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GM1 ORGH.GEN.150(a)(1) Findings and corrective actions

ED Decision 2025/007/R

ROOT CAUSE ANALYSIS

(a) It is important that the analysis does not primarily focus on establishing who or what caused the non‑compliance, but on why it happened. Establishing the root cause(s) of non‑compliance often requires an overarching view of the events and circumstances that led to it, to identify all possible systemic and contributing factors (regulatory, human, organisational, technical, operational, etc.) in addition to the direct factors.

(b) A narrow focus on single events or failures to identify the chain of events that led to the non‑compliance may not properly reflect the complexity of the issue. Such an approach may not consider important factors that must be addressed to prevent recurrence. An inappropriate or partial causal analysis often leads to defining ‘quick fixes’ that only address the effects of the non‑conformity. A peer review of the results of the causal analysis may increase its reliability and objectivity.

(c) It is expected that the root cause analysis consider organisational structures, processes and their interfaces, procedures, personnel, equipment, facilities and the environment in which the organisation operates to set up effective corrective actions to preventing recurrence. Root cause analysis methods — for example, fishbone diagrams, Pareto charts, the ‘5 whys’ and failure mode and effects analysis — may be used to identify the underlying causes of problems, failures and inefficiencies.