Overdue Calibration and the Unrecorded Rework at Vertex Packaging
Vertex Packaging converts flexible film for food-contact use, employing 210 people across two shifts. The QMS is six months into implementation. The maintenance log lists 120 measuring instruments; 14 calibration dates have passed, including three on the seal-strength tester used for a customer's mandatory burst test. Calibration certificates exist for the rest, but the register does not link instruments to the product characteristics they verify. Twelve agency workers have been on the packing line for four months; their induction was a 20-minute safety briefing, and no competence records exist. One print cylinder owned by a customer has been stored on an open rack for eight months and shows corrosion. Last month 2,300 m of film with print misregistration was found at final inspection; the shift leader reworked 900 m, scrapped the rest, and recorded nothing. The production manager says: 'We've always done it this way and we've never had a recall.'
1. Set out the order of actions for the 14 overdue instruments. Should production stop, and what must be done about product already tested on the overdue seal-strength tester?
Read the worked answer
Act by risk, not by completing the register alphabetically. 7.1.5.1 requires measuring equipment to be suitable and maintained to ensure valid results; 7.1.5.2 requires calibration or verification against traceable standards where measurement traceability is a requirement or is relied on for valid results.
The three overdue seal-strength testers matter most because they support a customer-mandated burst test. The sequence:
- Quarantine the instruments and stop releasing product on their results. Whether the whole line stops depends on whether an alternative verified instrument exists; stop the release decision, not necessarily all production.
- Identify all product tested since each calibration due date. Without instrument-to-characteristic links, use batch records and operator logs.
- Calibrate or verify. If an instrument is found out of tolerance, assess the validity of prior results (7.1.5.2) and act on affected product (8.7).
- Record the assessment and decision, including customer notification if the burst test is a contractual characteristic.
The remaining 11 overdue instruments should be triaged by effect on product and customer requirements, not treated as equal. Fix the register so each instrument is linked to the characteristic it verifies. 'No recall so far' is not evidence: the risk is that undetected nonconforming film has already shipped, and the customer's burst test is the only control.
2. Evaluate the competence arrangements for the 12 agency workers. What does clause 7.2 require, and how does agency status change the obligation?
Read the worked answer
Competence is a control condition, not an administrative record. 7.2 requires determining necessary competence, ensuring persons are competent (through training, mentoring or experience), and retaining documented information as evidence. 8.5.1 requires controlled conditions including the competence of persons.
For the 12 agency workers, define what competence the packing line needs: product identification, film handling, label checks, nonconformity escalation, food-contact hygiene. A 20-minute safety briefing covers none of it. Then:
- provide role-specific induction and supervised practice, with sign-off against observable criteria;
- record the sign-off; agency status does not remove the requirement, because the workers perform work under the organization's control;
- clarify with the agency (8.4) what training and records it provides, and verify rather than assume;
- consider whether 7.1.2 people resources are adequate, since 12 temps on the line for four months looks structural rather than seasonal.
If any of the 2,300 m misregistration occurred on their shift, competence should be tested as a contributing cause in the 10.2 investigation. 'No records' often also means nobody was accountable for the line, so check supervision as well.
3. The 2,300 m misregistration event and the corroded customer cylinder both need handling. Explain the actions required under 8.7, 10.2 and 8.5.3.
Read the worked answer
The event is a nonconforming output and requires both 8.7 control and 10.2 corrective action.
8.7: the organization must ensure output that does not conform is identified and controlled to prevent unintended use or delivery, and retain documented information describing the nonconformity, the actions taken, any concessions, and the authority deciding the action. Reworking 900 m and scrapping 1,400 m may be acceptable dispositions, but 'recorded nothing' means there is no evidence that the rework was verified or that the scrap was actually removed. Reconstruct from the shift, then fix the log.
10.2: treat it as a nonconformity with a cause to eliminate. Misregistration commonly traces to cylinder wear or damage, plate mounting, tension, ink viscosity, or registration control settings. The investigation should test those causes against batch records; the corrective action must address the cause, not just retrain the operator. Check whether similar events occurred on other jobs - if so, the scope of the investigation is too narrow.
8.5.3: the corroded customer-owned cylinder must be identified, protected, reported to the customer, and the record retained. The production manager's 'never had a recall' is not a control; the absence of a record is itself the finding.