The exclusion that wasn't: 8.3, calipers and agency labour at a small machine shop
Precision Components Ltd (42 employees) machines parts to customer drawings. Its quality manual states that clause 8.3 (design and development) is 'not applicable because design is carried out by our customers'. During the stage 2 audit you review three job cards for a valve housing and see that a technician re-drew the customer drawing, changed a 0,05 mm tolerance to 0,08 mm to suit the available tooling, and recorded the change on an internal concession note that the customer later signed. In the final inspection area, six digital calipers carry calibration labels dated 14 months ago; the stated interval is 12 months. Two agency operators have worked on the final assembly bench for five weeks; the supervisor says 'they are only labourers, they don't need training records'.
1. How do you evaluate the claim that clause 8.3 is 'not applicable', and what do you do with the concession-note evidence?
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Clause 4.3 permits a requirement to be declared not applicable only where it cannot be applied, and the justification must be documented and reviewed as the organisation changes. The test is not the label the company uses but what the organisation actually does: does it determine, review or change requirements for the product?
Re-drawing a customer drawing and altering a tolerance changes a product characteristic. That is a design change, whether or not the customer countersigns it. So at least 8.3.6 (control of design changes) applies, and arguably 8.3.2 to 8.3.5 depending on how much decision-making the company performs (tooling adaptation, material substitution). The exclusion is therefore unjustified; the finding sits against 4.3 (scope/justification) and/or 8.3.
Do not stop at one job card. Before grading, gather extent:
- how many concession notes in the last 12 months, across which product families;
- who authorises them, against what criteria;
- whether verification/validation (8.3.4, 8.3.5) and review of changes (8.3.6) are performed and recorded;
- whether the released drawing and inspection plan reflect the change.
Interview engineering rather than only top management, and confirm with top management during 5.1/4.3 discussion that the exclusion is a deliberate decision, not an oversight. If changes are routine and no change-control process exists, this is a system failure and normally graded major; a single, fully reviewed and customer-approved deviation would be a lesser finding. Record the job card identifiers and the concession notes as the objective evidence.
2. The calipers: is this a nonconformity, and if so against which requirement? How do you establish the extent?
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Clause 7.1.5.2 requires measuring equipment to be calibrated or verified, or both, at specified intervals, or prior to use, against measurement standards traceable to international or national standards, where measurement traceability is a requirement or is considered essential by the organisation.
Six calipers used for final inspection are 14 months into a stated 12-month interval. The organisation has defined a control (the interval and the label) and has not followed it. That is objective evidence of a nonconformity against 7.1.5.2. Whether the equipment is 'essential' is easy here: it is used to release product against drawing tolerances.
To establish extent and severity, before you decide minor versus major:
- obtain the equipment register and count how many of how many are overdue, and for how long;
- identify which products and batches were released using those assets since expiry (cross-reference 8.6 records);
- look for evidence of drift or failed re-verification, or a customer complaint traceable to measurement;
- check whether the calibration provider was itself competent and whether other equipment types (gauges, torque tools) share the same weakness;
- check 8.7: if product was released on unreliable measurement, was it identified and handled?
If product conformity was independently assured (e.g. a master ring gauge check, customer inspection) an isolated lapse may be minor. If there is no alternative verification and shipped product is affected, the failure threatens product conformity and is normally major. Write the finding with asset numbers, dates, interval, and the batches affected.
3. The two agency operators: what evidence do you need before deciding whether a nonconformity exists under 7.2?
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Clause 7.2 applies to persons doing work under the organisation's control that affects quality performance, regardless of the employment contract. The question is not status but effect: do their tasks affect conformity to requirements?
Evidence to collect before concluding:
- what the two operators actually do (assembly steps, torque, fittings, visual checks, signing records) and whether any output is released on their work;
- the competence criteria for that bench (7.2 a) and whether it exists at all;
- evidence of evaluation of competence (7.2 b) - training records, authorisation matrix, witnessed checks, probation sign-off;
- what supervision and verification exist (8.5.1 controlled conditions) - if every item is 100% verified downstream by a competent person, the risk is reduced but the requirement to be competent remains;
- the agency contract and induction records, to see whether the organisation takes any responsibility at all.
Also consider 8.4.1 if the agency is an external provider whose personnel provision affects the QMS.
If the operators carry out work affecting conformity with no competence criteria, no evaluation and no authorisation, that is a nonconformity against 7.2. If criteria exist and competence is evidenced by supervised sign-off, the finding is not supported and no nonconformity should be raised. Avoid stating that 'agency staff are untrained' from a supervisor's opinion; verify against records and, where possible, observe the work against the acceptance criteria.