The risk-analysis process

As a general rule, clinical data are required as evidence to support conformity with the requirements of the Active Implantable Medical Devices (AIMD) and the Medical Device (MD) directives with regards to safety and effectiveness under the normal conditions of use, evaluation of undesirable side effects, and the acceptability of the benefit/risk ratio. Risk analysis should be used to establish key objectives that need to be addressed by clinical data, or alternatively to justify why clinical data are not required (mainly for Class I devices). The risk analysis process should help the manufacturer to identify known (or reasonably foreseeable) hazards associated with the use of the device, and decide how best to investigate and estimate the risks associated with each hazard. The clinical data should then be used to establish the safety and effectiveness of the device under the intended use conditions, and to demonstrate that any of the residual risks are acceptable, when weighed against the benefits derived from use of the device. 

The Risk Analysis process consists of three components risk assessment, risk management, and risk communication. 

The decision as to which system needs to be qualified should result directly from the risk analysis process and should be described in the VMP or QMP. In any case, it would be a technical system that impacts on the quality of a pharmaceutical product. Installation qualification aims to check documentation against reality. The result is as-built documentation. The other task in the IQ is to ensure that the GMP requirements are fulfilled. The generally accepted way to perform an IQ is to... 

FIGURE 15.1 Steps in the risk analysis process of food allergens. 

The culmination of the risk analysis process is the Risk Management Plan (RMP). The RMP must be incorporated into the execution plan and contain provisions for ... 

In a safety risk analysis, initiating transportation events may include both accidents and non-accidents. Depending on the mode of transport. Table 3.2 details some of the types of accident-initiated events that should be considered in the risk analysis process. 

To this point in the risk analysis process, XYZ Chemical commissioned a separate study to review the bulk pesticide operation and all potential risk reduction options and combination of options that could be implemented to manage the risk of this operation. This study determined that the combination of several risk reduction options reduced the bulk pesticide risk from higher risk to lower risk. While management thought it was important to reduce identified risks, the costs of the available options were not justifiable and so the movement of bulk pesticide from this Asian facility was stopped. 

Demonstrating that the level of residual risk is acceptable will always be based on a degree of subjectivity. The safety case assessment procedures recognize the limitations of the risk analysis process and the problems associated with determination that risk has been reduced to as low as is reasonably practicable. This is achieved by focusing on the analysis of the operator s methodology in undertaking the risk analysis process. 

The VIRTHUALIS methodology includes a suite of hiunan factors and risk analysis tools aimed at assessing the risk level of several initiating events. The main objective is to improve the risk analysis process through a validation of assessments made by safety analysts and the collection of empirical data about human performance (e.g., estimates of task duration). For this reason, a Virtual Environment Lab has been developed that simulates the technical system behaviour and the performance of operator tasks in a realistic manner. Operators are able to manipulate... 

Always there is no need for hazards to appear individually. In fact, an individual effect may be negligible but in combination these may cause havoc. In this connection, Fig. 11/3.3.4-1 may be referred to. Another aspect on which emphasis must be placed is cumulative risk. Unless cumulative risk is assessed, the overall risk profile for the facility cannot be drawn up. This also makes it possible to evaluate key causes and control measures in the perspective of cumulative hazards. It is recommended that before starting the risk analysis process these aspects are well understood. 

One of the problems of safety engineering is that safety analysis many times identifies the worst-case scenario. The risk analysis process is a way to optimize a... 

This section describes the risk analysis process that was carried out, and follows the steps of the risk analysis process described by Aven (2009). 

Place of Technical Diagnostics during the Risk Analysis Process... 

The Management Index (e.g.. Risk Index x Sensitivity Index) provides further ranking for those risks with equal Risk Indexes. Given its scope, sensitivity analysis may not necessarily constitute an integrated step of the risk analysis process. 

Risk communication - the interactive exchange of information and opinions throughout the risk analysis process concerning risk, risk-related factors and risk perceptions among risk assessors, risk managers, risk communicators, the general public and other interested parties... 

ARTHUR j.R. (2008), General principles of the risk analysis process and its application to aquaculture. In M.G. Bondad-Reantaso, J.R. Arthur and R.P. Subasinghe (eds). Understanding and Applying Risk Analysis in Aquaculture. FAO Fisheries and... 

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