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Frm 820.90 complaint form cdb 7 9-2013 rev 1

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

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Frm 820.90 complaint form cdb 7 9-2013 rev 1

  1. 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)