TS16949认证五大手册
TS16949 certification five Handbook
依据ISO/TS16949：2002《质量管理体系  汽车生产件及相关服务件组织应用ISO9001：2000的特别要求》标准建立质量管理体系的组织，都有可能涉及到五个核心工具。这五个核心工具是美国通用、福特、克莱斯勒三大汽车公司对向他们提供汽车制造相关材料、汽车组装件或热处理、焊接、电镀、涂装及有关服务的供方提出的质量管理的具体方法和程序。它们是：
According to ISO / TS16949: 2002" quality management system for automotive production and relevant service part organizations use ISO 9001: 2000 the special requirements of the" standards to establish quality management system of organization, are likely to involve five core tool. The five core tool is the United States of America GM, Ford, Chrysler big three auto companies to provide automotive related materials, automotive assembly parts or heat treatment, welding, plating, painting and related services supplier put forward specific quality management method and program. They are:
APQP《产品质量先期策划与控制计划》
APQP" advanced product quality planning and control plan"
FMEA《潜在失效模式及后果分析》
FMEA" potential failure mode and effects analysis."
SPC《统计过程控制》
SPC" statistical process control."
MSA《测量系统分析》
MSA measurement systems analysis.""
PPAP《生产件批准程序》
PPAP" production part approval process"
共五本手册。
A total of five manual.
APQP《产品质量先期策划与控制计划》提供了组织产品实现策划的模式。它将汽车生产件的产品实现过程划分为五个里程碑（见下图：概念提出/批准、项目批准、样件、试生产、投产），确定为五个过程（见下图：计划和确定项目、产品设计和开发验证、过程设计和开发验证、产品与过程确认、反馈/评定和纠正措施）。 
APQP" advanced product quality planning and control plan" provides the organization and planning of product realization model. It will be the automotive production product realization process was divided into five milepost ( see below: concept / approval, project approval, samples, trial production, production ), identified as the five course ( see below: plan and the project, product design and development, process design and development verification, product and process validation feedback assessment and corrective action, / ).
APQP手册详细规定了每一个过程输入与输出的内容，对组织在产品实现的不同阶段开展质量策划有着很好的指导意义；它是一种满足并超越顾客要求的工具，是一种项目管理的方法，是一个有效的防错工具。作为质量策划重要输出内容之一的“控制计划”，是对汽车生产件进行控制以及制造过程的书面描述，它描述过程每个步骤所需的控制措施和要求，规定用来控制产品以及过程质量特性的监测和控制方法，它指导在生产中如何控制工序质量，反映过程使用的测量系统。
APQP manual details the every process of the input and output of the organization, in different stages of the product realization to carry out quality planning has a very good guide; it is a kind of meet and exceed customer requirements tool, is a project management method, is an effective error proofing tools. As the important content of the output of the quality plan" control plan", is on the automotive production manufacture process control and written descriptions, it describes the process of each step required control measures and requirements, regulations to control product and process quality monitoring and controlling method, its guidance in the production of how to control process quality, reflect process used a system of measurement.
对于五个核心工具来说，APQP是“纲”；而FMEA、SPC、MSA、PPAP是“目”，它们是支持APQP的。APQP是质量管理体系PDCA过程模式在汽车生产件组织产品实现过程如何“P”（策划）的一个具体方法，根据自己的产品、顾客的要求来学习并花时间应用APQP，有助于改变我们许多汽车生产件组织不会“P”、不愿“P”、“P”的意识不强的状态，有助于改变组织汽车生产件开发周期长、整个产品实现过程问题“层出不穷”、开发成本高的状况。
For the five core tool, APQP is "key link"; while FMEA, SPC, MSA, PPAP is the "eye", which is supported by APQP. APQP is a PDCA process model of quality management system in automotive production organization and the product realization process how to" P" ( Planning ) of a specific method, based on their own products, customer requirements to learn and spend time using APQP, help to change many of US automotive production organization will not" P", rather than" P"," P" consciousness is not strong state, contribute to the altered tissue automotive production development cycle long, the product realization process problem" emerge in an endless stream", the high cost of development status.
FMEA《潜在的失效模式及后果分析》是一种“事前的质量控制行为”，而不是“事后的行为”。为达到最佳效益，必须在产品实现的策划中、产品和制造过程设计中花时间进行综合的FMEA分析，发现、评价产品设计、制造过程设计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。从设计过程阶段来解决问题，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损失；全面实施FMEA能够避免汽车生产件在制造过程中、装配过程中以及整车使用过程中许多故障、不合格事件的发生，它是对设计过程的更完善化，以确保工程师们的产品设计和制造过程设计满足顾客的需要。ISO/TS16949标准在7.2.2.2/7.3.1.1条款中提出了风险分析、潜在失效模式及后果分析的开发和评审的要求，而FMEA这个专用工具给出了具体的方法，即在产品设计以及制造过程设计中：
FMEA" potential failure mode and effects analysis" is a kind of" advance quality control behavior", rather than" after the act of". For optimal effectiveness, must be in the planning of product realization, product and manufacturing process design of spent time in integrated FMEA analysis, discovery, evaluation of product design, manufacturing process design potential failure and its consequences; find can prevent or reduce the potential failure measures. From design process to solve the problem, which can be easily, low cost of the product or process changes, thus reducing the loss after modification; the full implementation of FMEA can avoid the automotive production in the manufacturing process, the assembly process as well as the vehicle in use process many fault, unqualified event to occur, it is on the process of design more perfect, in order to ensure that the engineers in product design and manufacturing process design to meet the needs of customers. The ISO / TS16949 standard in 7.2.2.2 / 7.3.1.1 presented in terms of risk analysis, potential failure mode and effects analysis the development and assessment requirements, and FMEA this special tool gives the specific methods, namely in the product design and manufacturing process design:
a）分析、发现潜在的失效，
A ) analysis, found the potential failure,
b）对失效及其后果进行风险分析；
B ) on failure and its consequences for risk analysis;
RPN＝S×O×D
RPN = S * O * D
其中 RPN–风险顺序数，S- 严重度，O- 频度，  D- 探测度
The RPN - risk priority number, S - severity, frequency of O -, D - Detection
c）确定不可接受或希望降低其风险的失效；
C ) identify unacceptable or wish to reduce the risk of failure;
d）在设计上采取措施，改进并优化设计；
D ) in the design measures, improvement and optimization design;
e）采取纠正措施、优化设计后，重新计算纠正后的RPN值，验证风险是否
E ) to take corrective measures, optimize the design, to calculate a corrected after the RPN, verify whether or not the risk
降低到了可接受的程度；
Reduced to an acceptable level;
f）如果风险仍不可接受，应重新提出纠正措施、予以实施并进行验证。
F ) if the risk is not acceptable, should the proposed corrective measures, to be implemented and tested.
所以说，FMEA是一种预防，是一种设计上的防错。我国许多汽车生产件组织在设计过程中或多或少开展了这种分析活动，但这类分析活动的有效性普遍不好，差距在于没有各方面专业人员参与多方论证的支持，并且没有形成相关的FMEA文件，不利于防错措施的落实、验证和追溯。
Therefore, FMEA is a kind of prevention, is a design error prevention. Many of our automotive production organization in the design process more or less to carry out this analysis activity, but this kind of analysis of the effectiveness of the activities in general is not good, the gap is not all professionals involved in the multidisciplinary support, and without the FMEA file, is not conducive to error prevention measures, verification and traceability.
SPC《统计过程控制》描述了几种基本的统计方法，包括与统计过程控制及过程能力分析有关的方法；定义了变差、造成变差的普通原因、特殊原因、过程能力、计量型数据、计数型数据等统计概念和术语；ISO/TS16949标准8.1.1/8.1.2条款提出的就是关于“统计工具的确定”、“基础统计概念知识”的要求。SPC描述的统计方法是控制图，它是用来表示一个过程特性的图象，图上标有根据那个特性收集到的一些统计数据，一条中心线（CL），一条或两条控制线（UCL、LCL）。
Statistical process control" SPC" describes several basic statistical methods, including statistical process control and process capability analysis relevant method; defines variation, caused by common causes of variation, for special reasons, process capability, measurement data, attribute data and other statistical concepts and terms; the standard of 8.1.1 / ISO / TS16949 8.1.2 article is about" identification of statistical tools"," knowledge of basic statistical concepts " requirement. SPC descriptive statistical methods is a control chart, it is used to denote a process characteristics of the image, and according to the characteristics of chart has collected some statistical data, a center line ( CL ), one or two control lines ( UCL, LCL ).
它有两个基本的用途，一是用来判定一个过程是否一直受统计控制；二是用来帮助过程保持受控状态。当过程出现变差的特殊原因时，控制图能有效地引起操作者、管理人员的注意；控制图还能帮助人们分析并减少由普通原因引起的变差。它供操作人员使用，对过程进行实时控制，同时有助于过程的质量与成本持续、可预测地保持下去，它有助于分析、减少变差，使过程达到更高的质量、更低的成本、更高的效率，它为讨论过程的状态提供了共同的语言，它区分变差的特殊原因和普通原因，为采取局部措施或对整个系统采取措施提供指南。
It has two basic purposes, one is used to determine if a process is always subject to statistical control; two is used to help maintain a state of control process. When the process has special causes of variation, control chart can effectively cause an operator, management attention; control chart can help people analyze and reduce by a common cause variation. It is for operator, to process real-time control, and contribute to the process of quality and cost, can be predicted to be maintained, it is helpful to the analysis, the reduction of variation, so that the process can achieve higher quality, lower cost, higher efficiency, it discusses the process of the state to provide a common language, it distinguishes between the special causes of variation and common cause, to take local measures or on the entire system to take measures to provide guidance.
控制图的另一个应用是帮助我们计算制造过程的过程能力，因为由普通原因引起的过程变差的大小正是过程能力的反映，所以我们可以通过控制图以及过程能力的计算来评价生产件制造的过程能力是否满足要求。对过程能力不能满足要求的过程，要分析其原因、制定措施，提高其能力，从而保证组织的每一个制造过程能力满足要求，持续、稳定地向顾客提供满足他们要求的产品。
Control charts for another application is to help us to calculate the manufacturing process capability, because by the common cause of process variation in size is the process ability reflection, so we can control chart and process capability were calculated to evaluate the production manufacturing process capability can meet requirements. Process capacity can not meet the requirements of the process, to analyze the reasons, enact measure, improve their ability, thus ensuring the organization of every manufacturing process capability to meet the requirements, continuously, stable to provide to meet the requirements of their products.
MSA《测量系统分析》是用来分析制造过程中所使用的监视和测量装置是否具备所要求的能力，是否能提供真实准确的监视和测量结果的专用工具。它应用控制图等方法，针对生产过程中测量系统可能存在的五种误差，即偏倚、线性、稳定性、重复性、再现性，提出了具体的分析方法以及测量系统是否符合要求能力的判断依据。这五种误差实际上正是制造过程中特定的测量工具、被测量工件、测量人员、测量环境以及测量方法诸要素组成的该测量系统的质量特性，它反映的是该测量系统满足要求的能力，用正态分布的方法对五种误差进行的描述如图：
MSA" measurement system analysis" is used to analyze the manufacturing process used in the monitoring and measuring device is the required capacity, can provide accurate monitoring and measuring the results of the special tool. It application control chart method, aiming at the production process measurement system may exist five kinds of error, namely the bias, linear, stability, repeatability, reproducibility, puts forward the concrete methods and measurement systems for compliance with the requirements of the ability of judgement basis. The five error is actually the manufacturing process specific measurement tools, measurement, measurement of workpiece by staff, for measurement of the environment and method of measuring elements consisting of the measurement system of quality characteristics, it reflects the measurement system 's ability to meet the requirements, use the normal distribution method for five kinds of errors are described as graph:
TS16949标准7.6.1条款明确要求应对制造过程中使用的测量系统进行测量系统分析（MSA），MSA《测量系统分析》手册给出了具体的分析方法，组织应对自己产品控制计划中确定的测量系统所存在的特性（测量误差），做出准确的判断，制定具体的测量系统分析计划和方案。分析计划和方案应经过评审，以避免分析过程发生判断错误、重复分析、过复杂化的问题。
The TS16949 standard 7.6.1 terms clear requirements on manufacturing process used in the measurement system of measurement system analysis ( MSA ), MSA" measurement system analysis" Handbook gives specific analysis method, the organization shall determine their product control plan in the measurement system the existing characteristic ( measurement error), make accurate judgement, to develop specific measurement system analysis plan and scheme. Analysis of plans and programmes should be after review, in order to avoid the analysis process occurring errors in judgment, repeated analysis, have complicated the issue.
PPAP 《生产件批准程序》是汽车主机厂对供方生产件按批量向其进行发运前必须进行的批准程序。该程序定义了生产件批准的一般要求，规定了提交批准的五个等级以及提交的技术文件、记录、样品等具体内容，由顾客对提交的内容进行评审，证实满足所有的顾客要求后，方可授权供方向顾客发运产品。本文已经叙述过的四个专用工具使用过程的输出文件及内容，均被列入了提交批准的内容；TS16949标准7.3.6.3条款规定的就是产品批准过程（PPAP）的要求。由顾客对汽车生产件进行PPAP，其目的就是确保供方提供的产品满足顾客的要求，确定供方是否已经正确理解了顾客的设计和规范的所有要求；是否能够按照要求，按规定的生产节拍来生产满足顾客要求的产品，同时具备持续满足这些要求的潜在能力；PPAP实际上是顾客对供方提供的生产件进行的验证加确认，这一程序的实施确保了整车最终能够满足使用者的要求。我国越来越多的汽车主机厂，为了加强对供方的管理、供应链的建设，纷纷出台自己的PPAP文件，强化生产件批准过程，其目的就是确保整车的质量。作为提供装配件的供方应按照主机厂的要求提交生产件批准，按照主机厂的要求不断解决改进产品存在的问题，提升产品的实物质量，为我国汽车整体质量的提高做出贡献。
PPAP" production part approval process" is the automotive OEM supplier for production in batch to the shipment must be made before approval procedure. The program defines production part approval of the general requirements, provides five levels of submitted for approval and submit technical documents, records, sample specific content, by the customers of the submitted content review, confirmed to meet all customer requirements, can be authorized for dispatch direction customer products. This article has described the four special tools used to process the output file and content, and were included in the submitted for approval content; TS16949 standard provisions of 7.3.6.3 is product approval process ( PPAP ) requirements. By the customer to the automotive production PPAP, its purpose is to ensure that the supplier to provide products to meet customer requirements, to determine whether the supplier has a correct understanding of the customer design and specification of all requirements; whether can according to the requirements, in accordance with the provisions of the production cycle to produce products to meet customer demand, at the same time have continued to meet the requirements of potential capacity; PPAP is actually the customer to provide production parts for verification and confirmation, the implementation of this procedure to ensure that the vehicle can meet the requirements of users. In China more and more the vehicle factory, in order to strengthen the management of suppliers, the supply chain construction, have introduced their PPAP files, strengthen the production part approval process, its purpose is to ensure that the quality of entire. As the provision of assembly parts supplier shall in accordance with the host plant required by production part approval, in accordance with the host plant requirements continue to solve the product problems, improve product quality, is our car to improve the overall quality of contributions.
《产品质量先期策划与控制计划》、《潜在失效模式及后果分析》、《统计过程控制》、《测量系统分析》、《生产件批准程序》五个核心工具的学习与借鉴或应用有助于组织ISO/TS16949质量管理体系要求的落实，提高组织的质量管理水平以及汽车生产件的质量。需注意的是：五个专用工具是美国三大汽车公司要求他们的供方必须使用的方法，没有向美国三大汽车公司提供汽车生产件的组织采用什么样的工具？这应依据你的顾客（主机厂）的要求；所以说，汽车生产件组织质量管理专用工具的应用也是一个顾客导向的过程。
" Advanced product quality planning and control plan"," potential failure mode and effects analysis, statistical process control""",""," measuring system analysis of production part approval process" five core tools to learn or use contributes to tissue ISO / TS16949 quality management system requirements of the implementation, improve tissue quality management level and automotive production quality. It must be noted that: five the special tool is the three largest American car companies require their suppliers must use a method, not to the American three big auto companies to provide automotive production organization with what tools? This should be based on your customers ( OEM ) requirements; therefore, automotive production organization quality management tools for the application is a customer oriented process.