Business risk

Building 5 is low occupancy and does not need to be considered for further evaluation, for the purposes of personnel protection. However, since Building 5 is critical to the long-term continued operation of the facility, the decision was made to keep it in the evaluation pool to see if business risks were created because of its location. 

Clarke S., 1997. Violations as a Source of Project Risk, The international journal of Project and Business Risk Management, 1(2), pp. 155-167. 

There have been attempts by companies to assign quantitative risk numbers to these regions. It is important to note that different values should be considered for workers vs. for the public near the facility. Generally, the risk to the public is one order of magnitude lower than for workers. The workers accept the risk, whereas the public wants a lower risk. Each company should establish their own risk tolerance values. This may be used to assess financial and business risk. 

Business risks—The risk that production or other business objective will be impaired because of unplanned incidents. 

The need to deposit viable cultures of microorganisms to meet the legal requirement of providing a sufficient or enabling disclosure of the invention represents a substantial business risk of giving competitors a head start in their R D if no worthwhile patent protection is obtained ultimately. In other technical areas only information describing the invention is disclosed, and not actual physical materials that either embody the invention or that are very closely related to the invention. 

Business Risk This is the risk that the business you have invested in will not do well. 

Further diversification within categories minimizes exposure to business risk. It recognizes that within an asset category some investments will do well while others will not. Unfortunately, you don t know ahead of time which ones to choose. Consider the following example of a diversified investment of 100,000 ... 

There is also an intrinsic risk of a product being withdrawn after it has been approved for marketing. Typically this risk is at its peak in the first 3 years on the market as the number of patients in the general population exposed to the product rapidly increases and less frequent adverse events come to light. The risk of removal is, however, relatively very small and would usually be considered a normal business risk unless there is a history of failures among products of the same class. This has recently been highlighted by the discovery of an association of adverse cardiac events with COX2 inhibitors and then... 

The more factors included in this review and the more concrete the answers to the questions raised, the smaller will be the business risk. 

Once the gap has been defined, there must be a decision made to either write the key documents and fill the gap or for management to take the business risk not to write them, if they are not available. Time and resources must be included in this plan. This list of documents to be written and authorized by management is the output of the Gap and Plan phase. The Gap and Plan identified in a particular example included ... 

Processes and functional requirements must be reviewed before issue to the design consultant. The objective of the review, or in some cases multiple reviews, shall be to ensure that processes and functions have been completely and accurately defined, and that performance criteria are unambiguous. Reviews must also determine the consequence of function failure that is, the risk to the research study, manufacturing process, and safety and regulatory compliance. These consequences must be documented so that the delivered solution is appropriate to the business risk, i.e., the design must be relevant to the operating context of the asset. 

The output of the FMEA analysis is paramount to the determination of the business risk (consequence of function failure) presented by a system. This risk is used to determine the level of rigor applied to the validation, operational control, maintenance, and documentation/information needed to verify and maintain system performance as indicated by Figure 31.5. It follows that the documentation/information supporting system functions is as critical to the pharmaceutical organization as the system function itself. 

What are the implications of different business risks across the infrastructure, e.g., GxP and non-GxP ... 

Comparison with industry peers can be a strong motivator for improved performance, especially when industry peers have demonstrated better performance is possible. This is true from the shop floor to the executive offices. Company executives do not want to be seen as managing their business in a subpar fashion, and process safety is one business risk that upper management cannot afford to manage poorly. 

What are the business risks and opportunities associated with this picture ... 

Similarly, metrics provide a means for comparing resource consumption and pollutant emissions for the manufacture of various products. The comparison of the metrics for various processes serves to highlight those areas, such as high energy intensity or toxics emissions, that pose potential business risks. An important characteristic of the metrics is that they are stackable - that is, they can be combined (or stacked) to calculate environmental impact per pound of product over the series of processes that comprise a supply chain. 

Stand-alone risk is the standard deviation in the return-on-investment calculations for different company-specific scenarios or, qualitatively, is a high/medium/low score relative to the typical business risk in the industry. The correlation with the portfolio risk reflects the correlation of major risks between projects and portfolios or, qualitatively, compares patterns of sensitivity analyses, and attaches high, medium and low scores. 

It is a business risk in that undetected impurities can give a false result in a toxicology study, resulting in premature termination of the project. 

The other major component influencing business decisions is risk. First, one needs to distinguish business risk from financial risk. 

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