1、文件控制程序Nypro Plastics & Molding Rev.Date.Total Pages.Products (Suzhou) Co., Ltd.版本日期总页码Q2008-6-3011Title: Document Control ProcedurePrepared by/DateReviewed by/DateApproved by/Date文件控制程序编制/日期审核/日期批准/日期Doc No: NSU-2402-QC-001Zhao AnnieHuang YingBill Luo CONTENTS PAGE AMENDMENT HISTORY 2 1.0 PURPOSE 3
2、2.0 SCOPE 3 3.0 RESPONSIBILITIES 3 4.0 PROCEDURE 3-10 5.0 RELEVANT DOCUMENT 10 6.0 QUALITY RECORD 11 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 12/20/2
3、001AInitial release Huang ying Luke01/08/2002BExplain detailed approval, issuing of documentsHuang ying Luke01/25/2002CAdd 4.5.2Huang ying Luke06/04/2002DModify 4.1,4.2.2,4.2.3Huang ying Luke2002/12/11EAdd QS9000 document concoctHuang ying Luke6/3/2003FModify 4.2.2, 4.2.3HansenWang Xian Fa6/29/2003G
4、4.4.7,4.4.8 deleted;4.4.1, 4.4.2, 4.5,4.6.1, 4.4.8,4.4.10 changed;NSU-4402-QC-004 updatedHansenWang Xian Fa7/29/2003HAdd 4.4.6HansenWang Xian Fa5/30/05IModify4.2.2,4.4.7,4.6.1Huang yingLuke11/30/05JModify4.4.8Huang yingLuke2/14/06KChange the formatHuangyingLuke6/22/2006LAdd the HSF document requirem
5、ent BettyLuke22/9/2006MModify 4.2.2 / 4.5.2Zeng defangYong Cheewoon17/11/06NModify 4.5.2Zeng defangYong Cheewoon1/18/07OAdd 4.4.14Zeng defangYong Cheewoon4/3/07PModify 4.3.4Zeng defangYong Cheewoon6/30/08QModify 2.0Zhao AnnieBill Luo1.0 Purpose目的The purpose of this procedure is to control documents
6、during the implementation of quality system and HSF system, ensure the documents are properly controlled. 本程序的目的是在质量体系及HSF体系运作中对文件和资料进行控制，确保文件受控.2.0 Scope范围 This Document Control Procedure applies to Nypro Plastics & Molding Products (Suzhou) Co., Ltd. This procedure is applicable to all the quality
7、 system documents and data, including external documents.本程序适用于耐普罗塑胶模具(苏州)有限公司与质量体系相关的文件及资料的控制，包括外来文件.Control of Document and Records shall include any form or type of medium.文件和记录的控制应包括任何表单或媒体的类型.3.0 Responsibilities职责3.1 Document Control personnel in QC Dept is responsible for the control of quali
8、ty system related documents and data, including external documents. 质量部文件控制人员负责与质量体系相关的文件及资料的控制，包括外来文件.3.2 All function departments are responsible for keeping documents and data used in each Dept. 各职能部门负责本部门所使用文件和资料的保管工作.4.0 Procedure 程序4.1 Document and data Level 质量体系文件和资料的级别分类 Level 1 Quality Man
9、ual一级文件：质量手册Level 2 Quality Procedures二级文件：程序文件Level 3 Work Instructions, Technical documents, Drawings, ECN, Process Flow Chart, Quality Plans and so on, 三级文件：作业指导书,技术文件,图纸,工程变更,过程控制图, 质量计划等Level 4 Quality Records/ Forms四级文件：质量记录/表格4.2 Compilation, Approval and Issuing of Documents and Data. 文件和资料的
10、编写、批准和发布4.2.1 Quality manual (Level 1) shall be compiled by the Management Representative and approved by GM; All procedures (Level 2) shall be compiled by each department and reviewed by involved department manager and approved by MR before issued.质量手册(一级文件)由管理者代表组织编写，由总经理批准后发布；程序文件(二级文件)由各部门组织编写，由
11、涉及到的部门经理审核，管理者代表批准后发布。4.2.2 Level 3、 Level 4 documents shall be compiled by the function department reviewed and approved by involved department manager.(Medical document final approved by QA.第三级文件和第四级文件由各职能部门组织编写并由所涉及到的部门经理审核，批准后发布。（医疗文件最终由QA批准后发布）4.2.3 The document shall be sent to the Document Co
12、ntrol Personnel to issue once it is approved. After issuing, department managers should supervise the understanding of the document for corresponding department members.一旦批准，文件应该递交文控人员发行。文件发行后，各文件接收部门经理应组 织本部门相关人员阅读并理解相应文件。4.3 Document Revision and Change 文件修改和变更程序4.3.1 To prevent any unauthorized c
13、hanges to the document, all changes shall be formally proposed through the Change Request /Issue Inform (NSU-4402-QC-004) by the Dept. Supervisor or Engineer requesting the change. The change shall be done through editing, reviewing and approving according to the procedure. 为防止对文件任何XX的修改，所有修改必须由部门主管
14、或工程师通过填写变更申请单/分发通知单(NSU-4402-QC-004)，正式提出申请.按照程序编制、审核、批准后实施更改。4.3.2 The changed documents shall be reviewed by original reviewer in principle. When original reviewer is out of duty, they shall be reviewed by personnel relay his position. 更改后的文件原则上由原审批人进行审批，当原审批人不在职时可以由接替其岗位的人员审批。4.3.3 The changed do
15、cument and Change Request shall be sent to the Document Control Personnel for update accordingly once it has been approved. 批准后，修订的文件和变更申请单都应送交文件控制人员以便作相应的更新.a) Update the version 版次升版 b) If documents have changes, the changes need to be recorded in the Amendment History (NSU-4402-QC-005). 当文件需要修改时,
16、需在修改历史记录中(NSU-4402-QC-005).反映出这些变更c) Update the original copy. 更新原件 4.3.4 Quality manual shall start from A. After documents have been changed, edition should not be changed, Revision of this item will be increased from 0 to 1,2.If Quality manual need great change.质量手册版本从A开始。文件修改后，版本保持不变但该条款修订栏从0依次递
17、增为1，2，如遇大的改动应立即升版.4.3.5 The others document revision shall start from A. The subsequent revisions will be B,C,D. 其他的公司文件版本从A开始.文件升版后，版本递增一个版次，以B、C的形式升版.4.4 Document Issue, Retrieval and Obsolete Document Control 文件分发、收回和作废文件控制4.4.1 Uncontrolled documents are the documents that are issued to customer
18、s, suppliers, third parties. And the issue shall not affect the normal product activity. All uncontrolled documents issued shall be stamped “Nypro (suzhou) Co., Ltd. Uncontrolled Document” and DC shall record the issue. It is not necessary to inform the update of uncontrolled document.非受控文件是指向公司外（如客
19、户、供应商、第三方）发放的公司文件与资料，并且该发放不对公司生产产生影响。非受控文件由文控人员在文件上加盖“耐普罗(苏州)公司 非文件受控”章。文控人员需对非受控文件的发放进行记录，但不负责版本更新。4.4.2 All issued controlled documents shall be stamped “Nypro (Suzhou) Co., Ltd. Control Document”. Unauthorised duplication of controlled copy is not allowed. System Document shall be issued by the D
20、ocument Control personnel according to the Change Request/Issue Inform filled by issuing Dept.颁发的受控文件应盖有“耐普罗(苏州)公司 受控文件” 章，未经允许复制受控文件是不允许的.体系文件由文控人员按照发出部门填写的文件分发通知单发放.分发代码如下： GM-General ManagerQC-Quality control DeptEN-Engineering DeptPD-Production Dept总经理质量部工程部生产部 MK-Sales&Marketing Dept FL-Facilit
21、yDept IT-InformationTechnology Dept HR&AMHuman resource and administration Dept市场销售部 设施部 信息部 行政人事部MR-MaterialDeptFA-Finance DeptHVS-High Velocity System Dept 物料部 财务部HVS部 4.4.3 The DC shall raise the Issue/Receipt (NSU-4402-QC-003) to effect the changes of the documents with the registered holders. 文
22、件控制人员应该使用签收单(NSU-4402-QC-003)，使得在签收单上签名的文件持有人随后能得到有效的变更文件.4.4.4 The DC shall maintain the Document Distribution Record (NSU-4402-QC-002) where each issuance of the document shall be registered. 文件控制人员应该保存文件分发记录(NSU-4402-QC-002)，文件的每一次分发都应有必要的记录.4.4.5 Upon receipt of an updated document, the recipien
23、t shall again register on the Issue / Receipt and return the obsolete copy(s) to the DC for disposal. 收到最新文件时，接收方应该在签收单上登记，并且将作废文件交还文控人员处理。4.4.6 When the document release objects are reduced upon the organization adjustment or the evaluation to document release range, all the documents shall be with
24、drawed from relative departments/persons. 当公司的组织结构发生调整或者经评估减少文件发放对象时，之前发放给相应部门或个人的文件需要全部收回。4.4.7 The original obsolete documents shall be stamped “Nypro (suzhou) Co., Ltd. obsolete” and kept for future reference. The period is the lifetime of the medical device or relevant regulation or customer req
25、uirements.作废文件的原件盖上“耐普罗(苏州)公司 作废”章.并由文控人员保留，以备查考.其年限是产品的生命周期或相关法律或客户要求。4.4.8 The obsolete documents for medical device should retained for a period, the period shall ensure that documents for which medical devices have been manufactured and tested are available for at least the lifetime of the medic
26、al device as defined by our company, but not less than the retention period of any resulting record, or as specified by relevant regulatory requirements.医疗器械的作废文件须保存一段期限，该储存期限应保证医疗器械的制造和测试纪录在公司规定的寿命期内，并不少于品质纪录的储存期限内，或相关的法规规定的期限内可以得到。4.4.9 Document Requisition Form(NSU-4402-QC-007) shall be filled in
27、 if some departments need add new documents, then approved by department manager and carried out by DC personnel accordingly. 如部门需增加新的文件，则须填写“文件申请单” (NSU-4402-QC-007)经部门负责人批准后由文控人员按文件发放规定执行.4.4.10 If a document is reported lost, the Document Requisition Form and “Document Losing List (NSU-4402-QC-00
28、9) shall be filled with the reason and signed by supervisor, DC shall re-issued a new controlled copy.如文件使用人将文件丢失，则必须在“文件申请单”和“文件丢失清单”( NSU- 4402-QC-009)上注明原因，并由主管签字。由文控人员给予补发文件。4.4.11 The Document Distribution Record list shall be updated with Re-issue on the document which is reported lost. If the
29、re is a revision, the column for Date of Withdrawal shall be updated and track for the S/N for replacement. 如果文件丢失, 重新分发的文件应在文件分发记录表中更新.如果有版本,收回日期应更新且与代替的序号对照. 4.4.12 DC should check the documents once a month in production line and record (NSU-4402-QC-014). .文控人员每个月应到生产线上检查一次文件的使用情况,做好检查记录（NSU-4402
30、- QC-014 ）。4.4.13 If documents are damaged or need change in time, relevant personnel shall transact change procedure to DC center and return damaged document, DC shall follow original controlled number, issue new documents and abolish old documents.如文件损坏需及时更换，则相关人员应到文控中心办理更换手续，交回破损文件，由文控人员沿用原文件受控号，分发新文件并销毁旧文件.4.4.14 When the photocopies of the original documents are unclear, multiple copies can be printed and approved individually. In this case, the approver shall be the same. 如果一份文件需发行几份,由于复印的不清楚,可以打印多份,由同一人签字批准.4.5 The Method for Document Concoct 文件编制方法
