【正文】 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(dāng)?shù)卣{(diào)校？√ 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(zhǔn)記錄?多久校驗一次 ?√ 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(biāo)準(zhǔn)操作程序來控制?√ 無此工序。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。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。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。 and segregated from production materials?在加工過程中, 不合格品是否被清楚地標(biāo)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(xì)如何從原材料追蹤到成品，也未有確定追蹤代碼系統(tǒng)。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。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。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。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。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。Only new workers training record were found. Are quality records available, plete and uptodate?品質(zhì)記錄是否有效并完成,且為最新 ?√ Are internal audits planned and documented?是否有內(nèi)審計劃及文件記錄?√ 每年進行一次。New workers should have training before start working. 建議工廠給工人一個定期的培訓(xùn)及考核，并記錄在檔案。Both finished product and semi finished product are not free from dust.已要求工廠須及時的清潔產(chǎn)品及使用干凈的容器存放產(chǎn)品，并密封防止污染。Use air gun to clean the product. If cleaned with pressed air, is air filtered to remove moisture?若用壓縮氣清潔,空氣過濾器是否除去濕氣 ?√ 過濾器只安裝在壓縮機上，生產(chǎn)現(xiàn)場沒有安裝。Wooden pallets were found in the packing area. Suggested to use plastic pallet. Are production operations appropriately separated to prevent odor, microbiological, foreign material and other types of contamination?生產(chǎn)運作適當(dāng)隔離以免受氣味/細(xì)菌/ 外來物污染√ 來料倉及壓制成型車間沒有封閉，可見生產(chǎn)過程產(chǎn)生的灰塵飄落在原料倉內(nèi)。No cover or lid for the semi product and finished product. 已要求工廠清潔用于貯放產(chǎn)品的容器，保持清潔，并加以封蓋，防止污染。No assigned zone for the waste material were found.已要求工廠加以標(biāo)識及提供貯存區(qū)域。Cleaning pounds, pesticides and sanitizers are not properly stored in designated area.已要求工廠須加以標(biāo)識。Trash and product place in the same area.已要求工廠劃分不同的區(qū)域擺放，避免產(chǎn)生污染。包裝車間的桌面未被完全用膠板覆蓋。Packing material and debris were found on production floor. Do all machines look clean and free from oil, dirt, and other contamination and appear to be maintained in good condition?是否所有的機器均保持干凈, 且無油、無塵及無污染？并良好保養(yǎng)？√ 部分沒有使用機器隨便擺放，同時也未標(biāo)識其待維修或待用，車間電箱也未有警告標(biāo)識和隔離。All production area with heavy dust.建議工廠增加清潔的頻次。工廠內(nèi)還有廢棄水塘和大約二千平方米的雜草地 Spider web were found in the packing area and desert pond in the fty area.要求工廠立刻清理及進行滅害。Trash bin are not properly covered with lid and easy attract insects. Trash empty once per day. 要求工廠使用可開合的垃圾筒，以及及時的清理垃圾。此外，貨倉沒有裝上適當(dāng)?shù)募喚W(wǎng)。Drinking cups found in the production area.建議加強 GMP 教育。Some workers without protective clothing. 建議加強 GMP 教育。建議工廠加強 GMP 教育。No hair for some workers and not properly worn.建議工廠給工人明確的佩戴方法以及管理人員須經(jīng)常去檢查和糾正不正確的佩戴。Yes, use Dettol sanitizer. Are signs posted instructing workers to use sanitizer before entering the production area?有沒有張貼標(biāo)識說明工人在進入生產(chǎn)區(qū)域前要洗手及干手?√ 建議工廠張貼 GMP 指引在生產(chǎn)區(qū)域入口。 Are inspection records available and plete, which identify accepted and nonconforming materials?可否提供完整的確認(rèn)合格或不合格材料的檢驗報告？√ IQC 收貨或退貨報告。 Is nonconforming material properly labeled as to the status and disposition instruction?不合格材料是否正確標(biāo)識其狀況及處理方法?(不合格品的處理程序)√ 部分不合格原料未被正確的標(biāo)識。 Explain to the fty and suggest them to obtain the MSDS of urea pound.FACILITY ASSESSMENT 8/19/2022 10:49 上午 11 Control of Ining Raw Materials 來 料 控 制Yes No NA Comments Are receiving procedures and records adequate to keep track of the date of receipt, lot number and vendor?是否有來料控制程序,并記錄收據(jù)日期 ,批次及供應(yīng)商名稱以便追蹤？√ Are quality requirements and acceptance criteria clearly defined with signed samples available for reference?客戶對質(zhì)量的要求及接受標(biāo)準(zhǔn)是否明確, 以及簽辦是否可供參考？√ Is nonconforming material properly segregated from other production materials to prevent use in production?不合格材料有沒有合理地與其它生產(chǎn)材料隔離以避免在生產(chǎn)中不小心使用？√ 部分不合格原料與合格原料存放在同一區(qū)域，且沒有明顯的標(biāo)識。No toxic material being used in the fty. Are MSDS sheets maintained for toxic and potentially hazardous materials?可提供有毒物質(zhì)及潛在危險材料的 MSDS？√ 兩種材料，密胺粉及尿素粉是制造產(chǎn)品的主要材料，但工廠只能提供密胺粉的MSDS。Some ining material label are not up to date and packaging are broken.建議工廠及時更新標(biāo)識，以及采取措施，封好已破損的包裝，防止污染。Raw material are placed with less than 18” perimeter.工廠須重擺放，以預(yù)留該通道。 Are fire extinguishers, sand and/or other fire protection equipment on hand properly maintained within expiration date?滅火器、消防沙及其它滅火設(shè)施是否在有效期內(nèi)適當(dāng)保養(yǎng)及隨時可取?