Risk-Based Inspection (RBI) is a methodology that rates manufacturing sites by the estimated risk they may pose to patients and product quality, and then plans the frequency, depth and breadth of inspection accordingly, using Quality Risk Management and site “signals” (complaints, NSQ, recalls, past findings, major changes, etc.). CDSCO
For WHO TRS 986 (Annex 2) points 12.6–12.10, RBI concentrates on how well the facility’s premises controls prevent contamination, mix-ups and process failures:
12.6 Premises maintenance without quality hazard
TRS requires premises be carefully maintained, ensuring repair/maintenance does not create hazards to product quality.
RBI checks: planned preventive maintenance, maintenance work permits, area clearance/protection (covers, isolation), post-maintenance cleaning, and QA assessment when maintenance occurred near exposed materials/products. Inspectors look for recurring “temporary fixes” (leaks, peeling paint) as risk signals.
12.7 Cleaning and disinfection with written procedures and records
Premises must be cleaned and, where applicable, disinfected per detailed written procedures, with records maintained.
RBI checks: area-wise cleaning SOPs, approved disinfectant programs (rotation where justified), cleaning verification, logbook integrity (ALCOA+ behavior), and deviation/CAPA for missed cleaning or repeated contamination findings.
12.8 Suitable utilities and environment
Electrical supply, lighting, temperature, humidity and ventilation must be appropriate and must not adversely affect products or equipment performance.
RBI checks: HVAC qualification and monitoring, temperature/RH mapping (warehouses/labs), alarm handling, calibration of sensors, and investigation quality for excursions—especially where product stability or critical measurements are involved.
12.9 Protection from pests/animals + pest control procedure
Premises must protect against entry of insects/birds/animals and have a rodent and pest control procedure.
RBI checks: pest-control contract and trend reports, bait map governance, gap sealing, drains/waste controls, and investigations for pest sightings with impact assessment.
12.10 Logical flow of materials and personnel
Premises should ensure logical flow of materials and personnel.
RBI checks: unidirectional flow where needed, segregation/barriers for status (quarantine/released/rejected), prevention of cross-overs, and whether actual shop-floor movement matches the designed flows.
If weaknesses are found in any of 12.6–12.10, RBI typically expands scope into sanitation effectiveness, deviation/CAPA, contamination control strategy, and batch release decision-making because premises failures are systemic risk amplifiers.