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Risk identification, systematic

Risk assessment starts with risk identification, a systematic use of available information to identify hazards (i.e., events or other conditions that have the potential to cause harm). Information can be from a variety of sources including stakeholders, historical data, information from the literature, and mathematical or scientific analyses. Risk analysis is then conducted to estimate the degree of risk associated with the identified hazards. This is estimated based on the likelihood of occurrence and resultant severity of harm. In some risk management tools, the ability to detect the hazard may also be considered. If the hazard is readily detectable, this may be considered a factor in the overall risk assessment. Risk evaluation determines if the risk is acceptable based on specified criteria. In a quality system environment, criteria would include impact on the overall performance of the quality system and the quality attributes of the finished product. The value of the risk assessment depends on how robust the data used in the assessment process is judged to be. The risk assessment process should take into account assumptions and reasonable sources of uncertainty. Risk assessment activities should be documented. [Pg.221]

As discussed in the chapter on Drug Surveillance, the safety surveillance mission is to implement the systematic review of spontaneous post-marketing data for proactive risk identification and assessment. In general, signal generation is done using clinical trials data, the medical literature, knowledge of class effects and spontaneous reports. [Pg.547]

One effective systematic method, a variation on which will be outlined further in this book, is the SWIFT or Structured What-If Technique. SWIFT is a systems-based risk identification technique that employs structured brainstorming, using pre-developed guidewords or headings in combination with prompts elicited from participants (which often begin with the phrases What if... or How could... ), to examine risks and hazards at a systems or subsystems level [1]. The technique was originally developed as a simpler alternative to HAZOP (see Sect. 13.6.2). [Pg.184]

In previous chapters the focus has been on risk identification and the systematic methods used to characterise hazards. Our next task is to exanune the practicalities of evaluating risk - studying the properties of hazards and their causes to establish the degree of risk and therefore its acceptability. Doing so allows us to prioritise those hazards which require further risk nutigation. [Pg.205]

ABSTRACT The article deals with the landfills and risk identification within waste disposal in a selected region of the Czech Republic. As a case study the systematic risk identification, its evaluation and selection of critical risks during waste disposal at the selected landfills was made. Within the risk management process the methodology of safety audit and checldist analysis were apphed. This methodology is based on semi-quantitative evaluation of received data which are the base for the risk comparison at the selected landfills. [Pg.894]

Risks change with time. The process of identifying risks requires a continual and systematic approach. Risk identification involves recognition of hazards and what can go wrong. It may involve attaching values to potential losses. The values in this step help establish how certain a loss is for general situations. A risk may change over time. [Pg.495]

Pharmacists will, in their work, reflect on all processes for which they are responsible, with the purpose of improving quality and availability of medicines and hence to minimise any risk of harm to patients. Quality risk management (QRM) offers a structure and tools for a systematic approach to these efforts. The process usually consists of the phases risk assessment (Sect. 21.3.1) (with sub processes risk identification, risk analysis and risk evaluation) and risk control... [Pg.423]

Risk identification The systematic use of infrumation to identify potential sources of harm (hazards) referring to the risk question or problem description. [Pg.425]

Probabilistic risk assessment, data sources, systematic risk identification methodologies (e.g. HAZOPS) assessment methodologies (fault trees and event trees) estimation of consequences. [Pg.708]

Today, the evaluation of risk and the systematic targeting of high-risk areas for elimination or reduction are ongoing components of managerial responsibility, which is framed by competitive forces that demand continuous improvement in operational performances. Administration of risk embraces all components of an effective risk management program—risk identification, risk analysis, risk reduction or elimination, and risk financing. However, specific steps or functions of each component may vary somewhat from industry to industry. For example, a widely used process of chemical risk assessment, as specified by the National Academy of Sciences (1983), has four steps ... [Pg.259]

Due to the fact that none of the existing SCRM approaches analysed, matches all of the requirements for SMEs, the researchers developed a systematic and practical methodology based on the three classical risk management phases of risk identification, risk assessment and risk mitigation (see Fig. 13.3). [Pg.209]

Equipment used to process, store, or handle highly hazardous chemicals must be designed constructed, installed and maintained to minimize the risk of release. A systematic, scheduled, test and maintenance program is preferred over "breakdown" maintenance " that could compromise safety. Elements of a mechanical integrity program include 1) identification and categorization of equipment and instrumentation, 2) documentation of manufacturer data on mean time to failure, 3 ) test and inspection frequencies, 4) maintenance procedures, 5) training of maintenance personnel, 6) test criteria, and 7) documentation of test and inspection results. [Pg.72]

This chapter has provided an overview of a recommended framework for the assessment of human error in chemical process risk assessments. The main emphasis has been on the importance of a systematic approach to the qualitative modeling of human error. This leads to the identification and possible reduction of the human sources of risk. This process is of considerable value in its own right, and does not necessarily have to be accompanied by the quantification of error probabilities. [Pg.241]

Considerable interest has been generated in hazard identification and risk analysis techniques, which provide a systematic means to help reduce and manage chemical process risks. CCPS has undertaken a series of Guidelines covering many aspects of the subjects to provide the latest information and useful techniques for the engineer in the... [Pg.281]

One of the most important elements of the PSM Rule is the process hazard analysis (PrHA). It requires the systematic identification of hazards and related accident scenarios. The PSM Rule allows the use of different analysis methods, but the selected method must be based on the process being analyzed. The PSM Rule specifies that PrHAs must be completed as soon as possible within a 5-year period. However, one-fourth of the PrHAs must have been completed by May 26, 1994, with an additional one-fourth completed each succeeding year. The highest risk processes were to be done first. A schedule for PrHAs must be established at the outset of a process safety management (PSM) program to give priority to the highest risk processes. PrHAs must be reviewed and updated at least every 5 years. [Pg.13]

Identifying and analyzing fire hazards and scenarios is the next step in a fire risk assessment. The hazard identification should be structured, systematic, audit-able, and address all fire hazards, including nonprocess fires. The result of the hazard identification is a list of potential fire hazards that may occur at the facility, for example, jet, pool, flash, BLEVE, electrical, or Class A fires. This list should also include the location where each fire could occur. Hazard identification techniques used to identify potential hazards are shown in Table 6-1. [Pg.102]

The quantitative evaluation of expected risk from potential incident scenarios. It examines both consequences and frequencies, and how they combine into an overall measure of risk. The CPQRA process is always preceded by a qualitative systematic identification of process hazards. The CPQRA results may be used to make decisions, particularly when mitigation of risk is considered. [Pg.434]

Systematic searches for hazard, assessment of risk, and identification of possible remediation are the basic steps of risk analysis methods reviewed in this chapter. [Pg.3]

There are really two phases in the pursuit of protein crystals for an X-ray diffraction investigation, and these are (1) the identification of chemical, biochemical, and physical conditions that yield some crystalline material, though it may be entirely inadequate, and (2) the systematic alteration of those initial conditions by incremental amounts to obtain optimal samples for diffraction analysis. The first of these is fraught with the greater risk, as some proteins simply refuse to form crystals, and any clues as to why are elusive or absent. The latter, however, often proves to be the more demanding, time-consuming, and frustrating. [Pg.28]

Mixtures Risk Assessment The mere occurrence of chemicals and contaminants in the environment does not increase the potential of risk to human or environment, but their exposure does. A five-step process is used to determine the extent, route, and duration of exposure and includes its environmental fate and transport. This process allows identification of likely site-specific exposure to chemicals and chemical mixtures, the extent of exposure, and the conditions under which the exposure occurred. This way contaminants of concern can be identified in a systematic manner by combining the chemical hazard and exposure data [7],... [Pg.604]

All leading food industries have to perform thorough risk assessments in the preservation of food products (Van Gerwen et al., 2000 Hoornstra and Notermans, 2001). The crucial point then is analysis of the production process as a whole, the so-called from farm to fork and consists of four subprocesses that are executed systematically (1) hazard identification, (2) hazard characterization, (3) exposure assessment, and (4) risk characterization (Brul et al., 2002). [Pg.248]

The risk assessment requires information about potential risks, effects, and impacts on current processes and environments. Process risk assessment is mainly determined by the probability of process interruption, system down times, and restart of a system. Typical chemical risk assessments comprise identification of hazards for personnel, customers, and environment, qualitative assessment of potential adverse consequences of the contaminant, and evidence of their significance. The previously described systems for toxicology estimation are useful software modules in this process. Environmental risks require additional dose-response assessments as well as quantification of exposure to determine the dose that individuals will receive. Einally, a qualitative assessment of the probability for recurrence of the exception is performed, or — in the case of systematic occurrence — the exception is linked to similar cases. [Pg.346]


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