ORA-LAB.5.9: Sections Included in This Document and Change History
ORA-LAB.5.9: Sections Included in This Document and Change History
6
ORA LABORATORY PROCEDURE ORA-LAB.5.9
Food and Drug Administration Page 1 of 12
Effective Date:
ASSURING THE QUALITY OF TEST RESULTS 10-01-03
Revised: 01-22-13
4.
Background None
When properly executed, quality control samples can monitor the various
aspects of data quality on a routine basis. In instances where performance
falls outside acceptable limits, the data produced can be questioned and,
after investigation, a determination made as to its validity. With
professional experience and a common sense approach quality control is
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Effective Date:
ASSURING THE QUALITY OF TEST RESULTS 10-01-03
Revised: 01-22-13
the principal recourse available for ensuring that only quality data is
released. The dual foundations of the laboratory quality control program is
its internal quality control, composed of day-to-day and sample-set to
sample-set monitoring of analytical performance, and its external QC,
based on the laboratory’s performance in proficiency testing programs.
The QC data generated is recorded in such a manner to detect trends.
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Effective Date:
ASSURING THE QUALITY OF TEST RESULTS 10-01-03
Revised: 01-22-13
Effective Date:
ASSURING THE QUALITY OF TEST RESULTS 10-01-03
Revised: 01-22-13
There are other QC procedures that may be occasionally used. These are:
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Effective Date:
ASSURING THE QUALITY OF TEST RESULTS 10-01-03
Revised: 01-22-13
which are found to be violative. The original sample results are verified
by using an alternative method or by rechecking results by the same
method. A violative chemistry result may be verified by a second
instrument, another method, a second analyst or repeated by the same
analyst. A violative microbiology result by a rapid screening method is
verified by a culture method.
All worksheets are submitted to the supervisor or designee for review. The
QC range of each quality control data is evaluated for acceptability. Data
that fall inside established control limits are judged to be acceptable, while
data lying outside of the control interval are considered suspect. Control
limits established by the laboratory are not be exceeded except as resolved
under a documented corrective action process. This planned action
includes the checking of results for calculation or transcription errors,
preparation or use of new standards, recalibration of instrument, reanalysis
of all samples with new controls or reagents, use of alternate system,
repeating analysis.
Effective Date:
ASSURING THE QUALITY OF TEST RESULTS 10-01-03
Revised: 01-22-13
Effective Date:
ASSURING THE QUALITY OF TEST RESULTS 10-01-03
Revised: 01-22-13
X
% Recovery = 100 X
K
where:
X = observed value
K = known value
Xs − Xu
Recovery = 100 X
K
where:
∑ (X X)
2
i−
σ =
N −1
where:
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Effective Date:
ASSURING THE QUALITY OF TEST RESULTS 10-01-03
Revised: 01-22-13
where:
where:
Effective Date:
ASSURING THE QUALITY OF TEST RESULTS 10-01-03
Revised: 01-22-13
# falsepositives
% false positive = X 100
total # knownnegatives
# falsenegatives
% false negative = X 100
total # knownpositives
c. Quality control data outside of the control limits (3SD) rejected due
to assignable cause remain in the permanent records of the
laboratory, for example, on QC charts. However, a datum so
determined to be an outlier will be flagged as such and is excluded
from the data set before statistical calculations are made. Control
limits calculated from data sets containing outliers are not valid.
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Effective Date:
ASSURING THE QUALITY OF TEST RESULTS 10-01-03
Revised: 01-22-13
d. The chart will disclose trends and shifts from assignable causes
which can be corrected. A trend will show a tendency or movement
in a particular direction. If a series of consecutive plottings move
steadily either upward or downward, a trend is indicated. If a series
of consecutive plottings fall either above or below the center line, a
shift is indicated. When a trend or shift is detected, it is annotated as
such on the chart and reviewed to the extent possible to identify if a
significant concern is indicated. If the review indicates a significant
concern, a corrective action is initiated to determine the cause.
Batch - A batch is the basic unit of measure by which the number of quality
control samples needed is determined The analytical batch is those samples,
sample extracts, or sample digestates that are analyzed together with the same
method sequence, the same lots of reagents, and manipulations common to
each sample within the same time period or in continuous sequential time
periods. The extraction batch is those samples extracted or digested using the
same techniques. Samples in each analytical or extraction batch should be of
similar composition.
Effective Date:
ASSURING THE QUALITY OF TEST RESULTS 10-01-03
Revised: 01-22-13
Duplicate samples – Duplicate samples are two separate samples taken from
the same source (i.e. samples in separate containers and analyzed
independently).
Effective Date:
ASSURING THE QUALITY OF TEST RESULTS 10-01-03
Revised: 01-22-13
10.
Attachments None
Document History
Version Status Date Location of Name & Title
No. (I, R, C) Approved Change History Author Approving Official
1.2 R 12/06/06 In Document LMEB LMEB
1.3 R 04/03/07 In Document LMEB LMEB
1.4 R 11/15/07 In Document LMEB LMEB
1.5 R 09/14/10 In Document LMEB LMEB
1.6 R 01-22-13 In Document LMEB LMEB
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