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Deviation records capture unexpected quality events from initial report through investigation and closure, with linked CAPAs where follow-up action is required.

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Deviation Register

All deviations are shown with severity (Critical, High, Medium, or Low), status, source, and date opened. Filter by severity to prioritize higher-risk events, and review aging regularly so open investigations do not stall.

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Investigation Detail

The detail page captures the event description, source, current root-cause and impact notes, timeline, linked CAPA, and closure signature. Starting the investigation assigns an initial investigator (persisted and audit-logged), record the investigation notes and a structured RCA, and create a linked CAPA when corrective or preventive action is needed. Ownership can be handed over later via Reassign investigator, which captures a reason for change.

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Closure Controls

Closing a deviation requires a closure note and credential re-verification from the signer. This creates an attributable, Part 11-style signature manifestation linking the signer, meaning, timestamp, and record transition. Do not close a deviation while evidence, containment, impact assessment, or linked CAPA decisions remain unresolved.

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Classification

New deviations are created as Unplanned. QA classifies a deviation as Planned with a signature while it is still open. A deviation with no recorded classification shows as Unclassified, and the register can be filtered by classification.

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Guided five Whys (where enabled)

Where guided RCA is enabled, choosing 5-Whys in Record RCA walks you through the analysis one question at a time. Enter a Problem statement, then answer each “why” in turn. Stop after three to five Whys with This is the root cause. Review the Root-cause conclusion, which starts from your last answer, add any Contributing factors, enter a reason and select Save RCA. The result is stored as the deviation’s RCA, the same as a free-entry RCA. A closed deviation must be reopened before its RCA is amended.

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Timeline (where enabled)

Where the deviation timeline is enabled, the detail page has a read-only Timeline. It shows the deviation, its CAPAs and their actions, linked change controls, and their quality tasks, each with status and due date. Items that run past the deviation’s due date, or past their parent’s due date, are flagged as overruns. The timeline shows links between records only, not finish-to-start dependencies. Deviations without an SLA due date are not evaluated for overruns. The Deviation Timelines page lists deviations that have overrunning linked work, with counts of open items past the deviation due date, items due after it and items finished after it. For the end-to-end procedure, see Raise a deviation.