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📄 681 articles in total 📅 Continuously updated 🔥 Pinned first, then sorted by rating, views and publish date
Quality Management System · Documentation, Records & Knowledge · Documented Information Structure

ISO9001 System Document Package (43) | Management Review Input Preparation Work Instruction

Document Number : WI QA 43 Document Level : Level 3 Document Work Instruction Corresponding Clause : ISO 9001:2015 9.3 M…

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

PPAP File Package Complete, but the Production Line Can't Keep Up? —— Five Steps for Capacity Verification (Run@Rate)

A certain automotive parts company submitted a PPAP, and the file package passed on the first attempt: 18 items were com…

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

The CC on the Drawing, but the Operator Doesn't Know — A Five-Step Method for Implementing Special Characteristics on the Shop Floor

1. The Question at the Audit Site A certain automotive parts company was undergoing a customer process audit. The audito…

Quality Management System · System Framework & Standards · ISO 9001 Core Clauses Interpretation

Deep Interpretation of ISO9001 Clauses (22) | 8.5.3 Customer or External Supplier Property + 8.5.4 Protection

1. Key Points of the Clauses 8.5.3 Customer or External Supplier Property : The organization should take care of custome…

Six Sigma & Statistical Quality · Statistical Process Control · Process Capability Cpk / Ppk

QE Skill Enhancement (10) | What's the Difference Between Cp/Cpk and Pp/Ppk: Correct Interpretation of Short-term and Long-term Capability

A precision machining company supplies drive shafts to a new energy client. During the client's audit, a process capabil…

Business & Enterprise Operations · Cost & Resource Management · Cost of Quality (COQ)

QM Management Depth (10) | COPQ: How to Calculate, Who to Present It To, and What Level of Granularity to Use

A certain electronics manufacturing company, with annual revenue of 860 million yuan, operates three product lines—indus…

Quality Management System · Documentation, Records & Knowledge · Documented Information Structure

ISO9001 System Document Package (42) | Internal Audit Implementation Work Instruction (Internal Auditor Manual)

Document Number : WI QA 42 Document Level : Level 3 Document Work Instruction/Internal Auditor Manual Corresponding Clau…

Six Sigma & Statistical Quality · Experimentation & Robustness · DOE Basics & Advanced

Random Trial Sequencing Can Lead to False Significant Factors? —— Five Steps for Randomization, Blocking, and Center Points in DOE

1. An Experiment That Reached the Opposite Conclusion A die casting company conducted a two level, three factor experime…

Continuous Improvement & Problem Solving · Structured Problem Solving · 8D & Recurrence Prevention

"Operator Negligence" Again? —— A Five-Step Method for Identifying Human Factors and Upgrading Systems

1. Three 8D Reports, the Same "Root Cause" A certain electronic connector company conducted 14 8D reports in the second …

Quality Management System · System Framework & Standards · ISO 9001 Core Clauses Interpretation

In-depth Interpretation of ISO9001 Clauses (21) | 8.5.1 Control of Production and Service Provision + 8.5.2 Identification and Traceability

1. Key Points of the Clauses 8.5.1 Control of Production and Service Provision : The organization shall carry out produc…

Six Sigma & Statistical Quality · Measurement & Inspection · MSA & Traceability

Advancing QE Skills (9) | Measurement System Analysis for Destructive Testing: Nested Design and Alternatives

A modified plastic company supplies interior components to an original equipment manufacturer OEM . Tensile strength is …

Business & Enterprise Operations · Cost & Resource Management · Cost of Quality (COQ)

QM Management Depth (9) | Four-Class Calculation Method for Quality Costs: Prevention, Appraisal, Internal Failure, External Failure

A certain automotive parts company, with annual revenue of 1.2 billion yuan, supplies two original equipment manufacture…