Appendix 10 - Guidance for Practical Application and Review Process of FSA
Clasification Society 2024 - Version 9.40
Statutory Documents - IMO Publications and Documents - Circulars - Maritime Safety Committee-Marine Environment Protection Committee Circulars - MSC-MEPC.2 Circulars - MSC-MEPC.2/Circular.12/Rev.2 – Revised Guidelines for Formal Safety Assessment (FSA) for Use in the IMO Rule-Making Process – (9 April 2018) - Appendix 10 - Guidance for Practical Application and Review Process of FSA

Appendix 10 - Guidance for Practical Application and Review Process of FSA

 Introduction

1 The guidance provides information on the following subjects:

  • .1 project management issues to be considered for an FSA study;

  • .2 application of FSA by a Member State or an organization having a consultative status with the IMO (hereinafter called Member), when proposing amendments to maritime safety and pollution prevention instruments, to support or analyse the implications of such proposals;

  • .3 application of FSA by a Committee or instructed subsidiary body, to provide a balanced view of a framework of regulations, so as to identify priorities and areas of concern, and to analyse the benefits and implications of proposed changes;

  • .4 consideration of the expertise for the team carrying out an FSA study and qualifications for those experts; and

  • .5 review of an FSA study.

2 Recommendations resulting from an FSA study should aim to be used by decision makers at all levels and in a variety of contexts at the IMO, without a requirement of specialist expertise. For this purpose, an FSA study should be open and transparent for review by all interested Member States and non-governmental organizations which have not participated in the conduct of the FSA study.

3 FSA studies submitted to the Organization in accordance with the Guidelines for formal safety assessment (FSA), for use in IMO rule-making process for consideration, when introducing or amending IMO instruments should be considered as one source but not the only source of valuable information to support IMO decision-making.

 Practice/Conduct of FSA Study

Project management

4 Any activity that uses resources to transform inputs to outputs can be considered a process, and this definition also fits FSA. Quality management in FSA can be applied by identifying each FSA step as a sub-process involving a number of interrelated activities, and by establishing means to facilitate, monitor and control these activities to achieve the desired objectives.

5 In principle, critical issues, controls and controlling measurements to monitor the quality of the process should be defined for each FSA step. Moreover, several issues should be identified up front, before the study initiation and periodically reviewed during the study:

  • .1 basic reasons to undertake the study;

  • .2 responsibilities and skills of the team in the various stages of the study;

  • .3 clear authority chart;

  • .4 extent of the coverage of the study (in particular, how many of the FSA steps are required, which tools are expected to be used);

  • .5 a project plan including the time scale of the study;

  • .6 potentially critical areas and key measures of quality assurance; and

  • .7 risk evaluation criteria.

Application of FSA by a Member

6 A Member State or an organization having a consultative status with IMO, or a pool of Members, may decide to carry out an FSA and submit its results for consideration by a Committee or instructed subsidiary body. The scope of the FSA definition of the problem and its boundaries should be decided by the Member(s) conducting the study, in the context of the submitted proposal. The costs involved in carrying out the study should be covered by the Member(s) conducting the study, who will also coordinate and keep responsibility for the work of subcontractors, if any.

7 The Member(s) carrying out the FSA study should make its/their best efforts to ensure that the report is presented in accordance with the Standard Format for Reporting FSA Applications, given in appendix 8 of the FSA Guidelines. It is important that the FSA report includes the names and credentials of the experts who have carried out or have been involved in the FSA.

Application of FSA by a Committee or an instructed sub-committee

8 The Committee may decide to carry out an FSA study following:

  • .1 a proposal by a Member;

  • .2 a proposal from a subsidiary body; or

  • .3 discussion in the Committee of an agenda item.

9 There are different options which may be followed by the Committee for undertaking the FSA study. In some circumstances, for instance when a proposal has far reaching implications and requires a balanced view between all relevant issues, the Committee may decide that the FSA study should be carried out by an instructed sub-committee, as described in paragraphs 15 to 24 below.

10 Further options for undertaking an FSA study may also be appropriate, one of which could be to invite a Member, or a pool of Members, to carry out the FSA study and report its results for consideration by the Committee. The Member(s) accepting this proposal could proceed according to the steps given in paragraphs 4 to 9 above.

11 In cases where the Committee decides that the study should be carried out by instructed sub-committee(s), the FSA study may be conducted in accordance with the flow chart shown in figure 1, as described below.

Figure 1

12 The Committee may decide to establish a working group, instructed to:

  • .1 develop the terms of reference for undertaking FSA;

  • .2 propose a list of required competencies;

  • .3 develop and execute a project management plan;

  • .4 coordinate the conduct of FSA;

  • .5 validate FSA, when necessary; and

  • .6 report the results of FSA to the Committee, for information and approval.

13 The terms of reference of FSA may include, inter alia:

  • .1 the definition of the problem under consideration and its boundaries (chapter 4 of these guidelines);

  • .2 characterization of the problem under consideration, for example in terms or features, characteristics and attributes which are relevant to the problem concerned (section 4.2 of the guidelines);

  • .3 the organization and tasks proposed for carrying out the five steps of the FSA process, including instructions to the relevant subsidiary bodies; and

  • .4 the list of competencies required for carrying out each step of FSA.

14 The Committee should examine the draft terms of reference developed by the working group, including in particular the necessary competencies, for approval. On the basis of the approved terms of reference, the Committee will:

  • .1 instruct the sub-committee(s) to undertake FSA (for instance a sub-committee or several sub-committees);

  • .2 endorse the list of competencies for carrying out each step of FSA; and

  • .3 invite Members willing to participate in the conduct of the FSA study to provide persons with the required competencies.

15 Members interested in participating in FSA should provide the Committee with a list of persons proposed to participate in the sub-committees instructed to carry out the FSA study, together with details of their relevant competencies. The working group should determine that such a list, when completed, covers the competencies deemed necessary for carrying out each step of the FSA study, and report to the Committee to decide as appropriate.

16 Each instructed subsidiary body should carry out the parts of the FSA study assigned to them. Any progress reports that the Committee may require, and, on completion of the FSA study, the final report should be submitted to the Committee. This final report should be in accordance with the Standard Reporting Format, given in annex 2 of the FSA Guidelines.

17 Interim reports may be submitted to the working group for the purposes of providing inputs to other parts of the process and enabling the working group to facilitate and monitor progress according to the project plan. The working group should review these reports and inform the Committee whether the FSA study proceeds in accordance with the approved project management plan. The working group should also propose necessary corrective actions, if any.

18 In addition to the final report submitted to the Committee by the sub-committees undertaking the FSA study, the working group should, at the completion of the FSA study, present to the Committee a summary report, which may include, inter alia:

  • .1 an evaluation that the methodology applied is in accordance with the interim guidelines;

  • .2 any proposals for improvement of the interim guidelines;

  • .3 deviations, if any, from the terms of reference approved by the Committee, and reasons therefor; and

  • .4 a list of recommendations resulting from the FSA study for a decision by the Committee.

19 The Committee should receive the recommendations made by the working group and decide as appropriate.

Participation of experts in an FSA study

20 The participation of experts in the various fields is an essential part for the success of an FSA application. The team carrying out the FSA study should be selected in accordance with the area of interest of the study and related problems. A number of other experts should be involved to gather expert views and judgements throughout the five steps of the FSA process.

21 The team carrying out an FSA study should cover the fields of expertise necessary to progress within the five steps of the FSA process. The composition of the team depends on the type of problem and level of detail of the assessment. For instance, the team might include:

  • .1 experts in risk assessment techniques;

  • .2 experts in statistical data gathering and analysing;

  • .3 experts involved in casualty investigations;

  • .4 experts in the human element;

  • .5 experts in the applicable rules and regulations;

  • .6 experts from the technical, operational and organizational field, (e.g. designers, builders and operators);

  • .7 experts in consequence assessment (e.g. SAR, salvage and environment protection); and

  • .8 experts in cost-benefit assessment.

22 The team carrying out an FSA study may involve other experts in order to provide additional expert views, technical evaluations and/or judgements. All the experts involved in FSA study should have, as far as possible, a basic knowledge and understanding of the FSA methodology, as set out in the FSA Guidelines.

23 The experts to be involved should cover the widest possible range of knowledge, qualifications and competence relevant to the problem under consideration, including, for instance:

  • .1 organizational and managerial aspects, e.g. pertinent to shipping companies;

  • .2 technical aspects, e.g. design, construction, operation and maintenance;

  • .3 legal, finance and insurance matters; and

  • .4 matters of concern to flag Administrations and port State controls.

24 The names and expertise of the members of the team carrying out an FSA study and other experts involved should be included in an annex to the report containing the results of the study.

25 Other experts in various fields may be involved when reviewing and discussing the results of the FSA study.

Review of FSA study

Review process

26 The Committee or an instructed subsidiary body should consider the submission of an FSA study and decide, on a case-by-case basis, the most appropriate course of action. When the subject is sufficiently clear, the Committee can form an opinion about the FSA study and its relevant proposals, and decide accordingly. In other circumstances, the Committee may decide that a review is necessary to validate the FSA study and its findings.

27 The review process should be carried out within the Organization, by a group of experts established by the Committee for that purpose following the flow chart shown in figure 2 below.

Figure 2

Flow chart for FSA review process

Terms of reference of the Experts Group

28 The terms of reference of such a review should be established by the Committee, based on the matter under consideration. The terms of reference should be to review the FSA studies submitted, in particular to:

  • .1 check:

    • .1 the adequacy of scope of the FSA; and definition of the problem;

    • .2 the validity of the input data (transparency, comprehensiveness, availability, etc.);

    • .3 the adequacy of expertise of participants in the FSA; identified hazards and their ranking; and the reasonableness of assumptions; and

    • .4 the adequacy of accident scenarios, risk models and calculated risks; identified RCMs and RCOs; selection of RCOs for Cost-Benefit Analysis (CBA); and CBA results;

  • .2 check methodologies used and relevance of methods and tools for:

    • .1 decision in the group(s) in the FSA;

    • .2 HAZID;

    • .3 Calculation of risk;

    • .4 Cost-Benefit Analysis (CBA); and

    • .5 Sensitivity and uncertainty analysis;

  • .3 if any deficiency was identified in the items above, consider whether they affect the results;

  • .4 consider whether the FSA was conducted in accordance with the guidelines;

  • .5 check whether the recommendations in the FSA ask to take any immediate action or propose any changes to IMO instruments;

  • .6 consider whether the results and the recommendations in the FSA are credible and advise the decision makers (e.g. Committees of the Organization) accordingly; and

  • .7 consider whether it is necessary to improve the FSA Guidelines, and, if so, the proposal for the improvement.

 Establishment of, and report from, the Experts Group

29 When the Committee decides to establish a group of experts for a specific project, it should determine the number of meetings necessary to meet the target completion date.

30 The Members, having carried out the FSA study, should provide timely and open access to relevant supporting documents, and any reasonable opportunity to take into consideration the comments received.

31 The results of the review by the group of experts should be presented to the Committee or instructed subsidiary body, as appropriate. The group of experts should, as a goal, try to reach consensus on its conclusions for the review of the FSA study, but where there are strong conflicting views, these should be indicated in the report.

Structure of the Experts Group

32 Participation in a group of experts will be voluntary and is open to all Member States and international organizations.

33 A Chairman and a Vice-Chairman should be selected by the Committee when it decides an FSA study should be reviewed by a group of experts.

34 When nominating experts, Member States and international organizations should nominate experts who have suitable qualifications in the field of formal safety assessment, as described in paragraph 37, and inform the Organization of particulars of the expert (e.g. name, expertise and contact details) with a short CV.

35 Participants in the group of experts should:

  • .1 have not been involved in the FSA study to be reviewed; and

  • .2 be capable of acting scientifically independent (i.e. acting in an individual capacity).

36 The review work should be conducted concisely in order to give timely conclusion(s) to the Committee(s) and, in order to do so, the review work can be conducted by holding meetings of the group (without interpretation) as well as by correspondence.

Qualifications of the experts

37 Members participating in a group of experts should, as a minimum, have knowledge/training in the application of the FSA Guidelines, and should have, at least, one of the following qualifications:

  • .1 risk assessment experience;

  • .2 a maritime background; or

  • .3 relevant knowledge or any unique concerns related to the FSA (e.g. human element).

Report of the Experts Group

38 Experts Groups' reports should only include the names of the experts but not of the nominating Member States or organizations.

Parent topic: MSC-MEPC.2/Circular.12/Rev.2 – Revised Guidelines for Formal Safety Assessment (FSA) for Use in the IMO Rule-Making Process – (9 April 2018)
Copyright 2022 Clasifications Register Group Limited, International Maritime Organization, International Labour Organization or Maritime and Coastguard Agency. All rights reserved. Clasifications Register Group Limited, its affiliates and subsidiaries and their respective officers, employees or agents are, individually and collectively, referred to in this clause as 'Clasifications Register'. Clasifications Register assumes no responsibility and shall not be liable to any person for any loss, damage or expense caused by reliance on the information or advice in this document or howsoever provided, unless that person has signed a contract with the relevant Clasifications Register entity for the provision of this information or advice and in that case any responsibility or liability is exclusively on the terms and conditions set out in that contract.