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The role of certification bodies in auditing

Prerequisite programmes in the food industry


sector, according to ISO 22000 / TS 220021:2009 (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 , .Sc.
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ISO / TS 22002-1:2009

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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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Auditing ISO / TS 22002-1:2009

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Auditing ISO / TS 22002-1:2009


DS 3027

GFSI
Guide
Eurepgap

ISO 9001

FAMI-QS

Waiterose
system

IFS

GMP standard for Corrugated &


Solid Board

Friesland Coberco FSS

BRC-Food

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EFSIS

ISO 14001

M&S system

BRC-IoP

Nestl NQS

Kraft food system

Aldi system

GMO

AG 9000

Dutch HACCP

SQF

GMP

McDonalds system

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GTP

Irish HACCP
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Auditing ISO / TS 22002-1:2009

Audit System Terms and Acronyms


CAC/RCP
ISO
ANSI
GFSI
IFC
GMP/GRP
FSMS
BRC
SQFI
GMA-Safe
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Codex Alimentarius Commission/


Recommended International Code of Practice
International Organization for Standardization
American National Standards Institute
Global Food Safety Initiative
International Food Standard
Good Manufacturing/Retail Practice
Food Safety Management System
British Retail Consortium
Safe Quality Foods Institute
Supplier Assessments For Food Excellence
Grocery Manufacturers Association (2001)
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This Technical Specification is intended to be used to support
management systems designed to meet the requirements
specified in ISO 22000:2005, and sets out the detailed
requirements for those programmes.

This Technical Specification does not duplicate requirements


given in ISO 22000:2005 and is intended to be used in
conjunction with ISO 22000:2005.

ISO 22000
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TS 22002-1

ISO / TS 22002-1:2009

Auditing ISO / TS 22002-1:2009


Food manufacturing operations are diverse in nature and not
all of the requirements specified in this Technical
Specification apply to an individual establishment or
process.
Role of the auditor and the certification body.
This Technical Specification is applicable to all
organizations, 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 22000
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TS 22002-1

ISO / TS 22002-1:2009

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Auditing ISO / TS 22002-1:2009

BS PAS 220: 2008

ISO / TS 22002-1:2009)

ISO 22000
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TS 22002-1
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Auditing ISO / TS 22002-1:2009


Prerequisite programmes
When selecting and/or establishing PRPs 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
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TS 22002-1
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Auditing ISO / TS 22002-1:2009


ISO / TS 22002-1:2009

Prerequisite
programmes

ISO 22000
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Auditing ISO / TS 22002-1:2009

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Auditing ISO / TS 22002-1:2009


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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Auditing ISO / TS 22002-1:2009


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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Auditing ISO / TS 22002-1:2009


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 logical
flow 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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Auditing ISO / TS 22002-1:2009


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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Auditing ISO / TS 22002-1:2009


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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Auditing ISO / TS 22002-1:2009


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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Auditing ISO / TS 22002-1:2009


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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Auditing ISO / TS 22002-1:2009


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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Auditing ISO / TS 22002-1:2009


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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Auditing ISO / TS 22002-1:2009


All materials and products shall be stored off the floor and
with sufficient space between the material and the walls
to 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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Auditing ISO / TS 22002-1:2009


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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Auditing ISO / TS 22002-1:2009


UTILITIES AIR, WATER, ENERGY

Sufficient supply of potable water


Boiler chemical approved
Established requirements for filtration, humidity and
microbiological specifications for air used as an
ingredient or in direct contact with food
Compressed air
Adequate lighting to enable operation in a hygienic
manner
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Auditing ISO / TS 22002-1:2009


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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Auditing ISO / TS 22002-1:2009


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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Auditing ISO / TS 22002-1:2009


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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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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Auditing ISO / TS 22002-1:2009


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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Auditing ISO / TS 22002-1:2009


Compressed air, carbon dioxide, nitrogen and other gas
systems 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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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 are
identified, collected, removed and disposed of in a manner
which prevents contamination of products or production areas.
.

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Auditing ISO / TS 22002-1:2009


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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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 daily
removal.

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Auditing ISO / TS 22002-1:2009


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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Auditing ISO / TS 22002-1:2009


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: Nutrition


Genetically modified food, allergens labeling

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Industry supplier requirements: Nutrition


Genetically modified food, allergens labeling
Nutrition information on processed foods
If they choose to provide nutrition information it must be in
Format 1: Big 4
one of two formats

Energy (kJ and kcal)


Protein
(g)
Carbohydrate (g)
Fat
(g)

Front-of-pack labelling
Traffic light labels on the front-of-pack
provides information on high (red), medium (amber) or
low (green) amounts of fat,
Format 2: Big 4 and Little 4
Energy
(kJ and kcal)
saturated fat, sugars and salt.
Protein
(g)
The number of grams of fat,
Carbohydrate
(g)
saturated fat, sugars and salt in
of which: sugars
(g)
Fat
(g)
what the manufacturer or retailer
which: saturates
(g)
suggests as a serving of the food of
Fibre
(g)
though the criteria are per 100g
Sodium
(g)
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Industry supplier requirements: Nutrition


Genetically modified food, allergens labeling

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Industry supplier requirements: Nutrition


Genetically modified food, allergens labeling
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: Nutrition


Genetically modified food, allergens labeling

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Industry supplier requirements: Nutrition


Genetically modified food, allergens labeling

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How do consumers react to nutrition labels?


Conclusions from research in Europe
New consumer trends

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Industry supplier requirements: Nutrition


Genetically modified food, allergens labeling
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: Nutrition


Genetically modified food, allergens labeling
Retailers & labelling systems
Different retailers and nutrition labelling systems.
Retailers

Labelling systems

UK

Tesco
Sainsburys
Asda

GDA
Colour coded traffic light (TL) levels
TL with GDA

France

Intermarch
Auchan

Colour coded levels (not TL) and GDA,


BOP
GDA

Germany

Lidl
Real

GDA
GDA (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
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.
BOP

85% average penetration of BOP nutritionQ-Check


information of any kind

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48% average penetration of FOP nutrition information of any kind

FOP

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How do consumers react to nutrition labels?


Conclusions from research in Europe
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: Nutrition


Genetically modified food, allergens labeling

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Industry supplier requirements: Nutrition


Genetically modified food, allergens labeling

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Industry supplier requirements: Nutrition


Genetically modified food, allergens labeling

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Industry supplier requirements: Nutrition


Genetically modified food, allergens labeling

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Auditing ISO / TS 22002-1:2009

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Industry supplier requirements: Nutrition


Genetically modified food, allergens labeling

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Industry supplier requirements: Nutrition


Genetically modified food, allergens labeling

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Industry supplier requirements:


Genetically modified food

Europe requires that all food that has any ingredient that is
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more than 1% GM be labeled as GM containing.

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Industry supplier requirements:


Genetically modified food

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Auditing ISO / TS 22002-1:2009


What 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 22002-1:2009


Food 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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What Is Food Defense?
reas important
Management
Outside Security
Inside Security
Slaughter/Processing
Storage
Shipping/Receiving
Water, Ice, Ingredients
Mail
Personnel
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Food 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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What 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 22002-1:2009


Food 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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What 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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Food 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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CARVER Food Defense?
CCriticality
AAccessibility
RRecuperability
VVulnerability
EEffect
RRecognizability
SHOCK
How deeply would an attack impact people?
Employees/community/nation, Symbolism/history
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The role of certification bodies in auditing


Prerequisite programmes in the food industry
sector, according to ISO 22000 / TS 220021:2009 (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 , .Sc.
Q-Check

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