Resources prioritization

In the effort to choose and accelerate programs that offer the best possible chance to move forward, a value and risk assessment at the start of lead optimization typically occurs along with project and resource prioritization (Table 1.3-5). 

Trend Analysis The process must include analysis of information such as injury/illness history, hazards identified during inspections, employee reports of hazards, and accident and near-miss investigations for the purpose of detecting trends. The results of trend analysis must be shared with employees and management and utilized to direct resources prioritize hazard controls and determine or modify goals, objectives, and training to address the trends. 

Introduction Theprevious sections dealt with techniques for the identification of hazards and methods for calculating the effects of accidental releases of hazardous materials. This section addresses the methodologies available to analyze and estimate risk, which is a function of both the consequences of an incident and its frequency. The apphcation of these methodologies in most instances is not trivial. A significant allocation of resources is necessary. Therefore, a selection process or risk prioritization process is advised before considering a risk analysis study. 

This section describes how both hypothetical and real accidents are analyzed. These methods varying greatly in complexity and resource requirements, and multiple methods may be used in an analysis. A simple method is used for screening and prioritization followed by a more complex method for significant accident scenarios. Some methods give qualitative results more complex methods give quantitative results in the form of estimated frequencies of accident scenarios. The process systems in Figures 3.3.1-1 and 3.3.1-2 are used in the examples. 

To establish a backlog and aid in defining the scope and duration, essential to resource allocation, prioritization and establishment of the mles. 

Because the validation of computerized systems is time consuming, expensive and resource intensive, many organizations are challenged to identify and prioritize which systems will be validated. There are organizational and system specific risk factors to consider in the regulated environment. Each organization must establish its own risk assessment process. 

For systems with regulatory impact, a numerical exercise is then conducted to prioritize the validation activities. This prioritization considers all of the following system criticality, industry distribution of the software, regulatory experience, and the vulnerability at downtime. The numerical rating facilitates prioritization of validation efforts utilizing limited resources. The numerical priority ranking of each system with regulatory impact can then be compared with other systems to identify the order in which to address the various activities. 

If the PrHA team is quite experienced, they may rank the action items according to the anticipated time and resources needed to implement changes. Or the team may make safety improvement and implementation recommendations. Ranking of action items or safety improvement recommendations may be valuable to management in several ways. It shows the significance that the PrHA team places on each item. It also allows management to prioritize the immediate efforts of corrective action and resolution. If resources are scarce, the ranking may affect the implementation schedule. 

Such prioritization is needed to assure that scarce testing resources are focused on those materials of greatest concern. 

HSPD -7 Critical Infrastructure Identification, Prioritization, and Protection. Establishes a national policy for federal departments and agencies to identify and prioritize critical U.S. infrastructure and key resources and to protect them from terrorist attacks. 

Because of the need to prioritize and focus limited resources, in the context of Project Prism, the misuse of the Internet will in future be addressed on a case-by-case basis. Information obtained by... 

The process owner with stakeholders will need to provide a process improvement proposal if the issue or change requires prioritization due to funds or additional resources from the enterprise. The proposal should include, at minimum, the problem and or opportunity statement, impact to the site based on risk, and proposal of an action and/or project, including both cost and resource requirements. 

Process improvements may be conducted by the completion of a task or a project. A task is an activity that can be completed by the process owner with minimal cost and/or resources over a short period of time. A project is defined as temporary work to provide a product or service that is beyond the process owner s support. In general, a project requires more than one full-time equivalent (FTE), crosses over multiple functional organizations, and the duration of the effort spans over a longer period of time. Improvement status, updates, and issues should be discussed on a regular basis by a management forum or steering committee. Tasks and projects should be prioritized based on the risk against patient safety and efficacy and compliance. 

The PAT guidance clearly states that industrial implementations should be risk based. Soon after the PAT team and objective have been identified, the project should commence with a formal risk assessment. The risk assessment should be focused on identifying and characterizing the failure modes which present risks to product quality the outcome of the risk assessment will provide a means prioritizing the allocation of PAT resources and a baseline for review of the effect of PAT in mitigating risks to quahty. 

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