Systematic pre-planned quality assurance may only be attained through using materials and equipment whose performance criteria have been validated
Validation
Method validation relies on the determination of the overall method performance parameters. Individual sources of error or uncertainty are typically investigated, the emphasis being on removing significant effects. The validation of the method would determine the precision which measures the repeatability and standard deviation of measurement. The observed precision of the analytical method is an essential component of the overall uncertainty of measurement combining the individual variances of the measuring processes of the method. The linearity of the analytical procedure over a range of sample ranges needs also to be identified. The linearity response to known standards and samples may be observed directly or indirectly through links to validated measuring devices whose uncertainties of measurement are associated with instrument calibration. To enable laboratories to compare analytical data with any level of confidence, assurance that the same measuring scale or reference points are used is essential. This is achieved by establishing an unbroken chain of comparisons to a primary standard, ideally to a primary SI unit. Traceability is the result of the total analytical procedure and may be established through:
- The use of traceable standards to calibrate measuring equipment
- By comparison of the result of a primary method, i.e. one that has the highest metrological qualities.
- By using pure substance reference materials
- By using a matrix certified reference material
- By using an accepted and qualified procedure
In each of these instances the calibration of measuring equipment must be traceable to appropriate standards. It is essential therefore that that analyst assures that there is traceability through calibration of primary measuring equipment i.e. balances & liquid dispensers and that reference standards have documentation traceable to national standards.
Verification:
MicroLab Technologies technicians offer fully documented and traceable instrument performance verification which supports your laboratories goal in achieving accuracy and precision to satisfy the analytical criteria of your validated procedures.
See also:
ISO 8655