Konstantinos Parinos Lead Auditor Q-Check Veterinarian, DVM, Chemist, Μ.Sc. Q-Check 1

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 1

ISO / TS 22002-1:2009 Q-Check 2

ISO / TS 22002-1:2009 Q-Check 3

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 4

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GFSI Guide Eurepgap BRC-IoP Nestlé NQS DS 3027 FAMI-QS Friesland Coberco FSS BRC-Food M&S system GMO Aldi system ISO 9001 GMP standard for Corrugated & Solid Board SQF ISO 14001 Dutch HACCP Waiterose system McDonalds system Kraft food system GMP EFSIS IFS AG 9000 GTP Irish HACCP Q-Check 6

Audit System Terms and Acronyms CAC/RCP ISO ANSI GFSI IFC GMP/GRP FSMS BRC SQFI GMA-Safe 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) Q-Check 7

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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 TS 22002-1 ISO / TS 22002-1:2009 9

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 TS 22002-1 ISO / TS 22002-1:2009 10

BS PAS 220: 2008 ISO / TS 22002-1:2009) ISO 22000 TS 22002-1 Q-Check 11

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 Q-Check 12

ISO / TS 22002-1:2009 Auditing ISO / TS 22002-1:2009 Prerequisite programmes ISO 22000 TS 22002-1 Q-Check 13

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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; Q-Check 15

f) management of purchased materials; g) measures for the prevention of cross-contamination; h) cleaning and sanitizing; i) pest control; j) personnel hygiene. Q-Check 16

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. Q-Check 17

DESIGN Buildings, Internal layout Movement patterns Openings Walls, floors, drains, ceilings and overhead fixtures Equipment Laboratory Storage areas Distribution of utilities Q-Check 18

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. Q-Check 19

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. Q-Check 20

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. Q-Check 21

Floors shall be designed to avoid standing water. In wet process areas, floors shall be sealed and drained. Drains shall be trapped and covered. Q-Check 22

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. Q-Check 23

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. Κ.Ν.Παρινός a Cert Ευρωπαϊκός Οργανισµός Πιστοποίησης Α.Ε. Q-Check 24

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. Q-Check 25

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. Q-Check 26

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. Q-Check 27

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.. Q-Check 28

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. Q-Check 29

A separate, secure (locked or otherwise access controlled) storage area shall be provided for cleaning materials, chemicals and other hazardous substances. Q-Check 30

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 Q-Check 31

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. Q-Check 32

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.. Q-Check 33

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. Q-Check 34

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. Q-Check 35

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. Κ.Ν.Παρινός Q-Check 36

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. Q-Check 37

Ventilation (natural or mechanical) shall be provided to remove excess or unwanted steam, dust and odours, and to facilitate drying after wet cleaning. Q-Check 38

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. Κ.Ν.Παρινός a Cert Ευρωπαϊκός Οργανισµός Πιστοποίησης Α.Ε. Q-Check 39

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.. Q-Check 40

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. Q-Check 41

WASTE DISPOSAL Auditing ISO / TS 22002-1:2009 Identification, collection and disposal of waste materials Appropriate containers for waste Segregation and storage of waste Drains and drainage Κ.Ν.Παρινός Q-Check 42

Waste disposal Auditing ISO / TS 22002-1:2009 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.. Κ.Ν.Παρινός Q-Check 43

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. a Cert Ευρωπαϊκός Οργανισµός Πιστοποίησης Α.Ε. Q-Check 44

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. Κ.Ν.Παρινός Q-Check 45

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. Q-Check 46

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 Q-Check 47

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. Q-Check 48

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.. Κ.Ν.Παρινός a Cert Ευρωπαϊκός Οργανισµός Πιστοποίησης Α.Ε. Q-Check 49

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.. Κ.Ν.Παρινός a Cert Ευρωπαϊκός Οργανισµός Πιστοποίησης Α.Ε. Q-Check 50

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. Κ.Ν.Παρινός Q-Check 51

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 Κ.Ν.Παρινός Q-Check 52

ISO / TS 22002-1:2009 MEASURES FOR PREVENTION OF CROSS CONTAMINATION Microbiological cross contamination Allergen management Physical contamination Chemical contamination Κ.Ν.Παρινός Q-Check 53

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 Κ.Ν.Παρινός Q-Check 54

ISO / TS 22002-1:2009 PEST CONTROL Pest control programmes Preventing access Harborage and infestations Monitoring and detection Eradication Κ.Ν.Παρινός Q-Check 55

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 Κ.Ν.Παρινός Q-Check 56

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 Κ.Ν.Παρινός Q-Check 57

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 Κ.Ν.Παρινός Q-Check 58

Industry supplier requirements: Nutrition Genetically modified food, allergens labeling Q-Check 59

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 one of two formats Format 1: Big 4 Energy (kj and kcal) Protein (g) (g) (g) Front-of-pack labelling Carbohydrate Traffic light labels on the front-of-pack Fat provides information on high (red), medium (amber) or low (green) amounts of fat, saturated fat, sugars and salt. Energy Protein The number of grams of fat, Carbohydrate saturated fat, sugars and salt in of which: sugars what the manufacturer or retailer Fat of which: saturates suggests as a serving of the food Fibre though the criteria are per 100g Format 2: Big 4 and Little 4 (kj and kcal) (g) (g) (g) (g) (g) (g) Sodium (g) Q-Check 60

Industry supplier requirements: Nutrition Genetically modified food, allergens labeling Q-Check 61

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 Q-Check 62

Industry supplier requirements: Nutrition Genetically modified food, allergens labeling Q-Check 63

Industry supplier requirements: Nutrition Genetically modified food, allergens labeling Q-Check 64

How do consumers react to nutrition labels? Conclusions from research in Europe New consumer trends Q-Check 65

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 Q-Check 66

Industry supplier requirements: Nutrition Genetically modified food, allergens labeling Retailers & labelling systems Different retailers and nutrition labelling systems. UK France Germany Retailers Tesco Sainsbury s Asda Intermarché Auchan Lidl Real Hungary Tesco, Interspar GDA Poland Tesco, Real GDA Labelling systems GDA Colour coded traffic light (TL) levels TL with GDA Colour coded levels (not TL) and GDA, BOP GDA GDA GDA (energy only FOP) Sweden ICA, Coop, Axfood Health logo (keyhole) + GDA Q-Check 67

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 FOP 85% average penetration of BOP nutrition Q-Check information of any kind 68 48% average penetration of FOP nutrition information of any kind

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 Q-Check 69

Industry supplier requirements: Nutrition Genetically modified food, allergens labeling Q-Check 70

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Industry supplier requirements: Nutrition Genetically modified food, allergens labeling Q-Check 73

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Industry supplier requirements: Genetically modified food Europe requires that all food that has any ingredient that is more than 1% GM be labeled as GM containing. Q-Check 77

Industry supplier requirements: Genetically modified food Q-Check 78

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 Q-Check 79

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 Q-Check 80

Αreas important Management Outside Security Inside Security Slaughter/Processing Storage Shipping/Receiving Water, Ice, Ingredients Mail Auditing ISO / TS 22002-1:2009 What Is Food Defense? Personnel Q-Check 81

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? Q-Check 82

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? Q-Check 83

Areas to Consider: Storage Is access limited? Is inventory maintained? Auditing ISO / TS 22002-1:2009 Food Defense? 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? Q-Check 84

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 Q-Check 85

Food Defense? Areas to Consider: Personnel Are background checks completed? Are personnel supervised? Are employees trained? Are lockers inspected? Are cameras allowed? Q-Check 86

CARVER 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 Q-Check 87

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