PFMEA附录A

产品质量先期策划程序1 目的：本程序规定了进行产品质量先期策划和控制计划以及过程策划的工作程序和职责。

2 适用范围公司的每一个新产品或更改产品，都要使用本程序进行产品质量先期策划，并制定控制计划。

通过过程FMEA，确定产品的风险因素。

3 职责和权限3.1 技术部长负责确定APQP小组组长。

3.2 APQP小组负责组织产品质量先期策划工作。

4 程序4.1 成立APQP小组（横向协调小组）：4.1.1 由组长确定与产品质量有关的人员组成APQP小组，并报技术部长批准；4.1.2 APQP小组负责各部门之间的协调工作。

APQP小组成员可根据产品质量先期策划阶段的不同而增减，必要时可以吸收顾客及分供方的有关人员参加小组会议并听取他们的意见和要求；4.1.3 由APQP小组组长安排专人，对小组成员进行新产品项目的技术标准及质量要求的培训，使小组成员充分了解新产品的项目技术要求；4.1.4 由APQP小组组长利用例会的形式，确定小组成员所代表的部门在每一阶段的作用和职责。

新的项目，必须通过对参加项目人员作出相应规定，确保数据资料的机密、安全得到妥善保护。

必要时，供应商亦包括在内。

4.2 计划和确定项目阶段：本阶段的输入有：顾客的呼声（市场调研、保修记录和质量信息、小组经验）；业务计划/营销策略；产品/过程指标；产品/过程设想；产品可靠性研究；顾客输入。

本阶段的输出有：设计目标；可靠性和质量目标；初始材料清单；初始过程流程图；特殊产品和过程特性的初始名细表；产品保证计划；管理者支持。

4.2.1 制定产品质量先期策划进度计划APQP小组在了解、掌握顾客的需要和期望之后，由组长从以阶段制定产品质量先期策划进度计划，并明确职责及时间：·计划和确定项目；·产品设计和开发；·过程设计和开发；·产品与过程确认；·反馈和评定并制定纠正措施。

组长将产品质量先期策划进度计划送交生产技术部部长批准后，下发到各相关职能部门，由组长监督计划的实施情况，定期向技术部长汇报，随时取得支持。

TS 5大手册培训辅导资料1TS的5大手册名称1.1APQP-CP《产品质量先期策划-控制计划》1.2PPAP《生产件批准》1.3 FMEA（DFMEA,PFMEA）《潜在失效模式和后果分析（设计，过程）》1.4SPC《统计过程控制》1.5MSA《测量系统分析》2 TS的5大手册目前所用最新版本是什么？1）APQP（CP）产品质量先期策划（控制计划）手册第二版。

2）PPAP生产件批准手册第四版。

3）FMEA（DFMEA,PFMEA）潜在失效模式和后果分析（设计，过程）手册第四版。

4）SPC统计过程控制手册第二版。

5）MSA测量系统分析手册第四版。

3 TS的5大手册分别体现在T S标准的哪些条款中？1、如果顾客没有明确提出特殊要求，那么，组织应该如何选择适用的参考手册？答：如果顾客没有明确指定使用哪些参考手册，我国的企业一般会选择使用由美国AIAG发布的通用手册。

这些参考手册的中文版曾经由中国汽车技术研究中心发行。

德国VDA发布的通用手册，国内也有使用，其中文版由德国IQM上海科美商务咨询有限公司发行。

国内与法国或意大利的汽车生产商合资的企业，一般采用FIEV或ANFIA发布的通用手册，其二方审核的检查清单（或评价准则）多引用这些通用手册中的规定。

美国三大汽车公司具有版权的五本参考手册包括：APQP、PPAP、FMEA、MSA和SPC。

在使用这五本参考手册时，组织应该注意使用最新的版本。

比如PPAP、MSA、FMEA，现在使用的是第四版，APQP、SPC现在使用的是第二版。

使用这些汽车行业较为普及的先进工具是希望能从这些工具的背后看到共性，使高效率、低成本的企业文化在使用工具的过程中，逐步形成。

2、《产品质量先期策划和控制计划》（APQP）（2008年11月1日生效的第二版）参考手册的内容是什么？答：这里只能简要地介绍如下：APQP是美国汽车工业行动集团（AIAG）克莱斯勒、福特和通用三大汽车公司发布的顾客通用参考手册之一。

10 Steps to Conduct a PFMEAStep 1∙Review the process—Use a process flowchart to identify each process component. Step 2∙Brainstorm potential failure modes—Review existing documentation and data for clues.Step 3∙List potential effects of failure—There may be more than one for each failure. Step 4∙Assign Severity rankings—Based on the severity of the consequences of failure. Step 5∙Assign Occurrence rankings—Based on how frequently the cause of the failure is likely to occur.Step 6∙Assign Detection rankings—Based on the chances the failure will be detected prior to the customer finding it.Step 7∙Calculate the RPN—Severity X Occurrence X Detection.Step 8∙Develop the action plan—Define who will do what by when.Step 9∙Take action—Implement the improvements identified by your PFMEA team. Step 10∙Calculate the resulting RPN—Re-evaluate each of the potential failures once improvements have been made and determine the impact of the improvements.Step 1: Review the ProcessReview the process components and the intended function or functions of those components.∙Use of a detailed flowchart of the process or a traveler (or router) is a good starting point for reviewing the process.There are several reasons for reviewing the process∙First, the review helps assure that all team members are familiar with the process. This is especially important if you have team members who do not work on the process on a daily basis.∙The second reason for reviewing the process is to identify each of the main components of the process and determine the function or functions of each of those components.∙Finally, this review step will help assure that you are studying all components of the process with the PFMEA.Using the process flowchart, label each component with a sequential reference number.∙These reference numbers will be used throughout the FMEA process.∙The marked-up flowchart will give you a powerful visual to refer to throughout the PFMEA.With the process flowchart in hand, the PFMEA team members should familiarize themselves with the process by physically walking through the process. This is the time to assure everyone on the team understands the basic process flow and the workings of the process components.For each component, list its intended function or functions.∙The function of the component is the value-adding role that component performs or provides.∙Many components have more than one function.Step 2: Brainstorm Potential Failure ModesIn Step 2, consider the potential failure modes for each component and its corresponding function.∙ A potential failure mode represents any manner in which the component or process step could fail to perform its intended function or functions.Using the list of components and related functions generated in Step 1, as a team, brainstorm the potential failure modes for each function.∙Don’t take shortcuts here; this is the time to be thorough.Prepare for the brainstorming session.∙Before you begin the brainstorming session, review documentation for clues about potential failure modes.Step 3: List Potential Effects of FailureDetermine the effects associated with each failure mode. The effect is related directly to the ability of that specific component to perform its intended function.∙An effect is the impact a failure could make if it occurred.∙Some failures will have an effect on the customers and others on the environment, the facility, and even the process itself.As with failure modes, use descriptive and detailed terms to define effects.∙The effect should be stated in terms meaningful to product or system performance.∙If the effects are defined in general terms, it will be difficult to identify (and reduce) true potential risks.Step 4: Assign Severity RankingsAssign a severity ranking to each effect that has been identified.∙The severity ranking is an estimate of how serious an effect would be should it occur.∙To determine the severity, consider the impact the effect would have on the customer, on downstream operations, or on the employees operating the process.The severity ranking is based on a relative scale ranging from 1 to 10.∙ A “10” means the effect has a dangerously high severity leading to a hazard without warning.∙Conversely, a severity ranking of “1” means the severity is extremely low.The ranking scales (for severity, occurrence, and detection) are mission critical for the success of a PFMEA because they establish the basis for determining risk of one failure mode and effect relative to another.∙The same ranking scales for PFMEAs should be used consistently throughout your organization. This will make it possible to compare the RPNs from different FMEAs to one another.∙See FMEA Checklists and Forms for an example PFMEA Severity Ranking Scale.The best way to customize a ranking scale is to start with a standard, generic scale and then modify it to be more meaningful to your organization.∙As you add examples specific to your organization, consider adding several columns with each column focused on a topic.∙One topic could provide descriptions of severity levels for operational failures, another column for customer satisfaction failures, and a third for environmental, health, and safety issues.∙See FMEA Checklists and Forms for an examples of Custom PFMEA Ranking Scales.(Examples of custom scales for severity, occurrence, and detection rankings are included in this Appendix.)Step 5: Assign Occurrence RankingsNext, consider the potential cause or failure mechanism for each failure mode; then assign an occurrence ranking to each of those causes or failure mechanisms.We need to know the potential cause to determine the occurrence ranking because, just like the severity ranking is driven by the effect, the occurrence ranking is a function of the cause. The occurrence ranking is based on the likelihood, or frequency, that the cause (or mechanism of failure) will occur.If we know the cause, we can better identify how frequently a specific mode of failure will occur. How do you find the root cause?∙There are many problem-finding and problem-solving methodologies.∙One of the easiest to use is the 5-Whys technique.∙Once the cause is known, capture data on the frequency of causes. Sources of data may be scrap and rework reports, customer complaints, and equipmentmaintenance records.The occurrence ranking scale, like the severity ranking, is on a relative scale from 1 to 10.∙An occurrence ranking of “10” means the failure mode occurrence is very high, and happens all of the time. Conversely, a “1” means the probability ofoccurrence is remote.∙See FMEA Checklists and Forms for an example PFMEA Occurrence Ranking Scale.Your organization may need an occurrence ranking scale customized for a low-volume, complex assembly process or a mixture of high-volume, simple processes and low-volume, complex processes.∙Consider customized occurrence ranking scales based on time-based, event-based, or piece-based frequencies.∙See FMEA Checklists and Forms for examples of Custom PFMEA Ranking Scales. (Examples of custom scales for severity, occurrence, and detection rankings are included in this Appendix.)Step 6: Assign Detection RankingsTo assign detection rankings, identify the process or product related controls in place for each failure mode and then assign a detection ranking to each control. Detection rankings evaluate the current process controls in place.∙ A control can relate to the failure mode itself, the cause (or mechanism) of failure, or the effects of a failure mode.∙To make evaluating controls even more complex, controls can either prevent a failure mode or cause from occurring or detect a failure mode, cause of failure, or effect of failure after it has occurred.∙Note that prevention controls cannot relate to an effect. If failures are prevented, an effect (of failure) cannot exist!The Detection ranking scale, like the Severity and Occurrence scales, is on a relative scale from 1 to 10.∙ A Detection ranking of “1” means the chance of detecting a failure is certain.∙Conversely, a “10” means there is absolute certainty of non-detection. This basically means that there are no controls in place to prevent or detect.∙See FMEA Checklists and Forms for an example PFMEA Detection Ranking Scale.Taking a lead from AIAG, consider three different forms of Custom Detection Ranking options. Custom examples for Mistake-Proofing, Gauging, and Manual Inspection controls can be helpful to PFMEA teams.∙See FMEA Checklists and Forms for examples of Custom PFMEA Ranking Scales. (Examples of custom scales for severity, occurrence, and detection rankings are included in this Appendix.)Step 7: Calculate the RPNThe RPN is the Risk Priority Number. The RPN gives us a relative risk ranking. The higher the RPN, the higher the potential risk.The RPN is calculated by multiplying the three rankings together. Multiply the Severity ranking times the Occurrence ranking times the Detection ranking. Calculate the RPN for each failure mode and effect.∙Editorial Note: The current FMEA Manual from AIAG suggests only calculating the RPN for the highest effect ranking for each failure mode. We do not agree with this suggestion; we believe that if this suggestion is followed, it will be too easy to miss the need for further improvement on a specific failure mode. Since each of the three relative ranking scales ranges from 1 to 10, the RPN will always be between 1 and 1000. The higher the RPN, the higher the relative risk. The RPN gives us an excellent tool to prioritize focused improvement efforts.Step 8: Develop the Action PlanTaking action means reducing the RPN. The RPN can be reduced by lowering any of the three rankings (severity, occurrence, or detection) individually or in combination with one another.A reduction in the Severity ranking for a PFMEA is often the most difficult. It usually requires a physical modification to the process equipment or layout.Reduction in the Occurrence ranking is accomplished by removing or controlling the potential causes.∙Mistake-proofing tools are often used to reduce the frequency of occurrence.A reduction in the Detection ranking can be accomplished by improving the process controls in place.∙Adding process fail-safe shut-downs, alarm signals (sensors or SPC), and validation practices including work instructions, set-up procedures,calibration programs, and preventative maintenance are all detection ranking improvement approaches.What is considered an acceptable RPN? The answer to that question depends on the organization.∙For example, an organization may decide any RPN above a maximum target of 200 presents an unacceptable risk and must be reduced. If so, then an action plan identifying who will do what by when is needed.There are many tools to aid the PFMEA team in reducing the relative risk of failure modes requiring action. Among the most powerful tools are Mistake-Proofing, Statistical Process Control, and Design of Experiments.Mistake-Proofing (Poka Yoke)∙Techniques that can make it impossible for a mistake to occur, reducing the Occurrence ranking to 1.∙Especially important when the Severity ranking is 10.Statistical Process Control (SPC)∙ A statistical tool that helps define the output of a process to determine the capability of the process against the specification and then to maintaincontrol of the process in the future.Design of Experiments (DOE)∙ A family of powerful statistical improvement techniques that can identify the most critical variables in a process and the optimal settings for thesevariables.Step 9: Take ActionThe Action Plan outlines what steps are needed to implement the solution, who will do them, and when they will be completed.A simple solution will only need a Simple Action Plan while a complex solution needs more thorough planning and documentation.∙Most Action Plans identified during a PFMEA will be of the simple “who, what, & when” category. Responsibilities and target co mpletion dates for specific actions to be taken are identified.∙Sometimes, the Action Plans can trigger a fairly large-scale project. If that happens, conventional project management tools such as PERT Charts and Gantt Charts will be needed to keep the Action Plan on track.∙Most Action Plans identified during a PFMEA will be of the simple “who, what, & when” category. Responsibilities and target completion dates for specific actions to be taken are identified.Step 10: Recalculate the Resulting RPNThis step in a PFMEA confirms the action plan had the desired results by calculating the resulting RPN.To recalculate the RPN, reassess the severity, occurrence, and detection rankings for the failure modes after the action plan has been completed.。

FMEA Case study DC10 Cargo Door
Reproduced from a paper issued by NASA March 21 2005
In 1969 per FAA requirements, Douglas, manufacturer of the DC-10 asked Convair to perform a FMEA of the DC-10 cargo door system The FMEA discovered 9 sequences that could potentially threaten life. 4 involved sudden depressurisation in flight 1 of the 4 was failure of the locking pin system causing the door lock not to latch, the door could fly open in flight causing sudden depressurisation and possible structural failure of the floor and damage to the tail
Lessons learned
A safety analysis is no better than the system we have in place to deal with it A test failure that does not go to root cause is a missed opportunity to prevent future mishaps A close call should be treated as an opportunity to prevent a mishap Risk management is about mitigating risks while their probability of occurrence is still less than 1