ISO 22716 Section 10 Explained: Treatment of Product That Is Out of Specification

By Robert Low, Lead Management System Specialist

Where Section 9.5 covers what happens when a laboratory result comes back out of specification, Section 10 covers what happens next — the actual physical disposition of product or material that has been confirmed not to meet the required criteria.

This post is part of a series working through ISO 22716 section by section. The series summary with links to every section is available at the end.

What the Standard Covers

Rejected materials and products. Investigations into rejected product or materials need performing by personnel who are authorised to do so. Decisions to destroy or reprocess need approving specifically by the personnel responsible for quality — this approval cannot be delegated down to whoever happens to be managing the warehouse that day.

Reprocessing. If all or part of a batch does not meet acceptance criteria, a decision to reprocess — bringing it back into compliance through one or more additional operations — needs approving by quality-responsible personnel. The reprocessing method itself needs defining and approving in advance, not improvised. Once reprocessing is complete, controls need performing on the reprocessed material, with results reviewed by authorised personnel to verify the product now genuinely conforms.

The Important Distinction This Section Draws

Reprocessing is explicitly different from simply re-testing until a result passes. Reprocessing means an actual additional operation is performed on the product — reworking a formulation, re-filtering a bulk product, repackaging with correct labelling — followed by genuine re-testing of the result. The standard’s careful sequencing here (approve the method, perform it, then test and review) exists to prevent reprocessing becoming a loophole for avoiding rejection.

Where This Commonly Goes Wrong

The most common gap is reprocessing happening without a pre-approved, defined method. A batch fails specification, someone identifies an ad hoc fix that seems reasonable, and the fix gets applied before anyone has formally defined or approved the reprocessing method as a documented procedure. Even if the resulting product genuinely passes testing afterward, the lack of an approved method beforehand is itself a nonconformance against this clause.

The second common gap is destruction or reprocessing decisions being made by someone without the explicit quality authority to make them — often under time or cost pressure to avoid wasting an expensive batch of raw material or finished product.

How This Connects to the Rest of the System

This section connects directly back to the nonconformance and CAPA process — a rejected or reprocessed batch is, by definition, a nonconformance, and the disposition decision should be recorded as part of that nonconformance record rather than handled separately. It also connects to stock and inventory management, since material awaiting a disposition decision needs to be physically or systemically separated from released stock to prevent it being used or shipped by mistake.

This post is part of the Cornerstone ISO 22716 series. See the full series summary with links to all 16 sections.