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The Relationship between Mistake-Proofing and FMEA

 In modern manufacturing, mistake-proofing (or poka-yoke) is widely adopted across various industries as a critical method for ensuring product quality. However, many companies commonly encounter a significant issue during its implementation: the development of mistake-proofing measures often lacks systematic risk assessment and appears to be based on intuition or ad hoc decisions, resulting in suboptimal effectiveness. A typical scenario is that a company maintains a detailed mistake-proofing checklist, which not only includes specific information about each characteristic but also clearly outlines the underlying principles, methods, and verification requirements for each mistake-proofing measure—and these measures are regularly validated. Yet, when tracing back to the FMEA (Failure Mode and Effects Analysis) documentation, one finds that the corresponding mistake-proofing information is missing. This raises an important question: why were certain characteristics selected for mis...
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The Art of Problem Solving: Introduction to 8D

  The 8D method (Eight Disciplines) is a structured problem-solving approach widely used in industries, particularly in automotive and manufacturing. It aims to eliminate problems (deviations from a defined target state) and prevent their recurrence by systematically addressing root causes. The core of 8D involves identifying the fundamental problem, understanding causal relationships, and implementing sustainable solutions. Below is a brief overview of the eight steps: D1: Establish a Problem-Solving Team/Project Form a cross-functional team with relevant expertise to lead the effort. A team leader coordinates resources and communication. D2: Problem Description Clearly define the problem using facts, data, and evidence. Describe the deviation, target state, and scope (e.g., what, where, when, how much). D3: Containment Actions Implement immediate measures to isolate the problem and minimize impact on customers or processes while a permanent solution is developed. ...

How Quality Engineers Can Build Professional Influence

The influence of a Quality Engineer (QE) within a team is critical for the effective implementation of inspection, gatekeeping, and oversight of improvements. This is not merely a matter of technical competence, but rather a comprehensive reflection of leadership, communication skills, and interpersonal relationship management. Below are specific strategies for how a Quality Engineer can build personal influence: 1. Establish Professional Competence and Reliability (Credibility & Expertise)   ● Become a technical expert:     ○ Deeply understand products and processes: Go beyond knowing quality standards —gain thorough insight into the technical details, architecture, implementation approaches, and the entire development lifecycle of the products your team builds. When you can identify potential risks or design flaws at the code level, your input carries far more weight than generic statements like “quality is important.”     ○ Master tools an...

Six Ways to Learn Quality Management System

 The quality management system is extensive, encompassing nearly all aspects of the company. However, different business areas have different focuses. As a first-time quality system engineer, it's crucial to understand the system requirements and adopt a systematic approach to learning. To master the quality management system, it's essential to "do six more." 1. Attend more formal training. Formal training corrects cognitive bias.For example, TUV, DNV, and other quality management system training course instructors have a wealth of multinational training and counseling experience. They transfer this experience to help you understand the quality management system efficiently and prevent you from making mistakes. For example, if an instructor has worked at General Motors for many years, he can teach you the practices at General Motors, which are difficult to master through your own study and reading.In some special cases, the teacher who holds the training is even the e...

What is manufacturing process stabilization?

  The characteristics of a "stable" process "Keeping the production process stable" is one of the most important tasks in quality management, but what kind of production process is stable? The understanding of those who have not studied statistical process control is that a process is stable if it consistently produces acceptable products, which is a misconception. From a process control point of view, we need to strictly control all aspects of the production process, including man, machine, material, method, environment, and measurement, and analyze, improve, and monitor the major sources of variation. Whenever possible, we also need to evaluate whether the process is truly stable in terms of the variation of key product characteristics of the process output over time. As defined by ISO 22514-1, a stable process is one that is affected only by random factors and can be considered to be under statistical control. The following points must be clarified: Stable proces...