Quality Control processes in a Test Laboratory: QA / QC

For now, very few laboratories tests that are able to demonstrate with objective evidence of applying analytical methods backed by consistent quality control criteria.

The quality control of the analytical data is crucial for evaluating the whole analytical process and to provide scientifically and legally defensible data.

Compared to what happened in the past, the quality controls have become more frequent and more specific, in order to evaluate each stage of the analytical process and sampling.

QC Samples (Ex. MB = Method Blank, MS = Matrix Spike, LCS = Control Sample Lab, etc ..) are required by the UNI EN 17025 and can be part of specific Insurance and Quality Control Plans (QAPP) requested by customers .

The use of such samples is often documented with difficulty or with “non-consistent systems” (Ex. MS / Excel folder not integrated with the LIMS to manage the “holding times” or for compiling summary tables of results, raw data and interim control, requested by customers).

The problems that are increasingly faced by laboratories are :

In short, the demonstration of the performance of QC Checks can be made through the organization of a “Data Package” structured :

The solution is the flowchart of the processes to support and their automation realized by a software module integrated with the LIMS, for the management of quality data.

Such software must be flexible and allow to treat all types of samples (not just those where they have to be applied ex. EPA methods), but must also offer the ability to treat in quality also internal controls.

It must also be able to capture data (including those of the control samples) directly from the Laboratory
instruments (Ex. GC, GCMS, GC-HRMS), thus providing customers of the Laboratory to guarantee of not tampering with the data and the utmost transparency.

It is crucial that the software offers a high level of configurability in the controls to be applied to methods, both to adapt over time to changing methods, either to be able to easily introduce new control criteria on existing methods.

Finally, the results must be presented to Customers :

These goals were successfully achieved by the “QA / QC” module of the LIMS “Analisi” which is set mainly on flexibility, proposing :