Our Methodology

The QA Audit.
10 questions, every engagement.

The 10-point quality engineering framework we apply to every consumer product we evaluate — and the same framework we run as a paid Pre-Launch Audit for small brands shipping into Amazon, retail, and DTC.

20+ Years QA Experience
Federal Recall Data Pipeline
One Engineer Per Project

Most consumer product reviews are guesswork dressed up as opinion. Most pre-launch quality reviews cost twenty to fifty thousand dollars and take six weeks. Neither of those works for the actual problem.

The QA Audit is a published, repeatable framework that closes the gap. A senior quality engineer with twenty years of experience across medical devices, aerospace, and consumer goods personally runs the methodology, reads the data, makes the calls, and signs the report. Research tooling helps pull spec sheets, surface one-star review patterns, and cross-reference federal recall databases — but every output that leaves this practice is reviewed and authored by the engineer leading the work.

It's the same methodology applied to every consumer product we write about on this site, and the same methodology we deliver as a written report when a small brand pays us to run it on a product they're about to ship. Publishing it here means you can see exactly what the work looks like before you decide whether you want it done on your own product.

The Framework

The 10 questions we ask of every product

Not every product needs every question answered in depth. But every product we evaluate gets every question asked — and the answers are what make a verdict more than an opinion.

1

Materials & Construction

What is it actually made of? Does the bill of materials match what's claimed in the listing? Are the materials appropriate for the product's intended use, lifespan, and operating environment?

2

Tolerances & Specifications

Where the product makes a measurable claim — power output, capacity, accuracy, weight rating — do the published specs hold up against documented user reports and category norms?

3

Failure Modes

What is most likely to break, and what happens when it does? A product that fails safely is fundamentally different from one that fails dangerously, even at the same break rate.

4

Manufacturer Track Record

What does federal recall and complaint data say about this manufacturer's other products? Patterns across a brand are usually more predictive than any single product's reviews.

5

Category Recall History

How often does this product category get recalled? Which failure modes show up over and over? CPSC, FDA, USDA, and NHTSA databases tell that story across years of data.

6

Regulatory Exposure

What compliance requirements does this product trigger? FDA registration, CPSC certification, FCC, UL, age-grading, labeling rules — what's table-stakes, what's optional, what's missing.

7

One-Star Review Patterns

Negative reviews contain more useful signal than positive ones. We read them at scale, group them by failure type, and look for patterns that contradict the listing or the manufacturer's claims.

8

Returns & Warranty Reality

What does the warranty actually cover? What does the return policy actually allow? The gap between policy and practice is where consumers — and small brands — get hurt.

9

Comparable Products

How does this product compare to two or three direct competitors on materials, specs, failure modes, and price? Context turns a verdict from an opinion into a recommendation.

10

Risk-Ranked Verdict

Findings are sorted into high, medium, and low risk — with specific evidence, recommended actions, and a final yes / no / with-caveats verdict that someone can actually act on.

Frameworks We Cover

The regulations and standards QESaaS services address.

Every service maps to specific frameworks. Below are the standards QESaaS is calibrated for — covering consumer products, medical devices, and quality management systems across U.S. and international regimes.

ISO 9001:2015
General quality management system — every QESaaS engagement
All Services
ISO 13485:2016
Medical device quality systems — Part 820 harmonized
ISO Audit Prep
ISO 14001:2015
Environmental management systems — manufacturing operations
ISO Audit Prep
ISO 10993
Biological evaluation — body-contact / mucosal / implant
Pre-Launch QA
21 CFR 820
FDA Quality System Regulation — medical device
FDA 483 Response
21 CFR 884
FDA OB-GYN device classification (510(k) pathways)
Pre-Launch QA
21 CFR 211
cGMP for finished pharmaceuticals — Quality Unit oversight
FDA 483 Response
FDA 510(k)
Premarket notification pathway — Class II devices
Pre-Launch QA
CPSIA / 16 CFR 1303
Children's product certification + lead surface coatings
Pre-Launch QA
ASTM F963-23
Toy safety — mechanical, small parts, labeling
Pre-Launch QA
UL 4200A
Reese's Law — button-cell battery accessibility
Pre-Launch QA
16 CFR 1610
Flammability of clothing textiles — Class 1 standard
Pre-Launch QA
ANSI Z21.97 / CSA 2.41
Outdoor decorative gas appliances — fire features
Pre-Launch QA
ASTM F2960
Wood-burning chimineas / outdoor fire-pits
Pre-Launch QA
OHSAS 18001
Occupational health & safety management (legacy)
ISO Audit Prep
ASTM F2057
Furniture stability — tip-over hazard testing
Pre-Launch QA
How the Work Splits

The engineer decides. Research tooling supports.

The honest version. Every finding, every risk ranking, every word of the verdict is authored by a senior quality engineer — never by a tool, and never delivered without review.

🧭 The engineer authors the findings

Judgment, verdict & sign-off

  • Deciding what's actually worth your money
  • Ranking findings by real-world risk vs. theoretical risk
  • Translating regulatory exposure into plain-English consequences
  • Calling out when claimed specs would not pass real QA review
  • Writing the final yes / no / with-caveats recommendation
  • Reviewing every finding, citation, and figure before delivery
  • Owning the verdict leading the work. No fictional staff names.
⚙️ Tooling supports — never substitutes

Research & data aggregation

  • Pulling spec sheets, manuals, and warranty fine print into one place
  • Surfacing one-star review themes across retailers for the engineer to read
  • Querying federal recall databases (CPSC, FDA, USDA, NHTSA) on demand
  • Highlighting patterns across a manufacturer's product catalog for review
  • Flagging missing information that would change the verdict
  • Every output is reviewed by the engineer before it informs a finding.
Practitioner-Led Engagement Aligned with 21 CFR 211.22(c) Quality Unit oversight

Every deliverable is authored by the engineer.

FDA's first AI overreliance Warning Letter (320-26-58, April 2026) put a long-standing rule in writing: any output from a research tool used inside a regulated quality system must be reviewed and cleared by a qualified human before it is treated as a finding. That standard is how this practice has always worked, and how this page states it explicitly.

Research tooling helps the engineer move faster through the data layer. It does not write findings, rank risks, decide verdicts, or sign reports. The engineer reads what the tooling surfaces, validates it against twenty years of cross-industry QA judgment, and authors the deliverable. Reports are delivered with one human name leading the work — and that name is accountable for every line.

For medical-device, regulated-manufacturer, and litigation engagements, this discipline is the entire point: a deliverable that holds up under inspection, deposition, or audit because a qualified person personally produced it.

Data Foundation

The federal databases we run daily

Recall and complaint data from four U.S. federal agencies, normalized and cross-referenced through pipelines we built and operate ourselves. The same pipelines that power the RecallSentry™ app.

CPSC
Consumer Product Safety Commission
Toys, electronics, household goods, appliances, child safety equipment
FDA
Food & Drug Administration
Food, drugs, cosmetics, OTC health products
USDA
U.S. Department of Agriculture
Meat, poultry, eggs, processed foods regulated by FSIS
NHTSA
Nat'l Highway Traffic Safety Admin.
Vehicles, tires, child seats, vehicle equipment, recalls and amendments
Transparency

What this methodology does NOT cover

If we won't see it in the documents we review, we'll say so. Knowing the limits is what makes the verdict honest.

The QA Audit does not include

  • Physical product testing. We review documentation, specifications, and field data — we do not break units on a test bench. Where physical testing would change a verdict, we say so explicitly.
  • In-person supplier or factory audits. Manufacturer track record is assessed through public regulatory data, not on-site visits.
  • Regulatory filings or submissions. We flag exposure and missing requirements; we do not handle FDA, CPSC, or other agency submissions on a client's behalf.
  • Litigation support or expert witness work. Available separately. Not part of the standard audit.
  • Anything we can't see in the documents reviewed. When information is missing, we list what's missing — we do not fill the gap with assumptions.

A QA Audit is a senior judgment layered onto well-organized data. It is not a substitute for product certification, formal regulatory clearance, or destructive testing where those are required by law or category norms.

Who Built This

The engineer behind the methodology

One person owns the verdict on every audit. No fictional staff, no rotating contractors.

MM
About the Practitioner
Mark Mayeux
Quality Engineer · QESaaS

Twenty-plus years in product quality engineering across three categories where the cost of getting it wrong varies from ruined-your-Tuesday to ruined-your-life: medical devices, aerospace, and consumer goods. Same instinct, different stakes.

Earlier roles include performing supplier quality audits across medical consumables, medical devices, and consumer goods — and leading teams through years of ISO 9001, ISO 14001, and OHSAS 18001 certification audits, authoring company process documents and work instructions across every department. Mark also built the entire quality department at a medical equipment startup from scratch — hiring, agency documentation, supplier quality requirements, and supplier scoreboards — which was later acquired by a larger company.

Also the builder behind RecallSentry™, a published iOS and Android app that monitors federal recall feeds across CPSC, FDA, USDA, and NHTSA. The same daily-running data pipelines that power that app feed the QA Audit's manufacturer and category data — and every output that lands in a paid deliverable is reviewed by us before delivery.

Quality & Six SigmaRegulatory AffairsSupplier Quality AuditingISO 9001 / 14001OHSAS 18001Medical DevicesAerospaceAutomotiveConsumer ProductsMed Equipment Startup → AcquisitionPractitioner-Led Engagement

Want this done on a product you're launching?

The Pre-Launch QA Audit applies this exact methodology to your product before it ships. Fixed price. One-week turnaround.