Control data sources

The lowest level of the figure is formed by the recording of the process traces, consisting of process values, quality and user data, and other information. To achieve this, it was necessary to integrate the various automatic control data sources, together with additional sources such as environmental conditions. As described in the previous subsection, many of these sources had not been integrated in any way, so that the issue of their heterogeneity had to be addressed first. Also, many important steps had not yet been recorded at all, or... 

A mass spectrometer consists of four basic parts a sample inlet system, an ion source, a means of separating ions according to the mass-to-charge ratios, ie, a mass analyzer, and an ion detection system. AdditionaUy, modem instmments are usuaUy suppUed with a data system for instmment control, data acquisition, and data processing. Only a limited number of combinations of these four parts are compatible and thus available commercially (Table 1). 

The major water desalination processes that ate currendy in use or in advanced research stages are described herein. Information on detailed modeling can be found in the Hterature cited. The major texts on water desalination written since the 1980s are those by Spiegler and Laird (47), Khan (48), which contains many practical design aspects, Lior (49) on the measurements and control aspects, Heitman (40) on pretreatment and chemistry aspects, and Spiegler and El-Sayed (50), an overview primer. Extensive data sources are provided in References 39 and 51. 

Appendix III of this report provides a detailed description of the reliability data used in event tree and fault tree quantification. Because of its extensive operating experience and the uniqueness of the BRP design, BRP plant-specific data was used whenever possible. Plant-specific data sources included plant maintenance orders, control room log books, surveillance tests, LERs, event reports, deviation reports, plant review committee meeting minutes, and USNRC correspondence. The plant-specific data used spanned the period from 1970 to 1979. Data before 1970 did not include maintenance orders or surveillance tests and therefore were excluded. The plant-specific data collected for BRP is presented in detail in Appendix XIII. Table III-4 summarizes 30 plant-specific component failure rates and Table 11-06 contains plant-specific maintenance unavailabilities for 20 components. These tables are a summary of the BRP component failure and maintenance outages. 

Documentation of data origin is essential. Each completed data collection form needs to contain a file reference number or code to connect it to the documentation sources. This provides an essential trail to audit data quality, to confirm risk or reliability estimates or to investigate data values that appear questionable. Procedures to control data during handling, processing, recording, and reviewing are also necessary to prevent loss of data and to assure that opportunities are not lost to check the content of a form, by... 

If the fit is poor and it is suspected that the full concentration range of data has not been tested, the top and/or bottom of the fit may be constrained if no data are available in these regions. If control data from other sources are available, this may be used to constrain maxima and/or minima. 

Figure 15. Variation in Dxh for garnet versns reciprocal temperature for experimental data sources listed in Table lb at a variety of pressures n = 33). A distinction is made between mantle solidus partition coefficients (Salters and Longhi 1999 Salters et al. 2002 McDade et al. 2003a,b) and the rest. Note the strong temperatnre dependence, which is qnalitatively similar to that incorporated in Equation (25b). The scatter is due to additional compositional controls.

Preliminary Hazard Analysis. The next step in the process is the development of a PHA. This analysis is the core of the FSS program and as such is vital in eliminating or reducing the inherent hazards associated with this laboratory operation. The PHA is used to further analyze the data identified in the PHL. This enhances the hazard control data base and provides specific recommended corrective action for the resolution of hazardous conditions. A combination of the informational sources used in the PHL development and any additional design information should be used in PHA development. 

Quality control data were used to verify the basic hypothesis Hb concerning the dominant source of contamination on the territory of... 

Parallel to the advance of pharmaceutical innovation, other determinants of health outcome may also change over time, such as income level and personal health care expenditures on other types of care. Because of the limitation of data sources, we are unable to construct the disease-specific data for health care expenditure and income. Rather, we use the average annual household income and time trend to control the influence of social and economic factors on health outcome. For simplicity, we assume that the health effect of pharmaceutical innovation occurs without lag when we extend our regression to include other explanatory variables. 

When limited historical data is available from the aforementioned sources, there are external sources of historical control data that can be used with the appropriate qualifiers. The leading source of historical control data for developmental toxicity remains the MARTA Historical Control Database. This data originated from industry surveys conducted by the Middle Atlantic Reproduction and Teratology Association (MARTA) and the Midwest Teratology Association (MTA) (4-6). It is the most comprehensive compilation of control data from developmental toxicity studies in CD rats and... 

Animal suppliers can be a source of historical control data, although it is usually limited, since they do not typically perform cesarean sections or fetal or pup evaluations, but they may compile some natural delivery data such as litter size and fertility rates in breeding colonies. This type of data can be useful when a laboratory is attempting to gain a basic understanding of the reproductive performance of a species/strain, or gather information about a particular supplier or supplier site with which they are not familiar. 

In-process monitoring of critical processing steps and end-product testing of current production can provide documented evidence to show that the manufacturing process is in a state of control. Such validation documentation can be provided from the test parameter and data sources disclosed in the section on retrospective validation. 

As with economic data, clinical information can be collected from primary and secondary data sources. Primary data can be collected at the point of care, when the pharmacist sees the patient. Primary data collection is the most reliable method of collecting clinical information because it provides the most control over the data collection process. The pharmacist can ask patients questions, perform necessary laboratory tests, conduct physical assessments, and record information either electronically or on paper. 

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