医疗产品历史纪录控制.doc

Nypro Plastics & Molding Rev.Date.Total Pages.Products (Suzhou) Co., Ltd.版本日期总页码C2007.02.077Title: Control of Device History recordPrepared by/DateReviewed by/DateApproved by/Date医疗产品历史纪录控制编制/日期审核/日期批准/日期Doc No: NSU-2402-QC-005Frank Li Yookie WangYong CWCONTENTS PAGE CONTENTS 1AMENDMENT HISTORY 21.0PURPOSE 32.0SCOPE 33.0DEFFNICATIONS&ABBREVIATION 34.0RESPONSIBILITIES AND AUTHORITIES 35.0PROCEDURE 4-56.0QUALITY RECORD 67.0QUALIFICATIONS AND TRAINING 78.0 ASSOCIATED PROCEDURES AND REFFERENCES 7 耐普罗塑胶模具(苏州)有限公司Nypro Plastics & Molding Products (Suzhou) Co., Ltd.Amendment HistoryAmendment History修改历史记录ChangeDate变更日期Rev.No.版本编号 Description of Changes 变更说明Prepared by:编写人Approved by:批准人 2006-2-14AInitial release SissiLuke2006-5-09BAmended point no. 6.3Zeng DefangLuke2007-2-07CAmended point no. 4.0,5.0,8.0Frank li Yong1.0 PURPOSE 目的To establish and maintain procedures to meet the requirements of CFR 820.184, to ensure that DHRs for each batch, lot, or unit are maintained to demonstrate that the device is manufactured in accordance with the DMR and the requirements of the respective part. 按照CFR 820.184 的要求建立和维护程序，以确保与DMR和产品的要求一致的每批 或者每单元的产品历史记录的维护。2.0 SCOPE 范围DHR will be prepared only for medical products只适用于医疗产品。3.0 DEFINITIONS & ABBREV IATIONS 定义和缩写 3.1 DHRDevice History Record, based on the requirements of DMR, basically a lot-specific file or the production lot record. A document is needed to establish the contents of the DHR.产品制造历史记录，基于DMR的需求，基本上是一个基于专用批或者生产批次的记录。需要一个文件来建立DHR的内容。 3.2 QD Quality Department 质量保证3.3 QM Quality Manger 质量经理3.4 CQE Customer Quality Engineer 客户质量工程师 3.5 BOM Bill of Material原材料清单 3.6 DCC Document Control Centre文控中心3.7 QC Quality Check 质量检验 3.8 MRB Material Review Board 物料评审委员会 3.9 PMC Production Material Control 生产物料控制 4.0 RESPONSIBILITIES AND AUTHORITIES 职责和权限4.1 QA Section 质量保证 QA Manager Build and maintain the DHR. QA Manager建立和维护DHR。 CQE Define DHR requirement. CQE 定义DHR需求。 CQE Transfer the DHR requirements to relating department. CQE 将DHR需求传递给相关部门。 CQE/DCC Define lot no format, structure and documentation. CQE/DCC 定义批号格式、结构和文件化形式。 QC Perform pre-shipment audit, verify DHR every shipment. QC 执行出货的检查，每批出货检查DHR。 QC Release products after the review of DHR records. QC 依据DHR记录结果发放产品。 QC Collect and transfer records to DCC QC 每天收集并移交记录给DCC。 4.2 DCC 文控中心 Keep records by above lot no format. 依据以上格式保管相关记录。 4.3 Production department 生产部门 Records. 记录。 Collect records and transfer it to QC. 每班收集记录并交给QC.5.0 PROCEDURE 程序 5.1 Develop template according to product structure; 依据产品结构建立模板； 5.2 Define information needed. Information needed in DHR:明确需要的信息。在DHR需要的信息如下： 5.3 Materials information 原材料信息5.4 Production traceability data information 产品生产追溯数据信息5.5 The label or labeling records used for each production unit 每个生产单元的标签或鉴别方法 5.6 The dates and the quantities of manufacture 制造日期/制造数量5.7 Key production run sheets 各种关键生产运行表格 5.8 Quality assurance test reports 质量保证测试报告 5.9 Deviation notices or discrepancy statements during the manufacture of lot 每个制造批次的偏差说明5.10 Results of test failure investigations 不合格产品的调查结果 5.11 Define the records according the requirements above; 根据以上需求定义需要的记录； 5.12 Implement the records collection, check, product release and storage. 执行记录收集、检查、产品放行、记录归档保存工作。 5.13 General steps and roles assignment 正常步骤与职责分工流程如下:ProcessThe normal process as below 正常流程如下:Roles:Time requirement:Records kept by Lot No.记录按批次归档保存QCProduction/QCCQEQMCQEEach shift in productionEach shift in productionEach shift in productionRecords Check记录检查After DHR finishedBefore productionEach dayMeet requirements? 是否满足要求?Before productionBuild and maintain the DHR建立和维护DHRBefore productionDefine DHR requirement定义DHR需求Transfer the DHR requirements to related department传递DHR需求给相关部门 Records按DHR要求记录Collect records 收集记录Production/QCQCNYQCProduct release产品放行DCC6.0 RECORDS 記錄 6.1 For each device or project, need to define the required DHR records due to product structure.对于每个具体的产品或项目，需要根据产品的特性定义DHR具体需要的记录。6.2 Records keeper: DCC 记录保管者：文控中心6.3 Records store requirement 记录保管要求No less than 7 years, according to GMP requirement or as per the Customers requirement; whichever is greater. 依据GMP标准不少于7年。或者按照客户的要求。7.0 QUALIFICATIONS AND TRAINING 培訓要求 The record collecting people need additional training for DHR requirements.记录收集人员需要专门的DHR要求培訓。8.0 ASSOCIATED PROCEDURES AND REFERENCES 相关程序和参考文件 Document control procedure (NSU-2402-QC-001)文件控制程序 (NSU-2402-QC-001)Control of Quality records procedure(NSU-2402-QC-002)记录控制程序 (NSU-2402-QC-002) D