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PHILIPS验厂辅导---PHILIPS质量介绍(八)

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: 组织应确保不符合产品要求的产品得到识别和控制,以防止其非预期的使用或交付。控制以及相关的职责和不合格品处置的当局应在形成文件的程序中定义。本组织应处理不合格品,由一个或多个下列方面︰

a) By taking action to eliminate the detected nonconformity; a)通过采取措施,消除发现的不合格;

b) By authorizing its use, release or acceptance under concession; b)通过授权其使用、放行或接收根据特许权;

c) By taking action to preclude its original intended use or application. c)通过采取措施防止其原预期的使用或应用。

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. 组织应确保不合格品被让步接收,只有满足监管要求。授权特许权的人员身份的记录应予保持记录不符合项的性质,应保持任何随后的行动包括批准的让步。当不合格品得到纠正它应重新验证,以证实符合要求。当分娩后发现产品不合格或开始使用后时,组织应采取的影响或潜在影响,不合格。如果产品需要返工 (一次或以上),本组织应记录返工过程中经历了原始的作业指导书相同的授权和批准程序的工作指示。之前授权和批准的作业指导书,须作出和记录测定产品返工的任何不良影响。


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被拒绝的材料必须加以分析,找出根本原因,防止复发。从汽车行业 8 D 技术常用


P08.01  Manufacturing process improvement

Manufacturing process improvement shall continually focus upon control and reduction of variation in product characteristics and manufacturing process parameters. 制造工艺的改进,应不断地侧重于控制和减少产品的特点和制造工艺参数的变化。NOTE 1 Controlled characteristics are documented in the control plan. 注 1受控特性都记录在控制计划中。NOTE 2 Continual improvement is implemented once manufacturing processes are capable and stable, or product characteristics are predictable and meet customer requirements注2持续改进实现一旦制造过程是有能力和稳定的或产品的特点是可预测的和满足客户的要求


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. 组织应建立维修活动,包括他们的频率,当这种活动或缺乏可以影响产品质量的记录的要求。这类维修的记录应予保持。


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"工具和设备的维修应确保运行的时间保证足够的输出,以实现飞利浦采购订单。工具,具有较高对飞利浦关键质量特性的影响最好应"预防性维护"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规划的过程 (IT,ERP) 必须到位,以计划和监督生产进度。应该很容易处理需求的变化


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