ISO 22000 nonconformities: how majors and minors are graded, answered and closed

What is a major and a minor nonconformity in ISO 22000?

A nonconformity is an unmet requirement of ISO 22000, of applicable law or of your own procedures. Accredited certification bodies classify each one using the concepts in ISO/IEC 17021-1, applied to food safety through ISO 22003-1.

A major nonconformity is one that affects the capability of the system to achieve its intended results, which in a plant means delivering safe product. Auditors grade a finding major when there is significant doubt that a process is under effective control, or when several minors against the same requirement show that the failure is systemic rather than a slip. A minor nonconformity is a genuine lapse that does not, on its own, put that capability in doubt.

Food auditors read severity through the hazard. A late cleaning signature in a dry store is rarely more than a minor. A metal detector running without its start-of-shift check, or a cooking step whose critical limit was never validated, goes to the heart of hazard control and is likely to be raised as a major. Opportunities for improvement need no formal answer. FSSC 22000 adds a critical grade; the HACCP, ISO 22000 and FSSC 22000 comparison covers the scheme.

How an ISO 22000 finding is written

Every finding has three parts:

• The requirement: for example, the standard's requirement that monitoring and measuring equipment is calibrated or verified at specified intervals, together with the plant's own calibration schedule.
• The objective evidence: the probe thermometer used to monitor the cooking CCP on line 2 carried no calibration record for the last five months; its reading differed from the reference thermometer by more than the tolerance the plant had set.
• The statement: the organisation could not show that the equipment used to monitor a CCP gives valid results.

The auditor discusses each finding with you before the closing meeting, so a record that exists but was not found during the audit should be produced at that point. Auditors do not propose the cause or the fix; that work is yours. Disputed grades go to the body's appeals process.

Correction, root cause and corrective action

ISO 22000 deals with nonconformity in two places. Clause 8.9, Control of product and process nonconformities, covers what happens on the line, including corrections, corrective actions and the handling of potentially unsafe product. Clause 10.1, Nonconformity and corrective action, covers the system as a whole. A certification finding usually needs both. Taking the thermometer finding above:

Correction: deal with the product and the instrument

Withdraw the thermometer, check it against the reference, and assess every batch cooked since the last known good calibration. Where the error could have let product pass below the critical limit, treat those batches as potentially unsafe product: hold, evaluate and, if any have left site, decide on withdrawal.

Root cause: why the control failed

The replacement probe was never added to the equipment register, so the calibration reminder never fired. Then ask whether other devices sit outside the register.

Corrective action: change the system

Tie the register to purchasing so that no monitoring device enters use without an identity and a calibration date, check every instrument against the register, and add a pre-use check at the CCP. Effectiveness is shown when the next two calibration cycles run on time. Replacing the probe alone is only a correction, and it invites the same finding at surveillance.

Examples of real food-safety nonconformities

The rows below are composites drawn from typical food safety audits, not extracts from any client report. The grade shown is the usual one for an isolated case; the certification body grades each finding on its own evidence.

Timescales and how closure is verified

At the closing meeting the audit team states the deadline for your analysis and plan; the certification body sets it, so ask for it in writing. In typical practice bodies expect majors to be evidenced faster than minors, but periods differ between bodies and schemes, so rely on your body's rules, not a general figure.

The body reviews your response and decides how to verify it: through documented evidence, a short follow-up visit, or a check at the next audit. Majors are verified before the certification decision; for minors, an accepted plan is normally enough, with implementation checked at surveillance. Good closure evidence shows the corrected process running after the audit:

• records dated after the audit, such as completed CCP sheets, calibration certificates or a timed mock recall report;
• the revised procedure, form or hazard analysis, with its approval and version;
• for effectiveness, a run of results rather than one good day.

What happens when a major stays open

Before a first certificate, no certification decision can be taken while a major is unverified, and if verification runs beyond six months from the last day of Stage 2, Stage 2 must be repeated. Later, an unclosed major can lead to suspension, when the certificate cannot be used with customers, then withdrawal or a reduced scope. At recertification, a major must be closed before expiry or the certificate is not renewed on time. The surveillance and recertification guide sets out the full three-year cycle.

How to avoid the common food-safety findings

Most findings above involve records that exist only after weeks of operation, which no one can create the week before the audit. Let your internal audit observe PRPs and the plan on the floor, and use the certification body's Stage 1 readiness review, described in the Stage 1 and Stage 2 guide, to hear about areas of concern early. The ten failures we see most often are in the common mistakes guide.

ISO 22000 nonconformities: questions buyers ask