Compliance metrics

The compliance metrics are shown in Figure 17. At the same time, measures were designed for key characterization elements and link to variation, performance, yield, and interval improvements. Results of improvements in operational performance for five manufacturing areas are shown in Figure 18. 

The SNL Compliance Metrics Department tabulates a set of Performance Indicators (Pis) for SNL/NM facilities and issues a quarterly report to track trends and provide data for analysis on these Pis. The Pis with particular applicability to HCF operations include personnel radiation exposures, low-level radioactive waste generation, reportable releases to the environment, DOE reportable occurrences, and Price Anderson Amendments Act violations. 

Yield and other mass-related metrics such as atom economy, reaction mass efficiency and mass intensity have been examined by Constable et al with regard to their significance concerning greenness and costs. The importance of using a (product) concentration term, which can be mass intensity or mass index, is additionally emphasized by Laird et al This is in compliance with Winterton, who in his twelve more green chemistry principles demands the establishment of full mass balances. 

How do assumptions regarding compliance affect overall revenue projections What are the market-level persistency metrics ... 

It is useful to recollect the limits set by WHO 90 pg/m3 for total suspended particulates, 50 pg/m3 for sulfur dioxide, and 50 pg/m3 for nitrogen dioxide. It is apparent that the world has a long way to go till compliance with these numbers is achieved. Mexico City is notorious for bad ah quality. Pollution levels exceed WHO standards 350 days per year. More than half of all children in the city have lead levels in their blood sufficient to lower intelligence and retard development. The 130,000 industries and 2.5 million motor vehicles spew out more than 5500 metric tons of ah pollutants every day, which are trapped by the mountains tinging the city. 

Figures 3 and 4 illustrate how a biennial document review process and document processing cycle time metrics faltered in their early stages due to lack of process ownership, definition, and management review. This situation presented a compliance risk to the organization and resulted in poor business efficiencies. Improve-...

This comprehensive approach allows for efficient integration between processes, different phases of product life cycle, and integration between different sites in the supply chain. This integration provides opportunity for efficiency in that process owners are integrated with each other s needs and expectations. Duplication of effort is avoided and efficiencies gained. Quality outputs from one process become reliable inputs into the next process. Management and leadership will have access and insight into compliance, infrastructure, and performance metrics of all processes on a comparable basis. This provides leadership the opportunity for risk-based resource allocation to appropriate areas of the enterprise. 

Documented process structure provides rapid employee assimilations when transferring employees between sites. New employees, replacing existing process owners, are enabled to rapidly execute process responsibilities due to the abbreviated learning curve when processes have been well defined and documented. Systems designed as described here provide meaningful and comparable metrics for leadership to evaluate progress, compliance, and performance. 

Process owners responsibilities include determining appropriate metrics for their process. These metrics should include lagging and leading metrics that are meaningful to the process owner and management in determining performance, compliance, and infrastructure of the process. 

Ignorance of system and process performance leads to inefficiency, poor compliance, and low employee morale. It is good business practice to have regular review of process metrics to gauge the health and output of the system and processes that drive the organization. 

Computer validation costs can be considerably higher than those metrics quoted above if bespoke functionality has to be incorporated for electronic record and electronic signature compliance. 

Many pharmaceutical and healthcare companies attribute higher costs to validation. One reason why higher costs may be quoted is that these include the cost of implementing basic quality assurance practices that should already be in place. A review of major computer validation non-compliance identified by regulators demonstrates that fundamental management controls are often missing or failing. The above metrics are predicated on the assumption that basic quality assurance practices are already in place. 

Q2.1 metric tons) per year (EPA 1990a). If all sources were in full compliance with the NESHAP for asbestos, waste disposal emissions would be reduced to 1,320 poimds (600 kg) per year (EPA 1990a). 

A final dimension of a metric is the intended audience. Information may be disseminated to internal audiences such as employees, supervisors, facility management, senior executives, and the board of directors or to external audiences such as a trade association, regulatory agency, or the general public. Any metric that must be reported for regulatory compliance is, by definition, an external metric. Chapter 6 discusses in greater detail the identification of metrics for various external and internal audiences. 

Metrics will become increasingly important as the discipline of process safety continues to evolve and improve. They hold promise to contribute to risk-based process safety, inherent safety, safety culture, and compliance with regulation as well as broader societal interests surrounding sustainability, globalization, and societal risk aversion. 

Level 1 — Facility compliance/conformance metrics, which are compliance-focused (e.g., number of reportable spills and violations, amount of fines, and injury rates) ... 

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