| General : | |
| Version: | 1.0 |
| Project : | |
| Author: | Wolfgang Kern |
| Status: | Approved |
| Created: | 20.12.2013 12:40:44 |
| Modified: | 03.09.2019 16:31:41 |
| Advanced : | |
| Appears In: | CS_Customer Support, 9. Production and post-production information, CFR 820.198 Complaint files, 8.1 General, 8.2.1 Feedback, 8.5.1 General, 8.2.1 Rückmeldungen, 6.1 * Establish software maintenance plan, 6.2.1.1 Monitor feedback, 6.2.1.2 Document and EVALUATE feedback, 8.1 Allgemeines, 6.2.1.3 Evaluate PROBLEM REPORT’S affects on SAFETY |
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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
- «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
- Provide Hotline and SERVICE LEVEL 0
«Activity» Ask for adverse event with patient involved- «Activity» Check service contract status
- «Activity» Immediate stop of system use
- «Activity» Note complaint
- «Activity» Set complaint SL1 active
- «Activity» Set complaint resolved in SL0
- «Activity» Solve complaint verbally
«StartEvent» Complaint
«EndEvent» Critical event managed
«IntermediateEvent» Inform about adverse event- «EndEvent» Service level 0 provided
«Gateway» Adverse event?- «Gateway» Does service contract cover request?
- «Gateway» Issue solved?
- «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