Hierarchies, recommendations development

Table 1-2 shows the hierarchy according to tier level for related recommendations. Numerous other observations and suggestions are discussed throughout the general text of the report. The report also includes a detailed assessment of information management systems, including physical facilities, software, and system development processes. 

Develop Remediation Proposals. When the results of the risk assessment indicate that risk elimination or reduction measures are to be taken, alternate proposals for the design and operational changes necessary to achieve an acceptable risk level would be recommended. In their order of effectiveness, the actions as shown in Chapter 12, Hierarchy of Controls The Safety Decision Hierarchy, would be the basis on which remedial proposals are made. For each proposal, the remediation cost would be determined and an estimate of its effectiveness in achieving risk reduction given. Risk elimination or reduction methods would then be selected and implemented. 

RECOMMENDATION A hierarchy of two levels of preclinical assessment, using techniques from cellular-molecular studies through whole-animal studies, should be implemented to assess the safety of ingredients new to infant formulas on developing organ... 

As a result, a functional hierarchy develops in which malfunctions of the lower hierarchy influence the upper functional hierarchy. Similarly, within one horizontal functional level there are reciprocal influences. This is why a hierarchical function stmcturing is recommended before a hazard and risk analysis, in order to be able to describe potential malfunctions. Any changes of the functional architecture, their implemented environment and of course their characteristics, could lead to new or other malfunctions and consequently change the result of the Hazard Analysis and Risk Assessment. This is a further indication why in many industries the word preliminary is attributed to this analysis or mentioned in its name. 

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