L5

LABORATORY MANAGEMENT &
QUALITY ASSURANCE COURSE

MC509
INSTRUCTOR
DR. ASMAA HAMOUDA
ENVIRONMENTAL SCIENCES AND INDUSTRIAL
DEVELOPMENT DEPARTMENT
2020
Process Control and Quality Control
Chapter 3
Dr. Asmaa Hamouda

content
• Process Control
• Quality Control
• QC Methods
• Elements of QC Program
• Process control for quantitative tests
Process Control
Process control is an essential element of the
quality management system, and refers to
control of the activities employed in the
handling of samples and examination
processes in order to ensure accurate and
reliable testing.
Goal of Quality Control
The goal of QC is to detect, evaluate, and correct

errors due to test system failure,
environmental conditions or operator
performance, before patient
results are reported.
Quality Control
• QC is the part of quality management focused

on fulfilling quality requirements (ISO 9000).
• it is examining “control” materials of known
substances along with patient samples to
monitor the accuracy and precision of the
complete analytic process.
• QC is required for accreditation purposes.
3.2 QC for varying methods
Quality control processes vary, depending on

the laboratory examinations use methods that
produce:
• quantitative,
• qualitative or
• semiquantitative results.
Quantitative examinations
• measure 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. For example, the result of a
blood glucose test might be reported as 5
mg/dL.
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”.
• Examples of qualitative examinations include
microscopic examinations, serologic procedures for
presence or absence of antigens and antibodies, and
many microbiological procedures.
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
amount”, “moderate amount”, or “1+, 2+, or 3+”.
• Examples are urine dipsticks, tablet tests for ketones and
some serologic agglutination procedures. In the case of
other serologic testing, the result is often expressed as a
titre —again involving a number but providing an
estimate, rather than an exact amount of the quantity
present
URINE DIPSTICKS
3.3 Elements of a QC programme
• establishing written policies and procedures,
including corrective actions
• assign responsibility for monitoring and
reviewing
• training all laboratory staff
• ensuring complete documentation
• reviewing quality control data
3.3 Elements of a QC programme
• select good QC material
• establish control ranges for the selected material
• develop graphs to plot control values
• establish a system for monitoring control values
• take immediate corrective action if needed
• maintain records of QC results and any corrective
actions taken.
3.4 Process control for quantitative
tests
Differentiating controls and calibrators materials
control materials
• Controls are substances that contain an
established amount of the substance being
tested—the analyte.
• Controls are tested at the same time and in the
same way as patient samples.
• The purpose of the control is to validate the
reliability of the test system and evaluate the
operator’s performance and environmental
conditions that might impact results.
Differentiating controls and
calibrators
• Calibrators are solutions with a specified
defined concentration that are used to set or
calibrate an instrument, kit, or system before
testing is begun.
• Calibrators are often provided by the
manufacturer of an instrument.
• Calibrators are sometimes called standards,
but the term calibrator is preferred.
Characteristics of control materials
• Controls must be appropriate for the targeted
diagnostic test—the substance being measured in
the test must be present in the control in a
measurable form.
• The amount of the analyte present in the controls
should be close to the medical decision points of
the test; this means that controls should check
both low values and high values.
• Controls should have the same matrix as patient
samples; this usually means that the controls are
serum based, but they may also be based on
plasma, urine or other materials.
Types and sources of control material
• Control materials are available in a variety of
forms. They may be frozen, freeze-dried or
chemically preserved.
• Control materials may be purchased, obtained
from a central or reference laboratory,
• Purchased controls may be either assayed or
unassayed.
Types and sources of control material
• Controls are usually available in "high",
"normal" and "low" ranges.
Establishing the value range for the
control material
variability
• QC materials are run to quantify the variability and
establish a normal range, and to decrease the risk of
error.
• The variability of repeated measurements will be
distributed around a central point or location. This
characteristic of repeated measurements is known as
central tendency.
• The three measures of central tendency are:
– Mode—the number that occurs most frequently.
– Median—the central point of the values when they are
arranged in numerical sequence.
– Mean—the arithmetic average of results.

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LABORATORY MANAGEMENT &

QUALITY ASSURANCE COURSE

Dr. Asmaa Hamouda

The goal of QC is to detect, evaluate, and correct

• QC is the part of quality management focused

Quality control processes vary, depending on

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