Review CAPA workflows, severity timings and sources

Understand the active workflow and how configuration affects new CAPAs.

Understand the active workflow and how configuration affects new CAPAs.

Inspect the active workflow

Product location: /qms/settings/capa

Open QMS / Settings / CAPA. The page shows the active default workflow, its description, number of steps and number of transitions. The step sequence identifies the initial stage and marks stages with signature or AI-assistance settings. Scroll the sequence horizontally when it extends beyond the panel.

The diagram communicates the configured sequence. It is not a record of a CAPA progressing through those stages. Inspect each actual CAPA's current stage and activity when reviewing work.

Workflow names, stages and descriptions can vary by organisation and provisioned templates. A template description that cites a standard is not proof that its configuration or an individual CAPA satisfies that standard.

Change the default for future work

Product location: /qms/settings/capa

Other available workflows appear below the current one. An active workflow that is not the default offers Set as Default. Inactive workflows are labelled and do not offer that action.

Review the intended workflow before selecting it. After the change, reopen Settings and verify the default, then inspect the banner on a new CAPA form. Existing CAPAs retain their stored workflow association; selecting a new default is not a migration action for them.

Some CAPAs created with a standard association can use a matching standard-specific workflow instead of the default. The generic manual creation form does not itself offer a standard selector. Inspect the resulting record when it originates through another workflow.

This customer page does not provide full workflow authoring, step editing or transition editing. Ask the responsible administrator to arrange configuration changes through the supported administration process.

Read severity timing

Product location: /qms/settings/capa

The severity table shows each configured level and the allotted days for Containment, Root Cause Analysis, Actions, Verification and Total. Inactive levels are visually muted. The displayed total adds the four phase durations.

At creation, phase deadlines are cumulative: containment starts from the creation date; root-cause time follows containment; action time follows root-cause work; verification follows action work. For example, durations of 2, 3, 5 and 7 days produce successive deadlines at 2, 5, 10 and 17 days from creation.

The create form initially selects the first severity in configured order. Review that selection instead of accepting it automatically. A provided source may define a default severity when none was supplied.

An explicit target close date is independent of the calculated phase dates. Changing the case's severity or target is not a reason to assume all existing deadlines were recalculated. Reopen the case and review each phase date.

Severity settings can also influence escalation and management-review requirements. The timing table is a reference display; it does not provide inline editing of those rules.

Review the source catalogue

Product location: /qms/settings/capa

Source entries describe how CAPAs originate, including whether an external or linked reference is required. Available sources can include manual entry, audit findings, form submissions, document nonconformities, incidents and other configured sources.

An Auto-create badge is a source-catalogue flag, not evidence that a particular event created a CAPA. The originating workflow and its policy determine the actual result.

A source classification does not create a link to a particular record by itself. Use the originating finding, form or document workflow when a traceable association is needed. For an external reference, retain an identifier that another reviewer can locate.

If configuration appears empty or incomplete, reload and check access before concluding that the organisation has no configured workflow, severity or sources. A loading failure and an intentionally empty catalogue require different follow-up.

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