| Quality Management System | ISO 9001:2015 certification maintained for the applicable manufacturing and quality-control scope. | Valid certificate showing certification scope, issue date, expiry date, and accredited certification body. | Confirm the certificate number and scope with the issuing certification body. |
| Component Dosing Accuracy | Target dosing accuracy of ±1% for controlled two-component silicone adhesive dispensing, subject to equipment, viscosity, temperature, and test-method conditions. | Calibration records, equipment specifications, and documented dosing test results. | Request a witnessed test using the agreed material, ratio, temperature, and sample size. |
| Batch Traceability | Each production lot linked to raw-material lots, production date, operator or line, inspection results, and packaging records. | Example batch record, lot-number format, material receiving record, and release documentation. | Conduct a traceability exercise from finished-goods lot to incoming raw materials. |
| Certificate of Analysis | A batch-specific COA should report agreed parameters such as appearance, viscosity, density, mix ratio, and curing performance. | Redacted sample COA with specification limits, actual results, test methods, and approval status. | Compare reported results with the approved product specification and purchase order. |
| Viscosity Control | Viscosity controlled within the agreed product specification using a defined temperature, spindle, speed, and test time. | Calibrated-viscometer records and a written viscosity test method. | Ensure the test conditions match the application and the approved technical data sheet. |
| Curing Performance | Cure time and final mechanical performance defined for the specified temperature, humidity, mix ratio, and bond-line thickness. | Technical data sheet, internal test report, and application-specific validation results. | Validate samples under actual production conditions before approving mass production. |
| Incoming Material Inspection | Critical raw materials inspected against defined acceptance criteria before release to production. | Incoming inspection plan, supplier COAs, sampling records, and nonconformance procedures. | Check controls for identity, packaging condition, shelf life, and storage requirements. |
| Packaging and Labeling | Containers labeled with product code, lot number, net quantity, manufacturing date, expiry or retest date, and storage conditions. | Packaging specification, label sample, palletization standard, and shipment photographs. | Verify label information, tamper protection, leak prevention, and export packaging suitability. |
| Storage and Shelf Life | Storage temperature, humidity limits, unopened shelf life, and FIFO or FEFO controls clearly documented. | Technical data sheet, warehouse temperature records, and inventory-control procedure. | Confirm that remaining shelf life at shipment meets the purchase agreement. |
| Nonconformance and Corrective Action | Documented process for defect containment, root-cause analysis, corrective action, and effectiveness review. | Redacted corrective-action report and complaint-handling procedure. | Review response time, evidence of root cause, and preventive-action follow-up. |
| Pre-Shipment Release | Finished goods released only after required inspections, documentation review, packaging checks, and lot confirmation. | Final inspection checklist, release approval, packing list, and batch-specific COA. | Match the released lot numbers and quantities with shipping documents. |