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Fronius品質(zhì)驗(yàn)廠審核內(nèi)容

編輯:上海勵(lì)奧 來源:Fronius驗(yàn)廠 日期: 2016-1-8 17:29:50

Fronius驗(yàn)廠品質(zhì)方面主要審核內(nèi)容: / Main aspects Performance

1. 不合格品 / Nonconforming material

2. 產(chǎn)品檢驗(yàn) / Inspection of parts

3. 供應(yīng)商管理 / Supplier management

4. 工藝管理 / Process suitability

5. 可持續(xù)性改進(jìn) / Continuous

6. 研發(fā) / Research & Development

7. 其它 / Miscellaneous


1、Fronius驗(yàn)廠 - 不合格品 / Nonconforming material

1.1 明確的不合格產(chǎn)品標(biāo)識(shí)要求 /Clear requirements for the identification of nonconforming product

1.2 儲(chǔ)存不合格品(隔離儲(chǔ)存,電腦鎖,分開存放合格產(chǎn)品和有缺陷產(chǎn)品)/Storage of nonconforming product (Quarantine store; IT-storage; separation between acceptable and nonconformance products) ?

1.3 在生產(chǎn)過程中是否分別記錄在公司批準(zhǔn)的格式文件中?(人員的資質(zhì),需求,可接受的返工,返修產(chǎn)品的流程) /Are discrepancies documented on company-approved forms during the manufacturing process?, (Qualification of personnel;Requirements, Acceptance procedure for reworked/repaired products)

1.4 特殊發(fā)放 (通知Fronius) /Special release (Information to Fronius)

1.5 客戶索賠的需求/流程(如何處理從客戶那里追回的產(chǎn)品) /Requirements/Process for customer claims (Handling of returned products from customer)


2、Fronius驗(yàn)廠之產(chǎn)品檢驗(yàn) / Inspection of parts

2.1 檢測(cè)指導(dǎo)書,樣品計(jì)劃, 目視檢測(cè),安全可靠測(cè)試,包裝說明等 /Inspection instruction, sample plans, visual inspection, safetycritical tests, Packing instructions

2.2 檢驗(yàn)標(biāo)識(shí) (檢驗(yàn)狀態(tài))Inspection identification (Status of the performed inspection)

2.3 對(duì)于各個(gè)批次的產(chǎn)品的可追溯性的檢測(cè)和實(shí)驗(yàn)記錄(包括文件儲(chǔ)存,詳細(xì)的文檔,可追溯的批次/批號(hào)/序列號(hào)和檢測(cè)記錄) /
How is the traceability of inspection and test records maintained for all lots/batch (file storage; detailed documentation;
Traceability to Charge/Lot/Serial Number and Inspection records)

2.4 測(cè)量工具和儀器的流程管理(文件) / Procedure for the Tool and Gage Control?


3、Fronius驗(yàn)廠之供應(yīng)商管理 / Supplier management

3.1 供應(yīng)商的認(rèn)可和發(fā)布Supplier Qualification and Supplier Release

3.2 供應(yīng)商索賠流程Claim process to the supplier

3.3 關(guān)于進(jìn)一步的送貨確認(rèn)供應(yīng)商的阻止和發(fā)放 Supplier blocked and release of the supplier for further deliveries

3.4 收貨檢驗(yàn)(根據(jù)目前制定的A,B,C等級(jí)制度)Procedure for the receiving inspection (in coordination of the current customer rating A,B, C)

3.5 風(fēng)險(xiǎn)管理的流程文件,特別是核心產(chǎn)品(單一資源;核心設(shè)備)
Procedure for the risk management for eg Key Products (Single source; Bottleneck machine)


4、Fronius驗(yàn)廠之工藝管理 / Process suitability

4.1 材料或零件生產(chǎn)的流程文件 (供應(yīng)指導(dǎo)書,作業(yè)指導(dǎo)書)
Process documentation for parts or materials that are manufactured (Process instructions, Work instructions)

4.2 工藝的發(fā)布 - 參照相應(yīng)的技術(shù)資料(圖紙和或工藝規(guī)范)執(zhí)行過程能力 Release of process - reference the appropriate technical data
(drawings and/or process specifications) to perform process capability?

4.3 員工資質(zhì)培訓(xùn)流程 /Procedure of the employees qualification

4.4 過程監(jiān)控程序(如測(cè)量,監(jiān)控,責(zé)任,過程的穩(wěn)定性)Procedure for process monitoring (eg measuring; monitoring;responsibilities; process stability);

4.5 工藝流程控制 (責(zé)任,工藝改進(jìn))Procedure for the process control (Responsibilities; Process improvement)


5、Fronius驗(yàn)廠之可持續(xù)性改進(jìn) / Continuous Improvement

5.1 可持續(xù)性改進(jìn)流程(整合相關(guān)的員工,責(zé)任,文件和資質(zhì)) /Continuous improvement process (responsibility, documentation,
qualification and integration of employees)

5.2 鑒別可持續(xù)性改進(jìn)的流程(從失敗的結(jié)果,評(píng)審,交貨期,客戶投訴索賠) /Procedure for the identification of continuous improvements (from failure re-porting, audits, delivery dates, customer claims)

5.3 可持續(xù)性改進(jìn)的報(bào)告(根源問題剖析,職責(zé)責(zé)任)/Reporting of the continuous improvements (root cause analysis, responsibility)

5.4 及時(shí)實(shí)現(xiàn)可持續(xù)和有效改善 /Timely realization of continous improvements and effectivity


6、Fronius驗(yàn)廠評(píng)估之研發(fā) / Research & Development

6.1客戶需求customer requirements

     - 需求 (在項(xiàng)目開展前的客戶需求,批準(zhǔn)的工藝流程)- Requirements(what is requested from the customer before project start,approval process)

     - 客戶澄清(書面文件)- Clarifications with customer (in writing, documentation)

6.2 衍生的技術(shù)參數(shù)derivation of technical parameter s

     - 技術(shù)規(guī)格(開發(fā),批準(zhǔn),客戶澄清)- technical specifications (development, approval,clarifications with customer

     - 應(yīng)用的標(biāo)準(zhǔn),認(rèn)證,法律規(guī)定- application of standards,certifications,legal requirements

     - 可行性檢查- feasibility check

6.3 R&D 流程 R&D process

     - 階段和關(guān)口(過程描述和標(biāo)準(zhǔn)/樣品)- phases and gates (process description and criteria / samples

     - 過錯(cuò)預(yù)防和分析,產(chǎn)品失效模式分析,經(jīng)驗(yàn)教訓(xùn)- fault prevention and analysis, FMEA,lessons learned

     - 項(xiàng)目管理- project management

6.4 R&D Know How

     - 能力和資格- capabilities and qualification

     - 經(jīng)驗(yàn)/同類產(chǎn)品參考- experience / references similar products

     - 工具和方法(CAD, 仿真測(cè)試)- tools and methods (CAD, simulation,testing, ...)

6.5 核查和驗(yàn)證研發(fā)成果/產(chǎn)品 verification and validation of R&D results / products

     - 測(cè)試(內(nèi)部/外部測(cè)試)- testing (internal/external)scope of testing

     - 與第三方的合作- experience and cooperation with 3 rd party testing

     - 客戶的批準(zhǔn)(樣品,報(bào)告)- approval by customer (sampling, reports, ...)

     - 文檔(內(nèi)容,歸屬,儲(chǔ)存)- documentation (content,submission, storage)

6.6 產(chǎn)品更改 product changes

     - 更改流程- change process

     - 溝通,內(nèi)部/客戶批準(zhǔn),舊版PCN- communication and internal / customer approval, PCN part history

     - 文檔(內(nèi)容,歸屬,儲(chǔ)存)- documentation (content,submission, storage)

     - 驗(yàn)證 / 確認(rèn)- verification / validation


7、其它 / Miscellaneous

7.1 處理,存儲(chǔ)和包裝ESD(散)/Are stored parts appropriately segregated and protected (eg. are materials protected in accordance to ESD requirements)?

7.2 風(fēng)險(xiǎn)管理(核心機(jī)器,刀具磨損,核心員工)/Does the company have a procedure for risk management(eg. second source; bottleneck ofa machine)?

7.3 內(nèi)部評(píng)審 (流程審核,產(chǎn)品審核) /Internal audits (process audits,product audits)

7.4 SOS (安全,整潔,清潔) /Safety, tidiness and cleanliness

7.5 流程中的質(zhì)量管理體系/Quality system in process

7.6 溝通 (內(nèi)部, 直接客戶;供貨情況;會(huì)面情況) Communication (internal, direction customer; Availability; Meeting architecture)

7.7 產(chǎn)品更改 product changes

     - 工藝修改- change process

     - 溝通和內(nèi)部/客戶的批準(zhǔn),PCN 零件的歷史 - communication and internal / customer approval, PCN part history

     - 文檔(內(nèi)容,歸屬,儲(chǔ)存)- documentation (content,submission, storage)

     - 驗(yàn)證 / 確認(rèn)- verification / validation

 

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