{"id":5553,"date":"2026-05-20T02:08:21","date_gmt":"2026-05-20T02:08:21","guid":{"rendered":"https:\/\/relish-tech.com\/?p=5553"},"modified":"2026-10-10T19:22:38","modified_gmt":"2026-10-10T19:22:38","slug":"%d1%87%d0%b5%d0%ba-%d0%bb%d0%b8%d1%81%d1%82-%d0%b0%d1%83%d0%b4%d0%b8%d1%82%d0%b0-%d1%84%d0%b0%d0%b1%d1%80%d0%b8%d0%ba%d0%b8-%d0%b2-%d0%ba%d0%b8%d1%82%d0%b0%d0%b5","status":"publish","type":"post","link":"https:\/\/relish-tech.com\/ru\/china-factory-audit-checklist\/","title":{"rendered":"\u041a\u043e\u043d\u0442\u0440\u043e\u043b\u044c\u043d\u044b\u0439 \u0441\u043f\u0438\u0441\u043e\u043a \u0430\u0443\u0434\u0438\u0442\u0430 \u0444\u0430\u0431\u0440\u0438\u043a\u0438 \u0432 \u041a\u0438\u0442\u0430\u0435: 30-\u043f\u0443\u043d\u043a\u0442\u043e\u0432\u043e\u0435 \u0440\u0443\u043a\u043e\u0432\u043e\u0434\u0441\u0442\u0432\u043e \u0434\u043b\u044f OEM"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-post\" data-elementor-id=\"5553\" class=\"elementor elementor-5553\" 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.mid-cta{padding:32px;gap:20px;min-width:0}\n#relish-factory-audit .mid-cta-text{min-width:0;flex:1 1 260px}\n#relish-factory-audit .mid-cta-text p{font-size:18px;line-height:1.7}\n#relish-factory-audit .mid-cta-btn{min-width:0;max-width:100%;min-height:44px;padding:12px 16px;white-space:normal;font-size:16px;line-height:1.6;color:#fff;text-align:center;display:inline-flex;align-items:center;justify-content:center;text-decoration:none}\n#relish-factory-audit .mid-cta-btn:hover{color:#fff;background:#2d6a4f;text-decoration:none}\n#relish-factory-audit .mid-cta-btn:focus-visible{outline:3px solid #1b4332;outline-offset:4px}\n#relish-factory-audit .tip-box,#relish-factory-audit .moq-box{padding:28px 32px}\n#relish-factory-audit .trust-badge{font-size:14px;min-width:0;max-width:100%}\n#relish-factory-audit .references a{font-size:14px;word-break:normal;overflow-wrap:anywhere}\n#relish-factory-audit .relish-article-illustration{max-width:none!important;width:100%}\n@container(max-width:650px){\n#relish-factory-audit .audit-item{grid-template-columns:24px minmax(0,1fr) 28px;padding:18px;gap:10px}\n#relish-factory-audit .item-num{grid-column:1;grid-row:1}\n#relish-factory-audit .item-desc{grid-column:2 \/ 4;grid-row:1}\n#relish-factory-audit .item-priority{grid-column:2;grid-row:2;text-align:left}\n#relish-factory-audit .item-checkbox{grid-column:3;grid-row:2}\n#relish-factory-audit .audit-category-header{padding:18px}\n#relish-factory-audit .audit-cat-count{flex-basis:100%;margin-left:0}\n}\n@media(max-width:768px){\n#relish-factory-audit .audit-item{font-size:16px;line-height:1.75}\n#relish-factory-audit .mid-cta{flex-direction:column;padding:24px 18px}\n#relish-factory-audit .mid-cta-text{flex:auto;width:100%}\n#relish-factory-audit .mid-cta-text p{font-size:16px;line-height:1.75}\n#relish-factory-audit .mid-cta-btn{width:100%}\n#relish-factory-audit .tip-box,#relish-factory-audit .moq-box{padding:24px 18px}\n}\r\n<\/style>\n<!-- Hero -->\n<section class=\"hero\">\n<div class=\"container\">\n\n<h2>China Factory Audit Checklist: <br\/>30-Point Guide for Oral Care Brands<\/h2>\n<p class=\"hero-lead\">Before placing your first order with a Chinese oral care manufacturer, use this 30-point factory audit checklist to assess certifications, quality systems, capacity and compliance. Built on 15 years of factory experience, it helps you turn supplier claims into practical checks.<\/p>\n<div class=\"hero-meta\">\n<span>ISO 13485 Verification<\/span>\n<span>30 Audit Points<\/span>\n<span>Critical \/ Major \/ Minor Priority<\/span>\n<span>Third-Party Audit Guidance<\/span>\n<\/div>\n<\/div>\n<\/section>\n<!-- Breadcrumb -->\n<div class=\"container\">\n<nav aria-label=\"Breadcrumb\" class=\"breadcrumb\">\n<a href=\"\/\">Home<\/a><span>\u203a<\/span>\n<a href=\"\/news\/\">Blog<\/a><span>\u203a<\/span>\n<span>China Factory Audit Checklist<\/span>\n<\/nav>\n<\/div>\n<div class=\"container\">\n<article>\n\n<div class=\"takeaways\">\n<h3>Key Takeaways<\/h3>\n<ul>\n<li>A factory audit is a <strong>key due-diligence step<\/strong> when sourcing oral care products from China.<\/li>\n<li>This 30-point checklist covers six areas: certifications and legal compliance, quality systems, production capacity, intellectual property, component supply, and labor and environmental practices.<\/li>\n<li>Priority levels: <strong>Critical<\/strong> (resolve before proceeding), Major (agree and verify corrective action), and Minor (follow up as part of improvement).<\/li>\n<li>Use <strong>USD 400\u2013900<\/strong> as an illustrative audit allowance, then obtain a quote for the location, auditor days, technical scope, travel and follow-up work.<\/li>\n<li>Resolve every <strong>Critical<\/strong> finding before proceeding. Use the remaining findings to agree corrective actions and decide whether a pilot order is appropriate.<\/li>\n<li>At Relish, custom orders typically start at <strong>1,000 units<\/strong> with flexibility for the specific order; wholesale orders for available stock start at 50 units. Match the audit scope to your product and sourcing risk.<\/li>\n<\/ul>\n<\/div>\n<!-- P2: trust badges -->\n<div class=\"trust-strip\">\n<div class=\"trust-badge\"><span class=\"badge-icon\">\ud83c\udfed<\/span> 20,000 m\u00b2 Shenzhen Factory<\/div>\n<div class=\"trust-badge\"><span class=\"badge-icon\">\u2705<\/span> ISO 13485 Certified<\/div>\n<div class=\"trust-badge\"><span class=\"badge-icon\">\ud83c\uddfa\ud83c\uddf8<\/span> FDA Registered<\/div>\n<div class=\"trust-badge\"><span class=\"badge-icon\">\ud83c\uddea\ud83c\uddfa<\/span> CE Certified<\/div>\n<div class=\"trust-badge\"><span class=\"badge-icon\">\ud83d\udccb<\/span> Audit-Ready \u2014 Anytime<\/div>\n<\/div>\n<p>A factory audit helps you assess whether a promising supplier can become a dependable manufacturing partner. Reviewing production records, quality controls and relevant documentation before ordering can expose delivery, product-quality, compliance and intellectual-property risks while there is still time to address them.<\/p>\n<p>This checklist focuses on electric toothbrushes, water flossers and related oral care products. Adapt the checks to the product and target market, including applicable FDA requirements, EU product legislation and relevant quality-system standards. Use it during a site visit, a remote screening call or when briefing a third-party auditor.<\/p>\n<!-- P0 Fix: H2 now contains core keyword -->\n<h2>How to Use This China Factory Audit Checklist<\/h2>\n<p>Work through all 30 points and record evidence, findings, owners and due dates. Agree which checks are Critical for your product before the audit; do not let a high overall score conceal an unresolved safety or legal issue.<\/p>\n<ul>\n<li><strong>Critical:<\/strong> A fail on any Critical item is a hard stop \u2014 do not proceed until resolved. These items affect safety, legality, or fundamental quality capability.<\/li>\n<li><strong>Major:<\/strong> Agree corrective actions, owners and deadlines, then verify closure before the relevant production or shipment milestone.<\/li>\n<li><strong>Minor:<\/strong> Record the improvement needed and follow up. Repeated findings or signs of a wider control problem can justify a further audit.<\/li>\n<\/ul>\n<div class=\"score-guide\">\n<div class=\"score-card pass\">\n<div class=\"score-range\">Ready<\/div>\n<div class=\"score-label\">All Critical findings resolved<\/div>\n<div class=\"score-action\">Consider a pilot order after reviewing Major actions<\/div>\n<\/div>\n<div class=\"score-card warn\">\n<div class=\"score-range\">Action needed<\/div>\n<div class=\"score-label\">Corrective actions remain open<\/div>\n<div class=\"score-action\">Agree deadlines and verify closure<\/div>\n<\/div>\n<div class=\"score-card fail\">\n<div class=\"score-range\">Stop<\/div>\n<div class=\"score-label\">Unresolved Critical finding<\/div>\n<div class=\"score-action\">Resolve the issue or choose another supplier<\/div>\n<\/div>\n<\/div>\n<h2>Category 1: Certifications &amp; Legal Compliance<\/h2>\n<p>Check the factory\u2019s legal identity and the certificates or product documents relevant to your target markets. Request complete, legible documents and verify the issuer, validity and scope. For a market-by-market overview, see our <a href=\"\/electric-toothbrush-oem-certifications-guide\/\">Electric Toothbrush Certifications Guide<\/a>.<\/p>\n<div class=\"audit-category\">\n<div class=\"audit-category-header\">\n<span class=\"audit-cat-num\">01\u201306<\/span>\n<span class=\"audit-cat-title\">Certifications &amp; Legal Compliance<\/span>\n<span class=\"audit-cat-count\">6 items<\/span>\n<\/div>\n<div class=\"audit-items\">\n<div class=\"audit-item\">\n<div class=\"item-num\">1<\/div>\n<div class=\"item-desc\">ISO 13485 certificate is valid and covers the relevant site and manufacturing scope.  <div class=\"item-note\">Check the company name, address, certificate number and status in IAF CertSearch at iafcertsearch.org, or with the certification and accreditation bodies. Confirm that accreditation covers the relevant standard.<\/div><\/div>\n<div class=\"item-priority\"><span class=\"priority-critical\">Critical<\/span><\/div>\n<div class=\"item-checkbox\"><span class=\"checkbox\"><\/span><\/div>\n<\/div>\n<div class=\"audit-item\">\n<div class=\"item-num\">2<\/div>\n<div class=\"item-desc\">\n          Business license is current and matches factory name, address, and legal representative\n          <div class=\"item-note\">Request original; verify on China's GSXT enterprise registration portal<\/div>\n<\/div>\n<div class=\"item-priority\"><span class=\"priority-critical\">Critical<\/span><\/div>\n<div class=\"item-checkbox\"><span class=\"checkbox\"><\/span><\/div>\n<\/div>\n<div class=\"audit-item\">\n<div class=\"item-num\">3<\/div>\n<div class=\"item-desc\">EU conformity documentation is available for the relevant product and configuration.  <div class=\"item-note\">Review the Declaration of Conformity, supporting technical documentation and applicable legislation; experience with a similar product does not automatically cover a new model.<\/div><\/div>\n<div class=\"item-priority\"><span class=\"priority-major\">Major<\/span><\/div>\n<div class=\"item-checkbox\"><span class=\"checkbox\"><\/span><\/div>\n<\/div>\n<div class=\"audit-item\">\n<div class=\"item-num\">4<\/div>\n<div class=\"item-desc\">Applicable FDA registration, listing and quality-system obligations have been identified.  <div class=\"item-note\">Verify the legal entity and device classification, and review supporting records. For manufacturers subject to 21 CFR Part 820, the QMSR has applied since February 2, 2026 and incorporates ISO 13485:2016; review the required medical device files and production records.<\/div><\/div>\n<div class=\"item-priority\"><span class=\"priority-major\">Major<\/span><\/div>\n<div class=\"item-checkbox\"><span class=\"checkbox\"><\/span><\/div>\n<\/div>\n<div class=\"audit-item\">\n<div class=\"item-num\">5<\/div>\n<div class=\"item-desc\">Applicable electrical-safety and lithium-battery transport documentation is available.  <div class=\"item-note\">Check model coverage, test standards and laboratory scope, including IEC 60335-1 with IEC 60335-2-52 where appropriate. For lithium batteries, request the applicable UN 38.3 test summary and confirm the shipment route\u2019s transport requirements.<\/div><\/div>\n<div class=\"item-priority\"><span class=\"priority-critical\">Critical<\/span><\/div>\n<div class=\"item-checkbox\"><span class=\"checkbox\"><\/span><\/div>\n<\/div>\n<div class=\"audit-item\">\n<div class=\"item-num\">6<\/div>\n<div class=\"item-desc\">RoHS and REACH evidence is available where applicable.  <div class=\"item-note\">Review material declarations and relevant test reports against the product, substances and current requirements; a safety data sheet alone does not establish full product compliance.<\/div><\/div>\n<div class=\"item-priority\"><span class=\"priority-major\">Major<\/span><\/div>\n<div class=\"item-checkbox\"><span class=\"checkbox\"><\/span><\/div>\n<\/div>\n<\/div>\n<\/div>\n<h2>Category 2: Quality Management Systems<\/h2>\n<p>Beyond holding ISO 13485 on paper, a qualified factory must demonstrate that its <a href=\"https:\/\/relish-tech.com\/electric-toothbrush-quality-control\/\">quality management system<\/a>\n is operational. Ask to see records, not just policies. Factories that can pass this section of a china factory audit checklist consistently are those most likely to maintain quality across long-term production runs.<\/p>\n<div class=\"audit-category\">\n<div class=\"audit-category-header\">\n<span class=\"audit-cat-num\">07\u201314<\/span>\n<span class=\"audit-cat-title\">Quality Management Systems<\/span>\n<span class=\"audit-cat-count\">8 items<\/span>\n<\/div>\n<div class=\"audit-items\">\n<div class=\"audit-item\">\n<div class=\"item-num\">7<\/div>\n<div class=\"item-desc\">Incoming Quality Control (IQC) covers motors, batteries, PCBs and other critical components.  <div class=\"item-note\">Review the inspection criteria, sampling or full-inspection rules, supplier records and recent rejection data. Confirm how the factory responds when incoming parts fail.<\/div><\/div>\n<div class=\"item-priority\"><span class=\"priority-critical\">Critical<\/span><\/div>\n<div class=\"item-checkbox\"><span class=\"checkbox\"><\/span><\/div>\n<\/div>\n<div class=\"audit-item\">\n<div class=\"item-num\">8<\/div>\n<div class=\"item-desc\">In-Process Quality Control (IPQC) checkpoints address the risks at each production stage.  <div class=\"item-note\">Review work instructions, inspection records and responses to deviations. Use SPC or AOI where these methods suit the process.<\/div><\/div>\n<div class=\"item-priority\"><span class=\"priority-critical\">Critical<\/span><\/div>\n<div class=\"item-checkbox\"><span class=\"checkbox\"><\/span><\/div>\n<\/div>\n<div class=\"audit-item\">\n<div class=\"item-num\">9<\/div>\n<div class=\"item-desc\">Outgoing Quality Control (OQC) follows an agreed finished-product test plan.  <div class=\"item-note\">Check functional tests, water-ingress tests, motion or pressure output and battery performance. Distinguish sample qualification tests from routine checks on each unit.<\/div><\/div>\n<div class=\"item-priority\"><span class=\"priority-critical\">Critical<\/span><\/div>\n<div class=\"item-checkbox\"><span class=\"checkbox\"><\/span><\/div>\n<\/div>\n<div class=\"audit-item\">\n<div class=\"item-num\">10<\/div>\n<div class=\"item-desc\">The sampling plan defines defect classes, inspection level, sample size, acceptance and rejection numbers, and any agreed AQL values.  <div class=\"item-note\">Verify records against the selected standard, such as ANSI\/ASQ Z1.4. Specify a zero-acceptance rule for Critical defects and the required safety checks; do not assign them an ordinary 1.5% allowance.<\/div><\/div>\n<div class=\"item-priority\"><span class=\"priority-major\">Major<\/span><\/div>\n<div class=\"item-checkbox\"><span class=\"checkbox\"><\/span><\/div>\n<\/div>\n<div class=\"audit-item\">\n<div class=\"item-num\">11<\/div>\n<div class=\"item-desc\">Defect records use clear definitions and show the number of inspected units, failures and customer returns over the review period.  <div class=\"item-note\">Compare like-for-like products and inspection stages, and examine trends and corrective actions rather than relying on an undefined industry benchmark.<\/div><\/div>\n<div class=\"item-priority\"><span class=\"priority-major\">Major<\/span><\/div>\n<div class=\"item-checkbox\"><span class=\"checkbox\"><\/span><\/div>\n<\/div>\n<div class=\"audit-item\">\n<div class=\"item-num\">12<\/div>\n<div class=\"item-desc\">\n          Non-conforming product quarantine area clearly marked and segregated\n          <div class=\"item-note\">Rejected goods must never re-enter production flow without documented approval<\/div>\n<\/div>\n<div class=\"item-priority\"><span class=\"priority-major\">Major<\/span><\/div>\n<div class=\"item-checkbox\"><span class=\"checkbox\"><\/span><\/div>\n<\/div>\n<div class=\"audit-item\">\n<div class=\"item-num\">13<\/div>\n<div class=\"item-desc\">\n          Corrective Action \/ Preventive Action (CAPA) system with documented resolution records\n          <div class=\"item-note\">Ask for 2\u20133 examples of CAPA cycles \u2014 quality improvement process maturity<\/div>\n<\/div>\n<div class=\"item-priority\"><span class=\"priority-major\">Major<\/span><\/div>\n<div class=\"item-checkbox\"><span class=\"checkbox\"><\/span><\/div>\n<\/div>\n<div class=\"audit-item\">\n<div class=\"item-num\">14<\/div>\n<div class=\"item-desc\">Batch records link incoming materials, production, finished goods and shipments.  <div class=\"item-note\">Trace a sample batch through the records and review complaint or recall procedures. For regulated medical devices, check the applicable ISO 13485 and FDA QMSR record requirements.<\/div><\/div>\n<div class=\"item-priority\"><span class=\"priority-critical\">Critical<\/span><\/div>\n<div class=\"item-checkbox\"><span class=\"checkbox\"><\/span><\/div>\n<\/div>\n<\/div>\n<\/div>\n<!-- P1 Fix: Mid-article CTA inserted here -->\n<figure class=\"relish-article-illustration\" data-concept=\"01-batch-traceability\" style=\"margin:28px auto;width:100%;max-width:960px;\"><img loading=\"lazy\" alt=\"Concept diagram showing batch traceability from components through production and finished goods to shipment.\" class=\"wp-image-7844\" decoding=\"async\" height=\"1024\" loading=\"lazy\" src=\"https:\/\/relish-tech.com\/wp-content\/uploads\/2026\/09\/oral-care-factory-audit-batch-traceability.webp\" style=\"display:block;width:100%;max-width:100%;height:auto;object-fit:contain;\" width=\"1536\" srcset=\"https:\/\/relish-tech.com\/wp-content\/uploads\/2026\/09\/oral-care-factory-audit-batch-traceability.webp 1536w, https:\/\/relish-tech.com\/wp-content\/uploads\/2026\/09\/oral-care-factory-audit-batch-traceability-300x200.webp 300w, https:\/\/relish-tech.com\/wp-content\/uploads\/2026\/09\/oral-care-factory-audit-batch-traceability-1024x683.webp 1024w, https:\/\/relish-tech.com\/wp-content\/uploads\/2026\/09\/oral-care-factory-audit-batch-traceability-768x512.webp 768w, https:\/\/relish-tech.com\/wp-content\/uploads\/2026\/09\/oral-care-factory-audit-batch-traceability-18x12.webp 18w\" sizes=\"auto, (max-width: 1536px) 100vw, 1536px\" \/><figcaption style=\"margin-top:10px;font-size:14px;line-height:1.5;text-align:center;\">Follow batch records from incoming components through production and finished goods to shipment. Concept illustration; B-001 is an illustrative batch identifier.<\/figcaption><\/figure><div class=\"mid-cta\">\n<div class=\"mid-cta-text\">\n<h3>Audit Relish Technology Before You Commit<\/h3>\n<p>ISO 13485 certified \u00b7 &lt;0.3% defect rate \u00b7 FDA registered \u00b7 CE certified \u00b7 Audit-ready on short notice. Request our factory documentation package today.<\/p>\n<\/div>\n<a class=\"mid-cta-btn\" href=\"\/contact\/\">Request Audit Docs \u2192<\/a>\n<\/div>\n<h2>Category 3: Production Capacity &amp; Capability<\/h2>\n<p>Verify the factory can actually deliver your volume, on your timeline, with the technology your product requires. This section is particularly important when evaluating factories against your MOQ requirements \u2014 capacity claims without evidence are one of the most common issues found during a china factory audit.<\/p>\n<!-- P1 Fix: MOQ content added -->\n<div class=\"moq-box\"><strong>MOQ and tooling:<\/strong> Relish custom orders typically start at <strong>1,000 units<\/strong>, with flexibility for the specific order; wholesale orders for available stock start at 50 units. Confirm the MOQ basis for each SKU, color, pack or set. Quote tooling separately, identify its ownership, and clarify which packaging, accessories, firmware and testing are included.<\/div>\n<div class=\"audit-category\">\n<div class=\"audit-category-header\">\n<span class=\"audit-cat-num\">15\u201320<\/span>\n<span class=\"audit-cat-title\">Production Capacity &amp; Capability<\/span>\n<span class=\"audit-cat-count\">6 items<\/span>\n<\/div>\n<div class=\"audit-items\">\n<div class=\"audit-item\">\n<div class=\"item-num\">15<\/div>\n<div class=\"item-desc\">Monthly capacity is supported by production and shipment records.  <div class=\"item-note\">Cross-check machine availability, staffing, shifts, utilization and existing orders, then confirm capacity for your product and delivery window.<\/div><\/div>\n<div class=\"item-priority\"><span class=\"priority-critical\">Critical<\/span><\/div>\n<div class=\"item-checkbox\"><span class=\"checkbox\"><\/span><\/div>\n<\/div>\n<div class=\"audit-item\">\n<div class=\"item-num\">16<\/div>\n<div class=\"item-desc\">Equipment can verify the agreed toothbrush motion specification.  <div class=\"item-note\">Confirm the measurement method, load condition and distinction between motor frequency, brush-head movement and marketing strokes per minute. Check calibration records or the qualified external testing arrangement.<\/div><\/div>\n<div class=\"item-priority\"><span class=\"priority-critical\">Critical<\/span><\/div>\n<div class=\"item-checkbox\"><span class=\"checkbox\"><\/span><\/div>\n<\/div>\n<div class=\"audit-item\">\n<div class=\"item-num\">17<\/div>\n<div class=\"item-desc\">Water-ingress testing matches the claimed IP rating and the agreed quality plan.  <div class=\"item-note\">IPX5 water-jet testing and IPX7 temporary-immersion testing are different. Review the applicable IEC 60529 method, test conditions, equipment and records; agree appropriate routine leak checks separately.<\/div><\/div>\n<div class=\"item-priority\"><span class=\"priority-critical\">Critical<\/span><\/div>\n<div class=\"item-checkbox\"><span class=\"checkbox\"><\/span><\/div>\n<\/div>\n<div class=\"audit-item\">\n<div class=\"item-num\">18<\/div>\n<div class=\"item-desc\">Injection molding is performed in-house or by a qualified, documented partner.  <div class=\"item-note\">Review tooling control, dimensional inspection, change approval and delivery arrangements across both sites.<\/div><\/div>\n<div class=\"item-priority\"><span class=\"priority-major\">Major<\/span><\/div>\n<div class=\"item-checkbox\"><span class=\"checkbox\"><\/span><\/div>\n<\/div>\n<div class=\"audit-item\">\n<div class=\"item-num\">19<\/div>\n<div class=\"item-desc\">The R&amp;D team and sample facilities support the required development work.  <div class=\"item-note\">Review relevant staff experience, prototype records and agreed sample lead times; assess capability against your project rather than a fixed engineer headcount.<\/div><\/div>\n<div class=\"item-priority\"><span class=\"priority-major\">Major<\/span><\/div>\n<div class=\"item-checkbox\"><span class=\"checkbox\"><\/span><\/div>\n<\/div>\n<div class=\"audit-item\">\n<div class=\"item-num\">20<\/div>\n<div class=\"item-desc\">The supplier can provide relevant customer references with the customers\u2019 permission.  <div class=\"item-note\">Where available, contact two or three references to discuss comparable products, quality, communication and delivery performance.<\/div><\/div>\n<div class=\"item-priority\"><span class=\"priority-major\">Major<\/span><\/div>\n<div class=\"item-checkbox\"><span class=\"checkbox\"><\/span><\/div>\n<\/div>\n<\/div>\n<\/div>\n<figure class=\"relish-article-illustration\" data-concept=\"02-on-site-capacity-audit\" style=\"margin:28px auto;width:100%;max-width:960px;\"><img loading=\"lazy\" alt=\"Concept illustration of an on-site electric toothbrush factory audit, reviewing assembly equipment and production schedules.\" class=\"wp-image-7845\" decoding=\"async\" height=\"1024\" loading=\"lazy\" src=\"https:\/\/relish-tech.com\/wp-content\/uploads\/2026\/09\/electric-toothbrush-factory-on-site-capacity-audit.webp\" style=\"display:block;width:100%;max-width:100%;height:auto;object-fit:contain;\" width=\"1536\" srcset=\"https:\/\/relish-tech.com\/wp-content\/uploads\/2026\/09\/electric-toothbrush-factory-on-site-capacity-audit.webp 1536w, https:\/\/relish-tech.com\/wp-content\/uploads\/2026\/09\/electric-toothbrush-factory-on-site-capacity-audit-300x200.webp 300w, https:\/\/relish-tech.com\/wp-content\/uploads\/2026\/09\/electric-toothbrush-factory-on-site-capacity-audit-1024x683.webp 1024w, https:\/\/relish-tech.com\/wp-content\/uploads\/2026\/09\/electric-toothbrush-factory-on-site-capacity-audit-768x512.webp 768w, https:\/\/relish-tech.com\/wp-content\/uploads\/2026\/09\/electric-toothbrush-factory-on-site-capacity-audit-18x12.webp 18w\" sizes=\"auto, (max-width: 1536px) 100vw, 1536px\" \/><figcaption style=\"margin-top:10px;font-size:14px;line-height:1.5;text-align:center;\">Compare observed equipment and production activity with the factory's capacity records. Concept illustration.<\/figcaption><\/figure>\n<h2>Category 4: IP &amp; Confidentiality<\/h2>\n<p>When your project involves proprietary designs, review intellectual-property and confidentiality arrangements before sharing detailed files. Put the agreed obligations, permitted use, access controls and tooling rights in writing. Our <a href=\"\/nnn-agreement-china\/\">NNN Agreement guide<\/a> provides a starting point for reviewing these issues.<\/p>\n<div class=\"audit-category\">\n<div class=\"audit-category-header\">\n<span class=\"audit-cat-num\">21\u201324<\/span>\n<span class=\"audit-cat-title\">IP &amp; Confidentiality<\/span>\n<span class=\"audit-cat-count\">4 items<\/span>\n<\/div>\n<div class=\"audit-items\">\n<div class=\"audit-item\">\n<div class=\"item-num\">21<\/div>\n<div class=\"item-desc\">A suitable NNN or confidentiality agreement is signed before proprietary information is shared.  <div class=\"item-note\">Confirm the legal parties, permitted use, disclosure controls, non-circumvention terms and applicable law. Resolve material disagreements before releasing sensitive designs.<\/div><\/div>\n<div class=\"item-priority\"><span class=\"priority-critical\">Critical<\/span><\/div>\n<div class=\"item-checkbox\"><span class=\"checkbox\"><\/span><\/div>\n<\/div>\n<div class=\"audit-item\">\n<div class=\"item-num\">22<\/div>\n<div class=\"item-desc\">The contract clearly states who owns custom tooling and who may use it.  <div class=\"item-note\">Identify each mold, the payment and acceptance conditions, storage and maintenance duties, and transfer rights. Verify these terms rather than assuming ownership follows from who paid for the mold.<\/div><\/div>\n<div class=\"item-priority\"><span class=\"priority-critical\">Critical<\/span><\/div>\n<div class=\"item-checkbox\"><span class=\"checkbox\"><\/span><\/div>\n<\/div>\n<div class=\"audit-item\">\n<div class=\"item-num\">23<\/div>\n<div class=\"item-desc\">\n          IT security: CAD files and product specs stored on restricted internal systems (not personal WeChat\/email)\n          <div class=\"item-note\">Ask about document management policies; factory staff using personal phones for file transfer is a red flag<\/div>\n<\/div>\n<div class=\"item-priority\"><span class=\"priority-major\">Major<\/span><\/div>\n<div class=\"item-checkbox\"><span class=\"checkbox\"><\/span><\/div>\n<\/div>\n<div class=\"audit-item\">\n<div class=\"item-num\">24<\/div>\n<div class=\"item-desc\">Any promised exclusivity is defined and followed.  <div class=\"item-note\">Distinguish shared ODM designs from buyer-owned designs, and review the agreed product, territory and duration. Similar-looking standard products alone do not prove a breach of a buyer\u2019s rights.<\/div><\/div>\n<div class=\"item-priority\"><span class=\"priority-major\">Major<\/span><\/div>\n<div class=\"item-checkbox\"><span class=\"checkbox\"><\/span><\/div>\n<\/div>\n<\/div>\n<\/div>\n<h2>Category 5: Supply Chain &amp; Component Quality<\/h2>\n<!-- P2: Category 5 intro paragraph added -->\n<p>Motors, batteries, PCBs and brush materials deserve particular attention in oral care products. Review the Approved Vendor List and qualification records for the components that affect your design. Check supplier approval, traceability and change control. Our <a href=\"\/sonic-vs-oscillating-rotating-electric-toothbrush\/\">Sonic vs. Oscillating-Rotating Technology guide<\/a> compares relevant component considerations.<\/p>\n<div class=\"audit-category\">\n<div class=\"audit-category-header\">\n<span class=\"audit-cat-num\">25\u201328<\/span>\n<span class=\"audit-cat-title\">Supply Chain &amp; Component Quality<\/span>\n<span class=\"audit-cat-count\">4 items<\/span>\n<\/div>\n<div class=\"audit-items\">\n<div class=\"audit-item\">\n<div class=\"item-num\">25<\/div>\n<div class=\"item-desc\">An Approved Vendor List (AVL) identifies qualified suppliers and the approval criteria for key components.  <div class=\"item-note\">Check how suppliers and substitute parts are assessed, approved and traced to production batches.<\/div><\/div>\n<div class=\"item-priority\"><span class=\"priority-critical\">Critical<\/span><\/div>\n<div class=\"item-checkbox\"><span class=\"checkbox\"><\/span><\/div>\n<\/div>\n<div class=\"audit-item\">\n<div class=\"item-num\">26<\/div>\n<div class=\"item-desc\">Continuity plans address critical components with a single source.  <div class=\"item-note\">Review stock, lead times, approved alternatives and the requalification needed before substitution; a second supplier is useful only if its parts meet the agreed requirements.<\/div><\/div>\n<div class=\"item-priority\"><span class=\"priority-major\">Major<\/span><\/div>\n<div class=\"item-checkbox\"><span class=\"checkbox\"><\/span><\/div>\n<\/div>\n<div class=\"audit-item\">\n<div class=\"item-num\">27<\/div>\n<div class=\"item-desc\">Battery records identify the cell or pack manufacturer, model and specification.  <div class=\"item-note\">Review applicable safety evidence, such as IEC 62133-2 reports where relevant, and the UN 38.3 transport test summary. Confirm that the documents cover the battery actually used in the product.<\/div><\/div>\n<div class=\"item-priority\"><span class=\"priority-critical\">Critical<\/span><\/div>\n<div class=\"item-checkbox\"><span class=\"checkbox\"><\/span><\/div>\n<\/div>\n<div class=\"audit-item\">\n<div class=\"item-num\">28<\/div>\n<div class=\"item-desc\">Brush filament specifications identify the material, supplier and agreed performance requirements.  <div class=\"item-note\">Review relevant safety evidence, tuft retention and filament-tip quality for the product design. Verify any material or recycled-content claim rather than treating a brand name or \u201cfood-grade\u201d label as complete proof of compliance.<\/div><\/div>\n<div class=\"item-priority\"><span class=\"priority-critical\">Critical<\/span><\/div>\n<div class=\"item-checkbox\"><span class=\"checkbox\"><\/span><\/div>\n<\/div>\n<\/div>\n<\/div>\n<h2>Category 6: Labor, Social &amp; Environmental Compliance<\/h2>\n<!-- P2: Category 6 intro paragraph added -->\n<p>Review labor and environmental practices against local law, customer requirements and any applicable due-diligence obligations. The EU CSDDD has a defined scope and application timetable; it does not make one social-audit certificate a universal requirement for all oral care brands. Buyer requirements can extend to suppliers through their sourcing programs.<\/p>\n<div class=\"audit-category\">\n<div class=\"audit-category-header\">\n<span class=\"audit-cat-num\">29\u201330<\/span>\n<span class=\"audit-cat-title\">Labor, Social &amp; Environmental Compliance<\/span>\n<span class=\"audit-cat-count\">2 items<\/span>\n<\/div>\n<div class=\"audit-items\">\n<div class=\"audit-item\">\n<div class=\"item-num\">29<\/div>\n<div class=\"item-desc\">Current social-compliance evidence matches the buyer\u2019s requirements.  <div class=\"item-note\">Distinguish an SA8000 certificate from an amfori BSCI or Sedex SMETA audit report. Review the site, date, findings and corrective actions, then agree the appropriate follow-up interval.<\/div><\/div>\n<div class=\"item-priority\"><span class=\"priority-major\">Major<\/span><\/div>\n<div class=\"item-checkbox\"><span class=\"checkbox\"><\/span><\/div>\n<\/div>\n<div class=\"audit-item\">\n<div class=\"item-num\">30<\/div>\n<div class=\"item-desc\">Environmental controls cover permits, waste handling, chemical inventories and applicable restricted substances.  <div class=\"item-note\">Review actual records and corrective actions against local requirements and the relevant product or buyer obligations.<\/div><\/div>\n<div class=\"item-priority\"><span class=\"priority-minor\">Minor<\/span><\/div>\n<div class=\"item-checkbox\"><span class=\"checkbox\"><\/span><\/div>\n<\/div>\n<\/div>\n<\/div>\n<h2>Third-Party Audit Options: Cost &amp; Scope Comparison<\/h2>\n<p>If you cannot visit the factory or need independent technical assessment, compare qualified third-party auditors. Agree the scope, relevant oral care experience, report format and follow-up arrangements. Our <a href=\"\/sourcing-oral-care-from-china\/\">Sourcing Oral Care from China Guide<\/a> explains how supplier audits fit into the sourcing process.<\/p>\n<div class=\"audit-options\">\n<div class=\"audit-option\">\n<div class=\"option-name\">SGS<\/div>\n<div class=\"option-cost\">Illustrative allowance: USD 500\u2013900<\/div>\n<div class=\"option-detail\">Ask SGS to quote the relevant factory-audit scope, technical checks and written report.<\/div>\n<\/div>\n<div class=\"audit-option\">\n<div class=\"option-name\">Bureau Veritas<\/div>\n<div class=\"option-cost\">Illustrative allowance: USD 450\u2013800<\/div>\n<div class=\"option-detail\">Ask Bureau Veritas about the auditor\u2019s relevant product and quality-system experience, scope and report schedule.<\/div>\n<\/div>\n<div class=\"audit-option\">\n<div class=\"option-name\">Intertek<\/div>\n<div class=\"option-cost\">Illustrative allowance: USD 400\u2013750<\/div>\n<div class=\"option-detail\">Ask Intertek to confirm local auditor availability, relevant technical expertise and the scope included in its quote.<\/div>\n<\/div>\n<div class=\"audit-option\">\n<div class=\"option-name\">QIMA<\/div>\n<div class=\"option-cost\">Illustrative allowance: USD 299\u2013500<\/div>\n<div class=\"option-detail\">Ask QIMA to confirm the audit scope, booking availability, report format and any travel or follow-up charges.<\/div>\n<\/div>\n<\/div>\n<div class=\"tip-box\"><strong>Relish Technology tip:<\/strong> Send your product specification and this 30-point checklist to the auditor in advance. Ask for evidence and findings on the relevant oral care checks, including water-ingress testing, battery documentation and brush-material quality.<\/div>\n<div class=\"warning-box\"><strong>Warning sign:<\/strong> A supplier that refuses reasonable independent audit access needs further investigation. Clarify the reason, confidentiality rules and scheduling constraints. If access or essential evidence remains unavailable, resolve that gap before committing to the order.<\/div>\n<!-- P1 Fix: additional internal links to C4 and OEM quality control guide -->\n<p>For a complete framework on working with Chinese oral care manufacturers, start with our <a href=\"\/sourcing-oral-care-from-china\/\">Sourcing Oral Care from China Guide<\/a>. For IP-specific protection after the audit, see our <a href=\"\/nnn-agreement-china\/\">NNN Agreement guide<\/a>. If you're also evaluating which technology platform to manufacture \u2014 sonic versus oscillating-rotating \u2014 our <a href=\"\/sonic-vs-oscillating-rotating-electric-toothbrush\/\">OEM Technology Comparison<\/a> covers motor selection, BOM cost, and certification implications. For ongoing quality control after the factory audit, see our <a href=\"\/electric-toothbrush-quality-control\/\">OEM Quality Control Guide<\/a>.<\/p>\n<!-- FAQ \u2014 P2 Fix: expanded to 8 items -->\n<section class=\"faq-section\">\n<h2>Frequently Asked Questions About China Factory Audits<\/h2>\n<div class=\"faq-item\">\n<div class=\"faq-q\">What is a China factory audit and why is it important?<\/div>\n<div class=\"faq-a\">A China factory audit reviews a manufacturer\u2019s facilities, quality systems, relevant documents, capacity and working practices. For oral care brands, it helps assess whether the supplier can meet the agreed product, delivery and compliance requirements. Record the findings and verify corrective actions before making the sourcing decision.<\/div>\n<\/div>\n<div class=\"faq-item\">\n<div class=\"faq-q\">How much does a China factory audit cost?<\/div>\n<div class=\"faq-a\">The figures in this guide are illustrative allowances, ranging from USD 299 to USD 900 across the listed providers. Obtain a current quote for the site, auditor days, technical scope, travel and follow-up work. Set the audit budget according to the product and supplier risk rather than assuming a fixed order value guarantees a return.<\/div>\n<\/div>\n<div class=\"faq-item\">\n<div class=\"faq-q\">What certifications should an oral care manufacturer in China have?<\/div>\n<div class=\"faq-a\">Choose requirements according to the product and market. ISO 13485 can be relevant to medical-device quality systems; applicable FDA registration, listing and QMSR obligations must be checked separately. For electrical oral care products, review the relevant EU conformity documents, electrical-safety reports, lithium-battery transport evidence and RoHS\/REACH records. Confirm exact model and site coverage.<\/div>\n<\/div>\n<div class=\"faq-item\">\n<div class=\"faq-q\">Can I audit a China factory remotely?<\/div>\n<div class=\"faq-a\">Yes. A remote video audit can help with initial screening, document review and follow-up. Plan the areas and records to review and note what cannot be independently observed. Use an on-site audit when product risk, order scope or unresolved findings require direct verification.<\/div>\n<\/div>\n<div class=\"faq-item\">\n<div class=\"faq-q\">What is the difference between a factory audit and a pre-shipment inspection?<\/div>\n<div class=\"faq-a\">A factory audit evaluates the supplier\u2019s capability and systems. A pre-shipment inspection checks a particular order against agreed specifications, samples and acceptance criteria when the goods are ready for the agreed inspection stage. They address different questions and can be combined in the quality plan.<\/div>\n<\/div>\n<div class=\"faq-item\">\n<div class=\"faq-q\">What is an AQL inspection and what level should I use?<\/div>\n<div class=\"faq-a\">AQL means Acceptance Quality Limit in ANSI\/ASQ Z1.4. A sampling plan also requires the lot size, inspection level, defect classification and acceptance\/rejection numbers. Agree these before inspection. Use a zero-acceptance rule and appropriate safety tests for Critical defects; set Major and Minor criteria for the product and risk. An AQL value is not a guaranteed defect rate or the number of defects allowed in every sample.<\/div>\n<\/div>\n<div class=\"faq-item\">\n<div class=\"faq-q\">What is the typical MOQ for Chinese oral care OEM manufacturers?<\/div>\n<div class=\"faq-a\">Relish custom orders typically start at 1,000 units, with flexibility for the specific order; wholesale orders for available stock start at 50 units. Confirm whether the quantity applies to each SKU, color, pack or set, and obtain separate tooling and customization quotes where needed. Use these details to plan the audit and first order.<\/div>\n<\/div>\n<div class=\"faq-item\">\n<div class=\"faq-q\">How do I verify a factory's ISO 13485 certificate is genuine?<\/div>\n<div class=\"faq-a\">Search IAF CertSearch at iafcertsearch.org by company name or certificate number where the record is available. Check status, legal entity, site, standard and scope, then verify the certification body\u2019s relevant accreditation. If a record is absent or unclear, contact the issuer and accreditation body directly before drawing a conclusion.<\/div>\n<\/div>\n<\/section>\n<!-- CTA -->\n<section class=\"cta-section\">\n<h2>Ready to Audit Relish Technology's Factory?<\/h2>\n<p>We welcome audits \u2014 by you or any accredited third party. ISO 13485 certified, &lt;0.3% defect rate, FDA registered, CE certified, 15 years of OEM experience. Request an audit invitation today.<\/p>\n<a class=\"cta-btn\" href=\"\/contact\/\">Request Factory Audit Invitation \u2192<\/a>\n<\/section>\n<!-- Related \u2014 P1 Fix: 7 internal links now (was 5) -->\n<div class=\"related\">\n<h3>Related Resources<\/h3>\n<div class=\"related-grid\">\n<a class=\"related-link\" href=\"\/sourcing-oral-care-from-china\/\">Sourcing Oral Care from China Guide<\/a>\n<a class=\"related-link\" href=\"\/nnn-agreement-china\/\">NNN Agreement &amp; IP Protection<\/a>\n<a class=\"related-link\" href=\"\/electric-toothbrush-quality-control\/\">OEM Quality Control Guide<\/a>\n<a class=\"related-link\" href=\"\/china-supply-chain-risks\/\">China Supply Chain Risks<\/a>\n<a class=\"related-link\" href=\"\/sonic-vs-oscillating-rotating-electric-toothbrush\/\">Sonic vs. Oscillating-Rotating OEM Guide<\/a>\n<a class=\"related-link\" href=\"\/electric-toothbrush-oem-certifications-guide\/\">Electric Toothbrush Certifications Guide<\/a>\n<a class=\"related-link\" href=\"\/certifications\/\">Relish Certifications &amp; Audit Records<\/a>\n<\/div>\n<\/div>\n<!-- References \u2014 APA style with inline clickable URLs -->\n<div class=\"references\">\n<h3>References<\/h3>\n<ol>\n<li>International Organization for Standardization. (2016). <em>ISO 13485:2016 \u2014 Medical devices \u2014 Quality management systems \u2014 Requirements for regulatory purposes.<\/em> ISO. Retrieved from <a href=\"https:\/\/www.iso.org\/standard\/59752.html\" rel=\"noopener\" target=\"_blank\">https:\/\/www.iso.org\/standard\/59752.html<\/a>.<\/li>\n<li>American Society for Quality. <em>ANSI\/ASQ Z1.4 and Z1.9: acceptance sampling systems and Acceptance Quality Limit (AQL).<\/em> Source: <a href=\"https:\/\/asq.org\/quality-resources\/z14-z19\" rel=\"noopener\" target=\"_blank\">https:\/\/asq.org\/quality-resources\/z14-z19<\/a><\/li>\n<li>Sedex. <em>SMETA: social-audit methodology, site assessment and corrective action planning.<\/em> Source: <a href=\"https:\/\/www.sedex.com\/solutions\/smeta.audit\/\" rel=\"noopener\" target=\"_blank\">https:\/\/www.sedex.com\/solutions\/smeta.audit\/<\/a><\/li>\n<li>International Electrotechnical Commission. <em>IEC 60335-2-52:2021: safety requirements for electric oral hygiene appliances, used with the relevant Part 1 requirements.<\/em> Source: <a href=\"https:\/\/webstore.iec.ch\/en\/publication\/67807\" rel=\"noopener\" target=\"_blank\">https:\/\/webstore.iec.ch\/en\/publication\/67807<\/a><\/li>\n<li>European Commission. <em>Corporate sustainability due diligence: current scope and application timetable.<\/em> Source: <a href=\"https:\/\/commission.europa.eu\/topics\/business-and-industry\/company-law-and-corporate-governance\/corporate-sustainability-due-diligence_en\" rel=\"noopener\" target=\"_blank\">https:\/\/commission.europa.eu\/topics\/business-and-industry\/company-law-and-corporate-governance\/corporate-sustainability-due-diligence_en<\/a><\/li>\n<li>United Nations Economic Commission for Europe. <em>UN Manual of Tests and Criteria, Rev.8 (2023) and Amendment 1 (2025), including subsection 38.3 on lithium cells and batteries.<\/em> Source: <a href=\"https:\/\/unece.org\/transport\/dangerous-goods\/rev8-files\" rel=\"noopener\" target=\"_blank\">https:\/\/unece.org\/transport\/dangerous-goods\/rev8-files<\/a><\/li>\n<li>U.S. <em>Food and Drug Administration. Quality Management System Regulation (QMSR), effective February 2, 2026.<\/em> Source: <a href=\"https:\/\/www.fda.gov\/medical-devices\/postmarket-requirements-devices\/quality-management-system-regulation-qmsr\" rel=\"noopener\" target=\"_blank\">https:\/\/www.fda.gov\/medical-devices\/postmarket-requirements-devices\/quality-management-system-regulation-qmsr<\/a><\/li>\n<li>IAF CertSearch. <em>Certificate validation and search guidance.<\/em> Source: <a href=\"https:\/\/support.iafcertsearch.org\/verifiers\/search\" rel=\"noopener\" target=\"_blank\">https:\/\/support.iafcertsearch.org\/verifiers\/search<\/a><\/li>\n<\/ol>\n<\/div>\n<\/article>\n<\/div><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>China Factory Audit Checklist: 30-Point Guide for Oral Care Brands Before placing your first order with a Chinese oral care [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":7845,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[71],"tags":[],"class_list":["post-5553","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-quality-compliance"],"_links":{"self":[{"href":"https:\/\/relish-tech.com\/ru\/wp-json\/wp\/v2\/posts\/5553","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/relish-tech.com\/ru\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/relish-tech.com\/ru\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/relish-tech.com\/ru\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/relish-tech.com\/ru\/wp-json\/wp\/v2\/comments?post=5553"}],"version-history":[{"count":27,"href":"https:\/\/relish-tech.com\/ru\/wp-json\/wp\/v2\/posts\/5553\/revisions"}],"predecessor-version":[{"id":8436,"href":"https:\/\/relish-tech.com\/ru\/wp-json\/wp\/v2\/posts\/5553\/revisions\/8436"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/relish-tech.com\/ru\/wp-json\/wp\/v2\/media\/7845"}],"wp:attachment":[{"href":"https:\/\/relish-tech.com\/ru\/wp-json\/wp\/v2\/media?parent=5553"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/relish-tech.com\/ru\/wp-json\/wp\/v2\/categories?post=5553"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/relish-tech.com\/ru\/wp-json\/wp\/v2\/tags?post=5553"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}