【正文】 工廠對于運作程序及工作指引有沒有制定相關(guān)的標準文件—質(zhì)量手冊 ?√FACILITY ASSESSMENT 8/19/2022 10:49 上午 18 Does the factory have an established GMP program?工廠是否建立 GMP 手冊?√ 無 GMP 手冊。NO GMP manual. Suggest fty to prepare their own GMP manual based on their production process.已建議工廠去建立 GMP 手冊。 Does the GMP program include a training program for workers?GMP 手冊包括工人的培訓(xùn)程序嗎?√ 無 GMP 手冊。NO GMP manual. Suggest fty to prepare their own GMP manual based on their production process.已建議工廠去建立 GMP 手冊。 Are internal selfaudits of GMPs conducted and documented?內(nèi)審對 GMP 執(zhí)行及文件證明?√ 無 GMP 手冊。NO GMP manual. Suggest fty to prepare their own GMP manual based on their production process.已建議工廠去建立 GMP 手冊。 Are corrective action reports from internal audits implemented to improve pliance?內(nèi)審不合格項的 CAP 及改善執(zhí)行?√ 無 GMP 手冊。NO GMP manual. Suggest fty to prepare their own GMP manual based on their production process.已建議工廠去建立 GMP 手冊。Total 62%Quality Systems:質(zhì)量系統(tǒng) Yes No N/A CommentsQUALITY PROGRAMS 品質(zhì)手冊 Does the factory apply statistical process control techniques?工廠有沒有應(yīng)用統(tǒng)計方法控制技術(shù)？√ 應(yīng)用于每月的生產(chǎn)質(zhì)量指標統(tǒng)計。Only for production quality statistics. Is objective evidence on SPC application available (control chart, histogram, etc.)? 可否提供 SPC(統(tǒng)計方法)應(yīng)用的客觀證據(jù)？(控制圖/柱狀圖等 )?√ *Is there an inprocess control plan and procedure available which identifies all critical manufacturing processes? 是否有半成品控制計劃和程序定義所有關(guān)鍵工序過程?√FACILITY ASSESSMENT 8/19/2022 10:49 上午 19 *Are critical control points affecting product safety clearly defined? 對會影響產(chǎn)品安全的所有關(guān)鍵生產(chǎn)程序和控制點有否清楚確定？√ Is rejected work inprocess clearly identified。 disposition established。 and segregated from production materials?在加工過程中, 不合格品是否被清楚地標識與處理并與生產(chǎn)材料區(qū)分開？√ Are inprocess inspection records available, plete, traceable to production lots, with disposition of acceptance or rejection?有沒有半成品檢驗記錄, 是否完整及可追蹤 , 并設(shè)有合格與不合格品？√ 文件程序沒有詳細如何從原材料追蹤到成品，也未有確定追蹤代碼系統(tǒng)。 * Recall Capabilities/Procedures: Is production identifiable throughout the production process? (. traceability system inspector should trace at least one final packed box of product through entire production system all materials should be able to be verified with corresponding batch numbers of raw materials.)產(chǎn)品召回能力/程序 :整個生產(chǎn)過程中是否定義生產(chǎn)工序?(例: 追蹤系統(tǒng)檢查員在整個生產(chǎn)過程中可至少追蹤成品包裝箱 1所有物料應(yīng)能夠追溯到原料批次)√ 文件程序沒有詳細如何從原材料追蹤到成品，也未有確定追蹤代碼系統(tǒng)。No detail procedure on how to trace the finished product and define the traceability code system.工廠未能從成品追蹤到每一批次原料，僅可追蹤整個訂單的原料批次，也無進行摸擬追蹤召回測試。Fty was not able work out the detail information from finished product to raw material. Total 71%Quality Systems 質(zhì)量系統(tǒng) Yes No N/A CommentsINPROCESS CONTROL AND TESTING制程控制與測試PAINTING PROCESS 噴油工序 Is the paint used for touch up from the same lot as production?油漆是否使用同一批型號?√ 無此類工序 N/A Are all painted parts painting process properly stored to avoid damage?所有油漆部件是否恰當存放以防損壞?√ 無此類工序 N/A Are all paints, solvents, spray mask cleaning agents clearly/ properly labeled?所有油漆/溶劑/噴油模/清洗劑是否清晰標識?√ 無此類工序 N/AFACILITY ASSESSMENT 8/19/2022 10:49 上午 20Quality Systems 質(zhì)量系統(tǒng) Yes No N/A Comments Is the painting process controlled by means such as reference samples and Standard Operating Procedures?噴油過程是否用參考辦及標準操作程序方法來控制?√ 無此類工序 N/AGLUING/SOLVENT BONDING PROCESS膠水/溶劑粘合工序 Is the application process well controlled to ensure consistent coverage and application of glue/solvent to pieces being joined? (. automated vs. syringe, stick, etc.)膠水/溶劑粘合過程較好控制確保一致覆蓋及膠件接合?例:自動與注射,粘合等√ 無此類工序 N/A Are the surfaces to be joined smooth, clean and dry?表面是否接合得光滑,干凈和干燥 ?√ 無此類工序 N/A If applicable, after the application of the glue, is constant pressure applied until the joint has bee dry and hard?若使用膠水后,是否使用固定壓力直到接合處變干和堅硬?√ 無此類工序 N/A Is additional processing on the joined parts started only after the joint has had ample time to set?在接合部位有沒有其它工序延遲直到接合外有足夠時間來設(shè)置?√ 無此類工序 N/A Is the gluing quality process controlled by means such as reference samples and Standard Operating Procedures?膠水質(zhì)量過程序是否用參考辦及標準操作程序方法來控制?√ 無此類工序 N/A Is there a break open procedure to verify amount of glue or solvent is adequate?是否有拆開程序檢查膠水或溶劑量足夠?√ 無此類工序 N/A Are glue and solvents properly labeled?膠水及溶劑是否適當標識?√ 無此類工序 N/AINJECTION MOLDING 啤塑 If regrind material is used, is the ratio correct as per plastic manufacturer specification?水口料比例是否正確?跟膠料供應(yīng)商的規(guī)格√ N/A 無水口料應(yīng)用。FACILITY ASSESSMENT 8/19/2022 10:49 上午 21Quality Systems 質(zhì)量系統(tǒng) Yes No N/A Comments Are all molding parameters recorded (cycle time, temperature, pressure)?記錄所有啤塑參數(shù)?(周期/溫度/壓力)√ 全部參數(shù)記錄在產(chǎn)品成型卡上。All parameter are record on the product card. Is the injection molding process quality controlled by means of reference samples and Standard Operating Procedures?啤塑過程是否用參考辦及標準操作程序來控制?√ 采用首件簽辦放產(chǎn)程序。Sign samples are available.SONIC WELDING PROCESS 超聲工序 Is there documentation for the welding parameters? (. frequency, hold time, weld time, pressure)是否記錄超聲參數(shù)?(例:頻率/暫放及超聲時間/ 壓力)√ 無此工序。N/A Is there any break open inspection after the sonic welding process?超聲焊接工序之后是否有檢查裂口的情況?√ 無此工序。N/A Is the sonic welding process quality controlled by means of reference samples and Standard Operating Procedures?是否超聲過程用到參考辦及標準操作程序來控制?√ 無此工序。N/ASCREWING PROCESS 螺絲工序 Are the automatic screwdrivers calibrated (torque)?自動螺絲批有校準(力矩)嗎?√ 無此工序。N/A Is there documentation of the calibration? How often is calibration? (note in ments)有無文件化校準記錄?多久校驗一次 ?√ 無此工序。N/A Is the screwing assembly process quality controlled by means of reference samples and Standard Operating Procedures?螺絲裝配過程是否有參考辦及標準操作程序來控制?√ 無此工序。N/A MANUAL ASSEMBLY(Eye to Washer, Wheel to Axle) 手工裝配（打眼，打軸） Are the ponents aligned properly?設(shè)備有沒有適當?shù)卣{(diào)校？√ 無此工序。N/A Is the di