Fecision uses documented quality systems to control silicone rubber production. Material traceability and inspection records support customer requirements, alongside environmental controls for factory operations.
These certifications provide a framework for how we control production and document quality. They also guide environmental management and the records we provide to customers.
ISO 9001 helps organizations demonstrate that their processes and procedures achieve customer satisfaction and business goals. It ensures a company鈥檚 services or products are of high quality, efficiently produced.
ISO 13485 helps organizations establish a quality management system designed for medical device manufacturing and related services. It ensures products are designed and produced to meet customer expectations, regulatory requirements, and safety standards.
IATF 16949 helps automotive organizations develop a quality management system focused on defect prevention, risk reduction, and continuous improvement. It ensures automotive products are manufactured with consistent quality, reliable processes, and compliance with requirements.
ISO 14001 helps organizations establish an environmental management system to effectively manage their environmental responsibilities. It ensures manufacturing activities are carried out with improved environmental performance and efficient resource utilization..
ISO Class 8 cleanroom, also described as a Class 100,000 cleanroom, helps control airborne contamination through defined cleanliness requirements and environmental monitoring. It supports sensitive products manufactured in a controlled environment with reduced contamination risks.
GMP helps organizations establish controlled manufacturing practices to ensure product quality, safety, and consistency. It ensures products are produced and tested under documented, hygienic, and validated processes.
For silicone rubber components, small changes in material, tooling, curing and inspection can affect sealing, dimensional stability and production release. Certification-backed systems help our teams make those controls visible and repeatable.
Quality requirements can be reviewed before tooling begins, including tolerances, critical features and inspection methods.
Incoming Quality Control, process records, dimensional checks, and first article inspection can be structured around the needs of each program.
Independent certification gives procurement, engineering, and quality teams a clearer foundation for supplier qualification and project launch.
Fecision follows a defined production route from incoming material to shipment. Separate storage and transfer areas keep each batch's status visible. Incoming inspection confirms material acceptance, and in-process checks control quality as work moves between departments. Finished parts are released only after the required inspections and records are complete.
Fecision uses inspection instruments to verify dimensions, hardness, sealing, pull force, aging behavior, and surface durability before release.
Checks dimensions, hole positions, outlines, flash, and molded feature consistency.
Verifies hardness for compression, sealing force, flexibility, and touch feel.
Tests leakage and sealing reliability for gaskets, valves, plugs, and assemblies.
Measures tensile, pull-off, bonding, insertion, release, and retention force.
Reviews material stability after heat, humidity, or time-based exposure.
Fecision operates in-house machining, silicone molding, printing, coating, curing, cutting, and dispensing equipment to support tooling, production, and secondary operations.
| Equipment | Qty. | Primary Use |
|---|---|---|
| CNC Machining Center | 5 sets | Precision mold components, inserts, fixtures, and tooling plates |
| Electrical Discharge Machine (EDM) | 5 sets | Complex mold cavities, fine details, and hardened tool steel features |
| CNC Engraving Machine | 2 sets | Fine mold features, markings, electrodes, and precision detailing |
| Hydraulic Compression Molding Press | 11 sets | Compression molding of solid silicone rubber components |
| Vacuum Compression Molding Press | 13 sets | Vacuum-assisted molding with reduced trapped air and voids |
| Two-Roll Rubber Mixing Mill | 4 sets | Solid silicone compounding, color blending, and additive dispersion |
| Solid Silicone Injection Molding Machine | 1 set | Automated injection molding of high-consistency silicone rubber |
| Liquid Silicone Rubber Injection Molding Machine | 9 sets | Precision LSR injection molding for repeatable production |
| Equipment | Qty. | Primary Use |
|---|---|---|
| Pad Printing Machine | 8 sets | Logos, symbols, legends, and identification marks |
| Spray Coating Machine | 3 sets | Functional and cosmetic surface coating application |
| Infrared Tunnel Oven | 2 sets | Continuous drying, curing, and post-treatment |
| Industrial Baking Oven | 4 sets | Batch curing, post-curing, drying, and thermal conditioning |
| Adhesive Roll-Coating Machine | 2 sets | Uniform adhesive or primer coating on flat materials |
| Precision Cutting Machine | 4 sets | Controlled cutting and trimming of sheets, profiles, and components |
| Punch Press | 6 sets | Die cutting, punching, blanking, and feature preparation |
| Automatic Adhesive Spraying Machine | 1 set | Repeatable spray application of adhesive or primer |
| Automatic Adhesive Dispensing Machine | 1 set | Metered adhesive dispensing for controlled bond lines |
Fecision delivers dimensional inspection, hardness testing and reliability testing to support documented silicone rubber parts review before shipment.
| Equipment | Qty. | Precision | Capacity |
|---|---|---|---|
| 2D Vision Measuring Machine | 5 sets | 0.003mm | 800 pcs/day |
| Infrared Thermometer | 2 sets | ±1.5°C | As required |
| High-Precision Electronic Counting Scale | 20 sets | ±0.01g | As required |
| Shore Hardness Tester | 3 sets | ±1A | 720 pcs/day |
| Automatic Inspection Equipment | 1 set | Project-defined | 280,000 pcs/day |
| Air Leak Tester | 3 sets | Project-defined test pressure and leak rate | As required |
| Push-Pull Force Tester | 1 set | Tensile, compression, insertion, withdrawal, and retention force | As required |
| Insulation Resistance Tester | 1 set | Electrical insulation resistance | As required |
| Digital Force Gauge | 1 set | Peak push and pull force | As required |
| Illuminated Magnifying Inspection Lamp | 20 sets | Surface defects, flash, contamination, and workmanship | As required |
| Automated Optical Inspection (AOI) System | 2 sets | Automated appearance and defect inspection | As required |
| Contour Measuring Machine | 1 set | Profiles, radii, angles, and surface contours | As required |
| Equipment | Qty. | Capability |
|---|---|---|
| Rubber Alcohol Abrasion Tester | 1 set | Abrasion distance: 10mm-50mm |
| Programmable Constant Temperature & Humidity Chamber | 1 set | Temperature fluctuation ±0.5°C; humidity fluctuation ±2.5% |
| RCA Paper Tape Abrasion Tester | 1 set | Load: 275g, 175g, 55g |
| Salt Spray Test Chamber | 1 set | Temperature fluctuation ≤0.5°C |
| Universal Testing Machine | 2 sets | Tensile, compression, load, and mechanical strength testing |
| Key Life Tester | 1 set | Actuation force, travel, rebound, and cyclic durability testing |
| Wear Resistance Tester | 1 set | Surface wear and repeated-friction durability testing |
Fecision Silicone can align inspection records and production evidence with customer quality workflows, from first samples to medical validation and automotive approval packages.
We inspect first article samples against the approved drawing and record the results, with material traceability linked to the report.
Process risk review for silicone molding, linked to controls, inspection points, corrective actions, and change records.
Medical validation support covering equipment readiness, process-window runs, performance lots, records, and change control.
We help prepare automotive production approval evidence and coordinate the PSW submission requirements with the customer.
Every silicone rubber project is managed under a robust quality assurance system with defined inspection standards and traceable processes.
