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JLY Precision Technology

CNC DFM Checklist + Aerospace/Medical Requirements (2026 Edition)

A practical DFM (Design for Manufacturing) checklist for CNC parts plus aerospace AS9100 and medical ISO 13485 requirements explained — written by application engineers, not lawyers.

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

A good DFM review can cut 10–30% off your production quote without changing functionality. This guide gives you the same checklist JLYPT engineers use on every quote, plus what changes when the part is destined for aerospace AS9100 or medical ISO 13485 work.

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%

Frequently Asked Questions

Do I need AS9100 certification for every aerospace part?
No. AS9100 is required for flight-critical and customer-mandated work. Many ground-support equipment, test fixtures and non-flight aerospace parts ship under standard ISO 9001 quality. Confirm with your end customer before paying the AS9100 premium.
What's the difference between ISO 9001 and AS9100?
AS9100 is ISO 9001 plus aerospace-specific requirements — configuration management, special processes, FAI, supplier control, risk management. AS9100 supplier audits typically take 3–5 days versus 1–2 days for ISO 9001.
Can JLYPT do FDA-registered medical work?
JLYPT operates under ISO 9001 with capability for ISO 13485-grade medical work. FDA registration of finished medical devices is the device manufacturer's responsibility, not the contract machine shop's. We supply components with full traceability that the device maker integrates into their FDA submission.
How long does a DFM review take?
For a typical CAD model, our engineers respond within 24 hours with a marked-up drawing showing tolerance relaxation opportunities, geometry simplification suggestions and material alternatives. Use the contact form.
What is NADCAP and do I need it?
NADCAP (National Aerospace and Defense Contractors Accreditation Program) audits special processes — heat treatment, surface finishing, NDT, welding. Required by major OEMs (Boeing, Airbus, Lockheed) for those specific processes. Your customer will tell you if NADCAP is required; otherwise it adds significant cost.
Can I send a draft CAD before the design is finalised?
Yes — that's actually the best time. We provide free DFM reviews on any draft CAD. Catching cost issues before the drawing is released saves real money. Send via the contact form.
What documents should I send with a quote request?
Minimum: 3D STEP file + 2D PDF drawing + material specification. Helpful: critical feature list, target quantity, target lead time, intended end-use industry. For aerospace/medical: any required customer specifications, quality clauses or special processes.

About the author

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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