TS16949认证程序文件：过程FMEA控制程序
TS16949 certification program file: process control procedures FMEA
⒈目的:
The purpose of:
预先评价发展过程因素变化可能产生的潜在失效及后果，找到避免或减少这些潜在失效的对策措施，最大限度地保证产品质量满足顾客的要求。
Pre evaluation of development potential failure factors and consequences, to avoid or reduce these potential failure measures, the maximum guarantee product quality to meet customer requirements.
⒉范围:
The range:
应用于新产品、新工艺及其更改，以及由普通变差引起的质量问题对工序过程可能造成失效后果的分析和预防。　
Application on new products, new technology and changing, and by the common variation caused by quality problems on process may cause the consequences of failure analysis and prevention.
⒊职责:
His duties:
3·1  技术部负责组织过程FMEA，制订相应对策措施。
3 / 1 technical department is responsible to organize the process of FMEA, formulate corresponding countermeasures.
3·2  技术部、生产部及相关部门参与PFMEA分析，并承担对策措施中的相应责任。
3 / 2 technical department, production department and relevant departments involved in PFMEA analysis, and assume the corresponding responsibility countermeasures.
3·3  生产车间负责对策措施的实施。
3 / 3 production workshop is responsible for the implementation of countermeasures.
3·4  技术部负责PFMEA对策的审批。
3 / 4 PFMEA countermeasure technology department is responsible for approving.
⒋工作程序:
The work program:
4·1  分析项目提出
Analysis of 4 1 project
4·1·1  技术部应对新产品、新工艺或更改的设计、工艺及影响质量要求的普通变差进行风险分析，对高风险的过程列为PFMEA项目，并提出PFMEA计划报技术部批准。
4, 1, 1 technical department to respond to the new products, new technology or changes to the design, process and influence the quality requirements of the general variation for the risk analysis, to the high risk of process as the PFMEA project, and put forward the plan approved PFMEA technology.
4·1·2  技术部、生产车间或其他部门负责人也可根据经验和生产中担心的问题提交技术部列为PFMEA项目，报技术部审批。
4 - 1 - 2 technical department, production workshop or other departments responsible person can also be based on experience and production concern to submit technical department as a PFMEA project, report the technical department for examination and approval.
4·2  技术部在审批PFMEA时应明确PFMEA责任人、责任部门、核心小组人员及关键日期。
4 / 2 technical department in the approval of PFMEA should be clear PFMEA responsibility, responsibility, the core team and key date.
4·2·1  PFMEA核心小组由设计、生产、检验、销售及在过程中有关的部门代表组成，核心小组由责任工程师任组长，负责编制PFMEA分析表及项目分析活动。
4 - 2 - 1 PFMEA core group from design, production, testing, sales and in the process of relevant departments, representatives, the core group by the responsible engineer leader, responsible for the preparation of PFMEA analysis and item analysis activities.
4·3  项目分析的内容与要求
4 3 project analysis of the contents and requirements
核心小组按以下内容展开分析:
The core group according to the following content analysis:
①分析过程动机或要求——简要说明该工艺过程或工序的目的；
Analysis of process of motivation or requirements -- brief description of the process or procedure to;
②描述潜在失效模式——简要说明可能发生的不能满足本工序或下道工序的过程要求或设计意图所表现缺陷；
The description of the potential failure mode -- a brief description of possible cannot satisfy the process or procedure process requirements or design intent to the performance flaw;
③描述失效后果——按失效后果对产品性能、加工工艺性能的影响来描述，并按失效后果评价准则 "1—10级" 严重度来定量评估；
The description of the consequences of failure -- according to the consequences of failure to product performance, process performance influence to describe, and according to the consequences of failure criterion for evaluation of" 1 - 10" severity to the quantitative assessment;
④分析失效原因——对潜在失效的发生起因依据可以纠正或控制的原则来简要描述，同时按 "可能失效率" 对失效起因用发生频率 "1—10级" 失效频度评价准则来定量评估；
The analysis of failure reason -- on the basis of potential failure cause can be corrected or control principles are briefly described, at the same time by" may lose efficiency" on the failure cause by the frequency of occurrence of" 1 - 10" failure frequency criterion for evaluation to quantitative evaluation;
⑤分析现行过程控制——针对潜在失效起因描述现行过程控制方法，并按 "1—10级" 不易探测度评价准则来定量评估；
The analysis of the current process control -- in view of potential failure cause of describing the current process control method, and according to the" 1 - 10" detection criterion for evaluation to quantitative evaluation;