Consolidated Product Work Instruction

Version: v1.0

1. Purpose

Provide an operator-friendly consolidated instruction covering key tasks across Lines 1–3 for glucose test strip production.

2. Scope

Frontline production operators cross-trained for multiple stations.

3. Quick Reference Overview

Station	Key Action	Critical Check	Record
Line 1 Dispense	3 µL enzyme per cell	Volume, bubbles	Batch record
Line 1 Dry	50°C 30 min (Auto Enzyme Oven)	Oven temp chart	Batch record
Vision	Scan defects + QR	DB sync	Vision DB
Line 2 Lamination	Align L3 @120°C (pin positioning)	Alignment ±0.1 mm	Lam log
NG Punch	Mark/remove mapped defects	Marking accuracy	Punch report
Row Cut	30 mm rows, segregate (Good/Partial/NG)	Dimension	Cutter log
Line 3 Slit	6mm strips (manual mode for partial rows)	No damage	Slitter counter
Vial Fill	Strips slide into vials 25/50 pcs	Count accuracy	Batch record
Cap	Press-type cap (top press)	Secure seal	Cap log
Weight Check	Scale verification	Count by weight	Scale log
Transfer	Interlock Pass-Through Chamber	Complete	Transfer log
Line 4 Label	Date/code/variation	Label accuracy	Label log
Line 4 Box	Insert vials + manual	Complete	Packing log
Line 4 Weigh	Content check	Weight in range	Weight log
Line 4 Shrink	12-box brick	Seal complete	Shrink log

4. Shift Start Checklist

• PPE worn (gloves, glasses, coat)
• Equipment calibration labels valid
• Enzyme solution lot released
• Environmental logs within limits

5. Core Steps

1. Retrieve released frames (L1/L2) & enzyme lot.
2. Operate dispenser: confirm last 3 cycle volumes.
3. Transfer to oven: verify target temperature stable (50°C).
4. After drying, move to vision: ensure QR printed & data upload success.
5. Lamination with L3: visually confirm pin positioning engaged.
6. Monitor NG punching: cross-check first 5 coordinates (mark defects).
7. Row cutting: verify first row dimension with gauge; segregate Good/Partial/NG rows.
8. Slitting: watch first vial fill for correct orientation; use manual mode for partial-defect rows.
9. Capping: verify press-cap secure after first 10 vials.
10. Weight check: use scale to verify vial count.
11. Transfer: pass through Interlock Chamber to Packing Room.
12. Label: verify lot & date/code vs system.

6. Common Issues & Actions

Issue	Symptom	Action
Under-volume	Light/Small droplet	Recalibrate dispenser; hold frame
Bubble in enzyme	Spot with void	Clean nozzle; review humidity
Lamination shift	Edge offset	Check platform wear; realign pins
Missed NG punch	Defect cell still present	Pause line; resync DB; manual punch
Miscount in vial	Weight out of range	Use scale to verify; recount manually; segregate
High breakage	Cracked strips	Inspect blade; reduce tension
Loose cap	Cap not secure	Check press force; adjust machine

7. Acceptance Quick Table

Parameter	Limit
Enzyme Volume	3.0 µL ±2%
Enzyme Dry	50°C 30 min
Alignment	±0.1 mm
Row Width	30.0 ±0.1 mm
Strip Width	6.0 ±0.1 mm
Vial Count	Exact 25 or 50 (by weight)
Cap Seal	Secure press-fit
Box Weight	Within range

8. Documentation

Complete batch record sections immediately after each station—no end-of-shift backfill.

9. Safety

Keep hands away from hot press & slitter; lockout for blade changes; report any near-miss.

10. End-of-Shift

• Clean surfaces (lint-free + IPA)
• Return unused materials (FIFO)
• Sign off batch record; handover notes for next shift

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Revision History: v1.0 Initial release.