1. What is Process FMEA (PFMEA).
Process FMEA (PFMEA) refers to the identification, prevention and elimination of potential hidden dangers through a comprehensive analysis and evaluation of potential failure modes and consequences in the process of products and services. It is a systematic approach to reliability analysis that can help companies identify factors that may lead to product failure and take appropriate measures to reduce risks.
Second, the application scope of process FMEA (PFMEA).Process FMEA (PFMEA) has a wide range of applications and is suitable for almost all processes to analyze potential hidden dangers that may arise in the process. Whether it is a traditional manufacturing industry or a modern service industry, process FMEA (PFMEA) can be used to improve the quality of products and services, reduce the defect rate, and improve customer satisfaction. Therefore, mastering the basic knowledge of Process FMEA (PFMEA) is an essential skill for every quality management professional. 3. Application steps of process FMEA (PFMEA).Step 1: Plan and prepare
The purpose of planning and preparation is to clarify the product processes that are or are not included in the project review, which helps us to review all processes at a higher level and determine which ones to analyze, while focusing resources on the highest priorities. When planning and preparing an FMEA, we first gather relevant information and discuss the following topics: Identify the project: the process or part of it to be analyzed. Scoping the analysis: What is included in the analysis? What's not included? Project plan: project timeline, team members, tasks and tools, etc. Lessons from the past. Step 2: Structural analysisThe purpose of PFMEA structural analysis is to identify and break down manufacturing systems into process items, processes, and process job elements. The main objective is the system structure of the product or process elements, the visualization of the scope of the analysis, and the identification of the procedural steps that provide the basis for the implementation of the functional analysis steps. The structure visualization is to more clearly identify each decomposition item, and the common methods for visualizing the structure in PFMA are process flow diagrams and structure trees. A process flow diagram is a tool that defines a process and provides input information for structural analysis. A structure tree is a tool that arranges system elements hierarchically and shows the dependencies between them through structural connections. This graphical structure can help understand the relationships between different process items, process steps, and process work elements. At the same time, it is used as the basis for subsequent functional analysis and failure analysis. Step 3: Functional AnalysisThe purpose of functional analysis is to ensure that the expected functions and requirements of the product process are appropriately assigned. The main goal of this step is to provide an overview of the process function, to associate features with functions and functions with process elements, to associate customer functions with relevant requirements, and to serve as the basis for failure analysis. Process flow diagrams, function matrices, or function nets based on structural analysis are generally used to visualize process functions. Functional Analysis Considerations: Describe the work that a process project or process step plans to complete. Each process project or process step plan may have more than one function; Relevant information (e.g., product functional information, requirements, manufacturing environmental conditions, cycle times, etc.) should be gathered before starting a functional analysis, which may come from multiple parties, both internal and external. Step 4: Failure analysisThe purpose of failure analysis is to determine the causes, modes, and effects of failures, and to show the interrelationships for risk assessment. In this step, we need to identify the failures of each function, and confirm the potential failures assigned to the process steps and the causes; Connect the failure modules in the failure chain to create a failure structure; Clearly show the relationship between the failed modules (Failure Effect – Failure Mode – Cause of Failure). Starting from the analysis of the process step, the functional failure of the process step is the failure mode; The failure of the 4m element is the cause of failure; Analyze the occurrence of failure modes and the consequences of failure, which is the impact of failure. Step 5: Risk AnalysisThe purpose of risk analysis is to score the failure chain identified in step 4 based on the existing control methods, and to judge the risk and prioritize the need for measures based on the three dimensions of severity, occurrence and detection. where severity (SEV) represents the severity of the impact of the failure; Incidence rate (OCC) represents the frequency with which failure causes occur in the process; Detectability represents the detectability of failure causes and/or failure modes that are prone to occur. After scoring the severity, occurrence and detection, the action priority (AP) is evaluated according to the score sheet to determine which risk should be prioritized to use measures to strengthen prevention or detection. PS: The old version of FMEA used RPN (risk ordinal value) to determine the limited level of measures (RPN = severity s occurrence o detection d); The new version of FMEA prioritizes measures using an AP table that provides detailed information on all 1000 logical combinations for S, O, and D. The AP value is not a priority for high, medium, or low risk, but a priority for reducing the need for risk. Step 6: Optimize and improveThe purpose of process optimization improvement is to develop measures to reduce risk and increase customer satisfaction by improving the design. In this step, the team reviews the results of the risk analysis and assigns actions to reduce the likelihood of a cause of failure or to enhance the effectiveness of controls to identify the cause or mode of failure. The main objectives are: to identify the measures needed to reduce risk; Assign responsibility for the implementation of measures and time to achieve goals; Implementing and documenting the measures taken; Confirm the effectiveness of the measures implemented. reassess risk after taking action; continuous improvement process; It also provides a basis for improving process requirements and preventive controls. Step 7: Documentation of resultsThe purpose of result documentation is to summarize and document the FMEA activities and document the output of the FMEA, and communicate the risks to relevant parties such as the organization, customers, and merchants. The main objectives of this step are: to document the content of the measures taken, to confirm the effectiveness of the measures taken and to assess the risk after the measures taken, and to minimize the risk analysis and risk reduction to an acceptable level; Share and communicate the results of risk assessments, e.g. within the organization and between customers and vendors, on risk mitigation measures. FMEA is intended to be acted "beforehand", not after the fact. The purpose of FMEA is to identify, assess, and ultimately mitigate risks. This requires that FMEA must be carried out before the product or process is implemented, when there is a potential risk, otherwise it loses its relevance. Therefore, the timing of FMEA introduction is also very important, and the best time for its implementation is: when new products and new processes are being developed; When adjustments are required due to the low capacity of the product process; When process changes are expected due to the introduction of new equipment, etc. When process changes are expected due to changes in the development and manufacturing environment; When potential hazards are anticipated due to improvements. At the same time, it is important to note that the adjustment of the FMEA at any stage of the product and process never stops, it is a living document that can be continuously adjusted and updated as needed. Successful implementation of Process FMEA (PFMEA) requires a certain amount of skill and experience. First and foremost, team members need to have the knowledge and ability to understand different FMEA tools and methodologies. Second, the team needs to work together to communicate and collaborate effectively to ensure that every step of the way runs smoothly. In addition, teams need to keep an open mind and keep learning and improving to adapt to changing market demands. The article ** on the Internet, invaded and deleted.