01
Problem
Low-volume, high-mix catheter assemblies required a manual crimp process that could deliver repeatable output despite operator dependency and tooling variability.
02
Constraints
- Manual process quality depended heavily on operator training and tool condition.
- Crimp results had to remain traceable across operators and production lots.
- Capital automation was not justified for the production mix.
- Ergonomics and operator fatigue were part of the process risk profile.
03
Engineering Decisions
- Standardized calibrated hand tools and setup sequence.
- Added go/no-go checks and visual aids to reduce interpretation differences.
- Defined operator qualification and retraining triggers.
- Aligned tool calibration and maintenance with the production control plan.
04
Validation
- Qualified operators through controlled execution and inspection evidence.
- Used pull-force and inspection data to demonstrate process acceptability.
- Compared results across operators to evaluate human-factor variability.
05
Risk & Mitigation
- Operator fatigue could reduce crimp consistency; mitigated through ergonomic tools and workflow control.
- Incomplete crimp cycles could cause weak connections; mitigated with ratchet-controlled tools.
- Tool wear could change output; mitigated through calibration and periodic verification.
06
Outcome
The manual crimp process was converted into a controlled production method suitable for flexible, low-volume manufacturing.