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
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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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DS 3027
M&S system FAMI-QS Aldi system

GFSI Guide
Eurepgap

Kraft food system EFSIS

ISO 14001
Waiterose system

ISO 9001

BRC-IoP
BRC-Food
Nestl NQS
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GMP standard for Corrugated & Solid Board

IFS
AG 9000

Friesland Coberco FSS

Dutch HACCP

SQF

GMP

GTP
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GMO

McDonalds system

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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Auditing ISO / TS 22002-1:2009 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.

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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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ISO / TS 22002-1:2009

Auditing ISO / TS 22002-1:2009

BS PAS 220: 2008

ISO / TS 22002-1:2009)

ISO 22000
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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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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 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) j) pest control; 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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Auditing ISO / TS 22002-1:2009 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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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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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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Auditing ISO / TS 22002-1:2009 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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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 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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Auditing ISO / TS 22002-1:2009 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

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 (g) suggests as a serving of the food of which: saturates Fibre (g) though the criteria are per 100g Sodium (g)
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Energy (kJ and kcal) Protein (g) Carbohydrate (g) Fat (g)

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
UK Tesco Sainsburys Asda Intermarch Auchan Lidl Real Tesco, Interspar Tesco, Real ICA, Coop, Axfood

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) GDA GDA Health logo (keyhole) + GDA

France

Germany Hungary Poland Sweden

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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 FOP

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

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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

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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 Q-Check ..Parinos 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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Auditing ISO / TS 22002-1:2009 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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Auditing ISO / TS 22002-1:2009 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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Auditing ISO / TS 22002-1:2009 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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Auditing ISO / TS 22002-1:2009 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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Auditing ISO / TS 22002-1:2009 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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Auditing ISO / TS 22002-1:2009 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.
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