Quality Test Report Template¶
Version: v1.0
Header¶
- Report ID: QTR-YYYYMMDD-XX
- Product: Glucose Test Strips
- Lot: (e.g., STR-20251130-01)
- Vial Count Mode: 25 pcs / 50 pcs
- Date of Test:
- Technician:
- QA Reviewer:
1. Environmental Conditions¶
| Parameter | Target | Actual | Pass (Y/N) |
|---|---|---|---|
| Temperature (°C) | 18–25 | ||
| Humidity (%RH) | 20 ±2 |
2. Sampling Details¶
| Total Vials Lot | Sample Vials | Sampling Method | AQL Reference |
|---|---|---|---|
3. Visual Inspection¶
| Check Item | Criteria | Sample Size | Defects Found | Status |
|---|---|---|---|---|
| Printing clarity | No blur / smear | |||
| Electrode area | Intact, no contamination | |||
| Physical damage | No cracks, bends | |||
| Label correctness | Lot & expiry correct |
4. Dimensional Check¶
| Parameter | Spec | Sample Size | Min | Max | Status |
|---|---|---|---|---|---|
| Length | Define | ||||
| Width | Define | ||||
| Thickness | Define |
5. Enzyme Deposition Verification¶
(If recheck required) | Parameter | Spec | Sample Size | Avg | Status | |-----------|------|-------------|-----|--------| | Volume (µL) | 3.0 ±2% | | | | | Spread diameter (mm) | Define range | | | |
6. Electrochemical Performance¶
| Test Solution (Glucose mg/dL) | Target Current Range (µA) | Measured Avg | SD | Status |
|---|---|---|---|---|
| Level 1 (Low) | ||||
| Level 2 (Mid) | ||||
| Level 3 (High) |
Calibration Curve Reference ID: ____
7. Defect Summary¶
| Defect Code | Count | Description | Action |
|---|---|---|---|
8. Non-Conformances¶
NCR IDs raised (if any): ______________________
9. Conclusion¶
Lot Status: Released / Hold / Reject
QA Reviewer Signature & Date: ___________________
10. Attachments¶
- Vision Analyzer Export
- Potentiostat Raw Data
- Environmental Log Snapshot
Revision History: v1.0 Initial release.