00196-MGE Audit questionnary.xls

synthesesynthese n de laudit :#ref!#ref! auditaudit processusprocessusdate :#ref!#ref! audit interne audit externe ligne :fournisseur : produit :site : sujet :ligne : site :produit : demandeur/sce.:demandeur/sce.: participants:participants: auditeursauditeursauditesaudites scesceaq production logistique pilote de laudit:sce:achats lgendedbut prp.auditrapportsuivi n1suivi n2 planning prvu ralis initialinitialsuivisuivicommentairescommentaires themesnb.qnb.q nb.nb. nana nb.nb. s snb.nb. a anb.nb. i inb.nb. s snb.nb. a anb.nb. i i 1. plan assurance qualit du produit# # 2. achats, rception, stockage# # 3. fabrication (postes, moyens fab. & contr.)# # 4. conditionnement, stockage, expdition# # 5. contrle, test, mtrologie# # 6. personnel, scurit, environnement# # 7. environnement# # 8. pilotage de la supply chain# # totaltotal : : # # qualificationqualification : : nonnonouiouinonnonouioui %#ref!#ref!%#ref!#ref! si nombre insuffisant = processus non qualifi et % commentaires: visa de lauditeur:visa de laudite: diffusion : page 2 de 22 m g e u p s s y s t e m s manufacturing process audit 制制程程稽稽核核 n criteriaremarksownerremarks assurance quality plan 確確保保品品質質計計劃劃 1is the full industrial file available? 是否有完整之工業檔案? the document control must be available and up to date 文件管制必須可行且隨時更新dcc 2presence of full quality assurance documents? 是否有完整品質保證文件? control range, fab. synoptic, quality records 管制範圍, 概要及品質記錄dcc 3analysis of eventual changes of the industrial file? 工業文件之最終變更分析? coherence between the industrial file (managed by the document control) and the industrial file extract 工業檔案(文件管制處理)與工業檔案概況要一致 dcc 4analysis of any critical points? 任何重要因素之分析? check on the implementation of corrective actions is dealt within question 50 在問題50中之糾正措施落實確認 pqc 5presence of test reports, of inspection? validation of products and production processes before manufacture and submissoin of industrial sampling? 是否有測試及檢驗報告? 在量產及工業 樣品承認前是否有經過產品及生產制程 之驗證, gap between if et va (verbal action) test ? (口頭措施)測試之間隙 pqc 6characterisitics conform to schedule and specifications? 電气特性是否符合進度及規格? in the case of periodic audits, check the full industrial sample documentation 在周期性的稽核情況下是否有確認完整的工業樣品文件 pqc page 3 de 22 manufacturing process audit 制制程程稽稽核核 n criteriaremarksownerremarks m g e u p s s y s t e m s purchasing- incoming goods - storage 采采購購-進進料料-儲儲存存 7purchase orders with specific requirements? 是否依據指定需求作采購定單? 采購 8 is the iss acceptence depends on the range supplying? 進料之允收標準是否依據分類供應 check each product being audited. eg of lock mechanism: closed order for is, open order once iss have been accepted. 每种產品受稽核之確認. 一旦訂單有被承認, mqc 9is there a procedure for checking incoming deliveries? 是否有確認進料交貨之程序? inspect that the delivery conforms to the order: identification, revision, packaging, presence of a certificate of conformity, check on delivery note, inspection stamp, shelf life. 檢驗交貨是否符合訂單要求. 良品承認是否有識別, 修正, 包裝 及保留, 確認出貨通知單, 檢驗樣品及保存期限 mqc 10 is there a procedure for checking incoming deliveries of special batches ? (see also: batch range) 是否有特別批之進料交貨檢驗之程序? prototypes, test batches, initial samples, pre-production parts, etc check on waivers, modifications, etc 原型, 測試批及原始樣品, 生產部品等特採, 修正等確認. mqc 11 are incoming products kept in separate areas? 進料產品是否有分不同區域隔開? eg: products to be inspected, products awaiting decisions, psa 產品檢驗, 產品待檢決定 mqc page 4 de 22 manufacturing process audit 制制程程稽稽核核 n criteriaremarksownerremarks m g e u p s s y s t e m s 12 is there a procedure for goods inwards inspection? 是否有內部檢驗程序 the products ordered and the product delivered have the same index of definition, set of inspection tests, rules for samplig, records, use and storage of results, rejected batches, handling customer packaging, etc 產品訂購與產品交貨是否有明確之看板, 檢驗測試設定, 抽樣規 範, 記錄, 使用與儲存結果, 不良批, 搬返客戶包裝等. mqc 13 list of products subject to product quality assurance? 產品目錄是否以產品品質保證為準? eg: computer processing of pqa, awareness of the status of each part. 例如: pqa電腦處理程序, 部品狀況之認知. mqc 14 physical identification of pqa? pqa檢驗識別? eg: label on delivered pieces. 例如l: 交貨品之標簽. mqc 15 is there an audit procedure for incoming products? 進行產品是否有稽核程序文件? periodic audit of products subject to pqa. does an audit schedule exist? 產品定期稽核是否以pqa為準. 是否有稽核計劃. mqc 16 pqa documentation with revision number for each product family? 針對每個產品家族是否有pqa文件之修 訂編號 mqc 17 identification and traceability of material batches and components with controlled critical, regulatory or safety characteristics? 原材料批及元件之標識及追蹤是否有嚴 格管控, 規笵或安規? mqc page 5 de 22 manufacturing process audit 制制程程稽稽核核 n criteriaremarksownerremarks m g e u p s s y s t e m s 18 quality status: awaiting decision, accepted, rejected, accepted under waiver, rework, etc? 品質狀況: 等確認, 允收, 不良, 等待特採 , 重工等再允收. formats used linked to procedures. origin of traceability, follow- up of component lists defined? 連接程序之格式, 起源追溯, 元件清單追蹤? mqc 19 means of inspection adapted, calibrated and available? 是否有檢驗, 校正方法? in relation to the products, tolerances, range, etc. 產品關系, 公差, 範圍等. mqc 20 special laboratory and metrology inspections carried out? 落實特別實驗及量測檢驗 if necessary. example: check that raw materials conform to the certificates supplied 如果有必要, 例如, 確認原物料是否符合承認書. mqc storage, logistics, non-conformity 儲儲存存, 服服務務及及不不良良 21 is there a procedure for handling and storage ? 搬運及儲存是否有程序文件? 資材 22 suitable and efficiently arranged storage areas, 適當及有效地安排儲存區域 risks of damage 損害之風險 資材 23 management of safety stocks of components and materials? 電子元件及物料之安全儲存管制 existence, rotation, storage conditions, etc 滯留, 周轉, 儲存條件等資材 24 rotation of stocks (fifo), expiry dates applied? 庫存周轉(先進先出), 逾期處理 資材 25 maintenance of storage and handling equipment? 庫存保養及設備操作 資材 page 6 de 22 manufacturing process audit 制制程程稽稽核核 n criteriaremarksownerremarks m g e u p s s y s t e m s 26 handling equipment suitable for the products and the safety of the personnel? 設備操作是否適合於產品及個人安全 including back-up equipment. 包括備用設備 資材 27 storage off-site or back-up storage? 零庫存或備用庫存 responsibilities, storage conditions and quality, evaluation of any additional risk. 責任, 儲存條件及品質, 任何附加風險評估 資材 28 packaging suitable for the product and in conformance with specifications? 包裝是否適合於產品及符合規格? dimensions, quantities, no risk of deterioration, etc. 尺寸, 數量, 老化之無風險等 資材 29 respect of identification rules for the spare parts and the subassemblies 對於備用品及部件之標識 issue and return to warehouse, expiry dates? 退回庫存, 逾期 資材 30 methods of controlling the movements of modified and unmodified products: version, identification, management of unusable products, end of production? 更改及未更改產品之周轉管制方法: 版 本, 識別, 不使用產品管制, 生產成品? 資材 page 7 de 22 manufacturing process audit 制制程程稽稽核核 n criteriaremarksownerremarks m g e u p s s y s t e m s 31 is there a procedure for dealing with non- conformance? 是否有處理不良之程序? for logistical and technical non-conformance. area fornon- conforming products with controlled access, identification, isolation, waivers, rejections, quarantine area, returns, etc. 判定不良之理論與技術. 不良產品區域管制, 通道, 識別, 隔離, 特採, 不良,隔離區, 判退等 mqc 32 is there a procedure for managing corrective actions? 是否有管制糾正措施程序? recording and analysis of defects, action plans. 不良記錄及分析, 糾正計劃 mqc 33 regulatory and safety list in the industrial file? do all documents and packages carry the necessary safety and regulatory symbols? 在工業檔案中是否有規範及安規. 所有 文件及包裝是否有執行必要之安規及適 當之標示. mqc external operations (sub-contractors and suppliers) 外外部部作作業業(外外包包商商及及供供應應商商) 34 specification clearly defined during the order? 在訂單的時候是否有明確定義規格? 采購 35 traceability of regulatory / safety and critical characteristics? 法規/安規及特殊電气特性之追蹤. mqc 36 inspection report on delivery? 交貨檢驗報告 mqc 37 monitoring plan checked? 監控計劃確認 mqc page 8 de 22 manufacturing process audit 制制程程稽稽核核 n criteriaremarksownerremarks m g e u p s s y s t e m s 38 audited and qualified process? 稽核及合格程序? mqc 39 initial samples accepted? 初步樣品允收? mqc manufacturing workstations 生生產產車車間間 denomination 命命名名 40 working instructions at each workstation and consistent with the monitoring plan? 在每個工位是否有作業指導書及是否與 管制計劃一致? 制發 41 are the working instructions up to date? 作業指導書是否有隨時變更? 制發 42 are the working instructions applied? 作業指導書是否適用? follow-up sheet (carried through each stage of the process), instruction and procedure sheets: manufacturing processes, inspections, first and second level maintenance, safety, adjustment, series changeovers, record documents (inspection and manufacture), identification of regulatory and safety characteristics, etc. 追蹤報表(制程每階段之落實), 作業指導書及程序書. 生產流程, 檢驗, 一二級水準保持, 安規, 調整, 系列變更, 記錄文件(檢驗與 生產), 標識及安全特性. 制發 43 issue of stock to workstations? 庫存發布到工作站 appropriate handling, fifo at the workstation and intermediate storage 適當搬運, 工作站及庫存先進先出 資材 page 9 de 22 manufacturing process audit 制制程程稽稽核核 n criteriaremarksownerremarks m g e u p s s y s t e m s 44 identification and traceability of work in progress during production (r=10 if r/s) 在生產中制程之識別與追蹤 identification: part number, index number, marking, visibility, readability, etc.traceability: existence of a link between the source and destination of the product. 識別: 部品纊號, 看板編號, 標識, 目視, 易讀等. 資源與產品目的 間之連績追蹤 廠務 45 no risk of damage at the workstations and during transfers? 在車間及周轉中之耗損風險 packaging, handling equipment, intermediate storage areas, etc 包裝, 設備操作,儲存等 廠務 46 is the production capacity sufficient to mge needs? and, will the production capacity be sufficient if there were a production increase? 對mge之需求產能是否充分. 如果產量 提高, 產能是否足夠? identified and managed bottlenecks 標識與管理 生管 47 production planning in conformance with mge requirements? identification of urgent batches? 生產計劃是否符合mge需求. 緊急批號 標示? 生管 start of production and machine start-up 生生產產開開始始與與機機器器啟啟動動 page 10 de 22 manufacturing process audit 制制程程稽稽核核 n criteriaremarksownerremarks m g e u p s s y s t e m s 48 is there a procedure for authorising the start of production? 開始生產認可是否有程序? procedure applied at start-up, elimination of machine-tuning parts, presence and conformance of production start-up parts. start of production: long shut-downs, team changeover, material batch changeover, series changeover, etc. 此程序是否適用於開始, 機器調整消除, 量產開始部品保留及一 致. 生產開始, 長期停滯, 團隊變更, 物料批變更, 系列變更等 制發 49 parameters affecting the process (external or internal)? 影響制程參數(外內部)? identified, specified, under control, recorded, etc. controlled access to machine settings (e.g. ture, air pressure, voltage, esd, cleanliness, etc.). 識別, 指定, 管制, 記錄等. 機器設定之管制(例如: 气壓, 電壓, 靜 電, 清潔等) 制發 50 traceability through product markings? 通過產品標識來追蹤 inspection stamp, date of manufacture, mould number, etc. 檢驗章, 生產日期, 模具號等 制發 manufacturing workstations 生生產產車車間間 51 check if approval report for production line? 針對生產線確認是否有核準之報告? corrective actions in the case of critical point, list of product / process parameters checked at the workstation, updated (modifications, incidents, revisions, etc.) 在緊急狀況下是否有開糾正措施單, 在工作站之產品清單/制程 參數, 是否有隨時變更(更改, 變更, 修訂) 廠務 52 check the process parameters? 確認制程參數? measured, recorded, capabilities, etc 量測, 記錄, 性能等 廠務 page 11 de 22 manufacturing process audit 制制程程稽稽核核 n criteriaremarksownerremarks m g e u p s s y s t e m s 53 measurement and inspection equipment 量測檢驗設備 inspection equipment and calibration parts recorded, operational, maintained, calibrated, r/r test, crc, etc. 檢驗設備及校正部品記錄, 操作, 保養, 校正, 測試等 qe 54 control of incidents arising during production? 在生產時發生之事變管制 incidents: power cuts, supply flow of parts, materials or consumables cut off, actions: detection, elimination of non- conforming products. 事變: 電源切斷, 部品供應流程, 原料及消費品短缺, 措施: 察覺 不良品排除 生管 55 management of downgraded processes? 不良制程管制 capacities, capabilities, balanced cycles, productivity, etc. 產能, 周期, 生產力等 pqc 56 anti-error systems? 不良系統 planned, completed, operational. during the audit, check that they are in place and effective. 計劃, 完成, 操作. 在稽核中, 是否有確認他們適當有效 qe 57 process audits? 制程稽核 question relates to process audits on the supplier carried out by the supplier. 針對供應商是否有相關之制程稽核 qe 58 special procedures? 特別之程序 continuous monitoring of the process parameters, recording, guarantee that the operation has been carried out. 制程參數之待續監控, 記錄, 保證作業有被落實 制發 product conformance 產產品品符符合合要要求求 page 12 de 22 manufacturing process audit 制制程程稽稽核核 n criteriaremarksownerremarks m g e u p s s y s t e m s 59 identification of quality status: awaiting decision, accepted, rejected, accepted under waiver, reworked, etc.? 品質狀況識別: 待確認, 允收, 判退, 特採 重工后再允收等 mqc 60 correct application of inspections based on (spc) and management of deviations with corrective actions? spc rules applied correctly? or recording of inspections other the spc in accordance with instructions? 基於spc檢驗之糾正申請及與糾正措施 不符是否有管制? spc是否有利於糾正 ? 其它spc檢驗記錄是否與指導書相符 ? pqc/廠務 61 final validation of the product before transfer to another workshop or release for external operations? 在轉移至另一車間或給外部作業前是否 有產品之最終驗證? 制發 62 product audits? 產品稽核planned, completed, in use.計劃, 完成, 使用 pqc management and maintenance of tooling 治治具具管管制制與與保保養養 63 identification and validation ? 鑒定與確 認 qe non-conformance 不不良良品品管管制制 64 is there a procedure for managing non- conformance? 是否有不良品管制程序? identification ,isolation at the workstation, recording, waivers, rejections, quarantine, returns, etc. 在車間之標識, 隔離, 記錄, 特採, 不良,保證, 判退等 pqc page 13 de 22 manufacturing process audit 制制程程稽稽核核 n criteriaremarksownerremarks m g e u p s s y s t e m s 65 is there a procedure for managing corrective and preventive actions and using the results? 是否有管制糾正, 預防措施及使用結果 之程序? effectiveness of corrective and preventive actions (non recurrence). 糾正與與預防措施效(不再發生) pqc product / process modifications 產產品品/制制程程變變更更 66 is there a procedure for dealing with modifications? 是否有處理變更之程序? 制發 67 internal and external validation by industrial sample? 工業產品之內外部驗證 presence of accepted iss before modifications are applied, information to customers, documentation updated (revision numbers) etc. 變更是否適用, 信息是否有轉遞給客戶, 文件更改(修訂編號)前 是否可允收 制發 packaging - storage of finished products - shipping 包包裝裝-成成品品儲儲存存-交交貨貨 packaging 包包裝裝 68 use of instructions sheets for packaging? 包裝作業指導書使用 in accordance with customer requirements if any, risk analysis 如分析到有任何風險是否符合客戶需求 制發 identification 識識別別 69 in accordance with mges requirements? 是否符合mge需求 safety and regulatory symbols, “fragile“ marking. 安規, 規定標示 qe 70 anti-error systems to avoid product mixing and incorrect 是否可避免產品混料及發生錯誤 制發 page 14 de 22 manufacturing process audit 制制程程稽稽核核 n criteriaremarksownerremarks m g e u p s s y s t e m s 71 identification of waivers and modifications? 特採及變更標示 制發 storage 庫庫存存 72 suitable and well-labeled storage areas? 適當地及區分庫存區域標示 conditions and quality of storage, space, identification, index numbers, fifo, expiry dates, audits, etc. 儲存條件及質量, 空間, 識別, 看板, 先進先出, 逾期, 稽核等 資材 73 maintenance of storage, handling, weighing, counting and packaging equipment? 儲存維護, 搬運, 稱重, 計算及包裝設備 資材 74 management of off-site and back-up storage areas? 場所及儲存備用區域之管制 defined responsibilities, conditions and quality of storage, fifo, audits, etc. 定義職責, 儲存條件及質量, 先進先出, 稽核等 資材 75 handling equipment suitable for the products and safe for personnel to use? 搬運設備是否適合於產品及個人使用之 安全性 資材 shipping 出出貨貨 76 is there a shipping procedure? 是否有出貨程序? shipping instruction sheets, release of batches with inspection check-list, conformance of documents, anti-error systems. 出貨指導書, 檢驗單之批發生, 符合文件, 預防不良系統 oqa 77 clear responsibilities? 明確責任oqa page 15 de 22 manufacturing process audit 制制程程稽稽核核 n criteriaremarksownerremarks m g e u p s s y s t e m s 78 labeled shipping areas? 出貨區域標識 if shipping area is close to goods inwards, check the risks of mixing products. 如果出貨區域緊靠內部產品, 確認混料之風險 oqa 79 transport audit? 運輸稽核 groupage area for each carrier, platform, instruction sheets. etc. 搬運器, 平臺, 指導書之區域 oqa 80 management of safety stock? 安全庫存管制 risk analysis, secure stock plan, index numbers controlled? 風險分析, 安全儲存計劃, 看板管制成品倉 81 conditions of use at the customer understood and taken into account? 客戶知悉及入帳之使用條件 成品倉 management of non-conformance 不不良良品品管管制制 82 is there a procedure for dealing with non- conformance? 是否有處理不良之程序 management of logisitcs complaints 抱怨管理 客服 inspection, testing, laboratory, metrology 檢檢驗驗, 測測試試, 實實驗驗, 量量測測 laboratory inspection and metrology 83 appropriate organisation and resources? 適當的組織與資源 external help if necessary.如果必要可尋求外部協助 pqc 84 is there a test procedure? 是否有測試程序 existence, suitability and application 存在, 適當, 申請 pqc 85 schedules? 排程表 existence, application and updating 存在, 適當, 申請 pqc page 16 de 22 manufacturing process audit 制制程程稽稽核核 n criteriaremarksownerremarks m g e u p s s y s t e m s 86 results? 結果 recording, approval, distribution, archiving, conformance to specifications, implementation of corrective actions if non- conformance is detected. 記錄, 核準, 發行, 存檔, 符合規格, 如果不良被察覺, 糾正措施是 否有被落實 pqc reliability testing 可可靠靠度度測測試試 87 appropriate organisation and resources? 適當的組織與資源 external help if necessary.如果必要可尋求外部協助 qe 88 is there a test procedure? 是否有測試程序 existence, suitability and application 存在, 適當, 申請 qe 89 schedules? 排程表 existence, application and updating 存在, 適當, 申請 qe 90 results? 結果 recording, approval, distribution, archiving, conformance to specifications, implementation of corrective actions if non- conformance is detected. 記錄, 核準, 發行, 存檔, 符合規格, 如果不良被察覺, 糾正措施是 否有被落實 qe personnel - environment - safety 職職員員-環環境境-安安全全 personnel 91 trained and authorised to carry out the tasks required. understand and apply working procedures and instructions? 執行所需求工作之培訓及認可. 理解及 應用程序及指導書 eg: authorised fork-lift driver, quality control, r/s characteristics, special resources, etc. 例如: 認可的叉車駕駛員, 品質管制, 特性, 特別資源等 資材 page 17 de 22 manufacturing process audit 制制程程稽稽核核 n criteriaremarksownerremarks m g e u p s s y s t e m s 92 vers