Out of tolerance as found, with no impact assessment recorded
The auditor's question: what did it measure since its last good calibration, and were those results still valid? ISO 9001, ISO 13485 and AS9100D ask the organization to judge whether earlier results remain valid; IATF 16949 asks for that judgement and for the customer to be told if suspect product shipped; ISO/IEC 17025 treats it as nonconforming work.
When the finder raises it
Fires when the as-found column reads out of tolerance and the impact assessment column is blank, "no" or pending. The period in question runs from the calibration before (the last calibration minus the interval) to the last calibration.
A question for the quality manager
Which parts or lots were measured with it between the calibration before and this one, and what was decided about them?
Clauses behind it
12 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 7.1.5.2.1 Calibration and verification records | an automotive supplier holding IATF 16949 certification |
| IATF 16949 | IATF 16949 8.7.1.3 Control of suspect product | an automotive supplier holding IATF 16949 certification |
| AS9100D | AS9100D 7.1.5 Monitoring and measuring resources | an aerospace supplier holding AS9100 certification |
| AS9100D | AS9100D 8.7 Control of nonconforming outputs | an aerospace supplier holding AS9100 certification |
| AS9100D | AS9100D 10.2 Nonconformity and corrective action | an aerospace supplier holding AS9100 certification |
| ISO 13485 | ISO 13485 7.6 Control of monitoring and measuring equipment | a medical device maker holding ISO 13485 certification |
| ISO 13485 | ISO 13485 8.3.1 Control of nonconforming product: general | a medical device maker holding ISO 13485 certification |
| ISO 13485 | ISO 13485 8.5.2 Corrective action | a medical device maker holding ISO 13485 certification |
| ISO/IEC 17025 | ISO/IEC 17025 7.10 Nonconforming work | a testing or calibration laboratory accredited to ISO/IEC 17025 |
| 21 CFR 58 | 21 CFR 58.63 Maintenance and Calibration of Equipment | a laboratory running nonclinical studies under 21 CFR 58 |
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.