Risk analysis control

European Commission for these and other substances by nominated dates. The toxicological data and estimation of exposure will form the basis of risk analysis and deterrnination of the appropriate restriction and control of substances in the workplace (58). Restriction of the sales of dangerous substances and preparations to the general pubHc is enforced under Directive 76/769 EC (59). 

RISKMAN is an integrated Microsoft Windows , personal computer software system for [H. i forming quantitative risk analysis. Used for PSAs for aerospace, nuclear power, and chemical [iroccsses, it has five main modules Data Analysis, Systems Analysis, External Events Analysis, Event Tree Analysis, and Important Sequences. There are also modules for software system maintenance, backup, restoration, software updates, printer font, and page control. PEG has also integrated the fault tree programs CAFTA, SETS, NRCCUT, and IRRAS into RISKMAN. 

Risks identified from risk analysis, measures to minimise and control risks and information on subject seiection... 

If a manufacturer has modified their own device they can avail of a special 510(k) procedure for declaring substantial equivalence to their existing device, provided that the intended use or the basic technology has not changed. They must apply design controls and risk analysis to the development process, but the advantage is that they can receive a faster review process. 

The other root causes were (1) the poor understanding of the chemistry, (2) an inadequate risk analysis, and (3) no safeguard controls to prevent runaway reactions. This EPA case history also summarized seven similar accidents with phenol-formaldehyde reactions during a 10-year period (1988-1997). 

In 1993, the Center for Chemical Process Safety (CCPS) published Guidelines for Safe Automation of Chemical Processes (referred to henceforth as Safe Automation). Safe Automation provides guidelines for the application of automation systems used to control and shut down chemical and petrochemical processes. The popularity of one of the hazard and risk analysis methods presented in Safe Automation led to the publication of the 2001 Concept Series book from CCPS, Layer of Protection Analysis A Simplified Risk Assessment Approach. This method builds upon traditional process hazards analysis techniques. It uses a semiquantitative approach to define the required performance for each identified protective system. 

Monte Carlo sampling, 26 999, 1001—1004 in control systems, 26 1046 future trends in, 26 1047-1048 HSGA algorithm and, 26 1032 in process scheduling, 26 1042-1043 in process synthesis and design, 26 1041 quasi-Monte Carlo sampling and, 26 1011-1016 for risk analysis, 26 1045 in supply chain management, 26 1043-1044... 

Process hazard analysis leads to risk reduction/control recommendations. 

There is a balance to be drawn between risks. Looking at nitrite again, this ion has been used since the Middle Ages to preserve meat. It is the preservative in saltpetre which helps preserve cured meats and stop those who eat them getting botulism. There has been much research to find an alternative to nitrite as it can react with some amines to form carcinogenic nitrosamines. Risk analysis, reviewed in Chapter 4, is an important tool in controlling the use of additives. 

Crume RV, Ryan WM, Peters TA, et al. 1990. Risk analysis on air from groundwater aeration. J Water Poll Control Fed 62 119-123. 

Perry WE, Kuong JE. EDP Risk Analysis and Controls Justification. Management Advisory Publications, 1981. 

Since risk analysis plays an important role in public policy decision making, efforts have been made to devise a means by which to identify, control, and communicate the risks imposed by agricultural biotechnology. A paradigm of environmental risk assessment was first introduced in the United States by Peterson and Arntzen in 2004. In this risk assessment, a number of assumptions and uncertainties were considered and presented. These include (1) problem formulation, (2) hazard identihcation, (3) dose-response relationships, (4) exposure assessment, and (5) risk characterization. Risk assessment of plant-made pharmaceuticals must be reviewed on a case-by-case basis because the plants used to produce proteins each have different risks associated with them. Many plant-derived biopharmaceuticals will challenge our ability to define an environmental hazard (Howard and Donnelly, 2004). For example, the expression of a bovine-specihc antigen produced in a potato plant and used orally in veterinary medicine would have a dramatically different set of criteria for assessment of risk than, as another example, the expression of a neutralizing nonspecihc oral antibody developed in maize to suppress Campylobacter jejuni in chickens (Peterson and Arntzen, 2004 Kirk et al., 2005). 

As risk assessment becomes more sophisticated and is extended to more chemicals, it will also be extended to smaller and smaller risks. Since it is not possible to regulate all risks, an important use of risk analysis must be to decide which chemicals should be regulated and to what degree. Under the Tbxic Substances Control Act (TOSCA), all new chemicals must be considered. The prioritization scheme for chemical testing is based upon a set of dichotomous criteria, toxicity, chemical reactivity, etc., which involve qualitative rather than quantitative risk analysis. As procedures for more quantitative analysis become available, the prioritization scheme will become more precise, (NAS/NRC, 1984). 

One important aspect of the quality systems approach is the ongoing collection and analysis of quality data to continuously evaluate quality system effectiveness. Historical data, process knowledge, and risk analysis methods can be applied to identify specific data requirements. Trending and other data analysis methods can allow identification of actual and potential sources of nonconformity so that appropriate corrective and preventive actions can be taken in accordance with established change control procedures. 

---