Test Kit Management: The Hidden Weak Point In Your Visual Inspection Program

Many pharmaceutical companies still manage the critical process of visual inspection using outdated, analog methods, often overlooking one of the most important components: defect test kits. While these kits are vital for inspector training, qualification, and ongoing performance monitoring, they are often poorly managed through manual processes, leading to significant risks.

Inconsistency in test kits can cause performance drift among inspectors, produce unreliable probability of detection (POD) metrics, and increase vulnerability during audits. Instead of being treated as secondary tools, defect test kits should be managed as calibrated inspection standards, ensuring their integrity and traceability. Adopting a structured management system can mitigate these risks and create an audit-ready inspection program.