B. CAPA DATA SOURCES CAPA data sources are designed to analyze processes, work operations, quality records, complaints, returned product and other sources of quality data to identify existing and potential causes of non-conforming product, or other quality problems. These CAPA data sources, associated documents, metrics, tracking, trending, responsible person and timing of management review are as follows: GN . 11-03 FORM PLANT CAPA CONTROLLING TRACKING METRIC/TRACKING TITLE OF TIMELY MGMT CAPA DATA TYPE DATA SOURCES DOCUMENT METHOD METHOD FOR RESPONSIBLE REVIEW SOURCES PLANT UNF./UNACCEPTABLE PERSON MECHANISM TRENDS BOP.X.1000-0006 Complaints I PCA CAPARS BOP.X.2500-0024 BOP.X.1000-0013 Unacceptable trends determined Quality Systems Monthly Management Customer issued by the by Fichers Exact Test Manager Review Board Medwatch Formally Meeting Field Service Designated Unit in Reports , Journal Articles (FDA service reports) Legal claims I CAPARS issued by N/A BOP.X.1000-0013 Unacceptable trends determined Quality Systems Monthly Management Quality Assurance by Fichers Exact Test Manager Review Board in , Meeting GN . 11-03 FORM PLANT CAPA CONTROLLING TRACKING METRIC/TRACKING TITLE OF TIMELY MGMT CAPA DATA TYPE DATA SOURCES DOCUMENT METHOD METHOD FOR RESPONSIBLE REVIEW SOURCES PLANT UNF./UNACCEPTABLE PERSON MECHANISM TRENDS BOP.X.1000-0006 Product I PCA CAPARS BOP.X.2500-0024 BOP.X.1000-0013 PCA CAPARS issued by the Quality Systems Monthly Management Warranty issued by the /Formally Designated Unit in , Manager Review Board Formally Meeting Designated Unit in , Inspections / test NCR DPMs BOP.X.2000-0019 BOP.X.1000-0013 Unacceptable trends determined Plant QA Manager Monthly Management data Restrictions BOP.X.2500-0020 by Fichers Exact Test Review Board Inprocess NCMR BOP.X.2500-0014 Meeting Final / Yield data NCR Restrictions BOP.X.2500-0020 BOP.X.1000-0013 Unacceptable trends determined Quality Systems Monthly Management NCMR BOP.X.2500-0014 by monthly management Mgr. Review Board review Meeting
B. CAPA DATA SOURCES CAPA data sources are designed to analyze processes, work operations, quality records, complaints, returned product and other sources of quality data to identify existing and potential causes of non-conforming product, or other quality problems. These CAPA data sources, associated documents, metrics, tracking, trending, responsible person and timing of management review are as follows: GN . 11-03 CAPA DATA SOURCES FORM TYPE PLANT CAPA DATA SOURCES CONTROLLING DOCUMENT TRACKING METHOD PLANT METRIC/TRACKING METHOD FOR UNF./UNACCEPTABLE TRENDS TITLE OF RESPONSIBLE PERSON TIMELY MGMT REVIEW MECHANISM BOP.X.1000-0006 Complaints Customer Medwatch Field Service Reports Journal Articles (FDA service reports) I PCA CAPARS issued by the Formally Designated Unit in , BOP.X.2500-0024 BOP.X.1000-0013 Unacceptable trends determined by Fichers Exact Test Quality Systems Manager Monthly Management Review Board Meeting Legal claims I CAPARS issued by Quality Assurance in , N/A BOP.X.1000-0013 Unacceptable trends determined by Fichers Exact Test Quality Systems Manager Monthly Management Review Board Meeting GN . 11-03 CAPA DATA SOURCES FORM TYPE PLANT CAPA DATA SOURCES CONTROLLING DOCUMENT TRACKING METHOD PLANT METRIC/TRACKING METHOD FOR UNF./UNACCEPTABLE TRENDS TITLE OF RESPONSIBLE PERSON TIMELY MGMT REVIEW MECHANISM BOP.X.1000-0006 Product Warranty I PCA CAPARS issued by the Formally Designated Unit in , BOP.X.2500-0024 BOP.X.1000-0013 PCA CAPARS issued by the /Formally Designated Unit in , Quality Systems Manager Monthly Management Review Board Meeting Inspections / test data Inprocess Final NCR DPMs Restrictions NCMR BOP.X.2000-0019 BOP.X.2500-0020 BOP.X.2500-0014 BOP.X.1000-0013 Unacceptable trends determined by Fichers Exact Test Plant QA Manager Monthly Management Review Board Meeting / Yield data NCR Restrictions NCMR BOP.X.2500-0020 BOP.X.2500-0014 BOP.X.1000-0013 Unacceptable trends determined by monthly management review Quality Systems Mgr. Monthly Management Review Board Meeting
CAPA%20Procedure.docx