Risk-based approach steps

Many of the steps involved in a risk-based approach are comparable to the standard transfer paradigm, but the risk-based approach requires significantly more upfront activities to better understand both process and methods. This increased investment increases both the likelihood of successful transfer, the risk of observing a step-change for ongoing stability testing, which could affect shelf-life of the product and the likelihood of future OOS investigations. 

There are three steps to implementing the risk-based approach ... 

This chapter identifies a variety of approaches for interpreting biomonitoring results, ranging from descriptive to risk-based. The descriptive approaches are useful as a first step in analyzing biomonitoring data, but they do not describe the level of risk. That requires the risk-based approaches... 

The system risk assessment is seen by the authors as one step of risk assessment when the system produces electronic records. The second part would be an assessment of the risks to the records stored in the system. Very recently, a new guidance document on a risk-based approach to e-records and signatures was published, focusing more on the risks related to records and signatures once they are maintained electronically, and proposes risk mitigation strategies for several types of records based on their risks. 

The general approach to safety taken by the M42 ATM project was a risk-based approach, in accordance with lEC 61508 and many other safety standards. In summary, this process involved the following steps ... 

Determining fireproofing requirements involves experience-based or risk-based evaluation as suggested in Chapter 6. An approach for selecting fireproofing includes the following steps ... 

This model has a straightforward structure and is simple to use. It is based on studies carried out in part for the specific purpose of model development. However, not all of the required information is publicly available. The databases are not described at the study level the exposure data are only available in classes, although more detailed information is available on request. The choice of the statistics is not discussed. In the risk-assessment approach, some steps are not clearly presented. Sub-chronic toxicity studies, and not chronic toxicity studies, are used in the risk assessment. Exposure duration and frequency considerations are not discussed. Route-to-route extrapolation is considered acceptable implicitly, without further evaluation of the various issues involved. The rationale for using a dermal absorption default of 10 %, in the absence of data, is not discussed. 

The data evaluation step in Tier 1 identifies the constituents of potential concern and the concentrations at which they occur in impacted media as determined by investigations conducted at the site. Most states do not require evaluation of historical data as part of the Tier 1 evaluation, although they may require submission of these data in the RBCA report as a basis for comparison (e.g., to demonstrate the decrease in constituent concentrations over time and/or demonstrate plume stability). However, the data that best represent the current environmental conditions at the site should be used in the risk-based decision-making approach. 

In addition to the development of CIBOCOF, an approach known as value driven maintenance policy (VDMP) was established in order to show the hidden values of maintenance and how organisadmis can benefit from these values [23]. In terms of VDMP, value is defined as the delivery of maximum availability at minimum cost [28]. The approach was developed using principles and concepts from TPM, RCM and risk-based inspection (RBI), and it requires an organisation to concentrate on the dynamic prospects for value creation using appropriate steps/ techniques instead of using a one method fits all approach [29]. The steps used to implement VDMP include [30] ... 

Prior to the development of a quantitative accident risk model for the active runway crossing operation considered, all risk assessment steps had been performed using an expert-based approach. In this study the following safety relevant scenarios were found ... 

Pharmaceutical QbD is a systematic scientific risk-based holistic and proactive approach to pharmaceutical development that begins with predefined objectives that address product and process understanding. Successful product development relies on consistent application of a proven methodology. The key steps are the same, irrespective of the product or formulation being developed. One proven methodology is described within this chapter. The framework is shown in Fig. 8.19, while a short description of the main steps is given below. 

In this research, we applied a QRA-based approach to estimate the risk originating from hazardous industries for surrounding communities and also to assess the degree of effectiveness of such a risk measure for guiding the landuse planning decisions in the area. In the following sections, the steps are described. 

MEHARI2010 (Method for Harmonized Analysis of Risk) (MEHARI 2010) is a (rare) IT RA check list based approach following these steps, basing on (Stonebumer et al. 2002), and the Code of Practice in IT security (ISO/IEC-27002 2005). 

The inclusion of several major mining houses in the EMESRT design philosophies approach is a considerable step forward in this context. However, a bolder and almost certainly more effective step would be to include a formal requirement for incorporation of risk-based ergonomics/human factors information within their purchasing requirements/design specifications etc. 

Step f considers all of the background information discussed in Section 2.f. If the information requirement is based on a regulatory concern or a special purpose need, then Steps 2 through 5 are bypassed and a QRA should be performed. If the information is needed for decision making, you must determine whether the significance of the decision warrants the expense of a QRA. If not, you may be able to use less resource-intensive qualitative approaches to satisfy your information requirements. Table 8 contains examples of typical conclusions reached from qualitative risk analysis results. 

In risk characterization, step four, the human exposure situation is compared to the toxicity data from animal studies, and often a safety -margin approach is utilized. The safety margin is based on a knowledge of uncertainties and individual variation in sensitivity of animals and humans to the effects of chemical compounds. Usually one assumes that humans are more sensitive than experimental animals to the effects of chemicals. For this reason, a safety margin is often used. This margin contains two factors, differences in biotransformation within a species (human), usually 10, and differences in the sensitivity between species (e.g., rat vs. human), usually also 10. The safety factor which takes into consideration interindividual differences within the human population predominately indicates differences in biotransformation, but sensitivity to effects of chemicals is also taken into consideration (e.g., safety faaor of 4 for biotransformation and 2.5 for sensitivity 4 x 2.5 = 10). For example, if the lowest dose that does not cause any toxicity to rodents, rats, or mice, i.e., the no-ob-servable-adverse-effect level (NOAEL) is 100 mg/kg, this dose is divided by the safety factor of 100. The safe dose level for humans would be then 1 mg/kg. Occasionally, a NOAEL is not found, and one has to use the lowest-observable-adverse-effect level (LOAEL) in safety assessment. In this situation, often an additional un-... 

The degree of confidence in the final estimation of risk depends on variability, uncertainty, and assumptions identified in all previous steps. The nature of the information available for risk characterization and the associated uncertainties can vary widely, and no single approach is suitable for all hazard and exposure scenarios. In cases in which risk characterization is concluded before human exposure occurs, for example, with food additives that require prior approval, both hazard identification and hazard characterization are largely dependent on animal experiments. And exposure is a theoretical estimate based on predicted uses or residue levels. In contrast, in cases of prior human exposure, hazard identification and hazard characterization may be based on studies in humans and exposure assessment can be based on real-life, actual intake measurements. The influence of estimates and assumptions can be evaluated by using sensitivity and uncertainty analyses. - Risk assessment procedures differ in a range of possible options from relatively unso-... 

---