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CFR 820.198 Complaint files :
General :
Version:
1.0
Project :
Author:
Wolfgang Kern
Created:
31.03.2014
Modified:
07.10.2017 11:57:10
Diagram Elements :
Clarify regulatory requirements for distribution in countries outside EU
Analyze complaints and nonconformities
FSCA customer notice
Define FSCA notice
Complaint report
Note complaint
Do root cause analysis
CAPA Corrective and preventive action
Manage blocked parts or products
Dispatch Customer Support
Manage CAPAs
Provide Hotline and SERVICE LEVEL 0
Subpart M - Records : Subpart M - Records
CFR 820.196 (g) Formally designated complaint unit outside USA
CFR 820.196 (f) Formally designated complaint unit oustide the company
CFR 820.196 (e) Record investigation
CFR 820.196 (d) Complaints that have to reported to FDA
CFR 820.196 (c) Complaints involving possible failures of a device
CFR 820.196 (b) Handle with non investigated complaints
CFR 820.196 (a) Receiving, reviewing and evaluating of complaints
