WHO TRS 986 – Point 11.4 (Personal hygiene) requires that all employees are instructed and encouraged to report to their immediate supervisor any conditions (relating to plant, equipment or personnel) that may adversely affect the product.
Why 11.4 is a high-focus area in Risk-Based Inspection (RBI)
RBI means inspectors prioritize high-risk systems and “go deeper” where failures could harm patients or where site signals suggest weak control (deviations, complaints, contamination events). Regulatory agencies describe using risk-based evaluation to prioritize inspections. U.S. Food and Drug Administration+1
11.4 is treated as high-impact because it is an early-warning human barrier: operators are often the first to notice leaks, damaged filters, abnormal odors, pest activity, poor cleaning, torn gloves, illness symptoms, or equipment malfunction—before those issues become contamination, mix-ups, or batch failures.
What RBI inspectors typically verify for compliance with 11.4
- Clear procedure and training
- Written SOP or GMP rule defining what must be reported, to whom, how fast, and how it is documented (logbook/deviation/near-miss).
- Induction + periodic training proving employees understand 11.4 expectations and escalation pathways.
- Reporting culture is real (not only on paper)
- Evidence of actual reporting events: entries for facility/equipment/personnel issues, with timestamps, signatures, and traceability (ALCOA+ behavior).
- Interviews on the floor: operators can explain examples of reportable conditions (e.g., water leak over open product path, damaged HEPA grille, abnormal differential pressure, missing line clearance tag, illness/lesions).
- Quality system response
- Reported conditions trigger risk assessment, documented investigation, batch impact evaluation, and CAPA with effectiveness checks (not just “cleaned and closed”).
- Trending: repeated “same-area” reports lead to system fixes (HVAC maintenance, preventive maintenance changes, cleaning frequency change, retraining). World Health Organization+1
- Management oversight
- Supervisor/QA review routines ensure reports are not ignored and that escalation is appropriate for critical risks.
Common RBI observations: fear of reporting, undocumented verbal reporting, delayed escalation, and CAPA that fixes symptoms but not root cause—each raising the site’s inspection risk profile.