Impact and Hold Control

Keep historical risk visible after recalibration

The impact workflow begins when an as-found failure, overdue use, damage or a reference concern may affect earlier measurements. A successful repair answers whether the instrument can be suitable for future work. It does not answer which earlier inspections, tests or products relied on questionable evidence. These questions remain connected through the instrument history but require separate decisions.

ImpactAssessments records an evidence-based window of potentially affected use. The Quality Manager documents why the window starts and ends where it does. A last known satisfactory calibration may help establish the boundary, but the application does not assume that all failures began on a convenient date. Uncertainty in the population is recorded explicitly.

Review affected use rather than guessing product outcome

AffectedUses links the assessment to historical InstrumentUseRecords and their external lot, serial, job or test identifiers. Each candidate receives a reasoned disposition. A candidate list is not a list of confirmed defective product; it is the work the quality team must evaluate using the relevant evidence.

• Record why a use is included or excluded from the assessment.
• Preserve retest evidence and external quality case references.
• Distinguish containment, further evaluation and accepted no-impact decisions.
• Keep missing use history visible as an unresolved population.
• Record external acknowledgement separately from a local handoff request.

Where detailed history is absent, the assessment must describe a conservative population and how it will be treated. An empty search result cannot be taken as proof that the instrument was unused. Approval needs that uncertainty addressed, with an explicit rationale and authorized external escalation where appropriate.

Keep product authority in the right workflow

The calibration application can assemble evidence and refer a case to the customer’s quality system. Product withdrawal, customer notification and recall execution require their own authorized process. An assistant may help prepare the affected-use list, but cannot approve a recall or mark an external case resolved from a successful request alone.

CorrectiveActions tracks the work needed for the calibration assessment, including repairs, evidence retrieval or process changes. Completion needs evidence and independent verification. A Quality Manager who prepared an assessment requires another eligible Quality Manager to approve it. These decisions remain auditable even after the instrument returns to service.