Performance Qualification of Automated Terminal Crimping Process for Heart-Lung Machine Production
A cardiovascular device manufacturer required documented evidence that their automated terminal crimping process using the AMP-O-lectric Model G machine for HLM (Heart-Lung Machine) cable assemblies would consistently produce product within IPC/WHMA-A-620B specifications when operated at nominal conditions across multiple production lots. The challenge involved validating automated crimping across two wire gauges (14 AWG and 22 AWG) with different terminal types and crimp height specifications. Critical concerns included ensuring the crimp fixture (Auto Crimp Applicator) setup was correct, validating the first piece article process with Precision Adjustment Lever calibration, preventing excessive or insufficient crimping through automation, and maintaining dimensional accuracy (crimp height) within tight tolerances (±0.002 inches).
Project Metrics
Tools & Standards
Problem Definition
A cardiovascular device manufacturer required documented evidence that their automated terminal crimping process using the AMP-O-lectric Model G machine for HLM (Heart-Lung Machine) cable assemblies would consistently produce product within IPC/WHMA-A-620B specifications when operated at nominal conditions across multiple production lots. The challenge involved validating automated crimping across two wire gauges (14 AWG and 22 AWG) with different terminal types and crimp height specifications. Critical concerns included ensuring the crimp fixture (Auto Crimp Applicator) setup was correct, validating the first piece article process with Precision Adjustment Lever calibration, preventing excessive or insufficient crimping through automation, and maintaining dimensional accuracy (crimp height) within tight tolerances (±0.002 inches).
System Constraints
Engineering Decisions
Validated two terminal/wire combinations: 14 AWG (0.076″ ± 0.002″) and 22 AWG (0.0295″ ± 0.002″)
Produced 450 total samples: 225 per wire gauge (75 per work order × 3 work orders)
Used AMP-O-lectric Model G automatic crimping machine with Auto Crimp Applicators
Implemented first piece article process: produce sample, measure, adjust Precision Adjustment Lever until within spec
Required all operators to be trained and certified to IPC/WHMA-A-620B standards
Tested both visual inspection (crimp form) and mechanical testing (crimp height)
Applied exact binomial confidence interval statistical method for tolerance analysis
Proved process capability during first piece article setup before production runs
Validation Strategy
- 14 Gage Wire: 225/225 samples passed visual inspection (0 failures)
- 14 Gage Wire: 225/225 samples passed crimp height testing (0 failures)
- 22 Gage Wire: 225/225 samples passed visual inspection (0 failures)
- 22 Gage Wire: 225/225 samples passed crimp height testing (0 failures)
- Total: 450/450 samples met IPC/WHMA-A-620B specifications (100% pass rate)
- Statistical claim validated: 94% of all units meet specifications with 99% confidence
- Zero excessive crimps, zero insufficient crimps, zero crimp form defects detected
- All crimp heights within ±0.002″ tolerance across all samples
- First piece article setup process validated for ensuring process capability
Risk & Mitigation
Final Outcome
Successfully qualified automated terminal crimping process for HLM production with zero defects across 450 samples spanning six work orders and two wire gauges. Demonstrated that the AMP-O-lectric Model G machine with proper Auto Crimp Applicator selection and first piece article setup using the Precision Adjustment Lever can consistently produce terminals meeting IPC/WHMA-A-620B specifications for both crimp form and crimp height. The validation established process capability with 99% confidence that 94% of all future production units will meet specifications, providing documented evidence for regulatory compliance and production release. The automated process demonstrated superior consistency compared to manual methods while maintaining the same quality standards.