Generating Data of Known and Documented Quality – What Does That Really Mean?
Oral Presentation
Prepared by R. Burrows
TestAmerica, 4955 Yarrow St. , Arvada , CO, 80002, United States
Contact Information: richard.burrows@testamericainc.com; 303-736-0145
ABSTRACT
The mission of TNI (The NELAC Institute) is to “foster the generation of environmental data of known and documented quality…”
How should TNI achieve that goal? One vision is that TNI accreditation should ensure that laboratories are effectively following the requirements of the analytical methods and documenting that they have done so. In this view, it is the analytical methods themselves that define minimum requirements.
Another perspective is that TNI can, should--and indeed must—do more. The driver for this alternative view is that there are cases where the specifications of the methods are inadequate to ensure that data of known and documented quality is generated. In these cases, TNI requirements must supplement method requirements to the extent necessary to provide confidence in the data.
In the several years since the completion of the 2009 standard, the Chemistry Expert committee has followed the second approach, which is reflected by language about to be adopted into the 2015/2016 standard, especially on the topics of detection, quantitation and calibration.
This presentation will examine why these changes were felt to be necessary and indeed compelling, the benefits they are expected to bring, and what remains to be done in future standards to actually achieve the goal of “known and documented data quality”.
Oral Presentation
Prepared by R. Burrows
TestAmerica, 4955 Yarrow St. , Arvada , CO, 80002, United States
Contact Information: richard.burrows@testamericainc.com; 303-736-0145
ABSTRACT
The mission of TNI (The NELAC Institute) is to “foster the generation of environmental data of known and documented quality…”
How should TNI achieve that goal? One vision is that TNI accreditation should ensure that laboratories are effectively following the requirements of the analytical methods and documenting that they have done so. In this view, it is the analytical methods themselves that define minimum requirements.
Another perspective is that TNI can, should--and indeed must—do more. The driver for this alternative view is that there are cases where the specifications of the methods are inadequate to ensure that data of known and documented quality is generated. In these cases, TNI requirements must supplement method requirements to the extent necessary to provide confidence in the data.
In the several years since the completion of the 2009 standard, the Chemistry Expert committee has followed the second approach, which is reflected by language about to be adopted into the 2015/2016 standard, especially on the topics of detection, quantitation and calibration.
This presentation will examine why these changes were felt to be necessary and indeed compelling, the benefits they are expected to bring, and what remains to be done in future standards to actually achieve the goal of “known and documented data quality”.
