A History of Lab Quality Systems How Quality Systems Evolved
In the Beginning! There was Nothing!
In 1973 Labs were not required to analyze blanks, duplicates, spikes, or control solutions n Control charts did not exist n Many reasons including visual clues, very few sophisticated “black boxes”, most concentrations in the parts per million, and many analysts were degreed chemists. n
Late 70’s Control Charts Appear
Control Charts and Underlying QA Requests for labs to run duplicates, spikes, and control solutions – frequency not well specified but usually one per analytical batch n Control Charts developed but abused n The concept of control via the quality system n
The 80’s Contract Lab Program
CLP Introduces Inclusion of quality systems into methods n Calibration checks n The 5% and 10% frequency n Quality codes n Separation of Quality into Control and Descriptive n FRAUD! n
The 90’s Garbage In – Garbage Out
The Rise of the Computer-Aided Black Box Many methods moved to some form of automated mechanical device aided by a computer n Automation allows analysts freedom but eliminates real-time correction n Reports become so complicated that the ability to assess quality is difficult n SOME MORE FRAUD! n
Today More of the 90’s with less money
Money Dictates Quality In the rush to do more with less, choices tend to impact quality n Sample replication not done if it is necessary to collect a second aliquot as labs charge for the analysis n Spiking a specific sample not done as labs charge for the analysis n Lab clients assume quality if lab certified n
Other Things Influencing Quality NELAC standards n Beginning use of Quality Planning Documents such as Quality Assurance Project Plans (QAPP) n Incorporation of quality requirements into compliance documents n
Quality Systems and the Board’s Quality Management Plan Begin Session
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