ORGH.GEN.150 Findings and corrective actions

GENERAL

(a)The corrective action plan defined by the organisation providing GH services should address the effects of the noncompliance, as well as its root cause(s) and contributing factors.

(b)When a finding is raised at an individual station of a GH organisation providing GH services in more than one Member State (which may or may not be part of a single GH organisation business grouping), the GH organisation may decide how to implement the corrective action — either at the station level, at Member State level or at the management system level, with the aim of addressing the issue at all stations where the same finding has been raised.

(c)In the case of level 2 findings, as referred to in point ARGH.OVS.325 of Commission Implementing Regulation (EU) 2025/23, the GH organisation should submit a root cause analysis and a corrective action plan to the competent authority within a specified period. This period should be shorter than the corrective action implementation period, in order to provide sufficient time for the competent authority to agree on the submitted corrective action plan and for the GH organisation to implement it before the end of the implementation period.

ROOT CAUSE ANALYSIS

(a)It is important that the analysis does not primarily focus on establishing who or what caused the noncompliance, but on why it happened. Establishing the root cause(s) of noncompliance 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 noncompliance 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 nonconformity. 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.