良好记录填写规范

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填写,良好,规范,记录


XXXXXXXXXX有限公司

编写: 审核:

XXXXXXXXXXXXXX TECHNOLOGY CO.,LTD

文件名称:Good Record Fill Practice

文件编号: 文件版本:A

制、修订日期:2014-8-20 页次: 1 / 3 部门: 批准:

良好记录填写规范

1. 目的 Purpose

规范记录填写要求,确保记录的清晰、及时、准确、完整、具备可追溯性。

Standard record fill requirement, insure record’s distinct, timely, accuracy, integrity and traceability. 2. 范围 Scope:

适用于公司质量管理体系相关的质量记录的填写。 Apply for the quality record fill control.

3. 职责 Responsibility

3.1 品质部Quality Dept.

3.1.1 依据此规范要求,控制本部门记录的填写;

According to the practice, control quality dept. record’s fill.

3.1.2 监督各部门质量记录的填写,对填写异常的向负责部门反馈纠正需求;

Monitoring the filling of quality record, release CA requirements for not comply with this practice.

3.2 各部门 Other dept.

3.2.1 依据此规范要求进行质量记录的填写;

According to this practice, fill the quality record.

3.2.2 依据规范要求对新进人员、转岗人员进行岗前培训。

According to this practice, train the new operator and job transfer employee.

4. 定义 Definition

None

5. 要求 Requirement

5.1 记录应不易擦掉(永久的),应使用可复制的媒体。

Entries shall be made in indelible (permanent) and reproducible media.



5.2 应即时记录所获取的原始数据以保持其可检索及可追溯。

Original data once observed shall be recorded so that it is retrievable and traceable.



5.3 应随时或随后在工作记录上签名并注明日期(如果多个记录项由同一记录人完成,允许使用大括号将这

些记录项标注后由该记录人共同签署)

Entries shall be signed and dated at or immediately following the time of the activity. When one person performs multiple items in one record, he/she can mark these items with a bracket, and sign his/her signature and date one time for these items.

5.3.1 逾期补填记录是绝不允许的。Back dating of entries is not permitted.

5.3.2 日期的签署形式应以不产生混淆为原则,推荐使用如:2011-09-242011.09.242011/09/24,




域鑫科技(惠州)有限公司

YUXIN TECHNOLOGY (HUIZHOU) CO.,LTD

文件编号: 文件版本:

制、修订日期: 页次: 2 / 3

5.4



September24,2011, Sept.24th ,2011, 24th Sept2011

The manner of date signing should be based on the date will not bring confusion,recommend use: 2011-09-242011.09.242011/09/24, September24,2011, Sept.24th ,2011, 24th Sept2011.

只能对你完成的工作签字或对被授权的工作签字。

Sign only for work that you completed or for which you are authorized to sign.

质量记录应该有总页码,如 1of 5, 1/5。每页质量记录的附件应包括适当的标识以便可以清楚地追 至该产品或质量记录。

Quality records have the requirement of pages, e.g. 1of 5, 1/5. Attachments to quality records shall contain the proper identification on each page so that the document(s) can clearly be traced back to the product or quality record.

书写应准确清晰。

Entries shall be accurate and legible.

以任何方式记录的信息都不能模糊不清。

Information that is recorded shall not be obscured in any manner.

不使用的地方可用 N/ANA(不适用)或在空格处划斜线。在多选一的选项中,不需要填写N/ANA ,在一份表格中不引起歧义的地方不需要写N/ANA 和斜线。

Identify unused space. e.g. N/A or NA , not applicable or cross out with one line on the

blank. Entry of N/A or NA is not required in one of many options and for that the blank of on sheet will not bring confusion as well.

不正确的书写不能被删除、擦去、刮掉或被涂改的难以辨认。

Erroneous entries shall not be canceled, erased, scratched out or otherwise rendered illegible. 5.9.1 当需要修改时,在错误书写的地方划一条横线并在修改处签字注明日期。修改的内容应尽可能

靠近被修改处。

When a correction is necessary, the erroneous entry must be crossed out with one (1) line and the correction signed and dated. The correction should be inserted as close to the error as space allows.

5.9.2 如果某个错误是显而易见的或某个信息可从其他记录中获取,那么纠正错误的人不一定为原始记

录人。

Error correction by an individual other than the person initially making the entry is permitted if the error is obvious or the information is retrievable from another document.

5.5

5.6

5.7

5.8

5.9

6. 引用文件 Reference documents

None

7. 引用表单 Reference form

None


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