ED Decision 2025/007/R
The GH organisation should ensure that the reporting process ends with clear follow‑up actions. The reporting process should include, besides the follow-up actions, at least the following, documented in writing:
(a) the investigation of the occurrence and the conduct of an analysis to identify the root cause;
(b) the results of the investigation;
(c) the conclusions of an investigation into an occurrence;
(d) the actions taken to prevent similar occurrences in the future — when relevant, those actions should be included in the SMS, with a safety risk assessment, mitigation measures and safety performance indicators;
(e) the dissemination and promotion of the actions taken, such as, but not limited to, a change in a procedure or the GH manual, updates to the training programme, providing feedback to the reporter (when this is not anonymous), safety promotion actions and further actions with other stakeholders involved.
Loading collections...