Quality Inspection Standard¶
Version: v1.0
1. Purpose¶
Define quality criteria & inspection regimes for glucose test strips from in-process to finished product.
2. Scope¶
Applies to incoming materials (L1/L2/L3), enzymatic stage, post-lamination, finished strips, and packaged vials.
3. Inspection Levels¶
| Level | Description | Focus |
|---|---|---|
| Incoming | Raw material incoming | Dimensions, coating, adhesive activation |
| In-Process | Process control | Enzyme volume, lamination alignment, defect removal |
| Intermediate | Semi-finished product | Row integrity, slitting quality |
| Final QC | Finished product | Electrochemical response, appearance, count |
| Release | Release approval | CoA sign-off, labeling correctness |
4. Sampling Plans¶
Sampling plans to be defined based on future requirements. Refer to ISO 2859-1 or ANSI/ASQ Z1.4 as reference when defining AQL.
5. Critical Quality Attributes (CQA)¶
| Attribute | Stage | Requirement | Test Method | Classification |
|---|---|---|---|---|
| Electrode continuity | L1 | 100% functional lines | Electrical probe | Critical |
| Enzyme volume | Line 1 | 3.0 µL ±2% | Gravimetric or imaging | Critical |
| Enzyme drying | Line 1 | 50°C 30 min complete | Oven chart | Major |
| Bubble absence | Line 1 | 0 bubbles active area | Vision | Major |
| Lamination alignment | Line 2 | ±0.1 mm | Optical measure | Major |
| Defect marking rate | Line 2 | ≥99% mapped defects marked | DB reconciliation | Major |
| Row dimension | Line 2 | 30.0 mm ±0.1 mm | Gauge | Major |
| Strip width | Line 3 | 6.0 mm ±0.1 mm | Gauge | Major |
| Physical damage | Line 3 | 0 cracks in sample | Visual | Major |
| Count per vial | Line 3 | 25 or 50 accurate | Scale (weight check) | Critical |
| Cap seal | Line 3 | Secure press-fit | Visual / pull test | Major |
| Label correctness | Line 4 | Lot/date/code/variation matches DB | Verification | Critical |
| Box weight | Line 4 | Within defined range | Scale | Critical |
6. Defect Classification¶
| Class | Examples | Action |
|---|---|---|
| Critical | Wrong enzyme volume, wrong count, electrochem failure | Lot hold, CAPA |
| Major | Alignment exceed tolerance, bubble presence | Rework/segregate |
| Minor | Cosmetic ink blemish not affecting function | Document, continue |
7. Environmental Controls¶
- Humidity: 20% RH maintained; deviation >±3% for >30 min triggers review.
- Temperature: 18–25°C; log hourly.
- Cleanliness: Weekly particulate test summary.
8. Data Integrity¶
Electronic records: Vision DB, potentiostat output, environmental logs. Ensure backup daily; access controlled.
9. Non-Conformance & CAPA¶
- NCR raised with unique ID.
- Root cause analysis (5 Whys / Fishbone) for repeated issues.
- CAPA effectiveness review after closure.
10. Records¶
- Incoming Inspection Log
- In-Process Check Sheets
- Final QC Report
- Release CoA
11. Change Control¶
Any spec adjustment requires risk assessment & QA approval.
Revision History: v1.0 Initial release.