In a risk-based inspection (RBI), Schedule M – Point 1.7 is assessed to confirm that the Product Quality System (PQS) is clearly defined and documented, and that a Quality Manual (or equivalent) exists and describes the quality management system including management responsibilities.
Why it matters (risk logic): If the PQS is poorly defined, controls become inconsistent across departments and shifts—leading to higher risk of batch failures, recurring deviations, weak CAPA, uncontrolled changes, and release errors. Point 1.7 is therefore inspected as a “governance control” that influences every GMP system.
What inspectors verify (RBI depth)
1) Quality Manual content and structure
Inspectors check that the manual (or equivalent set of controlled documents) defines:
- PQS scope (sites/activities/products covered)
- quality policy and objectives
- key PQS processes and their interaction (e.g., deviation → investigation → CAPA → effectiveness)
- roles, responsibilities, and escalation paths (QA independence and release authority).
2) Management responsibility is real, not ceremonial
They look for evidence that responsibilities described in the manual are implemented: org charts, job descriptions, training matrices, management review participation, and quality KPIs used for decisions.
3) Document control and “single source of truth”
RBI tests whether only current, approved procedures/templates are in use (production/QC/engineering), obsolete versions are withdrawn, and controlled distribution is effective—especially for high-risk documents (master formulas, BPR/BMR, cleaning SOPs, EM plans).
4) PQS effectiveness under stress
Inspectors select a recent high-impact event (major deviation, repeated OOS, complaint, recall simulation, critical change) and verify the PQS drove timely investigation, risk assessment, CAPA, and effectiveness checks—consistent with the defined system.
Common red flags: a generic/manual copy with no site-specific responsibilities, unclear QA authority, inconsistent SOP versions on shopfloor, and recurring deviations indicating the PQS exists only “on paper.”