Fourteen Days Overdue on a Critical Torque Wrench
At an assembly plant, six torque wrenches, TW-01 to TW-06, are controlled under procedure QP-07 with a six-month calibration interval. TW-04 was due on 2025-03-01 but was calibrated on 2025-03-15. It was used from 2025-03-02 to 2025-03-14 on three work orders, and 1,850 units were shipped. QP-07 states that no product may be released using overdue equipment. There is no evidence of a product impact assessment. The calibration lab backlog arose because purchasing did not renew the calibration contract on time. The production supervisor says the wrench read the same as TW-03 last week. Daily verification against a master checker passed on 2025-03-03 and 2025-03-10. Customer complaint history shows no torque-related complaints.
1. Is this a nonconformity? Against what requirement? What evidence should the auditor examine beyond the overdue date?
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Yes. Clause 7.1.5.2 requires measuring equipment to be calibrated or verified at specified intervals, identified to enable status determination, and safeguarded. TW-04 was used 13 days after its due date on three work orders and 1,850 units were shipped. The procedure QP-07 also prohibits release with overdue equipment. The daily verification checks against a master checker are relevant evidence of continued validity, but they do not replace the required calibration and do not by themselves prove product conformity.
The auditor should also examine 8.6 release records and whether an impact assessment was done. If the organization cannot show that the measurements remained valid, the nonconformity may extend to product release.
2. Classify the nonconformity as minor or major and justify your decision.
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Classification depends on risk and systemic failure. A minor NC is defensible if it is one device, the overdue period is short, daily verification passed on both dates, no complaints or nonconforming product are linked, and the cause is a one-off purchasing lapse. A major NC is defensible if torque is a critical characteristic, 1,850 units were shipped without impact assessment, the calibration contract lapse was known, or other devices are also overdue.
My decision would be minor only with the first set of conditions; if the device controls a safety or customer-critical characteristic and the organization cannot demonstrate product validity, I would raise major because release control failed across three lots. The auditor should not classify by the number of days alone.
3. What correction and corrective action should be required, and what audit conclusion follows?
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Correction: calibrate TW-04, quarantine any remaining product, identify the three work orders and assess measurement validity using the master checker and retained samples, and notify customers if risk cannot be excluded. Corrective action: restore the calibration contract, add a calibration due-date report with escalation, train supervisors, and require impact assessment before any overdue device is used.
The audit conclusion should record a nonconformity against 7.1.5.2 and possibly 8.6, verify containment, and schedule follow-up. If major, certification cannot be recommended until correction and corrective action are verified; if minor, follow-up at the next audit is acceptable with evidence.