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110 total results found

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-frequency, short-duration verifications performed by multiple levels of management to verify process discipline and prevent standardization drift. 8.5.1 The Tiered ...

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 ISO standard. Independence: Auditors cannot audit their own department. Engineering audits Purchasing; Purchasing audits HR. This ensures objectivity.Evidence-Based...

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 Registrar) audits the facility, success relies on controlling the flow of information. The audit is a formal examination, not a casual tour. The "Front Room" vs. "Back...

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 resistors). Therefore, Incoming Quality Control (IQC) relies on statistical sampling plans defined by ISO 2859-1 (ANSI/ASQ Z1.4). 8.8.1 The AQL (Acceptable Quality L...

8.9 Counterfeit Avoidance (AS5553)

09. Supply Chain & Material Management Part 1. The Material Strategy (Procurem...

Counterfeit components represent one of the highest risks in electronics manufacturing, undermining both product reliability and traceability. They can look convincing yet hide re-marked, re-balled, or aged parts that fail catastrophically. The defense is a st...

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 inefficiencies. A production line reporting 98% yield may still be hemorrhaging cash if that figure relies on extensive rework loops hidden from the final count. 8.10.1 ...

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 "is the process capable of consistently producing passing parts?" 8.11.1 Cp (Process Potential) Definition: Relates the width of the specification limits (Toler...

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) determines if the variation in data comes from the part (actual) or the gauge (error). 8.12.1 Gauge R&R (Repeatability & Reproducibility) Repeatability (Equipme...

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 part that meets all engineering and design requirements. 8.13.1 The FAIR (First Article Inspection Report) Structure Form 1 (Part Accountability): Identifies th...

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 framework for New Product Introduction (NPI). 8.14.1 The 5 Phases of APQP Plan & Define: Contract review, feasibility study, and reliability goals.Product Design...

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 potential failures to prioritize engineering resources. 8.16 The RPN Calculation RPN = Severity (S) \times Occurrence (O) \times Detection (D) Severity (1-10): How...

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) system form the "immune system" of the factory. 8.16.1 The Fishbone (Ishikawa) Diagram When a defect occurs, the investigation must look at six distinct categorie...

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 to observe reality vs. theory. The Protocol: Go see, ask why, show respect.The Checklist: Safety: Are paths clear? PPE worn?Standard Work: Is the operator follo...

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). IPC-A-600 is the acceptance standard for rigid and flexible bare boards. This chapter defines the criteria for Incoming Quality Control (IQC). 8.4.1 Base Mater...

8.6 Cable & Harness Assembly (IPC/WHMA-A-620)

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

Cable assemblies are the "nervous system" of the product. Failures here are often intermittent and difficult to diagnose. IPC/WHMA-A-620 governs the quality of crimps, insulations, and soldering of wires. 8.6.1 Crimping Criteria Bellmouth: The flared end of ...

8.7 Box Build & Mechanical Assembly (IPC-A-630)

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

IPC-A-630 covers the "Box Build"—the integration of PCBAs into chassis. 8.7.1 Hardware Installation Torque Verification: All structural screws must be torqued to specified values.Torque Striping: A line of "tamper paint" (Torque Seal) applied across the scre...

8.8 Cosmetic Inspection Standards (Visual Quality)

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

Cosmetic standards are subjective unless quantified. This section defines "Good" vs. "Bad" for surfaces. 8.8.1 Zoning Classifications Zone A (Primary): The face of the product always visible to the user (e.g., Screen, Buttons).Standard: No scratches visible ...

8.9 Rework & Repair (IPC-7711/7721)

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

This standard distinguishes between "Rework" (process correction) and "Repair" (restoration). 8.9.1 Rework (No Permission Needed) Definition: Reprocessing a non-conforming article to make it conform to the original drawings.Examples: Re-flowing a cold solder...

2.10 Strategic Stockpiling

09. Supply Chain & Material Management Part 3. Inventory Control (Inventory)

Policies for holding "Buffer Stock" for critical customers.

3.7 Changeover Reduction (SMED)

03. Surface Mount Technology Part 6. Changeover and Maintenance

Techniques for swapping from Product A to Product B efficiently.