Verification of the Effectiveness of Risk Management in the Medical Device Industry

Riess, Armin; Lepmets, Marion; McKechnie, Sharon P.; Walker, Alastair

doi:10.1007/978-3-319-97925-0_31

Cited by 1 publication

(1 citation statement)

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“…Verification capability encompasses various aspects, including software, hardware, documentation, rules, and regulations, which are essential for ensuring compliance with organizational requirements and keeping the final product on track. In the industrial sector, the verification process typically begins with assessing a firm's system capabilities [71]. Relevant agencies provide access to experts or recognized laboratories in the field who can assist in developing a firm's verification capability to ensure compliance with regulations such as RoHS.…”

Section: Verification Capabilitymentioning

confidence: 99%

Enablers for Adopting Restriction of Hazardous Substances Directives by Electronic Manufacturing Service Providers

Cheng

Huang

2023

Sustainability

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The Electronic Manufacturing Service (EMS) industry contributes significantly to toxic waste generation due to its fabrication processes. Notably, adherence to the Restriction of Hazardous Substances (RoHS) Directive varies amongst EMS providers, despite its aim to reduce electronic waste. This study explores the factors influencing EMS providers’ decision to adopt the RoHS directive, utilizing the technology–organization–environment (TOE) and the human–organization–technology (HOT) fit, or the TOE-HOT fit framework. We validated our framework using partial least squares structural equation modeling (PLS-SEM), based on responses from 379 questionnaires from major EMS providers. The results demonstrated that expert resources, adequate resources, perceived industrial pressure, institutional pressure, and costs were positively associated with RoHS adoption. However, innovation, relative advantage, and verification ability were identified as significant barriers. In particular, innovation in the human dimension was the key determinant for RoHS adoption. Therefore, clear policy instruments and regulations may enhance RoHS adoption by EMS providers. These findings can guide environmental policy definitions in governmental laws and strategies, encouraging EMS providers and other firms to adopt RoHS standards.

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Section: Verification Capabilitymentioning

confidence: 99%