Concepts

Key concepts & terminology

Quality Events uses four record types with a shared set of machinery: triggers, approvals signed by one-time password, and a small vocabulary that repeats across every guide. Once you recognize the pattern, every guide reads the same way.

The four record types

Deviation (DEV)

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

Nonconformity (NC)

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

CAPA

Corrective and preventive action. Eliminates the root cause of a problem so it does not recur, through a planned set of actions that is reviewed and approved before implementation, then checked for effectiveness.

Concession (CONC)

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.

Terms you will meet

Trigger

What surfaced the quality event: an incoming inspection, a batch or serialized item, a customer complaint, an audit finding, an asset or piece of equipment, or another quality event.

Immediate corrective action

Containment that stops further use, release, or impact of the affected item. Not a CAPA: it fixes the specific case without a root cause analysis, a systemic correction, prevention, or an effectiveness check.

Root cause analysis

Investigation into why the problem happened, using a method such as 5-Why or Ishikawa. Can be carried out in a controlled document and summarized on the record.

Disposition

What happens to the affected items: rework, reject or scrap, use as is, or return.

Disposition strategy

The disposition path chosen for the affected items, and the reasoning behind it. Choosing Use as is on a nonconformity requires a concession.

Effectiveness check

Confirmation that what was done actually worked and stopped the problem from recurring.

How approvals work

Every approval on a Quality Events record is signed. An approver responds Approve or Reject on the record’s Approvals field, adds a comment if needed, then confirms with the one-time password sent by email. The password is what records the signature: a decision entered without it is not recorded.

The three space roles

Quality Events Administrator

Administers and maintains the app. The only role that can cancel a record.

Quality Events Manager

Runs the quality event meetings and manages the activities.

Quality Engineer

Any user of the app.

Assigning these roles to users is covered in Set up Quality Events.

The four lifecycles

Deviation and nonconformity share one lifecycle. CAPA has no immediate corrective action or disposition step, and clears two separate approval gates, plan review and then closure, instead of one. Concession is the simplest of the four: no tasks, no disposition, no effectiveness check.

Record type	Main path	Side statuses
Deviation	`Identification` → `Evaluation` → `Immediate corrective action` → `Root cause analysis` (skippable) → `CAPA escalation` (optional) → `Disposition` → `Closure` → `Closed`	`Closure reject`, `Closure overdue`, `Canceled`
Nonconformity	`Identification` → `Evaluation` → `Immediate corrective action` → `Root cause analysis` (skippable) → `CAPA escalation` (optional) → `Disposition` → `Closure` → `Closed`	`Closure reject`, `Closure overdue`, `Canceled`
CAPA	`Identification` → `Evaluation` → `Root cause analysis` → `Plan` → `Plan review` → `Implementation` → `Effectiveness check` → `Closure` → `Closed`	`Plan review overdue`, `Effectiveness check overdue`, `Closure overdue`, `Closure reject`, `Canceled`
Concession	`Draft` → `In review` → `Approved`, then `Withdrawn` or `Expired`	`Rejected`, `Approval overdue`, `Canceled`

Terminal statuses behave differently by record type

On a concession, Rejected, Canceled, Withdrawn, and Expired are terminal: there is no transition out, the resolution is set to Won’t Do, and the record cannot be edited again. On a deviation, nonconformity, or CAPA, Closed and Canceled both stop editing, though either status can still be moved back to Identification, which is the only way back in. Once a record is closed, you cannot edit it in place.