it/ai/ncr.git - Gitblit

SQLite format 3@  00. ¦   8  8É# (Ö.s=tablerecordsrecordsCREATE TABLE records
                 (uniqueId TEXT PRIMARY KEY, fullFileName TEXT, category TEXT, 
                  site TEXT, yearMonth TEXT, sequence TEXT, customName TEXT, 
                  status TEXT, remarks TEXT, timestamp TEXT, responsibleUnit TEXT, recurring TEXT, customerCode TEXT, complaintId TEXT, model TEXT, penaltyDate TEXT, gracePeriod INTEGER, stopAlert TEXT, returnQty INTEGER, shippedQty INTEGER, defectThreshold REAL, closingDate TEXT, exceptionDesc TEXT, severity TEXT, handlingDesc TEXT, issueType TEXT, source TEXT, issuer TEXT, respUnitType TEXT, respUnitName TEXT, respPerson TEXT, rootCause TEXT, correctiveAction TEXT, trackingResult TEXT, fileDate TEXT, version INTEGER DEFAULT 1, filePath TEXT)o##%tablesystem_infosystem_infoCREATE TABLE system_info
                 (key TEXT PRIMARY KEY, value TEXT)5I#indexsqlite_autoindex_system_info_1system_infoP++Ytablesqlite_sequencesqlite_sequenceCREATE TABLE sqlite_sequence(name,seq)x##7tableaccess_logsaccess_logsCREATE TABLE access_logs
                 (id INTEGER PRIMARY KEY AUTOINCREMENT, 
                  user TEXT, 
                  action TEXT, 
                  ip_address TEXT, 
                  timestamp TEXT)##Gtablesystem_locksystem_lockCREATE TABLE system_lock
                 (id INTEGER PRIMARY KEY, user TEXT, lock_time REAL)ø#tablerecordsrecordsCREATE TABLE records
                 (uniqueId TEXT PRIMARY KEY, fullFileName TEXT, category TEXT, 
                  site TEXT, yearMonth TEXT, sequence TEXT, customName TEXT, 
                  status TEXT, remarks TEXT, timestamp TEXT, responsibleUnit TEXT)-Aindexsqlite_autoindex_records_1recordsâûöñìçâ   "EiT¨Ð0<Oj&+a A    !              NCR-TW202506002NCR-TW202506002-å·è¡çç¯æ£æªæ½æµç¨èç¨åºä¸ç¬¦-20250603NCRTW202506002å·è¡çç¯æ£æªæ½æµç¨èç¨åºä¸ç¬¦Closed2026-01-21T14:15:12.905795["QA"]NN2025-06-1820250603q&+g A    !                NCR-TW202506001NCR-TW202506001-éè¦é¶çµä»¶æ´æä¾æåæªæåºç³è«-20250603NCRTW202506001éè¦é¶çµä»¶æ´æä¾æåæªæåºç³è«Closed2026-01-21T14:01:55.761778["PUR"]NN2025-06-1720250603Q%+{I A    !              NCR-TW202505001NCR-TW202505001-é§åå¨é¢ç½©ç¼ºå°PMSè¨å-20250522NCRTW202505001é§åå¨é¢ç½©ç¼ºå°PMSè¨åClosed2026-01-21T13:32:31.542895["RD"]NN2025-06-1220250522I%-q= A    !            INCR-TW202503002INCR-TW202503002-æªæ´æ°ç¢ºæä¸»è¨å-20250319INCRTW202503002æªæ´æ°ç¢ºæä¸»è¨åClosed2026-01-21T13:14:32.447756["RD"]NN2025-03-2620250319U%-}I A    !            INCR-TW202503001INCR-TW202503001-ç°½æ ¸æ¬ä½èç¨åºæ¸ä¸ç¬¦-20250319INCRTW202503001ç°½æ ¸æ¬ä½èç¨åºæ¸ä¸ç¬¦Closed2026-01-21T11:41:12.503422["RD"]NN2025-03-2620250319Z&+O A    !            NCR-TW202503006NCR-TW202503006-é æ´æ°ä¾æåç©æä¸è¦½è¡¨-20250319NCRTW202503006é æ´æ°ä¾æåç©æä¸è¦½è¡¨Closed2026-01-21T11:25:31.934146["PUR"]NN2025-03-2620250319L %+uC A    !            NCR-TW202503005NCR-TW202503005-æªæ¯å£å¯©æ¥åè³ªæ¿ç-20250319NCRTW202503005æªæ¯å£å¯©æ¥åè³ªæ¿çClosed2026-01-21T11:23:55.391465["QA"]NN2025-03-2620250319&+ + A[+1 !                NCR-TW202503004NCR-TW202503004-HL858A1, HL858A1-B-æ¶ç´è¢ç¼é-ME21-20250314NCRTW202503004æ¶ç´è¢ç¼éClosed2026-01-21T10:02:16.045145["QA", "PUR", "SUP:\u5ee3\u9054\u5229"]NME21Q4-2025ME210003HL858A1, HL858A1-BN2025-03-2720250314Y&+7 A%   !                NCR-TW202503003NCR-TW202503003-åè³ªç®æ¨æªéæ¨-å°ååä¿-20250311NCRTW202503003åè³ªç®æ¨æªéæ¨Closed2026-01-20T16:33:30.676440["QA"]Nå°ååä¿N2025-03-1720250311Z
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e¤ÌÌ,8KK%+Q A                 NCR-TW202601001NCR-TW202601001-MDRç¨½æ ¸-20260108NCRTW202601001MDRç¨½æ ¸Open2026-01-19T16:39:46.9S%-u% A5  !            INCR-HT202601001INCR-HT202601001-HL710H-ååéé³-CI01-2026/01/08INCRHT202601001ååéé³Closed2026-01-15T14:13:49.498722["SUP:\u7965\u7eac"]NCI01HL710HN.°2026-03-24V%-{7 A   !            INCR-VN202510001INCR-VN202510001-HL868EA-Burn modeåºç¾å¤å-20250928INCRVN202510001Burn modeåºç¾å¤åClosed2026-01-19T10:52:54.576437["RD"]NHL868EAN#,2026-02-1020250928W%+1 A'+                NCR-VN202511001NCR-VN202511001-HL100K-ç¡æ³æ£å¸¸å´é§-AD03-2025/11/11NCRVN202511001ç¡æ³æ£å¸¸å´é§Open2026-01-19T10:55:20.186897["ENG", "QA"]NAD03Q4-2025AD030005HL100KNø7¹+a A    !             NCR-TW202506002NCR-TW202506002-å·è¡çç¯æ£æªæ½æµç¨èç¨åºä¸ç¬¦-20250603NCRTW202506002å·è¡çç¯æ£æªæ½æµç¨èç¨åºä¸ç¬¦ClosedY%-o+ A5   !            INCR-VN202510002INCR-VN202510002-HL858CE-LCDä¸ç·£æ¼å-20251017INCRVN202510002LCDä¸ç·£æ¼åClosed2026-01-19T10:53:42.632774["SUP:\u6676\u8a0a"]NHL858CEN¨æ2026-02-1020251017(+Q A    !UC%[ NCR-TW202601001NCR-TW202601001-MDRç¨½æ ¸-20260108NCRTW202601001MDRç¨½æ ¸Closed2026-01-19T16:39:46.955255["RA"]NN2026-02-06Multiple relevant documents were reviewed and interviews were conducted to determine how the manufacturer defines and manages substantial changes under MDR requirements. However, no consistent or clearly documented criteria could be confirmed in the following procedures and records:
- (QM000) Quality Manual, Rev 034, 2025-11-11
-   (QP0101) Management responsibility procedure, Rev 018, 2025-04-02
-   (QP1401) Corrective and preventive action program procedure, Rev 008, 2025-11-11
-   (QR1406) CAPA form (for type II improvement), Rev 04
These documents were reviewed as related sources; however, this finding does not imply that all listed documents are nonconforming. The manufacturer may determine the most appropriate location(s) to document or clarify the defined criteria within their quality system.MIåè³ªç³»çµ±ç¡ä¸åæ ¼åæä»¶ç¼ºå¤±ç¨½æ ¸CherryDeptæ³è¦é¨JoannaNo formal procedure or section within the QMS explicitly defines what constitutes a substantial change.Revise procedure to define criteria for substantial changes,
QM000 Quality Manual, Rev 034, 2025-11-11
QP0101 Management Responsibility Procedure, Rev 018, 2025-04-02
QP1401 CAPA Procedure, Rev 008, 2025-11-11
QR1406 CAPA Form (for type II improvement), Rev 0420260108Y&+7 A%   !             NCR-TW202503003NCR-TW202503003-åè³ªç®æ¨æªéæ¨-å°ååä¿-20250311NCRTW202503003åè³ªç®æ¨æªéæ¨Closed2026-01-20T16:33:30.676440["QA"]Nå°ååä¿N2025-03-1720250311Z
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ì_Ö©§¯I%-q= A    !            INCX%-i+ AA   !            INCR-HT202509003INCR-HT202509003-é¦¬éä¸å å£-FA03-20250919INCRHT202509003é¦¬éä¸å å£Closed2026-01-27T10:36:20.107603
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b.) 6.6.1 å°æ¡è² è²¬äººé å°æä»¶é²è¡ç°½æ ¸, ä»¥ç¢ºä¿å¶æ£ç¢ºæ¸æªå¨é¢¨éªç®¡çæªæ¡åDHF.  ä½ç°½æ ¸æ¬ä½ä¸¦ç¡å°æ¡è² è²¬äºº, èç¨åºä¸ç¬¦MIç¨åºåé¡ç¡ä¸åæ ¼åä¸ç¬¦åç¨åºç¨½æ ¸ç¼ºå¤±JackDeptç ç¼é¨Ray20250319Z&+O A    !            NCR-TW202503006NCR-TW202503006-é æ´æ°ä¾æåç©æä¸è¦½è¡¨-20250319NCRTW202503006é æ´æ°ä¾æåç©æä¸è¦½è¡¨Closed2026-01-21T11:25:31.934146["PUR"]NN2025-03-2620250319j&+a A    !                NCR-TW202506002NCR-TW202506002-å·è¡çç¯æ£æªæ½æµç¨èç¨åºä¸ç¬¦-20250603NCRTW202506002å·è¡çç¯æ£æªæ½æµç¨èç¨åºä¸ç¬¦Closed2026-01-21T14:15:12.905795["QA"]NN2025-06-1820250603q&+g A    !                NCR-TW202506001NCR-TW202506001-éè¦é¶çµä»¶æ´æä¾æåæªæåºç³è«-20250603NCRTW202506001éè¦é¶çµä»¶æ´æä¾æåæªæåºç³è«Closed2026-01-21T14:01:55.761778["PUR"]NN2025-06-1720250603Q%+{I A    !              NCR-TW202505001NCR-TW202505001-é§åå¨é¢ç½©ç¼ºå°PMSè¨å-20250522NCRTW202505001é§åå¨é¢ç½©ç¼ºå°PMSè¨åClosed2026-01-21T13:32:31.542895["RD"]NN2025-06-1220250522I%-q= A    !            INCR-TW202503002INCR-TW202503002-æªæ´æ°ç¢ºæä¸»è¨å-20250319INCRTW202503002æªæ´æ°ç¢ºæä¸»è¨åClosed2026-01-21T13:14:32.447756["RD"]NN2025-03-2620250319«-m A  !             INCR-HT202509002INCR-HT202509002-HL858A3-LCDæ·å-ME21-20250911INCRHT202509002LCDæ·åClosed2026-01-26T16:38:44.330173[]NME21HL85L %+uC A    !            NCR-TW202503005NCR-TW202503005-æªæ¯å£å¯©æ¥åè³ªæ¿ç-20250319NCRTW202503005æªæ¯å£å¯©æ¥åè³ªæ¿çClosed2026-01-21T11:23:55.391465["QA"]NN2025-03-2620250319&+ + A[+1 !              NCR-TW202503004NCR-TW202503004-HL858A1, HL858A1-B-æ¶ç´è¢ç¼é-ME21-20250314NCRTW202503004æ¶ç´è¢ç¼éClosed2026-01-21T10:02:16.045145["QA", "PUR", "SUP:\u5ee3\u9054\u5229"]NME21Q4-2025ME210003HL858A1, HL858A1-BN2025-03-2720250314M%+uC A    !            NCR-TW202511002NCR-TW202511002-ç£ç®¡ä»£çæ©æ§æªè©ä¼°-20251120NCRTW202511002ç£ç®¡ä»£çæ©æ§æªè©ä¼°Closed2026-01-21T17:25:36.608542["PUR"]NN2025-12-0820251120=%+g5 A    !             NCR-TW202511001NCR-TW202511001-PFMEAé¢¨éªæªéä½-20251120NCRTW202511001PFMEAé¢¨éªæªéä½Closed2026-01-21T17:17:50.176417["RD"]NN2025-12-0820251120X&+O A    !                NCR-TW202510003NCR-TW202510003-é æ´æ°é¢¨éªç®¡çå ±åç¨åº-20251016NCRTW202510003é æ´æ°é¢¨éªç®¡çå ±åç¨åºClosed2026-01-21T17:11:11.443161["RD"]NN2025-11-1720251016j&+a A    !              NCR-TW202510002NCR-TW202510002-è¨è¨æ¸¬è©¦è¨åèå ±åä¸ç¬¦åç¨åº-20251016NCRTW202510002è¨è¨æ¸¬è©¦è¨åèå ±åä¸ç¬¦åç¨åºClosed2026-01-21T17:03:42.201897["RD"]NN2025-11-1020251016k&+a A    !            NCR-TW202510001NCR-TW202510001-è¨è¨æ·å²æªæ¡æ¥æª¢è¡¨ä¸ç¬¦åç¨åº-20251016NCRTW202510001è¨è¨æ·å²æªæ¡æ¥æª¢è¡¨ä¸ç¬¦åç¨åºClosed2026-01-21T15:18:03.860384["RD"]NN2025-11-1020251016K%+uC A    !               NCR-TW202506003NCR-TW202506003-åå¨æ ¡æ£ä¸ç¬¦åæ¨æº-20250603NCRTW202506003åå¨æ ¡æ£ä¸ç¬¦åæ¨æºClosed2026-01-21T14:48:48.992429["QA"]NN2025-06-1820250603 :µ<Úx ³ Pî¶{C
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