Quality Risk Management Research Articles

Implementation of a quality risk management approch in a clinical mycobacteriology laboratory

Implementation of a quality risk management approch in a clinical mycobacteriology laboratory

Практика использования ESG-подходов в сделках секьюритизации

The spread of the sustainable development concept has given rise to sustainable finance, as well as the infrastructure of the financial and consulting industry of valuations, verifications and various databases in the field of ESG. This research is devoted to theoretical and practical study of the accumulated experience of ESG securitization transactions in order to systematize ESG financing instruments and directions of development of this sphere in modern conditions. The study showes that ESG securitization practices are being integrated into capital management processes in line with sustainable development goals, with the most developed centers in the USA, Europe and China. The study systematizes the main types of ESG securitized assets, gives their characteristics and identifies current trends. In Russia, despite its isolation from the world financial markets, the practice of ESG securitization is developing, covering new directions. The study notes the potential for the development of green mortgages, which will contribute to the activation of securitization transactions in the segment of residential and commercial real estate. High potential for development of the social segment of ESG securitization is also noted due to the growing demand for financing social projects in the regions. Expansion of the practice of social mortgage securitization will contribute to the redistribution of risks between the public and private sectors, while active involvement of Russian banks in a variety of ESG lending programs (car loans, lending to small and medium-sized businesses with a green and social focus, e.g. for the construction of social infrastructure, etc.) will expand the market. There is a suggestion that the development of digital ESG securitization platforms will help expand the reach of retail investors, while cooling the junk bond market. The article notes that the expansion of multi-tranche ESG securitization will allow long-term assets of pension funds and various ESG funds to be leveraged into mortgage-backed securities. Overall, ESG securitization improves the structure of transactions, expands the range of derivatives used, improves the quality of credit and interest rate risk management, and contributes to the achievement of sustainable development goals.

Major Hazard Competent Person Profession in Malaysia: A document analysis of trends and demands

Introduction: The Malaysian Control of Industrial Major Accident Hazard (CIMAH) Regulations introduced in 1996 resulted in the creation ‘Major Hazard Competent Person’ (MHCP) profession. However, after two decades of its establishment, there has been limited study conducted on this specific profession. The objectives of this study are to analyze 1) the trend of application and passing rates of MHCP registrations; and 2) the trend of Major Hazard Installations (MHI) registrations, and its relationship with the available supply of registered MHCP. Methods: The study used a document review approach, involving the extraction, examination, and interpretation of data from both published and unpublished documents by the Department of Occupational Safety and Health (DOSH), the regulatory body responsible for overseeing both MHCP and MHI registration status in Malaysia. The study looks into data from 1996 (beginning of 1996 CIMAH Regulation) to 2023, though the available data found and analyzed were from 1998 to 2021. Results: The study reveals a concerning lack of growth in the number of professionals being certified as MHCP, despite an increase in the number of MHIs over the past two decades. Potential causes of this shortage identified include a demanding certification process, limited availability of MHCP competency courses, and a lack of clear career paths and growth opportunities in the profession. Conclusion: The inadequate supply of MHCPs could potentially undermine their ability to provide sufficient coverage for MHIs, indirectly jeopardizing the quality of risk management in major hazard facilities. Therefore, there is merit in periodically reviewing the regulations and reforming the MHCP profession in response to changing trends.

The Requirements of Managing Phase I Clinical Trials Risks: The British and Italian Case Studies.

Phase I clinical trials represent a critical point in drug development because the investigational medicinal product is being tested in humans for the first time. For this reason, it is essential to evaluate and identify the Maximum Tolerated Dose (MTD) and the safety of the new compound. To mitigate the possible risks associated with drug administration and treatment, the European Competent Authority issued various guidelines to provide provisions and harmonize risk management processes. In the UK and Italy, particular attention should be paid to the Medicines & Healthcare Products Regulatory Agency (MHRA) phase I accreditation scheme and the specific rules set by the Italian Drug Authority through the AIFA Determination no. 809/2015. Both reference documents are based on the concept of quality risk management while conducting phase I clinical studies. Moreover, the AIFA determination outlines specific requirements for those sites that want to conduct non-profit phase I clinical trials. Indeed, the document reports peculiar activities to the "Clinical Trial Quality Team", which is a team that should support the clinical site researchers in designing, starting, performing, and closing non-profit phase I studies. In this paper, we provide a general overview of the main European guidelines concerning the management of risks during phase I trials, focusing on the main peculiarities of the schemes and rules set by the MHRA and AIFA.

Algorithm of innovation project risk management

Aim. To develop a risk management algorithm that can be used in risk management of innovations.Objectives. On the basis of the current international standards of risk management and scientific publications to study the existing practice of risk management, highlighting the main elements of the risk management process into a single generalized risk management algorithm; based on the results of the first task, as well as taking into account the identified features of the process of innovation implementation, to develop an algorithm for risk management of innovation projects.Methods. The work is based on the study of scientific publications in the field of risk management and analysis of international standards on risk management in order to adapt them to the peculiarities of innovation management.Results. The problem of risk management of innovation projects is one of the most difficult in project management because of the significant degree of uncertainty inherent in innovation. The article reflects the problem of investors’ acceptance of increased risk during the realization of an innovation project. The peculiarity of risk management of innovations is the need to accept increased risk, and in return the opportunity to present a new product or technology to the market. Taking into account the considered peculiarities, an algorithmic approach to risk management of innovation projects is given. The practical significance of the study lies in the possibility of applying the developed algorithm of innovation project risk management by economic entities, which will improve the quality of corporate risk management and increase the efficiency of resource utilization. The authors point out the necessity of selecting a project with positive NPV (discounted cash flow, DCF) and accepting the increased risk of the innovation project in the process of innovation management.Conclusions. The authors have created a comprehensive methodological approach to innovation project risk management in the form of a sequence of actions algorithm. The purpose of its application is to increase the efficiency of risk management and to achieve a successful result of innovation implementation.

Quality by Design (QbD) Paradigm: An Integrated Multivariate Approach to Transdermal Patch System Development

: The International Council on Harmonization issued quality by design (QbD) guidelines, including Q8 (R2) pharmaceutical development, Q9 quality risk management, and Q10 pharmaceutical quality system, to ensure the quality of pharmaceutical products. For continual and consistent improvement of the quality of pharmaceutical drug products, QbD tools, such as risk assessment, design of experiment, and control strategy, are used, which can solve the narrow areas in product development. Transdermal patch systems (TPS) are gaining attention among scientists and are one of the strong-growing drug delivery systems in the market as a result of numerous benefits, including lowering the dosing frequency, adverse effects and invasiveness, avoiding pre-systemic metabolism, and better patient efficiency and compatibility. Transdermal patch systems are a likable dosage form when compared to other dosage forms. However, several challenges are faced in TPS product development which has hindered enormous products concerning the market status of TPS in comparison to the oral dosage forms. The implementation of the QbD concept was much focused on oral dosage forms. Additionally, the lack of understanding of the development of TPS leads to failure and withdrawal from markets. Therefore, to understand the QbD concepts of TPS, an attempt has been made to review the QbD approach for the development of TPS from the identification of the Quality Target Product Profile to the arrival of design space, which might help the formulator to navigate the sticky areas, in the TPS development.

Quality by Design-driven Analytical Method: A Quality Risk Management-Based Liquid Chromatography Method for Daclatasvir and Characterization of its Putative Degradants by LC-MS/MS

Background:: Antiviral drugs can cure more than 95 percent of people with hepatitis C, but the inaccessibility of quality affordable medicines and the lack of their uninterrupted supply poses a major challenge. Impurities in drugs have a significant impact on their quality and are one of the substantial causes of drug recalls, ultimately leading to the unavailability of the drug in the market. Hence, there is a need for a robust, quality risk management and quality by design-driven analytical method that can detect the antiviral drug, Daclatasvir dihydrochloride, in the presence of its probable impurities. Objective:: This study aimed to develop a Quality by Design-driven stability- indicating liquid chromatography method for Daclatasvir dihydrochloride and the characterization of its putative degradants by LC-MS. Method:: The fishbone diagram and quality risk assessment investigated twenty-four process parameters and concluded that three risk parameters, i.e., flow rate, buffer pH, and stationary phase type, were the critical process parameters. The critical quality attributes viz. resolution between impurity 6 and DCV and impurity 2 & 3 (Rs˃1.5), the shape of the peak of DCV which is decided by the Number of Theoretical Plates (NTP˃5000), and the retention time of Daclatasvir (tR14-23 mins) were optimized using a two-level three-factor full factorial design with five center points. Results:: The optimized method is stability-indicating in its true sense as it can separate the sample with its degradants generated in basic (three), acidic (two), oxidative (H2O2: three, Azobisisobutyronitrile: one), photo (three), and dry heat (one) conditions. Degradants structures were elucidated, and degradation routes were established, using LC-MS and LC-MS/MS analyses. Conclusion:: The drug is highly susceptible to acid, base hydrolysis, and oxidation degradation conditions and poses a significant risk to the analytical method to fail in system suitability criteria. Hence, a robust and flexible chromatographic method with the capacity for continuous improvement was developed and successfully validated within the criteria of design space.

Improving the risk management process in quality management systems of higher education

The purpose of this paper is to improve the risk management process in the quality management system of higher education, taking into account the hazardous factors that increase the probability of occurrence and severity of consequences of undesirable events, as well as favorable factors that reduce the probability of occurrence and severity of consequences of hazardous events. The basis of risk management in the quality management systems of higher education institutions is the “Bowtie” method, which involves six main steps of identifying inconsistency, determining the impact of hazardous and favorable factors according to the impact group, ranking hazardous and favorable factors, calculating risk, substantiating precautionary measures and checking calculations. To rank hazardous and favorable factors, the authors used the “Decision Making Trial and Evaluation” method (hereinafter—DE-MATEL), which is based on paired comparison and decision-making tools based on graph theory. An improved process is proposed for risk assessment, which differs from the known ones by the presence of the identification of the cause-and-effect relationship “hazard (inconsistency)-hazardous event-consequences”, identification of hazardous and favorable factors of the internal and external environment that affect the probability and/or the degree of severity of a hazardous event—the appearance of an inconsistency, which is carried out after the inconsistency has been determined; determination of causal hazardous and favorable factors by an acceptable method. Registers of inconsistencies (hazards), hazardous and favorable factors have been developed and proposed based on the requirements for accreditation of educational programs and the international standard ISO 9001:2015, which will allow, based on a risk-oriented approach, to provide a basis for setting the goals of a higher education institution under martial law in order to guarantee effective implementation of the mission and strategy. They are proposed for decision-making in the quality management systems of educational organizations on the substantiation of precautionary or corrective measures based on ranking the risks from identified inconsistencies, which are determined taking into account the impact of the entire set of identified significant hazardous and favorable factors. The value of this paper is to improve the quality risk management process in educational organizations, taking into account the impact of hazardous and favorable factors, and to develop an appropriate step-by-step algorithm of actions and a risk assessment form.

Supply chain risk prioritization: a multi-criteria based Intuitionistic Fuzzy TOPSIS approach

Purpose Identifying and prioritizing supply chain risk is significant from any product’s quality and reliability perspective. Under an input-process-output workflow, conventional risk prioritization uses a risk priority number (RPN) aligned to the risk analysis. Imprecise information coupled with a lack of dealing with hesitancy margins enlarges the scope, leading to improper assessment of risks. This significantly affects monitoring quality and performance. Against the backdrop, a methodology that identifies and prioritizes the operational supply chain risk factors signifies better risk assessment.Design/methodology/approach The study proposes a multi-criteria model for risk prioritization involving multiple decision-makers (DMs). The methodology offers a robust, hybrid system based on the Intuitionistic Fuzzy (IF) Set merged with the “Technique for Order Performance by Similarity to Ideal Solution.” The nature of the model is robust. The same is shown by applying fuzzy concepts under multi-criteria decision-making (MCDM) to prioritize the identified business risks for better assessment.Findings The proposed IF Technique for Order Preference by Similarity to the Ideal Solution (TOPSIS) for risk prioritization model can improve the decisions within organizations that make up the chains, thus guaranteeing a “better quality in risk management.” Establishing an efficient representation of uncertain information related to traditional failure mode and effects analysis (FMEA) treatment involving multiple DMs means identifying potential risks in advance and providing better supply chain control.Research limitations/implications In a company’s supply chain, blockchain allows data storage and transparent transmission of flows with traceability, privacy, security and transparency (Roy et al., 2022). They asserted that blockchain technology has great potential for traceability. Since risk assessment in supply chain operations can be treated as a traceability problem, further research is needed to use blockchain technologies. Lastly, issues like risk will be better assessed if predicted well; further research demands the suitability of applying predictive analysis on risk.Practical implications The study proposes a hybrid framework based on the generic risk assessment and MCDM methodologies under a fuzzy environment system. By this, the authors try to address the supply chain risk assessment and mitigation framework better than the conventional one. To the best of their knowledge, no study is found in existing literature attempting to explore the efficacy of the proposed hybrid approach over the traditional RPN system in prime sectors like steel (with production planning data). The validation experiment indicates the effectiveness of the results obtained from the proposed IF TOPSIS Approach to Risk Prioritization methodology is more practical and resembles the actual scenario compared to those obtained using the traditional RPN system (Kim et al., 2018; Kumar et al., 2018).Originality/value This study provides mathematical models to simulate the supply chain risk assessment, thus helping the manufacturer rank the risk level. In the end, the authors apply this model in a big-sized organization to validate its accuracy. The authors validate the proposed approach to an integrated steel plant impacting the production planning process. The model’s outcome substantially adds value to the current risk assessment and prioritization, significantly affecting better risk management quality.

Pemanfaatan BIM dalam Integrasi Arsitektur dan MEP Pada Proyek Konstruksi Gedung Lab PUT PNJ

Recent building construction projects increasingly prioritize the integration of architectural (design) and MEP (mechanical, electrical, and plumbing) aspects as key elements to achieve effective and sustainable projects. This study aims to explore the close relationship between architecture and MEP in building construction projects and how integrating the two can provide optimal results. This article discusses the important role of Building Information Modeling (BIM) technology in supporting the integration of architecture and MEP. BIM enables architecture and MEP professionals to work collaboratively in an integrated virtual environment, facilitating monitoring, coordination, and early identification of design conflicts. The results showed that effective use of BIM can create more efficient projects in terms of planning, execution, and maintenance. In addition, the study explores planning strategies that support the integration of architecture and MEP, including the selection of environmentally friendly materials, optimal spatial design, and energy efficiency. Comprehensive, sustainable planning can reduce environmental impact, reduce energy consumption, and reduce long-term operating costs. Project control in the context of architectural integration and MEP is also the focus of this study, with emphasis on construction quality monitoring, cost control and risk management. The success of a project often depends on careful control of these aspects. Therefore, this research provides insight into the integration of architecture and MEP in building construction projects and shows how this comprehensive approach can improve efficiency, sustainability, and sustainability as well as overall project outcomes.

Evaluation of a Novel LC-MS/MS Based Analytical Method for the Risk Assessment of Nitrosamines in Pharmaceutical Products and Packaging Materials

The detection of nitrosamine impurities, particularly small dialkyl types, which are frequently known to be potent mutagenic carcinogens, in some Sartan group active pharmaceutical ingredients (APIs) and finished drug products caused global regulatory organizations to have concerns. Accordingly, Registration Holders/Applicants, API manufacturers, and their raw material suppliers are required to check the presence of nitrosamines in their products and carry out risk assessments using the quality risk management principles specified in the ICH Q9 guide. In this context, a new LC-MS/MS method has been developed and validated for the simultaneous determination of NDMA, NDEA, NMBA, NDIPA, NEIPA, NDBA, and MeNP nitrosamine compounds in API and finished products as well as in primary packaging materials, one of the risk sources. This validated method was applied to check the nitrosamine content may occur from canister, blister, printed aluminum foil, nasal spray, and eye drop packaging materials as part of the Extractables & Leachables studies arising from interactions between the product and the primary packaging. For the determination and quality control of nitrosamines in sartan group pharmaceutical products and packaging materials, the developed LC-MS/MS analytical method offers highly reliable, fast, high accuracy, good sensitivity and simultaneous detection even at low concentrations.

LITERATURE REVIEW ON DEVELOPMENT OF PROJECT PERFORMANCE AND CHARACTERISTICS IN CONSTRUCTION INDUSTRIES

The construction sector is always looking for efficient project management techniques. The purpose of this literature review is to build a solid project performance by carefully examining the inherent characteristics of construction projects. This review integrates various project elements, such as project scope, risk management, stakeholder engagement, resource allocation, and technological integration, which highlight the multifaceted nature of construction activities. A factual overview of certain key trends and findings from the research literature that relate to the construction sector encounters difficulties in achieving project success. This abstract also states that an in-depth investigation of the project performance is changing in the construction industry and the characteristics that go along with it. The paper investigates the complex relationship between project success criteria and quality assurance, sustainability, stakeholder engagement, risk management, cost control, scheduling, and industry reports and case studies. This paper provides an in- depth analysis of construction project. Keywords: Construction, Project Performance, Characteristics, Stakeholder Dynamics, Technology, Success Criteria, Sustainability, Risk Management.

Quality Assurance in metal additive manufacturing from a design perspective

Quality by design (QbD) is a strategic approach that ensures that quality becomes a built-in feature of processes in production. It presents a systematic approach to process development and quality management. It begins with defining quality objectives and emphasises process understanding and control based on scientific analysis and quality risk management. This study proposes and demonstrates QbD principles to address quality inconsistencies and reliability challenges in the LPBF process, especially for batch production. Our findings indicate that despite recent technological advancements in laser powder bed fusion (LPBF), it still faces challenges with process control and varying quality outcomes in batch productions. Due to these challenges, quality strategies become essential. The QbD principles and Failure Mode and Effect Analysis (FMEA) were applied to identify potential quality failures in LPBF, focusing on the screwdriver bit as a case study. Hardness appeared as one of the critical to quality elements. Low hardness was identified as a critical failure mode that could lead to substrate damage during the application of the screwdriver bits. Powder quality analysis before production and development of parameter selection tool proposed as countermeasures to address these potential defects. Furthermore, this study emphasises the significance of QbD in establishing process control and ensuring consistent quality in batch production in the technology.

Quality and Risk Management in Data Mining: A CRISP-DM Perspective.

The area of data science knowledge responsible for dealing with this new reality is diffuse, including mathematics, statistics, computing, engineering, psychology, and administration, among many other areas that make up a new scenario that is still changing. Different models have emerged over the years to systematize the procedures to be followed. Among them, CRISP-DM (Cross Industry Standard Process for Data Mining) has become one of the most widespread in the industry. However, the lack of detailed instructions means the framework is often incorrectly used. Therefore, this research aims to present a utilitarian and didactic model based on the latest advances in the literature and through the lens of production engineering. In order to achieve this objective, exploratory research was carried out based on a systematic review and subsequent categorization of each of the CRISP-DM steps, detailing the authors’ contributions to each stage. In addition, it is proposed that guidelines from the areas of Quality Management and Risk Management be added to the subject, consolidating a useful and didactic model of relevance.

Sustainable Compliance Programs in Complex Organizations

I identify and test the empirical implications of complexity theory to investigate the effectiveness of the firm’s risk management program in monitoring compliance program activity. I provide a direct link between the quality of Business Regulatory Compliance Unit (which executes and oversees the compliance program implementation) and the overall risk management quality of the firm. I use a multi-method design, incorporating survey questionnaires and econometric multivariate analysis of a sample of European firms. I find a relationship between the risk management exposure of European firms and the quality of their internal control department. I also find a strong relationship between earnings at risk for UK firms and asset-liability at risk for financial firms, but only a weak relationship between cash flow at risk and internal audit quality for European firms. The quality of internal compliance business units is strongly positively related to corporate performance over time.

IMPACT OF CREDIT RISK AND BANK-SPECIFIC FACTORS ON THE FINANCIAL PERFORMANCE OF LICENSED BANKS IN SRI LANKA

The objective of the study is to examine the impact of credit risk and bank-specific factors on the financial performance of licensed banks in Sri Lanka during the period of seven years (2015 - 2021). In the empirical investigation, return on assets and return on equity are used to measure financial performance while non-performing loans and capital adequacy are proxies for credit risk. Cost efficiency, average lending, loan-to-deposit ratio, and bank size are considered bank-specific factors. Seventeen licensed commercial banks and five licensed specialized banks are taken as samples of this study, and data is collected from annual reports of licensed banks in Sri Lanka during the period from 2015 to 2021. Panel data regression analysis is employed to examine the hypotheses. Results of the study revealed that non-performing loans have a negative impact on banks’ financial performance in terms of return on assets of licensed banks whereas average lending has a positive impact on banks’ financial performance in terms of return on assets. Other variables such as capital adequacy, cost efficiency, loan-to-deposit ratio, and bank size have not shown any significant impact on the financial performance of licensed banks. The output of the study may be useful to the bank lending unit’s decision-makers, investors, and economic policymakers of the country. The Banks should seek mechanisms to improve their risk management capacity efficiency and quality lending to remain competitive in the market.

Analytical QBD Approach to Redefine the Quality of Pharmaceuticals: A Review

As per the present scenario traditional techniques of quality by testing of finished pharmaceutical products have proved to be unsatisfactory, although focus on 'Total quality assurance can be attained only by in-process testing and analysis. The Quality by Design (QbD) idea has already been established and applied in all nations that adhere to the International Conference on Harmonization Guidelines. The proposed ICH Guidelines Q8 for pharmaceutical development, Q9 for quality risk management, and Q10 for pharmaceutical quality systems offer a foundation for incorporating quality into the product. Other components are being added and integrated into the analytical method development process, including as Quality Risk Management, the Pharmaceutical Quality System, and Process Analytical Technology (PAT) guidelines. The Quality by Design (QbD) idea has already been established and applied in all nations that adhere to the International Conference on Harmonization Guidelines. The proposed ICH Guidelines Q8 for pharmaceutical development, Q9 for quality risk management, and Q10 for pharmaceutical quality systems offer a foundation for incorporating quality into the product. Other components are being added and integrated into the analytical method development process, including as Quality Risk Management, the Pharmaceutical Quality System, and Process Analytical Technology (PAT) guidelines. They are widely acknowledged in the business as AQbD (Analytical Quality by Design) ideas. This paper attempts to summarize QbD achievements to date, regulatory perspectives on QbD, a comparative examination of conventional and analytical QbD techniques in method development, and issues about its fundamental application. Keywords Quality by Design, Design of Experiments, Analytical Quality, Critical Quality Attributes Analytical Target Profile, Process Control

Stability assessment of immunobiological medicinal products manufacturing for veterinary use with Shewhart control charts

According to the current Rules of Good Manufacturing Practice of the Eurasian Economic Union, the principles of risk management for product quality must be applied to all aspects of the production and use of medicines for medical and veterinary purposes. The recommended quality risk management method used by regulators is the Shewhart Chart. Control charts, proposed in 1924 by W. Shewhart, are a graphical tool for applying statistical principles to process control. Statistical process control is a methodology for establishing and maintaining production at an acceptable and stable level, providing the required product quality. Control charts are used to collect data during the continuous recording of the characteristics of the quality of manufactured products. As a result of continuous analysis of information, control charts help to identify unusual patterns of data variation and take preventive measures to eliminate them and increase process stability. The use of Shewhart maps leads to a more detailed understanding of the process and helps to discover ways for valuable improvements. The purpose of the work is to assess the stability of the production of immunobiological medicinal products for veterinary use using Shewhart's control charts. The immunobiological drug "Oralrabivak" produced at the Schelkovo Biokombinat FKP was used as a model object. We used control charts of individual values (X-chart) and moving ranges (Rm-chart) and maps of mean values (-chart) and sample standard deviations (s-chart). The assessment of the stability of the production of Oralrabivak using Shewhart's control charts showed that during two production cycles (2021 and 2022) the technological process was in a state of statistical controllability. To improve the process and ensure the quality of the finished product, the specialists of the enterprise have taken preventive measures. The methodology of control charts made it possible to visualize and study in detail a new production process for the enterprise for a deeper understanding of its features by the specialists of the enterprise and further improvement.

Controle interno e o Parlamento Estadual: uma análise da controladoria da Assembleia Legislativa do Ceará

This paper analyzes the Comptroller of the Legislative Assembly of Ceará in the light of the evolution of internal control. The area of knowledge on internal control applied to the public sector is thriving, but little is known about the scientific contributions developed in this branch of knowledge in the context of the Legislative Power. It used a documentary and bibliographic analysis of internal control as a methodology, with an approach on the legislation and good practices on the subject. Interviews were conducted with managers of the controllership areas. The joint use of these techniques allows us to characterize this research as a case study. The results express that the Legislative Assembly of Ceará (Alece) was administratively restructured, adapting to good practices and international and national legal proposals in activities and mechanisms aimed at preventive internal control, internal audit, transparency, risk management, integrity, and management quality.

Modelling of soil environmental quality and early warning of integrated ecological risk

The knowledge of dynamic trend in soil heavy metal contamination and associated risk is important for soil pollution prevention, safe utilization and early warning of soil environmental quality and ecological risk. In this study, a modified integrated risk index (NIRI) was adopted to evaluate ecological risk in agricultural soil in Wenzhou with 70 samples, which is located in the southeast of China. In addition, two scenarios with different metal fluxes (optimistic and default scenario) were constructed to predict future dynamic trend of metal concentrations. Results showed the agricultural soil was mainly contaminated by Cd and Pb. The NIRI indicated moderate to considerable risk in most sites and Cd posed the greatest contribution to NIRI value. Besides, higher risk was determined in paddy soil than that in vegetable. Scenario simulation results revealed general declining trend in optimistic scenario while increasing trend in default scenario for metal concentration. However, exceedance varied with prediction period, soil types and metals. Ecological risk probability showed similar trend with metal concentration, indicating significant shift to higher risk level in default scenario while insignificant decrease in optimistic scenario. The proposed scenario simulation results provide reference to support soil quality improvement and risk management.