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
GN . 11-03 CAPA DATA SOURCES FORM TYPE 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 Internal Audits Regulatory Inspection Observations and follow-up I QA Records BOP.X.2500-0013 BOP.X.2500-0011 BOP.X.2500-0013 Unacceptable trends determined by monthly management review Quality Systems Mgr. Monthly Management Review Board Meeting Device History Records I Work Errors Deviations BOP.X.2510-0001 BOP.X.2500-0017 BOP.X.1000-0013 Unacceptable trends determined by monthly management review Quality Systems Mgr. Monthly Management Review Board Meeting Training Records I Monthly Audit Report BOP.X.1500-0001 BOP.X.1000-0013 Unacceptable trends determined by monthly management review Quality Systems Mgr. Monthly Management Review Board Meeting Rework NCR EPWO Restrictions Return Goods BOP.X.MP-SP-022 BOP.X.2500-0020 BOP.X.MP-SP-102 BOP.X.1000-0013 Unacceptable trends determined by monthly management review Quality Systems Mgr. Monthly Management Review Meeting Non-conforming materials NCR NCMRs BOP.X.2500-0014 BOP.X.1000-0013 Unacceptable trends determined by monthly management review Quality Systems Mgr. Monthly Management Review Board Meeting