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396 total results found

2.3 Compressed Air Standards (ISO 8573)

07. Facility Infrastructure, TPM & EHS Part 2. Critical Utilities & Infrastruc...

Compressed air is the "Fourth Utility," but unlike electricity or water, you manufacture it on-site. If your air quality fails, you are injecting pollution directly into your precision equipment. Pneumatic actuators in pick-and-place heads operate at millisec...

3.2 The ESD Protected Area (EPA)

07. Facility Infrastructure, TPM & EHS Part 3. The Electrostatic Discharge (ES...

The EPA is not merely a room with a sign; it is a precisely engineered equipotential volume. Inside this zone, all conductive elements—floors, operators, equipment, and workbenches—are electrically bonded to a common ground point. This ensures that the voltage...

3.3 Flooring & Grounding Architecture

07. Facility Infrastructure, TPM & EHS Part 3. The Electrostatic Discharge (ES...

The floor is the primary electrical foundation of the EPA. It serves as the sole ground path for mobile operators, carts, and Autonomous Guided Vehicles (AGVs). If the flooring system fails (becomes insulative), every step a technician takes generates triboele...

4.2 Solder Fume Extraction

07. Facility Infrastructure, TPM & EHS Part 4. Environmental Health & Safety (...

Flux fumes are not merely an olfactory nuisance; they are a complex aerosol of colophony (rosin) particulates and gaseous byproducts capable of inducing permanent respiratory sensitization (occupational asthma). Treat fume extraction as a critical utility, equ...

4.1 Chemical Handling & Spill Response

07. Facility Infrastructure, TPM & EHS Part 4. Environmental Health & Safety (...

Chemical integrity is not a compliance box to check; it is a fundamental variable in facility uptime. Uncontrolled chemical energy—whether through corrosion, exothermic reaction, or flammability—compromises structural assets and halts production. Treat every c...

4.4 Fire Safety in Thermal Processes

07. Facility Infrastructure, TPM & EHS Part 4. Environmental Health & Safety (...

Thermal processing equipment (Reflow Ovens, Wave Soldering, Curing Ovens) essentially operates as a controlled fire inside a manufacturing enclosure. The boundary between a functional soldering profile and a catastrophic facility fire is defined strictly by th...

6.2 Preventive Maintenance (PM) Planning

07. Facility Infrastructure, TPM & EHS Part 6. Maintenance Operations & Reliab...

Preventive Maintenance is not a suggestion; it is a rigid contract between Engineering and Operations. In high-precision electronics manufacturing, facility systems are active process variables. A 5% drop in compressed air pressure can cause a pick-and-place n...

5.1 Physical Security & Access Control

07. Facility Infrastructure, TPM & EHS Part 5. Business Continuity & Security

Physical security in manufacturing is not about theft prevention; it is about preserving the "Chain of Custody" for client Intellectual Property (IP). A breach here compromises not just inventory, but the contractual integrity of the entire operation. Treat fa...

6.1 Maintenance Governance: KPIs, Roles, Escalation

07. Facility Infrastructure, TPM & EHS Part 6. Maintenance Operations & Reliab...

Total Productive Maintenance (TPM) is not a cleaning schedule; it is the fiscal discipline of Asset Utilization. In high-volume electronics, a machine sitting idle due to "unplanned downtime" is actively burning capital. We shift the operational model from "Re...

6.4 Asset Register, Criticality & Spare Parts Policy

07. Facility Infrastructure, TPM & EHS Part 6. Maintenance Operations & Reliab...

Managing assets in an ISO 9001/13485 environment is not an accounting exercise; it is a technical discipline of "Process Readiness." An uncalibrated torque driver does not just tighten a screw; it injects a latent failure into the product. A stockout of a $50 ...

3.4 Ionization & Insulator Control

07. Facility Infrastructure, TPM & EHS Part 3. The Electrostatic Discharge (ES...

Grounding straps and conductive floors have a fatal physical limitation: they only work on conductors. They are chemically incapable of draining charge from insulators (plastics, epoxy, glass). When an ungrounded insulator—like a plastic connector housing or a...

1.1 QMS Scope, Process Map & Mandatory Records

08. Quality Assurance & Regulatory Comp... Part 1. The Quality Management System (...

A Quality Management System (QMS) without defined boundaries becomes a bureaucracy engine. We define scope not to satisfy auditors, but to focus engineering resources on failure prevention rather than administrative overhead. If a process affects product safet...

1.2 Documentation Control & Data Integrity

08. Quality Assurance & Regulatory Comp... Part 1. The Quality Management System (...

Documentation is not administrative overhead; it is the frozen engineering intent. If a production line operates on Rev A instructions while Rev B is released, the result is 100% yield of non-conforming product. Data integrity ensures that what we think we bui...

5.2 IPC-A-610 Classifications & Criteria

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

IPC-A-610 "Acceptability of Electronic Assemblies" is the visual language of the electronics industry. It is not a suggestion box; it is the boundary between a shippable product and scrap. We do not inspect for "beauty"; we inspect for structural integrity and...

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 is a ticking time bomb. Layered Process Audits (LPA) are the immune system of the factory floor. They are high-frequency, short-duration checks performed by multip...

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 Internal Systems Audit asks if the rules themselves are compliant, effective, and actually being read. This is the health check of the Quality Management System (QMS). I...

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 auditor's goal is to find risk; your goal is to demonstrate control. Success relies on architecture, not just good coffee. You must control the flow of information, the ...

4.1 Governance and Operating Model

08. Quality Assurance & Regulatory Comp... Part 4. Supplier Quality Management

Supplier Quality Management (SQM) is not an administrative extension of Purchasing; it is the technical firewall separating external supply chain entropy from internal manufacturing stability. While Procurement optimizes for cost and logistics (Commercial), SQ...

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% Output Yield can still be bankrupting the company if 40% of those units required rework loops to pass. As a Quality Director, you must distinguish between making...

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). Inspection tells you that you just made a bad part; SPC tells you that you are about to make a bad part. It is the practice of listening to the "heartbeat" of t...