain non food
grade substances
•Allergens
Packaging
machinery and
associated
piping's mustbe
thoroughly
PHY Glass cleaned

Maintain glass
freezone
9. Cold storage BIO lack of Thermometer CCP2
temperature should be thereto
control incooler control the
bacterial growth
rate
 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 Visually inspect the filter to ensure it is intact
procedure
Frequency of 2x daily at startup and shutdown
monitoring
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
International Standard specifies requirements to enable an organization to
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)
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 Basic conditions and activities that are necessary to maintain a hygienic
program 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
5.1 Management organization.
Commitment •Establishing the food safety policy.
•Conducting management reviews.
•Ensuring the availability of resources.
 • Management creates for Food Safety
Policy
5.2 Food Safety • Management is responsible for
Policy communicating the policy
• Management is responsible for ensuring
that the policy is implemented

5.3 Food Safety • Planning of the food safety management

System planning system is carried out to meet
requirements.
• Integrity of food safety management
system is maintained.
 • Define responsibilities and authority
5.4 Responsibility • Communicate them
and Authority • Everyone is responsible for reporting
problems with the FSMS - make sure they
know that

• Manage a food safety team and organize

work
• Ensure relevant training and education of
5.5 Food Safety the food safety team members
Team Leader • Ensure that food safety management system
is established, implemented and updated.
• Report to top management on effectiveness
and suitability of the FSMS
 • External communication: suppliers and
contactors, costumers and consumers,
statutory and regulatory authorities and
5.6
Other organization
Communication
• Internal communication: communicating
with personnel about changes to each aspect
of food plant

 Establish, manage, implement and

maintain procedures to manage potential
emergency situations including
5.7 Emergency
• Fire
Preparedness
• Flood
• Accidents
• Contamination
 • General: Include assessing
opportunities for improvement and the
need for change to the FSM
• Review input: Information on follow-
up actions, analysis of results,
5.8 Management emergency situations, reviewing results
Review 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