? 亞馬遜質量驗廠(FQA)審核清單-深圳市九域企業管理顧問有限公司
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    Amazon亞馬遜驗廠

    亞馬遜質量驗廠(FQA)審核清單

    更新日期:2021-06-23 11:36:27  已瀏覽:2959次

    亞馬遜對工廠有兩個方面的要求:社會責任和質量FQA審核標準(Factory Quality Audit)。亞馬遜質量FQA驗廠是委托TUV萊茵審核機構來審,亞馬遜委托第三方來審核是半通知的,只可以約一周,提前一天通知。

    Amazon質量驗廠審核清單

    Section 1: Factory Facilities & Environment (第一部分:工廠設施和環境)

    1.1 Does factory look clean, organized, and secured in: production lines, storage of materials and products, rework / repair areas, inspection, and packing areas?
    (工廠整體是否干凈, 整潔,安全:包括生產線,原料倉和成品倉,重工返修區,檢查和包裝區?)

    1.2 Does factory's facilities (incl. production equipment, tooling) and their maintenances look good?
    (工廠的設施(包括生產機器和工裝用具)以及相應的維護保養是否是好的狀態?)

    1.3 Does factory have and maintain sanitation and/or pest controls in certain production workshops and / or warehouses, as necessary? (必要時,工廠是否在特定的生產車間和倉庫設立并執行衛生及蟲害防治?)

    Section 2: Quality System, Documentation Control, Training (第二部分:質量體系,文件管理,培訓)

    2.1 Does factory have a documented quality manual to define the factory's quality policy, objectives, and outline the high level quality operations? And the quality manual contents have been clearly communicated and understood by factory's management staff?
    (工廠是否有文件化的質量手冊去確定工廠的質量方針,質量目標,并且概述出高級別的質量活動,并且質量方針相關內容在內部進行充分的溝通并被管理層理解)

    2.2 Does factory have documented operation procedures and necessary work instructions to guide people to operate consistently and effectively achieve results as expected, and the procedures and work instructions are understood by related employees?
    (工廠是否有文件化的操作指引和必要的工作指引去指導員工一致性操作并有效地達到期望的結果,并且程序和工作指引被相關員工充分了解)

    2.3 Does factory control documents properly, i.e. review and approval, distribution, change control, etc.? The controlled documents should include external standard documents, and technical documents like spec., drawing, BOM, standard samples, etc..
    (工廠是否正確地進行文件控制,像文件審核,批準,分發,變更控制等?受控文件應該包括外部標準文件;內部規格,圖紙,物料清單,標準樣板等技術文件)

    2.4 Does factory clearly define quality records needs in various quality operations, and the retention time of those records?
    (工廠是否清晰的規定了哪些質量控制位需要質量記錄以及記錄的保存時間)

    2.5 Does factory properly keep the quality records, that includes identification, keeping in rigth environment, easy retrieval of records, etc.? (工廠是否正確地保存質量記錄,包括標識,保存環境以及易于取得等)

    2.6 Does factory have an independent Quality Department, with QA/QC personnel authorized to  inspect products and materials, and take necessary actions to assure quality?
    (工廠是否有獨立的質量部門,有授權的QA/QC人員檢驗產品和原料,并采取必要的質量保證措施.)

    2.7 Does factory have a well planned and implemented training program for workforces and QA/QC personnel, that includes training of product knowledge, production processes, inspection & testing, and, right operations of production, testing, and measuring equipment in production and in-house lab?
    (工廠是否很好地規劃和執行全體員工及QA/QC人員培訓體系,內容包括產品知識,生產流程,檢查和測試,正確的操作生產線和實驗室的生產,計量和測試等設備)

    2.8 Do factory's on-job production and QA/QC personnel have adequate knowledge of quality requirements for the product categories being sourced, relevant materials, and the production processes?
    (工廠員工和QA/QC人員對相關產品,原料的質量要求以及生產流程是否有足夠的知識)

    Section 3: Product Development Control (第三部分:產品設計開發控制)

    3.1 Does factory have good knowledge on safety and regulatory requirements in US/CA/EU/JP markets for the type of products, such as CARB,CA Prop 65 (limits, contaminations)?
    (工廠是否了解不同市場例如美國,加拿大,歐盟,日本等的法規方面的要求, 像CARB,CA65等)

    3.2 Does factory have a process to review with customers to define product requirements, that should include certain spec. product performance, safety, durability, etc. for product development?
    (工廠是否有相應的流程規定在確定產品要求前先和客戶充分溝通,溝通開發過程中的產品標準,表現,安全,可靠性等)

    3.3 Does factory‘s Engineering / PD team be trained / know how to apply DFMEA in product development?
    (工廠開發部門是否懂得或培訓過使用設計失效模式分析在產品開發中.)

    3.4 Does factory organize DFMEA in product development to assess product risks and identify product CTQs? (工廠設計開發階段是否有采用設計失效模式分析以識別產品風險和關鍵質量要求.)

    3.5 Does factory's product development plan for product's construction / functions, required materials / components, prototype sample making, review / verification arrangement for product design, etc.?
    (工廠是否有詳細的開發計劃去定義好以下開發進程,包括產品結構/功能,需要的物料/零件,手板樣本制作, 產品設計的審核/確認等)

    3.6 Does factory's engineers / technicians consider inputs from customer requirements reviews and DFMEA, eliminate the product's risks and enhance product CTQs during product development?
    (工廠的工程師和技術人員是否在產品開發過程中考慮了客戶要求及”產品失效模式分析“的結果,以消除產品質量風險并加強產品關鍵質量特性)

    3.7 Does factory's product development output right / updated product spec., drawings, and/or samples, to provide instructions for production, purchasing, and quality controls?
    (工廠設計開發階段是否有以下輸出:正確的產品規格,圖紙,樣板,并為生產,采購,質量控制提供相應的指引.)

    3.8 Does factory conduct necessary reviews, verifications at various stages of product development according to the plan?
    (工廠是否按產品開發計劃安排了必要的產品開發檢討,驗證).

    3.9 Does factory hold Pre-Production Meeting to communicate product quality requirements to production teams before mass production starts? (在量產前,工廠是否舉行產前會議交接產品質量要求給生產部門)

    Section 4: Purchasing Control & Materials Control (第四部分:采購控制和原材料(外包)控制)

    Section 5: Production and In-process Quality Control (General Part) (第五部分:生產和過程質量控制)

    Section 6: Final Inspection &Test (第六部分:最終成品檢查及測試)

    Section 7: Control of Measuring and Testing Equipment (第七部分:計量和測試設備的控制)

    Section 8: CAP and Continuous Improvement (第八部分:改正措施計劃和持續改善)

    (注:全部審核文件清單資料多不便一一列出,如果需要具體的可以聯系我們。)


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