Risk-Based Inspection (RBI) plans inspection frequency, depth, and breadth based on the site’s estimated risk to patients and product quality. In warehousing, inspectors go deeper when weak storage control could cause wrong material use, mix-ups, contamination, or expiry failures.
Schedule M – Point 14.2 (Raw materials): What it requires
Schedule M point 14.2 checks whether raw materials are stored in an orderly fashion so that they allow batch segregation and stock rotation by a FIFO principle.
How RBI inspects 14.2 in practice (what inspectors verify)
- Orderly storage with clear segregation
Inspectors confirm warehouse layout supports segregation by material name/code, supplier lot, and internal batch/control number, with defined locations (racks/bins) and no “mixed pallets.” They check whether receiving, quarantine, sampling, released, and rejected areas are physically separated or strongly segregated by status controls. - FIFO implementation (not just policy)
RBI tests whether FIFO is actually followed by sampling:
- pick lists/issuance records for the last few batches,
- ERP/stock cards showing oldest approved lots were issued first,
- physical location logic (oldest lots positioned for first access),
- handling of part containers (opened/part-used) to prevent hidden “older stock” being skipped.
Because some materials have retest/expiry dates, inspectors also expect FIFO to work alongside expiry control (often FEFO in practice) while still meeting the intent of 14.2.
- Batch segregation during “high-risk moments”
Inspectors watch the receiving → quarantine → sampling → approval flow. They verify that materials cannot be issued before release, that sampled containers are re-sealed and labeled correctly, and that quarantine lots are not stored in the same rack face as approved lots. - Investigation triggers and system robustness
RBI looks for deviations when FIFO is broken (urgent issue, shortage), including documented justification, QA approval (where required), impact assessment, and CAPA to prevent recurrence. Repeated FIFO failures are treated as a risk signal and can expand inspection into dispensing controls, supplier management, and mix-up prevention systems.