Thermo Scientific Phadia 100, User Manual

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Phadia 100 - User Manual Quality Assurance
12-3501-20/12 Page 8.3
8
Quality Assurance
The American Society for Quality Control defines quality assurance as “all those
planned or systematic actions necessary to provide adequate confidence that a
product or service will satisfy given needs”. See Glossary and tables for
statistical quality control. Milwaukee, WI: American Society for Quality
Control, 1983.
Quality assurance of an in vitro allergy, asthma and autoimmunity test
procedure involves the following four steps:
1. Documentation and implementation of routines regarding:
• Sample handling (type, collection, identity, transportation,
storage, handling)
• Calibration and maintenance of equipment (instruments, pipettes)
• Reagents (ordering, transportation, storage, handling)
• Reporting of results
2. Training and confirmation of operators
The laboratory staff has to go through a training program before a new
method can be used for routine testing. The skill of an operator can be
monitored by precision experiments using the same design as in a
manufacturer's Directions for Use. If the coefficients of variation within and
between runs are of the same magnitude as in the Directions for Use, the
operator's skill is considered acceptable.
3. Control charts (day-to-day precision control)
The control samples are assayed in each run and the results are plotted
against run number (or time). Such a plot is generally called a run chart.
4. External quality assessment
Participation in external quality assessment programs is a prerequisite for
obtaining information about accuracy. The same samples are assayed by,
preferably, all laboratories using the same method.
For steps 1 and 2, Phadia AB can help and advise laboratories to ensure the
best performance. For steps 3 and 4, Phadia AB has developed special
products and procedures for the laboratories.