Safety assessment outcome

IMO (2012) Formal Safety Assessment, Outcome Of MSC 90—Draft Revised FSA Guidelines and draft HEAP Guidelines. 

It should be kept in mind that there are a number of common mistakes (in both the design and conduct of studies and in how information from studies is used) that have led to unfortunate results, ranging from losses in time and money and the discarding of perfectly good potential products to serious threats to people s health. Such outcomes are indeed the great disasters in product safety assessment, especially since many of them are avoidable if attention is paid to a few basic principles. 

There are differences as to how safety factors greater than 100 are applied to risk assessment for workers. Some regulatory authorities (e.g. Canada) apply additional uncertainty and safety factors when conducting occupational risk assessments. Other jurisdictions (e.g. the USA) do not. Such divergent approaches can lead to different risk assessment outcomes. Consistent approaches to application of uncertainty and safety factors would greatly facilitate harmonization. 

The political decision to build and take into use a deep geological repository for long term storage of spent nuclear fuel will largely depend on the outcome of thorough scientifically-based safety assessments. Given the very long operational time span for the repository, the... 

The a priori identification of specific risk hypotheses leads to the ability to take some of the methodology normally applied to hypothesis testing of efficacy results and apply it to safety assessment. The most important difference between these two analysis domains is that in the case of efficacy, outcomes of interest are identified a priori with great specificity, and clear statistical hypotheses are laid out in advance with complete analysis and decision rules documented in the clinical protocol. In practice, only a few efficacy variables are identified as primary, and only a few others as second-ary. Sensitivity, statistical power, and sample size are all carefully analyzed in advance to assure the trial will have a high probability of detecting differences of interest in these few critical variables. 

As a final note on tools which might be used to select new employees, there are number of products on the market which claim to predict safely behaviors and safety-related outcomes. Providers of these assessment tools vary greatly in the claims that are made about their tools ability to predict employee safety behavior, and the degree of research based evidence which they provide to support these claims. Organizations using these products need to examine very carefully the nature of the instrument/measure, and the evidence that it is a valid predictor. As with other selection assessments, employees are likely to assume such measures will operate in a valid and reliable way. 

Where the outcome of an analysis is unexpected at least some consideration should be given to the possibility that the safety assessment process or its application could be flawed in some way. As part of the action plan it can be prudent to check that the issue is not a figment of the assessment methodology, especially when a CRM process is new and has not been previously tested. For example ... 

Biomarkers Some products may have identified biomarkers that impact the response to treatment. If biomarkers are being considered for safety assessment, methods to investigate the relationship among treatments, biomarkers, and safety outcomes could be described. 

Leading indicators are those measures that can be effective in predicting future safety performance (Dupont Corporation 2000). Leading indicators can be considered before-the-fact measures. These measures assess outcome actions taken before accidents occur and are measures of proactive efforts designed to minimize losses and prevent accidents. Leading indicators can help uncover weaknesses in the organization s operations or employee behaviors before they develop into full-fledged problems. 

A Safety Assessment involves detailed predictions of the likely hazardous behaviour of a system, often before it enters service. Before such an assessment can be made it is necessary to understand the nature of hazards and how system failures/inadequacies contribute to accidents and incidents. There is a causal chain from causes to hazards to accidents. Rhys (2002, page 4) defines an accident as an unintended event or sequence of events which causes death, injury, environmental damage or material damage . The accident is the undesired outcome, rather than the initiating event or any intermediate state or hazard. 

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