质量手册QUALITY MANUAL
1、主要执行对象: 质量保证部门.
2、内容(Team Members):
A) 产品Production
B) 检验QC
C) 仓贮Stores
D) 销售及后勤Distribution and Logistics
E) 维护Maintenance Deptt.
F) 其它HRD and Many others
质量手册Elements of Quality Manual
1. 编码National and International Codes
2. 质量方针Quality Policy
3. 岗位培训Personnel and Training
4. 组织机构Organisational Chart
5. 厂房设施Plant and facility design
6. 设备Equipments and manitenance
7. 生产线Product Line
8. 文件管理及执行Documentation management and execution
9. 产品Production
10.检验 QC
11. 贮存和销售Storage and Distribution
12. 研究与开发Research and Development
13. 合同Sub Contract
14. 供应商评估Vendor assessment
15. 保证项目Functional Assurance
- 变更控制Change Control
- 包装说明Out of Specification
- 风险分析Risk analysis
- 标签发放Lot release
- 验证Validations
- 稳定性研究Stability studies
- 安全性研究Safety studies
- 趋势分析Trend analysis and APR
- 召回与投诉Recall and Complaints
- 质量回顾Quality returns
- 自查自检Self Inspection and audit
- 留样Retained Sample