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简单介绍
5.2.1 | 所有记录必须记录清楚:如日期、品名、规格、主要内容等,栏位不可漏填,确实不需要填写时,以 | |||||||
划线方式处理。 | ||||||||
All records shall record clearly:e.g date、part name、specification、main content,no blank space is | ||||||||
allowed. | ||||||||
5.2.2 | 应易于阅读、易于识别与追溯其所涉及的产品。 | |||||||
Record shall be easily readable、identified and track to related products. | ||||||||
5.2.3 | 必须有人签核。并按「文件与资料管制程序」中的规范作业。 | |||||||
Records must be signed. Respective authorize signature is listed in「Quality Record Control Program」. | ||||||||
5.2.4 | 不可随意涂改,若需要修改时,更改人须在修改处签名,划线刪除修改处。并写上修改的内容,但原字 | |||||||
体应清楚可辨识。 | ||||||||
Record can't be altered at will,if needed anyone who make the alteration must put his/her initial.The original | ||||||||
wording must still be clearly readable. | ||||||||
5.2.5 | 不可用铅笔或易掉颜色的笔做记录。 | |||||||
Record can't be recorded in pencil or pen ink that fade easily. | ||||||||
5.2.6 | 记录应按设计规定的格式进行填写,该签署的地方一定要签署。 | |||||||
Record shall be filled according to specified design format and signed at designated space. | ||||||||
5.2.7 | 表單中"□"項目﹐為選擇性項目﹐以打"√"方式選擇。 | |||||||
"□" on record sheet is a selective item,drawn with a tick on the respective "□" for selection. | ||||||||
5.3 | 标识、收集、归档/Identify、collect、file | |||||||
5.3.1 | 各部门的记录由专人负责收集,按一定的索引方法进行编号、装订、保管、归档。 | |||||||
Records in every department shall be managed by authorized person in accordance with stated index method | ||||||||
(Coding、binding and filing). | ||||||||
5.3.2 | 所有的记录文件均须存放于相应的档案中,以便于查找,同时须安全,避免损坏或丢失。 | |||||||
All record documents shall be kept in relevant files for easily retrieval. And shall be safe to avoid damage or | ||||||||
loss. | ||||||||
5.3.3 | 记录文件也可以使用计算机微机软盘或其它方式来建档存储。 | |||||||
Filing of record documents can also use computer 、floppy disk or other methods for storage. | ||||||||
5.3.4 | 文控中心保存一套最新有效的记录表单,并建立最新的「品质记录控制清单],定期地发放给相关单位 | |||||||
核对。 | ||||||||
DCC must always have a set of latest record form. They will tabulate a「Quality Record Control List」to | ||||||||
distribute to relevant department on a periodical basis for their checking. | ||||||||
5.3.5 | 记录需做明显标识以利查阅,存放记录的设备( 如文件夹、文件柜等)也应做相应的标识。 | |||||||
Record need to have a systematic labeling and tracking including storage (suchas file、file cabinet etc). | ||||||||
5.4 | 保存/Filing | |||||||
5.4.1 | 传真文件(仅针对于热敏传真纸的传真文件)应复印后保存。 | |||||||
Faxed document ( for thermal paper only) shall be filed after photo copying . | ||||||||
5.4.2 | 记录文件由各部门保存,如部门文件太多,可将其标识,集中存放于仓库,标明是何文件,何时作废。 |