Formal Risk Assessment Methodology

Determine the level of exposure to the identified risks (the seriousness these carry coupled with the probability that they will occur). Formal risk assessment methodologies such as Kepner-Tregoe (KT) might play a useful part here. 

This chapter uses the formal EU risk assessment methodology laid down in the European Commission Regulation (1488/94) and follows closely the principles of the technical Guidance Document [1] of the Existing Substances Regulation (793/93). 

Analytical methodology was developed for accurate quantitative analysis of trichothecenes at low part-per-billion levels in blood. Although this methodology was arduous and lacked the ruggedness normally demanded of an analytical procedure which must nave a low failure rates it proved to be both qualitatively reliable and quantitatively accurate when it was combined with a well planned quality assurance program. An indispensable part of developing the quality assurance plan was a formal risk assessment which specifically took into account the possibility of human error. 

The remainder of this article is organized as follows Section 2 describes the hackgroimd for the assessment and definitions, section 3 a brief hterature review on risk management. In section 4 the outline of a Formal Vulnerability Assessment methodology is presented. Section 5 illustrates a practical case and discussion, and finally in section 6 the conclusions and future research. 

A Formal Vulnerability Assessment methodology may offer the possibility to assess and systemize risks, both to evaluate the current state, as well as to allow for assessing the impact of changes to the existing supply chain. It is beneficial that the methodology is based on existing and tested methods, and no current method, to the authors knowledge, exist... 

The M42 ATM project was the first major HA project to require an lEC 61508 safety programme and a formal safety case. This paper has described the risk assessment methodology that was developed to suit the particular features of the motorway environment. This methodology differed somewhat from the examples given in most safety standards, for the following reasons ... 

The proposed framework for formal vulnerability assessment [FVA] for maritime supply chains is presented below. In short, this is an expansion of the Formal Safety Assessment [FSA] methodology described by IMO for maritime applications (IMO 2002). FSA is a structured and systematic, tested and provenmethod-ology for enhancing safety, including protection of life, health, the marine environment and property, latest used for risk based design of vessels (SAFEDOR 2009). 

One of the key findings of the initial review after the accident was that there was no formal, methodical safety risk assessment process. So the company set out to develop one. They decided that it needed to be a uniform and consistent methodology that could be used worldwide, across all product lines. Though product lines vary greatly, how their safety risks should be assessed needed to be very methodical and repeatable. Also, it was important that safety hazards and their associated risks must be communicated to the corporate level in a uniform and consistent manner so that risks could be compared across all operations. 

The approach for dependable requirements engineering (DRE) is the joint result of research within requirements engineermg, systems modeling (mainly based on object-oriented, semi-formal and agent-oriented modeling methodologies), dependability analysis and model-based failure and risk analysis and assessment (Thunem 2003, 2004, 2006). The four main aspects of the method are ... 

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