In Risk-Based Inspection (RBI), WHO TRS 986 (Annex 2) points 11.1–11.2 are treated as frontline contamination-control barriers. Inspectors spend more time here when the site makes sterile products, high-risk dosage forms, or has contamination/complaint signals, because personnel hygiene failures can directly lead to product contamination and patient harm.
WHO TRS 986 requirements (11.1–11.2)
11.1 Health examinations
WHO requires that all personnel, prior to and during employment (as appropriate), undergo health examinations, and that personnel conducting visual inspections also undergo periodic eye examinations.
RBI intent: ensure people performing GMP tasks are medically fit and that vision-dependent inspection decisions are reliable.
11.2 Personal hygiene training + handwashing discipline
WHO requires that all personnel are trained in personal hygiene practices, that a high level of personal hygiene is observed by all involved in manufacturing, and specifically that personnel wash hands before entering production areas, with signs posted and instructions complied with.
RBI intent: ensure hygiene is a controlled system (training → behavior → verification), not just “rules on paper”.
What RBI inspectors typically verify (evidence and effectiveness)
- Medical fitness program (11.1)
- Written procedure defining pre-employment and periodic checks (risk-based by role).
- Records demonstrating completion, confidentiality controls, and clear decisions for restrictions/return-to-work where needed.
- Eye exam program for visual inspectors (frequency defined, results recorded, qualification maintained).
- Hygiene training system (11.2)
- Induction + refresher training coverage for operators, QC, maintenance, cleaning, and contract staff.
- Effectiveness checks: quizzes/observations, repeat-error reduction, linkage to deviations (e.g., glove tears, gowning breaches).
- Hand hygiene implementation
- Posted signage at entry points, wash/sanitization facilities available, and observed compliance during shop-floor walkthroughs (especially before aseptic/critical operations).
- Quality-system response when hygiene breaks down
- If non-compliance is seen, RBI expects deviation logging, risk assessment (batch impact), CAPA, and effectiveness verification—because hygiene issues are considered high patient-risk.
Strong compliance for 11.1–11.2 is demonstrated by documented programs + consistent real behavior at the entry points and in production areas.