complaint procedure flow-chart
2017-01-17 17:13:36 0 举报作者其他创作
大纲/内容
Product safety or efficiency involved?
Field Action Required
Yes
Adverse Event Procedure
Register complaint in system and collect further info. as necessary
CAPAProcedure
Impact AssessmentReview Level
Pass information to CHU Coordinator
Risk Management Procedure
Feedback/formal response to customer
Communication information
Investigation
Trigger Risk Management Report Update
ECR/ECO Procedure
Evaluate Complaint(Pass to MFG? SOLM Internal Issue)
Acknowledge Receipt of Complaint
No
N
Risk Assessment Review Result
Customer Complaint
Field Action Procedure
Reportable?
Monitoring and tracking trend of complaint
Trigger a CAPA?
CAPA Closure
Generate Investigation report
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