| General : | |
| Version: | 1.0 |
| Project : | |
| Author: | Wolfgang Kern |
| Created: | 20.03.2014 17:10:26 |
| Modified: | 16.09.2019 15:12:57 |
| Diagram Elements : |
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EA Project Browser
Overview- Organisation Chart
- Staff
- Roles
- Projects
- SOPs
Process landscape
Management- Quality and Regulatory
- Clinical Marketing
- Research and Development
Research and Development- IP_IP-Management
- RD_Research and Development
- RD_Research and Development
«BusinessProcess» Determine basic product characteristics- «BusinessProcess» Develop Software
- «BusinessProcess» Develop System
- «BusinessProcess» Do SW validation
- «BusinessProcess» Do system / usability verification
- «BusinessProcess» Manage tools and equipment RD
- «BusinessProcess» Plan integration and build functional model
- «BusinessProcess» Plan resources and budget RD
- «BusinessProcess» Provide SERVICE LEVEL 3
- «BusinessProcess» Report RD
- «BusinessProcess» Select and qualify development partner
- «BusinessProcess» Select and qualify development tools
- «BusinessProcess» Start development project
- «BusinessProcess» Manage development process
- «BusinessProcess» Manage engineering change requests (ECRs)
- «BusinessProcess» Create SysRS / US
- «BusinessProcess» Create DRS
- «BusinessProcess» Create DMRs and MMRs
- «BusinessProcess» Do Design-FMEA
Do Design-FMEA
«Activity» Analyze new risks induced by new mitigation- «Activity» Analyze potential design-failures and probability
- «Activity» Determine related effects and severity
- «Activity» Determine risk acceptability
- «Activity» Determine risk after mitigation
- «Activity» Determine risk before mitigation
- «Activity» Determine risk mitigations
- «Activity» Determine safety related components
- «Activity» Evaluate new risks induced by FMEA mitigation
«EndEvent» Design FMEA
«StartEvent» Need for design FMEA
«Gateway» Additional mitigations possible?- «Gateway» New risks?
- «Gateway» PRN < 20
- «BusinessProcess» Do product training
- «BusinessProcess» Do module verification
- «BusinessProcess» Review design phase
- «BusinessProcess» Review design transfer
- «BusinessProcess» Review product release
- «BusinessProcess» Review requirement phase
- «BusinessProcess» Review validation phase
- «BusinessProcess» Review verification phase
- ID_Industrial Design
- Operations
- Customer Support
- Sales
- Finance
- Information Technology
- Human Resources
- Templates
- Software tools
- Equipment
- Facilities
- Products
- Compliance
- Sandbox