FDA compliant complaint handling system, form created by Connie Dello Buono, QA consultant , motherhealth@gmail.com , 408-854-1883 , San Jose , California

1. Complaint Handling Form FRM-820.90
Page 1 of 1 Confidential
Complaint Handling Form
Complaint Number: C12-NNNN
CAPA Number: CAR12-NNNN
Reported by:_______ Date Received:__
Service Num/GP-ERP:__ RMA#___
Service Report Num:___
Date Complaint
Opened:
Complaint
Type:
Reportable: Y/N If Y, FDA Report Date:_______
Risk Assessment:
-----------------------------------------------------------------------------------------------
Patient Info:
Closed Date: __________
Status:
(Open, Closed, Review)
Source: Test , R&D/Mfg , Audit ,
Quality Records , Cal/Eqpt Records ,
Customer Complaints , Returned
Product
Customer Info: Quality Element:
Product /Process
Quality Service
Severity:
Death , Serious Injury , Malfunction
Product Issue , Serious , Non-serious
Product Type: S____
Product Info:
Qty:
Date Product Received:
Serial Number: Install Date:
Last Service Date:
Complaint Description:
Immediate Correction
Rationale for no further investigation:_
Investigation and Root Cause (Attach any supporting data):
Assigned to:
Date Performed:
Activity Participants:
Action Item and Action Results/Taken (Responsible Person and Target Date):
Effectiveness Check and Date:
CAPA Num: __________ [N/A if not applicable]
NCR Num: __________ [N/A if not applicable]
SCAR Num:__________ [N/A if not applicable]
CAR Owner: (Service/R&D/Mfg/Supplier)________________(Sign)_________(Date)
Reviewer: (QA Mgr)_____________________ ___(Sign)_________(Date)