Sampling misses gowning errors
QA samples little. Back and cuffs are missed. Non-compliant entry contaminates product and money is lost.
StoneDT
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StoneDT
Customer background
A well-known pharma site with strict sterile gowning. Before the cleanroom, staff must complete the official SOP covering front, side, cuffs, back, cap and shoe covers. Exposed skin or bad gowning quickly causes cross-contamination.
QA sampling is limited and fatigued eyes miss a lot. Non-compliant entry can scrap batches. There is no digital archive for later quality events. The plant needed full-dimension AI gowning checks with a complete trail.
Pain points Sampling misses gowning errorsQA samples little. Back and cuffs are missed. Non-compliant entry contaminates product and money is lost.
Inconsistent checks, human errorInspectors disagree. Clean control is uneven. GMP pressure is high.
No digital trail, hard to traceNo video. Quality cannot be traced to gowning. GMP and liability lack evidence.
SolutionEdge AI checks the five gowning steps live: exposed hair, torn hems, non-compliant dress. Failures alarm in seconds with video. Fail = blocked. Human plus machine at the cleanroom door.
SOP UI — pass
SOP UI — exception
7×24 capture of every gowning event. Person, crew and shop stats lift pass rate above 99% into a searchable database. Dashboards show plant-wide trends, hot violation types and focus people—evidence on tap for GMP audit, official inspection and full-process trace. Block hair, dust and microbes at entry; cut contamination, scrap and rework.