Biomedical Engineering Reference
In-Depth Information
SOP No. QCS-018.00 Effective date: mm/dd/yyyy
Approved by:
18.5.2.1.2
Sample Consideration
• Was the correct sample tested?
• Is there any evidence of sample contamination?
• Is there any evidence of improper sample appearance, storage, handling, or damage?
18.5.2.1.3
Equipment
• Was the correct equipment used?
• Were the settings correct?
• Is there any indication of equipment malfunction?
• Is the equipment calibration/maintenance current?
18.5.2.1.4
Test Performance
• Was correct test method used?
• Was raw data properly documented?
• Was the analyst trained on the technique?
18.5.2.1.5
Reagents, Standards, and Sample Preparation
• Were correct standards and reagents used?
• Were there any expired reagents, chemicals, or standards?
• Was the test sample homogeneous?
• Were the test solutions correctly prepared?
18.5.2.1.6
Other Error
Additional questions/information pertaining to specific test method, technique, or apparatus should
be recoded in this section by the analyst and the supervisor as part of determining the cause of OOS
test results.
18.5.3
P
reliminary
l
aB
i
nveStigation
c
oncluSion
: (S
ee
f
orm
01)
18.5.3.1
Qc supervisor
1. When the initial investigation demonstrates that the OOS result is attributable to
determi-
nate
(i.e.,
assignable
) analytical identifiable
error
, the supervisor must use the check box
to indicate that an assignable cause has been found.
2. The lab supervisor must then provide a brief description of the cause of the analytical error,
evaluate the possible corrective actions, and collaborate with QA department in imple-
menting them.
3. The supervisor must perform an impact assessment to determine the extent of retesting
required:
a.
Determine if the error has compromised the results of other tests.
b.
Evaluate the need for retest of other materials/products in order to confirm the validity
of their initial results.
4. The supervisor must instruct the original analyst to conduct a retest.
18.5.3.2
Qc analyst
5. The analyst must repeat the test as per the original method, on the initial aliquot from the
original sample.
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