A systemic methodology for risk management in healthcare sector

Cagliano, Anna Corinna; Grimaldi, Sabrina; Rafele, Carlo

doi:10.1016/j.ssci.2011.01.006

Cited by 101 publications

(94 citation statements)

References 36 publications

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“…Efforts specifically focused on standardizing aspects of health care delivery also have been shown to reduce errors (177). In addition, studies have demonstrated potential benefits for patient safety from time management (3), risk management (13), and remediation, i.e., disclosure (40) and apology (60). The literature also highlights common conditions that contribute to the inability of hospitals to reduce errors, such as health care worker stress and burnout (173) and the practice of work-arounds (55).…”

Section: Coordinating At Care Transitions and Across Interdependent Fmentioning

confidence: 99%

Reducing Hospital Errors: Interventions that Build Safety Culture

Singer¹,

Vogus

2013

Annu. Rev. Public Health

153

145

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Hospital errors are a seemingly intractable problem and continuing threat to public health. Errors resist intervention because too often the interventions deployed fail to address the fundamental source of errors: weak organizational safety culture. This review applies and extends a theoretical model of safety culture that suggests it is a function of interrelated processes of enabling, enacting, and elaborating that can reduce hospital errors over time. In this model, enabling activities help shape perceptions of safety climate, which promotes enactment of safety culture. We then classify a broad array of interventions as enabling, enacting, or elaborating a culture of safety. Our analysis, which is intended to guide future attempts to both study and more effectively create and sustain a safety culture, emphasizes that isolated interventions are unlikely to reduce the underlying causes of hospital errors. Instead, reducing errors requires systemic interventions that address the interrelated processes of safety culture in a balanced manner.

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Section: Coordinating At Care Transitions and Across Interdependent Fmentioning

confidence: 99%

Reducing Hospital Errors: Interventions that Build Safety Culture

Singer¹,

Vogus

2013

Annu. Rev. Public Health

153

145

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“…Lindholm and Host (2009) identified risks using controlled experiments for procurement of medical product. Cagliano et al (2011) used risk breakdown structure to identify risk sources. This paper identifies the risks involved in MPD process through the expertise of development team members.…”

Section: Medical Product Development Phases and Risk Managementmentioning

confidence: 99%

Risk management in medical product development process using traditional FMEA and fuzzy linguistic approach: a case study

Kirkire¹,

Rane²,

Jadhav

2015

J Ind Eng Int

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Medical product development (MPD) process is highly multidisciplinary in nature, which increases the complexity and the associated risks. Managing the risks during MPD process is very crucial. The objective of this research is to explore risks during MPD in a dental product manufacturing company and propose a model for risk mitigation during MPD process to minimize failure events. A case study approach is employed. The existing MPD process is mapped with five phases of the customized phase gate process. The activities during each phase of development and risks associated with each activity are identified and categorized based on the source of occurrence. The risks are analyzed using traditional Failure mode and effect analysis (FMEA) and fuzzy FMEA. The results of two methods when compared show that fuzzy approach avoids the duplication of RPNs and helps more to convert cognition of experts into information to get values of risk factors. The critical, moderate, low level and negligible risks are identified based on criticality; risk treatments and mitigation model are proposed. During initial phases of MPD, the risks are less severe, but as the process progresses the severity of risks goes on increasing. The MPD process should be critically designed and simulated to minimize the number of risk events and their severity. To successfully develop the products/devices within the manufacturing companies, the process risk management is very essential. A systematic approach to manage risks during MPD process will lead to the development of medical products with expected quality and reliability. This is the first research of its kind having focus on MPD process risks and its management. The methodology adopted in this paper will help the developers, managers and researchers to have a competitive edge over the other companies by managing the risks during the development process.

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“…A new methodology that combines principles, tools and practices from CRM and HLM could be a solution to facing multiple challenges. As Cagliano et al (2011) claim, the complexity of healthcare requires the adoption of tools coming from different managerial approaches; the development of FMEA and wastes tables suggests the possibility to integrate, at least at tools level, HLM and CRM. Connections between the two approaches have been demonstrated (Cagliano et al, 2011), even if a synergic methodology has been never developed (Crema and Verbano, 2013).…”

Section: Tools and Practicesmentioning

confidence: 99%