food safety and product quality control

RUDECO Vocational Training in Rural Development and Ecology

Module № 11

FOOD SAFETY AND PRODUCT QUALITY

CONTROL

Responsible University

Moscow State Agroengineering University named after Goryachkin V.P.

159357-TEMPUS-1-2009-1-DE-TEMPUS-JPHES This project has been funded with support from the European Commission. This publication reflects the views only of the authors, and the Commission cannot be held responsible for any use which may be made of the information contained therein.

УДК 641.1 ББК 51.23 Ф94 ISBN 978-5-906069-82-5 Food safety and quality control: Training matherials / V.V. Karpuzov [and others]. Series of training man-uals "RUDECO Vocational Training in Rural Development and Ecology“. М., 2012. – 212 p.

RUDECO Vocational Training in Rural Development and Ecology National Project Coordinator Sustainable Rural Development Center Russian State Agrarian University - Moscow Timiryazev Agricultural Academy, Russia Grant holder and Project Management Eastern Europe Centre University of Hohenheim, Germany

Authors

Vasiliy Karpuzov Ivan Krivchansky Svetlana Okrut Olga Panteleeva

Responsible University

Moscow State Agroengineering University named after Goryachkin V.P.

Working Group Partners

Kostroma State Agrarian Academy Stavropol State Agrarian University AgroSup (France)

Reviewer

Galina Yusupova, Doctor of Agricultural Sciences, Professor Anna Veber, Candidate of Technical Sciences, Docent

Contact

This text book or parts of it can be reproduced in any form for educational purposes with prior permission. For more information contact Professor Valeriy Chumakov Office for International Programs MSAU [email protected]

November 2012

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Preface

The present guide is one of the series of the guides that were developed within the frame-work of the project TEMPUS 159357-TEMPUS-1-2009-1-DE-TEMPUS-JPHES “Vocational Training in Rural Development and Ecology” (RUDECO) under TEMPUS programme.

The project RUDECO aims to improve the vocational training system in the sphere of rural development and ecology and involves various agricultural universities in Russia and Europe. The project goal is to facilitate the universities in acquiring the necessary qualifications by means of conceptualization and development of study guides (modules), as well as by training the instructors who will participate in the vocational training of governmental employees.

The project goals are:

- Development of the vocational training system in the sphere of ecology and rural areas at 11 agrarian universities of Russia, enabling them to obtain a higher qualification;

- Development of 12 modules for representatives of governmental agencies on the national, regional and local level;

- Training of the representatives of Russian public institutions and representatives of public administration of various levels in the sphere of ecology and rural development using pro-fessional training from certified instructors;

- Implementing «training for trainers» using the support of European partners;

- Development of international cooperation of Russian institutions of higher education.

The series of modules covers the following topics:

- Sustainable development: key terms and theoretical basis (Introductory Module1, Rus-sian State Agrarian University – Moscow Timiryazev Agricultural Academy)

- Sustainable rural development: approaches for regional and local programmes elabo-ration (Module 2, Russian State Agrarian University – Moscow Timiryazev Agricultural Academy)

- Ecolabeling and marketing of environmental and regional products from rural areas (Module 3, Orel State Agrarian University)

- Eco-tourism and tourism in rural areas (Module 4, Buryat State Agrarian Academy of Agriculture named after V.R.Philippov)

- Conversion of conventional farming into organic farming (Module 5, Yaroslavl State Agricultural Academy)

- Environmental regulations and laws (Module 6, Stavropol State Agricultural University)

- Ecological related problems of intensive agriculture (plant and animal production) (Module 7, Omsk State Agrarian University)

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- Participatory approach in rural development (Module 8, Kostroma State Agricultural Academy)

- Reducing pollution in rural areas caused by agricultural, industrial and municipal solid waste (Module 9, Novosibirsk State Agrarian University)

- Sustainable use of water resources in rural areas (Module 10, Samara State Agricultural Academy)

- Food safety and product quality control (Module 11, Moscow State Agroengineering University named after Goryachkin V.P.)

- Management of biological resources of rural areas (Module 12, Tambov State University named after G.R. Derzhavin)

The introducing module on the key terms and theoretical basis of sustainable development basis is an ideal preparation for all the above listed specific modules. Persons who start to get in-volved in the field of ecology and sustainable rural development, we recommend to read this basic module first, before deepening one of the other topics. Readers interested in the modules and further training can address also all involved university partners to get further information or training about the listed modules.

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Contents Preface ............................................. ................................................................................................................3

Contents........................................... ................................................................................................................5

List of figures .................................... ..............................................................................................................7

List of tables ..................................... .............................................................................................................10

Introduction ....................................... ............................................................................................................12

1 Food safety legislation............................ .............................................................................................14

1.1 National safety concept of the Russian Federation in the area of product and services quality. Food Safety Doctrine .......................................................................................................................................14

1.2 Russian national food safety laws ..........................................................................................................18

1.3 Administrative, civil and criminal liability for food safety .........................................................................25

1.4 Harmonization of legislative and other legal acts in modern conditions .................................................28

1.5 Control questions to chapter 1................................................................................................................33

1.6 Summary ................................................................................................................................................33

2 International activity in the context of food safet y............................................................................36

2.1 International organizations activity in context of food safety...................................................................36

2.2 Food raw material and food safety in the EU countries ..........................................................................39

2.3 Food safety ensuring system in France..................................................................................................44

2.4 Food safety ensuring experience in Germany........................................................................................55


2.6 Summary ................................................................................................................................................58

3 Food safety ensuring development in the Russian Fe deration ........................................... ...........60

3.1 Regulation methods for the goods and services market.........................................................................60

3.2 Technical standards and technical regulation.........................................................................................62

3.3 Technical regulation system modernization............................................................................................66

3.4 National and regional competitions and awards in the context of production quality..............................73


3.6 Summary ................................................................................................................................................79

4 Quality Management Systems on the basis of ISO 9000 series............................................. .........82

4.1 History and importance of international system of ISO 9000..................................................................82

4.2 QMS structure and primary elements.....................................................................................................84

4.3 QMS development stages ......................................................................................................................87

4.4 QMS implementation and certification....................................................................................................91

4.5 Control questions to chapter 4..............................................................................................................100

4.6 Summary ..............................................................................................................................................100

5 Environmental Management Systems on the basis of ISO 1 4000 series ......................................10 2

5.1 Environmental management system (EMS) development....................................................................102

5.2 EMS standards system.........................................................................................................................104

5.3 EMS organizational structure and documentation establishing ............................................................108

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5.4 EMS implementation and certification ..................................................................................................112


5.6 Summary ..............................................................................................................................................117

6 Food Quality Management System on the basic of HACCP and ISO 22000..................................119

6.1 HACCP principles .................................................................................................................................119

6.2 HACCP process flow diagram and worksheet ......................................................................................121

6.3 Supply chains importance for safety ensuring ......................................................................................123

6.4 Systems on the basis of ISO 22000 .....................................................................................................126


6.6 Summary ..............................................................................................................................................130

7 Conformity assessment .............................. .......................................................................................132

7.1 Russian National Certification System and its modernization...............................................................132

7.2 Obligatory and Voluntary conformity assessment.................................................................................138

7.3 Food products and raw materials Certification and Declaration ...........................................................144

7.4 Food products environmental certification and environmental marking................................................153


7.6 Summary ..............................................................................................................................................160

8 Quality control and product test ................... ....................................................................................162

8.1 State food quality control and inspection ..............................................................................................162

8.2 Classification of technical control types ................................................................................................167

8.3 Product tests in quality assessment and certification ...........................................................................169

8.4 Quality control development in the company and in the region ............................................................173


8.6 Summary ..............................................................................................................................................177

9 Regional product development and producing ......... ......................................................................180

10 Development of a Quality Management System.......... ....................................................................183

11 Development of documents on product declaration and quality systems certification ..............187

12 Development and arrangement of the regional compet ition “quality leader” ............................. 192

Test tasks......................................... ............................................................................................................193

References ......................................... ..........................................................................................................200

Glossary ........................................... ............................................................................................................201

Training material .................................. .......................................................................................................206

Visual aids......................................... ...........................................................................................................206

RUDECO partners and contact information............ ..................................................................................207

Basic partners and experts ......................... ...............................................................................................211

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List of figures Fig. 1.1 The indexes system for food safety level evaluation ..................................................................16

Fig. 1.2 The National Law No. 29-ФЗ structure .......................................................................................19

Fig. 1.3 State regulations for food products quality and safety ................................................................22

Fig. 1.4 Sanitary and epidemiological safety principles ...........................................................................24

Fig. 1.5 Technical standard “On food safety” structure............................................................................30

Fig. 2.1 Conformity mark to New Approach Directives ............................................................................37

Fig. 2.2 IFS requirements structure .........................................................................................................38

Fig. 2.3 The EU technical legislation scheme ..........................................................................................39

Fig. 2.4 The EU legislative system structure............................................................................................40

Fig. 2.5 The EU food legislation structure................................................................................................40

Fig. 2.6 Regulation No. 178/2002/EC of January 28, 2002 Aims.............................................................42

Fig. 2.7 General principles of Regulation 178/2002/EC on food safety ...................................................42

Fig. 2.8 Typical rural landscape of Burgundy...........................................................................................45

Fig. 2.9 Cattle farm of Mr. Pikar in Burgundy...........................................................................................45

Fig. 2.10 Mare machine-milking on the farm Semur-Shation.....................................................................46

Fig. 2.11 Vineyards in Morvan national park..............................................................................................46

Fig. 2.12 Henry Wezlee Wine Factory .......................................................................................................47

Fig. 2.13 Cheese production Gaugry .........................................................................................................48

Fig. 2.14 Essential parties of food safety ensuring in France ....................................................................49

Fig. 2.15 Food safety regulation levels in France ......................................................................................50

Fig. 2.16 Block-chart possible variants (a, b, c) of activities of Departmental Directorates for the Population Protection in France..................................................................................................52

Fig. 2.17 Logos of official food quality labels .............................................................................................54

Fig. 2.18 Food safety ensuring system in Germany...................................................................................57

Fig. 3.1 Regulation subjects and methods according to information type................................................61

Fig. 3.2 Regulation measures according to regulation methods..............................................................61

Fig. 3.3 Technical standards classification by the way of requirements definition ...................................62

Fig. 3.4 Technical standards classification by the field of application ......................................................63

Fig. 3.5 Technical regulation components. ..............................................................................................64

Fig. 3.6 Basic modernization tends of technical regulation system in the Custom Union countries ........68

Fig. 3.7 Unitary sign image of production distribution throughout the CU countries market ....................71

Fig. 3.8 100 Best Goods of Russia logo ..................................................................................................74

Fig. 3.9 Narodnaya Marka logo................................................................................................................74

Fig. 3.10 All-Russian food exhibition Pokupayte Rossiyskoe! logo............................................................75

Fig. 3.11 “III millennium” sign.....................................................................................................................75

Fig. 3.12 The Russian Federation Government Quality Award model.......................................................76

Fig. 3.13 Emblem of the Russian Federation Government Production Quality Award ..............................77

Fig. 4.1 Concerned parties benefits due to QMS implementation............................................................82

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Fig. 4.2 ISO 9000 series standards progress...........................................................................................83

Fig. 4.3 Product life cycle typical periods (quality loop) ...........................................................................85

Fig. 4.4 QMS model based on process approach....................................................................................86

Fig. 4.5 QMS development stages...........................................................................................................88

Fig. 4.6 Processes classification..............................................................................................................89

Fig. 4.7 Structural chart of Russky Chleb (Russian Bread) LTD QMS.....................................................92

Fig. 4.8 Functional chart of Russky Chleb (Russian Bread) LTD QMS....................................................93

Fig. 4.9 Documentation levels by GOST R ISO 9001–2008 ....................................................................94

Fig. 4.10 Canning factory documentation ..................................................................................................95

Fig. 4.11 Typical audit procedures.............................................................................................................97

Fig. 4.12 Organizational structure of Register quality systems ..................................................................98

Fig. 4.13 Conformity mark of Register Quality Systems ............................................................................98

Fig. 5.1 Chart of the environmental protection world development ........................................................102

Fig. 5.2 Connection between company activity and environment impacts.............................................103

Fig. 5.3 Interaction between requirements to a product and possible environmental impacts at any stage of a product lifecycle .................................................................................................................105

Fig. 5.4 ISO 14000 series standards complex structure ........................................................................106

Fig. 5.5 EMS model according to GOST R ISO 14001-2007.................................................................107

Fig. 5.6 EMS development stages .........................................................................................................109

Fig. 5.7 Flow-chart of EMS activities arrangement ...............................................................................110

Fig. 6.1 The HACCP system conformity sign.........................................................................................121

Fig. 6.2 The example of production process flow diagram.....................................................................122

Fig. 6.3 HACCP worksheet ....................................................................................................................122

Fig. 6.4 Food safety traceability .............................................................................................................124

Fig. 6.5 Information sharing in food production chain ............................................................................125

Fig. 6.6 A flow-chart of social survey on product and services quality and safety in the chain “from Stable to Table”.........................................................................................................................126

Fig. 7.1 Russian National Certification System structure .......................................................................134

Fig. 7.2 Typical structure of homogenous products certification system................................................135

Fig. 7.3 Organizational arrangement of GOST R certification system ...................................................137

Fig. 7.4 Conformity assessment forms...................................................................................................138

Fig. 7.5 Conformity assessment forms classification .............................................................................139

Fig. 7.6 Obligatory safety requirements structure ..................................................................................139

Fig. 7.7 Declaring schemes (according to law “On technical regulation”) ..............................................141

Fig. 7.8 Market circulation mark logo .....................................................................................................141

Fig. 7.9 GOST R certification system conformity mark ..........................................................................147

Fig. 7.10 Application form for a product certification ...............................................................................150

Fig. 7.11 Application form for registration of a conformity declaration .....................................................151

Fig. 7.12 Control types of environmental management ...........................................................................153

Fig. 7.13 Main objectives of environmental certification...........................................................................154

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Fig. 7.14 Obligatory certification system conformity mark based on environmental requirements ..........155

Fig. 7.15 Environmental norms structure .................................................................................................156

Fig. 7.16 International ecolabels ..............................................................................................................158

Fig. 8.1 Food safety estimation technology ...........................................................................................162

Fig. 8.2 Extraneous harmful substances in food....................................................................................163

Fig. 8.3 Control and inspection arrangements on quality and food safety .............................................164

Fig. 8.4 Inspecting authorities possible solutions in case of production nonconformity to safety requirements.............................................................................................................................165

Fig. 8.5 State control (inspection) authorities powers ............................................................................166

Fig. 8.6 Typical structure of TCD in food company................................................................................169

Fig. 8.7 Certification tests structure .......................................................................................................170

Fig. 8.8 Certification tests sample form..................................................................................................171

Fig. 8.9 General scheme of regional bodies interactions in development and implementation of regional quality politics ...........................................................................................................................175

Fig. 10.1 Employees responsibilities and powers matrix of JSC Dairy plant form ...................................186

Fig. 11.1 Declaration of conformity form..................................................................................................189

Fig. 11.2 Application form for QMS certification.......................................................................................190

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List of tables Table 1.1 Domestic products share in total commodity resources..............................................................17

Table 1.2 The Custom Union primary technical standards concerning food products raw materials (schedule fragment approved by the CU Committee Decision No. 492 dated December 8, 2010) .....................................................................................................................29

Table 2.1 General structure of the legislative EU acts applied in France....................................................48

Table 3.1 Adopted food technical standards...............................................................................................63

Table 3.2 Objectives and scope of the Russian technical regulation system modernization ......................67

Table 3.3 Work amount on different types of conformity assessment in Russian Standardization system in 2010 ............................................................................................................................................67

Table 3.4 Basic normative documents for the CU technical regulation system development.....................69

Table 3.5 Сertification authorities and testing laboratories assigned in the CU unified Register ................71

Table 3.6 Conformity assessment forms in he Russian Federation before transition period completion....72

Table 4.1 Company interested parties ........................................................................................................84

Table 4.2 QMS development planning form................................................................................................88

Table 4.3 QMS implementation calendar plan-schedule ............................................................................88

Table 4.4 Specification of small organization standards (STO) ..................................................................90

Table 4.5 Form for company internal audit schedule ..................................................................................96

Table 5.1 Main types of environmental agricultural contaminants and their possible risks.......................103

Table 5.2 Main national standards of environmental management systems ............................................106

Table 5.3 Essential principles of EMS development .................................................................................108

Table 5.4 Company environment-oriented documentation classification..................................................110

Table 5.5 Environmental management system processes .......................................................................111

Table 5.6 EMS implementation order........................................................................................................112

Table 5.7 Environment-oriented activities .................................................................................................114

Table 5.8 Environmental requirements register form ................................................................................115

Table 5.9 Responsibility assignment for environmental requirements revealing ......................................116

Table 5.10 Responsibility assignment for monitoring of normative documents creation.............................116

Table 7.1 Russian Federation obligatory certification basic systems (as on January, 1, 2011)................134

Table 7.2 Normative by-laws of federal level regulating conformity assessment rules and order.............136

Table 7.3 Basic differences between two forms of conformity assessment ..............................................140

Table 7.4 Product certification schemes applied before transitional period end .......................................142

Table 7.5 Recommended declaration schemes (by R 50.1.046-2003) .....................................................143

Table 7.6 Recommended certification schemes (by R 50.1.046–2003)....................................................144

Table 7.7 Extract from “Information on production requiring obligatory conformity assessment (in conformity declaration form) indicating the normative documents establishing the obligatory requirements” Nomenclature 2..................................................................................................145

Table 7.8 Product certification procedure .................................................................................................146

Table 7.9 Classification of homogenous food groups in conformity assessment......................................148

Table 7.10 Realization stages of obligatory and voluntary environmental certification ...............................156

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Table 7.11 Ecolabels applied in the Russian Federation............................................................................158

Table 8.1 Contaminants which are subject to control in various food and foodstuff raw materials groups163

Table 8.2 Product quality control types.....................................................................................................168

Table 8.3 Control tests schedule ..............................................................................................................173

Table 8.4 Extract from Production Control Program of a food company...................................................174

Table 9.1 Plan form of a regional food product development and producing............................................182

Table 10.1 Tasks variants on chapter 10....................................................................................................183

Table 10.2 A sample list of QMS standards of an organization ..................................................................184

Table 11.1 Practical tasks variants on “Development of documents on product declaration and quality systems certification” chapter” ..................................................................................................187

Table 11.2 Information on products requiring obligatory conformity assessment (in declaration of conformity form) (fragment) ........................................................................................................................188

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Introduction

The aim of the module Food Safety and Product Quality Control is to provide informa-tion about food safety ensuring, quality control and conformity assessment of agricultural produc-tion, as well as about development and certification of quality management systems and environ-mental management systems in the company and in the region.

The aim includes the following objectives:

- to study the legal basis of food safety ensuring; - to study the international policy in the area of food safety ensuring; - to study the development of food safety ensuring in the Russian Federation; - to learn the application methods of food safety ensuring development in the company and in

the region; - to learn the application ways of quality systems introduction and certification in the com-

pany and in the region based on ISO 9000, HACCP principles, ISO 22000 and ecological management systems;

- to understand the concepts of the national certification system, the state system of food safety and quality control, inspection, certification and declaration.

The required basic knowledge: higher humanitarian or agricultural education. Job experi-ence of regional or municipal administration is desirable.

At the module completion you will understand the following aspects: the national safety concept and national laws in the area of product quality; international organizations activities and EU experience on food quality ensuring; the national system of technical regulations and the Rus-sian Federation goods and services market regulation; quality management systems and ecological management systems as the tools for food safety ensuring; quality systems introduction and certifi-cation in the company and in the region; quality control and food safety development in the com-pany and in the region; product certification and declaration.

Key words: Food safety, food quality, technical standards on the product, quality manage-ment systems, HACCP and ISO 22000, product certification and declaration, food control and tests.

Learning outcomes:

- understand the issues of technical standards, legal and informational provision for food safety.

- participate actively in the food safety projects and programs designing in the company and in the region.

- carry out the projects on development and certification of quality management systems and ecological management systems in the region companies;

- use the elements of foreign experience in the food safety area while carrying out sustainable development projects of the region rural territories.

On the module elaboration have worked: Professor Vasiliy Karpuzov (MSAU), Associate professor Ivan Krivchansky (MSAU), Associate professor Svetlana Okrut (SSAU), Associate pro-fessor Olga Panteleeva (KSAA)

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PART 1 THEORETICAL COURSE BASES

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1 Food safety legislation

The chapter gives information about the issues of the Russian Federation national safety in the sphere of goods and services quality; national food safety ensuring laws; civil and administra-tive liability for consumer rights violations.

Plan

1.1 National safety concept of the Russian Federation in the area of product and services quality. Food Safety Doctrine.

1.2 Russian national food safety laws.

1.3 Administrative, civil and criminal liability for food safety.

1.4 Harmonization of legislative and other legal acts in modern conditions.

1.1 National safety concept of the Russian Federati on in the area of product and services quality. Food Safety Doctrine

The State Committee on Standardization, Measurements and Certification (Gosstandart), Russian Economic Development Ministry and Russian Ministry of Industry and Science, by order of the Russian Federation President and the Government, developed the Russian National Food Safety Policy concept in 2002.

The Russian national concept in the area of products and services quality is the system of official views on:

- the role of products and services quality in development of the Russian Federation national interests;

- goals of the Russian government police in the area of products and services quality; - main directions of the government policy in the area of products and services quality. - The concept is developed in accordance with The Constitution of the Russian Federation and is

directed at the assurance of Russia’s national interests which are defined by the Russian Na-tional Safety Concept, decreed by the President of the Russian Federation on December 17, 1997, No 1300.

The Doctrine is a framework document that outlines the role of products and services quality in assurance of Russia’s national interests in economic, social, military, international, informational and environmental areas.

Product quality is the key concept of the Doctrine.

In accordance with the Doctrine one product can be demanded at different quality levels, what depends on low purchasing capacity of the buyers. People with low purchasing capacity most-ly use cheaper products of low quality, as a rule; not numerous buyers of the middle class use prod-ucts of the middle quality and price level; and a small group of wealthy people can afford to buy expensive products of high quality.

It results in the enlargement of the population purchasing capacity, and, therefore, increasing

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of the demand for products of higher quality.

Herewith, competitiveness is an integral feature of the product, conditioning its marketing.

Competitiveness is also influenced by the quality, price, running expenses, serviceability of the product, producer reputation and ability to keep delivery time and other factors.

The Concept determines the main directions of the government policy in the area of prod-ucts and services quality that are framed on the basis of the principles aimed to develop quality cul-ture in the country, to improve products and services quality in all industries.

The policy in the area of products and services quality provides specific state and regional measures to improve the quality and assure the product competitiveness in the economy sectors that are priorities for developing Russia’s national and regional interests.

In the Concept it is noted that the government policy in the area of products and services quality must be realized in compliance with the state of domestic market development, as well as with the dynamics of Russian economy integration with the world economy and Russian market with the global one.

The Food Safety Doctrine is the most important document in the area of food safety. The present Doctrine represents the aggregated official views of the objectives, goals and main direc-tions of the government economic policy in the area of ensuring the Russian Federation food safety.

The present Doctrine follows up on the provisions of the Russian Federation National Safety Strategy until 2020 approved by the Decree of the President of the Russian Federation from May 12, 2009 No. 537 concerning food safety of the Russian Federation.

The Russian Federation food safety is the status of the national economy that ensures food independence of the Russian Federation, physical and economic availability of food products to every citizen that meet the requirements of the laws of the Russian Federation on technical regula-tion, in quantities no less that the balanced food consumption rates required for active and healthy lifestyle.

The Russian Federation food safety is one of the key areas of ensuring the country’s national safety in the medium term, the factor that contributes to maintaining its statehood, sovereignty, the essential component of its demographic policy, the necessary condition for implementing the na-tional priority, i.e. the improvement of the Russian citizens’ life quality through ensuring high sus-tenance standards.

The key objectives of ensuring food safety regardless of change in external and internal conditions are:

- timely forecasting, detection and prevention of internal and external threats to food safety, minimization of their negative consequences due to constant readiness of the food supply system, creation of strategic food stocks;

- sustainable development of domestic production of food and raw material sufficient to pro-vide for the country’s food independence;

- achieving and maintaining physical and economic availability of safe food products for each

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citizen in quantities and assortments that comply with the established balanced food con-sumption rates required to support active and healthy lifestyle;

- ensuring food products safety.

The system of indexes used to evaluate the level of food safety is shown in fig.1.1. A crite-rion to evaluate the food safety level is the share of domestic farm, fish products and food in total commodity resources (including carry-over stocks) of the domestic market of relevant products (ta-ble 1.1).

Fig. 1.1 The indexes system for food safety level evaluation

Ensuring food safety is greatly associated with technological risks caused by lagging behind the developed countries where it concerns the level of technological development of the domestic production facilities, differences in requirements to safety of food products and control systems over their compliance.

Indexes for the food safety level estimation

Consumption in-dexes

Production and national

competitiveness indexes

Management in-dexes

� Available resources of peoples’ house-holds by groups of population;

� Availability of trading and catering grounds per 1,000 people;

� Food consumption per capita;

� Volumes of targeted aid to the community;

� Daily diet calorific value;

� Amount of proteins, fats, carbohydrates, vitamins, macro- and microelements consumed by person per day;

� Consumer price index for products.

� Production volumes of farm and fish products, raw mate-rial and food;

� Import of farm and fish products, raw material and food;

� Budget support to producers of farm and fish products, raw material and food calculated per one ruble of product sold;

� Efficiency of land resources used in agriculture;

� Food products sales volumes by trade and foodservice industry.

� Food volumes in the state material re-serve formed in ac-cordance with the regulative legal acts of the Russian Fed-eration;

� Stocks of farm and fish product, raw material and food.

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Table 1.1 Domestic products share in total commodity resources

Products The level in the domestic market

Grain no less than 95 percent

Sugar no less than 80 percent

Vegetable oil no less than 80 percent

Meat and meat products no less than 85 percent

Milk and dairy products no less than 90 percent

Fish products no less than 80 percent

Potatoes no less than 95 percent

Edible salt no less than 85 percent

To ensure that food products are safe, it is required to enforce the compliance of farm, fish products and food including imported products and food with the requirements of the laws of the Russian Federation at every stage of their production, storage, transportation, processing and mar-keting. It is required to eliminate the uncontrolled food products distribution received from geneti-cally modified plants with the use of genetically modified microorganisms and microorganisms that have genetically modified analogues.

Efforts aimed at harmonization with the international food safety standards on the basis of fundamental research in the area of nutrition science will be continued.

It is necessary to improve the system of food safety controls including development of the advanced technical and procedural framework.

As it pertains to sustainable development of rural territories, the following areas must be developed:

- social arrangement of rural and coastal fish settlements; - increase in financial assistance to implement social programs in rural and coastal fish set-

tlements; - monitoring of the unemployment level and real income level of rural population; - diversification of rural population employment.

The most important Doctrine direction is the development of unified requirements applied by food processing plants to the control system and harmonized with recommendations of the inter-national organizations, transition of food industry to the integrated safety control system.

The system for ensuring food safety is defined in the national laws, decrees and orders of the President of the Russian Federation, resolutions and orders of the Government of the Russian Fed-eration, and also in the decisions of the Security Council of the Russian Federation. Public authori-ties of constituent entities of the Russian Federation in conjunction with the national authorities:

- pursue a common national economic policy in the area of ensuring food safety taking into consideration regional specifics;

- develop and adopt regulative legal acts of the constituent entities of the Russian Federation regarding issues related to ensuring food safety;

- create and maintain essential stores and food reserves in the constituent entities of the Rus-sian Federation;

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- provide for monitoring of the food safety status throughout the Russian Federation constitu-

ent entities.

1.2 Russian national food safety laws

The open market development brings to the fore civic organizations that are subject to goods market regulations and take the form of unions and associations of consumers. The rights of these organizations are protected by laws. National Law No. 171-ФЗ of December 21, 2004 on the Amendments to the Law of the Russian Federation on the Protection of Consumer Rights and on Invalidation of Item 28 of Article 1 of the National Law on the Amendments to the Law of the Rus-sian Federation on the Protection of Consumer Rights provides a wide range of rights for consum-ers’ civic organizations.

Goods and services in turnover are regulation subjects of goods market.

The following legislative acts form the basis for the state policy of the Russian Federation in the field of food safety protection: National Law on Protecting Consumer Rights, National Law on Technical Regulation, National Law on Quality and Safety of Food Products, National Law on En-vironmental Protection, National Law on Ecological Expertise, National Law on Sanitary and Epi-demiological Safety.

The National Law on Consumers Rights Protection regulates relations arising between con-sumers and manufacturers, providers, importers, and sellers of goods and services, establishes the rights of consumers to the acquisition of goods (services) of proper quality and safe for the life, health and property of consumers as well as the environment, to receive information regarding goods (services) and about their manufacturers (providers, sellers), to education, government and public protection of their interests, and also defines the mechanism of the these rights realization.

The Law sets out juridical regulation of relations in the area of consumer rights protection, defines rights and duties of manufactures (providers, sellers) to set the service life, working life of goods (services), the guarantee period of goods (services); the right of the consumer to acquire safe goods (services), to be informed about the manufacturer and the good; responsibility of the manu-facturer (provider, seller) to provide the proper information about goods (services), the moral dam-age compensation; judicial protection of consumer rights.

At the present moment Europe has a wide food legislation base with hundreds of directives, while Russia does not have such a base. It has just been developing on the basis of the national law on Technical Regulation (Law 184 - ФЗ) which comprises about 20 decreed technical standards.

According to the national law on Technical article No.7 the technical standard must be con-tained with:

1. the list objects of the technical regulation with their descriptions;

2. the requirements to the safety of technical regulation objects;

3. the rules of identification of technical regulation objects for the purpose of the law applica-tion;

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4. rules and forms of conformity assurance of technical regulation objects to the requirements of the law;

5. the requirements to the terminology, packing, marking of milk and dairy products, including the requirements to information about name, composition and consumer properties, ensured on the packing and in the documents to goods.

At present food technical standards are being actively developed. Technical standards on milk and dairy products, milk and fat products, juices, etc. are put in operation. At the same time the most important food safety issues are still regulated within only departmental documents (SanPiN (Hygienic Requirements), SNiP (Fire Safety of Buildings and Structures), Guidance Documents, Hygiene Rules).

The technical regulation system modernization is complicated by the introduction of the common customs space of Russia, Belarus and Kazakhstan.

National Law No. 29-ФЗ dated January 2, 2000 on The Quality and Safety of Food Prod-ucts regulates relations in the field of ensuring the quality of food products and their safety for hu-man health. This National Law structure is shown in fig. 1. 2.

Fig. 1.2 The National Law No. 29-ФЗ structure

This National Law basic terms are set in Article 1.

Food products - products in natural or processed form for human consumption as food (in-cluding children's foods and dietary foods), bottled drinking water, alcoholic products (including beer), nonalcoholic beverages, chewing gum, and also raw food materials, food additives and bio-logically active additives;

National Law on Quality and Safety

of Food Products

Chapter I

General pro-visions

Chapter II

The Russian Federation powers, the Russian Fed-eration con-stituent entities powers in en-suring of food products qual-ity and safety

Chapter III

Government control in en-suring of food prod-ucts quality and safety

Chapter IV

General re-quirements to food prod-ucts quality and safety ensuring

Chapter V

Responsibil-ity for viola-tion of this National Law

Chapter VI

Final provi-sions

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Raw food materials - raw materials of vegetable, animal, microbiological, mineral and arti-ficial origin and water used for the manufacture of food products.

Quality of food products - a set of characteristics of food products capable of satisfying human requirements in food under the normal conditions of their use.

Food products safety - a state of reasonable confidence that food products under the normal conditions of their use are not harmful and do not constitute any danger to the health of present and future generations.

Food products, materials and articles quality and safety Certificate – a document wherein the manufacturer attests the conformity of the quality and safety of each batch of food products, materials and articles to the requirements of normative or technical documents.

The legal relations regulation in the field of ensuring the food products quality and safety in the Russian Federation is carried out by the National Law No. 29.

National laws, laws of the entities of the Russian Federation and other normative legal acts adopted in accordance therewith in the part concerning the ensuring of the quality and safety of food products must not contain any norms that are contrary to this National Law.

The National Law sets main tends of the food products, materials and articles quality and safety ensuring:

- state regulation measures in the field of ensuring the quality and safety of food products, materials and articles;

- carrying out the organizational, agrochemical, veterinary, technological, engineering-technical, sanitary and epidemiological and phytosanitary arrangements for fulfilment of normative documents requirements to food products, materials and articles, conditions of their manufacture, storage, carriage and realization by citizens, including individual busi-nessmen, and by juridical persons of food products, materials and articles manufacturing and turnover activity;

- carrying out production control over food products quality and safety, materials and arti-cles, over the conditions of its manufacture, storage, carriage and realization, and over the introduction of the food products, materials and articles quality control systems;

- the measures application for deterring legislative violations, including the normative docu-ments requirements, and also civil law measures, administrative and criminal responsibility to persons guilty of the said violations commission.

The federal executive body in charge of the state inspection in the field of standardization and certification, federal executive body in the field of the state sanitary and epidemiological in-spection, federal executive body in the field of the state veterinary inspection shall furnish with in-formation about the quality and safety of food products, materials and articles, about the observance of the requirements of normative documents in the manufacture and turnover of food products, ma-terials and articles, about the rendering of services in the sphere of the retail trade in food products, materials and articles, and in the sphere of public catering, about the state registration of food prod-ucts, materials and articles, about the confirmation of their conformity to the requirements of nor-mative documents, and also about normative documents and the measures for preventing the reali-

21

zation of low-quality and dangerous food products, materials and articles.

The National Law regulates powers in the field of ensuring the food products quality and safety on the three levels.

The Russian Federation powers in the field of ensuring the quality and safety of food prod-ucts shall comprise:

- the elaboration and conduct of a single state policy in the Russian Federation; - the organization and carrying out of the state registration of food products, materials and ar-

ticles; - the organization and carrying of obligatory certification of certain types of food products,

materials and articles, and also of services rendered in the retail trade in food products, and in the sphere of public catering and quality systems;

- the organization and conduct of state inspection and control; - the carrying out of international cooperation of the Russian Federation.

The state power bodies of the Russian Federation subjects shall be entitled to participate in the exercise of the Russian Federation powers in the area of ensuring the quality and safety of food products by way of the following:

- the elaboration and conduct of a single state policy in the Russian Federation; - adoption in compliance with the national laws of laws and other normative legal acts of the

Russian Federation subjects; - development and implementation of regional programmes on quality and safety ensuring of

food products, materials and articles produced in the Russian Federation subjects; - special activities licensing on food turnover; - control and inspection over the quality and safety of food products, materials and articles in

the Russian Federation subjects; - carrying out other powers over the quality and safety of food products, materials and articles

which are not stipulated by the Russian Federation.

The local power bodies can be entitled to participate in the exercise of powers in the area of the food products quality and safety ensuring in the order stipulated by the Russian Federation leg-islation.

State control in the field of ensuring the quality and safety of food products is realized in several directions, fig. 1.3.

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State control on food products quality and safety ensuring

State standardization

State registration of food products

Licensing of special activi-ties on food products manufactuing and turnover

Food products and quality sys-tems estimation and confirma-tion of norma-tive documents conformity

State inspec-tion and con-trol concern-ing food prod-ucts quality and safety ensuring

Monitoring of the food products quality and safety and of the population health

Fig. 1.3 State regulations for food products quality and safety

State standardization in the field of food products, materials and articles quality and safety ensuring is set in Article 9 of the National Law No. 29:

6. The requirements to the quality of food products, materials and articles, to ensuring their safety, to packing, marking and production control over the quality and safety of food prod-ucts, materials and articles, to the procedures for the estimation and confirmation of their conformity to the requirements of normative documents, the methods of their testing and identification, and also to technical documents and quality systems, shall be established by relevant state standards.

7. The requirements to the nutritive value of food products, to the safety of food products, ma-terials and articles, to the safety of the conditions of their development, setup for production, manufacture and turnover, to the safety of the services rendered in the sphere of the retail trade in food products, materials and articles and in the sphere of public catering, shall be es-tablished by relevant sanitary rules and norms.

New food products, materials and articles shall be subject to state registration the in estab-lished order.

The National Law sets out the requirements to the food products, materials and articles qual-ity and safety ensuring in their manufacture.

The food products, materials and articles manufacture should be carried out in accordance with the technical documents, while observing the requirements of sanitary and veterinary rules and norms.

The manufacturer of food products, materials and articles shall, for the purpose of ensuring their quality and safety, elaborate and introduce quality systems in conformity with the require-ments of state standards.

For the manufacture of food products food raw materials must be used whose quality and safety conform to the normative documents requirements.

In the manufacture of food raw materials it shall be permissible to use fodder additives, an-imal growth stimulators (including hormonal preparations), medications, pesticides and agrochemi-

23

cals that have passed a sanitary and epidemiological expert examination and state registration ac-cording to the procedure established by the Russian Federation legislation.

Food raw materials of animal origin shall be permissible for the manufacture of food prod-ucts only after the carrying out of the veterinary and sanitary expert examination and receipt by the manufacturer of the conclusion of the state veterinary service of the Russian Federation attesting the conformity of food raw materials of animal origin to the requirements of the veterinary rules and norms.

The manufacturer must check the quality and safety of each products, materials and articles lot, and hand over to the buyer, together with the food products, materials and articles, the certifi-cate of food products, materials and articles quality and safety.

The conformity of food products, materials and articles approved by the Russian Federation Government to the normative documents requirements shall be confirmed by the conformity certifi-cate or the conformity declaration and the conformity mark.

The National Law sets out the requirements to ensuring the quality and safety of new food products, materials and articles in their development and setup for production, requirements to en-suring the quality and safety of food products, materials and articles in their manufacture, prepack-aging, packing and marking, in their storage, carriage and selling. Requirements to ensuring the quality and safety of food products, materials and articles imported in the Russian Federation are also set out.

Production control over the quality and safety of food products, materials and articles shall be carried out in accordance with the program of production control, which program shall be elabo-rated by an individual businessman or a juridical person on the basis of state standards and technical documents. The said program shall determine the procedure for the carrying out of production con-trol over the quality and safety of food products, materials and articles, the methods of such control and the methods of checking the conditions of their manufacture and turnover.

The National Law determines the product obligatory information that must be indicated in the Russian Language:

on the nutritive value (caloric value, content of proteins, fats, carbohydrates, vitamins, and macro and micro elements);

on the purpose and conditions of application (with respect to children's food, dietary foods and biological active additives);

on the methods and conditions of the manufacture of precooked dishes (with respect to con-centrates and half-finished food products);

on the conditions of storage (with respect to food products for which there are certain estab-lished requirements to the conditions of their storage);

on the date of manufacture and the date of packing of food products.

The National Law also establishes the requirements to the withdrawal from turnover of low quality and dangerous food products, materials and articles, requirements to the conduct of expert

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examination and to the utilization or destruction of low quality and dangerous food products, mate-rials and articles withdrawn from turnover, administrative, civil and criminal responsibility for vio-lation of this National Law.

The National Law on The Sanitary and Epidemiological Well-Being of the Population is aimed at the sanitary and epidemiological well-being of the population as one of the main condi-tions for the realization of the constitutional rights of citizens to the protection of health and favor-able environment. Main improvement tends of the mentioned sphere are described in the draft law of the general technical standard Sanitary and Epidemiological Requirements for Food Products, Materials and Articles in Contact with Them.

This draft law of the technical regulation sets out the sanitary and epidemiological safety principles, fig. 1.4.

Fig. 1.4 Sanitary and epidemiological safety principles

The draft law sets out the rights and duties of individuals, individual entrepreneurs and legal entities, requirements of sanitary and epidemiological safety and nutritional food value, responsibil-ity for violation of the national law, and regulates transitional provisions.

The law on Ecological Expertise regulates relations in the area of ecological expertise, and is aimed at the realization of the constitutional rights of citizens to the protection of healthy environ-ment by means of preventing harmful economic and other activities.

Ecological expertise is the establishing the compliance of documentation on the planned economic or other activities with environmental requirements, technical standards and environ-mental legislation in order to prevent possible harmful effects of activities on the environment (the Article enacted since January 1, 2007 by the National Law No. 232 – ФЗ of December 18, 2006).

Principle of food prod-ucts state registration

Principle of obligation to compliance with the food safety require-

ments by the companies

Principle of providing the food and raw mate-

rials conformity as-sessment to technical

standards requirements

Principle of state con trol and inspection concern-ing sanitary and epide-

miological safety

Principle of state stan-dardization concerning sanitary and epidemiol-ogical safety ensuring

Principle of state ensur-ing for providing the population with food

products not harmful to humans health

Food sanitary and epi-demiological safety & nutrition value princi-

ples

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The National Law on Environmental Protection sets out legal fundamentals for state policy in the sphere of environmental protection which provide balanced achievement of social and eco-nomic objectives, preservation of favorable environment, biological diversity and natural resources for the purposes of meeting needs of present and future generations, strengthening legal order in the sphere of environmental protection and ensuring ecological safety.

1.3 Administrative, civil and criminal liability fo r food safety

Legislation in Russia provides for civil, administrative and criminal penalties to protect con-sumer rights.

Administrative-law responsibility is the result of federal executive power bodies carrying out their control functions and includes imposition of a fine and issue a notice to offenders (individuals and legal entities). Administrative punishment is the means of responsibility and shall be applied in order to educate a person, who has committed administrative violation, as well as in order to pre-vent the violator of the rights, as well as other persons, from committing new violations.

There are the following forms of administrative punishment:

- warning; - fine; - confiscation of the administrative violation object or the instrument of commitment; - special right deprivation; - corrective labour; - administrative arrest; - foreigner or stateless person’s administrative deportation out the Russian Federation.

A number of state power bodies are authorized to protect consumer rights. One of them is the Federal Antimonopoly Service (FAS Russia), which is competent for violations of antimonopoly legislation and exercises control over the legal protection of consumer rights.

FAS works to protect

- consumer rights of a particular individual or - consumer rights of an indefinite circle of consumers.

The authorized federal executive body in charge of control (inspection) in the field of con-sumer rights protection (territorial agencies) are authorized to impose a fine in case of:

1. avoidance or non-observance of the date of their notices by the manufacturer (provider, sell-er) and in case of harm to consumers by goods (work, services) that do not comply with goods (work, services) safety requirements shall be punishable by a fine in the amount of up to five legal minimal wages;

2. selling goods (work, services), including imported, without certificates of conformity shall be punishable by a fine in the amount of value of goods (work, services) sold;

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3. violation of standards of obligatory certification of goods (work, services) by the certifica-tion bodies, as well as supplying with false goods (work, services) test results by testing la-boratories (centers) shall be punishable by a fine in the amount of two values of the goods (work, services).

All the mentioned fines should be paid in thirty-day payment period since the day of receiv-ing the corresponding decision about the penalty. Local self-governing bodies (town committees and regional departments on consumer rights protection) are also authorized with the right to im-pose administrative punishments.

Civil-law responsibility is a type of judicial responsibility and represents sanctions imposed on the offender in the form of additional duties.

Civil-law responsibility is mostly the contractual responsibility and represents a penalty or damages.

Regarding civil-law responsibility as a means of consumer rights protection it is necessary to mention that its general function is to compensate, i.e. this responsibility serves to restoration of the damaged property of the consumer at the offender expanse.

The Criminal Code of January 1, 1997 contains a number of articles on the protection of consumer rights and on responsibilities of guilty persons. They are described below.

Violation of sanitary and epidemiological rules (article 236) which has resulted in, by negli-gence, mass diseases or poisoning of people shall be punishable by a fine in the amount of up to 80,000 roubles or in the amount of the wage or any other income of the convicted person for a pe-riod up to six months, or by disqualification to hold specified offices or to engage in specific activi-ties for a term of up to three years, or by compulsory labour for a term of up to three hundred sixty hours, or by corrective labour for a term of up to one year. The same deed, which has involved by negligence the person death, shall be punishable by compulsory labour for a term of up to four hun-dred eighty hours, or by corrective labour for a term of six month to two years, or by obligatory la-bour for a term of up to five years,or by deprivation of liberty for the same term.

Goods and Products Manufacturing, Storage, Carriage or Sale, Works Fulfillment or Ser-vices Rendering Which Do Not Meet Consumers’ Life and Health Safety Standards (article 238) and equally illegal issue or application of the official document proving mentioned goods, work or ser-vices conformity to safety requirements shall be punishable by a fine in the amount of up to 300,000 roubles, or in the amount of the wage or any other income of the convicted person for a period of up to two years, or by compulsory labour for a term of up to three hundred sixty hours, or by restraint of liberty for a term of up to two years, or by obligatory labour for a term of up to two years, or by deprivation of liberty for the same term.

The same deeds, if

- they have been committed by individuals group under a preliminary conspiracy or by an or-ganized group;

- they have been committed in respect of goods or services intended for children under six years;

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- they have entailed by negligence serious damage to health or the person death.

Shall be punishable by a fine in the amount of 100,000 to 500,000 roubles, or in the amount of the wage or any other income of the convicted person for a period of one to three years, or by compulsory labour for a term of up to five years, or by deprivation of liberty for a term of up to six years with a fine in the amount up to 500,000 roubles or in the amount of the wage or any other in-come of the convicted person for a period of up to three years or without.

Mentioned deeds which have entitled by negligence the death of two or more persons shall be punishable by compulsory labour for a term of up to five years or by the deprivation of liberty for a term up to ten years.

Responsibility for similar deeds which have entitled less severe consequences is established by the Russian Federation Administrative Violation Code. According to this Code article 14.4 on goods selling, work performing or service rendering of bad quality or with violations of require-ments established by the Russian Federation legislation shall be punishable by an administrative fine to a physical person in the amount of 1,000 to 2,000 roubles, to an official person in the amount of 3,000 to 10,000 roubles, to a person performing business activities without forming a legal entity – from 10,000 to 20,000 roubles, to a legal person – from 20,000 to 30,000 roubles.

In the case of this administrative violation repeat it shall be punishable by an administrative fine to a physical person in the amount of 2,000 to 5,000 roubles, to an official person in the amount of 7,000 to 15,000 roubles or by disqualification for a term of up to one year, to a person perform-ing business activities without forming a legal entity – from 15,000 to 30,000 roubles with or with-out administrative violation articles withdrawal, to a legal person – from 30,000 to 50,000 roubles with or without administrative violation articles withdrawal.

The Russian Federation Administrative Violation Code establishes the responsibility on consumer fraud. According to this Code article 14.7 false measurements, false weighing, false ac-counts, false representation regarding consumer features, goods (work, service) quality or another consumer fraud of companies busy with goods selling or services rendering and equally of citizens registered as individual businessmen in trade (service rendering) and also of citizens employed in individual businessmen companies shall be punishable by an administrative fine to a physical per-son in the amount of 1,000 to 2,000 roubles, to an official person in the amount of 1,000 to 2,000 roubles, to a legal person – from 10,000 to 20,000 roubles.

The Russian Federation Civil Code (RF CC) establishes the seller responsibilities regarding providing the consumer with information on goods. According to this Code article 495 a seller must provide the consumer with required and correct information on selling goods according to legisla-tion, normative acts and requirements imposing in retailing on regular basic and asking for content and methods of this information providing. A seller who hasn’t provided a consumer with opportu-nity of this kind of information gathering is responsible for goods disadvantages appearance even after goods has been bought by consumer if a consumer would prove that these disadvantages arisen because of this information absence.

Consumers rights in the case of selling the goods of inadequate quality are determined in Civil Code article 503. A consumer who bought goods of inadequate quality if disadvantages

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weren’t said by a seller is able to demand according to his choice:

- inadequate quality goods substitute to adequate quality goods; - proportional decreasing of purchase price; - goods disadvantages immediate elimination that is free of charge; - expenses compensation for goods disadvantages elimination.

In the case of goods disadvantages reveal and if goods features do not let to eliminate these disadvantages (food products, household goods, etc.), a consumer can ask to change these goods for other ones of adequate quality or proportional decreasing of purchase price by his choice.

1.4 Harmonization of legislative and other legal ac ts in modern conditions

The Russian Federation legislative and normative base harmonization with common world norms and standards is integration and development logic result of international cooperation. Har-monization became more actual after the Russian Federation joining to WTO. The national Law On technical regulation adoption and realization let harmonize the Russian Federation legislative and normative base with norms of the EU and other developed WTO parties-countries essentially.

National legislative and other normative legal acts harmonization is of great importance concerning Commonwealth of Independent States. Mentioned activity was started in February 26, 1999 when Treaty on Customs Union and Common Economic Space (Treaty hereinafter) was signed. The Harmonization Program (convergence and unification) is systems of mutually agreed by Treaty parties’ views on their common objectives and priorities of legal platform development for the Customs union, ways, arrangements, mechanisms and steps of their practical implementa-tion.

The Harmonization Program core is states voluntariness and independence in directions and participation degree determination in national legislation convergence and unification (har-monization) processes, their gradualness and phasing of realization.

The necessity of the Harmonization Program development is impartially conditioned by ten-dencies of convergence of Treaty parties’ legislation systems and bringing in accordance with inter-state, intergovernmental and interdepartmental treaties in the frame of integration.

Harmonization is aimed to establish unified regulation of legal relations determined by the Treaty by judicial interpretation of provisions of interstate treaties, decisions made by integration management bodies into state legislation and other legal acts.

Essential principles of the harmonization:

- coordination of legal regulation on principles mutually acceptable for legislation of the Treaty parties;

- synchronism of adoption of acts in reintegration development; - gradualness of harmonization phases in accordance with judicial relevance and hierarchy of

legislative and other legal acts; - priority of common principles of international law over national legal acts.

The most important integration step under Eurasian Economic Community was Committee

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verdict #453 On documents projects in the area of the CU technical regulation dated November 18, 2010. Verdict mentioned above ratified:

- measures schedule of the Agreement “On unitary principles and rules of technical regulation in Republic of Belarus, Republic of Kazakhstan and the Russian Federation” implementa-tion;

- provision assigning development, adoption, alteration and cancellation of the CU technical standards;

- development schedule of the CU primary technical standards.

The list of the CU primary technical standards concerning food products raw materials are given in the table below.

Table 1.2 The Custom Union primary technical standards concerning food products raw materi-als (schedule fragment approved by the CU Committee Decision No. 492 dated Decem-ber 8, 2010)

Number Name of the Custom Union technical standards (TS)

TS responsible designer TS project date posted

4 On package security Republic of Belarus March 2011

8 On grain security Republic of Kazakhstan March 2011

18 On food products security The Russian Federation March 2011

19 Food products TR concerning its marking Republic of Belarus March 2011

20 Juice products TR The Russian Federation March 2011

21 Fat-and-oil products TR The Russian Federation March 2011

22 Milk and milk products TR The Russian Federation March 2011

23 On meat and meat products security Republic of Kazakhstan March 2011

24 On fish and fish products security Republic of Kazakhstan March 2011

29 On requirements to fertilizers Republic of Belarus March 2011

31 On dietic, special and therapeutic-preventive food products security Republic of Kazakhstan March 2011

33 On nutrient additives security Republic of Kazakhstan March 2011

34 On forage and its additives security Republic of Kazakhstan March 2011

44 On alcohol products security The Russian Federation March 2011

The basic CU technical standard concerning food safety ensuring is technical standard “On food safety”.

CU technical standard ТР ТС 021/2011 “On food safety” adopted by CU Committee Verdict No.880 dated December 9, 2011. Technical standard “On food safety” structure is given in the fig-ure below.

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Fig. 1.5 Technical standard “On food safety” structure

This technical standard ТР ТС 021/2011 establishes:

- technical regulation subjects; - safety requirements (incl. sanitary and epidemiological, hygienic and veterinary) concerning

technical regulation subjects; - technical regulation subjects identification rules; - conformity assessment forms and procedures of technical regulation subjects to technical

regulation requirements.

The aims of technical standard adoption are:

- human life and (or) health protection; - prevention of actions confusing consumers; - environment protection.

Technical standard ТР ТС 021/2011 subjects are

- food; - production, storage, transportation, selling and utilization processes connected with food re-

quirements.

Technical regulation doesn’t cover food products producing by citizens at home, in personal farms or by citizens busy with horticulture, livestock breeding; production, storage, transportation, selling and utilization processes of food products for personal needs and not for turnover through the CU custom territory; agricultural cultures and productive animals breeding in natural conditions.

Food products are put in market turnover with its conformity to technical standard ТР ТС 021/2011 and other CU technical standards influencing on them. Such kind of products is marked with unitary sign of production distribution throughout the CU countries market.

Food products and food raw materials being put in turnover must be accompanied with con-

The Custom Union technical Standard ТР ТС 021/2011 “On food safety”

Chapter I

General provisions

Chapter II

Require-ments to food safety

Chapter III

Requirements to food manu-facturing, storage, transporta-tion, selling and utilization processes

Chapter IV

Estima-tion and confor-mity assess-ment

Chapter V

State con-trol (inspec-tion)

Chapter VII

Saving clause

Chapter VI

Food marking

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signment documentation providing these products traceability.

Technical regulation establishes food safety general requirements. Food products in turnover through the CU custom territory must be safe during pointed expiration date and under appropriate usage.

Food raw materials with genetically modified organisms must be excluded for food products production of children, pregnant and nursing women nutrition.

Food raw materials obtained with pesticides application must be excluded for food products production of children nutrition.

Assessment forms of food products conformity to technical standards and (or) the CU tech-nical standards for special food products types are:

- food products conformity assessment (declaring); - state registration of special food products; - state registration of new food products; - veterinary and sanitary expertise.

Food products in turnover through the CU custom territory must be declared with the excep-tion of:

- unprocessed food products of animal origin; - special food products; - vinegar.

Special food products are subject to state registration.

Special food products are:

- food products for children nutrition incl. water; - food products of dietic medical and protective diet; - mineral natural water, medical table water, medical mineral water; - food products for sportsmen, pregnant and nursing women nutrition; - biologically active additives for food.

Data on state registration of special food products are entered into Unitary register of spe-cial food products.

New food products are subject to state registration.

Unprocessed food products of animal origin are under veterinary and sanitary expertise be-fore its emission in turnover through the CU custom territory if another condition is not established in the CU technical regulation on food fish products and are accompanied with a document contain-ing data proving its safety. Processed food products of animal origin are not under veterinary and sanitary expertise.

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An economic activity participant has a right to perform food products production processes through the CU custom territory only after state registration of production objects where mentioned production processes are carried out.

State registration of production object is actual if production object has an identification number and production object data are included in Register on food products production of produc-tion objects under state registration.

State control (inspection) for keeping the requirements of technical regulation regarding food products and production, storage, transportation, selling and utilization processes connected with food products requirements is carried out according to the CU country-member legislation.

Food products marking must correspond to the CU technical regulation requirements to food products marking and (or) must agree with corresponding requirements of the CU technical stan-dards for separate types of food products.

All technical standards which were applied in Russian Federation have been replaced for the CU unitary standards since January, 1, 2012. National requirements are stopped in operation as soon as the CU technical regulation becomes effective. Technical standards essential requirements violation fine amount was increased from 50, 000 to 1 mln roubles.

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1.5 Control questions to chapter 1

1. What is core notion of the Russian Federation National safety Concept concerning quality?

2. Specify main National Laws on food safety ensuring.

3. What is food safety?

4. What is indexes system for the food safety level estimation?

5. What does Law «On Environmental Protection» determine?

6. What is Ecological Expertise?

7. What does Law “On Consumers Rights Protecting” determine?

8. What does Law «On Sanitary and Epidemiological Safety of the Population» determine?

9. What is the Criminal Code article establishing the responsibility regarding goods and services which are not satisfied the safety requirements?

10. What is responsibility for consumers’ fraud?

11. What are consumers’ rights in the case of inadequate quality goods buying?

12. What is harmonization core?

13. What are harmonization essential principles?

14. Name the CU primary technical standards concerning food products and food raw materials?

15. Specify the product conformity assessment forms according to the CU technical standard ТР ТС 021/2011 On food safety.

1.6 Summary

National safety concept of the Russian Federation in the area of product and services qual-ity sets out the role of products and services quality in development of Russia’s national interests in economic, social, military, international, informational and ecological areas.

In the area of food safety the Food Safety Doctrine of the Russian Federation is the essential document. The Doctrine is the sum of official views on goals, objectives and main directions of government economic policy in the area of food safety ensuring in the Russian Federation. The most important direction of the Doctrine is the development of unified requirements applied by food processing plants to the control system, and harmonized with recommendations of the interna-tional organizations, transition of food industry to the integrated safety control system.

Food safety of the Russian Federation is the state of the country’s economy that ensures food independence of the Russian Federation, physical and economic availability of food productss to every citizen that meet the requirements of the laws of the Russian Federation on technical regu-lation, in quantities no less that the balanced food consumption rates required to support active and healthy lifestyle.

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Food safety indexes system includes indexes in the area of consumption, in the area of pro-duction and national competitiveness, and in the area of management. A criterion to evaluate the level of food safety is the share of domestic farm, fish products and food in total commodity re-sources of the relevant products domestic market.

Food products safety ensuring is an objective of the food safety ensuring of great impor-tance.

Food products safety is a state of reasonable confidence that food products under the normal conditions of their use are not harmful and do not constitute any danger to the health of present and future generations.

Main directions of the food, materials and articles quality and safety ensuring are the follow-ing:

- the application of measures of state regulation in the field of ensuring the quality and safety of food products, materials and articles;

- the conduct by citizens, including individual businessmen, and by juridical persons exercis-ing activity in the manufacture and turnover of food products, materials and articles, of or-ganizational, agrochemical, veterinary, technological, engineering-technical, sanitary and epidemiological and phytosanitary arrangements in the fulfilment of the requirements of normative documents on food products, materials and articles, to the conditions of their manufacture, storage, carriage and realization;

- the conduct of production control over the quality and safety of food products, materials and articles, over the conditions of their manufacture, storage, carriage and realization, and over the introduction of systems of control of the quality of food products, materials and articles;

- the application of measures for deterring violations of this National Law, including the re-quirements of normative documents, and also measures of civil law, administrative and criminal responsibility to persons guilty of the commission of the said violations.

The following legislative acts form the basis for the legislation in the field of food safety en-suring: National Law on Protecting Consumer Rights, National Law on Technical Regulation, Na-tional Law on Quality and Safety of Food Products, National Law on Environmental Protection, National Law on Ecological Expertise, National Law on Sanitary and Epidemiological Safety, etc.

Legislation provides for civil, administrative and criminal responsibility to protect consumer rights in the area of food safety.

Contemporary economic development is characterized by harmonization of the Russian Federation legislative and other legal acts in the area of food safety ensuring with the international with international practice. Essential principles of the harmonization are voluntary and independent determination of directions and participation degree in convergence and unification (harmonization) of state legislation; gradualness and phasing of the harmonization programs development.

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Harmonization gains special applicability concerning the CU creation. The CU basic techni-cal regulation regarding food safety ensuring is technical regulation On food safety. This technical regulation establishes:

- technical regulation subjects; - safety requirements (incl. sanitary and epidemiological, hygienic and veterinary) concerning

technical regulation subjects; - technical regulation subjects identification rules; - conformity assessment forms and procedures of technical regulation subjects to technical

regulation requirements.

All technical standards which were applied in Russian Federation have been replaced for the Custom Union unitary standards since January 1, 2012. National requirements are stopped in operation as soon as the Custom Union technical regulation becomes effective.

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2 International activity in the context of food saf ety

The chapter deals with the WTO, the UNECE and the WHO roles in food safety, as well as the Codex Alimentarius Commission activities; European principles of New and Global approach to technical harmonization and standardization; food raw material and food safety ensuring in the EU countries; France and Germany experience in the sphere of food safety.

Plan

2.1 International organizations activity in context of food safety.

2.2 Food raw material and food safety ensuring in the EU countries.

2.3 Food safety ensuring system in France.

2.4 Food safety ensuring experience in Germany.

2.1 International organizations activity in context of food safety

International trade coordination realized by intergovernmental organizations aims to liberal-ize the world trade. The world trade liberalization essentials methods eliminate or reduce the barri-ers between countries, in order to facilitate the more free flow of goods, services, persons and capi-tal. There exist financial (fiscal), physical and technical barriers that hamper the free movement of goods, services, persons and capital across borders.

Organizations acting on behalf of the countries-members of the international treaty – and undertaking to lower or remove technical trade barriers are regulation subjects of the international goods market. The member countries, acting under the treaty commitments and providing inspec-tion of their internal market, themselves are also subjects of goods market.

On the part of intergovernmental organizations the regulation objects are relations between interested parties concerning measures undertaking before products access in market and measures on market inspection.

WTO Agreement on technical barriers covers all goods, including industrial and agricultural products shall be subject to the provision of this agreement. In addition, there are specific agree-ments dealing with animals and plants, import of which is regulated by Sanitary and Phytosanitary Measures Agreement or SPS).

The World Trade Organization (WTO) created in 1995 and replaced the General Agreement on Tariffs and Trade (GATT) – as the only global international organization dealing with the rules of trade between nations. It is not a specialized agency but it possesses mechanisms and practice of collaboration with the United Nations.

WTO encourages regulation of trade relations on rules ground, settlement of commercial disputes between governments, and organizing of trade negotiations.

The EU Directives providing CE marking (fig 2.1) cover only industrial products as regula-tion objects.

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Fig. 2.1 Conformity mark to New Approach Directives

The EU approach to food regulation differs from that to industrial products by conformity assessment in the first place. The essential form of food products conformity assessment is market inspection. Lot indication of food products in the internal market of EU is an issue of great impor-tance. There was adopted the Directive 89/396/EC on Indications or Marks Identifying the Lot to which a Food products Belongs. It sets out that the food cannot be marketed unless it is accompa-nied by a lot indication in the form of labels, or marked packaging. Inspection body is obliged to check this information availability.

The Codex Alimentarius standards are documents establishing the food products require-ments internationally. The Codex Alimentarius Committee was established by the Food and Agri-culture Organization (FAO) and the World Health Organization (WHO) in 1961 – 1962 to provide consumer health protection and fair practices in the food trade. The Codex Alimentarius Committee organizes the world standards development for food products as well as leading principles and prac-tice codes. The EU food legislation is based on these main documents applied in the world trade on the basic of Activity organization Guidance of the Codex Alimentarius Committee.

The Codex Alimentarius develops the sets of standards for animal control before and after slaughter, sanitary rules, storage standards for fresh, preserved and frozen food products, natural mineral waters, food additives (maximum levels) and for safety assessment of genetically modified foods. These procedures are recommendations for governments as optional guidances.

Services as international goods market regulation objects have not reached the level of goods, though the value of trade in services between nations is growing rapidly. National govern-ments have the right to legally set requirements to services in the area of persons’ safety protection and environmental protection, as well as the necessary procedures of conformation on the condition that they are set in accordance with agreements or arrangements with concerned countries.

The United Nations Economic Commission for Europe is one of five regional commissions of the United Nation, set up in 1947 by Economic and Social Council (ECOSOC). Its aim is devel-opment of economy and promotion of economic integration within and outside the region. UNECE serves as a regional forum for governments to develop conventions, norms and standards aimed to facilitate harmonization and dialogue between member countries. UNECE ensures consumers with guarantees of safety and quality, assists to protect environment, simplifies trading, as well as pro-motes close collaboration of member countries within the region and their integration with the world economy.

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The essential function of the World Health Organization (WHO) is solving international is-sues of human health care and health security.

WHO deals with a wide range of issues. Though the special attention is paid to establishing and developing of effective health services, preventing eradicating diseases, improving environment and improving standards of teaching and training in the health and related professions.

The International Featured Standard (IFS) provides food products safety internationally.

IFS food standard is based on ISO 9001 and HACCP principles and ensures food and pack-aging safety used for food products production. IFS standard provides:

- common standards to food processing, hygiene, technologies and employees competence; - a uniform evaluation system to estimate the manufacturer’s capacity to produce and supply

with safe food products in accordance with product specifications and legislative standards; - costs reduction of food products conformity assessment procedures for supplies.

The requirements of the IFS can be divided into management of the quality system, resource management, production process, management responsibility, evaluation, analyses and improve-ment. IFS requirements structure is given below (Fig. 2.2).

Today IFS is a widely recognized international safety standard for all food producers. In par-ticular, IFS standard is supported by the largest retailers that account more than 60 percent of the whole world trade.

In the EU countries the IFS is the most important standard for the suppliers of leading retail-ers. For example, to make a supply agreement with members of the German retail federation (Hauptverband des Deutschen Einzelhandels) or its French counterpart (Fédération des enterprises du Commerce et de la Distribution) the supplier, regardless the country of food origin, should have the IFS certificate. The IFS is widely applied in Austria, Poland, Sweden, Italy and others. The IFS created the uniform system of evaluation of sellers, suppliers and producers of food products.

Fig. 2.2 IFS requirements structure

In the sphere of agricultural products safety the international standard GlobalGAP (former EurepGAP) of products safety ensuring Good Agricultural Practises (GAP) is widespread. The GAP standard is aimed to minimize the agricultural production risks by controlling the whole chain of food production. GAP practice means creating the conditions excluding the possibility of chemi-cal contaminants gathering in produced products and preventing mechanical and microbiological contamination. GAP certificate guarantees that the specific product is produced according to all strict standards and requirements.

IFS requirements

Quality and safety systems management

Resources management

Production processes

Responsibility management

Estimation, analyses, improvement

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The standard development in accordance with HACCP principles allows controlling produc-tion hazards and determines critical directions that can influence on safety and quality of the prod-uct. The standard deals with a wide range of industries of crop growing, livestock breeding and fish farming. At present GlobalGAP standard is the most widespread one in the world concerning the agricultural production safety. GAP effectively works in many countries, and more than 80 000 farms have been certified.

2.2 Food raw material and food safety in the EU cou ntries

Food safety and quality are essential for existence, prosperity and life quality. They are im-portant for sustainable development and focus a special attention on nature and environment protec-tion, as well as on demography and economy in the region. The European Union undertakes to en-sure the delivery of the safest food productss in the world. This approach is covered by the Direc-tive 2004/41/EC (93/43/EEC).

The European Union has introduced innovative instruments in the field of conformity as-sessment that ensures free circulation of goods within the EU market on the one hand, consumer and environment safety and protection on the other hand. This policy is embodied in the documents of New and Global Approach. The New Approach and the Global Approach are European direc-tives that ensure the uniform food standards and food conformity assessment and that must be ap-plied by each member state of the EU. Currently the technical legislation of the EU is represented by the three types of directives: general directives, “old approach” directives, the New Approach and the Global Approach (fig. 2.3)

Fig. 2.3 The EU technical legislation scheme

THE EU TECHNICAL LEGISLATION

«OLD» APPROACH DIRECTIVES

NEW APPROACH AND GLOBAL APPROACH DIRECTIVES

GENERAL DIRECTIVES

The general safety of products

Producer re-sponsibility

Horizontal directives Essential require-ments to hazards (risks)

Vertical directives Essential require-ments to products groups

Vertical directives Products specific requirements

Toys

Food products

Electromag-

netic compati-bility

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The New Approach to technical harmonization and standardization (1985) mostly covers the development of uniform EU norms that set out product regulation, while the Global Approach (1989) develops product conformity assessment. Concepts of the New and Global Approaches meet the requirement of the EU essential aim of ensuring free product movement and product safety.

Directives of the New Approach and Global Approach set out general requirements to a prod-uct. These directives can be nominally divided into horizontal and vertical. Horizontal directives de-scribe essential requirements to specific hazards and cover general groups of products. Vertical direc-tives set out requirements to specific products.

In conformity assessment the EU countries regard the conformity presumption as the essential principle, which means that the manufacturer declares his product to be complied with any harmonized standard/ standards. And this declaration can not be challenged until the opposite is proved.

The EU legislative framework plays the most important role in the area of food safety ensuring. The modern EU system of drafting and introducing of legal acts in food safety area has been shaped by the EU Institutions (fig. 2.4).

Fig. 2.4 The EU legislative system structure

The European Economic and Social Committee and Regions Committee are consultative as-semblies issuing opinions to the Council and the Commission.

The first three institutions are main law-making bodies. The Parliament and the Council are equal and can be compared with upper and lower chambers of any national parliament.

The European legislation in the area of food products can be divided into the three main groups (fig. 2.5)

Fig. 2.5 The EU food legislation structure

Food safety legislation deals with food hygiene, food additives, materials contacting with food, new types of food products, as well as control systems. Most of these laws are horizontal, i.e. requirements are applied to a wide range of products and processes. Besides, there are some specific (vertical) regulations.

EU Established Institutions

The European Parliament

The European Council

The European Court of Auditors

The European Court of Justice

The European Commission

The EU legislative system concerning food products

Food information legislation Food safety legislation Food quality legislation

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The second group of laws covers information to consumers, which is generally provided on labels.

The third group of laws – food quality acts – ensures the quality protection and includes ver-tical directives, i.e. directives concerning dairy products, diet food and food specific to some re-gions.

The EU technical legislation includes approximately 250 legal acts on food productss and food raw materials, there are more than 170 directives and regulation enforced in the EU concerning general methods of testing and food analysis.

The EU legislation meets the requirements of the Codex Alimentarius Commission and ful-fils its responsibility to the WTO. There are more than 300 international standards of the Codex Alimentarius that compose the bases of the EU food legislation.

Each member state is responsible for compliance with the directives. The directives also set out general approaches to control, test sampling and food testing. Member states are obliged to only inform the EU Commission about their activities.

The European policy in the area of food products tends to put responsibility for food control on manufactures. There have been developed and introduced food safety warning systems which allow to identify and control potential dangers. These systems ensure risk minimizing control rather than food safety control during the production. Therefore, the functions of the mentioned bodies are reduced to supervising the fact of introduction and controlling implementation of the corresponding systems.

The EU general principles on food and agricultural products safety were reviewed and adopted on January 28, 2002. Control and monitoring are provided through the food whole produc-tion chain from “farm to table”. The legislation in the area of uniform control is supported by the activity of the European Food Safety Authority – a body which provides scientific and technical support for the EU’s legislation.

The essential legal act of the EU in this area is Regulation No. 178/2002/EC of the Euro-pean Parliament and of the Council of January 28, 2002. This Regulation sets out general principles and requirements of food law, establishes the EFSA and describes the procedures concerning food safety. The Regulation of January 28, 2002 must be adopted by all EU member states.

This regulation is aimed to assure the basis for high level protection of human health and consumers’ interests in food industries taking into account the food products diversity. Such a gen-eralization has resulted in a solid scientific basis and an effective organizational structure. The Eu-ropean Food Safety Authority has been established by this Directive.

The EU Regulation aimed at free movement of safe and quality goods, health and prosperity of citizens, protection of their social and economic interests, a high level of life and health protec-tion.

The Regulation establishes the principles and procedures unification in order to create and uniform basis for decision making about food and forage products in member states independently and in the EU. The Regulation covers all the levels of production chain. All the principles and pro-

42

cedures set by the Regulation were introduced in member countries before January 1, 2007.

Main aims of the technical regulation (fig. 2.6) are:

1. Assuring a high level of protection of human life and health, of animal health, plant health and the environment on the basis of “from farm to table” principle;

2. Harmonization of the current national requirements in order to provide free movement of food and forage in the EU;

3. Developing the EU food laws in accordance with international standards.

Fig. 2.6 Regulation No. 178/2002/EC of January 28, 2002 Aims

Regulation No. 178/2002/EC also sets out the principles of the technical legislation in the area of food safety (fig. 2.7).

Fig. 2.7 General principles of Regulation 178/2002/EC on food safety

Regulation No. 178/2002/EC establishes the risk analysis principle in relation to food and establishes the structures and mechanisms for the scientific and technical evaluations which are un-dertaken by the European Food Safety Authority. The Regulation establishes the three inter-related components of risk analysis:

risk assessment – scientific assessment of risk which is undertaken in an independent, objec-tive and transparent manner on the best available science;

risk management – the process of weighing alternatives in the light of results of a risk as-sessment and, if required, selecting the appropriate actions necessary to prevent , reduce or elimi-nate the risk;

informing on risk – the process of communication with the general public where it is consid-ered necessary for the protection of human or animal health.

Regulation No. 178/2002/EC aims

Current national require-ments harmonization

Human, animals, plants and environment protection

The EU food legislation development

Food safety principles

Risk analysis and risk man-agement

Openness General obliga-tions in food trading

Food legislation general re-quirements

Food products and forage traceability

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Openness of food safety and the protection of consumer interests are of increasing concern to the general public, non-governmental organizations, professional associations and international trade partners. Therefore, the Regulation establishes the framework for the greater involvement of stakeholders at all stages in the development of food law.

The principle of general obligations of in food trading means that food and forage exported or imported for placing on the market shall comply with the requirements of the EU food law.

The principle of food legislation general requirements is the principle of great importance. Food should not be placed on the market if it is unsafe. Food is considered unsafe if it is injurious for health or/ and unfit for consumption. In determining whether any food is unsafe, regard should be regard to the normal conditions of use the food, to the information provided to the consumer, to the immediate effects on the health of a person consuming that food, to the toxic effects and to the health sensitivities of a specific category of consumers. Where any food which is unsafe is part of a lot, it should be presumed that all the food in the lot is also unsafe.

Forage should not be placed on the market or fed to any animal if it is unsafe. Forage should be deemed unsafe if it has an adverse effect on human or animal health. Where an unsafe forage is a part of a lot, it should be presumed that all the lot is also unsafe. Food and forage business operators at all stages of production should ensure that foods or forages satisfy the food law requirements.

The food, forage and any other substances traceability principle intended to be incorporated into a food or forage must be established at all stages of production, processing and distribution. For this purpose food and forage business operators should apply specific systems and procedures. The regulation sets out provisions (applied since January 1, 2005) for traceability. Traceability means the ability to track the movement, location and origin of food, animals and animal components in-tended to be used as food at all steps of production, processing and distribution. In the case of hu-man health hazard attributes generation by food products the authorized bodies are able to apply risk management corrective actions.

Importers must point out an exporter-company where the products were bought in the coun-try of origin. If a food business operator considers that a food or forage which has been imported, processed, manufactured or distributed is not in compliance with the food safety requirements, it should immediately initiate withdrawal procedures and inform the authorized bodies.

To ensure the high level of health protection in the EU there was established the principle of Environmental Conservation, resulting in barriers to free food and forage movement.

The European Food Safety Authority (EFSA), established by Regulation No. 178/2002/EC of January 28, 2002, provides scientific and technical advice and foundation for Eu-ropean policies and legislation in all areas which have direct or indirect impact on food and forage safety. It should provide objective information on any issues in the frame of these areas and should exchange information on risks. The Authority should contribute to the reaching of the high level of human life and health protection, therefore it should take into account animals and plants health and welfare in the context of the internal market functioning.

EFSA aim is also a creation of a net for the Rapid Alert System for Food and Forage that was established as a tool to exchange information about measures taken responding to risks de-

44

tected in relation to food and forage. The RASFF consists of surveillance authorities of the EU and member countries. EFSA’s role is to collect and analyze data to allow characterization and moni-toring of risks to foods and forages.

EFSA’s organizational structure:

- The Management Board; - The Executive Director and Employees; - The Advisory Forum; - The Scientific Committee and Panels.

EFSA started to work on January 1, 2002.

Danger formation reason could be pesticides, for example. These substances should be au-thorized (Directive 91/414/EC). The authorization is conducted by each member country separately. Only plant-protecting agents listed in the Directive Addition could be applied. European Parliament and Council Regulation No. 852/2004 of January 1, 2006 on the Food Hygiene is the most impor-tant legal act in this area.

There is also a separate Directive No. 89/397/EC of June 6, 1989 on the Official control over food products. It lays down the general principles for the performance of official control of food productss, additives, vitamins, mineral salts, materials intended to come into contact with food productss. In accordance with this Directive member states should ensure that products intended for consignment to another member state are inspected with the same care as those intended for mar-keting on their own territory.

Council Directive No. 2000/13/EC of March 20, 2000 lays down approximation of the member states laws relating to labeling, presentation and advertising of food products. Labeling should include the list of ingredients in descending order of weight. Besides, there must be indi-cated the date of minimum durability or “the use by” date in case of food products that are highly perishable from the microbiological point of view, special storage and consumption conditions de-scription. Label should contain the name and the address of the manufacturer, or packager, or seller established within the EU.

All the labeling information should be marked in such a way as to be easily visible, clearly legible and indelible. If food products are highly perishable from the microbiological point of view which after short period of time could be harmful for human health, the expiration dates must be replaced by consumption dates. These dates are written as follows: “Best before…/use in …” (men-tioning time for the goods of fast spoiling).

2.3 Food safety ensuring system in France

Food safety system of France is one of the most effective practices of ensuring food prod-ucts and food raw materials safety. Agricultural products are provided by farmers that account for 4 percent of the population. The typical rural landscape of Burgundy is in the pic. 2.8.

45

Fig. 2.8 Typical rural landscape of Burgundy

Agricultural products producing is provided by French farmers representing 4% of country population (pic. 2.9, 2.10). The livestock sector is dominated by the Charolais breed of cattle. The average size of the farm is 70 heads, the large farms account 300 – 400 heads.

Fig. 2.9 Cattle farm of Mr. Pikar in Burgundy

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Fig. 2.10 Mare machine-milking on the farm Semur-Shation

In France, there are 46 natural parks, where numerous programs of sustainable development have been realized. (pic. 2.11, 2.12). The general programs feature is their integrity consistency dur-ing their development and implementation.

Fig. 2.11 Vineyards in Morvan national park

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Fig. 2.12 Henry Wezlee Wine Factory

The French agricultural production is strictly controlled and financed by the government. In 2009 only direct assistance to producers was € 16 billion. Three fourths were ensured by the EU, ¼ was provided by the state government. ASP agency coordinates activities of the government and the manufacturer. The agency conducts 5, 5 mln payments per year, 114 mln refunds per year. Control of such large financial flows is an issue of a great importance. So, regional ASP centre in Burgundy undertakes 28 thousand audit procedures per year. 20 percent of the employees in the centre (15 persons) are auditors. They work with documents and visit farms.

There are 5 control points in food production:

- by manufacturer; - by the syndicate of food quality protection; - on the national level; - by the certification body; - on the level of the commune.

Besides, private and other kinds of norms can be applied. Most manufactories function in the condition of the highest hygiene standards (pic. 2.13).

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Fig. 2.13 Cheese production Gaugry

In production and putting on the market of farm products in France the regulation by the EU laws is 80 percent, while inner regulation is only 20 percent (table 2.1).

Table 2.1 General structure of the legislative EU acts applied in France

General Food Law (Regulation No. 178/2002)

Regulation

object Specific forage hygiene rules

General sanitary rules for all food products (including retail)

Special sanitary rules for food products of animal origin (ex-cluding retiling except for par-ticular cases)

Industry Regulation No. 183/2005

Regulation No.852/2004

Regulation No.853/2004

Control authorities Regulation No. 882/2004 Official controls

Regulation No. 854/2004

The Hygiene package includes: Directive 2002/99(sanitary police) и Directive 2004/41(directive on re-pealing)

Coordination of the measures on ensuring of food products and food raw materials safety in

France is provided by several authorities (fig. 2.14), on several levels of food safety regulation and their cooperation (fig. 2.15).

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Fig. 2.14 Essential parties of food safety ensuring in France

Ministry of Food production, Agriculture and Fishery ensures food safety for Veterinary and Phytosanitary in the following directions:

- animals health; - animal welfare; - plants health; - environment protection; - veterinary public health, food toxic infection in investigation

Ministry of Trade and Consumer Affairs ensures trading on mutually beneficial principles.

Ministry of Healthcare ensures investigations of facts of food toxic infections and water safety control.

Direction Générale de l'Alimentation (DGAL) (for food products) deals with issues of food products safety at every stage of production chain, from raw materials for cattle or plant breeding to retail system.

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Fig. 2.15 Food safety regulation levels in France

The directorate general for food products ensures food products quality (abundance, compli-ance to hygiene sanitary norms and norms of food indicators, sufficient food products quantity).

The directorate general for food products lays down food products legislation and controls the laws observation in regions.

The directorate general for food products commits the funds to regional directorates of food products, farming and fishery. Funds are committed for plan and special tasks. So, in 2010 the total amount of funding for regional directorates was € 565 mln.

Thus, in France there is an inseparable vertical from the central government to local authori-ties.

Departamental directorates for the population protection (DDPP) aim to:

- produce in a safe, harmless and painless way; - control the whole production chain from initial stages of processing up to final shipment; - control “from stable to table”.

All Departmental Directorates for the protection of the population are responsible for the following tasks:

1. Public Health Protection: Departmental Directorates for the Population Protection control the provision of requirements concerning infections of animal origin. Directorates are obliged to ensure food safety and prevent the risk of food contagiousness. Departmental di-rectorates for the protection of the population organize inspections for companys and check

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the self-control of food and forage manufactures. Departmental Directorates for the Popula-tion Protection work out the official plans on wastes and substances control and inspection annually.

2. Animal Health Protection: Departmental Diretorates for the Population Protection organize epidemiological control of general animal diseases. If an outbreak is suspected or confirmed, all the immediate precautions must be taken.

3. Environment protection: Departmental Directorates for the Population Protection work to make all the farms and plants environmentally friendly.

4. Among the duties of Departmental Directorates there is a seafood sanitary inspection.

5. Mutually beneficial trade. Departmental Directorates are obliged to ensure that participants follow the rules of mutually beneficial trading.

Departmental Directorates for the Population Protection have several governmental func-tions to ensure food safety. They grant certificates (or register them depending on a legislation) to companies which meet the EU requirements.

Departmental Directorates of the Protection of the Population exercise official control of the whole production chain (production, processing, retailing, transporting). They also check confor-mity assessment in relation to company operation, hygiene of the premises, transporting and stor-age.

The officials of the departmental directorates for the protection of the population have the right to:

- inspect food production, day and night, during the production phase; - withdraw food samples for additional checks and laboratory tests; - destroy food that is unsafe for people.

Some officials of the departmental directorates for the protection of the population work in slaughterhouses during the whole year, where they carry out daily sanitary meat inspection.

Regional certification of food is more important than the EU certification in France. And very often peculiar approaches in food safety ensuring are used. For instance, dairy plants pay to farmers for spoiled or infected milk in order to prevent milk suppliers from failure to mention harm-fulness of raw milk. Otherwise milk suppliers are imposed by a high finDepartmental Directorates for the Population Protection arranged their own block-chart of activities (fig. 2.16), and assumes the tasks of the Veterinary Services.

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Fig. 2.16 Block-chart possible variants (a, b, c) of activities of Departmental Directorates for the Population Protection in France

Departmental Directorates of the Population Protection also carry out the functions on ex-ported food safety providing.

Departmental Directorates of the Population Protection issue the license (or registration de-pending on legislation regulations) for companies meeting the third countries requirements.

Departmental Directorates of the Population Protection exercise spot checks for the third countries requirements.

Departmental Directorates of the Population Protection control the animals, plant, foods and forages certification.

The veterinary certification guarantees the compliance with all the sanitary requirements.

a)

Departmental directorate

Safety and risk man-agement in company

Food safety

Food and beneficial trade

Animals health, wel-fare and forage


Control Animals health and welfare

Food safety Environment

b)


Consumers’ rights protection and prices

monitoring

Food quality and mu-tually beneficial trade

Animals health and welfare: poultry and

others

Ruminant animals health and welfare

c)

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Certification is carried out by the official veterinarian (regulation EC 854/2004) – a state of-ficial with approved sanitary mandate. He is approved by the French Veterinary service to fulfill his tasks. He is not exerted to any commercial or financial pressure. His sphere of activity is regulated by laws. He is aware of legislation and certification procedure.

The certification procedure in France is standardized. And only highly skilled official vet-erinarians have the right to grant certificates. They check the information, necessary for the certifi-cation procedure, personally. Certificate can be given by:

- a veterinarian from one of the Departmental Directorates of the Population Protection; - a veterinarian of the slaughterhouse with a permission to export; - a veterinarian at the Duties (Marseille) (in very rare cases).

The Directorate General for Food products, regional and departmental levels have been re-cently accredited. In France official accreditation is fulfilled by the French Committee for Accredi-tation (COFRAC), the only authoritative organization by Decree of December 19, 2008. Accredita-tion should be operated by the national body (Regulation of July 9, 2008).

France anticipated the appearance and development of marks that characterize the food of a high quality. So, for instance, an exclusive product originating from the particular locality, AOC (protected geographical status), the name which has been used for long in France, has an imprint of culture, history, technology peculiarities, traditions, i. e. all the elements serving to designate the locality. Such a product personifies all the diversity and represents a national cultural heritage. Fol-lowing the example of France the European Union introduced measures to protect the reputation of the regional foods. In the framework of the EU legislation Protected Designation of Origin (AOP in French) serves to protect AOC. Protected Geographical Indication (IGP) is also associated with re-gional foods.

The long history of the French policy in the area food quality ensuring allowed to establish a platform of work ethic in agricultural sector and provided with legal tool that allow to identify the product origin, estimate specific technologies and protect the product reputation. Besides, there were introduced specific laws in the area of health and environment protection, so that the notion of quality could be included into any measures for the rational usage and reproduction of natural re-sources.

A specific French legal mechanism, comprising controlled names with AOC, agricultural trade marks, since 1980 includes the conformity certificate and label AB (product of biological agriculture). These official tools ensure food compliance with the certificates and control over the correctness of their application by official certificating bodies, approved by state authorities after the positive con-clusion of the Commission on trade marks and certification of agricultural products and food.

Logos of official food quality labels in France are shown in pic. 2.17.

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Fig. 2.17 Logos of official food quality labels

These four labels (AOC, Attests to the Superior Quality, the Certificate of Conformity and AB) were recognized by the European legislation, what allows to join the legal protection of food names with specific geographical origin of foods produced in a traditional way and those of bio-logical agriculture.

Any application for the product protection by AOP should include application for AOC to national authority. Any application for IGP should be applied only along with applying for a trade mark or a Certificate of Conformity. Authorities competent in the area of the European legislation are the National Institute for Certification and Trade Names Protection, and the Committee on Trade Marks that give their conclusion about passing AOP and IGP applications to the European Commission by the government of France.

In many countries it is believed that food with original quality specified by unique local conditions is a heritage that should be saved and protected.

The food quality in France is inspected on every stage of production and distribution. Produc-tion and distribution of food products is regulated by laws that set out minimum requirements to project-ing, makeover and facilities of the premises as well as hygiene rules for employees and equipment. Con-formity to these regulations is proved by the official sanitary conclusion.

State inspectors regularly check the rules observation by specialists. So, sanitary and epidemiol-ogical control is carried out from the moment of food production to its buying by a consumer. State au-thorities employ 5200 inspectors to control food quality and safety.

The European legislation was corrected in the result of the measures to harmonization of systems of inspection and certification in order to create conditions for food trade globalization. Currently specialists of the agricultural sector have tools to fulfill their responsibilities in the area of hygiene and quality of the product produced. It concerns, on the one hand, the application of the system of Hazard Analysis an Critical Control Point in the area of food safety ensuring; and on the

55

other hand, applying by manufacturers the Quality Assurance System, particularly in the form of plant certification.

So, adequate quality ensuring tendency while above mentioned norms keeping concerning food prices increasing because of food processing and concerning French and foreign consumers demands satisfying is a basic priority of high importance from the state authorities point of view.

The French Food Safety Agency was established by the Law of July 1, 1998 on monitoring public health and regulating products intended for human consumption.

The FSSA assesses “the sanitary and nutritional risks food intended for human and animal consumption”, including risks of “water intended for human consumption, methods and conditions of food products production, processing, conservation, transporting, storage and distributing”.

The agency also assesses risks posed by “animal diseases and infections, plant protection products, animal medicaments, incl. medicaments preparing right before application, medical food additives, agricultural pesticides and similar substances, fertilizers, plant growth stimulants” as well as “packaging materials and materials contacting with the mentioned above products”.

To fulfill its tasks this national authority for health, agriculture and consumer affairs can regulate any issues and offer to the competent bodies any measures directed to protection of public health. Being a consulting body in the area of sanitary control and inspection, it can draft any priori-ties and give its recommendations. In its disposal, there are state official and its own laboratories that control sanitary safety of food.

2.4 Food safety ensuring experience in Germany

Concerning enhancing of food safety, Germany has gained a lot, according to the German Minister of Food, Agriculture and Consumer Protection Ilse Aigner. There were improved organ-izational institutes, there was strengthened food safety control, ensured more transparent informa-tion for consumers, improved the EU legislation and developed collaboration with informational agencies of other member states. Scientists, businessmen, officials learned a lesson from the previ-ous experience. The gained knowledge about food allows them to improve the collaboration di-rected to consumers’ rights protection.

A high safety level of food from Germany is recognized all over the world. It results in a great demand for German foods on the world market. It is correct that German food products are safe today as never before. To save the current safety of food is an everyday non-stop task for every participant.

Variety of products of one average supermarket in Germany accounts 10 thousand names, and big supermarkets can offer as many as 60 thousand food names. There are hundreds of kinds of bread, meat, cheese, sausages, fruits and vegetables from different countries, fishes from all the seas, regional sweets and international traditional dishes, ham, pasta and others.

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Modern food processing, international trade and wide logistic system permits to have food at any time, whenever or wherever we want. It is as simple as never. But how not to be lost in this food abundance? This abundance also has its price. Global market, international product flows and dynamically developing tendencies of production technologies and consumption habits result in new risks and require new food safety ensuring strategies.

When the European Commission decides to introduce a new program of food quality and safety control, it is taken into account by inspectors in the area of food control. And vice versa, whenever there is a harmful substance discovered in food, the laboratory should inform other Euro-pean states.

The German system of food safety is shown in fig. 2.18. Tasks are shared between local, na-tional and the EU levels. Such a system is simple: each body in its place should ensure food safety and know the partners of the chain.

On the local level food safety is the responsibility of food companies (plants, farms, cater-ing) owners. They are highly responsible for food products safety if it is an industrial plant, farmer, baker or restaurant owner. Officials of city and regional food safety authorities and veterinary ser-vices make a sample monitoring of food safety quality management system.

Federal Land Ministry coordinates inspection of land. The lands representatives, in their turn, closely collaborate with federal authorities when it is necessary, for instance, to harmonize federal programs for food safety and quality control systems, or in case of emerging risks concern-ing food products.

On the federal level of safety ensuring there is applied a principle of division of compe-tences. The Federal Ministry for Food, Agriculture and Consumer Protection (BMELV) supervises the development of legal regulations, as well as develops other measures in the area of risk man-agement. It is generally responsible for appropriate measures choice.

Scientific work is sphere of the Federal Institute of Risk Estimation (BfR) competence. Its task is to give consulting assistance to BMELV. BfR gives objective scientific conclusions.

The Federal Office of Consumer Protection and Food Safety (BVL) exercises the practical assistance. This office coordinates the work between federal, lands and the EU authorities.

Similar division of competences can be found on the EU level of food safety ensuring. Alongside with the European Parliament and Council, the European Commission is one of political partners, with which BMELV collaborates. The Commission receives consultations from EFSA. The Food and Veterinary Office (FVO) fulfills the tasks similar to those of BVL on the national level. The Office checks the systems of food safety and quality control in member countries and in third countries as well. Outside the EU there are other authorities that develop food safety stan-dards, like Codex Alimentarius. German specialists also take part in this work.

57

Fig. 2.18 Food safety ensuring system in Germany

58


1. What are market regulation forms? Describe its sense.

2. Specify subjects and objects components of market regulation.

3. What is Codex Alimentarius committee?

4. What are the World Trade Organization objectives?

5. Describe the sense of New and Global approaches.

6. What is the order of production marking with CE mark?

7. Specify the requirements structure of IFS standard?

8. Name the directives of the EU Technical Legislation.

9. Describe the EU food legislative system structure.

10. What is the main EU legislative Act concerning food products safety?

11. Name the aims of Regulation 178/2002/EC on food safety.

12. Specify food safety principles.

13. What are the functions of European Food Safety Authority (EFSA)?

14. Name food safety regulation levels in France.

15. What are the functions of Departmental Directorates for the Population Protection?

16. What does “product of a region” term mean?

17. What are the main logos of the official food quality labels in France?

18. Name food safety regulation levels in Germany.

2.6 Summary

Organizations acting on behalf of the countries - members of the international treaty – and undertaking to lower or remove technical trade barriers are regulation subjects of international goods market. The member countries, acting under the treaty commitments and providing inspec-tion of their internal market, themselves are also subjects of international goods market.

On the part of intergovernmental organizations the regulation objects are relations between interested parties concerning measures undertaking before products access in market and measures on market inspection.

The World Trade Organization (WTO) was created in 1995 and replaced the General Agreement on Tariffs and Trade (GATT) – as the only global international organization dealing with the rules of trade between nations. WTO encourages regulation of trade relations on rules ground, settlement of commercial disputes between governments, and organizing of trade negotiations.

The EU Directives providing CE marking cover industrial products solely as regulation ob-jects. The EU approach to food regulation differs from that to industrial products by conformity as-sessment. The essential form of food products conformity assessment is market inspection.

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The Codex Alimentarius is an important collection of international standards for food prod-ucts. The Codex Alimentarius Commission was established by the Food and Agriculture Organiza-tion (FAO) and the World Health Organization (WHO) in 1961 – 1962 to provide consumer health protection and fair practices in the food trade. The Commission develops world standards, guide-lines and practice codes for food safety.

Currently the technical legislation of the EU is represented by the three types of directives: general directives, “old approach” directives, the New Approach and the Global Approach. In con-formity assessment the EU countries regard the presumption of conformity as the essential principle, which means that the manufacturer declares his product to be complied with any harmonized standard/ standards.

The International Featured Standard (IFS) provides food products safety internationally. The requirements of the IFS can be divided into management of the quality system, resource man-agement, production process, management responsibility, evaluation, analyses and improvement.

The EU legislative system plays the most important role in the area of food safety ensuring. The European legislation in the area of food products can be divided into the three main groups: food safety, food information, food quality requirements.

The EU essential legal act concerning food and agricultural products is Regulation No. 178/2002/EC. The regulation establishes principles of technical regulations in the area of food safe-ty, risk analysis and risk management, transparency, general obligations of food trade, general re-quirements of food law, traceability of foods and forages.

The European Food Safety Authority (EFSA) provides scientific and technical advice and foundation for European policy and legislation in all areas which have direct or indirect impact on food and forage safety.

Coordination of the measures on food safety ensuring in France is provided by the Ministry of Agriculture, Food and Fishery, Ministry of Trade and Consumer Affairs, Ministry of Health. Thus, in France there is an inseparable vertical from the central government to local authorities, including the Ministries, regional and departmental levels.

Departmental directorates for the Population Protection (DDPP) aim to produce in a safe, harmless and painless way; to control the whole production chain from initial stages of processing up to final shipment; to control “from stable to table”.

The four labels (AOC, Attests to the Superior Quality, the Certificate of Conformity and AB) were recognized by the European legislation, what allows to join the legal protection of food names with specific geographical origin of foods produced in a traditional way and those of bio-logical agriculture.

A high safety level of German food is recognized all over the world. It results in a great de-mand for German foods on the world market. System of food safety ensuring is one of the best practices in the EU. System tasks are divided between local, federal and the EU levels.

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3 Food safety ensuring development in the Russian Federation

The chapter describes the methods of products and services regulation, classification and features of technical standards, financial and economic aspects of introduction of technical stan-dards, national and regional competitions and rewards for product quality.

Plan

3.1 Regulation methods for the goods and services market.

3.2 Technical standards and technical regulation.

3.3 Technical regulation system modernization.

3.4 National and regional competitions and awards in the context of production quality.

3.1 Regulation methods for the goods and services m arket

Article 74 of the Russian Federation Constitution sets out limitations on the goods and ser-vices transfer may be introduced according to national law, if it is necessary to ensure security, pro-tect the life and health of people, protect nature and items of cultural values. This norm strictly re-duces any possible foreign impact on the goods market.

In other words, the properties of goods and services that can have a negative influence on human life and health, the environment and items of cultural value are outside the framework of the market self-regulation. The rest properties should be within direct market self-regulation. The in-formation character determines the regulation methods (fig. 3.1). Regulation measures according to regulation methods are given on fig. 3.2.

Descriptive information supposes applying of indirect regulating methods. These methods used by parties of economical activity on their own initiative or on the recommendation of such par-ties like Entrepreneurs Associations or Societies of Consumer Rights protection can be regarded as a specific aspect of self-regulation of goods market. The typical example of this regulation is applying of such regulating measures like Quality Management System and Ecological Management on the basis of international standards, etc.

Government when organizing the activity of goods market regulation (fig. 3.2) differentiates the regulation methods applied and correspondingly the regulation measures between direct – estab-lishing of mandatory requirements, compulsory conformity assessment – and indirect – applying of national voluntary standards, development of voluntary certification, insurance of damage liability, implementation of management systems, training and consumers informing, self-regulating organi-zation forming, national quality awards, etc.

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Fig. 3.1 Regulation subjects and methods according to information type

Fig. 3.2 Regulation measures according to regulation methods

REGULATION METHODS

DIRECT INDIRECT

LEGISLATION ON RESPONSIBI-LITY OF FOOD SAFETY

� Damage liability insurance

� Management sys-tems implementa-tion

� Training and con-sumers informing

� Self-regulatory or-ganization forming

� National quality award

REGULATING MEASURES

TECHNICAL REGULATION AND CONFORMITY ASSESSMENT

� Technical regu-lations

� Mandatory con-firmation of con-formity

� State control (inspection)

� Voluntary standards

� Rules codes � Voluntary cer-

tification

REGULATION OBJECTS

TYPE OF INFORMATION

ON REGU-LATION

OBJECTS

REGULATION METHODS

PRODUCTION

SERVICES, OPERATIONS, PROCESSES

DESCRIPTIVE

NORMATIVE

INDIRECT

DIRECT

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For each market segment – financial, funds, labour and goods – there exist specific forms, methods and ways of regulation and regulating measures that influence one another as well as neighboring segments. Goods market regulation form is technical regulation.

3.2 Technical standards and technical regulation

Technical standards are the base of creating technical regulation system. A technical stan-dard is a new technical regulatory document introduced by the National law and establishes only mandatory requirements to production, processes and other objects.

The technical standard is a document adopted by the Russian Federation international Agreement ratified in order established by the Russian Federation legislation, or by the intergov-ernmental arrangement agreed in order established by the Russian Federation legislation, or by the National Law, or by the Russian Federation President Decree, or by the Russian Federation Gov-ernment Decision, or by the normative legal act of executive federal authority on technical regula-tion and establishes compulsory requirements for application and implementation on technical stan-dards objects (production incl. buildings, constructions and installations or designing (incl. re-searches), production, building, mounting, maintenance, operating, storage, transportation, selling and utilization processes connected with production requirements).

The technical standards are aimed for:

- security for human life and health, natural and legal persons property, state or municipal property;

- environment, animals and plants life or health protection; - prevention of actions misinforming the purchasers; - energy efficiency and resource-saving providing.

Adoption of technical standards for other aims is not allowed.

Technical standard objects are:

- production; - production design (researches including), manufacture, construction, installation, setting-up,

running, storage, transportation, marketing and utilization processes containing the production safety requirements.

Technical standards can be classified by the way of requirements definition (fig. 3.3) or by field of application (fig. 3.4).

Fig. 3.3 Technical standards classification by the way of requirements definition

TECHNICAL STANDARDS

PRESCRIPTIVE TECHNICAL STANDARDS

BASIC TECHNICAL STANDARDS

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Fig. 3.4 Technical standards classification by the field of application

Technical standard has the following typical parts:

- scope and objects of the technical regulation; - basic concepts; - general provisions for placing the product on the internal market; - requirements to the product; - the presumption of conformity; - confirmation of conformity; - official control (inspection); - concluding and transitional provisions; - appendixes.

Technical standard can be adopted by:

- the Russian Federation international treaty ratified in accordance with the legislation of the Russian Federation;

- the intergovernmental agreement; - the national law; - the Russian Federation President Decree; - the Russian Federation Government Decree.

Adopted and active food products and raw materials technical standards are described in the table 3.1.

Table 3.1 Adopted food technical standards

Technical standard Adoption

1. National Law «Fruits and vegetables juice products technical standard»

National Law No. 178-ФЗ dated October 27, 2008

1. National Law «Milk and milk products technical standard»

2. About amendments introduction in National Law «Milk and milk products technical standard»

National Law No. 88-ФЗ (1) dated June 12, 2008 National Law No. 163-ФЗ dated July 22, 2010

1. National Law «Fat-and-oil products technical stan-dard»

National Law No. 90-ФЗ dated June 24, 2008

1. National Law «Technical standard on food safety for children and teenagers»

The Russian Federation Govern-ment Or-der No. 307 dated April 7, 2009

TECHNICAL STANDARDS

GENERAL TECHNICAL REGULATIONS (HORIZONTAL)

MACRO INDUSTRIAL TECHNICAL REGULATIONS

SPECIAL TECHNICAL REGULATIONS (VERTICAL)

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There are two main parts in global state economic regulation system. It is financial and technical (non financial) regulation.

Technical regulation is legal regulation of relations concerning compulsory requirements establishing, application and implementation on production or on designing (incl. researches), pro-duction, building, mounting, maintenance, operating, storage, transportation, selling and utilization processes connected with production requirements, and concerning voluntary requirements estab-lishing and application on production, on designing (incl. researches), production, building, mount-ing, maintenance, operating, storage, transportation, selling and utilization processes, work per-formance or service rendering and legal regulation of relations concerning conformity assessment.

Technical regulation components are presented on fig. 3.5.

Fig. 3.5 Technical regulation components.

Currently technical (non financial) regulation includes:

- compulsory standardization is national standards (GOSTs) multiple requirements, industry-specific standards, sanitary rules and standards (SanPiNs), constructive rules and standards (SNiPs), a lot of other departmental documents, different licensing and registration require-ments, etc.;

- market access system concerning both activity (licensing) and product (estimation and con-formity assessment particularly: declaring, obligatory and voluntary certification, registra-tion, etc.);

- state control and inspection (technological, sanitary-and-epidemiological, fire, building-operating, environmental, etc.).

Technical regulation is a half of global state economic regulation system. Moreover in ac-cordance with estimation of the National Institute of Technical Regulation the technical require-ments complex is more complicated structure comparing with sate financial budget.

Technical regulation is less modernized communication area between state and business community in Russia. The Russia Federation technical regulation system is one of the most crucial problems and at the same time is one of the most crucial resources of country economic and in par-ticular cases socio-political development.

The national law On technical regulation sets out that the submission of draft national law on technical regulation to State Duma by an entity of law if there is financial and economic inter-pretation of national law adoption on technical regulation. Economic interpretation of decisions on technical regulation has two separate objectives:

TECHNICAL REGULATION

Compulsory standardization

Market access system State control and inspection

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1. Costs estimating of the choice result of exact values for safety indicators of given product;

2. Conformity assessment forms and methods choice.

Currently, the main method of estimating investment projects is estimating the costs of their carrying out and planning their results by comparing situations “with the project” and “without the project”. Loss in the form of value loss can be seen in the three areas: public, property and ecologi-cal.

Efficiency is characterized by ratio between results and costs; efficiency always deals with one or several objects simultaneously. By the object indicators are classified as follows:

- public (social and economic) efficiency – towards society in general; - regional efficiency — in terms of the Russian Federation and administrative and territorial

units; - industrial efficiency – regarding economic industries, business associations, holding struc-

tures and financial and industrial groups; - budget efficiency - regarding budget of all levels (in terms of expenses and incomes); - efficiency of participating in the project for a particular company; - commercial efficiency – regarding individuals or legal entities, investing into the project. - In estimating of budget, social and economic effects there should be taken into account that:

а) the result of technical standard implementation has indicators with numerical value;

b) numerical values of results influence the input into GDP.

To determine economic effects of the production conformity assessment forms and methods choice the possible costs value is considered.

Main components of social risk costs are:

- payments for temporary disability; - economic losses resulting from injures, professional diseases or loss of employee’s life; - costs of first aid to the injured and medical treatment; - payments of disability pension; - payments of compensation to the family of a victim.

Main components of property risk costs are:

- costs of repair or replacement of basic assets; - costs of recouping for revolving funds losses; - costs of material and moral compensation in the result of the event of injury, etc.

Main components of environmental risk costs are:

- environmental fines; - costs of natural environment cleaning; - costs of farm lands and forests recultivation, etc.

At present there are several calculation methods of loss value as a result of people death or

66

harm infliction for their health. Main loss components in this case are:

- economic losses resulting from injures, professional diseases or loss of employee’s life; - costs of first aid to the injured and medical treatment; - payments of disability pension and payments of compensation to the family of a victim; - payments for temporary disability. - FTAEC (failures types analysis, effects and criticalness) method is used as a risk estimation

method.

3.3 Technical regulation system modernization

Reformation of the Russian Federation economy that began in 1992 resulted in continual corrective measures to improve separate elements of technical regulation. By the beginning of a new century it was evident that such separate measures can’t correlate the technical regulation sys-tem with the challenges of country development. The technical regulation reform concept was real-ized in National Law On technical regulation.

Modernization of the national certification system is carried out in the framework of forming a new system of technical regulation in Russia. Efficient international market can’t exist with tech-nical trade barriers, that is if there are divergent requirements of national and international stan-dards. Global modernization of the system of technical regulation is connected with the necessity to reduce bureaucracy of the Russian economy, with removal of excessive administrative barriers and with Russia’s entry to the WTO. Objectives and scope of modernization of the system of technical regulation are shown in table 3.2.

One of the main modernization issues is production requirements identifying in technical standards. Technical standards set up minimal necessary but sufficient requirements.

There have been considered the practice of the Community in solving this issue. Application of “old directives” revealed that detailed requirements of the directive lead to its enlarging and a great number of following amendments. Therefore, directives of New Approach only list essential requirements, while harmonized standards support technical details. Each New Approach Directive is supported by 100 harmonized euro standards meeting the requirements of these directives. The given approach is basic in creating of the Russian technical regulation system.

Unfortunately, it must be said that technical regulation modernization aims and objectives were not achieved in determined terms. It was impossible to develop planned technical standards be-fore completion (dated July 1, 2010) of transitional period established by national law On technical regulation. “Old” conformity assessment national system had been operating for the most part in Russian Federation before 2011 (table 3.3).

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Table 3.2 Objectives and scope of the Russian technical regulation system modernization

MODERNIZATION OBJECTIVES

Administrative and economic pressure reducing on pro-ducers

New opportunities for manufacturers due to removing of excessive requirements, duplicat-ing of procedures and as a result wider op-portunities to take commercial decision

Removing of technical trade barriers

Enhancing efficiency of market protection from hazardous products

MODERNIZATION SCOPE

Requirements division into ob-ligatory and vol-untary, enhanc-ing legal degree of adoption of TR providing obligatory re-quirements and give standards a status of docu-ments for volun-tary application

Obligatory re-quirements identification only in relation to life and health safety of peo-ple, animals, plants, protec-tion of property and environ-ment, and pro-tection of con-sumers against misleading ac-tivities

Functions separation into in-spection (control), accredita-tion and certifica-tion

Creation of transparent and open for interested parties pro-cedures of development of technical regulations and stan-dards

Creation of a uniform system of accredita-tion in the area of con-formity as-sessment

Ensuring com-pliance of tech-nical regulation with interests and level of na-tional economy and interna-tional norms and rules

Table 3.3 Work amount on different types of conformity assessment in Russian Standardization system in 2010

Issued certificates of production con-formity, thousand pcs

Registered declarations of conformity, thousand pcs

in GOST R (Russian State Standards) sys-

tem

for conformity to technical stan-

dards

Certificates share for technical

regulations conformity,

% in GOST R

system

for conformity to technical standards

Declarations share for techni-cal regulations conformity, %

244,4 80 24,7 202 24,5 10,8

Many conformity assessment leading specialists and experts seriously worry about present situation with technical regulation system condition and modernization speed. By their estimation

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production safety ensuring level has drastically decreased after the Government Decree No. 982 dated December 1, 2009 adoption that seriously expanded the list of products for declaring without other elements functioning in safety ensuring system, namely, control, inspection and producer re-sponsibility.

This area decision making main principle carried out by world community is interest balance keeping between product safety and its freedom of market circulation, i.e. business freedom from unreasonable administrative barriers. Decreasing condition of goods safety is a result of this princi-ple realization importance underestimation during business development.

Developed technical regulation system modernization concept in Russia was subject to es-sential correction because of the CU countries technical regulation system establishing. For the CU integration processes extension and intension under Eurasian Economic Community and common economic space forming the Agreement “On unitary principles and rules of technical regulation in Republic of Belarus, Republic of Kazakhstan and Russian Federation” was signed on November 18, 2010 by Republic of Belarus, Republic of Kazakhstan and the Russian Federation. Basic mod-ernization tends of technical regulation system in the CU countries are presented in fig. 3.6.

Fig. 3.6 Basic modernization tends of technical regulation system in the Custom Union countries

Many experts estimate this Agreement as stronger alliance type comparing with alliance type of the European Union because only supernational authority body sets the food products re-quirements binding on application within short period of time. National and Unitary Regulation modes have been in operation on alternative base since July 1, 2010 throughout the CU countries territory. Corresponding national norms will stop in operation within short period of time.

The Agreement parties establish cooperated policy concerning technical regulation, sanitary and phytosanitary measures. The CU technical standards have direct influence on the CU custom territory. Conformity assessment to the CU technical standards of production putting in turnover is

6. The CU countries cooperation

5. International & re-gional standards ap-plication for confor-

mity assessment 4. Unitary forms,

schemes and proce-dures of conformity

assessment

3. Delegation the powers on TR adop-

tion to supernational authority body (the

CU Committee)

2. Production re-quirements determi-

nation in unitary technical standards

(TS)

1. Creation the uni-tary list of potential dangerous produc-

tion

Modernization tends of cu technical regu-

lation system

69

accomplished before its putting in turnover.

Parties provide turnover of production that meets the CU technical standards requirement throughout the CU territory without asking the supplementary requirements concerning containing in the CU technical standards requirements to such kind of production and without asking the sup-plementary conformity assessment procedures. The most important normative documents for the CU technical regulation system development are given in table 3.4.

For the CU unitary normative base development concerning technical regulation the Agree-ment parties establish the unitary list of production that is under compulsory requirements within the CU. There are the CU legislative norms and the CU countries legislation norms concerning technical regulation for production included in this list but that is not under the CU technical stan-dards or Eurasian Economic Community technical standards. The unitary list and its introduction order are confirmed by the CU Committee. The parties do not allow to establish the compulsory re-quirements in their legislations concerning production that is not included in the unitary list.

Table 3.4 Basic normative documents for the CU technical regulation system development

Document name Adoption

The Agreement “On unitary principles and rules of technical regulation in Republic of Belarus, Republic of Kazakhstan and the Russian Federa-tion”

Agreement dated November 18, 2010

Unitary list of production which is subject to compulsory conformity as-sessment (confirmation) under the Custom Union arrangements with uni-tary documents release

Ratified by the CU Committee Decision No. 319 dated June 18, 2010

The Agreement on mutual recognition of certification (conformity as-sessment or confirmation) authorities and testing laboratories (centers) accomplishing conformity assessment or confirmation accreditation

December 11, 2009, Saint Petersburg

The Statute for Coordination Committee on technical regulation, sanitary, veterinary and phytosanitary efforts application


Conformity Certificate unitary form

Conformity Declaration unitary form


The Agreement on distribution of production which is subject to compul-sory conformity assessment (confirmation) throughout the CU custom area

December 11, 2009, Saint Petersburg

The Custom Union primary technical regulations development schedule Ratified by the CU Committee Decision No. 492 dated Decem-ber 8, 2010

Measures schedule of the Agreement “On unitary principles and rules of technical regulation in Republic of Belarus, Republic of Kazakhstan and the Russian Federation” implementation

Ratified by the CU Committee Decision No. 453 dated Novem-ber 18, 2010

The CU technical standards are developed only concerning production included in the uni-tary list if Eurasian Economic Community technical standards are not adopted regarding this type of production.

In the case of Eurasian Economic Community technical standard adoption regarding produc-tion under the CU technical standard the operating of the CU technical standard or its corresponding part has been stopped since a start day of Eurasian Economic Community technical standard.

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The CU technical standards are developed and adopted for providing the human life and (or) health, property, environment, animals and plants life and (or) health, prevention of actions confus-ing the customers and for energy efficiency and recourses saving throughout the CU custom terri-tory. The CU technical standards adoption for other purposes is not allowed.

Production requirements or production requirements and production, building, mounting, maintenance, operating, storage, transportation, selling and utilization processes connected with production requirements, and also identification rules, conformity assessment forms, schemes and procedures are established in the CU technical standards. Terms, package, marking, labels and its application rules, sanitary, sanitary-and-veterinary and phytosanitary requirements and procedures could be contained in the CU technical standard.

The CU technical standards are developed according to Recommendations on Eurasian Eco-nomic Community technical standard typical structure adopted by the Eurasian Economic Commu-nity International Council Decision No.321 dated October 27, 2006.

Corresponding international standards (rules, directives, recommendations and other docu-ments adopted by international organizations on standardization) are applied as a base for the CU technical standards development excepting the cases of corresponding documents absence or if they do not correspond with aims of the CU technical standards adoption.

Regional documents (standards, directives, decisions, reglaments, rules and other docu-ments), national (state) standards, national technical standards or its projects are applied as a base in the cases of corresponding documents absence.

Special requirements describing features of climate or geographic factors and technological characteristics which are actual only throughout the CU countries territories could contain in the CU technical standards.

National legislative compulsory requirements of the CU countries are stopped in operation as soon as the CU technical standards become effective.

Production under the CU technical standard/s is put in turnover throughout the CU custom territory if it passed conformity assessment compulsory procedures established by the CU technical standard/s.

Production compulsory conformity assessment to the CU technical standards requirements is carry out as conformity declaring or certification. Conformity assessment procedures are deter-mined in the CU technical standards based on conformity assessment typical schemes.

Production meeting the requirements of the CU actual technical standards for this produc-tion that passed the determined conformity assessment procedures is marked with unitary sign of production distribution throughout the CU countries market (fig. 3.7).

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Fig. 3.7 Unitary sign image of production distribution throughout the CU countries market

Conformity assessment typical schemes, conformity assessment documents (Declaration on the CU standards conformity, Certificate on the CU standards conformity) unitary forms, unitary sign image of production distribution throughout the CU countries market and its application order are confirmed by the Committee.

Assessment works on production conformity to technical standard requirements within the CU are accomplished by accredited certification authorities on conformity assessment and testing laboratories included in the CU unified Register of certification authorities and testing laboratories (table 3.5). The unified Register was introduced by the CU Committee Decision No. 343 dated Au-gust 17, 2010 according to the Agreement dated December 11, 2009 on turnover of production un-der compulsory conformity assessment throughout the CU custom territory.

Table 3.5 Сertification authorities and testing laboratories assigned in the CU unified Register

Name Indexes The Russian Federation

Republic of Kazakhstan

Republic of Belarus In CU totally

Total 1038 180 106 1324

In Register 259 120 52 431 Certification authorities

% 24,9 67 49 32,6

Total 3046 500 3000 6546

In Register 291 250 326 867 Testing

laboratories

% 9,5 50 10,7 13,2

The Agreement Parties must harmonize each Party legislation concerning responsibility for the CU technical standards requirements violation and also during assessment works on production conformity to the CU technical standard requirements.

State control (inspection) on the CU technical standard requirements keeping is carried out according to order established by each Party legislation.

Authorized Parties bodies send shortly the information to Integrated information system of the CU external and mutual trade, inform authorized bodies of other Parties and take measures on

72

such production non-admission on country territory while state control (inspection) on production conformation accomplishing, production putting in turnover adding to production of high danger for the human life and (or) health, property, environment, animals and plants life and (or) health.

The Parties form the information system concerning the CU technical regulation as a part of Integrated information system of the CU external and mutual trade.

Total activity coordination regarding technical regulation accomplishes by the CU Commit-tee. The Committee functions are:

- unitary list and its composition order confirmation; - plans (programs) confirmation of the CU technical standards development; - the CU technical standards adoption, correction and cancellation; - order establishing of the CU technical standards development, adoption, correction and can-

cellation; - order confirmation of the development and approval of the international and regional stan-

dards lists and in the case of its absence – the national (state) standards; - conformity assessment typical schemes confirmation; - conformity assessment documents (Declaration of the CU standards conformity, Certificate

of the CU standards conformity) unitary forms confirmation; - confirmation of the unitary sign image of production distribution throughout the CU coun-

tries market; - provision and application order confirmation of the unitary sign image of production distri-

bution throughout the CU countries market; - provision confirmation on order of entering the production under the CU compulsory re-

quirements to the CU custom territory.

It was decided to cease national technical standards development and concentrate the efforts on the CU technical standards development and adoption for the unitary normative base creation.

General situation describing conformity assessment different forms application before tran-sition period completion in the Russian Federation is given in the table 3.6.

Table 3.6 Conformity assessment forms in he Russian Federation before transition period comple-tion

PRODUCTION CONFORMITY ASSESSMENT

OBLIGATORY CONFORMITY ASSESSMENT

Before January 01, 2012 After January 01, 2012

Technical regulation is not developed

Technical regulation is de-veloped

The CU Technical regulation is developed

VOLUNTARY CONFORMITY ASSESSMENT

Conformity declaring

Obligatory certification


Obligatory certification


Obligatory cer-tification

Voluntary certifi-cation

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Document: Conformity Declaration

Document: Conformity Certificate





Document: Conformity Cer-tificate

Marking: Conformity sign without obligatory cer-tification code

Marking: Conformity sign with ob-ligatory certifi-cation code

Marking: production dis-tribution sign throughout market

Marking: production distribution sign throughout market

Marking: unitary sign of production distribution throughout the CU coun-tries market

Marking: unitary sign of production dis-tribution throughout the CU countries market

Marking: Conformity sign of voluntary Cer-tification system

Technical regulation system global modernization would allow excepting the multiple and repugnant departmental normative documents application that complicating companies operation, especially companies of small and medium business. Technical regulation system becomes effective and open, and technical harmonization would provide the technical barriers elimination in trade and conformity assessments results mutual admission which are the base of production free distribution, unitary world market development and operation. As a consequence, the comfortable producing conditions have to be created for a production manufacturer, supplier and consumer.

3.4 National and regional competitions and awards i n the context of production quality

Most developed countries in the world and all the countries of Europe have established na-tional quality rewards. One of the reasons for this is the fact that participating in the national quality competitions is regarded as a step to preparatory step for participation in the European competi-tions.

There are a lot of the Russian Federation constituent territories have already established re-gional quality competitions. It is for example, Arkhangelsk Quality, Top Goods and Services of Murmansk Region, etc. regional competitions. The competitions take part annually on regular basis.

All-Russian Program “100 Best Goods of Russia” and aimed to practical realization of na-tional projects, ensuring functioning of companies in compliance with the national law on Technical Regulation, rendering practical assistance for companies to attain objectives of sustainable devel-opment, improvement of goods and services quality, and increasing of their competitiveness.

All-Russian Program-Competition 100 Best Goods of Russia is an effective tool for boost-ing the prestige and quality of domestic products, involving more and more new manufactures into the world civilization process and providing them the integral understanding of competitive growth trends of companies and its production under the conditions of severe market competition.

Carrying out of the competition allows to monitor different economic industries and get in-formation about quality of produced goods, competitive and innovative potential of manufacturers, dynamics of manufacturer development, management level (quality management, risk management, ecological management, energy saving and resource management), etc.

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Any company on the Russian Federation territory as well as companies-winners of national quality competitions of the CIS, working on the territory can participate in the Competition. Logo of 100 Best Goods of Russia is shown in fig. 3.8.

Fig. 3.8 100 Best Goods of Russia logo

“People’s Mark” (“Narodnaya Marka ”) is the national award for branded consumer goods, one of the most crucial award in the context of branding in Russian market. “People’s Mark” award was established in 1998. (fig. 3.9).

Fig. 3.9 Narodnaya Marka logo

The distinguishing feature of the awardis its democratic and objective expressing of Russian consumers’ choice. There is no jury in this competition. Narodnaya Marka is rewarded by national buyers’ voting. Brands (in every category) that get majority of votes become winners.

Narodnaya Marka award categories are carefully chosen by COMCON RESEARCH Agen-cy after surveying market situation. The agency makes sure that goods represented in every cate-gory are nationally distributed brands consumed by most citizens. Every year about 20 goods groups are researched.

All-Russian food exhibition Pokupayte Rossiyskoe! (Buy made in Russia!) has been one of the most important events for Russian food producers since 1997. Show exposition demonstrates constant growth of quality of domestic goods and is a strong evidence of the fact that Russian goods can be various and competitive. Both exhibitors and visitors say that the exhibition contributes greatly to changing views of Russian consumers of national goods to the best.

Competitions companies-winners are awarded with golden and silver medals “Golden Sirin” of I and II degrees and diplomas of established forms. All-Russian food exhibition Pokupayte Ros-siyskoe! logo is shown in fig. 3.10.

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Fig. 3.10 All-Russian food exhibition Pokupayte Rossiyskoe! logo

“All-Russia brand (III millennium). XXI century quality mark” program is long-term large-scale advertising image-building program on qualitative goods, services and advanced technologies promoting throughout Russian and world market and is exhibition-competitions series started in 1999. Exhibition-competitions winners gain a right of their production marking with “III millen-nium” sign of four grades: bronze, silver, golden, platinum.

Fig. 3.11 “III millennium” sign

The Russian Federation Government Quality Award for quality achievements is awarded yearly. Its assessment criteria (fig. 3.12) are harmonized with the model of a prestigious European quality award. The Russian Federation Government Quality Award was established by the Russian Federation Government Decree No. 423 of April 12, 1996. This competition provided Russian companies with a modern instrument for development, work improvement and competitiveness in-creasing.

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Fig. 3.12 The Russian Federation Government Quality Award model

Award model baseline is the principles of overall quality management:

- alignment with customer requirements; - executives leadership and objectives achievement consistency; - management based on processes and facts understanding; - employees involving; - continual cognitive work and innovations; - partnership advancement; - society interaction; - results significance.

According to actual Provision on awards “the awards are granted annually within competi-tion to companies obtained significant results achievements concerning goods and services quality, its safety providing and also high efficiency methods of quality management”.

The competition accomplishment order, materials expertise determination and offers prepa-ration on awards granting are carry out by the Quality Council on awards granting of the Russian Federation Government.

The award is the Russian Federation Government diploma and the prize in established stan-dard form. Following the Competition results some companies are awarded with Council diploma for production quality progress. The Russian Federation Government Quality Awards are awarded by the Government Decree. A solemn awarding ceremony is held in the Government House of the Russian Federation.

Prize-winners receive the right to mark their products, company letterhead and advertise-

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ment with the Emblem of the Russian Federation Government Quality Award with the year of com-petition winning and company name indication, fig. 3.13.

Fig. 3.13 Emblem of the Russian Federation Government Production Quality Award

The Russian Federation Government Provision on quality awards was corrected several times. Three types of competition participants were established by the Russian Federation Govern-ment Decree No. 279 dated May 10, 2006:

- with employees number no more than 250 persons (no more than 3 awards); - with employees number from 250 to 1,000 persons (no more than 3 awards); - with employees number more than 1,000 persons (no more than 6 awards).

The rewarded company gains the leader image, reputation of safe and high quality product producer, that results in attraction of new business partners and clients, keeping and enlarging of the market share, income increasing and, therefore, appearing of new possibilities. Prize-winners can use emblems for advertising their products.

The regional quality competitions have become traditional over the last 10 – 15 years. Food products producers participate actively in Food products category of these competitions.

The best goods of Primorye annual review competition initiators are regional executive au-thorities, Primorye standardization, metrology and certification center state company, Nakhodka standardization, metrology and certification center state company. The competition aim is to reveal and more active promotion of high-quality goods and services into Primorye consumer market.

10 best goods and services of Novgorod Region competition is traditional in the Novgorod Region. The regional quality Committee resumes the competition results with support of Novgorod standardization and metrology Autonomous Non-Commercial Organization. Production quality is estimated by the following indicators: consumer properties level, social price acceptability level, quality, design, claims confirmed by experts and consumers’ complaints absence, marketing activ-ity efficiency level.

Tver century mark annual regional competition has been realized by regional executive au-thorities since 2000. About 150 companies which represented more than 200 production types have participated in Tver century mark competition.

Yaroslavl mark competition initiators are Yaroslavl region Chamber of Commerce and In-dustry and Old town municipal unitary company with the support of Department on industry,

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business, consumer market and tourism of Yaroslavl region. The competition serves for companies initiation to production quality improvement. Yaroslavl mark sign is set by the expert Committee to Yaroslavl producers’ best production of high consumers’ properties. The winners are able to mark their production with Yaroslavl mark logo.

In the context of Voronezh quality review-competition Voronezh executive authorities De-cree on Voronezh quality annual competition establishment was signed, regional Committee on quality and expert groups were created, the Provision on Voronezh quality sign was adopted. Vo-ronezh quality competition winners acquire a right to participate in 100 Best Goods of Russia com-petition by the decision of the regional Committee on quality.

Vladimir mark regional production quality competition official initiators are Vladimir re-gion executive authorities, Vladimir standardization, metrology and certification center state com-pany and Vladimir region Chamber of Commerce and Industry. The competition winners are awarded with Diplomas and Notable Prizes. Quality Leader special Prize are established in 2010 that is awarded to companies-winners of previous years.

Similar competitions are held in some other Russian Federation regions. As usually these competitions winners acquire a right to participate in 100 Best Goods of Russia competition.

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1. What are the aims of technical standards adoption?

2. What are the regulation objects of technical standards.

3. Name regulation objects and methods according to information type.

4. Technical standards classification by the way of requirements definition.

5. Technical standards classification by the field of application.

6. Specify technical standard typical parts.

7. What are market regulation forms? Describe its sense.

8. Do direct or indirect regulation methods depend on subject information type?

9. What areas do the effect of technical regulation project implementation reveal its influence?

10. Name the technical regulation system segments.

11. What are the aims of national technical regulation system modernization?

12. Name the basic normative documents on the CU technical regulation system development.

13. Specify the tends of technical regulation system modernization.

14. Give the unitary sign image of production distribution throughout the CU countries market.

15. What are the aims and objectives of the national and regional quality competitions and awards?

16. What are the requirements of all-Russia national competition “100 best goods of Russia”?

17. What is the aim of Russian national food products show “Buy Russian goods!”?

18. Name the grades of “All-Russian brand (III millennium)” quality sign:

19. Name estimation criterions of competition for the Russian Federation Government Produc-tion Quality Award.

20. Give the examples of regional competitions on goods and services quality.

3.6 Summary

The Government when organizing the activity of goods market regulation differentiates the methods of regulation between direct – establishing of mandatory requirements, compulsory con-formity assessment – and indirect – applying of national voluntary standards, development of vol-untary certification, insurance of damage liability, implementation of management systems, train-ing and informing of consumers, building of a self-regulating organization, national rewards for quality, etc.

Recreating technical regulation system base is technical standards. A technical standard is a new technical regulatory document establishing mandatory requirements to technical regulation ob-jects. The technical standard is a document adopted by the Russian Federation international Agree-ment ratified in order established by the Russian Federation legislation, or by the intergovernmental arrangement, or by the National Law, or by the Russian Federation President Decree, or by the Rus-

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sian Federation Government Decision.

The technical standards are aimed for:

- security for human life and health, natural and legal persons property, state or municipal property;

- environment, animals and plants life or health protection; - prevention of actions misinforming the purchasers; - energy efficiency and resource-saving providing.

Technical standards adoption for other aims is not allowed.

Technical standards classification is by the way of requirements definition and by the appli-cation field.

Limitations on the transfer of goods and services may be introduced according to national law, if it is necessary to ensure security, protect the life and health of people, protect nature and items of cultural values. This norm strictly reduces any possible foreign impact on the goods mar-ket.

The national law On technical regulation sets out that the submission of draft national law on technical regulation to State Duma by an entity of law if there is financial and economic inter-pretation of national law adoption on technical regulation. Economic interpretation of decisions on technical regulation has two separate objectives:

1. costs estimating of the choice result of exact values for safety indicators of given product;

2. conformity assessment forms and methods choice.

Developed technical regulation system modernization concept in Russia was subject to es-sential correction because of the CU countries technical regulation system establishing. For the CU integration processes extension and intension under Eurasian Economic Community and common economic space forming the Agreement “On unitary principles and rules of technical regulation in Republic of Belarus, Republic of Kazakhstan and Russian Federation” was signed on November 18, 2010 by Republic of Belarus, Republic of Kazakhstan and the Russian Federation.

Basic modernization tends of technical regulation system in CU countries are:

- creation the unitary list of potential dangerous production; - production requirements determination in unitary technical standards; - delegation the powers on technical standards adoption to supernational authority body (the

CU Committee); - unitary forms, schemes and procedures of conformity assessment; - international and regional standards application for conformity assessment; - the CU countries cooperation.

National and Unitary Regulation modes have been in operation on alternative base since Ju-ly 1, 2010 throughout the CU countries territory. Corresponding national norms will stop in opera-tion within short period of time.

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Production meeting the requirements of the CU actual technical standards for this produc-tion that passed the determined conformity assessment procedures is marked with unitary sign of production distribution throughout the CU countries market

Technical regulation system global modernization would allow excepting the multiple and repugnant departmental normative documents application that complicating companies operation, especially companies of small and medium business.

All-Russian Program-Competition 100 Best Goods of Russia is an effective tool for boost-ing the prestige and quality of domestic production.

Narodnaya Marka (People’s Mark) is a national award to brands, it is one of the important awards in branding of Russian market.

All-Russian food exhibition Pokupayte Rossiyskoe! (Buy made in Russia) has been one of the most important events for Russian food producers since 1997 and is one of the most significant events for domestic food products producers.

“All-Russia brand (III millennium). XXI century quality mark” program is long-term large-scale advertising image-building program on qualitative goods, services and advanced technologies promoting throughout Russian and world market.

The Russian Federation Government Quality Award competition, which assessment criteria are harmonized with the model of a prestigious European quality reward, has provided Russian companies with a modern instrument for development, work improvement and competitiveness in-creasing.

The regional quality competitions have become traditional over the last 10 – 15 years with the aim of revealing and more active promotion of high-quality regional goods and services into the consumer market. As usually these competitions winners acquire a right to participate in 100 Best Goods of Russia competition.

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4 Quality Management Systems on the basis of ISO 9000 series

The chapter describes the basic concepts of quality management system (QMS), story and

importance of ISO 9000, QMS principles and general elements. It also deals with principles and

guidelines on QMS development and implementation in company, internal auditing and QMS certi-

fication.

Plan

4.1. History and importance of international system of ISO 9000.

4.2. QMS structure and primary elements.

4.3. QMS development stages.

4.4. QMS implementation and certification.

4.1 History and importance of international system of ISO 9000

Quality systems - being one of the latest achievements in the area of quality problems solv-ing for any company – stand out among all modern management systems. Consumers require prod-ucts with characteristics that satisfy their needs and expectations. Quality management systems due to their importance for life and social development are becoming a necessity. QMS guarantees to the company itself and to consumers that the product supplied is up to the high quality level. Im-plementation of QMS provides some benefits for interested parties (fig. 4.1).

Fig. 4.1 Concerned parties benefits due to QMS implementation

QMS IMPLEMENTATION BENEFITS

For consumers

Consumers ob-tain production which meets safety require-ments; reliable, faultless and repairable; the production is available when needed.

For owners and investors

Owners and in-vestors gain the advantages from invested capital profit growth, market-share gain, effects im-proving of com-pany activity.

For suppliers

and partners Suppliers and partners gain the advantages due to increasing volume of sup-plies.

For society

Society gains the advantages from legal and regula-tory require-ments realiza-tion, reduced impact on envi-ronment, safety improving.

For employees

Employees gain the advantages from employment stability increas-ing and salary growth, improved labor conditions, better job satis-faction, safety arrangements rationalization, moral environ-ment improving.

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Currently certification of business to the ISO 9000 standards is increasing rapidly in the world and has almost become mandatory for doing business in some countries. The implementation of the ISO 9000 standards has become a matter of respect for a company or organization. System, integration, standardization have become essential principles for quality management of the com-pany in many countries, particularly industrially developed ones.

The history of the ISO 9000 family of standards for quality management started in 1987, when experts within technical committee ISO/TC 176 on “Quality and quality management ensur-ing” worked out (on the basis of the best practice accumulated by various industries and countries) and published the first five standards which were given the symbol of ISO 9000.

After a short period of time the ISO 9000 standards started to be used in most developed countries. The development of the ISO 9000 standards can be seen in fig. 4.2.

Fig. 4.2 ISO 9000 series standards progress

The first revision of the ISO 9000 standards had a limited character and was completed in 1994. In 2000 ISO/NC 176 finished the intensive work on preparation of the third ISO 9000 stan-dards version which includes the following four basic standards:

ISO 9000. Quality management systems. Fundamentals and vocabulary;

ISO 9001. Quality management systems. Requirements;

ISO 9004. Quality management systems. Guidelines for performance improvements;

ISO 19011. Guidelines for quality and/or environmental management system auditing.

In addition to the basic standards the ISO 9000 family of standards includes technical re-ports, technical specifications and supplementary document.

The following revision of the ISO 9000 series of standards was made in 2008; the revision of the ISO 9000 standards was completed in 2009. The ISO 9004 standard was called Managing for

ISO 9000:1987 ISO 9001:1987 ISO 9002:1987 ISO 9003:1987 ISO 9004:1987

GOST R 40.9001-88 GOST R 40.9002-88 GOST R 40.9003-88

ISO 9000-1:1994 ISO 9000-1:1994 ISO 9000-2:1994 ISO 9000-3:1994 ISO 9004-1:1994

GOST R ISO 9001-96 GOST R ISO 9002-96 GOST R ISO 9003-96

ISO 9000:2000 ISO 9001:2000 ISO 9004:2000


ISO 9000:2008 ISO 9001:2008 ISO 9004:2008


1ST VERSION (1987)

2ND VERSION (1994)

3RD VERSION (2000)

4TH VERSION (2008)

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the sustained success of an company -- A quality management approach and was modified greatly in order to meet the requirements of the modern business. The next revision is going to be in 2012, and the 2008 version has some slight changes, developed mostly to introduce clarifications to the existing requirements. This is connected with the intention to improve stability of the certification procedures of QMS; as well as with the fact that the ISO 9001 standard is less adaptable to business trends than the ISO 9004 standard.

The importance of the ISO 9000 standards can scarcely be overestimated. They reflect the bulk of the world experience in the area of product quality management. The mentioned standards have become the most required and used of all. Currently the ISO 9000 series standards are adopted in 175 countries all over the world, over 1 million companies and organizations have been certified to these standards. Lloyd’s Register surveys revealed that companies with ISO 9000 certification perform twice or three times more efficiently and they exceed the average level in the industry.

Development and implementation of QMS based on the ISO 9000 series assist companies in international recognizing of their products or services quality, in enhancing their competitiveness, prestige and image.

4.2 QMS structure and primary elements

The key aim of a company is to attain, to maintain and to improve its performance quality for consumers and other interested parties’ satisfaction.

The quality system of the ISO 9000 series does not imply creation of any completely new system.

In fact, most companies imply separate quality management procedures regulated by the ISO 9000 series, but they are not always properly arranged or meet the established requirements.

GOST R ISO 9001-2008 specifies requirements for a quality management system which can be used by a company for its internal application for certification and contract-negotiation. It is aimed to quality management system effectiveness in meeting customers’ requirements.

The standard represents the QMS tasks that are to be fulfilled. The standard does not de-scribe how to attain those tasks. The company executive leaders choose the ways to attain the tasks.

Every company producing goods or services has five main groups of interested parties (table 4.1).

Table 4.1 Company interested parties

Group of interested parties Typical requirements or demands consumers product quality

employees career, job satisfaction

owners investment indexes

suppliers possibility of a continual partnership

society responsible management

QMS certification to the ISO 9000 standards is voluntary for producers. Though, availability

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of the certificate is often a key factor that opens international doors to the company. It guarantees that the company or an organization is a part of a civilized business world. Besides, quality systems of many companies require the availability of certified quality systems from their suppliers.

ISO 9000 standards distinguish between requirements for a quality management system and requirements for products. Requirements for a quality management system are secondary to re-quirement for products. The ISO 9000 standards (version 2008) identify eight basic quality man-agement principles lead the company towards improved performance:

- customer focus; - executives leadership; - employees involving; - process approach; - system approach to management; - continual improvement; - decision making based on facts; - mutually beneficial supplier relationship.

Quality management system ISO 9000 covers production processes as well as all the periods of a product life cycle starting with marketing and up to product utilization (fig. 4.3).

Fig. 4.3 Product life cycle typical periods (quality loop)

Any company functioning is ensured by a series of processes with a rather complicated structure. The company creates, maintains and improves its products and services quality by estab-lishing and managing its processes and their interactions. This is the basic concept of the ISO 9000 standards. To show interactions, responsibilities and powers of every process there should be as-signed an owner – a responsible person.

In QMS - company forming processes are management targets. The elements of the system

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should not necessarily be defined or described. Only what is necessary can be described. But system management requires the knowledge about interdependencies between all the elements and people who work in it.

Every person involved in the system should know its objective and the objective should be common. A system cannot exist without a common objective.

Work of each system-forming component should be evaluated depending on its contribution to achieving of a common objective (not individually apart from the work of the whole system). Objectives of a system should be aligned with the resources available.

System approach is the most important element of quality management philosophy. In de-veloped countries it has been believed that only company of the system can allow to estimate mar-ket requirements correctly, foresee them, design and produce a product of the required quality and offer the product to a consumer for a competitive price. This explains a great worldwide interest to the ISO 9000 standards.

The main role of a company leader or company in setting a task and organizing its fulfill-ment is to remove functional barriers between system components on order to achieve a common system objective. The leader should not take make decisions without consideration of system com-ponents interaction for fulfillment the set task.

Fig. 4.4 QMS model based on process approach

Symbols:

value-adding activity;

information flow.

Output

QUALITY MANAGEMENT SYSTEM CONTINUAL IMPROVING

Consumers (and other interested

parties)

Consumers (and other interested

parties)

Needs Input

Needs satis-faction

product

Detecting, analys-ing and improving

Executives Responsi-bility

Resource Man-agement

Production Life cycle Processes

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The QMS model based on process approach and described in the ISO 9000 family of stan-dards is shown in fig. 4.4. This model is a focus of the world experience in the area of product quality management and covers all the main requirements of the ISO 9001 standard without their detailed description.

The ISO 9001 standard is applicable to any company, regardless of size, type and activity. If any requirement of this standard cannot be applied due to the nature of a company, this can be ex-cluded.

4.3 QMS development stages

A strategic decision of company is necessary for the QMS adoption.

The QMS development is its design and implementation in the activity of an company. The effective system development – not for getting a certificate system – is a time consuming process. It may take several years to adopt the system and it requires all the employees of a company be in-volved in a quality management activity.

General requirements to the procedure of QMS development is described in GOST R ISO 9000-2008. QMS design and implementation by the given standard includes the following steps:

- needs and expectations determination of consumers and other interested parties; - company policy and objectives development in the context of quality; - processes and responsibilities identification necessary for objectives achievement in the con-

text of quality; - essential resources identification and its ensuring for objectives achievement in the context

of quality; - methods development for effectiveness and efficiency evaluation of each process; - this evaluation data applying for effectiveness and efficiency assessment of each process; - identification of methods necessary for prevention of disparities and its causes elimination; - process development and application for continual QMS improving.

The same approach is applied for maintaining a system and improving an available quality management system.

The given approaches identify the general jobs (operations) content for adopting a QMS. While adopting a QMS all the operations should be differentiated. Usual number of operations listed in a plan of adopting a system is 50…60 positions. A simplified process of adopting a QMS is illustrated in fig. 4.5.

A practice has proved that development of a QMS by consulting companies is formal by na-ture and usually results in a system which cannot meet all the requirements and demands of inter-ested parties. The most part of work on development of a QMS should be done by company and company employees in collaboration with highly skilled outside consultants.

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Decision on QMS develop-

ment

Quality In-frastructure

develop-ment

Company activity analisys

QMS im-plement-

tation planning

Training

QMS docu-

menting

QMS doc-uments im-plementa-

tion

QMS in-

ternal au-dit

Execu-tives

analysis

Independ-ent as-

sessment

Fig. 4.5 QMS development stages

Another strategic feature is that a QMS is directed to meet the requirements of GOST R ISO 9004-2010 from the very beginning. Conformity certificate is not an end in itself. For most compa-nies or organizations it is more important to create an effective and efficient QMS which really en-sures products and services quality not only just meeting GOST R ISO 9001-2008 standard re-quirements formally.

QMS development starts with its planning. According to the set period of time a coordinated chart (table 4.2) or strip chart (table 4.3) plan-schedule is developed. Appointing people responsible for every stage, performance reporting and essential resources providing are compulsory planning elements.

Table 4.2 QMS development planning form

Work type Responsible person

Work perform-ance quality in-

dicators

Reporting type Target date

Table 4.3 QMS implementation calendar plan-schedule

MONTH There can be more detailed plan-schedules accounting several tens or even hun-

dreds of operations STAGE NAME

1 2 3 4 5 6 7 8 9 10 11 12

1. QMS applying area

2. Company policy and objec-tives in the context of quality

3. Tasks distribution between working groups

4. Standard technical docu-ments analysis ▬ ▬

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5. Processes and operations quality factors harmonization and description ▬ ▬

6. Transferring of the processes description into a Quality Manual ▬

7. Quality Manual completion and its mailing

8. Quality Management training for involved employees ▬ ▬ ▬ ▬ ▬

9. QMS documents develop-ment ▬ ▬ ▬ ▬ ▬

10. Training on procedures per-formance estimation according to specifies quality factors ▬ ▬ ▬ ▬

11. QMS implementation ▬ ▬ ▬ ▬ ▬

12. Internal audits ▬ ▬ ▬ ▬

13. QMS updating ▬ ▬

14. QMS conversion for certifi-cation ▬ ▬

15. QMS certification

QMS development planning includes operations on company processes planning. A quality management system is based on a process approach. Analysis and identification along with docu-mentation generating is an important and work –intensive QMS development stage. All company processes should be identified; for each process there should be identified inputs, outputs, owners and documents.

Processes of a top level of company are usually divided into basic (business processes), supplemen-tary (supporting) processes and management processes (fig. 4.6).

Fig. 4.6 Processes classification

QMS processes

Basic (business) processes

Supplementary (sup-porting) processes

Management processes

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Basic processes are processes the result of which is output of products or services provision.

Supporting processes are processes the result of which is establishing of conditions neces-sary for carrying out of basic processes.

Management processes are processes the result of which is enhancement of effectiveness and efficiency of basic and supporting processes. Management processes are often classified as supporting processes.

Basic processes are tools for carrying out a mission of a company; they shape an organiza-tional structure and determine a set of supporting processes and management processes. It is neces-sary to mark out key business processes that exert the greatest influence on achieving main objec-tives of a company.

In practice, the process approach to adopting a new version of the ISO 9000 series implies the following steps: identification, description, designing processes net, documentation. The pri-mary difference of the process approach from the functional approach is in management basic atten-tion is not focused on the separate departments and officials functions but on the interfunctional processes combining the separate functions into total flow and aimed to final results of company activity.

The typical list of top level processes has 25…30 processes by which the company – regard-ing its size – develops up to several tens of standards of an organization (STO), table 4.4.

Table 4.4 Specification of small organization standards (STO)

STO STO NAME

QMS STO 1 - 2010 Organizing of QMS development, improvement and functioning

QMS STO 2 - 2010 QMS STO 3 - 2 010 QMS STO 4 - 2010 QMS STO 5 - 2010 QMS STO 6 - 2010 QMS STO 7 - 2010

Organizing of process functioning Documentation and records management Meat market analysis Contract agreement analysis Information internal sharing QMS analysis on behalf of executives

QMS STO 8 - 2010 Infrastructure ensuring

QMS STO 9 - 2010 QMS STO 10 - 2010 QMS STO 11 - 2010 QMS STO 12 - 2010

Production planning Purchasing and control of the purchased meat Production process documenting Manufacturing equipment maintenance and repair

QMS STO 13 - 2010 QMS STO 14 - 2010

Meat products production Cargo-handling operations, storage, packing, supplying

QMS STO 15 - 2010 Metrological assurance

QMS STO 16 - 2010 QMS internal audit

QMS STO 17 - 2010 Risk management

QMS STO 18 - 2010 Corrective and preventive actions

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Every business process should be described in a special way, taking into account all the components necessary for its correct functioning. Any business process can include a number of sub-processes of various complexity, which in their turn can be also sub-divided (down to individ-ual activities).

4.4 QMS implementation and certification

Let’s have a closer look at certain stages of a QMS development. A QMS development typi-cal plan usually includes:

1. providing participants with standards and other documents;

2. special training and education of participants; explanatory work with employees members;

3. monitoring of QMS in operation;

4. identifying the scope of a new QMS in an company;

5. identifying needs and expectations of consumers and other interested parties;

6. development of documents Quality Policy, Quality Objectives;

7. development of a process identification system of an company;

8. identifying mail business processes and supporting processes of an company, appointment of owners and leaders of processes, setting objectives of processes;

9. development of a chart of business processes of an company with their sequence and inter-action;

10. identifying methods of control and improvement of basic and supporting processes, re-courses for quality management, development documents of processes;

11. providing basic and supporting processes with resources necessary to achieve objectives in the area of quality;

12. making a list and development of documents necessary to carrying out the processes, ap-pointment of owners, making a plan of their development and modernization;

13. development of a quality manual;

14. establishment of a quality system department with functions of an internal audit;

15. QMS implementation;

16. internal audit and corrective operations;

17. QMS certification.

After making a strategic decision about QMS development an informational communication is usually maintained between employees and top management and then an order on the QMS works beginning is issued. To develop, implement and maintain a QMS in compliance with the ISO 9001 standards there should be appointed a Quality Management Representative, organized a Qual-

92

ity Service and appointed Head of the Quality Service. Target dates, responsible persons and main stages of operations on a QMS development are also set.

In many cases a new QMS does not imply any changes of a employees structure of an com-pany. Usually the Quality Service coordinates the whole work. Other department that deals with quality control or product quality ensuring may be included into the Quality Service of an company. A Temporary working group consisting of the Quality Department representatives is usually made for a period of a QMS development.

QMS development usually implies the structural (fig. 4.7) and functional (fig. 4.8) schemes of the system.

Symbols:

R – quality department representative

Fig. 4.7 Structural chart of Russky Chleb (Russian Bread) LTD QMS

Structural chart shows relations in QMS. QMS structural chart is based on structural chart of the company where the Quality Department obtains the key importance and a quality department representative is appointed in each Department (fig. 4.7).

Deputy Director on Transport

Deputy Director on Pro-duction

Technologist De-partment

Bread producing Depart-ment

Quality Management Repre-sent ative

Quality Service

Quality Council

Outside Consultants

Company Head Executive

Deputy Director on Commerce

Chief Accountant

Bakery De-partment

Logistic Department

Food prod-ucts ware-house

Raw Mate-rials ware-house

Transport Depart-ment

Accounting Department

R

R R

R R R R R

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Fig. 4.8 Functional chart of Russky Chleb (Russian Bread) LTD QMS

The functional chart represents a model of a quality management process reflecting main QMS functions and its interaction with an outside environment.

Executives

Interacting with outside environ-ment

Decision-making

Quality policy

Quality planning

Operations arrangement

Employees education and moti-vation

Marketing and market analysis

Bakery products technology planning

Logistics

Bread production

Bakery production

Bakery products quality control

Packaging and storage

Selling

Utilization

I NPUTS

OUTPUTS

Government bodies, trade unions

Suppliers, labour resources, materi-als, services

Clients, goods market

Political, social, international factors

Competitors, progress

Carrying out of operations

Information

Quality control

Development of operations

Outside environment “Russky Chleb” LTD

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One of the most important and work-intensive stages is the stage of development of docu-mentation of a QMS. GOST R ISO 9001-2008 identifies four levels of documentation (fig. 4.9):

- documents on quality policy and quality objectives; - quality manual; - documented procedures and records; - documents needed by an company as necessary for processes effective planning, carrying

out and control.

Fig. 4.9 Documentation levels by GOST R ISO 9001–2008

QMS documentation is divided into internal and external. The ISO 9000 standards (2008 version) mostly cover external documentation and add its requirements. The example of agricultural processing company documentation is shown in fig. 4.10.

QMS documentation should include:

а) strategic documents:

Quality policy and Quality objectives Statement;

Quality Manual;

QMS Plans and Programs;

b) internal documents:

documented procedures required by MS ISO 9001:2008;

documented procedures describing other QMS processes;

Level А

Level B

Level C

Level D

Quality Policy and Quality Objectives Statement (Mission, Quality Policy, Quality objectives)

Quality Manual (QMS application area, documented procedures, processes descriptions)

Documented Procedures and Records (STO, Instructions)

Documents, records including, required for effi-cient work planning and processes management of a company (instructions, process flow charts, acts, protocols, reports, forms)

95

Fig. 4.10 Canning factory documentation

Quality policy and Quality objectives Statement

Quality Manual

Documented Procedures and Records

Consumers’ satis-faction analysis

QMS operat-ing organiz-ing

Processes functioning organizing

QMS development and improving

Documents including reports needed by the organizat ion to ensure the effective planning, operation and processes management

Contract analysis

Documents and records management

Internal communi-cation

Market analy-sis

Transport Employees management

Production process documentation

Equipment providing

QMS audit by top executives

Corrective actions

Production planning

Working space arranging

Purchases Purchases control

Product identifica-tion and traceabil-ity

Equipment maintenance and repair

Production manufacturing

Loading-unloading, pack-aging, storage, supplying

End product inspec-tion and measuring

Measuring equipment providing

Product inspection and measuring during production

QMS analysis organizing

Risk manage-ment

QMS internal audit

Preventive actions

PC and communica-tion

Quality Policy Quality Objectives

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c) external documents:

Laws, Acts, Decrees, national and industrial standards, norms and regulations specifying company activity;

d) company documents:

company Charter;

company Structure;

Regulations for departments (sister companies);

duties instructions.

QMS implementation is the most complicated stage as far as it requires the reconstruction of a employees structure in an company. Practical activity of a company should be reviewed and aligned with its new documentation in order to meet the requirements of the ISO 9001 standard.

Internal QMS audits are important tools in implementation and further functioning of a QMS. Internal audits are aimed to remove risks. The procedure of internal audits is regulated by GOST R ISO 19011-2003 and is carries out in compliance with documented procedures of a com-pany. An annual schedule is developed for internal audits. A plan should ensure that every depart-ment and every process is checked at least once a year. A form of an annual schedule is shown in table 4.5.

Table 4.5 Form for company internal audit schedule

Months

QMS processes

ISO 9001 stan-dard para-

graph 1 2 3 4 5 6 7 8 9 10 11 12

Report No.

1. QMS analysis on the part of execu-tives…….… 2. Risk manage-ment………………

5.6 8.3

Figure 4.11 shows the typical audit procedures.

A person responsible for auditing program management should appoint an audit group head.

Every audit should be based on documented objectives, scopes and criteria which are in-cluded in audit program.

Audit objectives are:

- to identify the QMS level of a company (or its departments) conformity to the audit criteria; - to ensure that a QMS does not conflict with contract compulsory requirements; - to evaluate the management system effectiveness concerning definite aims achievement; - to identify the possible ways of quality management improvement.

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Fig. 4.11 Typical audit procedures

To speed up the QMS introducing it is necessary to start an internal audit mechanism as soon as possible as it helps to inform the employees about changes connected with a QMS devel-opment. The Act and corrective actions are developed after the audit procedure. Internal audits of

Follow-up aud its

“On -the-spot” audit preparations : “On-the-spot” audit planning

Work determination for audit groups Work documentation preparations

Documents audit: QMS corresponding documents analysis including re-

cords and its correspondence determination.

Development, assignment and distribution of audit reports:

Audit report preparing Audit report ratification and mailing Documents safekeeping.

“On-the-spot” audit: Initial communication

Information sharing during audit Audit group responsibility

Information collecting and checking Audit results obtaining

Final meeting planning Final communication

Audit initialization : Audit group leader assignment

Objectives, application area and criteria determination Audit opportunities determination

Audit group determination Initial contact with auditable company

Audit completion: Documents preservation; Summarizing statements

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actual QMS are performed on a regular basis with equal intervals. During a year period all the com-pany processes should be audited. Audit results as other information sources dorm a base for QMS analysis by executive leaders. Audits must be realized within planned periods of time to provide QMS consistent suitability, sufficiency and efficiency.

Audit results are the base of corrective actions development and implementation. After completing of corrective actions a company QMS can be audited by a second party (representatives of a client), if it is regulated by a contract on production supplies, or by a third independent party (certificating authority).

In spite of the fact that the QMS certification systems number is constantly growing, the cer-tification system in the framework of GOST R the certification system of quality systems and pro-duction called Register of Quality systems for short is one of the most important systems. The legal basis of Register quality systems is set by national standards of GOST R 40. Organizational struc-ture of Register is shown in fig. 4.12 its Mark of Conformity is shown in fig. 4.13.

Fig. 4.12 Organizational structure of Register quality systems

Fig. 4.13 Conformity mark of Register Quality Systems

Register Technical Centre

Scientific and methodological cen-

tre of Register

Quality systems certification Bodies

Certificates holders

Appeals Commis-sion

Council on certifica-tion of quality sys-

tems and production

99

In certification of quality systems auditable units are:

- QMS scope; - product quality; - QMS documents; - QMS processes.

QMS operating assessment is of high importance for certification concerning real fulfillment of company QMS documents requirements and QMS efficiency providing according to GOST R ISO 9001–2008.

Company applicant gives to a certification body the following documents:

1. Quality Policy (if it not a part of Quality Manual);

2. Quality Manual;

3. Structural chart of a auditable company with indication of administrative, engineering de-partments, basic and supporting departments (workshops, sectors, production sites);

4. Structural chart of auditable company Quality Service (if it is not a part of a general struc-tural chart);

5. QMS documents list;

6. Documented procedures, regulated by GOST R ISO 9001–2008:

- Documentation management; - Records management; - Internal audits; - Risk management; - Corrective Actions; - Preventive Actions;

7. Documents needed by an company as necessary for effective planning, carrying out and monitoring of processes (chosen and demanded by a certification body).

A certification body has the right to demand from an auditable unit any other documents, in-cluding records necessary for analysis.

Stages and operations of quality systems and production certification are regulated by GOST R 40.003-2008 “Certification System. Register of Quality System. Certification procedure of qual-ity management systems to accordance with GOST R ISO 9001-2008 (ISO 9001:2008)”.

Requirements for certification audit and QMS certification auditors are regulated by GOST R ISO 19011-2003 (Guidelines for quality and/or environmental management systems auditing).

Development and implementation of a quality management system of an company based on MS ISO 9000 allows to carry out work on ensuring goods and services quality on a high interna-tional level, enlarge its competitiveness, reputation and prestige.

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1. When did the history of the ISO 9000 standards for quality management start?

2. What version of the ISO 9000 is actual now?

3. What are company concerned parties?

4. Name basic QMS principles.

5. Specify Product life cycle typical periods basic for QMS.

6. What are QMS requirements based on the ISO 9000?

7. Describe QMS documentation structure based on the ISO 9000.

8. What are main stages of QMS implementation in company?

9. Processes classification.

10. Give the examples of basic and supplementary processes.

11. What duties does executive representative on quality possess?

12. What are the differences between QMS structural and functional schemes?

13. Name QMS documentation levels according to GOST R ISO 9001–2008.

14. Specify QMS internal audit aims and typical procedures.

15. What is structure of Register quality systems?

4.6 Summary

Currently the QMS application based on international standards of ISO 9000 series is gen-eral practice. Mentioned standards includes concentrated world experience on production quality management and have become the most popular in ISO history.

QMSs based on ISO 9000 can be used by a company for its internal application for certifi-cation and contract-negotiation. Companies implemented QMSs based on ISO 9000 work more effective in 2 or 3 times and exceed the average level in the industry essentially.

QMSs based on ISO 9000 identify eight basic quality management principles: customer fo-cus; executives leadership; employees involvement; process approach; system approach to man-agement; continual improvement; factual approach to decision making; mutually beneficial supplier relationship.

QMS based on ISO 9000 covers production processes as well as 12 stages of a product life cycle starting with marketing and up to a product’s utilization. In QMS the system-forming com-pany processes are management targets. ISO 9001 standard requirements are applicable to any company, regardless of size, type and supplied production.

QMS design and implementation by given standard includes identification of needs and ex-pectations of consumers, development of company policy and objectives in the area of quality, identification of processes and responsibilities necessary for achieving objectives in the area of quality, identification of necessary resources and ensuring resources for achieving objectives in the area of quality, development of methods of measuring of effectiveness and efficiency of each proc-

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ess, and system continual improvement as well.

In practice, the process approach to adopting a new version of the ISO 9000 series implies the following steps: processes identification, description, net designing, and documentation.

To develop, implement and maintain a QMS there should be appointed a Quality Manage-ment Representative and a Quality Service is organized. Development of a QMS usually implies the structural and functional schemes of the system. ISO 9001 identifies four documentation levels: documents on quality policy and quality objectives; quality manual; documented procedures and records; documents including records needed by a company as necessary for effective planning, car-rying out and processes management.

QMS internal audits are important tools in QMS implementation and further functioning.

The QMSs and production certification in the Russian Federation is carried out by the Certi-fication system of quality systems and production called Register of Quality systems for short. In certification of quality systems auditable units are: QMS scope; product quality; QMS documents; QMS processes.

Development and implementation of QMS based on ISO 9000 in a company allow carrying out the work on ensuring goods and services quality on a high international level, increase company competitiveness, reputation and prestige.

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5 Environmental Management Systems on the basis of ISO 14000 series

The сhapter describes the development of environmental management and its significance for agricultural companies; EMS standards system (legal acts), principles and guidelines for EMS development, documenting, introduction and certification.

Plan

5.1. Environmental management system (EMS) development.

5.2. EMS standards system.

5.3. EMS organizational structure and documentation establishing.

5.4. EMS implementation and certification

5.1 Environmental management system (EMS) developme nt

Though environmental protection is more than 150 years old, society began to consider it as a means of environmental control only after the World War II. The stages of the environmental pro-tection world development in the second half of the last century are shown in fig. 5.1.

Fig. 5.1 Chart of the environmental protection world development

The pipe end concept means that negative ecological effects can be reduced by using various kinds of filters, dust- or gas-arrester installations, etc. The concept of waste-free technology shifts attention from “the pipe end” directly to sources of pollution. The concept of sustainable develop-ment ensures that the needs of people are met without harming the environment for the generations in the future.

Environmental management is paid much attention in the concept of sustainable develop-ment. The aim of environmental management is to minimize harmful effects on the environment. Standards of ISO 14000 play a leading role in the realization of the ideas of environmental man-agement.

The gives standards are developed by ISO/TC 207 Environmental Management (currently it is the largest ISO technical committee) and enforced in 1996. In Russia there were established the following national standards: GOST R ISO 14001-98 “Environmental Management Systems. Re-

Pipe end technology concept

Waste-free technol-ogyconcept

Sustainable Develop-ment concept

CONTROL PRECAUTION ENVIRONMENTAL MENAGEMENT

1980s 1990s 1970s

103

quirements with Guidance to use” and GOST R ISO 14004-98 “Environmental Management Sys-tems. General guidelines on principles, systems and support techniques.”

At present a significant international experience in environmental management in various industries (including agriculture) is accumulated. But in this country the process of environmental management has just started its development. As applied to agricultural companies, we do not have any real environmental management systems.

Until recently, the agribusiness industry has been considered the most eco-friendly type of industry. But wide use of chemicals (fertilizers, pesticides), deep processing of agricultural products demanding much power, water and other necessary components with pollutant emissions have en-dangered environment, natural resources and made climatic cataclysms more likely to happen.

An example of connection between activities of a company and ecological aspect and envi-ronmental impact is shown in fig. 5.2. Main types of environmental pollutants are shown in table 5.1.

Fig. 5.2 Connection between company activity and environment impacts

Table 5.1 Main types of environmental agricultural contaminants and their possible risks

Contaminants Contaminants major sources Possible impact for atmosphere

Suspended particles containing heavy metals Soil ploughing Heavy metals concentration increasing

in food chains

Nitrogen oxides NОx Nitrogen mineral fertilizers application

Climate change, acid rain fallout, ni-trates (nitrites) concentration increasing in food chains, corrosion spreading

Mercury Pesticides production Accumulation in organisms through the food chains

Phosphates Phosphorous fertilizers production Water pollution

Pesticides Pesticides production Accumulation in organism through the food chains

Toxic agents of exhausted gas-es (NОx, CO, CHx, C, SO2, SO3

etc.)

Agricultural equipment ap-plication Air pollution

Thereby, in the production area agriculture alongside with industry and transport is a source of pollution. Meeting environmental requirements in agriculture is of the utmost importance, for human life and national wealth (water, air, land) are engaged. Neglect of these requirements in modern production can result in huge losses both for agribusiness and for environment.

Currently an agro-industrial complex is an integrated system of obtaining of agricultural raw materials, their processing and final product producing. Environmental management of agricultural

Company activity

Motortransport repair

and maintenance

Ecological aspect

Fuels and lubricants overflow or leakage

Environmental im-pact

Soil pollution

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companies is a system of mechanisms ensuring economic development within existence limit of environmental impact. Environmental management of agricultural companies can include:

- during agro-industrial complex objects operating there should be met environmental re-quirements (there should be sanitary safety zones, treatment facilities minimizing land pol-lution, surface and underground water, water catchments areas and atmospheric air);

- companies should take measures for protection of soil, water, plants, animals and other or-ganisms from economic and other kinds of activities risks.

In case if a company does not follow these rules, the issue of environmental safety will not be solved.

Environmental management in agro-industrial complex, first of all, means creation of safer production and producing products of high quality.

Adoption of ISO 14000 standards becomes a necessity for Russian companies. Together with ISO 9000 standards the former ensure positive image for the company, they also serve as ad-mission to the European market. Adoption and regular implementation of various methods of envi-ronment management can ensure achieving best results to all interested parties. Therefore, adoption of environmental management systems by Russian companies deals both with environmental as-pects and the whole structure of the company. Wise implementation of the systems can become a general tool for a successful struggle against “diseases” of Russian management and an important step on the way to a sustainable development of the Russian economy.

5.2 EMS standards system

Environmental requirements and effective environmental management in the Russian Fed-eration is regulated by a great number of normative acts, including national standards GOST R ISO 14000 series, interindustrial system of standards such as System of standards in the area of envi-ronmental protection and improved management of natural resources and Laboursafety standards system. Possible environmental impacts are also regulated by standards for products at every stage of their life cycle, fig. 5.3.

105

Fig. 5.3 Interaction between requirements to a product and possible environmental impacts at any stage of a product lifecycle

The structure of standards system ISO 14000 series is shown on fig. 5.4. The most important national standards of environmental management systems are shown in table 5.2.

Strategy and methods of im-provement:

� resource saving; � pollution prevention; � designing of environmental protec-

tion methods.

Design and de-

velopment of the product

� choosing the materials;

� efficient use of energy and ma-terials;

� reliability; � recyclability

possibility.

Production

requirements

Product lifecycle � purchasing of

materials and raw materials;

� production; � implementation; � utilization.

Inputs - power; - materials.

Outputs � product; � emissions into air; � wastes flow; � other wastes;

Effects on environment

Product concept/ demand

� purpose; � safety; � health welfare; � environment; � legal and

normative acts.

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Fig. 5.4 ISO 14000 series standards complex structure

Table 5.2 Main national standards of environmental management systems

Normative act Act name

GOST R ISO 14001–2007 Environmental management systems. Requirements and Implemen-tation Guidance

GOST R ISO 14004–98 Environmental management systems. General guidelines on princi-ples, systems and support techniques

GOST R ISO 14031–2001 Environmental management. Environmental efficiency estimation. General requirements.

GOST R ISO 14040–99 Environmental management. Life cycle estimation. Principles and structure

GOST R ISO 14041–2000 Environmental management. Life cycle estimation. Goal and re-search area definition and inventory analysis

GOST R ISO 14042–2000 Environmental management. Life cycle estimation. Life cycle impact estimation

GOST R ISO 14043–2000 Environmental management. Life cycle estimation. Life cycle inter-pretation

GOST R ISO 14050–99 Environmental management. Terms and definitions

GOST R ISO 19011–2003 Guidelines on QMSs and/or EMSs audit

Companies perform under the pressure of more strict legal and other kinds of requirements, aimed to protect the environment, as well as under the pressure of growing interested parties’ con-cern in environmental issues, that is why every company wants to achieve the necessary (from pub-lic point of view) environmental efficiency and demonstrate it controlling environmental impacts of its activity, production and services.

EMS AUDIT

ISO 19011

Environmental aspects inclusion in product stan-dards

ISO 14061 ISO/Guidance 64

Environmental efficiency estimation ISO 14031 ISO/TR 14032

Terms and definitions ISO 14050

ENVIRONMENTAL MANAGEMENT

SYSTEMS

ISO 14001, ISO 14004 Product lifecycle estimation

ISO 14040, ISO14041, ISO 14042; ISO 14043 ISO/TR 14047; ISO/TR 14048; ISO/TR 14049

Ecolabelling and declaration ISO 14020, ISO 14021, ISO 14022; ISO 14023, ISO 14024, ISO 14025

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Adoption of national standards system on environmental management in compliance with requirements of GOST R ISO 14001-2007 and GOST R ISO 14004-98 will create a flexible mech-anism aimed not to struggle against environmental risks but, first of all, to remove their causes. A model of an environmental management system that meets GOST R ISO 14001-2007 is shown in fig. 5.5.

Fig. 5.5 EMS model according to GOST R ISO 14001-2007

According to the model, activity in the system moves from setting up of environmental pol-icy of a company towards continual improvement. Herewith, the system passes well known stages of quality management cycle PDCA: planning – doing – checking – corrections.

Planning of conservation activity that meets the requirements of ISO 14000 standards in-cludes identifying environmental aspects, meeting legal requirements, setting up environmental in-dicators corresponding to an environmental policy, as well as developing programs aimed to achieve the environmental indicators. As a rule, the most significant environmental aspects are:

- emission to air; - emission to water, to land and subsurface waste storage; - recycling of solid waste; - noise; - heat pollution.

Success of an environmental management system depends upon commitments to responsi-bilities taken by every department of a company and, first of all, by its top executives. This system enables to establish the environmental management processes and estimate its efficiency for corre-spondence between worded environmental politics and system real indicators, and show this corre-spondence to other interested parties.

Environmental management deals with the whole scale of problems of a company compris-ing problems associated with strategy and competitiveness. While developing an environment man-agement system that meets GOST R ISO 14001 a company should introduce and maintain proce-

Continual improvement

Environmental po licy

Planning

Implementation and operating

Control and corrections

Executives analysis

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dures of environmental aspects identification and associated with them activities assessment.

To develop an environment management system for a company it is necessary to follow the essential principles listed in table 5.3.

Table 5.3 Essential principles of EMS development

Principle Description

Executives responsi-bility

Top executives responsibility for potential resourcing with the purpose of eco-logical efficiency increasing in company.

Employees Continual involvement of new employees.

Deming cycle Application of Deming (PDCA) cycle (plan – do – check - act)

Product life cycle Product life cycle application for effective environmental management system development.

Process approach Process approach application for environmental aspects and impacts identifica-tion.

Processes relations Compliance of an environmental management system with a current quality management system based on GOST R ISO 9001.

Management proc-esses control

Continual processes control for environmental aspects alterations and environ-mental impacts reveal.

Documentation man-agement

Legislative and normative acts regular analysis for environmental management system improvement.

Mutually beneficial relations

Relations with external interested parties for ensuring the continual environ-mental management system improvement.

GOST R ISO 14001-2007 identifies a regular analysis and a company evaluation of its EMS in order to reveal favorable opportunities for improvement taking into consideration both external and internal (on market or in interested parties’ requirements) changes.

5.3 EMS organizational structure and documentation establishing

EMS development and implementation by organizations and companies is difficult enough and labour intensive process.

The order of development and implementation of EMS for standards ISO 14000 series is generally the same as the order of development of a quality management system for standards ISO 9000 series. This order includes the following sequence of stages (fig. 5.6).

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Fig. 5.6 EMS development stages

EMS organizational framework is the same as that of QMS. Works arrangement in EMS and participants main functions are shown in fig. 5.7.

EMS documentation comprises:

- environmental policy; - aimed and planned environmental indicators; - documents regulating duties, employees responsibilities and powers in the environmental

protection area; - documents describing main elements of EMS and their interaction; - duties instructions; - environmental manual; - recorded data on environmental conditions and EMS development and implementation; - external documents.

Stage 1 Preparation to EMS development

Goal Organizational preparations to EMS development and implementation

Stage 2 EMS designing

Goal EMS organizational arrangement development

Stage3 EMS documenting

Goal EMS organizational-and-normative base development

Stage4 EMS implementation

Goal EMS operation ensuring according to specified standards

Stage 5 Preparation to EMS certification

Goal Ensuring readiness of an company of agro-industrial complex to certification

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Fig. 5.7 Flow-chart of EMS activities arrangement

External documents include ISO standards and GOST R ISO 14000 series, and environment protection documents that concern activities of the company and compliance with which is con-trolled.

Identified documents are included in the Register of environment-oriented documentation (RED). Herewith, all conservation documents are classified by a certain indication. An option of such a classification is shown in table 5.4.

Table 5.4 Company environment-oriented documentation classification

RED section code Group code RED section name

1 – General documentation

2 WC Water consumption

3 AA Ambient air

4 WW Waste water

5 SP Soil pollution

6 WE Waste emplacement

Coordination Council

Executive special representative on environment

Environ-mental service

Work group

Internal auditors

EMS documentation

Coordination, control and estimation in standards implementation work. Stra-tegic decision-making.

Operational manage-ment in standards im-plementation

Methodological man-agement in standards implementation

Auditing, participation in corrective and preventive activities development

External consultants

Consultation, training, methodic guidelines de-velopment, EMS docu-mentation audit

The company's chief executive

General management in standards implementation

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RED section code Group code RED section name

7 HC Hazardous chemicals

8 RMC Raw material consumption (that is hazardous for environment)

9 CST Chemicals storage within the company territory

10 RH Risk of hazards

11 EC Energy consumption

12 OD Other documents

In every section of RED documents are grouped in the following order:

- international treaties, conventions, agreements and other legal acts, when the Russian Fed-eration is a legal successor;

- national laws (by-laws) setting up legal regulations on the territory of the Russian Federa-tion;

- the President decrees, resolutions of State Duma (Council of the Federation) and Govern-ment of the Russian Federation;

- laws, resolutions (directions) of executive authorities of the Federation subjects; - regulations on bodies of state administration, regulation and inspection; - national standards (GOST) and building norms and rules (SNiP); - standards of organizations (STO); - departmental scientific and technical documents; - privileges, permits (including licenses) or restrictions of controlling (inspecting) authorities

and regional administrative bodies.

EMS (similar to QMS) is based on the process approach. The approximate list of EMS proc-esses in accordance with GOST R ISO 14001 is given in table 5.5.

Table 5.5 Environmental management system processes

Code Name MP 1 (MP – management process)

EMS development and improvement

MP 2 EMS planning

MP 3 Essential environmental aspects identification and emphasizing

MP 4 Legislative requirements Register maintenance

MP 5 EMS documentation managing

MP 6 Internal information exchange

MP 7 Society interaction

MP 8 EMS analysis by executives

MP 9 EMS functioning ensuring

MP 10 Records management

MP 11 Emergency response

MP 12 Employees management

MP 13 Equipment provision

MP 14 Financial provision

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Code Name MP 15 Monitoring and measurements

MP 16 Risk management

MP 17 Corrective actions

MP 18 Preventive actions

MP 19 Internal audit

Employees responsibilities on EMS processes is fixed in a responsibility and powers matrix, as well as in regulations on departments and duties instructions.

5.4 EMS implementation and certification

The order of EMS implementation is shown in table 5.6.

Table 5.6 EMS implementation order

Activity Document

Appointment of the environmental man-agement representative

Order of appointment of the environmental representative. The representative’s authorities

Distribution of responsibilities and authori-ties

Draft of responsibilities and roles matrix

Resources provision Order, instructions and/or plans

Identification of environmental aspects and environmental impacts associated with them

Register of environmental aspects and impacts

Identification of legal and other obligatory requirements

Register of legal and normative documentation

Development of internal efficiency criteria Register of internal indexes of efficiency

Identification of requirements and documen-tation on materials, products, equipment, technology processes and other documents on environmental impacts

Proposal for environmental policy and program of environ-mental management

Identification of target environmental indica-tors and development of environmental pol-icy

Environmental policy

Identification of planned environmental indi-cators and development of environmental management

Environmental management program

Employees training Program of training or an element of a general employees training program

EMS documentation Environmental management manual including: - responsibilities and roles matrix; - documentation structure; - documented EMS procedures or reference to them EMS documentation development, EMS documentation amending, production documentation amending

Documentation management List of documents (filing). Procedure of documentation man-agement in EMS or an element of a general documentation management. Informing executors

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Activity Document

Management of the life cycle processes for which important environmental aspects are identified

Environmental management program. EMS documentation

Emergency preparedness and response Environment management program. Events plans and emer-gency preventing procedures and response

Monitoring and measurements (of current environmental efficiency)

Environment management program. Registered monitoring and measuring data. Schedules of measuring equipment checking

EMS audit Order of appointment of auditors. Audit plans. Registered au-dit data.

Non-conformity management Registered non-conformity data

Corrective and preventive activities Plans of corrective and preventive activities developed on the results of measurements, control, audit and other types of analysis

Top executives analysis Decisions to amend environmental policy, environmental management program, and other decisions and recommenda-tions

A company implying EMS develops environmental management program in accordance with identified target and planned environmental indicators, in which activities, executors, dates and resources are reflected.

Environmental monitoring and measurement during production process of a company should be directed to environmental safety ensuring for interested parties.

During monitoring the following parameters are measured:

- parameters of sewage discharge into a sewer; - parameters of storm water; - emissions into the air; - parameters of water in a monitoring transit; - sanitary and hygiene characteristics in production departments; - parameters of production waste generation and disposal.

Periodic analysis and evaluation of a company activity conformity to environment protection laws is carried out based on monitoring data as given in table 5.7.

The following non-conformities could occur during EMS performance:

- company environmental policy departures; - violation of legislation requirements, established normatives, technological regulations, in-

structions; - accepted environment managing programmes and plans departures; - violation of requirements for EMS documentation.

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Table 5.7 Environment-oriented activities

Environment object Monitored parameters Measurement frequency

Ambient air protection 1. Сontaminating agents (CA) emissions from emit-ters into ambient air. 2. CA concentration within company territory. 3. CA concentration on the border of sanitary pro-tection area.

Twice a year Quarterly Quarterly

Water resources protection

1. CA discharge with rainwater into river. 2. CA discharge with production waste water into canalization.

Monthly Monthly

Soil protection Toxic wastes accumulation, disposal and utilization. Once a year

Natural environment pro-tection

Environment protection cost, ecological and nature-resources payments.

Once a year

Workplace air CA content, noise, vibration, luminance, microcli-mate.

Quarterly

Non-conformities could be revealed:

- within production process; - while monitoring and measurements; - during audits; - within inspecting organization control; - by society.

The following EMS data are registered in production departments: the course of production process, performance of production, dust – gas cleansing equipment, waste management, employees training.

The given data are used for periodical environmental evaluation, statistical reporting, ana-lyzing of non-conformity reasons and development of corrective activities, assessment of depart-ments EMS activities, evaluating effectiveness of EMS, actualizing of environmental policy. Ap-proximate Register form of environmental requirements is shown in table 5.8.

A procedure of a periodical evaluation by top management of EMS conformity to the cur-rent environmental laws and identified environmental policy should be regulated by STO EMS. Op-tions of responsibility assignment for environmental requirements revealing and during a monitor-ing of conformity to normative documentation are shown in tables 5.9, 5.10.

The procedure of EMS certification audit is similar to that of QMS and is regulated by the general standard GOST R ISO 19011-2003. The procedure of preparation and carrying out of EMS certification includes the following stages:

- estimation of the system readiness level to certification; - certification authorities decision; - signing a contract on certification; - system preliminary estimation; - corrective actions;

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- certification audit; - conformity assessment of EMS to GOST R ISO 14001–2007 requirements; - informing every interested party; - inspection of certified system.

Table 5.8 Environmental requirements register form

Developed by: Approved by: Company name Environmental requirements

(ER) Register Date «___»______________201_ г.

Page_ of___

Normative docu-ment ND Validity

No

Name Requisites

ER (parag-raph No., require-ment description)

Com-pany organiza-tional depart-ments (OD) the ERs must be applied

Inform-ing employees about ER

Start date Expi-ration date

Docu-ment con-trolled copy holder

Data on ER im-plemen-tation result

Infor-mation about non-con-formi-ties

1 Ambient air (emissions)

1.1 Economic regulation

1.2 Environment control

1.3 Environment im-pacts

Proto-cols, acts, reports

1.4 Certification

1.5 Metrological ensuring

ER refer-ence in docu-ment

2 Water resources (wastes)

3 Waste products

4 Soils

5 Physical impacts (noise, vibration, etc.)

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Table 5.9 Responsibility assignment for environmental requirements revealing

Organizational department Environmental requirement s Legal Department Responsibility for environmental wrongdoing

Environmental Department Protection of water, atmospheric air, domestic and industrial waste management, environmental monitoring

Industrial Safety Department Hazardous objects insurance and certification

Electrical Supervisor Department Energy saving

Production Manager Department Metrological assurance within environment quality regulatory action

Accounting Department Accounting fees for environmental management

Table 5.10 Responsibility assignment for monitoring of normative documents creation

Organizational de-partment Monitoring aspects

Environmental Depart-ment

Internal audits on environmental condition (emissions, wastes, temporary waste disposal)

Work Safety Department Internal audits on operating culture and production sanitary at the workplaces

Electrical Department Internal audits on natural resources utilization

Quality Management De-partment

Internal audits on EMS conformity to GOST R ISO 14001-2007 requirements

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1. What is the sense of Sustainable development concept?

2. When was the ISO 14000 series developed?

3. Name the contaminants major sources in agriculture.

4. What national standard determines the requirements to EMS?

5. What activity stages does EMS model according to GOST R ISO 14001-2007 include?

6. Specify EMS essential principles.

7. Name EMS development stages.

8. What is a aim of EMS designing stage?

9. What documents are parts of EMS documentation?

10. What are the duties of executive representative on environment?

11. Give the examples of Register of conservation documentation sections.

12. Name EMS main processes.

13. Specify activities order for EMS implementation.

14. What parameters are measured within environmental monitoring?

15. Name the procedures of EMS certification audit.

5.6 Summary

Environmental management is paid much attention in the concept of sustainable develop-ment. ISO 14000 standards play a leading role in the realization of environmental management ide-as.

Currently a significant international experience in environmental management in various in-dustries (including agriculture) is accumulated. But in this country the process of environmental management has just started its development. The agribusiness industry activity is connected with ecological aspects and environmental impact. Agriculture is a source of different environment con-taminants. Thereby, now agriculture of the production area alongside with industry and transport is a source of pollution.

Environmental management in agro-industrial complex, first of all, means creation of safer production and producing products of high quality. Environmental requirements keeping and effec-tive environmental management in the Russian Federation is based on the standards GOST R ISO 14000 series and also on interindustrial system of standards such as System of standards in the area of environmental protection and improved management of natural resources and Labour safety standards system.

ISO 14000 standards set structure includes terms and definitions standards, standards on ecological aspects consideration in production standards, standards on product life cycle estimation, standards on environmental efficiency estimation and also standards on EMS environmental mark-

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ing and auditing.

According to EMS model, activity in the system moves from setting up of environmental policy of a company towards continual improvement. Herewith, the system passes well known stages of quality management cycle PDCA: planning – doing – checking – corrections.

Planning of conservation activity that meets the requirements of ISO 14000 standards in-cludes identifying environmental aspects, meeting legal requirements, setting up environmental in-dicators corresponding to an environmental policy, as well as developing programs aimed to achieve the environmental indicators.

Main stages of EMS development are generally the following: preparation to development, designing of EMS, EMS documenting, implementation, preparation to certification.

The approximate list of EMS processes in accordance with GOST R ISO 14001 is the fol-lowing: EMS planning, identification of environmental aspects and their significance, emergency response, etc.

Documentation of an environmental management system comprises:

- environmental policy; - environmental indicators; - documents regulating duties, responsibilities and employees authorities in the area of envi-

ronmental protection; - documents describing main elements of EMS and their interaction; - duties instructions; - environmental manual; - recorded data on environmental conditions and EMS implementation and operating; - external documents.

Identified documents are included in the Register of conservation documentation (RED).

A company implying EMS develops environmental management program in accordance with identified target and planned environmental indicators where the activities, executors, dates and resources are reflected. In order to fulfill the program there is an allocation of responsibility for identifying environmental requirements and during a monitoring of conformity to normative docu-mentation.

The procedure of EMS certification audit is similar to that of QMS and is regulated by the general standard GOST R ISO 19011-2003. The preparation and implementation procedure of EMS certification is similar to procedure of QMS certification.

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6 Food Quality Management System on the basic of HA CCP and ISO 22000

The chapter deals with the principles of HACCP, identification of critical control points on the basis of the production process analysis and record-keeping procedure. It describes the delivery chain significance for food safety, principles and guidelines for development and introduction of ISO 22000.

Plan

6.1 HACCP principles.

6.2 HACCP process flow diagram and worksheet.

6.3 Supply chains importance for safety ensuring.

6.4 Systems on the basis of ISO 22000.

6.1 HACCP principles

The Hazard Analysis and critical control Points (HACCP) is food safety ensuring system providing through all the stages of product life cycle the regular identification, estimation and man-aging of hazards essentially affecting on food safety. The HACCP principles are regulated by Di-rective EC 93/43.

In the Russian Federation main requirements to a quality management system based on HACCP are regulated by GOST R 51705.1-2001 “Quality systems. The HACCP principles for food products quality management. General requirements.” Mentioned national Standard is worked out in reliance on the European Council Directive 93/43.

The HACCP system is a state of the art management system that systematically identifies specific hazards and control measures to ensure food goods safety. The system has been recognized internationally and currently in the EU countries, USA, Canada implementation and application of the HACCP concept in food industry is obligatory.

The HACCP is based on the systematic approach which covers food gods safety at any stage of life cycle from raw materials to goods consumption.

Risk the combination of the probability of occurrence of harm and the severity of that harm. Critical control point is a step at which hazardous factor and/or hazard management can be identi-fied.

The HACCP system is developed considering seven principles:

1. To define the potential hazard or hazards (hazardous factors) associated with food produc-tion starting from raw materials (their breeding or growing) up to final consumption includ-ing all the stages of the product life cycle (processing, storage, distribution) in order to iden-tify conditions of potential hazard/s occurrence and appropriate control measures;

2. To determine critical control points of production process in order to minimize potential hazards occurrence; production process covers raw materials supply, ingredients selection,

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processing, storage, transportation, warehousing and distribution;

3. To establish in the HACCP system documents or in technological instructions the critical limits in order to assure that the critical point is controlled;

4. To develop the monitoring system ensuring inspection of the critical control points based on planned measures or observations;

5. To establish corrective actions and their implementing in case of negative monitoring re-sults;

6. To establish verification procedures that should be conducted on regular basis in order to ensure efficient performance of the HACCP system;

7. To documentation of all system procedures, forms and methods of the HACCP system re-cord keeping .

Company executives select and appoint the HACCP team that is responsible for system de-velopment, implementation and maintaining. Coordinator and technical secretary must be included in HACCP team.

The HACCP team should identify and evaluate any kinds of hazards including biological (argobiological), chemical and physical, and identify potential hazardous factors that can occur dur-ing production. For each potential factor there should be conducted a hazard analysis taking into account the possibility of factor arising and its results importance and made a list of hazards which are over acceptable safe level.

The HACCP team should identify and record preventive activities that remove potential hazards or minimize them to a safe level. Stages of the HACCP system development are considered in parts 6.2 and 6.3. The final stage is certification. The HACCP system conformity sign is shown on pic. 6.1.

The HACCP certification gives several internal benefits to the company:

- preventive approach to food safety what reduces the product recalls; - unique definition of responsibility for food safety ensuring; - correct detection of the hazards and centralization of company main resources and efforts on

them; - essential savings due to defective goods share decreasing in the total production value; - documented verification regarding food products safety that is particularly important in

claims analysis and court proceedings; - additional opportunities for integration with ISO 9001.

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Fig. 6.1 The HACCP system conformity sign

Main external benefits of the HACCP system implementation are:

- consumer confidence in produced goods; - opportunity to enter other (including international) markets, and to expand the commodity

market; - additional advantages in case of participating in tenders due to enlarged competitiveness of a

company; - enlarging of investment attractiveness; - reducing number of reclamations due to ensuring of stable product quality; - building the reputation of a producer of quality and safe food products.

In Russia GOST R 51705.1-2001 fits well in realization of the national law No. 29 “On Food products quality and safety” dated January 2, 2000.

Along with the HACCP principles there were developed practical steps towards food safety by the Codex Alimentarius Commission. Recommended by the Commission international regula-tions on good practice and food hygiene are important documents in the area of food safety.

The best practices are the tools that guarantee meeting the main food safety requirements. GMP (Good Manufacturing Practices) can be an example of a good practice. To realize the GMP a company allocates a GMP zone – an area, identified in a GMP map, where a manufactured product can be endangered with contamination or impurity directly or indirectly.

Other examples of good practices in the area of food production are:

GHP (good hygiene practice) provides hygiene and vermin and parasites control;

GAP (good agricultural practice) provides control for primary producing;

GLP (good laboratory practice) controls laboratories performance.

6.2 HACCP process flow diagram and worksheet

Making a flow-chart of a production process and determination of critical control points are the most complicated stages of development of HACCP-based systems. A HACCP team considers and approves an organizational structure, plans of production premises; identifies movements of raw materials and products, points at which potential contamination from lubricants, metal, glass, etc. can occur; classifies production processes, determines potential hazards; develops preventive actions.

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Critical control points are determined by conducting a hazard analysis of each hazardous factor and by considering gradually all the processes included in a production process flow diagram, fig. 6.2.

Fig. 6.2 The example of production process flow diagram

A hazard analysis and identification of critical control points is made using a decision tree. Critical control points should be justified and documented. Critical limits should be recorded in a HACCP worksheet (fig. 6.3).

Fig. 6.3 HACCP worksheet

Product name________________________________________________________________________ Production process name_______________________________________________________________

Processing step

Hazard Сritical control point No.

Controlling parameter and its limits

Monitoring procedure

Controlling actions

Record keeping document

Reception & storage

Oil purchasing Breading purchasing

Reception and dry storage

Grating

Water Flour purchasing

Grating

Mixing with water

Labeling

Check weighing (loss rate)

Package

Cooling

Storage

Complete frying

Breading

Deliv-ery&retailing

Reception and cold storage

Processing

Meat purchasing

Reception and dry storage

Packaging

Dozing unit & filter

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The best strategy of a HACCP system implementation is its implementation for several ho-

mogenous product groups, in which there should be considered the same hazards.

6.3 Supply chains importance for safety ensuring

Food quality and safety improvement is an essential problem of the world economy. The Federal law on Technical regulation determines safety as a condition when there is no non-permissible risk. Currently domestic manufacturers face a difficult task to ensure food products safety and quality while increasing their competitiveness. Food safety management system is based on the following main principles:

- food safety depends on raw materials safety; - planned production processes should ensure released food product quality; - marketing and food products delivery should be carried out with sanitary norms and rules

adherence saving products properties.

To prevent a disposal of hazardous for health food in the market there should be developed and implemented a traceability system of a production chain.

Traceability system is a system of technical tools and management activities aimed to assist a company in organizing its performance and allowing, when necessary, to identify the time, quality and location of a product or its ingredients. The system should include the complete production chain from grain and feed production to disposal of the end product (fig. 6.4).

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Fig. 6.4 Food safety traceability

Principles and main requirements to development and implementation of a food and feed product traceability system are identified in the national standard GOST R ISO 22005-2009 “Trace-ability in the feed and food chain. General principles and basic requirements for system design and implementation”.

The standard can be implied by any organization working at any stage of food and feed pro-duction. Implementation of the system should be flexible enough to allow organizations producing food and feed products to achieve their set tasks.

Information sharing is of great importance in food safety management system based on GOST R ISO 22000-2009. Information is exchanged at any stage of a production chain. At each successive stage there is need in information to identify and monitor hazards having impacts on end product safety. Sharing of information about identified hazards and control measures between consumers and suppliers permits to see if requirements are met and to evaluate impacts of identified hazards and control measures on end product. A flow-chart of information sharing is shown in fig. 6.5. The location of a company in a production chain has a great influence on the efficiency of in-formation sharing.

Compound animal feed production

Transportation

Primary processing companies

Raw materials for compound animal feed production

Trading companies

Export to the 3rd countries

Storage

Food industry companies

Consumers

Foodservice companies

Transportation

Import from the 3rd countries

Agriculture. Raw materials production

Transportation

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Fig. 6.5 Information sharing in food production chain

Development and carrying out of measures on the system improvement also greatly depend on information sharing. Fig. 6.5 shows the result of a social survey on getting information about product quality and safety in the chain “from Stable to Table”.

Grain producers

Service companies

Law

s a

nd s

tate

aut

horit

ies

Raw materials primary processors

Food raw materi-als producers

Pesticides, fertilizers and veterinary drugs producers

Food ingredients and additives producing chain

Transportation and storage services

Equipment producers

Detergents & sanitizers producers

Packing materials producers

Forage pro-ducers

Food producers

Wholesalers

Retailers, operators

Consumers

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Fig. 6.6 A flow-chart of social survey on product and services quality and safety in the chain “from Stable to Table”

HACCP food safety management system adoption allows identifying the critical points of an enterprise and ensures concentration of main resources and activities on those points.

6.4 Systems on the basis of ISO 22000

In January 1, 2008 in Russia there was introduced the national standard GOST R ISO 22000-2007 Food safety management systems. Requirements for any organization in the food chain. The standard was introduced to globally harmonize food safety requirements for any compa-nies and organizations in the food chain.

The standard is to apply in organizations tending to implement a specialized, successive and integrated food safety management system. As soon as the said standard is introduced organizations may chose to develop a HACCP system based either on GOST R 51705.1-2001 or GOST R ISO 22000-2007.

National standards both GOST R 51705.1-2001 and GOST R ISO 22000-2007 provide global harmonization of requirements for food safety management in any organization in the food chain.

GOST R ISO 22000-2007 sets up requirements for a food safety management system in-

Raw materials producers

Data on vegetable raw materials quality

Food production

Data on raw materials, food and production proc-

esses quality

Consumers

Data on food quality

Data on animal raw ma-terials quality

Catering services

Data on a quality of raw materials, dishes and

services

Res

pond

ents

Rec

yclin

g

Rec

yclin

g

Rec

yclin

g

Rec

yclin

g

Data on food and services quality

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cluding the generally recognized elements:

- interactive communication; - management system; - prerequisite programs; - principles of hazard analysis at critical control points (HACCP).

Implementing these elements ensures food safety at any stage of a chain up to the end con-sumption.

GOST R ISO 22000-2007 incorporates general principles of Hazard Analysis and Critical Control Points system with this system application steps developed by Codex Alimentarius Com-mission. The structure of GOST R ISO 22000-2007 is similar to the structure of GOST R ISO 9001-2008 and assumes food production management facilities similar with GOST R ISO 9001–2008 but adapted for application in food industry.

Hazard analysis is a key to efficient food safety management system as far as this analysis helps to systematize knowledge necessary for development of efficient control. The standards re-quires identification and assessment of any potential hazards in the chain including those associated with a technology process or equipment used. The management approach set by this standard can be implemented to consider other issues of food production like production ethics or informing con-sumers.

To make the food safety system more efficient it is necessary to develop, apply and actualize the system in the framework of structured management system and integrate with a general man-agement activity of an organization. This approach guarantees top benefits for the company and other interested parties. Therefore, ISO 22000 standard is aligned with ISO 9001 thus resulting in better compatibility of the two standards.

Like other standards of management systems, ISO 22000 is based on a process approach when to ensure food safety there is applied the management of various integrated activities for which it is important to prevent, remove or minimize food hazards.

Food safety ensuring can be more efficient when it is based upon ISO 9001 quality man-agement system subject to GMP, GHP and other HACCP principles and when it is controlled by ISO 22000 food safety management system. While developing and implementing the system there can be considered recommendations of ISO 22004, ISO 9004 and ISO 15161. GOST R ISO 22000-2007-based system can be applied, irrespectively of other management systems, taking into consid-eration requirements of management systems already introduced in a company.

All ISO 22000 requirements are fundamental and are to be applied in any company in the food chain regardless its size or specialization, as well as in companies directly or indirectly in-volved into the food chain at one or several stages. Such companies can be: feed producing, harvest-ing, ingredients producing; food producing; retailers; service organizations in food area; catering companies; cleaning and sanitary company; transporting, storing or distributing company; produc-ing equipment, cleansers and sanitizers, packaging materials and other materials contacting with food.

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Development and implementation of a food safety management system based on GOST R ISO 22000-2007includes the following stages and operations:

Stage 1. Work planning

1.1 Real data collection and analysis on food safety system state.

1.2 Food safety ensuring team making for FSMS implementation.

1.3 Process flow diagram development.

Stage 2.System design

2.1 Food safety team training on GOST R ISO 22000-2007.

2.2 Documentation development:

- production process maps;

- list of potential hazards, critical limits, monitoring procedures, corrective actions descrip-tions, audit schedule and procedures, records-keeping procedures;

- HACCP plan development with compulsory preliminaries programmes and critical control points indication.

2.3 Final hazard analysis report including monitoring measures and motivation for each identified hazard.

Stage 3. System implementation

3.1 Food safety system reorganization according to GOST R ISO 22000-2007 requirements and FSMS actual implementation.

Stage 4. System conformity verification to GOST R ISO 22000-2007 requirements.

4.1 Internal audits.

4.2 Executives analysis.

Stage 5. Corrective actions implementation according to executives’ analysis results

5.1 Corrective actions determination and accomplishment.

5.2 Validation decision (requirements accomplishment confirmation) and final decision on certification body.

5.3 Assistance in applying to certification body.

For implementation of GOST R ISO 22000-2007 requirements it is essential to develop and approve policy with top management commitment in the area of food safety. Communication be-tween suppliers, contractors, consumers and auditing bodies is important for guaranteeing efficient informing all consumers in the food chain about food safety aspects. It is also necessary to establish an internal communication for timely informing about requirements for products, production condi-

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tions, stuff management and outside regulation requirements.

Developing documentation requires describing raw materials, ingredients, substances and materials contacting with food to the extent needed to identify and evaluate risks, identification and evaluation of all biological, chemical and physical hazards, as well as the hazards control for each type of products and processes.

For certification of a food safety management program based on GOST R ISO 22000-2007 it is necessary to develop and document:

- procedures of analysis and control of emergencies and accidents influencing food safety; - flow-diagrams of processes for the product categories with identification and description of

additional control sites that influence food safety and with identification of process parame-ters or/and measured characteristics;

- layout drawings showing the physical flow of raw materials, intermediate products, end products and traffic of personnel through the facilities;

- monitoring system for each CCP to demonstrate that a CCP is under control; - actions when critical limits are exceeded; - critical limits control methods to identify hazards that should be controlled in the framework

of the methods; regulating procedures, instructions, forms, parameters of control and record-keeping;

- procedure of nonconformity product control to guarantee impossibility of its supply to con-sumers;

- procedure of nonconformity product withdrawal; - procedure of control of equipment for monitoring and measuring; - procedure of planning and carrying out internal audits of food safety management system as

well as its improvement.

Implementation of food safety management systems conformed with ISO 22000 require-ments enables the companies participating in food chain to display the efficiency of their risk man-agement systems and ability to ensure food safety at the consumption stage. This, in its turn, im-proves company’s image in the eyes of consumers and other interested parties, as well as increases competitiveness of the manufacturing product.

Meeting the ISO 22000 requirements allows to demonstrate company’s conformation with the requirements through certification of its safety management system. A company may be certi-fied to GOST R ISO 9001, GOST R 51705.1-2001 and GOST R ISO 22000-2007 in complex or separately.

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1. Give the explanation for HACCP abbreviation.

2. What does term risk mean?

3. What does Сritical Сontrol Point term mean?

4. Specify HACCP principles.

5. What are the duties of HACCP coordinator and team?

6. What are the benefits of HACCP system?

7. What is the reason of production process flow diagram making?

8. What is a procedure of critical control points reveal?

9. What is information of HACCP worksheet?

10. What is the aim of ISO 22000 implementation?

11. What is the reason of food safety traceability?

12. Name the food chain elements for traceability ensuring.

13. Specify the information sharing parties in food production chain.

14. Name the stages of food safety management systems development.

15. Specify the subjects of food safety management systems documentation.

6.6 Summary

The HACCP system is an internationally recognized, state of the art management system that systematically identifies specific hazards and control measures to ensure food goods safety.

The HACCP system is based on the seven principles. The Board of a company assembles and appoints the HACCP team that is responsible for development, implementation and mainte-nance of the system. The team should include a coordinator and a technical secretary.

Making of a production process flow-chart and determination of critical control points are the most complicated stages of development of HACCP-based systems. Critical control points are determined by conducting a hazard analysis of each hazardous factor and by considering gradually all the processes included in production process flow-chart.

A hazard analysis and identification of critical control points is made using a decision tree method. Critical control points should be justified and documented. Critical limits should be re-corded in a HACCP worksheet.

The best strategy of a HACCP system implementation is its implementation for several ho-mogenous product groups, in which there should be considered the same hazards.

In January 1, 2008 in Russia there was introduced the national standard GOST R ISO 22000-2007 “Food safety management systems. Requirements for any organization in the food chain”. The standard was introduced for global harmonization of food safety requirements for any

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companies and organizations in the food chain.

To prevent disposal of dangerous food products in the market traceability system should be developed and implemented in food chain. Information sharing is of great importance in food safety management system based on GOST R ISO 22000-2009. Information sharing should be provided for each stage of the food chain “from Stable to Table”.

GOST R ISO 22000-2007 incorporates general principles of Hazard Analysis and Critical Control Points system with application steps developed by Codex Alimentarius Commission. Be-sides the structure of GOST R ISO 22000-2007 is similar to the structure of GOST R ISO 9001-2008 and identifies adapted to food production management tools similar to those of GOST R ISO 9001-2008 but adapted for food industry application.

All ISO 22000 requirements are fundamental and are to be applied in any company in the food chain.

Development and implementation of a food safety management system based on GOST R ISO 22000-2007 includes the following stages and operations:

Stage 1. Work planning; Stage 2. System design; Stage 3. System implementation; Stage 4. System conformity verification to GOST R ISO 22000–2007 requirements; Stage 5. Corrective actions implementation according to executives’ analysis results.

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7 Conformity assessment

The chapter deals with objectives, principles and functioning of the Russian Federation Na-tional Certification System, as well as with the procedure of food products certification and declara-tion, ecological certification.

Plan

7.1 Russian National Certification System and its modernization.

7.2 Obligatory and Voluntary conformity assessment.

7.3 Food products and raw materials Certification and Declaration.

7.4 Food products environmental certification and environmental marking.

7.1 Russian National Certification System and its m odernization

Conformity assessment (certification) is a generally recognized, internationally accepted mechanism which allows setting a balance between the need to ensure a common economic space, on the one hand, and to protect citizens and society as a whole from products dangerous for human life and environment, on the other hand.

Certification became legally compulsory with introduction in 1992 of the federal law on consumer rights protection. Since May 1, 1992 the obligatory certification system GOST R has been introduced in the Russian Federation.

Currently objectives and principles of conformity assessment are harmonized with the inter-national practice and regulated by the federal law no. 184-FZ on Technical regulation of July 1, 2003. The federal law became a platform for capital reforms in the area of technical regulations in the country and now it is the main source of technical law in Russia. In accordance with require-ments of the federal law, conformity assessment is developed and applied equally and to equal ex-tend regardless the country or place of origin of a product or other factors.

Conformity assessment is applied for the purpose of:

- certificating compliance of a product, processes of production, performance, storage, trans-portation, marketing and utilization, works, services and other objects with technical stan-dards, norms, rules, agreement terms;

- assistance to purchasers in competent selecting of products, works and services; - enhancement of product (work, service) competitiveness in the national and international

markets; - creating conditions for free movement of products on the territory of the Russian Federation,

as well as for international economic, scientific and technical collaboration and for interna-tional trade.

- Conformity assessment is based on the following principles: - information availability on the order of conformity assessment to interested parties; - impermissibility of obligatory conformity assessment application for the objects with non-

established requirements of technical standards; - obligatory conformity assessment forms and schemes determination for definite products in

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appropriate technical regulations; - obligatory conformity assessment realization period and applicant costs reduction; - force impermissibility of voluntary conformity assessment particularly in a definite system

of voluntary certification; - protection of applicants’ properties interests, commercial secrets keeping concerning the in-

formation obtained while conformity assessment realization; - inadmissibility of obligatory conformity assessment substitution for voluntary certification.

Basic actual concepts of conformity assessment in the Russian Federation are identified by the federal law on technical regulation and based on Guidelines ISO/IEC 2.

Conformity assessment - is the documentary certifying of conformity of products or other objects, processes of production, operation, storage, transportation, marketing and utilization, exe-cuting of works or rendering of services to the requirements of technical regulations, provisions of standards or conditions of agreements.

Certification - the form of objects conformity assessment to the technical regulations re-quirements, to provisions of standards or conditions of agreements, realized by certification body.

Declaring of conformity is the form of products conformity assessment to the technical regulations requirements.

Conformity certificate - is the document certifying the conformity of an object to the re-quirements of technical regulations, to provisions of standards or conditions of agreements.

Conformity Declaration - is the document certifying the conformity of the released product to the technical regulations requirements.

Mark of market access - is the label intended for informing of purchasers on conformity of released products to the technical regulations requirements.

Conformity mark - is the designation intended for purchasers informing on conformity of certification object to the requirements of voluntary certification system or the national standard.

Certification system - is the set of rules for executing of works on certification, its partici-pants and rules for operation of the certification system as a whole.

Accreditation - is the official recognition, by accreditation body, of the competence of a natural or legal person to perform operations in definite area of conformity assessment.

By 2011 there were 19 systems of obligatory certifications and more than 750 systems of voluntary certification on the Russian Federation territory (fig. 7.1).

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Fig. 7.1 Russian National Certification System structure

Establishing the current national certification system, the RF Gosstandard was responsible for organizing and performing of obligatory certification. Other authorities (Ministry of Transport, Ministry of Communications, etc.) were responsible for certification of definite kinds of products. Basic obligatory certification systems of the Russian Federation (2011) are shown in table 7.1.

Table 7.1 Russian Federation obligatory certification basic systems (as on January, 1, 2011)

System Registered by

1. GOST R certification system The Russian Federation State Standard

2. Certification system of information safety tools ac-cording to information safety requirements

State Technical Committee under the President of the Russian Federation

3. Certification system of information safety tools The Russian Federation Ministry of Defense

4. Certification system of explosive industries safety Russian Agency for Ammunition

5. Certification system for national railway transport The Russian Federation Ministry of Communica-tion Lines

6. Certification system “Telecommunication” The Russian Federation Ministry of Telecommuni-cations and Information Technology

7. Certification system of production and services con-cerning fire safety

The Russian Federation Ministry of Internal Affairs

8. Certification system of information safety tools ac-cording to safety requirements

The Russian Federation External Intelligence Ser-vice

9. Certification system of naval civil ships The Russian Federation Ministry of Transport

10. Certification system for the Russian Federation air transport

The Russian Federation Ministry of Transport

11. Certification system of geodesic, topographic and cartographic production

The Russian Federation Geodesic and Carto-graphic Service (Ruscartography)

Russian National Certifcation System

Obligatory cer-tification sys-

tems

Voluntary certi-fication sys-

tems

GOST R certifi-cation system

Other obligatory certification systems

More than 750 voluntary certification systems

•••

44 subsystems of homogenous

products certific ation

135

12. Certification system of aviation equipment and civil aviation objects

International Aviation Committee

13. National certification system of space equipment for scientific and economical application

The Russian Aviation and Space Agency (Rosaviakosmos)

14. Certification system of equipment, production and technologies for nuclear plants, radiation sources and storage locations

The Russian Federation Ministry of Nuclear en-ergy; The Russian Federation Inspectorate for Nuclear and Radiation Safety; The Russian Federation State Standard

15. Certification system of information safety tools ac-cording to safety requirements for state secret informa-tion

The Russian Federation Federal Safety Service

16. Certification system of immunobiological medica-tions

The Russian Federation Ministry of Healthcare

Note: Ministries and departments names are actual on the moment of systems registration.

The typical chart of certification system (fig. 7.2) includes a number of participants. The cer-tification participants are: national certification body (Rosstandard), state authorities on certification (SA), central certification bodies (CCB), certification bodies (CB) or legal entities responsible for voluntary certification, testing laboratories (TL) or centers (TC), production producers (performers, sellers).

Fig. 7.2 Typical structure of homogenous products certification system

Certification system GOST R was introduced in 1992 to organize and perform obligatory certification of products, works or services and ensuring unbiased and credible certification results.

GOST R system certifies:

goods for personal (household) needs of people:

industrial-and-technological production including means of production;

goods for building;

ROSSTANDARD

CCBs

CBs CBs

TLs (TCs) TLs (TSs)

SA

Applicants Applicants

…

…

…

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works and services supplied to people;

quality systems;

manufactures;

personnel (experts).

Normative legal acts of conformity assessment in GOST R system include technical regula-tions, national standards, rules, sanitary rules and norms, building norms and rules and other docu-mentation that set up mandatory requirements to safety in accordance with the Russian legislation. Presently the number of documents exceeds 60,000.

Main organizational and methodical documents of federal level regulating conformity as-sessment rules and order in effective national certification system are shown in table. 7.2.

Table 7.2 Normative by-laws of federal level regulating conformity assessment rules and order

Document Date of introduction

Procedure of importing of goods that are subject to obligatory certification to the territory of the Russian Federation

Order of STC of Russia no. 217 of May 23, 1994

Procedure of carrying out certification of products in Russia Gosstandard Resolution no. 15 of July 21, 1994

Amendment № 1 Procedure of carrying out certification of prod-ucts in Russia

Goostandard Resolution no. 15 of July 25, 1994

General procedure of treating samples used in obligatory certifi-cation

Gosstandard Resolution of February 8, 1996

Rules of using a mark of conformity in obligatory certification of a product

Gosstandard Resolution no. 14 of July 25, 1996

Amendments to rules of using a mark of conformity in obligatory certification of a product

Gosstandard Resolution no. 154 of No-vember 20, 1999

Rules of works and services certification in the Russian Federa-tion

Gosstandard Resolution no. 17 of Au-gust 5, 1997

Procedure of state registration of certification systems and marks of conformity in effect in the Russian Federation

Gosstandard Resolution no. 18 of April 22, 1999

Remuneration for products or services certification Gosstandard Resolution no. 44 of Au-gust 23, 1999

Procedures of certification in the Russian Federation Gosstandard Resolution no. 26 of May 10, 2000

Regulation on State Register Gosstandard Order no. 203 of April 30, 1999

To determine which requirements of normative laws the produced or supplied product should comply with, it is necessary to use fundamental documents: “Information on production re-quiring obligatory conformity assessment (in a form of obligatory certification) indicating the nor-

137

mative documents establishing the obligatory requirements” and “Information on production re-quiring obligatory conformity assessment (in a form of conformity declaration) indicating the nor-mative documents establishing the obligatory requirements” and for importing production “Infor-mation on production requiring obligatory conformity assessment under customs treatment provid-ing the possible confiscation and application for its intended purpose on customs territory of the Russian Federation indicating the Customs Union commodity codes”.

GOST R system has its forms of certificates and marks of conformity. Organizational ar-rangement of GOST R system (fig. 7.3) includes: Rosstandard, central bodies of certification sys-tems of homogenous products (works, services), certification bodies, testing laboratories (centers).

Fig. 7.3 Organizational arrangement of GOST R certification system

GOST R system covers certification of domestic and imported products according to uni-form rules. GOST R system provides obligatory certification on the whole territory of the Russian Federation by establishing a net of duly accredited certification bodies and testing laboratories (centers) for all the nomenclature of products requiring obligatory certification. Certification bodies and testing laboratories (centers) have the right to carry out voluntary certification within the limits of their accreditation.

GOST R system is open for other federal executive authorities, various organizations recog-nizing and fulfilling its rules.

GOST R system includes 44 systems of homogeneous product (work, service) certification: certification of food products and food raw materials, certification of utensils, certification of high-voltage electric equipment, certification of toys, certification of civil and service weapons, certifica-tion of agricultural machinery, certification of vehicles and trailers, etc.

… L

ROSSTANDARD

SYSTEM COORDI-NATION COUNCIL

SYSTEM STATE REGISTER

APPEAL BOARD

Scientific-methodic cen-tres (Russian Scientific Research Institute for Cer-tification (RSRIC), etc.)

CCB

CCB CCB

B B B B B

C L C L L C L L

4TH … …

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There is a committee on appeal to consider a complaint of certification participants in com-pliance with approved Resolution.

Currently the Russian Federation national certification system is under essential moderniza-tion within national law “On technical regulation” and the CU establishment. Normative legal acts harmonization issues within the modernization program are described in part 1.4 in details, the main approaches and corrections connected with the CU establishment are given in part 3.3.

7.2 Obligatory and Voluntary conformity assessment

Several conformity assessment forms are used in everyday practice of economic activity (fig. 7.4).

FORMS OF CONFORMITY ASSESSMENT

Sta

te c

ontr

ol (

insp

ectio

n)

Acc

redi

tatio

n

Tes

ts

Reg

istr

atio

n of

tech

nica

l re

gula

tion

obje

ct

Con

form

ity a

sses

smen

t

Obj

ect a

ccep

tanc

e an

d op

erat

ion

Oth

er fo

rms

Fig. 7.4 Conformity assessment forms

The process of conformity assessment depends on modules comprising a number of proce-dures applicable to different stages of life cycle (development, production, control, product verifi-cation, etc), various assessment methods (documentation control, sample testing, QMS certification, assessment of production conditions, etc.), various types and volumes of work, complexity of an object of a technical regulation, various executors (individual or leagal entity), including producers, consumers or independent state bodies.

Conformity assessment is a form of conformity assessment. It can be carried out by first, se-cond or third party. The first party can be a producer or supplier of a product. The second party is a user, consumer of a product. The law on technical regulation identifies second party as a purchaser. In line with terminology of ISO/IEC Guide 2 the third party is “a person or a body independent from interested parties of the considered issue”.

There are several forms of conformity assessment. The law on technical regulation identifies the conformity assessment form as a documentary certifying of conformity of products or other ob-jects, processes of production, operation, storage, transportation, marketing and utilization, execut-ing of works or rendering of services to the requirements of technical regulations, provisions of standards or conditions of agreements.

139

Conformity assessment can have obligatory or voluntary character in the Russian Federation (see fig.7.5).

Conformity assessment

Obligatory Voluntary

Form: Obligatory

certification

Form: Declaration

Form: Voluntary certification

Fig. 7.5 Conformity assessment forms classification

Obligatory conformity assessment does not prove the product quality as a whole. Certifica-tion and declaration procedures just ensure confirmation of obligatory safety requirements for con-sumers and environment. Obligatory safety requirements structure - in line with the law “On techni-cal regulation” - is shown in fig. 7.6.

Voluntary conformity assessment is carried out in the form of voluntary certification. Oblig-atory conformity assessment is carried out in two forms: adoption of declaration of conformity and obligatory certification.

Fig. 7.6 Obligatory safety requirements structure

Conformity assessment form is regulated by an output document. Responsibility for this document is placed on the corresponding party. Differences between certification and declaration

Obligatory safety requirements

Thermal safety

Mechanical safety Chemical safety

Electric safety

Nuclear and Radiation safety

Fire safety

Industrial safety

Explosion safety

Biological safety (veteri-nary and sanitary, phy-tosanitary measures)

Radiation safety

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are shown in table 7.3.

Table 7.3 Basic differences between two forms of conformity assessment

Conformity Declaration Certification

Realized by manufacturer (supplier, executor). Realized by certification body.

Document proved the conformity is Conformity Dec-laration.

Document proved the conformity is Conformity Cer-tificate.

Information for consumers: � information about certified Declaration on a

product or in covering documents; � conformity mark labeling without certification

body code.

Information for consumers: � copy of the Conformity Certificate; � information about Conformity Certificate in cov-

ering documents; � conformity mark labeling with certification body

code.

Voluntary certification system can be established by a legal entity (entrepreneur) or several legal entities.

Person (or persons), created a system of voluntary certification, lists objects that are subject to certification, their characteristics in compliance with which the certification is carried out, proce-dures of this voluntary certification, and their remuneration, identify participants of this voluntary certification system. System of voluntary certification can provide only marks of conformity. Rosstandard provides a uniform register of voluntary certification systems.

Obligatory conformity assessment is only carried out in cases identified by relevant techni-cal regulation and exclusively to confirm conformity to technical regulation requirements.

Obligatory conformity assessment object can only be a product for placing in the Russian market.

Forms and charts of obligatory conformity assessment can only be identified by technical regulation taking into account nonconformity risks.

Declaration of conformity and certificate of conformity have equal legal power regardless schemes of obligatory conformity assessment and can be applied on the whole territory of the Rus-sian Federation. Works on obligatory conformity assessment are paid by an applicant.

Declaration of conformity (fig. 7.7) is carried out according to one of the following schemes:

- conformity declaration adoption on the basis of own evidences; - conformity declaration adoption on the basis of own evidences, evidences attained with the

help of a certification body or/and a registered testing laboratory (center).

Declaring conformity on the basis of own evidence an applicant himself obtains evidence in order to confirm conformity of a product to requirements of technical regulations. As evidence there can be used technical documentation, results of own tests and measurements, other documents that can be objective evidence for conformity assessment. A list of the necessary documents is identified by technical standard.

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Declaring Schemes

Based on own proves With third party participation

Test record in accredited TL

Quality system certification

Conformity Declaration Conformity Declaration Conformity Declaration

Fig. 7.7 Declaring schemes (according to law “On technical regulation”)

Declaring conformity on the basis of own evidence and evidence obtained with the help of the third party, an applicant (of his choice) in addition to own evidences includes records of tests and measurements, carried out by a registered testing laboratory (center), or provides certificate of a quality system in relation to which a control (inspection) is stipulated by a certification body that had given this certificate.

Obligatory certification is carried out by a certification body on the ground of an agreement with an applicant. Certification schemes for certification of a definite product are identified by a relevant technical regulation. Certification schemes used in transitional period with obligatory con-formity assessment are shown in table 7.4, new certification and declaration schemes are shown in tables 7.5, 7.6.

Fig. 7.8 Market circulation mark logo

Certificate of conformity issued by certification body confirms that a product meets the technical standards requirements. A product, conformity assessment of which is confirmed, is af-fixed by market circulation of production mark (fig. 7.8). This mark is not a specially protected mark; it is affixed for the informational purpose. An applicant is responsible for the marking and he can affix the mark by any convenient way.

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Table 7.4 Product certification schemes applied before transitional period end

Scheme No. Tests

Production check (quality systems)

Inspectional control of the certified products

1 Type test* – –

1а Type test Production condition es-timation –

2 » – Test of samples received from a seller

2а » Production condition es-timation

Test of samples received from a seller. Production condition estimation

3 » – Test of samples received from a producer


Test of samples received from a producer. Production condition evaluation

4 » – Test of samples received from a seller. Test of samples received from a producer


Test of samples received from a seller. Test of samples received from a producer. Production condition evaluation

5 » Production or quality sys-tem certification

Certified quality system (production) con-trol. Test of samples received from a sell-er or/and a producer.

6 Conformity Declara-tion review with at-tached documents

Quality system certifica-tion Control of certified quality system

7 Testing of a lot – –

8 Testing of each sam-ple – –

9 Conformity Declara-tion review with at-tached documents

– –

9а » Production condition evaluation –

10 » – Test of samples received from a seller or/and a producer.

10а » Production condition evaluation

Test of samples received from a seller or/and a producer. Production condition evaluation

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Table 7.5 Recommended declaration schemes (by R 50.1.046-2003) S

chem

e de

sign

a-tio

n

by R

50.1

.046

–200

3

Content of a scheme and performers

Eur

opea

n m

odul

e de

sign

atio

n si

mila

r to

the

sche

me

1d Applicant Presents own evidences of conformity in a technical file Adopts declaration of conformity

A

2d

Accredited testing laboratory Conducts tests of product type Applicant Adopts Declaration of Conformity

C

3d

Certification body Certifies the quality system at the stage of production Accredited testing laboratory Conducts tests of product type Applicant Adopts Declaration of Conformity Certification body Keeps the quality system under surveillance

D

4d

Certification body Certifies the quality system at the stages of control and tests Accredited testing laboratory Conducts tests of product type Applicant Adopts Declaration of Conformity Certification body Keeps the quality system under surveillance

E

5d

Accredited testing laboratory Conducts sampling tests of a product lot produced Applicant Adopts Declaration of Conformity

F

6d

Accredited testing laboratory Conducts sampling tests of each product unit Applicant Adopts Declaration of Conformity

G

7d

Certification body Certifies the quality system at the stages of design and production Applicant Conducts tests of product sample Adopts Declaration of Conformity Certification body Keeps the quality system under surveillance

H

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Table 7.6 Recommended certification schemes (by R 50.1.046–2003) D

esig

natio

n of

sc

hem

e by

R50

.1.0

46–

2003

Content of a scheme and performers

The

pre

viou

s ce

r-tif

icat

ion

sche

me

desi

gnat

ion

1с

Accredited testing laboratory Conducts tests of product type Accredited certification body Issues a certificate of conformity to an applicant

1

2с

Accredited testing laboratory Conducts tests of product type Accredited certification body Conducts evaluation of production conditions Issues a certificate of conformity to an applicant

1а

3с

Accredited testing laboratory Conducts tests of product type Accredited certification body Issues a certificate of conformity to an applicant Controls certified products (sample testing and production condition evaluation)

2, 3, 4

4с

Accredited testing laboratory Conducts tests of product type Accredited certification body Conducts evaluation of production conditions Issues a certificate of conformity to an applicant Controls certified products (sample testing and production condition evaluation)

2а, 3а, 4а

5с

Accredited testing laboratory Conducts tests of product type Accredited certification body Conducts certification of quality system and production Issues a certificate of conformity to an applicant Controls certified products (quality system [production] control, testing of sample received from a producer or seller)

5

6с

Accredited testing laboratory Conducts tests of product type Accredited certification body Conducts certification of quality system and production Issues a certificate of conformity to an applicant

7

7с

Accredited testing laboratory Conducts testing of each product sample Accredited certification body Issues a certificate of conformity to an applicant

8

7.3 Food products and raw materials Certification a nd Declaration

Historically, certification was the first form of conformity assessment in Russia. By Russian laws supplying goods to consumers is not allowed without a document certifying goods conformity

145

to safety requirements. Thus, certification of definite goods is obligatory condition of their place-ment on the market. Products conformity to requirements must be certified in cases covered by le-gal acts of the Russian Federation. At present, there are more than 30 legal acts of this kind. Most of them stipulate obligatory conformity assessment of objects to which they are applied.

The Russian Government and federal executive authorities’ by-laws – lists and nomencla-tures – help to identify and limit the objects group of obligatory conformity assessment. The work on lists and nomenclatures actualization had been finished by the end of 2009. The Russian Gov-ernment Resolution No. 982 dated December 1, 2009 adopted “Unitary list of commodities requir-ing conformity assessment in the form of obligatory certification”; “Unitary list of commodities re-quiring conformity assessment in the form of conformity declaration”. For the lists detailing there were developed and adopted the following normative documents: “Information on production re-quiring obligatory conformity assessment (in obligatory certification form) indicating the normative documents establishing the obligatory requirements” (Nomenclature 1) and “Information on pro-duction requiring obligatory conformity assessment (in conformity declaration form) indicating the normative documents establishing the obligatory requirements” (Nomenclature 2). Table 7.7 shows the mentioned documents structure that is similar for both Nomenclatures 1 and 2.

Table 7.7 Extract from “Information on production requiring obligatory conformity assessment (in conformity declaration form) indicating the normative documents establishing the obligatory requirements” Nomenclature 2

Object name Object code according to PC

005-93 (Production Codes Classification - PCC)

Regulating norma-tive legal act

Confirming requirements

1 2 3 4

Fresh food potato sold by retailers 97 3110 GOST R 51808-2001 5.2, 5.3, 5.5,

6.7

As shown from table 7.7, Nomenclature includes names and codes of objects in accordance with All-Russian Classification of Products (column 1,2) and definitely identifies objects of obliga-tory certification. For each object in column 3 there is a regulating normative legal act (for complex products several acts are given), which identifies safety requirements that are to be certified. Col-umn 4 has a list of sections, subsections, items and sub items of these acts in which specific safety requirements are identified.

Thus, Nomenclature 2 also definitely identifies a list of safety requirements confirmed by obligatory certification. Nomenclature 1 has a similar structure.

According to the Russian Federation Government Resolution No. 982 dated December 1, 2009 “Information on production requiring obligatory conformity assessment under customs treat-ment providing the possible confiscation and application for its intended purpose on customs terri-tory of the Russian Federation indicating the Customs Union commodity codes” developed and adopted by Rosstandard and the Russian Federal Customs Service. The document includes “Unitary list of commodities requiring obligatory certification under customs treatment providing the possi-ble confiscation and application for its intended purpose on customs territory of the Russian Federa-tion” and “Unitary list of commodities requiring conformity declaration under customs treatment providing the possible confiscation and application for its intended purpose on customs territory of

146

the Russian Federation”. Mentioned unitary lists contain production names and ten key Custom Commodity codes (ТН ВЭД in Russian).

Product certification in Russia is carried out by certification bodies. A producer (seller) can apply for obligatory certification to any accredited certification body. Rules and procedures of certi-fication are identified in all-Russian rules of certification, documents of GOST R system and based on them rules of certification of product category. Certification rules and procedures are established in all-Russian certification rules, in certification system GOST R and in certification rules for ho-mogenous products developed in accordance with regulations mentioned above.

Certification works list and consequence are contained in “Production certification order in the Russian Federation” with Amendment no. 1 to this order. These documents identify the order of carrying out procedures by participants of the certification, certification schemes and guidelines.

Basic operations of obligatory certification according to “Production certification order in the Russian Federation” are shown in table 7.8.

Table 7.8 Product certification procedure

Operation Performer Document

1. Application for certification Applicant Application

2. Decision on the application including scheme selec-tion

Certification body Conclusion

3. Samples selection, identification and testing Testing labora-tory*

Samples selection report

4. Production estimation (if provided by the certification scheme) Certification body

Production condition evaluation report or qual-ity system (production) conformity certificate

5. Results analysis and decision about issuing (or de-nial to issue) of conformity certificate Certification body

6. Conformity certificate issuing Certification body Conformity Certificate

7. Keeping of the certified product under inspectional control (if provided by the certification scheme) Certification body Inspectional control re-

port

8. Corrective actions (in case of the product noncon-formity or conformity mark wrong application) Applicant Corrective actions plan

9. Information on certification results Certification body

* selection of samples for tests can be carried out by the certification body (with assistance of a testing laboratory, if necessary)

An applicant submits an application of a set form to an accredited certification body, ac-creditation area of which includes the applied product, and selects a certification scheme. Certifica-tion schemes for the given product are identified in rules and procedures of certification of product category.

To carry out a certification for several types of products it is necessary to provide documents of federal executive authorities such as sanitary and epidemiological conclusion, veterinary certifi-cate, fire safety certificate, etc. the list of necessary documents is identified in rules and procedures of certification of product category. The certification body informs the applicant about documents

147

necessary for the certification of applied product.

The certification body considers the application as a rule during 3-7 days and takes a deci-sion about conducting (or denial of conducting) certification. In case of a positive decision, the cer-tification body acts in accordance with the certification scheme: selects samples of the product, sends them to an accredited testing laboratory, etc.

If certification results are positive the applicant (producer, supplier) receives a certificate of conformity what allows him to affix his product with the mark of conformity (fig. 7.9) or the market circulation mark (fig. 7.8) if there is a technical standard for this product.

For an obligatory certified product there is a code of a certification body affixed under the mark; when declaring a product, a code of a certification body is not affixed. Issuing of certificates on application of the mark of conformity was abolished in February 2002.

Fig. 7.9 GOST R certification system conformity mark

According to Gosstandard Resolution No. 21 «On Rules of food products and food raw ma-terials certification” of April 28, 1999, an object of obligatory certification can be definite food re-quirements to the quality and safety of which are identified on the Russian Federation territory. In accordance with item 4, article 7 of the Russian Federation law “On Consumer rights protection” the list of commodities of obligatory certification is approved. Objects of voluntary conformity as-sessment in GOST R system can be any food, foodstuff raw materials, food additives and other nat-ural or synthetic components used in food production.

Conformity assessment of food and foodstuff raw materials is carried out on the frameworks of the certification system of food products and food products. The structure of the system includes:

- System Central Body - Rosstandard administration of agricultural production, food, light and chemical industries.

In its turn, it includes

- System Council – a consultation body of the central body;

- Committee of Appeals of the central body;

148

- Council of experts for attestation – scientific and methodological center on the base of VNII (All-Russian Institute of Science and Research) of certification of Rosstan-dard;

- certification bodies; - testing laboratories, accredited for independent and technical competence or only technical

competence.

The certification system of food and foodstuff raw materials is a certification system of product category of GOST R system regulated by Resolution on GOST R certification system. Food that is subject to obligatory certification is classified by the System of food and foodstuff raw mate-rials into 11 groups of product category (table 7.9).

Table 7.9 Classification of homogenous food groups in conformity assessment

Group No. Group name 1 Grain and grain products

2 Bakery and pasta

3 Vegetable oils and vegetable oils products

4 Meat, meat products, poultry

5 Eggs and egg products

6 Fish and fish products

7 Milk and dairy products

8 Fruits, vegetables and their products

9 Food concentrates and starch

10 Drinks, wines, cognacs, drinkable ethyl alcohol and distilled beverages

11 Confectionery and pastry

Food subject to obligatory certification can be divided into perishable products with shelf life up to one month (short-term storage) and products with shelf life more than one month (long-term storage) what influences the selection of a conformity assessment scheme.

Conformity assessment of food is carried out by certification bodies accredited in the estab-lished order for food certification activities. Declaration of conformity is a document by which the producer (seller, performer) confirms the conformity of the released product to the requirements of technical regulations.

Lists of products which conformity can be confirmed by a declaration of conformity, re-quirements to the declaration of conformity and procedure of its adoption are approved by the Rus-sian Government. An adopted declaration of conformity is registered by a registration body and has legal power equal to that of a certificate of conformity.

Procedure of obligatory food certification includes:

- submitting and consideration of an application with attached documents; - taking a decision on the application including selecting a certification scheme; - selection, identification and tests of samples; - evaluation of production conditions (if provided by the certification scheme) or quality sys-

tem certification;

149

- obtained results analysis and taking a decision about issuing of a certificate of conformity (certificate);

- issuing the certificate; - certified product inspection (in accordance with the selected certification scheme); - corrective actions in the case of production conformity violation of defined requirements

and conformity mark wrong application.

An applicant provide following documents for certification:

- application form for a product certification (fig. 7.10); - application form for a conformity declaration registration (fig. 7.11).

150

____________________________________ certification body name

___________________________________________ address

APPLICATION FOR A PRODUCT CERTIFICATION

IN GOST R CERTIFICATION SYSTEM ___________________________________________________________________________

producer, seller company name (hereafter - applicant) _____________________________________________________________________________all-Russian Business and Organization Classification code or individual entrepreneur registra-

tion document No. Legal address______________________________________________________________ _________________________________________________________________________ Bank details _______________________________________________________________

___________________________________________________________________________ Phone___________________Fax_______________________E-mail__________________ On behalf of _______________________________________________________________

full name requests to carry out certification of product ______________________________certification

obligatory (voluntary) of production _______________________________________________________________

production name ______________________________________________________________________________________

К 005 (ARPC) code or (and) CIS customs commodity code

___________________________________________________________________________serial production or particular size lot or production item

produced according to ________________________________________________________ name and producer documentation (standard, technical specifications,

________________________________________________________________________________________ collective agreement, pre-production sample) symbol

for compliance with the requirements of the standards _______________________________ normative documents

______________________________________ to the scheme _________________________ name and symbol certification scheme No. The applicant undertakes to fulfill the certification rules. Additional information ________________________________________________________ ___________________________________________________________________________

Company executive leader signature name Chief accountant signature name Stamp Date

Fig. 7.10 Application form for a product certification

151

____________________________________ certification body name

___________________________________________ address

APPLICATION FOR DECLARATION REGISTRATION

ON PRODUCTION CONFORMITY ___________________________________________________________________________

producer, seller company name ___________________________________________________________________________

individual entrepreneur (hereafter - applicant) Legal address_____________________________________________________________

_________________________________________________________________________ Bank details _______________________________________________________________

__________________________________________________________________________ Phone_________________Fax_______________________ E-mail___________________

On behalf of _____________________________________________________________ full name

requests to carry out declaration registration on conformity of production _________________________________________________________________

production name ____________________________________________________________________________ Payment of works on registration is guaranteed. Application for registration of the given declaration was not submitted to other certification bodies Appendixes: 1. Declaration of conformity. 2. Documents duplicates stipulated for the product by relevant federal laws and given by authorized bodies and organizations, 1 copy. ___________________________________________________________________________________________

documents name 3. Other documents duplicates provided assuring the product conformity to established re-quirements or (and) competence to adopt Declaration of conformity* ____________________________________________________________________________

documents name

Company executive leader signature name Chief accountant signature name Stamp Date

* is provided at the discretion of a producer (seller) or an entrepreneur.

Fig. 7.11 Application form for registration of a conformity declaration

152

Following documents are attached to the application.

For domestic products copies of:

1. A document that is a base for products manufacturing (normative and technical documenta-tion);

2. Registration documents and documents from Russian Agency for Health and Consumer Rights (Rospotrebnadzor) on production permission;

3. Rospotrebnadzor sanitary and epidemiological decision;

4. Veterinary certificate (for livestock products);

5. Documents proving raw materials and packing materials safety.

For import products copies of:

1. Agreement, contract and delivery documents, producer’s documents for products manufac-turing;

2. Veterinary documents (for livestock products and forage);

3. Certificate of origin, supplier’s documents on quality products;


5. Producer’s documents for products manufacturing:

- veterinary documents (for livestock products and forage); - certificate of origin; - supplier’s documents on quality products; - Rospotrebnadzor sanitary and epidemiological decision.

For Conformity Declaration registration copies of:

1. Reports of tests arranged by producer independently or with 3rd party participation;

2. Conformity certificate or raw materials tests report;

3. Veterinary documents (for livestock products and forage);


5. Quality system or production certificate, supplier’s quality certificate.

The procedure of conformity assessment provides issuing the following certificates:

- registration of conformity declaration; - conformity certificate with requirements of a technical regulation; - certificate in GOST R system (voluntary).

As the CU technical standards are coming into operation corresponding national require-

153

ments become non effective. National Certification system modernization and its normative base issues are considered in details in 1.4 and 3.3 parts.

7.4 Food products environmental certification and e nvironmental marking

In Russia, procedures connected with conformity assessment (certification) appeared in 1992. The law on consumer rights protection was in the bases of them. Herewith, the aim of certifi-cation was to protect human health and environment from unsafe, environmentally hazardous products and services. According to the law “On consumers’ rights protection” (article 7, item 4) the goods (production) including imported ones without information on its obligatory conformity assessment (by Certificate or Declaration of Conformity) to compulsory requirements assuring safe-ty can not be sold.

But the mentioned law in fact did not cover issues of confirmation of a product conformity with environmental requirements. Therefore, Agreement “On Cooperation of the Ministry of Nature and Gosstandard of Russia in standardization, metrology and certification” dated April 5, 1993 es-tablished an independent system of environmental certification. By 1996 the system of environ-mental certification was developed and registered by Gosstandard of Russia as System of obligatory certification based on environmental requirements. However this System was not widespread be-cause of registration absence of acts regulating its work in the RF Ministry of Justice and national legislation noncompliance.

Conducting of environmental certification (or wider – conformity assessment) in Russia is identified by the law on Environmental protection (article 31, items 1-3). In line with this law envi-ronmental certification on the territory of the Russian Federation is carried out in order to provide environmentally friendly economic or other kinds of activity.

Currently environmental certification is performed according to Provisions of article 21 of national law “On technical regulation” where it is said that environmental safety compulsory re-quirements confirmation is carried out under production obligatory conformity assessment in oblig-atory certification or conformity declaring forms. Voluntary certification of objects on environ-mental requirements conformity is accomplished by several registered systems of voluntary certifi-cation.

Federal law also provides a possibility of voluntary environmental certification total imple-mentation of EMSs in companies and industries.

Environmental certification differs from other mechanisms of environmental management (fig 7.12).

Fig. 7.12 Control types of environmental management

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Environmental certification is certification confirming that the certification object conforms the normative document environmental and other requirements. Voluntary environmental confor-mity assessment is performed in voluntary certification form.

Main objectives of environmental certification are shown in fig. 7.13.

Fig. 7.13 Main objectives of environmental certification

Objects of environmental conformity assessment are:

- environmentally safe end product; - environmental management systems applied by a company as well as on the territories.

In certification of environmental management systems only one form of conformity assess-ment can be used: voluntary environmental certification.

Certificate of conformity to GOST R ISO 14001-2007 standard is an juridical document ap-plying for production process development, competitiveness increasing, company positive reputa-tion on the world market, etc. EMS certificate allows confirming in documents the presence and efficiency of well-functioning EMS activity, natural and energy resources preserving, the best exist-ing technologies application, actual normative requirements keeping and realization of program on environment pollution decreasing.

Environmental certification has been carried out in Russia since 1996 mostly in the frame-works of the system of obligatory certification based on environmental requirements. Its reregis-tered no. is POCC RU.001.01.ЭТ00. This system provided both voluntary and obligatory certifica-tion. The owner of the system is the Ministry of Nature of Russia. The mark on conformity of the system is shown in fig. 7.14.

MAIN OBJECTIVES OF ENVIRONMENTAL CERTIFICATION

Environmentally safe pro-cesses, equipment, indus-tries implementation

Preventing environ-mental contamination at any stage of a product life cycle

Environmental safety ensuring while working with production and con-sumption wastes

Country integration into world market and inter-national re-sponsibilities fulfillment con-cerning environment protec-tion

Prevention the import of environmentally hazardous products, technologies, wastes and services

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Fig. 7.14 Obligatory certification system conformity mark based on environmental requirements

Conformity assessment is carried out in the system by correlating indicators of the object with indicators of a relevant normative legal act (regulation, standard, agreement, norm, rule of the UNECE, EU directive, etc.). If there are several normative legal acts for the object, conformity as-sessment is carried out by correlating indicators of the object with those of a stricter normative legal act.

In actual voluntary certification systems based on environmental requirements the normative legal acts which conformity is certified should meet the following criteria:

- indicators should have a numerical expression and dimension; - documentation should contain a testing procedure for the given indicators or provide a refer-

ence to the document containing a procedure (for instrumental procedures a reference to the document regulating measuring tools is also necessary).

Environmental requirements are mainly identified by relevant national standards, but num-ber and quality of the latter does not evidently meet the demands of obligatory environmental certi-fication. Besides, often there are no requirements to environment protection in standards, and, even if there are some, they are not clearly identified.

Criteria for identification of environmental requirements in standards are the negative im-pacts that reveal themselves during a product usage, like hazardous substances in burned gases of motors. Fig. 7.15 shows a sample of environmental norms structure for rational use, reproduction and protection of forests.

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Fig. 7.15 Environmental norms structure

Selecting environmental requirements from standards it is necessary to take into account the following groups of factors:

- real and potential product danger, including toxic impurities generated during production process as well as hazard from side products appearing while using the product;

- conditions of allocation and spreading of toxic impurities or/and side products in the regions where the product is used (this includes mobility, migration, durability, stability and life-time);

- conditions of transformation, decomposition of side products in environment; - scale and duration of contacts of side products and environment, as well as possibility and

real feasibility of monitoring their spreading; - negative environmental impacts of emission of side products into environment; - side products and their analogs investigation degree.

Basic operations of environmental certification in the system of obligatory certification based on environmental criteria are shown in table 7.10.

Table 7.10 Realization stages of obligatory and voluntary environmental certification

Stage No. Content

1 Certification body receives an application for certification

2 Expertise of the application materials and selecting a certification scheme

3 Certification object audit

4 Issuing or denial to issue a certificate

Forest resources

Forests rational exploitation , reproduction and protection norms

Norms of acceptable im-pacts on forests during for-estry activities and target parameters of cultivating

forests of natural or artificial origin

Norms of pro-viding protec-

tive zones along spawning rivers & erosion preventive for-

ests

Norms of acceptable impacts on forests and soil during forest caring and target parameters of forest plantations

generating

Norms of quanti-tative estimation offorest environ-ment protecting

functions

Norms of cuttings for ecosystems and

norms of acceptable impacts on forests during lumbering

Norms of accept-able recreational

loads for composi-tion of different va-rieties and growing

conditions

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5 Agreement between the certification body and the certificate holder on conditions of inspec-tional control

6 Entering the information about the issued certificate into a Registry and sending the informa-tion to an accreditation body by fax

7 Inspectional control of the certificate holder activity including inspection of the certified ob-jects marking correctness

Application for environmental certification should include the following documents:

- list of objects which an applicant wants to certify and label with the mark of conformity and environmental mark;

- list of indicators value of which the applicant requests to confirm by certification; - list of normative legal acts conformity with requirements of which should be confirmed; - applicant reference that confirms that the object of the application conforms to requirements

of normative legal acts and that those legal acts conform to international standards in the area.

In voluntary environmental certification correlation is carried out with all internationally and nationally available documents for this object including documents not introduced in Russia. Thus, certification in the system guarantees the world level of the object under certification.

A holder of a conformity certificate or declaration of conformity has the right to advertise his product as environmentally friendly.

In the Russian Federation the environmental certification works have been accomplished by now as certification systems. Registration of the last ones started in 1994 and continues till now. In recent years Rosstandard has registered several systems of voluntary environmental certification, for example VNIIS system, Zarubezhgeologii system of soil use, CCM of Rosstandard system in Nizhny Novgorod, etc. It should be said that all the mentioned certification systems have the same object – environmental management systems based on MS ISO 14001. Certification in these sys-tems provides audit only of general, supranational requirements (policy, planning, implementation, analysis) for ISO 14000 standards do not regulate numeric indicators of impacts on environment.

According to the law “On technical regulation” voluntary environmental certification will be carried out in the frameworks of the given systems, while obligatory environmental conformity as-sessment – in the frameworks of relevant technical standards for homogenous products.

Environmental certification possibilities connect with technical standard “On environmental safety” adoption where production environmental obligatory conformity assessment and production environmental marking must be regulated.

As to voluntary environmental certification it will be necessary to develop a new voluntary environmental certification system after technical standard “On environmental safety” adoption for works regulation in this area.

Environmental marking is a complex of information of environmental character about a product. The basic objective of a marking is to provide consumers with safe, accurate and true in-formation about environmental aspects of a product, as well as facilitate to meet the demands in the product which has the lowest negative impact on environment.

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Environmental marking of a product is widely used in the world (fig. 7.16).

а – «Blue Angel», б – «Green Dot», в – Food safe, г – Ozone friendly, д – environmentally hazardous, е – ecolabel of a Japanese association of environment protection

Fig. 7.16 International ecolabels

In Russia environmental marking (ecolabels) has the form of graphic image, like the eco-label “Free of Chloride” (GOST R 51150-98), the ecolabel for petrol stations in Moscow, ecolabels of voluntary certification systems – Leaf of Life (St. Petersburg), Ecological Food (Moscow), Vol-untary certification system based om environmental criteria (St. Petersburg), Viluntary certification system “Quality Mark of St. Petersburg” (St. Petersburg) and others. Some of the ecolabels applied in Russia are shown in table 7.11.

Table 7.11 Ecolabels applied in the Russian Federation

Image Applicant is obliged to evidence

Chloroorganics absence

Mobius loop according to GOST R ISO 14021-2000 means: 1) production is made of recyclable materials or 2) production could be recycled

Ecolabel encouraging to save the environment and deliver need-less items for recycling

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Environmental marking is affixed directly onto a product or its package or label. It can be placed in the name of the product, covering documentation, advertisement leaflets or digital or elec-tronic mass media. Ecolabels can be either graphic images or a phrase.

Requirements to environmental marking are identified by GOST R ISO 14020 - 99, GOST R ISO 14021 - 2000, GOST R ISO 14024 - 2000 and ISO/ТО.

14025:2000. In accordance with the mentioned standards environmental marking is made in the frameworks of the three program types:

type I –on the bases of results of environmental conformity assessment;

type II – on the bases of controlled self-declarations;

type III – on the bases of numerical environmental data about the product on identified pa-rameters based on GOST R ISO 14040-14043, not excluding additional environmental information identified by the program of environmental declaration of type III.

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1. Name conformity assessment objectives.

2. Specify assessment objectives principles.

3. Describe the “market circulation mark” term.

4. What does conformity Certificate of the GOST R certification system prove?

5. Name certification participants.

6. What are the forms of Obligatory and Voluntary conformity assessment?

7. Name basic differences between Certification and Conformity Declaring.

8. What declaring schemes are established in federal law “On Technical regulation”?

9. Describe the structure of the Russian Federation national certification system?

10. Specify basic operations for production certification.

11. Describe the information of Nomenclature 1 and Nomenclature 2.

12. Give the examples of homogeneous production groups in food conformity assessment.

13. Name the documents provided by an applicant for food certification.

14. Name main objectives of environmental certification.

15. What is a purpose of environmental production marking?

7.6 Summary

Conformity assessment (certification) is a generally recognized, internationally accepted mechanism which allows to set a balance between the need to ensure a common economic space, on the one hand, and to protect citizens and society as a whole from products dangerous for human life and environment, on the other hand.

By 2011 there were 19 systems of obligatory certifications and more than 750 systems of voluntary certification on the territory of the Russian Federation. Certification system GOST R was introduced in 1992 to organize and perform obligatory certification of products, works or services and ensuring unbiased and credible certification results. GOST R system certifies goods for per-sonal (household) needs of people, industrial-and-technological production including means of pro-duction, goods for building, works and services supplied to people, quality systems, manufactures, personnel (experts).

Conformity assessment can have obligatory or voluntary character in the Russian Federa-tion. Voluntary conformity assessment is carried out in the form of voluntary certification. Obliga-tory conformity assessment is carried out in two forms: declaration of conformity and obligatory certification.

Certificate of conformity confirms that a product meets the requirements of technical regula-tions. A product, conformity assessment of which is confirmed, is affixed by market circulation mark.

The system of food products and food raw materials certification is a system of certification

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of product category of GOST R system regulated by Resolution on GOST R certification system. Food subject to obligatory certification is classified by the System of food and foodstuff raw mate-rials into 11 groups of product category.

Environmental certification is certification confirming the certification object conformity to the normative document environmental requirements and its other ones. Objects of environmental conformity assessment are:

- environmentally safe end product; - environmental management systems applied by a company as well as on the territories. Vol-

untary environmental conformity assessment is performed only in voluntary certification form.

In the Russian Federation the environmental certification works have been accomplished by now as certification systems. Registration of the last ones started in 1994 and continues till now. In 1996 in Russia the System of obligatory certification based on environmental requirements was de-veloped. In recent years Rosstandard has registered several systems of voluntary environmental cer-tification, for example VNIIS system, Zarubezhgeologii system of soil use, CCM of Rosstandard system in Nizhny Novgorod, etc.

Environmental certification possibilities connect with technical standard “On environmental safety” adoption.

Environmental marking is a complex of information of environmental character about a product. The basic objective of a marking is to provide consumers with safe, accurate and true in-formation about environmental aspects of a product, as well as facilitate to meet the demands in the product which has the lowest negative impact on environment.

Environmental marking is affixed directly onto a product or its packaging or label. It can be placed in the name of the product, covering documentation, advertisement leaflets or digital or elec-tronic mass media.

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8 Quality control and product test

The chapter gives information about control and inspection on the food market, classifica-tion of inspection modes during production, product test during quality assessment and certification, guidelines and principles of quality control development in the company and in the region.

Plan

8.1 State food quality control and inspection.

8.2 Classification of technical control types.

8.3 Product tests in quality assessment and certification.

8.4 Quality control development in the company and in the region.

8.1 State food quality control and inspection

The science of food safety has the following basic regulations: Maximum Permissible Con-centration (MPC), Maximum Permissible Level (MPL), Acceptable Daily Intake (ADI).

Basic technologies for food safety estimation are shown in fig. 8.1.

Fig. 8.1 Food safety estimation technology

Food, being a source of energy, along with plastic materials, vitamins, minerals and micro-elements could contain various chemical compounds that are potentially dangerous for human health, fig. 8.2.

FOOD SAFETY ESTIMATION TECHNOLOGY

Estimating the food contaminants of top priority

Determination of acceptable daily dose

MoniProduction and national competConsumption indexes ring of food contamination

Food products contaminants detection and quantitative estimation methods development

Determination of maximum per-missible concent-ration in food

Human population food monitoring

Human body daily load calculation

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Fig. 8.2 Extraneous harmful substances in food

On the results of monitoring there was identified a list of priority contaminants subject to control in various food groups (table 8.1). With the development of food toxicology the list will be added and revised. The system of control and inspection of foodstuff raw materials and food quality and safety in the Russian Federation is shown in fig. 8.3.

Table 8.1 Contaminants which are subject to control in various food and foodstuff raw materials groups

Food group Contaminants

Grain and grain products Pesticides, mycotoxins (aflatoxin В1, zearaleon, vomitoxin)

Meat and meat products Toxic components, antibiotics, nitrosamines, hormonal material, ni-trites, polychlorinated dibenzodioxines and dibenzofurans

Milk and dairy products Pesticides, toxic components, antibiotics, aflatoxin М1, polychlorinated diphenyls, polychlorinated dibenzodioxines and dibenzofurans

Vegetables, fruit, potato Pesticides , nitrates, patulin

FOOD

NATURAL FOOD COMPONENTS OF

HARMFUL INFLUENCE

Environmental substances of harmful influence (con-taminants)

Substances added for purpose according to technology

Chemicals (human-made substances)

Food additives

Biomaterial (natu-ral substances)

Toxic components

Components with significant pharmacological activity

Unusual components made of new raw materials sources

Alimentarius components

Unusual great concentra-tion of usual components

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Fig. 8.3 Control and inspection arrangements on quality and food safety

Control (inspection) of a market is carried out in the area of products circulation; its objec-tive is to ensure efficient meeting of compulsory requirements by all participants – suppliers, pro-ducers, sellers, importers. Inspection of the market is a responsibility of Government, therefore Government appoints official authorities that are allowed to carry out inspection.

The present Russian Federation legislation laws set out that control (inspection) is carried out in relation of observance of technical regulations requirements. The national law ‘On technical regulation” defines the control as “an inspection of execution by an individual or legal entity of the technical regulation requirements for products, processes of production, operation, storage, trans-portation, marketing and utilization, and taking appropriate measures on inspection results”. Prod-ucts are controlled (inspected) by Government exclusively on the stage of its circulation on the market.

Inspection as itself is carried out by inspectors who visit places of product distribution and examine products. If any nonconformity is revealed the following measures can be undertaken: block on delivery; product withdrawal from the market or/and consumers; liquidation of a danger-ous product (fig. 8.4).

Departmental Control

Social Control

State Control

Agricul-tural com-

plex

Federal In-spectional Service for Consumer Rights and

Human Welth-fare

Federal Service for Technical Regulation and Metrol-

ogy

Ministry of Agri-culture

Federal Service for Veterinary

and Phytosani-tary Inspection

Ministry of Economic Develop-ment and

Trade

State Bakery

Inspection

State Al-cohol In-spection

Consum-ers Union

Veterinary re-quirements and phytosanitary norms devel-

opment

GOSTs and normative legal acts develop-

ment

Safety indica-tors, physio-

logical norms, requirements, GOSTs, nor-mative legal

acts develop-ment

Normative legal acts develop-

ment

Complete control of food raw material, control of

end product along

technology chain

Selective control of

food safety indicators and nutri-

tional value

Selective control of indicators included

into GOSTs and norma-

tive legal acts

Selective con-trol of veteri-nary and phy-tosanitary in-

dicators

Food quality indicators selective control

End products selective control

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Fig. 8.4 Inspecting authorities possible solutions in case of production nonconformity to safety requirements

In the sphere of the market inspection there is much information from the following sources: producers, inspectors, consumers, analysis of accidents, statistics and results of risk estimation pro-cedures. There is established a special system to collect information and notify of a dangerous product placed on the market.

The following basic principles of government control (inspection) of observance of technical regulations requirements are set out in the federal law “On Legal Entities and Individual Entrepre-neurs Rights Protection during State Control (Inspection) performance” and “On Technical regula-tion”:

- the openness and accessibility to legal entities and individual entrepreneurs of normative le-gal acts of Russia identifying compulsory requirements compliance with which is checked in carrying out state control (inspection);

- elimination in full volume of committed violations by inspection authorities in case if the court satisfies a complaint of a legal entity or individual entrepreneur;

- impermissibility of charging a fee from a legal entity or individual entrepreneur by inspec-tion authorities for carrying out inspection, with exception of cases of recouping government inspection authorities’ expenses on carrying out tests and expertise which revealed violation of requirements;

- impermissibility of getting by government inspection authorities deductions from sums re-covered from a legal entity or individual entrepreneur in the result of inspection;

- legal entity or individual entrepreneur conscientiousness presumption; - correspondence between carrying out inspection object to state control (inspection) author-

ized body competence; - carrying out the control (inspection) by authorized officials of state control (inspection) au-

thorized bodies; - frequency and efficiency of inspection providing its full and fast fulfillment for a set period

of time; - records of inspection procedures carrying out by state control (inspection) authorized body; - possibility to appeal against authorized inspection agents violating inspection procedures; - impermissibility to combine inspection authorities with certification authorities; - impermissibility of out-of-budget financing of government (control) inspection of obser-

vance of technical standards requirements.

Solutions on nonconformed production

Delivery block Market withdrawal

Withdrawal from consumers

Liquidation

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The principle of legal entity or individual entrepreneur conscientiousness presumption means that inspection bodies are obliged to evidence a guilt of a subject of economic activity in case of a revealed fact of violation of technical regulation requirements.

If during inspection there will be revealed that a product is dangerous for human life, health or wealth as well as for environment, government inspection authority should inform consumers about a hazardous product and ways to prevent potential harm and take measures for nonadmission of causing harm including suspension of production or selling of the product or/and official with-drawal of the product from the market with the subsequent compensation for expenses by a guilty person.

The law “On technical regulation” establishes state control (inspection) authorities powers (fig. 8.5).

Fig. 8.5 State control (inspection) authorities powers

Apart from state control (inspection) of observance of technical regulations requirements there is also a state metrological inspection over number of commodities alienated during trade op-erations, and over number of commodities in any kind of packaging during packing and selling.

Control can be planned and unplanned.

Planned control is carried out by inspection authorities in its competence limits no more

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than once in two years.

Unplanned inspection is carried out with the purpose of the instructions fulfillment control on elimination of technical regulations requirements violations revealed during a planned inspec-tion.

Unplanned control can be undertaken by state control (inspection) authorized body in case of:

- receiving information from legal entities, individual entrepreneurs, government authorities about emergency, changes or shifts of production processes as well as problems with build-ings and equipment what can be harmful for human life, health and wealth and for environ-ment;

- danger to human life and health, environmental pollution, as well as harm to people’s prop-erty, including homogenous products of other subjects of economic activity;

- complaints of citizens, legal entities and individual entrepreneurs about violation of their rights and legal interests by actions (inaction) of other legal entities or/and individual entre-preneurs connected with non-fulfillment by them their compulsory requirements, as well as with receiving documented or proved by any other ways information affirming violations.

On the results of control authorized agents draw up a protocol of established form in two copies. Protocols of sample selection, of examining environmental objects, of tests and expertise, authorized agents’ explanations, involved employees’ explanations, and other documents on inspec-tion results or their copies are enclosed.

If information about violation is proved, the inspection authority in 10 days time gives in-structions to a producer to develop procedures of preventing harm, assists in carrying out the proce-dures and controls them, checks observance of dates and takes a decision about filing a claim about compulsory withdrawal of the product.

If danger can not be removed with relevant measures, a producer (seller) should immedi-ately suspend selling, withdraw it and compensate to a purchaser losses resulting from this danger.

Compulsory withdrawal of a product can be applied if:

- instructions of inspection authorities on preventing harm are not fulfilled; - procedures of preventing harm are not undertaken.

Violation of the law on withdrawal of a product can be punished according to criminal and administrative legislation of the Russian Federation.

8.2 Classification of technical control types

The most important element of food quality management at any stage of a life cycle is tech-nical control. Technical control is an inspection of objects’ conformity to established technical reg-ulations. Technical control objects can be products, production processes, transportation, storage, etc., as well as technical documentation.

Technical control includes a complex of procedures for identification of qualitative and quantitative indicators of products and other objects. Operation of a system of technical control is

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provided by a complex of technical procedures, methods and resources targeted to achieve object conformity to set technical regulations. Classification of types of product quality control is shown in table 8.2.

For operation of a system of technical control a technical control service is established in a company. Regarding the size of a company and its function, special structural departments are es-tablished: technical control departments (TCD) – in big companies, technical control groups (TCG) – in small companies. Products not accepted by a TCD are considered to be non-completed and should not be sold.

The company technical control main aim is to improve product quality, prevent and avert output of a product which does not meet requirements of normative and technical documentation.

Table 8.2 Product quality control types

Classification criteria Type of control

By production process stages Input, operation, acceptance, storage, transportation

By control period Primary, casual, periodical

By control scale Complete, selective

By control means Instrumental, organoleptic, visual

By control features Destructive, non-destructive

By controlled parameters By quantitative criteria, by qualitative criteria, by alternative criteria

By control organizational structure Self-control, single-stage, multistage

By automation level Manual, mechanized, automatized, automatic, active

Technical control service main functions are:

- operational quality control throughout all the stages of technological production process; - product final acceptance; - technological discipline keeping and production technical facilities status control throughout

all the stages; - product tests to normative and technical documentation conformity; - operators and departments labor quality assessment based on technical control results; - information collection and analysis on product quality during exploitation, taking corrective

measures; - defective products revealing on-time, defects causes determination and measures taking for

its elimination.

Fig 8.6 shows a typical structure of TCD in a food company. Structure and stuff of TCD de-pends on a total number of operators involved in a production process.

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Fig. 8.6 Typical structure of TCD in food company

The largest department of TCD is an operational control group, carrying out the main part of technical control at spot (in production rooms and zones). In small companies technical control can be carried out by an engineer-inspector (sometimes – directly by the Company executive leader).

8.3 Product tests in quality assessment and certifi cation

Test is a technical operation of determination of one or several characteristics of the product, process or service in compliance with the established procedure (ISO/IEC Guide 2).

Tests object – a product under testing.

Test procedure – detailed description of practical actions in carrying out tests of a definite method.

Test procedure is drawn in a separate document or a part of another document (test program and procedure, national standard). Test procedure can cover a group of homogenous products (type procedure) or a definite product (working procedure).

Test result - characteristics of a product received in the result of tests.

Test report – a document containing test results and other information concerning tests.

Tests conditions – totality of influencing factors or/and regimes of operation of an object during tests.

Test data – registered during tests indicators of characteristics of object properties and test conditions.

Test means – technical devices necessary for tests. Test means include testing equipment, measuring equipment and subsidiary technical devices.

Test executors – personnel involved in testing.

Tests basic types are classified by various criteria (stages of a life cycle, scale, date, place of

Company executive leader

TCD (TCG) chief

Input control group Operational con-trol group

End products acceptance

group

Central labora-tory

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testing, etc) and include several tens of tests. Certification tests are subdivided into certification and inspection tests.

Certification tests are carried out for input check of production sample for conformity to safety requirements.

Inspection tests identify if a type sample still conforms to safety requirements.

Main components of a test process are test object, test conditions, test means and test execu-tors. Certification tests structure is show in fig. 8.7, a sample form of a test report of certification tests is shown in fig. 8.8.

Fig. 8.7 Certification tests structure

Tests report

Tests data

Tests results

Tests conditions control

Object parame-ters estimation

Tests data processing

Tests conditions Tests object

Test results presentation

171

Testing laboratory «ХХХХХ»

Registration number РОСС RU.0000.000000

Legal address:

Sample registration number: 00000

REPORT

Sample tests

dated ________________ 20__

APPLICANT_________________________________________________________________

Sample name_________________________________________________________________

Date of production_____________________________________________________________

Producer_____________________________________________________________________

Lot volume___________________________________________________________________

Date of sample receiving________________________________________________________

Date and location of sampling____________________________________________________

Date of tests__________________________________________________________________

Additional information_________________________________________________________

Sample is tested to conform______________________________________________________

TEST DATA

Indicator Test re-

sult

Normalized

indicator

ND of

test methods

1.

2.

3.

…

Executors: (signature) (name)

(signature) (name)

Test results are applicable only to tested samples.

Corrections on the report are not permissible.

Fig. 8.8 Certification tests sample form

The procedure of applying with samples in certification tests is regulated by the certification rules 50.3.002-95 on “General procedure of applying with samples used for carrying out obligatory product certification”. The document sets out the following applying stages:

1. Informing an applicant about procedures of sampling order, sampling volume, normative le-gal acts regulating sampling and application procedures for certification;

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2. Sampling and sampling report presentation;

3. Samples isolation, packaging and stamping on a spot;

4. Samples tests;

5. Samples registration and its flow in a register book;

6. Non-Used samples return to the applicant;

7. Used samples writing-off;

8. Control samples writing-off.

Testing equipment attestation - official confirmation of possibility to carry out tests and de-termination of suitability of testing equipment in accordance with its purpose - is an the most im-portant element of certification tests.

There are three kinds of a testing equipment attestation:

Input attestation (when commissioning testing equipment);

Periodical attestation (during exploitation of testing equipment);

Repetitive attestation (after repair).

Attestation is carried out in the approved and set order. Results of attestation are recorded into a report on the bases of which a certificate of a set form is issued. A date of the next attestation is noted in the report.

All measuring equipment used in certification is metrological checked in the set order.

Information about attestation of testing and measuring equipment is noted in a report of cer-tification tests (test certificate or attestation No. and date).

Results of tests are noted in a report. The received results concern only tested samples.

Results of tests are confidential, therefore full or partial reproduction of test report is not al-lowed without a written permission of a head of a laboratory.

Certification tests are carried out by accredited testing laboratories (centres). In GOST R system there has been accredited over 2,800 testing laboratories. By January 1, 2011 3,391 testing laboratories had been registered in the unitary Register of organizations certified by Rosstandard. Not less than 2,500 testing laboratories certified in cetification system GOST R.

One of the largest testing centers in Europe is Rostest-Moscow. Rosttest-Moscow carries out tests of industrial products, food and household commodities: radio electronics, electric appliances, furniture, textile materials, etc.

Another large Russian testing center is Test-St.-Peterburg equipped with testing facilities to test household appliances and industrial machinery.

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8.4 Quality control development in the company and in the region

Organizing activity of product quality management in a food company is carried out by a technical control service in accordance with technological process of production. Developing a quality management system of an enterprise control of products and processes is carried out at any stage of a life cycle in line with standards requirements to monitoring and measuring processes. A sample schedule of periodical control tests of a food enterprise is shown in table 8.3.

Table 8.3 Control tests schedule

Test object Test subject Samples quantity per year

Test types Frequency

Made of pork, beef and chicken 144 Organoleptic, physicochemical,

microbiological indicators Three times per month

Made of pork, beef and chicken 12 Genomodified sources pres-

ence Once a month

Semi-finished products and packed by-products produc-tion Made of pork, beef

and chicken 4 Heavy metals, pesticides, toxic components presence

Once per three months

Equipment, tools, package surface 80 Microbiological indicators Twice a month

Production facili-ties

Operating conditions Temperature, moisture, illumi-nation, noise Once a month

Water supply system Drinking water 12 Microbiological, physicochemical

indicators Once a year

In HACCP-based quality systems control of indicators of dangerous factors is carried out at critical control points of production process, while in ISO 22000-based systems it is carried out at any stage of delivery chain. An extract from a program of production control of a food enterprise based on HACCP system is shown in table 8.4.

174

Table 8.4 Extract from Production Control Program of a food company

Critical Con-trol points

Controlled ob-ject or/and ma-

terial Estimating indicators Tests fre-

quency Normative legal acts

Responsible ex-ecutor

Register book

Input control of raw materials and materials quality and safety

CMR, Transportation documents Raw materials and materials Meat raw materials Packaging and marking

Presence of certificate of conformity, sanitary epi-demiological conclusion, CMR, certificate of quality and safety, veterinary certificate Belonging of a product to the lot noted in docu-ments Freshness indicators, organoleptic, microbiological indicators, presence of heavy metals, radionuclides, pesticides, antibiotics. Conformity of packaging and marking to sanitary norms

Every lot Once in three months

ФЗ no.29 of 02.01. 00 SR 3238-85, order MH RF no. 217 of 20.07.98 GOST, SAN-PiN 2.3.2.1078-01

Veterinarian Chief technologist

Register book of input control

Raw materials and supplies storage condi-tions

Refrigerating equipment Storehouse

Temperature in refrigerators, sanitary conditions Temperature in a storehouse, sanitary conditions

Daily Daily

SR 3238-85

Chief production di-rector, technical di-rector, chief process manager

Register book of refrigerators Register book of temperatures in rooms

Regional administrative executives play an important role in ensuring food and foodstuff raw materials quality and safety. In recent years in a number of Russian regions (Moscow, Yroslavl and others) there were developed and implemented various programs in the area of quality.

Let us consider quality regional policy of Orel region. A scheme of regional bodies interac-tions in development and implementation of regional policy in the area of quality is shown in fig. 8.9.

Fig. 8.9 General scheme of regional bodies interactions in development and implementation of regional quality politics

Initiator and developer of a system ensuring regional policy in the area of quality is Orel Quality Issues Academy regional Department. The basic element of the system is a Coordinating Council on developing and implementation of regional policy in the area of quality.

The main system objectives are:

- development and implementation of regional policy in the area of quality in order to im-prove quality of goods and services of enterprises;

- popularization of quality ideas in the region; - development of proposals on creation of legal, economic, social, organizational and techni-

cal conditions providing companies with possibility to solve successfully issues in the area of quality;

- consideration of proposals on developing new and reviewing of current quality programs.

Quality Issues Academy re-gional Department

Regional authorities

Orel State Techni-cal University

Academy regional Department of stan-dardization, metrol-ogy and certification

Center of control, meas-uring and testing equip-ment collective access

Federal State In-stitution (FSI)

«Orel Center of standardization &

metrology»

Coordinating Council

Industrial safety ex-pertise Center

Regional energy sav-ing Center

Testing laborato-ries Association

Scientific and creative Center of Architecture & Building Engineering

Academy

Independent noncom-mercial company Re-gional Quality Center

176

- Among the most prominent results in recent years there are the following: - development of a regional policy in the area of quality in Orel region and creation of the

system of implementation of the system including the necessary infrastructure; - development of a mechanism of motivation of companies; - propaganda of quality ethics in Orel region; - development of a uniform regional system of professional training and retraining in all sec-

tors of quality management; - promotion of a mechanism of consumer protection from harmful and false products; - development of a system and mechanisms of product and services quality management in

the region; - development of a mechanism of introduction new technologies into economic activity; - development of efficient systems and progressive methods of quality management in enter-

prises.

Experience of Orel region and other regions can be a platform for development and imple-mentation of regional projects on ensuring food and foodstuff raw materials quality in regions and municipal territories.

177


1. Give the explanation for State control (inspection) term.

2. Specify the inspecting authorities possible solutions in case of production nonconformity.

3. Name basic principles of state control implementation.

4. What is the sense of legal entity conscientiousness presumption principle?

5. What are the control types?

6. Specify the state control (inspection) authorities powers.

7. Name the reasons for unplanned control.

8. What is a reason of court claim about production compulsory withdrawal?

9. What are the types of product quality control?

10. What are the duties of company technical control Department?

11. Name certification tests object and main components.

12. Specify the certification tests samples applying stages.

13. Describe the information of certification tests report.

14. What parameters must be monitored in food companies?

15. Name the most important results of quality policy in Orel region.

8.6 Summary

Control (inspection) on market is carried out in the area of products circulation; its objective is to ensure efficient meeting of compulsory requirements by all participants – suppliers, producers, sellers, importers. Products are controlled (inspected) by Government exclusively on the stage of its circulation on the market.

The principle of legal entity or individual entrepreneur conscientiousness presumption means that inspection bodies are obliged to evidence a guilt of a subject of economic activity in case of a revealed fact of violation of technical regulation requirements.

Control can be planned and unplanned. Planned control is carried out by inspection authori-ties in the limits of its competence not oftener than once in two years. Unplanned inspection is car-ried out with the purpose of control execution of instructions on removing violations of technical regulations requirements revealed during a planned inspection.

By the control results authorized agents draw up a protocol in established form in two cop-ies. If danger can not be removed with relevant measures, a producer (seller) should immediately suspend selling, withdraw it and compensate to a purchaser losses resulting from this danger.

The most important element of food quality management at any stage of a life cycle is tech-nical control. Technical control is an inspection of objects’ conformity to established technical reg-ulations. Technical control objects can be products, production processes, transportation, storage, etc., as well as technical documentation. Quality control types are classified by stages of production process, by period of control, by scale of control, etc.

178

For operation of a system of technical control a technical control service is established in a company. The main aim of company technical control is to improve product quality, prevent and avert output of a product which does not meet requirements of normative and technical documenta-tion.

Certification tests are subdivided into certification and inspection tests. Main components of a test process are test object, test conditions, test means and test executors. Testing equipment at-testation - official confirmation of possibility to carry out tests and determination of suitability of testing equipment in accordance with its purpose - is an important element of certification tests. All measuring equipment used in certification is metrological checked in the established order. Results of tests are noted in a report. The received results concern only tested samples.

Organizing activity of product quality management of a food enterprise is carried out by a technical control service in accordance with technological process of production. Developing a quality management system in a company the control on products and processes is carried out at any stage of a life cycle including supply chain in line with standards requirements to monitoring and measuring processes.

Regional bodies of municipal administration play an important role in ensuring food and foodstuff raw materials quality and safety. Experience of Orel region and other regions can be a platform for development and implementation of regional projects on ensuring food and foodstuff raw materials quality in regions and municipal territories.

179

PART 2 PRACTICAL SECTION

180

9 Regional product development and producing

Objective: to get practical skill on planning, development and producing of a regional prod-uct.

Task on chapter 9

The strategic decision on planning, development and producing of a regional product with appellation of origin application was made for region sustainable development providing. This pro-ject aim is to provide the region sustainable development by regional quality politics implementa-tion, food product regional brand creation, goods and services quality increasing, high reputation for food companies providing, quality ideas wide popularization in the region, practical assistance for regional companies for sustainable development aims achievement under the conditions of the Rus-sian Federation joining to the WTO.

To get practical skill on high-quality food product regional brand creation with appellation of origin registration it is necessary to:

1. to examine the legislative and normative documents concerning food products safety ensur-ing (parts 1.2, 1.4, 3.2, 3.3);

2. to examine the legislative and normative documents concerning food products development;

3. to examine the legislative and normative documents concerning regional food products legal defense;

4. to choose on the alternative basic the regional products to be registered the appellation of origin;

5. to discuss and offer the names of products for producing and selling using the name of place of origin;

6. to discuss and offer the place name of product origin (producing);

7. to discuss and offer the place (geographic object borders) name indication of product origin (producing), whose natural conditions (human factors) determine the product special fea-tures solely or mainly;

8. to discuss and compose the list of project implementation interested parties;

9. to discuss and offer the dates due and main stages of project implementation;

10. to discuss and develop the list of main actions and schedule of project implementation;

11. to discuss and offer the ways of appellation of origin application in advertising and market-ing activity;

12. to discuss and offer the list of measures on project informational ensuring.

Guidelines for task performance

The high-quality food product regional brand creation with appellation of origin registration is an effective tool to provide the regional product promotion into market and region sustainable development.

181

While performing of this task paragraph No.1 it is necessary to examine the national law No. 29-AP dated January 2, 2000 “On food products quality and safety” (part 1.2) and the CU technical standard TP TC 021/2011 “On food products safety” adopted by the CU Committee Decision dated December 2011 (part 1.4).

While paragraph No.2 performing it is necessary to examine the national standard GOST R 51740-2001 (Industrial standards on food products development. General requirements on devel-opment and appearance).

At present food products legal defense issues with registration of the appellation of origin are regulated by the Russian Federation Civil Code (the 4th part, articles 1516 - 1537).

For choosing of region product to register the appellation of origin it is necessary to analyze 2 or 4 product types and choose a product variant for project implementation.

While this practical chapter paragraphs No. 5 – 7 performing it is necessary to take into ac-count geographic, natural and climatic, environmental, historical and other features of the region.

Project implementation completion period could be 1 or 2 years depending on product com-plexity and region opportunities.

Project implementation stages approximate list could include the following actions.

1. Organizational stage

- Interested parties reveal for project implementation. - Project coordinator assignment and work group forming. - Market analysis and choosing of region products to register of the appellation of origin. - Project financing variants search. - Concept and works plan development on a new product promotion.

2. Regional food product development using the appellation of origin

- Forming of compulsory safety requirements and conformity assessment order to compulsory safety requirements for considering product.

- Product special features description development (environmental indicators and other qual-ity indicators not requiring obligatory conformity assessment).

- Conformity assessment procedure development for product special features. - Product industry standards development. - Industry standards registration in regional Standardization, Metrology, and Certification

Center.

3. Regional food product producing arrangement using the appellation of origin

- Food raw materials producing system development with special features ensuring. - Technological process development of regional product producing. - Regional food product and food materials producing implementation. - Internal audits. - Correction actions development and implementation.

182

4. Regional food product registration using the appellation of origin

- Application preparations for product state registration of the appellation of origin. - Application expertise for product state registration of the appellation of origin. - State registration of the appellation of origin in the state names Register. - Product certificate obtaining on unique right of the appellation of origin. - Name application and safeguard sign application of the appellation of origin during product

producing.

5. Project efficiency estimation and informational ensuring.

- New product price determination considering competitive situation and competitive benefits. - Main promotion tools analysis and choosing the most effective selling channels for a new

product. - Application ways development for the product appellation name for advertising and market-

ing activity. - Measures development on the product appellation name safeguard from illegal application. - Actions list development on project informational ensuring.

Based on given operations list a student develops the project continuous plan-schedule (see table 9.1) considering region, implementation term and reviewing product features.

While paragraph No.11 performing the Russian Federation Civil Code 1519 article require-ments should be taken into account. Product appellation of origin application is this name indica-tion, namely:

13. on the goods, labels, package;

14. on the forms, invoices, other documents and printed sources;

15. in goods selling offers, and also in notifications and advertisements;

16. in Internet including in domain names and other addressing ways.

The task is finished with frontal presentation.

Table 9.1 Plan form of a regional food product development and producing

Months Operation

1 2 3 4 5 6 7 8 9 10 11 12

Responsi ble person

1. Organizational stage

� Interested parties reveal for project implementation.

� Project coordinator assign-ment and work group form-ing.

………………………………

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10 Development of a Quality Management System

Objective: to get practical skills of development and implementation of a quality manage-ment system based on MS ISO 9000 in a company.

Tasks types on chapter 10

1. Give a sample scheme of a quality management system based on the process approach (in line with GOST R ISO 9001-2008).

2. Develop a structure of QMS documentation and a list of standards of an organization of a given type (table 10.1).

3. Develop a schedule plan of implementation and certification of QMS according to the given variant (table 10.1).

4. Develop a responsibilities matrix in accordance with the given variant (table 10.1).

Table 10.1 Tasks variants on chapter 10

Variant first figure Type of a company Number

of STO

Second figure of

the variant

Term of devel-opment , months.

0 Greenhouse complex 30 0 12

1 Bread-baking plant 25 1 15

2 Stockbreeding complex 15 2 18

3 Confectionery plant 20 3 21

4 Sugar plant 18 4 24

5 Canning factory 26 5 12

6 Meat processing plant 28 6 15

7 Poultry plant 15 7 18

8 Feed mill 24 8 21

9 Dairy plant 20 9 24

Guidelines

A model of a system based on the process approach and involves all the basic requirements of GOST R ISO 9001-2008 without details is shown in fig. 4.4. a supervisor can ask to give details of some elements of the model: name categories of interested parties (see table 4.1), show stages of a life cycle (fig. 4.3), detail a structure of main blocks of requirements of the model according to the structure 5…8 of standard division, etc. When doing i. 1 of the given task it is important to show functional connections of separate model blocks, supplementing with value and information flows.

When developing a list of standards of an organization it is possible to use a sample STO list shown in table 10.2.

184

Table 10.2 A sample list of QMS standards of an organization

STO Name

Processes of QMS organizing STO QMS 1-2010 Organizing development and improvement of a QMS

STO QMS 2-2010 Organizing performance of a QMS

Processes of management STO QMS 3-2010 Organizing process functioning

STO QMS 4-2010 Documentation management

STO QMS 5-2010 Records management

STO QMS 6-2010 Analysis of a market

STO QMS 7-2010 Analysis of a contract

STO QMS 8-2010 Internal exchange of information

STO QMS 9-2010 Analysis of consumer and other interested parties satisfaction

STO QMS 10-2010 Top management review

Processes of resources provision STO QMS 11-2010 Stuff management

STO QMS 12-2010 Provision of working space

STO QMS 13-2010 Provision of equipment and transport

STO QMS 14-2010 Provision of soft ware and communication

Processes of production management STO QMS 15-2010 Production planning

STO QMS 16-2010 Purchasing

STO QMS 17-2010 Control of the purchased products

STO QMS 18-2010 Documentation of a production process

STO QMS 19-2010 Product identification and traceability

STO QMS 20-2010 Maintenance and repair of equipment

STO QMS 21-2010 production

STO QMS 22-2010 Product monitoring and measuring during production

STO QMS 23-2010 Monitoring and measuring of end product

STO QMS 24-2010 Loading-unloading, storage, packaging, supply

STO QMS 25-2010 Metrological provision

Processes of measuring and audit STO QMS 26-2010 Organizing QMS audit

STO QMS 27-2010 Internal QMS audit

STO QMS 28-2010 Non-conformity management

STO QMS 29-2010 Corrective actions

STO QMS 30-2010 Preventive actions

In real practice the number of standards of an organization is not limited. At the same time, number of documented procedures should be minimum but sufficient for efficient quality manage-ment and meeting requirements of ISO 9001 standard. Limitation of number of STO in this task al-lows to use a creative approach while analyzing main and supplementary processes of the given company’s type. Herewith, some processes (out of competence of the given company) can be omit-ted, while other processes can be additionally introduced.

185

Six obligatory documented procedures, required by ISO 9001 (table 10.2 in italics), should be included into the STO developing list. Processes of similar content can be documented in the frameworks of one standard: documentation and records management, analyses of a market and analysis of a contract, corrective and preventive actions, etc.

As soon as the list of standards is done, it is necessary to make a detailed structural scheme of QMS documentation. A structure meeting the requirements of GOST R ISO 9001-2008 (fig. 4.10) can be used as a basis. Here, the third level of documentation should be developed in accor-dance with the list of STO. A sample structure of documentation with detailed development of doc-uments of the third level is shown in fig. 4.11.

A schedule flow-chart (fig. 4.6) including 15 bulk stages of QMS development and certifica-tion can be used as a basis for development of a schedule for the given task. The identified stages can be detailed depending on the type of a company. In real development of QMS the differentia-tion of activities is wider and number of operations can be 100 and more.

While developing a schedule it is necessary to take into account a labour intensiveness and order of stages. It will take at least several months to carry out such stages as stuff training, QMS documentation development, implementation of the system, internal audits.

If it is possible it is better to plan activities rationally in time. It is preferable to plan a paral-lel carrying out of separate stages. On the other hand, it is necessary to remember that without stuff training it will be impossible to begin documentation development and implantation of the system; without implementation it is not possible to carry out internal audit, etc. Therefore dates of stages should be scheduled with a certain shift based on a logic of order and analysis of fulfillment this or that activity.

Responsibilities matrix is developed after development of a processes list (STO list) of an organization (company). A sample of responsibilities matrix is shown in fig. 10.1.

Approved byDirector JSC Dairy plant

EMPLOYEES RESPONSIBILITIES, POWERS AND INTERACTIONS MATRIX OF JSC DAIRY PLANT

Director

Director deputy on quality,

Quality Representative Production director

Management Division of GOST R ISO 9001-2008.

QMS processes Departments

4. QUALITY MANAGEMENT SYSTEM

4.1. Development & management of QMS processes

4.2.3 documentation management

4.2.4 records management

5. TOP MANAGEMENT RESPONSIBILITY

5.1. management commitment

5.2. consumer focus

5.3. quality policy

5.4. planning and development of targets

5.5. commitment, powers and informing

5.6. top management QMS review

6. RESOURCES MANAGEMENT

6.1. resources provision

6.2. human resources

6.3. infrastructure

6.4. production environment

7. PROCESSES OF PLC

7.1. planning of processes of PLC

7.2. processes connected with consumers

7.3. designing and development

7.4. purchases

7.5. production and maintenance

7.6. measuring equipment management

8. MEASURING, AUDIT, IMPROVEMENT

8.1. planning

8.2. monitoring and measuring

8.3. non-conformity management

8.4. data analysis

8.5. improvement RE

SP

ON

SIB

ILIT

IES

, PO

WE

RS

AN

D IN

TE

RA

CT

ION

S

IN C

AR

RY

ING

OU

T T

HE

PR

OC

ES

SE

S

P – process leader (owner), responsible for the budget, planning, allocation of responsibilities and powers, external interaction and informing, efficiency, effectiveness, audit and improvement; O – process implementation arrangements, responsible person for performing, control, inspection and process real-time management, internal interaction and informing; C – process joint contractor, И – a person providing the information for process; Д – a person engaging in docu-mentation development

Fig. 10.1 Employees responsibilities and powers matrix of JSC Dairy plant form

11 Development of documents on product declaration and quality systems certification

Objective: to study nomenclatures of products subject to obligatory conformity assurance, to get practical skills of documenting and registration of declaration of conformity in GOST R certi-fication system and skills of documenting application for organizational QMS certification.

Tasks types on chapter 11

1. To study forms of declaration of conformity in GOST R certification system, application form for registration of declaration of conformity, application form for QMS certification in GOST R certification system.

2. Draw up a declaration of conformity and application form for carrying out registration of declaration of conformity according to the given variant (table 11.1).

3. Draw up an application form for QMS certification according to the given variant (table 11.1).

Table 11.1 Practical tasks variants on “Development of documents on product declaration and quality systems certification” chapter”

Variant first figure Object No. by table 11.2 Variant second fig-

ure Type of a company

0 1 0 Greenhouse complex

1 2 1 Bread-baking plant

2 3 2 Stockbreeding plant

3 4 3 Confectionary plant

4 5 4 Sugar plant

5 6 5 Canning factory

6 7 6 Meat processing plant

7 8 7 Poultry plant

8 9 8 Feed mill

9 10 9 Dairy plant

Guidelines

When doing this task it is necessary to follow normative legal acts of GOST R certification system and materials of chapter 4 and 7 of this module. Objects of declaration (extract from No-menclature 2) are shown in table 11.2.

188

Table 11.2 Information on products requiring obligatory conformity assessment (in declaration of conformity form) (fragment)

Name of an object

Code of an object by ОК 005-93

(ОКP)

Regulating normative legal act Conformed requirements

1 2 3 4

GOST 16990-88 п. 1.1.4, табл. 3; п. п. 1.1.6, 1.1.7а, 1.1.8, 2.6, табл. 4

1. Rye 97 1971 97 1928

GOST 27850-88 п. п. 2.4 - 2.6

2. Buckwheat 97 1521 GOST 19092-92 п. 1.3, табл. 3; . п. 1.5, 1.8, 1,9

3. Sunflower 97 2111 GOST 22391-89 п. п. 1.3, 1.4, 1.5, 2.2, 2.3

SANPiN 2.3.2.1078-01 Приложение 1, п. 1.6.1

GOST R 51074-2003 Рр. 3, 4, п. 4.13.1

4. Fresh cabbage, sold by retailers

97 3211 97 3212

GOST R 51809-2001 Пп. 5.1, 5.2, .4, 6.7


GOST R 51074-2003 Рр. 3, 4, п. 4.13.1

5. Carrot, sold by retail-ers

97 3222

51782-2001 п. п. 5.2, 5.3, 5.5, 6.7


GOST R 51074-2003 Рр. 3, 4, п. 4.13.1

6. Fresh tomatoes 97 3241 97 3500

GST R 51782-2001 Пп. 5.1 - 5.3, 5.5, 6.7


GOST R 51074-2003 Рр. 3, 4, п. 4.13.1

7. Fresh cucumbers 97 3251

GOST 1726-85 п. п. 1.4, 1.7, 4.3


GOST R 51074-2003 Рр. 3, 4, п. 4.13.1

8. Fresh apples of later crops

97 6111

GOST1726-85 п. п. 1.4, 1.7, 4.3


GOST R 51074-2003 Рр. 3, 4, пп. 4.13, 4.13.2

9. Fresh grapes 97 6174

GOST 25896-83 п. п. 1.2 - 1.5, 4.4

10. Hen eggs 98 4135 GOST R 52121-2003 Пп. 5.2, 5.3

Declaration of product conformity and application form for registration of declaration are

drawn up according to the forms shown in figs. 11.1 and 7.11. A form of application for QMS certi-

fication is shown in fig 11.2.

189

DECLARATION OF CONFORMITY (1)_____________________________________________________________________

Company or individual entrepreneur name declaration of conformity holder (2)_____________________________________________________________________ Information on company or individual entrepreneur registration (the registration body name,

date of registration, registration number) (3)_____________________________________________________________________

Address, phone no, fax (4) on behalf of ________________________________________________________________________

Position, executive leader name of company-declaration holder (5) declares that ________________________________________________________________________

Name, type, kind, model of product (service) under declaring, ОК 005–93 code or (and) CIS Commodity Code, serial number (lot number, product number, details of agree-

ment /contract/, shipment, producer, country etc.) (6) conforms to requirements ________________________________________________________________________

Codes of normative legal acts, conformation with which is certified by the declara-tion, with noting of all the items of the documents including requirements got the given

product. (7) Declaration is accepted on the basis of ________________________________________________________________________

Information on documents justifying the declaration (8) Date of issue ________________________ (9) Validity period ______________________________

Stamp ___________________ Signature

_____________________________ Name

Information on declaration registration

(10)____________________________________________________________________

Certification body name and address

(11) stamp ______________________________________________________________

Signature, the certification body executive leader name

Fig. 11.1 Declaration of conformity form

190

certification body (name,

address)

APPLICATION FOR QUALITY MANAGEMENT SYSTEM CERTIFICA TION IN GOST R CERTIFICATION SYSTEM

applicant

code OCPO Legal address:

Phone fax ______________________ E-mail

Bank details __________________________________________________________________ on behalf of __________________________________________________________________

name of the head requests to certify the quality management system in respect to the product (service)

product (service) name

code ОКP to confirm conformity to

name of the standard Data on QMS implementation *

number and date of the order document Data on the certificate of QMS conformity certification system name, certification body, number and date of issue, producer (executer) doc-

umentation code

by which the product (service) is produced (standards, regulations, agreements, etc.) General information about the organization_________________________________________

stuff number,

employees number of the product producing under the application

The applicant is obliged to follow the rules of certification in GOST R certification system. Additional information Appendixes:

1. list of organizations-consumers of the product (service) 2. data of the organization-designer of the product

Name of the organization- product designer

Company executive leader name_______________________ ________________________ signature name Chief accountant _______________________ ________________________ signature name

stamp Date *fulfilled in case of presence of a precious certificate

Fig. 11.2 Application form for QMS certification

191

The name of a product is noted according to the first column of Nomenclature of products subject to declaration of conformity, table 11.2. Only OK 005-93 (OKP) code is noted in the decla-ration and application form.

The application form is filled from on behaf of a virtual company, therefore bank details and other specific parameters are not mandatory. The application is filled for a definite certification body in the region where applicant lives. Information about the food certification body is available on the website of VNIIS (http://www.gost.ru/).

The declaration is filled according to the rules of filling the declaration of conformity. In the declaration there should be listed all positions of conformed requirements of regulation normative legal acts identified by Nomenclature 2 (table 11.2).

192

12 Development and arrangement of the regional competition “quality leader”

Objective: to get practical skills of planning, development and implementation of system activities on product quality improvement in the region.

Tasks on chapter 12

To improve product quality in a company of a region there was established a strategic deci-sion to organize development and arrangement of a regional competition with the working name “quality leader”. The targets of the competition is to develop and implement the regional quality policy, to improve quality of products and services of regional companies, to popularize quality ideas in the region, to develop a mechanism of motivation of companies and organizations of the region, propaganda of quality ethics.

To develop and arrange the competition it is necessary to:

1. Discuss and offer a name of the competition.

2. Discuss and offer main stages, dates and periodicity of the competition.

3. Offer a logo of the competition and procedure of its application by prize-winners.

4. Discuss and list interested parties

5. Discuss and offer dates of the project realization.

6. Discuss and offer variants of financial resources of the competition.

7. Discuss and develop a list of main procedures of the project realization.

8. Discuss and develop a schedule of the project.

9. Discuss and offer a structure of a Resolution on the competition.

10. Discuss and offer groups of participants.

11. Discuss and offer members and procedures of forming the jury of the competition.

12. Discuss and offer criteria of participants assessment and determination of prize-winners.

13. Develop a list of procedures on informational support of the competition.

14. Discuss and offer forms of awarding.

15. Discuss and offer ways of using results of the competition for advertising and marketing.

Guidelines

To fulfill this tasks students it would be rational to divide students into three working groups. Work on the task should be rationally divided between the groups (group No.1 – items 1…5, group No. 2 – items 6…10, group No. 3 – items 11…15).

Every working group using “brainstorm” method generates ideas on its part of work. After that groups gather and present their ideas. During discussion they generate correlations, new ideas and decisions on separate acclivities of development and arrangement of the competition.

193

Test tasks

1. Name the national law that establishes the order of product technical standards development and application:

Correct answer: the national law “On technical regulation”.

Answers variants:

- the national law “On consumers’ rights protection”; - the national law “On food products quality and safety”; - the national law “On sanitary and Epidemiological Safety of the Population”; - the national law “On environmental Expertise”.

2. What task is not an element of food safety ensuring?

Correct answer: complete cancellation of imported food products and food raw materials.

Answers variants:

- food safety dangers planning and prevention; - sustainable development of domestic food products and raw materials production; - safe food products availability; - food safety ensuring.

3. What criterion is used for conditions estimation of food safety?

Correct answer: domestic products share in the total volume of market corresponding prod-ucts goods resources.

Answers variants:

- human daily energy value; - food products consumers’ prices indicator; - food products consumption per capita; - agricultural products production volume.

4. What article of the Russian Federation Criminal Code establishes the responsibility regard-ing products and services not keeping the safety requirements?

Correct answer: the Russian Federation Criminal Code article No. 238.

Answers variants:

- the Russian Federation Criminal Code article No. 236; - the Russian Federation Criminal Code article No. 237; - the Russian Federation Criminal Code article No. 182; - there is no correct answer.

5. What organization provides the development of the international standards, guiding princi-

194

ples and practices codes for food products?

Correct answer: the CODEX ALIMENTARIUS Committee.

Answers variants:

- the WTO; - the WHO; - the FAO; - the EU.

6. Who is responsible directly on food safety and environment protection in France?

Correct answer: on departmental Directorate for the Population Protection.

Answers variants:

- on the Ministry of Healthcare; - on the Directorate General for Food Products (DGAL); - on the region Prefect; - on the Ministry for Food Products, Agriculture and Fishery.

7. Control on the EU directives keeping concerning food products safety in the European Community is assigned on:

Correct answer: each EU country-member.

Answers variants:

- the European Food Safety Authority (EFSA); - the European Parliament; - the EU Council; - the EU Court.

8. What are the aims of the technical standards adoption?

Correct answer: economic efficiency increasing of company activity.

Answers variants:

- products conformity assessment to safety requirements; - assistance for sellers in production qualified choosing; - production competitiveness increasing; - goods free turnover ensuring throughout the Russian Federation unitary goods market and

international cooperation providing.

9. What is the top achievement concerning quality in the Russian Federation?

Correct answer: The Russian Federation Government Quality Award.

Answers variants:

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- “ People’s Mark” national award; - the winning in the all-Russian contest “100 best goods of Russia”; - the winning in the all-Russian exhibition “Buy Russian goods!”; - the winning in the all-Russian contest “III millennium quality mark”.

10. Specify the quantity of the Russian Federation Government quality awards for companies-participants with employees’ number under 250.

Correct answer: no more than 3 ones.

Answers variants:

- no more than 6 ones; - no more than 12 ones; - no more than 9 ones; - there is no correct answer.

11. What standard currently determines the QMS requirements?

Correct answer: GOST R ISO 9001-2008.

Answers variants:

- GOST R ISO 9000-2008; - GOST R ISO 9004-2010; - GOST R ISO 14001-2007; - GOST R ISO 19011-2003.

12. What is the main document of QMS in a company?

Correct answer: Quality Manual.

Answers variants:

- Quality Policy; - Quality Objectives; - Employees powers and responsibilities matrix; - Quality Department Provision.

13. What is not a requirements unit of QMS based on ISO 9000?

Correct answer: there is no correct answer

Answers variants:

- executives leadership; - resources management; - product life cycle processes; - estimation, analysis and improvement.

14. Name the management object in QMS.

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Correct answer: company processes.

Answers variants:

- employees; - main product producing; - departments and services; - products (services) quality.

15. What international standards determine the EMS requirements?

Correct answer: ISO 14000.

Answers variants:

- ISO 9000; - ISO 18000; - ISO 8000; - ISO 22000.

16. Name the initial unit of EMS model according to GOST R ISO 14001.

Correct answer: environmental policy.

Answers variants:

- planning; - implementation and operating; - executives analysis; - continual improvement.

17. What operational stage of EMS development is a stage for system organizational structure creation?

Correct answer: EMS design.

Answers variants:

- EMS documentation; - EMS implementation; - EMS certification preparations; - works organizing for EMS development.

18. What EMS document establishes the target environmental indicators?

Correct answer: environmental policy.

Answers variants:

- environmental management program; - appointment order for executives representative on environment; - Register of environmental aspects and impacts;

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- Matrix of activity types and responsibility assignment.

19. What principle is accomplished within the last stage of the HACCP system development?

Correct answer: All the system procedures documentation.

Answers variants:

- monitoring system development; - correction actions development; - critical control points reveal; - potential hazards identification.

20. What is a base for critical control points reveal in HACCP system?

Correct answer: production process flow-chart.

Answers variants:

- HACCP work-sheet; - correction actions plan; - company structure; - the Order on HACCP work group creation.

21. Who is not a participant of food products safety traceability system?

Correct answer: there is no correct answer.

Answers variants:

- agricultural goods producers; - primary processing companies; - food industry companies; - trading companies.

22. What management system allows to harmonize internationally the food products safety re-quirements for companies and enterprises operating in the food producing chain?

Correct answer: system based on ISO 22000.

Answers variants:

- system based on HACCP principles; - QMS system based on ISO 9000; - EMS system based on ISO 14000; - integrated management system.

23. An application for product certification is applied to:

Correct answer: the Certification body.

Answers variants:

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- Rosstandard; - certification system central body; - testing laboratory; - Accreditation body.

24. Market circulation mark proves

Correct answer: the technical standards requirements conformity of production releasing for turnover.

Answers variants:

- production high quality; - availability of the certificate on quality system; - availability of the production certificate; - production certification in voluntary certification system.

25. Name the main domestic certification system.

Correct answer: Certification system GOST R.

Answers variants:

- Certification system “Electrosvyaz”; - Certification system of immunobiological medicines; - Certification system of production and services concerning fire safety; - Certification system for national railway transport.

26. In the case of obligatory certification the conformity certificate is issued by:

Correct answer: certification body.

Answers variants:

- authorized testing laboratory; - the Certification System Central Body; - Rosstandard; - states authorities of municipal administration.

27. What activity type is not a power of state control (inspection) bodies?

Correct answer: Production Conformity Declaration registration.

Answers variants:

- technical standards keeping control; - producer (executor, seller) bringing to responsibility; - instructions issue on violations elimination; - checking of conformity Declaration or Certificate availability.

28. Give the technical control classification of production process stages.

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Correct answer: input, operating, acceptance, storage, transportation.

Answers variants:

- primary, current, periodical; - complete, selective; - disintegrating, integrating; - by quantitative criterion, by qualitative criterion, by alternative criterion.

29. What is the aim of production certification tests?

Correct answer: primary checking of product sample conformity to established safety re-quirements.

Answers variants:

- continuation assessment of product type sample conformity to established requirements; - establishment of tests equipment application suitability; - metrological checking of measurements tools; - tests work methodology development.

30. What control type allows the food industry company to ensure the qualitative raw materials obtaining?

Correct answer: input control.

Answers variants:

- production (operational) control; - final production acceptance; - control during storage stage; - control during transportation stage.

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References

а) basic references :

Техническое регулирование: Учебник / Под ред.В.Г. Версана, Г.И. Элькина. – М.: ЗАО «Издательство «Экономика», 2008. – 678 с.

Карпузов В.В. Системы качества Учебник для вузов. М. ФГОУ ВПО МГАУ, 2009. – 340 с.

Рогов И.А., Дунченко Н.И., Поздняковский В.М. и др. Безопасность продовольственного сырья и пи-щевых продуктов: Учебное пособие. – Новосибирск: Сиб. унив.. изд-во, 2007.- 227 с.

b) supplementary references:

Литвинов О.В. Маркировка товаров в России и за рубежом. Азбука знаков. – М.: РИА «Стандарты и качество», 2003. – 208 с.

ГОСТ Р ИСО 9000–2008. Системы менеджмента качества. Основные положения и словарь. – М.: Стандартинформ, 2009. – 26 с.

ГОСТ Р ИСО 9001-2008. Системы менеджмента качества. Требования. – М М.: Стандартинформ, 2009 – 25 с.

ГОСТ Р ИСО 14001-2007. Системы экологического менеджмента. Общие требования и руководствот по применению. М.: Стандартинформ, 2007. – 22 с.

ГОСТ Р 51705.1-2001. Управление качеством пищевых продуктов на основе принципов ХАССП. М: ИПК Издательство стандартов, 2004 – 10 с.

ГОСТ Р ИСО 22000-2007. Системы менеджмента безопасности пищевой продукции. Требования к организациям, участвующим в цепи создания пищевой продукции. М.: Стандартинформ, 2007 – 30 с.

Экологическое подтверждение соответствия. // Сб. «Все о качестве. Отечественные разработки». – 2003. – № 2 (23). – 92 с.

Системы экологического менеджмента. // Сб. «Все о качестве. Отечественные разработки». – 2004. – № 3 (30). – 88 с.

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Glossary

Food safety of the Russian Federation is one of the key areas of ensuing the country’s na-tional security in the medium term, the factor that contributes to maintaining statehood, sovereignty, the essential component of its demographic police, the necessary condition for implementing the national priority, i. e. the improvement of the Russian citizens’ life quality through ensuring high sustenance standards (Doctrine of Food Safety of the Russian Federation).

Food - products in natural or processed form for human consumption as food (including children's foods and dietary foods), bottled drinking water, alcoholic products (including beer), nonalcoholic beverages, chewing gum, and also raw food materials, food additives and biologically active additives (FZ no. 29 of January 2, 2000).

Food raw materials – raw materials of vegetable, animal, microbiological, mineral and arti-ficial origin and water used for the manufacture of food products.

Food quality – a set of characteristics of food products capable of satisfying human re-quirements in food under the normal conditions of their use (FZ no. 29 of January 2, 2000).

Food safety – a state of reasonable confidence that food products under the normal condi-tions of their use are not harmful and do not constitute any danger to the health of present and future generations (FZ no. 29 of January 2, 2000).

Certificate of food, materials and articles quality and safety – a document wherein the manufacturer attests the conformity of the quality and safety of each batch of food products, materi-als and articles to the requirements of normative or technical documents (FZ no. 29 of January 2, 2000).

Quality – degree to which a set of characteristics fulfills requirements (ISO 9001-2008).

Requirement – need of expectation that is stated, generally implied or obligatory (ISO 9001:2008).

Grade – category or rank given to different quality requirements for products, processes or systems having the same functional use (ISO 9001:2008).

Customer satisfaction – customer’s perception of the degree to which customer’s require-ments have been fulfilled (ISO 9001:2008).

Quality management – coordinated activities to direct and control an organization with re-gard to quality (ISO 9001:2008).

Quality planning – part of quality management focused on setting quality objectives and specifying necessary operational processes and related resources to fulfill quality objectives (ISO 9001:2008).

Quality control – part of quality management focused on fulfilling quality requirements (ISO 9001:2008).

Quality assurance – part of quality management focused on providing confidence that qual-

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ity requirements will be fulfilled (ISO 9001:2008).

Quality improvement – part of quality management focused on increasing the ability to ful-fill quality requirements (ISO 9001:2008).

Management system – system to establish police and objectives and to achieve those objec-tives (ISO 9001:2008).

Quality management system – management system to direct and control an organization with regard to quality (ISO 9001:2008).

Quality policy – overall intentions and direction of an organization related to quality as for-mally expressed by top management (ISO 9001:2008).

Effectiveness – extent to which planned activities are realized and planned results achieved (ISO 9001:2008).

Efficiency – relationship between the result achieved and the resources used (ISO 9001:2008).

Organization (company)– group of people and facilities with an arrangement responsibili-ties, authorities and relationships (ISO 9001:2008).

Infrastructure – system of facilities, equipment and services needed for the operation of an organization (ISO 9001:2008).

Work environment – set of conditions under which work is performed (ISO 9001:2008).

Customer – organization or person that receives a product (ISO 9001:2008).

Supplier – organization or person that provides a product (ISO 9001:2008).

Process – set of interrelated or interacting activities which transforms inputs into outputs (ISO 9001:2008).

Product – result of a process (ISO 9001:2008).

Procedure – specified way to carry out an activity or a process (ISO 9001:2008).

Non-conformity – non-fulfillment of a requirement (ISO 9001:2008).

Defect – non-fulfillment of a requirement related to an intended or specified use (ISO 9001:2008).

Preventive action – action to eliminate the cause of a potential non-conformity or other un-desirable potential situations (ISO 9001:2008).

Corrective action – Corrective actions are steps that are taken to eliminate the causes of an existing nonconformity (ISO 9001-2008).

Concession – permission to use or release a product that does not conform to specified re-

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quirements (ISO 9001:2008).

Deviation permit – permission to depart from the originally specified requirements of a product prior to realization (ISO 9001:2008).

Quality manual – a document specifying the quality management system of an organization (ISO 9001:2008).

Quality plan – document specifying which procedures and associated resources shall be ap-plied by whom and when to a specific project, product, process or contract (ISO 9001:2008).

Record – document stating results achieved or providing evidence of activities performed (ISO 9001:2008).

Inspection – conformity evaluation by observation and judgment accompanied as appropri-ate by measurement, testing or gauging (ISO 9001:2008).

Test – determination of one or more characteristics according to a procedure (ISO 9001:2008).

Verification – confirmation, through the provision of objective evidence, that specified re-quirements have been fulfilled (ISO 9001:2008).

Validation – confirmation, through the provision of objective evidence, that the require-ments for a specific intended use or application have been fulfilled (ISO 9001:2008).

Audit – a systematic examination to determine whether what is actually happening complies with documented procedures.

Internal audit sometimes called first party audits are conducted by, or on behalf of, the or-ganization itself for management review and other internal purposes, and may form the basis for an organization’s declaration of conformity (ISO 9001:2008).

External audit include those generally termed second- and third-party audits (ISO 9001:2008).

Integrated management system – a management system that conforms to requirement of two or more international standards for management.

Service – a result of direct interaction of a performer and a consumer, as well as of own ac-tivity of a performer on satisfaction of consumer’s need (GOST 50691-94).

Service quality – a set of characteristics of a service determining its ability to satisfy estab-lished or potential consumer’s needs (GOST 50691-94).

Audit group – one or more auditors conducting an audit supported if needed by technical experts (ISO 19011:2003).

Audit program – set of one or more audits planned for a specific time frame and directed towards a specific purpose (ISO 19011:2003).

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Audit plan – description of the activities and arrangements for an audit (ISO 19011:2003).

Scope of audit – extent and boundaries of an audit. The audit scope generally includes a de-scription of the physical locations, organizational units, activities and processes, as well as the time period covered (ISO 19011:2003).

HACCP (Hazards Analyses and Critical Control) – a systematic approach to the identifica-tion, evaluation, and control of food safety hazards (GOST R 51705.1 – 2001).

HACCP system – a set of organizational chart, documents, processes and resources neces-sary for realization of HACCP (GOST R 51705.1 – 2001).

HACCP group – the group of people who are responsible for developing, implementing and maintaining the HACCP system (GOST R51705.1 – 2001).

Risk - the combination of the probability of occurrence of harm and the severity of that harm (GOST R 51705.1 – 2001).

Non-permissible hazard – risk exceeding permitted limits (GOST R 51705.1 – 2001).

Safety – absence of non-permissible risks (GOST R 51705.1 – 2001).

Critical control point – a step at which control can be applied to identify a hazard and/or for risk management (GOST R 51705.1 – 2001).

Monitoring system – a set of procedures, processes and resources necessary for carrying out of monitoring (GOST R 51705.1 – 2001).

Conformity assessment – is the documentary certifying of conformity of products or other objects, processes of production, operation, storage, transportation, marketing and utilization, exe-cuting of works or rendering of services to the requirements of technical regulations, provisions of standards or conditions of contracts (FZ no. 184).

Certification – the form of conformity assurance of objects to the requirements of technical regulations, to provisions of standards or conditions of contracts, realized by certification body (FZ no.184).

Conformity declaring– is the form of conformity assurance of products to the requirements of technical regulations (FZ no.184).

Certificate of conformity – is the document certifying the conformity of an object to the re-quirements of technical regulations, to provisions of standards or conditions of contracts (FZ no. 184).

Declaration of conformity – is the document certifying the conformity of the released prod-uct to the requirements of technical regulations (FZ no. 184).

Market circulation mark – is the label intended for informing of purchasers on conformity of released products to the requirements of technical regulations FZ no. 184).

Mark of conformity – is the designation intended for informing of purchasers on conformity

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of certification object to the requirements of voluntary certification system or the national standard (FZ no. 184).

Certification system – is the set of rules for executing of works on certification, its partici-pants and rules for operation of the certification system as a whole (FZ no. 184).

Accreditation – is the official recognition, by accreditation body, of the competence of a natural or legal person to perform operations in definite area of conformity assessment (FZ no. 184).

Environmental certification is a procedure for confirming that the characteristic of the product are in compliance with environmental standards.

The principle of a legal entity or individual entrepreneur conscientiousness presumption means that inspection bodies are obliged to evidence a guilt of a subject of economic activity in case of a revealed fact of violation of technical regulation requirements.

Technical control is an inspection of objects conformity to established technical standards (ГОСТ 16504–81).

Test is a technical operation of determination of one or several characteristics of the product, process or service in compliance with the established procedure (ISO/IEC Guide 2).

Tests object – a product under testing.

Test procedure – detailed description of practical actions in carrying out tests of a definite method.

Test result - characteristics of a product received in the result of tests.

Test executors – personnel involved in testing.

Test report – a document containing test results and other information concerning tests.

Tests conditions – totality of influencing factors or/and regimes of operation of an object during tests.

Test data – registered during tests indicators of characteristics of object properties and test conditions.

Test means – technical devices necessary for tests. Test means include testing equipment, measuring equipment and subsidiary technical devices.

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Training material

The elaborated RUDECO modules serve for the purpose of “Vocational Training in Rural Development and Ecology” in Russia. They target on representatives of local and regional admini-strations and advanced students in the different fields of rural development.

All below listed RUDECO partners can be addressed in case of training interest in one of the modules. For readers of the module textbooks and training participants the project website provides the possibility to download additional material on http://tempus-rudeco.ru/en/modules (required password RD-modules), e.g. presentations and other didactic material used in the conducted train-ings.

Visual aids

Presentation for chapter 1. Food safety legislation

Presentation for chapter 2. International activities in the context of food safety

Presentation for chapter 3. Food safety ensuring development in the Russian Federation

Presentation for chapter 4. Quality management systems on the basis of ISO 9000 series

Presentation for chapter 5. Environmental management systems on the basis of ISO 14000 se-ries

Presentation for chapter 6. Food Quality Management Systems on the basis of HACCP and ISO 22000

Presentation for chapter 7. Conformity assessment

Presentation for chapter 8. Quality control and product tests

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RUDECO partners and contact information

Contact persons for the presented module

Moscow State Agroengineering University named after V.P. Goryachkin.

127550 Moscow, Timiryazewskaya Str.58 Vasiliy Karpuzov Konstantin Malashenkov Valeriy Chumakov

E-mail:[email protected]

All RUDECO partners

Russia/ Россия

Russian State Agrarian University-Moscow Timiryazev Agricultural Academy Sustainable Rural Development Center Moskva, Timiryazevskaya 49 Moscow 127550 [email protected] http://www.timacad.ru/en/

Российский государственный аграрный университет – МСХА имени К.А.Тимирязева Центр устойчивого развития сельских территорий Тимирязевская, 49 г. Москва, 127550 [email protected] http://www.timacad.ru/

Russian Ministry of Agriculture Department of Rural Development and Social Policy 1/11 Orlikov pereulok Moscow 107139 http://www.mcx.ru/

Министерство сельского хозяйства РФ Департамент сельского развития и социальной политики Орликов переулок, 1/11 г. Москва, 107139 http://www.mcx.ru/

All-Russian Alexander Nikonov Institute of Agrarian Problems and Informatics of the Russian Academy of Agricultural Sciences (VIAPI) B. Kharitonievskiy per. 21/6 Moscow 105064 [email protected] http://www.viapi.ru/

Всероссийский институт аграрных проблем и информатики им. А.А. Никонова Российской академии сельскохозяйственных наук Б. Харитоньевский пер. 21/6, г. Москва, 105064 [email protected] http://www.viapi.ru/

Tambov State University named after G.R.Derzhavin Internatsionalnaya 33 Tambov 392000 [email protected] http://tsutmb.ru/

Тамбовский государственный университет имени Г.Р. Державина Ул. Интернациональная, 33 г. Тамбов, 392000 [email protected] http://tsutmb.ru/

Administration of Tambov region Internatsionalnaya 14 Tambov 392000 http://www.tambov.gov.ru/

Администрация Тамбовской области Интернациональная, д.14 г. Тамбов, 392000 http://www.tambov.gov.ru/

Orel State Agrarian University Generala Rodina 69 Orel 302019 [email protected] http://www.orelsau.ru/

Орловский государственный аграрный университет ул. Генерала Родина, д. 69. г. Орел, 302019 [email protected] http://www.orelsau.ru/

208

Samara State Agricultural Academy settl. Ust-Kineskiy, 2 Uchebnaya str. Samara region 446442 [email protected] http://www.ssaa.ru/

Самарская государственная сельскохозяйственная академия п. Усть-Кинельский, ул. Учебная 2 Самарская обл., 446442 [email protected] http://www.ssaa.ru/

Yaroslavl State Agricultural Academy Tutaevskoe shosse 58 Yaroslavl 150042 S. Shchukin: [email protected] http://www.yaragrovuz.ru/

Ярославская государственная сельскохозяйственная академия Тутаевское шоссе, 58 г. Ярославль, 150042 С.В. Щукин: s.shhukin @ yarcx.ru http://www.yaragrovuz.ru/

Kostroma State Agricultural Academy Karavaevo Campus Kostromskoy rayon Kostromskaya oblast, 156530 [email protected] http://kgsxa.ru/

Костромская государственная сельскохозяйственная академия Учебный городок КГСХА пос. Караваево, Костромской район Костромская обл., 156530 [email protected] http://kgsxa.ru/

Stavropol State Agrarian University Per. Zootekhnicheskiy 12 Stavropol 355017 [email protected] http://www.stgau.ru/english/official.php

Ставропольский государственный аграрный университет пер. Зоотехнический 12 г. Ставрополь, 355017 [email protected] http://www.stgau.ru/

Omsk State Agrarian University named after P.A.Stolypin Institutskaya Ploshchad 2 Omsk 644008 [email protected] http://www.omgau.ru/

Омский государственный аграрный университет им.П.А.Столыпина Институтская площадь, 2 г. Омск, 644008 [email protected] http://www.omgau.ru/

Novosibirsk State agrarian University Dobrolubova 160 Novosibirsk, 630039 [email protected] http://nsau.edu.ru/

Новосибирский государственный аграрный университет ул. Добролюбова, 160 г. Новосибирск, 630039 [email protected] http://nsau.edu.ru/

Buryat State Academy of Agriculture named after V.R.Philippov Pushkina 8 Ulan-Ude, 670024 [email protected] http://www.bgsha.ru/

Бурятская государственная сельскохозяйственная академия им. В.Р. Филиппова ул. Пушкина, 8 г. Улан-Удэ, 670024 [email protected] http://www.bgsha.ru/

Association of organic and biodynamic agriculture "AGROSOPHIE" Krasnaya 20 Solnechnogorsk Moskovskaya Oblast, 141506 [email protected] http://www.biodynamic.ru/en/

Некоммерческое Партнёрство по развитию экологического и биодинамического сельского хозяйства «Агрософия» ул. Красная, 20 г. Солнечногорск, Московская область, 141506 [email protected] http://www.biodynamic.ru/ru/

LLC Company "Gutelot" Marshala Katukova Str. 20 Moscow 123592

ООО компания «Гутелот» ул. Маршала Катукова, д. 20 г. Москва, 123592

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The National Park "Plescheevo lake" Sovetskaya 41 Pereslavl-Zalesskiy Yaroslavlskaya Oblast, 152020

Национальный парк «Плещеево озеро» ул. Советская, 41 г. Переславль-Залесский, Ярославская область, 152020

Service on environmental safety, protection and use of fauna, aquatic bioresources Sauren Shaumyan Str. 16 Orel 302028

Управление по охране и использованию объектов животного мира, водных биоресурсов и экологической безопасности Улица Сурена Шаумяна,16 г. Орел, 302028

Moscow State Agroengineering University named after V.P. Goryachkin. Timiryazevskaya Str. 58 Moscow, 127550 [email protected] http://www.msau.ru/

Московский государственный агроинженерный университет им. В.П.Горячкина ул. Тимирязевская, 58 г. Москва, 127550 [email protected] http://www.msau.ru/

All-Russian Association of Educational Institutions of Agro-Industrial Complex and Fisheries Listvennichnaya alleya 16A, build. 3 Moscow, 127550 [email protected] http://www.agroob.ru/

Ассоциация образовательных учреждений агропромышленного комплекса и рыболовства ул. Лиственничная аллея, д. 16 А, корп.3 г. Москва, 127550 [email protected] http://www.agroob.ru/

Germany/ Германия

University of Hohenheim Institute of Landscape and Plant Ecology (320) Eastern Europe Centre (770) 70599 Stuttgart [email protected] https://oez.uni-hohenheim.de/

Университет Хойенхайм Институт ландшафтной экологии и экологии растений (320) Центр Восточной Европы (770) 70599 Stuttgart [email protected] https://oez.uni-hohenheim.de/

Agency for Development of Agriculture and Rural Areas of the Federal State of Baden-Wuerttemberg (LEL) Oberbettringer Strasse 162 73525 Schwäbisch Gmünd [email protected] https://www.landwirtschaft-bw.info

Агентство по развитию сельского хозяйства и сельской местности федеральной земли Баден-Вюртемберг (LEL) Oberbettringer Strasse 162 73525 Schwäbisch Gmünd [email protected] https://www.landwirtschaft-bw.info

Academy for Spatial Research and Planning (ARL), Section WR IV "Räumliche Planung, raumbezogene Politik" Hohenzollernstr. 11 30161 Hannover [email protected] http://www.arl-net.de/

Академия пространственных исследований и планирования (ARL) Отдел WR IV "Пространственное планирование, территориальная политика" Hohenzollernstr. 11 30161 Hannover [email protected] http://www.arl-net.de/

Terra fusca Ingenieure Marohn, Lange Partnerschaftsgesellschaft Karl-Pfaff-Str. 24 a 70597 Stuttgart http://www.terra-fusca.de/

Терра-фуска Marohn, Lange Partnerschaftsgesellschaft Karl-Pfaff-Str. 24 a 70597 Stuttgart http://www.terra-fusca.de/

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Poland / Польша

Warsaw University of Life Sciences Laboratory of Evaluation and Assessment of Natural Resources Nowoursynowska Street 166 Warsaw 02-787 [email protected] http://www.spoiwzp.sggw.pl

Варшавский университет естественных наук Лаборатория анализа и оценки природных рессурсов Nowoursynowska Street 166 Warsaw 02-787 [email protected] http://www.spoiwzp.sggw.pl

Association for Sustained Development of Poland Grzybowa Street 1 Warsaw-Wesola 05-077 [email protected] http://www.ekorozwoj.pl/

Ассоциация устойчивого развития Польши Grzybowa Street 1 Warsaw-Wesola 05-077 [email protected] http://www.ekorozwoj.pl/

France / Франция

L'Agence de services et de paiement Mission des affaires internationales Rue du Maupas 2 Limoges 87040 [email protected] http://www.asp-public.fr/

Агентство сервиса и платежей (ASP) Служба международных отношений Rue du Maupas 2 Limoges 87040 [email protected] http://www.asp-public.fr/

AgroSup Dijon 26 Boulevard Docteur Petitjean 21079 Dijion cedex [email protected] http://www.agrosupdijon.fr/

Национальный институт высшего образования в сфере агрономии, продуктов питания и окружающей среды (AGROSUP), Дижон 26 Boulevard Docteur Petitjean 21079 Dijion cedex [email protected] http://www.agrosupdijon.fr/

Italy / Италия

University of Udine Department of Agricultural and Environmental Sciences Via delle Scienze 208 33100 Udine [email protected] http://www.uniud.it/

Университет Удине Институт сельскохозяйственных наук и экологии Via delle Scienze 208 33100 Udine [email protected] http://www.uniud.it/

Slovakia / Словакия

Slovak University of Agriculture International Relations Office Tr.Andreja Hlinku 2 94976 Nitra [email protected] http://www.uniag.sk/

Словацкий университет сельского хозяйства Отдел международных отношений Tr.Andreja Hlinku 2 94976 Nitra [email protected] http://www.uniag.sk/

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Basic partners and experts

Organization Address Contacts

All-Russian Science and Research Institute of Classification, Terminology and Information on Standardizing and Quality (VNIICI RF *)

Moscow, Granatovy lane, 4 (М. «Pushkinskaja», «Barricadnaja»)

Tel. 290-50-94 Fax 291-79-65 www.vniiki.ru/ http://www.gostinfo.ru/

All-Russian Science and Research Institute of Certification (VNIIS)

Moscow, Electricheskij lane, 3/10 (М. «Belorusskaja-circle line»)

Library, Exhibition hall Tel. 253-34-04 Consultants Tel. 253-00-78, 253-03-79, 253-68-55 Department of development of quality systems Tel. 253-01-77, 253-05-96, 253-01-87 http://www.vniis.ru/

All-Russian Science and Research Institute of Metrological Service (VNIIMS)

Moscow, Ozernaja st., 46 Tel. 437-37-47 437-55-77 www.vniims.ru/

Shop of standards No. 1 Moscow, Donskaja st., 8 (М. «Octjabrskaja»)

Tel. 236-34-48

AIA «Standards and Quality»* Moscow, Mashinostroenija st.,. 17а, bld. 1 (М. «Dubrovka»)

Tel. 506-80-29, 771-66-524 Fax 177-84-67, 771-66-53 http://www.stq.ru/ http://www.gostinfo.ru

FSSE «Rosinformagrotech» Moscow region., Pushkino area, vil. Pravdinskij, Lesnaja st., 60

Tel. 993-44-04, 993-42-92, 993-55-83 http://www.rosinformagrotech.ru/