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亞馬遜質(zhì)量驗廠(chǎng)(FQA)審核清單

更新日期:2021-06-23 11:36:27  已瀏覽:4143次

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

Amazon質(zhì)量驗廠(chǎng)審核清單

Section 1: Factory Facilities & Environment (第一部分:工廠(chǎng)設施和環(huán)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(chǎng)整體是否干凈, 整潔,安全:包括生產(chǎn)線(xiàn),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(chǎng)的設施(包括生產(chǎn)機器和工裝用具)以及相應的維護保養是否是好的狀態(tài)?)

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

Section 2: Quality System, Documentation Control, Training (第二部分:質(zhì)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(chǎng)是否有文件化的質(zhì)量手冊去確定工廠(chǎng)的質(zhì)量方針,質(zhì)量目標,并且概述出高級別的質(zhì)量活動(dòng),并且質(zhì)量方針相關(guān)內容在內部進(jìn)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(chǎng)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(guān)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(chǎng)是否正確地進(jìn)行文件控制,像文件審核,批準,分發(fā),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(shù)文件)

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

2.5 Does factory properly keep the quality records, that includes identification, keeping in rigth environment, easy retrieval of records, etc.? (工廠(chǎng)是否正確地保存質(zhì)量記錄,包括標識,保存環(huán)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(chǎng)是否有獨立的質(zhì)量部門(mén),有授權的QA/QC人員檢驗產(chǎn)品和原料,并采取必要的質(zhì)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(chǎng)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(chǎn)品知識,生產(chǎn)流程,檢查和測試,正確的操作生產(chǎn)線(xiàn)和實(shí)驗室的生產(chǎn),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(chǎng)員工和QA/QC人員對相關(guān)產(chǎn)品,原料的質(zhì)量要求以及生產(chǎn)流程是否有足夠的知識)

Section 3: Product Development Control (第三部分:產(chǎn)品設計開(kāi)發(fā)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(chǎng)是否了解不同市場(chǎng)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(chǎng)是否有相應的流程規定在確定產(chǎn)品要求前先和客戶(hù)充分溝通,溝通開(kāi)發(fā)過(guò)程中的產(chǎn)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(chǎng)開(kāi)發(fā)部門(mén)是否懂得或培訓過(guò)使用設計失效模式分析在產(chǎn)品開(kāi)發(fā)中.)

3.4 Does factory organize DFMEA in product development to assess product risks and identify product CTQs? (工廠(chǎng)設計開(kāi)發(fā)階段是否有采用設計失效模式分析以識別產(chǎn)品風(fēng)險和關(guān)鍵質(zhì)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(chǎng)是否有詳細的開(kāi)發(fā)計劃去定義好以下開(kāi)發(fā)進(jìn)程,包括產(chǎn)品結構/功能,需要的物料/零件,手板樣本制作, 產(chǎn)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(chǎng)的工程師和技術(shù)人員是否在產(chǎn)品開(kāi)發(fā)過(guò)程中考慮了客戶(hù)要求及”產(chǎn)品失效模式分析“的結果,以消除產(chǎn)品質(zhì)量風(fēng)險并加強產(chǎn)品關(guān)鍵質(zhì)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(chǎng)設計開(kāi)發(fā)階段是否有以下輸出:正確的產(chǎn)品規格,圖紙,樣板,并為生產(chǎn),采購,質(zhì)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(chǎng)是否按產(chǎn)品開(kāi)發(fā)計劃安排了必要的產(chǎn)品開(kāi)發(fā)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(chǎn)前,工廠(chǎng)是否舉行產(chǎn)前會(huì )議交接產(chǎn)品質(zhì)量要求給生產(chǎn)部門(mén))

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(chǎn)和過(guò)程質(zhì)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(lián)系我們。)


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