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。FMEA 管理规范 1 目的 通过分析、预测设计、过程中潜在的失效研究失效的原因及其后果并采取必要的预防措施避免或减少这些潜在的失效从而提高产品、过程的可靠性。 2 适用范围 适用于公司设计FMEA、过程FMEA活动的控制。 3 职责 31 技术部负责组织成立DFMEA设计FMEA小组负责DFMEA活动的管理。 32 生产部负责

FMEA Management Guidelines

1. Purpose The purpose of FMEA (Failure Mode and Effects Analysis) is to analyze and predict potential failures in design and processes, study the causes and consequences of these failures, and take necessary preventive measures to avoid or reduce them, thus improving the reliability of products and processes.

2. Scope These guidelines apply to the control of design FMEA and process FMEA activities within the company.

3. Responsibilities 3.1 The Technical Department is responsible for organizing the Design FMEA (DFMEA) team and managing the DFMEA activities. 3.2 The Production Department is responsible for organizing the Process FMEA (PFMEA) team and managing the PFMEA activities. 3.3 Representatives from the Production Department, Quality Department, Technical Department, and Administrative Department, among others, shall participate in the DFMEA and PFMEA teams. When necessary, suppliers and customers may be invited by the Quality Department to participate. 3.4 The DFMEA team is responsible for developing the Evaluation Criteria for Severity (S) of Potential Failure Modes in DFMEA, the Evaluation Criteria for Occurrence (O) of Potential Failure Modes in DFMEA, and the Evaluation Criteria for Detection (D) of Potential Failure Modes in DFMEA. 3.5 The PFMEA team is responsible for developing the Evaluation Criteria for Severity (S) of Potential Failure Modes in PFMEA, the Evaluation Criteria for Occurrence (O) of Potential Failure Modes in PFMEA, and the Evaluation Criteria for Detection (D) of Potential Failure Modes in PFMEA.

4. Work Procedures 4.1 Development and Implementation of DFMEA 4.1.1 Timing of DFMEA Implementation 4.1.1.1 DFMEA should be conducted according to the APQP plan. 4.1.1.2 The DFMEA team should conduct DFMEA activities before the design of product drawings in the following situations:

• Development of new products or product changes
• Changes in the application environment of products
• Changes in materials or components

4.1.2 Preparation for DFMEA Implementation

• The Technical Department (R&D) leads the establishment of the DFMEA team, with representatives from the Production Department, Quality Department, Sales Department, Procurement, and other departments. When necessary, suppliers and customers may be invited by the Quality Department to participate.
• Before the implementation of DFMEA activities, the DFMEA team should develop the Evaluation Criteria for Severity (S) of Potential Failure Modes in DFMEA, the Evaluation Criteria for Occurrence (O) of Potential Failure Modes in DFMEA, and the Evaluation Criteria for Detection (D) of Potential Failure Modes in DFMEA. These criteria should be revised as needed when there are improvements in products or changes in the usage environment.

4.1.3 Steps for DFMEA Implementation

• Define the product: The person responsible for product development writes the "Product Standards" to determine the requirements of the product, including its functions, uses, performance, and usage conditions.
• Divide the functions: The DFMEA team decomposes the product based on its functions, progressively breaking it down to the most basic parts and components. The product functional logic diagram should be drawn based on the decomposition results (refer to section 3.2.5 in the main text). The scope and level of analysis should be considered during the decomposition. FMEA analysis is not necessary for components with low failure frequency and minimal impact, as well as those with proven effectiveness. The focus of DFMEA analysis should be on new components or components with significant performance impact.
• List all failure modes, causes, and potential failure effects for each function block: The failure modes should be appropriate for the level of the function block. At the lowest analysis level, list all possible failure modes for each unit (unit refers to elements, components, or systems) in that level, along with the causes and corresponding potential failure effects. When considering potential failure effects at a higher functional level, the aforementioned failure effects are interpreted as a failure mode. This iteration continues until the highest functional level of the system.
• Conduct risk analysis: Estimate the risk priority number (RPN) based on the severity (S), occurrence (O), and detection (D) of failure effects. Severity (S), occurrence (O), and detection (D) are judged on a scale of 1 to 10 (refer to the Evaluation Criteria for Severity (S) of Potential Failure Modes in DFMEA, Evaluation Criteria for Occurrence (O) of Potential Failure Modes in DFMEA, and Evaluation Criteria for Detection (D) of Potential Failure Modes in DFMEA). The product of these numbers is the risk priority number (RPN). The higher the RPN, the greater the risk.
• Develop control measures: For projects with an RPN ≥ 100 or severity (S) ≥ 8, the DFMEA team should develop control measures and implement them after approval from the Deputy General Manager of Production.
• Fill in the DFMEA analysis form - "Potential Failure Mode and Effects Analysis Report (DFMEA)" (see section 4.1.4).
• Track and manage control measures: The DFMEA team tracks the control measures proposed in DFMEA analysis and evaluates their effectiveness. If the evaluation indicates unsatisfactory results, new control measures should be developed. If the evaluation indicates effective methods, they should be included in the documentation. Summarize the analysis and implementation results in the form of the "Potential Failure Mode and Effects Analysis Report (DFMEA)" and report the results to the General Manager.
• Update DFMEA: DFMEA is a dynamic document and will be updated with subsequent changes and corrective actions. When DFMEA needs to be updated, the responsible engineer of the DFMEA team should organize timely revisions to the "Potential Failure Mode and Effects Analysis Report (DFMEA)" and related documents.

4.1.4 Inputs for DFMEA include: design objectives, reliability and quality objectives, performance objectives, initial material list, special characteristics list for products and processes, return material, complaint reports, corrective and preventive actions, usage reports, DFMEA for similar products, market recalls, and other documents and management support. DFMEA is a dynamic document, and subsequent changes and corrective actions will result in updates. When DFMEA needs to be updated, the responsible engineer of the DFMEA team should organize timely revisions to the "Potential Failure Mode and Effects Analysis Report (DFMEA)" and related documents