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

A History of Lab Quality Systems

How Quality Systems Evolved


In the beginning

In the Beginning!

There was Nothing!


In 1973

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

Late 70’s

Control Charts Appear


Control charts and underlying qa

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

The 80’s

Contract Lab Program


Clp introduces

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

The 90’s

Garbage In – Garbage Out


The rise of the computer aided black box

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!


Today

Today

More of the 90’s with less money


Money dictates quality

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

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

Quality Systems and the Board’s Quality Management Plan

Begin Session


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