GN . 11-03 FORM 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 Internal Audits I QA Records BOP.X.2500-0013 BOP.X.2500-0013 Unacceptable trends determined Quality Systems Monthly Management Regulatory BOP.X.2500-0011 by monthly management Mgr. Review Board Inspection review Meeting Observations and follow-up Device History I Work Errors BOP.X.2510-0001 BOP.X.1000-0013 Unacceptable trends determined Quality Systems Monthly Management Records by monthly management Mgr. Review Board Deviations BOP.X.2500-0017 review Meeting Training Records I Monthly Audit BOP.X.1500-0001 BOP.X.1000-0013 Unacceptable trends determined Quality Systems Monthly Management Report by monthly management Mgr. Review Board review Meeting Rework NCR EPWO BOP.X.MP-SP-022 BOP.X.1000-0013 Unacceptable trends determined Quality Systems Monthly Management Restrictions BOP.X.2500-0020 by monthly management Mgr. Review Meeting Return Goods BOP.X.MP-SP-102 review Non-conforming NCR NCMRs BOP.X.2500-0014 BOP.X.1000-0013 Unacceptable trends determined Quality Systems Monthly Management materials by monthly management Mgr. Review Board review 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
CAPA%20Procedure.docx