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1.2 Risk Assessment & Management of Change (MOC)
Stability is safe; change is dangerous. In a high-tech manufacturing environment, 70% of catastro...
9.4 The Quarterly Business Review (QBR) & Quality Strategy
Management Review is frequently misunderstood as a bureaucratic "death by PowerPoint" ritual. In ...
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 sen...
9.2 Hosting the Customer Audit
A customer audit is not a friendly visit; it is a verification of contract compliance. The audito...
9.1 Internal Systems Audits (ISO 19011)
While Layered Process Audits (LPA) check if the operator is following the rules today, the Intern...
8.5 RMA Processing & Field Failure Analysis
Field returns (RMA) are the only source of truth in manufacturing. Internal yield metrics only me...
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. ...
8.3 Root Cause Analysis (RCA) & CAPA
If you are fighting the same fire this week that you fought last month, your CAPA system is broke...
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 f...
7.4 Layered Process Audits (LPA)
Inspection checks the product; LPAs check the process. A perfect product made by a rogue process ...
7.3 Test Process Quality (ICT/FCT & Retest Limits)
Testing is not a value-added process; it is an interrogation. A test station does not fix quality...
7.2 Operational Metrics: FPY, RTY, CoQ & Review Cadence
In high-volume manufacturing, standard "Yield" is a vanity metric. A production line reporting 99...
7.1 Statistical Process Control (SPC): Cp & Cpk
SPC is the difference between inspecting quality in (reactive) and building quality in (proactive...
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 rea...
6.2 Calibration Management
Measurement without calibration is just an opinion. In a high-precision manufacturing environment...
6.1 Measurement System Analysis (MSA / Gauge R&R)
Before trusting data, you must trust the tool that generated it. If your ruler is elastic, every ...
5.7 Defect Taxonomy & Disposition Rules (Linked to MRB)
Ambiguity in defect classification paralyzes production lines. If an operator cannot instantly di...
5.6 Rework & Repair (IPC-7711/7721)
Rework is not a "Undo" button; it is controlled trauma. Every time you apply a soldering iron to ...
5.5 Cosmetic Inspection Standards (Visual Quality)
Cosmetic inspection is the most dangerous phase of manufacturing because it is subjective. Withou...
5.4 Box Build & Mechanical Assembly (IPC-A-630)
The "Box Build" is where precision electronics meet the brutal reality of the physical world. Whi...