01
Problem
A custom ICT fixture used for System 7 Battery PCBA production acceptance required objective evidence that it was installed correctly, operated as intended, detected known defects, and preserved data integrity.
02
Constraints
- The fixture operated with a Medalist i3070 ICT system and supplier-provided test software.
- Known good and known bad boards were required to challenge detection capability.
- Production data retention and access control needed verification.
- Certain operating procedures were draft-controlled and needed independent review.
03
Engineering Decisions
- Used an integrated IQ/OQ structure to link installation controls to functional performance.
- Verified barcode and autofile enforcement to prevent incorrect product testing.
- Included grounding resistance and safety checks before production use.
- Required independent review for executed evidence.
04
Validation
- IQ verified documentation, environment, hardware, interfaces, training, and software installation.
- OQ confirmed defect detection across PCB positions and repeated panel testing.
- Cycle-time and data-retention requirements were verified against acceptance criteria.
05
Risk & Mitigation
- Knowledge-loss risk was mitigated with training verification and controlled procedures.
- Equipment damage risk was mitigated with grounding verification and controlled vacuum steps.
- Data integrity risk was mitigated with access control and electronic record checks.
06
Outcome
The ICT fixture was qualified for production use with audit-ready evidence covering installation, operation, detection capability, cycle time, and data retention.