Articles

Long-form analysis on quality engineering, FDA enforcement, and recall patterns.

Written for quality leaders, regulated-industry founders, and litigation teams who need substance more than feed-fodder. No SEO clickbait, no AI-generated summaries — just the analysis we'd give a client.

Process Theatre: When Your Procedure Looks Clean but the Records Don't Match
QMS & Compliance

Process Theatre: When Your Procedure Looks Clean but the Records Don't Match

Process theatre is what happens when a documented procedure no longer reflects the actual practice. Four common patterns — CAPA, Internal Audit, Design Control, Training — and what an independent two-day process audit catches that internal audit usually misses.

Mark Mayeux · May 31, 2026 · process auditinternal auditcapadesign controliso 17021complianceqms
Six Situations Where a One-Day QMS Document Review Is the Right Call
QMS & Compliance

Six Situations Where a One-Day QMS Document Review Is the Right Call

When the full ISO mock audit is too much and a junior consultant's checklist isn't enough — six situations where a one-business-day senior-engineer document review against the standard you choose is the right tool.

Mark Mayeux · May 24, 2026 · qmsiso 9001iso 13485iso 14001iso 4500121 cfr 820document reviewcompliance
Fail-Safe Design Without the Aerospace Budget
Design Principles

Fail-Safe Design Without the Aerospace Budget

Fail-safe design principles get framed for aerospace, automotive, and medical devices. They apply to the $30 power bank, the $80 sous-vide stick, and the $129 countertop appliance just as cleanly — at a fraction of the cost, when the failure modes are caught before the PO clears.

Mark Mayeux · May 17, 2026 · pre-launch auditdesign principleskickstartercrowdfundingconsumer electronicsquality engineering
Why Sourcing Opacity Is a Quality Problem, Not Just a Margin Problem
Sourcing & QA

Why Sourcing Opacity Is a Quality Problem, Not Just a Margin Problem

Hidden commissions in offshore sourcing usually get framed as a margin problem. The bigger cost is that the same opacity hides the factory, and a quality audit cannot read recall history on a factory it does not know.

Mark Mayeux · May 14, 2026 · sourcingchina manufacturingpre-launch auditcrowdfundingkickstarterquality engineering
Five Quality Pains Founder-PMs and Sourcing Teams Carry Into Manufacturing
Pre-Launch Audit

Five Quality Pains Founder-PMs and Sourcing Teams Carry Into Manufacturing

Five quality pains that hit founder-PMs and sourcing leads in the week before a PO clears — what each one costs if it goes wrong, and what an outside Pre-Launch QA Audit does about each.

Mark Mayeux · May 11, 2026 · pre-launch auditfoundersproduct managementsourcingquality engineering
How the Pre-Launch QA Audit Improves on Traditional Quality Engineering Services
Service Comparison

How the Pre-Launch QA Audit Improves on Traditional Quality Engineering Services

A side-by-side comparison on speed, cost, scope clarity, and the federal-data layer no boutique consultant can build for a single engagement.

Mark Mayeux · May 10, 2026 · pre-launch auditquality engineeringservice comparisonconsumer products
The Crowdfunding Industry's Quality Gap, and the 'as a Service' Model That Closes It
Industry Analysis

The Crowdfunding Industry's Quality Gap, and the 'as a Service' Model That Closes It

Kickstarter and Indiegogo solved the funding problem for consumer hardware. Quality engineering stayed too slow and too expensive for the creators most exposed to recall risk. The structural gap, and the service model that fills it.

Mark Mayeux · May 9, 2026 · crowdfundingkickstarterindiegogoindustry analysisquality engineeringpre-launch audit
The Six-Gate NPI Process for Crowdfunded Consumer Hardware
Methodology

The Six-Gate NPI Process for Crowdfunded Consumer Hardware

Around 90% of new consumer products manufactured in China miss timing, quality, or cost. The six gates of the New Product Introduction process are what the 10% that ship clean run before they get there. Adapted for Kickstarter and Indiegogo creators and the product design firms working with them.

Mark Mayeux · May 7, 2026 · npikickstartercrowdfundingpre-launch auditquality engineering
How the Pre-Launch QA Audit Reads a Kickstarter Icemaker Spec Sheet
Audit Walkthrough

How the Pre-Launch QA Audit Reads a Kickstarter Icemaker Spec Sheet

A 10-point walk-through on a category where ice is legally food and CPSC has logged a recall pattern stretching back fifteen years.

Mark Mayeux · May 3, 2026 · pre-launch auditkickstartercrowdfundingconsumer productsquality engineering
Why Crowdfunded Products Fail in Manufacturing
Pre-Launch Audit

Why Crowdfunded Products Fail in Manufacturing

Kickstarter and Indiegogo creators carry quality risk on a public stage. What an outside QA engineer looks for before a Risks and Challenges section becomes a refund thread.

Mark Mayeux · April 29, 2026 · crowdfundingkickstarterpre-launch auditquality engineering
The 10-Point Audit That Catches What a Production Sample Hides
Methodology

The 10-Point Audit That Catches What a Production Sample Hides

A senior QA engineer's framework for finding consumer product problems before customers do. Built for startups, Amazon FBA brands, DTC operators, and crowdfunded creators heading into manufacturing.

Mark Mayeux · April 15, 2026 · quality engineeringpre-launch auditmethodology
DFM, DTC, DFQ, DFD: The Four Design Reviews Every Crowdfunded Product Needs
Methodology

DFM, DTC, DFQ, DFD: The Four Design Reviews Every Crowdfunded Product Needs

An NPI process runs four discrete design reviews between concept and tooling: Design for Manufacturing, Design to Cost, Design for Quality, and Design for Distribution. Each one closes a category of failure that has put crowdfunded products on the wrong side of fulfillment. The Pre-Launch QA Audit operationalizes all four in one week.

Mark Mayeux · April 7, 2026 · design reviewsnpipre-launch auditkickstarterquality engineering