Free ISO

22000:2018
Internal Auditor
Training
From Quality Asia Certifications
Private Limited
Structure of the Course
Clause 1-4
Structure, Scope,
Introduction Revision and History Important Concepts
Definitions, Context
of the Organization

Clause 5 Leadership Clause 6 Planning Clause 7 Support Clause 8 Operation

Clause 9 Impact on
Clause 10
Performance Organization and Internal Auditing
Improvement
Evaluation Auditors
Objectives of the
course

• Gain a comprehensive understanding of

the requirements of the ISO 22000:2018
Food Safety Management System
(FSMS) standard.
• Learn how to plan, conduct, and report
internal audits effectively.
• Understand how to verify compliance
with ISO 22000:2018 requirements.
• Foster a culture of food safety
responsibility within the organization
through effective communication and
audit practices.
Outcomes
• Gain a solid understanding of ISO 22000:2018 requirements and its
practical application.
• Develop the ability to plan, conduct, and report effective internal audits
for the Food Safety Management System (FSMS).
• Identify opportunities for food safety performance improvement and
ensure compliance with regulatory and organizational requirements.
• Enhance skills to support the organization’s continuous improvement
in food safety management.
• Contribute to the organization’s readiness for external audits and ISO
22000:2018 certification
 • Mr. Atul Suri
• BE (Electrical), MBA
• Certified Lead Auditor:
ISO 9001, 14001, 45001, 50001, 22000, 27001,
13485, and 26000
• BEE Certified Energy Auditor (CEA)
Trainer • Professional Experience:
• 30+ Years in the industry, with a strong foundation in
Introduction engineering and management.
• 20+ Years as a seasoned Management Systems
Auditor and Trainer, delivering expertise across
multiple sectors.
• Worked with Various Top Notch Certification Bodies as a
Lead Auditor and Reviewer like Quality Asia, Intertek,
Apave, Moody International, IRQS, etc
About Quality Asia

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ISO22000
Food Safety
Management
System
What is food safety?
Food Safety
…. from farm to fork

• The assurance that food will not cause

an adverse heath effect for the
consumer (human or animal) when it
is prepared and/ or consumed
according to its intended use.
ISO 22000 is…
• Food safety management systems - Requirements for any
organization in the food chain
• Control and reduce any food/feed safety hazards identified for the
end products delivered to the next step in the chain to acceptable
levels
• Implementation of process approach, which incorporates the
Plan-Do-Check-Act (PDCA) cycle and risk-based thinking also in
the food safety management part
Benefits of the ISO
22000
• Enhanced food safety: Ensures that food
products are safe for consumption.
• Regulatory compliance: Helps organizations
meet legal requirements.
• Improved customer confidence: Builds trust
with consumers and stakeholders by
demonstrating a commitment to food safety.
• Operational efficiency: Streamlines
processes and reduces the risk of food safety
incidents.
• Market access: Facilitates entry into new
markets and improves competitiveness.
Revision and history of ISO 22000
• First Edition (2005): Introduced the Food Safety Management System (FSMS)
framework, integrating HACCP principles and ISO's management system approach.
• 2018 Revision: Updated to align with the High-Level Structure (HLS) for consistency
with other ISO standards.
• Aligned with the High-Level Structure (HLS) to ensure compatibility with other
ISO standards like ISO 9001 and ISO 14001.
• Enhanced focus on risk-based thinking and PDCA (Plan-Do-Check-Act) at both
organizational and operational levels.
• Clear differentiation between organizational and operational risks.
• ISO 22000:2018/Amd 1:2024: Amendment 1: Climate action changes
Food safety management system
ISO 22000
Food Safety
Management
System
Key concepts and terms
Management
System

• Set of interrelated or
interacting elements of an
organization to establish
policies and objectives and
processes to achieve those
objectives.
“Food” as per ISO
22000

• Any substance (or ingredient), whether

processed, semi-processed or raw,
which is intended for consumption
(human and animal consumption).
The food chain

• Sequence of stages in the

production, processing,
distribution, storage and
handling of a food and its
ingredients, from primary
production to consumption.
ISO 22000:2018 PDCA
Risk based thinking
in ISO 22000

• Applied at organizational and

operational levels
The ISO 22000 family
ISO 22000
Requirements for any
organization in the food
chain
ISO 22005
Traceability in the food and
ISO/TS 22002 feed chain
Prerequisite programmes
on food safety
Six parts: Food manufacturing,
Catering, Farming,Food ISO/ TS 22003
packaging manufacturing, Requirements for
Transport and storage, Feed and certification bodies
animal food production
ISO 22000 structure
ISO 22000:2018 Requirements for any org anization in the food chain
1 Scope 8. Operation
2 Normative references 1. Operational planning and control
2. Prerequisite programmes (PRPs)
3 Terms and definitions 3. Traceability system
4. Emergency preparedness and response
4 Context of the organization 5. Hazard control
1. Understanding the organization and its context 6. Updating the information specifying the PRPs and the hazard
2. Understanding the needs and expectations of interested parties control plan
3. Determining the scope of the FSMS 7. Control of monitoring and measuring
4. Food safety management system 8. Verification related to PRPs and the hazard control plan
5 Leadership 9. Control of product and process nonconformities
1. Leadership and commitment 9. Performance evaluation
2. Policy 1. Monitoring, measurement, analysis and evaluation
3. Organizational roles, responsibilities and authorities 2. Internal audit
6 Planning 9.3. Management review
1. Actions to address risks and opportunities 10. Improvement
2. Objectives of the FSMS and planning to achieve them 1. Nonconformity and corrective action
3. Planning of changes 2. Continual improvement
7 Support 3. Update of the FSMS
1. Resources
2. Competence
3. Awareness
4. Communication
5. Documented information
Why do we need such high Hygiene
Standards?
The COSTS of Poor Hygiene The BENEFITS of Good Hygiene

• Food Poisoning Outbreaks & • One Satisfied Customer Leads to

Sometimes Death Another
• Customer Complaints • A Good Reputation
• Pest Infestation • Increased Business
• Wasted food (spoilage) • Compliance with the Law
• Closure of premises (loss of jobs) • Longer Food shelf Life
• Fines and costs of legal actions • Better Working environment
• Civil action taken by food poisoning • Higher Staff Morale
victims • Increased Profits
• Loss of Profit
Benefits of Serving Safe
Food product

• Protects Employees and Customers

• Reputation and Repeat Business
• Better Service- Higher Profits
• Reduce Health Code Violations
 Legal fees

Medical claims

By this You Lost wages

avoid; Cleaning & Sanitizing costs

Loss of food product- discarded

Bad Publicity
Clause 4: Context of the organization
S. No. Clause No. Clause name

1. 4.1 Understanding the organization and its

context
2. 4.2 Understanding the needs and
expectations of interested parties
3. 4.3 Determining the scope of the food
safety management system
4. 4.4 Food safety management system
4.1. Understanding the organization and its
context
• The organization shall determine external and internal issues that
are relevant to its purpose and that affect its ability to achieve the
intended result(s) of its FSMS.
• The organization shall identify, review and update information
related to these external and internal issues.
Context of the organization

• External issues: natural conditions,

legislation, competition, technology,
cultural and religious aspects,
consumption patterns, food fraud…
• Internal issues: position in the food
chain, infrastructure, competence,
working conditions, access to resources,
number and variety of customers…
4.2. Understanding the needs and expectation
of interested parties
• To ensure that the organization has ability to consistently provide
products and services that meet applicable statutory, regulatory
and customer requirements with regard food safety, the
organization shall determine:
• the interested parties that are relevant to the FSMS;
• the relevant requirements of the interested parties of the FSMS.
• The organization shall identify, review and update information
related to the interested parties and their requirements.
 Indian Law & FSSAI (Food
Safety and Standards
Authority of India)
• Established under the Food Safety and
Standards Act, 2006
• Apex body for food safety and regulation in
India
• Ensuring safe and wholesome food for
human consumption
Legal Framework of FSSAI
• Food Safety and Standards (Licensing and Registration of Food
Businesses) Regulations, 2011
• Food Safety and Standards (Packaging and Labelling) Regulations,
2011
• Food Safety and Standards (Contaminants, Toxins, and Residues)
Regulations, 2011
• Enforcement: Implemented by State and Central Authorities
Condition of License, Food Business Operators
Shall:
• Display a true copy of the license galways granted in Form Cat a prominent place in the premises.
• Give necessary access to licensing authorities or their authorized personnel to the premises.
• Inform authorities about any change or modifications in activities.
• Employ at least one technical person to supervise the production process. The person supervising the production process
shall possess at least a degree in science with Chemistry/ Biochemistry/ Food and Nutrition/ Microbiology or a degree or
diploma in Food Technology/ Dairy Technology/ Dairy Microbiology/ Dairy Chemistry/ Dairy Engineering/ Oil Technology/
Veterinary Science/ Hotel Management & Catering Technology or any degree or diploma in any other discipline related to the
specific requirement of the business from a recognized university or institute or equivalent.
• Furnish periodic annual return from 1st April to 31st March, within 31st May of each year. For
collection/handling/manufacturing of milk and milk product, half-yearly return is also to be furnished as specified.
• Ensure that no product other than the product indicated in the license/registration is produced in the unit.
• Maintain factory's sanitary and hygienic standards and workers’ hygiene as specified in Schedule-4 according to the
category of food business.
• Maintain daily records of production, raw materials utilization, and sales separately.
• Ensure that the source and standards of raw material used are of optimum quality.
Condition of License, Food Business Operators
Shall: (Contd.)
• Food business operator shall not manufacture, store, or expose for sale or permit the sale of any
article of food in any premises not effectively separated to the satisfaction of the licensing
authority from any privy, urine, sullage, drain, or place of storage of foul and waste matter.
• Ensure clean-in-place system (whatever necessary) for regular cleaning of machine & equipment.
• Ensure testing of relevant chemical and/or microbiological contaminants in food products in
accordance with these regulations as frequently as required on the basis of historical data and
risk assessment to ensure production and delivery of safe food through own or NABL-
accredited/FSSAI-recognized labs at least once in six months.
• Ensure that as much as possible the required temperature shall be maintained throughout the
supply chain from the place of procurement or sourcing till it reaches the end consumer,
including chilling, transportation, and storage, etc.
• The Manufacturer/ Importer/ Distributor shall buy and sell food products only from, or to,
licensed/registered vendors and maintain record thereof.
Other Conditions:
• Proprietors of hotels, restaurants, and other food stalls who sell or expose for sale savouries, sweets, or other
articles of food shall put up a notice board containing separate lists of the articles which have been cooked in
ghee, edible oil, vanaspati, and other fats for the information of the intending purchasers.
• Food business operator selling cooked or prepared food shall display a notice board containing the nature of
articles being exposed for sale.
• Every manufacturer (including ghani operator) or wholesale dealer in butter, ghee, vanaspati, edible oils,
solvent-extracted oil, de-oiled meal, edible flour, and any other fats shall maintain a register showing:
• Quantity of manufactured, received, or sold
• Nature of oil seed used
• Quantity of de-oiled meal and edible flour used
• Destination of each consignment of substances sent out from the factory or place of business
• The register shall be presented for inspection whenever required by the licensing authority.
• No producer or manufacturer of vegetable oil, edible oil, and their products shall be edible for license under
this act unless they have their own laboratory facility for analytical testing of samples.
Other Conditions:
• Every sale and movement of stocks of solvent-extracted oil, 'semi-refined' or 'raw grade I,' edible groundnut flour, or edible coconut flour, or both, by the
producer shall be a sale or movement of stocks directly to a registered user and not to any other person, and no such sale or movement shall be effected
through any third party.
• Every quantity of solvent-extracted oil, edible groundnut flour, or edible coconut flour, or both, purchased by a registered user shall be used by them in
their own factory entirely for the intended purpose and shall not be re-sold or otherwise transferred to any other person.
• Provided that nothing in this sub-clause shall apply to the sale or movement of the following:
• Karanjia oil
• Kusum oil
• Mahua oil
• Neem oil
• Tamarind seed oil
• Edible groundnut flour bearing the I.S.I. certification mark
• Edible coconut flour bearing the I.S.I. certification mark
• No food business operator shall sell, distribute, offer for sale, dispatch, or deliver any edible oil for sale that is not packed, marked, and labeled in the
manner specified in the regulations unless specifically exempted by notification in the official Gazette issued in the public interest by food safety
commissioners in specific circumstances and for a specific period with reasons recorded in writing.
Food
Sample Test
Report
(Example)
Interested parties

• Clients, consumers, employees,

authorities, shareholders, professional
associations, NGOs …
• They all have requirements that shall be
identified.
4.3. Determining the scope of the food safety
management system
• The organization shall determine
the boundaries and applicability
of the Food Safety Management
System. (products, services,
processes, production sites)

• The scope shall be documented

and maintained up to date.
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.
Climate action
changes
• Amendment 1 to ISO
22000:2018 from February
2024
CLIMATE ACTION
CHANGES

• The organization shall determine whether

climate change is a relevant issue (for its
context)
CLIMATE ACTION • Interested parties can have requirements related to
climate change
CHANGES
Recapitulation (Context
of the organisation)

• Identify factors that impact the Food Safety

Management System (FSMS), including regulatory,
market, technological, and organizational
influences.
• Recognize relevant stakeholders (e.g., suppliers,
customers, regulatory bodies, employees) and their
food safety-related needs and expectations.
• Establish the boundaries and applicability of the
FSMS based on internal and external issues and the
requirements of interested parties.
• Develop, implement, maintain, and continuously
improve an FSMS to achieve food safety objectives
and demonstrate continual improvement.
Clause 5: Leadership

S. No. Clause No. Clause name

1. 5.1 Leadership and commitment

2. 5.2 Policy
3. 5.3 Organizational roles,
responsibilities and authorities
5.1. Leadership and commitment
• The top management shall demonstrate leadership and
commitment with respect to the FSMS.
Top management
• Ensure a food safety policy and objectives are
established
• Provide resources
• Integrate food safety
• Communicate on food safety inside the company
• Supervise the FSMS
• Promote continual improvement
5.2. Policy
• Defines the direction of the company and
serves as the visible evidence of the top
management commitment
• Appropriate to the purpose and the context of
the organization
• Provides a framework for setting and
reviewing the food safety objectives
• Includes commitments:
• to satisfy legal and client requirements;
• for continual improvement
• The policy shall:
• address internal and external
communication
• address the need to ensure
competencies related to food safety
The food safety policy
• Documented
• Communicated, understood and applied
• Available to interested parties, as
appropriate
5.3. Organizational roles,
responsibilities and authorities

• Top management shall assign and communicate

responsibilities and authorities for relevant roles
• There should be clarity about responsibilities
and interfaces
• Responsibilities and authorities must be
understood
Top management shall assign the
responsibilities and authorities for…

Ensuring Reporting Appointing Designating

Ensuring that the Reporting on the Appointing the food Designating

FSMS conforms to performance of the safety team and persons with
the requirement of FSMS to top the food safety defined
this document management team leader responsibility and
authority to initiate
the document
action(s).
Food safety team
• Responsible to coordinate, monitor and improve the FSMS
• Appointed by the top management
• Multi-disciplinary
Food safety team leader (A key person-critical
for the success of the FSMS)
• Keeps the top management informed
• Knowledgeable of food hygiene and HACCP principles
• Understands the company’s operations and its food safety issues
• Has good communication and management skills
• Can be from outside the company
Recapitulation
(Leadership)
• Top management ensures the integration of the Food
Safety Management System (FSMS) into the
organization’s business processes.
• Drives continual improvement and alignment with
strategic objectives.
• Develop and maintain a food safety policy that supports
organizational goals, ensures compliance with
regulatory requirements, and promotes safe practices.
• Assign roles and communicate responsibilities across
the organization to ensure the effective implementation,
maintenance, and improvement of the FSMS.
Clause 6: Planning

S. No. Clause No. Clause name

1. 6.1 Action to address risk and opportunities

2. 6.2 Objectives of the food safety management system and

planning to achieve them
3. 6.3 Planning of changes
6.1. Actions to address
risks and opportunities

• The organization shall determine risks and

opportunities that need to be addressed to:
• give assurance that the FSMS can
achieve its intended result(s);
• enhance desirable effects;
• prevent, or reduce, undesired effects;
• achieve continual improvement.
Risks (examples)

• Product counterfeiting
• Product alteration
• Theft or diversion
• Lack of competence
• …
Opportunities (examples)
• New technologies
• Changes to processes
• Participation in groups,
associations…
The organization shall plan…
• actions to address these risks and opportunities;
• how to:
• integrate and implement the actions into its FSMS processes;
• Evaluate the effectiveness of these actions
Address risks and
opportunities
• Avoidance
• Mitigation
• Risk taking
• Acceptance
The actions taken by the organization to address
risks and opportunities shall be proportionate to:
• the impact on food safety requirements;
• the conformity of food products and services to customers;
• requirements of interested parties in the food chain.
6.2. Objectives of the FSMS
and planning to achieve them
• Consistent with the Food safety policy
• Considers applicable requirements (legal, customer, etc.)
• Measurable (whenever possible)
• Communicated
• Monitored and verified
• Updated
• Documented
Plan to achieve the
objectives
• What will be done?
• Resources required?
• Who is responsible?
• What are the deadlines?
• How to evaluate the results?
6.3. Planning of changes

• Changes shall be carried out and

communicated in a planned manner
• Consider purpose and potential
consequences
• Evaluate the impact and avoid unwanted
effects
• Estimate resources and make them
available
• Consider the allocation and re-allocation
of responsibilities
Change management
procedure
• Types of changes controlled by
change management
• Responsibilities and authorities for
managing, reviewing and approving
changes
• Requesting a change
• Testing prior to implementation
• Dealing with unsuccessful changes
• Documentation prepared
Recapitulation (Planning)
• Identify and address risks and opportunities to ensure food safety.
• Establish measurable food safety objectives and plan actions to
achieve them.
• Ensure planned changes are conducted systematically without
compromising food safety.
Clause 7: Support
S. No. Clause No. Clause name
1. 7.1 Resources
2. 7.1.2 People
3. 7.1.3 Infrastructure
4. 7.1.4 Work Environment
5. 7.1.5 Externally developed elements of the food safety management system
6. 7.1.6 Control of externally provided processes, products or services
7. 7.2 Competence
8. 7.3 Awareness
9. 7.4 Communication
10. 7.5 Documented Information
7.1. Resources
• The organization shall determine and provide the resources
needed for the establishment, implementation, maintenance,
update and continual improvement of the FSMS.
• The organization shall consider:
• the capability of, and any constraints on, existing internal resources;
• the need for external resources.
7.1.2. People
• The organization shall ensure that persons necessary to operate
and maintain an effective FSMS are competent (see 7.2).
• Where the assistance of external experts is used for the
development, implementation, operation or assessment of the
FSMS, evidence of agreement or contracts defining the
competency, responsibility and authority of external experts shall
be retained as documented information
 7.1.3. Infrastructure

• The organization shall provide

the resources for the
determination, establishment
and maintenance of the
infrastructure necessary to
achieve conformity with the
requirements of the FSMS.
• Infrastructure includes, land,
buildings and utilities, vessels,
equipment (hardware and
software), transportation,
IT&C…
7.1.4. Work environment
• Provide and maintain the adequate work environment.
7.1.5. Externally developed elements of the FSMS

• Conformity with the standard

• Applicable to the specifics of the
organization
• Adapted by the food safety team
• Retained as documented
information
7.1.6. Control of externally provided
processes, products or services
• Apply criteria for the evaluation, selection and
monitoring of external providers
• Ensure that processes, products and services from
external providers do not affect the ability to meet
food safety requirements
• Communicate requirements to external providers in
a suitable manner
• Retain documented information as evidence
 Supplier (re)evaluation

- Criteria

- Records

- On a regular basis
7.2. Competence
• Determine the necessary competence
• Ensure the persons are competent
• Take action to acquire the
necessary competence and
evaluate effectiveness

• Ensure that the food safety team has the

knowledge and experience required to
develop and implement the FSMS
• Retain documented information as evidence
7.3. Awareness

• All relevant persons doing work

under the company’s control
shall be aware of:
• the food safety policy
• the food safety objectives
relevant to them
• the individual contribution
to the effectiveness of the
FSMS and the benefits of
improved food safety
performance
• the implications of not
conforming to requirements
7.4. Communication
• The organization shall determine the internal and external
communications relevant to the FSMS, including:
• on what it will communicate;
• when to communicate;
• with whom to communicate;
• how to communicate;
• who communicates.
• The organization shall ensure that the requirement for effective
communication is understood by all persons whose activities
have an impact on food safety.
External communication
• Establish, implement and
maintain effective
communications with
customers, consumers,
external providers,
authorities and others.

• Assign responsibilities and

authorities for external
communication (regarding
food safety)
• Retain documented
information
Internal communication
• An effective system to communicate inside the company
on food safety matters.

• The food safety team shall be informed in a timely

manner about changes that may have an impact on food
safety
7.5. Documented
Information
• FSMS documentation includes:
• the documents required by
ISO 22000;
• documents not required by
the standard but necessary
for the FSMS;
• documents required by
authorities or customers.
Creatingand
updating
documents
• Identification and
description
• Format and media
• Review and approval
Control of documented information
Recapitulation (Support)
• Provide adequate resources for the effective FSMS.
• Ensure competent personnel to maintain food safety processes.
• Establish and maintain necessary infrastructure for FSMS.
• Provide a suitable work environment to ensure food safety.
• Control externally developed components of the FSMS.
• Ensure external processes, products, and services meet food safety
requirements.
• Ensure personnel are competent based on education, training, or experience.
• Ensure staff are aware of food safety policies, objectives, and roles.
• Establish internal and external communication for FSMS.
• Create, maintain, and control documented information for FSMS.
Clause 8: Operations
S. No. Clause No. Clause name
1. 8.1 Operational planning and control
2. 8.2 Prerequisite programmes (PRPs)
3. 8.3 Traceability system
4. 8.4 Emergency preparedness and response
5. 8.5 Hazard Control
6. 8.6 Updating the information specifying the PRPs and the hazard
control plan
7. 8.7 Control of monitoring and measuring
8. 8.8 Verification related to PRPs and the hazard control plan
9. 8.9 Control of product and process nonconformities
 8.1. Operational planning and control

• Establish criteria for the

processes

• Control the processes

according to criteria
• Keep documented
information to prove that the
processes have been carried
out as planned
Change
management
• Control planned changes
• Review unintended
changes
• Act to mitigate any
adverse effects
Outsourcing
Control outsourced
processes
8.2. Prerequisite
programmes (PRPs)
• Basic conditions and activities that are
necessary within the organization and
throughout the food chain to maintain food
safety.

The organization shall establish, implement, maintain and update

PRPs to facilitate the prevention and/ or reduction of contaminants
in the products, product processing and work environment.
Prerequisite programmes

• Appropriate to the organization

• Approved by the food safety team
• Applicable to the whole production system
or to a specific process/ product
Prerequisite programmes
• When selecting and/or establishing PRP(s), the organization shall
ensure that applicable statutory, regulatory and mutually agreed
customer requirements are identified. The organization should
consider:
• Applicable part of the ISO/TS 22002 series;
• Applicable standards, codes of practice and guidelines
What to consider when establishing PRPs?

Construction, Premises, Air, water, energy

Pest control, waste
buildings and workspace and and associated
disposal and sewage
utilities employee facilities utilities

Reception, storage,
dispatch, Prevention of cross-
Equipment Supplier approval
transportation and contamination
handling of products

Product information/ Others (e.g., food

Cleaning and
Personal hygiene consumer defense,
disinfection
awareness bioterrorism)
PRPs for food manufacturing - Construction and
layout of buildings
• Buildings shall be designed,
constructed and maintained for
food processing operations
(considering the hazards and the
potential sources of
contamination)
• Durable construction
• Locations close to waste dumps,
flood plains and heavy vegetated
areas should be avoided
• Clear identification of boundaries
• Roads, parking spaces, yards
shall be maintained
PRPs for food manufacturing - Layout of the
premises and workspace
• Sufficient space.
• Protection against contamination.
• Consider the logical flow
(materials, products, personnel).
• Separation between raw and
processed areas.
PRPs for food manufacturing - Layout of the
premises and workspace
• Washable/ cleanable walls and
floors.
• Standing water on the floor
avoided
• Ceilings and overhead fixture
shall prevent the
• accumulation of dirt and
condensation.
• Walls, floors, ceilings, doors
shall be non-corrosive,
impervious, non-absorbent
and constructed of durable
materials.
PRPs for food manufacturing - Layout of the
premises and workspace
• Screened windows and roof
vents.
• Closed/ screened external
doors (self closing).
• Equipment positioning shall
allow for cleaning, sanitizing,
maintenance and inspection.
PRPs for food manufacturing - Layout of the
premises and workspace
• Laboratory facilities shall not
open directly to the
production area.
• Temporary/ mobile premises
and vending machines shall
be designed, located,
constructed and operated to
prevent the harborage of
pests and the contamination
of the food products.
PRPs for food manufacturing - Layout of the
premises and workspace
• Storage areas shall be dry
and ventilated protected
from dust, condensation,
waste. Segregation
between raw materials,
work in progress and
finished products.
• Storage areas shall allow for
cleaning and maintenance
activities.
• Chemicals, cleaning
products, hazardous
substances shall be stored
separately.
PRPs for food manufacturing - Water supply and
boiler chemicals
• Sufficient potable water supply.
• Water quality testing.
• Separate system for non-potable water.
• Water filters shall be changed/
maintained.
• Water storage facilities shall prevent
contamination.
• Seawater (if used) shall be from an
approved source.
• Ice or steam shall be obtained from
potable water.
• Boiler chemicals shall be approved and
stored securely
PRPs for food manufacturing - Air quality and
ventilation
• Define the requirements for air
filtration, microbiology and
humidity.
• Monitoring systems shall be in
place wherever air temperature or
humidity are critical for the
process.
PRPs for food manufacturing - Air quality and
ventilation
• Sufficient air exchange.
• The design shall not allow the flow
of air from contaminated areas to
clean areas (air pressure
differentials).
• Quality monitoring for air supply.
PRPs for food manufacturing - Compressed air and
other gasses
• The systems shall be designed,
constructed and maintained to
prevent contamination.
• Food contact gases shall come
from an approved source.
• The organization shall define its
requirements for filtration,
humidity and microbiology.
PRPs for food manufacturing - Lighting
• Sufficient for the activity
performed.
• Should not alter the color of the
food.
• Light bulbs and fixtures shall be
protected in case of breakages.
PRPs for food manufacturing – Waste disposal
• Waste shall be identified,
collected, removed and disposed
of in a manner that prevents the
contamination of the product and
of the production areas.
PRPs for food manufacturing – Waste
management
• Designated areas for waste
containers.
• Waste segregation.
• Leak-proof and easy to clean
containers.
• Daily waste removal.
• Attention to printed packages,
labelled or trademark materials
that are disposed of.
 • Sufficient capacity.
PRPs for food
• Accessible for cleaning.
manufacturing – • Direction shall not be from a contaminated area to
Drains and drainage a clean one.
PRPs for food
manufacturing –
Equipment

• Designed and constructed to facilitate

cleaning, disinfection, maintenance.
• Constructed of durable materials.
• Hygienic design.
• Pipes and ducts cleanable, drainable and
with no dead ends.
• Product contact surfaces designed for food
use.
PRPs for food
manufacturing –
Equipment maintenance
• Preventive maintenance
programme.
• Maintenance activities shall not
contaminate food.
• Food safety related maintenance
requests shall be prioritized.
• Food grade lubricants and heat
transfer fluids.
• Maintenance personnel shall be
trained in the product hazards
associated with their activities.
PRPs for food
manufacturing –
Purchasing
• Control the process of purchasing
materials with an impact on food
safety.
• Ensure that suppliers are capable
to meet requirements.
• Verify the conformance of
incoming materials.
PRPs for food manufacturing
– Selection and management
of suppliers
• Process for the selection, approval
and monitoring of suppliers.
• Supplier audits
• Request for documentation (e.g.
certifications)
PRPs for food manufacturing
– Requirements for incoming
materials
• Check delivery vehicles before and
during unloading.
• Inspect, test, verify the products
prior to acceptance or use.
• Documented procedure for
managing non- conforming
materials.
• Access points to bulk material
receiving lines must be identified,
capped and locked.
PRPs for food manufacturing
– The prevention of cross-
contamination
• Programmes to prevent, control
and
• detect contamination:
• microbiological
• allergen
• physical
Microbiological contamination
• Hazard assessment.
• Control measures:
• separation of raw from
finished or ready- to-eat
products;
• barriers, walls, separate
buildings;
• access controls for
personnel;
• traffic patterns;
• air pressure differentials.
Allergen
• Allergens shall be declared.
• Products shall be protected from
unintended allergen cross-
contact.
• Rework containing allergens shall
only be used for products that
contain the same allergen or after
a process that removes or
destroys allergenic material.
• Training of employees on allergen
control measures
Physical contamination
• Avoid brittle materials (glass, hard
plastic).
• Keep records of glass breakages.
Possible control measures:
• covers over equipment or
containers;
• shatterproof light bulbs;
• screens, sieves, filters,
magnets;
• metal detectors or X-ray.
PRPs for food manufacturing – Cleaning and
sanitizing
• Cleaning and sanitizing
programmes to ensure that the
food processing equipment and
the environment are kept in a
hygienic condition.
PRPs for food manufacturing – Cleaning and
sanitizing agents and tools
• Agents and chemicals:
• appropriate,
• food grade,
• identified,
• stored separately,
• used according to
specifications.
• Tools and equipment:
• hygienic design,
• proper maintenance.
PRPs for food manufacturing – Cleaning and
sanitizing programmes
• Cleaning programmes
established and validated
including:
• what to clean;
• methods (Cleaning in Place
vs. Cleaning out of Place);
• substances;
• frequency;
• responsibilities;
• post-clean and pre-start-up
inspections.
Validation vs. Verification
 PRPs for food manufacturing – Cleaning in place (CIP)

• Define and monitor the

parameters for Cleaning in
Place systems.
PRPs for food manufacturing – Monitoring sanitation effectiveness

• The organization shall monitor its

cleaning and sanitation
programmes to ensure that they
are suitable and effective.
PRPs for food manufacturing – Pest control
• Nominated person to manage
pest control activities.
• Licensed/ approved pest
contractors.
PRPs for food manufacturing – Pest control
• Pest management programme(s)
including:
• pests targeted,
• plans,
• methods,
• frequency,
• inspections,
• training requirements,
• chemicals approved.
PRPs for food
manufacturing –
Pest control
PRPs for food manufacturing
– Personnel hygiene and
employee facilities
• Define, document and enforce
rules for personal hygiene and
behaviors, proportional to the
hazards.
PRPs for food manufacturing –
Personnelhygiene facilitiesand
toilets
• Sufficient and accessible hand washing facilities.
• Sinks should be of stainless steel (or another non-
corrosive material) and they shall not be hand
operated.
• Hand washing sinks separated from those for food
use and equipment cleaning-stations.
• Sufficient toilets, clean and properly maintained.
• Employee hygiene facilities shall not open directly
onto production, packing or storage areas.
• Changing facilities located to minimize the risk of
contaminating workwear.
PRPs for food
manufacturing – Staff
canteens and designated
eating areas
• Located to minimize the risk of
cross- contamination.
• Managed in a hygienic
condition.
• Staff shall consume and store
food only in designated areas.
PRPs for food manufacturing – Workwear and
protective clothing
• Suitable to the work and designed
to prevent contamination.
• Avoid buttons and external
pockets.
• Hair, beards, moustaches
covered.
• Gloves kept in good condition
(avoid latex).
• Workwear laundered to standards
at suitable intervals.
PRPs for food manufacturing – Health status
• Medical testing in accordance
with the provisions of the
legislation. Prior to employment
and regular testing.
PRPs for food manufacturing – Illness and injuries

• Conditions shall be reported.

• Wounds and burns must be
covered with dressings (colored,
metal detectable).
• Lost dressings must be reported.
PRPs for food manufacturing – Personal
cleanliness
• Wash (+ sanitize) hands.
• Refrain from sneezing or coughing
over materials or products.
• Fingernails clean and trimmed.
PRPs for food manufacturing – Personal behaviour

• A policy to describe the behaviors

required.
• Aspects to consider:
• smoking, chewing, eating in
designated areas;
• nail polish, false nails, false
eyelashes not allowed;
• pencils not carried behind the
ear;
• consideration to the risks posed
by jewellery and personal effects;
• personal lockers;
• storage of cigarettes, medicines,
lighters and other personal items
 PRPs for food
manufacturing – Rework

Nonconforming or returned products

that are suitable for reprocessing.

• Stored, handled and used so that

product safety, quality, traceability
and regulatory compliance are
maintained.
PRPs for food manufacturing – Rework
• Protected from contamination.
• Labelled and identified for
traceability.
• Records retained on rework
classification and reasons for
rework designation.
• Segregation, labelling and
identification for allergen control.
• Specify conditions, methods for
rework usage.
PRPs for food manufacturing – Product recall
• Products that fail to meet safety
requirements shall be identified,
located and removed.
• Maintain a list of all key
contacts to be used in case
of a recall.
• Investigate the safety of other
products manufactured in
similar conditions.
• Consider the need for public
warning.
PRPs for food manufacturing –
Warehousing
• Products and materials shall be stored in clean, dry, well-
ventilated spaces; protected from dust, condensation,
fumes, odors or other forms of contamination.
PRPs for food manufacturing –
Warehousing
• Temperature, humidity and other environmental
conditions must be controlled.
• Waste and chemicals stored separately.
• Segregation of non-conforming materials.
• Stock rotation systems (e.g. FIFO, FEFO).
• Diesel or gasoline forklifts shall not be used in product
storage areas.
PRPs for food manufacturing –
Vehicles, conveyances and
containers
• Clean and in a condition consistent with
requirements.
• Cleaned between loads, when used for food and
non- food transport.
• Shall provide adequate protection against damage
and environmental conditions.
• Appropriate loading and unloading procedures.
• Bulk containers for food use only.
PRPs for food
manufacturing –
Product information
and
consumer awareness
• Provide information to
consumers so that they
understand its importance and
can make informed choices.
PRPs for food manufacturing – Food defense
• The process to ensure the
security of food and drink from all
forms of intentional malicious
attacks, including ideologically
motivated attacks leading to
contamination.
• Assess the hazard to products
posed by potential acts of
sabotage, vandalism or terrorism
and implement control
measures.
PRPs for food
manufacturing –
Bioterrorism
• TACCP – Threat Analysis and
Critical Control Points.
• Access control – identify, map
and control sensitive areas.
• HR Security.
• Control of suppliers and
contractors.
What is Food Poisoning ?
• An unpleasant illness which normally happens within 1 to 36
hours of eating contaminated or poisonous food.
• Symptoms:
• Abdominal Pain
• Diarrhea
• Vomiting
• Fever
 Bacteria or their poisons

What are Viruses

the Main Chemicals

Causes of
Food
Metals

Poisoning ?
Poisonous Plants

BACTERIAL FOOD POISONING CAN BE FATAL & IS

THE MOST COMMON CAUSE OF FOOD POISONING
Different Types of
Bacteria

• FOOD POISONING BACTERIA

• Cause Illness
• Can not be detected by taste or smell
• Very Harmful due to difficulty to detect
• FOOD SPOILLAGE BACTERIA
• Can be detected (when in high numbers)
by smell, taste or even colour & texture
of food
• Relatively Harmless because of ease of
detection
How Bacteria Grow

• Bacteria reproduce by splitting in two

• Under ideal conditions bacteria can divide in
two every :10 minutes
• One bacteria can become 1,000,000 in 3
hours & 20 minutes
 12,00,000

Growth of Bacteria 10,00,000

8,00,000

Number of Bacteria
• THIS IS CALLED EXPONENTIAL
GROWTH
6,00,000

4,00,000

2,00,000

0
0 10 20 30 40 50 60 70 80 90 100110 120 130 140 150160 170 180 190 200
Minutes

NUMBER OF BACTERIA
Conditions for Bacterial Growth

FOOD WARMTH TIME WATER

The Temperature
‘DANGER ZONE’
for Food
 Destruction of Bacteria

HEAT IRRADIATION CHEMICALS

e.g., Cooking, Pasteurisation e.g. X-Rays, Gamma Rays e.g. Preservatives, Salt, etc.
 PEOPLE

Where do PESTS

Bacteria AIR

WATER
come ANIMALS & BIRDS

From ? RAW FOOD

SOIL & WASTE

Food Poisoning
Bacteria

• SALMONELLA
• Symptoms : Vomiting, Diarrhoea, Abdominal
Pains, Fever
• Incubation Period : 12-36 hours
• Duration of Illness : 1-8 days
• Source : All raw foods of animal origin, poultry in
particular. Humans can be carriers.
• STAPHYLOCOCCUS AUREUS
• Symptoms : Vomiting, Abdominal Pains
• Incubation Period : 1-7 hours
• Duration of Illness : 6-24 hours
• Source : Human Nose, throat, skin, hair, boils,
styes, septic cuts
Food Hygiene is..
PROTECTION of food from risk of contamination by bacteria, poisons, viruses
& foreign bodies.

PREVENTION of bacteria present in food multiplying to numbers that would

result in illness of people or result in premature spoilage of food.

DESTROYING any harmful bacteria in the food by proper cooking or

processing

CONTAMINATION is the presence of any OBJECTIONABLE MATTER in food.

This may be bacterial or physical, e.g. glass, wood, metal, etc.
 Food Contamination
PHYSICAL, Examples : PHYSICAL, Examples :

• Dead Insects (sometimes live) • Dead Insects (sometimes live)

• Paper & Cardboard • Paper & Cardboard
• Plastic, Metal, Plasters, • Plastic, Metal, Plasters,
• Cleaning Materials, String, • Cleaning Materials, String,
• Rodent hair & droppings, • Rodent hair & droppings,
• Sweet Papers, Pen Tops, Grease, • Sweet Papers, Pen Tops, Grease,
• Glass, Cigarette Ends, and so • Glass, Cigarette Ends, and so
on... on...
High Risk Foods
• Some foods are higher risk than others because they present a
better growth opportunity for Food Poisoning bacteria (and
viruses) than others.
• EXAMPLES :
• ALL COOKED FOODS - Already cooked, will not be cooked again, also free
from competition,
• FOODS CONTAINING RAW INGREDIENTS (or FOODS normally eaten RAW
or PART COOKED) - e.g. Mayonnaise, Rare Steak, Shellfish.
High Risk Foods

Food High Risk?

Cooked Meat Yes • A HIGH-RISK FOOD is one which
SUPPORTS THE GROWTH OF
Apple No BACTERIA and is INTENDED FOR
CONSUMPTION WITHOUT
FURTHER TREATMENT THAT
Cooked rice Yes WOULD DESTROY SUCH
BACTERIA, e.g., Cooking.
Milk, Cream, etc. Yes
Fresh meat No
Best
Practices -
Kitchen
Best practices
Colored
chopping
board and
knife
Date tagging
Good hygiene practice
Hygiene rule code -
FSSAI
For Restaurant
Hygiene rule code
- FSSAI
For Meat Retail
Hygiene rule code -
FSSAI
For Street Vendor
Hygiene rule code
- FSSAI
For Fruit and Vegetable vendor
FSSAI guidelines
for handling and
disposal of used
cooking oil
8.3. Traceability system
• Establish a traceability system
that allows to go one step back
and one step forward.
• It shall address at least:
• the relationship between the
lots of received materials,
ingredients and intermediate
products to the end products;
• the distribution of the end-
product;
• reworking of materials/
products.
Traceability system
• A traceability system should be:
verifiable, cost-effective, practical
to apply, results oriented.
• Retain documented information as
evidence of the traceability
system for a period that covers at
least the shelf life of the product.
• Verify and test the effectiveness of
the traceability system.
8.4.
Emergency
preparedness
and response
Procedures to respond to
emergencysituations that
can have an impact on food
safety
Emergency
preparedness
and response
• Respond to emergency
situations.
• Reduce the consequences.
• Test the procedures.
• Review and update the
procedures and
arrangements, as necessary.
8.5. Hazard control
Preliminary steps
to enable the hazard analysis
Raw materials, ingredients and product Flow diagrams
contact materials Establish, maintain and update flow diagrams for
Identify statutory and regulatory requirements the products or product categories. Confirm on-
site the accuracy of the flow diagrams.
Maintain documented information on each raw material,
ingredient or product that comes into contact with food

Characteristics of end products Description of the processes

Identify and statutory and regulatory requirements Layout of premises, equipment, PRPs, process
parameters, controls, external requirements,
Maintain documented information on the characteristics
any variations due to seasonal changes or shift
of end products
patterns

Intended use
Consider and document the intended use and any
reasonably expected mishandling or misuse. As
applicable groups of consumers/ users shall be identified.
Hazard
identification
and
determination
of acceptable
levels
Hazard identification
• Identify and document all food safety hazards that are reasonably
expected to occur, depending on the type of product, the type of
process and the environment.
• Hazards:
• Chemical
• Microbiological
• Physical
• Allergens
Hazard identification
Process Hazard
step category (C, M, P, A) Hazard description
M Bacillus mesentericus. Bacillus cereus. Molds. GMOs
Reception C Pesticides. Cleaning chemicals. Lubricants. Fuels
of flour P Dead insects. Metals. Wood. Stones
A Cross contamination with allergens
M Yeasts (Saccharomyces cerevisiae, Rhodotorula).
Storage of Molds
(Aspergillus, Penicillium). E-coli
flour
C Pesticides. Cleaning chemicals
P Dead insects. Pests. Foreign matter
A Cross contamination
M …
Sieving the C …
flour A …
P …
Acceptablelevels
• Determine the acceptable level in the end
• product of each food safety hazard identified.
• Acceptable level = a level of hazard in the end product that shall
not be exceeded in order to ensure food safety.
Hazard
assessment
• Purpose: to identify
significant hazards for
which it is essential to
act to prevent their
occurrence or to reduce
them to acceptable
levels.
Selection and categorization of control measures
• Select and apply appropriate
control measures to prevent or to
reduce to acceptable levels the
significant food safety hazards.
• Control measures are to be
managed at CCPs (Critical
Control Points) or as OPRPs
(Operational Prerequisite
Programmes).
CCP vs. OPRP
• CCP (Critical Control Point) – step in the process at
which control measures are applied to prevent or
reduce a significant food safety hazard to an
acceptable level and defined critical limit(s) and
measurement enable the application of corrections.
• OPRP (Operational Prerequisite Programme) – control
measure or combination of control measures applied
to prevent or reduce a significant food safety hazard
to an acceptable level and where action criterion and
measurement or observation enable effective control
of the process and/ or product.
CCP vs. OPRP
The decision
tree (CCP or
OPRP?)
Validation of control measure(s) and
combinations of control measures
• Validation is intended to ensure
that the control measure(s) and
combinations of control
measures are capable to achieve
the results expected.
• To validate = to obtain evidence
that a control measure (or a
combination of control measures)
will be capable to control
effectively a food safety hazard.

• Validation ≠ Verification
Validation methods
• Reference to technical or scientific literature.
• Use of previous validation studies or historical knowledge
of the of the performance of control measure(s).
• Use of experimental data that is scientifically valid.
• Collection of data during the operation of the entire
production process.
• Mathematical modelling.
• Surveys.
• Documented information on the validation method and
results.
What is HACCP?
• Problems
• Foodborne diseases
• Market access – importance of food safety all along the food-chain
• Solutions
• Food safety system that focuses on preventing problems before they occur
• Industry-led programme used to improve and verify food safety
• Answer
Hazard Danger to health
Analysis Investigation of the hazard
Critical Crucial for containment
Control Handling of conditions
Points Position in the process
What is HACCP?
Why adopt HACCP?
• A properly functioning HACCP system will result in the production of safer food.
• Benefits:
• Improved food safety
• Increased market access
• Protection against liability
• Drive for continuous improvement
• Enhanced process control
Where can
HACCP be
used?
• HACCP can be used in
any food sector from
production to retail
HACCPprinciples
(Hazard Analysis and CriticalControl Points)
Principles of HACCP
Conduct a hazard analysis
Identify critical control points (CCPs)
Establish critical limits
Monitor critical control points
Establish corrective actions
Establish verification procedures
Establish record keeping procedures
Implementing HACCP
• Preliminary Steps for the introduction of a HACCP System
• Gathering the resources and information needed
• Seven principles of HACCP in action
• Completion of all steps will result in a properly functioning HACCP plan
Preliminary steps
• Assemble the HACCP team
• Group of people that will oversee the implementation and maintenance of the
HACCP programme
• Multi-disciplinary (i.e. production, sanitation, management, etc.)
• Including a HACCP-trained person
• Description of products and identification of intended use and
consumers
• Full description of the product(s) being manufactured under the programme
• Product information assists with hazard analysis
• Which group(s) will be consuming the food product
• Where will the product be sold
• How will it be prepared
Development and verification of process flow
diagram(s)
• The flow diagram should
• Outline all processing steps
• Include all processing steps
• The plant schematic should
• Outline where all of the processing steps occur
• Display the movement of products, people and waste
Grouping of products
• Decide whether products can be grouped using process categories
• Slaughter – all species
• Raw product – ground/not ground
• Thermally processed – commercially sterile
• Heat/not heat treated – shelf stable
• Fully cooked – not shelf stable
• Heat treated but not fully cooked – not shelf stable
• Product with secondary inhibitors
• Further categories for grouping can be commodity group, hazards, etc.
• Products in the same process category may be covered by the same
HACCP plan
Principle I - Conduct a hazard analysis
• Evaluate information regarding potential hazards associated with
the manufacturing process and ingredients
• Determine which hazards are significant to food safety
• Consider:
• Probability of occurrence
• Severity of consequences
Principle II - Identify Critical Control Points
(CCPs)
• A CCP is a point, step or procedure at which a control measure
has to be applied to prevent, eliminate or reduce a food safety
hazard
• CCPs are not necessarily located where the hazard occurs, they
may be located at a subsequent step
• Some hazards cannot be controlled by the operator
Principle III - Establish Critical Limits (CL)
• What is a critical limit?
• The maximum and/or minimum value to which a parameter must be
controlled at a CCP
• The critical limit separates acceptability from unacceptability
• The critical limit must be clearly defined and measurable
Principle IV - Establish monitoring procedures
• Monitoring: Is the process of conducting a planned sequence of
measurements to determine if a CCP is under control. Monitoring
results must be recorded
• If monitoring shows that critical limits are not met, then the
process is out of control and the food may be unsafe.
Principle V - Establish corrective actions
• Corrective actions are pre-determined measures that have to be
implemented when monitoring indicates that a deviation has
occurred.
• Corrective actions must:
• Regain control of the process
• Locate and segregate affected product
• Determine disposal of affected product
• Prevent a recurrence
Principle VI - Establish verification procedures
• Validation
• Ensures that the HACCP plan is complete and valid
• Ensures that the plan is effective in achieving expected food safety
outcomes
• Ongoing verification
• Ensures that the HACCP plan is working effectively
• Confirms that the plan is operating according to written procedures
• Auditing
• Overall review of the HACCP plan
• To be performed whenever any changes occur that could affect the
hazard analysis or alter the HACCP plan
Principle VII - Establish record keeping
procedures
• Record keeping must be complete and accurate and includes:
• Documentation pertaining to all steps, including the HACCP principles
• Appropriate record storage procedures
• A logbook to keep track of changes
HACCP system – Summary
• HACCP systems consist of two elements
• Prerequisite Programmes
• Implemented prior to HACCP plans
• Control of the overall plant environment
• Control factors not directly related to food (e.g. water quality,
transportation and storage, plant sanitation, employee training)
• HACCP plans
• Implemented following pre-requisite programmes
• Tailored to a certain product or process
• Control factors directly related to food production
Hazard control plan (HACCP/OPRPplan)
• Establish, implement and maintain a hazard control plan.
Step in the Hazard Control CCP or Critical limit or Monitoring Corrections
process OPRP Action criterion
Monitoring Monitoring Procedure/ Who is
procedure frequency records responsible Flow valve
Survival of Pasteurization CCP 72 ͦ C, 15 sec Automated Continuous Procedure … … for
Thermal pathogens monitoring Automated recirculation
treatment Salmonell record of milk
a (M) keeping

For CCP – Critical limit (measurable)

For OPRP – Action criterion (measurable or

observable)
Monitoring systems
at CCPs and for
OPRPs
Actions when critical limits or action criteria are
not met
• Corrections and corrective
actions to ensure that:
• potentially unsafe products
are not released;
• the cause of the
nonconformity is identified;
• the parameters controlled at
the CCP or by the OPRP
return within the critical
limits/ action criteria;
• recurrence is prevented.
8.7. Control of monitoring and measuring
• The monitoring and measuring methods
and equipment must be adequate.

• Monitoring and measuring equipment:

• calibrated or verified (with records);
• adjusted and re-adjusted, as
necessary
• identified;
• safeguarded from adjustments that
would invalidate results;
• protected against damage and
deterioration.
Monitoring and
measuring
software
• The software used for
monitoring and measuring
must be validated.

• Commercial off-the-shelf
software is considered
sufficiently validated
8.8. Verification related to PRPs and the
hazard control plan
• Establish, implement and maintain verification activities.
• Verification to confirm that:
• PRPs are implemented and effective;
• the hazard control plan is implemented and effective;
• hazard levels are within acceptable levels;
• input to the hazard analysis is updated;
• other actions determined by the organization are implemented
and effective.
Verification

• Audits, inspections,
product testing, documents
review…

• Documented information +
objectivity.
8.9. Control of product
and process
nonconformities
• Nonconformities: Situations when
critical limits at CCPs and/ or action
criteria for OPRPs are not met.

• Correction – deals with the effects of a

nonconformity.

• Corrective action – deals with the

cause of the nonconformity.
• Whenever critical limits or
action criteria are not met the
organization shall ensure that
the products affected are
identified and controlled.
• If the critical limit is not met
(CCP) = potentially unsafe
product.
• If the action criterion is not met
(OPRP) = evaluation and
decision on the products
affected.

• Documented information
retained
• Review the nonconformity to
identify its cause and
implement actions to prevent
similar situations.

• Review the effectiveness of the

corrective actions.
• Retain documented
information.
Nonconforming
vs. Unsafe
• A nonconforming product may
be unsafe for consumption, or
not.
Potentiallyunsafe
products
• Potentially unsafe products
shall be prevented from
entering the food chain (with
conditions).
• Products affected by a
nonconformity must be
evaluated.
Evaluation
for release
Withdrawal/
recall
• The organization must be
able to ensure the timely
withdrawal/ recall of lots of
end products that have
been identified as
potentially unsafe.
Withdrawal/recall
• Withdrawal/ recall procedures(s):
• initiation of the withdrawal/ recall;
• notification of interested parties;
• responsibilities;
• handling of recovered products + products still in stock;
• investigation and documented information to be retained.

• Verify the effectiveness of withdrawals/ recalls (e.g. mock recalls)

and retain documented information.
Recapitulation (Operations)
• Plan, implement, and control operations to ensure food safety.
• Establish, implement, and maintain PRPs to control food safety hazards.
• Implement a traceability system to identify product batches and their status.
• Plan responses to food safety emergencies and test the plan regularly.
• Establish control measures for food safety hazards through HACCP and
PRPs.
• Keep hazard control plans and PRPs up to date based on changes.
• Monitor and measure processes to ensure food safety effectiveness.
• Verify that PRPs and hazard control plans are effective.
• Manage nonconformities to prevent unsafe products from reaching
consumers.
Clause 9: Performance evaluation

S. No. Clause No. Clause name

1. 9.1 Monitoring, measurement, analysis and
evaluation

2. 9.2 Internal audit

3. 9.3 Management review
9.1. Monitoring,
measurement, analysis
and evaluation
• The organization shall determine:

 what to monitor and measure;

 how to monitor and measure (i.e.

methods);

 when to monitor and measure;

 when to analyze and evaluate the results;

 who will analyze and evaluate the results.

Analysisand
evaluation
• The data and information
collected through monitoring
and measuring, the results of
verification activities and the
results of audits shall be
analyzed and evaluated.

• The results of the analysis and

the resulting actions shall be
retained as documented
information.
9.2. Internal Audit
• The organization shall conduct
internal audits of the FSMS at
planned intervals.
• The purpose of the internal audit
is to determine whether the
FSMS:
• conforms to requirements;
• is effectively implemented
and maintained.
Internalaudit • When planning the internal audits
consider:

programme • the importance of processes;

• changes in the FSMS;
• the results of monitoring and
measuring;
• previous audits.
For each internalaudit
• select competent and impartial auditors;
• develop an audit plan (to include at least
the audit objectives, scope and criteria);
• generate an internal audit report;
• implement corrections and corrective
actions for the findings, as necessary;
• Inform the food safety team and the
management on the results;
• retain documented information as
evidence (programme, plans, reports,
etc)
9.3. Management review
• The top management shall review the FSMS at planned intervals.
• Input elements:
• status of actions from previous reviews;
• changes;
• the performance and effectiveness of the FSMS;
• adequacy of resources;
• emergency, incident, withdrawal/ recall;
• requests, complaints, relevant communications received;
• opportunities for improvement.
Management review
• Output elements:
• decisions and actions for
continual improvement;
• updates and changes to the FSMS
• Documented information
retained as evidence.
Recapitulation (Performance Evaluation)
• Monitor, measure, and evaluate the performance of the FSMS.
• Conduct internal audits to ensure FSMS compliance and
effectiveness.
• Review FSMS performance and suitability at planned intervals.
Clause 10: Improvement

S. No. Clause No. Clause name

1. 10.1 Nonconformity and corrective action

2. 10.2 Continual improvement

3. 10.3 Update of the food safety management
system
Management of
nonconformities
• React – to control and correct the situation and
deal with the consequences (correction).
• Review the nonconformity to determine its cause.
Implement corrective actions.
• Review the effectiveness of the corrective actions.
Retain documented information.
Continual
improvement
• The organization shall
improve continually the
suitability, the adequacy
and the effectiveness of
its FSMS.
Updateof theFSMS
• The FSMS must be continually updated.
• The food safety team shall evaluate the FSMS at planned
intervals.
Recapitulation (Improvement)
• Identify, correct, and prevent recurrence of nonconformities.
• Continuously improve the effectiveness of the FSMS.
• Update FSMS to reflect changes, improvements, and lessons
learned.
Certification for
organizations

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act.php
 Audits:
Definition,
Principles, and
Types
Audit
• “Systemic, independent and documented process for obtaining
audit evidence and evaluating it objectively to determine the
extent to which audit criteria are fulfilled.”

• Alternative Definitions:
• Impartial documented activity
• Follows written checklists and documentation
• Uses examination of audit evidence to determine the existence of
objective evidence
• Verifies that applicable processes of a QMS have been identified and are
effectively controlled.
Reasons for Conducting Audits
• To examine the Food Safety Management System for
Improvements
• To ensure ISO 22000, and all other standards, are being complied
with.
• To determine compliance or non-compliance
• To meet regulatory requirements
• To enable certification
 Effective Audits - Requirements
Timely access to facilities, documents and personnel, including top management

Defined auditing procedures

Support/involvement of management

Competent audit team

Impartial and objective audit team

Type of Audit

First Party Audits

Second Party Audits

Third Party Audits

 • Internal audits
First Party • Performed within an organization

Audit • Auditors have no vested interest in the area being audited

Second • Performed by Customers on suppliers
• Before or after awarding a contract
Party Audit
Third Party Audit

• Performed by an audit organization

independent of the customer-supplier
relationship
• Free from any conflict of interest
 Client – Organization or
person requesting the audit

Audit Auditor – A Person who

participants conducts the audit

Auditee – Organization or
individual being audited
 Initiates audit

Determines audit purpose and scope

Client,
responsible Provide resources

for..
Receives the audit report

Determine the report distribution

Auditor, responsible for…

• Understand the purpose, scope and audit

criteria.
• Plans the audit
• Perform the audit
• Collect audit evidences
• Analyze audit evidences
• Reports the audit
• Follows up the action on audit findings
 Balance the strength and weaknesses of team
members

Lead Manage the audit process

auditor, Represent the audit team

responsible
for… Lead the audit team

Prepare and complete the audit report

 Provide resources
(interview room,
Inform the staff
communications and
clerical support)

Auditee,
responsible Assign a guide for the
audit team
Show objective
evidence

for…
Determine and initiate
Co-operate
corrective actions
 Technical Expert – a person who
provides specific knowledge or
expertise to the audit team.

Audit Observer – a person who

accompanies the audit team but
participants - 2 does not audit.

Guide – a person appointed by the

auditee to assist the audit team.
 Phases of an Audit
Phases of an Audit

• Planning
• Preparation
• Performance
• Reporting and Follow Up

Planning the Audit Stage

• Frequency and timing

• Responsibility
• Criteria
• Scope
• Methods
• Duration
 Planning Internal
Audits
Frequency and Based on status and importance
timing:

Responsibility: Competent auditor with technical knowledge

Organization’s own procedures, specifications, documents, etc.

Criteria:
Internal Standards e.g., ISO 22000:2018

A process
Scope:
An area of the company, e.g. distribution, Quality control, servicing

Duration Depends on the size of the scope

Planning Second Party Audits
Frequency and timing: As determined by the organization

Responsibility: Competent auditor with technical knowledge

Contractual obligations
Criteria: Organization’s management system
ISO 22000 or other agreed standards
The entire facility
Scope:
An area of the company, e.g. a product line

Duration Depends on the size of the scope

Planning third Party Audits

Frequency and
Responsibility: Criteria: Scope: Duration
timing:
• As determined • Qualified • ISO 45001 or • Entire • Depends on
by the auditor with other organization accreditation
accreditation technical standards • Management requirements
knowledge & system
experience operations as
defined by
applicable
standard
Audit Procedure
• External audits are usually agreed in advance with the
auditee and carefully planned, however ‘unannounced
audits’ may be carried out by the Certification Bodies or
Customers and their representatives as a policy or when
there is some justification for such an audit
 Create audit program and
audit plan and notify the
auditee

Activities
Prior to the Arrange audit logistics

Audit
Prepare audit checklist
 Audit preparation

Review documents: procedures,

Notify person to be audited and forms, previous reports,
agree to a date and time corrective action requests, work
instructions, etc.

Prepare/review/update checklists Brief auditor/team

Arrange for Audit Logistics
• Travel and accommodation
• Safety and security considerations
• Personal Protective Equipment (PPE)
• Location and/or Camera Permit
• Need for a Guide
• Translators
• Facilities
• Working area, conference room, internet,
printer, tea/coffee and working lunch
Audit Checklist
The Purpose of the
The Checklist Risks of the Checklist
Checklist
• To be used as a • To provide guidance to • Too focused on a
working document the auditor single area
and as a record • To ensure that the • Insufficient
• Tool to audit company audit scope is covered information included
processes, not (processes, activities) to evaluate
standard • To reinforce the conformance in
• Should follow the objectives and scope interviews
natural process of the of the audit • Not customized to
organization • To act as a record reflect company’s
practices
 Audit Checklist Assessment No.
Specification Location Date
REQUIREMENT SPEC OBSERVATIONS

Sample
Checklist Sheet of form QA1
 Opening meeting

Conduct the audit

Audit
Performance
Review findings

Closing meeting
Opening Meeting
• Introduce auditors or audit team
• Discuss audit scope and process
• Explain reporting and follow-up procedures
• Necessary for:
a) Good communication
b) Co-operation
c) Openness
 Deal with top management
Understand the key issues in the organization
Focus on the critical processes
Audit for business improvement
Meet the area representative first
The Auditor Always talk to those performing the task
must: Explain the purpose of the visit
Be calm, polite, reassuring
Never talk down
Never act superior
Speak clearly and carefully
The Auditor Process
Obtaining objective (audit) Evidence

May be gathered from: • People:

• Interviews with people
• Does anyone understand the systems and
• Observation of activities
documentation?
• Interactions between functions,
• Are the employees competent?
activities, processes
• Is there co-operation?
• Measurement of processes and
programs • Are there any system problems?
• Documents/records
• Data summaries, reports from other
sources (e.g., customer feedback)
Obtaining objective (audit) Evidence
(Continued)
• Observation of activities • Measurement of processes and programs
• Capacity of processes
• Are the processes efficient? • Product measurement
Effective? • Accuracy
• Are things in logical sequence? • Dependability
• Are the interactions between • Cycle times
processes defined? • Resource utilization
• What is the significance of links • Productivity
between processes?
• Can inputs and outputs be
identified?
Obtaining objective (audit) Evidence
(Continued)
Documents/records Data summaries
• Customer feedback
• Issue status? • Vendor analysis
• Complete and concise?
• Internal Audits
• Condition?
• Legibility? • Financial measurements
• Preventive, appraisal and failure cost
• Identity? analysis (Cost of quality)
• Approval? • Cost of nonconformity
• Availability?
Examine objective Evidence
Examine:
• Documents/data
• Fully complete
• Accurate data
• Check for authorization
• Review analysis of data
• Physical Evidence
• Environmental Conditions

Establish:
• Extent of conformity/nonconformity
• Nature for nonconformity
• Sample: According to the amount and variety of evidence
Use the Checklist
• To record conformity/nonconformity
• To track where you are and manage time
• To control the pace of the audit and manage auditee personalities
• To ensure all areas are covered
• To make notes for follow-up in other areas
• For future reference
 Questioning Techniques

Who? What? When? Where? Why? How?

Controlling the Audit
Insist that people being questioned answer for themselves

Do as little talking as possible

Do not let others dictate the pace

Rephrase misunderstood questions

Give compliments

Say, “Thank you”

Be aware of hidden agendas and emotional blackmail

Some Basic Issues
• Establish that the company is demonstrating control over the
operation
• Involve management in the audit process
• Observe work progression when possible
• Evaluate physical objective evidence
• Examine inputs and outputs
• Make comprehensive notes
Some Basic Rules
Seek verification

• Do not assume people will lie, but seek to verify statements if necessary

Do not accept pre-prepared samples

• Choose your own

 • Integrity – the foundation of professionalism
• Fair presentation – the obligation to report
truthfully and accurately
• Due professional care – the application of
diligence and judgment in auditing
General • Confidentiality – security of information
Principles of • Independence – the basis for the impartiality
of the audit and objectivity of the audit
Auditing conclusions
• Evidence-based approach – the rational
method for reaching reliable and
reproducible audit conclusions in a
systematic audit process
Auditor’s Personal Attributes
Observant – actively
Ethical – Fair, truthful, Open-minded – willing
Diplomatic – tactful in observing physical
sincere, honest and to consider alternative
dealing with people surroundings and
discreet ideas or points of view
activities

Decisive – able to
Perceptive – aware of Versatile – able to Tenacious – persistent reach timely
and able to understand readily adapt to and focused on conclusions based on
situations different situations achieving objectives logical reasoning and
analysis

Self-reliant – able to
act and function
independently whilst
interacting effectively
with others
 Audit principles, procedures and methods

General
knowledge Management system and reference documents

and skills of Organizational context

Management
System Applicable legal and contractual requirements and
other requirements that apply to the auditee

Auditors Discipline and sector-specific knowledge and

skills of management system auditors
 Audit team leaders should be able to:
• Balance the strengths and weaknesses of the individual audit
team members
• Develop a harmonious working relationship among the audit
team members.

Generic • Plan audits and effectively use audit resources

• Manage the uncertainty of achieving audit objectives
Knowledge • Protect the health and safety of the audit team members
including compliance with the requirements
and Skills of • Organize and direct the audit team members
• Provide direction and guidance to auditors-in-training
Audit Team • Prevent and resolve conflicts as necessary

Leaders • Represent the audit team

• Lead the audit team to reach the audit conclusions
• Prepare and complete the audit report
 • Introduce self and/or audit team

• Ensure agenda is understood

Good • Keep to agenda

Practices for • Keep control of the audit and time

Auditors • Avoid arguments

• Listen

• Keep records

• Remain polite, calm, professional

Audit Review
• Conduct a private review when the audit is finished
• Interim or “end of the day” reviews (or both) may be appropriate
• Review and complete checklists
• Study and compare notes (team)
• List nonconformities
Analyzing Results
Review if:

• The deficiency is an isolated error or a breakdown of a system

• Auditee is aware of the problem

• The deficiency has been reported before

Closing Meeting

Explain/discuss the State overall degree Mention the positive

Obtain agreement
findings of conformity points

Internal audits Second party audits Third party audits

• Informal • Contracts at stake • Contracts at stake
• Constructive • Reports used as future • Reports used as future
• System improvement reference reference
• More emotional • More emotional
situation than first situation than first
party audit meeting party audit meeting
• Be prepared to be • Be prepared to be
challenged challenged
 • Identification: Auditors identify non-
conformities against the organization’s
internal procedures or ISO requirements.
Non- • Recording: Non-conformances are
conformance documented in the audit report.
• Corrective Action: The organization takes
management corrective actions to address root causes and
in first party prevent recurrence.
• Verification: Follow-up audits or reviews
audits ensure actions are implemented effectively.
• Purpose: Improve internal systems, ensure
compliance, and prepare for external audits.
Non-conformance • Identification: Non-conformities against agreed terms,
product specifications, or food safety requirements are
identified.
management in • Reporting: Issues are communicated to the supplier
second party formally.
• Corrective Action:
audits • The supplier is required to provide a Corrective
Action Plan (CAP) within a specified timeline.
• Actions include root cause analysis, corrective
measures, and preventive actions.
• Verification: Follow-up audits or supplier reviews are
performed to verify corrections.
• Purpose: Ensure suppliers meet contractual
obligations and quality standards.
 • Identification: Non-conformities are classified as:
• Major: Systematic failures or high-risk non-compliance.
• Minor: Isolated issues that don’t pose significant risk.

Non- • Reporting: Non-conformities are included in the audit report

and communicated to the auditee.

conformance • Corrective Action:

• Auditees must submit an action plan with root cause

management
analysis, corrective actions, and preventive measures.
• A timeline is set to resolve major non-conformities (often
30-90 days).
in third party • Verification:
• Major non-conformities require evidence submission
audits and/or re-audit.
• Minor non-conformities are checked during the next
surveillance audit.
• Purpose: Achieve certification, regulatory compliance, or
demonstrate conformity to standards.
Nonconformance Statement
A short statement describing the nonconformity including:

• What - The issue in question

(a statement of nonconformity)

• Why - What the statement is raised against?

(the requirement, or specific reference to the requirement)

• Objective Evidence - The objective evidence found

(the objective evidence observed that supports statement of nonconformity)
Nonconformance report
• Used to report non-conformity audit findings
• Must be factual
• Must be understandable and traceable
• Raise non-compliances on completion of an audit
• Allow the auditee to implement corrective action prior to the
closing meeting
• The auditee is requested to sign signifying an understanding and
acceptance of the non-compliance
Wording of NC report
• It is important when preparing and wording NC-Report’s to take
care and ensure it is justified
• Failure to achieve clear information will invite challenge of the
findings at the closing meeting
• This will be particularly important in areas where the emphasis
has changed with respect to the requirements in order that they
will be clearly understood, i.e.
• Management Commitment
• Competence
• Communication
• Continual Improvement
Example of Nonconformance Statement
• A statement of nonconformity:
• The system for monitoring the temperature of perishable food
products during storage was not effectively implemented.
• The requirement, or specific reference to the requirement:
• ISO 22000:2018 Clause 8.5.1 - Control of Food Safety Hazards
"The organization shall establish and implement monitoring
activities for critical control points to ensure food safety
requirements are met.
• The objective evidence observed that supports statement of
nonconformity:
• No temperature monitoring records were retained for
perishable food storage between January 10-12, 2024, in
Warehouse Section A.
Audit Reporting
The audit report should include:
• Auditors, contracts, scope
• Overall conclusions
• Deficiencies, observations, supporting objective evidence
• Follow-up details
Exclude from Report:
• Confidential information given in interviews
• Matters not raised or discussed at the closing meeting
• Subjective opinions – use only verifiable facts / objective evidence
• Ambiguous statements
• Antagonistic words or phrases
Audit Reporting
• Description of audit aim, purpose and scope
• Number of non-compliances and summary of audit findings
• Description of good points and any main concerns
• Description of the identified opportunities for improvement
• Recommendations made because of audit findings
Audit Follow-Up
• Verify that action(s) are implemented
• Ensure short- and long-term effectiveness
• Record follow-up details & objective evidence reviewed
• Sign off forms
 Stage 1 Audit
Application Client Signup (Including
Document Review)

Registration
Process
Special Audit (If
Required) to
Stage 2 Audit Package Review
Follow-Up on
Nonconformances

Flow
Surveillance Audit Recertification
Certificate Issue (Annual or Semi- Audit (Every Three
Annual) Years)
Certifications and Internal Auditor Trainings
offered
• We offered certifications and internal auditor training for -
• ISO 9001 (QUALITY MANAGEMENT SYSTEMS)
• ISO 14001 (ENVIRONMENT MANAGEMENT SYSTEMS)
• ISO 45001 (OCCUPATIONAL HEALTH & SAFETY
MANAGEMENT SYSTEMS)
• ISO 50001 (ENERGY MANAGEMENT SYSTEMS)
• ISO 27001 (INFORMATION SECURITY MANAGEMENT
SYSTEMS)
• ISO 22000 (FOOD SAFETY MANAGEMENT SYSTEMS)
• ISO 13485 (MEDICAL DEVICES QUALITY MANAGEMENT
SYSTEMS)
• ISO 26000 (SOCIAL ACCOUNTABILITY MANAGEMENT
SYSTEMS)
Our Accreditation

• At Quality Asia Certifications, our commitment to excellence is

validated through our prestigious accreditations.
• We are proud to be recognized by leading national and
international accreditation body, including NABCB (National
Accreditation Board for Certification Bodies), IAF
Accredited ensuring the highest standards of quality and
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• Our accreditations reflect our rigorous adherence to industry
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testament to our expertise and our unwavering commitment to
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 LEADERSHIP TEAM

Mr Atul Suri Mrs. Seema Suri Mr Samarth Suri Ms Palak Ahuja

Lead Auditor & Director -
Managing Director GM - Certifications
Reviewer Accreditations
Responsible for Responsible for Heading
Responsible for
Responsible for Leading Maintaining and Managing
Marketing & Promotions,
Teams of Auditors and Accreditation Status and Certification and
and ensuring Right
Establishing Excellence Heading Audit Review Operations and Ensuring
Visibility of the
in Auditing Operations and Certification Client Success through
Certification Body
Decision Process Certifications
CORE TEAM

Mr Parveen Singh Negi Mr Sagar Mahour

Team of Auditors Team of Executives
Business Development Head Quality Assurance Officer

Responsible for compliance with

Responsible for Heading Sales accreditation standards, manages Responsible for Conducting Ethical
Teams and Ensuring Customer documentation and audits, assists and Quality Rich Audits, enabling Responsible for Managing the Shows
Acquisition in the Most Ethically in training programs, and supports Organizations to Understand and behind the scenes
Right Manner marketing and operational Upgrade their Systems and Processes
excellence initiatives.
 Training Material will be provided
to you through mail.

Training
Training Evaluation, a google form
Information link is provided to you through mail.
and
Evaluation Training Feedback is the part of the
Training evaluation form, please
provide your valuable feedback.
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