| General : | |
| Version: | 1.0 |
| Project : | |
| Author: | Wolfgang Kern |
| Status: | Approved |
| Created: | 04.06.2014 18:48:52 |
| Modified: | 27.02.2018 10:23:30 |
| Advanced : | |
| Appears In: | CFR 820.198 Complaint files, CFR 820.25 Personnel, QA_Quality Assurance, Analyze complaints and nonconformities |
|
|
|
|
|
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- Analyze complaints and nonconformities
«Activity» Analyze errors regarding improper job performance- «Activity» Analyze incoming nonconformities and complaints
- «Activity» Create nonconformities and complaints statistics and trend analysis
- «Activity» Define adequate measures to improve job performance
- «Activity» Evaluate significant nonconformities and complaints
- «Activity» Inform related staff about improper job performance
«EndEvent» Complaints and nonconformities analyzed
«StartEvent» Need to analyze complaints and nonconformities
«Gateway» Job performance issues?
- «BusinessProcess» Block nonconform components or products
- «BusinessProcess» Do QA review
- «BusinessProcess» Manage CAPAs
- «BusinessProcess» Manage blocked parts or products
- «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