1、目 的（purpose）
确保质量记录的有效、完整，为质量体系的有效运行和产品质量是否符合要求提供客观证据，并为有追朔要求的场合提供证实。
To ensure the effective and complete quality records, provide the objective evidence for the effective operation of the quality system and if the product quality is eligible. Provide the proof for the requirement.
 
2、适用范围（Scope）
适用于本公司所有与质量体系有关的记录，及来自供应商和顾客质量记录的控制。
Apply to the company with all the records of quality system and from the supplier and the customer’s quality control
 
3、职 责（Responsibility）
3.1 质量行政人事部：负责公司记录管理程序的制定和更新
The quality Admin/HR department is responsible for draw-up and update for the company records management program
 
3.2 各部门：负责本部门职责业务范围内记录格式的制定、发行；本部门日常工作所产生记录的收集、整理、保存管理。
Each department is responsible for draw-up and issue about the duty business scope of this department. And collect, tidy, conservation for the daily work of this department.
 
3.3 记录人员：负责认真填写记录，保证质量记录真实、准确、完整、清晰可辨。
The recorder is responsible for fill-in the record seriously, guaranteed quality.
 
4、定 义（Definition）   
无None
 
5、程 序（Procedure）
5.1 记录的编制Draw the record up
 
5.1.1各部门在编制本部门各级文件的同时，依据业务实际需要和文件的要求，确定所需记录并编制记录的样式。
Meanwhile each department draws the file up, according to the actual requirement of business and file, to ensure the record type.
 
5.1.2记录的表单样式应作为文件内容的一部分，以附件的形式后附在相应文件中。
The record type is a part of the file content, enclosed herewith relevant file.
 
5.1.3各级文件的审核、批准责任者在审批文件的同时，对所后附记录的表单样式的适用性进行审批。
Meanwhile the principle audit the files, to audit the applicability of the form type for the attachment.
 
5.2记录的标识Identifying
 
5.2.1各种记录都应有名称、管理编号、页码等识别标识。
Each report has the identification marks, such as name, management no., page.
 
5.2.2对于多部门通用的记录，表单样式、管理编号应统一，且在记录中设置用以区分使用部门的项目栏。
For the record is used by many departments, form style, management Numbers should be unified. And set the item to distinguish from the using departments.
 
5.3记录的发放、使用 Issue and usage
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5.3.1记录的表单式样作为文件的内容，由文件的发放部门向使用部门发放，并按《文件控制流程》中5.8条款的要求对记录的有效性、适用性定期进行评审。
The issue department provide the report form style to give the using department and audit the record’s effectiveness and applicability at fixed period according the clause 5.8 of the<Document control procedure>
 
5.3.2各部门将本部门内所使用的记录，列出《部门记录清单》，并在记录发生增减或式样修订时，及时更新《部门记录清单》。
Each department list the Department record list according to the using report of this department. The record have change, update the Department record list on time.
 
5.3.3当记录的表单样式需修订或记录废止时，应视为对后附本记录的文件的修订，遵循《文件管理规程》中的相关条款执行。.
When the type of list need to change or the record need to abolish, regard as the revise for the attachment. Do it with file management procedures.
 
5.4记录的填写 Fill-in the record
 
5.4.1由使用部门负责记录内容的填写。
The using departments are responsible for writing the content.
 
5.4.2记录填写应及时，内容真实完整，字迹清晰、工整，不得随意涂改，无漏项。如有无需填写的项目栏，应用斜线“/”表示。
Pay attention to the content should be real and full, the writing is clearness, don’t alter. If there is the item with no filling, show it “/”.
 
5.4.3涉及数据、日期、报告结果等影响记录真实性的内容，记入不得使用易于更改的铅笔，原则上也不允许涂改。当须更改时只能划改，不得使原字迹消失或模糊，且需要更改人签名，注明更改日期。
Refer to the date, date, and the result of report to affect the truth report, shouldn’t use the pencil. No change in principle. While it needs to change, it just cross that off and then change. It mustn’t disappear the original or dim. The person of changing the report needs to sign the name and the change date.
 
5.4.4每份记录在填写内容应经本部门相关责任者及的审核、承认，以确定内容完整性和准确性。审核、承认的时机（定期、上报、收集时等）根据各记录的实际情况而定。
The content of each report should be audited and confirmed by the principle of the relevant department, to ensure the content integrity and accuracy. According to practical situation to order the audit time, confirm time.
5.5记录的收集、保管Record collection and keeping
 
5.5.1使用部门根据实际情况确定每种记录的收集周期，并进行定期收集。
The usage department should fix the collection periodic of each record, and collect according to the periodic.
 
5.5.2公司外来的记录（供应商、顾客、第二、三方审核记录等），由业务对应部门负责接收、收集。
The external record, such as supplier, customer, auditor, be received and collected by Business correspondence department.
 
5.5.3各部门应对所收集的记录分类整理、装订入文件夹或档案袋中保管。文件夹或档案袋外标识出记录的名称、使用部门、记录时间段、份数等情况以便于检索。
Each department sorts the record and put it into the file folder. It should mark the record name, the using department, record time for future retrieval.
 
5.5.4记录的查阅Record looking-up
 
a）公司内部人员只能在记录的保存处进行查阅，查阅人须保留记录时，只能保留复印件，禁止带走原件。
The internal staffs look up at the place of storage. The reader need to keep the record, just keeping the copy. No taking the original away.
 
b）须向公司外部人员（顾客、第二、三方审核人员等）提供记录时，应先得到记录保管部门长的批准。所提供记录只能为复印件。
When the external staff, such as customer, auditor, look the record up, the storage department leader approve at first. The record is just the copy.
 
5.5.5记录使用部门每年年末将所收集的本年度的记录重新汇总、整理和封存。封存时应附本年度的《部门记录清单》标识出封存时间、记录的名称、记录的年度等信息，以便日后的检索。
The used departments collect, sorting and storage again at the end of the year. Enclosed herewith the Department record list and mark the storage time, record name, record year for future retrieval.
 
5.5.6记录的封存放置场所应注意防火、防盗、防潮、防光、防尘、防有害生物、防污染等。
Pay attention to prevention of fire, prevention of thievery, prevention of moist, prevention of light, prevention of pest, prevention of pollution at the place of the record storage.
 
5.5.7记录保存期： 详见下表Records storage life:in below list
 

	记录类型 Record type	保存期 Retention period		记录类型 Record type	保存期 Retention period
1	涉及产品安全性类 Refer to product safety class	10年 10 Years	8	计测器具相关 Related to measure instruments	与计测器具使用期限一致 The same as the lifetime of measure instruments
2	质量体系运行/审核相关 Related to quality system operation/Varity	2年 2 Years	9	设备相关 Related to equipment	与设备使用期限一致 The same as the lifetime of equipment
3	工艺技术及变更相关 Related to technology and modification	3年	10	刀具相关 Related to cutter	与刀具使用期限一致 The same as the lifetime of cutter
4	产品/过程认可相关 Related to production/Approval process	产品停产后再加1日历年 After stop production add 1 calendar year	11	采购合同、单据 Purchasing contract\Receipt	产品停产后再加1日历年 After stop production add 1 calendar year
5	生产管理相关 Related to production management	3年3 Years	12	销售合同、单据 Sales contract\Receipt	产品停产后再加1日历年 After stop production add 1 calendar year
6	检验试验相关 Related to check	3年3Years	13	培训记录 Training record	与职工在职期限一致 The same as the on-the-job deadline of staff
7	不合格品相关 Related to rejected product	3年3 Years

5.6记录处置Record disposal
 
5.6.1使用部门每年年末在封存新形成记录的同时，重新确认往年所封存记录的保存期。
When the used departments store the new record at the end of the year, reconfirm the retention period about the former records.
 
5.6.2已超过保存期的记录，由记录保管人提出申请、质保负责人审批后进行粉碎销毁。记录的销毁情况记入《记录销毁登记表》中
About the expired file, the keeper applied and destroyed after QA approval. Put the destroyed situation into the <registration of record destroyed>.
 
6、涉及文件（Reference Documents）
 
6.1《文件管理程序》File management procedures
 
7、记录（Records）
 
7.1《部门记录清单》Department record list
7.2《记录销毁登记表》The registration form of record destroyed
 
8、 附件(Attachment)
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