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7.6 Ionization & Insulator Control
Grounding only works for conductors. Insulators (plastic housings, connector bodies, circuit board fiberglass) cannot be grounded; charge stays on them until it naturally decays (hours/days) or discharges into a sensitive component. 7.6.1 Active Neutralizatio...
8.1 The Architecture of Compliance (ISO 9001 / 13485)
A Quality Management System (QMS) acts as the organization's engineered operating logic, not merely a repository of documents. Its primary function is to decouple product quality from individual human effort, ensuring that reliability is a systemic output rath...
8.2 Documentation Control & Data Integrity
The validity of a manufacturing process relies entirely on the integrity of its documentation. If a work instruction is obsolete, the product produced under it is technically non-conforming, regardless of its physical quality. This section establishes the hier...
8.3 Lean Quality Foundations: 5S & Visual Factory
Quality cannot exist in chaos. 5S is not a housekeeping methodology; it is a foundational quality discipline designed to make abnormalities immediately visible. If the standard state is not obvious, deviations cannot be detected. 8.3.1 The 5S Protocol for Qua...
8.5 IPC-A-610 Classifications & Criteria
IPC-A-610 "Acceptability of Electronic Assemblies" serves as the primary visual acceptance standard for the electronics industry. It defines the "Target," "Acceptable," "Process Indicator," and "Defect" conditions for solder joints and mechanical assembly. Adh...
8.5 Layered Process Audits (LPA)
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)
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
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)
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)
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
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
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)
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)
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
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)
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
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
"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)
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)
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 ...