Out-of-tolerance status reference
An approved calibration event with a failed or indeterminate result opens one out-of-tolerance case and quarantines eligible equipment in the same controlled transaction. The case then follows the lifecycle below.
Lifecycle overview
open -> under_investigation -> awaiting_approval -> closed
| ^ |
| | -> under_investigation
| |
-> cancelled -> cancelled
Assignment or the first investigation update moves an open case to under_investigation. Rejection from quality review returns an awaiting_approval case to under_investigation.
Statuses and next actions
| Status | Meaning | Legal next status | What users should do next |
|---|---|---|---|
open | Case has been created from approved unacceptable calibration work but investigation has not begun | under_investigation, awaiting_approval, cancelled | Assign an investigator and record containment, impact, cause, disposition, and closure evidence. Submit only when all required fields and actions are complete. Cancel only with a valid documented reason. |
under_investigation | Investigation evidence or assignment is being actively maintained | awaiting_approval, cancelled | Complete the required investigation fields and every non-cancelled corrective action, then submit for quality approval. |
awaiting_approval | Investigation and action evidence are frozen for independent quality review | closed, under_investigation | A different authorised quality user should approve and close, or reject with comments so the investigation can be revised. |
closed | Independent quality review approved the completed investigation | None | Review the approved disposition. Restore or retire equipment through its separate equipment action when justified. |
cancelled | The investigation was stopped with a retained cancellation reason | None | Retain the case as history. Resolve equipment status separately; cancellation does not restore equipment. |
closed and cancelled are terminal states. Cases are never hard-deleted.
Although the service can submit a complete open case directly, normal use moves it to under_investigation through assignment or the first saved investigation update.
Submission requirements
Before submission, record:
- severity;
- summary;
- immediate action;
- impact assessment;
- root cause;
- disposition; and
- closure summary.
Every corrective action that is not cancelled must be complete. Completed and cancelled corrective actions are terminal and remain retained. Submission freezes the investigation in awaiting_approval.
Separation of duties
The final approver must be a different authorised quality user. The assigned investigator, the case submitter, and the performer of the failed or indeterminate calibration event cannot approve and close the case. Holding an owner-level permission does not bypass these independence checks.
Rejection requires comments and returns the case to under_investigation. Users should correct the investigation or actions, then resubmit it for another independent review.
Disposition and equipment status
The implemented disposition values are:
| Disposition | Meaning for the investigation | Required follow-up |
|---|---|---|
eligible_for_return_to_service | Investigation supports a later restoration decision | Cite later approved acceptable calibration or a quality rationale, close the case, then use the separate equipment restoration action |
remain_quarantined | Equipment should stay quarantined | Leave equipment quarantined and continue the organisation's controlled follow-up |
retire_equipment | Investigation recommends retirement | Complete the separate equipment retirement workflow when its dependency checks permit |
no_further_action | Investigation concludes no additional case action is needed | Close independently, then make any necessary equipment decision separately |
Closing or cancelling a case never changes equipment back to active automatically. open, under_investigation, and awaiting_approval cases are active cases and block restoration. Restoration is also blocked while any other active case exists for the equipment.
Corrective-action states
Corrective actions use their own lifecycle and permissions. An action can be maintained while actionable, then completed with completion evidence or cancelled with a reason. Completed actions cannot be edited or reopened. Case closure does not erase any action or its revisions.
Permission implications
Case read, assign, update, submit, approve, reject, close, cancel, and corrective-action operations use separate permissions. Operational users may work only on cases or actions assigned to them unless they have wider work access. The Metra also enforces organisation scope, current version, required fields, action completion, lifecycle, and separation of duties.