NC关闭指导书
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NC关闭指导书
NC关闭指导书
NSF-ISR 张会DEAR CLIENT:
当审核组给你开出来NC后,请按照以下要求关闭。
1、方法,推荐采用8D的方法进行关闭(虽然这不是必须的,但是NSF-ISR对NC关闭的要求比较高,而且必须要包括不符合的描述,遏制措施,遏制措施的验证,根据原因分析,纠正措施及验证,永久性措施等内容,这几项加起来,跟8D也差不多了)。
2、采用8D关闭NC,一般要有以下几个步骤:问题描述,组成小组,遏止措施及遏止措施验证,根本原因分析,选择永久性纠正措施,实施永久性纠正措施及验证,预防再发生的措施,纠正预防措施清单。
下面将逐项说明有关要求。
2.1问题描述,如下图,只用把NC里面“客观证据”里的东东复制到这里即可
2.2组织小组,要把和NC有关系的过程负责人都拉过来进行NC 的关闭工作,而且要有一个组长,如下图
2.3遏止措施及验证Corrective method :这一项要注意了,所谓遏制措施,
第一步,是要采取“纠正”,也是先把问题解决了,把问题抵制住,必须把风险控制住。
比如,产品未检验,那么先把有关产品隔离、检验;测量系统分析未做,先把测量系统分析做一下;
第二步,要从顾客风险的角度,或对其它过程的影响,或其它过程是否存在类似问题考虑一下,例如,不符合项的内容会不会影响到已交付的产品,会不会影响到其它过程的运行
第三,如果本步骤涉及到证据,请列出来,例1
例2:
例3
1.Customer complaint Two parts shipped to the customer with the wrong colors..
2.
Containment Action Quarantine all products on line and in warehouse and identify them with Red tags, sorting process---
2.4原因分析,这一步是最麻烦的
基于多种可能原因上的导致问题产生的根本原因(建议用鱼刺图进行分析
/考虑方
法的更改/监控措施)
如果根本原因没有找到,而提出预防不符合再次发生的纠正措施是不可能的。
一个好的方法就是不断地问自己:如果我们解决了这个原因,不符合还会再发生吗?如果回答:会。
那么根本原因就没找到,还要再深入分析。
我们问这样的问题“为什么潜在的根本原因还会发生呢”多问几次的话,我们可能会找到根本原因所在(也就是我们常说的“五步法”“FIVE WHY”)。
一般的原因应分析至策划的问题。
下面是部分通常被认为不足够的根本原因分析:
“Operator error” or “Oversight on the part of the operator”,
“操作工失误”或“对操作工监督不够”
“Poor training” or “Training not effective ”,
“缺乏培训”或“培训不够”
“Didn’t understand the requirement” or “Not aware of the requirement”
“不理解要求”或“不知道要求”
“Isolated occurrence”
“孤立事件”
用以上的根本原因可能导致AQA要求进一步的阐述和调查因为他们不是特定的和将不可能完全避免不符合的再次发生。
例如,如果问为什么操作工失误呢,可能的原因是错误的开关看起来很象正确的按钮,而操作工在选择时出错了,那根本原因应该是采用防错的方法去消除按错键的事件发生
根本原因必须是被管理层控制的。
例1:
例2:
1. It’s a new caliper, there’s no system in place to enroll new measurement equipment into the system.
2. System for new caliper is in place, process owner was not defined or defined clearly
3. System in place, responsibility is clear, process owners didn’t follow the procedure
why
they just transferred from another job, transferred people were trained, however, training was not effective.
why
Training effectiveness evaluation and the methods were not
defined in the procedure,
It’s defined in the procedure that floor personnel are responsible to send the due caliper for calibration, however, the responsible person forgot due to no monitoring system.
More…
例3:
1 Why it’s escaped, why the process didn’t detect the problem & ship to customers?
Did not inspect part for color defects.
Why
Process design problem, PFMEA did not list wrong color as a failure mode, did not identify the detection method. No inspection in place in the control plan and WI.
Why – PFMEA only developed by production group, did not use the cross functional team. Missed some failure modes.
Why –Procedure did not define the cross functional team requirement for PFMEA development and no review and approval process in place
2 Why did the planning process not prevent produce the bad parts? Process design problem, it’s not identified as a failure mode in the P FMEA, so no control method in the control plan & WI.
Why
More
2.5选择永久措施Choose permanent method :这些措施要和原因分析能对照,特别说明的是,假如你的措施里有“修改文件”这样的内容,建议你最好把修改内容写清楚,如果本步骤涉及到证据,请列出来,例1
例2:
1.Updated the procedure to define this process and the process owners was trained.
2.Updated the procedure to identify the process owners and the process owners was
trained.
3.HR updated the procedure for training effectiveness evaluation and the process owners
was trained.
4. Update the procedure to include defined responsibilities, calibration tech will responsible for this, set up calibration system that can generate due equipment list automatically for every month. All process will be monitored by calibration tech.
2.6永久措施效果验证Verify the permanent method :验证要和永久性措施能对照,并且要同TS规范8.5.2.2联系起来,考虑防错,如果本步骤涉及到证据,例:
2.7系统预防措施,这一步应该同TS规范8.5.2.3联系起来,考虑纠正措施的影响,把措施应用到类似产品或项目上,如果本步骤涉及到证据,例1
例2:
1.Verify that all the measurement equipment used on site are
in the calibration system.
2.Verify the effectiveness of other process job transfer.
3.Retrain all the employees to use the identified measurement equipment
例3:
1.Updated PFMEA to include the wrong color as a failure mode, identify poka-yoke mistake
proof control method for wrong color, install poka-yoke system & conduct poka-yoke audit.
2.Update the PFMEA procedure and add cross functional team and approval requirements
3.More . . .
2.8证据清单:OE list:列出你在以上步骤里提到的证据,
2.9 附证据时,请对照8D报告,标出证据一、证据二,例
2.10 特别说明:假如整改措施里有“修改文件”的措施,请在文件里把修改的地方用不同的颜色标出来。