ISO 22000: 2005 ―Food safety

management systems —
Requirements for any
organization in the food chain
 Trainer

Haris Qasim
M.Sc Food Science & Technology,
MPhil © Quality Management

Food Safety & Management Consultant

Previous Experience :
Food Safety Auditor United Registrar of Systems (URS)
Asst. Manager Production & HSE Deer Food Private Limited
Food Technologist & Food Safety Auditor PepsiCo.

Current Research:
“ Barrier in the implementation of ISO 22000 In Food Industry.”
Introduction

 Participant Name :

 Switch off your mobile phones

 Avoid smoking in the training room

 Share your ideas, knowledge & experiences

3
Objective

 Why do we need a food safety program?

 What is a food safety program?
 What is ISO 22000:2005?
 What is a HACCP System?

Mode of Learning:
Discussions, Audio Visual , Quiz

4
Food Safety

Food safety is a scientific discipline describing

handling, preparation, and storage of food in
ways that prevent foodborne illness.

Assurance that food will not cause harm to

the consumer when it is prepared and/or
eaten according to its intended use.

5
What is hazard

 A biological, chemical or physical agent in, or condition

of, food with the potential to cause an adverse health
effect.

6
Food Safety - Hazards
Physical
 (metal, wood, glass, etc)

Biological
 (Bacteria, Viruses, Mold)

Chemical
 (bleach, caustic soda, detergents and Environmental Contaminants)

7
 Food Safety Management System

Aldi system
DS 3027
FAMI-QS Kraft food system
Irish HACCP
Nestlé NQS EFSIS
M&S system
McDonalds system
Eurepgap ISO 9001

BRC-IoP
GMP standard for Corrugated & IFS
Solid Board
AG 9000
Ducth HACCP
Friesland Coberco FSS GTP
BRC-Food
GFSI SQF GMP
GMO Guide
8
 ISO 22000 is to demonstrate ability of
organization to control food safety
hazards
 This International Standard specifies requirements
for a food safety management system where an
organization in the food chain needs to demonstrate
its ability to control food safety hazards in order to
ensure that food is safe at the time of human
consumption
 Standard is intended to address only aspects of food
safety concerns
 Developed as an auditable standard
 ISO 22000 for the food safety

 Is related to the presence of and levels of food-borne

hazards in food at the point of consumption
 As food safety hazards may be introduced at any
stage of the food chain, adequate control throughout
the food chain is essential
 Is a joint responsibility of all parties participating in
the food chain
 Failures in food supply can cause human suffering,
death, poor reputation, violations, poor nutrition,
poor quality products and decreased profits
ISO 22000 represents an international consensus

 Technological know-how
 Defines characteristics that products and services
will be expected to meet on export markets
 Give a basis for making the right decisions when
investing
 The existence of divergent national or regional
standards can create technical barriers to trade,
International Standards are the technical means by
which political trade agreements can be put into
practice
 Key elements

Standard specifies the requirements for a food safety

management system that combines the following
generally recognized key elements to ensure food
safety along the food chain, up to the point of final
consumption:
interactive communication
system management
prerequisite programmes
HACCP principles
 Communication

Essential to ensure that all relevant food safety hazards

are identified and adequately controlled at each step
within the food chain
This implies communication:
between organizations both upstream and
downstream in the food chain
with customers and suppliers about identified
hazards and control measures
ISO 22000 is consensus agreements between all
the economic stakeholders concerned:

 Suppliers
 Food business operators
 Government regulators
 Consumers
 NGO
 other stakeholders
Communication channels among
interestedparties of the food chain
 Benefits

 Confidence that organizations implementing ISO

22000 have the ability to identify and control food
safety hazards
 International in scope
 Provides potential for harmonization of national
standards
 Provides a reference for the whole food chain
 Provides a framework for third party certification
 Benefits

 Saves resources by reducing overlapping system

audits
 Organizes and targets communication among
partners
 Resource optimization
 Improves documentation
 Better planning, less post-process verification
Standard applicable to organizations
within the food chain
 feed producers
 primary producers
 food manufacturers
 transport and storage operators and subcontractors
 retail
 food service outlets
 inter-related organizations such as producers of
equipment, packaging material, cleaning agents,
additives and ingredients
 service providers
 ISO 22000 and ISO 9001?

 The most effective food safety systems are established,

operated and updated within the framework of a
structured management system and incorporated into
the overall management activities of the organization
 This provides maximum benefit for the organization and
interested parties
 ISO 22000 was specifically developed to be easily
integrated with ISO 9001 systems (Quality management
systems ). The management system elements of the
standard are largely word-for-word that of the ISO 9001
equivalent, with some small amendments relating
specifically to food safety
 The Scope of ISO 22000

 The standard is applicable to all organizations,

regardless of size, which are involved in any aspect of
the food chain
Strategy to be used to ensure hazard
control
 During hazard analysis, the organization determines
the strategy to be used to ensure hazard control by
combining:
 PRP(s)
 operational PRP(s)
 HACCP plan
 HACCP is an approach to food
safety
It’s about identifying and managing risk
Anticipating potential hazards
Designing controls to prevent hazards
Implementing controls
Monitoring the controls
Continuously improving the controls
 Standard specifies requirements to enable
an organization

 to plan, implement, operate, maintain and update a

food safety management system aimed at providing
products that, according to their intended use, are
safe for the consumer
 to demonstrate compliance with applicable statutory
and regulatory food safety requirements
 to evaluate and assess customer requirements and
demonstrate conformity with those mutually agreed
customer requirements that relate to food safety, in
order to enhance customer satisfaction
Standard specifies requirements to enable
an organization

to effectively communicate food safety issues to

their suppliers, customers and relevant interested
parties in the food chain
to ensure that the organization conforms to its
stated food safety policy
to demonstrate such conformity to relevant
interested parties
to seek certification or registration of its food
safety management system by an external
organization, or make a self-assessment or self-
declaration of conformity to this International
Standard
 Food safety requirements in the
Standard
 Food safety management system
 Management responsibility
 Resource management
 Planning and realization of safe products
 Validation, verification and improvement of the food
safety management system
 ISO 22000 and Codex Alimentarius

 ISO 22000 integrates the Codex Alimentarius

Commission’s 7 principles of HACCP and
dynamically combine it with PRPs necessary to
control and reduce any food safety hazards
 PRPs (PRE-REQUISITE PROGRAM) are also
referred to as good hygienic practices(GHP), good
agricultural practices, good production practices,
good manufacturing practices(GMP), good
distribution practices, and good trading practices
Food safety management
system
 General requirements for a food safety
management system
An effective food safety management system shall be:
developed
documented
implemented
maintained
evaluated
updated

Scope of application of FSMS shall be identified

 Organization shall:

 Ensure that hazards shall be identified, evaluated

and managed as food produced would not harm
consumer
 To communicate within food chain on the food safety
issues
 To ensure proper internal communication
 Periodically evaluate and update food safety
management system
 Any external process chosen shall me managed (incl.
documentation)
 Documentation requirements
 Food safety management documents shall include:
documents on food safety policy and objectives
procedures
records

 Food safety management documents shall be managed

procedure to control your FSMS documents shall be
developed

Food safety records shall be controlled

Set of records shall be established
Documented procedure to control FSMS records shall be
developed
Management responsibility
 Management commitment

 Top managers shall demonstrate commitment to

develop and implement food safety management
system
 Adequate resources shall be allocated
 Food safety policy shall be defined, documented and
communicated
 Food safety
management system planning

 Top managers plan the development of FSMS

 Integrity of FSMS shall be maintained when changes

in FSMS are planned and implemented
 Responsibility and authorities

 Top managers shall define and communicate

organization's FSMS responsibilities and authorities
 All personnel are responsible for reporting
organization's FSMS problems
 Designated personnel are given the responsibility
and authority to solve FSMS problems
 Food safety team
leader
 Appointed by top management
 Irrespective of other responsibilities has
responsibility and authority:
 to manage food safety team and organize its work
 ensure training and education of team members
 ensure that FSMS is established, implemented,
maintained and updated
 report to top managers on the effectiveness and
suitability of FSMS
 External communication

 Effective communication shall be established with:

suppliers and service providers
consumers
authorities
other relevant organizations
Information important for other organizations in the
food chain to address food safety issues shall be
communicated
Records on such communication shall be available
Responsibility and authority to communicate externally
about food safety shall be allocated
 Internal communication

 Effective internal communication arrangements

shall be established, implemented and updated on
the food safety issues
 Food safety team shall have appropriate information
on any changes related to food safety (e.g. new raw
materials, equipment, cleaning programmes, legal
requirements, complains etc.)
 Food safety team responsible for updating FSMS
according this information
 Emergency preparedness and response

 Procedures to manage food safety emergencies

and accidents shall be established, implemented
and maintained by top managers
 Management review

 Top managers shall plan and carry out regular food

safety management system reviews
 Records of your food safety management reviews
shall be kept
 Management review inputs

 Follow-up actions from previous reviews

 Verification results
 Changing circumstances
 Emergencies, accidents, withdrawals
 System-updating results
 Review of communication activities
 External audits or inspections
 Management review
outputs
Management review outputs shall generate decisions
and actions (outputs) that:
assure the safety of the food products
improve the effectiveness of organization’s FSMS
address FSMS resource needs
update and revise food safety policy and objectives
Resource management
 Provision of resources

 Organization shall be provided by the

resources needed to establish, implement,
maintain and update FSMS
 Human resources

 Competent food safety personnel

 Records of the contracts and agreements with
external food safety management system experts
shall be maintained
 Records of agreements or contracts defining the
responsibility and authority of external experts shall
be available
 Competence, awareness and
training
 Necessary competencies are identified
 Training to ensure that personnel have the
competencies they need is delivered
 Personnel aware of how their individual job
performance influences food safety
 Effectiveness of FSMStraining and awareness
activities is evaluated
 Records
 Infrastructure

 Organization shall provide the resources for the

establishment and maintenance of the infrastructure
needed to comply with ISO 22000
 Work environment

 The organization shall provide the resources for the

establishment, management and maintenance of
the work environment needed to implement the
requirements of the ISO 22000
Planning and realization of safe
products
 Implementation of food safety
program

Review
• Prerequisite programmes

Update
• Preliminary steps of HACCP

Document
• HACCP
 Planning and realization of safe
products
 The organization shall plan and develop the
processes needed to realize safe products
 The organization shall implement, operate and
ensure effectiveness of planned activities
 This includes:
 PRPs
 operational PRPs
 HACCP plan
 PRP and operational PRP

 Prerequisite programme (PRP) - (food safety) basic

conditions and activities that are necessary to maintain a
hygienic environment throughout the food chain
suitable for the production, handling and provision of
safe end products and safe food for human consumption
 Operational prerequisite programme
(Operational PRP) - PRP identified by the hazard
analysis as essential in order to control the likelihood of
introducing food safety hazards to and/or the
contamination or proliferation of food safety hazards in
the product(s) or in the processing environment
 Prerequisite programs (PRPs)

PRPs shall be established, implemented and

maintained to assist in controlling:
the likelihood of introducing food safety hazards
to the product through the work environment
biological, chemical and physical contamination
of the product including cross contamination
food safety hazard levels in food and
environment
 PRPs shall be suitable

 Meet organization’s unique food safety needs

 Reflect and respect the nature of
organization and how it operates
 Meet legal requirements
 Shall be approved by food safety team
 When selecting and/or establishing PRPs
appropriate information from external sources
shall be considered and utilized

 Construction and lay-out of buildings

 Lay-out of premisesSupplies of air, water, energy, etc.
 Supporting services (incl. waste and sewage disposal)
 Equipment

 Management of purchased materials, disposals and

handling of products
 Measures for prevention of cross-contamination
 Cleaning and sanitizing
 Pest control
 Personnel hygiene etc.
 Steps for the implementation of the
HACCP principles
1. Assemble HACCP team
2. Describe product
3. Identify intended use
4. Construct flow diagram
5. On-site confirmation of flow diagram
+ 7 HACCP principles
 7 HACCP Principles

1. Conduct a Hazard Analysis of the production process which identifies

on a flow diagram where significant hazards may occur
2. Identify the Critical Control Points (CCPs) in the production process
3. Establish Critical Limits for the preventative measures set up to
control the hazards associated with each CCP identified
4. Establish CCP monitoring requirements which will verify the efficacy
of the preventative measures
5. Establish Corrective Actions to take when monitoring results show
that a critical limit has not been met
6. Establish an effective record-keeping system that documents all
aspects of the HACCP system and its operation
7. Establish a program to verify the HACCP system is functioning
properly
 Step HACCP principle
1. Assemble HACCP team
2. Describe product
3. Identify intended use
4. Construct flow diagram
5. On-site confirmation of flow diagram
6. Identify potential hazards 1 principle
7. Determine critical control points 2 principle
8. Establish critical limits for critical control points 3 principle
9. Establish monitoring procedures 4 principle
10. Establish corrective actions 5 principle
11. Establish verification procedures 6 principle
12. Establish documentation and record keeping 7 principle
 Preliminary steps to enable hazard
analysis
All relevant information needed to conduct hazard
analysis shall be
collected,
maintained,
updated and
documented
 Food safety team

 Shall be appointed
 Multidisciplinary knowledge and experience
 Includes organization’s products, processes,
equipment and food safety hazards
 Records that show that your food safety team has
the necessary knowledge and experience shall be
maintained
Product characteristics. Raw materials,
ingredients and product-contact materials

All raw materials, ingredients and product-contact materials

shall be described in documents to the extent needed to
conduct the hazard analysis, including:
Product characteristics
Composition of ingredients
Origin
Method of production
Packaging and delivery methods
Storage conditions and shelf life
Preparation and handling before use
Food safety related acceptance criteria, specifications
 Product characteristics. Characteristics of
end products

Characteristics of end products shall be described in

documents to the extent needed to conduct the hazard
analysis, including:
Product name
Composition
Characteristics relevant to food safety
Intended shelf life and storage conditions
Packaging
Labelling
Method of distribution
 Intended use

 Shall be considered and described:

the intended use
the reasonably expected handling of the end product
any unintended bust reasonably expected mishandling
and misuse of the end product

User groups (groups of consumers) for each end product

shall be identified
Vulnerable to specific food safety hazards shall be
considered

Documents shall be kept up to date

 Flow diagrams

 Is schematic and systematic presentation of the sequence and

interactions of steps
 Provide basis for evaluating the possible occurrence, increase or
introduction of food safety hazards
 Clear, accurate and sufficiently detailed
 Flow diagrams include:
 Sequence and interaction of all steps in the operation
 Any outsourced processes and subcontracted work
 Where raw materials, ingredients and intermediate products enter
the flow
 Where reworking and recycling take place
 Where end products, intermediate products, by-products and waste
are released or removed
 Shall be checked on-site (verification)
 Hazard analysis

Hazard analysis shall be conducted by the food safety

team to determine:
which hazards need to be controlled
degree of control required to ensure food safety
which combination of control measures is required

All hazards shall be identified and recorded

The steps from raw materials, processing and
distribution at which each hazard may be introduced
shall be indicated
Acceptable level of food safety hazard in the end
product shall be determined
 Hazard assessment

 Shall be conducted to determine, for each hazard,

whether its elimination or reduction to acceptable
levels is essential to produce safe food and whether
its control is needed to enable acceptable levels to be
met
 Hazard assessment methodology shall be described
 Results of food safety hazard assessment shall be
recorded
 Selection and assessment of control
measures
 Based on hazard assessment, an appropriate
combination of control measures shall be selected
which are capable of preventing, eliminating or
reducing hazards to defined acceptable levels
 Control measures shall be reviewed with respect to
its effectiveness
 Control measures selected shall be categorized as to
whether they need to be managed through
operational PRPs or by the HACCP plan
Selection and categorization ofcontrol
measures includes:

Effect on identified hazard

Feasibility for monitoring
Its place within the system
relative to other control
measures
Likelihood of failure
Severity of consequences in
case of failure
Whether control measure is
specifically established and
applied to eliminate or
significantly reduce level of
hazard
Synergistic effects (interaction
Establishing operational prerequisite programs
(operational PRPs)

Operational PRPs include

following information for each
programme:
Hazard controlled by the
programme
Control measure
Monitoring procedure
Corrections and corrective
actions
Responsibilities and authorities
Records of monitoring
 Establishing HACCP plan

 Documented
 Shall include following information for each
identified CCP:
 food safety hazards to be controlled
 control measures
 critical limits for each (CCP)
 monitoring procedures
 corrections and corrective actions (if critical limits are
exceeded)
 responsibilities and authorities
 records of monitoring
 Determination of critical limits for
CCP
 Critical limits – for monitoring of each CCP
 Critical limits shall be established to ensure that the
identified acceptable level of the food safety hazard
in the end product is not exceeded
 Shall be measurable
 Rationale for the chosen critical limits shall be
documented
 Critical limits based on subjective data (e.g. visual
inspection) shall be supported by instructions or
specifications and/or education and training
 System for monitoring of CCP

 Demonstrates that CCP is under control

 Established for each CCP
 Covers:
 measurements or observations that provide results
within an adequate time frame
 monitoring devices used
 applicable calibration methods
 monitoring frequency
 responsibility and authority
 record requirements
 Actions when critical limits are
exceeded
 Planned corrections and corrective actions to be taken
when critical limits are exceeded shall be specified
 Actions shall ensure that:
 cause of conformity is identified
 parameters controlled at the CCP are brought back under
control
 recurrence is prevented
 Documented procedures shall be established and
maintained for the appropriate handling of potentially
unsafe products
 Updating

 If necessary, following information shall be updated:

 Product characteristics
 Intended use
 Flow diagrams
 Process steps
 Control measures
 HACCP plan
 Procedures and instructions specifying PRPs
 Verification planning

 Verification activities shall confirm that:

PRPs are implemented
input to hazard analysis is continually updated
operational PRPs and HACCP are implemented and
effective
hazard levels are within acceptable levels
…
 Results of verification activities shall be recorded
 Traceability
system
 Shall be established and applied
 Enables the identification of product lots and their
relation to batches of raw materials, processing and
delivery records
 Incoming materials from the immediate suppliers
and the initial distribution route of the end product
should be traceable
 Control of
nonconformity
 Nonconforming products (when CCPs are exceeded or
there is a loss of control of operational PRPs) shall be
identified and controlled with regard of their use and
release
 Documented procedure shall be established and
maintained defining:
 identification and assessment of effected end products
 review of the corrections carried out
 All corrections shall be approved by responsible person
 Cause and consequence, information needed for
traceability shall be recorded
 Corrective
actions
 Taken when critical limits are exceeded or there is a lack of
conformity with operational PRPs
 Documented procedures shall specify appropriate actions to
identify and eliminate the cause of detected nonconformities,
to prevent recurrence and bring process or system back into
control:
 reviewing nonconformities
 reviewing trends and monitoring results
 determining causes
 actions that nonconformities do not recur
 results of taken corrective actions
 reviewing corrective actions taken to ensure that they are
effective
 Handling of potentially unsafe
products
 It shall be prevented that nonconforming product enter
food chain unless it is possible to ensure that:
 hazards of concern have been reduced to defined
acceptable levels
 hazards of concern will be reduced to defined acceptable
levels prior to entering food chain
 product still meets defined acceptable levels despite of
nonconformity
 All lots affected shall be held under control until they
have been evaluated
 In case of determined unsafe product – relevant
interested parties shall be notified and withdrawal
initiated
 Evaluation for
release
 Each lot affected by nonconformity shall only be
released as safe when any of following conditions
apply:
 Evidence other than monitoring system
demonstrates that control measures have been
effective
 Evidence shows that combined effect of control
measures complies with intended performance
 Results of sampling, analysis or other verification
activities demonstrate that affected product complies
with the identified acceptable levels
 Disposition of nonconforming products

If following evaluation the lot of product is not

acceptable for release it shall be handled as follows:
reprocessing or further processing
destruction and/or other disposal as waste
 Withdrawals

 Top management shall appoint personnel having an

authority to initiate withdrawal and personnel
responsible for executing the withdrawal
 Documented procedure shall be established for:
 notification to relevant interested parties
 handling of withdrawn products and affected lots still in
stock
 sequence of actions to be taken
 Withdrawn products shall be held under supervision
 The cause, extent an result of withdrawal shall be
recorded and reported
 Effectiveness of withdrawal programme shall be verified
Validation, verification and improvement of
the food safety management system
Validation, verification and
improvement of the
FSMS

 Processes needed to validate control measures and

to verify and improve the FSMS shall be planned
and implemented
Validation of control measure
combinations
 Control measures shall be validated prior to
implementation in operational PRPs and the HACCP
plan and after any change that:
 selected control measures are capable of achieving the
intended control of food safety hazard
 control measures are effective and capable of, in
combination, ensuring control of identified hazards to
obtain end products that meet the defined acceptable
levels
 If the result of the validation shows that one or both of
the above elements cannot be confirmed, the control
measure and/or combinations thereof shall be modified
and re-assessed
 Control of monitoring and measuring

 Evidence shall be provided that the specified monitoring

and measuring methods and equipment are adequate to
ensure the performance of the monitoring and measuring
procedures
 Measuring equipment and methods used shall be:
 calibrated or verified at specified intervals
 identified to enable the calibration status to be
determined
 safeguarded from adjustments that would invalidate the
measurement results
 be protected from damage or deterioration
Food safety management system
verification
 Internal audits at planned intervals
 Selection of auditors and the conduct of audits shall
ensure the objectivity and impartiality of the audit
process
 Managers shall ensure that actions are taken
without undue delay to eliminate detected
nonconformities and their causes
 Follow up on the actions taken
 Evaluation of individual verification
results
 Food safety team shall systematically evaluate the
individual results of planned verification
 Actions shall be taken if verification does not
demonstrate conformity with the planned
arrangements, e.g. review of
 existing procedures and communication channels
 hazard analysis, operational PRPs, HACCP plan
 PRPs
 effectiveness of human resource management and of
training activities
 Analysis of results of verification
activities
 Food safety team shall analyse the results of verification activities,
including internal and external audits
 Analysis shall be carried out in order:
 to confirm that overall performance meets planned
arrangements
 to identify the need for updating
 to identify trends which indicate a higher incidence of potentially
unsafe products
 to establish information for planning internal audits
 to provide evidence that proves that actions taken to address
nonconformities are effective
 Results of verification analysis and the activities that
result from your analysis shall be recorded and reported
 Analytical results and activities shall be used as input to
update
FSMS
 Improvement

Top managers shall ensure that the organization

continually improves effectiveness of FSMS through:
the use of communication
management review
internal audit
evaluation of individual verification results
analysis of results of verification activities
validation of control measure combinations
corrective actions
food safety management system updating
 Updating the FSMS

 Top management shall ensure that FSMS is continually

updated
 Food safety team shall evaluate FSMS at planned
intervals
 Evaluation shall be based on:
 input from communication (internal and external)
 input concerning suitability, adequacy and effectiveness
 output from analysis of results of verification activities
 output from management review
 Updating activities shall recorded and reported
 ISO 22000 is under revision

 ISO 22000, Food safety management systems --

Requirements for any organization in the food chain
is under revision, with the draft version available
for purchase from mid 2016

 The final updated version is expected early 2017

http://www.iso.org/iso/home/standards/managemen
t-standards/iso22000.htm
 ISO 22000 family - number of standards each
focusing on different aspects of food
safety management

 ISO 22000:2005 - overall guidelines for food safety

management
 ISO 22004:2014 - application of ISO 22000
 ISO 22005:2007 - traceability in the feed and food chain
 ISO/TS 22002-1:2009 - specific prerequisites for food
manufacturing
 ISO/TS 22002-2:2013 - specific prerequisites for catering
 ISO/TS 22002-3:2011 - specific prerequisites for farming
 ISO/TS 22002-4:2013 - specific prerequisites for food
packaging manufacturing
 ISO/TS 22003:2013 - guidelines for audit and certification
bodies
Thank you