In WHO TRS 986 (Annex 2: GMP – Main principles), Section 11 “Personal hygiene” runs from 11.1 to 11.8—there is no clause numbered 11.11 in this edition.
In many RBI checklists, “11.11” is used as an internal renumbering, but the intended control theme is still WHO’s personal-hygiene system (especially 11.8, which extends hygiene rules to everyone entering production areas).
RBI view: why Personal Hygiene is high-risk
Risk-Based Inspection (RBI) increases depth where failures can cause contamination, mix-ups, or data/release errors. Personal hygiene is a frontline barrier: one weak behavior (ill worker, uncovered hair, bare-hand contact, eating in production, uncontrolled visitor) can contaminate product or compromise controlled areas.
What WHO TRS 986 Section 11 requires (and how RBI verifies it)
1) Health status controls (11.1, 11.3)
- Health examinations (as appropriate) and controls that prevent personnel with apparent illness/open lesions from handling materials/products.
RBI checks: health screening SOP, reporting mechanism, documented restriction/return-to-work decisions, and confidentiality-respecting records.
2) Training + visible hygiene discipline (11.2)
- All personnel trained in personal hygiene; handwashing instructions posted and followed.
RBI checks: training effectiveness (not only signatures), shop-floor observation (handwash/entry discipline), and recurring hygiene-related deviations.
3) Reporting culture for risk conditions (11.4)
- Employees encouraged to report conditions relating to plant/equipment/personnel that could affect product.
RBI checks: examples of real reports converted into deviations/near-misses, investigations, CAPA, and effectiveness checks.
4) Prevent direct contact contamination (11.5)
- Avoid direct hand contact with starting materials, primary packs, and intermediate/bulk product.
RBI checks: glove policy, use of tools (scoops/forceps), and “in-the-moment” behaviors during sampling/dispensing/packing interventions.
5) Protective clothing + behavior restrictions (11.6–11.7)
- Appropriate clean body coverings/hair covering; controls on laundering; no smoking/eating/drinking etc. in production/QC/storage.
6) The most common “11.11” intent: apply hygiene rules to everyone (11.8)
- Hygiene procedures apply to employees, contractors, visitors, senior managers, and inspectors entering production areas.
RBI checks: visitor briefing, PPE issuance, escorting, access logs, and supervision effectiveness.