6.8 Description of Final design, risk assessment report review and qualification method description

  6.8.1.1 Upon receipt of the preliminary approval statement, the description of the final design may commence. The final design elements and the scenarios imposed by the operational conditions will at this stage be subject to a risk assessment of all vital/safety critical elements.

  6.8.1.2 The risk assessment is to live up to the detail level necessary to examine risks with respect to the evaluation criteria as well as follow acceptable methods (qualification of the methodology should be part of the report submitted).

  6.8.1.3 Initially, the required level of detail mainly depends on the novelty impact of the issue addressed. In order to avoid possible conflict of interest, it is recommended that the party setting the requirements to the risk assessment and eventually approving it is not the party performing and delivering it.

  6.8.1.4 The Submitter has to consider:

• .1 all relevant IMO guidance documents;

• .2 further information, plans and drawing details in the course of such information being produced;

• .3 documentation on any previously unidentified risks, rendered evident by the increased comprehensiveness of the design, analysis of such risks and, and information on the analysis methods selected;

• .4 risk assessments performed and submitted, supplying sufficient information to render both method and content transparent to an external auditor (without requiring redundant documentation, testing or analysis from the Submitter);

• .5 applied evaluation criteria (relative, qualitative or quantitative), examined and explained. If a reference design exists, or equivalent arrangements can be found, then relative criteria should be applied;

• .6 a description of sources of frequency and consequence estimates, documenting relevance for the design in question;

• .7 statement on assumptions, exclusions, limitations and uncertainties;

• .8 a description of further planned tests and analyses of materials and systems; and

• .9 all calculations performed and historical data applied may be obtainable and reproducible by an independent third party to ensure that the methods and techniques are sufficiently robust and remain objective.

  6.8.1.5 The Administration has to consider:

• .1 whether relevant guidance has been taken into account;

• .2 whether the documentation supplied renders a complete picture of the design to the extent known at the given stage;

• .3 whether all previously and newly identified risks have been analysed:

  • .1 by means of applicable/approved tools;

  • Analyses performed by means of new tools may be considered, but observing that application of such tools may generate a request for further independent verification of the tools or independent analysis with alternative tools.

  • .2 by personnel with adequate knowledge and experience. The adequacy of personnel qualifications depends on the required analysis depth level;

  • .3 at an adequate depth level. The analysis may yield information to support confidence in the safety of the design and document risks being compliant with evaluation criteria agreed at the highest level possible;

  • .4 by means of adequate techniques. As stated, a HazId prevails as a minimum basic requirement. (Further analysis to be conducted if and as required if a qualitative evaluation does not provide for conclusive confidence in the safety of the design, e.g. HazOp, what-if, FMECA, etc., as applicable to the level and extent of the design or system assessed, the adequacy of technique chosen may be explained.); and

  • .5 sequentially and iteratively to ensure that any potential new or altered elements of risk are covered as the design process progresses;

• .4 whether agreement prevails on the selected evaluation criteria;

• .5 whether assumptions, exclusions and limitations are justified and whether the approach is sufficiently robust to retain confidence in the design;

• .6 whether the applied risk control options are considered effective and viable;

• .7 whether historical/statistical data is as recent as possible and is relevant for the application;

• .8 whether the numerical tools used are fit and validated for purpose; and

• .9 whether evidence prevails that intended or planned further tests and analyses will have an acceptable outcome.

  6.8.2.1 The Submitter supplies the following to the Approval Authority:

• .1 description of risk model(s), calculations and analyses (methodology, frequency and consequence estimates, sensitivity analysis, limitations of methods, assumptions made, reproducibility/falsification tests applicable);

• .2 basic source information (related work tasks, the origin of database material and its applicability, source of FN-diagram figures on societal risk, sources of individual risk, fatalities, lost time accidents, evaluation/evaluation criteria (for subsidiary operations/ship system operations));

• .3 clear indication where and how expert judgment was applied (where no data is available);

• .4 level of agreement in the expert group (concordance, see FSA Guidelines);

• .5 applicable risk control options and associated considerations, including the analysis efficiency of proposed options;

• .6 error/uncertainty/sensitivity discourse; and

• .7 main risk contributory factors.

  6.8.2.2 Queries by the Administration preceding approval:

• .1 Are the models used of an approvable methodology (recognized risk assessment techniques, adequate for the task)?

• .2 If requirements exist from the definition of approval basis stage (such as certain safety features or margins), does the documentation comply with these requirements as well as with the design specification?

• .3 Has an acceptable methodology and degree of consensus been achieved when applying expert judgment?

• .4 Can the results be reproduced by a third party having knowledge of the case?

• .5 Have limitations of the methodologies applied been accounted for?

• .6 Have all main risk contributory factors been accounted for and evaluated?

• .7 Is the documentation supplied clear, transparent, complete and adequate for its purpose (i.e. is the information supplied sufficient for a person of adequate knowledge in the field to comprehend it by means of the sources and methodologies quoted)?

• .8 Have issues of interaction effects or interface issues been considered (among other things aggravating or mitigating conditions)?