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3.6 Regulatory Compliance: The EMS Interface
As an Electronic Manufacturing Services (EMS) provider, we do not own the design, nor do we sign the Declaration of Conformity. However, we are the physical gatekeepers of compliance. If we build a product that deviates from the customer’s Technical Constructi...
5.7 Defect Taxonomy & Disposition Rules (Linked to MRB)
Ambiguity in defect classification paralyzes production lines. If an operator cannot instantly distinguish between a "process indicator" and a "functional failure," they will either scrap good parts (wasting money) or pass bad parts (risking liability). This c...
6.4 Inspection Method Validation (AOI/X-Ray/ICT/FCT Correlation)
Inspection is not a passive filter; it is a data acquisition system that defines the physical reality of the PCBA. Relying on unvalidated machines is arguably worse than no inspection at all, as it creates a false sense of security while satisfying neither phy...
8.1 NCR Workflow: Detect, Quarantine, Disposition, Close
A Non-Conformance Report (NCR) is not a bureaucratic punishment; it is the immune system of the factory. It flags foreign risks—defective parts, process drifts, or documentation errors—and isolates them before they infect the final product. A sloppy NCR proces...
8.4 Containment Playbook: Suspect Lots, Line Stop Triggers & Escape Handling
When a defect is detected, the immediate priority is not Root Cause Analysis; it is Containment. You cannot investigate a fire while the building is still burning. This chapter defines the emergency protocols to "stop the bleeding"—isolating the risk, defining...
9.3 Audit Program: Annual Plan, Checklist Library & Evidence Index
An audit program is not a calendar of meetings to satisfy an ISO registrar; it is the primary sensor network for organizational health. If your audits consistently report "No Findings" while your customer complaints are rising, your audit program is broken. Th...
5.2 Backup Power & UPS Systems
Grid stability is a variable, not a constant. In electronics manufacturing, a 50ms power sag does not just reset a clock; it scraps active wafers, jams SMT pick-and-place heads, and corrupts server databases. Backup power is not an insurance policy; it is an a...
3.5 ESD Compliance Verification & Auditing
Entropy guarantees that every ESD control system will eventually fail. Wrist straps fatigue, floor wax wears away, and ionizer needles oxidize. If you do not actively measure performance, you are not "protected"—you are merely hoping. Compliance Verification (...
4.3 Lockout/Tagout (LOTO) & Electrical Safety
Energy isolation is not an administrative exercise; it is a physical constraint applied to a kinetic or potential force. A plastic "Do Not Operate" tag offers zero mechanical resistance to a breaker being flipped. Therefore, the safety of the technician relies...
4.5 Contractor Management & Permits to Work
External contractors represent the single largest unmitigated risk to facility integrity. They possess the tools to destroy infrastructure but lack the institutional knowledge of your specific hazards (e.g., hidden chemical lines, ESD zones). Therefore, you do...
1.1 Legal Register & Compliance Calendar
Compliance is not an administrative exercise; it is the facility’s License to Operate. A missing statutory inspection for a pressure vessel or an expired environmental permit does not just result in a fine—it forces an immediate operational shutdown and expose...
1.2 Risk Assessment & Management of Change (MOC)
Stability is safe; change is dangerous. In a high-tech manufacturing environment, 70% of catastrophic failures (fires, chemical releases, quality excursions) trace back to an unmanaged change or a generic, "copy-paste" risk assessment. This chapter defines th...
1.3 Incident / Near-Miss Reporting + CAPA linkage
A silent factory is a dangerous factory. In high-reliability organizations, bad news must travel fast. If an operator hides a minor shock or a small spill out of fear of punishment, the system loses the critical data signal needed to prevent a fatality. This ...
1.4 Emergency Response & Drill Program
Hope is not a strategy. When an emergency alarm triggers, cognitive function drops by 50%. The goal of the Emergency Response program is to replace panic with Muscle Memory. A drill is not a theater production to please a local inspector. It is a stress test ...
1.5 Training & Competency Matrix
A signed attendance sheet proves nothing. In a high-reliability facility, Competency is the only metric that matters. Competency is the demonstrated ability to perform a task to standard, under pressure, without supervision. This chapter defines the engineeri...
2.5 Utility Capacity Planning & New Equipment Hookup Checklist
A facility is a finite resource. Every new Reflow Oven or Wave Solder machine consumes a slice of the building's total capacity (Amps, CFM, Cooling Tons). If you treat the facility as an infinite socket, you will eventually trip the main breaker or collapse th...
2.4 Nitrogen / Vacuum / Exhaust Utilities
These are the "Circulatory and Respiratory" systems of the factory. While power and air turn the machines on, Nitrogen, Vacuum, and Exhaust determine if the process is capable of producing a reliable solder joint. A fluctuation in Nitrogen pressure opens the ...
3.1 ESD Program Governance
Electrostatic Discharge (ESD) is the silent killer of yield. A discharge of <100V—too small for a human to feel—can puncture a gate oxide, causing latent failures that only appear months after shipment. Governance is not administrative; it is the control logic...
4.6 Waste Management & Environmental Compliance
Industrial waste is not "garbage"; it is material that has exited the value stream but retains full regulatory liability. Improper disposal—whether pouring solvent down a sink or mixing leaded dross with general trash—exposes the facility to fines, site shutdo...
4.7 Ergonomics & Manual Handling
Ergonomics is not about comfort; it is about Yield. A fatigued operator introduces variability into the manufacturing process. When physical stress exceeds the body's recovery rate, fine motor control degrades, leading directly to solder defects, dropped compo...