Safety Certification Research Articles

Andromeda: A model-connected framework for safety assessment and assurance

Safety is a key factor in the development of critical systems, encompassing both conventional types, such as aircraft, and modern technologies, such as autonomous vehicles. Failures during their operation can be potentially far-reaching and impact people and the environment. To certify these systems and enable their employment, regulatory bodies require, among others, a safety case. However, the growing complexity of modern systems and iterative nature of development pose significant challenges to the traditional approaches for creating safety cases that are still used in practice. Furthermore, safety cases are often generated in an ad-hoc manner and remain disconnected from system models and related artifacts. Without these connections it is difficult to construct the proper infrastructure for producing and maintaining safety cases in a structured manner throughout the system lifecycle. This paper presents our innovative method, Andromeda, and its underpinning metamodel, which establish connections between safety cases, system models, safety assessment activities aligned with international safety standards, and argument patterns. Automation is applied across various stages of the production of argument structures that support safety assurance and certification activities. Andromeda is complemented by tool-support designed to facilitate its application, and we demonstrate our work through a case study from the aviation industry.

Food Safety and Halal Certification Seminar Towards Mandatory Halal Food in October 2024

Food safety and halal certification are important aspects of the food industry in Indonesia, especially ahead of the mandatory halal certification in October 2024. This seminar aims to increase the understanding of food business actors about the importance of producing safe and halal food, as well as providing information about the process and requirements of halal certification. The methods used are seminars and interactive discussions organized by the collegiate association of Senior High School 2 Kediri (Ikasmada) on March 30, 2024. This seminar was attended by 39 collegiate who have businesses in the food sector and other. The results of the seminar showed an increase in participants' understanding of food safety regulations, the process of applying for a home industry product distribution permit, and self-declare halal certification. Interactive discussions generated questions about halal certification regulators, technical applications for home industry product distribution permit and halal certification, and suggestions for programs related to micro small business and food safety. In conclusion, this seminar is useful in providing insight and motivating food businesses actors to take care of licensing and halal certification to support government programs towards mandatory halal food in October 2024.

Food Safety Management System (FSMS): An Analysis of Restaurant Certificate Schemes in Malaysia

Customers of restaurants encounter some degree of uncertainty or risk due to their inability to evaluate the food or service qualities received before or after meal consumption. The Food Safety Management System (FSMS) certification schemes are intended to reduce the incidence of foodborne illnesses in Malaysia and to be used as a communication instrument to address the issue of information asymmetry. This investigation investigates the diverse FSMS certification programs that are accessible to food establishments, with a particular emphasis on restaurant operations in Malaysia. The study is dedicated to the identification of the concept of various FSMS certificate schemes that are designed and implemented in Malaysian restaurant operations. It also discusses the fundamental concept of the role differences of each FSMS certificate scheme that is obtained by numerous restaurant operations in Malaysia to communicate with potential customers. A content analysis was conducted on ten independent Malaysian-owned restaurants that had obtained and disclosed their FSMS certifications online (i.e., through their official website or social media account) to the public. All participating restaurant premises believe food safety certification through appropriate authorities is crucial, particularly in the context of the provision of information regarding sanitation, safety, and nutrition to guarantee high food quality standards and service delivery. FSMS eliminates the knowledge asymmetry between producers and consumers and demonstrates that a certified party adheres to a recognised standard. This investigation suggested that the Food Safety Management System (FSMS) should function as more than merely a mechanism for guaranteeing the safety and quality of food for consumers. It contributes to the establishment of client trust and confidence in the restaurant and improves the image of food businesses.

Impact of Transgenic Maize Ruifeng125 on Diversity and Dynamics of Bacterial Community in Rhizosphere Soil.

With the development of commercialized planting of genetically modified crops, their ecological security risks remain a key topic of public concern. Insect-resistant genetically modified maize, Ruifeng125, which expresses a fusion Bt protein (Cry1Ab-Cry2Aj), has obtained the application safety certificate issued by the Chinese government. To determine the effects of Ruifeng125 on the diversity and dynamics of bacterial communities, the accumulation and degradation pattern of the fusion Bt protein in the rhizosphere soil of transgenic maize were detected. Results showed that the contents of Bt protein varied significantly at different developmental stages, but after straw was returned to the field, over 97% of Bt proteins were degraded quickly at the early stages (≤10 d) and then they were degraded at a relatively slow rate. In addition, the variations in bacterial community diversity in the rhizosphere soil were detected by 16S ribosomal RNA (Rrna) high-throughput sequencing technology. A total of 44 phyla, 435 families, and 842 genera were obtained by 16S rRNA sequencing, among which Proteobacteria, Actinobacia, Acidobacter Acidobacterium, and Chloroflexi were the dominant taxa. At the same developmental stage, no significant differences in soil bacterial diversity were detected between Ruifeng125 and its non-transgenic control variety. Further analysis revealed that developmental stage, rather than the transgenic event, made the greatest contribution to the changes in soil microbial diversity. This research provides important information for evaluating the impacts of Bt crops on the soil microbiome and establishes a theoretical foundation for their environmental safety assessment.

Are female directors more employee-friendly? Board gender diversity and employee benefits: evidence from China.

The imperative of gender diversity in corporate governance and the adoption of a human-centric governance paradigm are intensifying globally. The structure of board directors, key influencers to corporate decisions, notably shape policies, crucially in emerging markets like China where gender issues are still evolving. Therefore, employing a penal dataset comprising 8,973 firm-year observations from publicly A-share-listed Chinese firms spanning 2006 to 2021, this study empirically examines the impact of board gender diversity on the responsiveness to both employee monetary incentives and non-monetary rewards. The findings unveil a positive correlation, indicating an augmentation in per-employee compensation and an increased likelihood of implementing non-monetary programs, including stock-ownership plans, retirement benefits, and occupational safety certification, in the presence of higher board gender diversity. Notably, these positive associations are more accentuated in state-owned firms, as well as those with lower executive compensation and diminished institutional ownership. Our results remain consistent after considering robustness as well as endogeneity. This empirical evidence not only contributes robust statistical support to the ongoing global initiatives advocating for gender diversity in corporate governance but also underscores the efficacy of boards of directors in effectively managing stakeholder interests, particularly in fostering employee-friendly practices within emerging markets like China.

The method of determining design assumptions for bogie platform

This article is devoted to the methods of designing running gear in compliance with recently changed requirements, regulations of rail authorities, technical specification for interoperability, and safety certification. Changes are focused on the certification process. According to ERA these changes are recommended for bogies holding IC certificate issued according to the former TSI WAG, without assessment of the strength of the bogie frame. The presented methods allow designing a bogie platform with a wide range of applications in regional, and long-distance trains. Issues related to calculations, and studies of bogie frames are described. Particular attention is paid to methods for determining loads applied to the bogie frame based on assumed axle loads, determining reference forces for the projected shock absorbers, and compiling computational cases for strength analysis of traction units.

Analysis of thermal cycles during DED-Arc of high-strength low-alloy steel and microstructural evolution

Additive manufacturing (AM), specifically Directed Energy Deposition (DED)-Arc, holds great potential for the fabrication of individually designed components. In the construction industry, the demand for tailored steel nodes is increasing, particularly for large-scale structures, where high-strength steel deployment can significantly reduce material consumption and production time. However, the thermal material deposition process has a strong impact on the technical properties of high-strength steel. Parameters like heat input, interpass temperature (IPT), and cooling strategies modulate cooling times and peak temperatures in thermal cycles, which are crucial for estimating mechanical properties indispensable for safety certification. The development of digital twins or digital shadows emerges as the primary approach for quality assurance and certification, deploying real-time monitoring of manufacturing parameters such as voltage, current, wire feed, thermal history, and bead shapes. This data can be correlated with specific regions in the fabricated part to draw quality inferences. To interpret this data effectively, an understanding of the influence of these process parameters on resultant properties is indispensable. Given that the resulting microstructure strongly depends on the thermal history in AM parts, temperature monitoring during DED-Arc using thermography emerges as a promising method. This article aims at providing fundamental knowledge about phase transformations of a high strength steel feedstock under repeated reheating and gaining comprehensive knowledge about microstructural evolution during DED-Arc Additive Manufacturing. This is done by the analysis of time-temperature profiles, resulting microstructure and mechanical properties, linking it to CCT diagrams. A novel approach for describing the degree of tempering in different regions of the samples by deploying tempering parameters for anisothermal heat treatments is presented. By using this approach, an estimation about the resulting microstructure and hence the mechanical properties can be drawn.

Numerical simulation of aircraft lightning attachment zone using the enclosing ball method

The initial stage in aircraft lightning protection design and safety certification involves delineating the lightning attachment zone. The lightning leader’s development is inherently random, favoring the shortest path to the aircraft fuselage. In response, we employ the enclosing ball method to establish the lightning attachment zone. First, define the center point of the aircraft as the coordinate position for the sphere’s center, creating a sphere with a specified radius. The leader’s initial position is then selected from any point on the sphere. Second, by calculating distances between the leader’s position and various areas on the aircraft surface, we determine the shortest path. The corresponding aircraft surface area along this path is identified as the lightning attachment zone for the leader. Subsequently, choose a new leading position on the sphere and iterate through the calculation process until all sphere positions are considered. Finally, tally the occurrence frequencies for all calculated attachment areas, representing the attachment probability of each area based on its frequency of occurrence. This paper not only compares our method with the electrostatic field simulation method but also contrasts it with the probability distribution of lightning attachment points obtained from aircraft flight experiments. The comparison results are highly favorable, providing robust verification for the correctness of our approach.

Experience in voluntary certification of quality and safety of medical activities of a multidisciplinary medical organization

The article presents the experience of obtaining a certificate of quality and safety of medical activities. The stages of implementation of this project and the basic requirements for documentation are presented. The author also provides recommendations on the implementation of the project for the heads of medical organizations.

Probabilistic reach-avoid for Bayesian neural networks

Model-based reinforcement learning seeks to simultaneously learn the dynamics of an unknown stochastic environment and synthesise an optimal policy for acting in it. Ensuring the safety and robustness of sequential decisions made through a policy in such an environment is a key challenge for policies intended for safety-critical scenarios. In this work, we investigate two complementary problems: first, computing reach-avoid probabilities for iterative predictions made with dynamical models, with dynamics described by Bayesian neural network (BNN); second, synthesising control policies that are optimal with respect to a given reach-avoid specification (reaching a “target” state, while avoiding a set of “unsafe” states) and a learned BNN model. Our solution leverages interval propagation and backward recursion techniques to compute lower bounds for the probability that a policy's sequence of actions leads to satisfying the reach-avoid specification. Such computed lower bounds provide safety certification for the given policy and BNN model. We then introduce control synthesis algorithms to derive policies maximizing said lower bounds on the safety probability. We demonstrate the effectiveness of our method on a series of control benchmarks characterized by learned BNN dynamics models. On our most challenging benchmark, compared to purely data-driven policies the optimal synthesis algorithm is able to provide more than a four-fold increase in the number of certifiable states and more than a three-fold increase in the average guaranteed reach-avoid probability.

Testing the moderated mediation effect of recreation safety climate on the interrelationship of serious leisure, recreation involvement, and flow experience

Recreational safety is critical to the growth of outdoor recreation and adventure tourism. Using a signaling-theory framework, this study investigates the possible moderated mediation effect of recreation safety climate (RSC) on the interrelationship of serious leisure, recreation involvement, and flow experience. The results of a survey of 353 recreational scuba divers at a popular diving site in Kenting, southern Taiwan showed that recreation involvement mediated the relationship between serious leisure and flow experience. We further found that RSC significantly and positively moderated a serious leisure - > recreation involvement - > flow experience model: i.e., that recreation involvement played a strong role as a mediator between serious leisure and flow experience because RSC was high. As well as highlighting the importance of RSC, this study contributes to the body of knowledge on recreational safety, and provides recreation operators with guidelines for RSC implementation. Management implicationsSpecifically, low recreation safety climate signals tend to reduce the power of recreation involvement as a mediator. Accordingly, operations and management units should actively seek to establish safe climate signals and culture, and promote the safety certification of recreational areas, to facilitate serious recreationists’ identification of safe sites and thereby enhance their recreational benefits.

Effects of Trigger Method on Fire Propagation during the Thermal Runaway Process in Li-ion Batteries

Abstract Lithium-ion batteries are prone to fire hazards due to the possibility of thermal runaway propagation. During battery product development and subsequent safety tests for design validation and safety certification, the thermal runaway onset is triggered by various test methods such as nail penetration, thermal ramp, or external short circuit. This failure initiation method affects the amount of heat contributions and the composition of gas generations. This study compares two such trigger methods, external heating and using a thermally-activated internal short circuit device (ISCD). The effects of the trigger method on total heat generation are experimentally investigated within 18650 cylindrical cells at single cell level as well as at multiple cell configuration level. The severity of failure was observed to be worse for cells with ISCDs at single cell level, whereas quite the opposite results were observed at multiple cell configuration level. A preliminary numerical analysis was performed to better understand the battery safety performance with respect to thermal runaway trigger methods and heat transfer conditions.

How trustful are food safety control measures – insight into their validation

PurposeThe main purpose of this paper was to evaluate the validation process of food safety control measures.Design/methodology/approachThe validation of control measures has been analyzed at 50 food companies in Serbia. The sample included companies that produce food of both plant and animal origin and have certified food safety management systems. A total of 156 control measures that combat physical hazards (41.6%), followed by microbial hazards (34.0%) and chemical hazards (24.4%), have been analyzed. To enable quantification of the validation protocols, each control measure was assigned a score.FindingsThe validation scores showed that the highest level of validation was observed in large companies, as opposed to small and medium-sized companies (p < 0.05). The type of food safety hazards and the food sector did not reveal any statistical differences in-between the scores. The main approach to validating control measures was referring to the technical documentation of equipment used (52.6%), followed by scientific and legal requirements (30.7%). Less than 20% of the analyzed control measures were validated with operational data collected on-site. No mathematical modeling was observed for the sampled food companies. Future steps should include the development of validation guides for different types of control measures and training modules.Practical implicationsThis study can serve as an improvement guide for food safety consultants, food safety auditors, certification bodies, inspection services, food technologists and food managers.Originality/valueThis study is one of the first to provide an insight into how food companies validate their control measures to combat microbial, chemical and physical food safety hazards.

Supervising in the Implementation of Integrated Pest Management (IPM) in good Horticultural Practices in the Sembalun agrotourism area

The use of natural enemies as pest control has long been known, but has been largely replaced by the rapid development of chemical pesticide industry technology, especially since the green revolution. One alternative pest control technology that is quite promising to be developed is the use of biological agents (predators or parasotoids) that have more natural characteristics than chemical characteristics. With the presence of natural enemies which are then used to suppress pest populations, it will be safe for human health and the environment. It can be hoped that the agricultural products produced will be acceptable and highly competitive on the global market. Considering the Sembalun area as a tourism destination, it will be very relevant if the local community understands good horticultural practices. The intervention of using technology for farmers as an alternative in good Horticultural Cultivation is highly expected by farmers in the Sembalun area. Therefore, assistance is needed to implement integrated Pest Management in good Horticultural practices. The method used in this activity is the Action Research Method by applying a Participatory Action Program approach from participants through discussion and group work in all activities. The result is that farmers are very interested in implementing good horticultural cultivation, especially with habitat management approaches such as using refugia plants to control pests. Participating farmers increase their knowledge and skills to recognize differences in pests and natural enemies (predators and parasitoids) found on potato plants that are integrated with refugia plants. The target group has increased knowledge and understanding of the importance of implementing Integrated Pest Management (IPM) practices in horticultural cultivation. It is hoped that training and assistance activities for healthy horticultural cultivation efforts will continue both by the university team and related agencies. This kind of activity needs to be continued by the participating group and spread to other groups nearby. There is a need for assistance in applying for Prima 3 and Prima 2 food safety certification to farmer groups in the Sembalun Agrotourism Area, so that the number of products from certified horticultural business actors will increase. Activities to implement Integrated Pest Management in horticultural farming business groups in the Sembalun Tourism Area need to continue

Safe Reinforcement Learning via a Model-Free Safety Certifier.

This article presents a data-driven safe reinforcement learning (RL) algorithm for discrete-time nonlinear systems. A data-driven safety certifier is designed to intervene with the actions of the RL agent to ensure both safety and stability of its actions. This is in sharp contrast to existing model-based safety certifiers that can result in convergence to an undesired equilibrium point or conservative interventions that jeopardize the performance of the RL agent. To this end, the proposed method directly learns a robust safety certifier while completely bypassing the identification of the system model. The nonlinear system is modeled using linear parameter varying (LPV) systems with polytopic disturbances. To prevent the requirement for learning an explicit model of the LPV system, data-based λ -contractivity conditions are first provided for the closed-loop system to enforce robust invariance of a prespecified polyhedral safe set and the system's asymptotic stability. These conditions are then leveraged to directly learn a robust data-based gain-scheduling controller by solving a convex program. A significant advantage of the proposed direct safe learning over model-based certifiers is that it completely resolves conflicts between safety and stability requirements while assuring convergence to the desired equilibrium point. Data-based safety certification conditions are then provided using Minkowski functions. They are then used to seemingly integrate the learned backup safe gain-scheduling controller with the RL controller. Finally, we provide a simulation example to verify the effectiveness of the proposed approach.

GMO와 Non-GMO 라벨에 따른 소비자의 지각된 혜택이 신뢰 및 구매 의도에 미치는 영향

In recent years, there has been an emphasis on food safety and sustainability. As a result, plant-based alternative meats have gained traction in the food industry as a sustainable source of protein. This study analyzed differences in consumer perceived benefits by categorizing types of plant-based meat currently in the spotlight as unlabeled, GMO, and Non-GMO, and by examining differences in perceived benefits with the presence or absence of a HACCP label. Additionally, this study explores the relationship between perceived benefits, trust, and purchase intention. The analysis results show that consumers perceive greater environmental and health benefits in the order of Non-GMO, unlabeled, and GMO. The moderating effect of food safety certification was found to be insignificant. The perceived environmental and health benefits of plant-based meat have a significant impact on both trust and purchase intention. This study expands upon existing literature by analyzing the implementation of plant-based meat in the food service industry and evaluating consumer attitudes towards its environmental and health benefits.

Consumers preferences food safety perceptions for beef – a cross-country comparison in the wake of COVID-19

Food safety is a pressing global concern, particularly in developing and emerging economies. The recent COVID-19 pandemic has further heightened consumer attention towards food safety, quality, and maintaining a healthy diet. This study provides insights into consumer awareness and perceptions related to food safety and the origin of beef products, with a specific focus on the impact of COVID-19. It draws comparisons between emerging economies, specifically Albania and Kosovo, where significant food safety challenges exist, and a highly developed economy, Austria. To assess consumer preferences, a discrete choice experiment was conducted, aiming to gauge the significance of various product attributes and consumers’ willingness to pay (WTP) for specific product features. The study’s findings revealed a strikingly strong sense of consumer patriotism across all surveyed countries. WTP estimates indicated a clear preference for domestically sourced food over imported alternatives. While the COVID-19 pandemic exerted a notable influence, its effects were generally contained. However, respondents from emerging economies perceived the pandemic’s impact to be more severe. Additionally, factors such as risk perception and risk acceptance played a role in shaping the importance of relevant product attributes in all the food markets examined in this study. Furthermore, distinct variations emerged between the countries concerning the importance of food safety standards. For instance, in Albania, the European Union (EU) food safety certificate holds higher utility compared to the national certificate, suggesting a potential lack of trust in national agencies. Notably, low trust in institutions, including those related to food safety, is a common issue in emerging and developing economies. This lack of trust, in turn, influences consumers’ perceptions of personal food safety, given that it is a credence attribute.

A processing-type active real-time traceable certification system

In addition to substituting low-price and low-quality materials for high-quality materials at the food processing stage, many dishonest businesses risk adulterating chemical materials in products to reduce production costs or increase product flavor with chemical synthesis spices. As a result, the risks to food safety are increased. Most safety management and certification regulations proceed with on-site examination or sampling inspection. As current certification systems lack complete tracking and real-time certification processes, they cannot comprehensively check foods’ processing and production processes and contents. Hence, food safety problems sway consumers’ trust and confidence in certification systems. This study intends to improve the agricultural processing end’s current food traceability certification system. Adding the design of raw material total quantity control provides a complete and sound real-time certification mechanism for citizens and businesses to assure consumer rights.

Enhancing Patient Safety in Spain: Streamlining Adverse Event Detection in Occupational Healthcare Records

Background: Given the lack of previous studies on adverse events (AEs) in the area of occupational healthcare in Spain, it is very important to begin to understand this phenomenon in order to act on it. The objective was to accurately quantify AE occurring in occupational healthcare in MC Mutual during May 2021. Methods: We conducted a review of a representative random sample of 250 clinical records to identify AEs through an active search audit, focused on the frequency, type, severity, and preventability of these events, categorized using standardized scales. Results: We detected seven AEs in the sample of clinical records, representing 3% AEs per clinical record, while in the APEAS Spanish Study, they were detected in 10% of patients. The most frequent AE type was postoperative, followed by medication and diagnostic delay. The AEs were of intermediate severity and high severity and with a variable degree of being preventable. Conclusions: The detection of AEs has been useful in the development of projects and action plans such as specific training courses, safety patient newsletters, ambulatory risk maps, and treatment plans framed in the official certification of patient safety. These results should be evaluated in other companies similar to MC Mutual.

Securing Pacemakers using Runtime Monitors over Physiological Signals

Wearable and implantable medical devices (IMDs) are increasingly deployed to diagnose, monitor, and provide therapy for critical medical conditions. Such medical devices are safety-critical cyber-physical systems (CPSs). These systems support wireless features introducing potential security vulnerabilities. Although these devices undergo rigorous safety certification processes, runtime security attacks are inevitable. Based on published literature, IMDs such as pacemakers and insulin infusion systems can be remotely controlled to inject deadly electric shocks and excess insulin, posing a threat to a patient’s life. While prior works based on formal methods have been proposed to detect potential attack vectors using different forms of static analysis, these have limitations in preventing attacks at runtime. This paper discusses a formal framework for detecting cyber-physical attacks on a pacemaker by monitoring its security policies at runtime. We propose a wearable device that senses the Electrocardiogram (ECG) and Photoplethysmogram (PPG) of the body to detect attacks in a pacemaker. To facilitate the design of this device, we map the security policies of a pacemaker w.r.t ECG and PPG, paving the way for designing formal verification monitors for pacemakers for the first time using multiple physiological signals. The proposed monitoring framework allows the synthesis of parallel monitors from a given set of desired security policies, where all the monitors execute concurrently and generate an alarm to the user in the case of policy violation. Our implementation and the performance evaluation results demonstrate the technical feasibility of designing such a wearable device for attack detection in pacemakers. This device is separate from the pacemaker, ensuring no need for re-certification of pacemakers. Our approach is amenable to the application of security patches when new attack vectors are detected, making the approach ideal for runtime monitoring of medical CPSs.