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Templates and records · ISO 22000 · Clause 10.1

ISO 22000 nonconformities and corrective actions record template

A CCP deviation, an audit finding or a consumer complaint: put today's problem right, find the cause and check that it does not happen again.

In one sentence

The ISO 22000 nonconformities and corrective actions record documents the nature of each nonconformity, whether of product or of the system, its correction, the cause, the corrective action and its effectiveness, because clauses 8.9.2, 8.9.3 and 10.1 require that information to be retained.

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Where the standard requires it
ISO 22000 · Clause 10.1 Clauses are cited using the numbering of ISO 22000:2018, the current edition. ISO is preparing a third edition that may renumber them; when it is published it will have its own transition period.
Type of information
Mandatory record Documented information to be retained (8.9.2, 8.9.3 and 10.1.2)
Who fills it in
Whoever detects it, plus the process owner The process owner takes on the analysis and quality verifies closure
When
As soon as it is detected Effectiveness is verified once enough time has passed to see whether it recurs
How long it is kept
Set by the organisation ISO 22000 only sets a minimum for traceability (8.3: the shelf life of the product). Covering the shelf life plus the three-year certification cycle lets you show the history at recertification.

What the standard requires


What ISO 22000 demands and what it leaves to your judgement

ISO 22000 deals with nonconformities in two places. Clause 8.9 covers product and process nonconformities: if a CCP fails its critical limit or an OPRP its criterion, corrections are applied, the need for corrective action is evaluated and the nature of the nonconformity, its cause and its consequences are retained, together with the information needed for traceability.

Clause 10.1 covers those of the system: audit findings, complaints, PRP failures. You react, analyse the cause, consider whether it could recur elsewhere, apply the action, review its effectiveness and, if necessary, update the system.

The standard does not require a particular root cause method. It requires the action to be proportionate to the effect and its effectiveness to be checked.

Structure


Fields the template should include

  • Number, date and source: CCP or OPRP monitoring, verification, audit, complaint, authority
  • Type: product or process (8.9) or system (10.1)
  • Description and evidence
  • Batch affected and reference to the product-on-hold record, if any
  • Immediate correction
  • Root cause analysis
  • Could it recur in another process or product?
  • Corrective action, owner and deadline
  • Verification of effectiveness: date, criterion and result
  • Update of the hazard analysis, plan or PRPs, where applicable

Example


Example: metal detector failure

Company, people and figures are fictitious: the example only shows what a properly completed record looks like.

Field Content
Number and source CA-26-014 · CCP-2 monitoring · 3 March 2026
Type Product and process (8.9)
Description The detector did not reject the stainless steel test piece in the 12:00 check
Batch L26-062: product since 11:00 held and rerun through another detector
Root cause Sensitivity was readjusted after a format change and was not recorded as a planned change
Could it recur elsewhere? Same risk on the line 1 detector
Corrective action Lock the sensitivity setting behind a maintenance password and handle every format change as a planned change · 20 March
Effectiveness 30 June: 41 format changes with no incidents in the test piece checks · Effective
Update A sensitivity check after each format change is added to the verification plan

At the audit


Mistakes auditors commonly flag

  • The cause stops at "operator error".
  • CCP deviations are corrected, but nobody assesses whether corrective action is needed.
  • The action is closed without verifying its effectiveness.
  • The action is not reflected in the hazard analysis or the plan when it should be.
  • Consumer complaints are handled separately and never reach this record.

In Kimobox


How this record is kept in Kimobox

  1. 1The nonconformity is opened from the deviation, the audit or the complaint, with a classified source.
  2. 2The root cause is mandatory to move forward.
  3. 3The action is assigned with a date, and the system warns you if it slips.
  4. 4Verification of effectiveness is scheduled within the same record.

Frequently asked questions


What people ask us before getting started

What is the difference between correction and corrective action?

Correction deals with the effect — holding the product and rerunning it; corrective action eliminates the cause — locking the detector setting. ISO 22000 asks for them separately.

Does every CCP deviation need a corrective action?

You have to evaluate whether one is needed. An isolated deviation with a known cause may not require it, but the decision must be recorded; if it recurs, the need is obvious.

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