The Role of and the Place of Method Validation in the Quality Assurance and Quality Control (QA/QC) System

Abstract

One of the main developmental trends in chemical analytics is the determination of analytes at ever decreasing detection levels in samples with increasingly complex matrices. This is an extremely difficult and complicated task therefore it poses a great challenge to analytical chemists, and it requires that appropriate attention be paid to the Quality Assurance and Quality Control (QA/QC) of the obtained measurements. In this article QA/QC system is described. Following topics are discussed: (1) measurement uncertainty, (2) traceability of analytical results, (3) reference materials, (4) interlaboratory comparisons and (5) method validation. The problems and challenges during method validation process are presented.

Keywords:

• quality control
• quality assurance
• method validation
• validation parameters
• uncertainty
• traceability
• reference material
• interlaboratory comparison

ACKNOWLEDGMENTS

This study has been financed by Ministry of Sciences and High Education (grant attributed by Department of Scientific Research).

Notes

^a It might be determined.