Transcription
Quality AssuranceManagement PlanApproved by:6IZMWMSR 2SZIQFIV Controlled Copy Number:UNCONTROLLED COPYUNCONTROLLED COPY1
5YERXIVVE 5%148EFPI SJ 'SRXIRXW(EXI -RMXMEXIH 1EVGL 6IZMWMSR 2S (EXI 6IZMWIH 2SZIQFIV 'ST]VMKLX F] 5YERXIVVE %PP VMKLXW VIWIVZIH )\GITX EW TIVQMXXIH YRHIV XLI 9RMXIH 7XEXIW'ST]VMKLX %GX SJ RS TEVX SJ XLMW TYFPMGEXMSR QE] FI VITVSHYGIH SV HMWXVMFYXIH MR ER] JSVQ SVF] ER] QIERW SV WXSVIH MR E HEXEFEWI SV VIXVMIZEP W]WXIQ [MXLSYX XLI TVMSV [VMXXIR TIVQMWWMSR SJ5YERXIVVE MMUNCONTROLLED COPYUNCONTROLLED COPY2
5YERXIVVE 5%148EFPI SJ 'SRXIRXW(EXI -RMXMEXIH 1EVGL 6IZMWMSR 2S (EXI 6IZMWIH 2SZIQFIV Preface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
5YERXIVVE 5%148EFPI SJ 'SRXIRXW(EXI -RMXMEXIH 1EVGL 6IZMWMSR 2S (EXI 6IZMWIH 2SZIQFIV MZUNCONTROLLED COPYUNCONTROLLED COPY4
5YERXIVVE 5%148EFPI SJ 'SRXIRXW(EXI -RMXMEXIH 1EVGL 6IZMWMSR 2S (EXI 6IZMWIH 2SZIQFIV Forward5%14 6IZMWMSR -QTPIQIRXEXMSR5YEPMX] %WWYVERGI 1EREKIVW EVI XS HMWXVMFYXI XLI HSGYQIRX ERH GSRHYGX XVEMRMRK SR XLI GLERKIW XSXLI 5%14 [MXLMR HE]W SJ XLI MWWYERGI HEXI -QTPIQIRXEXMSR SJ XLI GLERKIW XS XLI 5%14 WLEPP FIGSQTPIXIH [MXLMR HE]W SJ XLI MWWYERGI HEXI ZUNCONTROLLED COPYUNCONTROLLED COPY5
5YERXIVVE 5%148EFPI SJ 'SRXIRXW(EXI -RMXMEXIH 1EVGL 6IZMWMSR 2S (EXI 6IZMWIH 2SZIQFIV Table of Contents4EKITable of Contents8MXPI ERH 7MKREXYVI 4EKI M'ST]VMKLX 7XEXIQIRX MM4VIJEGI MMM*SV[EVH MZ8EFPI SJ 'SRXIRXW Z0MWX SJ *MKYVIW \M0MWX SJ 8EFPIW \MM0MWX SJ %TTIRHMGIW \MZ%GVSR]QW ERH -RMXMEPMWQW \Z1.0Management Commitment and Organization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uality System and Description 5YEPMX] 1EREKIQIRX 7]WXIQ 5YEPMX] %WWYVERGI ZMUNCONTROLLED COPYUNCONTROLLED COPY6
5YERXIVVE 5%148EFPI SJ 'SRXIRXW(EXI -RMXMEXIH 1EVGL 6IZMWMSR 2S (EXI 6IZMWIH 2SZIQFIV Table of Contents (continued)2.04EKIQuality System and Description (continued) 5YEPMX] (SGYQIRXW 5YEPMX] %WWYVERGI 1EREKIQIRX 4PER 5YEPMX] 4SPMG] (SGYQIRXW 7XERHEVH 3TIVEXMRK 4VSGIHYVIW 5YEPMX] %WWYVERGI 4VSNIGX SV 4VSKVEQ 4PERW 5YEPMX] %WWYVERGI 7YQQEV] 5%7 3XLIV (SGYQIRXW 3.0Associate Qualification and Training %WWSGMEXI 5YEPMJMGEXMSRW 3VMIRXEXMSR ERH 8IGLRMGEP 8VEMRMRK SJ 0EFSVEXSV] 7XEJJ 5YEPMX] 3VMIRXEXMSR 5YEPMX] 8VEMRMRK ,IEPXL ERH 7EJIX] 3VMIRXEXMSR ERH 8VEMRMRK 5% 1EREKIV 8VEMRMRK 8VEMRMRK *MPIW %WWSGMEXI 6IWYQIW -RHMZMHYEP 8VEMRMRK 6IGSVHW JSV XLI %VIEW SJ 5YEPMX] ,IEPXL ERH 7EJIX] ERH 8IGLRMGEP 4VSJMGMIRG] 1SRMXSVMRK 8VEMRMRK 6IGSVHW JSV 4VSJIWWMSREP (IZIPSTQIRX 8VEMRMRK 6IGSVHW JSV 6IKYPEXSV] 'SQTPMERGI -RJSVQEXMSR 4.0Procurement of Items and Services 7IPIGXMSR SJ :IRHSVW 4VSGYVIQIRX SJ 5YEPMX] 6IPEXIH -XIQW 6SPI SJ 'SVTSVEXI (MVIGXSV SJ 'SRXVEGXW 6SPI SJ 5YERXIVVE 4YVGLEWMRK 4VSGYVIQIRX 4VSGIHYVIW )ZEPYEXMSR SJ 56-W 7TIGMEP 6IUYMVIQIRXW JSV 7XERHEVH 6IJIVIRGI 1EXIVMEPW 4VSGYVIQIRX SJ 7YFGSRXVEGX 0EFSVEXSV] 7IVZMGIW :IRHSV 4EVXRIVWLMTW 5.0Documentation and Records Keeping System 5YEPMX] (SGYQIRXW ERH 6IGSVHW (SGYQIRX 6IZMI[ ERH 6IZMWMSR (SGYQIRX 'SRXVSP ERH (MWXVMFYXMSR ZMMUNCONTROLLED COPYUNCONTROLLED COPY7
5YERXIVVE 5%148EFPI SJ 'SRXIRXW(EXI -RMXMEXIH 1EVGL 6IZMWMSR 2S (EXI 6IZMWIH 2SZIQFIV Table of Contents (continued)5.04EKIDocumentation and Records Keeping System (continued)5 )JJIGXMZI (EXIW ERH (SGYQIRX ,MWXSV] 6IGSVHW 1EREKIQIRX 5YEPMX] 6IGSVHW 4VSNIGX 6IGSVHW )PIGXVSRMG (EXE 7XSVEKI 6IXIRXMSR ERH (MWTSWEP SJ 6IGSVHW (EXE 'SRJMHIRXMEPMX] 6.0Computer Hardware and Software 9WI SJ ,EVH[EVI 7IGYVMX] 9WI SJ 7SJX[EVI -RHYWXV] 7XERHEVH 7SJX[EVI 5YERXIVVE (IZIPSTIH 7SJX[EVI 'SRXVSP SJ 7SJX[EVI 'LERKIW 7SJX[EVI 6IZEPMHEXMSR (SGYQIRXEXMSR 'SQTYXIV :MVYWIW 7.0Planning (EXE 'SPPIGXMSR 4VSGIWW 3VKERM EXMSREP 6IWTSRWMFMPMXMIW (IXIVQMREXMSR SJ 4VSNIGX 5' 6IUYMVIQIRXW 'SQQYRMGEXMSR SJ 4VSNIGX 7TIGMJMG 6IUYMVIQIRXW 'YWXSQIV 7IVZMGI 8IEQW 'SRXMRKIRG] 4PERRMRK 8.0Work Processes and Operations 7XERHEVH 3TIVEXMRK 4VSGIHYVIW %REP]XMGEP 1IXLSHW (EXE 5YEPMX] 3FNIGXMZIW 4VIGMWMSR ERH %GGYVEG] 'SQTPIXIRIWW 6ITVIWIRXMXMZIRIWW 'SQTEVEFMPMX] 1IXLSH (IXIGXMSR 0MQMXW -RWXVYQIRX (IXIGXMSR 0MQMXW ZMMMUNCONTROLLED COPYUNCONTROLLED COPY8
5YERXIVVE 5%148EFPI SJ 'SRXIRXW(EXI -RMXMEXIH 1EVGL 6IZMWMSR 2S (EXI 6IZMWIH 2SZIQFIV Table of Contents (continued)8.04EKIWork Processes and Operations (continued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
5YERXIVVE 5%148EFPI SJ 'SRXIRXW(EXI -RMXMEXIH 1EVGL 6IZMWMSR 2S (EXI 6IZMWIH 2SZIQFIV Table of Contents (continued)8.04EKIWork Processes and Operations (continued) 7EQTPI (MWTSWEP ERH 6IXYVR 'LEMR SJ 'YWXSH] 'EPMFVEXMSR 4VSGIHYVIW ERH 'VMXIVME 4L]WMGEP 6IJIVIRGI 7XERHEVHW 'LIQMGEP 6IJIVIRGI 7XERHEVHW ERH 6IEKIRXW 7XERHEVH :IVMJMGEXMSR 4IVMSHMG 'EPMFVEXMSR 3TIVEXMSREP 'EPMFVEXMSR 'EPMFVEXMSR *EMPYVI 'EPMFVEXMSR 6IGSVHW 5YEPMX] %WWIWWQIRX (EXE 5YEPMX] %WWIWWQIRX 7XEXMWXMGEP )ZEPYEXMSR SJ (EXE (EXE 6IGSVHMRK 4VSGIHYVIW (EXE 6IHYGXMSR ERH :IVMJMGEXMSR 4VSGIHYVIW (EXE 6IHYGXMSR ERH -RMXMEP :IVMJMGEXMSR (EXE :IVMJMGEXMSR 'SQTPIXIRIWW :IVMJMGEXMSR (EXE 6ITSVXMRK (EXE 6ITSVXW :IVFEP 6IWYPXW 6ITSVXMRK %REP]XMGEP 6IWYPXW (EXE :EPMHEXMSR 4VIZIRXMZI 1EMRXIRERGI ERH 7IVZMGI %REP]XMGEP -RWXVYQIRXEXMSR ERH )UYMTQIRX *EGMPMXMIW *VIUYIRG] SJ 1EMRXIRERGI 3XLIV 6IUYMVIQIRXW ;EXIV 'SQTVIWWIH %MV ERH EWIW PEWW[EVI 4VITEVEXMSR 'LIQMGEP 7XSVEKI ;EWXI (MWTSWEP *EGMPMX] 7IGYVMX] \UNCONTROLLED COPYUNCONTROLLED COPY10
5YERXIVVE 5%148EFPI SJ 'SRXIRXW(EXI -RMXMEXIH 1EVGL 6IZMWMSR 2S (EXI 6IZMWIH 2SZIQFIV Table of Contents (continued)4EKI9.0Quality Assessment and Response 2SRGSRJSVQERGI ERH 'SVVIGXMZI %GXMSR 2SRGSRJSVQERGI 'SVVIGXMZI %GXMSR 6IWTSRWMFMPMXMIW 2SRGSRJSVQERGI 1IQS %YHMXW 4IVJSVQERGI %YHMXW 7]WXIQW %YHMXW -RHITIRHIRX -RXIVREP 7]WXIQW %YHMXW SV )ZEPYEXMSRW )\XIVREP 7]WXIQW %YHMXW (EXE %YHMXW 7TSX %WWIWWQIRXW 'PMIRX -RUYMVMIW ERH 'SQTPEMRXW 5YEPMX] 6ITSVXW XS 1EREKIQIRX 1EREKIQIRX 4VSGIWW 6IZMI[ 1EREKIQIRX 6IZMI[ SJ XLI 517 10.0Quality Improvement 7XERHEVHM EXMSR SJ 4VSGIHYVIW 'SRXMRYSYW 5YEPMX] -QTVSZIQIRX &IRGLQEVOMRK 5YEPMX] %WWIWWQIRX 9RHIVWXERHMRK XLI 'PMIRXW 2IIHW 5YEPMX] 1IEWYVIW ERH 7XERHEVHW \MUNCONTROLLED COPYUNCONTROLLED COPY11
5YERXIVVE 5%148EFPI SJ 'SRXIRXW(EXI -RMXMEXIH 1EVGL 6IZMWMSR 2S (EXI 6IZMWIH 2SZIQFIV List of -15YERXIVVE Organizational Chart Data Collection Process Flow Diagram Example 5YERXIVVE Quality Assurance Summary Example 5YERXIVVE Chain-of-Custody Form Example 5YERXIVVE Condition Upon Receipt Anomaly Report (CUR) Data Reduction, Verification, and Reporting \MMUNCONTROLLED COPYUNCONTROLLED COPY12
5YERXIVVE 5%148EFPI SJ 'SRXIRXW(EXI -RMXMEXIH 1EVGL 6IZMWMSR 2S (EXI 6IZMWIH 2SZIQFIV List of TablesTable No.Title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
7.4-1 Example 5YERXIVVE Quality Assurance Sum
