Risk assessment process controls

Risk assessors must be particularly sensitive to the potential for significantly higher exposures in areas of the world where hazardous environmental exposures are not sufficiently controlled. Compounding factors such as poverty, inadequate nutrition, and compromised health status must also be considered in problem formulation throughout the risk assessment process. 

Occupational and consumer protection are seen as technical exercises in France. The National Institute of Research and Security (INRS) and the Institute for the Industrial Environment and Safety (INERIS) may be aptly described as state apparatus to control costs to the state of poor regulation. INERIS plays little part in the development of risk-reduction strategies (RRS) because consumer protection and environmental protection follow directly from the risk assessment process. INERIS feeds relevant information directly to the MEDD. Because MESA acts only as a statistical and economic branch of occupational protection, responsibility for the development of occupational RRS is left to the INRS. 

R. Ruhl, E. Lechtenberg-Auffarth and G. Hamm, The Development of Process-Specific Risk Assessment and Control in Germany, Annals of Occupational Hygiene, 2002, 46, 119. 

The risk assessment process can be conducted by examining record types to see if they are GxP or non-GxP, and then applying severity checks, likelihood, and probability of detection criteria, as illustrated in Figure 15.2. The most severe scenarios shonld be linked to direct patient/consnmer impact. GxP noncompliance and broken license conditions are severe in their own right bnt not as critical as patient/consumer health in this analysis." Its likelihood will be influenced by the degree of human error in how the record is input and used. The probability of detection needs to take into account the probability of the impacted record being used. Once failure modes are understood, then the appropriate design controls can be introduced. These should be documented and validated as part of the computer system life cycle discussed earher in this book. 

These tools should not be considered limited in application to the initial validation effort. By keeping the traceability matrix up to date it becomes (and will remain) an important tool for assessing the impact of changes to the database, and both it and the risk assessment process are still important test planning tools as part of change control. Of course, sound change control practices are absolutely imperative for keeping an application validated. 

If hormetic effects are an evolutionary/biological/toxicological expectation, then it implies that hazard assessment strategies include a protocol to assess its possible occurrence. This has practical importance because hormetic effects may affect both the concept and derivation of the NOAEL. The derivation of the NOAEL could change if the low-dose stimulation were determined to be an adverse effect. The hormetic dose-response continuum in this instance (i.e., both the increase at low doses and the decrease at high doses from the control) could be viewed as adverse. However, if the low-dose stimulation were deemed as beneficial, it would have little direct effect on the concept of the NOAEL, but could affect how the traditional NOAEL is derived (59) as well as challenging the basic goal of the risk assessment process from the exclusive focus on the avoidance of potential harm to also include the concept of benefit. 

While risk assessment in the context of protecting public health has been performed for many years, it is the 1983 U.S. National Academy of Sciences Report (Committee on the Institutional Means for Assessment of Risks to Public Health Commission on Life Sciences National Research Council 1983) that has served as the tenet for practicing risk assessors (see Chapter 1). Risk assessment was defined as the characterization of the potential adverse health effects of human exposures to environmental hazards. The predictive aspect of risk assessment was set by the use of the word potential. A fundamental expectation of the risk assessment process was that it should attempt to accm-ately predict adverse effects before there is evidence of disease in the population. Thus, risk assessment goes beyond the mere description of epidemiological and clinical case-control studies. In that report, the committee defined logical components of a risk assessment which still serve as guiding principles today. They were and are (a) hazard assessment or the qualitative determination that a stressor poses a hazard as evidence by causal evidence of an ill effect,... 

The safety case regime of the United Kingdom and Australia is lypieal of the midpoint of the dimension whereby a process (risk assessment) is specified by which the goal of risk control is to be met, and acceptable methods of risk analysis are prescribed, but it is then left to the regulated company to convince the regulator of the way it is led to control risk by that risk assessment process. Further guidance is in the form of codes which have the status of acceptable translations of the goals, but leave the choice open to the company to comply in other ways. 

Less than adequate with respect to hazard analyses and risk assessment processes, for the identification, avoidance, elimination, and control of hazards. 

The important lesson from this case study is the necessary use of appropriate control materials. If no negative control, that is, placebo polymer-only material, had been used, the polymer in the naltrexone-containing beads would also have been considered as a causative agent of the extended chronic inflammatory response. Similar chronic inflammatory responses have been identified with dmgs, polymer plasticizers and other additives, fabrication and manufaauting aids, and sterilization residuals. Each case presents its own unique factors in a risk assessment process necessary for determining safety (biocompatibility) and benefit versus risk in clinical application. 

The facility system safety risk assessment process works such that if the initial risk assessment produces a RAC of 1 or 2, some type of control must be applied. After this control is applied, a second risk assessment or controlled RAC is determined. First, the control rating code is evaluated to ensure that the CRC rules have been met and then to ensure that the controlled RAC is 3 or 4. If the CRC rules are met and the controlled RAC is 3 or 4, the corrective action is taken and the risk has been reduced to an acceptable level. However, if the CRC rules have not been met and/or the RAC remains at 1 or 2, other controls must be applied and the reassessment cycle is repeated. If other controls are not available, then risk acceptance decisions must be made by the appropriate level of management, and risk acceptance decisions must be documented (Fig. 11-4). 

It is very likely that during the inspection historical events of the above-mentioned topics will be surveyed and it is expected that the involved persons have evaluated the processes with scientific expertise and appropriate risk assessments. A controlled, informed, and trained handling of these critical issues is mandatory. Compliance with set review-cycles for specification-documents will be checked randomly and should be considered in the preparation phase of the inspection. 

Human error is always preventable and you can have considerable control over the probabiUty that you make some mistake in a lab. However, since you cannot control other people in the lab, someone else may cause an accident that injures you and is beyond your control. Assessing the probabiUty of other people making mistakes depends on understanding the experience and attitudes of other students or co-workers. It is simply prudent to remember that the overall risk assessment process must involve all sources of risk in any environment. 

Thus, the case can be soundly made that risk assessment should be the core of an Occupational Risk Management System—and a significant element in a systemic causation model because less than adequate avoidance decisions or control methods may result from poorly done or totally absent risk assessments. An outcome of the risk assessment process is to prioritize risks for orderly consideration. 

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