| General : | |
| Version: | 1.0 |
| Project : | |
| Author: | Wolfgang Kern |
| Status: | Approved |
| Created: | 29.06.2014 19:04:06 |
| Modified: | 00:00:00 |
| Advanced : | |
| Appears In: | Do device acceptance test, CFR 820.120 Device labeling |
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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
- Operations
- Customer Support
CS_Customer Support
«BusinessProcess» Do field acceptance test- «BusinessProcess» Repair blocked parts in-house
- «BusinessProcess» Create application training material
- «BusinessProcess» Do device acceptance test
- Do device acceptance test
«Activity» Check valid calibration of test tool and do reference measurement before first use- «Activity» Document device inspection results
- «Activity» Inspect device
- «Activity» Inspect device labeling
- «Activity» Label device as approved
- «Activity» Return test tool after use
- «Activity» Store approved device
- «Activity» Update device inventory
«EndEvent» Device acceptance test done
«StartEvent» Device ready for acceptance
«Gateway» Device accepted?
- «BusinessProcess» Inspect incoming devices to be repaired
- «BusinessProcess» Inspect incoming service modules
- «BusinessProcess» Manage customer support
- «BusinessProcess» Manage spare parts
- «BusinessProcess» Provide on-site application support
- «BusinessProcess» Refurbish modules
- «BusinessProcess» Repair device in-house
- «BusinessProcess» Scrap parts
- «BusinessProcess» Do TSC on-site
- «BusinessProcess» Provide Hotline and SERVICE LEVEL 0
- «BusinessProcess» Provide SERVICE LEVEL 1
- «BusinessProcess» Provide SERVICE LEVEL 2
- «BusinessProcess» Execute customer basic training
- «BusinessProcess» Decomission device or module
- «BusinessProcess» Dismount system on-site
- «BusinessProcess» Do service remote
- «BusinessProcess» Repair on-site
- «BusinessProcess» Execute field safety corrective action (FSCA)
- «BusinessProcess» Do automatic remote monitoring
- «BusinessProcess» Install system on-site
- «BusinessProcess» Dispatch Customer Support
- Sales
- Finance
- Information Technology
- Human Resources
- Templates
- Software tools
- Equipment
- Facilities
- Products
- Compliance
- Sandbox