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Formal Safety Assessment (FSA) is the premier scientific method that is being currently used for the analysis of maritime safety and for the formulation of related regulatory policy. This paper conducts a critical review of the FSA methodology and proposes ways to improve it. All steps of the FSA approach are looked at and possible pitfalls or other deficiencies are identified. Then proposals are made to alleviate such deficiencies, with a view to achieve a more transparent and objective approach. The results of this paper may be useful if a revision of the FSA guidelines is contemplated along these lines. Recent IMO developments are also described