Corrective Action

1. Instruments failing QC are deactivated

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

and the Instrument disabled

Bika does not allow any further routine results capturing by this instrument until it has been recalibrated

All routine Analyses included on the same Worksheet should 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 will be 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 capturing valid results for it. Note: It is recommended to retract the Out-of-Range QC result and submit a valid new result, using the standard Bika re-testing workflow

Regardless of which route is taken, all steps are logged, traceable, and open to regulatory auditors

3. Re-testing

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