What counts as nonconforming work?
Nonconforming work is any activity or result that does not meet the laboratory's own procedures or the requirements agreed with the customer: a test item measured outside the required environmental conditions, a result produced with an out-of-calibration instrument, a method version that was not released, or a report with a wrong entry. What matters is not how severe the issue is, but that it is detected, evaluated and recorded.
Do not confuse it with corrective action (8.7), which removes the root cause so the problem does not recur. Clause 7.10 deals with the individual case and its consequences for results and customers.
What clause 7.10 requires
| Subclause | Requirement |
|---|---|
| 7.10.1 a) | Responsibilities and authorities for managing nonconforming work are defined. |
| 7.10.1 b) | Actions are based on the risk levels established by the laboratory, including halting or repeating work and withholding reports. |
| 7.10.1 c) | The significance of the nonconforming work is evaluated, including the impact on earlier results. |
| 7.10.1 d) | A decision is taken on the acceptability of the nonconforming work. |
| 7.10.1 e) | Where necessary, the customer is notified and work already released is recalled. |
| 7.10.1 f) | The responsibility for authorizing the resumption of work is defined. |
| 7.10.2 | Records of nonconforming work and the actions in 7.10.1 b) to f) are retained. |
| 7.10.3 | If the evaluation indicates the nonconformity could recur or doubts arise about compliance of the management system, corrective action is taken (8.7). |
A six-step workflow
- 1
Detect and report
Anyone in the lab can raise a nonconformity: technician, quality manager, customer or auditor. Record what, when, on which job, sample and instrument it was noticed.
- 2
Take immediate action
Depending on the risk level, halt the work, withhold reports or repeat the test. The procedure states who may decide this.
- 3
Evaluate significance
Which results are affected, including earlier ones? If an instrument is found out of tolerance at recalibration, review every result produced with it since its last valid calibration.
- 4
Decide on acceptability
The work is rejected, repeated, accepted after agreement with the customer, or corrected. Decision and rationale are documented.
- 5
Notify and recall
If released results are affected, notify the customer and amend or recall the report under 7.8.8. Define who contacts the customer.
- 6
Release and check the cause
A defined person authorizes resumption. If the issue could recur, open a corrective action; the cases feed into the management review.
Typical assessor findings
- No procedure exists, or the authority to halt work is not defined.
- Issues are fixed but not recorded; there is no evidence of evaluation and decision.
- The impact on earlier results is not checked, for example after an instrument was found out of tolerance.
- Customers are not notified although released reports are affected.
- Work resumes without a documented release.
- Recurring issues do not lead to a corrective action.
Tools and data sources
A register with number, job, finding, risk level, decision, owner and release is enough for the records. The hard part is usually evaluating earlier results: which jobs used the same instrument, method or test bench?
TestLabIQ records deviations per test case and links them to jobs, test items, test benches and measurement data; an audit log shows every change. That speeds up the search for affected results. The application does not provide a dedicated nonconforming-work register with risk levels, customer notification and release workflow; a maintained spreadsheet or your QMS covers that.