Developing effective risk assessment criteria in regulated environments

Richter, Sascha; Sereseanu, Alexandru

doi:10.1109/idaacs.2015.7341369

Cited by 2 publications

(2 citation statements)

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“…Such internationally obligatory criteria could help improving the safety of the AP. Quantitative risk acceptance criteria for medical devices are defined in each company based on organizational policies [102]. No risk acceptance criteria were applied here, though the RPN indicates the more critical faults.…”

Section: Risk Acceptance Criteriamentioning

confidence: 99%

Risk analysis for the design of a safe artificial pancreas control system

et al. 2018

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Closed-loop glucose control has the potential to improve the glycemic control in patients with diabetes mellitus type 1. Such an artificial pancreas (AP) should keep the user safe despite all disturbances and faults. The objective of this paper is to analyze those perturbations according to their effects on the glycemic status, and thereby supporting an informed design process of the control system. As suggested by the international standard ISO 14971 for risk management of medical devices, the well proven failure modes and effects analysis (FMEA) was chosen as instrument. An FMEA scheme was modified for this purpose and applied to a single-hormone system with subcutaneous and intraperitoneal routes for glucose sensing and insulin administration. Faults that imply urgent danger and thus require fast detection and diagnosis were identified and distinguished from disturbances that can be sufficiently addressed by basic control functions, e.g. by adaptive control algorithms. Requirements and testing criteria for basic control functions as well as fault detection and diagnosis functions can be derived from the provided overview.Safety is the primary requirement on a control system that doses insulin to regulate the blood glucose level (BGL) in diabetes mellitus type 1 (DM1). People with DM1 have an insufficient pancreatic insulin production and depend on lifelong insulin administration to avoid hyperglycemia. The chronically elevated BGL would otherwise lead to several long-term complications. Hypoglycemia caused by overdosing of insulin, on the other hand, may lead to unconsciousness and death in the F.

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Section: Risk Acceptance Criteriamentioning

confidence: 99%

Risk analysis for the design of a safe artificial pancreas control system

et al. 2018

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“…Employee involvement-Strategic level-management involvement in risk management [83,84], Tactical level-involvement of managers and coordinators [85,86], Operational level-operators' involvement [87,88];…”

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confidence: 99%

Risk-Based Approach in the Implementation of Integrated Management Systems: A Systematic Literature Review

2023

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The risk-based approach is one of the keys used in the implementation of management systems using requirements from the management standards. If the management systems are implemented separately, the risks are evaluated from only one perspective, but when two or more systems are integrated, the approach must take into account the synergetic effects of the risks due to system integration. The paper aims to highlight the specific risks encountered when implementing management systems in organizations, underlining the risks associated with systems management and integrated management systems. In this work, a synthesis was presented including an analysis of the risks that occurred during the implementation of management systems and those that occurred during their integration, the need and opportunity of risk management, the advantages, and barriers in the approach of risk management in the industrial sector. The review of the literature comprises the assessment of 190 papers, 11 books, and 5 standards. The content of the paper highlights a synthesis of risk-based thinking and the risks that can manifest in the implementation of quality, environmental, and occupational safety and health management systems in industrial organizations, as well as those which can manifest in the implementation of integrated management systems. In addition, the benefits and barriers in risk management and risk management strategies, with an emphasis on the presentation of the Deming approach to risk management, were evidenced. Some recommendations and proposals for future research were made.

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Developing effective risk assessment criteria in regulated environments

Cited by 2 publications

References 1 publication

Risk analysis for the design of a safe artificial pancreas control system

Risk analysis for the design of a safe artificial pancreas control system

Risk-Based Approach in the Implementation of Integrated Management Systems: A Systematic Literature Review

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