The role of certification bodies in auditing Prerequisite programmes in the food industry
sector, according to ISO 22000 / TS 22002-1:2009 (Prerequisite programmes on food
safety — Part 1: Food manufacturing).
New consumer trends, certifications and industry internal auditing protocols deriving
from Nutrition, Genetically modified food, allergens labeling and food defense issues
Konstantinos Parinos
Lead Auditor Q-Check
Veterinarian, DVM, Chemist , Μ.Sc.
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ISO / TS 22002-1:2009
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ISO / TS 22002-1:2009
ISO 22000:2005 sets out specific food safety requirements for organizations in the food
chain.
One such requirement is that organizations
establish, implement and maintain prerequisite programmes (PRP) to assist in controlling food
safety hazards (ISO 22000:2005, Clause 7).
ISO / TS 22002-1:2009
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EFSIS
Nestlé NQS
FAMI-QS
GMO
ISO 9001
GMP standard for Corrugated & Solid Board
IFS
GFSIGuide
SQF
AG 9000
ISO 14001
McDonalds system
Kraft food system
Eurepgap
Friesland Coberco FSS
DS 3027
BRC-IoP
BRC-Food
Dutch HACCP
Irish HACCP
M&S system
Aldi system
Waiterosesystem
GMP GTP
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CAC/RCP Codex Alimentarius Commission/ Recommended International Code of Practice
ISO International Organization for Standardization
ANSI American National Standards Institute
GFSI Global Food Safety Initiative
IFC International Food Standard
GMP/GRP Good Manufacturing/Retail Practice
FSMS Food Safety Management System
BRC British Retail Consortium
SQFI Safe Quality Foods Institute
GMA-Safe Supplier Assessments For Food Excellence Grocery Manufacturers Association (2001)
Audit System Terms and Acronyms
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This Technical Specification is intended to be used to supportmanagement systems designed to meet the requirements
specified in ISO 22000:2005, and sets out the detailedrequirements for those programmes.
This Technical Specification does not duplicate requirements
given in ISO 22000:2005 and is intended to be used inconjunction with ISO 22000:2005.
ISO / TS 22002-1:2009
ISO 22000 TS 22002-1
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Food manufacturing operations are diverse in nature and notall of the requirements specified in this Technical
Specification apply to an individual establishment orprocess.
Role of the auditor and the certification body.
This Technical Specification is applicable to allorganizations, regardless of size or complexity, which are
involved in the manufacturing step of the food chain and wish
to implement PRP in such a way as to address the
requirements specified in ISO 22000:2005, Clause 7.
ISO / TS 22002-1:2009
ISO 22000 TS 22002-1
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ISO / TS 22002-1:2009)
ISO 22000 TS 22002-1
BS PAS 220: 2008
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Auditing ISO / TS 22002-1:2009
Prerequisite programmes
When selecting and/or establishing PRP´s documents to be
considered are:
a) Regulatory and consumer requirements
b) Information from industry guidelines
c) Specific product requirements for foods to be produced
d) Any additional points linked to local environment
ISO 22000 TS 22002-1
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ISO / TS 22002-1:2009
Prerequisite programmes
ISO 22000 TS 22002-1
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This Technical Specification specifies detailed requirements to
be specifically considered in relation to ISO 22000:2005,
7.2.3:
a) construction and layout of buildings and associated utilities;
b) layout of premises, including workspace and employee
facilities;
c) supplies of air, water, energy and other utilities;
d) supporting services, including waste and sewage disposal;
e) suitability of equipment and its accessibility for cleaning,
maintenance and preventive maintenance;
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f) management of purchased materials;
g) measures for the prevention of cross-contamination;
h) cleaning and sanitizing;
i) pest control;
j) personnel hygiene.
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In addition, this Technical Specification adds other aspects
which are considered relevant to manufacturing operations:
1) rework;
2) product recall procedures;
3) warehousing;
4) product information and consumer awareness;
5) food defence, biovigilance and bioterrorism.
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Auditing ISO / TS 22002-1:2009
DESIGN
Buildings, Internal layout
Movement patterns
Openings
Walls, floors, drains, ceilings and overhead fixtures
Equipment
Laboratory
Storage areas
Distribution of utilities
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Auditing ISO / TS 22002-1:2009
Locations of establishments
The site boundaries shall be clearly identified.
Access to the site shall be controlled.
The site shall be maintained in good order.
Vegetation shall be tended or removed.
Roads, yards and parking areas
shall be drained to prevent
standing water and shall be
maintained.
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Auditing ISO / TS 22002-1:2009
The building shall provide adequate space, with a logicalflow of materials, products and personnel, and physical
separation of raw from processed areas.
Location of equipment. Equipment shall be designed and
located so as to facilitate good hygiene practices and
monitoring. Equipment shall be located to permit access for
operation, cleaning and maintenance.
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Internal structures and fittings
Process area walls and floors shall be washable or cleanable,
as appropriate for the process or product hazard. Materials of
construction shall be resistant to the cleaning system applied.
Wall floor junctions and corners shall be designed to facilitate
cleaning.
It is recommended that wall floor
junctions be rounded in processing areas.
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Floors shall be designed to avoid standing water.
In wet process areas, floors shall be sealed and drained.
Drains shall be trapped and covered.
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Auditing ISO / TS 22002-1:2009
Storage areas shall be designed or arranged to allow
segregation of raw materials, work in progress and finished
products.
External opening windows, roof vents or fan, where present,
shall be insect screened.
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Auditing ISO / TS 22002-1:2009
Ceilings and overhead fixtures shall be designed to
minimize build-up of dirt and condensation.
Lighting The lighting provided (natural or artificial) shall allow
personnel to operate in a hygienic manner. The intensity of the
lighting should be appropriate to the nature of the operation.
Light fixtures shall be protected to ensure that materials,
product or equipment are not contaminated in the case of
breakages.
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Openings intended for transfer of materials shall be designed
to minimize entry of foreign matter and pests.
External opening doors shall be closed or screened when
not in use.
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In-line and on-line test facilities shall be controlled to
minimize risk of product contamination.
Microbiology laboratories shall be designed, located and
operated so as to prevent contamination of people, plant and
products.
They shall not open directly on to a production area.
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Temporary structures shall be designed, located and
constructed to avoid pest harbourage and potential
contamination of products.
Additional hazards associated with temporary structures and
vending machines shall be assessed and controlled.
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Facilities used to store ingredients, packaging and products
shall provide protection from dust, condensation, drains, waste
and other sources of contamination.
Storage areas shall be dry and well ventilated. Monitoring
and control of temperature and humidity shall be applied
where specified.
.
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• All materials and products shall be stored off the floor and
with sufficient space between the material and the wallsto allow inspection and pest control activities to be carried
out.
The storage area shall be designed to allow maintenance and
cleaning, prevent contamination and minimize deterioration.
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• A separate, secure (locked or otherwise access controlled)
storage area shall be provided for cleaning materials,
chemicals and other hazardous substances.
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UTILITIES – AIR, WATER, ENERGY
Sufficient supply of potable water
Boiler chemical approved
Established requirements for filtration, humidity andmicrobiological specifications for air used as aningredient or in direct contact with food
Compressed air
Adequate lighting to enable operation in a hygienicmanner
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Water supply
The supply of potable water shall be sufficient to meet the
needs of the production process(es).
• Facilities for storage, distribution and, where needed,
temperature control of the water shall be designed to meet
specified water quality requirements.
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Water used as a product ingredient, including ice or steam
(including culinary steam), or in contact with products or
product surfaces, shall meet specified quality and
microbiological requirements relevant to the product.
.
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Water for cleaning or applications where there is a risk of
indirect product contact (e.g. jacketed vessels, heat
exchangers) shall meet specified quality and microbiological
requirements relevant to the application.
Where water supplies are chlorinated, checks shall ensure
that the residual chlorine level at the point of use remains
within limits given in relevant specifications.
Non-potable water shall have a separate supply system that
is labelled and not connected to the potable water system.
Take measures to prevent non-potable water refluxing into the
potable system.
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Auditing ISO / TS 22002-1:2009
Boiler chemicals, if used, shall be either:
a) approved food additives which meet relevant additive
specifications; or
b) additives which have been approved by the relevant
regulatory authority as safe for use in water intended for
human consumption.
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Auditing ISO / TS 22002-1:2009
Boiler chemicals shall be stored in a separate, secure(locked or otherwise access-controlled) area when not in
immediate use.
• Where oil is used for compressors and there is potential for
the air to come into contact with the product, the oil used
shall be food grade.
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The organization shall establish requirements for filtration,humidity (RH%) and microbiology of air used as an
ingredient or for direct product contact.
Where temperature and/or humidity are deemed critical by
the organization, a control system shall be put in place and
monitored.
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Auditing ISO / TS 22002-1:2009
Ventilation (natural or mechanical) shall be provided to
remove excess or unwanted steam, dust and odours, and to
facilitate drying after wet cleaning
.
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Auditing ISO / TS 22002-1:2009
• Room air supply quality shall be controlled to minimize risk
from airborne microbiological contamination.
Protocols for air quality monitoring and control shall be
established in areas where products which support the growth
or survival of microorganisms are exposed.
Ventilation systems shall be designed and constructed such
that air does not flow from contaminated or raw areas to clean
areas. Filters supplying air with direct product contact and
potential to introduce pathogens must be regularly monitored
and replaced when necessary.
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Specified air pressure differentials shall be maintained.
Systems shall be accessible for cleaning, filter changing and
maintenance. Exterior air intake ports shall be examined
periodically for physical integrity.
.
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Compressed air, carbon dioxide, nitrogen and other gassystems used in manufacturing and/or filling shall be
constructed and maintained so as to prevent contamination.
Gases intended for direct or incidental product contact
(including those used for transporting, blowing or drying
materials, products or equipment) shall be from a source
approved for food contact use, filtered to remove dust, oil and
water.
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Auditing ISO / TS 22002-1:2009
WASTE DISPOSAL
Identification, collection and disposal of waste materials
Appropriate containers for waste
Segregation and storage of waste
Drains and drainage
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Waste disposal
Systems shall be in place to ensure that waste materials areidentified, collected, removed and disposed of in a manner
which prevents contamination of products or production areas.
.
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Containers for waste and inedible or hazardous substances
shall be: a) clearly identified for their intended purpose;
b) located in a designated area;
c) constructed of impervious material which can be readily
cleaned and sanitized;
d) closed when not in immediate use;
e) locked where the waste may pose a risk to the product.
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Auditing ISO / TS 22002-1:2009
Waste management and removal
Provision shall be made for the segregation, storage and
removal of waste. Accumulation of waste shall not be allowed
in food-handling or storage areas. Removal frequencies shall
be managed to avoid accumulations, with a minimum dailyremoval.
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Labelled materials,
products or printed packaging
designated as waste shall be
disfigured or destroyed to ensure that trademarks cannot be reused.
Removal and destruction shall
be carried out by approved
disposal contractors.
The organization shall retain
records of destruction.
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EQUIPMENT SUITABILITY, CLEANING AND MAINTENANCE
Design and construction of food contact equipment
Hygienic design eg. Smooth, accessible, compatible with
intended products
Temperature control and monitoring equipment
Cleaning plant, utensils and equipment
Preventive and corrective maintenance
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Food contact equipment shall be designed and constructed
to facilitate cleaning, disinfection and maintenance.
Contact surfaces shall not affect, or be affected by, the
intended product or cleaning system. Food contact equipment
shall be constructed of durable materials able to resist
repeated cleaning.
Hygienic design Equipment shall be able to meet established
principles of hygienic design, including:
a) smooth, accessible, cleanable surfaces, self draining in wet
process areas;
b) use of materials compatible with intended products and
cleaning or flushing agents;
c) framework not penetrated by holes or nuts and bolts.
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ISO / TS 22002-1:2009
Temperature control and monitoring equipment
Equipment used for thermal processes shall be able to meet
the temperature gradient and holding conditions given in
relevant product specifications.
Equipment shall provide for the monitoring and control of the
temperature..
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ISO / TS 22002-1:2009
Cleaning plant, utensils and equipment. Wet and dry
cleaning programmes shall be documented to ensure that all
plant, utensils and equipment are cleaned at defined
frequencies. The programmes shall specify what is to be
cleaned (including drains), the responsibility, the method of
cleaning (e.g. CIP, COP), the use of dedicated cleaning tools,
removal or disassembly requirements and methods for verifying the effectiveness of the cleaning. .
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ISO / TS 22002-1:2009
Preventive and corrective maintenance
A preventive maintenance programme shall be in place.
The preventive maintenance programme shall include all
devices used to monitor and/or control food safety hazards.
Corrective maintenance shall be carried out in such a way that
production on adjoining lines or equipment is not at risk of
contamination.
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ISO / TS 22002-1:2009
Management of purchased materials
Selection and management of suppliers
Incoming material requirements
Inspection of incoming material
Nonconforming received materials
Identification, segregation and handling of purchased materials
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ISO / TS 22002-1:2009
MEASURES FOR PREVENTION OF CROSS CONTAMINATION
Microbiological cross contamination
Allergen management
Physical contamination
Chemical contamination
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ISO / TS 22002-1:2009
CLEANING AND SANITIZING
Cleaning and sanitizing agents and tools
Cleaning and sanitizing programmes
Cleaning in place (CIP) systems
Monitoring sanitation effectiveness
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ISO / TS 22002-1:2009
PEST CONTROL
Pest control programmes
Preventing access
Harborage and infestations
Monitoring and detection
Eradication
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ISO / TS 22002-1:2009
PERSONNEL HYGIENE AND EMPLOYESS FACILITIES
Adequate numbers, locations and means of hygienically
washing and drying
Adequate number of toilets
Not directly open into production
Changing facilities for personnel
Canteens and designated areas for food storage
Work wear and protective clothing
Health status
Illness and injuries
Personal cleanliness
Personal behavior
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ISO / TS 22002-1:2009
REWORK
Storage, identification and traceability
Segregation requirements for rework
Classification for rework
Rework usage – permissible incorporation
PRODUCT RECALL PROCEDURES
Recall requirements
System for identification, location and removal
Need for public warning
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ISO / TS 22002-1:2009
WAREHOUSING
Effective control of warehousing temperature, humidity and
environmental conditions
Proper stacking
Waste materials, lubricants, chemicals, cleaning materials and
pesticides stored separately
Vehicles, conveyances and containers
PRODUCT INFORMATION / CONSUMER AWARENESS
Proper presentation
Labeling of pre-packed food
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Industry supplier requirements: NutritionGenetically modified food, allergens labeling
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Industry supplier requirements: NutritionGenetically modified food, allergens labeling
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Nutrition information on processed foodsIf they choose to provide nutrition information it must be in
one of two formats
Front-of-pack labelling
• Traffic light labels on the front-of-packprovides information on high (red), medium (amber) or low (green) amounts of fat, saturated fat, sugars and salt.• The number of grams of fat, saturated fat, sugars and salt in what the manufacturer or retailer suggests as a ‘serving’ of the food though the criteria are per 100g
Format 2: ‘Big 4 and Little 4’Energy (kJ and kcal)Protein (g)Carbohydrate (g)of which: sugars (g)Fat (g)of which: saturates (g)Fibre (g)Sodium (g)
Format 1: ‘Big 4’Energy (kJ and kcal)Protein (g)Carbohydrate (g)Fat (g)
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Industry supplier requirements: NutritionGenetically modified food, allergens labeling
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Industry supplier requirements: NutritionGenetically modified food, allergens labeling
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Guideline Daily Amount (GDA)Guideline Daily Amounts (GDAs) are guidelines for healthy
adults and children on the approximate amount of calories,
fat, saturated fat, carbohydrate, total sugars, protein, fibre, salt
and sodium required for a healthy diet
GDAs are not targets for individuals to consume, but a
guideline or benchmark to help them make dietary choices
and balance their daily intake
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Industry supplier requirements: NutritionGenetically modified food, allergens labeling
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Industry supplier requirements: NutritionGenetically modified food, allergens labeling
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How do consumers react to nutrition labels? Conclusions from research in Europe
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New consumer trends
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Industry supplier requirements: NutritionGenetically modified food, allergens labeling
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Front of pack labelling evaluation research
• Research is to evaluate the impact of the various FOP nutritional signposting schemes on consumer knowledge and behaviour
• The coexistence of a range of FOP label formats causes difficulty for shoppers
• The strongest labels are those which include all of:
- Words ‘High/med/low’ +
- Traffic lights +
- %Guideline Daily Amount
BUT
• European Parliament failed to adopt traffic light labeling (June 2010)
• Quantities per 100g, GDAs and country of origin labeling
were approved
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Industry supplier requirements: NutritionGenetically modified food, allergens labeling
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Retailers & labelling systems
Different retailers and nutrition labelling systems.
Retailers Labelling systems
UK TescoSainsbury’sAsda
GDAColour coded traffic light (TL) levelsTL with GDA
France IntermarchéAuchan
Colour coded levels (not TL) and GDA, BOP GDA
Germany LidlReal
GDAGDA (energy only FOP)
Hungary Tesco, Interspar GDA
Poland Tesco, Real GDA
Sweden ICA, Coop, Axfood Health logo (keyhole) + GDA
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How do consumers react to nutrition labels? Conclusions from research in Europe
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New consumer trends Widespread interest in nutrition information
Consumers like the idea of simplified front of pack information
But differ in their ‘liking’ of different formats
Most consumers believe they understand the most common
graphic formats. Very little insight into how labelling
information is/will be used in real life.
85% average penetration of BOP nutrition information of any kind
48% average penetration of FOP nutrition information of any kind
BOP FOP
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How do consumers react to nutrition labels? Conclusions from research in Europe
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New consumer trends Did you look for any nutrition information on the packaging?
Less than 27% said they looked for nutrition information
� These figures are supported by respective respondents being able to
� name at least one nutrient and
� show where on the pack that info is found
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Industry supplier requirements: NutritionGenetically modified food, allergens labeling
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Industry supplier requirements: NutritionGenetically modified food, allergens labeling
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Industry supplier requirements: NutritionGenetically modified food, allergens labeling
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Industry supplier requirements: NutritionGenetically modified food, allergens labeling
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Auditing ISO / TS 22002-1:2009
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Industry supplier requirements: NutritionGenetically modified food, allergens labeling
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Industry supplier requirements: NutritionGenetically modified food, allergens labeling
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Industry supplier requirements: Genetically modified food
Q-Check 77Europe requires that all food that has any ingredient that is
more than 1% GM be labeled as “GM containing”.
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Industry supplier requirements: Genetically modified food
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Κ.Ν.Parinos
Auditing ISO / TS 22002-1:2009What Is Food Defense?
FOOD DEFENCE, BIOVIGILANCE AND TERROISIM
Assessment of hazards to products posed by potential acts of
sabotage, vandalism or terrorism. Access controls.
Food defense is not food safety. Food safety addresses
predictable and unintentional risks. Food safety is best
addressed through HACCP.
Food defense addresses intentional attacks on the safety or
quality of food. It is not well suited to HACCP.
Who Would Do This?
Terrorists or Activists, Competitors, Disgruntled employees
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Auditing ISO / TS 22002-1:2009Food Defense?
Why?
Anger over national, business, or personal differences
Seeking changes in culture, Seeking economic disruption
Seeking public fear, Seeking harm to others
Factors that increase risk:
Making large batches of food
Foods with short shelf lives
Uniformly mixed products
Products that reach key populations, Ease of access
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Auditing ISO / TS 22002-1:2009What Is Food Defense?
Αreas important
Management
Outside Security
Inside Security
Slaughter/Processing
Storage
Shipping/Receiving
Water, Ice, Ingredients
PersonnelQ-Check 81
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Auditing ISO / TS 22002-1:2009Food Defense?
Areas to Consider: Food Defense Management.
Do you have a food defense plan?
Is someone responsible?
Do you have related necessary plans, such as product
withdraw or recall and personnel emergency or evacuation
procedures?
Do you keep doors closed?
Do you have a fence?
Is there adequate lighting?
Do you control access by people and vehicles?
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Auditing ISO / TS 22002-1:2009What Is Food Defense?
Areas to Consider: Inside Defense Measures
Do you use surveillance?
Do you have alert systems?
Do you control access?
Do you take inventory?
Areas to Consider: Slaughter/Processing Measures
Are animals or batches or product exposed to tampering?
Are areas or equipment left unobserved?
Will employees report unusual situations?
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Auditing ISO / TS 22002-1:2009Food Defense?
Areas to Consider: Storage
Is access limited?
Is inventory maintained?
Can the impact of an attack be minimized?
Areas to Consider: Shipping and Receiving T
Are trailers sealed?
Are drivers identified and deliveries scheduled?
Are all vendors selected thoughtfully?
Are returned goods examined closely?
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Auditing ISO / TS 22002-1:2009What Is Food Defense?
Areas to Consider: Water, Ice, and Ingredients.
Are water lines secure?
Is ice-making equipment protected?
Are all bulk ingredients protected when not in use?
Areas to Consider: Mail
Is mail opened away from other areas?
Are procedures understood for handling suspect mail
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Auditing ISO / TS 22002-1:2009Food Defense?
Areas to Consider: Personnel
Are background checks completed?
Are personnel supervised?
Are employees trained?
Are lockers inspected?
Are cameras allowed?
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Auditing ISO / TS 22002-1:2009CARVER Food Defense?
C—Criticality
A—Accessibility
R—Recuperability
V—Vulnerability
E—Effect
R—Recognizability
SHOCK
How deeply would an attack impact people?
Employees/community/nation, Symbolism/history
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Κ.Ν.Παρινός Q-Check 88
The role of certification bodies in auditing Prerequisite programmes in the food industry
sector, according to ISO 22000 / TS 22002-1:2009 (Prerequisite programmes on food
safety — Part 1: Food manufacturing).
New consumer trends, certifications and industry internal auditing protocols deriving
from Nutrition, Genetically modified food, allergens labeling and food defense issues
Konstantinos Parinos
Lead Auditor Q-Check
Veterinarian, DVM, Chemist , Μ.Sc.
Q-Check 89