REAV

Glossary

Non-conformity

also: nonconforming output

Anything that fails to meet a requirement - a device, a process step, or the management system itself - together with what was decided about it.

ISO 9001 handles non-conformity in two places, and the split is worth knowing. Clause 8.7 covers nonconforming output: an item that does not meet requirements has to be identified and controlled so it cannot be used or delivered by accident, and the disposition has to be recorded. Clause 10.2 covers what you then do about the cause.

The permitted dispositions are limited on purpose: correct it, segregate or scrap it, inform the customer, or obtain a concession to release it as is. Each leaves a record, and the record is what an auditor samples.

In a repair operation non-conformities arrive from three directions: incoming equipment that does not match the declared condition, parts that fail on arrival, and devices that fail final test after being declared repaired. The third is the expensive one, because the cost of the rework is already sunk.

The failure mode to avoid is a register that only contains the polite non-conformities. If reporting a problem creates work for the person reporting it, the register fills with paperwork issues and empties of the real ones.

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