3 minute read
ISO 22716
By Robert Low, Lead Management System Specialist
Section 7.3 of ISO 22716 covers packaging operations — the stage where bulk product becomes the finished item that actually reaches a customer. It mirrors the structure of the manufacturing operations clause closely, which makes sense, since both are production stages governed by the same underlying logic.
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.
The same overarching principle from Section 7 applies here: measures at each stage should produce a finished product meeting defined acceptance criteria. Packaging introduces its own specific risks, primarily around labelling accuracy and line mix-ups, which is why the standard gives this its own detailed sub-section rather than treating it as a generic continuation of manufacturing.
Documentation. Packaging needs to follow documentation including suitable equipment, a list of the packaging materials defined for that specific finished product, and detailed instructions covering filling, closing, labelling, and coding.
Start-up checks. Before packaging begins: the area needs clearing of materials from the previous operation, documentation needs to be available, all packaging materials need to be present, equipment needs to be in working order and appropriately cleaned, and any coding needed to identify the product needs to be defined in advance.
Batch numbering. Each unit of finished product needs a batch number, which again does not need to match the bulk product’s batch number as long as the relationship between the two is traceable.
Packaging line identification. At all times, it should be possible to identify the packaging line itself, the finished product running on it, and the batch number — three separate pieces of identification that all need to be correct simultaneously.
On-line control equipment checks. Where used, this equipment needs regular checking against a defined programme.
In-process control. As with manufacturing, controls and acceptance criteria need defining in advance and performing to a defined schedule, with out-of-criteria results reported and investigated.
Re-stocking. Unused packaging materials returned to stock need their containers closed and properly identified.
Work-in-process handling. Filling and labelling are usually continuous processes. Where they are not — for example, a line stops mid-run — special measures including segregation and identification need applying so that no mix-up or mislabelling can occur during the gap.
Mislabelling risk during interrupted runs is the most common practical gap. When a packaging line stops partway through a batch — for maintenance, a shift change, or a material shortage — the work-in-process sitting on the line needs clear segregation and identification before the line resumes or before different product runs on the same line. Skipping this step is exactly how a product ends up shipped with the wrong label, which is one of the more serious and reputationally damaging nonconformances a manufacturer can have.
The second common gap is packaging line identification not being kept current in real time — a line still displaying signage for the previous product after a changeover, even briefly, creates exactly the risk this clause is designed to prevent.
Packaging line identification and batch numbering connect directly to production control and batch traceability — without a clean batch number trail from bulk product through to packaged finished goods, recall capability is compromised. Work-in-process mishandling that does occur needs capturing as a formal nonconformance, with root cause analysis, rather than being quietly corrected on the line and never recorded.
This post is part of the Cornerstone ISO 22716 series. See the full series summary with links to all 16 sections.
Back to all
