01
Problem
A high-volume catheter assembly process required reliable electrical and mechanical crimp performance while reducing manual variability and ensuring traceable acceptance data.
02
Constraints
- Crimp quality had to meet IPC/WHMA-A-620 expectations for high-reliability assemblies.
- Cycle time targets required automated actuation and rapid inspection.
- Crimp force, crimp height, and pull strength had to remain inside a defensible process window.
- Production release required regulated validation documentation.
03
Engineering Decisions
- Selected automated crimp equipment with integrated force monitoring.
- Defined process-window studies around crimp height, pull force, and visual/electrical acceptance.
- Used cross-section review to confirm conductor compression and gas-tight connection quality.
- Established daily verification to maintain the validated state.
04
Validation
- Performed OQ to define operating limits and nominal settings.
- Executed PQ using production lots to demonstrate repeatability under intended use.
- Reviewed pull-test and inspection evidence against predefined acceptance criteria.
05
Risk & Mitigation
- Crimp-height drift could reduce connection reliability; mitigated with force monitoring and verification.
- Wire-strand damage could create latent failures; mitigated with controlled stripping and inspection.
- Operator setup variation could affect output; mitigated with standardized setup and documented settings.
06
Outcome
The automated crimp process was validated as a repeatable production method with reduced manual variability and stronger in-process control.