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...