# records

uniqueId: NCR-TW202601001
fullFileName: NCR-TW202601001-MDR稽核-20260108
category: NCR
site: TW
yearMonth: 202601
sequence: 001
customName: MDR稽核
status: Closed
timestamp: 2026-01-19T16:39:46.955255
responsibleUnit: ["RA"]
recurring: N
stopAlert: N
closingDate: 2026-02-06
severity: MI
handlingDesc: 品質系統無不合格品
issueType: 文件缺失
source: 稽核
issuer: Cherry
respUnitType: Dept
respUnitName: 法規部
respPerson: Joanna
fileDate: 20260108
exceptionDesc:
Multiple 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.

rootCause:
No formal procedure or section within the QMS explicitly defines what constitutes a substantial change.

correctiveAction:
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 04


uniqueId: INCR-TW202503001
fullFileName: INCR-TW202503001-簽核欄位與程序書不符-20250319
category: INCR
site: TW
yearMonth: 202503
sequence: 001
customName: 簽核欄位與程序書不符
status: Closed
timestamp: 2026-01-21T11:41:12.503422
responsibleUnit: ["RD"]
recurring: N
stopAlert: N
closingDate: 2025-03-26
severity: MI
handlingDesc: 程序問題無不合格品
issueType: 不符合程序
source: 稽核缺失
issuer: Jack
respUnitType: Dept
respUnitName: 研發部
respPerson: Ray
fileDate: 20250319
exceptionDesc:
經查 MF-858DK003-US (A003) Design FMEA Matrix 設計失效模式效應分析矩陣表, 
a.) 有符合程序 5.2.1 過程已被文件化並實施, 也符合程序6.2 ~ 6.5 進行風險估算與評估.
b.) 6.6.1 專案負責人須對文件進行簽核, 以確保其正確歸檔在風險管理檔案及DHF.  但簽核欄位並無專案負責人, 與程序不符


uniqueId: INCR-VN202603003
fullFileName: INCR-VN202603003-HL868EA-上殼黑點刮傷-JO03-20260313
category: INCR
site: VN
yearMonth: 202603
sequence: 003
customName: 上殼黑點刮傷
status: Open
timestamp: 2026-03-16T13:12:07.246288
responsibleUnit: ["PUR", "SUP:\u5929\u9577"]
recurring: N
customerCode: JO03
model: HL868EA
stopAlert: N
exceptionDesc: 黑点（20PCS)，刮伤(6PCS)
severity: MI
handlingDesc: 1. 立即确认厂内生产机台及库存成品，无此类划伤情况； 2. 长途运输避免划伤，需要增加保护措施（目前保护措施已很完善，若再加增保护措施可能涉及成本增加，请贵司给与明确答复）；
issueType: TYPE1
source: IQC
issuer: RUBY
respUnitType: Supplier
respUnitName: 正亞
respPerson: 蘇州
fileDate: 20260313
rootCause:
1.发货前产品车间是100%全检的，员工生产/检验时都是对照贵司点规标准执行，可能长时间盯着产品看会出现眼疲劳导致有漏超标准的黑点情况。（贵司能否提供不良实物，不良比例）
2.确认在全检时未发现此类划伤，判断为长途运输过程中磕碰、摩擦，导致表面出现划伤痕迹。

correctiveAction:
1.	立即确认厂内生产机台及库存成品，无此类划伤情况；
2.	长途运输避免划伤，需要增加保护措施（目前保护措施已很完善，若再加增保护措施可能涉及成本增加，请贵司给与明确答复）；
Explain
1.	黑点：盯着产品看半小时后，抬头看下远处，放松下眼睛，不要长期盯着产品看。
2.	划伤：若是可以增加保护措施，减少长途运输过程中造成的，磕碰、摩擦伤害。


uniqueId: NCR-TW202604003
category: NCR
site: TW
yearMonth: 202604
sequence: 003
customName: 2026BSI外稽研發處缺失，對設計變更 #PR-202505004 的審查並未在「評估預期市場和對現有/已售產品的影響」，因此對加拿大監管管轄區的影響沒有得到充分評估。
status: Open
timestamp: 2026-04-30T18:28:19.400183
responsibleUnit: []
recurring: N
customerCode: NA
model: NA
stopAlert: N
fileDate: 20260430
fullFileName:
NCR-TW202604003-NA-2026BSI外稽研發處缺失，對設計變更 #PR-202505004 的審查並未在「評估預期市場和對現有/已售產品的影響」，因此對加拿大監管管轄區的影響沒有得到充分評估。-NA-20260430


uniqueId: NCR-TW202604004
category: NCR
site: TW
yearMonth: 202604
sequence: 004
customName: 臨床評估報告 [(#TH-100K008)，修訂版 04，日期 2024-07-30]舊版設備臨床評估報告中的預期用途聲明與已核准的使用說明書 (IFU) 及相關技術文件不一致。
status: Open
timestamp: 2026-04-30T18:31:36.169751
responsibleUnit: []
recurring: N
customerCode: NA
model: NA
stopAlert: N
fileDate: 20260430
fullFileName:
NCR-TW202604004-NA-臨床評估報告 [(#TH-100K008)，修訂版 04，日期 2024-07-30]舊版設備臨床評估報告中的預期用途聲明與已核准的使用說明書 (IFU) 及相關技術文件不一致。-NA-20260430


