Templates and records · ISO 22716 · Clause 13

GMP deviation record template for ISO 22716

Every factory departs from the plan at some point. The difference between a controlled deviation and a problem lies in recording it, assessing it with data, authorising it and preventing it happening again.

In one sentence

The deviation record documents each time manufacturing, packaging or control departs from what is specified, with the data needed to assess the impact on the product, the authorisation of whoever decides and the corrective action to prevent recurrence, because ISO 22716 recommends that deviations be authorised with sufficient data to support the decision and corrected to prevent recurrence (chapter 13).

Content reviewed on 17 October 2026

Where the standard requires it: ISO 22716 · Clause 13 Chapters are those of ISO 22716:2007, the only edition published, confirmed by ISO in 2022. It is a guidelines standard: it recommends; the obligation comes from Article 8 of Regulation (EC) 1223/2009.
Type of information: Mandatory record ISO 22716 recommendation (13), enforceable through Article 8 of Regulation 1223/2009
Who fills it in: Whoever detects it, and quality Anyone can report it; assessment and authorisation rest with authorised quality staff
When: On detection or before it is applied Planned deviations are authorised beforehand; unplanned ones as soon as they are detected and before the batch is released
How long it is kept: Defined by the company ISO 22716 asks for the archiving period to be set according to applicable legislation (17.5.2). As a reference, the product information file is kept for ten years after the last batch was placed on the market (Article 11(1) of Regulation 1223/2009).

What the standard requires

What ISO 22716 demands and what it leaves to your judgement

Chapter 13 is short but clear: deviations from specified requirements are authorised with sufficient data to support the decision, and corrective actions are taken to prevent their recurrence.

The standard does not distinguish between planned and unplanned deviations, but in practice it is worth doing so: a one-off change authorised in advance, such as using an alternative piece of equipment, is not the same as an error discovered afterwards.

If the deviation affects product quality, the batch is not released until quality has assessed its impact. If it is a permanent change, it is not a deviation: it goes through change control (chapter 15).

Read it in context: Nonconformities, complaints, and recalls, in the ISO 22716 Academy

Structure

Fields the template should include

Number, date and who detected or requested it
Type: planned or unplanned
Requirement, procedure or formula departed from
Batches, products and equipment affected
Description of what happened
Data to assess the impact on quality
Quality decision and authorisation
Cause and corrective action to prevent recurrence
Impact on batch release
Closure and verification

Example

Example: weighing error in a shower gel

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

Field	Content
Number	DV-2026-014 · 5 May 2026 · detected by the laboratory
Type	Unplanned
Requirement	Formula GD-12 version 5: sodium chloride 6.0 kg per batch
Affects	Bulk batch 26-0502
Description	4.8 kg weighed: the balance was showing the tare of a different container
Data	Viscosity out of specification; other parameters conforming; no safety risk
Decision	Reprocessing authorised by the quality manager (see the result investigation)
Corrective action	Weighing containers with a fixed, identified tare and double verification of salt weighings · 20 May
Closure	30 June: 22 batches with no weighing errors · effective

At the audit

Mistakes auditors commonly flag

Deviations are jotted in the margin of the batch record and never assessed.
Deviations authorised without any data to support the decision.
The same deviation recurs every month with no corrective action.
Permanent changes processed as a series of deviations.
Batches released with open deviations.

In Kimobox

How this record is kept in Kimobox

1Each deviation is recorded as a nonconformity, linked to the batch and equipment affected.
2The root cause is mandatory, and the corrective action has an owner and a deadline, with a delay warning.
3Verification of effectiveness is scheduled and forms part of the same record.
4The deviation is linked to the batch record, alongside its release decision.

Frequently asked questions

What people ask us before getting started

What is a deviation in cosmetics?

A departure from a specified requirement: a formula, a process parameter, a procedure or a specification. ISO 22716 asks for it to be authorised with data and for action to prevent recurrence.

Is it the same as nonconforming product?

Not exactly. The deviation describes the departure in the process; out-of-specification product describes the result. A deviation may not affect the product, and an out-of-specification product almost always has a deviation behind it.

Must the customer be told?

The standard does not generally require it. In contract manufacturing, the contract usually requires the customer to be informed of deviations affecting their product (chapter 12).

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Sources

Where each figure comes from

References to the official text in force. If a standard is revised, this page is updated and the review date says so.

ISO 22716:2007 — Cosmetics. Good Manufacturing Practices (GMP). Guidelines on Good Manufacturing Practices ISO · 2007 ed., confirmed in 2022
Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products EUR-Lex · 30 November 2009, consolidated text