1、目 的（purpose）
確保質(zhì)量記錄的有效、完整，為質(zhì)量體系的有效運行和產(chǎn)品質(zhì)量是否符合要求提供客觀證據(jù)，并為有追朔要求的場合提供證實。
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、適用范圍（Scope）
適用于本公司所有與質(zhì)量體系有關(guān)的記錄，及來自供應(yīng)商和顧客質(zhì)量記錄的控制。
Apply to the company with all the records of quality system and from the supplier and the customer’s quality control
 
3、職 責（Responsibility）
3.1 質(zhì)量行政人事部：負責公司記錄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 各部門：負責本部門職責業(yè)務(wù)范圍內(nèi)記錄格式的制定、發(fā)行；本部門日常工作所產(chǎn)生記錄的收集、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 記錄人員：負責認真填寫記錄，保證質(zhì)量記錄真實、準確、完整、清晰可辨。
The recorder is responsible for fill-in the record seriously, guaranteed quality.
 
4、定 義（Definition）   
無None
 
5、程 序（Procedure）
5.1 記錄的編制Draw the record up
 
5.1.1各部門在編制本部門各級文件的同時，依據(jù)業(yè)務(wù)實際需要和文件的要求，確定所需記錄并編制記錄的樣式。
Meanwhile each department draws the file up, according to the actual requirement of business and file, to ensure the record type.
 
5.1.2記錄的表單樣式應(yīng)作為文件內(nèi)容的一部分，以附件的形式后附在相應(yīng)文件中。
The record type is a part of the file content, enclosed herewith relevant file.
 
5.1.3各級文件的審核、批準責任者在審批文件的同時，對所后附記錄的表單樣式的適用性進行審批。
Meanwhile the principle audit the files, to audit the applicability of the form type for the attachment.
 
5.2記錄的標識Identifying
 
5.2.1各種記錄都應(yīng)有名稱、管理編號、頁碼等識別標識。
Each report has the identification marks, such as name, management no., page.
 
5.2.2對于多部門通用的記錄，表單樣式、管理編號應(yīng)統(tǒng)一，且在記錄中設(shè)置用以區(qū)分使用部門的項目欄。
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記錄的發(fā)放、使用 Issue and usage
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5.3.1記錄的表單式樣作為文件的內(nèi)容，由文件的發(fā)放部門向使用部門發(fā)放，并按《文件控制流程》中5.8條款的要求對記錄的有效性、適用性定期進行評審。
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各部門將本部門內(nèi)所使用的記錄，列出《部門記錄清單》，并在記錄發(fā)生增減或式樣修訂時，及時更新《部門記錄清單》。
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當記錄的表單樣式需修訂或記錄廢止時，應(yīng)視為對后附本記錄的文件的修訂，遵循《文件管理規(guī)程》中的相關(guān)條款執(zhí)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記錄的填寫 Fill-in the record
 
5.4.1由使用部門負責記錄內(nèi)容的填寫。
The using departments are responsible for writing the content.
 
5.4.2記錄填寫應(yīng)及時，內(nèi)容真實完整，字跡清晰、工整，不得隨意涂改，無漏項。如有無需填寫的項目欄，應(yīng)用斜線“/”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涉及數(shù)據(jù)、日期、報告結(jié)果等影響記錄真實性的內(nèi)容，記入不得使用易于更改的鉛筆，原則上也不允許涂改。當須更改時只能劃改，不得使原字跡消失或模糊，且需要更改人簽名，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每份記錄在填寫內(nèi)容應(yīng)經(jīng)本部門相關(guān)責任者及的審核、承認，以確定內(nèi)容完整性和準確性。審核、承認的時機（定期、上報、收集時等）根據(jù)各記錄的實際情況而定。
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記錄的收集、保管Record collection and keeping
 
5.5.1使用部門根據(jù)實際情況確定每種記錄的收集周期，并進行定期收集。
The usage department should fix the collection periodic of each record, and collect according to the periodic.
 
5.5.2公司外來的記錄（供應(yīng)商、顧客、第二、三方審核記錄等），由業(yè)務(wù)對應(yīng)部門負責接收、收集。
The external record, such as supplier, customer, auditor, be received and collected by Business correspondence department.
 
5.5.3各部門應(yīng)對所收集的記錄分類整理、裝訂入文件夾或檔案袋中保管。文件夾或檔案袋外標識出記錄的名稱、使用部門、記錄時間段、份數(shù)等情況以便于檢索。
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記錄的查閱Record looking-up
 
a）公司內(nèi)部人員只能在記錄的保存處進行查閱，查閱人須保留記錄時，只能保留復(fù)印件，禁止帶走原件。
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）須向公司外部人員（顧客、第二、三方審核人員等）提供記錄時，應(yīng)先得到記錄保管部門長的批準。所提供記錄只能為復(fù)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記錄使用部門每年年末將所收集的本年度的記錄重新匯總、整理和封存。封存時應(yīng)附本年度的《部門記錄清單》標識出封存時間、記錄的名稱、記錄的年度等信息，以便日后的檢索。
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記錄的封存放置場所應(yīng)注意防火、防盜、防潮、防光、防塵、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記錄保存期： 詳見下表Records storage life:in below list
 

	記錄類型 Record type	保存期 Retention period		記錄類型 Record type	保存期 Retention period
1	涉及產(chǎn)品安全性類 Refer to product safety class	10年 10 Years	8	計測器具相關(guān) Related to measure instruments	與計測器具使用期限一致 The same as the lifetime of measure instruments
2	質(zhì)量體系運行/審核相關(guān) Related to quality system operation/Varity	2年 2 Years	9	設(shè)備相關(guān) Related to equipment	與設(shè)備使用期限一致 The same as the lifetime of equipment
3	工藝技術(shù)及變更相關(guān) Related to technology and modification	3年	10	刀具相關(guān) Related to cutter	與刀具使用期限一致 The same as the lifetime of cutter
4	產(chǎn)品/過程認可相關(guān) Related to production/Approval process	產(chǎn)品停產(chǎn)后再加1日歷年 After stop production add 1 calendar year	11	采購合同、單據(jù) Purchasing contract\Receipt	產(chǎn)品停產(chǎn)后再加1日歷年 After stop production add 1 calendar year
5	生產(chǎn)管理相關(guān) Related to production management	3年3 Years	12	銷售合同、單據(jù) Sales contract\Receipt	產(chǎn)品停產(chǎn)后再加1日歷年 After stop production add 1 calendar year
6	檢驗試驗相關(guān) Related to check	3年3Years	13	培訓(xùn)記錄 Training record	與職工在職期限一致 The same as the on-the-job deadline of staff
7	不合格品相關(guān) Related to rejected product	3年3 Years

5.6記錄處置Record disposal
 
5.6.1使用部門每年年末在封存新形成記錄的同時，重新確認往年所封存記錄的保存期。
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已超過保存期的記錄，由記錄保管人提出申請、質(zhì)保負責人審批后進行粉碎銷毀。記錄的銷毀情況記入《記錄銷毀登記表》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、記錄（Records）
 
7.1《部門記錄清單》Department record list
7.2《記錄銷毀登記表》The registration form of record destroyed
 
8、 附件(Attachment)
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