Line 4 Work Instruction (Packaging)¶
Version: v1.0
1. Purpose¶
Define standardized packaging flow: labeling, box packing, weight verification, and shrink-wrapping for finished glucose test strip vials.
2. Scope¶
Applies to Packing Room operations for Line 4 equipment and personnel.
3. Equipment¶
- Automatic Vial Transport System
- Automatic Labeling Machine (date, time, code, test liquid report variation)
- Box Packing Machine (auto insert vials + user manual; date & code marking)
- Weighing Machine (content check, reject if below normal)
- Thermo-Shrinking Film Wrapper (12-box brick)
4. Inputs¶
- Capped vials from Line 3 (QC passed)
- Printed labels (lot, date, code, variation data)
- Product boxes & user manuals
- Shrink film rolls
5. Procedure¶
| Step | Description | Detail | Record |
|---|---|---|---|
| 1 | Start transport | Start automatic vial transport system; vials move from Line 3 | Transport log |
| 2 | Labeling | Labeling machine applies label (date, time, code, testing liquid report variation) | Label log |
| 3 | Box packing | Box packing machine inserts vials into boxes, adds user manual | Packing log |
| 4 | Code marking | Box marking with date and code | Packing log |
| 5 | Weight check | Weighing machine checks box contents; reject if weight below normal | Weight log |
| 6 | Non-conformance handling | Rejected boxes segregated for investigation | Reject log |
| 7 | Shrink wrap | Assemble 12 boxes into a brick with thermo-shrinking film | Shrink log |
| 8 | Finished goods storage | Move finished bricks to warehouse staging | Inventory sheet |
6. Acceptance Criteria¶
| Parameter | Requirement |
|---|---|
| Label Accuracy | Correct lot, date, code, variation data |
| Label Adhesion | No peeling, bubbling |
| Box Contents | Vial(s) + user manual present |
| Weight Check | Within defined range (specify) |
| Shrink Seal | Complete seal, no gaps |
7. Defect Codes¶
| Code | Description |
|---|---|
| P1 | Missing label |
| P2 | Label data error |
| P3 | Missing manual |
| P4 | Underweight |
| P5 | Shrink seal incomplete |
8. Records¶
- Line 4 Batch Record
- Label Application Log
- Weight Verification Log
- Reject Log
- Shrink Wrapper Counter
9. Reaction Plan¶
- Label mismatch: Stop labeler; verify print queue; reprint.
- Consecutive underweight rejects: Check vial count from Line 3; inspect vials.
- Shrink incomplete: Adjust temperature/speed; check film tension.
10. Safety¶
- Heat hazard at shrink wrapper; keep hands clear during operation.
Revision History: v1.0 Initial release.