WHO TRS 986 – Point 8.6 (Follow-up action) requires that there is an effective follow-up programme after self-inspection, and that company management evaluates both the self-inspection report and the corrective actions as necessary.
In a Risk-Based Inspection (RBI), this clause is treated as a “system effectiveness” check: inspectors don’t just ask whether self-inspections happen, but whether findings are closed with risk-based CAPA and proven effectiveness. RBI planning itself is risk-driven—inspection depth and breadth increase when systems show poor control or recurring issues. CDSCO
What “effective follow-up programme” means in practice (what inspectors expect)
- Formal CAPA workflow linked to self-inspection
- Every observation is logged, risk-ranked (critical/major/minor or equivalent), assigned an owner, target dates, and required evidence.
- The system prevents “open forever” actions and flags overdue items.
- Management review and escalation (core 8.6 expectation)
- Inspectors look for proof that management reviews the self-inspection report and approves/monitors actions—minutes, review signatures, dashboards, or management review outputs.
- Critical findings must trigger immediate containment (e.g., stop use, quarantine, enhanced monitoring) and prompt escalation to QA leadership.
- Root cause + risk assessment
- RBI checks whether the site investigates beyond symptoms (e.g., “retrained operator”) to real causes (design flaw, maintenance weakness, supplier issue, poor procedure).
- The batch/product impact assessment should be documented when findings could affect released product.
- Effectiveness verification (the usual RBI differentiator)
- Inspectors expect effectiveness checks, such as: repeat self-inspection of the area, trend improvement, no recurrence over defined cycles, EM trend recovery, right-first-time records improvement, etc.
- Closure should require objective evidence, not just a completion date.
- Trending and continuous improvement
- A mature follow-up programme uses trending of recurring observations (same area/system) and converts them into preventive actions (procedure redesign, engineering controls, training redesign).
Typical RBI “red flags” for 8.6
- Self-inspection reports exist but actions are superficial, overdue, or repeatedly reopened.
- Management review is missing or “rubber-stamp”.
- No effectiveness evidence; repeat observations appear in consecutive cycles.
If 8.6 is weak, RBI usually expands scope into deviations/CAPA governance, change control, and batch release decision-making because the follow-up program is a key predictor of overall GMP control.