3 minute read
ISO 22716
By Robert Low, Lead Management System Specialist
Section 8 of ISO 22716 picks up where packaging operations end — the point at which a finished cosmetic product exists and needs managing through release, storage, shipment, and potentially, return.
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.
Finished products should meet defined acceptance criteria, and storage, shipment, and returns should all be managed in a way that maintains product quality throughout. The section breaks into release, storage, shipment, and returns.
Release. Before any finished product reaches the market, it needs controlling against established test methods and needs to comply with acceptance criteria. Critically, release has to be carried out by authorised personnel responsible for quality — not by a production manager eager to ship, and not automatically once packaging is complete. This is sometimes called positive release: nothing leaves without an explicit, documented decision from someone with the authority to make it.
Storage. Finished products need storing in defined areas, under appropriate conditions, for an appropriate length of time, with monitoring where necessary. Storage areas need to permit organised storage, and released, quarantined, and rejected product all need separating — either physically or through an equivalent system of assurance. Identification on finished product containers needs to show name or code, batch number, storage conditions where critical, and quantity.
Stock turnover. Except in special circumstances, the oldest released stock should be used or shipped first. Periodic inventory checks need performing to confirm both accuracy and continued compliance with acceptance criteria, with any significant discrepancy investigated.
Shipment. Measures need to ensure the correct, defined finished product is what actually ships, with precautions taken to maintain quality where appropriate during transport.
Returns. Returned products need identifying appropriately and storing in defined areas. They need evaluating against established criteria to determine disposition, and release back onto the market only happens after that evaluation — not automatically because the product was returned unopened or appears undamaged. The standard also specifically requires measures to distinguish reprocessed returns and to prevent unreleased product being redistributed by accident.
The most common finding is release authority drifting in practice, even when the documented procedure is correct. A documented procedure might correctly state that only the quality manager can release product, but if a production supervisor has, in practice, been releasing batches during the quality manager’s absence without formal deputisation, that gap between paper and practice is exactly what an audit interview tends to surface.
The second common gap is returns handling. Returns sitting in a general warehouse area rather than a clearly defined, separate location — pending the required evaluation — risk being picked, packed, and shipped again by mistake before any disposition decision has actually been made.
Release decisions and storage status connect directly to stock and inventory management — a system that does not distinguish released, quarantined, and rejected stock at a structural level makes accidental shipment of unreleased product a real and recurring risk rather than a rare mistake. Returns handling should also generate a nonconformance record where appropriate, particularly if the return relates to a quality defect rather than a simple customer change of mind.
This post is part of the Cornerstone ISO 22716 series. See the full series summary with links to all 16 sections.