In a risk-based inspection (RBI), Schedule M points 15.6–15.8 are checked as practical error-prevention controls in manufacturing areas—because poor visibility and weak changeover discipline directly increase risks of mix-ups, wrong setting/reading, poor cleaning, and missed defects.
15.6 – Production area adequately lit
Inspectors verify that the production area is adequately lit, not only “visually acceptable” but suitable for the tasks performed (dispensing, equipment checks, IPC readings, cleaning verification, and documentation). The RBI focus is on high-risk steps where an operator can misread labels, settings, or batch details under poor lighting. The checklist explicitly asks whether the production area is adequately lit. CDSCO
15.7 – Lux levels observed (production, visual inspection, other areas)
RBI then requires objective measurement: inspectors ask you to state lux levels observed in production, visual inspection, and other areas, and confirm the site has a defined monitoring approach. The checklist provides examples such as Production: 400–500 lux, Visual inspection: 500–600 lux, and Other areas: 200–400 lux, and flags cases where no specific lux level is maintained. CDSCO
Inspectors typically review: lux mapping locations, frequency, calibrated lux meter records, maintenance of lights/diffusers, and deviation handling when lighting falls below defined limits.
15.8 – Procedure followed during product changeover
Changeover is treated as a high-risk transition where cross-contamination and mix-ups occur. Inspectors ask you to specify in detail the procedure followed during product changeover and verify that a specific SOP exists and is followed.
RBI evidence usually includes: line-clearance checklist, removal/segregation of previous batch materials, cleaning status labeling, verified cleaning (and where applicable validation linkage), reconciliation of printed components/WIP, setting verification, QA/QC release checks, and documented start-up authorization after changeover.
Common RBI red flags: “adequate lighting” claimed without lux data, poorly maintained lighting, and informal changeovers without documented line clearance and reconciliation.