10. QC

Reference Definitions

Reference Sample templates are maintained in Senaite as Reference Definitions. When fresh reference sample batches arrive from suppliers, their records are easily created from these, and saved with its own lot number, expiry date etc.

Creating Reference Samples

Senaite tracks results of control analyses done on reference samples with specified expected. These often have limited shelve life, and expires and new ones are regularly added to the system using Reference Definitions

Users include QC samples as Controls on Worksheets with routine Analyses, and then use their results to consider routine results  for Verification or Retraction/Rejection in context of their accompanying QC results Exclusively on Worksheets, for Reference Samples put through routine SOP

Capturing QC results

When Out-of-Range QC results are captured, they are flagged and depending QC configuration, initiate corrective actions - quarantining affected routine results and taking the Instrument off line until it passes QC again

QC failure workflow

Instrument QC, on the Instrument pages

Control Charts

All QC results are captured against their Sample, Instrument and Analyst records, which can then be accessed from these pages, as well as a QC report, tabling results per Analyte in Basis, Cardinal and Linear interpolations

Reference Sample Expiry Alerts

Order new stock in good time. Email, online alerts and report

Audit logs

Extensive logging of changes and transitions of both transactional Samples and Worksheets, but also configuration objects which are also versioned for database integrity purposes

Reference Sample workflow

Records for perishable Reference Sample are easily created from Templates, Reference Definitions in Bika terminology. Also manually for durable Sample Types
Reference Sample Samples are not available for analysis after they expired. Their status will move on to expired on the expiry date capture when it was created
When the lab disposes or destroy reference Samples, they should Dispose of them in the system too

Type of QC Analysis

Controls

Reference material with known specification included on Worksheets, to 'control' or 'check' the validity of the routine analyses they accompany. Can be any of internally made up stock dilutions, certified external reference material, CRM, spikes, etc.

Blanks

Blanks are treated exactly like the other Reference Samples above, except that their expected results are zero. The differentiation makes it easier to pick them up in lists and look-ups

Duplicates

Duplicates Analyses are done on the same routine Sample, not a CRM, and their results compared. If they differ by more than specified in the Analysis Service's setup, they are high-lighted as out of range too