In-Process Quality Control¶
Quality is not tested into a product at the end — it is controlled at every stage of production. This page documents the four-layer quality-control system Migibio runs on the production line, plus the environmental controls that keep the process stable.
The Four QC Gates¶
| Gate | Stage | What is checked | Action on failure |
|---|---|---|---|
| IQC | Incoming inspection | Raw materials vs. specification | Reject / quarantine lot |
| IPQC | In-process inspection | Coating, conjugation, lamination, cutting | Stop line, correct, re-inspect |
| FQC | Final QC | Finished product vs. release spec | Quarantine, investigate, rework/reject |
| OQC | Outgoing QC | Packaged lot, labeling, documentation | Correct before shipment |
IQC — Incoming Quality Control¶
Before any raw material enters production, it is tested against its specification:
- Antibodies — affinity and lot-consistency verification.
- Fluorescent labels — size uniformity and conjugation efficiency.
- Membranes and pads — capillary speed, pore size, background.
A raw-material lot that fails IQC is quarantined and does not reach the production line.
IPQC — In-Process Quality Control¶
During production, operators and automated checks monitor each critical step:
| Process step | In-process check |
|---|---|
| Membrane coating | Line width, dispense volume, fluorescence intensity |
| Drying | Residual moisture |
| Conjugation | Conjugation ratio, unbound-label removal |
| Lamination | Alignment, dimensional inspection |
| Cutting | Strip width tolerance, edge quality |
| Assembly | Seal integrity, desiccant presence, label accuracy |
FQC — Final Quality Control¶
Every finished lot is tested against the release specification before it can be released:
- Analytical performance (LOD, CV%, linearity) on reference material.
- Appearance and packaging integrity.
- Label and documentation accuracy (IFU, COA).
OQC — Outgoing Quality Control¶
Before shipment, OQC confirms the lot is complete and correctly documented:
- Lot number matches the batch record and COA.
- Quantity, packaging, and shipping labels are correct.
- The IFU insert is present in every kit.
Environmental Monitoring¶
The production environment is monitored continuously because temperature and humidity directly affect membrane and reagent stability:
| Parameter | Control | Why it matters |
|---|---|---|
| Temperature | Controlled range | Reagent and membrane stability |
| Relative humidity | Low, via rotary dehumidification | Prevents hygroscopic degradation |
| Cleanliness | Controlled production area | Reduces contamination risk |
Why Multi-Layer QC Matters¶
A single end-of-line test cannot catch every defect. The four-gate system catches problems where they occur, which is why Migibio lots maintain tight lot-to-lot consistency (see Lot-to-Lot Consistency Report).
FAQ¶
What is the difference between FQC and OQC? FQC verifies the product meets its release specification; OQC verifies the lot is complete, correctly labeled, and documented for shipment.
What happens to a lot that fails FQC? It is quarantined and investigated. It is only released after the root cause is corrected and the lot re-tested — or it is rejected.
For the batch release criteria, see Batch Release & Traceability.
Authored by: Migibio Clinical & Scientific Affairs, Guangzhou Magic Biotech Co., Ltd.
Reviewed by: Migibio R&D Quality Committee
Last updated: 2026-08-14
Disclosure: Migibio (Guangzhou Magic Biotech Co., Ltd.) is the manufacturer of the FIA680/FIA880 analyzers and FICT reagents referenced in this content. See our Editorial & Review Policy.