Lost, quarantined or out of service but marked for product acceptance, or lost with no impact assessment
An instrument that is not in service should not be accepting product, and one that is lost cannot be checked again: the standards ask whether its earlier results remain valid, and for nonconforming output to be controlled.
When the finder raises it
Fires when the status reads lost, quarantined, out of service or retired and the register marks the instrument for product acceptance, or when a lost instrument has no impact assessment recorded.
A question for the quality manager
Is the acceptance mark on the register wrong, or was it used? For a lost instrument, what did it measure since its last calibration?
Clauses behind it
6 across the standards| Standard | Clause | Applies to |
|---|---|---|
| ISO 9001 | ISO 9001 7.1.5 Monitoring and measuring resources | a manufacturer holding ISO 9001 certification |
| ISO 9001 | ISO 9001 8.7 Control of nonconforming outputs | a manufacturer holding ISO 9001 certification |
| IATF 16949 | IATF 16949 8.7.1.3 Control of suspect product | an automotive supplier holding IATF 16949 certification |
| AS9100D | AS9100D 8.7 Control of nonconforming outputs | an aerospace supplier holding AS9100 certification |
| ISO 13485 | ISO 13485 8.3.1 Control of nonconforming product: general | a medical device maker holding ISO 13485 certification |
| ISO/IEC 17025 | ISO/IEC 17025 6.4 Equipment | a testing or calibration laboratory accredited to ISO/IEC 17025 |
ISO 9001 7.1.5Monitoring and measuring resourcesWhere monitoring or measurement is used to check that products and services conform, the organization identifies and provides the resources needed for results to be valid and reliable. It makes sure those resources suit the kind of monitoring and measurement done and are maintained so they stay fit for purpose, and it retains documented information as evidence that they are. Where traceability of measurement is required, or the organization judges it essential to confidence in the results, measuring equipment is: calibrated or verified, or both, at set intervals or before use, against standards traceable to international or national ones (and where none exist, the basis used is recorded); identified so its status is known; and protected from adjustment, damage or deterioration that would make its calibration status or later results invalid. If equipment proves unfit for its purpose, the organization judges whether earlier results remain valid and acts as needed.
On Solo, every instrument that raises this finding gets a block on the impact assessment worksheet: what the register said, the period in question with its dates, and blank fields for the lots or parts measured, the action taken (re-inspect, quarantine, notify the customer, accept with a written justification), who decided and when. The worksheet is your own record; the finder makes no judgement on any product.