Instrument Qualification, Calibration and Maintenance

Obviously, only trained and qualified analysts should be allowed to operate the mass spectrometer. However, in addition to the practical considerations around this topic, an up-to-date record of the qualifications of each analyst should be maintained in the laboratory s facility records, which can be cited as verification that the analyst who performed the analyses in support of the generation of data used to support validation and sample analysis was indeed qualified to do so. 

A list of common terms and definitions that are used with respect to instrument qualification, cahbration and maintenance is provided below. More details are provided in cited sections or later in this section. 

Calibration An operational check that generally involves the use of traceable standard materials or test instruments. In the present context this term apphes to both calibration of a particular apparatus, e.g. an analytical balance (Section 2.3.1) or the mjz scale of a mass spectrometer (Sections 6.4.1 and 9.5.1b), and to calibration of the response vs analyte concentration (or amount) for the analytical instrument (e.g. GC/MS or LC/MS) or alternatively for the entire analytical method (Sections 2.6 and 8.5). 

Equipment (also referred to as instrument or system) Analytical measurement or processing hardware including firmware (Section 6.1). In some cases, a reference to equipment may actually refer to an integrated system that is comprised of two or more instruments. In a computerized system the equipment may be controlled by the computer system (instrument work station). The instrument work station may also collect measurement data from the equipment and be included as part of the overall system definition. 

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