Periodic inspection

What is a nonconformity and how is it classified?

A nonconformity is the non-fulfilment of a requirement — of the standard, of legislation, or of the organisation's own procedure. The common classification has three levels: a major nonconformity showing that an element of the system is absent or has broken down entirely, a minor one showing a single deviation, and an observation flagging something that is not yet a nonconformity but is on its way to becoming one.

Definition

A nonconformity is the non-fulfilment of a requirement. The requirement can come from three places: a clause of the standard, a legal provision, or a procedure the organisation wrote itself. The third is often forgotten: not following your own procedure is a nonconformity.

Three levels

ClassWhat it meansConsequence
MajorAn element of the system is missing or has broken down entirely; or many minor findings cluster on the same elementRoot cause analysis and dated corrective action; at certification, a barrier to the certificate
MinorThe element exists and works; there is a single deviationCorrective action, with verification possibly at the next audit
ObservationNot yet a nonconformity; a condition that will become one if it continuesAn improvement opportunity, followed up by the organisation

Minors add up to a major

Minor findings repeating on the same clause show that the element is not in fact working, and together they constitute a major nonconformity. Findings are therefore assessed not only one by one but clause by clause in aggregate.

The purpose of classification

Class is a tool for prioritisation, not punishment. An auditor who writes everything as major paralyses the system; one who writes everything as an observation changes nothing. The classification criteria are written down in advance and applied the same way by every auditor.

Manage this in Optifora

Optifora is not a single program but a compliance platform assembled from modules. The catalogue states which module is ready today and which is on the roadmap.

See what Optifora is