Alertness Management Program

Encourage disclosure of personal problems with controlled substances and alcohol within a safe environment by having an open-door policy with management or using an Employee Assistance Program (EAP). An EAP enables drivers to alert management of concerns about other personnel and to seek help for their own substance abuse and/or alcohol problems. 

A documented environmental control program is followed by company management. The program dehnes responsibility, authority, alert and action limits for viable and nonviable particulates, temperature, humidity, and pressure differential specihcations for the aseptic core of the facility. 

The objective of the microbial monitoring program is to obtain representative estimates of the bioburden of the environment. When data are compiled and analyzed, any trends should be evaluated by trained personnel. While it is important to review environmental results on the basis of recommended and specified frequency, it is also critical to review results over extended periods to determine whether or not trends are present. Trends can be visualized through the construction of statistical control charts that include alert and action levels. The microbial control of controlled environments can be assessed in part on the basis of these trend data. Periodic reports or summaries should be issued to alert the responsible manager [13]. 

In addition, the valne of root canse analysis has been demonstrated beyond medical accidents. Root canse analysis has proved useful for some organizations outside clinical areas and can serve as the beginning for decision support tools. For example, one hospital, when it implemented its program of root cause analysis, established significant defection of key personnel as one of the criteria for a sentinel event. This criterion was shown to be an effective indicator when the vice president for hnman resoirrces contacted the vice president for performance improvement and alerted her that seven pharmacists had resigned within one week. The discovery allowed a significant management problem to be rapidly resolved. 

Data integration with enterprise systems Management of Change features to include chemical approval workflows, new/revised product notifications and regulatory alerts Requirements vary by industry, company size, areas of operation, number of hazardous chemicals, and a host of other criteria. Corrpile a list of program objectives that this system should achieve when fully implemented. 

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