Deviation occurrence and identification
Report to supervisor or technician
Report to director and Qua. Dept.
Whether emergency measures is taken?
Yes
No
Take emergency measures
Whether product quality is influenced
Possible No
Root cause investigation
Impact assessment
Determine CAPA
If changed
Record & Explanation
Deviation investigation result and its quality assessment
偏差发生、识别
上报主管或技术员
上报部门负责人及质量管 理部
是否采取 紧急措施
是
否
执行紧急措施
是否影响 产品质量
可能影响 不影响
根本原因调查
偏差影响评估
确定纠正和预防措施
如有变更
记录解释
偏差调查结果及质量评价
按变更控制执行
分管QA、QA主管审核
批准偏归档
偏差处理结束
偏差调查处理流程图
Conduct as change control
Reviewed by QA and QA supervisor
Approve deviation investigation report
CAPA system trace
File deviation record
Deviation close