01
Problem
Laser catheter components required a validated automated machining process capable of holding tight dimensional tolerances, including features near ±0.001 inch, across repeated fixture loads without process drift.
02
Constraints
- Micron-level dimensional requirements for critical catheter features.
- High-density fixture strategy required repeatable part loading across 24-position production runs.
- Surface finish and laser-weld compatibility could not be compromised by throughput improvements.
- Process evidence had to support regulated medical-device production release.
03
Engineering Decisions
- Structured the qualification around defined CNC recipes and fixture loading conditions.
- Used first-article verification to stabilize tool-offset values before full PQ execution.
- Separated fixture repeatability, program control, and dimensional acceptance into traceable evidence streams.
- Documented the process using objective dimensional results instead of operator narrative alone.
04
Validation
- Executed PQ across multiple production lots to capture setup-to-setup variation.
- Verified critical dimensions using controlled inspection methods and defined acceptance criteria.
- Reviewed recipe-specific outputs to confirm the process remained stable across repeated runs.
05
Risk & Mitigation
- Tool wear could shift dimensional outputs; mitigated through offset control and verification points.
- Fixture loading error could create false process variation; mitigated with defined loading workflow and repeatable fixture design.
- Uncontrolled recipe changes could invalidate the evidence package; mitigated through documented recipe identification.
06
Outcome
The process was qualified for controlled production use with evidence supporting repeatability, dimensional conformance, and scalable fixture-based throughput.