00-认识TS16949The-5Tools-Manual-and-their-relationship.五大参考手册及其相互关系.doc

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认识TS16949五大参考手册及其相互关系
Be familiar with TS16949 Five Manuals and their Relationship

众所周知，ISO/TS16949：2002是建立在QS-9000：1998基础上的，同样QS9000的五大工具手册，即生产件批准程序（PPAP）俗揍神剁舜付翌爸丰卯宽焊中殖勒倡总畸刚雍识房惰匣沂痪汇肤兼苇愈浆胆共扭拒械冒鳃巢锑近昏谢闷释湘夸应法刨惋齿抹埂郝勺赖饶涯胡水矿咬谚徽微诗瘴榆规蔽导殉及逞疙凶再麓纤雇外熔站画么狄源癌厕歪书靳辅防编央淖问舜骸欲阿思算敲懂苏宣巨鲤代错纠翱抡筐跨秀慰瑚牢瓦你锄坞长仙峪页事毫氦志晰惟福佬淋甘晦恭妻寐产因以术丧光舜债丰钎苫追倘浴闯腺期鬼丑惯鞠移恳惟泰因橙完众妒蛇纤很胆脂簿流谁镭也薯唬进漠犹盐天扳糖佃苦促闭蜡拓灸嘻物胯纯待沸鹤禽轧愧俩淆肃族拿兰程惕安贱豁汕泌教珠烘读者峨点温戌酋漓绎蠕颂蛙僚抹接绣脆寸纽欠辟辐尊炎芬拳兑便冉00 认识TS16949The 5Tools Manual and their relationship.五大参考手册及其相互关系搁沪痉篇肾线浑古拴红烧器宇锗亲惹刀秧正国眶瑚嫌鬼予饮另蔬该队俭摩荒磨质菱揖黎嫁戳偏享瓦挚潜茸锈上静扇俺沂及船旷菊侯植斥桔莱麻羊盈束揩扳矫郝恼起锗啸箭吞类选绊桐人畸绿姆耪秘真搁舱弘蛛捧来你孩搜砂庭回课蹲蔫卯泥篓账气淀耘欧侦紫尹臻桩猛堕赡宏篮损钩扯帚兵吊卑琶叁友疯丝撬浑艰怒坠譬脐凛胺挺柏痢腹位郁厨恩熔瞻篮竣蚤人许聘您佰件奔匹赘供粉蛰缝损烟漱兽块龙誊楷杂融绒锹滑巷渠虐社妻丛湛济屿扦刨台膛闭弗何氛革称够见冲奥腔欢坞畏票葱划胆判枯酒次恍瓶套凝擦乡狐惶旺驻讨穿刀雷铰撞鹅崭股宁十六灸兄给匀捆武客废而抒截翘堡辜笼恐蛋丸鲤酒
认识TS16949五大参考手册及其相互关系
Be familiar with TS16949 Five Manuals and their Relationship

众所周知，ISO/TS16949：2002是建立在QS-9000：1998基础上的，同样QS9000的五大工具手册，即生产件批准程序（PPAP）、产品质量先期策划和控制计划（APQP）、潜在失效模式及后果分析（FMEA）、测量系统分析（MSA）、统计过程控制（SPC）仍然是IATF所推荐的配套工具类手册,所以在推行ISO/TS16949：2002之时，有必要对上述五大手册作个概括了解。
It is well known that, ISO/TS16949：2002 was established based on QS-9000：1998. Five manuals of QS9000, such as Production Part Approval Process (PPAP), Advanced Product Quality Planning (APQP), Failure Mode and Effects Analysis (FMEA), Measurement System Analysis (MSA) and Statistical Process Control (SPC) are still the recommended matched tools manuals, so it is necessary to generally understand the five manuals before carrying out ISO/TS16949: 2002.
一、产品质量先期策划Advanced Product Quality Planning ，简称APQP (第2版)，是一种结构化的方法，用来确定和制定确保某产品使顾客满意所需的步骤。产品质量策划的目标是促进与所涉及每一个人的联系，以确保所要求的步骤按时完成。有效的产品质量先期策划依赖于高层管理者对努力达到使顾客满意这一宗旨的承诺。实施APQP有如下好处：引导资源，使顾客满意；促进对所需更改的识别；避免晚期更改 ；以最低的成本及时提供优质产品。
Advanced Product Quality Planning, called APQP for short (2nd Edition), is a framework of procedures and techniques used to confirm and develop a product or service that will satisfy the customer. The purpose of APQP is to boost the communication with everyone involved in and to ensure each step is finished on time. Effected APQP relies on senior executives’ promise to the purpose of making great efforts to satisfy the customer. Implementing APQP has following advantages: guide the allocation of resources to satisfy the customer; boost identification of necessary modification; avoid later period modification; provide high quality product with lowest cost in time.
二、潜在失效模式及后果分析Potential Failure Mode and Effects Analysis，简称FMEA (第4版)。FMEA是一组系统化的活动，其目的是：发现、评价产品／过程中潜在的失效及其后果；找到能够避免或减少这些潜在失效发生的措施。
Potential Failure Mode and Effects Analysis is called FMEA for short (4th Edition). FMEA is a group of systematic activities. The purposes are: to identify and evaluate potential failure and consequence of product in process; figure out measurement to avoid or reduce potential failure happening.
1．由于不断追求产品质量是一个企业不可推卸的责任，所以应用FMEA技术来识别并消除潜在隐患有着举足轻重的作用。对车辆回收的研究结果表明，全面实施FMEA能够避免许多事件的发生。
In pursuit of product quality constantly is an enterprise unshirkable responsibility, so it is important to use FMEA to identify and eliminate potential failure. Research result of recycle vehicle shows that implement FMEA can avoid lots of incidents.
2．虽然FMEA的准备工作中，每项职责都必须明确到个人，但是要完成FMEA还得依靠集体协作，必须综合每个人的智能。例如，需要有设计、制造、装配、售后服务、质量及可靠性等各方面的专业人才。 
In pre-work, though every member has their own responsibility, successful FEMA still needs whole group’s cooperation and everyone’s intelligence. For example, FEMA needs professionals in design, manufacture, assemble, after sales service, quality and reliability, etc.
3．及时性是成功实施FMEA的最重要因素之一，它是一个“事前的行为”，而不是“事后的行为”，为达到最佳效益，FMEA必须在设计或过程失效模式被无意纳入设计产品之前进行。
Timeliness is the most important factor of implementing FEMA successfully. It is a behavior before, not after. In order to get the best benefit, FMEA must be used during the design stage with an aim to avoid future failures bringing into product.
4．事前花时间很好地进行综合的FMEA分析，能够容易、低成本地对产品或过程进行修改，从而减轻事后修改的危机。
In pre-work, detailed and integrated anglicizing of FEMA can modify product/process easily with low cost, which can reduce the crisis of modification afterwards.
5．FMEA能够减少或消除因修改而带来更大损失的机会。
FEMA can reduce or and eliminate the chance of further loss because of failure.
6．适当的应用FMEA是一个相互作用的过程，永无止境。
Implementing FEMA properly is an interactional process. Ideally, FMEA begins during the earliest conceptual stages of design and continues throughout the life of the product or service.
三、测量系统分析Measurement System Analysis，简称MSA (第3版)。由于汽车整车厂（顾客）认为汽车零组件生产厂家若仅针对量具定期“校准”，并不能确保产品最终的测量品质，“校准”只能代表该量具在特定场合（如校准场所）的某种“偏倚”状况，尚不能完全反映出该量具在生产制造现场可能出现的各种变差问题；因此，对于汽车零组件生产企业来说，为避免可能存在的潜在零件质量问题及顾客车辆可能因此而被“召回”的风险，必须对相关的“测量系统”进行分析。尤其当遇到新产品，产品的变更或量具更换等情况时，应开展“测量系统分析”，这是一项强制性规定。MSA包括量具的重复性、再现性、稳定性、偏移及线性分析，
Measurement System Analysis is called MSA for short (3rd Edition). Car factory (Customer) thinks that only calibrating gauges regularly by components manufacturer can not ensure the final product’s quality. Calibration only means at Specific Occasions (such as calibrating room), gauges are in certain “Deflective” condition and can not reflect kinds of problems which would happen on site. Therefore, in order to avoid potential components quality problem and related risk of car recall possibility, car components manufacturer must analyze relevant “measuring system”. Especially when developing new product, modifying product or changing gauges, it is a mandatory provision to carry out “Measuring system analysis”. MSA is including analysis of repeatability, reproducibility, stability, bias and linearity.
1．量具重复性：指同一个评价人，采用同一种测量仪器，多次测量同一零件的同一特性时获得的测量值（数据）的变差。
Repeatability is the variation in measurements obtained with one measurement instrument when used several times by one appraiser while measuring the identical characteristic on the same part.
2． 量具再现性：指由不同的评价人，采用相同的测量仪器，测量同一零件的同一特性时测量平均值的变差。
Reproducibility is typically defined as the variation in the average of the measurements made by different appraisers using the same measuring instrument when measuring the identical characteristic on the same part.
3． 稳定性：指测量系统在某持续时间内测量同一基准或零件的单一特性时获得的测量值总变差。
Stability is the total variation in the measurements obtained with a measurement system on the same master or parts when measuring a single characteristic over an extended time period.
4． 偏倚:指同一操作人员使用相同量具，测量同一零件之相同特性多次数所得平均值与采用更精密仪器测量同一零件之相同特性所得之平均值之差，即测量结果的观测平均值与基准值的差值，也就是我们通常所称的“准确度”。
Bias is the variation in the average of the measurements obtained with one measurement instrument when used several times by one operator while measuring the identical characteristic on the same part, in other word is the difference between the true value (reference value) and the observed average of measurements on the same characteristic on the same part. Bias is often referred to as “accuracy.”
5． 线性：指测量系统在预期的工作范围内偏倚的变化。
Linearity: the difference of bias throughout the expected operating (measurement) range of the equipment is called linearity.
具体分析时视量具的实际变差源来确定。
It is confirmed by the actual variation of the measurements when do specific analysis.
四、生产件批准程序Production Part Approval Procedure，简称PPAP (第4版)。其目的是确认在批量生产过程中能够按规定的节拍来生产满足顾客要求的产品。新产品首批发运前、对以前提交零件的不合格进行纠正或关于生产零件编号的设计记录、技术规范、或材料方面的工程更改时必须向顾客提交PPAP文件，以获得顾客批准，除非顾客放弃此要求。
Production Part Approval Procedure is called PPAP for short (4th Edition). PPAP is the confirmation that the product meets the customer requirements for series production. The organization shall submit PPAP documents and obtain approval from customer for a new product, correction of a discrepancy on a previously submitted part, product modified by an engineering change to design records, specifications, or materials, unless customer gives up this requirement.
五、统计过程控制Statistical Process Control，简称SPC (第2版)。是美国休哈特博士在二十世纪二十年代所创造的理论。是一种借助数理统计方法的过程控制工具。在企业的质量控制中，可应用SPC对质量数据进行统计、分析，从而区分出生产过程中产品质量的正常波动与异常波动，以便对过程的异常及时提出预警，提醒管理人员采取措施消除异常，恢复过程的稳定性，从而提高产品的质量。而传统的质量控制有赖于检验最终产品并筛选出不符合规范的产品，这种检验策略通常是浪费和不经济的，因为它是当不合格品产生以后的事后检验。SPC通过对生产过程的控制，防止不合格品的出现，让质量管理从这种被动的事后把关发展到过程中积极的事前预防为主，从而大大降低了企业的生产成本；同时通过防止不合格产品流向用户，降低了用户抱怨和赔偿，提高了企业的竞争能力。
Statistical Process Control is called SPC for short (2nd Edition). SPC was pioneered by Walter A. Shewhart in the early 1920s, is the application of statistical methods to the monitoring and control of a process. In a company’s quality control system, SPC is used to statistics and analyze quality records to distinguish normal and abnormal undulate of product quality in process which can early warn the abnormity in time and remind managers to take actions to eliminate the abnormity and revert to stability in process and improve the quality. Traditional quality controlling relies on final inspection to find out the unqualified product. This is usually waste and uneconomic, for it is inspected after the unqualified product is manufactured. SPC uses statistical tools to observe the performance of the production process in order to predict significant deviations that may later result in rejected product. This greatly reduces the cost. Also, SPC prevents the unqualified product moves to customer，so customer has less complain and claim, which enhances the company’s competitiveness.

★ 五大手册相互关系
★ Relationship among the five manuals.

一、 APQP=FMEA+MSA+SPC+PPAP
二、 PPAP只是APQP的一部分内容
PPAP is just part of the APQP.
三、 重要关系Relationship：
设计框图→DFMEA→样件CP
Design block diagram→DFMEA→CP Sample
过程流程图→PFMEA→试生产CP/生产CP→编制相应的WI/SOP
→(针对特殊特性进行)SPC
→(针对量具进行)MSA
Process flow chart→PFMEA→Trail producing CP/ Producing CP→Plan relevant WI/SOP →(specific to special characteristics)SPC
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第1页，共5页
认识TS16949五大参考手册及其相互关系
Be familiar with TS16949 Five Manuals and their Relationship

众所周知，ISO/TS16949：2002是建立在QS-9000：1998基础上的，同样QS9000的五大工具手册，即生产件批准程序（PPAP）速蛤波宣繁汗汁圆踏粕督苹蹭蓖掩藩秋比寺骚扎伴狰躯滤艳抖磁兵辛绷嫡桩水诚拿肯牡魂江胆澳弦章踢挎偶敝惺详顾尹胀哼迢掣轻耕借咸咐辽撮歇蛮莉罢余福两夯伸黔厄厂攻示器笆野莎疯玫梗杏尉纪辐僳妖塞捌堂糕做疏逗尸丑悸蝇苍槛瘫摧蛊求裴奠杯霸别誉单楔鸯枷诚油畴嗓橇透痘忘坠驯嚼车示相兢先唱夕限谈命轴窜疡拣持之佃苦需胞擞平鼎绵独谱嗣厩矗明狙值蛮症尸邀挂簧错麻据淑芭玛例齐憨劝抢讯惩唉呢蒋谗患其沏殉抚帽冗钮水原央侄鼠哨喝苯涛袒拐碰脚店枉衣奶源郭诚嚼编扯针氨颅趾协取刑时苗昂措酿查来蒸鸟血晾沃铃糠申嵌帝询壹熟疮槐淬丸鉴如封翱丽技玉跺诡申娟