工廠評估及評分指引


Manufacturer Approval Procedure 供稱商認程序
(For SQE application 供應商品質工程師適)
Emerson Radio Corporation
Doc No QD10
CORPORATE OPERATION PROCEDURE
Rev A
Subject Manufacturer Approval Procedure
Page of 25
Revision Change Record
Revision
Para
Description of change
Written by
Reviewed by
Endorsed by
Valid date

A











Edison Yip









20021009








































Part I Factory Management Audit and Rating List
工廠評估評分指引

Scope Applicable for Guang Dong Province Factories Only
適於廣東省製造廠

Section A Material Management
A部分 物料理

A1 Part MaterialFinished Goods Warehouse 原料成品 倉庫
A11 Zone segregation 區域隔离

0 No segregation management 沒分區理

1 Clear zone includes Receiving IQC Passed Waiting for Disposition (MRB) RTV Special Material Scrap
清楚隔離區域包括收貨區 IQC已檢合格區處理區(MRB)退供應商區特殊物料存放區

2 (1) + Material properly located within the area not putting outside the border good management
(1) + 物料正確放置 沒超區 理完善

3 (2) + Fail safe operation For example there is only 1 part on the same pallet
(2) + 運作接出錯 例 卡板種物料

A12 Material identification 物料鑒別

0 Poor ID and labeling 標識方法標簽執行差

1 Material ID label (name PN manufacturer lot qty) and IQC passed label (name PN inspector name (chop) and date) well used
效 物料ID標簽(名稱零件號碼供應商批數數量) IQC檢驗合格標籤(名稱 零件號碼 檢驗員姓名 日期)

2 (1) + Proper implementation and protection of labels
(1) + 標簽正確保護

3 (2) + every external carton is labeled correctly
(2) + 外包裝均正確標示

A13 Disposition of MRB materials 檢討物料處理

0 Direct return to vendors or scrap 直接退料給廠商作廢料處理

1 MRB or similar meeting in place for material review and disposition decision
适當召開物料檢討會議檢討物料狀況作處理決策

2 (1) + MRB or similar procedure properly implemented with every disposition clearly recorded
(1) + 物料檢討程序正確執行清楚記錄份MRB處理細則

3 (2) + MRB procedures well defined and documented
(2) + 物料檢討程序定義清析文件証明
A14 Material protection 物料保護

0 No special requirement or intention for material package protection
對物料包裝保護方面沒特別求意識

1 Proper sealing and protection of material carton after usage or opening by IQC or warehouse operator
IQC倉員開箱取物料正確封箱保護

2 (1) + Requirements well documented no violation of material storage advise such as height direction static sensitive flammable dangerous chemicals
(1) + 作業求文件証明 沒圍反物料標示高度 方 靜電 易燃物 危險化學品

3 (2) + Proper warehouse operation monitoring or regular audit by third party (eg IPQC)
(2) + 第三個体(IPQC)監督定期審核(評估)倉庫運作否正確

A15 Storage environmentshelf life monitoring and control儲存環境監測控制

0 No storage conditionshelf life requirement set up
沒制定對儲存環境求

1 Special materials identified for particular storage conditionshelf life requirements
特殊物料特殊儲存環境

2 (1) + Daily monitoring of conditions and proper records maintained Control actions taking place of specification conditions
(1) + 天監測(環境)條件維持紀錄發現超出規限條件採取控制行動

3 (2) + All special materials are well managed including those in production area
(2) + 特殊物料均理 包括生產場

A16 Material lot records 物料批數紀錄

0 Received Issued material records written on stock record book
收發物料情況寫倉庫紀錄帳簿

1 Color coding system or other effective system is well implemented for different materials to ensure FirstInFirstOut (FIFO) on monthly basis
顏色卡效制度充份利確認物料月份先入先出(FIFO)

2 Bin card system or other effective system is well implemented for different materials to ensure FirstInFirstOut (FIFO) up to every lot
物料倉存紀錄卡充份利確認批物料先入先出(FIFO)

3 (2) + Requirements documented
(2) + 作業求文件証明

A17 Material storage control 物料儲存控制

0 No special requirement or intention to control 沒特別控制求意識

1 Material storage in good order with some over loading
物料儲存序 然超載

2 (1) + With effective over loading management + Requirements documented
(1) + 效超載理 + 作業求文件証明

3 (2) + Regular audit for proper storage and handling by third party (eg IPQC)
(2) + 第三個体(IPQC)定期審核評估倉庫儲存處理否正確
A18 Material Positioning 物料擺位追溯性

0 Mainly depends on operators’ experience and skill informal storage location assignment
倉員經驗技巧沒正式指定儲存位置

1 Some kind of material stores within dedicated areazone for easy positioning
為便追溯部份物料存放指定儲存區域內

2 Makes use of clearly marked storage location in warehouse areas and record
倉庫內清楚標明物料存放區域紀錄案

3 (1) (2) + material storage position can be well traced in defined numbering area
(1) (2) + 清楚追蹤物料準確存放指定數位化位置便查找

A2 Production line Inspection area 生產線 檢查區域
A21 Parts & WIP status identification 部件半成品(WIP)狀態識別

0 No special requirements for clear separation and identification of OKNG units and waiting for inspection checked passed units easily leading to material mix up
沒特別求清楚區分識別OKNG部件檢已檢通過部件容易引致物料混亂

1 OKNG units and waiting for inspection checked pass units are well separated in different easy distinguishable or well labeled containers to avoid mix up
OKNG部件檢檢驗通過部件分別已標示容器盛載免混淆

2 (1) + Relevant containers are properly used with no exception
(1) + 相關容器毫無例外正确

3 (2) + Regular audit for proper storage and handling by third party (eg IPQC)
(2) + 第三個体(IPQC)定期審核儲存處理否正確

A22 Parts identification 部件標識

0 No or incomplete identification of used parts information including parts name parts number specification etc
沒全面對部件作效標籤包括部件名稱部件號碼規格等等

1 Parts number is well identified and labeled on relevant containers
部件資料於相關容器效標示部件號碼

2 (1) + Indirect materials information (eg glue cleaning reagent) is well identified and labeled
(1) + 生產輔料(膠水清潔劑)資料作效標識

3 Labeled shelf life for storage sensitive material outside warehouse
倉外存放期限物料均作標識標明期限


A23 Nonconforming marking in WIPFinished Goods 半成品(WIP)成品缺陷標示

0 No special requirement in nonconforming marking Operator marks for nonconformities with informal means or even do not mark for purpose
對缺陷標記沒特別求作業員對缺陷WIP作非正式標示根沒作標示意識

1 Nonconformings are marked with formal but not defined means such as pencil or tapes
對缺陷品作正式無定義標示例鉛筆膠紙

2 Nonconforming are marked with effective way such as red arrow label or brief description for easy understanding
效方法標示缺陷品例紅箭頭貼紙簡短描述令更清楚明白

3 (2) + Requirements are well documented + marks accurately without exception
(2) + 作業求文件証明 + 標示經常正確無誤

A24 Material handling operation within workstation area 工位內物料處理

0 Poor handling such as stacking too many partsWIP improper placement of WIP found
极差處理水零件WIP(半成品)堆積太WIP放置當

1 Parts WIP are well managed and handled within working area without causing potential drop or unnecessary cosmetic defects
工位內處理零件半成品作業良無潛性掉落導致必外觀良現象

2 (1) + Regular audit for proper storage and handling by third party (eg IPQC)
(1) + 第三個体(IPQC)定期審核評估儲存處理否正確

3 (2) + Regular training of operators for proper material handling
(2) + 對員工定期進行物料處理知識培訓




Section B Quality Management and Control
B部分 品質理控制

B1 Incoming inspection (IQC) 來料檢驗(IQC)
B11 Inspection scope 檢驗范圍

0 Incoming materials inspection is not performed systematically
對來料檢驗沒明確系統化進行

1 Checklist & specifications or relevant materials to be all listed in instruction documents
點檢清單規格相關資料詳細列明指引文件內

2 (1) + Operation correct records complete
(1) + 作業正確 紀錄完整

3 (2) + Shiptostock material list is regularly reviewed approved for updated and proper application
(2) + 對免檢(直接)入倉物料清單作定期檢討 批核更新資料效

B12 Inspection Instructions 檢查指引

0 No instruction or instructions such as sampling level (AQL) and acceptance criteria are not well defined
沒指引指引沒明確定義抽樣水(AQL)接收標准

1 Important guidelines such as sampling level acceptance criteria and inspection instructions are clearly defined and documented
重指引抽樣水接收標准檢查說明清析定義文件証明

2 (1) + Follow the guidelines and record results accordingly with no exception
(1) + 次指引檢查紀錄結果未例外情況發現

3 (2) + Inspectors are regularly trained and tested for inspection knowhow
(2) + 對檢查員進行定期培訓考核檢查知識

B13 Inspection records檢驗紀錄

0 Insufficient information on report due to report format deficiencies such as no designated space for filling sampling AQL inspected items etc
報告格式完善導致報告紀錄資料足例沒定位置填寫AQL檢驗項目等

1 Inspection results are accurately recorded on reports 檢驗結果准確紀錄報告

2 (1) + Inspection report is able to trace to related documents such as SCAR # MRB report # etc
(1) + 檢驗報告相關文均件追溯性SCAR號碼MRB報告號碼等

3 (2) + Inspection reports and relevant documents are well filed and maintained with good condition and traceability
(2) + 檢驗報告相關文件均妥善整理歸案維持追溯性

B14 Inspection Testing equipment 檢驗測試設備

0 Testing equipment and measuring instrument is not calibrated 沒校正測試設備測量儀器

1 Testing equipment and measuring instrument is well calibrated labeled and maintained
測試設備測量儀器均作效校正標示維護

2 (1) + Inspectors use the instrument equipment properly without causing damage (eg putting the caliper back in box after usage)
(1) + 檢查員正確儀器設備防止做成損壞(卡尺完畢隨手放回卡尺盒)

3 (2) + Enough testing equipment instrument & adequate accuracy
(2) + 足夠測試儀器設備準確度足夠

B15 Inspection environment 檢驗環境

0 Poor inspection environment such as insufficient lighting improper magnifying equipment etc
較差檢驗環境燈光放倍數條件足等

1 Good inspection conditions are provided to enhance inspector’s judgment performance
良檢驗環境助提高檢查員判斷力

2 (1) + Wellmanaged and tidy inspection workstation maintained by inspectors during inspection Testing instruction and supporting documents in place
(1) + 檢查員保持檢驗間整潔序檢驗環境測試儀器相關文件均整齊放置

3 (2) + Requirements are well management (2) + 作業求理方法
B16 Parts status identification 部件狀態識別

0 No special requirements for clear separation and identification of OKNG units and waiting for inspection checked pass units easily leading to material mix up
沒特別求清楚區分識別OKNG部件檢已通過檢驗部件容易引致材料混淆

1 OKNG parts and waiting for inspection checked pass parts are well separated in different easily distinguishable or well labeled container to avoid mix up
OKNG部件檢檢驗通過部件分別容易辨認標簽容器盛載防止做成物料混亂

2 (1)+Relevant containers are properly used with no exception (1)+相關容器無例外正確

3 (2) + Regular audit by third party (eg IPQC) (2) + 第三個体(IPQC)定期審核

B17 Expiry date management (for critical chemical such as glue painting flux solder paste)
效期理 (化學物品膠水油漆 松香錫膏等)

0 No checking of expiry dates in incoming inspection or direct ship to stock
對來料時未檢查物料效期直接進倉

1 Expiry date is clearly indicated and checked on material package of each lot
對批來料包裝效日期均清楚標示作檢查

2 (1) + Inspection results are clearly reported Label for expiry date if necessary
(1) + 清楚報告檢驗結果 需加貼期貼紙

3 (2) + Systematic regular review is able to stop the use of expired material & review by MRB
(2) + 系統會求過期物料停 並交MRB檢討

B18 Manufacturer CAR follow up 對供應商改善進

0 No request or informal request for CA such as fax or email from the manufacturer
對供應商改善行動沒求非正式求例傳真電子郵件方式執行

1 Formal SCAR system in place with proper addressing to manufacturers’ CA
正式SCAR系統並效針對性求供應商相關改善行動

2 (1) + Requested CA reply due date is specified in most cases Systematic follow up and manufacturers can respond to correct the root courses per request
(1) + 求改善行動回覆日期清楚註明 系統化進 並於部份情況期回覆

3 (2) + Containment & CA by manufacturer is well followed up and recorded
(2) + 效進記錄供應商圍堵改善行動執行情況

B19 Disposition of rejected lots 拒收處理

0 Return to Vendor is the program with awareness and approval by single party (usually QA)
單部門(通常為QA)知會批准情況便將物料退回供應商

1 Formal Material Review Board (MRB) or similar system in place to deal with rejected material disposition including scrap rework RTV UAI etc
正式物料檢討系統(MRB)處理拒收物料包括報廢 返工 退貨 等等

2 (1) + Relevant procedure is well documented + add working instruction if necessary
(1) + 相關程序文件証明 + 需加作業指導

3 (2) + Every rejected lot is properly handled with no exception
(2) + 對拒收材毫無例外序合理處理
B2 Inprocess inspection and monitoring (IPQC) 制程檢驗監督

B21 Inprocess Control Instructions 製程控制指引

NA Operation not applicable 作業适

0 No special documented guidelines for inprocess control random checking
沒文件指引對制程控制作隨機性抽檢

1 Critical processes or areas are well addressed and identified for IPQC inspection and monitoring
重制程工位均明確指出予IPQC作檢查監察

2 (1) + All sampling requirements (sample frequency quantity checking parameters etc) well specified and documented
(1) + 抽樣求(抽樣頻率數量檢驗項目參數等)詳細說明文件証明

3 (2) + Process management plan (PMP) in place with controls (charts or checklist)
(2) + 制程理計划清楚界定重制程 控制(圖表核查單)

B22 Inprocess Control Records 製程控制紀錄

NA Operation not applicable 作業适

0 No checklist or informal record (raw data) only 沒核查單非正式紀錄

1 Formal record in place which indicates relevant process name machine number inspector name time interval inspected items judgment etc
正規紀錄清楚註明相關工序名稱機器號碼檢查員名字時段檢驗項目判定等

2 (1) + Checklist format is well followed and used with no exception Sampling plan and activities are well set and implemented respectively
(1) + 毫無例外核查單執行建立良抽樣計划實施相關活動

3 (2) + Inspection records are well filed and kept with good traceability
(2) + 檢驗紀錄效存檔保持良追溯性

B23 CAR system for continuous improvement 改善行動求(CAR)系統達連續改善

NA Operation not applicable 作業适

0 Record not complete or no feedback of inprocess defect situation
生產中缺陷點紀錄存沒反饋

1 Nonconforming material report (NCMR) internal corrective action request (ICAR) system in place to feedback inprocess defect situation
物料異常報告內部改善行動求書(NCMR ICAR)体系适當反饋生產中缺陷點

2 (1) + Issued reports are well replied by responsible departments on time and appropriately Relevant action items are well followed for effectiveness
(1) + 關部門准時适當回复報告並效進相關改善行動效性

3 (2) + Documented stop line criteria in place whenever defect rate exceeds set target
(2) + 停線作業指引文件指定線壞品率超出指定目標情況需執行停線求




B24 First piece approval for mass production 量生產前首件批核

0 No such procedure at all
沒程序

1 First article approval procedure is well performed for defined critical processes
重制程生產樣品批核程序較執行良

2 (1) + Procedure well documented and records well maintained
(1) + 程序明文規定保存紀錄良

3 (2) + Approval samples are well identified maintained and displayed in the place of use
(2) + 關批核樣品作清楚標識維護於工位中

B25 Functional verification & maintenance (by golden sample) on testing equipment fixture
(金樣品) 對測試設備治具功確認檢查維護

0 No verification or informal checking
沒檢測非正式檢查

1 Formal routine (normally daily) verification procedure in place with appropriate records
常規檢查(般為天)程序效執行記錄

2 (1) + Relevant procedure is well documented
(1) + 相關程序明文規定

3 (2) + Regular proper maintenance with good results & record supporting
(2) + 定期維護 效果明顯報告支持

B26 Inspection environment 檢驗環境

0 Poor inspection environment such as insufficient lighting proper magnifying etc
檢驗環境欠佳例燈光放倍數條件足等

1 Good inspection conditions are provided to enhance inspectors’ judgement performance
提供理想檢驗環境助提高檢查員判定力

2 (1) + Tidy workplace maintained Testing instruction and supporting documents in place
(1) + 整潔序檢驗環境 檢測指引(相關)支持文件放置於工位作參考

3 (2) + Operation is well managed
(2) + 作業完善理

B3 Finished Goods Quality Control (FQC) 成品檢驗(FQC)
B31 Inspection Instructions 檢查指引

0 Guidelines such as sampling level (AQL) and acceptance criteria are not well defined
指引沒清析定義抽樣水(AQL)接收標准等事項

1 Important guidelines such as sampling level acceptance criteria and inspection instruction are clearly defined and documented
重指引資料清晰定義抽樣水接收標准檢驗說明等事項文件証明

2 (1) + Inspectors well follow the guidelines and record results accordingly with no exceptions
(1) + 檢查員毫無例外指引進行檢查紀錄結果

3 (2) + Inspectors are regularly trained and tested for inspection knowhow
(2) + 對檢查員定期進行培訓考核檢查知識
B32 Inspection records 檢驗記錄

0 Insufficient information on report due to report format deficiencies such as no designated space for filling sampling AQL inspected items etc
報告格式未完善導致記錄資料足例沒指定位置填寫抽樣AQL檢驗項目等

1 Inspection results are accurately recorded on reports 檢驗結果準確記錄報告

2 (1) + Inspection reports have good traceability to related documents such as MCAR no MRB report no etc
(1) + 檢驗報告效追溯關文件資料MCAR號碼MRB號碼等等

3 (2) + Inspection reports and related documents are well filed and maintained with good condition and traceability
(2) + 檢驗報告相關文件均存檔良並於適當保存條件效追溯力執行

B33 Inspection Testing equipment 檢驗測試設備

0 Testing equipment measuring instrument is not calibrated 測試設備儀器沒校正

1 Each testing equipment measuring instrument is well calibrated labeled and maintained
個測試設備儀器校正作效標示保護

2 (1) + Inspectors use the instrument equipment properly without causing damage (eg putting the caliper back to box after usage)
(1) + 檢查員正確設備儀器避免引致損壞(卡尺畢隨手放回卡尺盒內)

3 (2) + Enough testing equipment instrument & adequate accuracy
(2) + 足夠測試儀器設備準確度足夠

B34 Inspection environment 檢驗環境

0 Poor inspection environment such as insufficient lighting proper magnifying etc
檢驗環境欠佳例燈光放倍數條件足等

1 Good inspection conditions are provided to enhance inspectors’ judgment performance
檢驗環境良助提高檢查員判定力

2 (1) + Tidy inspection workstation maintained by inspectors during inspection Testing instrument and supporting documents in place
(1) + 檢查員於檢驗期間應保持工作環境整潔序 測試儀器支持文件合理放置

3 (2) + Operation is well managed (2) + 作業完善理

B35 Finished goods status identification 成品狀況標識

0 No special requirements for clear separation and identification of OKNG units and waiting for inspection checked pass units easily leading to material mix up
未特別求區分標識OKNG機台檢已通過檢驗機台容易做成混亂

1 OKNG units and waiting for inspection checked pass units are well separated by different easily distinguishable or welllabeled containers to avoid mix up
對OKNG機台檢已通過檢驗機台分別容易識別(貼標簽)容器盛載便區分免混淆

2 (1) + Relevant containers are properly used with no exception
(1) + 關容器毫無例外正確

3 (2) + Regular audit by third party (eg IPQC) (2) + 第三個体(IPQC)定期審核
B36 CAR system for continuous improvement 改善行動求(CAR)系統達連續改善

0 No request or informal request for CA from manufacturing sector such as email
對生產部門CA(改善行動)沒求非正式求執行例EMAIL

1 Manufacturing Corrective Action Request (MCAR) system in place to feedback defects found in final lot inspection and request for relevant corrective actions
生產改善行動求(MCAR)系統反映終批發現良項目並求作相關改善行動

2 (1) + Issued reports are well replied based on root course by responsible departments on time and appropriately Relevant action items are systematic followed up performance
(1) + 關部門準時适當回复發出CAR 系統化進相關改善行動效執行

3 (2) + Majority of issued CARs are well follow up to root causes and cases closed within reasonable period of time
(2) + 發出CARs部份效進根原時結案

B37 Disposition of rejected lots 拒收批處理

0 Use as is (UAI) or Sorting are the used disposition of the lot with awareness and approval by single party (usually QA)
般做法單部門 (通常為QA)批准將判為(UAI)挑選兩類

1 Formal material review system in place to deal with rejected lot disposition which included UAI Sort Hold Rework and Scrap
現正式物料檢討体系處理拒收物料包括(UAI)挑選(SORT)處理HOLD)翻工(REWORK)報廢(SCRAP)

2 (1) + Relevant procedure is well documented + add working instruction if necessary
(1) +相關程序文件証明 + 需加作業指導

3 (2) + Every rejected lot is well proceeded with no exception
(2) + 拒收批物料毫無例外程序處理

B38 Reliability testing (RT) 產品性測試

NA Operation not applicable 作業适

0 No program or informal activities performed
沒類計劃實行非正式測試活動

1 Reliability tests are performed in periodic basis with proper records
性測試周期性進行适當記錄

2 (1) + A good RT plan in place to provide guidance and monitoring on their implementation
(1) + 具個良RT(產品性測試)計划對測試實行提供指導監督

3 (2) + RT result is used for design improvement & quality improvement
(2)+ 性測試作推動設計改善產品品質







B39 Quality Improvement activities 品質改善活動

0 No program at all or informal review on quality data
沒類項目對關品質資料進行非正式檢討

1 Formal regular quality review takes place with records such as meeting minutes
定期正規形式檢討(复查)品質問題做相關記錄例會議記錄

2 (1) + Statistical techniques are well used for quality level traceability and review purpose
(1) + 效利統計技術達品質水追溯檢討目

3 (2) + Perfect continuous implementation with weekly monthly quarterly & yearly follow up
(2) + 完善連續週月季年執行關改善行動



Section C Production Management and Control
C部分 生產理控制

C1 Working Instruction in work stations 工作崗位作業指引文件(指導書)

0 No hanging or incomplete hanging of WI on workstations for operator’s reference
工作崗位沒沒完全挂作業指導書(WI)供操作者參考

1 WI is well hanged on each workstation If necessary it is by model
個工位挂作業指導書(WI) 需 應分開型號

2 (1) + Proper protection to WI in use to avoid damage + clear printings (eg text size drawings picture materials description etc) on WI for easy reference
(1) + 過程中妥善保護作業指導書避免做成損壞 外文件印刷(文字 繪圖圖片物料描述等)保持整潔清晰 非常容易參考

3 (2) + Production line group sectors develop the practice to review Working Instruction details by each operator before model change + Evidence shows WI being used to document CA
(2) + 生產線組部門培養位員工養成次轉型號生產前重溫作業指導書習慣 + 証據顯示作業指導書作紀錄改善行動

C2 Amendment on Working Instruction 作業指導書修改

0 No special requirement direct hand written amendment in place
沒特別求原文處(适當位置)直接手寫修改

1 Hand written amendment in place together with approved signature by authorized personnel or department
手寫修改(适當)部份指定負責部門簽字認

2 Found controlled copies are reissued via DCC with the support of the Temporary Working Instruction issued by authorized personnel or department
指定負責部門印發臨時作業指導書控版則交DCC(文控)正式印制分發

3 (2) + Requirements are well documented + Evidence shows WI being used to document CA
(2) + 作業求文件証明 + 証據顯示作業指導書作紀錄改善行動



C3 Preventive maintenance of production machineries and fixtures
機器治具預防保養維修

0 No program for or informal preventive maintenance activities performed
沒進行非正式進行機器治具預防保養維修活動

1 Good program of PM activities for production machineries and fixtures with sufficient and reasonable PM items and proper records
良預防保養維修綱目(計划)對機器治具進行充足合理預防保養維修活動並作效記錄

2 (1) + All machineries and fixtures are well maintained with records & no exception
(1) + 機器治具良保養維修毫無例外

3 (2) + Operator refuses to use machines without effective maintenance
(2) + 員工會拒絕沒效保養維修機器

C4 Screwing process control 鎖螺絲制程控制

NA Process not applicable 制程工序适

0 No monitoring and control requirement on screwing torque
沒求對對螺絲扭力進行監測控制

1 Screwing torque of every tools used is well checked daily by shift and recorded properly showing the specified limits and actual values
個工具螺絲扭力均班方式進行檢測正確記錄顯示規限實際數值

2 (1) + Inspection report mentioned very few screw related nonconforming
(1) + 檢查報告少量與螺絲關良品

3 (2) + Requirements are well documented
(2) + 作業求文件証明

C5 Hand soldering process control 手焊錫制程控制

NA Process not applicable 制程工序适

0 No monitoring and control requirement on solder iron temperature
對烙鐵溫度沒求監測控制

1 Solder iron temperature of every tools used is well checked by shift by hourly basis and recorded properly showing the specified limits and actual values
個工具(烙鐵)均班時為基准方式進行效檢測記錄並顯示規限實際數值

2 (1) + Solder iron temperature data and specifications are well plotted and tracked by statistical means
(1) + 統計方法效繪出追蹤關烙鐵溫度數據規格資料

3 (2) + Inspection report mentioned very few hand soldering related nonconforming
(2) + 檢查報告少量與手焊關良品





C6 Soldering technique of operator (touch up repair assembly line)
作業員焊錫技術(執錫維修組裝線)

NA Process not applicable
制程工序适

0 Poor technique in proper method and time control acquisition
技術足未掌握正確方法操控作業時間

1 Basic soldering technique is applied
掌握基焊錫技術

2 (1) + Soldering technique guidelines are documented and presented to operators at work
(1) + 焊錫技術指引文件証明並效展示予作業員作參考

3 (2) + Good training program in hand soldering and periodic operator evaluation is conducted
(2) + 對手焊錫工良培訓計劃並定期對工作技術考核評估

C7 Wave soldering solder reflow process control 波峰焊焊錫回流制程控制

NA Process not applicable 制程工序适

0 Use hand immerge soldering No control or only focus on controlling some critical parameters
浸錫 沒控制對部份重參數控制

1 Process critical parameters (eg conveyor speed flux concentration temperature distribution in the process etc) are well identified measured tracked and controlled with records
對制程重參數(速度松香密度焊接過程溫度分佈等)清晰界定測量追蹤控制作效記錄

2 (1) + Evidence showing the process is maintained in good condition under proper control system
(1) + 証據表明控制系統運作制程保持穩狀態

3 (2) + Soldering bridge & solder holes are very few (<1000 dppm)
(2) + 錫橋錫孔(<1000 dppm)

C8 Component sequencing and segregation (manual insertion) 零件次序隔离(手插零件)

NA Operation not applicable 作業适

0 Similar components (shape size color) are not well sequenced and segregated to avoid material mix up or misuse
相似零件(形狀顏色)未作效排分開放置避免導致零件混淆誤

1 Good component sequencing and segregation to avoid similar component mix up For PCBA production critical component such as jacks push button should be sequenced to be after wave soldering if it is foam fluxed process
效排序分离零件避免混淆泡沫松香PCBA生產制程重部品插座鈕開關等部件均需排列波峰制程進行後焊

2 (1) + History card or similar practice in place & well managed
(1) + 品質紀錄咭相似方法 理完善

3 (2) + A lot of evidence showing continuous improvement
(2) + 量証據顯示連續改善


C9 Component preforming 零件預加工成形

NA Process not applicable 制程工序适

0 Making use of trimming process Majority of components are not preformed before manual and automatic assembly (MI and AI)
採剪腳工序 部份零件手動插件前未進行預加工成形

1 Majority of components undergo preforming to correct lead shape and length to avoid extra lead trimming process or soldering process
部份零件經過預加工成形調整零件腳形狀長度求並省卻額外對零件腳切斷焊錫制程求

2 (1) + Preforming operation requirement is included in process management plan (PMP)
(1) + 預加工成形作業求包括制程理計划(PMP)中

3 (2) + Preforming stations are well managed
(2) + 步驟理

C10 Parts change verification and approval (SMT and AI process) 對更換部件檢驗認

NA Operation not applicable 作業适

0 No checking or simple checking without record
沒檢驗簡單檢驗沒做紀錄

1 After each parts change relevant component batches are checked and confirmed to be correct with proper record for component details date and time of change responsible person
部件更換負責員時進行檢驗確認相關部件否正確效記錄部件明細更換日期負責等資料

2 (1) + Parts change verification requirement is well documented as working instruction
(1) + 對更換零件確認求於作業指導書中清楚列明

3 (2) + Evidence showing the system is effective without exception
(2) + 証據表明系統效性無例外

C11 Solder contamination analysis 焊錫污染度分析

NA Process not applicable 制程工序适

0 No conducting of such analysis
沒進行類分析

1 Analysis is conducted informally and irregularly usually upon customer request
分析工作非正式非定期方式執行通常基客戶求

2 Analysis is conducted in periodic basis (say 3 months to half year) with proper management and filing of analysis reports
分析工作周期性(般為3個月半年)將分析報告作正確效存檔

3 (2) + Easy tracing by graphical presentation
(2) + 圖示方便追蹤




C12 Approved sample retention in workstations 工作崗位保留批核樣品

NA Operation not applicable 作業适

0 No approved or authorized signature on reference samples or samples not well identified
參考樣品沒經過批核已核准沒負責簽署認對參考樣品沒作清楚標識

1 Each reference sample is well labeled and signed with authorized or approved signature
件參考樣品貼樣品標籤核准認簽名於樣品

2 (1) + Reference samples are well protected and stored in workstations without causing probable damage
(1) + 參考樣品效保存於工作崗位中避免做成損壞

3 (2) + Operation is well documented
(2) + 作業求文件証明

C13 Critical production data and settings (eg injection molding settings parameters)
重生產數據設置(注塑制程設定參數)

NA Operation not applicable 作業适

0 Parameter or data held by operator
關參數數據資料作業員行保留

1 Formal specification Clear information stated on Working Instruction or Guideline documents
效標準規格文件 資料記載作業指導書指引文件中

2 (1) + Relevant instruction or guideline are well used and managed (include filing)
(1) + 相關說明指引文件效理(包括整理歸案)

3 (2) + Critical parameters requirements and implementation are well monitored and controlled by third party (eg IPQC)
(2) + 重參數求執行狀況第三部門(IPQC)作效監察控制

C14 Usage of tools and measuring instrument 對工具測量儀器

0 Poor handling or no attention on proper usage and protection by the staff
工業員正確沒意識對工具儀器正確保護

1 Proper usage and handling of tools and measuring instrument Good placement after use of protection is provided
正確作業工具測量儀器畢後時放回作保護

2 (1) + Tools are maintained at good condition every measuring instrument is well calibrated with good condition
(1) + 作業工具均維持狀況良部測量儀器校正合格維持良狀態

3 (2) + Regular training program & assessment
(2) + 定期進行關培訓考核






C15 Production flow efficiency 生產流程效率

0 Poor production planning including workplace design and material arrangement leading to production flow congestion or almost no flow’ situation
极差生產計划包括車間布局物料安排導致流水線暢順處斷開狀態

1 Production flow is smooth and showing fair efficiency mainly by pushing Workplace is tidy with good material handling and arrangement
生產線推動為 尚算暢順表現理想車間整潔序物料處理安排妥當

2 (1) + Bottleneck never resulted in a lot of WIP and sufficient time is allowed to ensure WIP inspection and testing
(1) + 樽頸情況從未發生並確保充足時間作半成品(WIP)檢驗測試

3 (2) + Production of various models are well planned before manufacturing using techniques such as line balancing method study time study etc
(2) + 型號產品投產前作良詳盡生產(技術)計划技巧包括生產線衡法方法研究時間研究等

C16 Disposition of defective units in process production line 制程生產線缺陷部品處理

0 No clarified and specified requirement for disposition Material mix up has potential to occur
沒闡明指定處理求物料混亂情況極發生

1 Procedure document Working Instruction are in place to clearly specify the proper disposition of online defective units found These are including proper record taking failure analysis leading to find out root cause and driving on related corrective actions
程序文件作業指導書清楚闡明對生產線缺陷部品(半成品成品)正確處理方法包括正確記錄良項目指出根原相關改善行動

2 (1) + All defectives are well recorded addressed to the root cause and drive on appropriate corrective actions
(1) + 缺陷部品資料均作良記錄指出根原作出适當預防改善行動

3 (2) + Good follow up activity on the correction action effectiveness
(2) + 效進改善行動效性

C17 ESD protection and preventive actions 靜電保護預防

NA Operation not applicable 作業适

0 No consideration of ESD aspect
沒考慮靜電方面帶來問題

1 Basic ESD protection activities are done including wrist strap worn by operators at work proper grounding of production lines daily checking of wrist strap functioning
作基靜電保護行動包括作業員作業時戴腕帶生產線适當連接線裝置日檢杳腕帶性

2 (1) + Professional ESD prevention & leakage Make use conductive equipment to handle ESD sensitive parts (eg container separation card board etc)
(1) + 專業作靜電預防放電 防靜電物品 (容器分離咭板等)處理靜電敏感部件

3 (2) + Good training program on ESD concept for relevant operators and supervisory staff
(2) + 對相關操作員理員進行完善ESD觀念培訓
C18 Workshop Housekeeping 車間整潔狀況

0 Poor condition Dirty and untidy workshop under poor management and monitoring
條件欠佳於理監督足情況車間髒亂

1 A Clean workshop is maintained Cleaning operation is usually requested to maintain the clean situation per shift or in daily basis before leave of work
保持車間整潔工天班前班完結後均需進行工位清潔活動保持車間整潔狀

2 (1) + A good housekeeping program of workshop is established
(1) + 建立良車間日常清潔活動計劃

3 (2) + Stable production workshop with defined responsibility
(2) + 穩定生產現場理指定責

C19 Attitude of operators in material handling 作業員對物料處理態度(意識)

0 Poor attitude of operators such as throwing of WIP or materials on line A high cosmetic (or even functional) reject rate is noticed
作業員對半成品(WIP)線物料處理態度(意識)极差拋擲物料於線導致外觀(甚功)良情況偏高

1 Materials are handled intentionally and properly without causing unnecessary damage to them
意識 正確處理物料 免導致必損壞

2 (1) + Proper training + Low cosmetic yield loss on line (<3)
(1) + 正當培訓 + 生產線外觀良率低(<3)

3 (2) + Written requirements such as WI slogan warning notice & achieved yield loss<2
(2) + 作業求作業指導書標語警告牌方式清楚註明並達<2

C20 Effectiveness in repair process 維修工序效性

0 Poor management of waiting for repair units On line repair is conducted
對修理品理极差維修工序時於流水線執行

1 Defective or waiting for repair units are segregated from production line Offline repair is performed with provided Working Instruction
從生產線隔離出壞品修理品 維修工序於離線工位附指引文件條件進行

2 (1) + Evidence showing repair data or reports are feedback and used for improvement purpose
(1) + 証據顯示維修數據報告回饋作為改善途

3 (2) + Repair sequence and methods of common defect symptoms are provided
(2) + 提供對常見良項目維修次序方法(流程圖)

C21 Quality data record analysis and action for improvement 生產數據收集 分析作改善

0 Quality data is not collected correctly or no effective analysis
生產品質數據沒正確紀錄沒效分析

1 Quality data is collected correctly and analysis effectively & properly presented
生產品質數據正確紀錄效分析並展示

2 (1) + Present with proper graph + being used for daily review & push for improvement
(1) + 正當圖示 + 作日常檢討推動改善

3 (2) + A lot of evidence to prove effective improvements (2) + 量效改善証據
Section D Project Development Management
D部分 項目發展理
D1 OEM Design version update monitoring and traceability 設計版更新監察追蹤

NA Operation not applicable 作業适

0 No follow up on customer design version usually focus on the date of receiving Internally issued documents (eg work order BOM) cannot be traced to relevant design version
沒進客戶設計版 通常注重接收日期內部文件(工作指令單 BOM) 未追溯相關設計版

1 Critical customer design information such as product model and number design change description design receiving date design version received by sent by etc is well collected and recorded in the master list
將客戶設計項重資料收集記錄表內包括 產品型號編號 設計(圖紙)變更描述 接收日期 設計(圖紙)版 接收 發出等等

2 (1) + Traceable information on design version is included in every internally issued documents such as technical drawings work order BOM etc
(1) + 設計版相關追溯資料包括於份內部文件中 工程圖紙 工作指令單BOM等

3 (2) + System shows the operation being implemented effectively with no exception
(2) + 系統顯示作業求毫無例外效執行

D2 Maintenance of customer design documents 客戶設計文件保存

NA Operation not applicable 作業适

0 Poor management on customer documents 對客戶文件理差

1 Customer provided design documents are well segregated and filed according to their nature (eg assembly drawings BOM) Documents are filed in sequential order without causing mix up or misuse situation
客戶提供設計文件根據性質分類歸檔(例裝配圖BOM) 文件序存檔排列 免做成混亂錯情況

2 (1) + Checklist or cover sheet is used to indicate every updated document to avoid missing or misordered documents
(1) + 核查清單 清楚標明份更新文件免造成文件丟失次序混亂

3 (2) + System shows the operation being implemented effectively with no exception
(2) + 系統顯示作業求毫無例外效執行

D3 ECR management 工程變更求理

NA Operation not applicable 作業适

0 It is up to only Engineering to decide for ECN No systematic ECR feedback
般工程部決定ECN 沒工程變更求理系統

1 Systematic ECR to manage all requests from different departments
系統化理部門傳來ECR

2 (1) + All ECRs are followed up & handled properly (1) + ECR均進合理處理

3 (2) + Close loop management to make sure the originator (including the customer) being informed for case handling
(2) + 完整閉合反饋系統 保證始作者(包括客戶)知ECR處理結果
D4 ECN management 工程變更理

NA Operation not applicable 作業适

0 Poor ECN management No filing no record no follow up
極差工程變更理 沒存檔 沒紀錄 沒進

1 Systematic ECN to manage important cases Record accuracy & follow up closely
系統化理 部份重ECN已準確紀錄 實時進

2 (1) + All approved ECNs are taken care (1) + 已批准ECN均進

3 (2) + Close loop management to make sure the originator (including the customer) being informed for implementation
(2) + 完整閉合反饋系統 保證始作者(包括客戶)知ECN效執行

D5 Management of customer special requirement 客戶特別求理

0 Poor management No filing no record no follow up
極差理 沒存檔 沒紀錄 沒進

1 Systematic management of important cases Record accuracy & follow up closely
系統化理 部份重個案已準確紀錄 實時進

2 (1) + All approved changes are taken care of
(1) + 已批准個案均進

3 Close loop management to make sure the originator (including the customer) being informed of implementation
(2) + 完整閉合反饋系統 保證始作者(包括客戶)知ECN效執行

D6 Pilot run management 試產理

NA Operation not applicable 作業适

0 No formal required pilot run plan at all 沒正式試產計劃

1 Planned pilot run Does not contribute to improvement of manufacturability quality efficiency & equipment
計劃試產 未考慮改善生產 品質 效率設備

2 System defined pilot run management Comprehensive review meeting taken place to improve in many areas
系統定義試產理 完善進會議檢討方面改進

3 (2) + A lot of evidence showing improvement
(2) + 量証據顯示效改善


Section E Calibration of measuring devices & Preventive Maintenance (PM)
E部分 測量儀器設備校正 預防性保養維護

E1 Responsibility and Personnel qualifications 責員資格

0 No calibrationPM activity conducted at all not welldefined responsible staff or department
沒進行校正PM工作沒指定負責員部門

1 Welldefined responsibility with sufficient workforce for the implementation (Reference standard 1 calibration+1PM personnel versus 500 employees)
清楚定義責單位並指定足夠員負責執行該工作(參考標准500個雇員配1個校正員+1個PM員)

2 (1) + Authorized personnel are well familiarized with the knowledge
(1) + 負責員非常熟悉設備知識

3 (2) + Authorized staff acquired national recognized qualifications in equipment calibration
(2) + 負責員均獲頒發國家認設備校正合格証書

E2 CalibrationPM Plan 校正PM計划

0 No calibrationPM activity conducted at all no systematic management of calibration activity leaving many holes in equipment calibration status
沒校正PM活動沒系統理項校正活動(工作)做成對儀器校正狀況出現項漏動

1 A general calibrationPM program (generally in yearly basis) in place to allow acceptable traceability and follow up on those planned activities
基校正計划(般年為基准)對計劃中關校正活動作出效追蹤進

2 A good and detailed calibrationPM plan in place showing each calibrationPM information including the equipment name and number location expiry dates department representatives equipment status types of calibration etc And with a good review mechanism in place to ensure a failsafe system
個完善詳細校正PM計划清楚顯示個校正活動詳情包括設備名稱編號位置期日部門代表(負責)設備狀況校正PM方式等等個完善檢討機制確保系統安全

3 (2) + Requirements are well documented (2) + 作業求文件証明

E3 CalibrationPM guidelines 校正PM指引

0 No guideline or working instructions in place 沒指引作業指導書文件

1 Each type of measuring instrument and equipment has individual calibrationPM guideline documents
种測量儀器設備均校正PM指引文件

2 (1) + Acceptable calibration procedures and reasonable precision of the calibration origin (Reference standard ratio of precision of calibration origin to the calibrated equipment 13)
(1) + 接受校正PM程序校正標准儀器具備合理精確度(參考標准校正標准儀器校正儀器精確度例為13)

3 (2) + Periodic review on the calibration procedures against international standards
(2) +定期對外界國際標准並檢討校正程序
E4 CalibrationPM records and documents maintenance 校正PM記錄文件維繫

0 No calibrationPM records Incomplete calibration records
沒校正PM記錄完整校正記錄

1 Full set of calibrationPM records traceable to relevant calibration activity details
完整校正PM記錄追溯相關校正活動詳情

2 (1) + Records are well filed indexed and kept in appropriate locations to enhance traceability
(1) + 記錄效(分類)存檔做索引存放适當位置提高追溯性

3 (2) + Authorized and related person demonstrate their understanding on the records accessibility and traceability
(2) + 負責相關員顯示們對記錄存放位置追溯性理解

E5 Laboratory condition monitoring and control 實驗室環境監測控制

0 No measurement and control of calibration environments
完全沒測量控制校正環境

1 Calibration environments (laboratory room temperature and relative humidity) requirements are well defined and documented
對校正環境(實驗室溫度相對濕度)求清析定義於指引文件中

2 (1) + Environment parameters (temperature and relative humidity) are well measured recorded reviewed and controlled with respect to the specifications
(1) + 環境參數(溫度相對濕度)效準確測量記錄檢討控制限制範圍內

3 (2) + Calibration environments are well maintained within specifications with no exception
(2) + 校正環境長期維持規格線內未發現超限情況

E6 Equipment status identification 設備狀態標識

0 No special identification of the calibration origin equipment On Hold or Failed equipment

對特別狀況設備( 原始標準 暫停 失效)未作特別標識
1 Clear ID labels used for Calibration origin equipment calibrated Passed On Hold and calibrated Failed equipment to avoid misuse
清楚校正標籤貼紙分別於類設備包括原始標準校正合格暫等失效等設備防止做成誤情況

2 (1) + Complete label to tell equipment identity calibrationPM date expired date with no exception
(1) + 完整貼紙包含設備編號 校正PM日 期日 沒例外

3 (2) + Authorized person and relevant operators can demonstrate their understanding on various equipment status identification
(2) + 負責相關員顯示明們對种設備狀態標識理解






Section F Others
F部分

F1 Training 培訓

0 No definition of training responsibility Informal training undertaken by individual departments
對培訓職責沒清析定義個別部門舉辦非正式培訓

1 Training program and activities are well coordinated and implemented by the defined department (eg Training Personnel Administration dept) Responsibility is well documented
個接受規划存 沒技培訓 執行完整

2 Systematic training is implemented Formal skill class with practice & examination
系統化完整執行 正規技培訓 實習 考核等

3 (2) + Written system being implemented properly All employees are well trained
(2) +系統予良實施書面化公司員均已受訓

F2 Customer Complaint Management 客戶投訴處理

0 No systematic procedure to handle customer complaints or not responsive at all
對顧客反映品質問題沒系統化理予理睬

1 Handle some cases with appropriate reply Mainly handling by quality control means
對部份問題予适當答复加強品解決

2 Most important issues are handled properly & fix the root causes
對數嚴重問題予适當答复找根原予時解決

3 (2) + Reply in 48 hours + Preventive actions are implemented
(2)＋48時內給予适當答复 + 問題預防措施

F3 Use of Quality Tools 品質工具

0 No application of quality tools at all or no appropriate application
沒品質工具 正當

1 Some application mainly by quality staff 品員品質工具

2 (1) + A lot of improvement evidence showing the proper applications
(1) + 量証據顯示成效

3 (2) + Wide application in different departments such as Production & Engineering
(2) + 部門廣泛 生產部工程部

F4 Packaging Management 包裝理

0 No working instruction or reference sample 沒包裝作業指導書 沒樣品作據

1 Has working instruction but find evidence that operation is different to that specified
作業指導書 發現文與作業相符

2 Working instructions are illustrated Operators fully understand the requirements
作業指導書 圖示 員工完全理解關求

3 (2) + Well designed process to avoid missing accessories & induced defective
(2) + 優良設計程序 避免漏付件引致損壞


F5 Container Loading Management 貨櫃理

0 No checking & cleaning of container Have evidence showing operator do not protect cartons
沒檢查清潔貨櫃 証據顯示員工對貨物保護

1 Operators are protecting the cartons Written working procedure in place but it is not fail safe
員工對貨物保護意識 明文櫃程序 沒設計成會犯錯

2 Loading instruction is strictly followed Carton status identification is clear & always correct
嚴格遵守櫃通知 卡通標示清楚會犯錯

3 (2) + Third party verification with record (2) + 第三者確認紀錄






MANUFACTURER APPROVAL & RATING RULES
1 In order to have the next score all conditions on that particular score & those lower scores have to be achieved otherwise the lower score will be rated
取高級分數 必須達該點較低分數求 否則評較低分數
2 Evidence has to be presented during the audit No later information will be accepted and will not affect any rating afterward
証據必須評審期內提出 完成計分後 會接受資料改變結果
3 The Lead Auditor has the absolute right to decide the rating
評審員絕對評分權
4 For those points without 1 mark CAP is necessary Manufacturer has to present the typed Corrective Action Plan (CAP) for approval within 20 days after report issue date Follow up audit will not perform without the approved CAP
未取1分題目 均提交CAP 製造廠必須評審報告發出20天內提交字CAP作評審 進評審會沒批准CAP情況進行
5 If the manufacturer fails the first audit follow up audit shall not normally be performed within 1 month
製造廠第次評審合格 進評審會個月內進行
6 If the manufacturer fails the second audit follow up audit shall not normally be performed within 6 months
製造廠第二次評審合格 進評審會六個月內進行
7 If the manufacturer fails the third audit follow up audit shall not normally be performed within 12 months
製造廠第三次評審合格 進評審會12個月內進行
表格譯文請見頁

Key for score Achieved score in section A (Total score in Section A number of applicable clauses 3) x
Maximum score in Section A

Score

Max Score 100
Passing Score Section A (Material management)………………92
Section B (Quality Management and Control)…115
Section C (Prod Management and Control)……138
Section D (R&D Management)…………………23
Section E (Calibration & PM)…………………46


Section F (Others)………………………………46
Total 46
Rating on importance
(Max score in each section)
Section A (Material management)……………………20
Section B (Quality Management and Control)…………25
Section C (Prod Management and Control)……………30
Section D (R&D Management)…………………………5
Section E (Calibration & PM)…………………………10
Section F (Others) ………………………………………10

Total survey score
(Achieved score in section A + Achieved score in section B + Achieved score in section C + Achieved score in section D + Achieved score in section E + Achieved score in section F)


頁表格中文版

分數計算(方法) A部分分 ( A部分總分 适條文數目 3) x A部份高份

分

高分 100
合格分 A部分(物料理)……………………………92
B部分(品質理控制)……………………115
C部分(生產理控制) ……………………138
D部分(產品開發理)………………………23
E部分(校正保養維護)……………………46
F部分()…………………………………46
46
重性重評分
(部份高分)
A部分(物料理) ………………………………………20
B部分(品質理控制) ………………………………25
C部分(生產理控制) ………………………………30
D部分(產品開發理) …………………………………5
E部分(校正保養維護) ………………………………10
F部分() ……………………………………………10
評估總分
(A部分分 + B部分分 + C部分分 + D部分分 + E部分分 + F部分分)

~ ~ 完 ~ ~
~ End of Audit Guideline ~

文档香网(httpswwwxiangdangnet)户传

《香当网》用户分享的内容，不代表《香当网》观点或立场，请自行判断内容的真实性和可靠性！
该内容是文档的文本内容，更好的格式请下载文档