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📄 75 articles in total 📅 Continuously updated 🔥 Pinned first, then sorted by rating, views and publish date
Advanced Quality & R&D Quality · Process Development & Approval · PFMEA

In PFMEA, Should "Inspection" Always Result in a Lower Score for Detection (D)? —— A Five-Step Method for Correctly Assessing and Correcting Detection Scores

When the PFMEA for a steering bracket at an automotive parts factory was submitted to the client, the severity and occur…

Advanced Quality & R&D Quality · Design Quality · DVP/DV/PV & Validation Strategy

Advancing QE Competence (30) | Reliability Verification Testing and Growth Management

1. A "Qualified but Rejected by the Customer" Qualification Test A manufacturing company conducted a reliability qualifi…

Advanced Quality & R&D Quality · Design Quality · DVP/DV/PV & Validation Strategy

Advancing QE Skills (29) | Practical Weibull Analysis: Predicting Failures Using Lifespan Data

1. Handing Over 5 Failure Points to Software Yields a "Lifespan Conclusion" A batch of electric actuators from a manufac…

Advanced Quality & R&D Quality · Design Quality · Special Characteristics & Drawing Specifications

What to Do When Three Special Characteristics Lists Don't Match? —— A Five-Step Method for Compiling and Verifying the SC/CC Master List

The customer requests a special characteristics list. The quality department copies one from the drawings, the design en…

Advanced Quality & R&D Quality · Design Quality · DVP/DV/PV & Validation Strategy

Advancing QE Skills (28) | Accelerated Life Test Design: Models for Temperature, Humidity, and Vibration

1. Treating 1000 Hours at 125°C as "Equivalent to 20 Years" A manufacturing company was conducting a life test for a pro…

Advanced Quality & R&D Quality · Design Quality · DVP/DV/PV & Validation Strategy

QE Skill Enhancement (27) | Reliability Basics: Failure Rate, MTBF, and the Bathtub Curve

1. How "MTBF 50,000 Hours" Was Misinterpreted as "Can Be Used for Over 5 Years" A manufacturing company participated in …

Advanced Quality & R&D Quality · Design Quality · Special Characteristics & Drawing Specifications

QE Capability Advancement (26) | Safety and Regulatory Characteristics Management: A Closed Loop from Identification to Monitoring

1. An Expired List for Two Years A certain electronics manufacturing company underwent a customer audit. The auditor did…

Advanced Quality & R&D Quality · Advanced Planning · Project Quality Plan

Advancing QE Competence (25) | The Effectiveness of Design Reviews: Turning Reviews into Technical Dialogues, Not Signing Ceremonies

In a detailed design review at an automotive parts company, 12 people were seated in the meeting room for a 90 minute ag…

Advanced Quality & R&D Quality · Process Development & Approval · PFMEA

Does Every New Project Start FMEA from Scratch? —— Five Steps to Establish and Reuse Baseline FMEA (Family FMEA)

When a new project is launched, the client demands the PFMEA to be submitted within two weeks. Quality engineers typical…

Advanced Quality & R&D Quality · Design Quality · DVP/DV/PV & Validation Strategy

Advancing QE Skills (24) | Design Verification (DV) and Production Validation (PV): How to Design a Valid Test Plan

A car sensor produced by an electronics manufacturing company was questioned by a customer quality engineer during a new…

Advanced Quality & R&D Quality · Process Development & Approval · Control Plan (CP)

Why Do People Always Fill in "Product Characteristics" and "Process Characteristics" Incorrectly in Control Plans? —— A Five-Step Method to Align the Two Columns

During a customer audit at an automotive parts factory, the auditor pointed to a control plan for a welding process and …

Advanced Quality & R&D Quality · Design Quality · DFMEA

Advancing QE Skills (23) | The Synergy of DFMEA and PFMEA: How Design Changes Affect Processes

A wire harness connector produced by an automotive parts company received a batch of complaints about pin withdrawal in …