【文章內(nèi)容簡介】
Disposition of rejected lots 拒收的處理0 Return to Vendor is the program, with awareness and approval by single party (usually QA).在單一部門(通常為QA)知會(huì)及批準(zhǔn)的情況下便將物料退回供應(yīng)商.1 Formal Material Review Board (MRB) or similar system in place to deal with rejected material disposition, including “scrap”, “rework”, “RTV”, “UAI”, etc.有正式的物料檢討系統(tǒng)(如MRB),處理拒收物料,包括“報(bào)廢”, “返工”, “退貨”, “可用”等等.2 (1) + Relevant procedure is well documented + add working instruction if necessary. (1) + 相關(guān)程序有文件証明 + 如需要加上作業(yè)指導(dǎo).3 (2) + Every rejected lot is properly handled with no exception.(2) + 對所有拒收材都毫無例外地按序合理處理. B2 Inprocess inspection and monitoring (IPQC) 制程的檢驗(yàn)和監(jiān)督. Inprocess Control Instructions 製程控制指引NA Operation not applicable. 此作業(yè)不適用.0 No special documented guidelines for inprocess control, random checking.沒有文件指引對制程的控制,只作隨機(jī)性的抽檢.1 Critical processes or areas are well addressed and identified for IPQC inspection and monitoring.重要制程或工位均有明確指出予IPQC作檢查及監(jiān)察.2 (1) + All sampling requirements (sample frequency, quantity, checking parameters, etc.) well specified and documented.(1) + 所有抽樣要求(抽樣頻率,數(shù)量,檢驗(yàn)項(xiàng)目及參數(shù)等)都有詳細(xì)說明和有文件証明.3 (2) + Process management plan (PMP) in place, with controls (charts or checklist).(2) + 制程管理計(jì)劃清楚界定各重要制程及控制(圖表或核查單). Inprocess Control Records 製程控制紀(jì)錄NA Operation not applicable. 此作業(yè)不適用.0 No checklist, or informal record (raw data) only. 沒有核查單或只有非正式紀(jì)錄.1 Formal record in place which indicates relevant process name, machine number, inspector name, time interval, inspected items, judgment, etc.正規(guī)紀(jì)錄清楚註明相關(guān)工序之名稱,機(jī)器號碼,檢查員名字,時(shí)段,檢驗(yàn)項(xiàng)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) + 毫無例外地跟按核查單執(zhí)行,建立良好的抽樣計(jì)劃及實(shí)施相關(guān)活動(dòng).3 (2) + Inspection records are well filed and kept with good traceability.(2) + 檢驗(yàn)紀(jì)錄能有效存檔保持良好之可追溯性. CAR system for continuous improvement 改善行動(dòng)要求(CAR)系統(tǒng)以達(dá)至連續(xù)改善NA Operation not applicable. 此作業(yè)不適用.0 Record not plete or no feedback of inprocess defect situation.生產(chǎn)中的缺陷點(diǎn)紀(jì)錄不存或沒有反饋.1 Nonconforming material report (NCMR) / internal corrective action request (ICAR) system in place to feedback inprocess defect situation.物料異常報(bào)告/內(nèi)部改善行動(dòng)要求書(NCMR/ ICAR)體系適當(dāng)?shù)胤答伾a(chǎn)中的缺陷點(diǎn).2 (1) + Issued reports are well replied by responsible departments on time and appropriately. Relevant action items are well followed for effectiveness.(1) + 有關(guān)部門準(zhǔn)時(shí)適當(dāng)?shù)鼗貜?fù)報(bào)告並能有效地跟進(jìn)相關(guān)改善行動(dòng)的有效性. 3 (2) + Documented “stop line” criteria in place whenever defect rate exceeds set target.(2) + “停線”作業(yè)指引文件,指定線上壞品率超出指定目標(biāo)情況下需執(zhí)行“停線”要求. First piece approval for mass production 大量生產(chǎn)前之首件批核.0 No such procedure at all.沒有此程序.1 First article approval procedure is well performed for defined critical processes.各重要制程之生產(chǎn)樣品批核程序較好地執(zhí)行良好.2 (1) + Procedure well documented and records well maintained.(1) + 程序有明文規(guī)定及保存紀(jì)錄良好.3 (2) + Approval samples are well identified, maintained and displayed in the place of use.(2) + 有關(guān)批核樣品作清楚標(biāo)識,維護(hù)及使用於工位中. Functional verification amp。 maintenance (by golden sample) on testing equipment, fixture (用金樣品) 對測試設(shè)備,治具之功能確認(rèn),檢查及維護(hù)0 No verification or informal checking.沒有檢測或非正式的檢查.1 Formal routine (normally daily) verification procedure in place with appropriate records.常規(guī)檢查(一般為每天)程序有效執(zhí)行及記錄.2 (1) + Relevant procedure is well documented.(1) + 相關(guān)程序有明文規(guī)定.3 (2) + Regular proper maintenance with good results amp。 record supporting.(2) + 定期維護(hù), 效果明顯且有報(bào)告支持. Inspection environment 檢驗(yàn)環(huán)境0 Poor inspection environment such as insufficient lighting, proper magnifying, etc.檢驗(yàn)環(huán)境欠佳,例如燈光及放大倍數(shù)條件不足等.1 Good inspection conditions are provided to enhance inspectors’ judgement performance.提供理想檢驗(yàn)環(huán)境有助于提高檢查員的判定能力. 2 (1) + Tidy workplace maintained. Testing instruction and supporting documents in place.(1) + 整潔有序的檢驗(yàn)環(huán)境, 檢測指引及(相關(guān))支持文件放置於工位作參考使用.3 (2) + Operation is well managed.(2) + 作業(yè)有完善管理.B3 Finished Goods Quality Control (FQC) 成品檢驗(yàn)(FQC) Inspection Instructions 檢查指引0 Guidelines such as sampling level (AQL) and acceptance criteria are not well defined.指引沒有清析定義如抽樣水平(AQL),接收標(biāo)準(zhǔn)等事項(xiàng).1 Important guidelines such as sampling level acceptance criteria and inspection instruction are clearly defined and documented.重要指引資料清晰定義,如抽樣水平,接收標(biāo)準(zhǔn),檢驗(yàn)說明等事項(xiàng),有文件証明.2 (1) + Inspectors well follow the guidelines and record results accordingly, with no exceptions.(1) + 檢查員毫無例外地依照指引進(jìn)行檢查并紀(jì)錄結(jié)果.3 (2) + Inspectors are regularly trained and tested for inspection knowhow.(2) + 對檢查員定期進(jìn)行培訓(xùn)及考核其檢查知識. Inspection records 檢驗(yàn)記錄0 Insufficient information on report due to report format deficiencies, such as no designated space for filling sampling AQL, inspected items, etc.因報(bào)告格式未完善導(dǎo)致記錄資料不足,例如:沒有指定位置填寫抽樣AQL,檢驗(yàn)項(xiàng)目等.1 Inspection results are accurately recorded on reports. 檢驗(yàn)結(jié)果準(zhǔn)確地記錄在報(bào)告上.2 (1) + Inspection reports have good traceability to related documents such as MCAR no., MRB report no., etc.(1) + 檢驗(yàn)報(bào)告能有效追溯各有關(guān)文件資料,如:MCAR號碼及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(yàn)報(bào)告及相關(guān)文件均存檔良好,並於適當(dāng)保存條件及有效追溯能力下執(zhí)行. Inspection / Testing equipment 檢驗(yàn)/測試設(shè)備0 Testing equipment / measuring instrument is not calibrated. 測試設(shè)備/儀器沒有校正. 1 Each testing equipment / measuring instrument is well calibrated, labeled and maintained.每個(gè)測試設(shè)備/儀器都校正好,并作有效標(biāo)示及保護(hù).2 (1) + Inspectors use the instrument / equipment properly without causing damage (. putting the caliper back to box after usage). (1) + 檢查員能正確地使用設(shè)備/儀器,避免引致?lián)p壞(如:卡尺用畢,隨手放回卡尺盒內(nèi)).3 (2) + Enough testing equipment / instrument amp。 adequate accuracy. (2) + 足夠測試儀器/設(shè)備,且準(zhǔn)確度足夠. Inspection environment 檢驗(yàn)環(huán)境0 Poor inspection environment such as insufficient lighting, proper magnifying, etc.檢驗(yàn)環(huán)境欠佳,例如:燈光及放大倍數(shù)條件不足等.1 Good inspection conditions are provided to enhance inspectors’ judgment performance.檢驗(yàn)環(huán)境良好,有助于提高檢查員的判定能力.2 (1) + Tidy inspe