3 minute read
ISO 22716
By Robert Low, Lead Management System Specialist
Section 5 of ISO 22716 covers equipment — everything from production machinery to the measuring instruments used to check whether a batch meets specification. It is a practical, detail-heavy section, and one where gaps tend to be procedural rather than physical.
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.
Equipment should be suitable for its intended purpose and capable of being cleaned, sanitised where necessary, and maintained. That single sentence covers design, installation, calibration, cleaning, maintenance, and access control — the standard then breaks each of those into specific expectations.
Design. Equipment needs designing to prevent product contamination. Bulk product containers need protecting from dust and moisture. Transfer hoses not currently in use need to be cleaned, kept dry, and protected from contamination. The materials used to build the equipment itself need to be compatible with both the product and whatever cleaning agents will touch it.
Installation. Equipment needs positioning so that the movement of materials, mobile equipment, and personnel around it does not create a quality risk. Reasonable access for maintenance and cleaning has to be designed in from the start, not retrofitted. Major equipment needs to be readily identifiable.
Calibration. This is where Section 5 gets the most specific. Measuring instruments important to product quality need regular calibration. If a calibration check comes back outside acceptance criteria, the instrument needs identifying and removing from service immediately — and critically, the out-of-calibration condition needs investigating to determine whether it actually affected product quality during the period it was out of tolerance.
Cleaning and maintenance. Equipment needs an appropriate cleaning and sanitisation programme, with effective and specified agents. Where equipment runs continuous production or successive batches of the same product, cleaning needs to happen at defined intervals — not just at the end of a production run. Maintenance needs to be regular, and maintenance work itself should not introduce a quality risk.
Authorisation and back-up. Equipment and automated systems should only be accessed by authorised personnel. The standard also expects adequate alternative arrangements for systems that might fail or break down — a back-up plan, not just an assumption that the primary system will always work.
Calibration is the single most common finding in this section, and it is rarely about missing a calibration entirely. It is far more often about the investigation step being skipped. An instrument calibrated last month, found out of tolerance, gets recalibrated and put back into service — but nobody checks whether any product measured during the out-of-tolerance period was affected. That investigation is explicitly required by the standard, and skipping it is one of the easiest gaps for an auditor to find by simply asking “what happened to the batches measured before this was caught?”
Equipment records connect directly to production control, since in-process checks depend on equipment being correctly calibrated and functioning. They also connect to document control, since calibration schedules, maintenance records, and equipment registers are themselves controlled documents that need version history and accountability.
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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