ISO 22000

Food Safety Management

Systems (FSMS)
An-Najah National University

By: Mohammed Sabah

ISO 22000


ISO 22000:2005

ISO 9001:2008

Organization

HACCP

OHSAS
18001:2007

ISO 14001:2004

?What food businesses were looking for

Better planning, less post-process verification

More efficient & dynamic hazard control
Systematic management of prerequisite programs
Better documentation
Communication among trade partners
Resource optimization

what is ISO 22000:2005 ?

A

management system standard (based on

ISO 9001:2000)
Specific to food safety management (not quality, etc)
Based on Codex HACCP approach with some
innovations
Designed for all segments of food chain & all types
of food business (micro to global)
Enables a food business to plan, implement, operate,
maintain and update a system to provide safe end
products and demonstrate conformity with applicable
regulatory requirements

 FSMS

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 FSMS


HACCP ISO 22000:2005

.

,
Preventive

 FSMS
ISO 22000:2005
) (ISO
CODEX 2005

.

 FSMS
ISO 22000:2005

RTE
Food


ISO 9001:2000 HACCP

Example for communication along the food

chain

Key elements

ISO 22000:2005
Interactive
Systems Approach
Communication
to FSM

system management

Pre-requisite
Programs

HACCP
Principles

Control Food Safety

Hazards

The ISO 22000 Family of Standards

ISO 22000:2005,
22000:2005 Food safety management system -

Requirements for any organization in the food chain

ISO/TS
22003:2007,
22003:2007 Food safety management
systems Requirements for bodies providing audit
and certification of food safety management systems
ISO/TS 22004:2005,
22004:2005 Food safety management
systems Guidance on the application of ISO 22000
ISO 22005:2007,
22005:2007 Traceability in the feed and food
chain General principles and basic requirements
for system design and implementation
TS= Technical Specification


ISO 22000:2005
ISO 22000 :2005

Food Safety Management Systems

Food SMS
Requirements for any organization
In the food chain

ISO 22000 - Outline

Introduction
1 Scope
2 Normative reference
3 Terms and definitions
4 Food safety management requirements
- 4.1 General requirements
- 4.2 Documentation requirements
5 Management responsibility
- 5.1 Management commitment
- 5.2 Food safety policy

- 5.3 Food safety management system planning

- 5.4 Responsibility and authority
- 5.5 Food safety team leader
- 5.6 Communication
- 5.7 Contingency preparedness and response
- 5.8 Management review
6 Resource management
- 6.1 Provision of resources
- 6.2 Human resources
- 6.3 Infrastructure
- 6.4 Work environment

 7 Planning and realization of safe products

- 7.1 General
- 7.2 Prerequisite programe(s)
- 7.3 Preliminary steps to enable hazard analysis
- 7.4 Hazard analysis
- 7.5 Design and redesign of the operational PRPs
- 7.6 Design and redesign of the HACCP plan
- 7.7 Updating of preliminary information and documents
specifying the PRP(s) and the HACC Plan
- 7.8 Verification planning
- 7.9 Operation of the food safety management system

 8 Verification, validation and improvement of the food

safety management system

- 8.1 General
- 8.2 Monitoring and measuring
- 8.3 Food safety management system verification
- 8.4 Validation of control measure combinations
- 8.5 Improvement

1-Scope of ISO 22000

This
International
Standard
specifies
requirements for a food safety management
system in the food chain where an organization
needs to demonstrate its ability to control food
safety hazards in order to consistently provide
safe end products that both meet agreed customer
and
applicable
regulatory
food
safety
requirements, and aims to enhance customer
satisfaction through the effective control of food
safety hazards, including processes for updating
the system.

Food safety management requirements. 4

Establish, document, implement and maintain

an effective Food SMS and update it.
, ,
.
Define the Scope of Food SMS.
Products categories.
Processes and production sites.

Documentation requirements

Food safety policy & related objectives

Documented procedures required by the standard

Records required by the standard
Documents
needed
to
ensure
effective
development, implementation and updating of the
Food SMS

Required documented procedures

Document control (4.2.2)

Record control (4.2.3)
Action when monitoring results exceed critical
limit (7.6.5)
Nonconformity control

Corrections (7.10.1)
Corrective action (7.10.2)
Withdrawals (7.10.4)

Internal Audit (8.4.1)

Control of documents 4.2.2

Documented procedure defining controls for Food SMS
required documents:

FSMS:
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, , .
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Approval for adequacy before use

Review/update as nec. & re-approval
Changes and current revision status clearly identified
Relevant version available at points of use

Control of documents 4.2.2

Documents remain legible and readily
identifiable
Documents of external origin are
identified
and
their
distribution
controlled
Prevent use of obsolete documents, and
identify if retained

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.

Control of records 4.2.3

Maintained to demonstrate conformance
to requirements and the effective
operation of the Food SMS

System-level procedure for identifying,

storage, retrieval, protection, retention
times and disposal

,,
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5. Management responsibility

General 5.1
Top Management to provide evidence of its commitment to
development & implementation of the Food SMS & continually
improving its effectiveness

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)How??? (think first, then see next slide

..Cont 5.1

Top Management
training school

Showing
food
safety
is
supported
by
business
objectives.
Communicating
the
importance
of
meeting
customer/statutory/
regulatory requirements.
Establishing the food safety
policy.
Holding management reviews
Ensuring
availability
of resources.

Im out
of here!

Food safety policy 5.2

5-2
Top management to ensure it:

Is appropriate to the role of organization
in food chain.

Conforms with both statutory and
regulatory and with agreed food safety
requirements of customers

.

Food safety policy 5.2

5-2
Is communicated, implemented and
maintained at all levels of organization

.
Is reviewed for continuing suitability

.

Food safety policy 5.2

5-2

Is supported by measurable
objectives.

 " " X
X " "
Y

:

.

.

.

Food safety management system 5.3

planning
Top

Management
conducted to:

to

ensure

planning

-:
meet the overall requirements and food
safety objectives

Ensure system integrity during changes

.

Responsibility and authority 5.4

Top Management to ensure that R&A are

defined & communicated

.
All personnel have the responsibility to report
problems with the Food SMS to identified
person (s).

That designated personnel shall initiate and
record action.

Food Safety Team Leader 5.5

Manage a food safety team

.
Ensure
relevant
training
and
education of team

.
Ensure the Food SMS is established,
implemented, maintained and updated

, ,
.
Reporting effectiveness and suitability
to top management

5.6 Communication

External communication

Supplier and contractors

Customers or consumers
Statutory and regulatory authorities

 5.6 Communication
Other impacted organization on
food SMS

Known food safety hazards, needed to
be controlled by other organizations.

Communication (Cont.) 5.6

Internal communication
1. Food safety team is informed of
changes in food SMS.

.
2. Food safety team shall ensure the
updating of the Food SMS.

.

5.7 Emergency preparedness and

response
Procedure to manage potential
emergency situation and accidents
that can impact food safety


Role of the organization in the food
chain.
.

39

Food Safety Plan

 5.8 Management review

Top management reviewing Food SMS to

ensure
suitability,
adequacy
&
effectiveness



.
Defined intervals
Is there a need to amend the Food SMS,
food safety policy.

Management review (cont..) 5.8

Review information to:

Follow up issues from previous reviews

Analysis of results of verification activities

Changing circumstances that affect to food

safety.

Management review (cont..) 5.8

Emergency situation, accident and withdrawals

Reviewing results of system updating activities.

Review of communication activities, including customer feed back

External audits or inspection

.
Data shall be presented in link to objectives

Management review (cont) 5.8

Output shall include decisions and actions related to:

-:
Assurance of food safety

Improvement of Food SMS

Resource needs
Revision of Food safety policy and objectives

6. Resource management

6.1 Provision of Resource

Provide the adequate resources for
established,
implementation,
maintenance and updating Food
SMS

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 6.2 Human resources

All personnel shall be competent
Have appropriate education training skills and
experience
Maintain agreement or contract of external
experts, defining the responsibility and
authority.

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Human resources 6.2

Competence, awareness and training

, ,

Identify competence needs

Provide training or other action
Train personnel who responsible for monitoring,
correction and corrective actions
Evaluate effectiveness of training or other actions
Ensure that personnel are aware of activity/contribution
Ensure effective communication
Training or development records

6.3 Infrastructure
6.4 Work environment
Provide

infrastructure and work

environment needed to implement this
Standard.

Planning and realization of. 7

Safe Products

General 7.1
Plan & develop necessary processes for
realization of safe products

.
Implement,
operate
and
ensure
the
effectiveness of planned activities,
Including PRP, operational PRP and HACCP
plan

3.8 PRP prerequisite programme

food safety basic conditions and activities that

are necessary to maintain a hygienic

environment throughout the food chain (3.2)
suitable for the production, handling and
provision of safe end products (3.5) and safe
food for human consumption

, ,
.

3.8 PRP prerequisite programme

NOTE The PRPs needed depend on the segment of

the food chain in which the organization operates

and the type of organization
) (

-:
Examples of equivalent terms are: Good Agricultural Practice
(GAP), Good Veterinarian Practice (GVP), Good Manufacturing
Practice (GMP), Good Hygienic Practice (GHP), Good Production
Practice (GPP), Good Distribution Practice (GDP) and Good
Trading Practice (GTP).

CODE OF PRACTICE FOR THE REDUCTION OF

AFLATOXIN B1 IN RAW MATERIALS AND

SUPPLEMENTAL FEEDINGSTUFFS CAC/RCP 451997

3.9 operational PRP

PRP (3.8) identified by the hazard analysis as

essential in order to control the likelihood of

introducing food safety hazards (3.3) to and/or the
contamination or proliferation of food safety hazards
in the product(s) or in the processing environment

7.2 Prerequisite programmes

(PRPs)
7.2.1 Establish, implement and maintain PRP to
assist in controlling

Likelihood Food safety hazards thru

work environment
B / C / P contamination, cross
contamination between product
Food safety hazard level in product and
process environment

PRP
( / / )

58

Food Safety Plan

7.3 Preliminary steps to enable

hazard analysis

Collect information needed

Appoint food safety team, multi-disciplinary

knowledge & experienced

Raw materials, ingredients, product-contact
materials
Characteristics of end products
Intended use
Flow diagrams, process step and control
measure

...A Process is

Methods Materials Machines

Process

Output

People Environment Measurement

Process B

Process A

Process Z

Shewharts PDCA Model

1.Plan

2.Do

4.Act

3.Check

Example of a Flow Diagram for the Production of Frozen

Cooked Beef Patties

Freezing

Receiving (Beef)

Boxing

Grinding

Distributing

Mixing

Reheating

Forming

Serving

Cooking

Step

Potential Hazard(s)

Justification

5. Cooking

Enteric pathogens:
e.g., Salmonella,
verotoxigenic-E.
coli

enteric pathogens have been

associated with outbreaks of
foodborne illness from
undercooked ground beef

CCP Decision Tree

Hazard to be addressed
in plan?
Y/N

Control
Measure(s)

Cooking

Establish critical limits

Process Step

5.
Cooking

CCP

Critical Limits

YES Oven temperature:___ F

Time; rate of heating and cooling (belt speed
in ft/min): ____ft/min
Patty thickness: ____in.
Patty composition: e.g. all beef
Oven humidity: ____% RH

7.4 Hazard analysis

Determine which hazards need to be

controlled,
degree
of
control
combination of control measures
Hazard identification and determine
acceptable levels, base on
Preliminary collected information &
data
Experience
External information
Information from food chain

Establishing the operational 7.5

prerequisite programme

Document operational PRP

Food safety hazard(s) to be controlled
Control measure
Monitoring procedures
Correction and corrective action to be
taken
Responsibilities and authorities
Record of monitoring

Establishing the HACCP plan 7.6

Document HACCP plan

Identification of critical control points

Determine critical limit for CCP
System for monitoring of CCP
Action when monitoring results exceed
critical limit

7.7

Updating of preliminary information and

document specifying the PRP and HACCP plan

Updating the following information , if

nec

Product char
Intended use
Flow diagram
Process step
Control measure

7.8 Verification planning

Verification activities shall confirm that
PRP are implemented
Input to hazard analysis is updated
Effective of operational PRP and

HACCP plan
Hazard levels are within acceptable
level
Other procedure are implemented and
effective

 Haccp
-1

CCPs


77

Food Safety Plan

 Haccp
-2

) (CCP




78

Food Safety Plan

 Haccp
-3

79

Food Safety Plan

 Haccp
-4
:

CCP
:

80

Food Safety Plan

 Haccp
-5
:

140 ) (

155

155

81

Food Safety Plan

 Haccp
-6

:
.1
.2

.3

.4
82

Food Safety Plan

 Haccp
-7
:

) (







83

Food Safety Plan

7.9 Traceability system

Traceability system for product lot and

their relation to batch of raw material,
processing and delivery record

.
Able to identify incoming material from
immediate
suppliers
and
initial
distribution route of end product

 7.10 Control of nonconformity

Corrections
o Identify and assessment affected
end product to determine proper
handling
o
)
CCP ( PRP
.
o Review of the corrections carried out
o

 7.10 Control of nonconformity

Corrective actions


CCP & PRP
, ,
.
o Eliminate cause of detected N/C
o Prevent recurrence
o Bring the process or system back into
control

Control of nonconformity 7.10

Handling

of

potentially

unsafe

product
To prevent the N/C product from
entering the food chain
N/C product shall be held until
they have been evaluated
Notify interested parties and
initiate a withdrawal

Control of nonconformity 7.10

Evaluation for release

N/C product shall only be released as
safe when
Evidence of effective control measure,
other than monitoring system
Evidence
of
complies
with
performance intended
Result of sampling, analysis or thier
verification shows product complies
acceptable level

Control of nonconformity 7.10

Disposition of N/C products

Reprocessing or further processing to
acceptable levels
Destruction or disposal as waste
Withdrawals

Appoint authority personnel to initiate

and execute the withdrawal

Notify to interested parties

Handling of withdraw product

Procedure sequence of action to be

taken

Validation, verification and. 8

improvement of the Food SMS
8.1 General
Plan & implement
Processes needed to validate
control measures
To verify and improve the Food
SMS

Validation of control measure 8.2

combinations
Validate the control measures are

capable to control the Hazard

Modify the control measures, as
necessary.

8.3 Control of measuring &

monitoring
To ensure valid results, devices are:
Calibrated / adjusted prior to use or

at
specified
intervals
against
devices traceable to national /
international stds. if not, define
basis for calibration
identified & calibration status
defined
Safeguarded from adjustments

Control of measuring & 8.3

monitoring
Protected from damage & deterioration
during handling, maintenance & storage
Assess & record previous results
validity & take action when device found
not conforming to requirements
Record calibration & verification results
Software validated prior to use & when
req.

8.4 Food safety management system

verification

8.4.1 Internal Audit

Verify Food SMS is complying &
effectively implemented
Planned based on status, importance
and previous results
Independent auditors
Documented procedure
Timely corrective action by relevant mgt.
Follow-up

Evaluation of 8.4.2
individual verification results
Systematic evaluate the individual
results of planed verification
Take action to achieve the require
conformity

8.4.3 Analysis of results of verification

activities
Analyse the results of verification activities,

incl. Internal / External audit

To confirm overall performance of system.
To identify need for updating / improving the
Food SMS
To identify trends of potential unsafe products
Information for internal audit
To provide evidence the effectiveness of
correction and corrective action

8.5 Improvement
8.5.1 Continual improvement
Continually improve Food SMS
effectiveness through use of various
sources of information:
Communication,
management
review, internal audit, verification
activities,
validate
result,
corrective action, etc.

8.5.2 Updating the Food SMS

Continually update the food SMS
Consider whether it is necessary to

review hazard analysis, PRP and

HACCP plan
As the input for management review.


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+ +
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)(Dowepack


FSMS
internal audit

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