Les risques sont inhérents à l’activité industrielle. Les prévoir et les maîtriser sont essentiels pour la conception et la conduite en sécurité des procédés. La réglementation des risques majeurs impose aux exploitants la réalisation d’études de sécurité quantitatives. La stratégie de maîtrise des risques repose sur la pertinence des analyses de risques. En marche dégradée, la dynamique des événements est déterminante pour quantifier les risques. Toutefois, de nos jours cette connaissance est difficilement accessible. Ce travail propose une méthodologie d’analyse de risques quantitative qui combine la méthode HAZOP, le retour d’expérience et la simulation dynamique de dérives de procédés. Elle repose sur quatre grandes étapes : La première étape est l’étude du fonctionnement normal du procédé. Pour cela, le procédé est décrit de façon détaillée. Des études complémentaires de caractérisation des produits et du milieu réactionnel sont menées si nécessaires. Ensuite, le procédé est simulé dynamiquement en fonctionnement normal. Lors de la seconde étape, parmi les dérives définies par l’HAZOP et le retour d’expérience, l’analyste discrimine celles dont les conséquences ne sont pas prévisibles et/ou nécessitent d’être quantifiées. La troisième phase fournit une quantification du risque sur la base de la simulation dynamique des scenarii retenus. Lors de la dernière étape, des mesures de maîtrise des risques sont définies et ajoutées au procédé lorsque le niveau de risque est supérieur au risque tolérable. Le risque résiduel est ensuite calculé jusqu’à l’atteinte de la cible sécurité. Le logiciel Aspen Plus Dynamics est sélectionné. Trois études de cas sont choisies pour démontrer d’une part, la faisabilité de la méthodologie et d’autre part, la diversité de son champ d’application : · la première étude de cas porte sur un réacteur semi-continu siège d’une réaction exothermique. L’oxydation du thiosulfate de sodium par le peroxyde d’hydrogène est choisie. Ce cas relativement simple permet d’illustrer la diversité des causes pouvant être simulées (erreur procédurale, défaut matériel, contamination de produits, …) et la possibilité d’étudier des dérives simultanées (perte de refroidissement du milieu et sous dimensionnement de la soupape de sécurité). · le deuxième cas concerne un réacteur semi-batch dans lequel une réaction exothermique de sulfonation est opérée. Elle est particulièrement difficile à mettre en œuvre car le risque d’emballement thermique est élevé. Cette étude montre l’intérêt de notre approche dans la définition des conditions opératoires pour la conduite en sécurité. · le troisième cas d’étude porte sur un procédé continu de fabrication du propylène glycol composé d’un réacteur et de deux colonnes de distillation en série. L’objectif est ici d’étudier la propagation de dérives le long du procédé. Sur la base du retour d’expérience, deux dérives au niveau du rebouilleur de la première colonne sont étudiées et illustrent les risques de pleurage et d’engorgement. La simulation dynamique illustre la propagation d’une dérive et ses conséquences sur la colonne suivante. / Risks are inherent to industrial activity. Predicting and controlling them is essential to the processes design and safe operation. Quantitative safety studies are imposed by the major hazard regulations. The risk management strategy relies on the relevance of risk analyzes. In degraded conditions, the dynamics of events are decisive for risks quantification. However, nowadays this knowledge is a real challenge. This work proposes a methodology of quantitative risk analysis, which combines the HAZOP method, the lessons learned from previous accidents and the dynamic simulation of process deviations. It is based on four main stages: The first stage is the study of the process normal operation. For this, the process is described in detail. Additional studies to characterize the products and the reaction are carried out if necessary. Then, the process is dynamically simulated in normal operation conditions. During the second step, among all the deviations defined by the HAZOP and lessons learned, the analyst discriminates those whose consequences are not predictable and/or need to be quantified. The third phase provides a risk quantification based on the dynamic simulation of the selected scenarios. In the last step, safety barriers are defined and added to the process when the risk level is greater than the tolerable risk. The residual risk is then calculated until the safety target is reached. Aspen Plus Dynamics software is selected. Three case studies are chosen in order to demonstrate, on the one hand, the feasibility of the methodology and, on the other hand, the diversity of its scope: · the first case study is a semi-continuous reactor with an exothermic reaction study. The oxidation of sodium thiosulfate by hydrogen peroxide is selected. This relatively simple case illustrates the diversity of causes that can be simulated (procedural error, material defect, product contamination …) and the possibility of studying simultaneous deviations (loss of cooling and under sized safety valve for example). · the second case concerns a semi-batch reactor in which an exothermic reaction of sulphonation is carried out. This reaction is particularly difficult to conduct because of the thermal runaway high risk. This study shows our approach’s interest in the definition of the operating conditions for safe operation. · the third case study concerns a continuous process of propylene glycol production. It is composed of a reactor and two distillation columns in series. The objective is to study the propagation of deviations along the process. Based on lessons learned, two deviations in the first column reboiler are studied and illustrate the flooding and weeping risks. Dynamic simulation illustrates the propagation of a deviation and its consequences on the second column

Em novembro de 2005, com o guia de Gestão de Riscos à Qualidade (Q9) - a Conferência Internacional de Harmonização (ICH), em conjunto com as agências regulatórias dos Estados Unidos, Japão e Europa, passaram a recomendar que seja aplicado o gerenciamento de riscos para regulação da indústria farmacêutica. Em concordância, a Agência Nacional de Vigilância Sanitária (ANVISA) publicou a Resolução de Diretoria Colegiada - RDC 17/2010 que dispõe sobre as Boas Práticas de Fabricação de Medicamentos que possibilita a comercialização de produtos farmacêuticos. Esta resolução preconiza que a validação de um processo produtivo seja efetuada com base em uma análise de risco. Seguindo as orientações da RDC este trabalho se propôs a aplicar a ferramenta de análise de risco de Estudos de Perigos e Operabilidade HAZOP num sistema de biorreação bacteriana para produção de proteínas recombinantes instalado no Instituto de Tecnologia em Imunobiológicos Bio-Manguinhos/Fiocruz. Este sistema é formado por fermentadores de 100 (FE01) e 600 (FE02) litros, um tanque de colheita de 600 litros (HT01) e um tanque de preparo de meios de cultura de 600 litros (MT01). Através da aplicação desta ferramenta de análise de riscos foi possível classificar os riscos dos sistemas identificando os nós, palavras-guia primárias (parâmetros) e secundárias (desvios), assim como a severidade e frequência dos eventos. Foram identificados 82 riscos associados aos fermentadores FE01 e FE02, sendo 8,5% riscos insignificantes, 65,9% riscos aceitáveis e 25,6% riscos não desejáveis. No tanque de colheita HT01 foram identificados 55 riscos, dos quais 14,5% são insignificantes, 67,3% são aceitáveis e 18,2% não desejáveis. Para o tanque de preparo de meios MT01 foram identificados 66 riscos que estão divididos em 9% de riscos insignificantes, 69,7% de riscos aceitáveis e 21,3% de riscos não desejáveis. Foi percebido que não houve riscos catastróficos que pudessem comprometer os equipamentos fabricados, porém somente com utilização dos mesmos na rotina de produção e o ciclo de melhoria continua dos equipamentos será possível validar este estudo prospectivo / In November 2005, with the guidance of the Quality Risk Management (Q9) the International Conference on Harmonization (ICH) in conjunction with regulatory agencies in the United States, Japan and Europe started recommending applying risk management for regulation of the pharmaceutical industry. Following this argument, the National Health Surveillance Agency (ANVISA) published the Board Resolution RDC 17/2010 which establish the Good Manufacturing Practices in Pharmaceutical Manufacturing, allowing the commercialization of pharmaceutical products. This resolution states to perform the production process validation on a risk analysis basis. Following the guidelines, this work intend to use the risk analysis tool Hazards and Operability Studies HAZOP in a bacterial bioreaction system for recombinant protein installed in Bio-Manguinhos/Fiocruz. This system consists of 100 (FE01) and 600 (FE02) liters fermenters, a harvest tank of 600 Liters (HT01) and a 600 Liters tank for culture media preparation (MT01). By applying, this tool was possible to classify the system risk identifying nodes, primary and secondary (deviations) guidewords, as well as, the severity and frequency of events. Thus, ones identified 82 risks within FE01 and FE02 fermenters, with 8.5% being irrelevant risks, 65.9% acceptable risks and 25.6% undesirable risks. In the harvest tank HT01 were identified 55 risks, which 14.5% are significant, 67.3% are acceptable and 18.2% undesirable. For media preparation tank, MT01 were identified 66 risks divided into 9% negligible risks,69.7% acceptable risks and 21.3% of unwanted risks. With these data, it is possible to ensure that there was not fatal risks that could harm the manufactured equipment, but only operation of this equipment during production routine and continual improvement cycle can validate this prospective study

Em novembro de 2005, com o guia de Gestão de Riscos à Qualidade (Q9) - a Conferência Internacional de Harmonização (ICH), em conjunto com as agências regulatórias dos Estados Unidos, Japão e Europa, passaram a recomendar que seja aplicado o gerenciamento de riscos para regulação da indústria farmacêutica. Em concordância, a Agência Nacional de Vigilância Sanitária (ANVISA) publicou a Resolução de Diretoria Colegiada - RDC 17/2010 que dispõe sobre as Boas Práticas de Fabricação de Medicamentos que possibilita a comercialização de produtos farmacêuticos. Esta resolução preconiza que a validação de um processo produtivo seja efetuada com base em uma análise de risco. Seguindo as orientações da RDC este trabalho se propôs a aplicar a ferramenta de análise de risco de Estudos de Perigos e Operabilidade HAZOP num sistema de biorreação bacteriana para produção de proteínas recombinantes instalado no Instituto de Tecnologia em Imunobiológicos Bio-Manguinhos/Fiocruz. Este sistema é formado por fermentadores de 100 (FE01) e 600 (FE02) litros, um tanque de colheita de 600 litros (HT01) e um tanque de preparo de meios de cultura de 600 litros (MT01). Através da aplicação desta ferramenta de análise de riscos foi possível classificar os riscos dos sistemas identificando os nós, palavras-guia primárias (parâmetros) e secundárias (desvios), assim como a severidade e frequência dos eventos. Foram identificados 82 riscos associados aos fermentadores FE01 e FE02, sendo 8,5% riscos insignificantes, 65,9% riscos aceitáveis e 25,6% riscos não desejáveis. No tanque de colheita HT01 foram identificados 55 riscos, dos quais 14,5% são insignificantes, 67,3% são aceitáveis e 18,2% não desejáveis. Para o tanque de preparo de meios MT01 foram identificados 66 riscos que estão divididos em 9% de riscos insignificantes, 69,7% de riscos aceitáveis e 21,3% de riscos não desejáveis. Foi percebido que não houve riscos catastróficos que pudessem comprometer os equipamentos fabricados, porém somente com utilização dos mesmos na rotina de produção e o ciclo de melhoria continua dos equipamentos será possível validar este estudo prospectivo / In November 2005, with the guidance of the Quality Risk Management (Q9) the International Conference on Harmonization (ICH) in conjunction with regulatory agencies in the United States, Japan and Europe started recommending applying risk management for regulation of the pharmaceutical industry. Following this argument, the National Health Surveillance Agency (ANVISA) published the Board Resolution RDC 17/2010 which establish the Good Manufacturing Practices in Pharmaceutical Manufacturing, allowing the commercialization of pharmaceutical products. This resolution states to perform the production process validation on a risk analysis basis. Following the guidelines, this work intend to use the risk analysis tool Hazards and Operability Studies HAZOP in a bacterial bioreaction system for recombinant protein installed in Bio-Manguinhos/Fiocruz. This system consists of 100 (FE01) and 600 (FE02) liters fermenters, a harvest tank of 600 Liters (HT01) and a 600 Liters tank for culture media preparation (MT01). By applying, this tool was possible to classify the system risk identifying nodes, primary and secondary (deviations) guidewords, as well as, the severity and frequency of events. Thus, ones identified 82 risks within FE01 and FE02 fermenters, with 8.5% being irrelevant risks, 65.9% acceptable risks and 25.6% undesirable risks. In the harvest tank HT01 were identified 55 risks, which 14.5% are significant, 67.3% are acceptable and 18.2% undesirable. For media preparation tank, MT01 were identified 66 risks divided into 9% negligible risks,69.7% acceptable risks and 21.3% of unwanted risks. With these data, it is possible to ensure that there was not fatal risks that could harm the manufactured equipment, but only operation of this equipment during production routine and continual improvement cycle can validate this prospective study

This thesis participates to the effort launched after the Fukushima-Daiichi disaster to improve the robustness of national institutions involved in nuclear safety because of the role that the failing nuclear regulator had in the accident. The driving idea is to investigate how engineering techniques used in high-risk industries can be applied to institutions involved in nuclear safety to improve their robustness. The thesis focuses specifically on the Office for Nuclear Regulation (ONR), the British nuclear regulator, and its process for structured inspections. The first part of the thesis demonstrates that the hazard and operability (HAZOP) technique, used in the nuclear industry to identify hazards associated with an activity, can be adapted to qualitatively assess the robustness of organisational processes. The HAZOP method was applied to the ONR inspection process and led to the identification of five significant failures or errors. These are: failure to focus on an area/topic deserving regulatory attention; failure to evaluate an area/topic of interest; failure to identify a non-compliance; failure to identify the underlying issue, its full extent and/or safety significance and failure to adequately share inspection findings. In addition, the study identified the main causal chains leading to each failure. The safeguards of the process, i.e. the mechanisms in place to prevent, detect, resolve and mitigate possible failures, were then analysed to assess the robustness of the inspection process. The principal safeguard found is the superintending inspector who performs reviews of inspection reports and debriefs inspectors after inspections. It was concluded that the inspection process is robust provided recruitment and training excellence. However, given the predominant role of the superintending inspector, the robustness of the process could be improved by increasing the diversity of safeguards. Finally, suggestions for improvement were made such as establishing a formal handover procedure between former and new site inspectors, formalising and generalising the shadowing scheme between inspectors and setting minimum standards for inspection debriefs. These results were shared with ONR, which had reached the same conclusions independently, thus validating the new application for the HAZOP method. The second part of the thesis demonstrates that computational modelling techniques can be used to build digital twins of institutions involved in safety which can then be used to assess their effectiveness. The knowledge learned thanks to the HAZOP study was used in association with computational modelling techniques to build a digital twin of the ONR and its structural inspection process along with a simple model of a nuclear plant. The model was validated using the face-validity and predictive validation processes. They respectively involved an experienced ONR inspector checking the validity of the model’s procedures and decision-making processes and comparing the model’s output for oversight work done to data provided by the ONR. The effectiveness of the ONR was then evaluated using a scenario where a hypothetical, newly discovered phenomenon threatens the integrity of the plant, with ONR inspectors gradually learning and sharing new information about it. Monte-Carlo simulation was used to estimate the cost of regulatory oversight and the probability that the ONR model detects and resolves the issue introduced before it causes an accident. Different arrangements were tested and in particular with a superintending inspector reviewing inspection reports and a formal information sharing process. For this scenario, these two improvements were found to have a similar impact on the success probability. However, the former achieves it for only half the cost.

When even seemingly benign and routine processes fail in healthcare, people sometimes die. The profound effect on the patient’s families and the healthcare staff involved is clear (Vincent and Coulter, 2002), while further consequences are felt by the institution involved, both financially and by damage to reputation. The trend in healthcare for learning through experience of adverse events is no longer a viable philosophy (Department of Health,Sir Ian Carruthers OBE and Pauline Philip, 2006). In order to make progress towards preventative learning, three Prospective Hazard Analysis (PHA) methods used in other industries were evaluated for use in the area of ward based healthcare. Failure Modes and Effects Analysis (FMEA), Fault Tree Analysis (FTA) and Hazard and Operability Analysis (HAZOP) were compared to each other in terms of ease of use, information they provide and the manner in which it is presented. Their results were also compared to baseline data produced through empirical research. Oxygen Therapy was used in this research as an example of a common ward based therapy. The resulting analysis listed 186 hazards almost all of which could lead to death, especially if combined. FTA and FMEA provided better system coverage than HAZOP and identified more hazards than were contained in the initial hazard identification method common to both techniques. FMEA and HAZOP needed some modification before use, with HAZOP requiring the most extensive adjustment. FTA has a very useful graphical presentation and was the only method capable of displaying causal linkage, but required that hazards be translated into events for analysis. It was concluded that formal Prospective Hazard Analysis (PHA) was applicable to this area of healthcare and presented added value through a combination of detailed information on possible hazards and accurate risk assessment based on a combination of expert opinion and empirical data. This provides a mechanism for evidence based identification of hazard barriers and safeguards as well as a method for formal communication of results at any stage of an analysis. It may further provide a very valuable vehicle for documented learning through prospective analysis incorporating feedback from previous experience and adverse incidents. The clear definition of systems and processes that form part of these methods provides a valuable opportunity for learning and the enduring capture and dissemination of tacit knowledge that can be continually updated and used for the formulation of strategies for safety and quality improvement.

This thesis investigates the proposition that use must be made of quantitative information to control the reporting of hazard scenarios in automatically generated HAZOP reports. HAZOP is a successful and widely accepted technique for identification of process hazards. However, it requires an expensive commitment of time and personnel near the end of a project. Use of a HAZOP emulation tool before conventional HAZOP could speed up the examination of routine hazards, or identify deficiencies I in the design of a plant. Qualitative models of process equipment can efficiently model fault propagation in chemical plants. However, purely qualitative models lack the representational power to model many constraints in real plants, resulting in indiscriminate reporting of failure scenarios. In the AutoHAZID computer program, qualitative reasoning is used to emulate HAZOP. Signed-directed graph (SDG) models of equipment are used to build a graph model of the plant. This graph is searched to find links between faults and consequences, which are reported as hazardous scenarios associated with process variable deviations. However, factors not represented in the SDG, such as the fluids in the plant, often affect the feasibility of scenarios. Support for the qualitative model system, in the form of quantitative judgements to assess the feasibility of certain hazards, was investigated and is reported here. This thesis also describes the novel "Fluid Modelling System" (FMS) which now provides this quantitative support mechanism in AutoHAZID. The FMS allows the attachment of conditions to SDG arcs. Fault paths are validated by testing the conditions along their arcs. Infeasible scenarios are removed. In the FMS, numerical limits on process variable deviations have been used to assess the sufficiency of a given fault to cause any linked consequence. In a number of case studies, use of the FMS in AutoHAZID has improved the focus of the automatically generated HAZOP results. This thesis describes qualitative model-based methods for identifying process hazards by computer, in particular AutoHAZID. It identifies a range of problems where the purely qualitative approach is inadequate and demonstrates how such problems can be tackled by selective use of quantitative information about the plant or the fluids in it. The conclusion is that quantitative knowledge is' required to support the qualitative reasoning in hazard identification by computer.

The master's thesis deals with risk prevention in the production of masterbatches in company Lifocolor, s.r.o. The theoretical part is focused on the overall risk management process, specifying individual methods of risk analysis. The following section pertains masterbatch production process. Analysis of history of disagreeable products, application of methods described in theoretical parts, their evaluation and design of corrective precautions are described in the practical part.

Risk can be viewed as a state where there is a possibility of a loss but also a hope of gain. To realise the existence of a risk, one must be aware of both the gains and losses incurred.Increased number of natural disasters and companies having global supply chains to a higher extent, are both factors which have increased the number of risks that can affect anorganisation’s supply chain negatively. This fact has made it even more important to focus on risk prevention. In the beverage industry market, characterized by fast-moving products,manufacturing companies like Coca-Cola Enterprises Sweden (CCES) can be highly affected if disturbances occur in their supply chain. Risk management is, according to ISO 31000, “coordinated activities to direct and control an organization with regard to risk “. A risk management processes therefore aims at mitigatingnegative impact of external and internal disturbances in order to avoid interruptions in production, product quality issues and financial losses. CCES’s control over internal processes and its disturbances is mostly based on reactive approaches rather than a proactive strategy and there exist no guidelines of how to identify and handle occurring disturbances. The main purpose of the project has therefore been to identify the most critical risks the company is facing within their “Source” and “Make” processes, and find both proactive and reactive mitigation actions. Another significant part of the project delivery is to present a model for how the company should organize and maintain a sustainable risk picture. The model aims to present a dynamic risk management process that can be used by CCES as well as other companies in the future. The project consists of three major phases; Risk Identification, Risk Avoidance Mapping and Implementation of a Risk Management Process. In the first phase, the brainstorming tool Hazard and Operability (HAZOP) has been used during workshop events for risk identification and assessment. Some of the most critical risks identified are; Sabotage during  transport from supplier to CCES, Lack of spare parts for maintenance, Lost production time due to long beverage change overs and Filling bottles with too much beverage. In order to find feasible preventive and reactive mitigation actions for the critical risks, both employee interviews and the Supply Chain Operations Reference (SCOR) model has been applied. Some of the actions recommended to perform are concluded to be; Let suppliers own transports, Standardize the product change process and the shift hand overs and Implement routines of having locked transports from supplier to CCES. The structure of the project has acted as a basis for the recommended way of continuing the risk management work at CCES. The authors have identified the importance of keeping the risk management process dynamic, and therefore a Risk Register have been introduced for documentation and follow-up. Another way of following up the risk management work, is to perform Risk Audits after the event of a disturbance. This will help the organisation to realize the impact a certain disturbance brings, but it will also measure of the recovery work’s effectiveness. The authors highlight the importance of having a dedicated owner of the risk management process in order to keep it dynamic. A complete risk management process has finally been created, adaptable to different kind of organisations. By making this process a part of SCOR, the authors believes that the process can be used to identify individual risks within the management processes Plan, Source, Make, Deliver and Return for all SCOR member companies. Thereafter, a general risk mapping can be created from the individual risks that can be used to share information and experiences among the member companies. / En risk kan förklaras som ett tillstånd där det finns en chans att vinna, men också en sannolikhet för förlust. För att vara medveten om en risks existens måste man därför förstå både vad det finns att förlora och vinna. Under de senaste årtiondena har antalet naturkatastrofer och annan extern påverkan ökat. Detta i kombination med att företag idag har globala värdekedjor i allt större utsträckning, har gjort att organisationer utsätter sig för risker till en större grad idag. Därför har betydelsen av att fokusera på riskförmildrande åtgärder ökat. I dryckesindustrin, karaktäriserat av snabbrörliga produkter, kan företag såsom Coca-Cola Enterprises Sweden (CCES) påverkas hårt om störningar sker i deras värdekedja. Risk Management är, enligt ISO 31000, ”koordinerade aktiviteter för att styra och kontrollera riskhantering i en organisation”. En riskhanteringsprocess ämnar därför förmildra negativ påverkan av interna och externa störningar för att undvika till exempel avvikelser i produktion, försämrad produktkvalitet och finansiella förluster. CCES’s kontroll över interna processer och dess störningar baseras främst på reaktiva åtgärder, och företaget har inga riktlinjer för hur de ska identifiera och hantera uppkommande störningar. Syftet med detta projekt har därför varit att identifiera kritiska risker inom företagets leverantörs- och produktionsprocesser och att hitta proaktiva och reaktiva lösningar för att förmildra och undvika störningar. Ytterligare en stor del av projektets syfte har varit att presentera en dynamisk process för hur CCES, samt andra företag, ska organisera en hållbar riskbild. Projektet består av tre huvudsakliga delar; riskidentifiering, riskförmildrande åtgärder och implementering av en riskhanteringsprocess. I den första fasen har verktyget Hazard and Operability (HAZOP) används under workshops för att identifiera och värdera risker. Några av de mest kritiska riskerna som identifierats är; Sabotage under transport från leverantör till CCES, Brist på reservdelar för underhållsarbete, Förlorad produktionstid på grund av för långa dryckesbytartider och Fyller flaskor med för mycket dryck. För att hitta passande reaktiva och proaktiva lösningar för de kritiska riskerna har både intervjuer med anställda genomförts och referensmodellen Supply Chain Reference Model (SCOR) använts. Några av de åtgärder rekommenderade att göra har identifierats till att vara; Låta leverantörerna själva sköta transporter, Standardisera produktbytesprocessen samt skiftöverlämningar och Implementera rutiner för att ha låsta transporter från leverantör till CCES. Strukturen av projektet har använts som en bas för den rekommenderade strukturen på CCE’s fortskridande arbete inom riskhantering. Författarna vill bestryka vikten av att hålla den framtida riskhanteringsprocessen dynamisk och i detta syfte har därför ett riskregister tagits fram för dokumentation och uppföljning. Ett annat sätt att följa upp riskprocessarbetet är att genomföra så kallade audits efter en störning har inträffat. Detta hjälper organisationen både att förstår en störnings påverkan på verksamheten, men fungerar också som ett verktyg för att mäta hur effektivt återhämtningsarbetet efter en störning har varit. Författarna menar också att en dedikerad ägare till riskprocessen är av stor betydelse för ett dynamiskt, framgångsrikt och effektivt riskarbete. En fullständig riskhanteringsprocess har slutligen sammanställts, användbar för många olika typer av organisationer. Genom att göra processen till en del av SCOR-modellen, kan processen i framtiden användas till att identifiera individuella risker inom de fem managementprocesserna Planering, Inköp, Tillverkning, Leverans och Retur för alla SCOR’s medlemsföretag. Därefter menar författarna att en generell kartläggning över de mest kritiska riskerna inom varje managementprocess kan skapas för att dela information och utbyta erfarenheter mellan medlemsföretagen.

Intermitted Water Supply strategy is implemented commonly in some developing countries nowadays in order to minimize the water scarcity problems. Unstable hydraulic conditions in the distribution system, low pressure, high risk of water contamination, wasting water, rising costs paid by consumers and water providers, failures and problems with consumption metering and inconvenience to consumers are some of the consequences. Risk Analysis Methodology is developed to handle with intermittent water supply systems in developing countries conditions that include undesired events identification; risk estimation and risk evaluation and reduction plan, the catalogue list of potential undesired events (UE) which may occur in these types of systems have been also developed using the HAZard and OPerability technique (HAZOP). The developed methodology is implemented and tested in this research on one of the potential undesired events UE _ Low operational pressure

Identifying hazards is fundamental for ensuring the safe design and operation of a system in process plants and other facilities. Several techniques are available to identify hazardous situations, all of which require their rigorous, thorough, and systematic application by a multi-disciplinary team of experts. Success rests upon first identifying and subsequently analyzing possible scenarios that can cause accidents with different degrees of severity. While hazard identification may be the most important stage for risk management, it depends on subjectivity issues (e.g., human observation, good judgment and intuition, creativity, expertise, knowledge) which introduce bias. Without a structured identification system, hazards can be overlooked, thus entailing incomplete risk-evaluations and potential loss. The present Thesis is focused on developing both managerial and technical aspects intended to standardize one of the most used techniques for hazard identification; viz. HAZard & Operability (HAZOP) study. These criteria have been carefully implemented not only to ensure that most of the hazardous scenarios will be identified, but also that US OSHA PSM Rule, EPA RMP, and Seveso Directive requirements will be accomplished. Chapter I pioneers the main research topic; from introducing the process safety concept up to the evidence of more detailed information is required from related regulations. A review of regulations (i.e., US, Europe legislation) focused on Hazard Identification has been conducted, highlighting, there is an absence of specific criteria for performing techniques intended to identify what can go wrong. Chapter II introduces the risk management system required to analyze the risk from chemical process facilities, and justifies that hazard identification stage is the Process Safety foundation. Hereafter, an overview of the key Process Hazard Analyzes (PHA) has been conducted, and the specific HAZOP weaknesses and strengths have been highlighted to establish the first steps to focus on. Chapter III establishes the scope, the purpose and the specific objectives that the research covers. It answers the following questions on the spot: why the present research is performed, which elements are included, and what has been considered for acquiring the final conclusions of the manuscript. Chapter IV gathers HAZOP-related literature from books, guidelines, standards, major journals, and conference proceedings with the purpose of classifying the research conducted over the years and finally define the HAZOP state-of-the-art. Additionally, and according to the information collected, the current HAZOP limitations have been emphasized, and thus, the research needs that should be considered for the HAZOP improvement and advance. Chapter V analyzes the data collected while preparing, organizing, executing and writing HAZOPs in five petroleum-refining processes. A statistical analysis has been performed to extract guidance and conclusions to support the established criteria to conduct effectively HAZOP studies. Chapter VI establishes the whole set of actions that have to be taken into account for ensuring a wellplanned and executed HAZOP study. Both technical and management issues are addressed, criteria supported after considering the previous chapters of the manuscript. Chapter VI itself is the result of the present research, and could be used as a guideline not only for team leaders, but also for any related party interested on performing HAZOPs in continuous chemical processes. Chapter VII states the final conclusions of the research. The interested parties should be released about the hazard identification related-gaps present in current process safety regulations; which are the key limitations of the HAZOP study, and finally, which are the criteria to cover the research needs that have been found Annex I proposes the key tools (tables, figures and checklists "ready-to use'') to be used for conducting HAZOPs in continuous chemical processes. The information layout is structured according to the proposed HAZOP Management System. This information is intended to provide concise and structured documentation to be used as a reference book when conducting HAZOPs. Annex II is intended to overview the most relevant petroleum refining processes by highlighting key factors to take into account in the point of view of process safety and hazard identification, i.e. HAZOP. In this sense, key health and safety information of specific petroleum refining units is provided as a valuable guidance during brainstorming sessions. Annex III illustrates the complete set of data collected during the field work of the present research, and also analyzed in Chapter V of the manuscript. Additionally, it depicts a statistical summary of the key variables treated during the analysis. Finally, the Nomenclature, References, and Abbreviations & Acronyms used and cited during the manuscript have been listed. Additionally, a Glossary of key terms related to the Process Safety field has been illustrated. / La present Tesis doctoral té com a objectiu estandarditzar l'aplicació d'una de les tècniques més utilitzades a la industria de procés per a la identificació de perills; l'anomenat HAZard & OPerability (HAZOP) study, específicament a processos complexes, com per exemple, unitat de refineria del petroli.El capítol I defineix el concepte de Seguretat de Processos, i progressivament analitza les diferents regulacions relacionades amb la temàtica, detallant específicament les mancances i buits d'informació que actualment hi ha presents a la primera etapa de la gestió del risc en industries de procés: la identificació de perills.El capítol II defineix el sistema de gestió del risc tecnològic que aplica a les industries de procés, i es justifica que l'etapa d'identificació de perills és el pilar de tot el sistema. Finalment, es mencionen algunes de les tècniques d'identificació més utilitzades, els anomenats Process Hazard Analysis (PHA), i es detallen les seves mancances i fortaleses, característiques que han acabat definint la temàtica específica de la Tesis. Concretament, es dóna èmfasis a la tècnica anomenada HAZard & OPerability (HAZOP) study, objecte principal de la recerca.El capítol III defineix l'abast, el propòsit i els objectius específics de la recerca. La intenció d'aquest capítol és donar resposta a les següents qüestions: el perquè de la recerca, quins elements han estat inclosos i què s'ha considerat per tal d'assolir les conclusions de la Tesis.El capítol IV descriu l'estat de l'art de la literatura relacionada amb el HAZOP. Aquesta revisió no només permet classificar les diferents línies de recerca relacionades amb el HAZOP, sinó que també permet assolir un coneixement profund de les diferents particularitats de la pròpia tècnica. El capítol finalitza amb un conjunt de mancances tant de gestió com tècniques, així com les necessitats de recerca que poden millorar l'organització i execució dels HAZOPs.El capítol V analitza la informació que ha estat recopilada durant la fase experimental de la tesis. Les dades procedeixen de la participació en cinc estudis HAZOP aplicats a la industria de refineria del petroli.En aquest sentit, el capítol V desenvolupa una anàlisi estadística d'aquestes dades per extreure'n conclusions quant a la preparació, organització i execució dels HAZOPs.El capítol VI estableix el conjunt d'accions que s'ha de tenir en compte per tal d'assegurar que un estudi HAZOP estigui ben organitzat i executat (la metodologia). Es defineix un Sistema de Gestió del HAZOP, i a partir de les seves fases, es desenvolupa una metodologia que pretén donar suport a tots aquells punts febles que han estat identificats en els capítols anteriors. Aquesta metodologia té la intenció de donar suport i guia no només als líders del HAZOP, sinó també a qualsevol part interessada en aquesta temàtica.El capítol VII descriu les conclusions de la recerca. En primera instància s'enumeren les mancances quant a la definició de criteris a seguir de diferents regulacions que apliquen a la Seguretat de Processos.Seguidament, es mencionen les limitacions de la pròpia tècnica HAZOP, i finalment, es descriuen quins són els criteris establerts per donar solució a totes aquestes febleses que han estat identificades.L'Annex I és una recopilació de diferents criteris que han estat desenvolupats al llarg de l'escrit en forma de taules i figures. Aquestes han estat ordenades cronològicament d'acord amb les diferents fases que defineixen el Sistema de Gestió HAZOP. L'annex I es pot utilitzar com a una referència concisa i pràctica, preparada i pensada per ésser utilitzada directament a camp, amb la intenció de donar suport a les parts interessades en liderar estudis HAZOP.L'annex II recopila informació relacionada amb aspectes clau de seguretat i medi ambient en diferents unitats de refineria. Aquest informació és un suport per tal de motivar el "brainstorming" dels diferents membres que conformen l'equip HAZOP.L'Annex III recopila les dades de les diferents variables que han estat considerades a la fase experimental de la recerca, juntament amb un conjunt de figures que mostren la seva estadística bàsica.