P04.05 External laboratory
External/commercial/independent laboratory facilities used for inspection, test or calibration services by the organization shall have a defined laboratory scope that includes the capability to perform the required inspection, test or calibration, and either由組織用于檢驗、試驗或校準(zhǔn)服務(wù)的外部/商業(yè)/獨立實驗室設(shè)施須包括的能力來執(zhí)行所需的檢驗、驗或校準(zhǔn),并定義的實驗室范圍
? there shall be evidence that the external laboratory is acceptable to the customer, or ?有須證據(jù)表明外部實驗室是可以接受的客戶,或
? the laboratory shall be accredited to ISO/IEC 17025 or national equivalent. ISO/IEC 17025?實驗室應(yīng)派駐或相應(yīng)國家標(biāo)準(zhǔn)。
NOTE 1 Such evidence may be demonstrated by customer assessment, for example, or by customer-approved second party assessment that the laboratory meets the intent of ISO/IEC 17025 or national equivalent. 注意1 這種證據(jù)可能由顧客評定,舉個例子,證明,或由客戶認(rèn)可第二方評定證明實驗室滿足ISO/IEC 17025 或相應(yīng)國家標(biāo)準(zhǔn)的意圖。
NOTE 2 When a qualified laboratory is not available for a given piece of equipment, calibration services may be performed by the equipment manufacturer. In such cases, the organization should ensure that the requirements listed in ISO16949: 7.6.3.1 have been met. 一段給定的設(shè)備,校準(zhǔn)服務(wù)可以由設(shè)備制造商不合格的實驗室時,注意到2。在這種情況下,組織應(yīng)確保在 ISO16949 中列出的要求︰7.6.3.1 遇到。
P05.05 Work place organization and housekeeping
Good work place organization supports the realization of quality parts. The 5S model is an excellent technique to bring workplace organization up to industry standards. 工作的好地方組織支持實現(xiàn)質(zhì)量的零件。5S 模型是一種優(yōu)秀的技術(shù),使工作場所組織達(dá)到行業(yè)標(biāo)準(zhǔn)。
P05.06 ESD protection
Where ever ESD sensitive material is being used, adequate measures to prevent damage from shock should be applied在任何地方使用 ESD 敏感材料,則應(yīng)適用適當(dāng)措施,防止造成沖擊的傷害
P06.01 Monitoring and measurement of manufacturing processes
The organization shall perform process studies on all new manufacturing (including assembly or sequencing) processes to verify process capability and to provide additional input for process control. The results of process studies shall be documented with specifications, where pplicable, for means of production, measurement and test, and maintenance instructions. These ocuments shall include objectives for manufacturing process capability, reliability, maintainability and availability, as well as acceptance criteria. 組織應(yīng)執(zhí)行過程研究,對所有新的制造(包括程序集或測序)工藝驗證過程能力并為過程控制提供附加的輸入。工藝研究的結(jié)果應(yīng)記錄與規(guī)格,在哪里鐵芯,為生產(chǎn)、測量和測試,以及維修說明的手段。這些憑證應(yīng)包括目標(biāo)制造過程能力、 可靠性、可維護(hù)性和可用性,以及驗收標(biāo)準(zhǔn)。
The organization shall maintain manufacturing process capability or performance as specified by the customer part approval process requirements. The organization shall ensure that the control plan and process flow diagram are implemented, including adherence to the specified組織應(yīng)保持制造過程能力或性能作為指定由客戶件批準(zhǔn)過程的要求。組織應(yīng)確??刂朴媱澓瓦^程流程圖被執(zhí)行,包括加入到指定的。
? measurement techniques, ? 測量技術(shù)
? sampling plans, ? 抽樣計劃
? acceptance criteria, and? 驗收標(biāo)準(zhǔn),和
? reaction plans when acceptance criteria are not met. ? 反應(yīng)計劃時不符合驗收標(biāo)準(zhǔn)。
Significant process events, such as tool change or machine repair, shall be recorded. 應(yīng)記錄重要的過程事件,如模具的更換或機械維修。