MP001记录控制程序

1、精选优质文档-倾情为你奉上Security Level保密级别: Top Confidential 绝密 Confidential机密 Controlled受控 Common普通 Doc. Name/文件名称： Record Control Procedure记录控制程序Doc. NO/文件编号：MP-002Issued Edition/发行版本：A/2Prepared by/制定： Date/日期： Checked by/审核： Date/日期： Approved by/批准： Date/日期： Signature 会签Signature Department会签部门Signature/Da

2、te签名/日期Signature Department会签部门Signature/Date签名/日期Signature Department会签部门Signature/Date签名/日期 生产一部PROD 生产二部PROD 人力资源部HR 营销部MKT 采购部PUR 品质部QA 财务部FIN 物控部PMC 工程技术部TD 产品开发部R&D 厂房部/厂长室FE 其他 OTHERDistribution分发Distribution Department发放部门Quantity 份数Distribution Department发放部门Quantity 份数Distribution Depa

3、rtment发放部门Quantity 份数 生产一部PROD 生产二部PROD 人力资源部HR 营销部MKT 采购部PUR 品质部QA 财务部FIN 物控部PMC 工程技术部TD 产品开发部R&D 厂房部/厂长室FE 其他 OTHER History of Modification修改历史纪录Ver.版次Modification description修改描述Date of changed变更日期PreparedBy 作者ApprovedBy 批准Department部门A/0New issue新发行2013-1-5罗飞黄谦品质部A/11、 部门名称变更2、 部门职能变更3、文件字体统

4、一2014-1-10李勇婵黄谦品质部A/2修改条款//5.5.7/5.7.12014-5-14石开发许瑞品质部1.Purpose/目的Standardization control and manage the records of the quality / environmental, ensure the records are complete and effective, provide objective evidence to prove the products meet the specified system effectively runnin

5、g, and provide the prove to the tracing of product quality and the implement of corrective / prevent actions.规范控制和管理质量/环境等记录，确保记录的完整、有效，为证明产品满足规定的体系有效运行提供客观证据，并为产品质量的可追溯性和采取纠正、预防措施的行动提供依据。2.Scope/范围 Applies to all the quality / environment standards system records.适用于所有质量/环境标准等体系内的质量记录。3.Definition/

6、定义 The definition refer to ISO9001：2008 /ISO14001:2004.采用ISO9001：2008 /ISO14001:2004中的定义。4.Responsibility and authority /职责和权限4.1 Each department is responsible for design and management of the record to ensure the records are complete and effective.各部门负责相关记录表单的设计与管理，确保记录的完整、有效。4.2 The recorder to f

7、ill out the record follow the requirement and to ensure the record is authenticity.记录人员按要求填写记录，并确保其真实性。4.3 The department of record using is responsible for the identification, sorting, use, preservation and disposal.使用部门负责记录的标识、整理、利用、保存和处置。4.4 Each departments supervisor is responsible for the audi

8、ting of the correctness, completeness and timeliness about the record.各部门权责主管负责记录之正确性完整性和时效性的审核。4.5 DCC: Need to establish “Record Management List” and to control the S/N and the issuance.文控中心:需建立记录管理清单，控制记录的编号和发放。5.Procedure Contents/程序5.1 Record sheet formation， checked and approved.记录表单的编制、审核与批准5

9、.1.1 Record form draws up by the relative department staff, the relative (quality) form and documents need be draft and approved together during preparation / revision of the first lever document (quality manual), the second lever documents (procedure documents) or the third lever documents记录表单由各部门相

10、关人员编制，在编制/修订一阶文件（质量手册）、二阶文件（程序文件）或三阶文件时，相关控制流程的管理（质量）表单与文件一起编制并得到审批。5.1.2 Record form format: 记录表单的格式： The record form contents should be set to reflect the main contents and effects during the implementation of quality / environment activities, and set the appropriate and fully records for t

11、racking, such as the record date, the recorder and so on.记录表单项目的设置应能反映质量/环境等活动实施的主要内容和效果，并设置充分适宜的记录可追溯项目，如记录日期、记录人等 Head of the record：Company "logo" locate in the top left corner, the Chinese company name (no need English name here, other documents specified the fixed format or hav

12、e special requirements except) center, use the 4th（14） block letter Brand new Microsoft Yahei font ,the name of the form used the small 4th（12）song typeface font word below the company name; Content: use used the 5th song typeface.记录台头：公司“logo”居左侧，公司中文名称（此处不需要英文名称，其他文件中规定了固定格式的或有特殊要求的除外）居中，采用四号（或14号

13、）微软雅黑加粗字体，表单名称用小四号（或12号）宋体加粗，位于公司名称下面；记录正文,正文用五号宋体字。 Form number with a small 5th song typeface fonts and preceded by "No.:"，locate the side of the right-aligned, record number aligned to the upper right side in the form and set "No:" or "record number:" in this

14、location for filling in the record number when requirement. 表单编号用小五号宋体字，居表单下侧向右对齐，并在前面加“No.”；记录编号在表单上侧靠右对齐设置“No.”或“记录编号”字样，以方便填写视需要给出记录编号。 If the other first lever, second lever or third lever documents as define the record form format, the format need accordance with the prescribed format. B

15、ut all the formats should be first reference to the provisions of this procedure firstly (including logo, company name, font, number etc.).在除本程序外的其他一阶、二阶或三阶文件里已经规定的表单格式依据已规定的格式执行。但所有格式应首先参照本程序之规定的应有的格式（包括logo，公司名称、字体、编号等）。5.1.3 Record number of the form: the record contents of the form should includ

16、e the company logo / name, name of the form, the form number, record date, encode regulations implement according as “Document Control Procedure”. All records must be able to fully express the desired quality information, can be traced to achieve the level of quality and to determine the effectivene

17、ss of the quality management system.记录表单的编号:记录表单内容应包括公司logo/名称、表单名称、表单编号、记录日期等, 其编号规定依文件控制程序执行。所有记录必须能充分表达所需质量信息,可以追查所达到的质量水准,并能判定质量管理体系的有效性。5.1.4 The record can exist in the form of text or software.记录可以以文字或软件的形式存在。5.1.5 Because communication, statistical analysis (does not include all types of pro

18、duct / process monitoring records), the report conclusion, the temporary and not commonly used form that each departments of the company prepared, can be exempted from the form editorial process and preparation requirements in this procedure.公司各部门因应联络沟通、统计分析（不包括各类产品/过程监测记录）、报告总结需要而编制的临时性、不常用的表单，可免于以

19、上表单编审流程和编制要求。5.2 Record form management记录表单的管理5.2.1 DCC needs to establish “Records Management List” 文控中心需建立记录管理清单。5.2.2 The modify of record form must be strictly implemented in accordance with the “Document Control Procedure”, all of the departments will be not allowed to change.记录表单的修改必须严格按文件控制程序

20、执行，各部门不得擅自更改。5.2.3 The record form need to be ordered by the Purchasing Department, Document Control Center provides the recent version of the form format to PUR.需订做的记录表单由采购部统一安排，文控中心提供最新版本的表单格式。5.2.4 All departments must stop to use the old revision form when new record form format release and DCC

21、recycle the old revision. Form must be strictly implemented in accordance with the “Document Control Procedure” .新版本的记录表单生效后，各部门必须将不再使用的旧版表单交文控中心作废。必须按文件控制程序执行。5.3 Records fill and modify记录的填写及修改5.3.1 Records should be filled and arranged by the relative department which use the record form, and fol

22、low the procedure documents/SOP;记录由所在部门相关人员按程序文件或作业指导书的要求及时填写和整理。5.3.2 The recorder must fill in the record according with actual results, the records should be truthful, timely, complete, and indicate the recording date and the name of the recorder.记录填写时,记录人员按实际结果做好记录,应做到真实、及时、完整，并注明记录日期和记录人姓名。5.3.

23、3 Records should be possible to be formatting and standardization, and not allow to be modified;记录应尽可能做到格式化、规范化，不得随意涂改。5.3.4 Records exist in the form of text should be legible, neat, easy to identify / easy to save, it can not use a pencil to fill; records shall be filled out completely according a

24、s requirement, the NA column can replace use”/”or”.以文字形式存在的记录应做到字迹清晰、工整、便于识别/保存，不能用铅笔填写；记录应按要求填写完整，不适用的栏目可画斜线。5.3.5 Records be entered into the computer is completely consistent with the original recordings, it can not be changed if not got consent. 输入电脑的记录应与原始记录内容完全一致，未经授权人同意不得更改。5.3.6 If need to m

25、odify the record because of filling wrong information or others. in principle, the correction fluid are not allow to be used. The modification that directly related to the product quality (such as data, determine YES / NO, date, etc.), it is required to add the Strikethrough ("-" symbol) o

26、n the error place, then write the correct information in the next blank space, and signature or cover the seal then write the modify date.因填写失误等原因要进行记录修改时，原则上不得使用涂改液。与产品品质直接有关的记录（如数据、判定YES/NO、日期等）修改时，须以删除线（""符号）划错误处，再写正确资料于旁边空白处，并签名或盖章及修改日期。5.3.7 Should let recorder to change or let the re

27、corder know the content has been changed. 应当让记录编制人更改或者使其知道已经更改和更改的内容。5.4 Records approved 记录的审批5.4.1 Direct supervisor of the recorder check and audit the records, the second high lever supervisor approve the records. The auditor and approver should be checked the correctness, completeness and timel

28、iness of the records, then marked the approval date.记录填写人员的直接上级审核，再上一级批准，审批者应核准记录填写的正确性完整性和时效性，并标注审批日期。5.4.2 The record has defined the approval authority in relevant documents, need according with the provisions 相关记录有文件规定审批权限的依据相关文件规定。5.4.3 If quality records have changed, the records should be rec

29、onfirmed after corrections.质量记录有更改的应在更正后再次确认。5.5 Classification, archiving and preservation of the records记录的分类、归档与保存5.5.1 For searching expediently, every department should establish “Records Management List”.为查阅方便，各部门应建立记录管理清单。5.5.2 Record implement centralized management and department management

30、, the records collection, classification and cataloging follow date order,. DCC is responsible for the centralized management of records, preparation the “Records Management List” and auditing departments recorded control status; each department set up a part-time record administrator, the administr

31、ator responsible for the “record list” preparation, and responsible for collection, classification, storage, protection, retrieval (similar records can be retrieved through product, date, department, customers and so on), shelf life and disposal.记录实行归口管理和按部门分管的办法，记录按日期为序收集、分类编目和整理。DCC负责记录的归口管理、编制记录管

32、理清单和检查各部门记录的控制情况；各部门设兼职的管理员，管理员负责编制本部门的“记录管理清单”，并具体负责本部门的文件资料和记录收集、分类、贮存、保护、检索（同类记录可按产品、日期、部门、客户等加以检索）和保存期限及处置的管理事项。5.5.3 IT assist DCC to be responsible for the management of electronic records, storage, identification, protection, to prevent the loss of data or virus infection.网络管理员协助DCC负责电子记录的管理，

33、定期存盘，按时作好标识、贮存和保护管理工作，防止数据的丢失或病毒的感染。5.5.4 The relevant departments should be collected and included in the centralized management for the records from the supply-side.来自供方的记录，应由相关部门收集后纳入归口管理。5.5.5 Storage life保存期限 For the records that the contents remain unchanged after filled in, can be dete

34、rmined the fixed storage life, Relevant quality records, normally the storage life of the records are two year (except special provisions); report file important records and other data, at least two years or more, Employee training records are storage to the employee turnover, Management review reco

35、rds kept for at least three years, School records and other machines, instrument, relative record data and, if necessary, kept up to scrap the equipment.对于记录中一旦记载后，内容保持不变的，可确定固定保存期，有关质量记录,一般保存期限为2年（有特殊规定的除外）；重要记录报告文件等数据，至少保存二年以上，但员工教育训练记录，则保存至该员工离职,管理审查会议记录至少保留三年,机器、仪校记录等，相关记录数据，必要时得保存至该设备报废为止。5.5.5

36、.2 The storage life is permanent about below records: Engineering /Process Experiment records, Engineering /Process Experiment report, technical development information, Engineering /Process Experiment change and so on. 各种工程实验过程记录、工程实验报告、技术开发资料、工程变更等等，保存期为永久。 The records storage life in less

37、than one year (including one year) and the dynamic record of no fixed storage life, need to collect, classify and preserve by the using department; The records storage life in more than one year, need to collect, classify, preserve and mark by record administrator of the using department and transfe

38、r to DCC base on determined time limit.保存年限在一年以内的（含一年）的质量记录和无固定保存期限的动态记录，由本部门负责收集、整理和保管；保存年限在一年以上的，由本部门文件和资料管理员收集、整理、装订和标识，按规定期限移交DCC归档。 For the records need update timely, the latest version (the effective date of records need to recalculate from the updated date) need be saved by relative d

39、epartment. Such records, such as: BOM, product list.对于记录内容随时间发生变化的，应进行及时更新，由各部门保存其最新版本（记录更新后的有效期从更新日期起重新计算其有效期）。此类记录如：相关资源清单、产品名录等。5.5.6 The protection of records记录的保护 Records shall be kept in a suitable environment, and pay attention to fire, moisture, and injurious insect, prevent damage an

40、d loss;记录应保存于适宜的环境，并注意防火、防潮、防虫害、防止损坏和丢失。 The important records entered into the computer need keep a backup. The floppy disk, CD-ROM, etc. should be identified, and safekeeping, transfer to DCC unified management if necessary.输入计算机的重要的记录应有备份，软盘、光盘等应进行标识、并妥善保管，必要时应交DCC统一管理。 Each departm

41、ent need to manage the record regularly, bookbinding, cataloging, archiving, and for safe-keeping, in order to avoid data corruption and lost. When the same file to store different types of records, need to use mark or index table for convenient searching.各部门定期整理记录，加以装订、编目、归档, 并作妥善保存，以免资料损坏、遗失。同一档案存

42、放不同类型记录时，应使用标识或索引表，以利查阅。5.5.7 Provisions of the record transfer 记录移交规定The records that need to transfer to DCC for storage should be kept for six months in the original department in order to provide support to improve. Then transfer to DCC on the 10th of the seventh month. It is need to fill in “Do

43、cument/record transfer form” and sign both of the transfer persons name between transfer department and DCC. When there are special circumstances can not be transfer on time, need to explain the reasons, such as purchases or sales contract. 需移交DCC保存的记录，应在原部门保存六个月以便及时为改进提供支持。在满六个月的次月10日前移交给DCC。移交部门应和

44、DCC办理交接手续，填写文件/记录移交表，并经双方当事人签名。当有特殊情况不能按时移交应说明原因并申明移交限期，如采购或者销售合同。5.6 Record lending 记录的借阅5.6.1 Except the saving department, the direct supervisor and above can directly lending, the other lending provides is as follows:公司内除保存部门、直属主管及以上级别可直接取阅外，其它借阅规定如下： The record that only use in designat

45、ed places and not lend out need agreed by the management staff , need to send back on the spot after used.只在指定场所查阅而不借出时，需经管理人员同意，查阅完毕当场归还。 The records that need lending outside required borrowers to fill “Records Lending Application”, it can be lent out after the department supervisor who keeps the record approved.若需借出本部门外，需借出人填写记录借阅申请单，经保管该记录的主管审批后可借出。 When t