Biomedical Engineering Reference
In-Depth Information
SOP No. QCS-018.00 Effective date: mm/dd/yyyy
Approved by:
Note:
• If the initial aliquot from the original sample is not suficient for retest, a second aliquot
from the original sample is used.
• In the event that the original sample has been consumed during analysis, a second sample
(new sampling) can be used.
• When the original test samples are found to be the cause of OOS results, a new set of
samples must be used for retest.
6. Analyst must record and report the retest results in the laboratory notebook.
18.5.3.3
Qc supervisor
7. If all repeat test values are within the specification:
a. The supervisor must invalidate the initial test results and report the repeat test values
as final.
b. The supervisor must sign off the OOS report and strike out the other parts of the OOS
form (see Form 01).
c. The supervisor must then forward the OOS form to the QC manager, director, and QA
director for approval.
8. If the repeat test values are out of specification (OOS), the supervisor must investigate the
cause of failure according to the preliminary laboratory investigation section.
9. If the preliminary investigation of the OOS test result demonstrates that it is not attribut-
able to indeterminate (i.e., nonassignable or unknown ) error, the supervisor must use the
check box to indicate that a nonassignable cause has been found.
Note: Statistical tests have their own retest processes, following the compendia guidelines. For these
exceptions, failure to meet the criteria of any stage prior to the last stage is not a test failure and does
not require the OOS investigation report.
10. Where the initial aliquot from the original sample (i.e., working test sample) is sufficient,
a repeat test must be performed to confirm initial OOS test results under identical condi-
tion as the initial test.
11. The result of nonassignable preliminary OOS investigation must be reported to the QC
manager and director and QA department immediately.
18.5.4
ooS r eteSt P lan : (S ee f orm 01)
18.5.4.1
Qc manager
1. It is the responsibility of the QC manager to notify the QA department when the prelimi-
nary investigation is inconclusive.
18.5.4.2
Qa specialist
2. The QA department is responsible for reviewing, following up, and approving all investigations
of OOS test results, decision for final disposition of material, and issuance of the final report.
18.5.4.3
Qc manager and Qa
3. The QC manager and QA must lead the investigation from this point onward when the
result of the preliminary investigation is inconclusive.
4. The QC manager and QA must decide on retest plan.
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