Release an Instrument
Resolve an individual hold against current evidence before returning an instrument to use.
5 stages · 1 approval
Roles and responsibilities
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Step 2Check prerequisites
Hold NumberInstrumentReasonOpened AtCalibration In Progress
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Step 3Decide the release
Release NumberInstrumentHoldCertificate
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Step 5Confirm operating status
Instrument NumberNameLocationCustodian
Process steps
Follow the process from start to finish. Select a step to see who acts and what changes.
Assemble the request
Calibration Coordinator or Instrument Custodian identifies the hold and attaches the required certificate, assessment and completion evidence. The request records the requester and the evidence versions being presented for review.
Check prerequisites
Quality Manager inspects the current plan, accepted unsuperseded evidence, result suitability and unresolved required actions. Historical impact holds require an approved assessment. Failing or indeterminate final results prevent return to service.
Decide the release
An independent Quality Manager approves or rejects the request with a reason. The authenticated approver must differ from the requester. Any intended-use restriction must be explicit and compatible with the approved technical evidence.
Apply the decision atomically
The approved decision releases only the named hold and appends audit evidence in the same transaction. The system rechecks record versions and dates; a new concurrent hold prevents the instrument from becoming available.
Confirm operating status
Instrument Custodian confirms the resulting status before new use. Instruments with another active hold, an expired obligation or incomplete qualification remain unavailable, even though an individual release request was approved. Every new use also checks the selected range and applied restrictions. An instrument-level Available state never permits a blocked range; unsupported restrictions keep the instrument held.
1 approval required in this process
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Decide the release
Quality Manager signs · apply the decision atomically waits
ReleaseRequests - Repeated approval requests must return the original outcome without duplicate effects.
- A changed certificate or stale request needs renewed review.
- An administrator cannot bypass quality approval through configuration access.
- Due-date authorization checks use the current date even when scheduled checks are delayed.
- Historical invalid use remains evidence for assessment; it is never rewritten as permitted use.
When the process needs attention
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hold
Assemble the request
Calibration Coordinator or Instrument Custodian identifies the hold and attaches the required certificate, assessment and completion evidence.
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hold
Check prerequisites
Historical impact holds require an approved assessment.
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reject
Decide the release
An independent Quality Manager approves or rejects the request with a reason.
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hold
Apply the decision atomically
The approved decision releases only the named hold and appends audit evidence in the same transaction.
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hold
Confirm operating status
Instruments with another active hold, an expired obligation or incomplete qualification remain unavailable, even though an individual release request was approved.
Records and postings
| Stage | Records | Effect |
|---|---|---|
| 1 Assemble the request | ReleaseRequests | Freeze the proposed supporting evidence versions |
| 2 Check prerequisites | CertificatesImpactAssessmentsCorrectiveActions | Confirm current release conditions |
| 3 Decide the release | ReleaseRequests | Authorize or reject independently |
| 4 Apply the decision atomically | HoldRecordsInstrumentsAuditEvents | Resolve one hold and recompute availability |
| 5 Confirm operating status | InstrumentsInstrumentUseRecords | Permit only eligible new use |
Process reports
All reportsHistorical Impact Exposure
Groups affected uses and documented unknown populations by assessment, disposition and acknowledgement state without treating candidates as confirmed defective product.
Hold and Release History
Shows every instrument hold, request, decision owner and residual restriction after individual releases.
Certificate Review Backlog
Identifies submitted evidence awaiting independent technical review and rejected documents awaiting correction.
Calibration Due Exposure
Groups current approved plans by location and criticality, showing overdue instruments and unresolved holds without counting superseded plans.
Interval Decision History
Links approved or rejected cadence changes to evidence, effective dates and superseding plans.
Agent support
An assistant cannot invent measurement results, uncertainty values or missing use history. It cannot approve its principal's own preparation, assert accreditation, release a held instrument or issue a product recall. Human decisions must use authenticated authority and the server-enforced controls specified for the application.
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Other processes
4 morePlan and Recall
Approve calibration obligations and arrange the instrument return before its due date.
5 stages · 1 approval
Calibrate and Review
Preserve original observations and independently review the resulting certificate.
5 stages · 1 approval
Assess Out-of-Tolerance Impact
Investigate potentially affected use and record an independent quality disposition.
5 stages · 1 approval
Review Calibration Intervals
Change future calibration timing using reviewed evidence while preserving earlier obligations.
5 stages · 1 approval