Case study • CTQ evidence • Export-ready delivery

Case Study: 316 Stainless Clamp Component (Passivation + Documentation)

An anonymized stainless clamp component where finish expectations, traceable documentation, and CTQ reporting supported a U.S. medical-adjacent program.

Medical device machining — 316 Stainless Clamp Component (Passivation + Documentation)
Medical machining — evidence-driven delivery

Program snapshot

Customer: Medical-adjacent equipment team (U.S. program; name withheld)

Part: 316 stainless clamp-like component used in a controlled environment

Why it mattered: Stainless machining plus finishing requirements can create receiving disputes without clear documentation

SEMIX role: Machining execution, finishing coordination, CTQ inspection evidence, and documentation

Program details (disclosure‑safe)
FieldDetails (public)
Material / finish316 stainless
Size envelopeAnonymized (available under NDA)
Qty rangePrototype to low-volume programs (anonymized)
CTQ focusDatums + functional features (CTQs defined at RFQ)
Tolerance & verificationTight/critical features verified on CTQ-focused report (ranges shared under NDA)
Lead timeQuoted per RFQ; schedule aligned to customer gate dates (ranges under NDA)
Evidence packCTQ report • CoC • material/finish certs (as applicable) • packaging notes

Key requirements

Key requirements (anonymized)
AreaRequirement
Material316 stainless with controlled machining and handling
Finish / treatmentPassivation or surface treatment as required (scope defined at contract review)
CTQsFit and functional features verified and reported
DocumentationCoC + CTQ inspection report; MTR when required
PackagingProtective packaging to prevent surface damage

How we executed

SEMIX approached the build as a controlled workflow: confirm CTQs, plan measurement methods, and prevent revision drift.

  1. Contract review: clarified treatment scope, acceptance criteria, and documentation requirements.
  2. Machining plan: executed with attention to burr control and feature integrity.
  3. Inspection plan: mapped CTQs and produced a receiving-friendly report.
  4. Finishing coordination: aligned finishing requirements and maintained traceability.
  5. Packaging: protected surfaces and labeled by revision/PO line.

engineering services DFM checklist

Quality evidence and documentation

To make receiving easy for a U.S.-based program, we shipped with evidence aligned to CTQs and revision control.

  • CTQ inspection report aligned to functional features
  • CoC and optional MTR (as required) with traceability
  • Finishing documentation aligned to the agreed scope
  • Protective packaging to preserve surface condition

Evidence pack preview (redacted)

On request, we can share redacted examples of the exact report formats our U.S. buyers receive—so your receiving team knows what to expect.

CTQ dimensional report (sample)

Redacted layout showing CTQ callouts, datums, and how pass/fail is stated.

Request sample pack

Packaging / kitting notes (sample)

Redacted packaging notes for protection, labeling, and kitted shipments (if applicable).

Packaging & kitting

Documentation packages Inspection & metrology

Outcome

  • Receiving and quality review simplified by a complete documentation package
  • Surface condition preserved through packaging discipline
  • CTQ evidence enabled smooth acceptance for follow-up builds

Outcome metrics are anonymized. The point is the workflow: stable routing, CTQ measurement, and receiving-ready documentation.

Outcome highlights

Receiving acceptance

Evidence formatted for receiving review; CTQs highlighted to reduce back-and-forth.

Quality control

CTQ inspection plan executed; CoC and required certs packaged with the shipment.

Schedule & handoff

Delivery and documentation aligned to the customer’s internal gate / PO flow-down.

Evidence patterns (technical case studies)

Incident-style write-ups that show how SEMIX handles common failure modes and prevents receiving disputes:

Documentation templates (print-to-PDF)

Want consistent receiving-ready evidence? These templates show typical formats SEMIX can provide with shipments (redacted samples available under NDA):

All evidence patterns Document samples

Request a QuoteEvidence pack