A history of lab quality systems
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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 Control charts did not exist

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A History of Lab Quality Systems

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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

  • 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’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

  • Control Charts developed but abused

  • The concept of control via the quality system

The 80’s

Contract 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’s

Garbage 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



More 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

Begin Session

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