Custom Silicone Baby Products Manufacturer | OEM/ODM
Quality Assurance Laboratory

Where Safety Meets Precision.

Our in-house laboratory operates under ISO 9001 standards, performing rigorous testing on every batch of silicone baby products. From raw material verification to finished goods inspection, we uphold uncompromising safety for the most delicate end users.

100%

Full Inspection

±0.1mm

Tolerance

ISO9001

Certified SOP

Baby product assurance laboratory
FDA
LFGB
Compliant

01 -- Incoming Quality Control

Raw Material Inspection.

Every batch of silicone, pigment, and auxiliary material undergoes strict verification before entering production. We ensure 100% food-grade compliance from the very first step.

Certificate Verification

Supplier COA, MSDS, RoHS and REACH documents reviewed per lot.

Physical Properties

Hardness, viscosity, color, and odor measured against baseline samples.

Chemical Safety

BPA, phthalate, heavy metal screening on each raw material batch.

Lot Segregation

Approved materials tagged and stored by lot ID with full traceability.

02 -- In-Process Quality Control

First Article & Process Inspection.

Before mass production begins, our quality engineers validate the first article against engineering drawings. Throughout the run, QC personnel with 5+ years experience monitor key parameters at defined checkpoints.

In-process inspection station
01

First Article Approval

Dimensional, visual, and functional sign-off against golden sample and 2D/3D drawings before production releases.

02

Molding Parameter Control

Temperature, pressure, and curing time logged hourly on each of our 64 injection molding machines.

03

Patrol Inspection

Hourly rotational checks on dimension, flash, color, and surface finish by dedicated line QC staff.

04

Post-Processing Checks

Trimming, printing, oil spraying and bonding verified at each secondary operation.

03 -- Outgoing Quality Control

Finished Goods & Shipment Inspection.

Before any carton leaves our facility, finished products pass through full inspection and AQL sampling, aligned to each customer's acceptance plan.

Finished goods inspection

100% Full Inspection

Appearance, dimension, functional and adhesion checks performed on every unit of key SKUs.

AQL Sampling (MIL-STD-105E)

Level II sampling with customer-specified AQL for Critical / Major / Minor defects.

Packaging & Labeling Verification

Barcode scan, carton marking, inner pack quantity and shipping mark cross-checked against PO.

Pre-Shipment Report

Photo-documented inspection report issued and shared with customer prior to container loading.

04 -- Performance Testing

Product Testing Support.

Our in-house laboratory simulates real-world use conditions. Material toughness has been improved by 45% through continuous validation.

Tensile Strength

Aging Resistance

Tear Resistance

Temp. / Humidity

Impact Test

Adhesion Test

Toughness Improved by 45%

Through continuous iteration of formulation and curing parameters, our silicone compounds maintain elasticity and stability across diverse end-use environments.

+45%
Food contact testing
100%
Food Grade

05 -- Food Contact Safety

Food Contact Testing Support.

Baby bottles, teethers, bibs and feeding sets interact directly with food and skin. Our testing protocol covers every migration and extraction scenario required by global regulators.

FDA

FDA 21 CFR 177.2600

Rubber articles intended for repeated food contact use.

LFGB

LFGB §30 & §31

German food contact compliance -- the world's strictest safety benchmark.

EU

EU 10/2011 & EC 1935/2004

European framework regulation on food contact materials.

BPA

BPA / Phthalate / Heavy Metal Free

Verified non-toxic, odorless, safe for babies and infants.

06 -- Full Traceability

Batch & Quality Traceability.

Every finished product can be traced back to its raw material lot, mold ID, operator, and inspection record -- ensuring full accountability from supplier to shipment.

01

Raw Material Lot ID

Supplier, batch and COA tagged on arrival.

02

Mold & Machine Record

Linked to specific cavity and press.

03

Production Date Code

Shift, operator and date logged.

04

Inspection Records

IPQC and OQC data archived digitally.

05

Shipment Barcode

Carton code links back to all steps.

In the rare event of a market complaint, we can isolate the root cause within 24 hours and quarantine affected inventory immediately -- protecting your brand and consumers.

07 -- CAPA Process

Exception Handling & Continuous Improvement.

When non-conformance occurs, we respond with discipline -- not blame. Our 8D-based CAPA process ensures every exception becomes a lesson that strengthens the system.

D1

Containment & Isolation

Suspect lots are immediately quarantined. QC issues a hold tag and notifies the customer within 24 hours.

D2

Root Cause Analysis

Fishbone diagram and 5-Why analysis conducted by cross-functional team covering Man, Machine, Material, Method, and Environment.

D3

Corrective Action

Immediate corrective measures implemented and verified through re-inspection before production resumes.

D4

Preventive Action

SOPs, control plans, and FMEA documents updated. Operator retraining and poka-yoke added where possible.

D5

Effectiveness Review

Monthly quality review confirms recurrence rate after corrective action -- closed only when verified effective over three production cycles.

08 -- Documentation

Quality Documentation & Records.

Complete, auditable, and shareable. All records are retained for a minimum of three years and available for customer audits upon request.

PDF

Inspection Reports

IQC, IPQC, OQC checklists with measurement data and photos.

PDF

Third-Party Test Reports

SGS / Intertek / Bureau Veritas certifications per shipment or annual.

PDF

Material COA & MSDS

Certificate of Analysis and Safety Data Sheets per raw material lot.

DOC

Control Plan & FMEA

Process control plans and failure mode analysis per SKU.

DOC

CAPA Reports

8D reports documenting non-conformance root cause and resolution.

Private

Customer-Specific Records

Dedicated inspection formats and NDA-protected documentation on request.

09 -- Partner With Us

Submit Your Quality Requirements.

Share your acceptance criteria, inspection standards, and certification requirements. Our quality team will align our SOP to your protocol before the first production run.

1

Technical Specification

2D/3D drawings, tolerance table, material grade, hardness and color requirements.

2

AQL / Acceptance Plan

Preferred AQL levels for critical / major / minor defects and sampling standard.

3

Certification Requirements

Target market compliance: FDA, LFGB, EN 71, CPSIA, CA Prop 65, etc.

4

Packaging & Marking

Retail packaging artwork, carton specifications, barcodes and shipping marks.

Ready to send your quality package?

Attach specifications to your email and our QA engineer will respond within one business day.