First Article Inspection (FAI)
Standard on every tooled project. The first part from a new or revised mold is fully measured against the drawing — critical dimensions, hardness, visual appearance and material — and documented before volume release.
Silicone PPAP & Quality Documentation
The quality document set regulated buyers need to approve a silicone part for production — FAI inspection, Gage R&R, SPC control and PPAP Level 3, delivered from a single supplier.
The Document Set
Four Core Quality Documents
These are the documents that prove a silicone part is ready for production — each answering a different approval question.
Gage R&R / Measurement Systems Analysis
Calibrated equipment — calipers, Shore durometers, tensile testers, optical and vision systems — is assessed for repeatability and reproducibility, so acceptance decisions rest on a capable gage, not just a capable process.
SPC & Capability Studies
Statistical process control on critical dimensions, with Cpk capability studies that prove the process holds the tolerance over the run. Example: a medical LSR diaphragm at Cpk 1.24 (study LSR-MED-007).
Control Plan & PFMEA
A documented control plan (what is measured, how often, by whom, and the reaction plan) plus a process FMEA (failure modes, effects and controls) — quality defined before production, not discovered after.
PPAP
Production Part Approval Process — Level 3
For automotive and other regulated programs we deliver a complete PPAP package to Level 3. Levels 2 and 4 are available on request.
| PPAP Element | What we deliver |
|---|---|
| Design records | Approved drawing and specification set |
| Engineering change notes | Documented changes and approvals where applicable |
| Dimensional results | Full dimensional report with Cpk on critical dimensions |
| Material & performance results | Material certifications and performance test results |
| Process flow diagram | The production sequence from material to shipment |
| PFMEA | Failure modes, effects and controls |
| Control plan | Measurement, frequency, responsibility and reaction plan |
| Measurement systems analysis | Gage R&R study for acceptance gages |
| Capability studies | Cpk process capability on critical characteristics |
| Production sample | Reference samples from the production run |
This is the same document set we describe in our manufacturing process framework — no need to source validation from a separate vendor.
What Backs the Numbers
Calibrated Measurement, Not Estimates
The documents above are only as good as the measurement behind them. Our in-house lab uses calibrated instruments with documented traceability.
Dimensional
Calipers, micrometers, optical and vision measurement for critical dimensions and tolerances.
Material & Hardness
Shore A durometers and tensile testers verify hardness and material properties against the spec.
Surface & Visual
Automated optical inspection (AOI) and visual checks catch surface defects before release.
See the full equipment and calibration detail in quality inspection.
Need Validation Documentation?
Tell us your program's approval requirements — we'll confirm the document set we can deliver, including PPAP Level 3.
Confirm Your Documentation