Risk-Based Approval
4.5 Requirements to the Documentation Related to the Approval
4.5.1 The Approval Matrix – An Easy Guideline
4.5.1.1 Project Category
In order to rank the novelty of a design, a simple categorization may be used. Tech- nology in category 1 is proven technology used in known application areas where methods for classification, testing, calculations and analyses exist. Technology in categories 2–4 is defined as new technology, and shall follow the procedures de- scribed in this report. The distinction between categories 2–4 serves to facilitate the focusing of efforts on areas of concern. Another objective of the categorisation is the establishment of, whether or not the design qualifies as a novel design, and to align estimates of required workload with the requirements eventually stated by the approval authority. The categorization also serves to assist in defining the level of detail of the analyses required in the following phase (Fig. 4.12).
Technology status Application Area
1
1 Proven
2
2
2
3
4 3
3 1. Known
2. New
Limited field history
New or un- proven
Fig. 4.12 Categorization of new technology Winther and Juhl (2007)
A matrix as shown in Fig. 4.13 may be applied for guidance to the client when performing preliminary estimates on the extent of the work to be performed and submitted for approval.
The matrix has two axes: one referring to the level of novelty in the design (project category); the other referring to requirements in the risk assessment and to the amount of documentation (row A–E). The following paragraphs are explana- tory notes to the approval matrix.
Row A: Basic risk assessment: This row contains information on description of hazards to individuals, arising from a specific setup or operation. Reference can be made to existing practice; hazards are ranked in qualitative terms.
Row B: Further analysis requirements: Due to the difference in complexity in the various ship designs it is obvious that a differentiation in the requirements to documentation is required.
• Semi-quantitative risk assessment: A description of frequency and impact of the consequences of a setup or operation, qualitative as well as quantified. Scenarios are described, and categorized according to their probability and impact. Ele- ments are prioritised according to their severity (sometimes described as a con- sequence analysis).
• Quantified risk assessment: A description of probability and consequence of haz- ards (usually to a well defined group of people) through a specific operation or activity. The risk levels are represented numerically to be compared with agreed criteria. Varying levels of depth in the quantitative risk assessment may be re- quired. It can demonstrate and quantify the effect of event sequences/scenarios which may affect structural integrity and/or may be a significant impediment to normal operational conditions, it can perform an evaluation of impact on individ- uals immediately involved or affected and quantifies potential fatalities, as well as amounts of environmentally noxious substances released and analyse the total impact on group health and the impact on the environment.
If a qualitative risk assessment describes (and suggests reduction of risks) to a satisfactory level, then requirements for quantitative assessments are redundant.
Row C: Qualifications of Analyst: This subject will be dealt with in depth in Chapter 4.3, but stems from the general assumption, that the client will to a certain extent be able to perform or contribute to at least basic risk assessment by means of own qualified personnel, as such assessments benefit as much from operational experience as from expert knowledge in specific analysis disciplines. Actual risk analysis, however, require specific expertise in the field. The guiding principle re- mains to limit the amount of external experts the client will need to employ, if a sufficient level of risk reduction can be achieved by relatively simpler means.
Row D: Applied rules and guidance: This element reflects the various sources of regulation and guidance on specific requirements in the individual case.
Row E: Potential additional tests, surveys and compliance control (after commissioning): Anticipated follow-up after construction.
Due to the variety and difference in complexity of novel ship designs, the appli- cation for approval of risk based designs will be assessed on a case by case basis.
Fig.4.13Theapprovalmatrix
Furthermore, requirements for tests and analysis may vary with the confidence in the design within the Approval Authority. When reference designs or similar projects exist, and have been approved, characteristics inferred from one design may be ap- plied to other similar designs.
Alternative evidence of compliance may be deemed acceptable by the approval authority, provided such evidence (in the form of certificates or documents of com- pliance) is produced as a result of testing or verification by an accredited indepen- dent third party.
The responsibility for documentation, testing and analysis, as required to achieve a reasonable level of safety rests with the client. This is no different from the well- known existing approval process.
The risk based approval process will apply a staged approach, initially stating conditions based on analyses of the proposed design as it is known at that stage, and later refining the requirements on which approval will be based, as knowledge of the design increases.
Assumptions made in the risk assessment in the design phase will be subject to verification, and the design as such will be subject to greater scrutiny through the initial phases of operation than what is expected for a conventional design.
The above is prevalent until appropriate references exist for most types of devia- tions from existing regulation.
Completely novel designs will be evaluated from scratch, case by case, and can thus become subject to more extensive documentation requirements. It is, though, expected, that such requirements will be relaxed as confidence in the methods and techniques applied for evaluation of safety grows, as well as the knowledge base on potential reference systems.
Traditionally, in the marine industry, “safety” has been interpreted as “compli- ance with rules”. The risk based approach, on the other hand, encourages the in- dustry to actively examine their goals with regards to safety, and also requires a re-examination of existing regulation – indeed it requires to redefine safety, and considers just how safe ship operations should be in the future.
A main challenge in this process is the balance between a volume and level of documentation, encouraging the client to examine his design and his systems (without imposing extensive burdens) and at the same time supplying sufficient in- formation for the approval authority to have confidence in the safety of a design.