P07.01 Control of nonconforming product
The organization shall ensure that product which does not conform to product requirements is identified and controlled to prevent its unintended use or delivery. The controls and related responsibilities and authorities for dealing with nonconforming product shall be defined in a documented procedure. The organization shall deal with nonconforming product by one or more of the following ways: 組織應(yīng)確保不符合產(chǎn)品要求的產(chǎn)品得到識(shí)別和控制，以防止其非預(yù)期的使用或交付。控制以及相關(guān)的職責(zé)和不合格品處置的當(dāng)局應(yīng)在形成文件的程序中定義。本組織應(yīng)處理不合格品，由一個(gè)或多個(gè)下列方面︰
a) By taking action to eliminate the detected nonconformity; a）通過(guò)采取措施，消除發(fā)現(xiàn)的不合格;
b) By authorizing its use, release or acceptance under concession; b）通過(guò)授權(quán)其使用、放行或接收根據(jù)特許權(quán);
c) By taking action to preclude its original intended use or application. c）通過(guò)采取措施防止其原預(yù)期的使用或應(yīng)用。
The organization shall ensure that nonconforming product is accepted by concession only if regulatory requirements are met. Records of the identity of the person(s) authorizing the concession shall be maintained Records of the nature of nonconformities and any subsequent actions taken, including concessions obtained, shall be maintained. When nonconforming product is corrected it shall be subject to re-verification to demonstrate conformity to the requirements. When nonconforming product is detected after delivery or use has started, the organization shall take action appropriate to the effects, or potential effects, of the nonconformity. If product needs to be reworked (one or more times), the organization shall document the rework process in a work instruction that has undergone the same authorization and approval procedure as the original work instruction. Prior to authorization and approval of the work instruction, a determination of any adverse effect of the rework upon product shall be made and documented. 組織應(yīng)確保不合格品被讓步接收，只有滿足監(jiān)管要求。授權(quán)特許權(quán)的人員身份的記錄應(yīng)予保持記錄不符合項(xiàng)的性質(zhì)，應(yīng)保持任何隨后的行動(dòng)包括批準(zhǔn)的讓步。當(dāng)不合格品得到糾正它應(yīng)重新驗(yàn)證，以證實(shí)符合要求。當(dāng)分娩后發(fā)現(xiàn)產(chǎn)品不合格或開始使用后時(shí)，組織應(yīng)采取的影響或潛在影響，不合格。如果產(chǎn)品需要返工 （一次或以上），本組織應(yīng)記錄返工過(guò)程中經(jīng)歷了原始的作業(yè)指導(dǎo)書相同的授權(quán)和批準(zhǔn)程序的工作指示。之前授權(quán)和批準(zhǔn)的作業(yè)指導(dǎo)書，須作出和記錄測(cè)定產(chǎn)品返工的任何不良影響。
P07.02 Root-cause analysis is done
Rejected material must be analyzed to find root causes and to prevent recurrence. The 8D techniques from the automotive industry are commonly used被拒絕的材料必須加以分析，找出根本原因，防止復(fù)發(fā)。從汽車行業(yè) 8 D 技術(shù)常用
P08.01 Manufacturing process improvement
Manufacturing process improvement shall continually focus upon control and reduction of variation in product characteristics and manufacturing process parameters. 制造工藝的改進(jìn)，應(yīng)不斷地側(cè)重于控制和減少產(chǎn)品的特點(diǎn)和制造工藝參數(shù)的變化。NOTE 1 Controlled characteristics are documented in the control plan. 注 1受控特性都記錄在控制計(jì)劃中。NOTE 2 Continual improvement is implemented once manufacturing processes are capable and stable, or product characteristics are predictable and meet customer requirements注2持續(xù)改進(jìn)實(shí)現(xiàn)一旦制造過(guò)程是有能力和穩(wěn)定的或產(chǎn)品的特點(diǎn)是可預(yù)測(cè)的和滿足客戶的要求
P09.01 Preventive maintenance
The organization shall establish documented requirements for maintenance activities, including their frequency, when such activities or lack thereof can affect product quality. Records of such maintenance shall be maintained. 組織應(yīng)建立維修活動(dòng)，包括他們的頻率，當(dāng)這種活動(dòng)或缺乏可以影響產(chǎn)品質(zhì)量的記錄的要求。這類維修的記錄應(yīng)予保持。
P09.02 Tooling maintenance and repair
Tooling and equipment maintenance should ensure that the up time guarantees sufficient output to realize Philips purchase orders. Tooling that has a high impact on Philips Critical to Quality characteristics should preferably be a part of "preventive maintenance"工具和設(shè)備的維修應(yīng)確保運(yùn)行的時(shí)間保證足夠的輸出，以實(shí)現(xiàn)飛利浦采購(gòu)訂單。工具，具有較高對(duì)飛利浦關(guān)鍵質(zhì)量特性的影響最好應(yīng)"預(yù)防性維護(hù)"的一部分
P14.05 Production planning system is in place
A planning process (IT, ERP) must be in place to plan and monitor production progress. Changes in demand should be processed easily規(guī)劃的過(guò)程 (IT，ERP) 必須到位，以計(jì)劃和監(jiān)督生產(chǎn)進(jìn)度。應(yīng)該很容易處理需求的變化