| Legal Business Qualification | Current business license, registered business scope, legal address, and authorized sales contact. | The registered scope should cover chemical manufacturing, distribution, laboratory reagents, or the specific products being supplied. | Check official Chinese enterprise-registration records and match the legal entity across contracts, invoices, certificates, and bank details. | Different legal entities appear on quotations, certificates, and contracts. |
| Product-Specific Regulatory Permits | Applicable production, storage, transport, or hazardous-chemical permits; safety-management documents where required. | All permits must be valid, issued to the supplying legal entity, and applicable to the product category and facility location. | Confirm permit numbers, validity dates, product categories, and issuing authorities; request a facility or third-party compliance review. | The supplier provides only an expired permit, a generic certificate, or a document issued to another entity. |
| Quality Management System | Quality manual, organization chart, document-control procedure, deviation records, CAPA procedure, and internal-audit summary. | A documented, implemented quality system with controlled procedures, training records, complaint handling, and corrective-action tracking. | Review a current ISO 9001 certificate when applicable and audit several controlled records rather than relying on the certificate alone. | The supplier cannot explain batch release, deviation handling, or change-control procedures. |
| Laboratory Competence | Laboratory equipment list, calibration records, analytical methods, analyst training records, and test reports. | Critical instruments should be calibrated or verified at defined intervals; test methods should identify standards, instruments, and acceptance criteria. | Check calibration certificates, method-validation or verification summaries, raw-data availability, and laboratory procedures. ISO/IEC 17025 accreditation may be relevant for testing services. | Only a template certificate of analysis is supplied, with no test method, instrument information, or raw-data support. |
| Product Specification and Purity | Product specification, certificate of analysis, impurity profile, moisture or residue limits, appearance criteria, and shelf-life information. | The specification must define measurable limits, test methods, units, batch number, manufacturing date, retest or expiry date, and authorized approval. | Compare three recent batch records with retained samples or independent laboratory results, especially for critical impurities and water content. | Every batch shows identical results with excessive rounding or lacks a traceable batch number. |
| Production Capacity | Production-line list, equipment capacities, annual output by product, normal batch size, lead time, and recent capacity-utilization data. | Available capacity should cover forecast demand with contingency for maintenance, quality holds, and seasonal fluctuations; capacity figures should be product-specific. | Conduct a site audit, review production schedules and batch records, and request evidence of recent deliveries at comparable volumes. | The supplier quotes a large capacity but cannot identify equipment, batch size, or recent production evidence. |
| Batch Consistency | Results from multiple consecutive batches, process-control records, out-of-specification investigations, and stability data where applicable. | Consecutive batches should meet the agreed specification without unexplained changes in purity, color, particle size, or other critical attributes. | Compare historical certificates, trend charts, retain-sample results, and customer complaint records over at least several production cycles. | Large unexplained variation occurs between batches or the supplier refuses to provide historical quality trends. |
| Raw-Material Traceability | Approved-vendor list, incoming inspection records, raw-material lot numbers, manufacturing batch records, and finished-product release records. | Each finished-product batch should be traceable back to critical raw-material lots and forward to shipment records. | Select a finished-product batch and perform a backward-and-forward traceability exercise during the audit. | Raw-material sources, lot numbers, or production records cannot be linked to the final batch. |
| Safety Data and Packaging | Current Safety Data Sheet, transport classification, label artwork, packaging specification, and compatibility information. | SDS content should follow the requirements of the destination market; packaging must be compatible, sealed, labeled, and suitable for transport conditions. | Review SDS revision date, hazard classification, UN transport information where applicable, label language, and packaging test or inspection records. | The SDS is outdated, missing hazard information, or inconsistent with the product label and COA. |
| Export and Destination-Market Compliance | Export experience, customs documents, product registration or notification records where required, and destination-specific compliance support. | The supplier should understand the buyer’s destination requirements for labeling, SDS, customs classification, restricted substances, and import documentation. | Review redacted shipping documents and confirm requirements with the importer, customs broker, or competent authority before purchase. | The supplier promises compliance without asking for the destination country or intended use. |
| Environmental and Safety Performance | Environmental permits, emissions or wastewater records where applicable, occupational-safety procedures, emergency plans, and incident history. | The facility should have legally required environmental and safety controls, documented training, emergency equipment, and incident-correction procedures. | Review permits and audit records; verify site conditions, chemical storage, spill controls, ventilation, and emergency signage during an inspection. | Poor chemical segregation, missing secondary containment, blocked emergency exits, or incomplete safety records. |
| Change Control and Continuity | Procedures for changes to raw materials, process parameters, equipment, site, specification, packaging, and subcontractors. | Material changes should be assessed, documented, communicated, and approved before implementation when they may affect quality or regulatory status. | Request the change-notification policy, business-continuity plan, backup utilities, and alternative-source assessment for critical materials. | The supplier may change raw materials or production sites without advance notice. |
| Commercial Reliability | Formal quotation, agreed Incoterms, minimum order quantity, lead time, payment terms, warranty terms, and complaint-response procedure. | Commercial documents should clearly identify product grade, specification, packaging, delivery responsibilities, acceptance criteria, and remedies for nonconforming goods. | Use a signed sample order or quality agreement, conduct pre-shipment inspection, and define independent testing and claim procedures. | The supplier avoids written commitments or requests payment to an unrelated personal account. |