Qualitative Risk Assessment Approach Research Articles

Application of quantitative risk analysis to fireproofing

AbstractOne of the core elements of fire protection for petrochemical processing plants is the consideration of passive fire protection (PFP). This general category, often referred to as fireproofing, is addressed in the American Petroleum Institute (API)‐recommended practice (RP) 2218. This RP provides guidelines for the selection and application of fireproofing with what is mostly a qualitative risk assessment approach. The logic focuses on predicting pool fires based on rough characterizations of system properties combined with equipment layout. Although pool fire impacts are often localized, jet fires can affect larger areas. API RP 2218 addresses jet fires in an appendix because of their unpredictable nature, leaving pool fire exposures as the default basis for structural fireproofing. To properly account for both fire types, fire exposure can be evaluated with quantitative risk analysis (QRA) tools that incorporate both jet and pool fire impacts for a wide variety of accident scenarios, weather conditions, and release orientations. By evaluating the thermal radiation impacts of fires in relation to the vulnerability of steel structural elements, a QRA‐based approach to placement of PFP can be achieved. This approach has the benefit of applying PFP where it is needed the most, to best protect a company's infrastructure.

Risk Management in the Development of Drilling Technological Projects

Recovery of hydrocarbon is an important aspect of the O&G industry, which has gained much importance in recent times. It can be achieved through a set of activities and decisions in which successfully drilling the oil/gas deposits is very important. Drilling is a critical step in the exploration process, and it has a high level of risk in terms of cost, timeline, safety, and project completion. The study focuses on identifying, evaluating and estimating unforeseen events that may occur during the drilling projects. The methodology acquired for this paper includes a thorough focus on the literature review which has been done. It consists of a model/theory related to risk management and the concept of risk management processes. A comprehensive project life cycle model with six stages has correlated with the drilling phases. Detailed risk management has been practised for an integrated risk portfolio for the development project. A generalized risk identification approach has been utilized to recognize possible threats. A qualitative risk assessment has been executed for the findings. Impact and probability benchmarks are categorized per the past historical well's performances and published data. Considering the importance of risk management for said projects, the study focused on the literature review that highlights the processes, procedures, and models for drilling risk management. Risks have been recognized through a rigorous and comprehensive risk identification process and have been evaluated with the qualitative risk assessment approach. The risk register for development drilling projects has been developed along with the risk matrix as per the defined criteria of risk impact and probability for drilling. Furthermore, a detailed risk breakdown structure has been formulated according to the general area categorization to enlighten the risks focused on each area of interest. Overall, the study will provide a value-added and detailed risk management approach for new ventures, which may be planned with the implementation of comprehensive drilling risks management.

Development of a qualitative approach to assessing risks associated with the use of treated wastewater in agricultural irrigation

The European Commission’s draft regulation for minimum requirements for water reuse in agriculture addresses microbial and basic water quality parameters but does not consider the potential impacts of chemicals of emerging concern (CECs) on human and environmental health. Because insufficient data prevents the quantitative characterisation of risks posed by CECs in treated wastewater (TWW), this paper presents a framework, which combines data and expert judgement to assess likelihood of occurrence and magnitude of impact. An increasing relative scale is applied where numeric values are pre-defined to represent comparative levels of importance. Subsequently, an overall assessment of the level of risk is characterised by multiplying together allocated scores, to obtain a single discrete overall score per CEC. Guidelines to support implementation of the framework as far as soil (the initial receiving compartment and pathway to further protected targets) are developed and applied. The approach is demonstrated through its application to clarithromycin, where results indicate that – under the considered scenario - there is limited possibility of its occurrence in soil in a bioavailable form. The role of a qualitative risk assessment approach is considered and the opportunity for its outputs to inform future research agendas described.

A qualitative risk assessment approach to microbial foodborne hazards in Brazilian intensive pork production: A step towards risk prioritization

The application of biosecurity measures in pig farms has prompted a shift in epidemiological reality, altering the risk profile attributed to the consumption of pork. The inspection of pig carcasses in Brazil is based on incisions and palpations to seek lesions mainly related to classic zoonotic diseases. We describe the use of a qualitative risk assessment from the farm to the table to characterize the risk of foodborne disease caused by biological hazards to humans due to the consumption of pork. The model was adapted from the Codex Alimentarius and comprises four steps: (I) hazard identification, (II) hazard characterization, (III) exposure assessment, and (IV) risk characterization. The exposure assessment step considers the release of hazards at a pre-harvest level (i.e., swine in herds) and the amplification or reduction of the release during the procedure to obtain pork from a carcass. Risk characterization is classified into five levels, from very low to very high. No hazard had very high risk, Salmonella sp. [nontyphoidal] had high risk, no hazard had moderate risk, seven hazards had low risk, and other hazards had very low risk. When the initial release was increased, the risk for hazards with higher adverse effects (e.g. C. botulinum, B. suis, and E. coli [STEC]) increased to very high or high. The uncertainty was very high for seven hazards and very low for three. These findings can help the Brazilian Ministry of Agriculture discuss changes in the routine inspection of the carcasses of pigs raised in industrial systems in Brazil.

Pictorial HIRAC: A concept of incident prevention in oil and gas process Industry

Oil and gas process industry is the most hazardous industry as it contains flammable, volatile liquids and gases. Accidents are happening worldwide and major cause is the communication gap. Workers face difficulties in reading written documents of risk assessments available at the company. If workers are not given proper training on reading these risk assessment sheets, then it is useless. To avoid such communication gap, I want to introduce a new technique which is called Pictorial HIRAC through this paper. HIRAC is abbreviated as Hazard Identification Risk Assessment and Control is a qualitative risk assessment approach to minimize all possible hazards and their associated risks in the work environment. It is an all new generation idea of converting a normal ‘written HIRAC’ into the ‘Pictorial’ form. Hazards Identification is also one of the fourteen pillars of PSM Process Safety Management where it is termed as Process Hazard Analysis. It is well understood that visual is better than written because it leaves 70 percent faster impressions than reading. Illustration by pictures can be easily understood by the workers. Through this paper we want to convey an idea of making Pictorial HIRAC for creating more awareness about the workplace safety.

Epidemiological investigation of bovine tuberculosis herd breakdowns in Spain 2009/2011.

We analyzed the most likely cause of 687 bovine tuberculosis (bTB) breakdowns detected in Spain between 2009 and 2011 (i.e., 22% of the total number of breakdowns detected during this period). Seven possible causes were considered: i) residual infection; ii) introduction of infected cattle from other herds; iii) sharing of pastures with infected herds; iv) contiguous spread from infected neighbor herds; v) presence of infected goats in the farm; vi) interaction with wildlife reservoirs and vii) contact with an infected human. For each possible cause a decision tree was developed and key questions were included in each of them. Answers to these key questions lead to different events within each decision tree. In order to assess the likelihood of occurrence of the different events a qualitative risk assessment approach was used. For this purpose, an expert opinion workshop was organized and ordinal values, ranging from 0 to 9 (i.e., null to very high likelihood of occurrence) were assigned. The analysis identified residual infection as the most frequent cause of bTB breakdowns (22.3%; 95%CI: 19.4–25.6), followed by interaction with wildlife reservoirs (13.1%; 95%CI: 10.8–15.8). The introduction of infected cattle, sharing of pastures and contiguous spread from infected neighbour herds were also identified as relevant causes. In 41.6% (95%CI: 38.0–45.4) of the breakdowns the origin of infection remained unknown.Veterinary officers conducting bTB breakdown investigations have to state their opinion about the possible cause of each breakdown. Comparison between the results of our analysis and the opinion from veterinary officers revealed a slight concordance. This slight agreement might reflect a lack of harmonized criteria to assess the most likely cause of bTB breakdowns as well as different perceptions about the importance of the possible causes. This is especially relevant in the case of the role of wildlife reservoirs.

Aquaculture Farm Food Safety and Diseases Risk Assessment (AquaFRAM): Development of a spreadsheet tool for salmon farms

Atlantic salmon (Salmo salar) is the most significant aquaculture species in Europe, both in terms of production and economic value, with Norway, followed by Scotland and Ireland as the three major European producers. The objective of the present study was to develop a spreadsheet tool for aquaculture farm-food safety and diseases risk assessment (AquaFRAM) for salmon farms in the UK, (and possibly more widely) to encourage farms to assess potential hazards and diseases. AquaFRAM functions primarily as a self-assessment risk ranking and risk-learning tool to determine the potential of farm food safety hazards, diseases and the level of possible risk for contamination and infections. AquaFRAM has been developed using MS Excel software utilising a qualitative risk assessment approach for farmers to evaluate their food safety practices and diseases on their farms. The risk assessment is based on the risk matrix of frequency of likelihood×severity, where the farmers can judge the likelihood of the hazards occurring on their farm based on given examples or scenarios. Grounding of the model, based on severity scoring is predicated on relevant reports in the literature and expert opinion derived from a separate Delphi study. The AquaFRAM Tool has since been tested on 9 salmon companies throughout UK. All of the farms which tried and tested the AquaFRAM Tool reported it being farmer-friendly and practical. It was highlighted that the current tool focused mainly on risk reduction and not risk elimination. However, such farm food safety and diseases risk assessment tool would be helpful, and certainly timely, to further encourage farms to assess potential hazards and diseases. It is also appropriate for educational and training of full-time and seasonal farm workers.

A qualitative approach to measure the effectiveness of active avian influenza virus surveillance with respect to its cost: A case study from Switzerland

The aim of the project was to apply cost-effectiveness analysis to the economic appraisal of avian influenza virus (AIV) surveillance, using the implemented surveillance programme in Switzerland as a case study. First a qualitative risk assessment approach was used to assess the expected impact of surveillance on the transmission and spread of AIV. The effectiveness of surveillance was expressed as the difference in defined probabilities between a scenario with surveillance and a scenario without surveillance. The following probabilities were modelled (i) transmission of highly pathogenic AIV (HPAIV) from wild birds to poultry, (ii) mutation from low pathogenic AIV (LPAIV) into HPAIV in poultry, and (iii) transmission of HPAIV to other poultry holdings given a primary outbreak.The cost-effectiveness ratio was defined conventionally as the difference in surveillance costs (ΔC) divided by the change in probability (ΔP), the technical objective, on the presumption that surveillance diminishes the respective probabilities. However, results indicated that surveillance in both wild birds and poultry was not expected to change the probabilities of primary and secondary AIV outbreaks in Switzerland. The overall surveillance costs incurred were estimated at 31,000 €/year, which, to be a rational investment of resources, must still reflect the value policy makers attribute to other benefits from having surveillance (e.g. peace of mind). The advantage of the approach adopted is that it is practical, transparent, and thus able to clarify for policy makers the key variables to be taken into account when evaluating the economic efficiency of resources invested in surveillance, prevention and intervention to exclude AIV.

Field application of farm-food safety risk assessment (FRAMp) tool for small and medium fresh produce farms

The objective of this study was to develop a farm food safety-risk assessment tool (FRAMp) which serves as a self-assessment and educational tool for fresh produce farms. FRAMp was developed in Microsoft® Excel spreadsheet software using standard mathematical and logical functions and utilised a qualitative risk assessment approach for farmers to evaluate their food safety practices. The FRAMp tool has since been tested on 12 fresh produce farms throughout UK. All the farms determined that FRAMp was interesting but 17% found it too long while 25% of the farms felt the tool was too complicated. The instructions on FRAMp usage were revised and farmers were given the options to skip and select specific steps in the farm risk assessment. The end users (farmers/farm managers) determined that developing their own action plans and using it as proof of assessment for future third-party audits were most useful to them. FRAMp tool can be described as an illustrative risk ranking tool to facilitate farms to identify potential risk factors during their crop production.

Fuzzy inference system for fire and explosion risk assessment of floating storage and offloading vessels

A case study for the fire and explosion risk assessment of a floating storage and offloading (FSO) vessel is presented in this paper. The fire and explosion hazards affecting the storage tanker for different operating modes were first identified. Two approaches for risk assessment were then adopted. The first is a qualitative risk assessment approach using a qualitative risk matrix. The second is a fuzzy risk assessment approach using a fuzzy inference system (FIS). The use of a fuzzy representation for probabilities, consequences, and risk values takes into account the imprecision associated with the assignment of their values. A comparison is provided between the results obtained using the two approaches for an FSO vessel which is located about 120 km offshore from Libya. Results show that the use of an FIS approach provides a more robust framework for fire and explosion risk assessment and more output information than the qualitative matrix approach. The results also show that the computed risk values using a fuzzy risk index measure are consistent with those obtained using a qualitative risk matrix approach.

A Qualitative Risk Assessment Approach for Swiss Dairy Products: Opportunities and Limitations

Switzerland implemented a risk-based monitoring of Swiss dairy products in 2002 based on a risk assessment (RA) that considered the probability of exceeding a microbiological limit value set by law. A new RA was launched in 2007 to review and further develop the previous assessment, and to make recommendations for future risk-based monitoring according to current risks. The resulting qualitative RA was designed to ascertain the risk to human health from the consumption of Swiss dairy products. The products and microbial hazards to be considered in the RA were determined based on a risk profile. The hazards included Campylobacter spp., Listeria monocytogenes, Salmonella spp., Shiga toxin-producing Escherichia coli, coagulase-positive staphylococci and Staphylococcus aureus enterotoxin. The release assessment considered the prevalence of the hazards in bulk milk samples, the influence of the process parameters on the microorganisms, and the influence of the type of dairy. The exposure assessment was linked to the production volume. An overall probability was estimated combining the probabilities of release and exposure for each combination of hazard, dairy product and type of dairy. This overall probability represents the likelihood of a product from a certain type of dairy exceeding the microbiological limit value and being passed on to the consumer. The consequences could not be fully assessed due to lack of detailed information on the number of disease cases caused by the consumption of dairy products. The results were expressed as a ranking of overall probabilities. Finally, recommendations for the design of the risk-based monitoring programme and for filling the identified data gaps were given. The aims of this work were (i) to present the qualitative RA approach for Swiss dairy products, which could be adapted to other settings and (ii) to discuss the opportunities and limitations of the qualitative method.

Assessment of exotic fish disease introduction and establishment in the United Kingdom via live fish transporters

Live fish transporters returning empty from mainland Europe may mechanically introduce exotic pathogens and parasites to the UK. A qualitative risk assessment approach was adopted to investigate the likelihood of introduction and establishment in rainbow trout farms of viral haemorrhagic septicaemia (VHS), infectious haematopoietic necrosis (IHN) and Gyrodactylus salaris via this route. A scenario tree was developed and estimates made for the likelihood of each step based on a review of the available information. The level of uncertainty associated with each step was qualitatively assessed. The likelihood of a lorry becoming contaminated with any of the 3 hazards was only greater than negligible if the lorry made movements between farms in mainland Europe. In these circumstances, the overall likelihood of introduction and establishment was extremely low (would occur very rarely), extremely low to negligible and very low (would occur rarely) for VHS, IHN and G. salaris, respectively. A high level of uncertainty existed due to the lack of data on farm-level prevalence, minimum infectious dose (of the viral hazards) and the large variability in duration and conditions of transport. A telephone survey of live fish transporters found that cleaning and disinfection practices after return to the UK were implemented. Currently, no UK-based transporters make movements between farms in mainland Europe. Thus, the likelihood that UK-owned transporters may become infected is negligible. Changes in the way in which UK-based live fish transporters operate in mainland Europe need to be monitored and development of a code of practice to minimise the risk of disease introduction considered.

Synthesis of semantic modelling and risk analysis methodology applied to animal welfare

Decision-making on animal welfare issues requires a synthesis of information. For the assessment of farm animal welfare based on scientific information collected in a database, a methodology called ‘semantic modelling’ has been developed. To date, however, this methodology has not been generally applied. Recently, a qualitative Risk Assessment approach has been published by the European Food Safety Authority (EFSA) for the first time, concerning the welfare of intensively reared calves. This paper reports on a critical analysis of this Risk Assessment (RA) approach from a semantic-modelling (SM) perspective, emphasizing the importance of several seemingly self-evident principles, including the definition of concepts, application of explicit methodological procedures and specification of how underlying values and scientific information lead to the RA output. In addition, the need to include positive aspects of welfare and overall welfare assessments are emphasized. The analysis shows that the RA approach for animal welfare could benefit from SM methodology to support transparent and science-based decision-making.

Impact of Antimicrobial Use in Animals and Regulatory Response

There is accumulating evidence that the use of antimicrobials in food-producing animals has adverse human health consequences. The use of these drugs in food animals selects for resistant pathogens and resistance genes that may be transferred to humans through the consumption or handling of foods of animal origin. Recent studies have demonstrated that antimicrobial resistance among foodborne bacteria may cause excess cases of illness, prolonged duration of illness, and increased rates of bacteremia, hospitalization and death.
 The US Food and Drug Administration (FDA) is committed to resolving the public health impact arising from the use of antimicrobial drugs in food-producing animals. The FDA's goal is to ensure that significant human antimicrobial therapies are not compromised or lost while providing for the safe use of antimicrobials in food animals. The FDA published a guidance document titled "Evaluating the Safety of Antimicrobial New Animal Drugs with Regard to their Microbiological Effects on Bacteria of Human Health Concern" that outlines a pathway drug sponsors can use to address concerns about antimicrobial resistance prior to approval of their drug. 30 The process uses a qualitative risk assessment approach to assess the potential of the intended use of a product to develop resistance in bacteria that may harm humans. The level of risk determines the level of risk management that is required for the drug to be approved.

Developing New Regulatory Approaches to Antimicrobial Safety

Resistance to antimicrobial agents is of concern to public health officials worldwide. In industrialized countries, a significant source of antimicrobial-resistant food-borne infections in humans is the acquisition of resistant bacteria originating from animals. The US Food and Drug Administration (FDA) is committed to resolving the public health impact arising from the use of antimicrobial drugs in food-producing animals. The FDAs goal is to ensure that significant human antimicrobial therapies are not compromised or lost while providing for the safe use of antimicrobials in food animals. Recently the FDA published a guidance document titled 'Evaluating the Safety of Antimicrobial New Animal Drugs with Regard to their Microbiological Effects on Bacteria of Human Health Concern' (US Food and Drug Administration, Center for Veterinary Medicine, 2003). This document outlines a pathway drug sponsors can use to address concerns about antimicrobial resistance prior to approval of their drug. The process uses a qualitative risk assessment approach to assess the potential of the intended use of a product to develop resistance in bacteria that may harm humans. The level of risk determines the level of risk management that is required for the drug to be used. The Food and Drug Administration (FDA) always has the option of not approving a drug if the risk of a public health consequence is too high.