EVT · Engineering Validation
Did we build it right? The first article is measured against the drawing to confirm the mold produces parts to specification.
EVT / DVT / PVT Manufacturing Validation
A three-phase validation framework that de-risks silicone product development — from first-article engineering checks, through functional design validation, to process capability proof before mass production.
Why Three Phases
Each Phase De-Risks a Different Question
EVT, DVT and PVT answer three different questions, so problems are caught at the cheapest possible stage — not discovered in the field.
DVT · Design Validation
Did we build the right thing? The part is tested in its actual use — function, reliability and compliance — to confirm the design works.
PVT · Process Validation
Can we build it consistently? A pilot run proves the production process is capable and repeatable before ramp-up.
Phase 2 · EVT
Engineering Validation Test
EVT confirms the tooling and process produce a part that meets the engineering specification. This is the first-article gate — nothing ships to you until the first article passes.
| Item | Detail |
|---|---|
| Engineering inputs | Signed drawing / CAD, DFM report, mold design, material specification |
| Test items | First-shot mold trial; first-article dimensional measurement; Shore A hardness; visual, flash and fill review; weight or shot-size check |
| Acceptance criteria | First article meets drawing tolerances; no short-shot, flash, sink or demolding defects; hardness within range |
| Customer approval node | FAI report issued and reviewed before any sample ships |
| Deliverable | First Article Inspection (FAI) report |
Phase 3 · DVT
Design Validation Test
DVT confirms the part works in its real application. This is where function, reliability and regulatory compliance are proven before the design is frozen.
| Item | Detail |
|---|---|
| Engineering inputs | Approved EVT samples, design specification, customer test plan (where provided), regulatory requirements |
| Test items | Functional testing; reliability and life testing; regulatory compliance verification (food-contact, medical, RoHS, REACH); material verification and migration testing |
| Acceptance criteria | Part meets functional and reliability requirements in use; material complies with the applicable standard |
| Customer approval node | Golden sample approved and design frozen before volume tooling |
| Deliverable | Design validation report, material compliance results, golden-sample sign-off |
Phase 4 · PVT
Process Validation Test
PVT confirms the production process can hold the specification consistently. A pilot run at production intent generates the capability and measurement data that justify mass production.
| Item | Detail |
|---|---|
| Engineering inputs | Frozen design, production tooling, pilot-run plan, control plan draft |
| Test items | Pilot production run; process capability study (Cpk); measurement systems analysis (Gage R&R); yield and cycle-time review |
| Acceptance criteria | Pilot run meets agreed Cpk and yield targets; the gage, not just the process, is proven capable |
| Customer approval node | Pilot results reviewed and production process released for ramp |
| Deliverable | Process capability report (Cpk), Gage R&R study, control plan, PFMEA |
Measured Evidence
Validation We Document, Not Just Describe
FAI on Every Tooled Project
First-article inspection is standard — the first part from every new or revised mold is measured against the drawing before release.
Cpk Process Capability
Critical dimensions carry a documented capability study. Example: a medical LSR diaphragm verified at Cpk 1.24 (study LSR-MED-007).
Gage R&R / MSA
Calibrated measurement systems are assessed for repeatability and reproducibility before acceptance decisions depend on them.
See the full six-phase framework in our manufacturing process, and the document set in PPAP & quality documentation.
Bring Your Product Through Validation
Tell us your product and target market — we'll recommend the validation depth your program needs.
Discuss Your Validation Plan