| General : | |
| Version: | 1.0 |
| Project : | |
| Author: | Wolfgang Kern |
| Status: | Approved |
| Created: | 28.05.2014 19:41:04 |
| Modified: | 00:00:00 |
| Advanced : | |
| Appears In: | Manage blocked parts or products |
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EA Project Browser
Overview- Organisation Chart
- Staff
- Roles
- Projects
- SOPs
Process landscape
Management- Quality and Regulatory
Quality and Regulatory- QA_Quality Assurance
- QA_Quality Assurance
«BusinessProcess» Analyze complaints and nonconformities- «BusinessProcess» Block nonconform components or products
- «BusinessProcess» Do QA review
- «BusinessProcess» Manage CAPAs
- «BusinessProcess» Manage blocked parts or products
- Manage blocked parts or products
«Activity» Check compliance with legal standards before release of blocked parts- «Activity» Document and label reason and restrictions for use in case of special release
- «Activity» Investigate and document root cause for suspension
- «Activity» Release blocked part by removing label
- «Activity» Take blocked part from stock
«EndEvent» Blocked part managed
«StartEvent» Need to manage blocked parts
«Gateway» Parts compliant with legal standards?- «Gateway» Repair or scap?
- «BusinessProcess» Audit supplier
- QM_Quality Management
- RA_Regulatory Affairs
- RM_Risk Management
- «BusinessProcess» Plan resources and budget Q&R
- «BusinessProcess» Report Q&R
- Clinical Marketing
- Research and Development
- Operations
- Customer Support
- Sales
- Finance
- Information Technology
- Human Resources
- Templates
- Software tools
- Equipment
- Facilities
- Products
- Compliance
- Sandbox