標(biāo)識(shí)和可追溯性控制程序

1、精選優(yōu)質(zhì)文檔-傾情為你奉上文件分發(fā)號(hào)：_ Distribution No. 審批過(guò)程Approval姓名Name職務(wù)Title起草人Initiator審閱人Reviewer批準(zhǔn)人Approver分發(fā)表Distribution 部門(mén)Dept.分發(fā)號(hào)Distributed No.部門(mén)Dept.分發(fā)號(hào)Distributed No.QA/QC01倉(cāng)儲(chǔ)部02生產(chǎn)部03技術(shù)部04更改履歷Change Summary版本號(hào)VERSION 更改描述DESCRIPTION OF CHANGE 011. 新文件New document1.0 目 的Purpose對(duì)產(chǎn)品及其狀態(tài)以適當(dāng)?shù)姆绞竭M(jìn)行標(biāo)識(shí)，防止從原材料進(jìn)入

2、公司至成品交付的全過(guò)程產(chǎn)品混淆和誤用。通過(guò)適當(dāng)?shù)目刂坪陀涗泴?shí)現(xiàn)產(chǎn)品的可追溯性。The purpose of this procedure is to prevent product mixups and wrong using in all stages from material receiving to product distribution, using appropriate method to identify the product and its status so as to achieve the traceability of product. 2.0 范圍Scope本程

3、序適用于從原材料入庫(kù)、生產(chǎn)過(guò)程、檢驗(yàn)和試驗(yàn)過(guò)程到成品交付各階段產(chǎn)品的標(biāo)識(shí)控制和可追溯性控制。This procedure is applicable for identification and traceability control of all product realization stages from material receiving, in process production, inspection and test until product distribution. 3.0 責(zé)任Responsibility3.1 質(zhì)量部負(fù)責(zé)本程序的起草修訂。QA is respons

4、ible for draft and revising of this procedure. 3.2 各相關(guān)部門(mén)負(fù)責(zé)按程序?qū)嵤?。The related department is responsible for its implementation.4.0 產(chǎn)品標(biāo)識(shí)Identification4.1. 產(chǎn)品標(biāo)識(shí)的范圍The scope of product identification4.1.1. 原材料Material4.1.2. 過(guò)程產(chǎn)品（包括半成品）Process product (include semi-finished product)4.1.3. 成品Finished produ

5、ct4.2. 產(chǎn)品標(biāo)識(shí)內(nèi)容Product identification產(chǎn)品標(biāo)識(shí)的內(nèi)容包括,但不限于以下內(nèi)容,Product identification includes but not limited below contents,4.2.1. 原材料：產(chǎn)品名稱(chēng)、編號(hào),接收批號(hào)、生產(chǎn)廠家、產(chǎn)品規(guī)格、數(shù)量、生產(chǎn)日期、失效日期等；Material: Product name, product code, receiving lot number, vendor name, size, quantity, manufacture date and expired date. 4.2.2. 過(guò)程產(chǎn)品

6、：產(chǎn)品名稱(chēng)、編號(hào),批號(hào),工序名稱(chēng),生產(chǎn)日期, 失效期等。Process product: Product name, product code, lot number and process description, manufacture date, expired date.4.2.3. 成品：產(chǎn)品名稱(chēng)、編號(hào),批號(hào),生產(chǎn)日期,失效期等.Finished product: Product name, code, lot number, manufacture date and expired date.4.3. 產(chǎn)品標(biāo)識(shí)方法The method of product identificati

7、on4.3.1. 原材料：倉(cāng)管人員在收貨時(shí)應(yīng)核對(duì)供應(yīng)商的標(biāo)識(shí)進(jìn)行檢查，如發(fā)現(xiàn)有缺失采購(gòu)人員應(yīng)馬上聯(lián)系供應(yīng)商。同時(shí)倉(cāng)管理人員應(yīng)貼上本公司物料標(biāo)識(shí)。Material. Warehouse personal shall check the identification of the vendor, and ask buyer to response to vendor if any missing information found. Warehouse personal is also responsible for identify the material with AMO identific

8、ation label.4.3.2. 過(guò)程產(chǎn)品：生產(chǎn)過(guò)程中的標(biāo)識(shí)由生產(chǎn)部門(mén)人員負(fù)責(zé)進(jìn)行標(biāo)識(shí).標(biāo)識(shí)一般由白標(biāo)簽進(jìn)行標(biāo)識(shí)。 Process product. Manufacturing personal is responsible for identify the process product. Usually white label will be used for identification.4.3.3. 成品：生產(chǎn)人員負(fù)責(zé)成品標(biāo)識(shí)。Finished product. Manufacturing personal is responsible for identify the finis

9、hed product.4.3.4. 對(duì)產(chǎn)品標(biāo)識(shí)的特別說(shuō)明：Special description for product identification . 對(duì)原料和成品應(yīng)分別采用專(zhuān)用的印刷標(biāo)簽粘貼，原料標(biāo)簽上信息應(yīng)在入庫(kù)時(shí)由技術(shù)部和倉(cāng)儲(chǔ)部人員共同確認(rèn)填寫(xiě)完成，成品應(yīng)由生產(chǎn)部在粘貼和填寫(xiě)完整。5.0 檢驗(yàn)和試驗(yàn)狀態(tài)的標(biāo)識(shí)Inspection and testing Status identification5.1. 檢驗(yàn)和試驗(yàn)狀態(tài)標(biāo)識(shí)的分類(lèi)Inspection and testing status identification type 5.1.1. 待驗(yàn),包括未完成檢驗(yàn),以及因一些特殊的原因

10、,如生產(chǎn)過(guò)程有異常，或返回的產(chǎn)品，還不能確定其是否合格的狀態(tài)。Quarantine. Including material which not finished inspection, or due to some special reason such as process deviation, product returned, it is not confirmed that the product is qualified or not. 5.1.2. 合格Qualified5.1.3. 不合格Non-conformity5.2. 狀態(tài)標(biāo)識(shí)的顏色規(guī)定The color provisio

11、n of status identification5.2.1. 待驗(yàn)/待決：黃色Quarantine/Pending: yellow5.2.2. 合格：綠色Qualified: green5.2.3. 不合格：紅色Non-conformity: red5.3. 狀態(tài)標(biāo)識(shí)方法The method of inspection and testing status identification5.3.1. 采購(gòu)產(chǎn)品的標(biāo)識(shí)方法 Identification for purchasing product5.3.1.1倉(cāng)管員將未經(jīng)檢驗(yàn)的產(chǎn)品放入原料庫(kù)待檢區(qū)，對(duì)于化學(xué)原材料,需要在每件單個(gè)包裝上貼上待驗(yàn)證

12、 Warehouse personal shall put the not inspected material in quarantine area, for chemical material, the quarantine label shall be attached on each single package. .5.3.1.2 質(zhì)量部對(duì)采購(gòu)產(chǎn)品檢驗(yàn)后： After inspection by QA,a. 確定為合格的產(chǎn)品，該批產(chǎn)品的每一單個(gè)外包裝上貼上合格證，然后倉(cāng)管員將產(chǎn)品放入合格品區(qū)；For the qualified product, the “Qualified Labe

13、l” shall be attached on the every package of material, then warehouse personal will put then in qualified area.b. 確定為不合格的，其每一單個(gè)外包裝上需貼上不合格證，倉(cāng)管員將產(chǎn)品放入不合格品區(qū)，并進(jìn)行隔離； For the unqualified product, “Disqualified Label” shall be attached to every package of this batch, and then warehouse personal shall isolat

14、e it to disqualified area. 5.3.2過(guò)程產(chǎn)品的狀態(tài)標(biāo)識(shí)方法： Identification for process product5.3.2.1工序產(chǎn)品由生產(chǎn)部對(duì)生產(chǎn)的產(chǎn)品的進(jìn)行過(guò)程自檢，然后： Manufacture operators shall self-check the process product, and then, a. 各車(chē)間的產(chǎn)品經(jīng)自檢確認(rèn)合格后，裝入相應(yīng)的容器，并在相應(yīng)的容器上予以標(biāo)識(shí)。For the qualified product through self-inspection, it will be put in the relate

15、d container and then identified.b. 將不合格品放入貼有紅色“不合格品”字樣的容器內(nèi)； For the nonconformity product, it will be put in the container with “Disqualified” labeled.5.3.3最終產(chǎn)品的標(biāo)識(shí)方法： Identification for finished product5.3.3.1倉(cāng)庫(kù)將包裝好的產(chǎn)品接收至成品接收區(qū)；倉(cāng)庫(kù)對(duì)接收后的成品每托進(jìn)行包膜，并在每托上貼上一張待驗(yàn)證。 Warehouse personnel will put it in quaranti

16、ne area, then pack every pallet with membranes, and attach the “Quarantine” label on every pallet.5.3.3.2 質(zhì)量部對(duì)最終產(chǎn)品檢驗(yàn)后： When the testing finished by QA,a. 確定為合格產(chǎn)品的，將該批產(chǎn)品的待驗(yàn)證換成合格證。 For the qualified product, the “Quarantine” will be replaced with “Qualified” label for every pallet.b. 確定為不合格的，將該批產(chǎn)品的待驗(yàn)證

17、換成不合格證，倉(cāng)管員將產(chǎn)品放入不合格品區(qū)，并進(jìn)行隔離；For disqualified product, the “Quarantine” label will be replaced with “Disqualified” label, warehouse personnel will also isolated them in the disqualified area.5.3.3對(duì)于召回/退回的產(chǎn)品，無(wú)法馬上確定處理的產(chǎn)品，倉(cāng)管人員應(yīng)將該些物品放在召回/退回區(qū)域等待最終的處理。 For the recalled and returned product which cant be det

18、ermined the final disposal right away, warehouse personnel will put these product in “Recalled/Returned Product” area and waiting for final disposal.5.4檢驗(yàn)和試驗(yàn)狀態(tài)標(biāo)識(shí)的保護(hù) Protect of inspection and testing status identification5.4.1非質(zhì)保部人員確認(rèn)不得擅自移動(dòng)或更改產(chǎn)品檢驗(yàn)和試驗(yàn)狀態(tài)標(biāo)識(shí)；如需移動(dòng)需得到質(zhì)保的確認(rèn)。 Inspection and testing status id

19、entification cant be removed or changed by the personnel without confirmation of QA, the status identification change shall be confirmed by QA.5.4.2如在搬運(yùn)過(guò)程中丟失或損壞了標(biāo)識(shí)，則應(yīng)立即報(bào)告質(zhì)量部，并采取補(bǔ)救措施。 If the status label missed during transition, it shall be report to QA and take action as remedy.6.0 可追溯性Traceability

20、6.1. 對(duì)原材料、過(guò)程產(chǎn)品、成品以批為單位追溯，對(duì)應(yīng)相應(yīng)的批號(hào)。具體批號(hào)原則見(jiàn)批號(hào)的編制程序。The material, process product, finished product can be traced by batch with related batch number. Details see SOP20-0086 Batch/lot Numbering Procedure. 6.2. 追溯方法可通過(guò)相應(yīng)的記錄實(shí)現(xiàn)追溯，如收貨入庫(kù)記錄、發(fā)貨記錄、批記錄、檢驗(yàn)記錄等。Traceability can be realized via related record, such a

21、s material receiving record, delivery record, batch record and test record etc.7.0 相關(guān)文件Document Related7.1. 批號(hào)的編制程序Batch/lot numbering procedure 8.0 附錄 Appendix附錄1:物料標(biāo)簽式樣Appendix 1: Material Label Format附錄1 Appendix 1 英妃原料標(biāo)識(shí)卡 AKM Raw Material ID Card原料批號(hào) Batch Number：原料名稱(chēng) Material Name：數(shù)量Qty：供應(yīng)商Supplier：入庫(kù)日期 Receiving Date：倉(cāng)管員 Material Han