你是公司的一名译者请你用准确的英语翻译以下内容并按照原文格式进行排版。414 DFMEA标准表格的填写要求 ① FMEA编号①为表格中的序号以下类推。 填入FMEA文件编号以便查询。 ② 系统、子系统或零部件的名称及编号。 注明适当的分析级别并填入所分析系统、子系统或零部件的名称、编号。 ③ 设计责任。 填入负责设计的厂家、部门和小组。 ④ 编制者。 填入负责DFMEA准备工作的工程师的姓名、电

4.1.4 DFMEA Standard Form Filling Requirements

① FMEA Number (① is the serial number in the form, and so on). Fill in the FMEA file number for reference.

② Name and number of the system, subsystem, or component. Specify the appropriate analysis level and fill in the name and number of the analyzed system, subsystem, or component.

③ Design responsibility. Fill in the manufacturer, department, and team responsible for the design.

④ Preparer. Fill in the name and phone number of the engineer responsible for preparing the DFMEA.

⑤ Product category/product model. Fill in the expected product category and model that will be affected by the design being analyzed (if known).

⑥ Key dates. Fill in the initial scheduled completion date of the FMEA, which should not exceed the planned formal design completion date.

⑦ FMEA date. Fill in the date of the original draft of the DFMEA and the date of the latest revision.

⑧ Core team. List the responsible departments and individual names authorized to identify and/or perform tasks (it is recommended to record the names, departments, phone numbers, addresses, etc. of all DFMEA team members on a distribution list).

⑨ Project. Fill in the name and number of the analyzed project (part/component/subsystem/system).

⑩ Function. Describe the function of the analyzed project, including the environmental information in which the system operates (such as temperature, pressure, humidity range). If the project has multiple functions and different failure modes, all functions should be listed separately.

11 Potential failure modes. List the potential failure modes that the analysis object may experience.

12 Potential failure effects. Describe the impact on the system once the failure mode occurs.

13 Severity (S). Severity represents the severity of the consequences of failure. Severity ratings for design FMEA analysis can be selected according to the "DFMEA Severity (S) Evaluation Criteria."

14 Level. This column can be used to classify the characteristics of parts, subsystems, or system products (such as key, major, important, focus, etc.). The grading can refer to Table 1. Each item identified as "Key Characteristic (☆)" or "Important Characteristic (△)" in the DFMEA should have special process control measures in the process FMEA.

Table 1 Definition of Product Characteristic Importance Level

Characteristic Level Symbol Level Definition Key Characteristic SC If exceeding the specified limit will cause loss of human life and property or make the product lose its function. Important Characteristic D If exceeding the specified limit will cause product functional failure or reduce the original use function. Minor Characteristic Not indicated Even if it exceeds the specified limit, it will not affect the performance of the product or only have a slight impact.

Note: Key characteristics and important characteristics are collectively referred to as special characteristics.

15 Potential failure causes/mechanisms. For each failure mode, analyze and list the causes of failure.

16 Occurrence (O) - Probability of occurrence. Occurrence is used to characterize the likelihood of failure causes occurring. Frequency ratings for design FMEA can be found in the "DFMEA Potential Failure Mode Occurrence (O) Evaluation Criteria."

17 Current design controls. List the current control methods or indicate if they are not controlled.

18 Detection difficulty (D). Detection difficulty represents the degree of knowledge about failure modes and potential causes of failure. Detection difficulty ratings for design FMEA analysis can be found in the "DFMEA Potential Failure Mode Detection Difficulty (D) Evaluation Criteria."

19 Risk Priority Number (RPN). The RPN is the product of Severity (S), Occurrence (O), and Detection difficulty (D): RPN = S × O × D. RPN is a measure of design risk and is used to prioritize concerns in the design.

20 Recommended actions. Briefly list the recommended corrective actions.

21 Responsibility and target completion date. Fill in the organization and individual responsible for implementing the recommended actions and the expected completion date in this column.

22 Actions taken. After implementing an action, briefly record the specific action and effective date.

23 RPN after actions. Once corrective actions are identified, estimate and record the severity, occurrence, and detection difficulty values after the actions are taken and calculate the result of RPN. If no corrective actions are taken, leave the "RPN after actions" column and the corresponding value column blank.

24 Evaluation conclusion. Fill in the evaluation conclusion for the control measures.

4.2 Development and Implementation of Process FMEA

4.2.1 Timing of PFMEA Implementation

4.2.1.1 Conduct PFMEA according to APQP plans.

4.2.1.2 When the following situations occur, the PFMEA team should conduct PFMEA activities for all manufacturing processes from individual parts to assemblies before tooling preparation and before finalizing process documents (work instructions):

① Development of new products/product changes;

② Production process changes;

③ Production environment/processing conditions change;

④ Material or component changes.

4.2.2 Preparation work before PFMEA implementation

① The production department leads the establishment of the PFMEA (Process FMEA) team, and personnel from the technical department, quality department, production department, administrative department, and purchasing department participate in the PFMEA team. Suppliers and customers may be invited if necessary.

② Before the implementation of PFMEA activities, the PFMEA team should develop the "PFMEA Severity (S) Evaluation Criteria," "PFMEA Potential Failure Mode Occurrence (O) Evaluation Criteria," and "PFMEA Potential Failure Mode Detection Difficulty (D) Evaluation Criteria." These criteria should be revised as needed when there are changes in process level or production environment.

4.2.3 Steps for PFMEA implementation

① Determine the product manufacturing and assembly process flow. The production department's process responsible person prepares the "Process Flow Chart" (or "Process Operation Card") to determine the content of each operation, process requirements (5M1E), including product/process characteristic parameters, quality requirements that the process production should achieve, etc.

② Determine the processes that need PFMEA analysis. The PFMEA team assesses the risks of each process in the process flow based on the "Process Flow Chart" (or "Process Operation Card"). After risk assessment, the processes are divided into low risk, medium risk, and high-risk processes, and only high-risk processes are subjected to PFMEA analysis.

③ List the potential failure modes, causes, and potential failure effects for each high-risk process.

④ Conduct risk analysis. Estimate the risk priority number (RPN) based on the severity (S), occurrence (O), and detection difficulty (D) of failure impacts. Severity (S), occurrence (O), and detection difficulty (D) are judged on a scale of 1 to 10 (see "PFMEA Severity (S) Evaluation Criteria," "PFMEA Potential Failure Mode Occurrence (O) Evaluation Criteria," and "PFMEA Potential Failure Mode Detection Difficulty (D) Evaluation Criteria" for reference). The product of these ratings is the risk priority number (RPN). RPN = S × O × D. The higher the RPN, the greater the risk