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Quality closed-loop scheme based on FMEA 2020-06-19

  In the process of informatization, enterprises have gradually built design data management, manufacturing data management and other systems, but most enterprises only focus on the evaluation and analysis of inspection data in the manufacturing process for the management of quality data, lack of management of quality data in the process of product design and process planning, lack of closed-loop management of physical quality and design quality, and lack of timely and effective on-site quality problems It is unable to analyze problems and optimize product design or process plan in time when it is transferred to design and process department.


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  After more than ten years of development, Lianhong technology has summarized the experience of many enterprises in implementing PLM and mom systems (Teamcenter and opcenter systems), fully implemented the design concept of PDCA closed-loop control and implemented the quality closed-loop scheme based on FMEA.


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  Through FMEA, design quality and physical quality can be closed-loop, and real continuous improvement can be achieved in product and process design, supply chain, workshop and service customers. The specific quality business scenarios involved include:

   ● Product design and design quality

   ● process design and process quality

   ● supplier quality

   ● manufacturing process quality

   ● defect handling and customer complaint handling process

  The core of quality closed-loop scheme based on FMEA is to use FMEA to realize the closed-loop of quality data flow in the whole product life cycle. The solution includes the following functions:

  1. Product structure tree and FMEA data management

  Change the common practice of FMEA preparation in Excel format, take product BOM or process BOP structure tree as the main line, add quality nodes under the parts or processes of structure tree, including quality requirements, inspection requirements, failure mode, failure reason and failure impact, determine the structural mapping relationship between product design, process design and FMEA, and manage design data and FMEA uniformly The single data source of quality data is convenient for FMEA data update and reuse.


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  2. Construction of enterprise level FMEA database

  Use the idea of classification management, classify and sort out all kinds of quality data, establish enterprise level fault case base and search strategy, help enterprises analyze the potential failure of design or process, and expand the means of defect collection. According to the product / function / process similarity, establish the corresponding classification knowledge base of potential failure mode, failure cause, prevention and control, detection and control, and recommended measures, so as to realize the rapid iterative update and experience accumulation of enterprise level FMEA database.


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  3. Quality business process driven

  To realize the quality closed-loop of plan plan, do execution, check evaluation and act improvement in the whole process, it requires the connection of multiple business processes in the enterprise. According to the system requirements and enterprise quality regulations, the process management scheme of workflow driven and system integration is adopted to define the quality business flow rules of the enterprise, drive the interconnection and intercommunication of data between various business scenarios and systems, and increase the process transparency And version control.


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  4. Change implementation and process traceability

  Strictly control the process of defect or problem handling, use FMEA to guide the whole process of change management mechanism of pr-ecr-ecn, supervise the process of defect handling and improvement, analyze and excavate the root cause in the system for major quality problems in the process of product design, process planning, incoming inspection, process inspection, outbound inspection and market after-sale, and introduce the root cause of product failure Develop continuous improvement of design and update FMEA, record process information in detail, make the whole process controllable and traceable.


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  5. Continuous quality improvement

  Establish a process preparation environment with structured BOP as the main index line, realize the collaborative preparation and integrated control of process flow chart, PFMEA, control plan and operation standard, inspection instruction, and improve the consistency and accuracy of process documents through the unique index of the same data. Support EC process, evaluate the impact analysis of PFMEA, control plan and inspection plan, keep the dynamic update of PFMEA and control plan, and effectively control the accuracy of FMEA documents and physical quality inspection instructions.


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