回收料使用的控制程序.doc

. 可編輯修改 1 Fresenius Medical Care (Jiangsu) Co. Ltd. 江蘇費森尤斯醫(yī)藥用品有限公司江蘇費森尤斯醫(yī)藥用品有限公司 Title 題目題目: CONTROLLING PROCEDURE OF RECYCLE MATERIALS USING 回收料使用的控制程序回收料使用的控制程序 ISO Level: ISO 級別： GMP Level: GMP 級別： Document Number: 文檔序列號： Version Number: 版本： Page: 頁數(shù)： Level N/ACPRD-SOP-01902Page 1 of 6 Document Type 文件類型:SOP Other_ Approval/批準批準 Author: 編寫者： Jack Lu 陸敬杰 Designation / Role: 職位： Injection Molding Supervisor 注塑主管 Signature: 簽名： Date : 日期 By signing this document, it is to confirm that I am the author; this document is prepared according to technical standards. 通過簽名，確認本人即為本文編寫者；且本規(guī)程是參照技術標準編寫的。 Note: Signature and date are only required for Master Copy, which is kept in Quality Department 注意：只有主文件需要簽名和日期，并被保存在質(zhì)量部。注意：只有主文件需要簽名和日期，并被保存在質(zhì)量部。 Approver: 批準人： Peter zhu 朱玉軍 Designation / Role: 職位： Head of Production Components Production 塑料部件生產(chǎn)經(jīng)理 Signature: 簽名： Date : 日期 By signing this document, it is to confirm that this document is fit for technical standards and fit for release. 通過簽名，確認本文件符合技術標準并準予發(fā)行。 Note: Signature and date are only required for Master Copy, which is kept in Quality Department 注意：注意： 只有主文件需要簽名和日期，并被保存在質(zhì)量部。只有主文件需要簽名和日期，并被保存在質(zhì)量部。 . 可編輯修改 2 Table of Contents 目錄目錄 1.PURPOSE / 目的.3 2.SCOPE / 范圍 3 3.REFERENCE /參考資料.3 4.DEFINITIONS / 定義 .3 5.AUTHORITY/RESPONSIBILITY /權責.3 6.PROCEDURE /程序3 7.REVISION RECORD/修訂記錄6 8.ATTACHMENT/附件 .6 . 可編輯修改 3 1.PURPOSE 目的 1.1.Establish recycling process of shuikou materials and recycled unqualified injection products, to ensure that the quality of the injection products meets the requirement. 建立水口料和可回收的報廢注塑件的循環(huán)使用流程，以確保注塑件的質(zhì)量達到規(guī)定要求。 2.SCOPE 范圍 2.1.This procedure applies to the shuikou materials and recycled unqualified injection molding parts of all products. 本程序適用于注塑區(qū)所有產(chǎn)品的水口料和可回收的不合格注塑件。 3.REFERENCE 參考資料 3.1. CPRD-SOP-046-01 PULVERIZER INSTRUCTION CPRD-SOP-046-01 粉碎機工作指導書 3.2 CPRD-SOP-047-01 SIEVE MACHINE INSTRUCTION CPRD-SOP-047-01 篩選機工作指導書 3.3 FPRD-SOP-040-03 MOLDING DEPARTMENT SET-UP GUIDE FPRD-SOP-040-03注塑設置指南 3.4 FQAD-SOP-054-03 INJECTION MOLDING PROCESS MATERIALS LOG BOOK 4. FPRD-BMR-BL-02-01注塑批記錄-生產(chǎn)原料日志 5.DEFINITIONS 定義 N/A 無 6.AUTHORITY/RESPONSIBILITY 權責 6.1.Production Department Responsibilities 生產(chǎn)部職責 5.1.1 Ensuring that the material is corresponds to the product. 確保物料與所要生產(chǎn)的產(chǎn)品相符。 5.1.2 Changing container label every time material is issued to the line. 每次向生產(chǎn)線發(fā)出物料時及時更換容器上的標簽。 5.1.3 Replace full chambers containers with empty containers from the chamber/ top cap/filter machine. 及時用空的容器更換機臺水口料的滿容器。 5.1.4 Ensuring that the mixing ratio is right, not beyond the specified requirement. And do the r 確保物料配比正確，未超過文件規(guī)定，并做好相關記錄。 5.1.5 The supervisor/designee is responsible for conducting random audits of the lines to verify that the physical material matches the management system inventory. 主管或其代理人負責對生產(chǎn)線進行隨機檢查以確認實際使用的物料與管理系統(tǒng)中信息相符。 6.2.Quality Assurance Department Responsibilities: QA 部門職責 . 可編輯修改 4 5.2.1 Supervise that the materials are not mixed during the manufacturing process and the mixing ratio is qualified. 監(jiān)督物料在生產(chǎn)過程中未發(fā)生混淆和物料配比合格。 7.PROCEDURE 程序 6.1 The recycling material control process in the following chart: 回收料的控制流程如下圖所示： 流程圖 Flow Chart 責任人 Responsible Part 風險 Risk 措施 Action 生產(chǎn)人員 Production Staff A.生產(chǎn)水口中混入異物、 雜質(zhì)、金屬黑點、油污、 被污染或其他產(chǎn)品等； A. There are impurity, oil, metal, polluted, foreign matters, or other products, B. 不良注塑件的缺陷 造成不能立即回收。 B. The defects cause unqualified injection parts not recycle immediately. A.水口料在粉碎前進行確認，合格則 粉碎； A. Confirm the shuikou materials whether qualified, if they are qualified, then crushed. B. 可回收的不良注塑件根據(jù)缺陷分 類處理后在送至粉碎車間進行粉碎。 B. Deal with the unqualified products on the basis of different defect kinds, and then send them to crushing workshop. 生產(chǎn)人員 Production Staff 在粉碎過程中混入雜質(zhì)， 造成粉碎后料不能使用。 Mixing impurity in crushing process, it causes the material crushed unqualified. 嚴格按照粉碎機工作指導書 進行粉碎。 Strictly crush according toPulverize Instruction. 生產(chǎn)人員 Production Staff 生產(chǎn)主管 Production Surpervisor A.配比超出文件規(guī)定的 范圍； A. Mixing ratio is beyond documented range. B.在混料時，用錯原料 粒子和回收料； B. Add wrong particles and recycle materials, when mixing. A對添加的原料和回收料進行稱量， 從而控制所添加的量并記錄在配料 日報表中； A. Weigh flesh material and recycle material and record mixing ratio in the sheetMixing Materials Daily Report B拌料標識清楚，貼好拌料標識 單送至機臺，從而防止使用錯誤的 料生產(chǎn)產(chǎn)品。 B. Label clear with Mixed material IDand send the materials to relevant machine, to prevent using wrong materials to production. C品管監(jiān)督配比過程，查看物料是 否發(fā)生混淆。 C. QM supervises the mixing process, and checks the material whether is wrong. D.生產(chǎn)主管隨機確認和監(jiān)控。 D. Production supervisor checks and supervises mixing materials randomly. 6.2 The recycle control process of shuikou materials and recycled unqualified injection products: . 可編輯修改 5 水口料和不良品循環(huán)使用管控流程： 6.2.1 Before loading leftover materials and recycle unqualified injection products, the plastic barrels should be labeled with Recycle material IDto indicate the material name, date, operator, lot number, machine number. If there are some problems, they can be traced. 膠桶在裝水口料/廢品前，需貼上回收料標識單，注明原料名稱、日期、操作員、批號、機臺號，以便發(fā) 現(xiàn)問題時，能追溯。 6.2.2 Workers use clean plastic barrels to hold leftover material and unqualified injection products, and put the cover timely. The recycle materials of different products cannot be mixed together in one barrel. 員工把水口料和不良品放在干凈的塑料桶中，并及時把桶蓋上做好防護工作。不同回收料不得混在一起放置。 6.2.3 When leftover materials are full, the plastic barrels are transported to crushing workshop. Before crushing shuikou materials, workers confirm whether there are foreign substances, impurity, metal or other products and so on. If there are unclean recycle materials, clean the materials before crushing. If the shuikou materials are dropped on the ground and polluted, then there are scrapped. 水口料的塑料桶滿后，拉至粉碎車間。在粉碎前確認水口料里是否有異物、雜質(zhì)、金屬或其他產(chǎn)品等。若有 不干凈的水口料，則在碎料之前處理干凈再進行碎料。掉落在地面的水口料和被污染水口料則以報廢處理。 6.2.4 Before the recycle unqualified injection parts transported to crushing workshop, workers deal with the unqualified products on the basis of different defect kinds, clean the unqualified products with oil, dark point, foreign substance and so on. After cleaning, transport them to crushing workshop. 可回收不良注塑品在拉至粉碎車間前，員工根據(jù)不良注塑品的缺陷不同分類進行處理，把有油污、黑點、異 物等缺陷的不良品清除。清理干凈后拉至粉碎車間粉碎。 6.2.5 Crushing recycle according to CPRD-SOP-046-01 PULVERIZER INSTRUCTION. 按 CPRD-SOP-046-01粉碎機工作指導書進行粉碎。 6.2.6 Weigh the weight of crushed recycle materials, fill Re-grindded material ID and store them neatly in the designated area. 粉碎好的回收料裝好稱重，填寫粉碎料標識單, 在指定的區(qū)域堆放整齊。 6.2.7 Unusable recycle materials are scrap process according to companys procedure. 無法使用的回收料按公司流程予以報廢處理。 6.2.8 Workers should clean the mixing barrel before mixing materials, using air gun to clean the foreign substance, masterbatch and so on. 配料員在配料前，須將混料筒內(nèi)清理干凈,用氣槍吹盡混料筒內(nèi)的異物、色母等。 6.2.9 When mixing materials, operator add the recycle materials no more than the documented mixing ratio and stir well. The mixing ratio is defined in FPRD-SOP-040-03Molding department set-up guideInjection setting manual according to the mixing ratio when validation. Add the dosage of masterbatch according to the new particles, do not mixing wrong recycle materials. Record every mixing dosage and batch and mixing ratio in the sheetMixing Materials Daily Reportand hand in workshop supervisor to confirm. The article NO and batch of recycle material is same as the fresh material which produce recycle material. 摻混回收料時，配料員按照回收料配比表加入不超出規(guī)定比例的回收料，并確保攪拌均勻?；厥樟系呐浔纫?guī) 定依據(jù)FPRD-SOP-040-03注塑設置指南上驗證時回收料配比。按所加新量多少來添加色母用量，不可 用錯回收料。每次配好料后需記錄下配料量、批號和配比，做好配料日報表上交車間主管確認?；厥樟?的物料代碼和批號與產(chǎn)生回收料的原料的代碼和批號一致。 6.2.10 Transport the plastic barrels filled with mixed materials to the injection machine. Do not fill too much mixed materials in the plastic barrel, spill on the ground and put the cover timely. Label on the plastic barrel of the the material name, batch of fresh material, batch of recycle material, batch of color resin, ratio of recycle material, date, operator. . 可編輯修改 6 攪拌好的料裝入塑料桶送到各機臺。向塑料桶中裝料時，不可加得過多，嚴禁將料弄灑于地面上，及時蓋上 塑料桶。在塑料桶上做好標示，注明粒子名稱、原料批號、次料批號、色母批號、回收料比例、日期、拌料 人。 6.2.11 Inspection operator at the machine record the batch of fresh material, batch of recycle material, ratio of recycle ma