CHAPTER 1
General Considerations on Quality in the Food Analysis Laboratory
1 Introduction
Customers of the providers of analytical data need to be assured about the quality of the data that is being given to them. They must be assured that the data they receive are of the required quality for their purposes; ideally they should stipulate before any analysis is undertaken the 'quality of analysis' that they require. This requirement has long been recognised by users and providers (customers and contractors) of analytical data as part of a normal 'contract', but it is increasingly being prescribed by legislation. Laboratories must, therefore, ensure that they are providing data that are appropriate, i.e. that they meet 'fit-for-purpose' requirements, by implementing a programme of quality assurance measures. In essence a laboratory must ensure that the results it provides satisfy its customers' needs. Ultimately, the introduction of quality assurance within a food laboratory is beneficial for both the laboratory and its customers.
In addition, it is now both internationally and nationally recognised that for a laboratory to produce consistently reliable data it must implement a programme of appropriate quality assurance measures. Without such quality assurance measures being introduced there will be no confidence in the work of any particular analytical laboratory and that laboratory will be seriously disadvantaged. This book aims to survey the quality assurance measures that it may undertake with particular emphasis being placed on the international and legislative requirements that have been developed as well as the requirements for 'mutual recognition'. Experiences in some particular aspects of the quality assurance measures that may be introduced into a laboratory will be described, these aspects having been found to be of concern and so addressed in some other European countries.
2 Difference Between Food Analysis and Food Examination
In the United Kingdom (UK) a distinction is made between chemical analysis and microbiological examination for the purposes of the Food Safety Act 1990 and Regulations made under the Act. This is unusual in that most countries do not make this distinction and, for them, 'analysis' embraces both chemical and microbiological analysis. Thus, in the European Union (EU) general analysis legislation is taken to refer to both chemistry and micro-biology. It is important that this is appreciated when non-UK analytical documents are considered. However, the distinction is maintained throughout this book.
3 Mutual Recognition in the European Union: The Single Market and the Free Movement of Products
There is a new philosophy behind EU legislation, namely there has been a change from 'recipe' to 'information' and 'safety'. In the foodstuff sector there has been a change from controlling and preparing controlled detailed compositional standards to encouraging the consumer to purchase what he/she wishes provided that the food is clearly and informatively labelled and is safe. This means that in the foodstuffs area the development of vertical directives laying down detailed compositional standards has been reduced and replaced by the development of a series of horizontal directives. This is a part of the 'New Approach' that the EU (then the European Community) adopted in 1985.
This has a consequential effect for the work of laboratories and the production of analytical data. In particular it is central to the 'New Approach' and of the Single Market of the Union that there is recognition and acceptance of results and certificates from one Member State in other Member States (i.e. 'mutual recognition'). Although this is now recognised in principle across the Union, there is some mistrust of mutual recognition by many Member States and in order to promote the recognition and acceptance of other Member States' results, approved laboratories will of necessity have to conform to agreed standards of competency. The standards that have now been developed are described in the following section of this book.
Manufacturers wishing to sell their products in the EU experience problems due to the need to meet different national testing and certification requirements. In the run-up to the Single Market, the European Organisation for Testing and Certification was set up specifically to overcome these problems by encouraging the development of mutual recognition agreements. The free circulation of products throughout the EU is a key objective of the Single Market.
To achieve this goal a multiplicity of obstacles to trade will have to be or have been dismantled. In particular, what are referred to as 'technical' barriers to trade (as distinct from physical barriers such as Customs controls or fiscal barriers) have been high on the list of these obstacles. Typically, they result from differences between national tradition and practice in the areas of regulations, standards, testing and certification.
Such barriers fall into two categories: those which result from national legislation and those which are the result of purely commercial activities, i.e. the requirements of private parties, notably individual customers and insurers, that products should meet certain national or industry technical specifications or standards.
Whichever category these technical requirements fall into — the regulated or voluntary areas respectively — the effect of such national differences is that a manufacturer wishing to sell the same product in a number of different national markets in the Union may have to meet a number of different national requirements.
In the field of testing and certification this may mean having to have products re-tested or re-certified every time they cross a national boundary in order to fulfil local commercial or regulatory requirements. This takes time and costs money and so a European policy to overcome trade barriers has been developed. The EU, in co-operation with the countries of the European Free Trade Association, has developed a policy on the testing and certification of products which is intended to overcome these barriers to trade.
The Regulated Area
In the regulated field this is being achieved through a series of directives. Products within a defined (fairly broad) scope which meet set criteria are to be entitled to circulate freely anywhere within the Union. Except where a manufacturer is entitled simply to declare the conformity of his products and chooses to do so, appropriate tests or certification procedures must be carried out by bodies approved and notified to the European Commission.
The advantage of this development is that the authorities in all Member States will be required to accept the findings of bodies notified in other Member States in the same way as they would those of bodies they had notified themselves; there is therefore no need for a manufacturer to have products checked more than once within the Union.
The Voluntary Area
Overcoming barriers in the area covered by EU legislation can only be partially effective so long as there remain national differences with regard to the identifying mark of the test laboratory or certification body which individual customers prefer to see.
A manufacturer's products may be legally entitled to circulate freely throughout the Union, but this will be of little comfort if the realities of the market place are such that the manufacturer cannot, in practice, sell those products without going through onerous re-checking procedures simply because products were tested by this rather than that laboratory or certificated by one rather than another certification body.
The European Commission's proposals were set out in their 1989 'Global Approach' document, and were broadly endorsed by a Resolution of the Union's Council of Ministers adopted in December of that year. Creating a suitable environment within which to encourage the development of mutual recognition agreements between those most nearly concerned or the creation of pan-European certification agreements was seen as the best way to overcome technical barriers in this purely voluntary area. The idea is to build on existing systems and institutions to get them to work together according to European standards.
4 Legislative Requirements
It is essential that customers demand of providers of analytical data that their data meet established quality requirements. Formal quality requirements have now been developed and adopted on an international basis by both the EU and the Codex Alimentarius Commission (CAC); these are described below. Customers will be appreciative of these requirements so it is advisable that the laboratory fully complies with them to ensure that it meets its customer demands.
The European Union
For analytical laboratories in the food sector there are legislative requirements regarding analytical data which have been adopted by the European Union. In particular, methods of analysis have been prescribed by legislation for a number of foodstuffs since the UK acceded to the European Community in 1972. However, the Union now recognises that the competency of a laboratory (i.e. how well it can use a method) is equally as important as the 'quality' of the method used to obtain results. This is best illustrated by consideration of the Council Directive on the Official Control of Foodstuffs (OCF) which was adopted by the Community in June, 1989.
In Article 13 it is stated:
'In order to ensure that the application of this Directive is uniform throughout the Member States, the Commission shall, within one year of its adoption, make a report to the European Parliament and to the Council on the possibility of establishing Community quality standards for all laboratories involved in inspection and sampling under this Directive.'
Following that the Commission, in September 1990, produced a Report which recommended establishing Community quality standards for all laboratories involved in inspections and sampling under the OCF Directive. Proposals on this have now been adopted by the Community in the Directive on Additional Measures Concerning the Food Control of Foodstuffs (AMFC).
The relevant Articles are:
Article 3, which states:
'1. Member States shall take all measures necessary to ensure that the laboratories referred to in Article 7 of Directive 89/397/EEC comply with the general criteria for the operation of testing laboratories laid down in European standard EN 45001 supplemented by Standard Operating Procedures and the random audit of their compliance by quality assurance personnel, in accordance with the OECD principles Nos. 2 and 7 of good laboratory practice as set out in Section II of Annex 2 of the Decision of the Council of the OECD of 12 Mar 1981 concerning the mutual acceptance of data in the assessment of chemicals.
2. In assessing the laboratories referred to in Article 7 of Directive 89/397/ EEC Member States shall:
(a) apply the criteria laid down in European standard EN 45002; and
(b) require the use of proficiency testing schemes as far as appropriate. Laboratories meeting the assessment criteria shall be presumed to fulfil the criteria referred to in paragraph 1.
Laboratories which do not meet the assessment criteria shall not be considered as laboratories referred to in Article 7 of the said Directive.
3. Member States shall designate bodies responsible for the assessment of laboratories as referred to in Article 7 of Directive 89/397/EEC. These bodies shall comply with the general criteria for laboratory accreditation bodies laid down in European Standard EN 45003.
4. The accreditation and assessment of testing laboratories referred to in this article may relate to individual tests or groups of tests. Any appropriate deviation in the way in which the standards referred to in paragraphs 1, 2 and 3 are applied shall be adopted in accordance with the procedure laid down in Article 8.'
and Article 4, which states:
'Member States shall ensure that the validation of methods of analysis used within the context of official control of foodstuffs by the laboratories referred to in Article 7 of Directive 89/397/EEC comply whenever possible with the provisions of paragraphs 1 and 2 of the Annex to Council Directive 85/591/ EEC of 23 December 1985 concerning the introduction of Community methods of sampling and analysis for the monitoring of foodstuffs intended for human consumption.'
As a result of the adoption of the above directives, legislation is now in place to ensure that there is confidence not only in national laboratories but also those of the other Member States, thus facilitating the so-called 'mutual recognition' aspects which were described above.
The effect of the AMFC Directive is that organisations must consider the following aspects within the laboratory:
• the organisation of the laboratory,
• how well the laboratory actually carries out analyses, and
• the methods of analysis used in the laboratory.
All these aspects are inter-related, but in simple terms may be thought of as:
• becoming accredited to an internationally recognised standard; such accreditation is aided by the use of internal quality control procedures,
• participating in proficiency schemes, and
• using validated methods.
In addition it is important that there is 'co-operation with customers' as this is also required by virtue of the EN 45001 Standard at paragraph 6, and will be emphasised even more in future revised versions of EN 45001 and ISO/IEC Guide 25.
Although the legislative requirements apply only to food control laboratories, the effect of their adoption is that other food laboratories will be advised to achieve the same standard in order for their results to be recognised as equivalent and accepted for 'due diligence' purposes.
The AMFC Directive requires that food control laboratories should be accredited to the EN 45000 series of Standards as supplemented by some of the OECD GLP principles. In the UK, Government Departments will nominate the United Kingdom Accreditation Service (UKAS) to carry out the accreditation of official food control laboratories for all the aspects prescribed in the Directive. However, as the accreditation agency will also be required to comply with the EN 45003 Standard and to carry out assessments in accordance with the EN 45002 Standard, all accreditation agencies that are members of the European Co-operation for Accreditation of Laboratories (EAL) may be asked to carry out the accreditation of a food control laboratory within the UK. Similar procedures will be followed in the other Member States, all having or developing equivalent organisations to UKAS. Details of the UK draft requirements for food control laboratories are described later in this Chapter.
Requirements of the Codex Alimentarius Commission: Guidelines for the Assessment of the Competence of Testing Laboratories Involved in the Import and Export Control of Food
The requirements of the Codex Alimentarius Commission (CAC) are becoming of increasing importance because of the acceptance of Codex Standards in the World Trade Organisation agreements. They may be regarded as being semi-legal in status. Thus, on a world-wide level, the establishment of the World Trade Organisation (WTO) and the formal acceptance of the Agreements on the Application of Sanitary and Phytosanitary Measures (SPS Agreement) and Technical Barriers to Trade (TBT Agreement) has dramatically increased the status of Codex as a body. As a result, Codex Standards are now seen as de facto international standards and are increasingly being adopted by reference into the food law of both developed and developing countries. In spite of the increased status of Codex Standards, funding constraints within the United Nations Organisation and associated agencies such as FAO and UNDP mean that the capacity of such agencies to support initiatives that may assist developing countries to implement Codex Standards is limited. It should also be noted that international trade in all commodities, including meat and meat products, is increasingly occurring under country-to-country certification agreements.
Because of the status of the CAC described above, the work that it has carried out in the area of laboratory quality assurance must be carefully considered. One of the CAC Committees, the Codex Committee on Methods of Analysis and Sampling (CCMAS), has developed criteria for assessing the competence of testing laboratories involved in the official import and export control of foods. These were recommended by the Committee at its 21st Session in March 1997 and adopted by the CAC at its 22nd Session in June 1997; they mirror the EU recommendations for laboratory quality standards and methods of analysis.
The guidelines provide a framework for the implementation of quality assurance measures to ensure the competence of testing laboratories involved in the import and export control of foods. They are intended to assist countries in their fair trade in foodstuffs and to protect consumers.
The criteria for laboratories involved in the import and export control of foods, now adopted by the CAC, are:
