Step 1 · Intake

Describe the new quality event

Matches against historical deviations — matching terms appear in the next step.

Quality Event NumberProblem CategorizationCriticalityDate of Occurrence

Short DescriptionProblem Statement

On 10SEP26, during the routine review and release of previously collected viable environmental monitoring (EM) sample monitor groups in LabVantage, an Environmental Control (EC) Technician identified a sample record without the required collection attribute for Activity Type (Production or Rest). A subsequent review identified 336 viable EM samples collected from January 1, 2025, through September 10, 2026 that were missing this attribute.

The Activity Type attribute is expected to be documented for viable EM samples in LabVantage to support complete sample record data and transfer of applicable data to the Sigma digital trending system. The affected samples did not transfer to Sigma and therefore were excluded from routine electronic trending. This represents a departure from the expected LabVantage functionality and data-management process for viable EM sample collection and trending. The cause of the missing attribute and associated transfer failure has not yet been determined and is under evaluation by DTS.

Matching inputs

Match ScopeScope dimension is an open question (OQ-4) — your choice is recorded with the verdict.Lookback periodHistorical events older than the window are excluded from matching.

Keywords