標(biāo)識和可追溯性控制程序

1、Amelia Knight英妃STANDARD OPERATING PROCEDURE標(biāo)準(zhǔn)操作程序文件編號：SOP20-0164DOCUMENT NO:版本號：01VERSION:第1頁共10頁P(yáng)AGE 1 OF 10標(biāo)題：標(biāo)識和可追溯性控制程序TITLE: IDENTIFICATION AND TRACEAQBILITY CONTROL PROCEDURE文件分發(fā)號：Distribution No.審批過程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Dept.分發(fā)號Distributed N

2、o.部門Dept.分發(fā)號Distributed No.QA/QC01倉儲部02生產(chǎn)部03技術(shù)部04更改履歷Change Summary版本號VERSION更改描述DESCRIPTION OF CHANGE011.新文件New documentAmelia Knight英妃STANDARD OPERATING PROCEDURE標(biāo)準(zhǔn)操作程序文件編號：SOP20-0164DOCUMENT NO:版本號：01VERSION:第2頁共10頁P(yáng)AGE 2 OF 10標(biāo)題：標(biāo)識和可追溯性控制程序TITLE: IDENTIFICATION AND TRACEAQBILITY CONTROL PROCEDUR

3、E1.0目的Purpose對產(chǎn)品及其狀態(tài)以適當(dāng)?shù)姆绞竭M(jìn)行標(biāo)識，防止從原材料進(jìn)入公司至成品交付的全過程產(chǎn)品混淆和 誤用。通過適當(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 th

4、e traceability of product.2.0范圍Scope本程序適用于從原材料入庫、生產(chǎn)過程、檢驗(yàn)和試驗(yàn)過程到成品交付各階段產(chǎn)品的標(biāo)識控制和 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Responsi

5、bility質(zhì)量部負(fù)責(zé)本程序的起草修訂。QA is responsible for draft and revising of this procedure.各相關(guān)部門負(fù)責(zé)按程序?qū)嵤?。The related department is responsible for its implementation.4.0產(chǎn)品標(biāo)識Identification產(chǎn)品標(biāo)識的范圍The scope of product identification原材料Material過程產(chǎn)品(包括半成品)Process product (include semi-finished product)成品Finished prod

6、uctAmelia Knight英妃STANDARD OPERATING PROCEDURE標(biāo)準(zhǔn)操作程序文件編號：SOP20-0164DOCUMENT NO:版本號：01VERSION:第3頁共10頁P(yáng)AGE 3 OF 10標(biāo)題：標(biāo)識和可追溯性控制程序TITLE: IDENTIFICATION AND TRACEAQBILITY CONTROL PROCEDURE產(chǎn)品標(biāo)識內(nèi)容Product identification產(chǎn)品標(biāo)識的內(nèi)容包括，但不限于以下內(nèi)容，Product identification includes but not limited below contents,原材料：產(chǎn)品名

7、稱、編號，接收批號、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.過程產(chǎn)品：產(chǎn)品名稱、編號 ，批號，工序名稱，生產(chǎn)日期，失效期等。Process product: Product name, product code, lot number and process description, manufacture date, expired date

8、.成品：產(chǎn)品名稱、編號，批號，生產(chǎn)日期，失效期等.Finished product: Product name, code, lot number, manufacture date and expired date.產(chǎn)品標(biāo)識方法The method of product identification原材料：倉管人員在收貨時(shí)應(yīng)核對供應(yīng)商的標(biāo)識進(jìn)行檢查，如發(fā)現(xiàn)有缺失采購人員應(yīng)馬上聯(lián)系供應(yīng)商。同時(shí)倉管理人員應(yīng)貼上本公司物料標(biāo)識。Material. Warehouse personal shall check the identification of the vendor, and ask buy

9、er to response to vendor if any missing information found. Warehouse personal is also responsible for identify the material with AMO identification label.過程產(chǎn)品：生產(chǎn)過程中的標(biāo)識由生產(chǎn)部門人員負(fù)責(zé)進(jìn)行標(biāo)識.標(biāo)識一般由白標(biāo)簽進(jìn)行標(biāo)識。Process product. Manufacturing personal is responsible for identify the process product. Usually white lab

10、el will be used for identification.成品：生產(chǎn)人員負(fù)責(zé)成品標(biāo)識。Finished product. Manufacturing personal is responsible for identify the finished product.對產(chǎn)品標(biāo)識的特別說明：Special description for product identification.對原料和成品應(yīng)分別采用專用的印刷標(biāo)簽粘貼，原料標(biāo)簽上信息應(yīng)在入庫時(shí)由技術(shù)部和倉儲部人員共同確認(rèn)填寫完成，成品應(yīng)由生產(chǎn)部在粘貼和 填寫完整。Amelia Knight英妃STANDARD OPERATING

11、PROCEDURE標(biāo)準(zhǔn)操作程序文件編號：SOP20-0164DOCUMENT NO:版本號：01VERSION:第4頁共10頁P(yáng)AGE 4 OF 10標(biāo)題：標(biāo)識和可追溯性控制程序TITLE: IDENTIFICATION AND TRACEAQBILITY CONTROL PROCEDURE5.0檢驗(yàn)和試驗(yàn)狀態(tài)的標(biāo)識Inspection and testing Status identification檢驗(yàn)和試驗(yàn)狀態(tài)標(biāo)識的分類Inspection and testing status identification type待驗(yàn)，包括未完成檢驗(yàn)，以及因一些特殊的原因，如生產(chǎn)過程有異常，或返回的

12、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.合格Qualified不合格Non-conformity狀態(tài)標(biāo)識的顏色規(guī)定The color provision of status identification待驗(yàn)/待決：黃色

13、Quarantine/Pending: yellow合格：綠色Qualified: green不合格：紅色Non-conformity: red狀態(tài)標(biāo)識方法The method of inspection and testing status identification.采購產(chǎn)品的標(biāo)識方法Identification for purchasing product倉管員將未經(jīng)檢驗(yàn)的產(chǎn)品放入原料庫待檢區(qū)，對于化學(xué)原材料，需要在每件單個(gè)包裝上貼上待驗(yàn)證Warehouse personal shall put the not inspected material in quarantine area

14、, for chemical material, the quarantine label shall be attached on each single package.質(zhì)量部對采購產(chǎn)品檢驗(yàn)后：After inspection by QA,Amelia Knight英妃STANDARD OPERATING PROCEDURE標(biāo)準(zhǔn)操作程序文件編號：SOP20-0164DOCUMENT NO:版本號：01VERSION:第5頁共10頁P(yáng)AGE 5 OF 10標(biāo)題：標(biāo)識和可追溯性控制程序TITLE: IDENTIFICATION AND TRACEAQBILITY CONTROL PROCEDU

15、REa.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 倉管員將產(chǎn)品放入合格品區(qū)；For the qualified product, the“Qualified Label shall beattached 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，倉管員將產(chǎn)品放入 不合格品區(qū)，并進(jìn)行隔離；For the unqualified product,aDisqualified Label sh

16、all beattached to every package of this batch, and then warehouse personal shall isolate it to disqualified area.過程產(chǎn)品的狀態(tài)標(biāo)識方法：Identification for process product工序產(chǎn)品由生產(chǎn)部對生產(chǎn)的產(chǎn)品的進(jìn)行過程自檢，然后：Manufacture operators shall self-check the process product, and then,a.各車間的產(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。For the

17、qualified product through self-inspection, it will be put in the related 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 a Disqualified labeled.最終產(chǎn)品的標(biāo)識方法：Identification for finished product倉庫將包裝好的產(chǎn)品接收至成品接收區(qū)；倉庫對接收后的成品每托進(jìn)行包 膜，

18、并在每托上貼上一張待驗(yàn)證。Warehouse personnel will put it in quarantine area, then pack every pallet with membranes, and attach thea Quarantine label on everypallet.Amelia Knight英妃STANDARD OPERATING PROCEDURE標(biāo)準(zhǔn)操作程序文件編號：SOP20-0164DOCUMENT NO:版本號：01VERSION:第6頁共10頁P(yáng)AGE 6 OF 10標(biāo)題：標(biāo)識和可追溯性控制程序TITLE: IDENTIFICATION AND

19、 TRACEAQBILITY CONTROL PROCEDURE5.3.3.2質(zhì)量部對最終產(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 replacedwith a Qualified label for every pallet.b.確定為不合格的，將該批產(chǎn)品的待驗(yàn)證換成不合格證，倉管員將產(chǎn)品放入不 合格品區(qū)，并進(jìn)行隔離； For disqualified product, the“ Quarantine l

20、abel will bereplaced with a Disqualified label, warehouse personnel will also isolated them in the disqualified area.5.3.3對于召回/退回的產(chǎn)品，無法馬上確定處理的產(chǎn)品，倉管人員應(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 can t be determinedthe final disposal right away, warehouse personnel will put thes

21、e 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)識的保護(hù)Protect of inspection and testing status identification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；如需移動(dòng)需得到質(zhì) 保的確認(rèn)。Inspection and testing status identification can t be removed or changedby the personnel without confirmation

22、of QA, the status identification change shall be confirmed by QA.如在搬運(yùn)過程中丟失或損壞了標(biāo)識，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Traceability6.1.對原材料、過程產(chǎn)品、成品以批為單位追溯，對應(yīng)相應(yīng)的批號。具體批號原則見批 號的編制程序。Amelia Knight英妃STANDARD OPERATING PRO

23、CEDURE標(biāo)準(zhǔn)操作程序文件編號：SOP20-0164DOCUMENT NO:版本號：01VERSION:第7頁共10頁P(yáng)AGE 7 OF 10標(biāo)題：標(biāo)識和可追溯性控制程序TITLE: IDENTIFICATION AND TRACEAQBILITY CONTROL PROCEDUREThe material, process product, finished product can be traced by batch with related batch number. Details see SOP20-0086 Batch/lot NumberingProcedure .6.2.追溯

24、方法可通過相應(yīng)的記錄實(shí)現(xiàn)追溯，如收貨入庫記錄、發(fā)貨記錄、批記錄、檢驗(yàn)記錄等。Traceability can be realized via related record, such as material receiving record, delivery record, batch record and test record etc.7.0相關(guān)文件Document Related7.1.批號的編制程序Batch/lot numbering procedure8.0附錄Appendix附錄1:物料標(biāo)簽式樣Appendix 1: Material Label FormatAKM RnwMd

25、減睛rCardupplier e:Receiving Date 鋤| j|PCS)Qty:Material HandlerFilling ,Date:卷ualityStatus:Line Leader:QuChyck Date:SfetUs:員QC Inspector :檢驗(yàn)員QC Inspector:Amelia Knight英妃STANDARD OPERATING PROCEDURE標(biāo)準(zhǔn)操作程序文件編號：SOP20-0164DOCUMENT NO:版本號：01VERSION:第8頁共10頁P(yáng)AGE 8 OF 10標(biāo)題：標(biāo)識和可追溯性控制程序TITLE: IDENTIFICATION AND

26、 TRACEAQBILITY CONTROL PROCEDURE附錄1Appendix 1原料批號jBatchLNumber - BOChNUmber:期麗禰Name prOduQtName:香味 Aroma:一箱號 Carton Number: _人上檢 日.期 Recheck Date:合格qualified口下合格 unqualified口扣留 on hold 口待檢 pending test線別 Line Number: 口 合格qualified口 不合格 unqualified口扣留on hold口 待檢pending test驗(yàn)日期 Inspection Date: Amelia Knight英妃STANDARD OPERATING PROCEDURE標(biāo)準(zhǔn)操作程序文件編號：SO