This is a collection of Provision, Procedure, and Forms for Complaint Handling in a form consistent with the FDA QSR.
Complaint Handling required by FDA must be closely related to CAPA and whether or not to report to FDA.
List of Forms
The following forms are included with your purchase.
・MD-QMS-K14 Complaint Handling Provision
・MD-QMS-S1401 Complaint Handling Procedure
・MD-QMS-F1401 Complaint and Evaluation Report
・MD-QMS-F1402 Complaint List
Table of Contents
Provision
1 Purpose
2 Scope
3 Definitions of Terms
4 Organization of Compliant Manager
5 Responsibilities of Complaint Handling Manager
6 Complaint level
6.1 Handling of Minor and Major complaints
6.2 Handling of Critical complaints
7 Complaint reception
7.1 Acceptance of information from customers
7.2 Evaluation of information
8 Evaluation of complaint and judgement of necessity to reporting the Authority
8.1 Evaluation of complaints
8.2 Judgement of necessity to reporting the Authority
9 Complaint management materials
10 Judgement standard of necessity for investigation
11 Conducting investigation
12 Handling of the present product
13 Action for the product relating the complaint
14 Responses to client
15 Judgement standard of necessity for revision or corrective/preventive actions
16 Determination of necessity for SCAR and issuance of SCAR
17 Complaint file
18 Complaint List
19 Complaint data analysis and reporting
20 Handling complaints concerning products purchased
21 Reference
22 APPENDICES
Procedure
1 Purpose
2 Scope
3 Definition of Terms
4 Roles and Responsibilities
5 Implementation procedure
5.1 Acceptance of information
5.2 Complaint reception
5.3 Evaluation of complaints
5.4 Judgement of necessity for investigation
5.5 Conducting investigation
5.6 Handling
5.7 Additional Risk Analysis
5.8 Responses to client
5.9 Judgement of necessity for corrective/preventive actions
5.1 Judgement of necessity for SCAR and issuance of SCAR
5.11 Complaint data analysis
5.12 Report to Management Review
6 Complaint File
6.1 Creation of complaint files
6.2 Retention of complaint files
7 Record keeping
8 Form
9 Reference
10 APPENDICES