Templates and records · ISO 22716 · Clause 9.5 y 10

ISO 22716 out-of-specification result investigation

When a test comes back out of specification, the temptation is to repeat it until it passes. The standard asks for the opposite: investigate first and retest only with justification.

In one sentence

The out-of-specification investigation record documents the result obtained, the investigation by authorised staff to establish whether it is a laboratory error or a genuine defect, the justification for any retest and the decision — deviation, rejection, pending or reprocessing approved by quality — because ISO 22716 recommends this for laboratory results (9.5) and for product that does not conform (10).

Content reviewed on 17 October 2026

Where the standard requires it: ISO 22716 · Clause 9.5 y 10 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 (9.5 and 10), enforceable through Article 8 of Regulation 1223/2009
Who fills it in: Quality control laboratory The analyst reports; the investigation and decision rest with authorised quality staff
When: As soon as the result is obtained The batch is held until the decision
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

Out-of-specification results are reviewed by authorised staff and properly investigated. Any retest needs sufficient justification, and after the investigation it is decided whether to treat it as a deviation, reject it or hold it pending.

For rejected product or material, the decision to destroy or reprocess is approved by quality staff. Reprocessing requires a defined, approved method, and the reprocessed product is controlled again before release (chapter 10).

It differs from the deviation record in that it starts from an analytical result; if the investigation reveals a process failure, the two records are linked.

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

Structure

Fields the template should include

Product or material, batch and test
Result obtained and specification
Date, analyst and equipment
Laboratory investigation: calculations, standards, equipment, sample preparation
Conclusion: laboratory error demonstrated or result confirmed
Retests and their justification
Process investigation, if the result is confirmed
Decision: deviation, rejection, pending, reprocessing
Approved reprocessing method and results after reprocessing
Who decides and date

Example

Example: out-of-specification viscosity in a bulk product

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

Field	Content
Batch and test	Shower gel GD-12 · bulk batch 26-0502 · viscosity
Result	3,100 mPa·s against a specification of 4,000 to 6,000
Laboratory investigation	Viscometer verified with a standard: conforming · correct spindle and temperature · no laboratory error
Retest	Not repeated: there is no laboratory cause to justify it
Process investigation	Batch record: sodium chloride added 1.2 kg below the planned amount due to a weighing error
Decision	Reprocessing approved by the quality manager: adjustment with sodium chloride according to method RP-03
After reprocessing	4,900 mPa·s · conforming · released for packaging on 6 May
Link	Deviation DV-2026-014 for weighing error

At the audit

Mistakes auditors commonly flag

The test is repeated until a conforming result is obtained and earlier ones are discarded.
The result is put down to "analyst error" without proof.
Reprocessing carried out by production without quality approval.
Reprocessed product not retested before release.
No search for the cause in the process when the result is confirmed.

In Kimobox

How this record is kept in Kimobox

1An out-of-criterion result is recorded as a nonconformity linked to the batch, which is held.
2The root cause is mandatory before deciding, and the decision is recorded with whoever took it.
3Reprocessing and its new results are kept in the same batch record.
4Repeated results for the same test are visible so trends can be spotted.

Frequently asked questions

What people ask us before getting started

Can an out-of-specification test be repeated?

Only with sufficient justification, for example a demonstrated laboratory error. Retesting without cause until the result conforms invalidates the control and is one of the most serious findings at an inspection.

Who approves reprocessing?

Responsible quality staff, with a defined, approved reprocessing method. The reprocessed product is controlled again and the result is reviewed by authorised staff.

How does it differ from a deviation?

An out-of-specification result arises from an analytical control; a deviation from departing from what is planned in the process or documentation. One often leads to the other, as in the example, and it is worth linking them.

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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