3 minute read
ISO 22716
By Robert Low, Lead Management System Specialist
Section 3 of ISO 22716 is where the standard starts, and it is a deliberate choice. Before premises, equipment, or production processes, the standard addresses the people who will operate all of it. The logic is straightforward — a perfectly designed facility staffed by untrained or unsupervised people will still produce inconsistent, unsafe products.
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.
Section 3 breaks into four areas: organisation, key responsibilities, training, and hygiene and health.
Organisation. The standard expects a defined organisational structure that is understandable and appropriate to the size of the company. Critically, it requires that quality assurance and quality control functions are shown as independent from other units on the organisation chart — even if, in a smaller company, the same person holds both responsibilities. The independence is about reporting structure and authority, not necessarily separate departments.
Key responsibilities. Top management has to visibly support the GMP system, and every person needs to know their position, their responsibilities, and which documents apply to their role. The standard also asks that personnel be encouraged to report irregularities — not punished for raising them. This sounds obvious in principle but is worth stating plainly, because a culture where reporting a problem feels risky is one where problems get hidden instead of fixed.
Training. This is the largest part of the section, and for good reason. ISO 22716 wants training to be tailored to the individual’s actual role, evaluated for effectiveness (not just attendance), and treated as ongoing rather than a one-time induction. New starters specifically need training appropriate to their assigned duties before they begin unsupervised work.
Hygiene and health. The standard requires hygiene programmes adapted to the specific plant, hand-washing facilities, appropriate protective clothing, and restrictions on eating, drinking, and smoking in production, control, and storage areas. There is also a requirement to exclude anyone with an apparent illness or open wounds from direct product contact until cleared.
The most frequent gap auditors find here is not an absence of training — most manufacturers do train staff. It is the absence of evidence that training was effective, not just attended. A signed attendance sheet proves someone was in the room. It does not prove they understood the material or can apply it correctly on the production floor.
The second common gap is the organisation chart not actually reflecting reality. If the document shows quality as independent from production, but in practice the quality function reports to and is overruled by a production manager, that is exactly the kind of gap an auditor will find by asking a few direct questions rather than just reviewing the chart.
Personnel requirements are not isolated — they connect directly to almost every other section of the standard. Training records feed into your competence management system. Hygiene non-compliance often surfaces as a nonconformance that needs investigating. And the organisation chart’s independence requirement matters most when someone needs to make an unpopular quality decision, such as rejecting a batch a production manager wants to ship.
This post is part of the Cornerstone ISO 22716 series. See the full series summary with links to all 16 sections.
Back to all
