Audits and inspections are never enough: a critique to enhance food safety

Internal and external food safety audits are conducted to assess the safety and quality of food including on-farm production, manufacturing practices, sanitation, and hygiene. Some auditors are direct stakeholders that are employed by food establishments to conduct internal audits, while other auditors may represent the interests of a second party purchaser or a third-party auditing agency. Some buyers conduct their own audits or additional testing, while some buyers trust the results of third-party audits or inspections. Third-party auditors, however, use various food safety audit standards and most do not have a vested interest in the products being sold. Audits are conducted under a proprietary standard, while food safety inspections are generally conducted within a legal framework. There have been many foodborne illness outbreaks linked to food processors that have passed third-party audits and inspections, raising questions about the utility of both. Supporters argue third-party audits are a way to ensure food safety in an era of dwindling economic resources. Critics contend that while external audits and inspections can be a valuable tool to help ensure safe food, such activities represent only a snapshot in time. This paper identifies limitations of food safety inspections and audits and provides recommendations for strengthening the system, based on developing a strong food safety culture, including risk-based verification steps, throughout the food safety system

A BIM-based PSS approach for the management of maintenance operations of building equipment

The service-centered economy has grown considerably in the last few years, shifting from product-based solutions towards service centered offerings, i.e., Product-Service System (PSS) solutions. Such an approach is also emerging in the context of building equipment, where maintenance activities play a fundamental role in facility management. In this field, Building Information Modeling (BIM) based tools are diffusely used to improve the performances of facility management. However, few studies have addressed the above issues while considering a shift from product-based approaches in favor of more advanced servitization models. The study aims at integrating BIM based approaches in a PSS context for the improvement of the management of maintenance operations of building equipment. A general framework for maintenance management has been developed, merging the implementation of the PSS components in a BIM model for the definition of maintenance management. A first application of this methodology to a real case study concerning the elevators of an existing building has shown the efficacy of the proposed approach. The study highlighted the benefits that can be achieved, especially in terms of reduced periods of equipment unavailability, reduced costs and augmented customer satisfaction, while enhancing the information exchange between the PSS actors. Hence, although further research is still needed for its validation, the proposed approach can offer practical insights for the development of promising BIM-based PSS solutions for facility management in the construction industry

The South African Medicines Control Council: Comparison of Its Registration Process With Australia, Canada, Singapore, and Switzerland

© 2019 Keyter, Salek, Banoo and Walker.Introduction: Comparisons between regulatory authorities of similar size and regulatory characteristics facilitate value-added benchmarking and provide insight into regulatory performance. Such comparisons highlight areas for improvement as authorities move toward achieving their regulatory goals and stakeholders’ demands. The aims of this study were to compare the registration process and the regulatory review model of the South African Medicines Control Council (MCC) to that of four other similar-sized regulatory authorities and to identify areas for improvement that may inform recommendations to the South African Health Products Regulatory Authority (SAHPRA) as it looks to re-engineer and enhance the registration process in South Africa. Methods: A questionnaire describing the organisational structure, the registration process, good review and decision-making practices of the MCC was completed by the author (AK) for the purpose of this study and validated by the Registrar of the MCC. Similar questionnaires were also completed and validated by Australia’s Therapeutic Goods Administration (TGA), Canada’s Health Canada, Singapore’s Health Science Authority (HSA) and Switzerland’s Swissmedic. Results: A comparison of the MCC regulatory process with the four comparative agencies indicated that they all have similar requirements and employ a full-review model although the timelines for the MCC were considerably longer. However, similar quality measures were implemented by all authorities as part of their good review practices (GRevP) including prioritising transparency, communication, continuous improvement initiatives and training. Conclusion: Comparisons made through this study provided insight into the areas of the MCC registration process that may be improved and have informed recommendations to SAHPRA including the implementation of facilitated regulatory pathways, definition of targets for key milestones in regulatory review and formal implementation and monitoring of GRevP. In order to build quality into the review process the application of a standardised template for the clinical assessment of medicines such as the Universal Methodology for Benefit-Risk Assessment (UMBRA) could be considered as well as enhancing transparency and communication through the application of an electronic management system and the development of publicly available summaries for the basis of approval.Peer reviewedFinal Published versio

Slush Hydrogen (SLH2) technology development for application to the National Aerospace Plane (NASP)

The National Aerospace Plane (NASP) program is giving us the opportunity to reach new unique answers in a number of engineering categories. The answers are considered enhancing technology or enabling technology. Airframe materials and densified propellants are examples of enabling technology. The National Aeronautics and Space Administration's Lewis Research Center has the task of providing the technology data which will be used as the basis to decide if slush hydrogen (SLH2) will be the fuel of choice for the NASP. The objectives of this NASA Lewis program are: (1) to provide, where possible, verified numerical models of fluid production, storage, transfer, and feed systems, and (2) to provide verified design criteria for other engineered aspects of SLH2 systems germane to a NASP. This program is a multiyear multimillion dollar effort. The present pursuit of the above listed objectives is multidimensional, covers a range of problem areas, works these to different levels of depth, and takes advantage of the resources available in private industry, academia, and the U.S. Government. The NASA Lewis overall program plan is summarized. The initial implementation of the plan will be unfolded and the present level of efforts in each of the resource areas will be discussed. Results already in hand will be pointed out. A description of additionally planned near-term experimental and analytical work is described

A fuzzy-QFD approach for the enhancement of work equipment safety: a case study in the agriculture sector

The paper proposes a design for safety methodology based on the use of the Quality Function Deployment (QFD) method, focusing on the need to identify and analyse risks related to a working task in an effective manner, i.e. considering the specific work activities related to such a task. To reduce the drawbacks of subjectivity while augmenting the consistency of judgements, the QFD was augmented by both the Delphi method and the fuzzy logic approach. To verify such an approach, it was implemented through a case study in the agricultural sector. While the proposed approach needs to be validated through further studies in different contexts, its positive results in performing hazard analysis and risk assessment in a comprehensive and thorough manner can contribute practically to the scientific knowledge on the application of QFD in design for safety activities

Developing a distributed electronic health-record store for India

The DIGHT project is addressing the problem of building a scalable and highly available information store for the Electronic Health Records (EHRs) of the over one billion citizens of India

Stronger Partnerships for Safer Food: An Agenda for Strengthening State and Local Roles in the Nation's Food Safety System

Examines federal, state, and local agencies' responsibilities, strengths, and weaknesses in ensuring food safety. Recommends systemwide reforms to enhance state and local roles and improve surveillance, outbreak response, and regulation and inspection

THE FDA'S FOOD SAFETY MODERNIZATION ACT AND ITS ECONOMIC IMPLICATIONS

The 111th Congress, Resource /Energy Economics and Policy, Q18,