SEARCH

As a framework, I thought Nancy Leveson’s Hierarchical Safety Model which incorporates Rasmussen’s risk The following diagram is a slightly modified version of her model outlining engineering activities across

Process modeling is necessary to design, implement, and improve compliance. In this blog, I will look at how the Activity Model compares with the Phase-Gate Model which is used Activity Model Activity based models typically diagram the process using flow charts containing: boxes Phased-Gate Model This modeling technique is based on a state driven approach depicting the life cycle benefits of the using the phase-gate model.

have observed that regulatory and standards bodies are expecting companies to use capability maturity models While capability maturity models are not new they have seldom been used to improve compliance. One of the places where capability maturity models has been used successfully is in software development The CMMI (Capabilities Maturity Model Integration) Institute publishes and develops maturity models continuing The latest version of the CMMI model is V2 with specific versions for product and service development

While this model provides a framework for higher levels of safety and quality it requires manufacturers Conclusion In conclusion, the concept of manufacturers' integrity and self-regulation emerges as a crucial model This model emphasizes the need for manufacturers to establish internal governance, programs, systems,

Currently, the AI field lacks established frameworks for comprehensive assurance, but several existing models management, and medical device life-cycle management could be adapted to create an effective AI assurance model If adapted for AI, this model could include threat modelling, attack surface analysis, and security control With AI-specific threat detection and control mechanisms, this model could serve as a proactive defence and Medical Device models both emphasize life-cycle management.

As artificial intelligence models strive for greater accuracy, an unexpected phenomenon is emerging: requesting an outline on a specific topic typically yields nearly identical responses from these different models Model convergence occurs when multiple AI models, despite being developed by different organizations, The convergence of AI models towards singular responses could potentially limit the exposure to alternative Do you think model convergence is a problem?

Integrating these essential metrics into the Bowtie Risk Model offers a powerful framework for evaluating This article will delve into the process of mapping KPIs, KRIs, and KCIs to the Bowtie Risk Model to Understanding the Bowtie Risk Model The Bowtie Risk Model is a visual and qualitative risk analysis tool Mapping KPI, KRI, and KCI to the Bowtie Risk Model Identify Relevant Metrics : Start by identifying the Map KRIs to Threats : Associate the KRIs with the identified threats in the Bowtie Risk Model.

With all the talk about artificial intelligence it’s easy to get caught up in a world of machine models

At the heart of the Shingo Model™ are three pivotal insights that guide organizations toward mission Elevate Systems (Lean Compliance) Insight 1: Ideal Results Require Ideal Behaviour Central to the Shingo Model Leaders are urged to inspire and model the behaviours that align with the organization's goals, fostering Conclusion The Shingo Institute’s along with the Lean Compliance Model offer profound approaches to organizational

This will look different across industry sectors, but each will have an operational model that must be following maps are helpful to identify where these places are: Total Value Chain Map Organizational Model The Operating Model Canvas book is a good place to start understanding operating models from which you

It provides context for how compliance fits into the overall business model. 2. into the operational business model. Evaluate Compliance Operability The final step is to assess how well the integrated compliance model One area where capability maturity models have been successfully employed is in software development, by Carnegie Mellon University, continues to develop and publish maturity models.

As a result many business process modelling and execution systems offer very limited support for other Example Responsibility Assignment Matrix (RAM) using modified RACI model: This often leads to significant The requirements for these tools may include: Representing the entire RACI model along with its variations Automated mapping to BPMN models to support execution platforms Implementation mapping for each type RACI) Support for early and late binding of responsibilities during execution Audit of design, model,