Overview

Quality Events overview

Quality Events tracks what went wrong, what you did to contain it, and whether the fix actually worked, across four record types: deviations, nonconformities, CAPA, and concessions. Each one runs in its own Jira space, with the same approval and audit trail as the rest of your quality system.

A quality event can start almost anywhere: a failed inspection, a customer complaint, an audit finding. Which record you open depends on what actually happened, not on where the problem was found.

What you can do

Record a deviation

A departure from an approved instruction, procedure, or specification. Every deviation carries a Planned field: planned when it is authorized before the work happens, unplanned when it is found after the fact.

Register a nonconformity

Product, material, or a component that fails to meet requirements. Its disposition decides what physically happens to the affected items.

Run a CAPA

Corrective and preventive action that eliminates a root cause so the problem does not recur. The plan of actions is reviewed and approved before implementation, then checked for effectiveness.

Grant a concession

A documented authorization to use or release something that does not meet requirements, limited in scope and by a validity period with a start and an end date.

How they connect

The four record types are not separate silos. Work can escalate from one into another, and closing a record can depend on tasks or approvals that live on a different one.

Deviation / Nonconformity → CAPA

Escalate when the departure or nonconformance needs a root cause fix, not just a one-off disposition. The CAPA then runs its own lifecycle while the original record continues its own.

Deviation / Nonconformity / CAPA → Concession

Any of the three can produce a concession. On a nonconformity, choosing the Use as is disposition strategy requires one.

Deviation / Nonconformity / CAPA → Task

Each carries its own tasks, with their own lifecycle. Every task on a record has to be done before that record can close.

Records also link out to affected documents in Document Control, to affected training requirements, to risks, and to changes.

Where the work happens

Each record type lives in its own Jira space: Deviations (DEV), Nonconformities (NC), CAPA, and Concessions (CONC). Inside a space, the app appears as a space tab called Quality Events, with a sub-tab per record type and a Tasks sub-tab. Any record can also be reached from the space’s All work tab, filtered on the work type. To see across every space at once, open the Jira side menu, select Apps, then Quality Events.

The global Quality Events view, with a tab for each record type and its tasks. The Deviations tab shown here summarizes status, planned versus unplanned, and warnings, then lists every deviation in the Deviations space.

Standards it supports

Quality Events supports the nonconformity control, corrective and preventive action, and deviation-handling requirements of ISO 13485. Every approval is signed by a one-time password, so each record carries an electronic signature attributable to one person. Configured correctly, that supports compliance with FDA 21 CFR Part 11.

New to Quality Events? Start with Key concepts for the vocabulary, then follow Manage a deviation to work through your first record start to finish.