Assess Out-of-Tolerance Impact
Investigate potentially affected use and record an independent quality disposition.
5 stages · 1 approval
Roles and responsibilities
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Step 1Contain the instrument
Hold NumberInstrumentReasonOpened AtCalibration In Progress
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Step 5Approve the assessment
Assessment NumberInstrumentWindow StartWindow End
Process steps
Follow the process from start to finish. Select a step to see who acts and what changes.
Contain the instrument
Metrology Reviewer raises the relevant hold and records the technical concern. Immediate containment preserves the reason and time. It does not decide whether every prior product or test result is defective.
Define the exposure window
Quality Manager prepares an assessment with the earliest and latest possibly affected use and a reason for the boundaries. Evidence may support a narrower window, while gaps can require a more conservative population.
Reconcile affected use
Quality Manager links use records to external inspection, lot, serial or test identifiers. Where detailed history is missing, describe the unknown population explicitly. An empty import or search result is not evidence that no instrument use occurred.
Propose dispositions
Quality Manager records the basis for no-impact, retest, containment or escalation decisions. External case references and acknowledgements remain separate. Corrective work receives an owner and completion evidence requirements.
Approval required
Approve the assessment
A different eligible Quality Manager reviews the population, uncertainty and disposition evidence. Approval requires treatment of every candidate and documented handling of incomplete history, including accepted external escalation where applicable.
Approvals and exception handling
1 approval required in this process
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Approve the assessment
Quality Manager signs · closes the process
ImpactAssessments
When the process needs attention
- exception Recalibration success is used to close the historical investigation without reviewing affected work.
- exception Missing use data is silently interpreted as no exposure.
- exception A local escalation record is mistaken for an acknowledged external quality case.
- exception The investigator approves their own population and disposition decisions.
Records and postings
| Stage | Records | Effect |
|---|---|---|
| 1 Contain the instrument | HoldRecords | Restrict further use |
| 2 Define the exposure window | ImpactAssessments | Record evidence-based boundaries |
| 3 Reconcile affected use | InstrumentUseRecordsAffectedUses | Retain known and unknown populations |
| 4 Propose dispositions | AffectedUsesCorrectiveActions | Assign supported treatment and follow-up |
| 5 Approve the assessment | ImpactAssessments | Independently authorize the quality decision |
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.
Calibration Due Exposure
Groups current approved plans by location and criticality, showing overdue instruments and unresolved holds without counting superseded plans.
Hold and Release History
Shows every instrument hold, request, decision owner and residual restriction after individual releases.
Interval Decision History
Links approved or rejected cadence changes to evidence, effective dates and superseding plans.
Run by an agent
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.
# Example after configuration
curl -fsSL https://www.erp.ai/skill.md
# Paste the output into your agent
assess out-of-tolerance impact · contain the instrument on HoldRecords
Metrology Reviewer raises the relevant hold and records the technical concern.
assess out-of-tolerance impact · define the exposure window on ImpactAssessments
Quality Manager prepares an assessment with the earliest and latest possibly affected use and a reason for the boundaries.
assess out-of-tolerance impact · reconcile affected use on InstrumentUseRecords, AffectedUses
Quality Manager links use records to external inspection, lot, serial or test identifiers.
assess out-of-tolerance impact · propose dispositions on AffectedUses, CorrectiveActions
Quality Manager records the basis for no-impact, retest, containment or escalation decisions.
assess out-of-tolerance impact · approve the assessment on ImpactAssessments
approval · waiting for the quality manager
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
Release an Instrument
Resolve an individual hold against current evidence before returning an instrument to use.
5 stages · 1 approval
Review Calibration Intervals
Change future calibration timing using reviewed evidence while preserving earlier obligations.
5 stages · 1 approval