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Excerpts the-magic-of-thinking-big refuse to worry about your health: do not make excuses, look at the bright side of health, be grateful that your health is as good as it is.
David Schwartz
MSDS SDS labelling SOP GHS of classification labelling of chemConnie Dello Buono
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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)