Record Control记录控制和保存程序(中英文).docx

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1、批准:审核:作成:Change History变更记录Revision版本Effective Date生效日期Originator编写人Reasons for Change修改原因1.0 Purpose 目的This procedure defined the controls needed for establishment, identification, storage, protection,retention time and disposition of records and point out responsibility of related department. Andp

2、rovided evidence of conformity to requirements and of the effective operation of the managementsystem in *Automotive Mechanisms Co., Ltd.该程序规定了记录建立、标识、贮存、保护、保存期限和处置所需的控制,并指定相应部门的职责;为*汽车科技有限公司管理体系符合要求和有效运行提供证据。2 . 0 Scope 范围This procedure is applicable to the control of all * Automotive Mechanisms Co

3、., Ltd. managementrecords, including quality records, environmental related records, as well as safety managementrelated records,本程序适用于*汽车科技有限公司所有质量、环境、安全等管理相关的记录的控制过程。3 .0 Definitions 定义3.1 Form: a formatted document for recording the data and facts.表格:用来填写数据和事实的格式化文件。3.2 Record: document stating r

4、esults achieved or providing evidence of activities performed.记录:为标准在体系的运行提供证据的数据或其他一些信息。3.3 Retention periods: storage time limit for management system related documents and records,according to PTE management requirements or to satisfy regulatory and customer requirements as aminimum :保存期限:是指为了满足法

5、规、顾客要求以及本公司管理要而设定的对管理相关记录保存的最低时间期限。3.4 Hard copy: the documents or records which is printed out or written in paper硬拷贝:在纸上打印出来的文件或记录。3.5 Soft copy: the electronic format documents or records which is stored in Hard disc, video-disc,软拷贝:储存在电子档或硬盘、光盘中的文件或记录信息。3.6 DCC: Document Control Center.DCC:文控中心。

6、3.7 Document controller: the staff whos responsible for document control of a dept or the wholecompany.文控人员:部门或者公司中负责文件管理与维护的人员。4.0 Procedure and Flow chart 程序和流程图4.1 Responsibility 职责4.1.1 The Document controller of DCC is responsible for storage (on hard disk), code, registration,release of all fo

7、rms and making FN-QA-050Controlled Form List.文控中心的文控人员负责对表格进行统一存盘、编号、登记、发放并制定FN-QA-050受控记录清单。4.1.2 Each related responsibility department draft out ,use and revise applicable record form for itsown department, and make systematical and orderly storage of own departments recordsaccording to FN-QA-050

8、.各相关部门负责起草、使用、及修订本部门用于记录的表格,并按FN-QA-050受控记录清单对本部门的记录进行系统、有序地保存。4.1.3 Dept. Supervisor or Manager is responsible for auditing and validating the forms which areused in related SP (QP, EP)and Wl.部门主管或经理负责审核并确认相关程序文件和作业指导书中应用到的表格。4.2 Process Descriptions 过程描述4.2.1 Editing the form 编制表格:Each related res

9、ponsibility department draft out the form (format of applicable record) for its owndepartment各部门自行制定所需的记录表格格式。4.2.2 Numbering and registration 编号、登记:DCC will give the new form a number according to WD-QA-072 Numbering of Documents, andrecord it in FN-QA-050 for the registration.质量部的文控中心按照WD-QA-004文件

10、编码规则对此新表单进行统一编号,并在FN-QA-050受控记录清单中进行备案;4.2.3 Usage 使用:4.2.3.1 Each dept can get the format of controlled forms from DCC and print the forms for using.表格受控后使用部门根据需要自行复印或领用;4.2.3.2 The records should be filled out accurately, timely, clearly and easy to recognize. All therecords must keep the traceabi

11、lity, signature and the stamp marking.填写的记录应准确、及时,内容清晰,字迹工整,不允许有乱涂乱改现象,所有记录数据必须保持可追溯性,每张记录的签字、印章齐全;4.2.3.3 Any wrong characters has been written in a record, please cycle the words / numbers ormark them in cancel-line, then correct them around and sign your name beside.如不慎填写错误则需要在错误处划一横线或将错误之处圈起来,然后

12、将正确的内容写在其上面或下面,并签上自己的姓名。4.2.3.41 n principle, all records shall be accessible to staff who requires them for work reference only.However the requestor is to verbally inform the responsible record keeping staff of his intention. Therecord is given to him only after his need is checked to be genuine.

13、The requestor should return therecords timely after making reference.原则上,所有的质量记录都应该对那些以此作为工作参考的员工开放,记录查阅者应该向记录保存人员口头说明其借阅目的,征得保存人员同意后可借出记录,并及时归还。4.2.4 Storage, protection and retention periods 贮存、防护和保存期限:1.1.1.1 2. 4. 1 All used records are collected by the responsible departments for record retenti

14、on. Eachdept. should appoint a person for the management and keeping their records in the archives.填写完成的质量记录由产生此记录的部门收集并保存。各部门应指定专人对建立的质量记录进行管理、存档;1.1.1.2 Records should be kept through applicable cataloguing, and method, in proper environment,to prevent it from damage, missing, and for easy searchi

15、ng and using. To ensure propermaintenance, the storage area shall not be exposed to rain and shine and be free from insectinfestation.记录应以适当的编目及方法贮存,存放在合适的环境中,防止其损坏、流失,以便于检索及存取。保存的记录应该得到适宜的维护,防止雨淋、阳光暴晒以及虫蛀等。1.1.1.3 Record keeper should define the methods such for keeping (in disk) and searching. Forexample, trace-ability could be made sure according to document type, date, and serial no.记录保存者需界定质量记录的存盘及索引方法,如:可根据文件种类、日期及编号等做到文件的可追溯性。1.1.1.

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