07. Facility Infrastructure, TPM & EHS
ESD, safety, and maintenance systems that keep production stable and audit-ready.
Part 1. Facility & EHS Governance System
1.1 Legal Register & Compliance Calendar
Compliance is not an administrative exercise; it is the facility’s License to Operate. A missing ...
1.2 Risk Assessment & Management of Change (MOC)
Stability is safe; change is dangerous. In a high-tech manufacturing environment, 70% of catastro...
1.3 Incident / Near-Miss Reporting + CAPA linkage
A silent factory is a dangerous factory. In high-reliability organizations, bad news must travel ...
1.4 Emergency Response & Drill Program
Hope is not a strategy. When an emergency alarm triggers, cognitive function drops by 50%. The go...
1.5 Training & Competency Matrix
A signed attendance sheet proves nothing. In a high-reliability facility, Competency is the only ...
Part 2. Critical Utilities & Infrastructure
2.1 HVAC Monitoring, Alarms & Control Limits
The manufacturing environment is not just "air"; it is a critical process ingredient. In electron...
2.2 Power Quality & Grounding
Electricity is the fuel of the factory, but "dirty" fuel destroys the engine. Modern SMT equipmen...
2.3 Compressed Air Standards (ISO 8573)
Compressed air is the "Fourth Utility," but unlike electricity or water, you manufacture it on-si...
2.4 Nitrogen / Vacuum / Exhaust Utilities
These are the "Circulatory and Respiratory" systems of the factory. While power and air turn the ...
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...
Part 3. The Electrostatic Discharge (ESD) Control Program
3.1 ESD Program Governance
Electrostatic Discharge (ESD) is the silent killer of yield. A discharge of <100V—too small for a...
3.2 The ESD Protected Area (EPA)
The EPA is not merely a room with a sign; it is a precisely engineered equipotential volume. Insi...
3.3 Flooring & Grounding Architecture
The floor is the primary electrical foundation of the EPA. It serves as the sole ground path for ...
3.4 Ionization & Insulator Control
Grounding straps and conductive floors have a fatal physical limitation: they only work on conduc...
3.5 ESD Compliance Verification & Auditing
Entropy guarantees that every ESD control system will eventually fail. Wrist straps fatigue, floo...
Part 4. Environmental Health & Safety (EHS)
4.1 Chemical Handling & Spill Response
Chemical integrity is not a compliance box to check; it is a fundamental variable in facility upt...
4.2 Solder Fume Extraction
Flux fumes are not merely an olfactory nuisance; they are a complex aerosol of colophony (rosin) ...
4.3 Lockout/Tagout (LOTO) & Electrical Safety
Energy isolation is not an administrative exercise; it is a physical constraint applied to a kine...
4.4 Fire Safety in Thermal Processes
Thermal processing equipment (Reflow Ovens, Wave Soldering, Curing Ovens) essentially operates as...
4.5 Contractor Management & Permits to Work
External contractors represent the single largest unmitigated risk to facility integrity. They po...
4.6 Waste Management & Environmental Compliance
Industrial waste is not "garbage"; it is material that has exited the value stream but retains fu...
4.7 Ergonomics & Manual Handling
Ergonomics is not about comfort; it is about Yield. A fatigued operator introduces variability in...
Part 5. Business Continuity & Security
5.1 Physical Security & Access Control
Physical security in manufacturing is not about theft prevention; it is about preserving the "Cha...
5.2 Backup Power & UPS Systems
Grid stability is a variable, not a constant. In electronics manufacturing, a 50ms power sag does...
5.3 Outage / Disaster Recovery Playbooks + Test Schedule
Disaster recovery is not about "hope"; it is about Mean Time to Recovery (MTTR). In a crisis, adr...
Part 6. Maintenance Operations & Reliability (TPM)
6.1 Maintenance Governance: KPIs, Roles, Escalation
Total Productive Maintenance (TPM) is not a cleaning schedule; it is the fiscal discipline of Ass...
6.2 Preventive Maintenance (PM) Planning
Preventive Maintenance is not a suggestion; it is a rigid contract between Engineering and Operat...
6.3 Predictive Maintenance (PdM)
Predictive Maintenance is not about fixing machines; it is about buying time. While Preventive Ma...
6.4 Asset Register, Criticality & Spare Parts Policy
Managing assets in an ISO 9001/13485 environment is not an accounting exercise; it is a technical...
6.5 Breakdown Response Standard (safe isolation, restart verification)
A machine breakdown is a high-pressure event where adrenaline often overrides protocol. This is w...
6.6 Root Cause Analysis (RCA)
In Total Productive Maintenance (TPM), "fixing" the machine is merely the first step. The goal is...