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: 組織應確保不符合產品要求的產品得到識別和控制，以防止其非預期的使用或交付?？刂埔约跋嚓P的職責和不合格品處置的當局應在形成文件的程序中定義。本組織應處理不合格品，由一個或多個下列方面︰
a) By taking action to eliminate the detected nonconformity; a）通過采取措施，消除發現的不合格;
b) By authorizing its use, release or acceptance under concession; b）通過授權其使用、放行或接收根據特許權;
c) By taking action to preclude its original intended use or application. c）通過采取措施防止其原預期的使用或應用。
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. 組織應確保不合格品被讓步接收，只有滿足監管要求。授權特許權的人員身份的記錄應予保持記錄不符合項的性質，應保持任何隨后的行動包括批準的讓步。當不合格品得到糾正它應重新驗證，以證實符合要求。當分娩后發現產品不合格或開始使用后時，組織應采取的影響或潛在影響，不合格。如果產品需要返工 （一次或以上），本組織應記錄返工過程中經歷了原始的作業指導書相同的授權和批準程序的工作指示。之前授權和批準的作業指導書，須作出和記錄測定產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，防止復發。從汽車行業 8 D 技術常用
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，應不斷地側重于控制和減少產品的特點和制造工藝參數的變化。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持續改進實現一旦制造過程是有能力和穩定的或產品的特點是可預測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. 組織應建立維修活動，包括他們的頻率，當這種活動或缺乏可以影響產品質量的記錄的要求。這類維修的記錄應予保持。
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"工具和設備的維修應確保運行的時間保證足夠的輸出，以實現飛利浦采購訂單。工具，具有較高對飛利浦關鍵質量特性的影響最好應"預防性維護"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規劃的過程 (IT，ERP) 必須到位，以計劃和監督生產進度。應該很容易處理需求的變化