4 minute read
ISO 22716
By Robert Low, Lead Management System Specialist
Section 7 of ISO 22716 covers production, split into manufacturing operations and packaging operations. This post covers the manufacturing half — the process of turning raw materials into bulk product.
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.
At each stage of manufacturing, measures need to be in place to produce a finished product meeting defined acceptance criteria. The detail underneath that principle covers documentation, pre-start checks, batch identification, in-process control, bulk storage, and re-stocking.
Availability of documentation. Manufacturing needs to follow documentation that includes suitable equipment, the formula, a list of raw materials with batch numbers and quantities, and detailed step-by-step instructions covering additions, temperatures, speeds, mixing times, sampling, and cleaning requirements.
Start-up checks. Before manufacturing begins, four things need confirming: all relevant documentation is available, all raw materials are available and released, equipment is in working order and appropriately cleaned, and the area has been cleared to avoid mixing with materials from a previous operation. This last point — line clearance — is one of the most commonly checked items during an audit.
Batch numbering. Every batch of manufactured bulk product needs a batch number. It does not have to match the finished product’s eventual batch number, but if it differs, the relationship between the two needs to be easy to trace.
In-process identification. Raw materials need measuring or weighing into clean, properly labelled containers, or directly into manufacturing equipment. At all times it should be possible to identify major equipment and the containers of both raw materials and bulk product in use.
In-process control. Controls and their acceptance criteria need defining in advance, performed according to a defined programme, with any result outside acceptance criteria reported and investigated — not just noted and moved past.
Bulk product storage. Bulk product needs storing in suitable containers, in defined areas, under appropriate conditions, with a maximum storage duration defined. If that duration is reached, the product needs re-evaluating before use rather than being used automatically.
Re-stocking. Raw materials that go unused after weighing, if deemed acceptable to return to stock, need their containers closed and properly identified — not left open or unlabelled in a general storage area.
Line and area clearance is the most frequently cited gap. The requirement sounds simple — clear the area before starting — but in busy facilities with tight changeover times, this step gets rushed or skipped under production pressure, and the resulting risk of cross-contamination between consecutive batches is exactly what an auditor is trained to probe.
The second common gap is bulk product storage duration. Many facilities define a maximum duration on paper but have no active mechanism flagging when a specific batch of bulk product is approaching that limit, which means the required re-evaluation simply does not happen until someone notices by chance.
Production control software exists specifically to enforce the sequence this section describes — start-up checks that cannot be skipped, batch numbers generated automatically, and bulk storage duration tracked against a real clock rather than relying on someone remembering. In-process control failures also need to flow directly into nonconformance management rather than being handled informally on the production floor.
This post is part of the Cornerstone ISO 22716 series. See the full series summary with links to all 16 sections.
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