Results of the second inventory on quality assurance/quality control (QA/QC) and good laboratory practice (GLP) for European Union National Reference Laboratories for residue analyses†‡

Abstract

In February 1996 the “Second inventory on QA/QC and GLP for EU-NRLs” was submitted to all European Union National Reference Laboratories (EU-NRLs) for residue analyses. This second inventory was a follow up on the “Inventory on QA/QC” (1993) which was used for the organisation of the first workshop on “GLP for EC-NRLs”. In February 1997 a response on the second inventory of 100% was achieved. From the completed inventories it became evident that almost all EU-NRLs for residue analyses now have a described quality program based on an international standard. However only 33% of the EU-NRLs are officially accredited, certified or in compliance with good laboratory practice (GLP) principles. Most of the accredited EU-NRLs have a quality program based on the European Standard EN45001. Seven of the EU-NRLs still do not have a described quality program or have not appointed a quality officer and for 12 of the EU-NRLs the independence of the QA officer is not formally arranged. Only about 50% of the EU-NRLs have a standard operating protocol (SOP) to handle complaints. Almost all of the EU-NRLs have SOPs available and a system to control them. In comparison with the results of the first inventory it is evident that most of the EU-NRLs have made considerable progress in the implementation of quality systems. However it is also evident that a substantial number of EU-NRLs still lack some critical QA facilities. The new deadline for the full implementation of all relevant QA facilities is January 2002.