CAMO.A.150(a) Findings receival
After receipt of notification of findings according to point CAMO.B.350, the organisation shall:
(1) identify the root cause or causes of and contributing factors to the non-compliance;
(2) define a corrective action plan;
(3) demonstrate corrective action implementation to the satisfaction of the competent authority.
CAMO.A.150(b) Corrective action(s) period
Actions referred to in points (a)(1), (a)(2) and (a)(3) shall be performed within the period agreed with that competent authority as defined in point CAMO.B.350.
AMC1 CAMO.A.150 General
The action plan defined by the organisation should address the effects of the non-compliance, as well as its root cause(s) and contributing factor(s).
Depending on the issues, the action plan should address correction/containment of the issue, corrective action and preventive action.
GM1 CAMO.A.150 Causal 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 was caused. Establishing the root cause or causes of a non-compliance often requires an overarching view of the events and circumstances that led to it, to identify all the possible systemic and contributing factors (regulatory, human factors (HF), organisational factors, technical, etc.) in addition to the direct factors.
(b) A narrow focus on single events or failures, or the use of a simple, linear model, such as a fault tree, to identify the chain of events that led to the non-compliance, may not properly reflect the complexity of the issue, and therefore there is a risk that important factors that must be addressed in order to prevent a reoccurrence will be ignored.
Such an inappropriate or partial causal analysis often leads to defining ‘quick fixes’ that only address the symptoms of the non-conformity. A peer review of the results of the causal analysis may increase its reliability and objectivity.
(c) A system description of the organisation that considers the organisational structures, processes and their interfaces, procedures, staff, equipment, facilities and the environment in which the organisation operates, will support both effective causal (reactive) and hazard (proactive) analyses.