A History of Lab Quality SystemsHow Quality Systems Evolved

In the Beginning!

There was Nothing!

In 1973 Labs were not required to analyze blanks,

duplicates, spikes, or control solutions Control charts did not exist Many reasons including visual clues, very

few sophisticated “black boxes”, most concentrations in the parts per million, and many analysts were degreed chemists.

Late 70’sControl 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

Control Charts developed but abused The concept of control via the quality

system

The 80’sContract Lab Program

CLP Introduces Inclusion of quality systems into methods Calibration checks The 5% and 10% frequency Quality codes Separation of Quality into Control and

Descriptive FRAUD!

The 90’sGarbage In – Garbage Out

The Rise of the Computer-AidedBlack Box

Many methods moved to some form of automated mechanical device aided by a computer

Automation allows analysts freedom but eliminates real-time correction

Reports become so complicated that the ability to assess quality is difficult

SOME MORE FRAUD!

TodayMore of the 90’s with less money

Money Dictates Quality In the rush to do more with less, choices

tend to impact quality Sample replication not done if it is

necessary to collect a second aliquot as labs charge for the analysis

Spiking a specific sample not done as labs charge for the analysis

Lab clients assume quality if lab certified

Other Things Influencing Quality NELAC standards Beginning use of Quality Planning

Documents such as Quality Assurance Project Plans (QAPP)

Incorporation of quality requirements into compliance documents

Quality Systems and the Board’s Quality Management Plan

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