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JLY Precision Technology

CNC DFM 체크리스트 + 항공/의료 요구사항 (2026 에디션)

CNC 부품에 대한 실용적 DFM(제조를 위한 설계) 체크리스트와 항공우주 AS9100 및 의료 ISO 13485 요구사항 — 응용 엔지니어가 작성.

14 min read
Aerospace-grade CNC machined components alongside medical implant parts on inspection bench

좋은 DFM 검토는 기능성을 변경하지 않고도 제품 견적에서 10–30%를 절감할 수 있습니다. 이 가이드는 JLYPT 엔지니어가 모든 견적에서 사용하는 체크리스트를 제공합니다.

Why DFM matters

Design for Manufacturing (DFM) is the practice of designing parts so they can be made faster, cheaper and more reliably without sacrificing function. The earlier in the design process you apply DFM, the more it pays back.

  • 10–30% cost savings on the production quote, no design changes needed beyond DFM optimisations.
  • 2–5× shorter lead times when the part doesn’t need special tooling, fixtures or hand operations.
  • Better first-pass yield — fewer scrapped parts, fewer revisions, fewer surprises at FAI.
  • Easier scaling — what works at 10 units works at 10,000.

The 20-point DFM checklist

Run through every item before sending a part to quote. Each one fixes a real cost or quality issue we see weekly:

  1. Internal corner radii ≥ 0.5 mm. Sharp internal corners need expensive small tools. Default to 1 mm where possible.
  2. Avoid deep narrow pockets. Pocket depth more than 4× tool diameter causes chatter and poor finish. Split into multiple operations or shallower pockets.
  3. Add tool-clearance to bottoms of pockets. Leave at least 0.5 mm flat clearance for the cutter to land on.
  4. Standard hole sizes for tapping. Use M3, M4, M5, M6, M8, M10 metric or #4-40, 1/4-20 imperial. Custom thread sizes need custom taps.
  5. Hole-to-edge distance ≥ 2× hole diameter. Closer distances cause edge break-out, especially on aluminium and plastics.
  6. No blind holes deeper than 4× diameter. Drill cycle becomes complex and chip evacuation fails. Add a relief or split the hole.
  7. Threaded hole depth = 1.5× thread diameter. Anything more is wasted; the engagement length doesn’t add strength.
  8. Wall thickness ≥ 0.8 mm in metals, 1.5 mm in plastics. Thinner walls deflect during cutting and warp on cool-down.
  9. Wall thickness consistency. Sudden changes in wall thickness cause warping. Taper transitions over a length of 3× thickness.
  10. Avoid undercuts where possible. Undercut tools are expensive and slow. If unavoidable, design for a standard T-slot cutter (e.g., 6 mm slot).
  11. Datum scheme: A-B-C. Pick the largest stable face as A. B and C perpendicular. Reference all GD&T from this scheme.
  12. One-sided machining when possible. Reduce setups by designing all critical features on one side or two opposing sides.
  13. Avoid sharp external corners. Add 0.2–0.5 mm chamfers to all external edges — improves handling, prevents burrs, looks more professional.
  14. Standard fastener clearance holes. M4 clearance = 4.5 mm (close), 5.0 mm (free). Don’t use 4.3 or 4.7 mm — they’re non-standard drills.
  15. Avoid mirror-finish surface specs unless required. Ra 0.8 µm is standard. Ra 0.4 µm requires extra polishing time.
  16. Specify a single overall material per part. Multi-material parts are an assembly, not a single CNC operation.
  17. Tolerance only what matters. 80% of dimensions can stay at ISO 2768-m default. Tighten only critical features.
  18. Provide a 3D STEP file. 2D drawings as the only source of truth lead to interpretation errors. Send STEP + PDF drawing.
  19. Mark up critical features clearly. Star or note the 3–5 features that absolutely must be in spec. Helps the shop prioritise inspection.
  20. Communicate the part’s purpose. One sentence — “this bracket holds a sensor in a vibration test rig” — helps the engineer suggest better DFM that you might never have considered.
Well-designed CNC aluminium parts with clear datums and proper fillet radii
Production aluminium parts that follow JLYPT’s standard DFM guidelines — fast to machine, cheap to inspect.

Aerospace requirements (AS9100 and friends)

When a part is destined for aerospace use, several layers of additional requirements kick in. They are not optional:

Quality system requirements

  • AS9100D (or revision) — the aerospace quality management system. The supplier must be certified.
  • AS9102 First Article Inspection — every dimension verified on the first part of a production run, with documented reports.
  • NADCAP accreditation for special processes (heat treat, surface finish, NDT, welding).
  • Production Part Approval Process (PPAP) — formal customer approval before serial production.

Material & traceability

  • Mill test reports (MTRs) for every batch of raw material.
  • Heat-lot traceability — each part traceable back to a specific batch of bar stock.
  • Certificates of conformance (CoC) with shipment.
  • DFARS / FAR 252 compliance for US defence work — material origin restrictions.
  • Specialty alloys — Ti-6Al-4V, Inconel 718, 17-4PH, often AMS-grade specifications.

JLYPT operates an ISO 9001 certified quality system with AS9100 capability for designated aerospace work. See our certifications page for current scopes and our aerospace manufacturing overview.

Medical device requirements (ISO 13485 and FDA)

Medical CNC work — surgical instruments, orthopaedic implants, drug-delivery components — operates under similar but distinctly different rules:

  • ISO 13485 — the medical device quality management standard. Equivalent role to AS9100 in aerospace.
  • FDA 21 CFR Part 820 — the US Quality System Regulation. Required for parts entering the US medical device supply chain.
  • EU MDR (Medical Device Regulation) — replaced MDD in 2021. Stricter clinical evidence and unique device identification (UDI) requirements.
  • Material biocompatibility — ISO 10993 testing for parts that contact patients. Common implant materials: Ti-6Al-4V ELI, CP-Ti Grade 4, 316L stainless, PEEK.
  • Lot traceability — every part traceable to material lot, machine, operator, inspection record.
  • Cleaning validation — for parts shipped clean or sterile, validated cleaning procedure with residue testing.
  • Environmental controls — controlled humidity and temperature in the machining cell prevent thermal expansion errors and contamination.
Precision-machined surgical instrument components in 316L stainless steel
Medical-grade 316L stainless surgical instruments — passivated, electropolished and lot-traced.

Documentation you must provide

For regulated work, the documentation package is part of the deliverable. Plan for this from day one:

DocumentStandard workAerospaceMedical
STEP file + 2D PDF drawing
Tolerance list / GD&T scheduleRecommended
Material specification (alloy + spec)Recommended
Surface finish specification
Critical feature listOptional
Acceptance criteriaOptional
Cleaning / packaging requirementsOptionalOptional
Lot identification schemeOptional
Special process requirements (heat, NDT)OptionalSometimes
Customer-specific quality clausesOptional

Common pitfalls

  • Specifying a tolerance you can’t inspect. “±0.005 mm true position over 200 mm” on a $10 part is impossible to verify economically.
  • Assuming the supplier knows your standards. If you need MIL-DTL-13924 black oxide rather than commercial black oxide, say so explicitly.
  • Forgetting the supply chain. If your customer requires DFARS-compliant materials, your supplier must source them — typically 20–40% premium and longer lead time.
  • Mixing up similar materials. Ti Grade 2 ≠ Ti Grade 5. 316L ≠ 316. CP Titanium ≠ Ti-6Al-4V. Specify the exact grade.
  • Treating documentation as optional. For aerospace and medical, the paperwork IS the deliverable. Without certs and traceability, the parts are unusable.
  • Late spec changes. Changing the alloy after machining starts, or the surface finish after kit-out, cascades into rework and lost time.

Cost implications of regulated work

These are realistic premiums vs the same part run as standard ISO 9001 work. Your mileage varies by program complexity.
Cost driverStandard partAerospace AS9100Medical ISO 13485
Quality system overhead0+10–15%+10–15%
Material certification0+5–10% (mat'l)+5–10% (mat'l)
First Article Inspection0–5%+5–10%+5–10%
Lot traceability0+3–5%+3–5%
Specialty NADCAP processes0+20–30% (when used)Not typical
Cleaning & sterile packaging00+10–20%
Special documentation0+5%+5%
Total typical premium+25–50%+25–50%

자주 묻는 질문

모든 항공우주 부품에 AS9100 인증이 필요한가요?
아니요. AS9100은 비행 중요 및 고객 명령 작업에 필요합니다. 많은 지상 지원 장비 및 비행 외 부품은 표준 ISO 9001 품질로 출하됩니다.
ISO 9001과 AS9100의 차이점은?
AS9100은 ISO 9001 + 항공우주 특정 요구사항입니다 — 구성 관리, 특수 프로세스, FAI, 공급업체 통제, 위험 관리.
JLYPT는 FDA 등록 의료 작업을 할 수 있나요?
JLYPT는 ISO 13485 등급 의료 작업 능력으로 ISO 9001 하에서 운영됩니다. 완성된 의료기기의 FDA 등록은 기기 제조업체의 책임입니다.
DFM 검토는 얼마나 걸립니까?
일반적인 CAD 모델의 경우 엔지니어는 공차 완화 기회 및 형상 단순화 제안을 보여주는 표시된 도면으로 24시간 이내에 응답합니다.
NADCAP이 무엇이고 필요한가요?
NADCAP은 특수 프로세스 — 열처리, 표면 마감, NDT, 용접 — 를 감사합니다. 주요 OEM(Boeing, Airbus)이 해당 프로세스에 필요합니다.
디자인이 완성되기 전에 초안 CAD를 보낼 수 있나요?
네 — 사실 그게 최선의 시기입니다. 모든 초안 CAD에 대해 무료 DFM 검토를 제공합니다. 문의 양식을 통해 보내주세요.
견적 요청 시 어떤 문서를 보내야 하나요?
최소: 3D STEP 파일 + 2D PDF 도면 + 재료 사양. 유용: 중요 특징 목록, 목표 수량, 목표 리드 타임, 의도된 최종 사용 산업.

저자 소개

JLYPT Engineering Team

Senior CNC Application Engineers

Our application engineering team brings 15+ years of combined experience producing precision components for aerospace, medical, robotics and industrial automation customers.

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