5.4 Corrective Action

If configured, instruments decommission themselves when failing QC

1. Instruments failing QC are deactivated

Please 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

Configuring Instrument disabling after failed QC in Bika and Senaite Open Source LIMS

The OOR result is indicated on the Worksheet

And the Instrument disabled

1.1 NB Uncertain results are quarantined

Bika 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

2. Corrective Action

Recover the disabled Instrument

After 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 results

The 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 Worksheets

Best 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 Bika

To 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 QC

Bika disables the Instrument and quarantines routine results on the same Worksheet that cannot be trusted, discussed in details overleaf

Calibration Certificate expired

When 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, Validation

The 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
See overleaf...
When Instruments failing QC remain available and the compromised routine results in the failed Worksheet amendable, inaccurate results will be verified and published to clients. Very bad practice

Do rest assured managers, that all actions remain traceable and open to audit by regulatory inspectors

The feature remains handy for correcting and testing temperamental instruments, recording all results and graphing them in the LIMS' control charts