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Out-of-tolerance status reference

Exact investigation states, legal transitions, closure checks, and equipment restoration implications.

Reference and support For Owner, Administrator, Quality manager, Calibration manager, Calibration engineer

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

StatusMeaningLegal next statusWhat users should do next
openCase has been created from approved unacceptable calibration work but investigation has not begununder_investigation, awaiting_approval, cancelledAssign 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_investigationInvestigation evidence or assignment is being actively maintainedawaiting_approval, cancelledComplete the required investigation fields and every non-cancelled corrective action, then submit for quality approval.
awaiting_approvalInvestigation and action evidence are frozen for independent quality reviewclosed, under_investigationA different authorised quality user should approve and close, or reject with comments so the investigation can be revised.
closedIndependent quality review approved the completed investigationNoneReview the approved disposition. Restore or retire equipment through its separate equipment action when justified.
cancelledThe investigation was stopped with a retained cancellation reasonNoneRetain 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:

DispositionMeaning for the investigationRequired follow-up
eligible_for_return_to_serviceInvestigation supports a later restoration decisionCite later approved acceptable calibration or a quality rationale, close the case, then use the separate equipment restoration action
remain_quarantinedEquipment should stay quarantinedLeave equipment quarantined and continue the organisation's controlled follow-up
retire_equipmentInvestigation recommends retirementComplete the separate equipment retirement workflow when its dependency checks permit
no_further_actionInvestigation concludes no additional case action is neededClose 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.