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1.2 Risk Assessment & Management of Change (MOC)

07. Facility Infrastructure, TPM & EHS Part 1. Facility & EHS Governance System

Stability is safe; change is dangerous. In a high-tech manufacturing environment, 70% of catastro...

Updated 1 month ago by Sergey Zorin

9.4 The Quarterly Business Review (QBR) & Quality Strategy

08. Quality Assurance & Regulatory Comp... Part 9. Continuous Improvement

Management Review is frequently misunderstood as a bureaucratic "death by PowerPoint" ritual. In ...

Updated 1 month ago by Sergey Zorin

9.3 Audit Program: Annual Plan, Checklist Library & Evidence Index

08. Quality Assurance & Regulatory Comp... Part 9. Continuous Improvement

An audit program is not a calendar of meetings to satisfy an ISO registrar; it is the primary sen...

Updated 1 month ago by Sergey Zorin

9.2 Hosting the Customer Audit

08. Quality Assurance & Regulatory Comp... Part 9. Continuous Improvement

A customer audit is not a friendly visit; it is a verification of contract compliance. The audito...

Updated 1 month ago by Sergey Zorin

9.1 Internal Systems Audits (ISO 19011)

08. Quality Assurance & Regulatory Comp... Part 9. Continuous Improvement

While Layered Process Audits (LPA) check if the operator is following the rules today, the Intern...

Updated 1 month ago by Sergey Zorin

8.5 RMA Processing & Field Failure Analysis

08. Quality Assurance & Regulatory Comp... Part 8. The Audit Architecture

Field returns (RMA) are the only source of truth in manufacturing. Internal yield metrics only me...

Updated 1 month ago by Sergey Zorin

8.4 Containment Playbook: Suspect Lots, Line Stop Triggers & Escape Handling

08. Quality Assurance & Regulatory Comp... Part 8. The Audit Architecture

When a defect is detected, the immediate priority is not Root Cause Analysis; it is Containment. ...

Updated 1 month ago by Sergey Zorin

8.3 Root Cause Analysis (RCA) & CAPA

08. Quality Assurance & Regulatory Comp... Part 8. The Audit Architecture

If you are fighting the same fire this week that you fought last month, your CAPA system is broke...

Updated 1 month ago by Sergey Zorin

8.1 NCR Workflow: Detect, Quarantine, Disposition, Close

08. Quality Assurance & Regulatory Comp... Part 8. The Audit Architecture

A Non-Conformance Report (NCR) is not a bureaucratic punishment; it is the immune system of the f...

Updated 1 month ago by Sergey Zorin

7.4 Layered Process Audits (LPA)

08. Quality Assurance & Regulatory Comp... Part 7. Process Control & Metrics (Moni...

Inspection checks the product; LPAs check the process. A perfect product made by a rogue process ...

Updated 1 month ago by Sergey Zorin

7.3 Test Process Quality (ICT/FCT & Retest Limits)

08. Quality Assurance & Regulatory Comp... Part 7. Process Control & Metrics (Moni...

Testing is not a value-added process; it is an interrogation. A test station does not fix quality...

Updated 1 month ago by Sergey Zorin

7.2 Operational Metrics: FPY, RTY, CoQ & Review Cadence

08. Quality Assurance & Regulatory Comp... Part 7. Process Control & Metrics (Moni...

In high-volume manufacturing, standard "Yield" is a vanity metric. A production line reporting 99...

Updated 1 month ago by Sergey Zorin

7.1 Statistical Process Control (SPC): Cp & Cpk

08. Quality Assurance & Regulatory Comp... Part 7. Process Control & Metrics (Moni...

SPC is the difference between inspecting quality in (reactive) and building quality in (proactive...

Updated 1 month ago by Sergey Zorin

6.4 Inspection Method Validation (AOI/X-Ray/ICT/FCT Correlation)

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

Inspection is not a passive filter; it is a data acquisition system that defines the physical rea...

Updated 1 month ago by Sergey Zorin

6.2 Calibration Management

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

Measurement without calibration is just an opinion. In a high-precision manufacturing environment...

Updated 1 month ago by Sergey Zorin

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

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

Before trusting data, you must trust the tool that generated it. If your ruler is elastic, every ...

Updated 1 month ago by Sergey Zorin

5.7 Defect Taxonomy & Disposition Rules (Linked to MRB)

08. Quality Assurance & Regulatory Comp... Part 5. Workmanship Standards (The "Bui...

Ambiguity in defect classification paralyzes production lines. If an operator cannot instantly di...

Updated 1 month ago by Sergey Zorin

5.6 Rework & Repair (IPC-7711/7721)

08. Quality Assurance & Regulatory Comp... Part 5. Workmanship Standards (The "Bui...

Rework is not a "Undo" button; it is controlled trauma. Every time you apply a soldering iron to ...

Updated 1 month ago by Sergey Zorin

5.5 Cosmetic Inspection Standards (Visual Quality)

08. Quality Assurance & Regulatory Comp... Part 5. Workmanship Standards (The "Bui...

Cosmetic inspection is the most dangerous phase of manufacturing because it is subjective. Withou...

Updated 1 month ago by Sergey Zorin

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

08. Quality Assurance & Regulatory Comp... Part 5. Workmanship Standards (The "Bui...

The "Box Build" is where precision electronics meet the brutal reality of the physical world. Whi...

Updated 1 month ago by Sergey Zorin