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Food safety is the process of
preventing food from the risk that
may affect it and affect directly or
indirectly to consumers.
19
What are the factors which have potential
to make food unsafe????
Food Safety Hazards
A Food safety hazard is presence of any agent or condition of food with
the POTENTIAL TO CAUSE HARM or an adverse health affect.
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4. Context of the organization
34
External/Internal Issues
• Legal,
• Technological,
• Competitive
• Market,
• Cultural,
• Social
• Economic Environment
• Cyber security
• Food fraud
• Food defense
• Knowledge
• Performance of the organization
• 4.1 What are internal and external issues
• 4.2 Who are all the interested parties
• Understanding the needs and expectations of interested parties
4.3 Scope
• Product /Services
• Processes
• Production site
4.4 Food safety management system
The organization shall establish, implement, maintain,
update and continually improve a FSMS, including the
processes needed and their interactions, in accordance with
the requirements of this document.
5. Leadership
5.1 Leadership and Commitment
• Policy & objectives compatible
• Integration of FSMS into business processes
• Resource availability
• Conforming to relevant statutory, regulatory & customer requirements
• FSMS is evaluated & maintained
• Directing & supporting persons
• Promoting continual improvement
• Supporting other relevant management roles
• 5.2 Establishing & communicating the policy
• 5.3 Organizational roles,responsibilities& authorities (including FSTL)
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Policy statement - Example
• We, XYZ are committed to offer fine and safe product. To pursuit this
commitment, we shall,
Implement & maintain a FSMS in accordance with ISO 22000:2018 and
continually improve its effectiveness.
Implement system based on HACCP principles
Ensure that all staff is competent and trained as and when required
Ensure effective communication to relevant parties
Conform to applicable statutory & regulatory requirements
Monitor and update objectives to achieve customer satisfaction to the fullest
Sign
37
6. Planning
• 6.1 Actions to address risks and
opportunities
• 6.2 Planning to achieve
Objectives of the food safety
management system
• 6.3 Planning of changes
Determine the risk and opportunities
Internal and external
issues
(4.1)
Needs and
expectations of
interested parties
(4.2)
Avoiding
risk
Taking risk
in order to
pursue an
opportunity
Eliminatin
g the risk
source
Changing
the
likelihood
&
consequenc
es
Sharing risk
or accepting
presence of
risk by
informed
decision
Scope of FSMS
(4.3)
6.2 Objectives - SMART
39
S
• Specific
M
• Measurable
A
• Achievable
R
• Realistic
T
• Timely
Example…
• To reduce rework by 5%
• Achieve customer satisfaction at least
85%
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6. Planning
• Planning to achieve Objectives of the food safety management system
Signature
with Date
Remarks by
Process owner
Monitoring results
Monitoring
Frequency
Responsibility
Objective
Annually
FSTL
Customer
satisfaction
85%
6. Planning
6.3 Planning of changes
Define purpose of
change and potential
consequences
Establish availability
of resources
Formal approval for proposed
change
Allocation / reallocation
of responsibility &
authority
Effectiveness of change &
integrity of FSMS
7. Support
42
7.1.2
People
- Shall ensure
that persons
necessary to
operate and
maintain an
effective FSMS
are competent
7.1.3
Infrastructure
- shall provide
the resources
for the
determination,
establishment
and
maintenance of
the
infrastructure
7.1.4
Work
Environment
- shall determine,
provide and
maintain the
resources for the
establishment,
management and
maintenance of the
work environment
7.1.5
(Externally
developed
elements of
FSMS -retained
as documented
information
7.1.6
Control of externally
provided processes,
products or services -
retained as documented
information
-
Persons doing work under the
organization’scontrol shall be aware of:
Implications of
not conforming
to FSMS
requirements
Individual
contribution to
FSMS
Objectives of the
FSMS relevant to
their task(s)
Food Safety
Policy
7.2 Competency
7.3 Awareness
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7. Support
Determine the
communication
Internal
External
What to communicate
When to
communicate
Whom to
communicate
How to communicate
7.4 Communication
Who communicates
7.5 Documented information- Creating & updating, Control of documents & records
• What are the titles of clauses no. 4 to 7, also
enlist various terms within theses clauses
44
8. Operation
8.1 Operational planning and control
8.2 Prerequisite programs
8.3 Traceability system – Forward & Backward
8.4 Emergency preparedness & response – Handling emergencies &
incidents
8.5 & 8.6 Hazard control
8.7 Control of monitoring & measuring – Calibration, Safeguarded
8.8 Verification related to PRPs & Hazard control plan
8.9 Control of product & process nonconformities
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8.1 Operational planning and control-
The organization shall plan, implement, control, maintain and update the processes needed to
meet requirements for the realization of safe products, and to implement the actions by:
- Establishing criteria for the processes
- Implementing control of the processes in accordance with the criteria
- keeping documented information to the extent necessary to have the confidence to
demonstrate that the processes have been carried out as planned
Control planned changes and review the consequences of
unintended changes, taking action to mitigate any
adverse effects, as necessary”
Ensure the outsourced processes are controlled
8.2 Generic PRPs : ISO 22000:2018
Prerequisite Program (PRP) Defined by ISO as the basic conditions and
activities necessary to maintain a hygienic environment throughout the
food chain which are suitable for the production, handling and
provision of safe end products and safe food for human consumption.
Pre Requisite Program
8.2 P R P
48
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Sector Specific PRPs
EQUIPMENT SUITABILITY,
CLEANING &
MAINTENANCE
LAYOUT OF PREMISES
& WORKSPACE
Managementof
Purchased Materials
CLEANINGAND
SANITIZING
Waste Disposal
UTILITIES - AIR,
WATER, ENERGY
Pest control
CONSTRUCTIONAND
LAYOUT OF BUILDINGS
MEASURESFOR THE
PREVENTION OF CROSS
CONTAMINATION
Various Clauses under PRP as per ISO/TS 22002-1
PERSONNELHYGIENE
& EMPLOYEE
FACILITIES
REWORK
WAREHOUSING&
Transportation
PRODUCT INFORMATION/
CONSUMER AWARENESS
Product Recall
Procedures
FOOD DEFENSE, BIO
VIGILANCE &
BIOTERRORISM 50
51
PRPs
Description
Prerequisite programme
Building maintenance ,Drainage maintenance, Externalvegetation,
External environment
Construction & layout
of a building
Internal layout, Man material movement pattern, segregated storage
Layout of premises &
workspace
Air , water of appropriate quality, Air, water, environmental air
monitoring , Light intensity check, shatterproofcover
Utilities – Air, water,
energy
Garbage segregation, Designated area, color coded enclosed dustbins,
Waste disposal schedule, Waste disposal , disposalof hazardous,
trademark product
Waste disposal
Use of equipment material of suitable quality, Preventive maintenance,
Cleaning and sanitation programs, CIP, COP
Equipment suitability,
cleaning &
maintenance
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• Enlist names of prerequisite programs which
we have discussed just now……
52
53
PRPs
Description
Prerequisite
programme
Supplier selection procedure, QC of purchased material, vehicle
inspection
Management of
purchased
material
Avoid use of glass, brittle plastic, metal, Allergen management
Measures of
prevention of
cross
contamination
Area wise cleaning and sanitation schedule, cleaning chemicals
and tools at designated area, method of cleaning and
concentration of cleaning & sanitizing agent, swab test
Cleaning &
sanitation
Pest control contact, MSDS of chemicals, post treatment
monitoring of pest activity
Pest control
oFollow personal hygiene practices, Follow jewelry policy, Health
check ups
Personal hygiene
• Enlist names of prerequisite programs which
we have discussed just now……
54
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55
PRPs
Description
Prerequisite
programme
Rework at designated area, Line clearance, Appropriate QC checks,
disposition
Rework
Traceability, reconciliation statement, disposition, communication
to regulatory body
Product recall
Storage above the floor away from walls, Temperature , humidity
maintain if required, Segregated storage, Vehicle inspection
Warehouse &
transportation
Label declaration as appropriate,label verification
Product
information /
consumer
awareness
Control on deliberate contamination, vulnerability & threat plan,
Intentional contamination points (vulnerability & threat)
identification, Access control, CCTV surveillance, Supervision,
supplier control, QC methods
Food defence
• Enlist names of prerequisite programs which
we have discussed just now
56
8.3 Traceability system
Documented information as an evidence of traceability shall be maintained.
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8.4 Emergency preparedness & response
• Respond to actual emergencies by:
1. Ensuring applicable statutory & regulatory requirements are identified.
2. Communicating internally (with relevant departments)
3. Communicating externally (Suppliers, customers, appropriate authorities
etc.)
• Take actions to reduce consequences of emergency
• Periodically test procedures
• Review and update if required
Preliminary documented information shall be collected, maintained and updated by the food
safety team –
Applicable statutory regulatory and customerrequirements
The organization’s products, processes and equipment
Food safety hazards relevant to the FSMS
Planning of HACCP
• Where relevant expertise is not available in house, expert advice should be obtained from other
sources-
Trade and industry associations
Independent experts
Competent authorities
HACCP literature and HACCP guides
8.5 Hazard control
8.5.1 Preliminary steps to enable hazard analysis
Comprises of –
A team of individuals within the company +
Assistance from outside experts
Purpose:
Availability of appropriate product specific
knowledge and expertise for the development of
an effective HACCP plan
Responsibility:
Identify scope of HACCP plan
Describe food chain segment and address
general classes of hazards
1. Assemble food safety team
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2. Characteristics of Raw
materials, ingredients and
product contact materials-
Biological Characteristics
Physical Characteristics
Chemical Characteristics
Origin
Method of production
Packaging and delivery methods
Storage conditionsand shelf life
Precaution and/or handling before use or processing
Food safety-related acceptance criteria or specifications of
purchased materials
3. Characteristics of end products
Material name
Composition
Biological characteristics relevant to food safety
Physical characteristics relevant to food safety
Chemical characteristics relevant to food safety
Intended shelf life and storage condition
Packaging
Labeling related to food safety and/or instructions for handling
preparation and usage
Method of distribution
Expected handling
Intended use
Misuse or mishandling of end
products
Group of users
Intended use
Handling of the end
product
Mishandling and
misuse of the end
product
Identified food safety
hazard
Thermal Processing
CCP1
Thermal Processing
CCP1
Receiving
Storage
Preparation
Storage
Testing
CCP 2
Testing
CCP 2
Storage
Sale or Service
Discard
4. Develop a
Process Flow
Diagram followed
by on-site
verification
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5. Description of processes & process environment
Layout of premises – food , non food handling areas
Processing equipment and product contact surfaces
Implementation of PRPs, process parameters (strictness
of their application)
Hazard
identification
and
determination
of acceptable
levels
Conduct Hazard Analysis utilizing below guiding points-
The likely occurrence of hazards and severity of their adverse health effects
The qualitative and/or quantitative evaluation of the presence of hazards
Survival or multiplication of micro-organismsof concern
Production or persistence in foods of toxins, chemicals or physical agents
Conditions leading to the above
Hazards assessment matrix - Example
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67
Inference
Observation
Question
Sr. No
-
Depends on specific system
Effect of control measure on
identified hazard
1.
-
Depends on specific system
The location of control measure
2.
CCP
Yes
Is it specifically established
3.
-
Depends on specific system
Single measure or combination
4.
CCP
Yes
Establishing measurable limits
5.
CCP
If online monitoring with
measured value
Monitoring to detect any failure
6.
CCP
Yes
Applying timely correction
7.
Selection and categorization of control measure using systematic approach.
Validation of control measures
Validation of control measure(s) and combinations of control measures
Validate selected control measures are capable of achieving the intended control
of the significant food safety hazard(s).
-prior to implementation of control measure(s) and combinations of control
measures to be included in the hazard control plan.
-after any change therein
- If result of validation shows control measures(s) is (are) not capable of
achieving the intended control: -modify
-re-assess the control measure(s) and/or combination(s) of control measure(s).
Hazard control plan (CCP/OPRP plan) Determine
Critical Limits & action criteria
A critical limit is a maximum or minimum value to which a biological, chemical or
physical limit must be controlled at a CCP.
This is set in order to prevent, eliminate or reduce a hazard to an acceptable level.
Critical limits shall not be exceeded.
Shall be measurable and have some rationale.
Action criteria- OPRP – Yes/No, present / absent – observable /
measurable
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70
Critical Control Point CCP/ OPRP monitoring
A planned series of observations need to be taken to determine whether a CCP is
within critical limits.
This also helps to create an accurate record for future use in verification.
The monitoring system shall include the following:
◦ What (measurement), How (devices, method) , when (frequency of monitoring)
◦ who (Responsibility)
Monitoring frequency & method shall be capable of determining if critical limits
get exceeded.
Establish corrections & Corrective actions – Actions when critical limits
/ action criteria not met
Corrective actions to be followed
when a hazard is identified in the
food production.
The aim is to correct and
eliminate the cause of the hazard
and bring CCP back under
control.
The cause of problem must be
identified to prevent future
recurrence.
Correction: Immediate action to
eliminate non conformity
Corrective action : Immediate
action to eliminate non conformity
& to prevent recurrence ( Root cause
analysis )
8.6 Review of HACCP – Updating the information relevant to PRPs, HACCP etc
The design and running of the HACCP structure should be reviewed whenever
the food operation is changed.
The system should be reviewed (e.g. once a year) even when there have been
no changes.
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8.7 Control of monitoring & measuring
• Monitoring & measuring equipment shall
be:
1. Calibrated and verified after certain
interval prior to use – records maintained
2. Adjusted as necessary
3. Calibrated status – identified
4. Safeguarded from doing invalidated
adjustments
5. Protected from damage & deterioration
6. The calibration of all the equipment shall
be traceable to international or national
measurement standards
7. Software used in monitoring and
measuring within the FSMS shall be
validated, updated and authorized
8.8 Verifications related to PRPs and HACCP plan
• HACCP verification – already discussed
• PRP verification – To ensure effective implementation, defined frequency
etc.
8.9 Control of
product &
process
nonconformities
8.9.2 Corrections
8.9.4.2 Evaluation for
release
8.9.5 Withdrawal/Recall
8.9.3 Corrective actions
8.9.4 Handling potentially
unsafe products
8.9.4.3 Disposition of
nonconformingproducts
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• What are the key terms to be remembered
from clause no. 8?
76
9. Performance evaluation
9.1 Monitoring,measurement, analysis and evaluation
-what needs to be monitored and measured;
-the methods for monitoring, measurement, analysisand evaluation,as applicable,
to ensure valid results;
-when the monitoringand measuring shall be performed;
--who shall analyse and evaluate the results from monitoring and measurement.
Retain appropriate documented information as evidence of the results.
9.2 Internal audit
- Frequency?
- Methods?
- Responsibilities?
- Planning requirements?
- Reporting?
- Retain documented
information
- implementation of the audit
programme and the audit
results
9.3 ManagementReview
• Inputs- IA result, complainys,NCs etc
• Outputs – Decisions & actions
• Defined frequency
• Minutes of meeting
9.1.2 Analysis & evaluation
• Results of verification activities
• Overall performance of FSMS & need to
update
• Trends – higher incidences of potentially
unsafe product
10.1 Nonconformity and corrective action
10.2 Continual improvement - Top management shall ensure that the organization continuallyimproves the effectiveness of the FSMS
10. 3 Update of the food safety management system-Ensure that the FSMS is continually updated. Retain documented information
1. -System updating activities
2. -Reported as input to management review
10. Improvement
Nonconformity
React to
nonconformity
Action to control and correct
Deal with consequences
Review the nonconformity
Determine the causes of nonconformity
Determining if similar nonconformitiesexist, or could
potentially occur
Implement any action needed
Corrective actions shall be appropriate to the effects of
nonconformity
Suitability
Adequacy
Effectivenessof FSMS
Continuallyimprove
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79
FSSC 22000 : Scope – Food chain categories
As per v. 5.1 Revised – as per v.6
FSSC 22000 V.5.1 to V.6 Main changes
• Realignment of food chain categories in accordance with ISO 22003-1:2022
• The scope has expanded to trading & brokering & reduced by removing farming of animals &
FSSC-Quality.
• The requirements of food safety & quality culture have been integrated
• There are new requirements on quality control, food loss & waste, equipment management.
• Allergen management & environmental monitoring have been strengthened.
• There has also been changes & clarifications made to the certification process.
• The certified organizations identification code (COID) & QR code has been added to FSSC 22000
certificates for improved traceability.
80
FSSC 22000 V.5.1 upgraded to v.6
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82
83
Transport, storage & warehousing (All
categories)
2.5.10
Managementof services & purchased materials
(All categories)
2.5.1
Hazard control & measures of prevention of
cross contamination
(All categories, excluding FII)
2.5.11
Product labelling & printed material (All
categories)
2.5.2
PRP verification (BIII, C, D, G, I & K)
2.5.12
Food defense (All categories)
2.5.3
Product design & development (BIII, C, D, E ,F, I
& K)
2.5.13
Food fraud mitigation (All categories)
2.5.4
Health status(D)
2.5.14
Logo use (All categories)
2.5.5
Equipment management (All categories,
excluding FII)
2.5.15
Managementof allergens (All categories)
2.5.6
Food loss & waste (All categories, excluding I)
2.5.16
Environmental monitoring (BIII, C, I & K)
2.5.7
Communicationrequirements (All categories)
2.5.17
Food safety & quality culture (All categories)
2.5.8
Requirements for organizations with multi-site
certification(E, F, G)
2.5.18
Quality control (All categories)
2.5.9
FSSC 22000 V. 6 Additional requirements
2.5.1 MANAGEMENT OF SERVICES AND PURCHASED MATERIALS (ALL FOOD CHAIN CATEGORIES)
84
a)In addition to clause 7.1.6 of ISO 22000:2018, - where laboratory analysis services are used shall be conducted by a competent
laboratory (internal and external) (e.g. successful participation in proficiency testing programs, regulatory approved programs
or accreditation to internationalstandards such as ISO 17025).
b)For food chain categories C, D, I, FII, G and K, - The organization shall have a documented procedure for procurement in
emergency situations to ensure that products still conform to specified requirements and the supplier has been evaluated.
c)For food chain categories C0, CI, CIII and CIV: In addition to ISO/TS 22002-1:2009 clause 9.2, the organization shall have a policy
for the procurement of animals, fish and seafood that are subject to control of prohibited substances (e.g., pharmaceuticals,
veterinary medicines, heavy metals, and pesticides);
d)For food chain categories C, D, I, FII, G and K, - The organization shall establish, implement, and maintain a review process for raw
material and finished product specifications to ensure continued compliance with food safety, quality, legal and customer
requirements.
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2.5.2 PRODUCT LABELING AND PRINTED MATERIALS (ALL FOOD CHAIN
CATEGORIES)
85
a)In addition to clause 8.5.1.3 of ISO 22000:2018, the organization shall ensure that finished
products are labelled according to all applicable statutory and regulatory requirements in the
country of intended sale, including allergen and customer specific requirements.
b)Where a product is unlabeled, all relevant product information shall be made available to
ensure the safe use of the food by the customer or consumer.
c)Where a claim (e.g. allergen, nutritional, method of production, chain of custody, raw material
status, etc.) is made on the product label or packaging, the organization shall maintain
evidence of validation to support the claim and shall have verification systems in place,
including traceability and mass balance, to ensure product integrity is maintained.
2.5.3 Food defense
• Threat assessment and mitigation plan
2.5.4 Food Fraud Mitigation
• Vulnerability assessment and
mitigation plan
Note: For food chain category FII, in
addition to other requirements the, the
organization shall ensure that their
suppliers have a food defense & food fraud
mitigation plan in place.
Threats Assessment & Critical Control Points - TACCP
Political, Religious Terrorism
• => Driven by change of culture, politics … In search of
media impact
Employees
Driven by wishes of revenge
Subcontractors
• => Driven by revenge, repression…
Competitors
• => Search of destabilization
Vandalism
• => Willful destruction /damaging of the property
Foolish act
PAS 96:2017 – can be used as learning material
