Templates and records · ISO 22716 · Clause 14

ISO 22716 cosmetic complaints and recalls record

A complaint may be an isolated case or the first sign of a defective batch. The record forces you to investigate it, look at other batches and, if there is a risk, recall in time.

In one sentence

The complaints and recalls record centralises each product defect complaint with its original details, the investigation of the batch concerned and of other batches, the actions to prevent recurrence and, where appropriate, the coordinated recall and its notification to the authority, because ISO 22716 recommends this in chapter 14 and Regulation 1223/2009 requires the responsible person to withdraw nonconforming product and notify serious undesirable effects.

Content reviewed on 17 October 2026

Where the standard requires it: ISO 22716 · Clause 14 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 (14), with obligations under Regulation 1223/2009 (Articles 5 and 23)
Who fills it in: Authorised quality staff Centralises complaints and coordinates recalls with the responsible person for the product
When: On receipt of each complaint Recall as soon as it is decided; mock recalls at the frequency the company sets
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

The standard asks for complaints to be centralised by authorised staff, for product defect complaints to be kept with their original details and follow-up, for the batch concerned and, where appropriate, other batches to be investigated, for action to be taken to prevent recurrence and for complaints to be reviewed periodically to spot trends.

For recalls, it asks for them to be coordinated by authorised staff and able to start promptly, for the authority to be notified where consumer safety is affected, for recalled product to be stored separately in a secure area and for the process to be evaluated periodically.

Regulation 1223/2009 requires the responsible person to take corrective measures, withdraw or recall nonconforming product and inform the authorities where there is a risk to health (Article 5), and to notify serious undesirable effects without delay (Article 23).

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

Structure

Fields the template should include

Number, date received and channel
Customer or consumer and contact details
Product, batch and original description of the complaint
Type: quality defect, undesirable effect, labelling, packaging
Severity and whether it is a serious undesirable effect
Batch investigation: records, retained sample, testing
Check of other batches
Actions to prevent recurrence
Recall decision, scope and notification to the authority
Response to the complainant and closure
Periodic trend review

Example

Example: complaints about a cap that will not close

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

Field	Content
Complaints	RC-2026-031 to 033 · 3 to 10 June · three distributors
Product and batch	Shower gel GD-12 · 400 ml · batch 26-0502-B
Description	The flip-top cap will not close and the product leaks in transit
Severity	Quality defect with no health risk
Investigation	Retained sample: 4 of 6 caps with a deformed hinge · cap batch TP-2640
Other batches	Cap batch TP-2640 was also used in batch 26-0509-A: same defect in the sample
Decision	Both batches withdrawn from distribution, with no notification to the authority as there is no safety risk
Recovered	94% of units within 10 days, identified and stored in a segregated area
Action	Complaint to the cap supplier and closure check by sampling at receipt

At the audit

Mistakes auditors commonly flag

Complaints handled by sales that never reach quality.
The batch complained about is investigated, but not those sharing a raw material or container.
The recall has never been rehearsed and, when needed, nobody knows where the batch went.
No distinction between a serious undesirable effect, which must be notified, and a quality complaint.
Trends are not reviewed: ten similar complaints treated as isolated cases.

In Kimobox

How this record is kept in Kimobox

1Customer complaints are managed from the customer portal, with follow-up through to closure.
2Each complaint is linked to the batch and its traceability, from raw materials to shipments.
3The recall plan is simulated using the system's batch traceability, in minutes rather than days.
4Repeated complaints follow the nonconformity route, with root cause and verification of effectiveness.

Frequently asked questions

What people ask us before getting started

What is a serious undesirable effect?

Regulation 1223/2009 defines it as an undesirable effect that results in temporary or permanent functional incapacity, disability, hospitalisation, congenital anomalies, an immediate vital risk or death. The responsible person must notify it without delay to the authority of the Member State where it occurred.

Who decides on a recall?

The responsible person for the product under the Regulation, supported by the manufacturer's quality function. ISO 22716 asks for the process to be coordinated by authorised staff and to be able to start quickly.

Are mock recalls needed?

The standard asks for the recall process to be evaluated periodically. An exercise that traces a batch through to its customers is the most direct way to show it works.

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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
Cosmetics and personal care products Agencia Española de Medicamentos y Productos Sanitarios (AEMPS, Spanish Agency of Medicines and Medical Devices) · Competent authority in Spain