Fresenius' Journal of

Fresenius J Anal Chem (1990) 337 :218 - 219

@ Springer-Verlag 1990

Quality assurance in the industry B. te Nijenhuis International Bio-Synthetics B. V., P.O. Box t820, NL-2280 DV Rijswijk, The Netherlands

Quality is an all-important factor in the market place today. Companies which fail to deliver what they promise cannot survive on long notice. Total quality management is nowadays an important tool of managing a business. Quality management includes both quality assurance and quality improvement, which are permanent activities in a company. Quality is defined as: "the totality of features and characteristics of a product, a process or service that bear on its ability to satisfy stated and implied needs". Quality assurance is defined as: "all those planned and systematic actions necessary to provide adequate confidence that a product, process or service will satisfy given quality requirements". The most important issue is thus conformance to requirements of the customer. In order to reach that high level of quality it is not good enough anymore to test the properties of the final product at the end of the production process whether it meets the expected values or not. The ultimate goal of a production process today is to convert the incoming raw materials in such a controlled process that the final product cannot be different from the expected product. The system that ensures this controlled process of production of the required goods is the quality system. Important parts of in such a quality system are:

Policy statements

Activity involved

Quality procedures

Purchasing policy Process design Customer requirement

Raw materials supply Production Final product

Testing Process control Final testing Complaint procedure

Sources for this high attention for quality are two-fold. In the field of drugs, food, cosmetics, etc. the government has played an important role in defining good practices. Good practices can be divided into Good Laboratory Practices (GLP) in the research stage and Good Manufacturing Practices (GMP) in production. The USA have taken the lead by FDA, EPA & TOSCA regulations, converted in Europe into the OESO regulations and national regulations and laws.

In other industrial areas, following Japan, the industry has recognised the extreme value of quality in the market and has set themselves rules on a voluntary basis for compliance with widely accepted quality assurance regulations. In this case industry follows the rules set in generally accepted norms like the norms defined in the ISO 9000 series. These international norms have been accepted as EC/ European. They have replaced now own national norms in many countries. The main issues of these norms are: quality awareness, integrity of results, well structured reporting and filing. The ultimate goal of certification to one of these norms is the assurance that the results presented are unambiguous and will be accepted by customers on the basis of trust without additional testing. Besides a proper and well defined operational structure in the company an important task is put aside for the quality control function in the company. To assure that laboratory results will be accepted unanimously the following requirements have to be met 1 :

1. Usage of widely accepted, normalised analytical methods. Harmonisation and standardisation of methods between companies, nationally and internationally, and compliance with organisation for standardisation is almost obligatory. 2. Introduction of a quality system based on one of the national or international norms like ISO 9000 etc. ; certification of the activities in the laboratory by a national laboratory accreditation organisation. 3. Regular calibration of equipment to comply with national or international standards.

4. Use of certified reference materials. 5. Participation in collaborative assays or proficiency testing in order to get an idea of the quality of the own organisation compared to others. In Europe the process of conformity assessment is actively supported by the set-up of a European Organisation for Testing and Certification. To my belief, in order to comply with these developments, the industrial analytical chemist should have at least the following qualifications: 1. Have practical experience in analytical chemical techniques with the aim of the development of problem-solving capabilities; 1 Derived from a lecture given by Dr P. J. H. A. M. van de Leemput on "Quality assurance in chemical laboratories", September 22, 1989

219 2. Have practical education in statistical-mathematical techniques and chemometrics; 3. Be trained in the concepts of quality, quality management, quality assurance and certification and accreditation systems; 4. Be able to compose a quality handbook. It is apparent that these developments have an important influence on the analytical laboratory, its methods, its workers and its management.

Consequences of these statements were discussed in more detail in a second session.

Acknowledgements. The discussions with Dr P. J. H. A. M. van de Leemput and Dr. B. Griepink and with the Dutch Working Group on Quality in Analytical Chemistry have been of significant value for this contribution. Received January 26, 1990