5.4 Corrective Action
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1. Instruments failing QC are deactivatedPlease do read Disabling this feature in left hand panel With this feature enabled on the Instrument's configuration pages, it will be taken off-line when the LIMS picks up Out-of-Range, OOR, results imported The OOR result is indicated on the Worksheet
1.1 NB Uncertain results are quarantinedBika and Senaite do not allow any further routine results capturing by this instrument until it has been recalibrated All routine Analyses included on the same Worksheet are quarantined and have to be retested when the Instrument is back online
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2. Corrective ActionRecover the disabled InstrumentAfter the Analyst or maintenance personnel resolved the issue on the Instrument, most often a simple calibration, and it produces In-Range results for Reference Samples, best practice is to import the freshest set of these The Instrument will be back online and the message wrt to its unavailability removed, and it is back for a next routine run The instrument can also be brought back by adding a new Control on the failed worksheet, and capture valid results for it. Note recommended is to retract the Out-of-Range QC result and submit a valid new result, using standard Bika Senaite re-testing workflow Regardless of which route is taken, all steps are logged, traceable and open to regulatory auditors 3. Re-testing Quarantined resultsThe previously Quarantined results are compromised and cannot be verified. Select and Retract the routine Analyses on the Worksheet Then produce a new set of results on the Instrument for the corresponding samples and import the results. All should be in order, providing the Instrument does not fail QC in the same run:) and the user may go ahead and Verify the results
The suspicious Retracted results stay on record but are neither shown or published to the client. |
3.1 Rejecting WorksheetsBest practice is to Reject the Worksheet, and retest all the Samples with new QC samples as per Worksheet Template. This feature has been disabled in some versions of Senaite Instruments disabled by BikaTo ensure only accurate results with high confidence level reach clients, Bika and Senaite embeds GLP and ISO 17025 recommended procedures that are best be left untouched, but could be configured and customised to lab specific SOP Instrument fails QCBika disables the Instrument and quarantines routine results on the same Worksheet that cannot be trusted, discussed in details overleaf Calibration Certificate expiredWhen the LIMS does not find a valid Calibration Certificate for the instrument, it is taken off-line until a fresh certificate has been captured Undergoing Maintenance, ValidationThe Instrument is also taken off-line while undergoing maintenance, and brought back when completed. Ditto Validation NB. Disabling Instrument de-activation. Don't do it |
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