The overdue gauge and the unaudited night shift
Precision Parts Ltd machines bearing housings for agricultural equipment. It has 42 employees on two shifts; the night shift produces about 30% of output. The certification body is conducting the second surveillance audit of an ISO 9001:2015 certificate issued 26 months ago.
During the audit the following is found:
- The bore gauge used for 100% final inspection of a 62 mm bearing seat, tolerance ±0.010 mm, carries a calibration label dated 14 months ago. The equipment register records a 12-month interval. No product has been re-verified since expiry.
- Nine months of complaint records show four oversize-bore complaints, including one returned lot of 240 pieces.
- The internal audit programme for the last three years covers only day-shift processes. Night shift, despatch and purchasing have never been audited. Two of the three audit reports record no findings at all.
- The most recent management review minutes are one page: sales, on-time delivery, and a note to keep an eye on scrap.
1. How would you classify the calibration finding - minor or major nonconformity - and against which clause? Set out the evidence you would gather before deciding, and state what would change your classification.
Read the worked answer
Clause. ISO 9001:2015 clause 7.1.5.2 a) requires measuring equipment to be calibrated or verified at specified intervals against traceable standards. The register sets a 12-month interval; the label shows 14 months. Secondary clauses: 8.6 (was product released on valid conformity evidence?) and 10.2.
Test the system, not the sticker. Ask: is there any mechanism that flags overdue equipment - a list reviewed monthly, a calibration contract with recall, a software prompt? Is there an interim check (daily check against a setting master) that would detect drift? Was the gauge itself verified after the event against the CMM or a calibrated master? If it is still within ±0.002 mm, the product risk collapses. Do other gauges share the same failure mode? Were the four complaints investigated in a way that would have surfaced this?
Judgement. A single overdue sticker where a recall process exists and the gauge is proven accurate is normally minor. Here the interval is recorded but nothing triggers recall, the gauge is the sole means of verifying a ±0.010 mm characteristic on 100% of output, and there is an unresolved complaint history. If accuracy since expiry cannot be demonstrated, the organization cannot show product conformity → major nonconformity, with immediate containment: identify and verify every lot inspected since expiry.
2. The internal audit programme covers only day-shift processes and has produced almost no findings in three years. Is that a nonconformity against clause 9.2, or an opportunity for improvement? Justify your position.
Read the worked answer
Requirement. 9.2.1 requires audits at planned intervals. 9.2.2 a) requires the programme to consider the importance of the processes concerned, changes affecting the organization and the results of previous audits; 9.2.2 b) requires criteria and scope to be defined for each audit.
Reasoning. The standard does not require every process to be audited every year, and it does not require internal audits to find nonconformities - a clean audit is not in itself a nonconformity. What it does require is that the programme be planned around process importance and risk. Here a shift producing 30% of output, plus despatch and purchasing, has never been audited in three cycles, while the same day-shift processes are audited repeatedly. That is a programme built for convenience, not for importance: minor nonconformity against 9.2.2 a).
Second thread. Three years with essentially no findings, one-page reports and no night-shift coverage raises a competence question (7.2). Who performs the audits, what training do they have, do they understand CNC processes, and are they independent of the area? Interview the internal auditors directly.
Action. Report the programme as the nonconformity, not the absence of findings. Do not let the client 'fix' the issue by inserting a finding into the next report - that treats the symptom, not the planning failure.
3. Assess the management review against clause 9.3. What would you report, and how would you obtain the evidence efficiently?
Read the worked answer
Requirement. 9.3.2 lists the inputs the review must cover; 9.3.3 the outputs. The format is free, but the inputs must be addressed.
Evidence against the list. Present: sales, on-time delivery (c1 performance). Absent: status of actions from previous reviews (a); changes in external and internal issues (b); customer satisfaction trends; extent to which quality objectives are met; process performance and product conformity, with scrap reduced to 'keep an eye on' (c3); nonconformities and corrective actions (c4); monitoring and measurement results, including calibration; audit results (c6); performance of external providers (c7 - directly relevant here); adequacy of resources (c8); effectiveness of actions on risks and opportunities (c9); opportunities for improvement (c10). Outputs on improvement, changes and resource needs are also missing.
Judgement. Minor nonconformity against 9.3.2: the review does not give top management the information needed to show the QMS is suitable, adequate and effective. Link to 5.1.1 if top management has effectively delegated the whole review.
Efficient evidence. Ask the managing director what the last review told them about calibration, complaints and night-shift scrap. The answer usually establishes the finding faster than reading the minutes, and the minutes then corroborate it. Check also whether the outputs fed into any change to the QMS - a review with no outputs is a meeting, not a review.