3 minute read
ISO 22716
By Robert Low, Lead Management System Specialist
Section 9 of ISO 22716 covers the quality control laboratory — the function responsible for confirming, through actual testing, that materials and products meet the acceptance criteria the rest of the standard assumes are being checked. This post covers the methods, criteria, sampling, and retained sample requirements. Out-of-specification results, a substantial topic in their own right, get their own post next in this series.
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 standard is explicit that the general principles already covered for personnel, premises, equipment, subcontracting, and documentation all apply equally to the laboratory — it is not a separate world with its own rules. The laboratory’s specific job is ensuring that materials are only released for use, and products only released for shipment, when their quality genuinely fulfils acceptance criteria.
Test methods. The laboratory needs to use whatever test methods are necessary to confirm compliance, performed on the basis of defined, appropriate, and available methods — not improvised on the day.
Acceptance criteria. These need establishing in advance for raw materials, packaging materials, bulk products, and finished products. A result cannot be judged against a standard that does not yet exist on paper.
Results review. Every result needs reviewing, with a clear decision following — approval, rejection, or pending further information. Results do not get to sit unreviewed.
Reagents, solutions, reference standards, and culture media. These need identifying by name, strength or concentration where relevant, expiry date where relevant, who prepared them, the opening date, and storage conditions where relevant. This level of detail exists because a test result is only as reliable as the materials used to generate it.
Sampling. Sampling needs performing by authorised personnel and defined in terms of method, equipment, amounts taken, precautions against contamination, sample identification, and frequency. Samples themselves then need identifying by name or code, batch number, sampling date, the container sampled from, and the sampling point if relevant.
Retain samples. Finished product samples need retaining appropriately, in designated areas, in a quantity sufficient to allow analysis in line with local regulations, kept in their primary packaging under recommended storage conditions for an appropriate time. Raw material samples may be retained according to company practice or local regulation.
The most common gap is sampling procedures that exist on paper but are not consistently followed in practice — particularly around documenting the precautions taken to avoid contamination during sampling itself. If a sample is contaminated during collection, any subsequent test result is meaningless regardless of how rigorous the testing method is.
The second common gap is retain sample management. Retained samples kept past their useful storage life, or stored under conditions that do not match what is documented, undermine their entire purpose — if a complaint or recall investigation later needs the retain sample, it needs to genuinely represent the batch as shipped.
Laboratory results feed directly into release decisions covered in finished products and into the supplier approval process when testing concerns incoming raw materials. Where a result genuinely falls outside acceptance criteria, that outcome flows into the out-of-specification process — covered in detail in the next post in this series.
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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