Quality Assurance
Strict Quality Control System
ISO 13485 Batch Release
ISO13485 Certified • FDA Registered • CE Approved
Multi-stage Inspection • Medical-Grade Standards • OEM/ODM Assurance
QC System
Quality Control Overview
Multi-stage QC from incoming IQC through in-process SPC and final AQL release — lot COAs and batch travelers under ISO 13485. Biocompatibility evidence via testing lab.
- • IQC quarantine before press or kitting release
- • In-process golden samples and SPC triggers
- • Final AQL with lot-linked COA dispatch
- • 100% monitoring on critical rim and volume dims
- • Material change control tied to re-validation
Supplier Gate
Incoming Material Inspection
Quarantine release
All LSR, pigments, films, and packaging stay in IQC quarantine until lot COA, viscosity, and mix-ratio checks pass.
Silicone acceptance
Approved-supplier list, A/B ratio verification, pigment delta-E vs master, and barcode lot ID at quarantine exit.
Packaging IQC
Carton grammage, pouch peel-strength, print registration vs signed artwork, and fiber-content checks on pouches.
Audit traceability
Client-nominated materials complete 50-shot trials before approval; IQC records indexed per project for vendor audits.
Line Discipline
In-Process Quality Control
First-article hold
Mold, silicone, or pigment changes reset to 100% screening on the first ten shots before steady-state release.
Patrol & golden samples
45–60 min routes compare live parts to boundary samples — rim OD, wall thickness, stem flash, disc notch burr.
SPC & press holds
Control charts on critical dims; Western Electric violations trigger red hold tags and quarantine totes until disposition.
Disc escalation
Bowl-roundness gauges, 2-hour leak spots, and notch magnification every patrol — stricter than cup-line intervals.
Outbound Authority
Final Product Inspection
Cosmetic boundary
Lit booths and limit samples for flow lines, emboss clarity, color — backlight on translucent SKUs.
Dimensional & volume
CMM on AQL samples; gravimetric fill ±3 ml on cups; profile gauges on disc bowl depth.
Functional bench
Disc seal-leak cycles, cup stem pull tests, rim flex on stemless models, Shore A per batch.
Packaging & barcode
EAN/UPC Class C+, pouch seals, bilingual panels vs artwork, master-carton count reconciliation.
CoC release
Pass lots get certificate of conformance; fail lots segregated — launch SKUs may run 100% OQC.
Upstream Thinking
Defect Prevention System
Poka-yoke fixtures
Keyed mold plates, pigment tags on route cards, barcode SKU interlocks, trim depth stops.
Defect analytics
Standard codes (RIM-SHORT, STEM-FLASH, DISC-LEAK); weekly Pareto with production and tooling owners.
CAPA & andon
8D on critical events; complaints traced to batch in one day; andon alerts when hourly defect limits breach.
Operator certification
Skill matrices for gowning, golden-sample comparison, defect coding — re-training after human-factor CAPAs.
External Proof
Compliance & Third-Party Testing
ISO 13485 backbone
Annual surveillance; controlled route cards, AQL plans, CoCs — aligned with ISO 13485 and FDA/EU registrations.
Independent lab panels
ISO 10993 biocompatibility, VOC, aging tests — retest on pigment or supplier change. Detail: testing lab.
Retailer audit dossiers
IQC plans, CAPA samples, calibration certs, and 30-minute lot-to-COA traceability drills for vendor gates.
Market extensions
UKCA, Prop 65, and retailer checklists coordinated — submittal samples from production batch travelers.
Menstrual Cup Quality Control FAQ
What QC stages apply to OEM menstrual cups?
Incoming material inspection, in-process dimensional checks, functional bench tests, final AQL inspection, and batch COA release — aligned with ISO 13485.
Do you provide Certificates of Analysis per lot?
Yes — lot-linked COAs with material lot numbers, inspection results, and release signatures for marketplace and pharmacy vendor gates.
What AQL level do you use for final inspection?
Default ISO 2859-1 sampling unless your buyer specifies otherwise. Critical dimensions (rim, volume) use 100% in-process monitoring.
How does QC connect to biocompatibility testing?
Material change control triggers re-validation. Full biocompatibility evidence via testing lab and SGS reports.
Related Manufacturing & OEM Resources
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