PROCESS CONTROL – INRODUCTION TO QUALITY
CONTROL
Process control refers to control of the activities employed in the handling of samples and
examination processes in order to ensure accurate and reliable testing.
Quality Control monitors activities related to the examination (analytical) phase of testing. The
goal of the QC is to detect, evaluate, and correct errors due to test system failure,
environmental conditions or operator performance, before patient results are reported.
2 TYPES OF QUALITY CONTROL
1. Internal Quality Control
Electronic, internal and procedural controls contained within the test
system that ensures the reliability. Allows identification of analytical errors
within a week cycle. Detects changes in performance between the
present operation and stable operation.
2. External Quality Control
Commercial controls used to verify accuracy and reliability of patient test
results. It is important in maintaining long term accuracy of analytical
methods. Involves proficiency testing programs.
Quality Control for varying methods
Quantitative examinations – measures the quantity of an analyte present in the sample, and
measurements need to be accurate and precise. The measurement produces a numeric value
as an end-point expressed in a particular unit of measurement.
Qualitative examinations - are those that measure the presence or absence of a substance or
evaluate cellular characteristics such as morphology. The results are not expressed in
numerical terms, but in qualitative terms such as “positive” or “negative”, “reactive” or
“nonreactive”, “normal” or “abnormal” and “growth” or “no growth”
Semiquantitative examinations – are similar to qualitative examinations, in that the results are
not expressed in quantitative terms. The difference is that results of these tests are expressed
as an estimate of how much of the measured substance is present. Results might be expressed
in terms such as “ trace” or 1+,2+ or 3+