Quality and Compliance
Two different jobs share one word. Quality is whether the product was built to the specification. Compliance is whether it is legal to sell. MakeMine manages both, inspecting during the run at the factory and identifying what your category requires before the specification is ever locked.
Book an Intro CallA product can be perfectly made and still be illegal to sell
By the time goods reach final inspection, the run is complete. A defect found at that point is either shipped, reworked at cost, or scrapped. None of those is a good outcome, and all of them were avoidable at the moment the first units came off the line.
The other half is the half most brands don't see coming. A missing fiber content statement. No country of origin. A drawstring in a child's hood. An unregistered facility. A claim that quietly turned a cosmetic into a drug. Every one of those describes a product built exactly to specification, and held at customs, refused by the retailer, or recalled.
Compliance is decided in development and proven in production. It is not something that can be added at the end.
What quality and compliance covers
Factory audit
Every facility in the network is vetted for social compliance and evaluated for the categories and processes it actually does best.
Incoming material inspection
Components checked before the run starts, while a defect is still the supplier's problem rather than yours.
First article and in-process inspection
Checks during the run, so a systemic defect is caught while the line can still be corrected.
Final random inspection
AQL sampling against the approved pre-production sample before goods are released.
Dimensional and fill audit
Measured against the specification with tolerances applied across the full range, not spot-checked on one unit.
Regulatory scoping
What your category, your market, and your claims require, identified during development, before the specification is locked.
Third-party testing
Coordinated with accredited laboratories, with results held on file against the lot they belong to.
Defect documentation
Findings recorded with photographs and classified by severity, so disputes resolve against evidence rather than recollection.
Where inspection happens
Six points, not one. The value of each is measured by how much of the run is still recoverable when it finds something.
| Stage | When | What it catches |
|---|---|---|
| Pre-production meeting | Before the run starts | Specification misunderstandings, equipment allocation, operator briefing |
| Incoming material inspection | Components in house | Material defects, shade and batch variance, weight and dimensional deviation |
| First article | First units off the line | Construction and process errors, while the line can still be corrected |
| In-process (DUPRO) | 20–40% complete | Systemic defects, before they run through the remainder of the order |
| Top-of-production check | Mid-run | Bulk drift from the approved pre-production sample |
| Final random inspection | 100% produced, 80%+ packed | Overall defect rate, dimensional conformity, packing and labeling accuracy |
AQL inspection standards
Inspection follows ISO 2859-1, equivalent to ANSI/ASQ Z1.4. Sample size is drawn from lot size at General Inspection Level II; the AQL sets how many defects are acceptable within that sample.
| Term | Definition | Common standard |
|---|---|---|
| Critical defect | Renders the product unsafe or unsalable, or violates a regulation | AQL 0, none accepted |
| Major defect | Would likely cause a return or a customer complaint | AQL 2.5 |
| Minor defect | Departs from the standard but is unlikely to affect saleability | AQL 4.0 |
| Inspection level | Determines sample size relative to lot size | General Level II |
| Dimensional tolerance | Allowable deviation per measurement point | Set in the specification; commonly ±1/4" to ±1/2" per point of measure on apparel |
US compliance requirements by category
What has to be true before a product can be sold in the United States, arranged by the category it applies to. Requirements stack: a children's garment carries the textile rules and the CPSIA rules and the flammability rules.
| Applies to | Requirement | Regulation |
|---|---|---|
| Apparel and textiles | Fiber content by generic name and percentage, country of origin, and manufacturer identity by RN number or full company name | Textile Fiber Products Identification Act |
| Apparel and textiles | Care instructions | 16 CFR Part 423 (Care Labeling Rule) |
| Apparel and textiles | General wearing apparel flammability | 16 CFR Part 1610 |
| Children's products, 12 and under | Third-party testing for lead and phthalates, a Children's Product Certificate, and permanent tracking labels on product and packaging | CPSIA |
| Children's sleepwear, 9 months–14 | Sleepwear flammability | 16 CFR Parts 1615 and 1616 |
| Children's upper outerwear, 2T–16 | Drawstring restrictions | 16 CFR Part 1120 / ASTM F1816 |
| Cosmetics | Facility registration, product listing, a named Responsible Person, adequate safety substantiation, and adverse event reporting | MoCRA |
| OTC drug products | Monograph compliance, a Drug Facts panel, an NDC number, and manufacture under GMP | FD&C Act / 21 CFR Parts 210 and 211 |
| Regulated consumer products | General Certificate of Conformity based on a test or reasonable program | Consumer Product Safety Act |
| All imported goods | Country of origin marking | 19 CFR Part 134 |
| Any "Made in USA" claim | All or virtually all of the product made in the United States | FTC Made in USA Labeling Rule |
| Products sold into California | Chemical exposure warning | California Proposition 65 |
This table covers the United States. Products sold into the EU, UK, or Canada carry their own labeling, chemical, and registration rules, and in several cases require a legal representative established in that market.
Factory audit and manufacturing standards
| Standard | What it covers |
|---|---|
| amfori BSCI | Social compliance: labor practices, working hours, health and safety, wages |
| WRAP | Worldwide Responsible Accredited Production, a social and legal compliance certification |
| SEDEX / SMETA | Ethical trade audit covering labor, health and safety, environment, and business ethics |
| SA8000 | Social accountability certification against international labor standards |
| ISO 22716 | Good manufacturing practice for cosmetics |
| 21 CFR Parts 210 and 211 | Good manufacturing practice for drug products, including OTC monograph drugs |
Every factory in the MakeMine network meets BSCI compliance standards.
What MakeMine won't do on quality
- We don't release goods that fail final inspection to protect a ship date.
- We don't quote a children's product without the testing and certification cost included. It is not an add-on.
- If a facility cannot meet the compliance requirements of your category, we don't place your order there, even if it is the cheapest quote you have.
- If your product is a drug and you believed it was a cosmetic, you hear it in the first conversation. It changes the facility, the cost, and the timeline.
- Audit status and compliance documentation are shared with you, not guarded as leverage.
Frequently asked questions
What does AQL mean in product inspection?
AQL stands for Acceptable Quality Limit. It defines the maximum number of defects allowed in a randomly drawn sample before the lot is rejected. Consumer goods commonly inspect at AQL 2.5 for major defects and 4.0 for minor, using ISO 2859-1 General Inspection Level II. Critical defects are accepted at zero.
What is a DUPRO inspection?
DUPRO stands for "during production" inspection. It is performed when roughly 20 to 40 percent of the order is complete. That is early enough to correct a systemic defect before it runs through the remaining units, and late enough to see the line at steady output rather than at start-up.
Who decides which regulations apply to my product?
Intended use and category decide it, and the answer is often not the one a brand assumes. A moisturizer is a cosmetic; add an SPF claim and it becomes an OTC drug with a different facility, a Drug Facts panel, and an NDC number. A sweatshirt is apparel; make it in a child's size with a hood cord and CPSIA and the drawstring rule both attach. MakeMine scopes this during development, because the answer changes the specification.
What labels are legally required in the US?
It depends on the category. Textile apparel requires four things: fiber content by generic name and percentage of weight, country of origin, the manufacturer's RN number or full company name, and care instructions. Cosmetics require an ingredient declaration in INCI order, net contents, the responsible party, and any required warnings. Imported goods of every kind require country of origin marking.
Are MakeMine's factories audited?
Yes. Facilities in the MakeMine network are vetted for social compliance against standards including amfori BSCI and WRAP, and audit documentation is shared with clients rather than withheld.
Who pays for rework if goods fail inspection?
Responsibility depends on cause, and it is defined at PO issuance rather than after the fact. Defects against the approved specification are the factory's to correct. Changes you request after pre-production approval are yours. Defining this before the PO is issued is what keeps it from becoming a negotiation once goods are already made. MakeMine defines it on the PO.
Does MakeMine arrange third-party lab testing?
Yes. Testing is coordinated with accredited laboratories and the results are held on file against the lot they cover, which is what a retailer or a regulator will ask for. Testing cost is quoted as part of the product rather than surfaced later as an extra.
Built right, and legal to sell.
Inspection, audit, and regulatory scoping handled as part of production. Book a call to review what your category actually requires.