A History of Lab Quality Systems How Quality

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A History of Lab Quality Systems How Quality Systems Evolved A History of Lab Quality Systems How Quality Systems Evolved

In the Beginning! There was Nothing! In the Beginning! There was Nothing!

In 1973 Labs were not required to analyze blanks, duplicates, spikes, or control solutions 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 Late 70’s Control Charts Appear

Control Charts and Underlying QA Requests for labs to run duplicates, spikes, and control 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 The 80’s Contract Lab Program

CLP Introduces Inclusion of quality systems into methods n Calibration checks n The 5% 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 90’s Garbage In – Garbage Out

The Rise of the Computer-Aided Black Box Many methods moved to some form of 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 Today More of the 90’s with less money

Money Dictates Quality In the rush to do more with less, choices tend to 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 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 Quality Systems and the Board’s Quality Management Plan Begin Session




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