Sigma metric & QC strategy planner template
A qc sheet in the Internal Quality Control procedure (PR23), mapped to ISO 15189:2022 clause 7.3.7.2. Fill it in whenever the task occurs. Used by the laboratory team.
Qc sheetISO 15189 · 7.3.7.2As needed
Calculated automaticallyRed = outside limits
Your LaboratorySigma metric & QC strategy planner | YL-LAB-FRM-23-T02 v1.0
Record: Sigma metric & QC strategy planner — October 2026
Sigma = (TEa % − |bias %|) ÷ CV %. TEa = allowable total error from your chosen performance specification (state the source). Use the suggested QC rules as a starting point and confirm with your QC procedure (PR23).
| No. | Analyte | IQC level | TEa % | Bias % | CV % | Sigma | Performance | Suggested QC approach |
|---|---|---|---|---|---|---|---|---|
| 1 | Glucose | 93.60 | 92.50 | 93.10 | 0.0 | Poor | Improve the method; maximum QC | |
| 2 | Creatinine | 97.60 | 87.50 | 87.70 | 0.1 | Poor | Improve the method; maximum QC | |
| 3 | ALT | 92.10 | 86.80 | 92 | 0.1 | Poor | Improve the method; maximum QC | |
| 4 | Haemoglobin | 95.10 | 93.50 | 86.90 | 0.0 | Poor | Improve the method; maximum QC | |
| 5 | Potassium | 96.60 | 89.30 | 96.10 | 0.1 | Poor | Improve the method; maximum QC | |
| 6 | Glucose | 92.90 | 86.50 | 91.70 | 0.1 | Poor | Improve the method; maximum QC | |
| 7 | Creatinine | 87.40 | 91.80 | 91.30 | -0.0 | Poor | Improve the method; maximum QC | |
| 8 | ALT | 97.50 | 87.90 | 89.80 | 0.1 | Poor | Improve the method; maximum QC |
Sign-off
| Role | Name | Signature | Date |
|---|---|---|---|
| Completed by | |||
| Reviewed by |
Shaded cells are calculated automatically. Values in red are outside their limits. † marks a corrected value (see Corrections).
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What it records
- Analyte
- IQC level
- TEa %
- Bias %
- CV %
- Sigma
- Performance
- Suggested QC approach
Instructions on the form
- Sigma = (TEa % − |bias %|) ÷ CV %. TEa = allowable total error from your chosen performance specification (state the source). Use the suggested QC rules as a starting point and confirm with your QC procedure (PR23).
Sign-off
- Completed by
- Reviewed by
Related templates
- IQC Frequency Determination Form (PR23-F01)
- In-house IQC Preparation Log (PR23-F02)
- IQC Statistical Tool — Levey-jennings Chart Setup (PR23-F03)
- IQC Daily Log (PR23-F04)
- CV Calculator — Alternative IQC Method (PR23-F05)
- Levey-Jennings chart & Westgard multirule monitor (PR23-T01)
- Guide: Levey-Jennings charts and Westgard rules
- Guide: ISO 15189 documentation checklist
Clause references are to ISO 15189:2022; check them against your licensed copy of the standard.