Custom Silicone Baby Products Manufacturer | OEM/ODM
Quality Control System

Safety You Can
Trust, Quality You Can Measure.

Our seven-stage quality control system governs every silicone baby product -- from raw material intake to final shipment -- ensuring 100% food-grade safety, dimensional accuracy, and full traceability for every batch.

±0.1mm

Tolerance

100%

Full Inspection

ISO 9001

SOP Standard

QC Report
Tensile Test PASS ✓
Aging Resistance PASS ✓
Tear Strength PASS ✓
Food Contact PASS ✓
BPA-Free PASS ✓
7-Stage
Inspection

01 · Foundation

Quality Standards & Inspection Documents.

Every project begins with clearly documented quality criteria. We align internal SOPs with international standards and customer-specific requirements before production starts.

Product Specification

Material grade, Shore hardness, dimensions, color, surface finish, and packaging requirements.

Inspection Checklist

AQL sampling plans, critical/major/minor defect classifications, and acceptance limits.

Compliance Standards

FDA, LFGB, CE, RoHS, REACH, UL -- selected per target market and product category.

Golden Sample

Signed-off reference sample retained for comparison throughout mass production.

FDA LFGB CE RoHS REACH UL ISO 9001 BPA-Free

02 · IQC

Incoming Material Inspection.

Only food-grade silicone from certified suppliers enters our warehouse. Each raw material lot is verified against COA documents and physically tested before release to production.

1

COA & Document Review

Verify Certificate of Analysis, RoHS/REACH test reports, and supplier lot numbers.

2

Physical & Chemical Testing

Hardness, viscosity, color, and odor verification against golden standard samples.

3

Quarantine & Release

Materials held in quarantine zone until IQC pass; rejected lots returned to supplier with reports.

Incoming silicone material inspection with lab testing equipment

Rejection Policy

Zero tolerance for non-food-grade materials.

First article silicone baby bottle sample

7

Dimensional checkpoints

100%

Sample validation before run

Precision measurement of silicone first article

03 · FAI

First Article Confirmation.

Before any batch runs at scale, the first molded piece undergoes complete validation. This gate ensures mold, machine parameters, and material are all aligned to specification.

  • Full dimensional measurement with calipers & CMM

    Tolerance verified within ±0.1mm across all critical dimensions.

  • Visual & surface finish comparison with golden sample

    Color, gloss, flash, and parting lines inspected under standard lighting.

  • QC Manager & Production sign-off required

    Mass production begins only after dual approval and documented FAI report.

04 · IPQC

In-Process Patrol Inspection.

Our QC inspectors patrol every production line at scheduled intervals, catching deviations before they affect output. Each inspector has 5+ years of silicone molding experience.

2h

Patrol Frequency

Every two hours, each production line is sampled and recorded.

5+

Years QC Experience

Minimum qualification per inspector assigned to baby product lines.

64

Machines Monitored

32 solid + 32 liquid silicone injection machines under continuous watch.

360°

Parameter Control

Temperature, pressure, curing time, and operator compliance verified.

Patrol checkpoints include:

✦ Molding parameter stability

✦ Flash & burr check

✦ Color consistency

✦ Dimensional spot checks

✦ Operator SOP compliance

✦ Workstation cleanliness

05 · FQC

Final Product Inspection.

Before packaging, every finished item passes through 100% visual inspection plus statistical sampling for functional, dimensional, and adhesion testing.

Visual inspection of silicone baby products
A

Appearance Check

Scratches, flash, color spots, dust contamination, and gloss uniformity under D65 lighting.

Dimensional measurement of silicone products
B

Dimensional Measurement

Caliper, gauge, and projector verification of critical dimensions against drawing tolerances.

Functional testing of silicone pacifier
C

Functional Testing

Tensile, tear, suction, assembly fit, and multi-material bonding integrity verification.

Adhesion test on silicone bottle
D

Adhesion Check

Printing, coating, and silicone-to-plastic/metal bonding tested via cross-cut and peel methods.

Aging and durability testing
E

Durability Testing

Constant temperature/humidity, aging, drop, and impact tests on sampling lots.

AQL 1.0 / 2.5 / 4.0

Statistical sampling based on ISO 2859-1. Critical, major, and minor defects classified per customer specification.

Full-batch acceptance report issued

06 · OQC

Outgoing Shipment Inspection.

Before any carton leaves our facility, our outgoing QC team performs a final audit to ensure the right product, right quantity, right packaging -- every single time.

Carton labeling & shipping mark ✓ Verified
Quantity & packing list reconciliation ✓ Verified
Inner & outer packaging integrity ✓ Verified
Drop test on master cartons ✓ Verified
Customer-specific labeling requirements ✓ Verified
Third-party inspection coordination ✓ Supported
Outgoing quality control shipment inspection warehouse

Third-Party Welcome

We fully support SGS, BV, TÜV, Intertek, and client-appointed audits.

07 · NCR

Non-Conforming Product Handling.

Defects are opportunities. Every non-conforming unit triggers a documented 5-step process, feeding corrective actions back into production and preventing recurrence.

01

Identify & Tag

Defective items immediately isolated with red tag and NCR number.

02

Document

Defect photographed, quantity logged, line and shift recorded.

03

Root Cause

5-Why / Fishbone analysis conducted by QC + Production.

04

Disposition

Rework, scrap, or concession -- decided per severity and customer approval.

05

CAPA & Close

Corrective & Preventive Actions logged, verified, and shared with client.

LOT

Lot Number

YMS-2024-11-A082

MAT

Material Batch

SI-FG-2411-003

LN

Line / Machine

L-07 / M-LSR-14

QC

QC Inspector

Chen L. · Signed ✓

08 · Traceability

Records & Responsibility Traceability.

Every product is traceable from raw silicone batch to finished carton. All QC records are retained for a minimum of 3 years, giving our clients full audit visibility whenever needed.

Material Traceability

Raw material lot ↔ supplier ↔ COA linked to each finished batch.

Production Traceability

Machine, mold, operator, and shift logged for every production run.

Inspection Records

IQC, FAI, IPQC, FQC, OQC reports digitally archived & searchable.

3-Year Retention

All quality documents preserved and available upon customer request.

09 · Partnership

Your Quality Standards. Our Priority.

Quality isn't static -- it evolves with your market. Our dedicated QC liaison works directly with your team to translate specific requirements into enforceable production standards.

Pre-production alignment

Dedicated meetings to review specs, AQL, and acceptance criteria before kickoff.

Transparent reporting

Weekly QC updates, photo documentation, and inspection reports via email or portal.

Rapid issue response

Dedicated contact window -- concerns acknowledged within 24 hours.

Discuss Your QC Requirements

Share your specifications -- we'll return with a customized quality plan within 48 hours.

Phone / WhatsApp

+86 134 1898 3587

Contact: Edwin

Request QC Documentation