First analytical instruments qualified
The first analytical instruments at the Tandalja laboratory have been installed and qualified, establishing the principle that no result is generated on equipment whose performance has not been demonstrated.
Qualification proceeds in the familiar three stages. Installation qualification confirms the instrument arrived as specified and was installed under the right conditions. Operational qualification demonstrates it performs across its working range. Performance qualification shows it does so with the site's own methods, analysts and samples — which is the only stage that proves anything about the results the laboratory will actually issue.
“An unqualified instrument does not produce a doubtful result. It produces no result at all.”
High-performance liquid chromatography, ultraviolet spectrophotometry and analytical balances form the first tranche. Balances are calibrated with traceable weights and checked daily at the working range rather than only at annual calibration, because a balance that drifts between calibrations invalidates every weighing made in between.
Each instrument carries a logbook recording use, calibration, maintenance and any fault, so that a result can always be traced back to the state of the instrument on the day it was produced.
Key facts
- Stages
- Installation, operational and performance qualification
- First tranche
- HPLC, UV spectrophotometry, analytical balances
- Balances
- Traceable weights; daily checks at working range
- Traceability
- Instrument logbook per unit, retained with records