OEM/ODM

Factory Audit Checklist for Adult Wellness Buyers: 67 Questions to Ask Before You Order

Why Factory Audits Are Not Optional for Wellness Brands

The adult wellness category carries specific product safety and brand reputation risks that make factory quality system verification non-negotiable. Products with body contact materials, embedded electronics, and lithium batteries require consistent production quality in three dimensions simultaneously: material safety, electrical safety, and mechanical integrity. A factory that doesn't maintain documented quality procedures cannot consistently deliver across all three.

Beyond product safety, the regulatory environment for wellness products has tightened substantially. EU market surveillance authorities conduct factory-level assessments for non-compliant products found in the market. When a product fails market surveillance testing in the EU, the economic operator (typically the importer/brand) is required to demonstrate due diligence in supplier selection and product verification. A factory audit report is a key element of that due diligence defence.

This checklist is organised into four sections: Facility and Production Capability (17 questions), Quality Management System (23 questions), Ethical and Social Compliance (14 questions), and Product-Specific Technical Verification (13 questions). Complete all four sections for a comprehensive view of supplier capability.

Section A: Facility and Production Capability (17 Questions)

A1. Legal and Registration

  1. Is the factory's business licence current and does it include manufacturing in the relevant product category?
  2. Does the registered production address match the actual production location?
  3. Does the factory hold a valid export registration with China Customs?

A2. Physical Facility

  1. What is the total production floor area (m²)?
  2. Is the production facility owned or leased? (Owned indicates more stable long-term operations)
  3. Is there dedicated space separation between injection moulding, assembly, testing, and warehousing?
  4. Is the assembly area for body-contact products (silicone handling) in a clean room or controlled environment?
  5. What is the current utilisation rate of production capacity?

A3. Equipment

  1. How many injection moulding machines does the factory operate? What is the clamping force range (tonnes)?
  2. Does the factory have SMT (surface mount technology) PCB assembly capability in-house?
  3. What functional testing equipment is available for electrical products (oscilloscope, power analyser, EMC pre-compliance chamber)?
  4. Does the factory have in-house waterproofing testing equipment (pressure chamber for IPX7/IPX8)?
  5. What metrology equipment is available (CMM, calibrated calipers, optical comparator)?

A4. People and Organisation

  1. How many full-time production workers? How many are permanent vs temporary contract?
  2. Does the factory have a dedicated R&D/engineering team separate from production?
  3. How many QC inspectors are there per 100 production workers?
  4. What is the management team's average tenure at this factory?

Section B: Quality Management System (23 Questions)

B1. QMS Certification and Documentation

  1. Does the factory hold a current ISO 9001:2015 certificate? (Verify against CB registry)
  2. When was the most recent ISO surveillance or recertification audit?
  3. Can the factory provide a high-level quality manual and relevant SOPs?

B2. Incoming Material Inspection

  1. Is there a documented incoming inspection procedure for all raw materials?
  2. Are silicone and ABS materials tested for grade/specification upon receipt?
  3. Does the factory maintain certificates of conformance for all body-contact material batches?
  4. How are non-conforming incoming materials identified, quarantined, and dispositioned?

B3. In-Process Quality Control

  1. Is there a first-piece approval process at the start of each production run?
  2. What in-process inspection frequency is applied (every Nth unit, at shift change, hourly)?
  3. Are critical dimensions documented and trended using SPC (Statistical Process Control)?
  4. How are in-process defects recorded and escalated to production management?
  5. Is there a system for traceability (linking finished units to material batches and production dates)?

B4. Outgoing Quality Inspection

  1. What AQL level is applied for finished goods inspection?
  2. Is outgoing inspection conducted by dedicated QC staff separate from production workers?
  3. What functional tests are conducted on every unit or per sampling plan?
  4. Are waterproofing tests conducted as part of outgoing inspection (sample-based)?
  5. How is finished goods inspection documented?

B5. Non-Conformance and Corrective Action

  1. Does the factory have a formal NCR (Non-Conformance Report) system?
  2. What is the average NCR closure time for customer-reported defects?
  3. Can the factory provide a sample 8D (Eight Disciplines) corrective action report?
  4. What was the factory's OQC (Outgoing Quality Control) defect rate in the last 12 months?

B6. Calibration and Measurement System

  1. Are all measurement tools calibrated with current calibration certificates?
  2. What is the calibration frequency for critical measurement equipment?

Section C: Ethical and Social Compliance (14 Questions)

Social and ethical compliance is increasingly required by retail buyers and brand reputation management demands it. This section covers minimum standards aligned with international frameworks (ETI Base Code, SA8000, BSCI).

C1. Working Hours and Compensation

  1. Does the factory comply with legal working hour limits (maximum 49 hours per week per Chinese labour law, with voluntary overtime not exceeding 60 hours)?
  2. Are workers paid at least the local minimum wage for all regular hours?
  3. Is overtime compensated at legally required premium rates (150%/200%/300% of standard rate)?
  4. Do workers receive legally mandated social insurance contributions?

C2. Worker Rights and Environment

  1. Is employment voluntary? Are there signs of forced labour, debt bondage, or retention of identity documents?
  2. Is there a factory-level worker grievance mechanism?
  3. Is child labour prohibited? What is the verified minimum employment age?
  4. Is there a written anti-harassment and anti-discrimination policy?

C3. Health and Safety

  1. Are fire exits clearly marked, unobstructed, and sufficient in number for evacuation?
  2. Is personal protective equipment (PPE) provided and worn for relevant tasks (injection moulding, chemical handling)?
  3. Are chemical hazards (adhesives, cleaners) identified, stored safely, and accompanied by SDS (Safety Data Sheets)?
  4. Is there a written emergency response procedure and evidence of drills?

C4. Environmental Management

  1. Does the factory hold any environmental management certifications (ISO 14001)?
  2. How are plastic waste and silicone offcuts managed (recycled, landfilled, incinerated)?
  3. Does the factory have a wastewater treatment system for any chemical effluent?

Section D: Product-Specific Technical Verification (13 Questions)

This section is specific to adult wellness electrical devices with body-contact materials. Adapt as needed for non-electrical or non-silicone products.

D1. Material Safety

  1. Can the factory provide ISO 10993-5 (cytotoxicity) and ISO 10993-10 (sensitisation) data for the silicone grade used in your product category?
  2. Is the silicone supplier's grade certification (food-grade or medical-grade) on file for the specific compound used?
  3. Are all plastic materials in the product BOM REACH-compliant, with documentation?

D2. Electrical Safety

  1. Does the factory have a CE declaration of conformity covering LVD and EMC directives for products equivalent to yours?
  2. Can the factory provide test reports from accredited laboratories for LVD (EN 62368-1 or equivalent) and EMC (EN 55032) for relevant products?
  3. Does the factory test battery pack performance and safety (overcharge, over-discharge, short circuit) before assembly?

D3. Waterproofing Process

  1. What sealing process does the factory use to achieve IPX7 in silicone-ABS assemblies?
  2. What is the in-process waterproofing test frequency and test method?
  3. Has the factory achieved and documented IPX7 certification for a current or comparable product?

D4. Packaging and Labelling Compliance

  1. Does the factory verify that packaging labelling meets destination market requirements (CE mark placement, warnings, importer contact details)?
  2. Is barcode accuracy verified before shipment (every carton scanned)?
  3. Can the factory produce a certificate of conformance for each shipped batch covering all tested parameters?

Score each question Y/N or N/A. Calculate section percentages and overall score. Share results with the factory and require a corrective action plan for any score below 75% in any section.

Frequently Asked Questions

Can I use this checklist for a remote (video) audit?

Yes, with modification. For a remote audit, request that the factory's QA manager conduct a live video tour following the checklist sequence, with the camera showing the actual areas being discussed. Remote audits cannot replace physical measurement and sample collection but can cover 70–80% of the checklist content. Critical items (material testing, measurement tool calibration) should be verified through documentation requests.

How long does a factory audit take?

A thorough factory audit of a mid-size manufacturing facility (50–300 workers) takes 6–8 hours for an experienced auditor. Third-party audits typically run as a one-day engagement. Self-conducted remote audits via video call typically take 3–4 hours including document review.

What is a passing score on a factory audit?

There is no universal standard. Most third-party audit frameworks score on a 0–100% basis with defined thresholds: 85%+ = Approved; 70–84% = Conditional Approval (must address identified gaps within 60 days); below 70% = Not Approved. Critical failures (child labour, falsified certifications, no functioning quality system) should be automatic disqualifications regardless of overall score.

What is the difference between a factory audit and a pre-shipment inspection?

A factory audit evaluates the management system — the factory's capability to produce correctly next month, next year, and on a reorder you have not placed yet. A pre-shipment inspection evaluates one lot: a sample drawn from your actual order against the approved golden sample, using a published sampling plan such as ANSI/ASQ Z1.4 General Inspection Level II. They answer different questions and should both appear in your supplier plan. An audit before the first purchase order, an inspection before the first payment release.

Who should pay for the audit — me or the factory?

You should pay, and you should control the appointment. A factory-funded audit gives the factory control over scope, timing, and reporting, which turns an independent check into a supplier marketing document. Published 2026 rates for a one-man-day China inspection run from roughly USD 149 at the self-service end to USD 268–419 at the mid tier and USD 400–500+ at the global testing houses. Treat that fee as part of first-order cost of goods, not as an overhead you can negotiate away.

What should I do if the factory fails the audit?

Separate capability gaps from integrity failures. Capability gaps (no SPC, no calibration records, no IPX7 test rig) are fixable with a written corrective action plan and a 60-day re-check. Integrity failures (falsified certificates, undisclosed subcontracting, expired ISO certificate presented as current) are not fixable by the same management team and should end the conversation. Never let a low score be resolved by a discount.

How often should a factory be re-audited?

Every 18–24 months for a stable relationship, and immediately after any of four triggers: a change of production site or ownership, a defect spike on a delivered batch, a new product family that uses processes the original audit did not cover, or a retail customer requesting a current audit report. Audit findings describe a moment; quality systems drift as staff, equipment, and order mix change.

VOVOHO MOQ by service model

Service modelMOQSample lead time
White Label (label/packaging only)50–200 units7–14 days
ODM Private Label (logo, color, packaging)100–500 units7–14 days
App-Connected ODM200–500 units7–14 days
OEM Custom Mold500–1,000+ units30–60 days (mold) + 7–14 days

VOVOHO production lead times

StageTimeline
Sample — existing platform7–14 days
Sample — new custom mold30–60 days (tooling) + 7–14 days
Bulk production25–35 days after sample approval
Total ODM project (brief → shipment)≈ 35–55 days
Total OEM project (brief → shipment)≈ 75–110 days

Data source: VOVOHO · Last updated: · Request a quote

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