Introduction to FSSC 22000 6/13/2013
1
INTRODUCTION
TO FSSC 22000
FOOD SAFETY
MANAGEMENT
SYSTEMBy
Jacqueline Toon
SQC Management Sdn Bhd
�SECTION 1: BACKGROUND OF FSSC 22000
�SECTION 2: BACKGROUND OF ISO 22000
�SECTION 3: TERMS & DEFINITIONS
�SECTION 4: ISO 22000 REQUIREMENTS
COURSE CONTENT
SECTION 1:BACKGROUND OF FSSC 22000
FOODBORNE INCIDENTS � According to the Centers for Disease Control and Prevention, Atlanta, foodborne illness affects an estimated 48 million people in the United States every year.
�Of those, 128,000 are hospitalized and around 3,000 die.
Source: http://www.foodsafetymagazine.com/fsm-edigest/food-safety-focus-on-packaging/ , June 4, 2013
Introduction to FSSC 22000 6/13/2013
2
Key Food Safety Issues� Existing Issues Being addressed
� Hygiene of eating establishment
� Residue of veterinary drugs
� Pesticides
� Abuse and overuse of food additives
� Mycotoxin
� inorganic contaminants
Effort already taking place to reduce the contravention and risk to consumers.
Key Food Safety Issues� New Issues beginning to be addressed
� Migration of chemicals substances from packaging materials and other
� materials in contact with food
� Persistent Organic Environmental Pollutants(dioxin, PCBs, PAH)
� Chemical substances formed during cooking/processing
� Hypersensitivity, intolerance and allergic reactions
� Antibiotic resistant microorganism
Food Packaging Safety Quotes …
� “If you supply a food company, you are
no longer just the packaging industry, you
are a part of the food industry”
� “We treat food packaging with the same
food safety rigor as food ingredients.”
(Ms. Wade-Kudla senior manager of packaging at
General Mills Inc., Minneapolis)
What is FSSC 22000
� A set of requirements for a Food Safety
Management System (FSMS)
� It was developed to fill the need for a
worldwide Food Safety Standard
Introduction to FSSC 22000 6/13/2013
3
WHY FSSC 22000?There have been an
abundance of food safety standards in use, the problem
was that they were not equivalent.
It was hard to know what each certification really
meant.
If your customers want to see a
GFSI recognized certification …
� you will need to use FSSC 22000, ISO 22000
is not recognized.
GFSI determine that the prerequisite
programs requirements in ISO 22000 were
not specific enough!!
Global Food Safety Initiative
(GFSI)
� A food retail initiative created in May 2000
by the Global Food Business Forum (CIES)
� A network of 175 retailers and 175
suppliers in over 150 countries,
representing 65 percent of global food
retail revenue.
How the GFSI requirements are covered in the
key global food safety standards:
Introduction to FSSC 22000 6/13/2013
4
SCOPE OF FSSC 22000
� Applies to Food manufacturers or food packaging
manufacturers
� Uses ISO 22000 for the food safety management system
requirements
� Uses an additional document for prerequisite requirements
� Food Manufacturers/Processors - ISO/TS 22002-1 (supersedes PAS
220: 2008)
� Food Packaging Manufacturers - PAS 223
THE ORIGINS OF A GLOBAL
STANDARD
WHY FSSC 22000 WORKS?� Integrates food safety management easily with other management
systems, such as quality, environmental and safety management systems;
� Fully incorporates ISO 22000:2005, PAS 220:2008 Pre-requisite Programmes (PRPs), HACCP, and the application steps of CODEX;
� Is fully recognised by the Global Food Safety Initiative (GFSI);
� Controls/reduces food safety hazards and promotes continuous improvement on Food Safety Aspects;
� Fosters legal compliance;
� Increases transparency throughout the food supply chain; and
� Allows small and/or less developed organisations to implement an externally developed system.
SECTION 2:BACKGROUND OF ISO 22000
Introduction to FSSC 22000 6/13/2013
5
ISO 22000 throughout the food
chain What is ISO 22000?Food Safety Management Systems -Requirements for any organization in the food chain.
� ISO Technical Committee 34
� Working Group 8 (ISO TC 34/ WG 8)
� Also members:
� Global Food Safety Initiative (CIES)
� Codex Alimentarius
� CIAA
Why ISO 22000?
� Problems in food supply chains
� Needs for harmonization
� Integration Food Safety in management
systems (ISO 9001, ISO 14001 etc)
Characteristics of ISO 22000� Food Safety Management System standard
� Apply to all suppliers within the food supply chain
� Requirements for internal & external communications Food safety hazards: controlled by CCPs & Operational PRPs
� Reference: List of specific code of practices
Introduction to FSSC 22000 6/13/2013
6
SECTION 3:TERMS & DEFINITIONS
TERMS AND DEFINITIONS
Food Safety Concept that food will not cause harm to the consumer when it is prepared and/or eaten according to its intended use
Food Safety Hazard
Biological, chemical or physical agent in food, or condition of food, with the potential to cause an adverse health effect
Control Measure
<Food safety> action or activity that can be used to prevent or eliminate a food safety hazard or reduce it to an acceptable level
TERMS AND DEFINITIONS
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
Critical Control Point (CCP)
<Food safety> step at which control can be applied and is essential to prevent or eliminate a food safety hazard or reduce it to an acceptable level
TERMS AND DEFINITIONS
Critical Limit Criterion which separates acceptability from unacceptability
Monitoring Conducting a planned sequence of observations or measurements to assess whether control measures are operating as intended
Correction Action to eliminate a detected nonconformity
Corrective Action
Action to eliminate the cause of a detected
nonconformity or other undesirable situation
Introduction to FSSC 22000 6/13/2013
7
TERMS AND DEFINITIONS
Validation <Food safety> obtaining evidence that the
control measures managed by the HACCP
plan and by the operational PRPs are
capable of being effective
Verification Confirmation, through the provision of
objective evidence, that specified
requirements have been fulfilled
Producers of ingredients
Producers of equipment
Producers of cleaning
agents
Producers of packaging
materials
Others
Services providers
Re
gu
lato
ry a
uth
oritie
s
Figure 1 : Communication along the food chain
Feed producers
Primary food producers
Food processors
Transport and storage operators
Distributors
Retailers
Consumer
Components of Food Safety
Management System Outline of ISO 22000?Sections 4 - 8 Contain the requirements� ISO 22000 Standard
� Section 1: Scope� Section 2: Normative Reference� Section 3: Terms & Definit ions� Section 4: General Requirements� Section 5: Management Responsibility� Section 6: Resource Management� Section 7: Planning & Realizat ion of Safe Products� Section 8: Validation, Verificat ion & Improvement
Introduction to FSSC 22000 6/13/2013
8
SECTION 4:ISO 22000 REQUIREMENTS
4.1 General
� Establish an effective
Food Safety
Management System
(FSMS)
� Keep it current
� Identify outsourced
processes
4.2 Documentation
Requirements
� Document your system
�Control your documents
4.2 Records
�Maintain required
records
�Control your records
Introduction to FSSC 22000 6/13/2013
9
5.1 Management
Commitment
�Management must be involved in and
committed to the FSMS.
� Objectives support safety
� Everyone knows the importance of meeting the requirements
5.2 Food Safety Policy
�Management creates for Food Safety
Policy
�Management is responsible for
communicating the policy
�Management is responsible for ensuring
that the policy is implemented
5.3 FSMS Planning
� As top management, take an active role
in planning the system
� Be involved in the design and implementation
� Make sure the integrity is maintained as changes are made
5.4 Responsibility and
Authority
� Define responsibilities and authority
�Communicate them
� Everyone is responsible for reporting
problems with the FSMS - make sure they
know that
Introduction to FSSC 22000 6/13/2013
10
5.5 Food Safety Team
Leader
� Appointed by top management
� Reports to top management on the status
of the FSMS
5.6 Communication
� Establish a system for external
communication
� Suppliers, contractors, customers, SR&R authorities, external expert
� Establish a system for internal
communication
� Food safety team meeting
5.7 Emergency
Preparedness
� Be prepared to respond to emergency
situations
� Prepare an emergency plan to address
potential situations:
� Fire
� Flood
� Accidents
� Contamination
� Others...
5.8 Management Review
� Key step in a Management Systems
Approach
�Management meets to evaluate the
performance of the FSMS
Introduction to FSSC 22000 6/13/2013
11
6 Resource Management
� Top management is responsible for
providing the resources required
� Human resources
� Infrastructure
� Work Environment
Pre-requisite
Programme
7 Planning & Realization of
Safe Product
� Your organization will need to plan all of
the processes that go into making your
product in order to ensure a safe end
product
� PRP
� OPRP
� HACCP
7.2 Prerequisite Program
� Basic Conditions and activities that are
necessary to maintain a hygienic
environment throughout the food chain
� The Food safety Team establishes PRPs
� For FSSC 22000 you will also include prerequisite programs to meet the requirements of PAS 223
7.3 Preliminary Steps
� The Food Safety Team
� Identifies product characteristics
� Describe intended use
� Prepare flow diagrams
� Describe process steps and control measures
Introduction to FSSC 22000 6/13/2013
12
7 core principle steps of HACCP
� The HACCP system is implemented as described
above which includes five preparatory steps and
seven principle steps.
Hazard Analysis
Critical control point
Critical Limits
Monitoringand sampling
Corrective Action
Verification
Documentation
7.4 Hazard Analysis
� The Food Safety Team
� Verifies the accuracy of the flow diagrams
� Conducts hazard analysis to identify potential food safety hazards
� Selects control measures to prevent or eliminate those hazards
FOOD SAFETY HAZARDS &
CONTROL
� Types of Hazards
� Biological
� Physical
� Chemical
BIOLOGICAL HAZARD� Bacillus cereus
� Campylobacter jejuni� Clostridium botulinum� Clostridium perfringens
� Escherichia coli� Listeria Monocytogenes
� Salmonella species� Shigella dysenteriae
� Staphylococcus aureus� Vibrio cholerae� Yersinia ente
Introduction to FSSC 22000 6/13/2013
13
FACTORS AFFECTING
MICROBIAL GROWTH
Food Acidity)
Temperature
TimeOxygen
Moisture
Preservative
PHYSICAL HAZARDS� Hair, feather
� Pest & their droppings
� metal fragment , glass
� Sand, wood, stone
� peeled off paint
� jewelry, buttons
� cigarette butts
� band aid, pen caps
� rubber band, plastic pieces
CHEMICAL HAZARDS� Naturally occurred
� mushroom, some fish species, some tapioca
species, allergen
� Commercially added
� pesticides, herbicides, colouring, additives
� Unintentionally added
� cleaning agents, sanitizers, lubricants
Risk is to be calculated for each hazard and a risk rating
sheet can be developed as described below:
Food Hazard Assessment
Introduction to FSSC 22000 6/13/2013
14
Food Safety Risk Matrix
� Value of 15 – 25 (red area): High Risk, control measure is essential, determined by Decision Tree
� Value of1– 12 (green area): Low Risk, Up to the HACCP team to decide whether it makes sense to have the control measures
CCP Decision Tree
Q1 Is there a hazard with this raw material?
Q2 Are you or the customer going to processthis hazard out of the product?
NONot a CCP
Go to next raw material
Q3 Is there a cross contamination risk to thefacility or to other products which will not becontrolled?
YES
YES
NO
NO
Not a CCP
YES
Go to next raw
materialCCP
CCP
RAW MATERIAL CCP DECISION
TREE Q1 Are there preventive measure(s) for theidentified hazard?
Q2 Is the step specifically designed to eliminate orreduce the likely occurrence of a hazard to anacceptable level?
Q3 Could contamination occur atunacceptable level(s) or increase to anunacceptable level?
Is control necessary at thisstep for safety?
Modify step, process or product)
Q4 Will a subsequent process step eliminate orreduce the hazard to an acceptable level?
YES
YES
YES
YES
YES
Not a CCP
(Ctrl by OPRP)
NO
NO
NO
Next process step
NO
NO
CCP
Next process step
Next process step
PROCESS STEP CCP DECISION
TREE
Not a CCP
(Ctrl by OPRP)
Not a CCP
(Ctrl by OPRP)
Introduction to FSSC 22000 6/13/2013
15
7.5 Establish Operational
PRPs
� Similar to a Critical Control Point, an Operational Prerequisite Program is a control point where biological, physical, or chemical hazards identified in hazard analysis can be controlled.
� Your food safety team will determine if the control point is a CCP or oPRP using the decision criteria in Section 7 of the standard.
� The Food Safety Team establishes Operational PRPs
7.6 Establish the HACCP
Plan
� Documents the HACCP plan
7.7 Updating
� Updates any preliminary information that
may have changed during or as a result
of the hazard analysis
7.8 Verification Planning
� Identify what verification activities are
required including verification of PRPs, the
HACCP Plan and other procedures.
� Verification will include internal audits, any
food safety or GMP audits, verification of
cleaning records and HACCP records
and other activities that you identify for
your system.
Introduction to FSSC 22000 6/13/2013
16
7.9 Traceability
� A traceability system ensures that the
identification of product is maintained
from raw material to delivery.
� Establish the traceability of product
� From supplier to distribution
7.10 Control of Nonconformity
�When a control limit is exceeded or an
OPRP is found to be out of control
affected product must be controlled.
� Corrections
� Corrective actions
� Handling of potentially unsafe product
7.10.4 Withdrawal
� To have complete & timely withdrawal of
lots of end products
8.2 Validation, & 8.3 Control of
Measuring & Monitoring
� All measuring equipment must be
capable of the required measurements
and show calibration to national or
international standards.
�Calibrate and control measuring
equipment to ensure that measurements
are valid
Introduction to FSSC 22000 6/13/2013
17
8.4 Verification
� Establish and document an internal audit
process
� The Food Safety Team evaluates and
analyzes verification results
� The Food Safety Team takes any
necessary action
8.5 Improvement
�Continually improve the FSMS through the
use of:
� Management review
� Internal audits
� Corrective actions
� Verification results
� Validation results
8.5 Updating the FSMS
� Top management is responsible for seeing
that the FSMS is continually updated
� The Food Safety Management Team
evaluates the FSMS at planned intervals
THANK YOU FOR YOUR
ATTENTION
QUESTIONS
?
Top Related