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8.5 IPC-A-610 Classifications & Criteria

08. Quality Assurance & Regulatory Comp... Part 2. Workmanship Standards

IPC-A-610 "Acceptability of Electronic Assemblies" serves as the primary visual acceptance standa...

Updated 4 days ago by Sergey Zorin

8.4 Bare Board Inspection (IPC-A-600)

08. Quality Assurance & Regulatory Comp... Part 2. Workmanship Standards

The quality of the final assembly cannot exceed the quality of the raw Printed Circuit Board (PCB...

Updated 4 days ago by Sergey Zorin

8.17 The Gemba Walk

08. Quality Assurance & Regulatory Comp... Part 8. Continuous Improvement

"Gemba" means "The Real Place." Engineers and managers must leave the office and walk the process...

Updated 4 days ago by Sergey Zorin

8.16 Root Cause Analysis (RCA) & CAPA

08. Quality Assurance & Regulatory Comp... Part 8. Continuous Improvement

The management of Non-Conforming Material (NCM) and the Corrective and Preventive Action (CAPA) s...

Updated 4 days ago by Sergey Zorin

8.15 Failure Mode and Effects Analysis (FMEA)

08. Quality Assurance & Regulatory Comp... Part 7. Advanced Planning (NPI)

FMEA is the engine of risk reduction. It assigns a quantitative Risk Priority Number (RPN) to pot...

Updated 4 days ago by Sergey Zorin

8.14 APQP & PPAP

08. Quality Assurance & Regulatory Comp... Part 7. Advanced Planning (NPI)

Quality must be planned, not inspected. Advanced Product Quality Planning (APQP) is the standard ...

Updated 4 days ago by Sergey Zorin

8.13 First Article Inspection (AS9102)

08. Quality Assurance & Regulatory Comp... Part 6. Measurement & Validation

First Article Inspection (FAI) validates that the manufacturing process is capable of producing a...

Updated 4 days ago by Sergey Zorin

8.12 Measurement System Analysis (MSA / Gauge R&R)

08. Quality Assurance & Regulatory Comp... Part 6. Measurement & Validation

Before measuring parts, we must measure the measurement system. Measurement System Analysis (MSA)...

Updated 4 days ago by Sergey Zorin

8.11 Statistical Process Control (SPC): Cp & Cpk

08. Quality Assurance & Regulatory Comp... Part 5. Process Control & Metrics

Manufacturing processes naturally vary. The engineering question is not "did this part pass?" but...

Updated 4 days ago by Sergey Zorin

8.10 Operational Metrics: FPY vs. RTY

08. Quality Assurance & Regulatory Comp... Part 5. Process Control & Metrics

In high-volume electronics manufacturing, standard "Yield" metrics often conceal systemic ineffic...

Updated 4 days ago by Sergey Zorin

8.7 Hosting the Customer Audit

08. Quality Assurance & Regulatory Comp... Part 3. The Audit Architecture

8.7.1 Audit Strategy: The "War Room" Protocol When a customer or regulatory body (FDA, ISO Regis...

Updated 4 days ago by Sergey Zorin

8.8 Incoming Inspection (AQL & Sampling)

08. Quality Assurance & Regulatory Comp... Part 4. Supplier Quality Management

It is statistically impossible to inspect 100% of incoming components (e.g., a reel of 10,000 res...

Updated 4 days ago by Sergey Zorin

8.6 Internal Systems Audits (ISO 19011)

08. Quality Assurance & Regulatory Comp... Part 3. The Audit Architecture

While LPAs check the floor execution, Internal Audits verify the management system against the IS...

Updated 4 days ago by Sergey Zorin

8.5 Layered Process Audits (LPA)

08. Quality Assurance & Regulatory Comp... Part 3. The Audit Architecture

Inspection checks the product; Audits check the process. Layered Process Audits (LPA) are high-fr...

Updated 4 days ago by Sergey Zorin

8.3 Lean Quality Foundations: 5S & Visual Factory

08. Quality Assurance & Regulatory Comp... Part 1. The Quality Management System (...

Quality cannot exist in chaos. 5S is not a housekeeping methodology; it is a foundational quality...

Updated 4 days ago by Sergey Zorin

8.2 Documentation Control & Data Integrity

08. Quality Assurance & Regulatory Comp... Part 1. The Quality Management System (...

The validity of a manufacturing process relies entirely on the integrity of its documentation. If...

Updated 4 days ago by Sergey Zorin

8.1 The Architecture of Compliance (ISO 9001 / 13485)

08. Quality Assurance & Regulatory Comp... Part 1. The Quality Management System (...

A Quality Management System (QMS) acts as the organization's engineered operating logic, not mere...

Updated 4 days ago by Sergey Zorin

7.9 Fire Safety in Thermal Processes

07. Facility Infrastructure & EHS Part 3. Environmental Health & Safety (...

Reflow ovens and Wave soldering machines contain heaters (up to 300°C), flammable flux residues, ...

Updated 4 days ago by Sergey Zorin

7.8 Chemical Management (HazMat)

07. Facility Infrastructure & EHS Part 3. Environmental Health & Safety (...

Electronics manufacturing utilizes solvents (IPA, Acetone), fluxes, adhesives, and coatings that ...

Updated 4 days ago by Sergey Zorin

7.7 Solder Fume Extraction

07. Facility Infrastructure & EHS Part 3. Environmental Health & Safety (...

Soldering processes generate colophony (rosin) particulates and gaseous byproducts, which are pot...

Updated 4 days ago by Sergey Zorin